Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions, 7664-7889 [2012-1620]
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REGULATORY INFORMATION
SERVICE CENTER
Introduction to the Unified Agenda of
Federal Regulatory and Deregulatory
Actions
Regulatory Information Service
Center.
ACTION: Introduction to the Unified
Agenda of Federal Regulatory and
Deregulatory Actions.
AGENCY:
The Regulatory Flexibility Act
requires that agencies publish
semiannual regulatory agendas in the
Federal Register describing regulatory
actions they are developing that may
have a significant economic impact on
a substantial number of small entities (5
U.S.C. 602). Executive Order 12866
‘‘Regulatory Planning and Review,’’
signed September 30, 1993 (58 FR
51735), and Office of Management and
Budget memoranda implementing
section 4 of that Order establish
minimum standards for agencies’
agendas, including specific types of
information for each entry.
The Unified Agenda of Federal
Regulatory and Deregulatory Actions
(Unified Agenda) helps agencies fulfill
these requirements. All Federal
regulatory agencies have chosen to
publish their regulatory agendas as part
of the Unified Agenda.
Editions of the Unified Agenda prior
to fall 2007 were printed in their
entirety in the Federal Register.
Beginning with the fall 2007 edition, the
Internet is the basic means for
conveying regulatory agenda
information to the maximum extent
legally permissible. The complete
Unified Agenda for fall 2011, which
contains the regulatory agendas for 59
Federal agencies, is available to the
public at https://reginfo.gov.
The fall 2011 Unified Agenda
publication appearing in the Federal
Register consists of agency regulatory
flexibility agendas, in accordance with
the publication requirements of the
Regulatory Flexibility Act. Agency
regulatory flexibility agendas contain
only those Agenda entries for rules that
are likely to have a significant economic
impact on a substantial number of small
entities and entries that have been
selected for periodic review under
section 610 of the Regulatory Flexibility
Act.
ADDRESSES: Regulatory Information
Service Center (MI), General Services
Administration, One Constitution
Square, 1275 First Street NE., 651A,
Washington, DC 20417.
FOR FURTHER INFORMATION CONTACT: For
further information about specific
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regulatory actions, please refer to the
agency contact listed for each entry.
To provide comment on or to obtain
further information about this
publication, contact: John C. Thomas,
Executive Director, Regulatory
Information Service Center (MI),
General Services Administration, One
Constitution Square, 1275 First Street
NE., 642, Washington, DC 20417, 202
482–7340. You may also send comments
to us by email at: RISC@gsa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
Introduction to the Regulatory Plan and the
Unified Agenda of Federal Regulatory and
Deregulatory Actions
I. What Are the Regulatory Plan and the
Unified Agenda?
II. Why Are the Regulatory Plan and the
Unified Agenda Published?
III. How Are the Regulatory Plan and the
Unified Agenda Organized?
IV. What Information Appears for Each
Entry?
V. Abbreviations
VI. How Can Users Get Copies of the Plan
and the Agenda?
Introduction to the Fall 2011 Regulatory
Plan
AGENCY REGULATORY PLANS
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of Housing and Urban
Development
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Department of Veterans Affairs
Other Executive Agencies
Architectural and Transportation Barriers
Compliance Board
Environmental Protection Agency
Equal Employment Opportunity Commission
Financial Stability Oversight Council
General Services Administration
National Aeronautics and Space
Administration
National Archives and Records
Administration
Office of Personnel Management
Pension Benefit Guaranty Corporation
Small Business Administration
Social Security Administration
Independent Regulatory Agencies
Consumer Financial Protection Bureau
Consumer Product Safety Commission
Federal Trade Commission
National Indian Gaming Commission
Nuclear Regulatory Commission
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AGENCY AGENDAS
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Other Executive Agencies
Architectural and Transportation Barriers
Compliance Board
Environmental Protection Agency
General Services Administration
National Aeronautics and Space
Administration
Small Business Administration
Joint Authority
Department of Defense/General Services
Administration/National Aeronautics
and Space Administration (Federal
Acquisition Regulation)
Independent Regulatory Agencies
Consumer Financial Protection Bureau
Federal Communications Commission
Federal Deposit Insurance Corporation
Federal Reserve System
Nuclear Regulatory Commission
Securities and Exchange Commission
Introduction to the Unified Agenda of
Federal Regulatory and Deregulatory
Actions
I. What Is the Unified Agenda?
The Unified Agenda provides
information about regulations that the
Government is considering or
reviewing. The Unified Agenda has
appeared in the Federal Register twice
each year since 1983 and has been
available online since 1995. To further
the objective of using modern
technology to deliver better service to
the American people for lower cost,
beginning with the fall 2007 edition, the
Internet is the basic means for
conveying regulatory agenda
information to the maximum extent
legally permissible. The complete
Unified Agenda is available to the
public at https://reginfo.gov. The online
Unified Agenda offers flexible search
tools and will soon offer access to the
entire historic Unified Agenda database.
The fall 2011 Unified Agenda
publication appearing in the Federal
Register consists of agency regulatory
flexibility agendas, in accordance with
the publication requirements of the
Regulatory Flexibility Act. Agency
regulatory flexibility agendas contain
only those Agenda entries for rules that
are likely to have a significant economic
impact on a substantial number of small
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entities and entries that have been
selected for periodic review under
section 610 of the Regulatory Flexibility
Act. Printed entries display only the
fields required by the Regulatory
Flexibility Act. Complete agenda
information for those entries appears, in
a uniform format, in the online Unified
Agenda at https://reginfo.gov.
These publication formats meet the
publication mandates of the Regulatory
Flexibility Act and Executive Order
12866, as well as move the Agenda
process toward the goal of eGovernment, at a substantially reduced
printing cost compared with prior
editions. The current format does not
reduce the amount of information
available to the public, but it does limit
most of the content of the Agenda to
online access. The complete online
edition of the Unified Agenda includes
regulatory agendas from 59 Federal
agencies. Agencies of the United States
Congress are not included.
The following agencies have no
entries identified for inclusion in the
printed regulatory flexibility agenda. An
asterisk (*) indicates agencies that
appear in The Regulatory Plan. The
regulatory agendas of these agencies are
available to the public at https://
reginfo.gov.
Department of Housing and Urban
Development*
Department of State
Department of Veterans Affairs*
Agency for International Development
Commission on Civil Rights
Committee for Purchase From People Who
Are Blind or Severely Disabled
Corporation for National and Community
Service
Court Services and Offender Supervision
Agency for the District of Columbia
Equal Employment Opportunity
Commission*
Federal Mediation and Conciliation Service
Financial Stability Oversight Council*
Institute of Museum and Library Services
National Archives and Records
Administration*
National Endowment for the Humanities
National Science Foundation
Office of Government Ethics
Office of Management and Budget
Office of Personnel Management*
Peace Corps
Pension Benefit Guaranty Corporation*
Railroad Retirement Board
Selective Service System
Social Security Administration*
Commodity Futures Trading Commission
Consumer Product Safety Commission*
Farm Credit Administration
Federal Energy Regulatory Commission
Federal Housing Finance Agency
Federal Maritime Commission
Federal Trade Commission*
National Credit Union Administration
National Indian Gaming Commission*
National Labor Relations Board
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Postal Regulatory Commission
Surface Transportation Board
The Regulatory Information Service
Center (the Center) compiles the Unified
Agenda for the Office of Information
and Regulatory Affairs (OIRA), part of
the Office of Management and Budget.
OIRA is responsible for overseeing the
Federal Government’s regulatory,
paperwork, and information resource
management activities, including
implementation of Executive Order
12866. The Center also provides
information about Federal regulatory
activity to the President and his
Executive Office, the Congress, agency
managers, and the public.
The activities included in the Agenda
are, in general, those that will have a
regulatory action within the next 12
months. Agencies may choose to
include activities that will have a longer
timeframe than 12 months. Agency
agendas also show actions or reviews
completed or withdrawn since the last
Unified Agenda. Executive Order 12866
does not require agencies to include
regulations concerning military or
foreign affairs functions or regulations
related to agency organization,
management, or personnel matters.
Agencies prepared entries for this
publication to give the public notice of
their plans to review, propose, and issue
regulations. They have tried to predict
their activities over the next 12 months
as accurately as possible, but dates and
schedules are subject to change.
Agencies may withdraw some of the
regulations now under development,
and they may issue or propose other
regulations not included in their
agendas. Agency actions in the
rulemaking process may occur before or
after the dates they have listed. The
Unified Agenda does not create a legal
obligation on agencies to adhere to
schedules in this publication or to
confine their regulatory activities to
those regulations that appear within it.
II. Why Is the Unified Agenda
Published?
The Unified Agenda helps agencies
comply with their obligations under the
Regulatory Flexibility Act and various
Executive orders and other statutes.
Regulatory Flexibility Act
The Regulatory Flexibility Act
requires agencies to identify those rules
that may have a significant economic
impact on a substantial number of small
entities (5 U.S.C. 602). Agencies meet
that requirement by including the
information in their submissions for the
Unified Agenda. Agencies may also
indicate those regulations that they are
reviewing as part of their periodic
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review of existing rules under the
Regulatory Flexibility Act (5 U.S.C.
610). Executive Order 13272 entitled
‘‘Proper Consideration of Small Entities
in Agency Rulemaking,’’ signed August
13, 2002 (67 FR 53461), provides
additional guidance on compliance with
the Act.
Executive Order 12866
Executive Order 12866 entitled
‘‘Regulatory Planning and Review,’’
signed September 30, 1993 (58 FR
51735), requires covered agencies to
prepare an agenda of all regulations
under development or review. The
Order also requires that certain agencies
prepare annually a regulatory plan of
their ‘‘most important significant
regulatory actions,’’ which appears as
part of the fall Unified Agenda.
Executive Order 13497, signed January
30, 2009 (74 FR 6113), revoked the
amendments to Executive Order 12866
that were contained in Executive Order
13258 and Executive Order 13422.
Executive Order 13132
Executive Order 13132 entitled
‘‘Federalism,’’ signed August 4, 1999 (64
FR 43255), directs agencies to have an
accountable process to ensure
meaningful and timely input by State
and local officials in the development of
regulatory policies that have
‘‘federalism implications’’ as defined in
the Order. Under the Order, an agency
that is proposing a regulation with
federalism implications, which either
preempt State law or impose
nonstatutory unfunded substantial
direct compliance costs on State and
local governments, must consult with
State and local officials early in the
process of developing the regulation. In
addition, the agency must provide to the
Director of the Office of Management
and Budget a federalism summary
impact statement for such a regulation,
which consists of a description of the
extent of the agency’s prior consultation
with State and local officials, a
summary of their concerns and the
agency’s position supporting the need to
issue the regulation, and a statement of
the extent to which those concerns have
been met. As part of this effort, agencies
include in their submissions for the
Unified Agenda information on whether
their regulatory actions may have an
effect on the various levels of
government and whether those actions
have federalism implications.
Executive Order 13563
Executive Order 13563 entitled
‘‘Improving Regulation and Regulatory
Review,’’ signed January 18, 2011,
supplements and reaffirms the
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principles, structures, and definitions
governing contemporary regulatory
review that were established in
Executive Order 12866, which includes
the general principles of regulation and
public participation, and orders
integration and innovation in
coordination across agencies; flexible
approaches where relevant, feasible, and
consistent with regulatory approaches;
scientific integrity in any scientific or
technological information and processes
used to support the agencies’ regulatory
actions; and retrospective analysis of
existing regulations.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4, title II) requires
agencies to prepare written assessments
of the costs and benefits of significant
regulatory actions ‘‘that may result in
the expenditure by State, local, and
tribal governments, in the aggregate, or
by the private sector, of $100,000,000 or
more * * * in any 1 year * * *.’’ The
requirement does not apply to
independent regulatory agencies, nor
does it apply to certain subject areas
excluded by section 4 of the Act.
Affected agencies identify in the Unified
Agenda those regulatory actions they
believe are subject to title II of the Act.
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Executive Order 13211
Executive Order 13211 entitled
‘‘Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use,’’ signed May 18,
2001 (66 FR 28355), directs agencies to
provide, to the extent possible,
information regarding the adverse
effects that agency actions may have on
the supply, distribution, and use of
energy. Under the Order, the agency
must prepare and submit a Statement of
Energy Effects to the Administrator of
the Office of Information and Regulatory
Affairs, Office of Management and
Budget, for ‘‘those matters identified as
significant energy actions.’’ As part of
this effort, agencies may optionally
include in their submissions for the
Unified Agenda information on whether
they have prepared or plan to prepare a
Statement of Energy Effects for their
regulatory actions.
Small Business Regulatory Enforcement
Fairness Act
The Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104–
121, title II) established a procedure for
congressional review of rules (5 U.S.C.
801 et seq.), which defers, unless
exempted, the effective date of a
‘‘major’’ rule for at least 60 days from
the publication of the final rule in the
Federal Register. The Act specifies that
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a rule is ‘‘major’’ if it has resulted, or is
likely to result, in an annual effect on
the economy of $100 million or more or
meets other criteria specified in that
Act. The Act provides that the
Administrator of OIRA will make the
final determination as to whether a rule
is major.
III. How Is the Unified Agenda
Organized?
Agency regulatory flexibility agendas
are printed in a single daily edition of
the Federal Register. A regulatory
flexibility agenda is printed for each
agency whose agenda includes entries
for rules which are likely to have a
significant economic impact on a
substantial number of small entities or
rules that have been selected for
periodic review under section 610 of the
Regulatory Flexibility Act. Each printed
agenda appears as a separate part. The
parts are organized alphabetically in
four groups: Cabinet departments; other
executive agencies; the Federal
Acquisition Regulation, a joint
authority; and independent regulatory
agencies. Agencies may in turn be
divided into subagencies. Each agency’s
part of the Agenda contains a preamble
providing information specific to that
agency. Each printed agency agenda has
a table of contents listing the agency’s
printed entries that follow.
The online, complete Unified Agenda
contains the preambles of all
participating agencies. Unlike the
printed edition, the online Agenda has
no fixed ordering. In the online Agenda,
users can select the particular agencies
whose agendas they want to see. Users
have broad flexibility to specify the
characteristics of the entries of interest
to them by choosing the desired
responses to individual data fields. To
see a listing of all of an agency’s entries,
a user can select the agency without
specifying any particular characteristics
of entries.
Each entry in the Agenda is associated
with one of five rulemaking stages. The
rulemaking stages are:
1. Prerule Stage—actions agencies
will undertake to determine whether or
how to initiate rulemaking. Such actions
occur prior to a Notice of Proposed
Rulemaking (NPRM) and may include
Advance Notices of Proposed
Rulemaking (ANPRMs) and reviews of
existing regulations.
2. Proposed Rule Stage—actions for
which agencies plan to publish a Notice
of Proposed Rulemaking as the next step
in their rulemaking process or for which
the closing date of the NPRM Comment
Period is the next step.
3. Final Rule Stage—actions for which
agencies plan to publish a final rule or
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an interim final rule or to take other
final action as the next step.
4. Long-Term Actions—items under
development but for which the agency
does not expect to have a regulatory
action within the 12 months after
publication of this edition of the Unified
Agenda. Some of the entries in this
section may contain abbreviated
information.
5. Completed Actions—actions or
reviews the agency has completed or
withdrawn since publishing its last
agenda. This section also includes items
the agency began and completed
between issues of the Agenda.
Long-Term Actions are rulemakings
reported during the publication cycle
that are outside of the required 12month reporting period for which the
Agenda was intended. Completed
Actions in the publication cycle are
rulemakings that are ending their
lifecycle either by Withdrawal or
completion of the rulemaking process.
Therefore, the Long-Term and
Completed RINs do not represent the
ongoing, forward-looking nature
intended for reporting developing
rulemakings in the Agenda pursuant to
Executive Order 12866, section 4(b) and
4(c). To further differentiate these two
stages of rulemaking in the Unified
Agenda from active rulemakings, LongTerm and Completed Actions are
reported separately from active
rulemakings, which can be any of the
first three stages of rulemaking listed
above. A separate search function is
provided on reginfo.gov to search for
Completed and Long-Term Actions
apart from each other and active RINs.
A bullet (•) preceding the title of an
entry indicates that the entry is
appearing in the Unified Agenda for the
first time.
In the printed edition, all entries are
numbered sequentially from the
beginning to the end of the publication.
The sequence number preceding the
title of each entry identifies the location
of the entry in this edition. The
sequence number is used as the
reference in the printed table of
contents. Sequence numbers are not
used in the online Unified Agenda
because the unique Regulation Identifier
Number (RIN) is able to provide this
cross-reference capability.
Editions of the Unified Agenda prior
to fall 2007 contained several indexes,
which identified entries with various
characteristics. These included
regulatory actions for which agencies
believe that the Regulatory Flexibility
Act may require a Regulatory Flexibility
Analysis, actions selected for periodic
review under section 610(c) of the
Regulatory Flexibility Act, and actions
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that may have federalism implications
as defined in Executive Order 13132 or
other effects on levels of government.
These indexes are no longer compiled,
because users of the online Unified
Agenda have the flexibility to search for
entries with any combination of desired
characteristics. The online edition
retains the Unified Agenda’s subject
index based on the Federal Register
Thesaurus of Indexing Terms. In
addition, online users have the option of
searching Agenda text fields for words
or phrases.
IV. What Information Appears for Each
Entry?
All entries in the online Unified
Agenda contain uniform data elements
including, at a minimum, the following
information:
Title of the Regulation—a brief
description of the subject of the
regulation. In the printed edition, the
notation ‘‘Section 610 Review’’
following the title indicates that the
agency has selected the rule for its
periodic review of existing rules under
the Regulatory Flexibility Act (5 U.S.C.
610(c)). Some agencies have indicated
completions of section 610 reviews or
rulemaking actions resulting from
completed section 610 reviews. In the
online edition, these notations appear in
a separate field.
Priority—an indication of the
significance of the regulation. Agencies
assign each entry to one of the following
five categories of significance.
(1) Economically Significant
As defined in Executive Order 12866,
a rulemaking action that will have an
annual effect on the economy of $100
million or more or will adversely affect
in a material way the economy, a sector
of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
or tribal governments or communities.
The definition of an ‘‘economically
significant’’ rule is similar but not
identical to the definition of a ‘‘major’’
rule under 5 U.S.C. 801 (Pub. L. 104–
121). (See below.)
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(2) Other Significant
A rulemaking that is not
Economically Significant but is
considered Significant by the agency.
This category includes rules that the
agency anticipates will be reviewed
under Executive Order 12866 or rules
that are a priority of the agency head.
These rules may or may not be included
in the agency’s regulatory plan.
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(3) Substantive, Nonsignificant
A rulemaking that has substantive
impacts but is neither Significant, nor
Routine and Frequent, nor
Informational/Administrative/Other.
(4) Routine and Frequent
A rulemaking that is a specific case of
a multiple recurring application of a
regulatory program in the Code of
Federal Regulations and that does not
alter the body of the regulation.
(5) Informational/Administrative/Other
A rulemaking that is primarily
informational or pertains to agency
matters not central to accomplishing the
agency’s regulatory mandate but that the
agency places in the Unified Agenda to
inform the public of the activity.
Major—whether the rule is ‘‘major’’
under 5 U.S.C. 801 (Pub. L. 104–121)
because it has resulted or is likely to
result in an annual effect on the
economy of $100 million or more or
meets other criteria specified in that
Act. The Act provides that the
Administrator of the Office of
Information and Regulatory Affairs will
make the final determination as to
whether a rule is major.
Unfunded Mandates—whether the
rule is covered by section 202 of the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4). The Act requires that,
before issuing an NPRM likely to result
in a mandate that may result in
expenditures by State, local, and tribal
governments, in the aggregate, or by the
private sector of more than $100 million
in 1 year, agencies, other than
independent regulatory agencies, shall
prepare a written statement containing
an assessment of the anticipated costs
and benefits of the Federal mandate.
Legal Authority—the section(s) of the
United States Code (U.S.C.) or Public
Law (Pub. L.) or the Executive order
(E.O.) that authorize(s) the regulatory
action. Agencies may provide popular
name references to laws in addition to
these citations.
CFR Citation—the section(s) of the
Code of Federal Regulations that will be
affected by the action.
Legal Deadline—whether the action is
subject to a statutory or judicial
deadline, the date of that deadline, and
whether the deadline pertains to an
NPRM, a Final Action, or some other
action.
Abstract—a brief description of the
problem the regulation will address; the
need for a Federal solution; to the extent
available, alternatives that the agency is
considering to address the problem; and
potential costs and benefits of the
action.
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Timetable—the dates and citations (if
available) for all past steps and a
projected date for at least the next step
for the regulatory action. A date
displayed in the form 12/00/11 means
the agency is predicting the month and
year the action will take place but not
the day it will occur. In some instances,
agencies may indicate what the next
action will be, but the date of that action
is ‘‘To Be Determined.’’ ‘‘Next Action
Undetermined’’ indicates the agency
does not know what action it will take
next.
Regulatory Flexibility Analysis
Required—whether an analysis is
required by the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) because the
rulemaking action is likely to have a
significant economic impact on a
substantial number of small entities as
defined by the Act.
Small Entities Affected—the types of
small entities (businesses, governmental
jurisdictions, or organizations) on which
the rulemaking action is likely to have
an impact as defined by the Regulatory
Flexibility Act. Some agencies have
chosen to indicate likely effects on
small entities even though they believe
that a Regulatory Flexibility Analysis
will not be required.
Government Levels Affected—whether
the action is expected to affect levels of
government and, if so, whether the
governments are State, local, tribal, or
Federal.
International Impacts—whether the
regulation is expected to have
international trade and investment
effects, or otherwise may be of interest
to the Nation’s international trading
partners.
Federalism—whether the action has
‘‘federalism implications’’ as defined in
Executive Order 13132. This term refers
to actions ‘‘that have substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
Independent regulatory agencies are not
required to supply this information.
Included in the Regulatory Plan—
whether the rulemaking was included in
the agency’s current regulatory plan
published in fall 2010.
Agency Contact—the name and phone
number of at least one person in the
agency who is knowledgeable about the
rulemaking action. The agency may also
provide the title, address, fax number,
email address, and TDD for each agency
contact.
Some agencies have provided the
following optional information:
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RIN Information URL—the Internet
address of a site that provides more
information about the entry.
Public Comment URL—the Internet
address of a site that will accept public
comments on the entry. Alternatively,
timely public comments may be
submitted at the Governmentwide erulemaking site, https://
www.regulations.gov.
Additional Information—any
information an agency wishes to include
that does not have a specific
corresponding data element.
Compliance Cost to the Public—the
estimated gross compliance cost of the
action.
Affected Sectors—the industrial
sectors that the action may most affect,
either directly or indirectly. Affected
sectors are identified by North
American Industry Classification
System (NAICS) codes.
Energy Effects—an indication of
whether the agency has prepared or
plans to prepare a Statement of Energy
Effects for the action, as required by
Executive Order 13211 ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use,’’ signed May 18,
2001 (66 FR 28355).
Related RINs—one or more past or
current RIN(s) associated with activity
related to this action, such as merged
RINs, split RINs, new activity for
previously completed RINs, or duplicate
RINs.
Some agencies that participated in the
fall 2010 edition of The Regulatory Plan
have chosen to include the following
information for those entries that
appeared in the Plan:
Statement of Need—a description of
the need for the regulatory action.
Summary of the Legal Basis—a
description of the legal basis for the
action, including whether any aspect of
the action is required by statute or court
order.
Alternatives—a description of the
alternatives the agency has considered
or will consider as required by section
4(c)(1)(B) of Executive Order 12866.
Anticipated Costs and Benefits—a
description of preliminary estimates of
the anticipated costs and benefits of the
action.
Risks—a description of the magnitude
of the risk the action addresses, the
amount by which the agency expects the
action to reduce this risk, and the
relation of the risk and this risk
reduction effort to other risks and risk
reduction efforts within the agency’s
jurisdiction.
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V. Abbreviations
The following abbreviations appear
throughout this publication:
ANPRM—An Advance Notice of
Proposed Rulemaking is a preliminary
notice, published in the Federal
Register, announcing that an agency is
considering a regulatory action. An
agency may issue an ANPRM before it
develops a detailed proposed rule. An
ANPRM describes the general area that
may be subject to regulation and usually
asks for public comment on the issues
and options being discussed. An
ANPRM is issued only when an agency
believes it needs to gather more
information before proceeding to a
notice of proposed rulemaking.
CFR—The Code of Federal
Regulations is an annual codification of
the general and permanent regulations
published in the Federal Register by the
agencies of the Federal Government.
The Code is divided into 50 titles, each
title covering a broad area subject to
Federal regulation. The CFR is keyed to
and kept up to date by the daily issues
of the Federal Register.
EO—An Executive order is a directive
from the President to Executive
agencies, issued under constitutional or
statutory authority. Executive orders are
published in the Federal Register and in
title 3 of the Code of Federal
Regulations.
FR—The Federal Register is a daily
Federal Government publication that
provides a uniform system for
publishing Presidential documents, all
proposed and final regulations, notices
of meetings, and other official
documents issued by Federal agencies.
FY—The Federal fiscal year runs from
October 1 to September 30.
NPRM—A Notice of Proposed
Rulemaking is the document an agency
issues and publishes in the Federal
Register that describes and solicits
public comments on a proposed
regulatory action. Under the
Administrative Procedure Act (5 U.S.C.
553), an NPRM must include, at a
minimum:
• A statement of the time, place, and
nature of the public rulemaking
proceeding;
• A reference to the legal authority
under which the rule is proposed; and
• Either the terms or substance of the
proposed rule or a description of the
subjects and issues involved.
PL (or Pub. L.)—A public law is a law
passed by Congress and signed by the
President or enacted over his veto. It has
general applicability, unlike a private
law that applies only to those persons
or entities specifically designated.
Public laws are numbered in sequence
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throughout the 2-year life of each
Congress; for example, Pub. L. 112–4 is
the fourth public law of the 112th
Congress.
RFA—A Regulatory Flexibility
Analysis is a description and analysis of
the impact of a rule on small entities,
including small businesses, small
governmental jurisdictions, and certain
small not-for-profit organizations. The
Regulatory Flexibility Act (5 U.S.C. 601
et seq.) requires each agency to prepare
an initial RFA for public comment when
it is required to publish an NPRM and
to make available a final RFA when the
final rule is published, unless the
agency head certifies that the rule
would not have a significant economic
impact on a substantial number of small
entities.
RIN—The Regulation Identifier
Number is assigned by the Regulatory
Information Service Center to identify
each regulatory action listed in the
Unified Agenda, as directed by
Executive Order 12866 (section 4(b)).
Additionally, OMB has asked agencies
to include RINs in the headings of their
Rule and Proposed Rule documents
when publishing them in the Federal
Register, to make it easier for the public
and agency officials to track the
publication history of regulatory actions
throughout their development.
Seq. No.—The sequence number
identifies the location of an entry in the
printed edition of the Unified Agenda.
Note that a specific regulatory action
will have the same RIN throughout its
development but will generally have
different sequence numbers if it appears
in different printed editions of the
Unified Agenda. Sequence numbers are
not used in the online Unified Agenda.
U.S.C.—The United States Code is a
consolidation and codification of all
general and permanent laws of the
United States. The U.S.C. is divided into
50 titles, each title covering a broad area
of Federal law.
VI. How Can Users Get Copies of the
Agenda?
Copies of the Federal Register issue
containing the printed edition of the
Unified Agenda (agency regulatory
flexibility agendas) are available from
the Superintendent of Documents, U.S.
Government Printing Office, P.O. Box
371954, Pittsburgh, PA 15250–7954.
Telephone: 202 512–1800 or 1 866 512–
1800 (toll-free).
Copies of individual agency materials
may be available directly from the
agency or may be found on the agency’s
Web site. Please contact the particular
agency for further information.
All editions of The Regulatory Plan
and the Unified Agenda of Federal
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Regulatory and Deregulatory Actions
since fall 1995 are available in
electronic form at https://reginfo.gov,
along with flexible search tools.
In accordance with regulations for the
Federal Register, the Government
Printing Office’s GPO FDsys Web site
contains copies of the Agendas and
Regulatory Plans that have been printed
in the Federal Register. These
documents are available at https://
www.fdsys.gov.
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Dated: December 19, 2011.
John C. Thomas,
Director.
Introduction to the Fall 2011
Regulatory Plan
Executive Order 12866, issued in
1993, requires the annual production of
a Unified Regulatory Agenda and
Regulatory Plan. It does so to promote
transparency—or in the words of the
Executive Order itself, ‘‘to have an
effective regulatory program, to provide
for coordination of regulations, to
maximize consultation and the
resolution of potential conflicts at an
early stage, to involve the public and its
State, local, and tribal officials in
regulatory planning, and to ensure that
new or revised regulations promote the
President’s priorities and the principles
set forth in this Executive order.’’
The requirements of Executive Order
12866 were reaffirmed in Executive
Order 13563, issued in 2011. Consistent
with Executive Orders 13563 and 12866,
we are now providing the Unified
Regulatory Agenda and the Regulatory
Plan for public scrutiny and review.
Such scrutiny and review are closely
connected with the general goal, central
to Executive Order 13563, of promoting
public participation in the rulemaking
process.
It is important to understand that the
Agenda and Plan are intended merely to
serve as a preliminary statement, for
public understanding and assessment,
of regulatory and deregulatory policies
and priorities that are now under
contemplation. This preliminary
statement often includes a number of
rules that are not issued in the following
year and that may well not be issued at
all. This year, we have taken several
new steps to clarify the purposes and
uses of the Agenda and Plan and to
improve its presentation. Among other
things, we have narrowed the list of
‘‘active rulemakings’’ to rules that are
not merely under some form of
contemplation but that also have at least
some possibility of issuance over the
next year. We have also made it easier
to understand which rules are active
rulemakings rather than long-term
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actions or completed actions. But it
remains true that rules on this list,
designed among other things ‘‘to involve
the public and its State, local, and tribal
officials in regulatory planning,’’ must
undergo serious internal and external
scrutiny before they are issued—and
that there are rules on the list that may
never be issued.
In this light, it should be clear that
this preliminary statement of policies
and priorities has extremely important
limitations. No regulatory action can be
made effective until it has gone through
legally required processes, including
those that involve public scrutiny and
review. For this reason, the inclusion of
a regulatory action here does not
necessarily mean that it will be finalized
or even proposed. Any proposed or final
action must satisfy the requirements of
relevant statutes, Executive Orders, and
Presidential Memoranda. Those
requirements, public comments, and
new information may or may not lead
an agency to go forward with an action
that is currently under contemplation
and that is included here. For example,
the directives of Executive Order 13563,
emphasizing the importance of careful
consideration of costs and benefits, may
lead an agency to decline to proceed
with a regulatory action that is
presented here.
It is also important to note that under
Executive Order 12866, whether a
regulation counts as ‘‘economically
significant’’ is not an adequate measure
of whether it imposes high costs on the
private sector. Economically significant
actions may impose small costs or even
no costs. For example, regulations may
count as economically significant not
because they impose significant costs,
but because they confer large benefits.
Moreover, many regulations count as
economically significant not because
they impose significant regulatory costs
on the private sector, but because they
involve transfer payments as required or
authorized by law.
It should be observed that the number
of economically significant actions
listed as under active consideration
here—138—is lower than the
corresponding figure for Spring 2011
(149) and for Fall 2010 (140). It is
notable that the number of such rules
has not grown even taking account of
rules implementing the Affordable Care
Act and the Wall Street Reform and
Consumer Protection Act. We also note
that the net benefits of regulation were
unusually high in Fiscal Year 2011 (well
over $50 billion for the year alone). In
addition, the aggregate costs for that
year (under $8 billion) were lower than
in Fiscal Year 2010 and were not out of
line with those in recent years,
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including during the Bush
Administration.
With these notes and qualifications,
the Regulatory Plan provides a list of
important regulatory actions that are
now under contemplation for issuance
in proposed or final form during the
upcoming fiscal year. In contrast, the
Unified Agenda is a more inclusive list,
including numerous ministerial actions
and routine rulemakings, as well as
long-term initiatives that agencies do
not plan to complete in the coming year.
We hope that public scrutiny of the
Regulatory Plan and the Unified Agenda
might help ensure, in the words of
Executive Order 13563, a regulatory
system that protects ‘‘public health,
welfare, safety, and our environment
while promoting economic growth,
innovation, competitiveness, and job
creation.’’
As discussed below, a large number of
significant recent steps have been taken,
consistent with Executive Order 13563,
to reduce regulatory costs and ensure
that our regulatory system is consistent
with promoting growth and job creation.
At the same time, a number of steps
have been taken to promote public
health, welfare, safety, and our
environment. It is important to
emphasize that the net benefits of recent
rules, including the monetized benefits,
are high—over the first two fiscal years
of this Administration, in excess of $35
billion. Rules have been issued and
initiatives have been undertaken that
are saving lives on the highways and in
workplaces; reducing air and water
pollution, preventing thousands of
deaths in the process; increasing fuel
economy, thus saving money while
reducing pollution; making both trains
and planes safer; increasing energy
efficiency, saving billions of dollars
while increasing energy security;
combating childhood obesity; and
creating a ‘‘race to the top’’ in
education. Consider, as merely one
example, the fact that in 2010, the rates
of roadway fatalities and injuries fell to
their lowest recorded levels and to their
lowest numbers since 1949. The
decrease is attributable, in part, to a
range of regulatory actions and to
private-public partnerships that have
increased safety.
Since President Reagan’s Executive
Order 12291, issued in 1981, a principal
focus of the Office of Information and
Regulatory Affairs, and of regulatory
policy in general, has been on
maximizing net benefits. In this
Administration, agencies and OMB have
worked together to issue a number of
rules for which the benefits exceed the
costs, and by a large margin. Consider
the following figure:
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These figures reflect the numbers for
2009 and 2010. As noted, the net
benefits for 2011 are expected to be
unusually high (in excess of $50
billion); they will be discussed in detail
in the 2012 Report to Congress on the
Benefits and Costs of Federal
Regulations.
The recent steps build on a great deal
of new learning about regulation. As a
result of conceptual and empirical
advances, we know far more than
during the New Deal and the Great
Society. We have also learned much
since the 1980s and 1990s. These
lessons have informed the
Administration’s efforts to protect
public health and safety while also
promoting economic growth and job
creation. Eight points are particularly
important:
1. We are now equipped with state-ofthe-art techniques for anticipating,
cataloguing, and monetizing the
consequences of regulation, including
both benefits and costs.
2. We know that risks are part of
systems, and that efforts to reduce a
certain risk may increase other risks,
perhaps even deadly ones, thus
producing ancillary harms—and that
efforts to reduce a certain risk may
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reduce other risks, perhaps even deadly
ones, thus producing ancillary benefits.
3. We know that flexible, innovative
approaches, maintaining freedom of
choice and respecting heterogeneity and
the fact that one size may not fit all, are
often desirable, both because they
preserve liberty and because they
frequently cost less.
4. We know that large benefits can
come from seemingly modest and small
steps, including simplification of
regulatory requirements, provision of
information, and sensible default rules,
such as automatic enrollment for
retirement savings.
5. We know, more clearly than ever
before, that it is important to allow
public participation in the design of
rules, because members of the public
have valuable information about likely
effects, existing problems, creative
solutions, and possible unintended
consequences.
6. We know that if carefully designed,
disclosure policies can promote
informed choices and save both money
and lives.
7. We know that intuitions and
anecdotes are unreliable, and that
advance testing of the effects of rules, as
through pilot programs or randomized
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controlled experiments, can be highly
illuminating.
8. We know that it is important to
explore the effects of regulation in the
real world, to learn whether they are
having beneficial consequences or
producing unintended harm. We need
to consult, and to learn from, those who
are affected by rules.
Executive Order 13563 draws on these
understandings and emphasizes the
importance of protecting ‘‘public health,
welfare, safety, and our environment
while promoting economic growth,
innovation, competitiveness, and job
creation.’’ Executive Order 13563
explicitly points to the need for
predictability and for certainty, and for
use of the least burdensome tools for
achieving regulatory ends. It indicates
that agencies ‘‘must take into account
benefits and costs, both quantitative and
qualitative.’’ It explicitly draws
attention to the need to measure and to
improve ‘‘the actual results of regulatory
requirements’’—a clear reference to the
importance of retrospective evaluation.
Executive Order 13563 reaffirms the
principles, structures, and definitions in
Executive Order 12866, which has long
governed regulatory review. In addition,
it endorses, and quotes, a number of
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provisions of that Executive Order that
specifically emphasize the importance
of considering costs—including the
requirement that to the extent permitted
by law, agencies should not proceed in
the absence of a reasoned determination
that the benefits justify the costs.
Importantly, Executive Order 13563
directs agencies ‘‘to use the best
available techniques to quantify
anticipated present and future benefits
and costs as accurately as possible.’’
This direction reflects a strong emphasis
on quantitative analysis as a means of
improving regulatory choices and
increasing transparency.
Among other things, Executive Order
13563 sets out five sets of requirements
to guide regulatory decision making:
• Public participation. Agencies are
directed to promote public
participation, in part by making
supporting documents available on
Regulations.gov in order to promote
transparency and public comment.
Executive Order 13563 also directs
agencies, where feasible and
appropriate, to engage the public,
including affected stakeholders, before
rulemaking is initiated.
• Integration and innovation.
Agencies are directed to attempt to
reduce ‘‘redundant, inconsistent, or
overlapping’’ requirements, in part by
working with one another to simplify
and harmonize rules. This important
provision is designed to reduce
confusion, redundancy, and excessive
cost. An important goal of simplification
and harmonization is to promote rather
than to hamper innovation, which is a
foundation of both growth and job
creation. Different offices within the
same agency might work together to
harmonize their rules; different agencies
might work together to achieve the same
objective. Such steps can also promote
predictability and certainty.
• Flexible approaches. Agencies are
directed to identify and consider
flexible approaches to regulatory
problems, including warnings,
appropriate default rules, and disclosure
requirements. Such approaches may
‘‘reduce burdens and maintain
flexibility and freedom of choice for the
public.’’ In certain settings, they may be
far preferable to mandates and bans,
precisely because they maintain
freedom of choice and reduce costs. The
reference to ‘‘appropriate default rules’’
signals the possibility that important
social goals can be obtained through
simplification—as, for example, in the
form of automatic enrollment, direct
certification, or reduced paperwork
burdens.
• Science. Agencies are directed to
promote scientific integrity, and in a
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way that ensures a clear separation
between judgments of science and
judgments of policy.
• Retrospective analysis of existing
rules. Agencies are directed to produce
preliminary plans to engage in
retrospective analysis of existing
significant regulations to determine
whether they should be modified,
streamlined, expanded, or repealed.
Executive Order 13563 addresses both
the ‘‘flow’’ of new regulations that are
under development and the ‘‘stock’’ of
existing regulations that are already in
place. Executive Order 13563
emphasizes the importance of
promoting predictability, of carefully
considering costs, of choosing the least
burdensome approach, and of selecting
the most flexible, least costly tools. In
addition, Executive Order 13563 calls
for careful reassessment, based on
empirical analysis. It is understood that
the prospective analysis required by
Executive Order 13563 may depend on
a degree of speculation and that the
actual costs and benefits of a regulation
may be lower or higher than what was
anticipated when the rule was originally
developed. It is also understood that
circumstances may change in a way that
requires reconsideration of regulatory
requirements. After retrospective
analysis has been undertaken, agencies
will be in a position to reevaluate
existing rules and to streamline, modify,
or eliminate those that do not make
sense in their current form.
In August 2011, over two dozen
agencies released final plans to remove
what the President has called
unjustified rules and ‘‘absurd and
unnecessary paperwork requirements
that waste time and money.’’ Over the
next five years, billions of dollars in
savings are anticipated from just a few
initiatives from the Department of
Transportation, the Department of
Labor, the Department of Health and
Human Services, and the Environmental
Protection Agency. And all in all, the
plans’ initiatives will save tens of
millions of hours in annual paperwork
burdens on individuals, businesses, and
state and local governments.
The plans span over 800 pages and
offer more than 500 proposals. Some
plans list well over 50 reforms. Many of
the proposals focus on small business.
Indeed, a number of the initiatives are
specifically designed to reduce burdens
on small business and to enable them to
do what they do best, which is to create
jobs. Some of the proposed initiatives
represent a fundamental rethinking of
how things have long been done—as, for
example, with numerous efforts to move
from paper to electronic reporting. For
both private and public sectors, those
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efforts can save a great deal of money.
Over the next five years, the Department
of Treasury’s paperless initiative will be
saving $400 million and 12 million
pounds of paper.
Many of the reforms will have a
significant economic impact:
• The Occupational Safety and Health
Administration has announced a final
rule that will remove over 1.9 million
annual hours of redundant reporting
burdens on employers and save more
than $40 million in annual costs.
Businesses will no longer be saddled
with the obligation to fill out
unnecessary government forms,
meaning that their employees will have
more time to be productive and do their
real work.
• To eliminate unjustified economic
burdens on railroads, the Department of
Transportation is reconsidering parts of
a rule that requires railroads to install
equipment on trains. DOT has proposed
to refine the requirements so that the
equipment is installed only where it is
really needed on grounds of safety. DOT
expects initial savings of up to $325
million, with total 20-year savings of up
to $755 million.
• EPA has proposed to eliminate the
obligation for many states to require air
pollution vapor recovery systems at
local gas stations, on the ground that
modern vehicles already have effective
air pollution control technologies. The
anticipated annual savings are $87
million.
• The Departments of Commerce and
State are undertaking a series of steps to
eliminate unnecessary barriers to
exports, including duplicative and
unnecessary regulatory requirements,
thus reducing the cumulative burden
and uncertainty faced by American
companies and their trading partners.
These steps will make it a lot easier for
American companies to reach new
markets, increasing our exports while
creating jobs here at home.
• To promote flexibility, the
Department of Health and Human
Services has proposed two rules, and
finalized another, to reduce burdensome
regulatory requirements now placed on
hospitals and doctors. These reforms are
expected to save more than $1 billion
annually.
The regulatory lookback is not merely
a one-time exercise. Regular reporting,
about recent progress and coming
initiatives, is required. The goal is to
change the regulatory culture to ensure
that rules on the books are reevaluated
and are effective, cost-justified, and
based on the best available science. By
creating regulatory review teams at
agencies, we will continue to examine
what is working and what is not and to
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eliminate unjustified and outdated
regulations.
In addition to looking back at existing
regulations, we are looking forward to
ensure that future regulations are welljustified. Executive Order 13563
provides critical guidance with its
emphasis on careful consideration of
costs and benefits, public participation,
integration and innovation, flexible
approaches, and science. These
requirements are meant to produce a
regulatory system that draws on recent
learning, that is driven by evidence, and
that is suited to the distinctive
circumstances of the twenty-first
century.
DEPARTMENT OF AGRICULTURE
Regulation
Identifier No.
Sequence No.
Title
1 ........................
2 ........................
Wholesale Pork Reporting Program .........................................................................
National Organic Program: Sunset Review for Nutrient Vitamins and Minerals
(NOP–10–0083).
Animal Welfare; Regulations and Standards for Birds ............................................
Plant Pest Regulations; Update of General Provisions ...........................................
Importation of Live Dogs ..........................................................................................
Animal Disease Traceability .....................................................................................
Supplemental Nutrition Assistance Program: Farm Bill of 2008 Retailer Sanctions
National School Lunch and School Breakfast Programs: Nutrition Standards for
All Foods Sold in School, as Required by the Healthy, Hunger-Free Kids Act of
2010.
WIC: Electronic Benefit Transfer (EBT) Implementation .........................................
Nutrition Standards in the National School Lunch and School Breakfast Programs
Direct Certification of Children in Food Stamp Households and Certification of
Homeless, Migrant, and Runaway Children for Free Meals.
Eligibility, Certification, and Employment and Training Provisions of the Food,
Conservation, and Energy Act of 2008.
Supplemental Nutrition Assistance Program: Nutrition Education and Obesity Prevention Grant.
Prior Labeling Approval System: Generic Label Approval .......................................
Product Labeling: Use of the Voluntary Claim ‘‘Natural’’ on the Labeling of Meat
and Poultry Products.
New Poultry Slaughter Inspection ............................................................................
Electronic Imported Product Inspection Application and Certification of Imported
Product and Foreign Establishments; Amendments to Facilitate the Public
Health Information System (PHIS).
Electronic Export Application and Certification as a Reimbursable Service and
Flexibility in the Requirements for Official Export Inspection Marks, Devices,
and Certificates.
Performance Standards for the Production of Processed Meat and Poultry Products; Control of Listeria Monocytogenes in Ready-To-Eat Meat and Poultry
Products.
Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments.
3
4
5
6
7
8
........................
........................
........................
........................
........................
........................
9 ........................
10 ......................
11 ......................
12 ......................
13 ......................
14 ......................
15 ......................
16 ......................
17 ......................
18 ......................
19 ......................
20 ......................
Rulemaking Stage
0581–AD07
0581–AD17
Proposed Rule Stage.
Proposed Rule Stage.
0579–AC02
0579–AC98
0579–AD23
0579–AD24
0584–AD88
0584–AE09
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
0584–AE21
0584–AD59
0584–AD60
Proposed Rule Stage.
Final Rule Stage.
Final Rule Stage.
0584–AD87
Final Rule Stage.
0584–AE07
Final Rule Stage.
0583–AC59
0583–AD30
Proposed Rule Stage.
Proposed Rule Stage.
0583–AD32
0583–AD39
Proposed Rule Stage.
Proposed Rule Stage.
0583–AD41
Proposed Rule Stage.
0583–AC46
Final Rule Stage.
0583–AD34
Final Rule Stage.
DEPARTMENT OF COMMERCE
Regulation
Identifier No.
Sequence No.
Title
21 ......................
Revisions to the Export Administration Regulations (EAR): Control of Military Vehicles and Related Items That the President Determines do not Warrant Control on the United States Munitions List.
Fishery Management Plan for Regulating Offshore Marine Aquaculture in the
Gulf of Mexico.
Reducing Disturbances to Hawaiian Spinner Dolphins From Human Interactions
Designation of Critical Habitat for the North Atlantic Right Whale ..........................
Regulatory Amendments To Implement the Shark Conservation Act and Revise
the Definition of Illegal, Unreported, and Unregulated Fishing.
22 ......................
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23 ......................
24 ......................
25 ......................
Rulemaking
Stage
0694–AF17
Final Rule Stage.
0648–AS65
Proposed Rule Stage.
0648–AU02
0648–AY54
0648–BA89
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
DEPARTMENT OF EDUCATION
Regulation
Identifier No.
Sequence No.
Title
26 ......................
Title IV of the Higher Education Act of 1965, as Amended .....................................
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Proposed Rule Stage.
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DEPARTMENT OF ENERGY
Sequence No.
27
28
29
30
......................
......................
......................
......................
31 ......................
Regulation
Identifier No.
Title
Energy Efficiency Standards for Battery Chargers and External Power Supplies ..
Energy Conservation Standards for Walk-In Coolers and Walk-In Freezers ..........
Energy Efficiency Standards for Manufactured Housing .........................................
Energy Conservation Standards for ER, BR, and Small Diameter Incandescent
Reflector Lamps.
Energy Efficiency Standards for Fluorescent Lamp Ballasts ...................................
Rulemaking Stage
1904–AB57
1904–AB86
1904–AC11
1904–AC15
Proposed
Proposed
Proposed
Proposed
Rule
Rule
Rule
Rule
Stage.
Stage.
Stage.
Stage.
1904–AB50
Final Rule Stage.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Regulation
Identifier No.
Sequence No.
Title
32 ......................
Health Information Technology: New and Revised Standards, Implementation
Specifications, and Certification Criteria for Electronic Health Record Technology.
Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals.
Unique Device Identification .....................................................................................
Produce Safety Regulation .......................................................................................
Hazard Analysis and Risk-Based Preventive Controls ............................................
Foreign Supplier Verification Program .....................................................................
Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes.
Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors.
Medical Device Reporting; Electronic Submission Requirements ...........................
Electronic Registration and Listing for Devices .......................................................
Food Labeling: Nutrition Labeling for Food Sold in Vending Machines ..................
Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and
Similar Retail Food Establishments.
Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS–3244–P).
Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS–9070–P).
Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS–1589–P).
Revisions to Payment Policies Under the Physician Fee Schedule and Part B for
CY 2013 (CMS–1590–P).
Changes to the Hospital Inpatient an Long-Term Care Prospective Payment System for FY 2013 (CMS–1588–P).
Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS–
2349–F).
Establishment of Exchanges and Qualified Health Plans Part I (CMS–9989–F) ....
State Requirements for Exchange—Reinsurance and Risk Adjustments (CMS–
9975–F).
33 ......................
34 ......................
35
36
37
38
39
......................
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40 ......................
41
42
43
44
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45 ......................
46 ......................
47 ......................
48 ......................
49 ......................
50 ......................
51 ......................
52 ......................
Rulemaking Stage
0991–AB82
Proposed Rule Stage.
0910–AC52
Proposed Rule Stage.
0910–AG10
Proposed Rule Stage.
0910–AG31
0910–AG35
0910–AG36
0910–AG64
0910–AG66
Proposed
Proposed
Proposed
Proposed
Proposed
0910–AF27
Final Rule Stage.
0910–AF86
0910–AF88
0910–AG56
0910–AG57
Final
Final
Final
Final
0938–AQ89
Proposed Rule Stage.
0938–AQ96
Proposed Rule Stage.
0938–AR10
Proposed Rule Stage.
0938–AR11
Proposed Rule Stage.
0938–AR12
Proposed Rule Stage.
0938–AQ62
Final Rule Stage.
0938–AQ67
0938–AR07
Final Rule Stage.
Final Rule Stage.
Rule
Rule
Rule
Rule
Rule
Rule
Rule
Rule
Rule
Stage.
Stage.
Stage.
Stage.
Stage.
Stage.
Stage.
Stage.
Stage.
DEPARTMENT OF HOMELAND SECURITY
Regulation
Identifier No.
Sequence No.
Title
53 ......................
54 ......................
55 ......................
Secure Handling of Ammonium Nitrate Program .....................................................
Asylum and Withholding Definitions .........................................................................
New Classification for Victims of Criminal Activity; Eligibility for the U Nonimmigrant Status.
Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected
Status, and Withholding of Removal.
Electronic Filing of Requests for Immigration Benefits; Requiring an Application
To Change or Extend Nonimmigrant Status To Be Filed Electronically.
Immigration Benefits Business Transformation: Nonimmigrants; Student and Exchange Visitor Program.
Application of the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 to Unaccompanied Alien Children Seeking Asylum.
Administrative Appeals Office: Procedural Reforms To Improve Efficiency ............
New Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T Nonimmigrant Status.
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57 ......................
58 ......................
59 ......................
60 ......................
61 ......................
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Rulemaking Stage
1601–AA52
1615–AA41
1615–AA67
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
1615–AB89
Proposed Rule Stage.
1615–AB94
Proposed Rule Stage.
1615–AB95
Proposed Rule Stage.
1615–AB96
Proposed Rule Stage.
1615–AB98
1615–AA59
Proposed Rule Stage.
Final Rule Stage.
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DEPARTMENT OF HOMELAND SECURITY—Continued
Regulation
Identifier No.
Sequence No.
Title
62 ......................
Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status.
Application of Immigration Regulations to the Commonwealth of the Northern
Mariana Islands.
Implementation of the 1995 Amendments to the International Convention on
Standards of Training, Certification, and Watchkeeping (STCW) for Seafarers,
1978.
Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System.
Nontank Vessel Response Plans and Other Vessel Response Plan Requirements.
Offshore Supply Vessels of At Least 6000 GT ITC .................................................
Revision to Transportation Worker Identification Credential (TWIC) Requirements
for Mariners.
Importer Security Filing and Additional Carrier Requirements ................................
Changes to the Visa Waiver Program To Implement the Electronic System for
Travel Authorization (ESTA) Program.
Establishment of Global Entry Program ...................................................................
Implementation of the Guam-CNMI Visa Waiver Program ......................................
General Aviation Security and Other Aircraft Operator Security .............................
Freight Railroads, Public Transportation and Passenger Railroads, and Over-theRoad Buses—Security Training of Employees.
Freight Railroads and Passenger Railroads—Vulnerability Assessment and Security Plan.
Standardized Vetting, Adjudication, and Redress Services .....................................
Aircraft Repair Station Security ................................................................................
Continued Detention of Aliens Subject to Final Orders of Removal .......................
Continued Detention of Aliens Subject to Final Orders of Removal .......................
Extending Period for Optional Practical Training by 17 Months for F–1 Nonimmigrant Students With STEM Degrees and Expanding the CAP–GAP Relief
for All F–1 Students With Pending H–1B Petitions.
Update of FEMA’s Public Assistance Regulations ..................................................
63 ......................
64 ......................
65 ......................
66 ......................
67 ......................
68 ......................
69 ......................
70 ......................
71
72
73
74
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75 ......................
76
77
78
79
80
......................
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81 ......................
Rulemaking Stage
1615–AA60
Final Rule Stage.
1615–AB77
Final Rule Stage.
1625–AA16
Final Rule Stage.
1625–AA99
Final Rule Stage.
1625–AB27
Final Rule Stage.
1625–AB62
1625–AB80
Final Rule Stage.
Final Rule Stage.
1651–AA70
1651–AA72
Final Rule Stage.
Final Rule Stage.
1651–AA73
1651–AA77
1652–AA53
1652–AA55
Final Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
1652–AA56
Proposed Rule Stage.
1652–AA61
1652–AA38
1653–AA60
1653–AA13
1653–AA56
Proposed Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Final Rule Stage.
1660–AA51
Proposed Rule Stage.
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
Regulation
Identifier No.
Sequence No.
Title
82 ......................
Federal Housing Administration (FHA): Strengthening the Home Equity Conversion Mortgages (HECM) Program to Promote Sustained Homeownership (FR–
5353).
Supportive Housing for Persons With Disabilities Implementing New Project
Rental Assistance Authority (FR–5576).
Tenant-Based Rental Assistance; Improving Performance Through a Strengthened Section 8 Management Assessment Program (FR–5201).
83 ......................
84 ......................
Rulemaking Stage
2502–AI79
Proposed Rule Stage.
2502–AJ10
Proposed Rule Stage.
2577–AC76
Proposed Rule Stage.
DEPARTMENT OF JUSTICE
Regulation
Identifier No.
Sequence No.
Title
85 ......................
National Standards to Prevent, Detect, and Respond to Prison Rape ...................
1105–AB34
Rulemaking Stage
Final Rule Stage.
DEPARTMENT OF LABOR
Regulation
Identifier No.
Title
86 ......................
87 ......................
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Construction Contractors’ Affirmative Action Requirements ....................................
Persuader Agreements: Employer and Labor Relations Consultant Reporting
Under the LMRDA.
Equal Employment Opportunity in Apprenticeship Amendment of Regulations ......
Labor Certification Process and Enforcement for Temporary Employment in Occupations Other Than Agriculture or Registered Nursing in the United States
(H–2B Workers).
Definition of ‘‘Fiduciary’’ ............................................................................................
Respirable Crystalline Silica .....................................................................................
Criteria and Procedures for Proposed Assessment of Civil Penalties ....................
Proximity Detection Systems for Mobile Machines in Underground Mines .............
88 ......................
89 ......................
90
91
92
93
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Rulemaking Stage
1250–AA01
1245–AA03
Proposed Rule Stage.
Final Rule Stage.
1205–AB59
1205–AB58
Proposed Rule Stage.
Final Rule Stage.
1210–AB32
1219–AB36
1219–AB72
1219–AB78
Proposed
Proposed
Proposed
Proposed
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DEPARTMENT OF LABOR—Continued
Regulation
Identifier No.
Sequence No.
Title
94 ......................
Lowering Miners’ Exposure to Coal Mine Dust, Including Continuous Personal
Dust Monitors.
Proximity Detection Systems for Continuous Mining Machines in Underground
Coal Mines.
Pattern of Violations .................................................................................................
Examination of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety Standards.
Infectious Diseases ..................................................................................................
Injury and Illness Prevention Program .....................................................................
Occupational Exposure to Crystalline Silica ............................................................
Improve Tracking of Workplace Injuries and Illnesses ............................................
Hazard Communication ............................................................................................
95 ......................
96 ......................
97 ......................
98 ......................
99 ......................
100 ....................
101 ....................
102 ....................
Rulemaking Stage
1219–AB64
Final Rule Stage.
1219–AB65
Final Rule Stage.
1219–AB73
1219–AB75
Final Rule Stage.
Final Rule Stage.
1218–AC46
1218–AC48
1218–AB70
1218–AC49
1218–AC20
Prerule Stage.
Prerule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
DEPARTMENT OF TRANSPORTATION
Regulation
Identifier No.
Sequence No.
Title
103 ....................
104 ....................
105 ....................
Accessibility of Carrier Websites and Ticket Kiosks ................................................
Enhancing Airline Passenger Protections III ............................................................
Carrier-Supplied Medical Oxygen, Accessible In-Flight Entertainment Systems,
Service Animals, and Accessible Lavatories on Single-Aisle Aircraft.
Qualification, Service, and Use of Crewmembers and Aircraft Dispatchers ...........
New York Congestion Management Rule for LaGuardia Airport, John F. Kennedy
International Airport, and Newark Liberty International Airport.
Air Ambulance and Commercial Helicopter Operations; Safety Initiatives and Miscellaneous Amendments.
Safety Management Systems for Certificate Holders ..............................................
Carrier Safety Fitness Determination .......................................................................
National Registry of Certified Medical Examiners ....................................................
Passenger Car and Light Truck Corporate Average Fuel Economy Standards
MYs 2017 and Beyond.
Sound for Hybrid and Electric Vehicles ...................................................................
Motorcoach Rollover Structural Integrity ..................................................................
Electronic Stability Control Systems for Heavy Vehicles .........................................
Require Installation of Seat Belts on Motorcoaches, FMVSS No. 208 ...................
Major Capital Investment Projects (RRR) ................................................................
Regulations To Be Followed by All Departments, Agencies, and Shippers Having
Responsibility To Provide a Preference for U.S.-Flag Vessels in the Shipment
of Cargoes on Ocean Vessels.
106 ....................
107 ....................
108 ....................
109
110
111
112
....................
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....................
....................
113
114
115
116
117
118
....................
....................
....................
....................
....................
....................
Rulemaking Stage
2105–AD96
2105–AE11
2105–AE12
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
2120–AJ00
2120–AJ89
Proposed Rule Stage.
Proposed Rule Stage.
2120–AJ53
Final Rule Stage.
2120–AJ86
2126–AB11
2126–AA97
2127–AK79
Final Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
2127–AK93
2127–AK96
2127–AK97
2127–AK56
2132–AB02
2133–AB74
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
DEPARTMENT OF VETERANS AFFAIRS
Regulation
Identifier No.
Sequence No.
Title
119 ....................
120 ....................
VA Compensation and Pension Regulation Rewrite Project ...................................
Caregivers Program .................................................................................................
2900–AO13
2900–AN94
Rulemaking Stage
Proposed Rule Stage.
Final Rule Stage.
ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD
Regulation
Identifier No.
Sequence No.
Title
121 ....................
Accessibility Standards for Medical Diagnostic Equipment .....................................
3014–AA40
Rulemaking Stage
Proposed Rule Stage.
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ENVIRONMENTAL PROTECTION AGENCY
Regulation
Identifier No.
Sequence No.
Title
122 ....................
Risk and Technology Review for National Emission Standards for Hazardous Air
Pollutants From the Pulp and Paper Industry.
Joint Rulemaking To Establish 2017 and Later Model Year Light Duty Vehicle
GHG Emissions and CAFE Standards.
Petroleum Refinery Sector Risk and Technology Review and NSPS .....................
Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and
Fuel Standards.
123 ....................
124 ....................
125 ....................
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2060–AQ41
Proposed Rule Stage.
2060–AQ54
Proposed Rule Stage.
2060–AQ75
2060–AQ86
Proposed Rule Stage.
Proposed Rule Stage.
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ENVIRONMENTAL PROTECTION AGENCY—Continued
Regulation
Identifier No.
Sequence No.
Title
126 ....................
Greenhouse Gas New Source Performance Standard for Electric Generating
Units for New Sources.
National Emission Standards for Hazardous Air Pollutant Emissions: Group IV
Polymers and Resins, Pesticide Active Ingredient Production, and Polyether
Polyols Production Risk and Technology Review.
National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and Institutional Boilers and Process Heaters; Proposed
Reconsideration.
National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial, and Institutional Boilers; Reconsideration and Proposed
Rule Amendments.
Standards of Performance for New Stationary Sources and Emission Guidelines
for Existing Sources: Commercial and Industrial Solid Waste Incineration Units;
Reconsideration and Proposed Amendments.
NPDES Electronic Reporting Rule ...........................................................................
Pesticides; Certification of Pesticide Applicators .....................................................
Pesticides; Agricultural Worker Protection Standard Revisions ..............................
Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products.
Mercury; Regulation of Use in Certain Products .....................................................
Lead; Renovation, Repair, and Painting Program for Public and Commercial
Buildings.
Revisions to the National Oil and Hazardous Substances Pollution Contingency
Plan; Subpart J Product Schedule Listing Requirements.
Stormwater Regulations Revision To Address Discharges From Developed Sites
Effluent Limitations Guidelines and Standards for the Steam Electric Power Generating Point Source Category.
National Pollutant Discharge Elimination System (NPDES) Concentrated Animal
Feeding Operation (CAFO) Reporting Rule.
National Pollutant Discharge Elimination System (NPDES) Application and Program Updates Rule.
Review of the Secondary National Ambient Air Quality Standards for Oxides of
Nitrogen and Oxides of Sulfur.
National Emission Standards for Hazardous Air Pollutants From Coal- and OilFired Electric Utility Steam Generating Units and Standards of Performance for
Electric Utility Steam Generating Units.
Oil and Natural Gas Sector—New Source Performance Standards and National
Emission Standards for Hazardous Air Pollutants.
Criteria and Standards for Cooling Water Intake Structures ...................................
127 ....................
128 ....................
129 ....................
130 ....................
131
132
133
134
....................
....................
....................
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135 ....................
136 ....................
137 ....................
138 ....................
139 ....................
140 ....................
141 ....................
142 ....................
143 ....................
144 ....................
145 ....................
Rulemaking Stage
2060–AQ91
Proposed Rule Stage.
2060–AR02
Proposed Rule Stage.
2060–AR13
Proposed Rule Stage.
2060–AR14
Proposed Rule Stage.
2060–AR15
Proposed Rule Stage.
2020–AA47
2070–AJ20
2070–AJ22
2070–AJ44
Proposed
Proposed
Proposed
Proposed
2070–AJ46
2070–AJ56
Proposed Rule Stage.
Proposed Rule Stage.
2050–AE87
Proposed Rule Stage.
2040–AF13
2040–AF14
Proposed Rule Stage.
Proposed Rule Stage.
2040–AF22
Proposed Rule Stage.
2040–AF25
Proposed Rule Stage.
2060–AO72
Final Rule Stage.
2060–AP52
Final Rule Stage.
2060–AP76
Final Rule Stage.
2040–AE95
Final Rule Stage.
Rule
Rule
Rule
Rule
Stage.
Stage.
Stage.
Stage
EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
Regulation
Identifier No.
Sequence No.
Title
146 ....................
Disparate Impact and Reasonable Factors Other Than Age Under the Age Discrimination in Employment Act.
3046–AA76
Rulemaking Stage
Final Rule Stage.
NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
Regulation
Identifier No.
Sequence No.
Title
147 ....................
Federal Records Management; Electronic Records Archives (ERA) ......................
3095–AB74
Rulemaking Stage
Proposed Rule Stage.
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Sequence No.
148
149
150
151
....................
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Identifier No.
Title
Small Business Technology Transfer (STTR) Policy Directive ................................
Small Business Innovation Research (SBIR) Program Policy Directive ..................
Acquisition Process: Task and Delivery Order Contracts, Bundling, Consolidation
´ ´
Small Business Jobs Act: Small Business Mentor-Protege Programs ....................
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3245–AF84
3245–AG20
3245–AG24
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Proposed
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
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SOCIAL SECURITY ADMINISTRATION
Sequence No.
152
153
154
155
156
....................
....................
....................
....................
....................
157 ....................
Regulation
Identifier No.
Title
Revised Medical Criteria for Evaluating Respiratory System Disorders (859P) ......
Revised Medical Criteria for Evaluating Hematological Disorders (974P) ..............
Revised Medical Criteria for Evaluating Mental Disorders (886F) ...........................
How We Collect and Consider Evidence of Disability (3487P) ...............................
Amendments to Regulations Regarding Withdrawals of Applications and Voluntary Suspension of Benefits (3573F).
Expedited Vocational Assessment Under the Sequential Evaluation Process
(3684P).
Rulemaking Stage
0960–AF58
0960–AF88
0960–AF69
0960–AG89
0960–AH07
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Final Rule Stage.
Final Rule Stage.
0960–AH26
Final Rule Stage.
NUCLEAR REGULATORY COMMISSION
Regulation
Identifier No.
Sequence No.
Title
158 ....................
Medical Use of Byproduct Material—Amendments/Medical Event Definition
[NRC–2008–0071].
Fitness-For-Duty Programs [NRC–2009–0090] .......................................................
U.S. Evolutionary Power Reactor (EPR) Design Certification Amendment [NRC–
2010–0132].
Disposal of Unique Waste Streams [NRC–2011–0012] ..........................................
Revision of Fee Schedules: Fee Recovery for FY 2012 [NRC–2011–0207] ..........
Risk-Informed Changes to Loss-of-Coolant Accident Technical Requirements
[NRC–2004–0006].
Physical Protection of Byproduct Material [NRC–2008–0120] ................................
Environmental Effect of Renewing the Operating License of a Nuclear Power
Plant [NRC–2008–0608].
AP1000 Design Certification Amendment [NRC–2010–0131] .................................
U.S. Advanced Boiling Water Reactor (ABWR) Aircraft Impact Design Certification Amendment [NRC–2010–0134].
Economic Simplified Boiling-Water Reactor (ESBWR) Design Certification [NRC–
2010–0135].
List of Approved Spent Fuel Storage Casks—MAGNASTOR, Revision 2 [NRC–
2011–0008].
159 ....................
160 ....................
161 ....................
162 ....................
163 ....................
164 ....................
165 ....................
166 ....................
167 ....................
168 ....................
169 ....................
BILLING CODE 6820–27–P
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DEPARTMENT OF AGRICULTURE
(USDA)
Statement of Regulatory Priorities
USDA’s focus in 2012 will be on
programs that create/save jobs,
particularly in rural America, while
identifying and taking action on those
programs that could be modified,
streamlined, and simplified, or
reporting burdens reduced, particularly
with the public’s access to USDA
programs. In addition, USDA’s
regulatory efforts in the coming year
will be focused on achieving the
Department’s goals identified in the
Department’s Strategic Plan for 2010 to
2015.
• Assist rural communities to create
prosperity so they are self-sustaining, repopulating, and economically thriving.
USDA is the leading advocate for rural
America. The Department supports rural
communities and enhances quality of
life for rural residents by improving
their economic opportunities,
community infrastructure,
environmental health, and the
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sustainability of agricultural production.
The common goal is to help create
thriving rural communities with good
jobs where people want to live and raise
families, and where children have
economic opportunities and a bright
future.
• Ensure that all of America’s
children have access to safe, nutritious,
and balanced meals. A plentiful supply
of safe and nutritious food is essential
to the well-being of every family and the
healthy development of every child in
America. USDA provides nutrition
assistance to children and low-income
people who need it and works to
improve the healthy eating habits of all
Americans, especially children. In
addition, the Department safeguards the
quality and wholesomeness of meat,
poultry, and egg products and addresses
and prevents loss and damage from
pests and disease outbreaks.
• Ensure our national forests and
private working lands are conserved,
restored, and made more resilient to
climate change, while enhancing our
water resources. America’s prosperity is
inextricably linked to the health of our
lands and natural resources. Forests,
farms, ranches, and grasslands offer
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3150–AI82
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3150–AJ03
3150–AH29
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
3150–AI12
3150–AI42
Final Rule Stage.
Final Rule Stage.
3150–AI81
3150–AI84
Final Rule Stage.
Final Rule Stage.
3150–AI85
Final Rule Stage.
3150–AI91
Final Rule Stage.
enormous environmental benefits as a
source of clean air, clean and abundant
water, and wildlife habitat. These lands
generate economic value by supporting
the vital agriculture and forestry sectors,
attracting tourism and recreation
visitors, sustaining green jobs, and
producing ecosystem services, food,
fiber, timber and non-timber products,
and energy. They are also of immense
social importance, enhancing rural
quality of life, sustaining scenic and
culturally important landscapes, and
providing opportunities to engage in
outdoor activity and reconnect with the
land.
• Help America promote agricultural
production and biotechnology exports
as America works to increase food
security. A productive agricultural
sector is critical to increasing global
food security. For many crops, a
substantial portion of domestic
production is bound for overseas
markets. USDA helps American farmers
and ranchers use efficient, sustainable
production, biotechnology, and other
emergent technologies to enhance food
security around the world and find
export markets for their products.
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Important regulatory activities
supporting the accomplishment of these
goals in 2012 will include the following:
• Rural Development and Renewable
Energy. USDA priority regulatory
actions for the Rural Development
mission will be to revise regulations for
the Business and Industry Guaranteed
Loan Program, Rural Development’s
flagship job creation and capital
expansion business program, and
finalize regulations for the bioenergy
programs.
• USDA will continue to promote
sustainable economic opportunities to
create jobs in rural communities
through the purchase and use of
biobased products through the
BioPreferred® program. USDA will
continue to designate groups of
biobased products to receive
procurement preference from Federal
agencies and contractors. BioPreferred
has made serious efforts to minimize
burdens on small business by providing
a standard mechanism for product
testing, an online application process,
and individual assistance for small
manufacturers when needed. Both the
Federal preferred procurement and the
certified label parts of the program are
voluntary, and both are designed to
assist biobased businesses in securing
additional sales.
• Nutrition Assistance. As changes
are made to the nutrition assistance
programs, USDA will work to foster
actions that ensure access to program
benefits, improve program integrity,
improve diets and healthy eating
through nutrition education, and
promote physical activity consistent
with the national effort to reduce
obesity. In support of these activities in
2012, the Food and Nutrition Service
(FNS) plans to publish the final rule
regarding the nutrition standards in the
school meals programs; finalize a rule
updating the WIC food packages; and
establish permanent rules for the Fresh
Fruit and Vegetable Program. FNS will
continue to work to implement rules
that minimize participant and vendor
fraud in its nutrition assistance
programs.
• Food Safety. In the area of food
safety, USDA will continue to develop
science-based regulations that improve
the safety of meat, poultry, and
processed egg products in the least
burdensome and most cost-effective
manner. Regulations will be revised to
address emerging food safety challenges,
streamlined to remove excessively
prescriptive regulations, and updated to
be made consistent with hazard analysis
and critical control point principles. In
2012, the Food Safety and Inspection
Service (FSIS) plans to propose
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regulations to establish new systems for
poultry slaughter inspection,
requirements for federally inspected egg
product plants to develop and
implement hazard analysis and critical
control point systems and sanitation
standard operating procedures, and
finalize regulations on catfish
inspection. To assist small entities to
comply with food safety requirements,
the FSIS will continue to collaborate
with other USDA agencies and State
partners in the enhanced small business
outreach program.
• Farm Loans, Disaster Designation,
and Environmental Compliance. USDA
will work to ensure a strong U.S.
agricultural system through farm
income support and farm loan
programs. In addition, USDA will
streamline the disaster designation
process and update and consolidate the
environmental compliance regulations.
• Forestry and Conservation. In the
conservation area, USDA plans to
finalize regulations that would provide
financial assistance grants to local
governments, tribal governments, and
nonprofit organizations to establish
community forests by acquiring and
protecting private forestlands.
• Marketing and Regulatory
Programs. USDA will work to support
the organic sector and continue
regulatory work to protect the health
and value of U.S. agricultural and
natural resources. USDA will also
implement regulations to enhance
enforcement of the Packers and
Stockyards Act. In addition, USDA
plans to finalize acceptable animal
disease traceability standards. Regarding
plant health, USDA anticipates revising
the permitting of movement of plant
pests and biological control organisms.
For the Animal Welfare Act, USDA will
propose specific standards for the
humane care of birds and finalize
specific standards for the humane care
of dogs imported for resale.
Retrospective Review and Executive
Order 13563
In January 2011, President Obama
issued Executive Order (E.O.) 13563 on
Improving Regulation and Regulatory
Review. As part of this E.O., agencies
were asked to review existing rules that
may be outmoded, ineffective,
insufficient, or excessively burdensome,
and to modify, streamline, expand, or
repeal them accordingly. Reducing the
regulatory burden on the American
people and our trading partners is a
priority for USDA, and we will
continually work to improve the
effectiveness of our existing regulations.
As a result of our regulatory review
efforts in 2011, USDA will make
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regulatory changes in 2012, including
the following:
Labeling—Generic Approval and
Regulations Consolidation. FSIS is
developing a rule that will expand the
circumstances in which the labels of
meat and poultry products will be
deemed to be generically approved by
FSIS. The rule will reduce duplication
and streamline the regulations on this
subject by combining them into a single
part of the Code of Federal Regulations
(CFR);
Electronic Export Application and
Certification Fee. FSIS is planning a rule
to provide for the electronic transmittal
of foreign establishment certifications
between FSIS and foreign governments.
The rule will consolidate four
inspection certificates (meat, meat byproducts, poultry, and egg products)
into one certificate. The rulemaking is
intended, in part, to accommodate the
Agency’s electronic Public Health
Information System.
Environmental Compliance. The Farm
Service Agency (FSA) will consolidate
and update the environmental
compliance regulations to ensure
regulations are consistent and current
for all FSA programs and remove
obsolete regulations;
National Environmental Policy Act
(NEPA) Streamlining. The Natural
Resources and Environment mission
area and the Forest Service (FS), in
cooperation with the Council on
Environmental Quality (CEQ), is
considering a series of initiatives to
improve and streamline the NEPA
process as it applies to FS projects;
Rural Energy for America Program.
This new program will modify the
existing grant and guaranteed loan
program for renewable energy system
(RES) and energy efficiency
improvement (EEI) projects. In addition,
it would add a grant program for RES
feasibility studies and a grant program
for energy audits and renewable energy
development assistance. This
rulemaking will streamline the process
for smaller grants, lessening the burden
to the customer. It will also make the
guaranteed portion of the rule consistent
with other programs Rural Development
(RD) manages and allow applications to
be accepted year around;
Business and Industry Loan
Guaranteed Program. RD plans to
rewrite the regulations, which will
result in improved efficiency and
effectiveness of the program, fewer
errors because the guidelines and
requirements will be clearer, and items
will be more easily found in a better
organized volume of regulations; and
Water and Waste Loans and Grants.
RD will update the operations aspects of
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the loan and grant program to reduce
the burden on the borrower.
Reducing the Paperwork Burden on
Customers and Executive Order 13563
USDA has continued to make
substantial progress in realizing the goal
of the Paperwork Reduction Act. For
example, the Farm and Foreign
Agricultural Services (FFAS) mission
area will reduce the paperwork burden
on program participants by
consolidating the information
collections required to participate in
farm programs administered by FSA and
the Federal crop insurance program
administered by the Risk Management
Agency (RMA).
FFAS will evaluate methods to
simplify and standardize, to the extent
practical, acreage reporting processes,
program dates, and data definitions
across the various USDA programs and
agencies. FFAS expects to allow
producers to use information from their
farm-management and precision
agriculture systems for reporting
production, planted and harvested
acreage, and other key information
needed to participate in USDA
programs. FFAS will also streamline the
collection of producer information by
FSA and RMA with the agricultural
production information collected by
National Agricultural Statistics Service.
These process changes will allow for
program data that is common across
agencies to be collected once and
utilized or redistributed to Agency
programs in which the producer
chooses to participate. FFAS plans to
implement the Acreage and Crop
Reporting Streamlining Initiative
(ACRSI) in an incremental approach
starting in late 2012 with a pilot in
Kansas for growers of winter wheat
when OMB approves the information
collection. Full implementation is
planned for 2013. When specific
changes are identified, FSA and RMA
will make any required conforming
changes in their respective regulations.
Increasingly, USDA is providing
electronic alternatives to its
traditionally paper-based customer
transactions. As a result, customers
increasingly have the option to
electronically file forms and other
documentation online, allowing them to
choose when and where to conduct
business with USDA.
For example, Rural Development
continues to review its regulations to
determine which application
procedures for Business Programs,
Community Facilities Programs, Energy
Programs, and Water and Environmental
Programs can be streamlined and its
requirements synchronized. RD is
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approaching the exercise from the
perspective of the people it serves, by
communicating with stakeholders on
two common areas of regulation that can
provide the basis of reform.
The first area provides support for
entrepreneurship and business
innovation. This initiative would
provide for the streamlining and
reformulating of the Business & Industry
Loan Guarantee Program and the
Intermediary Relending Program—the
first such overhauls in over 20 years.
The second area would provide for
streamlining programs being made
available to municipalities, tribes, and
non-profit organizations; specifically
Water and Waste Disposal, Community
Facilities, and Rural Business Enterprise
Grants, plus programs such as Electric
and Telecommunications loans that
provide basic community needs. This
regulatory reform initiative has the
potential to significantly reduce the
burden to respondents (lenders and
borrowers).
To the extent practicable, each reform
initiative will consist of a common
application and uniform documentation
requirements making it easier for
constituency groups to apply for
multiple programs. In addition, there
will be associated regulations for each
program that will contain program
specific information.
Natural Resources Conservation
Service will also improve the delivery of
technical and financial assistance by
simplifying customer access to NRCS’
technical and financial assistance
programs, streamlining the delivery and
timeliness of conservation assistance to
clients, and enhancing the technical
quality of its conservation planning and
services. The streamlining initiatives
will allow NRCS field staff to spend
more time on conservation planning in
the field with customers, reduce the
time needed to implement cost-share
contracts, and provide more flexibility
for customers to work with NRCS in
different ways. NRCS estimates that this
initiative has the potential to reduce the
amount of time required for producers
to participate in USDA’s conservation
programs by almost 800,000 hours
annually. This includes efficiencies
from reduced paperwork, data entry by
the client, and reduced travel time to
and from the local office to complete
forms and other administrative tasks.
Improvements being considered include
the following:
• Providing an online portal that will
allow customers to apply for programs
or services, review their plans and
contracts, view and assess natural
resource information specifically about
their farm, evaluate the costs and
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benefits for various conservation
treatment alternatives, notify NRCS of
installed practices, and check on
contract payments at their convenience;
• Creating an e-customer profile that
will improve customer service by
allowing the client to view, finalize, and
electronically sign documents using
remote electronic signature, on-site
rather than at a local office;
• Providing clients with more timely
and specific information on alternative
conservation treatments, including the
environmental benefits of their planned
and applied practices;
• Accelerating payments to clients;
and
• Simplifying conservation plan
documents to more specifically address
client needs and goals.
Major Regulatory Priorities
This document represents summary
information on prospective significant
regulations as called for in E.O.s 12866
and 13563. The following USDA
agencies are represented in this
regulatory plan, along with a summary
of their mission and key regulatory
priorities in 2012:
Food and Nutrition Service
Mission: FNS increases food security
and reduces hunger in partnership with
cooperating organizations by providing
children and low-income people access
to food, a healthful diet, and nutrition
education in a manner that supports
American agriculture and inspires
public confidence.
Priorities: In addition to responding to
provisions of legislation authorizing and
modifying Federal nutrition assistance
programs, FNS’ 2012 regulatory plan
supports USDA’s Strategic Goal ‘‘Ensure
that all of America’s children have
access to safe, nutritious, and balanced
meals,’’ and its two related objectives:
Access to Nutritious Food. This
objective represents FNS’s efforts to
improve nutrition by providing access
to program benefits (food consumed at
home, school meals, commodities) and
distributing State administrative funds
to support program operations. To
advance this objective, FNS plans to
publish a final rule of the 2008 Farm
Bill that ensures access to SNAP
benefits and addresses other eligibility,
certification, employment, and training
issues. An interim rule, implementing
provisions of the Child Nutrition and
WIC Reauthorization Act of 2004 to
establish automatic eligibility for
homeless children for school meals,
further supports this objective.
Promote Healthy Diet and Physical
Activity Behaviors. This objective
represents FNS’ efforts to improve the
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diets of its clients through nutrition
education, support the national effort to
reduce obesity by promoting healthy
eating and physical activity, and to
ensure that program benefits meet
appropriate standards to effectively
improve nutrition for program
participants. In support of this objective,
FNS plans to publish the final rule
regarding the nutrition standards in the
school meals programs, finalize a rule
updating the WIC food packages, and
establish permanent rules for the Fresh
Fruit and Vegetable Program, which
currently operates in a select number of
schools in each State, the District of
Columbia, Guam, Puerto Rico, and the
Virgin Islands.
Food Safety and Inspection Service
Mission: FSIS is responsible for
ensuring that meat, poultry, egg, and
catfish products in interstate and foreign
commerce are wholesome, not
adulterated, and properly marked,
labeled, and packaged.
Priorities: FSIS is committed to
developing and issuing science-based
regulations intended to ensure that
meat, poultry, egg, and catfish products
are wholesome and not adulterated or
misbranded. FSIS regulatory actions
support the objective to protect public
health by ensuring that food is safe
under USDA’s goal to ensure access to
safe food. To reduce the number of
foodborne illnesses and increase
program efficiencies, FSIS will continue
to review its existing authorities and
regulations to ensure that it can address
emerging food safety challenges, to
streamline excessively prescriptive
regulations, and to revise or remove
regulations that are inconsistent with
the FSIS’ hazard analysis and critical
control point (HACCP) regulations. FSIS
is also working with the Food and Drug
Administration (FDA) to improve
coordination and increase the
effectiveness of inspection activities.
FSIS’ priority initiatives are as follows:
➢ Rulemakings that support
initiatives of the President’s Food Safety
Working Group:
• Poultry Slaughter Inspection. Based
on the Administration’s top-to-bottom
review of food safety activities, the Food
Safety and Inspection Service will issue
regulations that will prevent thousands
of food-borne illnesses by more clearly
focusing FSIS inspection activities on
improving food safety, streamline
poultry inspections, and reduce
Government spending.
• Revision of Egg Products Inspection
Regulations. FSIS is planning to propose
requirements for federally inspected egg
product plants to develop and
implement HACCP systems and
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sanitation standard operating
procedures. FSIS will be proposing
pathogen reduction performance
standards for egg products and will
remove prescriptive requirements for
egg product plants.
➢ Initiatives that provide for
disclosure or that enable economic
growth. FSIS plans to issue two rules to
promote disclosure of information to the
public or that provide flexibility for the
adoption of new technologies:
• Product Labeling; Use of the
Voluntary Claim ‘‘Natural’’ in the
Labeling of Meat and Poultry Products.
FSIS will propose to amend the meat
and poultry products regulations to
define the conditions under which the
voluntary claim ‘‘natural’’ may be used
on meat and poultry product labeling.
• Food Ingredients and Sources of
Radiation Listed and Approved for Use
in the Production of Meat and Poultry
Products. FSIS will propose to amend
its food ingredient regulations to
provide for the use under certain
conditions of benzoic acid, sodium
propionate, or sodium benzoate.
Notification, Documentation, and
Recordkeeping Requirements for
Inspected Establishments. As authorized
by the 2008 Farm Bill, FSIS will issue
final regulations that will require
establishments that are subject to
inspection to promptly notify FSIS
when an adulterated or misbranded
product received by or originating from
the establishment has entered into
commerce. The regulations also will
require the establishments to prepare
and maintain current procedures for the
recall of all products produced and
shipped by the establishments and to
document each reassessment of the
establishments’ process control plans.
Catfish Inspection. FSIS is developing
final regulations to implement
provisions of the 2008 Farm Bill
provisions that make catfish an
amenable species under the Federal
Meat Inspection Act (FMIA).
Public Health Information System. To
support its food safety inspection
activities, FSIS is implementing the
Public Health Information System
(PHIS). PHIS, which is user-friendly and
Web-based, will replace many of FSIS’
current systems and automate many
business processes. PHIS also will
improve FSIS’ ability to systematically
verify the effectiveness of foreign food
safety systems and enable greater
exchange of information between FSIS
and other Federal agencies (such as
U.S. Customs and Border Protection)
involved in tracking cross-border
movement of import and export
shipments of meat, poultry, and
processed egg products. To facilitate the
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implementation of some PHIS
components, FSIS is proposing to
provide for electronic export and import
application and certification processes
as alternatives to the current paperbased systems for these certifications.
Other Planned Initiatives. FSIS plans
to finalize a February 2001 proposed
rule to establish food safety performance
standards for all processed ready-to-eat
(RTE) meat and poultry products and for
partially heat-treated meat and poultry
products that are not ready-to-eat. Some
provisions of the proposal addressed
post-lethality contamination of RTE
products with Listeria monocytogenes.
In June 2003, FSIS published an interim
final rule requiring establishments to
prevent L. monocytogenes
contamination of RTE products. FSIS
has carefully reviewed its economic
analysis of the interim final rule and is
planning to affirm the interim rule as a
final rule with changes.
FSIS Small Business Implications.
The great majority of businesses
regulated by FSIS are small businesses.
Some of the regulations listed above
substantially affect small businesses.
FSIS conducts a small business outreach
program that provides critical training,
access to food safety experts, and
information resources (such as
compliance guidance and questions and
answers on various topics) in forms that
are uniform, easily comprehended, and
consistent. FSIS collaborates in this
effort with other USDA agencies and
cooperating State partners. For example,
FSIS makes plant owners and operators
aware of loan programs, available
through USDA’s Rural Business and
Cooperative programs, to help them in
upgrading their facilities. FSIS
employees meet with small and very
small plant operators to learn more
about their specific needs and provide
joint training sessions for small and very
small plants and FSIS employees.
Animal and Plant Health Inspection
Service
Mission: A major part of the mission
of the Animal and Plant Health
Inspection Service (APHIS) is to protect
the health and value of American
agricultural and natural resources.
APHIS conducts programs to prevent
the introduction of exotic pests and
diseases into the U.S. and conducts
surveillance, monitoring, control, and
eradication programs for pests and
diseases in this country. These activities
enhance agricultural productivity and
competitiveness and contribute to the
national economy and the public health.
APHIS also conducts programs to
ensure the humane handling, care,
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treatment, and transportation of animals
under the Animal Welfare Act.
Priorities: With respect to animal
health, APHIS is continuing work to
revise its regulations concerning bovine
spongiform encephalopathy (BSE) to
provide a more comprehensive and
universally applicable framework for
the importation of certain animals and
products. In the area of plant health,
APHIS is in the midst of a revision to
its regulations for the importation and
interstate movement of plant pests and
biological control organisms to clarify
the factors that would be considered
when assessing the risks associated with
the movement of certain organisms,
facilitate the movement of regulated
organisms and articles in a manner that
also protects U.S. agriculture, and
address gaps in the current regulations.
APHIS also plans to propose standards
for the humane handling, care,
treatment, and transportation of birds
covered under the Animal Welfare Act.
Additional information about APHIS
and its programs is available on the
Internet at https://www.aphis.usda.gov.
Agricultural Marketing Service
Mission: The Agricultural Marketing
Service (AMS) provides marketing
services to producers, manufacturers,
distributors, importers, exporters, and
consumers of food products. The AMS
also manages the Government’s food
purchases, supervises food quality
grading, maintains food quality
standards, and supervises the Federal
research and promotion programs.
Priorities: AMS’ priority items for the
next year include rulemaking that
impact the organic industry, as well as
the wholesale pork industry.
Rulemakings the Agency intends to
initiate within the next 12 months
include:
Sunset Review (2012)—Nutrient
Vitamins and Minerals. On March 26,
2010, the National Organic Program
(NOP) issued an Advanced Notice of
Proposed Rulemaking (ANPRM)
announcing the National Organic
Standards Board’s (NOSB) sunset
review of exempted and prohibited
substances codified at the National List
of Allowed and Prohibited Substances
of the NOP regulations. This review
included a listing for ‘‘Nutrient vitamins
and minerals’’ scheduled to sunset on
October 21, 2012. AMS intends to
publish a proposed rule to address a
recommendation submitted by the
NOSB for this listing. This proposed
rule would continue the exemption
(use) for nutrient vitamins and minerals
for 5 years after the October 21, 2012,
sunset date. This proposed rule would
amend the annotation for nutrient
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vitamins and minerals to correct an
inaccurate cross reference to U.S. Food
and Drug Administration (FDA)
regulations as AMS determined that the
current exemption for the use of
nutrient vitamins and minerals in
organic products in the NOP regulations
is inaccurate. In effect, the proposed
amendment would clarify what
synthetic substances are allowed as
nutrient vitamins and minerals in
organic products. Further, the NOP
regulations do not correctly provide for
the fortification of infant formula that
would meet FDA requirements. This
proposed rule would incorporate the
correct FDA citation with respect to the
addition of required vitamins and
minerals to organic infant formula.
Livestock Mandatory Reporting;
Establishing Regulations for Wholesale
Pork. As directed by the 2008 Farm Bill,
the Secretary conducted a study to
determine advantages, drawbacks, and
potential implementation issues
associated with adopting mandatory
wholesale pork reporting. The report
from this study concluded that
negotiated wholesale pork price
reporting is thin and becoming thinner
and found some degree of support for
moving to mandatory price reporting
exists at every segment of the industry
interviewed. That study also concluded
that the benefits likely would exceed the
cost of moving from a voluntary to a
mandatory reporting program for
wholesale pork.
Subsequently, the Mandatory Price
Reporting Act of 2010 (2010
Reauthorization Act) (Pub. L. 111–239),
was signed into law on September 28,
2010, and reauthorized Livestock
Mandatory Reporting for 5 years and
added a provision for mandatory
reporting of wholesale pork cuts. The
2010 Reauthorization Act directed the
Secretary to engage in negotiated
rulemaking to make required regulatory
changes for mandatory wholesale pork
reporting.
Further, the 2010 Reauthorization Act
directed the Secretary to establish a
Committee that represented the
spectrum of interests within the pork
industry, as well as related stakeholders,
to ensure all parties had input into the
regulatory framework. Specifically, the
statute required that the Committee
include representatives from (i)
organizations representing swine
producers; (ii) organizations
representing packers of pork, processors
of pork, retailers of pork, and buyers of
wholesale pork; (iii) Department of
Agriculture; and (iv) interested parties
that participate in swine or pork
production.
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The Agricultural Marketing Service
(AMS) convened the Wholesale Pork
Reporting Negotiated Rulemaking
Committee (Committee) through notice
in the Federal Register on January 26,
2011. The Committee met three times
over the period February through May
of 2011 to develop the regulatory
framework necessary to implement a
mandatory program of wholesale pork
reporting.
The regulatory text developed by the
Committee will serve as the primary
basis for the proposed rule, consistent
with both the intent of Congress and the
Negotiated Rulemaking Act. It is
important to note that the Committee
reached consensus on all items included
in the proposed rule—where consensus
was defined by the Committee bylaws as
being unanimous agreement. Therefore,
AMS is confident the proposed rule to
implement wholesale pork reporting
will be met with little or no resistance
from the industry members who will be
required to report under the mandatory
system.
Grain Inspection, Packers, and
Stockyards Administration
Mission: The Grain Inspection,
Packers, and Stockyards Administration
(GIPSA) facilitates the marketing of
livestock, poultry, meat, cereals,
oilseeds, and related agricultural
products and promotes fair and
competitive trading practices for the
overall benefit of consumers and
American agriculture. GIPSA’s activities
contribute significantly to USDA’s goal
to increase prosperity in rural areas by
supporting a competitive agricultural
system.
Priorities: GIPSA intends to issue a
final rule that will define practices or
conduct that are unfair, unjustly
discriminatory, or deceptive, and/or that
represent the making or giving of an
undue or unreasonable preference or
advantage, and ensure that producers
and growers can fully participate in any
arbitration process that may arise
relating to livestock or poultry contracts.
This regulation is being finalized in
accordance with the authority granted to
the Secretary by the Packers and
Stockyards Act of 1921 and with the
requirements of sections 11005 and
11006 of the 2008 Farm Bill.
Farm Service Agency
Mission: FSA’s mission is to equitably
serve all farmers, ranchers, and
agricultural partners through the
delivery of effective, efficient
agricultural programs, which
contributes to two USDA goals: Assist
rural communities in creating prosperity
so they are self-sustaining, re-
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populating, and economically thriving;
and enhance the Nation’s natural
resource base by assisting owners and
operators of farms and ranches to
conserve and enhance soil, water, and
related natural resources. FSA supports
the first goal by stabilizing farm income,
providing credit to new or existing
farmers and ranchers who are
temporarily unable to obtain credit from
commercial sources, and helping farm
operations recover from the effects of
disaster. FSA supports the second goal
by administering several conservation
programs directed toward agricultural
producers. The largest program is the
Conservation Reserve Program (CRP),
which protects nearly 32 million acres
of environmentally sensitive land.
Priorities: Farm Loan Programs. FSA
will develop and issue regulations to
amend programs for farm operating
loans, down payment loans, and
emergency loans to include socially
disadvantaged farmers, increase loan
limits, loan size, funding targets,
interest rates, and graduating borrowers
to commercial credit. In addition, FSA
will further streamline normal loan
servicing activities and reduce burden
on borrowers while still protecting the
loan security.
Disaster Designation. FSA will revise
the disaster designation process to
streamline it and reduce the burden on
States and tribes requesting disaster
designations. One result may be fewer
delays in delivering disaster assistance
to help farm operations recover from the
effects of disaster.
Forest Service
Mission: The mission of the Forest
Service is to sustain the health,
productivity, and diversity of the
Nation’s forests and rangelands to meet
the needs of present and future
generations. This includes protecting
and managing National Forest System
lands, providing technical and financial
assistance to States, communities, and
private forest landowners, and
developing and providing scientific and
technical assistance and scientific
exchanges in support of international
forest and range conservation. FS’
regulatory priorities support the
accomplishment of USDA’s goal to
ensure our national forests are
conserved, restored, and made more
resilient to climate change, while
enhancing our water resources.
Priorities: Special Areas; StateSpecific Inventoried Roadless Area
Management: Colorado. FS planned
final rulemaking would establish a
State-specific rule to provide
management direction for conserving
and managing inventoried roadless
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areas on National Forest System lands
in the State of Colorado.
Land Management Planning Rule. FS
is required to issue rulemaking for
National Forest System land
management planning under 16 U.S.C.
1604. The first planning rule was
adopted in 1979, and amended in 1982.
FS published a new planning rule on
April 21, 2008 (73 FR 21468). On June
30, 2009, the United States District
Court for the Northern District of
California invalidated FS’ 2008
Planning Rule published at 36 CFR 219
based on violations of NEPA and the
Endangered Species Act in the
rulemaking process. The District Court
vacated the 2008 rule, enjoined USDA
from further implementing it, and
remanded it to USDA for further
proceedings. USDA has determined that
the 2000 planning rule is now in effect,
including its transition provisions as
amended in 2002 and 2003, and as
clarified by interpretative rules issued
in 2001 and 2004, which allows the use
of the provisions of the 1982 planning
rule to amend or revise plans. FS is now
in the 2000 planning rule transition
period. FS published a proposed
planning rule on February 14, 2011 (76
FR 8480). The final rule is expected to
be published December 2011. In so
doing, FS plans to correct deficiencies
that have been identified over two
decades of forest planning and update
planning procedures to reflect
contemporary collaborative planning
practices.
Community Forest and Open Space
Conservation Program. The purpose of
the Community Forest Program is to
achieve community benefits through
financial assistance grants to local
governments, tribal governments, and
nonprofit organizations to establish
community forests by acquiring and
protecting private forestlands.
Community forest benefits are specified
in the authorizing statute and include
economic benefits from sustainable
forest management, natural resource
conservation, forest-based educational
programs, model forest stewardship
activities, and recreational
opportunities.
Rural Business-Cooperative Service
Mission: Promoting a dynamic
business environment in rural America
is the goal of the Rural BusinessCooperative Service (RBS). Business
Programs works in partnership with the
private sector and the community-based
organizations to provide financial
assistance and business planning, and
helps fund projects that create or
preserve quality jobs and/or promote a
clean rural environment. The financial
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resources are often leveraged with those
of other public and private credit source
lenders to meet business and credit
needs in under-served areas. Recipients
of these programs may include
individuals, corporations, partnerships,
cooperatives, public bodies, nonprofit
corporations, Indian tribes, and private
companies. The mission of Cooperative
Programs of RBS is to promote
understanding and use of the
cooperative form of business as a viable
organizational option for marketing and
distributing agricultural products.
Priorities: In support USDA’s goal to
increase the prosperity of rural
communities, RBS regulatory priorities
will facilitate sustainable renewable
energy development and enhance the
opportunities necessary for rural
families to thrive economically. RBS’
priority will be to publish regulations to
fully implement the 2008 Farm Bill.
This includes promulgating regulations
for the Biorefinery Assistance Program
(sec. 9003), the Repowering Assistance
Program (sec. 9004), the Bioenergy
Program for Advanced Biofuels (sec.
9005), and the Rural Microentrepreneur
Assistance Program (RMAP). RBS has
been administering sections 9003, 9004,
and 9005 through the use of Notices of
Funds Availability and Notices of
Contract Proposals. Revisions to the
Rural Energy for America Program (sec.
9007) will be made to incorporate
Energy Audits and Renewable Energy
Development Assistance and Feasibility
Studies for Rural Energy Systems as
eligible grant purposes, as well as other
Farm Bill initiatives and various
technical changes throughout the rule.
In addition, revisions to the Business
and Industry Guaranteed Loan Program
will be made to implement 2008 Farm
Bill provisions and other program
initiatives. These rules will minimize
program complexity and burden on the
public while enhancing program
delivery and RBS oversight.
Rural Utilities Service
Mission: The mission of the Rural
Utilities Service (RUS) is to improve the
quality of life in rural America by
providing investment capital for the
deployment of critical rural utilities
telecommunications, electric, and water
and waste disposal infrastructure.
Financial assistance is provided to rural
utilities, municipalities, commercial
corporations, limited liability
companies, public utility districts,
Indian tribes, and cooperative, nonprofit, limited-dividend, or mutual
associations. The public-private
partnership, which is forged between
RUS and these industries, results in
billions of dollars in rural infrastructure
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development and creates thousands of
jobs for the American economy.
Priorities: RUS’ regulatory priorities
will be to achieve the President’s goal to
bring affordable broadband to all rural
Americans. To accomplish this, RUS
will continue to improve the Broadband
Program established by the 2002 Farm
Bill. The 2002 Farm Bill authorized RUS
to approve loans and loan guarantees for
the costs of construction, improvement,
and acquisition of facilities and
equipment for broadband service in
eligible rural communities. The 2008
Farm Bill significantly changed the
statutory requirements of the Broadband
Loan Program. As such, RUS issued an
interim rule to implement the statutory
changes and requested comments on the
section of the rule that was not part of
the proposed rule published in May
2007. Comments were received and the
agency will analyze the comments and
finalize the rule.
Departmental Management
Mission: Departmental Management’s
mission is to provide management
leadership to ensure that USDA
administrative programs, policies,
advice, and counsel meet the needs of
USDA program organizations, consistent
with laws and mandates, and provide
safe and efficient facilities and services
to customers.
Priorities: In support of the
Department’s goal to increase rural
prosperity, USDA’s departmental
management will finalize regulations to
revise the BioPreferred program
guidelines to continue adding
designated product categories to the
preferred procurement program,
including intermediates and feedstocks
and finished products made of
intermediates and feedstocks.
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Aggregate Costs and Benefits
USDA will ensure that its regulations
provide benefits that exceed costs but is
unable to provide an estimate of the
aggregated impacts of its regulations.
Problems with aggregation arise due to
differing baselines, data gaps, and
inconsistencies in methodology and the
type of regulatory costs and benefits
considered. Some benefits and costs
associated with rules listed in the
regulatory plan cannot currently be
quantified as the rules are still being
formulated. For 2012, USDA’s focus will
be to implement the changes to
programs in such a way as to provide
benefits while minimizing program
complexity and regulatory burden for
program participants.
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USDA—Agricultural Marketing Service
(AMS)
Proposed Rule Stage
1. Wholesale Pork Reporting Program
Priority: Other Significant.
Legal Authority: 7 U.S.C. 1635 to 1636
CFR Citation: 7 CFR 59.
Legal Deadline: Final, Statutory,
March 28, 2012.
With the passage of S. 3656, the
Mandatory Price Reporting Act of 2010,
the Secretary of Agriculture is required
to amend chapter 3 of subtitle B of the
Agricultural Marketing Act of 1946 by
adding a new section for mandatory
reporting of wholesale pork cuts. To
make these amendments, the Secretary
was directed to promulgate a final rule
no later than 11⁄2 years after the date of
the enactment of the Act. Accordingly,
a final rule will be promulgated by
March 28, 2012.
Abstract: On September 15, 2010,
Congress passed the Mandatory Price
Reporting Act of 2010 reauthorizing
Livestock Mandatory Reporting for 5
years and adding a provision for
mandatory reporting of wholesale pork
cuts. The Act was signed by the
President on September 28, 2010.
Congress directed the Secretary to
engage in negotiated rulemaking to
make required regulatory changes for
mandatory wholesale pork reporting.
Further, Congress required that the
negotiated rulemaking committee
include representatives from (i)
organizations representing swine
producers; (ii) organizations
representing packers of pork, processors
of pork, retailers of pork, and buyers of
wholesale pork; (iii) the Department of
Agriculture; and (iv) interested parties
that participate in swine or pork
production.
Statement of Need: Implementation of
mandatory pork reporting is required by
Congress. Congress delegated
responsibility to the Secretary for
determining what information is
necessary and appropriate. The Food,
Conservation, and Energy Act of 2008
(Pub. L. 110–234) directed the Secretary
to conduct a study to determine
advantages, drawbacks, and potential
implementation issues associated with
adopting mandatory wholesale pork
reporting. The report from this study
generally concluded that voluntary
wholesale pork price reporting is thin
and becoming thinner, and some degree
of support for moving to mandatory
price reporting exists at every segment
of the industry interviewed. The report
was delivered to Congress on March 25,
2010.
Summary of Legal Basis: Livestock
Mandatory Reporting is authorized
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7683
under the Agricultural Marketing Act (7
U.S.C. 1635 to 1636). The Livestock and
Seed Program of USDA’s Agricultural
Marketing Service has day-to-day
responsibility for collecting and
disseminating LMR data.
Alternatives: There are no
alternatives, as this rulemaking is a
matter of law based on the Mandatory
Price Reporting Act of 2010.
Anticipated Cost and Benefits:
Estimation of costs will follow the
previous methodology used in earlier
Livestock Mandatory Reporting
rulemaking. The focus of the cost
estimation is the burden placed on
reporting companies in providing pork
marketing data to the Livestock and
Seed Program. Previous rulemaking cost
estimates of boxed beef reporting of
similar data found the burden to be an
annual total of 65 hours in additional
reporting requirements per firm.
Because no official USDA grade
standards are used in the marketing of
pork, and there are fewer cutting styles,
the burden for pork reporting firms in
comparison with beef reporting firms
could be lower. However, the impact is
not truly known at this stage.
Risks: Implementing wholesale pork
reporting presents few risks to the
Agency and the impacted industry.
Members of the industry who served on
the negotiated rulemaking committee
expressed some concern with reporting
prices under a different reporting basis
than what is used for voluntary pork
reporting. However, ultimately the
committee reached consensus on having
prices reporting on both an FOB Omaha
and FOB Plant basis in order to reduce
market volatility.
Timetable:
Action
Date
FR Cite
Changes to Livestock Mandatory
Reporting.
Wholesale Pork
Reporting; Notice of Meeting.
NPRM ...................
Final Action ...........
11/24/10
75 FR
71568
01/26/11
76 FR 4554
02/00/12
10/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Michael P. Lynch,
Department of Agriculture, Agricultural
Marketing Service, 14th and
Independence Avenue SW.,
Washington, DC 20250, Phone: 202 720–
6231.
RIN: 0581–AD07
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USDA—AMS
2. • National Organic Program: Sunset
Review for Nutrient Vitamins and
Minerals (NOP–10–0083)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 7 U.S.C. 6501
CFR Citation: 7 CFR 205.
Legal Deadline: None.
Abstract: This proposed rule would
address a recommendation submitted to
the Secretary of Agriculture (Secretary)
by the National Organic Standards
Board (NOSB) on April 29, 2011. The
recommendation pertains to the 2012
Sunset Review of the listing for nutrient
vitamins and minerals on the U.S.
Department of Agriculture’s (USDA)
National List of Allowed and Prohibited
Substances (National List). As
recommended by the NOSB, the
proposed rule would continue the
exemption (use) for nutrient vitamins
and minerals for 5 years after the
October 21, 2012, sunset date. In
addition, the proposed rule would
amend the annotation to correct an
inaccurate cross reference to U.S. Food
and Drug Administration regulations.
The proposed amendment to the
annotation would clarify what synthetic
substances are allowed as nutrient
vitamins and minerals in organic
products labeled as ‘‘organic’’ or ‘‘made
with organic (specified ingredients or
food group(s)).’’
Statement of Need: The Agricultural
Marketing Service (AMS) has
determined that the current exemption
for the use of nutrient vitamins and
minerals in organic products in the
National Organic Program (NOP)
regulations (7 CFR part 205) is
inaccurate. The proposed rule would
amend the annotation for nutrient
vitamins and minerals to correct an
inaccurate cross reference to U.S. Food
and Drug Administration (FDA)
regulations. In effect, the proposed
amendment would clarify what
synthetic substances are allowed as
nutrient vitamins and minerals in
organic products. Further, the NOP
regulations do not correctly provide for
the fortification of infant formula that
would meet FDA requirements. This
proposed rule would incorporate the
correct FDA citation with respect to the
addition of required vitamins and
minerals to organic infant formula.
Summary of Legal Basis: This
proposed rule would address a
recommendation submitted to the
Secretary of Agriculture by the National
Organic Standards Board (NOSB) on
April 29, 2011, to continue the
exemption for nutrient vitamins and
minerals in organic products as
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provided by the NOP National List of
Allowed and Prohibited Substances
(National List). The Organic Foods
Production Act of 1990 (OFPA)
authorizes the Secretary to amend the
National List based on proposed
amendments developed by the NOSB.
The Sunset Provision, in section 6517(e)
of the OFPA, provides that no
exemption or prohibition on the
National List will remain valid after 5
years unless the exemption or
prohibition has been reviewed and the
Secretary renews the listing. The
exemption for nutrient vitamins and
minerals is scheduled to sunset on
October 21, 2012.
Alternatives: AMS considered two
alternatives to this proposed
rulemaking: (1) Renew the existing
listing for nutrient vitamins and
minerals or (2), in lieu of a rule, issue
guidance stating NOP’s intent to
interpret the current listing for nutrient
vitamins and minerals as proposed in
this action. AMS determined that
neither alternative is viable as both
would retain a regulatory provision that
is inaccurate and remains vulnerable to
misinterpretations of what substances
are permitted in organic products.
Anticipated Cost and Benefits: This
proposed rule would establish a finite
list of essential and required vitamins
and minerals for use in organic food and
infant formula. The action addresses the
requests of a broad spectrum of public
commenters for clarification on the
parameters for adding nutrient vitamins
and minerals to organic products and is
expected to reduce the submission of
consumer complaints alleging the
unlawful addition of substances to
organic products. This proposed rule
would also provide more certainty to
certifying agents and organic operations
in determining whether substances are
acceptable for use in organic products.
Further, this proposed action also
would foster greater transparency by
ensuring that exemptions for the use of
vitamins, minerals, and other nutrients
are subject to National Organic
Standards Board (NOSB) evaluation in
accordance with the criteria established
in OFPA.
This action could directly impact a
subset of certified organic operations,
which add substances to organic
products that are not essential vitamins
and minerals for human nutrition (21
CFR 101.9) or required vitamins and
minerals for infant formula (21 CFR
107.100 or 107.10), as enumerated by
FDA regulation. AMS believes the
impacts will be concentrated within five
categories of organic products in which
nutrient supplementation has been more
prevalent: Infant formula, baby food,
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milk, breakfast cereal, and pet food. The
proposed rule could indirectly impact
producers who supply organic
agricultural commodities to affected
product categories. However, AMS
expects that there will be opportunities
for producers to divert organic
agricultural products to other
purchasers to buffer the impact of any
disruption to the manufacture of certain
processed organic products as a result of
this proposed action.
There are several impact mitigation
factors which are expected to reduce the
costs of complying with this proposed
action. AMS is proposing a 2-year
implementation phase, which is
intended to provide time for NOSB to
consider petitions for substances that
are affected by this action and for AMS
to conclude any rulemaking to add
substances to the National List. The
implementation phase would also
provide entities the time to explore
reformulation of affected products.
Further, if some products are
discontinued as a result of this proposed
rule, AMS anticipates that some
consumers will purchase, as an
alternative, an organic product within
the same category rather than a
nonorganic product.
Risks: For the 2-year implementation
phase to function as a mitigation
measure, the timeframe may be tight to
complete the review of petitions
received by publication of this proposed
rule and for any rulemaking action
recommended by NOSB. Therefore,
AMS has requested comments on the
length of the implementation phase as
part of this proposed rule.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
01/12/12
03/12/12
77 FR 1980
10/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Local,
State.
Agency Contact: Melissa R. Bailey,
Director, Standards Division,
Department of Agriculture, Agricultural
Marketing Service, Washington, DC
20250, Phone: 202 720–3252, Fax: 202
205–7808, Email:
melissa.bailey@usda.gov.
Related RIN: Split from 0581–AC96.
RIN: 0581–AD17
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USDA—ANIMAL AND PLANT HEALTH
INSPECTION SERVICE (APHIS)
Proposed Rule Stage
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3. Animal Welfare; Regulations and
Standards for Birds
Priority: Other Significant.
Legal Authority: 7 U.S.C. 2131 to 2159
CFR Citation: 9 CFR 1 to 3.
Legal Deadline: None.
Abstract: APHIS intends to establish
standards for the humane handling,
care, treatment, and transportation of
birds other than birds bred for use in
research.
Statement of Need: The Farm Security
and Rural Investment Act of 2002
amended the definition of animal in the
Animal Welfare Act (AWA) by
specifically excluding birds, rats of the
genus Rattus, and mice of the genus
Mus, bred for use in research. While the
definition of animal in the regulations
contained in 9 CFR part 1 has excluded
rats of the genus Rattus and mice of the
genus Mus bred for use in research, that
definition has also excluded all birds
(i.e., not just those birds bred for use in
research). In line with this change to the
definition of animal in the AWA, APHIS
intends to establish standards in 9 CFR
part 3 for the humane handling, care,
treatment, and transportation of birds
other than those birds bred for use in
research and to revise the regulations in
9 CFR parts 1 and 2 to make them
applicable to birds.
Summary of Legal Basis: The Animal
Welfare Act (AWA) authorizes the
Secretary of Agriculture to promulgate
standards and other requirements
governing the humane handling, care,
treatment, and transportation of certain
animals by dealers, research facilities,
exhibitors, operators of auction sales,
and carriers and immediate handlers.
Animals covered by the AWA include
birds that are not bred for use in
research.
Alternatives: To be identified.
Anticipated Cost and Benefits:
Benefits of the rule would stem from
improvements in the humane handling
and care of birds by affected dealers,
exhibitors, carriers, and intermediate
handlers. At a minimum, these entities
would be required to satisfy certain
reporting provisions and undergo
periodic compliance inspections by
APHIS—measures that they are not
subject to now with respect to birds.
Regulated entities, therefore, may incur
certain costs because of the proposed
rule. Most facilities that use birds in
research, such as pharmaceutical
companies, universities, and research
institutes, would not be affected. Retail
pet stores could be affected to the extent
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that regulatory costs are passed on to
them by breeders and other suppliers.
Most entities affected by the proposal
are likely to be small in size, based on
Small Business Administration
standards. We have not been able to
conduct a comprehensive analysis of the
rule’s potential economic impact
because of the paucity of available data
on the affected industries. APHIS
welcomes public comment that would
permit a more complete assessment of
the proposed rule’s impact.
Risks: Not applicable.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
FR Cite
05/00/12
08/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Additional Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
Agency Contact: Johanna Briscoe,
Veterinary Medical Officer and Avian
Specialist, Animal Care, Department of
Agriculture, Animal and Plant Health
Inspection Service, 4700 River Road,
Unit 84, Riverdale, MD 20737–1234,
Phone: 301 734–0658.
RIN: 0579–AC02
USDA—APHIS
4. Plant Pest Regulations; Update of
General Provisions
Priority: Other Significant.
Legal Authority: 7 U.S.C. 450; 7 U.S.C.
2260; 7 U.S.C. 7701 to 7772; 7 U.S.C.
7781 to 7786; 7 U.S.C. 8301 to 8817; 19
U.S.C. 136; 21 U.S.C. 111; 21 U.S.C.
114a; 21 U.S.C. 136 and 136a; 31 U.S.C.
9701; 42 U.S.C. 4331 and 4332
CFR Citation: 7 CFR 318 and 319; 7
CFR 330; 7 CFR 352.
Legal Deadline: None.
Abstract: We are proposing to revise
our regulations regarding the movement
of plant pests. We are proposing to
regulate the movement of, not only
plant pests, but also biological control
organisms and associated articles. We
are proposing risk-based criteria
regarding the movement of biological
control organisms and are proposing to
exempt certain types of plant pests from
permitting requirements for their
interstate movement and movement for
environmental release. We are also
proposing to revise our regulations
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7685
regarding the movement of soil and to
establish regulations governing the
biocontainment facilities in which plant
pests, biological control organisms, and
associated articles are held. This
proposed rule replaces a previously
published proposed rule, which we are
withdrawing as part of this document.
This proposal would clarify the factors
that would be considered when
assessing the risks associated with the
movement of certain organisms,
facilitate the movement of regulated
organisms and articles in a manner that
also protects U.S. agriculture, and
address gaps in the current regulations.
Statement of Need: APHIS is
preparing a proposed rule to revise its
regulations regarding the movement of
plant pests. The revised regulations
would address the importation and
interstate movement of plant pests,
biological control organisms, and
associated articles, and the release into
the environment of biological control
organisms. The revision would also
address the movement of soil and
establish regulations governing the
biocontainment facilities in which plant
pests, biological control organisms, and
associated articles are held. This
proposal would clarify the factors that
would be considered when assessing the
risks associated with the movement of
certain organisms, facilitate the
movement of regulated organisms and
articles in a manner that also protects
U.S. agriculture, and address gaps in the
current regulations.
Summary of Legal Basis: Under
section 411(a) of the Plant Protection
Act (PPA), no person shall import,
enter, export, or move in interstate
commerce any plant pest, unless the
importation, entry, exportation, or
movement is authorized under a general
or specific permit and in accordance
with such regulations as the Secretary of
Agriculture may issue to prevent the
introduction of plant pests into the
United States or the dissemination of
plant pests within the United States.
Under section 412 of the PPA, the
Secretary may restrict the importation or
movement in interstate commerce of
biological control organisms by
requiring the organisms to be
accompanied by a permit authorizing
such movement and by subjecting the
organisms to quarantine conditions or
other remedial measures deemed
necessary to prevent the spread of plant
pests or noxious weeds. That same
section of the PPA also gives the
Secretary explicit authority to regulate
the movement of associated articles.
Alternatives: The alternatives we
considered were taking no action at this
time or implementing a comprehensive
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
risk reduction plan. This latter
alternative would be characterized as a
broad risk mitigation strategy that could
involve various options such as
increased inspection, regulations
specific to a certain organism or group
of related organisms, or extensive
biocontainment requirements.
We decided against the first
alternative because leaving the
regulations unchanged would not
address the needs identified
immediately above. We decided against
the latter alternative, because available
scientific information, personnel, and
resources suggest that it would be
impracticable at this time.
Anticipated Cost and Benefits: To be
determined.
Risks: Unless we issue such a
proposal, the regulations will not
provide a clear protocol for obtaining
permits that authorize the movement
and environmental release of biological
control organisms. This, in turn, could
impede research to explore biological
control options for various plant pests
and noxious weeds known to exist
within the United States, and could
indirectly lead to the further
dissemination of such pests and weeds.
Moreover, unless we revise the soil
regulations, certain provisions in the
regulations will not adequately address
the risk to plants, plant parts, and plant
products within the United States that
such soil might present.
Timetable:
Date
FR Cite
Notice of Intent
To Prepare an
Environmental
Impact Statement.
Notice Comment
Period End.
NPRM ..................
NPRM Comment
Period End.
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Action
10/20/09
74 FR 53673
11/19/09
05/00/12
07/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Organizations.
Government Levels Affected: Local,
State, Tribal.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Additional Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
Agency Contact: Shirley Wager—Page
Chief, Pest Permitting Branch, Plant
Health Programs, PPQ, Department of
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Agriculture, Animal and Plant Health
Inspection Service, 4700 River Road,
Unit 131, Riverdale, MD 20737–1236,
Phone: 301 734–8453.
RIN: 0579–AC98
of Hawaii for resale purposes at less
than 6 months of age.
Alternatives: To be identified.
Anticipated Cost and Benefits: To be
determined.
Risks: Not applicable.
Timetable:
USDA—APHIS
Action
Final Rule Stage
5. Importation of Live Dogs
Priority: Other Significant.
Legal Authority: 7 U.S.C. 2148
CFR Citation: 9 CFR 1 and 2.
Legal Deadline: None.
Abstract: This rulemaking would
amend the Animal Welfare Act (AWA)
regulations to regulate dogs imported for
resale as required by a recent
amendment to the AWA. Importation of
dogs for resale would be prohibited
unless the dogs are in good health, have
all necessary vaccinations, and are 6
months of age or older. This proposal
would also reflect the exemptions
provided in the amendment to the AWA
for dogs imported for research purposes
or veterinary treatment and for dogs
legally imported into the State of Hawaii
from the British Isles, Australia, Guam,
or New Zealand.
Statement of Need: The Food,
Conservation, and Energy Act of 2008
mandates that the Secretary of
Agriculture promulgate regulations to
implement and enforce new provisions
of the Animal Welfare Act (AWA)
regarding the importation of dogs for
resale. In line with the changes to the
AWA, APHIS intends to amend the
regulations in 9 CFR parts 1 and 2 to
regulate the importation of dogs for
resale.
Summary of Legal Basis: The Food,
Conservation, and Energy Act of 2008
(Pub. L. 110–246, signed into law on
Jun. 18, 2008) added a new section to
the Animal Welfare Act (7 U.S.C. 2147)
to restrict the importation of live dogs
for resale. As amended, the AWA now
prohibits the importation of dogs into
the United States for resale unless the
Secretary of Agriculture determines that
the dogs are in good health, have
received all necessary vaccinations, and
are at least 6 months of age. Exceptions
are provided for dogs imported for
research purposes or veterinary
treatment. An exception to the 6-month
age requirement is also provided for
dogs that are lawfully imported into
Hawaii for resale purposes from the
British Isles, Australia, Guam, or New
Zealand in compliance with the
applicable regulations of Hawaii,
provided the dogs are vaccinated, are in
good health, and are not transported out
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Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
09/01/11
10/31/11
76 FR 54392
08/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
Additional Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
Agency Contact: Gerald Rushin,
Veterinary Medical Officer, Animal
Care, Department of Agriculture,
Animal and Plant Health Inspection
Service, 4700 River Road, Unit 84,
Riverdale, MD 20737–1234, Phone: 301
734–0954.
RIN: 0579–AD23
USDA—APHIS
6. Animal Disease Traceability
Priority: Other Significant.
Legal Authority: 7 U.S.C. 8305
CFR Citation: 9 CFR 90.
Legal Deadline: None.
Abstract: This rulemaking would
establish a new part in the Code of
Federal Regulations containing
minimum national identification and
documentation requirements for
livestock moving interstate. The
proposed regulations specify approved
forms of official identification for each
species covered under this rulemaking
but would allow such livestock to be
moved interstate with another form of
identification, as agreed upon by animal
health officials in the shipping and
receiving States or tribes. The purpose
of the new regulations is to improve our
ability to trace livestock in the event
that disease is found.
Statement of Need: Preventing and
controlling animal disease is the
cornerstone of protecting American
animal agriculture. While ranchers and
farmers work hard to protect their
animals and their livelihoods, there is
never a guarantee that their animals will
be spared from disease. To support their
efforts, USDA has enacted regulations to
prevent, control, and eradicate disease,
and to increase foreign and domestic
confidence in the safety of animals and
animal products. Traceability helps give
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that reassurance. Traceability does not
prevent disease, but knowing where
diseased and at-risk animals are, where
they have been, and when, is
indispensable in emergency response
and in ongoing disease programs. The
primary objective of these proposed
regulations is to improve our ability to
trace livestock in the event that disease
is found in a manner that continues to
ensure the smooth flow of livestock in
interstate commerce.
Summary of Legal Basis: Under the
Animal Health Protection Act (7 U.S.C.
8301 et seq.), the Secretary of
Agriculture may prohibit or restrict the
interstate movement of any animal to
prevent the introduction or
dissemination of any pest or disease of
livestock, and may carry out operations
and measures to detect, control, or
eradicate any pest or disease of
livestock. The Secretary may
promulgate such regulations as may be
necessary to carry out the Act.
Alternatives: As part of its ongoing
efforts to safeguard animal health,
APHIS initiated implementation of the
National Animal Identification System
(NAIS) in 2004. More recently, the
Agency launched an effort to assess the
level of acceptance of NAIS through
meetings with the Secretary, listening
sessions in 14 cities, and public
comments. Although there was some
support for NAIS, the vast majority of
participants were highly critical of the
program and of USDA’s implementation
efforts. The feedback revealed that NAIS
has become a barrier to achieving
meaningful animal disease traceability
in the United States in partnership with
America’s producers.
The option we are proposing pertains
strictly to interstate movement and gives
States and tribes the flexibility to
identify and implement the traceability
approaches that work best for them.
Anticipated Cost and Benefits: A
workable and effective animal
traceability system would enhance
animal health programs, leading to more
secure market access and other societal
gains. Traceability can reduce the cost
of disease outbreaks, minimizing losses
to producers and industries by enabling
current and previous locations of
potentially exposed animals to be
readily identified. Trade benefits can
include increased competitiveness in
global markets generally, and when
outbreaks do occur, the mitigation of
export market losses through
regionalization. Markets benefit through
more efficient and timely
epidemiological investigation of animal
health issues.
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Other societal benefits include
improved animal welfare during natural
disasters.
The main economic effect of the rule
is expected to be on the beef and cattle
industry. For other species such as
horses and other equine species,
poultry, sheep and goats, swine, and
captive cervids, APHIS would largely
maintain and build on the identification
requirements of existing disease
program regulations.
Costs of an animal traceability system
would include those for tags and
interstate certificates of veterinary
inspection (ICVIs) or other movement
documentation, for animals moved
interstate. Incremental costs incurred
are expected to vary depending upon a
number of factors, including whether an
enterprise does or does not already use
eartags to identify individual cattle. For
many operators, costs of official animal
identification and ICVIs would be
similar, respectively, to costs associated
with current animal identification
practices and the in-shipment
documentation currently required by
individual States. To the extent that
official animal identification and ICVIs
would simply replace current
requirements, the incremental costs of
the rule for private enterprises would be
minimal.
Risks: This rulemaking is being
undertaken to address the animal health
risks posed by gaps in the existing
regulations concerning identification of
livestock being moved interstate. The
current lack of a comprehensive animal
traceability program is impairing our
ability to trace animals that may be
infected with disease.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
08/11/11
11/09/11
76 FR 50082
08/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: State,
Tribal.
Additional Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
Agency Contact: Neil
Hammerschmidt, Program Manager,
Animal Disease Traceability, VS,
Department of Agriculture, Animal and
Plant Health Inspection Service, 4700
River Road, Unit 46, Riverdale, MD
20737–1231, Phone: 301 734–5571.
RIN: 0579–AD24
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USDA—FOOD AND NUTRITION
SERVICE (FNS)
Proposed Rule Stage
7. Supplemental Nutrition Assistance
Program: Farm Bill of 2008 Retailer
Sanctions
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 110–246
CFR Citation: 7 CFR 276.
Legal Deadline: None.
Abstract: This proposed rule would
implement provisions under section
4132 of the Food, Conservation, and
Energy Act of 2008, also referred to as
the Farm Bill of 2008. Under section
4132, the Department of Agriculture’s
Food and Nutrition Service (FNS) is
provided with greater authority and
flexibility when sanctioning retail or
wholesale food stores that violate
Supplemental Nutrition Assistance
Program (SNAP) rules. Specifically, the
Department is authorized to assess a
civil penalty and to disqualify a retail or
wholesale food store authorized to
participate in SNAP. Previously, the
Department could assess a civil penalty
or disqualification but not both. Section
4132 also eliminates the minimum
disqualification period, which was
previously set at 6 months.
Statement of Need: This proposed
rule would implement provisions under
section 4132 of the Food, Conservation,
and Energy Act of 2008, also referred to
as the Farm Bill of 2008. Under section
4132, the Department of Agriculture’s
Food and Nutrition Service (FNS) is
provided with greater authority and
flexibility when sanctioning retail or
wholesale food stores that violate
Supplemental Nutrition Assistance
Program (SNAP) rules. Specifically, the
Department is authorized to assess a
civil penalty and to disqualify a retail or
wholesale food store authorized to
participate in SNAP. Previously, the
Department could assess a civil penalty
or disqualification, but not both. Section
4132 also eliminates the minimum
disqualification period, which was
previously set at 6 months. In addition
to implementing statutory provisions,
this rule proposes to provide a clear
administrative penalty when an
authorized retailer or wholesale food
store redeems a SNAP participant’s
program benefits without the knowledge
of the participant. All program benefits
are issued through the Electronic
Benefits Transfer (EBT) system. The
EBT system establishes data that may be
used to identify fraud committed by
retail food stores. While stealing
program benefits could be prosecuted
under current statute, program
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regulations do not provide a clear
penalty for these thefts. The proposed
rule would establish an administrative
penalty for such thefts equivalent to the
penalty for trafficking in program
benefits, which is the permanent
disqualification of a retailer or
wholesale food store from SNAP
participation. Finally, the Department
proposes to identify additional
administrative retail violations and the
associated sanction that would be
imposed against the retail food store for
committing the violation. For instance,
to maintain integrity, FNS requires retail
and wholesale food stores to key enter
EBT card data in the presence of the
actual EBT card. The proposed rule
would codify this requirement and
identify the specific sanction that would
be imposed if retail food stores are
found to be in violation.
Summary of Legal Basis: Section
4132, Food, Conservation, and Energy
Act of 2008 (Pub. L. 110–246).
Alternatives: Because this proposed
rule is under development, alternatives
are not yet articulated.
Anticipated Cost and Benefits:
Because this proposed rule is under
development, anticipated costs and
benefits have not yet been articulated.
Risks: The risk that retail or wholesale
food stores will violate SNAP rules, or
continue to violate SNAP rules, is
expected to be reduced by refining
program sanctions for participating
retailers and wholesalers.
Timetable:
Date
NPRM ..................
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Action
FR Cite
02/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Additional Information: Note: This
RIN replaces the previously issued RIN
0584–AD78.
Agency Contact: James F. Herbert,
Regulatory Review Specialist,
Department of Agriculture, Food and
Nutrition Service, 10th Floor, 3101 Park
Center Drive, Alexandria, VA 22302,
Phone: 703 305–2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584–AD88
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USDA—FNS
8. • National School Lunch and School
Breakfast Programs: Nutrition
Standards for All Foods Sold in School,
as Required by the Healthy, HungerFree Kids Act of 2010
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 111–296
CFR Citation: 7 CFR 210; 7 CFR 220.
Legal Deadline: None.
Abstract: This proposed rule would
codify the following provisions of the
Healthy, Hunger-Free Kids Act (Pub. L.
111–296; the Act) as appropriate, under
7 CFR parts 210 and 220.
Section 203 requires schools
participating in the National School
Lunch Program to make available to
children free of charge, as nutritionally
appropriate, potable water for
consumption in the place where meals
are served during meal service.
Section 208 requires the Secretary to
promulgate proposed regulations to
establish science-based nutrition
standards for all foods sold in schools
not later than December 13, 2011. The
nutrition standards would apply to all
food sold outside the school meal
programs, on the school campus, and at
any time during the school day. (11–
004)
Statement of Need: This proposed
rule would codify the following
provisions of the Healthy, Hunger-Free
Kids Act (Pub. L. 111–296; the Act) as
appropriate, under 7 CFR parts 210 and
220.
Section 203 requires schools
participating in the National School
Lunch Program to make available to
children free of charge, as nutritionally
appropriate, potable water for
consumption in the place where meals
are served during meal service.
Section 208 requires the Secretary to
promulgate proposed regulations to
establish science-based nutrition
standards for all foods sold in schools
not later than December 13, 2011. The
nutrition standards would apply to all
food sold outside the school meal
programs, on the school campus, and at
any time during the school day.
Summary of Legal Basis: There is no
existing regulatory requirement to make
water available where meals are served.
Regulations at 7 CFR parts 210.11 direct
State agencies and school food
authorities to establish such rules or
regulations necessary to control the sale
of foods in competition with lunches
served under the NSLP. Such rules or
regulations shall prohibit the sale of
foods of minimal nutritional value in
the food service areas during the lunch
periods. The sale of other competitive
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foods may, at the discretion of the State
agency and school food authority, be
allowed in the food service area during
the lunch period only if all income from
the sale of such foods accrues to the
benefit of the nonprofit school food
service or the school or student
organizations approved by the school.
State agencies and school food
authorities may impose additional
restrictions on the sale of and income
from all foods sold at any time
throughout schools participating in the
Program.
Alternatives: None.
Anticipated Cost and Benefits:
Expected Costs Analysis and Budgetary
Effects Statement: The Congressional
Budget Office determined these
provisions would incur no Federal
costs.
Expected Benefits of the Proposed
Action: The provisions in this proposed
rulemaking would result in better
nutrition for all school children.
Risks: None known.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Governmental
Jurisdictions.
Government Levels Affected: Local,
State.
Agency Contact: James F. Herbert,
Regulatory Review Specialist,
Department of Agriculture, Food and
Nutrition Service, 10th Floor, 3101 Park
Center Drive, Alexandria, VA 22302,
Phone: 703 305–2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584–AE09
USDA—FNS
9. • WIC: Electronic Benefit Transfer
(EBT) Implementation
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 111–296
CFR Citation: 7 CFR 246.
Legal Deadline: NPRM, Statutory,
October 1, 2020, Require all WIC State
agencies to implement EBT Statewide.
Abstract: This proposed rule would
revise and expand regulations regarding
WIC EBT at 7 CFR 246 and implement
statutory provisions related to EBT as
defined in the Healthy, Hunger-Free
Kids Act of 2010, Public Law 11–296.
The EBT requirements addressed in the
proposed rule would promote improved
access to Program benefits, standardize
EBT operations, and establish
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implementation guidelines and
timeframes.
Statement of Need: This proposed
rule would revise and expand
regulations regarding WIC EBT at 7 CFR
246 and implement statutory provisions
related to EBT as defined in the Healthy,
Hunger-Free Kids Act of 2010, Public
Law 11–296. The EBT requirements
addressed in the proposed rule would
promote improved access to program
benefits, standardize EBT operations,
and establish implementation
guidelines and timeframes.
WIC EBT has been an ongoing effort
within the WIC community for several
years. The proposed rule would address
the following:
• Set forth the definition of EBT.
• Require all WIC State agencies to
implement EBT statewide by October 1,
2020.
• Require State agencies to submit
status reports demonstrating their
progress toward Statewide EBT
implementation.
• Revise the current provision
regarding the imposition of EBT costs to
vendors to include: (1) The formation of
cost-sharing criteria associated with any
equipment or system not solely
dedicated to EBT; (2) the allowance of
the payment of fees imposed by a thirdparty processor for EBT transactions; (3)
the disallowance of the payment of
interchange fees; (4) clarification of EBT
cost impositions after Statewide
implementation; (5) elimination of the
requirement for State agencies to fund
ongoing maintenance costs for vendors
using multi-function EBT equipment;
and (6) require vendors to demonstrate
the capability to accept program benefits
electronically prior to authorization
after Statewide implementation of EBT.
• Establish minimum lane coverage
guidelines for vendor equipment, as set
forth in the operating rules, and require
State agencies to provide the necessary
EBT-only equipment if vendors do not
wish to acquire multi-function
equipment.
• Require that EBT technical
standards and operating rules be
established and adhered to by State
agencies.
• Require all State agencies to use the
universal product code database.
Summary of Legal Basis: Healthy,
Hunger-Free Kids Act of 2010 (Pub. L.
111–296).
Alternatives: None.
Anticipated Cost and Benefits:
Expected Costs Analysis and Budgetary
Effects Statement:
FNS estimates costs of approximately
$30 to $60 million per fiscal year (as
reflected in the program’s budget) for
State agencies to comply with the
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mandate. The costs will vary depending
on implementation activity and are
expected to decline as more State
agencies adopt WIC EBT.
Expected Benefits of the Proposed
Action: The EBT requirements
addressed in the proposed rule would
promote improved access to program
benefits, standardize EBT operations,
and establish implementation
guidelines and timeframes.
Risks: None known.
Timetable:
Action
Date
NPRM ..................
FR Cite
06/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: James F. Herbert,
Regulatory Review Specialist,
Department of Agriculture, Food and
Nutrition Service, 10th Floor, 3101 Park
Center Drive, Alexandria, VA 22302,
Phone: 703 305–2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584–AE21
USDA—FNS
Final Rule Stage
10. Nutrition Standards in the National
School Lunch and School Breakfast
Programs
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 108–265, sec
103
CFR Citation: 7 CFR 210; 7 CFR 220.
Legal Deadline: None.
Abstract: Public Law 108–265
requires the Secretary to issue
regulations that reflect specific
recommendations for increased
consumption of foods and food
ingredients in school nutrition programs
based on the most recent Dietary
Guidelines for Americans.
The current regulations require that
reimbursable meals offered by schools
meet the applicable recommendations of
the Dietary Guidelines for Americans.
This rule would revise the regulations
on meal patterns and nutrition
standards to ensure that school meals
reflect the 2005 Dietary Guidelines for
Americans (04–017).
Statement of Need: This final rule
will implement the requirement in
section 201 of the Healthy, Hunger-Free
Kids Act of 2010 (Pub. L. 111–296) (the
Act) that USDA promulgate regulations
to update the meal patterns and
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nutrition standards for school lunches
and breakfasts based on
recommendations made by the Institute
of Medicine (IOM). USDA issued a
proposed rule on January 13, 2011. The
Act requires USDA to issue interim or
final regulations not later than 18
months after promulgation of the
proposed regulation.
This final rule will implement meal
patterns and nutrition standards
recommended by IOM in its report
‘‘School Meals: Building Blocks for
Healthy Children.’’ In addition, the final
rule will address the comments
submitted by the public in response to
USDA’s proposed rule.
Summary of Legal Basis: The meal
patterns and nutrition standards for
school lunches and breakfast are
established in 7 CFR 210.10 and 7 CFR
220.8, respectively. State agencies
monitor compliance with the meal
patterns and nutrition standards
through program reviews authorized in
7 CFR 210.19.
Alternatives: None.
Anticipated Cost and Benefits:
Expected Costs Analysis and Budgetary
Effects Statement:
While there are no increased Federal
costs associated with implementation of
this final rule, the Act provides schools
that comply with the new meal
requirements with an increased Federal
reimbursement. The Act also provides
Federal funding for training, technical
assistance, certification, and oversight
activities related to compliance with
this rule. It is expected that the total
costs of compliance with the final rule
will exceed $100 million per year.
Expected Benefits of the Proposed
Action: The final rule is projected to
make substantial improvements to the
meals served daily in over 101,000
schools nationwide to more than 31
million children. It will align school
meals with national nutrition guidelines
and help safeguard the health of school
children.
Risks: None known.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
01/13/11
04/13/11
76 FR 2494
02/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Local,
State.
Federalism: This action may have
federalism implications as defined in
EO 13132.
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Agency Contact: James F. Herbert,
Regulatory Review Specialist,
Department of Agriculture, Food and
Nutrition Service, 10th Floor, 3101 Park
Center Drive, Alexandria, VA 22302,
Phone: 703 305–2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584–AD59
USDA—FNS
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11. Direct Certification of Children in
Food Stamp Households and
Certification of Homeless, Migrant, and
Runaway Children for Free Meals
Priority: Other Significant. Major
under 5 U.S.C. 801.
Legal Authority: Pub. L. 108–265, sec
104
CFR Citation: 7 CFR 210; 7 CFR 215;
7 CFR 220; 7 CFR 225; 7 CFR 226; 7 CFR
245.
Legal Deadline: None.
Abstract: In response to Public Law
108–265, which amended the Richard B.
Russell National School Lunch Act, 7
CFR 245, Determining Eligibility for
Free and Reduced Price Meals and Free
Milk in Schools, is amended to establish
categorical (automatic) eligibility for
free meals and free milk upon
documentation that a child is (1)
homeless as defined by the McKinneyVento Homeless Assistance Act; (2) a
runaway served by grant programs
under the Runaway and Homeless
Youth Act; or (3) migratory as defined
in section 1309(2) of the Elementary and
Secondary Education Act. The rule also
requires phase-in of mandatory direct
certification for children who are
members of households receiving
benefits from the Supplemental
Nutrition Assistance Program and
continues discretionary direct
certification for other categorically
eligible children (04–018).
Statement of Need: The changes made
to the Richard B. Russell National
School Lunch Act concerning direct
certification are intended to improve
program access, reduce paperwork, and
improve the accuracy of the delivery of
free meal benefits. This regulation will
implement the statutory changes and
provide State agencies and local
educational agencies with the policies
and procedures to conduct mandatory
and discretionary direct certification.
Summary of Legal Basis: These
changes are being made in response to
provisions in Public Law 108–265.
Alternatives: None; statutory
requirements.
Anticipated Cost and Benefits: This
regulation will reduce paperwork, target
benefits more precisely, and will
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improve program access of eligible
school children.
Risks: This regulation may require
adjustments to existing computer
systems to more readily share
information between schools and
assistance agencies.
Timetable:
available only through waivers. These
provisions would allow State agencies
to average student work hours and to
provide telephone interviews in lieu of
face-to-face interviews. FNS anticipates
that this rule would impact the
associated paperwork burdens (08–006).
Statement of Need: This proposed
rule would amend the regulations
governing SNAP to implement
Action
Date
FR Cite
provisions from the FCEA concerning
Interim Final Rule
04/25/11 76 FR 22785 the eligibility and certification of SNAP
Interim Final Rule
06/24/11
applicants and participants and SNAP
Effective.
employment and training. In addition,
Interim Final Rule
10/24/11
this proposed rule would revise the
Comment PeSNAP regulations throughout 7 CFR
riod End.
part 273 to change the program name
Final Rule ............
05/00/12
from the Food Stamp Program to SNAP
and to make other nomenclature
Regulatory Flexibility Analysis
changes as mandated by the FCEA. The
Required: No.
statutory effective date of these
Small Entities Affected: No.
provisions was October 1, 2008. FNS is
Government Levels Affected: Local,
also proposing two discretionary
State.
revisions to SNAP regulations to
Agency Contact: James F. Herbert,
provide State agencies options that are
Regulatory Review Specialist,
currently available only through
Department of Agriculture, Food and
Nutrition Service, 10th Floor, 3101 Park waivers. These provisions would allow
State agencies to average student work
Center Drive, Alexandria, VA 22302,
hours and to provide telephone
Phone: 703 305–2572, Email:
interviews in lieu of face-to-face
james.herbert@fns.usda.gov.
interviews. FNS anticipates that this
Related RIN: Merged with 0584–
rule would impact the associated
AD62.
paperwork burdens.
RIN: 0584–AD60
Summary of Legal Basis: Food,
Conservation, and Energy Act of 2008
(Pub. L. 110–246).
USDA—FNS
Alternatives: Most aspects of the rule
are non-discretionary and tie to explicit,
12. Eligibility, Certification, and
Employment and Training Provisions of specific requirements for SNAP in the
the Food, Conservation, and Energy Act FCEA. However, FNS did consider
alternatives in implementing section
of 2008
4103 of the FCEA, Elimination of
Priority: Economically Significant.
Dependent Care Deduction Caps. FNS
Major under 5 U.S.C. 801.
considered whether to limit deductible
Legal Authority: Pub. L. 110–246; Pub. expenses to costs paid directly to the
L. 104–121
care provider or whether to permit
CFR Citation: 7 CFR 273.
households to deduct other expenses
Legal Deadline: None.
associated with dependent care in
Abstract: This proposed rule would
addition to the direct costs. FNS chose
amend the regulations governing the
to allow households to deduct the cost
Supplemental Nutrition Assistance
of transportation to and from the
Program (SNAP) to implement
dependent care provider and the cost of
provisions from the Food, Conservation, separately identified activity fees that
and Energy Act of 2008 (Pub. L. 110–
are associated with dependent care.
246) (FCEA) concerning the eligibility
Section 4103 signaled an important shift
and certification of SNAP applicants
in congressional recognition that
and participants and SNAP employment dependent care costs constitute major
and training. In addition, this proposed
expenses for working households. In
rule would revise the SNAP regulations addition, it was noted during the floor
throughout 7 CFR part 273 to change the discussion in both houses of Congress
program name from the Food Stamp
prior to passage of the FCEA that some
Program to SNAP and to make other
States already counted transportation
nomenclature changes as mandated by
costs as part of dependent care
the FCEA. The statutory effective date of expenditures.
these provisions was October 1, 2008.
Anticipated Cost and Benefits: The
Food and Nutrition Service (FNS) is also estimated total SNAP costs to the
proposing two discretionary revisions to Government of the FCEA provisions
SNAP regulations to provide State
implemented in the rule are estimated
agencies options that are currently
to be $831 million in FY 2010 and
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$5.619 billion over the 5 years FY 2010
through FY 2014. These impacts are
already incorporated into the
President’s budget baseline.
There are many potential societal
benefits of this rule. Some provisions
may make some households newly
eligible for SNAP benefits. Other
provisions may increase SNAP benefits
for certain households. Certain
provisions in the rule will reduce the
administrative burden for households
and State agencies.
Risks: The statutory changes and
discretionary ones under consideration
would streamline program operations.
The changes are expected to reduce the
risk of inefficient operations.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
05/04/11
07/05/11
76 FR 25414
10/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: Local,
State.
Agency Contact: Kevin Kwon, Chief,
Planning and Regulatory Affairs Branch,
Department of Agriculture, Food and
Nutrition Service, 10th Floor, 3101 Park
Center Drive, Alexandria, VA 22302,
Phone: 703 605–0800, Email:
kevin.kwon@fns.usda.gov.
RIN: 0584–AD87
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USDA—FNS
13.• Supplemental Nutrition
Assistance Program: Nutrition
Education and Obesity Prevention
Grant
Priority: Other Significant.
Legal Authority: Pub. L. 111–296
CFR Citation: 7 CFR 272.
Legal Deadline: Final, Statutory,
January 1, 2012, Pub. L. 111–296
Abstract: [Pub. L. 111–296, The
Healthy, Hunger-Free Kids Act of 2001,
title II; Reducing Childhood Obesity and
Improving the Diets of Children, subtitle
D; Miscellaneous, sec. 241.] The
Nutrition Education and Obesity
Prevention Grant Program amends the
Food and Nutrition Act of 2008 to
replace the current nutrition education
program under the Act with a program
providing grants to States for the
implementation of a nutrition education
and obesity prevention program that
promotes healthy food choices
consistent with the most recent Dietary
Guidelines for Americans.
Statement of Need: The Nutrition
Education and Obesity Prevention Grant
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Program rule amends the Food and
Nutrition Act of 2008 to replace the
current nutrition education program
under the Act with a program providing
grants to States for the implementation
of a nutrition education and obesity
prevention program that promotes
healthy food choices consistent with the
most recent Dietary Guidelines for
Americans. This rule will implement all
requirements of the law. It makes
eligible for program participation: (1)
Supplemental Nutrition Assistance
Program (SNAP) participants, (2)
participants in the school lunch or
breakfast programs, and (3) individuals
who reside in low-income communities
or are low-income individuals. The rule
continues commitment to serving lowincome populations while focusing on
the issue of obesity, a priority of this
Administration. It ensures that
interventions implemented as part of
State nutrition education plans
recognize the constrained resources of
the eligible population.
The rule requires activities be sciencebased and outcome-driven and provides
for accountability and transparency
through State plans. It will require
coordination and collaboration among
Federal agencies and stakeholders,
including the Centers for Disease
Control and Prevention, the public
health community, the academic and
research communities, nutrition
education practitioners, representatives
of State and local governments, and
community organizations that serve the
low-income populations. The rule
allows for 100 percent Federal funding,
and States will not have to provide
matching funds. The grant funding will
be based on 2009 expenditures. For 3
years after enactment, States will
receive grant funds based on their level
of funds expended for the 2009 base
year with funds indexed for inflation
thereafter. The new funding structure is
phased in over a 7-year period. From
fiscal year 2014 forward, funds will be
allocated based on a formula that
considers participation.
Summary of Legal Basis: Section 241,
Healthy, Hunger-Free Kids Act of 2010
(Pub. L. 111–296).
Alternatives: None.
Anticipated Cost and Benefits:
Expected Costs Analysis and Budgetary
Effects Statement:
The action allows for 100 percent
Federal funding which gives States
more flexibility to target services where
they can be most effective without the
constraints of a State match. For 3 years
after enactment, States will receive grant
funds based on their level of funds
expended for the 2009 base year with
funds indexed for inflation thereafter.
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The new funding structure is phased in
over a 7-year period. From fiscal year
2014 forward, funds will be allocated
based on a formula that considers
participation.
Expected Benefits of the Proposed
Action: This regulatory action seeks to
improve the effectiveness of the
program and make it easier for the
States to administer, while still allowing
funding to grow. It allows for 100
percent Federal funding, which gives
States more flexibility to target services
where they can be most effective
without the constraints of a State match.
It allows grantees to adopt individual
and group-based nutrition education, as
well as community and public health
approaches. It allows coordinated
services to be provided to participants
in all the Federal food assistance
programs and to other low-income
persons.
Risks: None known.
Timetable:
Action
Date
Interim Final Rule
FR Cite
01/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: State.
Agency Contact: James F. Herbert,
Regulatory Review Specialist,
Department of Agriculture, Food and
Nutrition Service, 10th Floor, 3101 Park
Center Drive, Alexandria, VA 22302,
Phone: 703 305–2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584–AE07
USDA—FOOD SAFETY AND
INSPECTION SERVICE (FSIS)
Proposed Rule Stage
14. Prior Labeling Approval System:
Generic Label Approval
Priority: Other Significant.
Legal Authority: 21 U.S.C. 451 to 470;
21 U.S.C. 601 to 695
CFR Citation: 9 CFR 317; 9 CFR 327;
9 CFR 381; 9 CFR 412.
Legal Deadline: None.
Abstract: This rulemaking will
continue an effort initiated several years
ago by amending FSIS’ regulations to
expand the types of labeling that are
generically approved. FSIS plans to
propose that the submission of labeling
for approval prior to use be limited to
certain types of labeling, as specified in
the regulations. In addition, FSIS plans
to reorganize and amend the regulations
by consolidating the nutrition labeling
rules that currently are stated separately
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for meat and poultry products (in part
317, subpart B, and part 381, subpart Y,
respectively) and by amending their
provisions to set out clearly various
circumstances under which these
products are misbranded.
Statement of Need: Expanding the
types of labeling that are generically
approved would permit Agency
personnel to focus their resources on
evaluating only those claims or special
statements that have health and safety
or economic implications. This would
essentially eliminate the time needed
for FSIS personnel to evaluate labeling
features and allocate more time for staff
to work on other duties and
responsibilities. A major advantage of
this proposal is that it is consistent with
FSIS’ current regulatory approach,
which separates industry and Agency
responsibilities.
Summary of Legal Basis: 21 U.S.C.
457 and 607.
Alternatives: FSIS considered several
options. The first was to expand the
types of labeling that would be
generically approved and consolidate
into one part all of the labeling
regulations applicable to products
regulated under the FMIA and PPIA and
the policies currently contained in FSIS
Directive 7220.1, Revision 3. The
second option FSIS considered was to
consolidate only the meat and poultry
regulations that are similar and to
expand the types of generically
approved labeling that can be applied
by Federal and certified foreign
establishments. The third option, and
the one favored by FSIS, was to amend
the prior labeling approval system in an
incremental three-phase approach.
Anticipated Cost and Benefits: The
proposed rule would permit the Agency
to realize an estimated discounted cost
savings of $2.9 million over 10 years.
The proposed rule would be beneficial
because it would streamline the generic
labeling process, while imposing no
additional cost burden on
establishments. Consumers would
benefit because industry would have the
ability to introduce products into the
marketplace more quickly.
Risks: None
Timetable:
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Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
12/05/11
02/03/12
76 FR 75809
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Jeff Canavan,
Labeling and Program Delivery Division,
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Department of Agriculture, Food Safety
and Inspection Service, Patriots Plaza 3,
8th Floor, 8–146, Stop 5273, 1400
Independence Avenue SW.,
Washington, DC 20250–5273, Phone:
301 504–0878, Fax: 301 504–0872,
Email: jeff.canavan@fsis.usda.gov.
RIN: 0583–AC59
USDA—FSIS
15. Product Labeling: Use of the
Voluntary Claim ‘‘Natural’’ on the
Labeling of Meat and Poultry Products
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601 et seq.;
21 U.S.C. 451 et seq.
CFR Citation: 9 CFR 317; 9 CFR 381.
Legal Deadline: None.
Abstract: The Food Safety and
Inspection Service (FSIS) is proposing
to amend the Federal meat and poultry
products inspection regulations to
define the conditions under which it
will permit the voluntary claim
‘‘natural’’ to be used in the labeling of
meat and poultry products. FSIS is also
proposing that label approval requests
for labels that contain ‘‘natural’’ claims
include documentation to demonstrate
that the products meet the criteria to
bear a ‘‘natural’’ claim. FSIS is
proposing to require that meat or
poultry products meet these conditions
to qualify for a ‘‘natural’’ claim to make
the claim more meaningful to
consumers.
Statement of Need: A codified
‘‘natural’’ claim definition will reduce
uncertainty about which products
qualify to be labeled as ‘‘natural’’ and
will increase consumer confidence in
the claim. A codified ‘‘natural’’
definition that clearly articulates the
criteria that meat and poultry products
must meet to qualify to be labeled as
‘‘natural’’ will make the Agency’s
approval of ‘‘natural’’ claims more
transparent and will allow the Agency
to review labels that contain ‘‘natural’’
claims in a more efficient and consistent
manner. A codified ‘‘natural’’ definition
will also make the claim more
meaningful to consumers.
Summary of Legal Basis: 21 U.S.C.
601 et seq.; 21 U.S.C. 451 et seq.
Alternatives: The Agency has
considered not proceeding with
rulemaking and maintaining the existing
policy guidance on ‘‘natural’’ claims
and using that policy guidance to
evaluate ‘‘natural’’ claims on a case-bycase basis. The Agency has also
considered alternative definitions of
‘‘natural’’ and establishing separate
codified definitions of ‘‘natural,’’
‘‘natural * * * minimally processed,’’
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and ‘‘natural * * * minimally
processed/all natural ingredients.’’
Anticipated Cost and Benefits: FSIS
anticipates that a clear and simple
definition of ‘‘natural’’ will minimize
cognitive costs to consumers. FSIS also
anticipates benefits from a consistent
USDA policy on ‘‘natural’’ claims. FSIS
anticipates costs to establishments to
change their labels or change their
production practices.
Risks: None.
Timetable:
Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
09/14/09
11/13/09
74 FR 46951
09/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Rosalyn MurphyJenkins, Director, Labeling and Program
Delivery Division, Department of
Agriculture, Food Safety and Inspection
Service, Patriots Plaza 3, 8th Floor,
Room 8–148, Stop 5273, 1400
Independence Avenue SW, Washington,
DC 20250–5273, Phone: 301 504–0878,
Fax: 301 504–0872, Email:
rosalyn.murphy-jenkins@fsis.usda.gov.
RIN: 0583–AD30
USDA—FSIS
16. New Poultry Slaughter Inspection
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 451 et seq.
CFR Citation: 9 CFR 381.66; 9 CFR
381.67; 9 CFR 381.76; 9 CFR 381.83; 9
CFR 381.91; 9 CFR 381.94.
Legal Deadline: None.
Abstract: FSIS is proposing a new
inspection system for young poultry
slaughter establishments that would
facilitate public health-based
inspection. This new system would be
available initially only to young chicken
and turkey slaughter establishments.
Establishments that slaughter broilers,
fryers, roasters, and Cornish game hens
(as defined in 9 CFR 381.170) would be
considered as ‘‘young chicken
establishments.’’ FSIS is also proposing
to revoke the provisions that allow
young chicken slaughter establishments
to operate under the current
Streamlined Inspection System (SIS) or
the New Line Speed (NELS) Inspection
System, and to revoke the New Turkey
Inspection System (NTIS). FSIS
anticipates that this proposed rule
would provide the framework for action
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to provide public health-based
inspection in all establishments that
slaughter amenable poultry species.
Under the proposed new system,
young chicken slaughter establishments
would be required to sort chicken
carcasses and to conduct other activities
to ensure that carcasses are not
adulterated before they enter the
chilling tank.
Statement of Need: Because of the risk
to the public health associated with
pathogens on young chicken carcasses,
FSIS is proposing a new inspection
system that would allow for more
effective inspection of young chicken
carcasses, would allow the Agency to
more effectively allocate its resources,
would encourage industry to more
readily use new technology, and would
include new performance standards to
reduce pathogens.
This proposed rule is an example of
regulatory reform because it would
facilitate technological innovation in
young chicken slaughter establishments.
It would likely result in more costeffective dressing of young chickens that
are ready to cook or ready for further
processing. Similarly, it would likely
result in more efficient and effective use
of Agency resources.
Summary of Legal Basis: 21 U.S.C.
451 to 470.
Alternatives: FSIS considered the
following options in developing this
proposal:
(1) No action.
(2) Propose to implement HACCPbased Inspection Models Pilot in
regulations.
(3) Propose to establish a mandatory,
rather than a voluntary, new inspection
system for young chicken slaughter
establishments.
Anticipated Cost and Benefits: Not
publicly available at this time.
Risks: Salmonella and other
pathogens are present on a substantial
portion of poultry carcasses inspected
by FSIS. Foodborne salmonella cause a
large number of human illnesses that at
times lead to hospitalization and even
death. There is an apparent relationship
between human illness and prevalence
levels for salmonella in young chicken
carcasses. FSIS believes that through
better allocation of inspection resources
and the use of performance standards, it
would be able to better address the
prevalence of salmonella and other
pathogens in young chickens.
Timetable:
Action
Date
NPRM ..................
FR Cite
01/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
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Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Dr. Daniel L.
Engeljohn, Assistant Administrator,
Office of Policy and Program
Development, Department of
Agriculture, Food Safety and Inspection
Service, 1400 Independence Avenue
SW., Washington, DC 20250, Phone: 202
205–0495, Fax: 202 401–1760, Email:
daniel.engeljohn@fsis.usda.gov.
RIN: 0583–AD32
USDA—FSIS
17. Electronic Imported Product
Inspection Application and
Certification of Imported Product and
Foreign Establishments; Amendments
To Facilitate the Public Health
Information System (PHIS)
Priority: Other Significant.
Legal Authority: Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 to
695), the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451 to 470); Egg
Products Inspection Act (EPIA) (21
U.S.C. 1031 to 1056)
CFR Citation: 9 CFR 304.3; 9 CFR
327.2 and 327.4; 9 CFR 381.196 to
381.198; 9 CFR 590.915 and 590.920.
Legal Deadline: None.
Abstract: FSIS is proposing to amend
the meat, poultry, and egg products
import inspection regulations to provide
for an electronic import inspection
application, and electronic imported
product foreign inspection and foreign
establishment certification system. FSIS
is also proposing to delete the
‘‘streamlined’’ import inspection
procedures for Canadian product. In
addition, the Agency is proposing that
official import inspection establishment
must develop, implement, and maintain
written Sanitation SOPs, as provided in
9 CFR 416.11 through 416.17. FSIS is
also announcing that it is discontinuing
its practice of conducting imported
product reinspection based on a foreign
government’s guarantee.
Statement of Need: FSIS is proposing
these regulations to provide for the
electronic import system, which will be
available through the Agency’s Public
Health Information System (PHIS), a
computerized, Web-based inspection
information system. The import system
will enable applicants to electronically
submit and track import inspection
applications that are required for all
commercial entries of FSIS-regulated
products imported into the U.S. FSIS
inspection program personnel will be
able to access the PHIS system to assign
appropriate imported product
inspection activities. The electronic
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import system will also facilitate the
imported product foreign inspection
and annual foreign establishment
certifications by providing immediate
and direct electronic government-togovernment exchange of information.
The Agency is proposing to delete the
Canadian streamlined import inspection
procedures because they have not been
in use since 1990 and are obsolete.
Sanitation SOPs are written procedures
establishments develop, implement, and
maintain to prevent direct
contamination or adulteration of meat or
poultry products. To ensure that
imported meat and poultry products do
not become contaminated while
undergoing reinspection prior to
entering the U.S., FSIS is proposing to
clarify that official import inspection
establishments must develop written
Sanitation SOPs.
Summary of Legal Basis: 21 U.S.C.
601 to 695; 21 U.S.C. 451 to 470; 21
U.S.C. 1031 to 1056.
Alternatives: The use of the electronic
import system is voluntary. The Agency
will continue to accept and process
paper import inspection applications,
and foreign establishment and imported
product foreign inspection certificates.
The Canadian streamlined import
inspection procedures are not currently
in use. Proposing Sanitation SOPs in
official import inspection
establishments will prevent direct
contamination or adulteration of
product. Therefore, no alternatives were
considered.
Anticipated Cost and Benefits: Under
this proposed rule, the industry will
have the option of filing inspection
applications electronically and
submitting electronic imported foreign
inspection product and establishment
certificates through the PHIS. Since the
electronic option is voluntary,
applicants and the foreign countries that
choose to file electronically will do so
only if the benefits outweigh the cost.
Sanitation SOPs are a condition of
approval for official import inspection
establishments and as a requirement for
official import inspection
establishments to continue to operate
under Federal inspection. The proposed
rule will clarify that official import
inspection establishments must have
developed written Sanitation SOPs
before being granted approval and that
existing official import inspection
establishments must meet Sanitation
SOP requirements. Since, in practice,
FSIS has always expected official
import inspection establishments to
maintain Sanitation SOPs during the
reinspection of imported products, the
proposed amendment for these
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sanitation requirements will have little,
if any, cost impact on the industry.
Risks: None.
Timetable:
Action
Date
NPRM ..................
FR Cite
03/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Mary Stanley,
Director, International Policy Division
Office of Policy and Program,
Department of Agriculture, Food Safety
and Inspection Service, Room 2125,
1400 Independence Avenue SW.,
Washington, DC 20250, Phone: 202 720–
0287.
RIN: 0583–AD39
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USDA—FSIS
18. Electronic Export Application and
Certification as a Reimbursable Service
and Flexibility in the Requirements for
Official Export Inspection Marks,
Devices, and Certificates
Priority: Other Significant.
Legal Authority: Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 to
695); Poultry Products Inspection Act
(PPIA) (21 U.S.C. 451 to 470); Egg
Products Inspection Act (EPIA) (21
U.S.C. 1031 to 1056)
CFR Citation: 9 CFR 312.8; 9 CFR
322.1 and 322.2; 9 CFR 350.7; 9 CFR
362.5; 9 CFR 381.104 to 381.106; 9 CFR
590.407; 9 CFR 592.20 and 592.500.
Legal Deadline: None.
Abstract: The Food Safety and
Inspection Service (FSIS) is proposing
to amend the meat, poultry, and egg
product inspection regulations to
provide an electronic export application
and certification system. The electronic
export application and certification
system will be a component of the
Agency’s Public Health Information
System (PHIS). The export component
of PHIS will be available as an
alternative to the paper-based
application and certification process.
FSIS is proposing to charge users for the
use of the proposed system. FSIS is
proposing to establish a formula for
calculating the fee. FSIS is also
proposing to provide establishments
that export meat, poultry, and egg
products with flexibility in the official
export inspection marks, devices, and
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certificates. In addition, FSIS is
proposing egg product export
regulations that parallel the meat and
poultry export regulations.
Statement of Need: FSIS is proposing
these regulations to facilitate the
electronic processing of export
applications and certificates through the
Public Health Information System
(PHIS), a computerized, Web-based
inspection information system. The
current export application and
certification regulations provide only for
a paper-based process. This proposed
rule will provide this electronic export
system as a reimbursable certification
service charged to the exporter.
Summary of Legal Basis: 21 U.S.C.
601 to 695; 21 U.S.C. 451 to 470; 21
U.S.C. 1031 to 1056; 7 U.S.C. 1622(h).
Alternatives: The electronic export
applications and certification system is
being proposed as a voluntary service;
therefore, exporters have the option of
continuing to use the current paperbased system. Therefore, no alternatives
were considered.
Anticipated Cost and Benefits: FSIS is
proposing to charge exporters an
application fee for the electronic system.
Automating the export application and
certification process will facilitate the
exportation of U.S. meat, poultry, and
egg products by streamlining and
automating the processes that are in use
while ensuring that foreign regulatory
requirements are met. The cost to an
exporter would depend on the number
of electronic applications submitted. An
exporter that submits only a few
applications per year would not be
likely to experience a significant
economic impact. Under this proposal,
inspection personnel workload is
reduced through the elimination of the
physical handling and processing of
applications and certificates. When an
electronic government-to-government
system interface or data exchange is
used, fraudulent transactions, such as
false alterations and reproductions, will
be significantly reduced, if not
eliminated. The electronic export
system is designed to ensure
authenticity, integrity, and
confidentiality. Exporters will be
provided a more efficient and effective
application and certification process.
The proposed egg product export
regulations provide the same export
requirements across all products
regulated by FSIS and consistency in
the export application and certification
process. The total annual paperwork
burden to egg processing industry to fill
out the paper-based export application
is approximately $32,340 per year for a
total of 924 hours a year. The average
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establishment burden would be 11
hours, and $385.00 per establishment.
Risks: None.
Timetable:
Action
Date
NPRM ..................
FR Cite
01/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Dr. Ron Jones,
Assistant Administrator, Office of
International Affairs, Department of
Agriculture, Food Safety and Inspection
Service, 1400 Independence Avenue
SW., Washington, DC 20250, Phone: 202
720–3473.
RIN: 0583–AD41
USDA—FSIS
Final Rule Stage
19. Performance Standards for the
Production of Processed Meat and
Poultry Products; Control of Listeria
Monocytogenes in Ready-to-Eat Meat
and Poultry Products
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 451 et seq.;
21 U.S.C. 601 et seq.
CFR Citation: 9 CFR 301; 9 CFR 303;
9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR
320; 9 CFR 325; 9 CFR 331; 9 CFR 381;
9 CFR 417; 9 CFR 430; 9 CFR 431.
Legal Deadline: None.
Abstract: FSIS has proposed to
establish pathogen reduction
performance standards for all ready-toeat (RTE) and partially heat-treated meat
and poultry products, and measures,
including testing, to control Listeria
monocytogenes in RTE products. The
performance standards spell out the
objective level of pathogen reduction
that establishments must meet during
their operations in order to produce safe
products, but allow the use of
customized, plant-specific processing
procedures other than those prescribed
in the earlier regulations. With HACCP,
food safety performance standards give
establishments the incentive and
flexibility to adopt innovative, sciencebased food safety processing procedures
and controls, while providing objective,
measurable standards that can be
verified by Agency inspectional
oversight. This set of performance
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standards will include and be consistent
with standards already in place for
certain ready-to-eat meat and poultry
products.
Statement of Need: Although FSIS
routinely samples and tests some readyto-eat products for the presence of
pathogens prior to distribution, there are
no specific regulatory pathogen
reduction requirements for most of these
products. The proposed performance
standards are necessary to help ensure
the safety of these products; give
establishments the incentive and
flexibility to adopt innovative, sciencebased food safety processing procedures
and controls; and provide objective,
measurable standards that can be
verified by Agency oversight.
Summary of Legal Basis: 21 U.S.C.
601 to 695; 21 U.S.C. 451 to 470.
Alternatives: As an alternative to all of
the proposed requirements, FSIS
considered taking no action. As
alternatives to the proposed
performance standard requirements,
FSIS considered end-product testing
and requiring ‘‘use-by’’ date labeling on
ready-to-eat products.
Anticipated Cost and Benefits:
Benefits are expected to result from
fewer contaminated products entering
commercial food distribution channels
as a result of improved sanitation and
process controls and in-plant
verification. FSIS believes that the
benefits of the rule would exceed the
total costs of implementing its
provisions. FSIS currently estimates net
benefits from the 2003 interim final rule
at $470 to $575 million, with annual
recurring costs at $150.4 million, if FSIS
discounts the capital cost at 7 percent.
FSIS is continuing to analyze the
potential impact of the other provisions
of the proposal.
The other main provisions of the
proposed rule are: Lethality
performance standards for Salmonella
and E. coli O157:H7 and stabilization
performance standards for C.
perfringens that firms must meet when
producing RTE meat and poultry
products. Most of the costs of these
requirements would be associated with
one-time process performance
validation in the first year of
implementation of the rule and with
revision of HACCP plans. Benefits are
expected to result from the entry into
commercial food distribution channels
of product with lower levels of
contamination resulting from improved
in-plant process verification and
sanitation. Consequently, there will be
fewer cases of foodborne illness.
Risks: Before FSIS published the
proposed rule, FDA and FSIS had
estimated that each year
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L. monocytogenes caused 2,540 cases of
foodborne illness, including 500
fatalities. The Agencies estimated that
about 65.3 percent of these cases, or
1660 cases and 322 deaths per year,
were attributable to RTE meat and
poultry products. The analysis of the
interim final rule on control of
L. monocytogenes conservatively
estimated that implementation of the
rule would lead to an annual reduction
of 27.3 deaths and 136.7 illnesses at the
median. FSIS is continuing to analyze
data on production volume and Listeria
controls in the RTE meat and poultry
products industry and is using the FSIS
risk assessment model for
L. monocytogenes to determine the
likely risk reduction effects of the rule.
Preliminary results indicate that the risk
reductions being achieved are
substantially greater than those
estimated in the analysis of the interim
rule.
FSIS is also analyzing the potential
risk reductions that might be achieved
by implementing the lethality and
stabilization performance standards for
products that would be subject to the
proposed rule. The risk reductions to be
achieved by the proposed rule and that
are being achieved by the interim rule
are intended to contribute to the
Agency’s public health protection effort.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period Extended End.
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
NPRM Comment
Period Reopened.
NPRM Comment
Period Reopened End.
Affirmation of Interim Final Rule.
Final Action .........
02/27/01
05/29/01
66 FR 12590
07/03/01
66 FR 35112
09/10/01
06/06/03
10/06/03
68 FR 34208
01/31/05
03/24/05
70 FR 15017
05/09/05
01/00/12
09/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Dr. Daniel L.
Engeljohn, Assistant Administrator,
Office of Policy and Program
Development,Department of
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Agriculture, Food Safety and Inspection
Service, 1400 Independence Avenue
SW., Washington, DC 20250, Phone: 202
205–0495, Fax: 202 401–1760, Email:
daniel.engeljohn@fsis.usda.gov.
RIN: 0583–AC46
USDA—FSIS
20. Notification, Documentation, and
Recordkeeping Requirements for
Inspected Establishments
Priority: Other Significant.
Legal Authority: 21 U.S.C. 612 to 613;
21 U.S.C. 459
CFR Citation: 9 CFR 417.4; 9 CFR 418.
Legal Deadline: None.
Abstract: The Food Safety and
Inspection Service (FSIS) has proposed
to require establishments subject to
inspection under the Federal Meat
Inspection Act and the Poultry Products
Inspection Act to promptly notify the
Secretary of Agriculture that an
adulterated or misbranded product
received by or originating from the
establishment has entered into
commerce, if the establishment believes
or has reason to believe that this has
happened. FSIS has also proposed to
require these establishments to: (1)
Prepare and maintain current
procedures for the recall of all products
produced and shipped by the
establishment and (2) document each
reassessment of the process control
plans of the establishment.
Statement of Need: The Food,
Conservation, and Energy Act of 2008
(Pub. L. 110–246, sec. 11017), known as
the 2008 Farm Bill, amended the
Federal Meat Inspection Act (FMIA) and
the Poultry Products Inspection Act
(PPIA) to require establishments subject
to inspection under these Acts to
promptly notify the Secretary that an
adulterated or misbranded product
received by or originating from the
establishment has entered into
commerce, if the establishment believes
or has reason to believe that this has
happened. Section 11017 also requires
establishments subject to inspection
under the FMIA and PPIA to: (1)
Prepare and maintain current
procedures for the recall of all products
produced and shipped by the
establishment and (2) document each
reassessment of the process control
plans of the establishment.
Summary of Legal Basis: 21 U.S.C.
612 and 613; 21 U.S.C. 459, and Public
Law 110–246, section 11017.
Alternatives: The option of no
rulemaking is unavailable.
Anticipated Cost and Benefits:
Approximate costs: $5.0 million for
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labor and costs; $5.2 million for firstyear costs; $0.7 million average costs
adjusted with a 3.0 percent inflation rate
for following years. Total approximate
costs: $10.2 million. The average cost of
this final rule to small entities is
expected to be less than 1/10 of 1 cent
of meat and poultry food products per
annum. Therefore, FSIS has determined
that this rule will not have a significant
economic impact on a substantial
number of small entities. Approximate
benefits: Benefits have not been
monetized because quantified data on
benefits attributable to this final rule are
not available. Non-monetary benefits
include improved protection of the
public health, improved HACCP plans,
and improved recall effectiveness.
Risks: In preparing regulations on the
shipment of adulterated meat and
poultry products by meat and poultry
establishments, the preparation and
maintenance of procedures for recalled
products produced and shipped by
establishments, and the documentation
of each reassessment of the process
control plans by the establishment, the
Agency considered any risks to public
health or other pertinent risks
associated with these actions.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
03/25/10
05/24/10
75 FR 14361
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Victoria Levine,
Program Analyst, Policy Issuances
Division, Department of Agriculture,
Food Safety and Inspection Service,
1400 Independence Avenue SW.,
Washington, DC 20250, Phone: 202 720–
5627, Fax: 202 690–0486, Email:
victoria.levine@fsis.usda.gov.
RIN: 0583–AD34
BILLING CODE 3410–90–P
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DEPARTMENT OF COMMERCE (DOC)
Statement of Regulatory and
Deregulatory Priorities
Established in 1903, the Department
of Commerce is one of the oldest
Cabinet-level agencies in the Federal
Government. The Department’s mission
is to create the conditions for economic
growth and opportunity by promoting
innovation, entrepreneurship,
competitiveness, and environmental
stewardship. Commerce has 12
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operating units, which are responsible
for managing a diverse portfolio of
programs and services, ranging from
trade promotion and economic
development assistance to broadband
and the National Weather Service.
The Department touches Americans
daily, in many ways—making possible
the daily weather reports and survey
research; facilitating technology that all
of us use in the workplace and in the
home each day; supporting the
development, gathering, and
transmission of information essential to
competitive business; enabling the
diversity of companies and goods found
in America’s and the world’s
marketplace; and supporting
environmental and economic health for
the communities in which Americans
live.
Commerce has a clear and compelling
vision for itself, for its role in the
Federal Government, and for its roles
supporting the American people, now
and in the future. To achieve this vision,
the Department works in partnership
with businesses, universities,
communities, and workers to:
• Innovate by creating new ideas
through cutting-edge science and
technology from advances in
nanotechnology, to ocean exploration,
to broadband deployment, and by
protecting American innovations
through the patent and trademark
system;
• Support entrepreneurship and
commercialization by enabling
community development and
strengthening minority businesses and
small manufacturers;
• Maintain U.S. economic
competitiveness in the global
marketplace by promoting exports,
ensuring a level playing field for U.S.
businesses, and ensuring that
technology transfer is consistent with
our Nation’s economic and security
interests;
• Provide effective management and
stewardship of our Nation’s resources
and assets to ensure sustainable
economic opportunities; and
• Make informed policy decisions
and enable better understanding of the
economy by providing accurate
economic and demographic data.
The Department is a vital resource
base, a tireless advocate, and Cabinetlevel voice for job creation.
The Regulatory Plan tracks the most
important regulations that implement
these policy and program priorities,
several of which involve regulation of
the private sector by the Department.
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Responding to the Administration’s
Regulatory Philosophy and Principles
The vast majority of the Department’s
programs and activities do not involve
regulation. Of the Department’s 12
primary operating units, only the
National Oceanic and Atmospheric
Administration (NOAA) will be
planning actions that are considered the
‘‘most important’’ significant
preregulatory or regulatory actions for
FY 2012. During the next year, NOAA
plans to publish four rulemaking actions
that are designated as regulatory plan
actions. The Bureau of Industry and
Security (BIS) will also publish
rulemaking actions designated as
regulatory plan actions. Further
information on these actions is provided
below.
The Department has a long-standing
policy to prohibit the issuance of any
regulation that discriminates on the
basis of race, religion, gender, or any
other suspect category and requires that
all regulations be written so as to be
understandable to those affected by
them. The Secretary also requires that
the Department afford the public the
maximum possible opportunity to
participate in departmental
rulemakings, even where public
participation is not required by law.
National Oceanic and Atmospheric
Administration
NOAA establishes and administers
Federal policy for the conservation and
management of the Nation’s oceanic,
coastal, and atmospheric resources. It
provides a variety of essential
environmental and climate services vital
to public safety and to the Nation’s
economy, such as weather forecasts,
drought forecasts, and storm warnings.
It is a source of objective information on
the state of the environment. NOAA
plays the lead role in achieving the
Departmental goal of promoting
stewardship by providing assessments
of the global environment.
Recognizing that economic growth
must go hand-in-hand with
environmental stewardship, the
Department, through NOAA, conducts
programs designed to provide a better
understanding of the connections
between environmental health,
economics, and national security.
Commerce’s emphasis on ‘‘sustainable
fisheries’’ is designed to boost long-term
economic growth in a vital sector of the
U.S. economy while conserving the
resources in the public trust and
minimizing any economic dislocation
necessary to ensure long-term economic
growth. The Department is where
business and environmental interests
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intersect, and the classic debate on the
use of natural resources is transformed
into a ‘‘win-win’’ situation for the
environment and the economy.
Three of NOAA’s major components,
the National Marine Fisheries Service
(NMFS), the National Ocean Service
(NOS), and the National Environmental
Satellite, Data, and Information Service
(NESDIS), exercise regulatory authority.
NMFS oversees the management and
conservation of the Nation’s marine
fisheries, protects threatened and
endangered marine and anadromous
species and marine mammals, and
promotes economic development of the
U.S. fishing industry. NOS assists the
coastal States in their management of
land and ocean resources in their
coastal zones, including estuarine
research reserves; manages the national
marine sanctuaries; monitors marine
pollution; and directs the national
program for deep-seabed minerals and
ocean thermal energy. NESDIS
administers the civilian weather
satellite program and licenses private
organizations to operate commercial
land-remote sensing satellite systems.
The Department, through NOAA, has
a unique role in promoting stewardship
of the global environment through
effective management of the Nation’s
marine and coastal resources and in
monitoring and predicting changes in
the Earth’s environment, thus linking
trade, development, and technology
with environmental issues. NOAA has
the primary Federal responsibility for
providing sound scientific observations,
assessments, and forecasts of
environmental phenomena on which
resource management, adaptation, and
other societal decisions can be made.
In the environmental stewardship
area, NOAA’s goals include: Rebuilding
and maintaining strong U.S. fisheries by
using market-based tools and ecosystem
approaches to management; increasing
the populations of depleted, threatened,
or endangered species and marine
mammals by implementing recovery
plans that provide for their recovery
while still allowing for economic and
recreational opportunities; promoting
healthy coastal ecosystems by ensuring
that economic development is managed
in ways that maintain biodiversity and
long-term productivity for sustained
use; and modernizing navigation and
positioning services. In the
environmental assessment and
prediction area, goals include:
Understanding climate change science
and impacts, and communicating that
understanding to government and
private sector stakeholders enabling
them to adapt; continually improving
the National Weather Service;
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implementing reliable seasonal and
interannual climate forecasts to guide
economic planning; providing sciencebased policy advice on options to deal
with very long-term (decadal to
centennial) changes in the environment;
and advancing and improving shortterm warning and forecast services for
the entire environment.
Magnuson-Stevens Fishery
Conservation and Management Act
Magnuson-Stevens Fishery
Conservation and Management Act
(Magnuson-Stevens Act) rulemakings
concern the conservation and
management of fishery resources in the
U.S. Exclusive Economic Zone
(generally 3–200 nautical miles). Among
the several hundred rulemakings that
NOAA plans to issue in FY 2012, a
number of the preregulatory and
regulatory actions will be significant.
The exact number of such rulemakings
is unknown, since they are usually
initiated by the actions of eight regional
Fishery Management Councils (FMCs)
that are responsible for preparing
fishery management plans (FMPs) and
FMP amendments, and for drafting
implementing regulations for each
managed fishery. NOAA issues
regulations to implement FMPs and
FMP amendments. Once a rulemaking is
triggered by an FMC, the MagnusonStevens Act places stringent deadlines
upon NOAA by which it must exercise
its rulemaking responsibilities. FMPs
and FMP amendments for Atlantic
highly migratory species, such as
bluefin tuna, swordfish, and sharks, are
developed directly by NOAA, not by
FMCs.
FMPs address a variety of issues
including maximizing fishing
opportunities on healthy stocks,
rebuilding overfished stocks, and
addressing gear conflicts. One of the
problems that FMPs may address is
preventing overcapitalization
(preventing excess fishing capacity) of
fisheries. This may be resolved by
market-based systems such as catch
shares, which permit shareholders to
harvest a quantity of fish and which can
be traded on the open market. Harvest
limits based on the best available
scientific information, whether as a total
fishing limit for a species in a fishery or
as a share assigned to each vessel
participant, enable stressed stocks to
rebuild. Other measures include
staggering fishing seasons or limiting
gear types to avoid gear conflicts on the
fishing grounds and establishing
seasonal and area closures to protect
fishery stocks.
The FMCs provide a forum for public
debate and, using the best scientific
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information available, make the
judgments needed to determine
optimum yield on a fishery-by-fishery
basis. Optional management measures
are examined and selected in
accordance with the national standards
set forth in the Magnuson-Stevens Act.
This process, including the selection of
the preferred management measures,
constitutes the development, in
simplified form, of an FMP. The FMP,
together with draft implementing
regulations and supporting
documentation, is submitted to NMFS
for review against the national standards
set forth in the Magnuson-Stevens Act,
in other provisions of the Act, and other
applicable laws. The same process
applies to amending an existing
approved FMP.
Marine Mammal Protection Act
The Marine Mammal Protection Act
of 1972 (MMPA) provides the authority
for the conservation and management of
marine mammals under U.S.
jurisdiction. It expressly prohibits, with
certain exceptions, the take of marine
mammals. Exceptions allow for
permitting the collection of wild
animals for scientific research or public
display or to enhance the survival of a
species or stock. NMFS initiates
rulemakings under the MMPA to
establish a management regime to
reduce marine mammal mortalities and
injuries as a result of interactions with
fisheries. The MMPA also established
the Marine Mammal Commission,
which makes recommendations to the
Secretaries of the Departments of
Commerce and the Interior and other
Federal officials on protecting and
conserving marine mammals. The Act
underwent significant changes in 1994
to allow for takings incidental to
commercial fishing operations, to
provide certain exemptions for
subsistence and scientific uses, and to
require the preparation of stock
assessments for all marine mammal
stocks in waters under U.S. jurisdiction.
Endangered Species Act
The Endangered Species Act of 1973
(ESA) provides for the conservation of
species that are determined to be
‘‘endangered’’ or ‘‘threatened,’’ and the
conservation of the ecosystems on
which these species depend. The ESA
authorizes both NMFS and the Fish and
Wildlife Service (FWS) to jointly
administer the provisions of the MMPA.
NMFS manages marine and
‘‘anadromous’’ species, and FWS
manages land and freshwater species.
Together, NMFS and FWS work to
protect critically imperiled species from
extinction. Of the 1,310 listed species
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found in part or entirely in the United
States and its waters, NMFS has
jurisdiction over approximately 60
species. NMFS’ rulemaking actions are
focused on determining whether any
species under its responsibility is an
endangered or threatened species and
whether those species must be added to
the list of protected species. NMFS is
also responsible for designating,
reviewing, and revising critical habitat
for any listed species. In addition, under
the ESA’s procedural framework,
Federal agencies consult with NMFS on
any proposed action authorized, funded,
or carried out by that agency that may
affect one of the listed species or
designated critical habitat, or is likely to
jeopardize proposed species or
adversely modify proposed critical
habitat that is under NMFS’ jurisdiction.
NOAA’s Regulatory Plan Actions
While most of the rulemakings
undertaken by NOAA do not rise to the
level necessary to be included in the
Department’s regulatory plan, NMFS is
undertaking four actions that rise to the
level of ‘‘most important’’ of the
Department’s significant regulatory
actions and thus are included in this
year’s regulatory plan. The four actions
implement provisions of the MagnusonStevens Fishery Conservation and
Management Act, as reauthorized in
2006. The third action may be of
particular interest to international
trading partners as it concerns the
Certification of Nations Whose Fishing
Vessels are Engaged in Illegal,
Unreported, and Unregulated Fishing or
Bycatch of Protected Living Marine
Resources. A description of the four
regulatory plan actions is provided
below.
1. Fishery Management Plan for
Regulating Offshore Marine Aquaculture
in the Gulf of Mexico (0648–AS65): In
January 2009, the Gulf of Mexico
Fishery Management Council approved
the Aquaculture Fishery Management
Plan, which authorizes NMFS to issue
permits to culture species managed by
the Council (except shrimp and corals).
This was the first time a regional
Fishery Management Council approved
a comprehensive regulatory program for
offshore aquaculture in U.S. Federal
waters. On September 3, 2009, the
Aquaculture Fishery Management Plan
entered into effect by operation of law
and Dr. Lubchenco announced that
NOAA would develop a new National
Aquaculture Policy, which would
provide context for the Aquaculture
Fishery Management Plan. On June 9,
2011, NOAA released the final National
Aquaculture Policy and announced that
the Agency will move forward with the
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rulemaking to implement the
Aquaculture Fishery Management Plan.
The Aquaculture Plan has received
regional and national media attention
and was challenged in two lawsuits.
Although the lawsuits were dismissed,
additional legal challenges are
anticipated when the final rule is
issued. A vocal coalition of
environmental, non-governmental
organizations and fishermen’s groups
opposed to marine aquaculture has been
actively following the process. Others,
including some fishing and seafood
groups, support the Aquaculture Fishery
Management Plan.
2. Amend the Definition of Illegal,
Unreported, and Unregulated Fishing
Under the High Seas Driftnet Fishing
Moratorium Protection Act to Include
International Provisions of the Shark
Conservation Act (0648–BA89): As
required under the international
provisions of the Shark Conservation
Act, the rule would amend the
identification and certification
procedures under the High Seas Driftnet
Fishing Moratorium Protection to
include the identification of a foreign
nation whose fishing vessels engaged
during the preceding calendar year in
fishing activities in areas beyond any
national jurisdiction that target or
incidentally catch sharks if that nation
has not adopted a regulatory program to
provide for the conservation of sharks
that is comparable to that of the United
States, taking into account different
conditions. NMFS also intends to
amend the regulatory definition of
‘‘illegal, unreported, and unregulated
(IUU) fishing’’ for purposes of the
identification and certification
procedures under the Moratorium
Protection Act.
3. Critical Habitat for North Atlantic
Right Whale (0648–AY54): In 1994,
NMFS designated critical habitat for the
northern right whale in the North
Atlantic Ocean. This critical habitat
designation includes portions of Cape
Cod Bay and Stellwagen Bank, the Great
South Channel, and waters adjacent to
the coasts of Georgia and Florida. In
2008, NMFS published final
determinations listing right whales in
the North Atlantic and North Pacific as
separate endangered species under the
ESA and initiated work on new critical
habitat designations triggered by these
2008 listings. On October 1, 2009,
NMFS received a petition from the
Center for Biological Diversity,
Defenders of Wildlife, Humane Society
of the United States, Ocean
Conservancy, and the Whale and
Dolphin Conservation Society to revise
the designated critical habitat of the
North Atlantic right whale. The petition
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seeks an expansion of the areas
designated as critical feeding and
calving habitats and also seeks to
include a migratory corridor as part of
the critical habitat designation. On
October 6, 2010, NMFS published a 90day finding and 12-month
determination stating the intent to
proceed with publishing a proposed
rule to revise critical habitat.
4. Reduce Disturbance to Hawaiian
Spinner Dolphins from Human
Interactions (0648–AU02): Spinner
dolphins are being disturbed in their
natural resting habitats by human
activities, which may be altering the
dolphins’ normal behavioral patterns.
NMFS is proposing time-area closures to
protect the essential resting habitat of
spinner dolphins and to reduce the
human activities that cause
unauthorized taking of these dolphins
under the Marine Mammal Protection
Act and its implementing regulations.
The proposed rule lists time-area
closures including four bays on the
island of Hawaii, and one on the island
of Maui. Adaptive management
strategies will be used to monitor the
effectiveness of the proposed rule and
allow for necessary improvements. This
proposed action will set a precedent for
NMFS’ management of wildlife viewing
activities. This proposed action
represents the first proposal by NMFS to
use regulated area closures to reduce
harassment of non-ESA listed marine
mammals resulting from activities
aimed at viewing and interacting with
these animals.
At this time, NOAA is unable to
determine the aggregate cost of the
identified Regulatory Plan actions as
several of these actions are currently
under development.
Bureau of Industry and Security
The Bureau of Industry and Security
(BIS) advances U.S. national security,
foreign policy, and economic objectives
by maintaining and strengthening
adaptable, efficient, and effective export
control and treaty compliance systems,
as well as by administering programs to
prioritize certain contracts to promote
the national defense and to protect and
enhance the defense industrial base.
In August 2009, the President directed
a broad-based interagency review of the
U.S. export control system with the goal
of strengthening national security and
the competitiveness of key U.S.
manufacturing and technology sectors
by focusing on the current threats and
adapting to the changing economic and
technological landscape. In August
2010, the President outlined an
approach under which agencies that
administer export controls will apply
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new criteria for determining what items
need to be controlled and a common set
of policies for determining when an
export license is required. The control
list criteria are to be based on
transparent rules, which will reduce the
uncertainty faced by our Allies, U.S.
industry and its foreign customers, and
will allow the Government to erect
higher walls around the most sensitive
export items in order to enhance
national security.
Under the President’s approach,
agencies will apply the criteria and
revise the lists of munitions and dual
use items that are controlled for export
so that they:
Are ‘‘tiered’’ to distinguish the types
of items that should be subject to stricter
or more permissive levels of control for
different destinations, end-uses, and
end-users;
Create a ‘‘bright line’’ between the two
current control lists to clarify
jurisdictional determinations and
reduce government and industry
uncertainty about whether particular
items are subject to the control of the
State Department or the Commerce
Department; and
Are structurally aligned so that they
potentially can be combined into a
single list of controlled items.
BIS’ current regulatory plan action is
designed to implement the initial phase
of the President’s directive.
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Major Programs and Activities
BIS administers four sets of
regulations. The Export Administration
Regulations (EAR) regulate exports and
reexports to protect national security,
foreign policy, and short supply
interests. The EAR also regulates
participation of U.S. persons in certain
boycotts administered by foreign
governments. The National Defense
Industrial Base Regulations provide for
prioritization of certain contracts and
allocations of resources to promote the
national defense, require reporting of
foreign government-imposed offsets in
defense sales, and address the effect of
imports on the defense industrial base.
The Chemical Weapons Convention
Regulations implement declaration,
reporting, and on-site inspection
requirements in the private sector
necessary to meet United States treaty
obligations under the Chemical
Weapons Convention treaty. The
Additional Protocol Regulations
implement similar requirements with
respect to an agreement between the
United States and the International
Atomic Energy Agency.
BIS also has an enforcement
component with eight field offices in
the United States. BIS export control
officers are also stationed at several U.S.
embassies and consulates abroad. BIS
works with other U.S. Government
agencies to promote coordinated U.S.
Government efforts in export controls
and other programs. BIS participates in
U.S. Government efforts to strengthen
multilateral export control regimes and
to promote effective export controls
through cooperation with other
governments.
BIS’ Regulatory Plan Actions
As the agency responsible for leading
the administration and enforcement of
the U.S. dual-use export control system,
BIS plays a central role in the
Administration’s efforts to
fundamentally reform the export control
system. Changing what we control, how
we control it, and how we enforce and
manage our controls will help
strengthen our national security by
focusing our efforts on controlling the
most critical products and technologies,
and by enhancing the competitiveness
of key U.S. manufacturing and
technology sectors.
In FY 2011, BIS took several steps to
implement the President’s Export
Control Reform Initiative. BIS published
a final rule (76 FR 35276, June 16, 2011)
implementing a license exception that
authorizes exports, reexports, and
transfers to destinations that do not pose
a national security concern, provided
certain safeguards against diversion to
other destinations are taken. BIS also
proposed a rule that provides a
framework for controlling militarily less
significant defense articles, largely
generic parts and components, on the
Commerce Control List (CCL) rather
than the United States Munitions List.
In the immediate future, BIS will work
with other agencies to implement
transfers of such items to the CCL and
to make the CCL a more positive list.
Looking further ahead BIS will work
with other agencies to place items on
RIN
0610–AA66
0625–AA81
0648–AN55
0648–AL92
VerDate Mar<15>2010
the CCL into one of three tiers,
corresponding to different levels of
sensitivity.
Tier 1 will include the most sensitive
items. These are items that provide a
critical military or intelligence
advantage to the United States and are
available almost exclusively from the
United States, or are items that are a
weapon of mass destruction.
Tier 2 will include items that are
sensitive but not as sensitive, as those
in Tier 1. These are items that provide
a substantial military or intelligence
advantage to the United States and are
available almost exclusively from either
the United States or our partners and
allies.
Tier 3 will include items that are less
sensitive than those in Tier 2. These
items will be those that provide a
significant military or intelligence
advantage but are available more
broadly. BIS will also be developing
other rules to implement additional
aspects of the export control reform as
those aspects are identified and
decided.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Accordingly, the Agency is reviewing
these rules to determine whether action
under E.O. 13563 is appropriate. Some
of these entries on this list may be
completed actions, which do not appear
in The Regulatory Plan. However, more
information can be found about these
completed rulemakings in past
publications of the Unified Agenda on
Reginfo.gov in the Completed Actions
section for the Agency. These
rulemakings can also be found on
Regulations.gov. The final Agency
retrospective analysis plan can be found
at: https://open.commerce.gov/sites/
default/files/Commerce%20Plan%20for
%20Retrospective%20Analysis%20of
%20Existing%20Rules%20-%20201108-22%20Final.pdf.
Expected To
Significantly Reduce
Burdens on
Small Businesses?
Title
................
................
................
................
Revisions to EDA’s Regulations ......................................................................................................
Foreign Trade Zones .......................................................................................................................
Amendments 61/61/13/8 to Implement Major Provisions of the American Fisheries Act.
Western Alaska Community Development Quota Program.
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RIN
0648–AP12
0648–AO62
0648–AL41
0648–AP78
0648–AN75
................
................
................
................
................
0648–AP37
0648–AO35
0648–AP76
0648–AP39
................
................
................
................
0648–AO20 ................
0648–AQ05 ................
0648–AN88 ................
0648–AK23 ................
0648–AP21 ................
0648–AP49 ................
0648–AM40 ...............
0648–AP79 ................
0648–AO69 ................
0648–AK70
0648–AP81
0648–AP17
0648–AP68
0648–AN29
0648–AK50
................
................
................
................
................
................
0648–AM72 ...............
0648–AN23 ................
0648–AL95 ................
0648–AO02 ................
0648–AF87
0648–AN27
0648–AL51
0648–AO41
0648–AO97
0648–AO42
0648–BA42
0648–BA06
................
................
................
................
................
................
................
................
0694–AF03 ................
0694–AF17 ................
Atlantic Mackerel, Squid and Butterfish Fisheries; Framework Adjustment 2 ................................
Reef Fish Fishery of the Gulf of Mexico: Charter Vessel and Headboat Permit Moratorium ........
Nearshore Area Closures Around American Samoa by Vessels More Than 50 Feet in Length.
Fisheries of the Northeastern United States: Northeast Multispecies Fishery.
Pelagic Longline Gear Restrictions, Seasonal Area Closure, and Other Sea Turtle Mitigation
Measures.
Atlantic Herring Fishery; 2002 Specifications.
Measures To Reduce the Incidental Catch of Seabirds in the Hawaii Pelagic Longline Fishery.
Atlantic Deep-Sea Red Crab Fishery Management Plan.
Pacific Coast Groundfish Fishery: Experimental Setnet Sablefish Landings To Qualify Limited
Entry Sablefish-Endorsed permits for Tier Assignment.
Fisheries of the Exclusive Economic Zone off Alaska: Revisions to Recordkeeping and Reporting Requirements.
Extend the Interim Groundfish Observer Program Through December 31, 2007, and Amend
Regulations for the North Pacific Groundfish Observer Program.
Taking of Marine Mammals Incidental to Commercial Fishing Operations: Atlantic Large Whale
Take Reduction Plan Regulations.
Fisheries Off West Coast States and in the Western Pacific: Precious Corals Fisheries; Harvest
Quotas, Definitions, Size Limits, Gear Restrictions, and Bed Classification.
Implementation of the Shark Finning Prohibition Act.
Atlantic Highly Migratory Species; Pelagic Longline Fishery; Shark Gillnet Fishery: Sea Turtle
and Whale Protection Measures.
License Limitation Program for Groundfish of the Bering Sea and Aleutian Islands Area.
Prohibition of Non-pelagic Trawl Gear in Cook Inlet in the Gulf of Alaska.
Fisheries Off the West Coast States and in the Western Pacific; Pacific Coast Groundfish Fishery: Annual Specifications and Management Measures.
Fisheries of the Exclusive Economic Zone Off Alaska: Individual Fishing Quota Program.
Sea Turtle Conservation Measures of the Pound Net Fishery in Virginia Waters.
Take of Four Threatened Evolutionarily Significant Units of West Coast Salmon.
Atlantic Large Whale Seasonal Area Management Program.
Regulations Governing the Approach to Humpback Whales in Alaska.
Fisheries of the Exclusive Economic Zone Off Alaska: Improved Individual Fishing Quota Program.
Western Alaska Community Development Quota Program.
Fisheries of the Exclusive Economic Zone Off Alaska: Revisions to Definition of Length Overall
of a Vessel.
Fisheries of the Exclusive Economic Zone Off Alaska: License Limitation Program.
Atlantic Coastal Fisheries Cooperative Management Act Provisions: Horseshoe Crab Fishery—
Closed Area.
Fisheries of the Northeastern United States: Fishery Management Plan for Tilefish.
Pacific Coast Groundfish Fishery: Groundfish Observer Program.
West Coast Salmon Fisheries: Amendment 14.
Pacific Coast Groundfish Fishery: Amendment 13.
Pacific Coast Groundfish Fishery: Amendment 14.
International Fisheries Regulations: Pacific Tuna Fisheries.
Fisheries of the Northeastern United States; Tilefish Cost Recovery Regulatory Amendment.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of
Mexico; Emergency Rule To Authorize Re-Opening the Recreational Red Snapper Season.
Export Control Reform Initiative: Strategic Trade Authorization License Exception.
Revisions to the Export Administration Regulations (EAR): Control of Items the President Determines No Longer Warrant Control Under the United States Munitions List (USML).
DOC—BUREAU OF INDUSTRY AND
SECURITY (BIS)
erowe on DSK2VPTVN1PROD with PROPOSALS2
Final Rule Stage
21. Revisions to the Export
Administration Regulations (EAR):
Control of Military Vehicles and
Related Items That the President
Determines Do Not Warrant Control on
the United States Munitions List
Priority: Other Significant.
Legal Authority: 10 U.S.C. 7420; 10
U.S.C. 7430(e); 15 U.S.C. 1824a; 22
U.S.C. 287c; 22 U.S.C. 6004; 22 U.S.C.
7201 et seq.; 22 U.S.C. 7210; 30 U.S.C.
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Expected To
Significantly Reduce
Burdens on
Small Businesses?
Title
15:08 Feb 10, 2012
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185(s); 42 U.S.C. 2139a; 42 U.S.C.
2139a; 42 U.S.C. 6212; 43 U.S.C. 1354;
50 U.S.C. 1701 et seq.; 50 U.S.C. 2401
et seq.; 50 U.S.C. 5; EO 12058; EO
12851; EO 12938; EO 12947; EO 13026;
EO 13099; EO 13222; EO 13224; 22
U.S.C. 2151 note; 22 U.S.C. 3201 et seq.;
EO 11912; EO 12002; EO 12214; EO
12854; EO 12918; EO 12918; EO 12981;
EO 13020; EO 13338; 30 U.S.C. 185(u)
CFR Citation: 15 CFR 740; 15 CFR
743; 15 CFR 744; 15 CFR 748; 15 CFR
774; 15 CFR 730; 15 CFR 732; 15 CFR
738; 15 CFR 742; 15 CFR 746; 15 CFR
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Yes.
Yes.
Yes.
Yes.
Yes.
756; 15 CFR 762; 15 CFR 770; 15 CFR
772.
Legal Deadline: None.
Abstract: In August 2009, President
Obama directed a fundamental review
of the U.S. Export control system be
conducted. This review included a
fundamental review of the two primary
control lists of the U.S. Export control
system; i.e., the Commerce Control List
(CCL) and the United States Munitions
List (USML). In December 2010, the
Departments of Commerce and State
each published an Advanced Notice of
Proposed Rulemaking (ANPRM)
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requesting public comments on creating
more ‘‘positive’’ and clear control lists
and recommendations for how items
listed on the two control lists could be
tiered based on criteria developed
during the Export Control Reform (ECR)
initiative.
An integral part of creating a
‘‘positive’’ USML requires a proper
control structure be put into place under
the EAR to appropriately control the
less significant items moved from the
USML to the CCL, which is the subject
of this proposed rule. This rule outlines
the control structure developed under
the ECR initiative to ensure appropriate
controls are in place for these less
significant items moved from the USML
to the CCL.
Statement of Need: This rule is
needed to describe how items that no
longer warrant ITAR control—but,
because they are specially designed for
military applications, warrant some
degree of control—will be made subject
to the EAR and listed on the CCL. In
particular, this rule establishes the
framework within which items that are
transferred from the ITAR to the EAR
will be identified in and controlled by
the EAR. Such ready identification is
needed to allow for public
understanding of the changes and to
facilitate executive branch compliance
with the requirements to notify
Congress when items are removed from
the ITAR. Such controls are needed to
accomplish the national security and
foreign policy objectives of controlling
transfers of military items, which
includes complying with statutory and
international obligations to prevent the
transfer of such items to certain
countries, end uses, and end users.
Summary of Legal Basis: The Export
Administration Act of 1979, as
amended, authorizes the President to
prohibit or curtail exports for national
security or foreign policy reasons.
Section 3(1) of that Act provides that ‘‘It
is the policy of the United States to
minimize uncertainties in export control
policy and to encourage trade with all
countries with which the United States
has diplomatic or trading relations,
except those countries with which such
trade has been determined by the
President to be against the national
interest.’’ Although the Export
Administration Act of 1979 (EAA), as
amended, expired on August 20, 2001,
Executive Order 13222 of August 17,
2001 (3 CFR, 2001 Comp., p. 783 (2002))
as extended by Notice of August 12,
2010, 75 FR 50681 (Aug. 16, 2010)
continues the EAR in effect under the
International Emergency Economic
Powers Act (IEEPA). The EAA and the
IEEPA provide the President with the
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15:08 Feb 10, 2012
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discretion to tailor controls, such as
through the use of license exceptions
and the creation of country groups in
the implementing regulations, over
different types of items based on their
significance or other factors relevant to
the national interest.
The Arms Export Control Act (22
U.S.C. 2778) gives the President the
authority to identify any item as a
‘‘defense article.’’ The list of ‘‘defense
articles’’ is identified on the U.S.
Munitions List (USML) of the
International Traffic in Arms
Regulations (ITAR) (22 CFR chapter I,
subchapter M). Section 38(f) of the
AECA requires the President to
periodically review the list of defense
articles and determine which, if any,
should be removed from the list. Section
38(f) authorizes the President to remove
defense articles from the USML and
control them under other statutory and
regulatory authorities, such as the
export control regulations administered
by the Commerce Department, after
completing a 30-day congressional
notification.
Alternatives: BIS considered several
alternative regulatory structures for the
items that would be moved from the
ITAR to the EAR, including creating a
separate Commerce Munitions List in
the EAR and attempting to insert all
items transferred into the existing ECCN
structure. BIS selected the ‘‘600 series’’
structure because it provided the best
balance between ease of use and the
need to readily identify items moved or
to be moved from the ITAR to the EAR
for congressional notification purposes.
A separate Commerce Munitions List
would have readily identified items
moved from the ITAR, but would have
required the public to consult two lists
to assess whether license requirements
applied to a particular item. Attempting
to place all transferred items within the
existing ECCN structure would have
minimized the number of ECCNs to be
consulted but would have unduly
obscured the ITAR origin of the
transferred items.
Anticipated Cost and Benefits: The
underlying policy motivation for the
reform effort is not a traditional
economic cost/benefit analysis. Rather,
it is a national security effort. When the
Administration first began to consider
how the export control system should
be reformed to enhance national
security, it did not take into account
whether there would be particular
economic benefits or costs. After
conducting the review, the
Administration ultimately determined
that our national security will be
strengthened if (i) our export control
system allows for more interoperability
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7701
with our NATO and other close allies;
(ii) our industrial base is enhanced by,
for example, reducing the current
incentives created by the export control
rules for foreign companies to design
out or avoid U.S.-origin content; and
(iii) our resources are more focused on
controlling or prohibiting, as needed,
the items that provide at least a
significant military or intelligence
advantage to the United States. Items
made subject to the EAR as a result of
this rule generally would require a
license to all destinations except Canada
and exporters, reexporters and
transferors would incur the costs
associated with applying for such
licenses. BIS would need additional
resources to review the additional
licenses and to handle the related
compliance activities that will
accompany the planned change in
jurisdictional status of items. The net
burden on the government and that the
government imposes on industry,
however, would be substantially
reduced because this rule would apply
to items that currently are subject to
strict, generally inflexible ITAR license
requirements that impose many
collateral compliance burdens and costs
on exporters and the U.S. Government.
BIS believes that replacing such ITAR
license requirements with the more
flexible EAR license requirements is not
likely to result in any net increase in
costs. However, the benefits of the move
would be substantial, although not
readily quantifiable.
Risks: Not all items currently subject
to the ITAR are appropriate for
movement to the EAR. Care must be
taken to ensure that large sophisticated
weapons and other inherently military
items (as opposed to items unique to
defense articles merely because of a
change in form or fit) are not moved to
the EAR. BIS believes that the ongoing
interagency review process is adequate
to guard against any transfers contrary
to national security and foreign policy
interests. At the same time, one must
consider the risks of not transferring to
the EAR defense articles that no longer
warrant ITAR controls. These risks
include continued excessive costs to
exporters in complying with
unnecessarily restrictive rules,
continued disincentives for defense
manufacturers to use U.S. origin parts
and components, and continued
excessive costs associated with
supplying allied armed forces with U.S.
origin parts and components. BIS
believes that this rule sets up a structure
for controls that will allow for the
appropriate balance between the risks of
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continuing the status quo and the risks
of unwarranted relaxation of controls.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
07/15/11
09/13/11
76 FR 41958
12/00/11
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Timothy Mooney,
Export Policy Analyst, Department of
Commerce, Bureau of Industry and
Security, 14th Street and Pennsylvania
Avenue NW., Washington, DC 20230,
Phone: 202 482–3371, Fax: 202 482–
3355, Email:
timothy.mooney@bis.doc.gov.
Related RIN: Merged with 0694–
AF09.
RIN: 0694–AF17
DOC—NATIONAL OCEANIC AND
ATMOSPHERIC ADMINISTRATION
(NOAA)
Proposed Rule Stage
erowe on DSK2VPTVN1PROD with PROPOSALS2
22. Fishery Management Plan for
Regulating Offshore Marine
Aquaculture in the Gulf of Mexico
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1801 et seq.
CFR Citation: 50 CFR 622.
Legal Deadline: None.
Abstract: The purpose of this fishery
management plan (FMP) is to develop a
regional permitting process for
regulating and promoting
environmentally sound and
economically sustainable aquaculture in
the Gulf of Mexico (Gulf) exclusive
economic zone. This FMP consists of
ten actions, each with an associated
range of management alternatives,
which would facilitate the permitting of
an estimated 5 to 20 offshore
aquaculture operations in the Gulf over
the next 10 years, with an estimated
annual production of up to 64 million
pounds. By establishing a regional
permitting process for aquaculture, the
Gulf of Mexico Fishery Management
Council will be positioned to achieve
their primary goal of increasing
maximum sustainable yield and
optimum yield of federal fisheries in the
Gulf by supplementing harvest of wild
caught species with cultured product.
Statement of Need: Demand for
protein is increasing in the United
States and commercial wild-capture
fisheries will not likely be adequate to
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meet this growing demand. Aquaculture
is one method to meet current and
future demands for seafood.
Supplementing the harvest of domestic
fisheries with cultured product will
help the U.S. meet consumers’ growing
demand for seafood and may reduce the
Nation’s dependence on seafood
imports.
Currently, the U.S. imports over 80
percent of the seafood consumed in the
country, and the annual U.S. seafood
trade deficit is at an all time high of over
$9 billion.
Summary of Legal Basis: MagnusonStevens Fishery Conservation and
Management Act, 16 U.S.C. 1801 et seq.
Alternatives: The Council’s
Aquaculture FMP includes 10 actions,
each with an associated range of
alternatives. These actions and
alternatives are collectively intended to
establish a regional permitting process
for offshore aquaculture. Management
actions in the FMP include: (1)
Aquaculture permit requirements,
eligibility, and transferability; (2)
duration aquaculture permits are
effective; (3) aquaculture application
requirements, operational requirements,
and restrictions; (4) species allowed for
aquaculture; (5) allowable aquaculture
systems; (6) marine aquaculture siting
requirements and conditions; (7)
restricted access zones for aquaculture
facilities; (8) recordkeeping and
reporting requirements; (9) biological
reference points and status
determination criteria; and (10)
framework procedures for modifying
biological reference points and
regulatory measures.
Anticipated Cost and Benefits:
Environmental and social/economic
costs and benefits are described in detail
in the Council’s Aquaculture FMP.
Potential benefits include: establishing a
rigorous review process for reviewing
and approving/denying aquaculture
permits; increasing optimum yield by
supplementing the harvest of wild
domestic fisheries with cultured
products; and reducing the nation’s
dependence on imported seafood.
Anticipated costs include increased
administration and oversight of an
aquaculture permitting process, and
potential negative environmental
impacts to wild marine resources.
Approval of an aquaculture permitting
system may also benefit fishing
communities by creating new jobs or
impact fishing communities if cultured
products economically displace
domestic seafood.
Risks: National offshore aquaculture
legislation has also been previously
proposed by the Administration. This
action may reduce the need for uniform
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national legislation and allow
aquaculture regulations to vary by
region.
Timetable:
Action
Date
FR Cite
Notice of Availability (NOA).
NOA Comment
Period End.
NPRM ..................
Final Action .........
06/04/09
74 FR 26829
08/03/09
12/00/11
03/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Roy E. Crabtree,
Southeast Regional Administrator,
Department of Commerce, National
Oceanic and Atmospheric
Administration, 263 13th Avenue
South, St. Petersburg, FL 33701, Phone:
727 824–5305, Fax: 727 824–5308,
Email: roy.crabtree@noaa.gov.
RIN: 0648–AS65
DOC—NOAA
23. Reducing Disturbances to Hawaiian
Spinner Dolphins From Human
Interactions
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1361 et seq.
CFR Citation: 50 CFR 216.
Legal Deadline: None.
Abstract: The National Marine
Fisheries Service proposes regulations
to protect the essential resting habitat of
wild spinner dolphins (Stenella
longirostris) in the main Hawaiian
Islands, and to reduce the human
activities that may cause ‘‘take,’’ as
defined in the Marine Mammal
Protection Act (MMPA) and its
implementing regulations, or from other
actions that otherwise adversely affect
the dolphins, by proposing time-area
closures in four bays on the island of
Hawaii, and one on the island of Maui.
Statement of Need: NMFS is
concerned about the cumulative impacts
on Hawaiian spinner dolphin
populations from human interactions.
Human interactions with dolphins in
their resting habitats has increased over
the past decade, with spinner dolphins
now being the target of viewing or
swim-with-wild-dolphins tours on a
daily basis. Because spinner dolphins
routinely use the same habitats, and stay
in the bays for most of the day to rest,
these same animals may be disturbed
multiple times per day from the
multiple tours that seek these animals
daily. The unauthorized taking of
spinner dolphins is occurring at these
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bays, with many adverse impacts as a
result including: behavioral changes,
shorter resting periods, and
displacement from primary resting
habitats. By protecting the essential
resting habitat of the spinner dolphins,
NMFS proposes to prevent the taking of
these animals.
Summary of Legal Basis: All marine
mammals are protected under the
Marine Mammal Protection Act
(MMPA). NMFS is proposing these
regulations pursuant to its rulemaking
authority under MMPA 16 U.S.C. 1361
et seq.; 16 U.S.C. 1372 et seq., which
generally prohibits the take of any
marine mammals; and 16 U.S.C. 1382 et
seq.
Alternatives:
1. No Action.
2. Regulate human behaviors and
activities.
3. Implement time-area closures in
specified spinner dolphin resting
habitats.
4. Combine limits on specified human
behaviors with time-area closures.
5. Full closure of all identified
spinner dolphin resting habitats.
6. Codify the West Hawaii Voluntary
Standards for Marine Tourism.
Anticipated Cost and Benefits: The
primary benefit of this action would be
to reduce the unauthorized taking of
spinner dolphins in their primary
resting habitat. These animals are being
disturbed in an area that is significant
to their health, reproduction and
survival. Managing the amount of
interactions humans can have with
spinner dolphins will help protect the
animals in their natural environment.
Costs with this proposed rule would
affect humans as their use of these
particular bays would be limited.
Commercial tour operators, kayak
companies, and spiritual retreat
operators may be negatively
economically impacted. The public at
large would not be allowed to engage in
activities in the closure areas, and they
may therefore associate a cost with this
proposed action.
Risks: No risks to public health, safety
or the environment were identified with
implementation of this rule.
Timetable:
erowe on DSK2VPTVN1PROD with PROPOSALS2
Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
12/12/05
01/11/06
70 FR 73426
12/00/11
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
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Agency Contact: Melissa Andersen.
Fishery Biologist, Management,
Department of Commerce, National
Oceanic and Atmospheric
Administration, 1315 East-West
Highway, Silver Spring, MD 20910,
Phone: 301 713–2322, Fax: 301 713–
2521, Email:
melissa.andersen@noaa.gov.
RIN: 0648–AU02
DOC—NOAA
24. Designation of Critical Habitat for
the North Atlantic Right Whale
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1361 et
seq.; 16 U.S.C. 1531 to 1543
CFR Citation: 50 CFR 226; 50 CFR
229.
Legal Deadline: None.
Abstract: In June 1970, the northern
right whale was listed as endangered
under the Endangered Species
Conservation Act, the precursor to the
Endangered Species Act (ESA) (35 FR
8495; codified at 50 CFR 17.11).
Subsequently, right whales were listed
as endangered under the ESA in 1973,
and as depleted under the Marine
Mammal Protection Act (MMPA) the
same year. In 1994, NMFS designated
critical habitat for the northern right
whale, a single species thought at the
time to include right whales in both the
north Atlantic and the North Pacific.
In 2006, NMFS published a
comprehensive right whale status
review that concluded that recent
genetic data provided unequivocal
support to distinguish three right whale
lineages (including the southern right
whale) as separate phylogenetic species
(Rosenbaum et al. 2000). Rosenbaum et
al. (2000), concluded that the right
whale should be regarded as the
following three separate species: (1) The
North Atlantic right whale (Eubalaena
glacialis) ranging in the North Atlantic
Ocean; (2) the North Pacific right whale
(Eubalaena japonica), ranging in the
North Pacific Ocean; and (3) the
southern right whale (Eubalaena
australis), historically ranging
throughout the southern hemisphere’s
oceans.
Based on these findings, NMFS
published a proposed and final
determination listing right whales in the
North Atlantic and North Pacific as
separate endangered species under the
ESA (71 FR 77704, Dec. 27, 2006; 73 FR
12024, Mar. 6, 2008). Based on the new
listing determination, NMFS is required
by the ESA to designate critical habitat
separately for both the North Atlantic
right whale and the North Pacific right
whale.
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In April 2008, a final critical habitat
determination was published for the
North Pacific right whale (73 FR 19000;
Apr. 8, 2008). At this time, NMFS is
preparing a proposal to designate
critical habitat for the North Atlantic
right whale.
Statement of Need: Under section 4 of
the Endangered Species Act, NOAA
Fisheries is required to designate critical
habitat for newly listed species.
Summary of Legal Basis: Endangered
Species Act.
Alternatives: Because this rule is
presently in the beginning stages of
development, no alternatives have been
formulated or analyzed at this time.
Anticipated Cost and Benefits:
Because this rule is presently in the
beginning stages of development, no
analysis has been completed at this time
to assess costs and benefits.
Risks: Loss of critical habitat for a
species listed as protected under the
ESA and MMPA, as well as potential
loss of right whales due to habitat loss.
Timetable:
Action
Date
NPRM ..................
FR Cite
12/00/11
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Marta Nammack,
Office of Protected Resources,
Department of Commerce, National
Oceanic and Atmospheric
Administration, 1315 East-West
Highway, Silver Spring, MD 20910,
Phone: 301 713–1401, Fax: 301 427–
2523, Email:
marta.nammack@noaa.gov.
RIN: 0648–AY54
DOC—NOAA
25. Regulatory Amendments To
Implement the Shark Conservation Act
and Revise the Definition of Illegal,
Unreported, and Unregulated Fishing
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1826d to
1826k
CFR Citation: 50 CFR 300.
Legal Deadline: Final, Statutory,
January 4, 2012, The rule needs to be
published by December 4, 2011, due to
the 30-day delay in effectiveness.
Abstract: NMFS is amending
identification and certification
procedures under the High Seas Driftnet
Fishing Moratorium Protection Act to
help achieve shark conservation in
international fisheries. NMFS must
identify nations whose fishing vessels
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have engaged in high seas fisheries
targeting or incidentally catching sharks
not subject to a regulatory program for
the conservation of sharks comparable
to that of the United States, taking into
account different conditions, as required
under the Shark Conservation Act (Pub.
L. 111–348). NMFS would subsequently
certify whether identified nations have
adopted regulatory programs governing
the conservation of sharks that are
comparable to U.S. programs, taking
into account different conditions, and
established management plans for
sharks. The absence of sufficient steps
may lead to prohibitions on the
importation of certain fisheries products
into the United States and other
measures.
NMFS is also amending the regulatory
definition of ‘‘illegal, unreported, and
unregulated fishing’’ under the High
Seas Driftnet Fishing Moratorium
Protection Act.
The procedures for identification and
certification would entail a multilateral
approach of consultations and
negotiations with other nations to
achieve shark conservation.
This action is not expected to have
adverse economic impacts, and any
such impacts would be well below the
economic threshold of impact pursuant
to E.O. 12866. In addition, there are no
novel legal or policy issues associated
with this action since identification and
certification procedures have already
been established in regulations (50 CFR
part 300). However, this action is
significant under the meaning of E.O.
12866 because it could lead to trade
restrictive measures applied against
foreign nations.
Statement of Need: These regulatory
amendments are required to implement
the international provisions of the Shark
Conservation Act to identify and certify
nations whose vessels are engaged in
shark finning and/or fishing for sharks
in a manner that is not consistent with
international management efforts.
Additionally, this rule would revise the
definition of Illegal, Unreported, and
Unregulated (IUU) Fishing in response
to comments on a prior rulemaking
(0648–AV51) that set out the regulatory
definition of IUU fishing.
Summary of Legal Basis: Shark
Conservation Act (Pub. L. 111–348) and
16 U.S.C. 1826d to 1826k.
Alternatives: This action is
categorically excluded from analysis
under the National Environmental
Policy Act because the proposed action
is the promulgation of regulations of an
administrative, financial, legal,
technical, or procedural nature and the
environmental effects of which are too
broad, speculative, or conjectural to
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lend themselves to meaningful analysis
and for which any potential cumulative
effects are negligible. Consequently, no
alternatives were analyzed.
Anticipated Cost and Benefits: This
action is not expected to have adverse
economic impacts, and any such
impacts would be well below the
economic threshold of impact pursuant
to E.O. 12866. Potential benefits, if any,
would be indirect and accrue to
internationally managed fisheries by
strengthening Regional Fishery
Management Organizations and by
restricting U.S. market access through
prohibiting illegally harvested fishery
products.
Risks: There are no novel legal or
policy issues associated with this action
since identification and certification
procedures have already been
established in regulations (50 CFR part
300). However, this action is significant
under the meaning of E.O. 12866
because it could lead to trade restrictive
measures applied against foreign
nations.
Timetable:
Action
Date
NPRM ..................
Final Action .........
FR Cite
12/00/11
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Christopher Rogers,
Division Chief, Department of
Commerce, National Oceanic and
Atmospheric Administration, 1315 EastWest Highway, Silver Spring, MD
20910, Phone: 301 713–9090, Fax: 301
713–9106, Email:
christopher.rogers@noaa.gov.
RIN: 0648–BA89
BILLING CODE 3510–12–P
DEPARTMENT OF DEFENSE
Statement of Regulatory Priorities
Background
The Department of Defense (DoD) is
the largest Federal department,
consisting of 3 Military departments
(Army, Navy, and Air Force), 10 Unified
Combatant Commands, 14 Defense
Agencies, and 10 DoD Field Activities.
It has 1,434,450 military personnel and
782,386 civilians assigned as of March
31, 2011, and over 200 large and
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medium installations in the continental
United States, U. S. territories, and
foreign countries. The overall size,
composition, and dispersion of DoD,
coupled with an innovative regulatory
program, presents a challenge to the
management of the Defense regulatory
efforts under Executive Order (E.O.)
12866 ‘‘Regulatory Planning and
Review’’ of September 30, 1993.
Because of its diversified nature, DoD
is affected by the regulations issued by
regulatory agencies such as the
Departments of Energy, Health and
Human Services, Housing and Urban
Development, Labor, Transportation,
and the Environmental Protection
Agency. In order to develop the best
possible regulations that embody the
principles and objectives embedded in
E.O. 12866, there must be coordination
of proposed regulations among the
regulatory agencies and the affected
DoD components. Coordinating the
proposed regulations in advance
throughout an organization as large as
DoD is straightforward, yet a formidable
undertaking.
DoD is not a regulatory agency, but
occasionally it issues regulations that
have an effect on the public. These
regulations, while small in number
compared to the regulating agencies, can
be significant as defined in E.O. 12866.
In addition, some of DoD’s regulations
may affect the regulatory agencies. DoD,
as an integral part of its program, not
only receives coordinating actions from
the regulating agencies, but coordinates
with the agencies that are affected by its
regulations as well.
Overall Priorities
The Department needs to function at
a reasonable cost, while ensuring that it
does not impose ineffective and
unnecessarily burdensome regulations
on the public. The rulemaking process
should be responsive, efficient, costeffective, and both fair and perceived as
fair. This is being done in DoD while
reacting to the contradictory pressures
of providing more services with fewer
resources. The Department of Defense,
as a matter of overall priority for its
regulatory program, fully incorporates
the provisions of the President’s
priorities and objectives under
Executive Order (E.O.) 12866.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review (January 18, 2011),
the following Regulatory Identifier
Numbers (RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
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retrospective review of regulations plan.
All are of particular interest to small
businesses. Some of these entries on this
list may be completed actions, which do
not appear in The Regulatory Plan.
However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov in the
Completed Actions section for that
agency. These rulemakings can also be
found on Regulations.gov. The final
agency plans can be found at: https://
www.regulations.gov/exchange/topic/
eo-13563
• 0750–AH19—Accelerated Payments
to Small Business (DFARS Case 2011–
D008)
• 0750–AH44—Extension of DoD
´ ´
Mentor-Protege Pilot Program (DFARS
Case 2011–D050)
• 0750–AH45—Deletion of Text
Implementing 10 U.S.C. 2323 (DFARS
Case 2011–D038)
Administration Priorities
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1. Rulemakings That Are Expected To
Have High Net Benefits Well in Excess
of Costs
The Department plans to—
• Finalize the DFARS rule to permit
offerors to propose an alternative line
item structure to reflect the offeror’s
business practices for selling and billing
commercial items, and initial
provisioning of spares for weapon
systems. This rule should prevent
misalignment of line item structure in
receipt documents and invoices, which
causes manual intervention and can
delay payment;
• Finalize the DFARS rule to conduct
discussions prior to contract award for
source selections of $100 million or
more. A DoD study showed a significant
positive correlation between high-dollar
source selections that were conducted
without discussions and protests
sustained. This rule should reduce the
number of protests filed and their
resultant costs to contractors and the
Government; and
• Finalize the DFARS rule to
implement section 866 of the National
Defense Authorization Act (NDAA) for
Fiscal Year (FY) 2011 establishing a
pilot program to acquire military
purpose nondevelopmental items. This
pilot program is designed to test
whether the streamlined procedures,
similar to those available for
commercial items, can serve as an
effective incentive for nontraditional
defense contractors to (1) channel
investment and innovation into areas
that are useful to DoD and (2) provide
items developed exclusively at private
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expense to meet validated military
requirements. (2011–D034)
2. Rulemakings That Promote Open
Government and Use Disclosure as a
Regulatory Tool
The Department plans to—
• Finalize the Federal Acquisition
Regulation (FAR) to inform contractors
of the statutory requirement of section
3010 of Public Law 111–212, to make
Federal Awardee Performance and
Integrity Information System
information, excluding past
performance reviews, available to the
public;
• Finalize the FAR rule that
implements section 743 of Division C of
the Fiscal Year 2010 Consolidated
Appropriations Act, which requires
agencies to develop inventories of their
service contacts, including number and
work location of contractor employees;
• Finalize the FAR rule to establish
standard evaluation factors and rating
scales for documenting contractor
performance;
• Finalize the FAR rule that
implements the Federal Funding
Accountability and Transparency Act of
2006, which requires the Office of
Management and Budget (OMB) to
establish a free, public, Web site
containing full disclosure of all Federal
contract award information. This rule
requires contractors to report executive
compensation and first-tier
subcontractor awards on unclassified
contracts expected to be $25,000 or
more, except contracts with individuals;
• Finalize the FAR rule that
implements section 811 of the NDAA
for FY 2010, which requires a written
justification and approval prior to
awarding a sole-source contract in an
amount over $20 million under the 8(a)
program; and
• Finalize the DFARS rule to
implement section 814 of the NDAA for
FY 2010, which imposed additional
reporting requirements for awards of
single task and delivery-order contracts.
3. Rulemakings That Streamline
Regulations and Reduce Unjustified
Burdens
The Department plans to—
• Finalize the DFARS rule to remove
the requirement to use DD Forms 2626
and 2631 to report past performance
information for construction and
architect-engineer services and to
instead provide the performance reports
electronically;
• Finalize the DFARS rule to amend
the definition of ‘‘qualifying country
end product’’ to make it comparable to
the change in the definition of
‘‘domestic end product’’ by waiving the
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7705
component test for qualifying country
end products;
• Finalize the DFARS rule to update
appendix F, Material Inspection and
Receiving Report, to incorporate
procedures for using the electronic
Wide Area WorkFlow (WAWF)
Receiving Report, which is required for
use in most contracts in lieu of the DD
Form 250. WAWF is the electronic tool
for documenting receipt and acceptance
of supplies and services and for
electronic invoicing; and
• Finalize the rule for DFARS
coverage of patents, data, and
copyrights, which significantly reduces
the amount of regulatory text and the
number of required clauses.
4. Efforts To Minimize Burdens on
Small Businesses
Of interest to Small Businesses are
regulations to—
• Finalize the DFARS rule to
accelerate payments to all DoD small
business contractors.
5. Rules To Be Modified, Streamlined,
Expanded, or Repealed To Make the
Agency’s Regulatory Program More
Effective or Less Burdensome in
Achieving the Regulatory Objectives
• DFARS Case 2011–D028—Removes
component test for COTS items that are
qualifying country end products.
Require only determination of country
of origin of the COTS item, not the
components of the COTS item.
• DFARS Case 2011–D013—Only
One Offer. Motivate effective
competition by driving behavior to
allow sufficient time for submission of
offers.
• DFARS Case 2011–D008—
Accelerate Small Business Payments.
Accelerate payments to all small
businesses, not just small disadvantaged
businesses.
• DFARS Case 2010–D018—
Responsibility and Liability for
Government Property. Includes fixedprice contracts that are awarded on the
basis of adequate competition on the list
of contract types whereby contractors
are not held liable for loss of
Government property.
• DFARS Case 2010–D001—Patents,
Data, and Copyrights. Rewrite of DFARS
part 227, Patents, Data, and Copyrights.
• DFARS Case 2009–D026—
Multiyear Contracting. Comprehensive
review of DFARS subpart 217.1 to
simplify and clarify the coverage of
multiyear acquisition.
Specific DoD Priorities
For this regulatory plan, there are six
specific DoD priorities, all of which
reflect the established regulatory
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principles. In those areas where
rulemaking or participation in the
regulatory process is required, DoD has
studied and developed policy and
regulations that incorporate the
provisions of the President’s priorities
and objectives under the Executive
order.
DoD has focused its regulatory
resources on the most serious
environmental, health, and safety risks.
Perhaps most significant is that each of
the priorities described below
promulgates regulations to offset the
resource impacts of Federal decisions
on the public or to improve the quality
of public life, such as those regulations
concerning acquisition, security, energy
projects, education, and health affairs.
1. Defense Procurement and Acquisition
Policy
The Department of Defense
continuously reviews the DFARS and
continues to lead Government efforts
to—
• Revise the DFARS to specify
circumstances under which the U.S.
Government needs to obtain data other
than certified cost or pricing data from
Canadian contractors via the Canadian
Commercial Corporation.
• Revise the DFARS to provide
detailed guidance and instruction to
DoD contracting officers for the use of
DoD’s performance-based payments
analysis tool when contemplating the
use of performance-based payments on
new fixed-price type contracts.
• Revise the DFARS to implement a
DoD Better Buying Power initiative by
providing a proposal-adequacy checklist
in a provision to ensure offerors take
responsibility for providing thorough,
accurate, and complete proposals.
• Revise the DFARS to address
standards and structures for the
safeguarding of unclassified DoD
information.
• Revise the DFARS to implement the
DoD Better Buying Power initiative to
address acquisitions using competitive
procedures in which only one offer is
received. With some exceptions, the
contracting officer must resolicit for an
additional period of at least 30 days, if
the solicitation allowed fewer than 30
days for receipt of proposals and only
one offer is received. If a period of at
least 30 days was allowed for receipt of
proposals, the contracting officer must
determine prices to be fair and
reasonable through price or cost
analysis or enter negotiations with the
offeror.
• Revise the DFARS to implement a
DoD Better Buying Power initiative by
requiring contractors to submit annual
technical descriptions for their
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independent research and development
projects.
• Revise the DFARS to establish
means for cleared contractors, who have
unclassified U.S. Government
information resident on or transiting
through contractor information systems,
to share cyber threat information.
• Revise the FAR to implement
section 841 of the National Defense
Authorization Act for FY 2009, which
required a review of the FAR coverage
on organizational conflicts of interest
(OCIs).
• Finalize the DFARS rule to clarify
DoD policy regarding the definition and
administration of contractor business
systems to improve the effectiveness of
DCMA/DCAA oversight of contractor
business systems;
• Finalize the DFARS rule to
implement a DoD Better Buying Power
initiative to increase the use of fixedprice incentive (firm target) contracts;
2. Logistics and Materiel Readiness,
Department of Defense
The Department of Defense published
or plans to publish rules on contractors
supporting the military in contingency
operations:
• Final Rule: Private Security
Contractors (PSCs) Operating in
Contingency Operations, Combat
Operations or Other Significant Military
Operations. In order to meet the
mandate of section 862 of the 2008
National Defense Authorization Act
(NDAA) (as amended by section 813 (b)
of the 2010 NDAA and section 832 of
the 2011 NDAA), this rule establishes
policy, assigns responsibilities, and
provides procedures for the regulation
of the selection, accountability, training,
equipping, and conduct of personnel
performing private security functions
under a covered contract during
contingency operations, combat
operations, or other significant military
operations. It also assigns
responsibilities and establishes
procedures for incident reporting, use of
and accountability for equipment, rules
for the use of force, and a process for
administrative action or the removal, as
appropriate, of PSCs and PSC personnel.
DoD published an interim final rule on
July 17, 2009 (74 FR 34690 to 34694),
with an effective date of July 17, 2009.
The comment period ended August 31,
2009. DoD, in coordination with the
Department of State and the United
States Agency for International
Development, prepared a final rule,
which included the responses to the
public comments, and incorporated
changes to the interim final rule, where
appropriate. The final rule also
incorporated the legislative changes
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required by section 813 (b) of the 2010
NDAA and section 832 of the 2011
NDAA. The final rule was published
August 11, 2011 (76 FR 49650), with an
effective date of September 12, 2011.
• Interim Final Rule: Operational
Contract Support. This rule will
incorporate the latest changes and
lessons learned into policy and
procedures for operational contract
support (OCS), including OCS program
management, contract support
integration, and the integration of DoD
contractor personnel into contingency
operations outside the United States.
DoD anticipates publishing the interim
final rule in the first or second quarter
of FY 2012.
3. Installations and Environment,
Department of Defense
The Department of Defense will
publish a rule regarding the process for
evaluating the impact of certain types of
structures on military operations and
readiness:
• Interim Final Rule: This rule
implements policy, assigns
responsibilities, and prescribes
procedures for the establishment and
operation of a process for evaluation of
proposed projects submitted to the
Secretary of Transportation under
section 44718 of title 49, United States
Code. The evaluation process is
established for the purpose of
identifying any adverse impact of
proposed projects on military operations
and readiness, minimizing or mitigating
such adverse impacts, and determining
if any such projects pose an
unacceptable risk to the national
security of the United States. The rule
also includes procedures for the
operation of a central DoD siting
clearinghouse to facilitate both informal
and formal reviews of proposed
projects. This rule was required by
section 358 of Public Law 111–383. DoD
anticipates publishing an interim final
rule in fourth quarter of FY 2011.
4. Military Community and Family
Policy, Department of Defense
The Department of Defense plans to
publish a final rule to implement policy,
assign responsibilities, and prescribe
procedures for the operation of
voluntary education programs within
DoD:
• Final Rule: Voluntary Education
Programs. In this rule, the Department
of Defense (DoD) implements policy,
assigns responsibilities, and prescribes
procedures for the operation of
voluntary education programs within
DoD. Several of the subject areas in this
rule include: Procedures for Service
members participating in education
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programs; guidelines for establishing,
maintaining, and operating voluntary
education programs including, but not
limited to, instructor-led courses offered
on-installation and off-installation, as
well as via distance learning;
procedures for obtaining on-base
voluntary education programs and
services; minimum criteria for selecting
institutions to deliver higher education
programs and services on military
installations; the establishment of a DoD
Voluntary Education Partnership
Memorandum of Understanding (MOU)
between DoD and educational
institutions receiving tuition assistance
payments; and procedures for other
education programs for Service
members and their adult family
members. The new requirement for a
signed MOU with DoD from
participating educational institutions
will be effective January 1, 2012. The
Department published a proposed rule
on August 6, 2010 (75 FR 47504 to
47514). The comment period ended
October 10, 2010, which contained a
total of 110 comments. Several
comments from the general public were
accepted, including suggestions to
clarify terms such as ‘‘one single tuition
rate’’ and a ‘‘needs assessment.’’ DoD
anticipates publishing the final rule
during the first quarter of FY 2012.
5. Health Affairs, Department of Defense
The Department of Defense is able to
meet its dual mission of wartime
readiness and peacetime health care by
operating an extensive network of
medical treatment facilities. This
network includes DoD’s own military
treatment facilities supplemented by
civilian health care providers, facilities,
and services under contract to DoD
through the TRICARE program.
TRICARE is a major health care program
designed to improve the management
and integration of DoD’s health care
delivery system. The program’s goal is
to increase access to health care
services, improve health care quality,
and control health care costs.
The TRICARE Management Activity
has published or plans to publish the
following rules:
• Final rule on TRICARE:
Reimbursement of Sole Community
Hospitals and Adjustment to
Reimbursement of Critical Access
Hospitals. The rule implements the
statutory provision in 10 United States
Code 1079(j)(2) that TRICARE payment
methods for institutional care shall be
determined to the extent practicable in
accordance with the same
reimbursement rules as those that apply
to payments to providers of services of
the same type under Medicare. This rule
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implements a reimbursement
methodology similar to that furnished to
Medicare beneficiaries for services
provided by sole community hospitals.
It is projected that implementation of
this rule will result in a health care
savings of $31 million per year with
proposed phase-in period and an
estimated initial start-up cost of
$200,000. Any on-going administrative
costs would be minimal and there are
no applicable risks to the public. The
proposed rule was published July 5,
2011 (76 FR 39043). The comment
period ended on September 6, 2011.
DoD anticipates publishing a final rule
in the second quarter of FY 2012.
• Final rule on TRICARE: TRICARE
Young Adult. The purpose of this
interim final rule is to establish the
TRICARE Young Adult program
implementing section 702 of the Ike
Skelton NDAA for FY 2011 (Pub. L.
111–383) to provide medical coverage to
unmarried children under the age of 26
who no longer meet the age
requirements for TRICARE eligibility
(age 21, or 23 if enrolled in a full-time
course of study at an institution of
higher learning approved by the
Secretary of Defense) and who are not
eligible for medical coverage from an
eligible employer-sponsored plan (as
defined in section 5000A(f)(2) of the
Internal Revenue Code of 1986). If
qualified, they can purchase TRICARE
Standard/Extra or TRICARE Prime
benefits coverage. The particular
TRICARE plan available depends on the
military sponsor’s eligibility and the
availability of the TRICARE plan in the
dependent’s geographic location. It is
projected that implementation of this
rule will result in an estimated initial
start-up cost of $3,000,000. Premiums
are designed to cover the anticipated
health care costs, as well as ongoing
administrative costs. The interim final
rule was published April 27, 2011 (76
FR 23479), with an immediate effective
date. The comment period ended June
27, 2011. DoD anticipates publishing a
final rule in the first quarter of FY 2012.
6. Personnel and Readiness, Department
of Defense
The Department of Defense will
publish a rule regarding Service
Academies:
• Final Rule: Service Academies. This
rule establishes policy, assigns
responsibilities, and prescribes
procedures for Department of Defense
oversight of the Service Academies.
Administrative costs are negligible and
benefits are clear, concise rules that
enable the Secretary of Defense to insure
that the Service Academies are
efficiently operated and meet the needs
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of the armed forces. The proposed rule
was published October 18, 2007 (72 FR
59053), and included policy that has
since changed. The final rule,
particularly the explanation of
separation policy, will reflect recent
changes in the Don’t Ask, Don’t Tell
policy. DoD anticipates publishing the
final rule in the second quarter of FY
2012.
BILLING CODE 5001–06–P
DEPARTMENT OF EDUCATION (DOE)
Statement of Regulatory Priorities
I. Introduction
The U.S. Department of Education
(Department) supports States, local
communities, institutions of higher
education, and others in improving
education nationwide and in helping to
ensure that all Americans receive a
quality education. We provide
leadership and financial assistance
pertaining to education at all levels to
a wide range of stakeholders and
individuals, including State educational
agencies, local school districts,
providers of early learning programs,
elementary and secondary schools,
institutions of higher education, career
and technical schools, nonprofit
organizations, postsecondary students,
members of the public, families, and
many others. These efforts are helping
to ensure that all children and students
from pre-kindergarten through grade 12
will be ready for, and succeed in,
postsecondary education and that
students attending postsecondary
institutions are prepared for a
profession or career.
We also vigorously monitor and
enforce the implementation of Federal
civil rights laws in educational
programs and activities that receive
Federal financial assistance, and
support innovative programs, research
and evaluation activities, technical
assistance, and the dissemination of
research and evaluation findings to
improve the quality of education.
Overall, the laws, regulations, and
programs we administer will affect
nearly every American during his or her
life. Indeed, in the 2011 to 2012 school
year, about 55 million students will
attend an estimated 99,000 elementary
and secondary schools in approximately
13,800 public school districts, and about
21 million students will enroll in
degree-granting postsecondary schools.
All of these students may benefit from
some degree of financial assistance or
support from the Department.
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In developing and implementing
regulations, guidance, technical
assistance, and monitoring related to
our programs, we are committed to
working closely with affected persons
and groups. Specifically, we work with
a broad range of interested parties and
the general public including families,
students, and educators; State, local,
and tribal governments; and
neighborhood groups, community-based
early learning programs, elementary and
secondary schools, colleges,
rehabilitation service providers, adult
education providers, professional
associations, advocacy organizations,
businesses, and labor organizations.
We also continue to seek greater and
more useful public participation in our
rulemaking activities through the use of
transparent and interactive rulemaking
procedures and new technologies. If we
determine that it is necessary to develop
regulations, we seek public
participation at the key stages in the
rulemaking process. We invite the
public to submit comments on all
proposed regulations through the
Internet or by regular mail.
To facilitate the public’s involvement,
we participate in the Federal Docketing
Management System (FDMS), an
electronic single Governmentwide
access point (www.regulations.gov) that
enables the public to submit comments
on different types of Federal regulatory
documents and read and respond to
comments submitted by other members
of the public during the public comment
period. This system provides the public
with the opportunity to submit
comments electronically on any notice
of proposed rulemaking or interim final
regulations open for comment, as well
as read and print any supporting
regulatory documents.
We are continuing to streamline
information collections, reduce the
burden on information providers
involved in our programs, and make
information easily accessible to the
public.
II. Regulatory Priorities
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A. American Recovery and
Reinvestment Act of 2009
On February 17, 2009, President
Obama signed into law the American
Recovery and Reinvestment Act of 2009
(ARRA), historic legislation designed, in
part, to invest in critical sectors,
including education. ARRA laid the
foundation for education reform by
supporting investments in innovative
strategies that are most likely to lead to
improved results for students, long-term
gains in school and school system
capacity, and increased productivity
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and effectiveness. ARRA provided
funding for several key discretionary
grant programs, including the Race to
the Top Fund and the Investing in
Innovation Fund (i3) programs.
The Race to the Top Fund program,
the largest competitive education grant
program in U.S. history, is designed to
provide incentives to States to
implement system-changing reforms
that result in improved student
achievement, narrowed achievement
gaps, and increased high school
graduation and college enrollment rates.
Congress authorized and provided $4.35
billion for ARRA in 2010, and the
Department awarded approximately $4
billion in Race to the Top State grant
funds in two phases. The Department
awarded $600 million to Delaware and
Tennessee under the Race to the Top
Phase 1 competition and approximately
$3.4 billion to the winners of the Phase
2 competition: The District of Columbia,
Florida, Georgia, Hawaii, Maryland,
Massachusetts, New York, North
Carolina, Ohio, and Rhode Island.
In announcing the winners of the
Race to the Top Phase 2 competition,
the Secretary noted that ‘‘[we] had many
more competitive applications than
money to fund them in this round’’ and
expressed the hope that any Race to the
Top funding included in the
Department’s FY 2011 appropriations
would be available for Race to the Top
Phase 3 awards. In particular, there
were nine finalists in the Phase 2
competition that did not receive funding
despite submitting bold and ambitious
plans for comprehensive reforms and
innovations in their systems of
elementary and secondary education.
These nine finalists were: Arizona,
California, Colorado, Illinois, Kentucky,
Louisiana, New Jersey, Pennsylvania,
and South Carolina.
On April 15, 2011, President Obama
signed into law Public Law 112–10, the
Department of Defense and Full-Year
Continuing Appropriations Act, 2011
(FY 2011 Appropriations Act), which
made $698.6 million available for the
Race to the Top Fund, authorized the
Secretary to make awards on ‘‘the basis
of previously submitted applications,’’
and amended ARRA to permit the
Secretary to make grants for improving
early childhood care and learning under
the program.
Race to the Top—Early Learning
Challenge (RTT–ELC). On May 25, 2011,
Secretary Duncan and the Secretary of
Health and Human Services, Kathleen
Sebelius, announced the RTT–ELC, a
new $500 million State-level grant
competition to be held in 2011 and
authorized under ARRA and the FY
2011 Appropriations Act. The
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Departments of Education and Health
and Human Services are administering
this competition jointly. At its core is a
strong commitment by the
Administration to stimulate a national
effort to make sure all children enter
kindergarten ready to succeed. Through
the RTT–ELC, the Administration seeks
to help close the achievement gap
between children with high needs and
their peers by supporting State efforts to
build strong systems of early learning
and development that provide increased
access to high-quality programs for the
children who need it most. This
competition represents an
unprecedented opportunity for States to
focus deeply on their early learning and
development systems for children from
birth through age five. It is an
opportunity to build a more unified
approach to supporting young children
and their families—an approach that
increases access to high-quality early
learning and development programs and
services, and helps ensure that children
enter kindergarten with the skills,
knowledge, and dispositions toward
learning that they need to be successful.
The Departments of Education and
Health and Human Services have
published requirements for the FY 2011
competition and will complete the
competition and make awards by the
end of 2011.
Race to the Top Phase 3. On May 25,
2011, the Department also announced
that approximately $200 million of the
FY 2011 Race to the Top funds would
be made available to some or all of the
nine unfunded finalists from the 2010
Race to the Top Phase 2 competition.
The Department recognizes that $200
million is not sufficient to support full
implementation of the plans submitted
during the Phase 2 competition, and
therefore believes that making these
funds available to the remaining nine
finalists is the best way to create
incentives for these States to carry out
the bold reforms proposed in their
applications. We have issued final
eligibility requirements for the nine
unfunded finalists to apply for Race to
the Top Phase 3 funds.
B. Elementary and Secondary Education
Act of 1965, as Amended
In 2010, the Administration released
the Blueprint for Reform: The
Reauthorization of the Elementary and
Secondary Education Act, the
President’s plan for revising the
Elementary and Secondary Education
Act of 1965 (ESEA) and replacing the
No Child Left Behind Act of 2001
(NCLB). The blueprint can be found at
the following Web site: https://www2.ed.
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gov/policy/elsec/leg/blueprint/index.
html.
We look forward to congressional
reauthorization of the ESEA that will
build on many of the reforms States and
LEAs will be implementing under the
ARRA grant programs. In the interim,
we may propose amendments to our
current regulations implementing the
ESEA.
Additionally, as we continue to work
with Congress on reauthorization of the
ESEA, we are currently implementing a
plan to provide flexibility on certain
provisions of current law for States and
school districts that are willing to
embrace reform. The mechanisms we
are implementing will ensure continued
accountability and commitment to
quality education for all students while
at the same time providing States and
school districts with increased
flexibility to implement State and local
reforms to improve student
achievement.
C. Higher Education Act of 1965, as
Amended
Changes to the FFEL and Direct Loan
Programs. On March 30, 2010, the
President signed into law the Health
Care and Education Reconciliation Act
of 2010, Public Law 111–152, title II of
which is the SAFRA Act. SAFRA made
a number of changes to the Federal
student financial aid programs under
title IV of the Higher Education Act of
1965, as amended (HEA). One of the
most significant changes made by
SAFRA is that it ended new loans under
the Federal Family Education Loan
(FFEL) Program authorized by title IV,
part B, of the HEA as of July 1, 2010.
On May 5, 2011, ED announced
through a notice in the Federal Register
that it was beginning a negotiated
rulemaking process to streamline the
loan program regulations by repealing
unnecessary FFEL Program regulations
and incorporating and modifying
necessary requirements within the
Direct Loan Program regulations, as
appropriate. ED held four public
hearings in May 2011 to obtain public
feedback on proposed amendments, as
well as on possible amendments to
other ED regulations, including those
governing income-based and incomecontingent loan repayment plans and
loan discharges based on the total and
permanent disability of the borrower.
Based on the feedback received from
these hearings, ED will soon form a
negotiated rulemaking committee to
consider proposed amendments and
intends to conduct these negotiations in
2012.
Approval of New Gainful
Employment Programs. Over the last 2
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years, the Department has conducted
two significant rulemakings to enhance
its program integrity regulations related
to the title IV, student aid programs. As
part of this effort, on October 29, 2010,
the Department issued regulations that
included requirements for an institution
to notify the Department before offering
a new educational program that
provides training leading to gainful
employment in a recognized occupation
(Gainful Employment—New Programs).
The Department established the
notification requirement out of concern
that some institutions might attempt to
circumvent proposed regulations
regarding gainful employment standards
by adding new programs before those
standards could take effect. The
Department explained that the
notification process requirements were
intended to remain in effect until the
final regulations that established
eligibility measures for gainful
employment programs would take
effect.
We published the final regulations
establishing the gainful employment
eligibility measures on June 13, 2011
(Gainful Employment—Debt Measures).
In those regulations, the Department
established measures for gainful
employment programs that are intended
to identify the worst performing
programs. We believe that when these
new regulations go into effect on July 1,
2013, the notification process for all
new gainful employment programs
established in the Gainful
Employment—New Programs final
regulations will no longer be needed.
Accordingly, the Department has issued
a new NPRM, which among other
changes, proposes to reduce burden for
institutions by amending the Gainful
Employment—New Programs final
regulations to establish a smaller group
of gainful employment programs for
which an institution must obtain
approval from the Department.
Title II of the HEA. The Secretary
intends to develop regulations under
title II of the HEA to streamline the
program, institutional, and State report
cards; prescribe data quality standards
to ensure reliability, validity, and
accuracy of the data submitted; and
establish standards for identifying lowperforming teacher preparation
programs.
D. Individuals With Disabilities
Education Act
We have issued final regulations that
revise the regulations implementing the
Early Intervention Program for Infants
and Toddlers with Disabilities
authorized under part C of the
Individuals with Disabilities Education
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Act (IDEA) to make changes needed for
the appropriate implementation of the
early intervention program. The final
part C regulations incorporate
provisions from the 2004 amendments
to part C of the IDEA. Additionally, the
final regulations provide States with
flexibility in some areas, while ensuring
State accountability to improve results,
and needed services for infants and
toddlers with disabilities and their
families.
The Department has also issued a
notice of proposed rulemaking to revise
the regulations implementing the
Assistance to States for the Education of
Children with Disabilities program
authorized under part B of the IDEA and
intends to issue final regulations in the
coming year.
Specifically, over the last 6 months,
we engaged in a review of one particular
provision of the part B regulations,
relating to the use of public benefits or
insurance to pay for services provided
to children under part B. IDEA and the
part B regulations allow public agencies
to use public benefits or insurance (e.g.,
Medicaid) to provide or pay for services
required under part B with the consent
of the parent of a child who is enrolled
in a public benefits or insurance
program. Public insurance is an
important source of financial support
for services required under part B. With
respect to the use of public insurance,
our current regulations specifically
provide that a public agency must
obtain parental consent each time access
to public benefits or insurance is sought.
We are now proposing to amend the
regulations to provide that, instead of
having to obtain parental consent each
time access to public benefits or
insurance is sought, the public agency
responsible for providing special
education and related services to a child
would be required, before accessing a
child’s or parent’s public benefits or
insurance, to provide written
notification to the child’s parents. The
notification would inform parents of
their rights under the part B regulations
regarding the use of public benefits or
insurance to pay for part B services,
including information about the
limitations on a public agency’s billing
of public benefits or insurance
programs, as well as parents’ rights
under the Family Educational Rights
and Privacy Act and IDEA to consent
prior to the disclosure of personally
identifiable information.
We are proposing these amendments
to reduce unnecessary burden on a
public agency’s ability to access public
benefits or insurance in appropriate
circumstances but still maintain critical
parent protections, and we do this for
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several reasons. Specifically, we are
mindful of the importance of ensuring
that parents have sufficient information
to make decisions about a public
agency’s use of their public benefits or
insurance and the disclosure of their
child’s educational records for that
purpose. At the same time, these
proposed amendments are designed to
address the concern expressed to the
Department by many State personnel
and other interested parties that, since
the publication of the part B regulations
in 2006, the inability to obtain parental
consent has contributed to public
agencies’ failure to claim all of the
Federal financial assistance available for
part B services covered under Medicaid.
In addition, public agencies have
expressed concern over using limited
resources and the significant
administrative burden of obtaining
parental consent for the use of Medicaid
and other public benefits or insurance
each time that access to public benefits
or insurance is sought. Consequently,
many of these parties have requested
that the Department remove the parental
consent requirement.
E. Family Educational Rights and
Privacy Act
Given the President’s emphasis on
improving the collection and use of data
as a key element of educational reform,
we intend to issue final regulations in
the coming year to amend our current
regulations for the Family Educational
Rights and Privacy Act of 1974 (FERPA)
to ensure that States are able to
effectively establish and expand robust
statewide longitudinal data systems
while protecting student privacy.
F. Other Potential Regulatory Activities
Congress may reauthorize the Adult
Education and Family Literacy Act
(AEFLA) (title II of the Workforce
Investment Act of 1998) and the
Rehabilitation Act of 1973 (title IV of
the Workforce Investment Act of 1998).
The Administration is working with
Congress to ensure that any changes to
these laws (1) improve the State grant
and other programs providing assistance
for adult education under the AEFLA
and for vocational rehabilitation and
independent living services for persons
with disabilities under the
Rehabilitation Act of 1973; and (2)
provide greater accountability in the
administration of programs under both
statutes. Changes to our regulations may
be necessary as a result of the
reauthorization of these two statutes.
III. Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Some of the entries on this list may be
completed actions, which do not appear
in The Regulatory Plan. However, more
information can be found about these
completed rulemakings in past
publications of the Unified Agenda on
Reginfo.gov in the Completed Actions
section for that agency. These
rulemakings can also be found on
Regulations.gov. The final agency plans
can be found at: https://www2.ed.gov/
about/open.html.
Do we expect this
rulemaking to significantly reduce burden
on small businesses?
RIN
Title of Rulemaking
1820–AB64 ................
1840–AD01 ................
Assistance to States for the Education of Children With Disabilities .............................................
High School Equivalency Program and College Assistance Migrant Program, the Federal TRIO
Programs, and Gaining Early Awareness, and Readiness for Undergraduate Program.
Program Integrity Issues .................................................................................................................
Title IV of the Higher Education Act of 1965, as Amended ............................................................
Program Integrity: Gainful Employment—Measures .......................................................................
Titles III and V of the Higher Education Act of 1965, as Amended ...............................................
Application and Approval Process for New Programs ....................................................................
Family Educational Rights and Privacy ...........................................................................................
The Freedom of Information Act .....................................................................................................
Direct Grant Programs and Definitions That Apply to Department Regulations ............................
Department of Education Acquisition Regulations ..........................................................................
1848–AD02
1840–AD05
1840–AD06
1840–AD08
1840–AD10
1880–AA86
1880–AA84
1890–AA14
1890–AA16
................
................
................
................
................
................
................
................
................
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IV. Principles for Regulating
Over the next year, other regulations
may be needed because of new
legislation or programmatic changes. In
developing and promulgating
regulations we follow our Principles for
Regulating, which determine when and
how we will regulate. Through
consistent application of the following
principles, we have eliminated
unnecessary regulations and identified
situations in which major programs
could be implemented without
regulations or with limited regulatory
action.
In deciding when to regulate, we
consider the following:
• Whether regulations are essential to
promote quality and equality of
opportunity in education.
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• Whether a demonstrated problem
cannot be resolved without regulation.
• Whether regulations are necessary
to provide a legally binding
interpretation to resolve ambiguity.
• Whether entities or situations
subject to regulation are similar enough
that a uniform approach through
regulation would be meaningful and do
more good than harm.
• Whether regulations are needed to
protect the Federal interest; that is, to
ensure that Federal funds are used for
their intended purpose and to eliminate
fraud, waste, and abuse.
In deciding how to regulate, we are
mindful of the following principles:
• Regulate no more than necessary.
• Minimize burden, to the extent
possible, and promote multiple
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No.
No.
No.
No.
No.
No.
Yes.
No.
No.
No.
No.
approaches to meeting statutory
requirements if possible.
• Encourage coordination of federally
funded activities with State and local
reform activities.
• Ensure that the benefits justify the
costs of regulating.
• To the extent possible, establish
performance objectives rather than
specify compliance behavior.
• Encourage flexibility, to the extent
possible, and as needed to enable
institutional forces to achieve desired
results.
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ED—OFFICE OF POSTSECONDARY
EDUCATION (OPE)
DEPARTMENT OF ENERGY (DOE)
Proposed Rule Stage
26. Title IV of the Higher Education Act
of 1965, as Amended
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 20 U.S.C. 1070a; 20
U.S.C. 1071 to 1087–4; 20 U.S.C. 1087a
to 1087j; 20 U.S.C. 1098e; Pub. L. 111–
152
CFR Citation: 34 CFR chapter VI.
Legal Deadline: None.
Abstract: The Secretary proposes to
amend the title IV, HEA student
assistance regulations to (1) reflect that,
as of July 1, 2010, under title II of the
Health Care and Education
Reconciliation Act of 2010 (the SAFRA
Act), no new Federal Family Education
Loan Program loans will be made and
(2) to reflect other changes to improve
the effectiveness and efficiency of the
student loan programs, particularly with
regard to the discharge of loans for
persons with total and permanent
disabilities.
Statement of Need: These regulations
are needed to reflect the provisions of
the SAFRA Act (title II of the Health
Care and Education Reconciliation Act
of 2010) and to reflect other
amendments to the HEA resulting from
the SAFRA Act.
Summary of Legal Basis: Health Care
and Education Reconciliation Act of
2010, Public Law 111–152.
Alternatives: The Department is still
developing these proposed regulations;
our discussion of alternatives will be
included in the notice of proposed
rulemaking.
Anticipated Cost and Benefits:
Estimates of the costs and benefits are
currently under development and will
be included in the notice of proposed
rulemaking.
Risks: None.
Timetable:
Date
NPRM ..................
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Action
FR Cite
03/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
URL for Public Comments:
www.regulations.gov.
Agency Contact: David Bergeron,
Department of Education, Office of
Postsecondary Education, Room 8022,
1990 K Street NW., Washington, DC
20006, Phone: 202 502–7815, Email:
david.bergeron@ed.gov.
RIN: 1840–AD05
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Fall 2011 Statement of Regulatory and
Deregulatory Priorities
The Department of Energy
(Department or DOE) makes vital
contributions to the Nation’s welfare
through its activities focused on
improving national security, energy
supply, energy efficiency,
environmental remediation, and energy
research. The Department’s mission is
to:
• Promote dependable, affordable,
and environmentally sound production
and distribution of energy;
• Advance energy efficiency and
conservation;
• Provide responsible stewardship of
the Nation’s nuclear weapons;
• Provide a responsible resolution to
the environmental legacy of nuclear
weapons production;
• Strengthen U.S. scientific
discovery, economic competitiveness,
and improving quality of life through
innovations in science and technology.
The Department’s regulatory activities
are essential to achieving its critical
mission and to implementing major
initiatives of the President’s National
Energy Policy. Among other things, the
Regulatory Plan and the Unified Agenda
contain the rulemakings the Department
will be engaged in during the coming
year to fulfill the Department’s
commitment to meeting deadlines for
issuance of energy conservation
standards and related test procedures.
The Regulatory Plan and Unified
Agenda also reflect the Department’s
continuing commitment to cut costs,
reduce regulatory burden, and increase
responsiveness to the public.
Energy Efficiency Program for Consumer
Products and Commercial Equipment
The Energy Policy and Conservation
Act (EPCA) requires DOE to set
appliance efficiency standards at levels
that achieve the maximum improvement
in energy efficiency that is
technologically feasible and
economically justified. The standards
already published in 2011 have an
estimated net benefit to the Nation of up
to $16.6 billion over 30 years. By 2045,
these standards are expected to save
enough energy to operate all U.S. homes
for more than 7 months.
The Department continues to follow
its schedule for setting new appliance
efficiency standards. These rulemakings
are expected to save American
consumers billions of dollars in energy
costs. The schedule outlines how DOE
will address the various appliance
standards rulemakings necessary to
meet statutory requirements established
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in EPCA, the Energy Policy Act of 2005
(EPACT 2005), and the Energy
Independence and Security Act of 2007
(EISA 2007).
The overall plan for implementing the
schedule is contained in the Report to
Congress under section 141 of EPACT
2005 that was released on January 31,
2006. This plan was last updated in the
August 2011 report to Congress and now
includes the requirements of the Energy
Independence and Security Act of 2007
(EISA 2007). The reports to Congress are
posted at: https://www.eere.energy.gov/
buildings/appliance_standards/
schedule_setting.html. The August 2011
report identifies all products for which
DOE has missed the deadlines
established in EPCA (42 U.S.C. section
6291 et seq.). It also describes the
reasons for such delays and the
Department’s plan for expeditiously
prescribing new or amended standards.
Information and timetables concerning
these actions can also be found in the
Department’s regulatory agenda, which
is posted online at: www.reginfo.gov.
Estimate of Combined Aggregate Costs
and Benefits
The regulatory actions included in
this regulatory plan are expected to
provide significant benefits to the
Nation for product categories including:
Fluorescent lamp ballasts, manufactured
housing, battery chargers and external
power supplies, walk-in coolers and
freezers, and incandescent reflector
lamps. DOE believes that the benefits to
the Nation of the proposed energy
standards for fluorescent lamp ballasts
(energy savings, consumer average
lifecycle cost savings, national net
present value increase, and emission
reductions) outweigh the costs (loss of
industry net present value and life-cycle
cost increases for some consumers).
DOE estimates that these regulations
will produce an energy savings between
3.7 and 6.3 quads over 30 years. The
benefit to the Nation will be between
$8.1 billion (7% discount rate) and
$24.7 billion (3% discount rate). DOE
believes that the proposed energy
standards for manufactured housing,
battery chargers and external power
supplies, walk-in coolers and freezers,
and incandescent reflector lamps will
also be beneficial to the Nation.
However, because DOE has not yet
proposed candidate standard levels for
this equipment, DOE cannot provide an
estimate of combined aggregate costs
and benefits for these actions. DOE will,
however, in compliance with all
applicable law, issue standards that
provide the maximum energy savings
that are technologically feasible and
economically justified. Estimates of
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energy savings will be provided when
DOE issues the notices of proposed
rulemaking for this equipment.
DOE—ENERGY EFFICIENCY AND
RENEWABLE ENERGY (EE)
Proposed Rule Stage
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27. Energy Efficiency Standards for
Battery Chargers and External Power
Supplies
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 6295(u)
CFR Citation: 10 CFR 430.
Legal Deadline: Final, Statutory, July
1, 2011.
Abstract: In addition to the existing
general definition of ‘‘external power
supply,’’ the Energy Independence and
Security Act of 2007 (EISA) defines a
‘‘Class A external power supply’’ and
sets efficiency standards for those
products. EISA directs DOE to publish
a final rule to determine whether the
standards set for Class A external power
supplies should be amended. EISA also
requires DOE to issue a final rule
prescribing energy conservation
standards for battery chargers, if
technologically feasible and
economically justified.
Statement of Need: The Energy Policy
and Conservation Act (EPCA) requires
minimum energy standards for
appliances, which has the effect of
eliminating inefficient appliances and
equipment from the market.
Summary of Legal Basis: Title III of
EPCA sets forth a variety of provisions
designed to improve energy efficiency.
Part A of title III (42 U.S.C. 6291 to
6309) provides for the Energy
Conservation Program for Consumer
Products other than Automobiles. EPCA
directs DOE to conduct a rulemaking to
establish energy conservation standards
for battery chargers or determine that no
energy conservation standard is
technically feasible and economically
justified (42 U.S.C. 6295 (u)(1)(E)(i) and
(ii)).
In addition to the existing general
definition of ‘‘external power supply,’’
EPCA defines a ‘‘Class A external power
supply’’ (42 U.S.C. 6291(36)(C)) and sets
efficiency standards for those products
(42 U.S.C. 6295(u)(3)). EPCA directs
DOE to publish a final rule to determine
whether amended standards should be
set for Class A external power supplies,
or new standards set for other classes of
external power supplies. If such
determination is positive, DOE must
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include any amended or new standards
as part of that final rule.
DOE is bundling the two requirements
to establish energy conservation
standards for battery chargers and to
consider amended or new standards for
external power supplies into a single
rulemaking.
Alternatives: The statute requires the
Department to conduct rulemakings to
review standards and to revise
standards to achieve the maximum
improvement in energy efficiency that
the Secretary determines is
technologically feasible and
economically justified. In making this
determination, the Department conducts
a thorough analysis of the alternative
standard levels, including the existing
standard, based on the criteria specified
by the statute.
Anticipated Cost and Benefits:
Because DOE has not yet proposed
candidate standard levels for this
equipment, DOE cannot provide an
estimate of combined aggregate costs
and benefits for these actions. DOE will,
however, in compliance with all
applicable law, issue standards that
provide the maximum energy savings
that are technologically feasible and
economically justified. Estimates of
energy savings will be provided when
DOE issues the notices of proposed
rulemaking for this equipment.
Timetable:
Action
Date
FR Cite
Notice: Public
Meeting,
Framework
Document
Availability.
Comment Period
End.
Notice: Public
Meeting, Data
Availability.
Comment Period
End.
Final Rule (Technical Amendment).
NPRM ..................
Final Action .........
06/04/09
74 FR 26816
07/20/09
09/15/10
75 FR 56021
10/15/10
09/19/11
76 FR 57897
12/00/11
07/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local,
State.
Federalism: Undetermined.
URL for More Information:
www1.eere.energy.gov/buildings/
appliance_standards/residential/
battery_external.html.
Agency Contact: Victor Petrolati,
Office of Building Technologies
Program, EE–2J, Department of Energy,
Energy Efficiency and Renewable
PO 00000
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Energy, 1000 Independence Avenue
SW., Washington, DC 20585, Phone: 202
586–4549, Email: victor.petrolati@ee.
doe.gov.
Related RIN: Related to 1904–AB75.
RIN: 1904–AB57
DOE—EE
28. Energy Conservation Standards for
Walk-In Coolers and Walk-In Freezers
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 6313(f)(4)
CFR Citation: 10 CFR 431.
Legal Deadline: Final, Statutory,
January 1, 2012.
Abstract: The Energy Independence
and Security Act of 2007 amendments
to the Energy Policy and Conservation
Act require that DOE establish
maximum energy consumption levels
for walk-in coolers and walk-in freezers.
Statement of Need: The Energy Policy
and Conservation Act requires
minimum energy efficiency standards
for appliances, which has the effect of
eliminating inefficient appliances and
equipment from the market.
Summary of Legal Basis: Section 312
of the Energy Independence and
Security Act of 2007 (EISA) establishes
definitions and standards for walk-in
coolers and walk-in freezers. EISA
directs DOE to establish performancebased standards not later than January 1,
2012 (42 U.S.C. 6313 (f)(4)).
Alternatives: The statute requires the
Department to conduct rulemakings to
review standards and to revise
standards to achieve the maximum
improvement in energy efficiency that
the Secretary determines is
technologically feasible and
economically justified. In making this
determination, the Department conducts
a thorough analysis of the alternative
standard levels, including the existing
standard, based on the criteria specified
by the statute.
Anticipated Cost and Benefits:
Because DOE has not yet proposed
candidate standard levels for this
equipment, DOE cannot provide an
estimate of combined aggregate costs
and benefits for these actions. DOE will,
however, in compliance with all
applicable law, issue standards that
provide the maximum energy savings
that are technologically feasible and
economically justified. Estimates of
energy savings will be provided when
DOE issues the notice of proposed
rulemaking for this equipment.
Timetable:
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Action
Date
FR Cite
Notice: Public
Meeting,
Framework
Document
Availability.
Notice: Public
Meeting, Data
Availability.
Comment Period
End.
NPRM ..................
Final Action .........
01/06/09
74 FR 411
04/05/10
75 FR 17080
05/20/10
12/00/11
02/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local,
State.
Federalism: Undetermined.
Additional Information: Comments
pertaining to this rule may be submitted
electronically to WICF–2008–STD–
0015@ee.doe.gov.
URL for More Information: www.eere.
energy.gov/buildings/appliance_
standards/commercial/wicf.html.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Charles Llenza,
Office of Building Technologies
Program, EE–2J, Department of Energy,
Energy Efficiency and Renewable
Energy, 1000 Independence Avenue
SW., Washington, DC 20585, Phone: 202
586–2192, Email:
charles.llenza@ee.doe.gov.
Related RIN: Related to 1904–AB85.
RIN: 1904–AB86
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DOE—EE
29. Energy Efficiency Standards for
Manufactured Housing
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 17071
CFR Citation: 10 CFR 460.
Legal Deadline: Final, Statutory,
December 19, 2011.
Abstract: The rule would establish
energy efficiency standards for
manufactured housing and a system to
ensure compliance with, and
enforcement of, the standards.
Statement of Need: The Energy
Independence and Security Act requires
increased energy efficiency standards
for manufactured housing.
Summary of Legal Basis: Section 413
of the Energy Independence and
Security Act of 2007 (EISA), 42 U.S.C.
17071, directs DOE to develop and
publish energy standards for
manufactured housing.
Alternatives: The statute requires DOE
to conduct a rulemaking to establish
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standards to achieve the maximum
improvement in energy efficiency that
the Secretary determines is
technologically feasible and
economically justified. In making this
determination, DOE conducts a
thorough analysis of the alternative
standard levels, including the existing
standard, based on the criteria specified
by the statute.
Anticipated Cost and Benefits:
Because DOE has not yet proposed
candidate standard levels, DOE cannot
provide an estimate of combined
aggregate costs and benefits for these
actions. DOE will, however, in
compliance with all applicable law,
issue standards that provide the
increased energy savings that are
technologically feasible and
economically justified. Estimates of
energy savings will be provided when
DOE issues the notice of proposed
rulemaking.
Timetable:
Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
Final Action .........
02/22/10
03/24/10
75 FR 7556
02/00/12
12/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
URL for More Information: www.
energycodes.gov/status/mfg_
housing.stm.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Ronald B. Majette,
Program Manager, Office of Building
Technologies Program, EE–2J,
Department of Energy, Energy Efficiency
and Renewable Energy, 1000
Independence Avenue SW.,
Washington, DC 20585, Phone: 202 586–
7935, Email: ajett.majette@hq.doe.gov.
RIN: 1904–AC11
DOE—EE
30. Energy Conservation Standards for
ER, BR, and Small Diameter
Incandescent Reflector Lamps
Priority: Other Significant. Major
under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C.
6291(30)(C)(ii) and (F); 42 U.S.C. 6295(i)
CFR Citation: 10 CFR 430.
Legal Deadline: None.
Abstract: Amendments to Energy
Policy and Conservation Act (EPCA) in
the Energy Independence and Security
Act of 2007 (EISA) amended the energy
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conservation standards to extend
coverage to certain classes of IRL that
had previously been outside the
statutory definition of ‘‘incandescent
reflector lamp’’ although these lamps
were excluded from the statutory
standard levels. However, EISA 2007
authorized DOE to amend these
standards if such amendments were
warranted. Specifically, as amended,
EPCA exempted certain small diameter,
ellipsoidal reflector (ER) and bulged
reflector (BR) lamps from standards. In
June 2009, DOE published a final rule
amending existing standards for IRL. In
earlier stages of the June 2009
rulemaking, DOE had interpreted its
authority with regard to IRL as limited
to amending congressionally established
standard levels only, and not to the
exemptions set by Congress for certain
explicitly identified small diameter ER
and BR lamps, commonly used in track
lighting and recessed cans. On further
review, DOE has concluded that DOE
has authority to establish efficiency
standards for these currently exempt
small diameter ER and BR lamps.
However, as a practical matter, DOE
could not consider these lamps as part
of the previous rulemaking because it
had not conducted the requisite
analyses to set appropriate standard
levels. Pursuant to EPCA, DOE is now
conducting a rulemaking as to energy
conservation standards for certain
incandescent reflector lamps (IRL) that
have ER or BR bulb shapes, and for
certain IRL with diameters less than
2.25 inches.
Statement of Need: The Energy Policy
and Conservation Act requires
minimum energy efficiency standards
for appliances, which has the effect of
eliminating inefficient appliances and
equipment from the market.
Summary of Legal Basis: Section 322
of the Energy Independence and
Security Act of 2007 (EISA) establishes
definitions and standards for ER, BR,
and BPAR incandescent reflector lamps.
(42 U.S.C. 6291(54) to 6291(56), 42
U.S.C. 6295 (i)) Furthermore, section
305 of EISA directs DOE to, not later
than 6 years after issuance of any final
rule establishing or amending a
standard, publish either a notice of
determination that standards do not
need to be amended or a notice of
proposed rulemaking including new
proposed standards. (42 U.S.C. 6295
(m))
Alternatives: The statute requires the
Department to conduct rulemakings to
review standards and to revise
standards to achieve the maximum
improvement in energy efficiency that
the Secretary determines is
technologically feasible and
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
economically justified. In making this
determination, the Department conducts
a thorough analysis of the alternative
standard levels, including the existing
standard, based on the criteria specified
by the statute.
Anticipated Cost and Benefits:
Because DOE has not yet proposed
candidate standard levels for this
equipment, DOE cannot provide an
estimate of combined aggregate costs
and benefits for these actions. DOE will,
however, in compliance with all
applicable law, issue standards that
provide the maximum energy savings
that are technologically feasible and
economically justified. Estimates of
energy savings will be provided when
DOE issues the notice of proposed
rulemaking for this equipment.
Timetable:
Action
Date
FR Cite
Notice: Public
Meeting,
Framework
Document
Availability.
Comment Period
End.
NPRM ..................
Final Action .........
05/03/10
75 FR 23191
06/17/10
12/00/11
01/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
URL for More Information: www1.
eere.energy.gov/buildings/appliance_
standards/residential/incandescent_
lamps.html.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Lucy Debutts, Office
of Building Technologies Program, EE–
2J, Department of Energy, Energy
Efficiency and Renewable Energy, 1000
Independence Avenue SW.,
Washington, DC 20585, Phone: 202 287–
1604, Email: lucy.debutts@ee.doe.gov.
Related RIN: Related to 1904–AA92.
RIN: 1904–AC15
DOE—EE
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Final Rule Stage
31. Energy Efficiency Standards for
Fluorescent Lamp Ballasts
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 42 U.S.C. 6295(g)
CFR Citation: 10 CFR 430.
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Legal Deadline: Final, Judicial,
October 28, 2011.
Abstract: DOE is reviewing and
updating energy efficiency standards, as
required by the Energy Policy and
Conservation Act, to reflect
technological advances. All amended
energy efficiency standards must be
technologically feasible and
economically justified. This is the
second review of the statutory standards
for fluorescent lamp ballasts.
Statement of Need: The Energy Policy
and Conservation Act requires
minimum energy efficiency standards
for appliances, which has the effect of
eliminating inefficient appliances and
equipment from the market.
Summary of Legal Basis: The Energy
Policy and Conservation Act (EPCA) of
1975 (42 U.S.C. 6291 to 6309)
established an energy conservation
program for major household
appliances. Amendments to EPCA in
the National Appliance Energy
Conservation Amendments of 1988
(NAECA 1988) established energy
conservation standards for fluorescent
lamp ballasts. These amendments also
required that DOE (1) conduct two
rulemaking cycles to determine whether
these standards should be amended, and
(2) for each rulemaking cycle, determine
whether the standards in effect for
fluorescent lamp ballasts should be
amended to apply to additional
fluorescent lamp ballasts. (42 U.S.C.
6295(g)(7)(A) and (B)). On September
19, 2000, DOE published a final rule in
the Federal Register, which completed
the first rulemaking cycle to amend
energy conservation standards for
fluorescent lamp ballasts. 65 FR 56740.
This rulemaking encompasses DOE’s
second cycle of review to determine
whether the standards in effect for
fluorescent lamp ballasts should be
amended and whether the standards
should be applicable to additional
fluorescent lamp ballasts.
Alternatives: The statute requires DOE
to conduct rulemakings to review
standards and to revise standards to
achieve the maximum improvement in
energy efficiency that the Secretary
determines is technologically feasible
and economically justified. In making
this determination, DOE conducts a
thorough analysis of the alternative
standard levels, including the existing
standard, based on the criteria specified
by the statute.
Anticipated Cost and Benefits: DOE
believes that the benefits to the Nation
from energy standards for fluorescent
lamp ballasts (energy savings, consumer
average lifecycle cost (LCC) savings,
national net present value (NPV)
increase, and emission reductions)
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outweigh the burdens (loss of NPV and
LCC increases of some small electric
motor users). DOE estimates that energy
savings from electricity will be between
3.7 and 6.3 quads over 30 years and the
benefits to the Nation will be between
$8.1 and $24.7 billion.
Timetable:
Action
Date
FR Cite
Notice: Public
Meeting,
Framework
Document
Availability.
Notice: Public
Meetings, Data
Availability.
NPRM ..................
NPRM Comment
Period End.
Notice of Data
Availability
(NODA); Request for Comments.
NODA Comment
Period End.
Final Action .........
01/22/08
73 FR 3653
03/24/10
75 FR 14319
04/11/11
06/11/11
76 FR 20090
08/24/11
76 FR 52892
09/14/11
12/00/11
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local,
State.
Federalism: This action may have
federalism implications as defined in
EO 13132.
URL for More Information: www1.
eere.energy.gov/buildings/appliance_
standards/residential/fluorescent_
lamp_ballasts.html
URL for Public Comments:
www.regulations.gov.
Agency Contact: Tina Kaarsberg,
Office of Building Technologies
Program, EE–2J, Department of Energy,
Energy Efficiency and Renewable
Energy, 1000 Independence Avenue
SW., Washington, DC 20585, Phone: 202
287–1393, Email:
tina.kaarsberg@ee.doe.gov.
Related RIN: Related to 1904–AB77,
Related to 1904–AA99.
RIN: 1904–AB50
BILLING CODE 6450–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Statement of Regulatory Priorities for FY
2012
The Department of Health and Human
Services is the Federal Government’s
principal agency charged with
protecting the health of all Americans
and providing essential human services,
especially for those least able to help
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themselves. The Department operates
more than 300 programs covering a
wide spectrum of activities, manages
almost a quarter of all Federal outlays,
and administers more grant dollars than
all other Federal agencies combined.
The Department’s major program
responsibilities include: Medicare and
Medicaid; control and prevention of
communicable and chronic disease;
support for public health preparedness
and emergency response; biomedical
research; substance abuse and mental
health treatment and prevention;
assuring safe and effective drugs,
devices, and other medical products;
protecting the food supply; assistance to
low-income families; the Head Start
program; and improving access to health
care services to the uninsured, isolated,
or medically vulnerable. Currently, the
Department is the principal agency
charged with implementing one of the
President’s signature achievements—
transformative health care reform
through the Affordable Care Act of 2010.
To implement this vast program
portfolio, the Department develops an
active regulatory agenda each year,
driven largely by statutory mandates
and interactions with stakeholders. The
President also called upon Federal
agencies to reform the regulatory
process in his January 18, 2011,
Executive Order 13563 ‘‘Improving
Regulation and Regulatory Review.’’ A
key directive in that Executive order
was to require agencies to conduct an
inventory of existing regulations to
determine whether such regulations
should be modified, streamlined,
expanded, or repealed to make an
agency’s regulatory scheme more
effective or less burdensome in
achieving its programmatic objectives.
With these regulatory drivers in mind,
Secretary Kathleen Sebelius has worked
with HHS agencies to craft a regulatory
agenda that reflects her commitments to
implementing meaningful health care
reform, access to health care coverage,
and high value health care services that
are safe and effective for all Americans.
The agenda also reflects her other
strategic initiatives, which include
securing and maintaining health care
coverage for all Americans; improving
quality and patient safety; more rapidly
responding to adverse events;
implementing a 21st century food safety
system; helping Americans achieve and
maintain healthy living habits;
advancing scientific research; and
streamlining regulations to reduce the
regulatory burden on industry and
States. Within this agenda, the Secretary
has also been mindful of the need to
reform the ongoing regulatory process
through retrospective review of existing
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regulations, and this agenda reflects her
commitment to that review by
incorporating some of the most
significant burden reduction reforms
across all Federal agencies. In fact, of
the $10 billion in savings from
retrospective regulatory review across
all Federal agencies announced by the
Administrator of the Office of
Information and Regulatory Affairs, $5
billion was attributable to regulations
contained within this Department’s
current regulatory agenda.
What follows is an overview of the
Department’s regulatory priorities for
FY 2012 and some of the regulations on
the agenda that best exemplify these
priorities.
Making Health Insurance Coverage More
Secure for Those Who Have Insurance
and Extending Coverage to the
Uninsured
As a result of the Affordable Care Act,
the Department is making affordable
health care coverage more stable and
secure through insurance market
reforms designed to protect consumers
against unreasonable insurance
premium increases, provide them with
more comprehensive and
understandable information with which
to make decisions, and enable eligible
consumers to receive financial support
for health insurance easily and
seamlessly. In 2014, all people who
suffer from chronic conditions will no
longer be excluded from insurance
coverage or charged higher premiums
because of a pre-existing condition or
medical history.
Already, insurers are prohibited from
putting lifetime dollar limits and
restrictive annual caps on what they
will pay for health care services needed
by the people they insure, ensuring that
those people have access to medical
care throughout their lives, especially
when it is most needed. HHS is working
with States to help identify and put a
stop to unreasonable health insurance
premium rate increases and will require
new health plans to implement a
comprehensive appeals process for
those beneficiaries who have been
denied coverage or payment by the
insurance plan. New health insurers
will also be required to spend the
majority of health insurance premiums
on medical care and health care quality
improvement, not on administration
and overhead. As well, the Affordable
Care Act is providing reimbursement to
employers that offer health benefits to
early retirees, providing insurance
coverage through the Pre-existing
Condition Insurance Plan to people who
would otherwise be locked out of the
insurance market because of their pre-
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existing health conditions, and
requiring plans that offer dependent
coverage to make that coverage available
to young adults up to age 26.
Moving forward this year, the
Department will continue to implement
the Affordable Care Act to promote
consumer protections, improve quality
and safety, provide incentives for more
efficient care delivery, and slow the
growth of health care costs. The Centers
for Medicare & Medicaid Services (CMS)
will finalize three rules that will expand
access to health insurance and provide
consumers with better options and
information about insurance:
• CMS will issue standards for the
establishment of the Affordable
Insurance Exchanges (Exchanges) to
provide competitive marketplaces for
individuals and small employers to
directly compare available private
health insurance options on the basis of
price and quality. These Exchanges will
help enhance competition in the health
insurance market, improve choice of
affordable health insurance, and give
small businesses the same purchasing
clout as large businesses.
• Another rule helps to make
coverage more secure by offsetting
market uncertainty and risk selection to
maintain the viability of Exchanges.
Under risk adjustment, HHS, in
consultation with the States, will
establish criteria and methods to be
used by States in determining the
actuarial risk of plans within a State to
minimize the negative effects of adverse
selection. Under reinsurance, all health
insurance issuers, and third-party
administrators on behalf of self-insured
group health plans, will contribute to a
nonprofit reinsurance entity to support
reinsurance payments to individual
market issuers that cover high risk
individuals.
• To extend health insurance to
greater numbers of low-income people,
Medicaid eligibility in 2014 will expand
to cover adults under the age of 65
earning up to 133 percent of the Federal
poverty level, and those who earn above
that level may be eligible for tax credits
through the Exchanges to help pay their
premiums. New, simplified procedures
for determining Medicaid, CHIP, and tax
credit eligibility will be forthcoming in
2012. CMS will simplify eligibility rules
to make it easier for eligible individuals
and families to obtain premium tax
credits and Medicaid coverage,
including ensuring that Medicaid uses
the same eligibility standards as other
insurance affordability programs
available through the Exchange, as
directed by law. The rule further
outlines how Medicaid and CHIP will
coordinate closely with the Exchange,
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including sharing data to ensure that
individuals are determined eligible for
the appropriate insurance affordability
program regardless of where an
applicant submits the application.
Improving Health Care Quality and
Patient Safety
Across America and for all
Americans, the Department is working
to improve patient outcomes, ensure
patient safety, promote efficiency and
accountability, encourage shared
responsibility, and reduce health care
costs. Through improved administrative
processes, reforms, innovations, and
additional information to support
consumer decisionmaking, HHS is
supporting high-value, safe, and
effective care across health care settings
and in the community.
In 2011, the Department published a
key regulation to advance this priority—
the final rule for Accountable Care
Organizations. This rule establishes a
system of shared savings for qualified
organizations that deliver primary care
services to a given patient population.
The objective is to promote
accountability and shared responsibility
for the delivery of care, especially to
those with co-morbidities of chronic
health problems in order to prevent
unnecessary and costly in-patient
hospital care, reduce health care
acquired conditions, and improve the
quality of life for those individuals. This
rule serves as a companion to additional
demonstration programs designed to
explore alternative services delivery and
payment systems that are being
sponsored by the new Center for
Medicare and Medicaid Innovation.
Several more key regulations are on the
agenda to move forward in meeting
these quality and patient safety goals:
• CMS is implementing value-based
purchasing programs throughout its
payment structure in order to reward
hospitals and other health care
providers for delivering high-quality
care, rather than just a high volume of
services. The payment rules scheduled
for publication this year will reflect a
mix of standards, processes, outcomes,
and patient experience of care measures,
including measures of care transition
and changes in patient functional status.
• The Department continues to
encourage health care providers to
become meaningful users of health
information technology (IT) by
accelerating health IT adoption and
promoting electronic health records to
help improve the quality of health care,
reduce costs, and ultimately, improve
health outcomes. Electronic health
records and health information
exchange can help clinicians provide
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higher quality and safer care for their
patients. By adopting electronic health
records in a meaningful way, clinicians
will know more about their patients to
better coordinate and improve the
quality of patient care, and they can
make better decisions about treatments
and conditions.
Improving Response to Adverse Events
In a related activity, the FDA will be
proposing a new rule to establish a
unique identification system for medical
devices in order to track a device from
pre-market application through
distribution and use. This system will
allow FDA and other public health
entities to track individual devices so
that when an adverse event occurs,
epidemiologists can quickly track down
and identify other users of the device to
provide guidance and recommendations
on what steps to take to prevent
additional adverse actions.
Implementing a 21st Century Food
Safety System
The Food Safety Modernization Act of
2010, signed into law by the President
in January 2011, directs the Food and
Drug Administration (FDA), working
with a wide range of public and private
partners, to build a new system of food
safety oversight—one focused on
applying the best available science and
good common sense to prevent the
problems that can make people sick. In
implementing that Act, the
Department’s goal is to shift emphasis
from removing unsafe products from the
market place to keeping unsafe food
from entering commerce in the first
place.
FDA will propose several new rules to
establish a robust, enhanced food safety
program.
• FDA will propose regulations
establishing preventive controls in the
manufacture and distribution of human
foods and of animal feeds. These
regulations will constitute the heart of
the food safety program by instituting,
for the first time, good manufacturing
practices for the manufacture and
distribution of food products to ensure
that those products are safe for
consumption and will not cause or
spread disease.
• Perhaps most anticipated in light of
food borne illnesses occurring in 2011,
FDA will introduce a rule addressing
produce safety to ensure that produce
sold in the marketplace meets rigorous
safety standards. The regulation will set
enforceable, science-based standards for
the safe production and harvesting of
fresh produce at the farm and the
packing house to minimize the risk of
serious adverse health consequences.
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• In another proposed rule, FDA will
require food importers to have a foreign
supplier verification program that will
be adequate to provide assurances that
each foreign supplier produces food in
a manner that provides the same level
of protection as required for domestic
production under the Food Drug and
Cosmetic Act.
• FDA will establish a program to
accredit third-party auditors to conduct
food safety audits of foreign entities.
Such a program will relieve importers of
having to establish such programs
themselves and, instead, allow them to
contract with an accredited auditor to
meet the audit requirements.
Empowering Americans To Make
Healthy Choices in the Marketplace
Roughly two-thirds of adults and onethird of children in the United States are
overweight or obese, increasing their
risk for chronic diseases, including
heart disease, type 2 diabetes, certain
cancers, stroke, and arthritis. Almost 10
percent of all medical spending is used
to treat obesity-related conditions. In
order to reverse the obesity epidemic,
HHS is employing a comprehensive
approach that includes both clinical and
public health strategies and touches
people where they live, work, learn, and
play.
To help advance this agenda, FDA
will finalize two rules aimed at
empowering consumers to make healthy
eating choices. The rules require
nutrition labeling on standard menu
items in restaurants and similar retail
food establishments, as well as on food
sold in vending machines. One rule will
require restaurants and similar retail
food establishments with 20 or more
locations to list calorie content
information for standard menu items on
restaurant menus and menu boards,
including drive-through menu boards.
Other nutrient information—total
calories, fat, saturated fat, cholesterol,
sodium, total carbohydrates, sugars,
fiber and total protein—would have to
be made available in writing upon
request. The other rule will require
vending machine operators who own or
operate 20 or more vending machines to
disclose calorie content for some items.
The Department anticipates that such
information will ensure that patrons of
chain restaurants and vending machines
have nutritional information about the
food they are consuming.
Two additional rules will also
improve dietary information available to
consumers. One is a revision to the
nutrition and supplement facts labels.
Much of the information found on the
Nutrition Facts label has not been
updated since 1993 when mandatory
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nutrition labeling of food was first
required. The aim of the proposed
revision is to provide updated and
easier to read nutrition information on
the label to help consumers maintain
healthy dietary practices. The other
proposed rule will focus on the serving
sizes of foods that can reasonably
consumed in one serving. This rule
would amend the labeling regulations to
provide updated reference amounts for
certain food categories with new
consumption data derived from the
current National Health and Nutrition
Survey.
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Advancing Scientific Research
To effectively address the challenges
the Department faces in crafting the
best, evidence-based approaches to
advance health services delivery,
protect the public health, ensure
essential human services, promote
biomedical research, and ensure the
availability of safe medical and food
products, the Department must rely on
research. The lynchpin of this research
is found in the ethical rules governing
research on human subjects.
In a major undertaking, the
Department is in the process of
reviewing and revising those ethical
rules, commonly referred to as the
Common Rule. The Common Rule
serves to guide researchers and
investigators in the Department, but also
throughout the Federal Government, in
the conduct and protocols for doing
research on human subjects. The
proposed revisions will be designed to
better protect human subjects who are
involved in research, while facilitating
research and reducing burden, delay,
and ambiguity for investigators.
Streamlining Regulations To Reduce
Regulatory Burdens
Consistent with the President’s
Executive Order 13563, the Department
continues its commitment to reducing
the regulatory burden on the health care
industry through the use of modern
technology. As part of this effort, FDA
will advance several rules designed to
reduce the reporting and data
submission requirements from
manufacturers of drugs and medical
devices.
In one such rule, FDA will permit
manufacturers, importers, and users of
medical devices to submit reports of
adverse events to the FDA
electronically. This proposed change
will not only reduce the paper reporting
burden on industry, but also allow FDA
to more quickly review safety reports
and identify emerging public health
issues. Under another proposed rule,
FDA would revise existing regulations
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to allow clinical study data and
bioequivalence data for new drug
applications and biological license
applications to be provided
electronically. Again, this rule will
reduce the reporting burden on industry
and also permit FDA to more readily
process and review applications.
CMS is also engaged in regulatory
reduction and streamlining activities. Of
particular note are several rules on
conditions of participation for hospitals
and other providers. The most
comprehensive of these rules is the one
reducing regulatory burdens on
hospitals, which is expected to save as
much as $940 million annually over the
next 5 years. This rule will implement
changes to hospital conditions of
participation to reflect substantial
advances in health care delivery and
patient safety knowledge and practices.
HHS—OFFICE OF THE SECRETARY
(OS)
Proposed Rule Stage
32. • Health Information Technology:
New and Revised Standards,
Implementation Specifications, and
Certification Criteria for Electronic
Health Record Technology
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 300jj–14
CFR Citation: 45 CFR 170.
Legal Deadline: None.
Abstract: The final rule that
established the initial set of standards,
implementation specifications, and
certification criteria was published in
the Federal Register on July 28, 2010.
The initial set represented the first
round of an incremental approach to
adopting future sets of standards,
implementation specifications, and
certification criteria to enhance
electronic health record (EHR)
interoperability, functionality, and
utility. Under the authority provided by
section 3004 of the Public Health
Service Act (PHSA), this notice of
proposed rulemaking would propose
that the Secretary adopt revisions to the
initial set as well as new standards,
implementation specifications and
certification criteria. The proposed new
and revised standards, implementation
specifications, and certification criteria
would establish the technical
capabilities that certified EHR
technology would need to include to
support meaningful use under the CMS
Medicare and Medicaid EHR Incentive
Programs.
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Statement of Need: The final rule that
established the initial set of standards,
implementation specifications, and
certification criteria was published in
the Federal Register on July 28, 2010.
The initial set represented the first
round of an incremental approach to
adopting future sets of standards,
implementation specifications, and
certification criteria for electronic health
record (EHR) technology. In a notice of
proposed rulemaking, the Secretary
would propose new and revised
standards, implementation
specifications, and certification criteria
that would establish the technical
capabilities that certified EHR
technology would need to include in
order to support meaningful use under
the CMS Medicare and Medicaid EHR
Incentive Programs.
Summary of Legal Basis: Under the
authority provided by section 3004 of
the Public Health Service Act (PHSA),
the Secretary would propose to adopt
revisions to the initial set of standards,
implementation specifications, and
certification criteria and propose new
standards, implementation
specifications and certification criteria.
Alternatives: No alternatives are
available because eligible professionals,
eligible hospitals, and critical access
hospitals under the CMS Medicare and
Medicaid EHR Incentive Programs are
required to demonstrate meaningful use
of certified EHR technology. This rule
ensures that the certification
requirements necessary to support the
achievement of meaningful use Stage 2
keep pace with the changes to the
requirements in the CMS Medicare and
Medicaid EHR Incentive Programs.
Anticipated Cost and Benefits: EHR
technology developers seeking
certification are expected to incur costs
related to EHR technology redesign,
reprogramming, and new capability
development. Benefits include greater
standardization and increased EHR
technology interoperability and
functionality.
Risks: Absent a rulemaking, it is
unlikely that currently certified EHR
technology would include the requisite
capacities to support an eligible
professional’s, eligible hospital’s, or
critical access hospital’s achievement of
meaningful use under the CMS
Medicare and Medicaid EHR Incentive
Programs.
Timetable:
Action
Date
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Regulatory Flexibility Analysis
Required: Undetermined.
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Government Levels Affected: None.
Agency Contact: Steven Posnack,
Policy Analyst, Department of Health
and Human Services, Office of the
Secretary, Office of the National
Coordinator for Health Information
Technology, 200 Independence Avenue
SW., Washington, DC 20201, Phone: 202
690–7151.
RIN: 0991–AB82
HHS—FOOD AND DRUG
ADMINISTRATION (FDA)
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Proposed Rule Stage
33. Electronic Submission of Data From
Studies Evaluating Human Drugs and
Biologics
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 21 U.S.C. 355; 21
U.S.C. 371; 42 U.S.C. 262
CFR Citation: 21 CFR 314.50; 21 CFR
601.12; 21 CFR 314.94; 21 CFR 314.96.
Legal Deadline: None.
Abstract: The Food and Drug
Administration is proposing to amend
the regulations governing the format in
which clinical study data and
bioequivalence data are required to be
submitted for new drug applications
(NDAs), biological license applications
(BLAs), and abbreviated new drug
applications (ANDAs). The proposal
would revise our regulations to require
that data submitted for NDAs, BLAs,
and ANDAs, and their supplements and
amendments, be provided in an
electronic format that FDA can process,
review, and archive.
Statement of Need: Before a drug is
approved for marketing, FDA must
determine that the drug is safe and
effective for its intended use. This
determination is based in part on
clinical study data and bioequivalence
data that are submitted as part of the
marketing application. Study data
submitted to FDA in electronic format
have generally been more efficient to
process and review.
FDA’s proposed rule would address
the submission of study data in a
standardized electronic format.
Electronic submission of study data
would improve patient safety and
enhance health care delivery by
enabling FDA to process, review, and
archive data more efficiently.
Standardization would also enhance the
ability to share study data and
communicate results. Investigators and
industry would benefit from the use of
standards throughout the lifecycle of a
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study—in data collection, reporting, and
analysis. The proposal would work in
concert with ongoing Agency and
national initiatives to support increased
use of electronic technology as a means
to improve patient safety and enhance
health care delivery.
Summary of Legal Basis: Our legal
authority to amend our regulations
governing the submission and format of
clinical study data and bioequivalence
data for human drugs and biologics
derives from sections 505 and 701 of the
Act (21 U.S.C. 355 and 371) and section
351 of the Public Health Service Act (42
U.S.C. 262).
Alternatives: FDA considered issuing
a guidance document outlining the
electronic submission and the
standardization of study data, but not
requiring electronic submission of the
data in the standardized format. This
alternative was rejected because the
Agency would not fully benefit from
standardization until it became the
industry standard, which could take up
to 20 years.
We also considered a number of
different implementation scenarios,
from shorter to longer time-periods. The
2-year time-period was selected because
the Agency believes it would provide
ample time for applicants to comply
without too long a delay in the effective
date. A longer time-period would delay
the benefit from the increased
efficiencies, such as standardization of
review tools across applications, and the
incremental cost savings to industry
would be small.
Anticipated Cost and Benefits:
Standardization of clinical data
structure, terminology, and code sets
will increase the efficiency of the
Agency review process. FDA estimates
that the costs resulting from the
proposal would include substantial onetime costs, additional waves of one-time
costs as standards mature, and possibly
some annual recurring costs. One-time
costs would include, among other
things, the cost of converting data to
standard structures, terminology, and
cost sets (i.e., purchase of software to
convert data); the cost of submitting
electronic data (i.e., purchase of file
transfer programs); and the cost of
installing and validating the software
and training personnel. Additional
annual recurring costs may result from
software purchases and licensing
agreements for use of proprietary
terminologies. The proposal could result
in many long-term benefits associated
with reduced time for preparing
applications, including reduced
preparation costs and faster time to
market for beneficial products. In
addition, the proposed rule would
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improve patient safety through faster,
more efficient, comprehensive and
accurate data review, as well as
enhanced communication among
sponsors and clinicians.
Risks: None.
Timetable:
Action
Date
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Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Martha Nguyen,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, Center for Drug
Evaluation and Research, WO 51, Room
6352, 10903 New Hampshire Avenue,
Silver Spring, MD 20993–0002, Phone:
301 796–3471, Fax: 301 847–8440,
Email: martha.nguyen@fda.hhs.gov.
RIN: 0910–AC52
HHS—FDA
34. Current Good Manufacturing
Practice and Hazard Analysis and RiskBenefit Preventive Controls for Food for
Animals
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 342; 21
U.S.C. 350e; 21 U.S.C. 371; 21 U.S.C.
374; 42 U.S.C. 264; Pub. L. 110–85, sec
1002(a)(2); Pub. L. 111–353
CFR Citation: 21 CFR 228.
Legal Deadline: Final, Statutory,
September 27, 2009, FDA is directed to
issue proposed and final regulations
under FDA Amendments Act by the
statutory deadline.
The legal deadline for FDA under the
Food Safety and Modernization Act to
promulgate regulations is July 2012.
Abstract: The Food and Drug
Administration (FDA) is proposing
regulations for preventive controls for
animal feed ingredients and mixed
animal feed to provide greater assurance
that marketed animal feed ingredients
and mixed feeds intended for all
animals, including pets, are safe. This
action is being taken as part of the
FDA’s Animal Feed Safety System
initiative. This action is also being taken
to carry out the requirements of the
Food and Drug Administration
Amendments Act of 2007, under section
1002(a), and the Food Safety
Modernization Act of 2010 (FSMA),
under section 103.
Statement of Need: Regulatory
oversight of the animal food industry
has traditionally been limited and
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focused on a few known safety issues,
so there could be potential human and
animal health problems that remain
unaddressed. The massive pet food
recall due to adulteration of pet food
with melamine and cyanuric acid in
2007 is a prime example. The actions
taken by two protein suppliers in China
affected a large number of pet food
suppliers in the United States and
created a nationwide problem. By the
time the cause of the problem was
identified, melamine and cyanuric acid
contaminated ingredients resulted in the
adulteration of millions of individual
servings of pet food. Congress passed
FSMA which the President signed into
law on January 4, 2011 (Pub. L. 111–
353). Section 103 of FSMA amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding section 418 (21
U.S.C. 350g) Hazard Analysis and Risk
Based Preventive Controls. In enacting
FSMA, Congress sought to improve the
safety of food in the United States by
taking a risk-based approach to food
safety, emphasizing prevention. Section
418 of the FD&C Act requires owners,
operators, or agents in charge of food
facilities to develop and implement a
written plan that describes and
documents how their facility will
implement the hazard analysis and
preventive controls required by this
section.
Summary of Legal Basis: FDA’s
authority for issuing this rule is
provided in FSMA (Pub. L. 111–353),
which amended the FD&C Act by
establishing section 418, which directed
FDA to publish implementing
regulations. FSMA also amended
section 301 of the FD&C Act to add
301(uu) that states the operation of a
facility that manufactures, processes,
packs, or holds food for sale in the
United States if the owner, operator, or
agent in charge of such facility is not in
compliance with section 418 of the
FD&C Act is a prohibited act. Further
authority comes from section 1002(a) of
title X of the FDAAA of 2007 (21 U.S.C.
2102) requiring the Secretary to update
standards for the processing of pet food.
FDA is also issuing this rule under the
general requirements of section 402 of
the FD&C Act (21 U.S.C. 342) for
adulterated food.
In addition, section 701(a) of the
FD&C Act (21 U.S.C. 371(a)) authorizes
the Agency to issue regulations for the
efficient enforcement of the Act.
Alternatives: The 2011 FSMA limited
the Agency’s flexibility to exclude many
requirements. It described in detail its
requirements for subpart C, concerning
the hazard analysis and risk-based
preventive controls part of the proposed
rule. Alternatives include certain
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requirements listed in subpart B
concerning operations and practices.
Anticipated Cost and Benefits: The
benefits of the proposed rule would
result from fewer cases of contaminated
animal food ingredients or finished
animal food products. Discovering
contaminated food ingredients before
they are used in a finished product
would reduce the number of recalls of
contaminated animal food products.
Benefits would include reduced medical
treatment costs for animals and humans,
reduced loss of market value of live
animals, reduced loss of animal
companionship, and reduced loss in
value of animal food products. More
stringent requirements for animal food
manufacturing would maintain public
confidence in the safety of animal foods
and protect animal and human health.
FDA lacks sufficient data to quantify the
benefits of the proposed rule.
The compliance costs of the proposed
rule would result from the additional
labor and capital required to perform
the hazard analyses, write and
implement the preventive controls,
monitor and verify the preventive
controls, take corrective actions if
preventive controls fail to prevent feeds
from becoming contaminated, and
implement requirements from the
operations and practices section.
Risks: FDA is proposing this rule to
provide greater assurance that food
intended for animals is safe and will not
cause illness or injury to animals or
humans. This rule would implement a
risk-based, preventive controls food
safety system intended to prevent
animal food containing hazards, which
may cause illness or injury to animals
or humans, from entering into the food
supply. The rule would apply to
domestic and imported animal food
(including raw materials and
ingredients). Fewer cases of animal food
contamination would (1) reduce the risk
of serious illness and death to animals,
(2) reduce the risk of adverse health
effects to humans handling animal food,
and (3) reduce the risk of consuming
human food from animals that
consumed contaminated food.
Timetable:
Action
Date
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Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
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effects, or otherwise be of international
interest.
Agency Contact: Kim Young, Deputy
Director, Division of Compliance,
Department of Health and Human
Services, Food and Drug
Administration, Center for Veterinary
Medicine, Room 106 (MPN–4, HFV–
230), 7519 Standish Place, Rockville,
MD 20855, Phone: 240 276–9207, Email:
kim.young@fda.hhs.gov.
RIN: 0910–AG10
HHS—FDA
35. Unique Device Identification
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Not Yet Determined
CFR Citation: 21 CFR 16; 21 CFR 801;
21 CFR 803; 21 CFR 806; 21 CFR 810;
21 CFR 814; 21 CFR 820; 21 CFR 821;
21 CFR 822.
Legal Deadline: None.
Abstract: The Food and Drug
Administration Amendments Act of
2007 (FDAAA), amended the Federal
Food, Drug, and Cosmetic Act by adding
section 519(f) (21 U.S.C. 360i(f)). This
section requires FDA to promulgate
regulations establishing a unique
identification system for medical
devices requiring the label of medical
devices to bear a unique identifier,
unless FDA specifies an alternative
placement or provides for exceptions.
The unique identifier must adequately
identify the device through distribution
and use, and may include information
on the lot or serial number.
Statement of Need: A unique device
identification system will help reduce
medical errors; will allow FDA, the
healthcare community, and industry to
more rapidly review and organize
adverse event reports; identify problems
relating to a particular device (even
down to a particular lot or batch, range
of serial numbers, or range of
manufacturing or expiration dates); and
thereby allow for more rapid, effective,
corrective actions that focus sharply on
the specific devices that are of concern.
Summary of Legal Basis: Section
519(f) of the FD&C Act (added by sec.
226 of the Food and Drug
Administration Amendments Act of
2007) directs the Secretary to
promulgate regulations establishing a
unique device identification (UDI)
system for medical devices, requiring
the label of devices to bear a unique
identifier that will adequately identify
the device through its distribution and
use.
Alternatives: FDA considered several
alternatives that would allow certain
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requirements of the proposed rule to
vary, such as the required elements of
a UDI and the scope of affected devices.
Anticipated Cost and Benefits: FDA
estimates that the affected industry
would incur one-time and recurring
costs, including administrative costs, to
change and print labels that include the
required elements of a UDI, costs to
purchase equipment to print and verify
the UDI, and costs to purchase software
and integrate and validate the UDI into
existing IT systems. FDA anticipates
that implementation of a UDI system
would help improve the efficiency and
accuracy of medical device recalls and
medical device adverse event reporting.
The proposed rule would also
standardize how medical devices are
identified and contribute to future
potential public health benefits of
initiatives aimed at optimizing the use
of automated systems in healthcare.
Most of these benefits, however, require
complementary developments and
innovations in the private and public
sectors.
Risks: This rule is intended to
substantially eliminate existing
obstacles to the consistent identification
of medical devices used in the United
States. By providing the means to
rapidly and accurately identify a device
and key attributes that affect its safe and
effective use, the rule would reduce
medical errors that result from
misidentification of a device or
confusion concerning its appropriate
use. The rule will fulfill a statutory
directive to establish a unique device
identification system.
Timetable:
Date
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Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: John J. Crowley,
Senior Advisor for Patient Safety,
Department of Health and Human
Services, Food and Drug
Administration, Center for Devices and
Radiological Health, WO 66, Room
2315, 10903 New Hampshire Avenue,
Silver Spring, MD 20993, Phone: 301
980–1936, Email:
jay.crowley@fda.hhs.gov.
RIN: 0910–AG31
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HHS—FDA
36. Produce Safety Regulation
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 21 U.S.C. 342; 21
U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C.
264; Pub. L. 111–353 (signed on Jan. 4,
2011)
CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Statutory,
January 4, 2012, Proposed rule not later
than 12 months after the date of
enactment of the Food Safety
Modernization Act.
Abstract: The Food Safety
Modernization Act requires the
Secretary to establish and publish
science-based minimum standards for
the safe production and harvesting of
those types of fruits and vegetables,
including specific mixes or categories of
fruits and vegetables, that are raw
agricultural commodities for which the
Secretary has determined that such
standards minimize the risk of serious
adverse health consequences or death.
FDA is proposing to promulgate
regulations setting enforceable
standards for fresh produce safety at the
farm and packing house. The purpose of
the proposed rule is to reduce the risk
of illness associated with contaminated
fresh produce. The proposed rule will
be based on prevention-oriented public
health principles and incorporate what
we have learned in the past decade
since the Agency issued general good
agricultural practice guidelines entitled
‘‘Guide to Minimize Microbial Food
Safety Hazards for Fresh Fruits and
Vegetables’’ (GAPs Guide). The
proposed rule also will reflect
comments received on the Agency’s
1998 update of its GAPs guide and its
July 2009 draft commodity specific
guidances for tomatoes, leafy greens,
and melons. Although the proposed rule
will be based on recommendations that
are included in the GAPs guide, FDA
does not intend to make the entire
guidance mandatory. FDA’s proposed
rule would, however, set out clear
standards for implementation of modern
preventive controls. The proposed rule
also would emphasize the importance of
environmental assessments to identify
hazards and possible pathways of
contamination and provide examples of
risk reduction practices recognizing that
operators must tailor their preventive
controls to particular hazards and
conditions affecting their operations.
The requirements of the proposed rule
would be scale appropriate and
commensurate with the relative risks
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and complexity of individual
operations. FDA intends to issue
guidance to assist industry in complying
with the requirements of the new
regulation.
Statement of Need: FDA is taking this
action to meet the requirements of the
FSMA and to address the food safety
challenges associated with fresh
produce and thereby protect the public
health. Data indicate that between 1973
and 1997, outbreaks of foodborne illness
in the U.S. associated with fresh
produce increased in absolute numbers
and as a proportion of all reported
foodborne illness outbreaks. The
Agency issued general good agricultural
practice guidelines for fresh fruits and
vegetables over a decade ago.
Incorporating prevention-oriented
public heath principles and
incorporating what we have learned in
the past decade into a regulation is a
critical step in establishing standards for
the growing, harvesting, packing, and
storing of produce and reducing the
foodborne illness attributed to fresh
produce.
Summary of Legal Basis: FDA is
relying on the amendments to the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), provided by section 105
of the Food Safety Modernization Act
(codified primarily in sec. 419 of the
FD&C Act (21 U.S.C. 350h)). FDA’s legal
basis also derives in part from sections
402(a)(4) and 701(a) of the FD&C Act (21
U.S.C. 342(a)(4) and 371(a)). FDA also
intends to rely on section 361 of the
Public Health Service Act (PHS Act) (42
U.S.C. 264), which gives FDA authority
to promulgate regulations to control the
spread of communicable disease.
Alternatives: Section 105 of the Food
Safety Modernization Act requires FDA
to conduct this rulemaking.
Anticipated Cost and Benefits: FDA
estimates that the costs to more than
300,000 domestic and foreign producers
and packers of fresh produce from the
proposal would include one-time costs
(e.g., new tools and equipment) and
recurring costs (e.g., monitoring,
training, recordkeeping). FDA
anticipates that the benefits would be a
reduction in foodborne illness and
deaths associated with fresh produce.
Monetized estimates of costs and
benefits are not available at this time.
Risks: This regulation would directly
and materially advance the Federal
Government’s substantial interest in
reducing the risks for illness and death
associated with foodborne infections
associated with the consumption of
fresh produce. Less restrictive and less
comprehensive approaches have not
been sufficiently effective in reducing
the problems addressed by this
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regulation. FDA anticipates that the
regulation would lead to a significant
decrease in foodborne illness associated
with fresh produce consumed in the
U.S.
Timetable:
Action
Date
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01/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Samir Assar,
Supervisory Consumer Safety Officer,
Department of Health and Human
Services, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition, Office of Food
Safety, 5100 Paint Branch Parkway,
College Park, MD 20740, Phone: 240
402–1636, Email:
samir.assar@fda.hhs.gov.
RIN: 0910–AG35
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HHS—FDA
37. Hazard Analysis and Risk-Based
Preventive Controls
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 342; 21
U.S.C. 371; 42 U.S.C. 264; Pub. L. 111–
353 (signed on Jan. 4, 2011)
CFR Citation: 21 CFR 110.
Legal Deadline: Final, Statutory, July
4, 2012, Final rule must be published no
later than 18 months after the date of
enactment of the FDA Food Safety
Modernizaton Act.
Not later than 9 months after the date
of enactment of the FDA Food Safety
Modernization Act.
Abstract: The Food and Drug
Administration (FDA) Food Safety
Modernization Act (the FSMA) requires
the Secretary of Health and Human
Services to promulgate regulations to
establish science-based minimum
standards for conducting a hazard
analysis, documenting hazards,
implementing preventive controls, and
documenting the implementation of the
preventive controls; and to define the
terms ‘‘small business’’ and ‘‘very small
business.’’ The FSMA also requires the
Secretary to promulgate regulations
with respect to activities that constitute
on-farm packing or holding of food that
is not grown, raised, or consumed on a
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farm or another farm under the same
ownership and activities that constitute
on farm manufacturing or processing of
food that is not grown, raised, or
consumed on a farm or another farm
under the same ownership.
FDA is proposing to amend its current
good manufacturing practice (CGMP)
regulations (21 CFR part 110) for
manufacturing, packing, or holding
human food to require food facilities to
develop and implement a written food
safety plan. This proposed rule would
require a food facility to have and
implement preventive controls to
significantly minimize or prevent the
occurrence of hazards that could affect
food manufactured, processed, packed,
or held by the facility and to provide
assurances that such food will not be
adulterated under section 402 or
misbranded under section 403(w).
Statement of Need: FDA is taking this
action to meet the requirements of the
FSMA and to better address changes
that have occurred in the food industry
and thereby protect public health.
FDA last updated its food CGMP
regulations for the manufacturing,
packing, or holding of human food in
1986. Modernizing these food CGMP
regulations to address risk-based
preventive controls and more explicitly
address issues such as environmental
pathogens, food allergens, mandatory
employee training, and sanitation of
food contact surfaces, would be a
critical step in raising the standards for
food production and distribution. By
amending 21 CFR 110 to modernize
good manufacturing practices, the
agency could focus the attention of food
processors on measures that have been
proven to significantly reduce the risk of
food-borne illness. An amended
regulation also would allow the agency
to better focus its regulatory efforts on
ensuring industry compliance with
controls that have a significant food
safety impact.
Summary of Legal Basis: FDA is
relying on section 103 of the FSMA.
FDA is also relying on sections
402(a)(3), (a)(4) and 701(a) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 342(a)(3),
(a)(4), and 371(a)). Under section
402(a)(3) of the FD&C Act, a food is
adulterated if it consists in whole or in
part of any filthy, putrid, or
decomposed substance, or if it is
otherwise unfit for food. Under section
402(a)(4), a food is adulterated if it has
been prepared, packed, or held under
unsanitary conditions whereby it may
have become contaminated with filth or
may have been rendered injurious to
health. Under section 701(a) of the
FD&C Act, FDA is authorized to issue
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regulations for the efficient enforcement
of the FD&C Act. FDA’s legal basis also
derives from section 361 of the Public
Health Service Act (PHS Act) (42 U.S.C.
264), which gives FDA authority to
promulgate regulations to control the
spread of communicable disease.
Alternatives: An alternative to this
rulemaking is not to update the CGMP
regulations, and instead issue separate
regulations to implement the FDA Food
Safety Modernization Act.
Anticipated Cost and Benefits: FDA
estimates that the costs from the
proposal to domestic and foreign
producers and packers of processed
foods would include new one-time costs
(e.g., adoption of written food safety
plans, setting up training programs,
implementing allergen controls, and
purchasing new tools and equipment)
and recurring costs (e.g., auditing and
monitoring suppliers of sensitive raw
materials and ingredients, training
employees, and completing and
maintaining records used throughout
the facility). FDA anticipates that the
benefits would be a reduced risk of
food-borne illness and death from
processed foods and a reduction in the
number of safety related recalls.
Risks: This regulation will directly
and materially advance the Federal
Government’s substantial interest in
reducing the risks for illness and death
associated with food-borne infections.
Less restrictive and less comprehensive
approaches have not been effective in
reducing the problems addressed by this
regulation. The regulation will lead to a
significant decrease in foodborne illness
in the U.S.
Timetable:
Action
Date
NPRM ..................
FR Cite
01/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: John F. Sheehan,
Director, Office of Food Safety, Division
of Plant and Dairy Food Safety,
Department of Health and Human
Services, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition (HFS–315), 5100
Paint Branch Parkway, College Park, MD
20740, Phone: 240 402–1488, Fax: 301
436–2632, Email:
john.sheehan@fda.hhs.gov.
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RIN: 0910–AG36
HHS—FDA
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38. Foreign Supplier Verification
Program
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Title III, sec 301 of
FDA Food Safety Modernization Act,
Pub. L. 111–353, establishing sec 805 of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act)
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory,
January 4, 2012.
Abstract: The proposed rule would
establish regulations concerning the
content of foreign supplier verification
programs. The regulations will require
that each importer have a foreign
supplier verification program that is
adequate to provide assurances that
each foreign supplier produces food in
compliance with: (1) Processes and
procedures that provide the same level
of public health protection as those
required under section 418 (concerning
hazard analysis and risk-based
preventative controls) or section 419
(concerning produce safety standards) of
the FD&C Act; and (2) sections 402
(concerning adulteration) and 403(w)
(concerning major food allergens) of the
FD&C Act. In promulgating the foreign
supplier verification regulations, we
will, as appropriate, take into account
differences among importers and types
of imported foods, including differences
related to the level of risk posed by an
imported food. Methods of foreign
supplier verification may include
monitoring records for shipments, lotby-lot certifications of compliance,
annual on-site inspections, checking the
hazard analysis and risk-based
preventive control plans of foreign
suppliers, and periodically testing and
sampling shipments.
Statement of Need: The proposed rule
is needed to help improve the safety of
food that is imported into the United
States. Imported food products have
increased dramatically over the last
several decades. Data indicate that about
15% of the U.S. food supply is
imported. FSMA provides the Agency
with additional tools and authorities to
help ensure that imported foods are safe
for U.S. consumers. Included among
these tools and authorities is a
requirement that importers perform riskbased foreign supplier verification
activities to verify that the food they
import is produced in compliance with
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U.S. requirements and is not adulterated
or misbranded. This proposed rule on
the content of foreign supplier
verification program (FSVPs) sets forth
the proposed steps that food importers
would be required to take to fulfill their
responsibility to ensure the safety of the
food they bring into this country.
Summary of Legal Basis: Section
805(c) of the FD&C Act (21 U.S.C.
384a(c)) directs FDA, not later than
1 year after the date of enactment of
FSMA, to issue regulations on the
content of FSVPs. Section 805(c)(4)
states that verification activities under
such programs may include monitoring
records for shipments, lot-by-lot
certification of compliance, annual
onsite inspections, checking the hazard
analysis and risk-based preventive
control plans of foreign suppliers, and
periodically testing and sampling
shipments of imported products.
Section 301(b) of FSMA amends section
301 of the FD&C Act (21 U.S.C. 331) by
adding section 301(zz), which
designates as a prohibited act the
importation or offering for importation
of a food if the importer (as defined in
section 805) does not have in place an
FSVP in compliance with section 805.
In addition, section 301(c) of FSMA
amends section 801(a) of the FD&C Act
(21 U.S.C. 381(a)) by stating that an
article of food being imported or offered
for import into the United States shall
be refused admission if it appears from
an examination of a sample of such an
article or otherwise that the importer is
in violation of section 805.
Alternatives: We are considering a
range of alternative approaches to the
requirements for foreign supplier
verification activities. These might
include: (1) Establishing a general
requirement that importers determine
and conduct whatever verification
activity that would adequately address
the risks associated with the foods they
import; (2) allowing importers to choose
from a list of possible verification
mechanisms, such as the activities listed
in section 805(c)(4) of the FD&C Act; (3)
requiring importers to conduct
particular verification activities for
certain types of foods or risks (e.g., for
high-risk foods) but allowing flexibility
in verification activities for other types
of foods or risks; and (4) specifying use
of a particular verification activity for
each particular kind of food or risk. To
the extent possible while still ensuring
that verification activities are adequate
to ensure that foreign suppliers are
producing food in accordance with U.S.
requirements, we will seek to give
importers the flexibility to choose
verification procedures that are
appropriate to adequately address the
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risks associated with the importation of
a particular food.
Anticipated Cost and Benefits: We
have not yet quantified the cost and
benefits for this proposed rule.
However, the available information
suggests that the costs will be
significant. Our preliminary analysis of
FY10 OASIS data suggests that this rule
will cover about 60,000 importers,
240,000 unique combinations of
importers and foreign suppliers, and
540,000 unique combinations of
importers, products, and foreign
suppliers. These numbers imply that
provisions that require activity for each
importer, each unique combination of
importer and foreign supplier, or each
unique combination of importer,
product, and foreign supplier will
generate significant costs. An example
of a provision linked to combinations of
importers and foreign suppliers would
be a requirement to conduct a
verification activity, such as an onsite
audit, under certain conditions. The
cost of onsite audits will depend in part
on whether foreign suppliers can
provide the same onsite audit results to
different importers or whether every
importer will need to take some action
with respect to each of their foreign
suppliers. The benefits of this proposed
rule will consist of the reduction of
adverse health events linked to
imported food that could result from
compliance with the FSVP
requirements. We have not yet
estimated the benefits of the rule.
Risks: As stated above, about 15
percent of the U.S. food supply is
imported, and many of these imported
foods are high-risk commodities.
According to recent data from the
Centers for Disease Control and
Prevention, each year, about 48 million
Americans get sick, 128,000 are
hospitalized, and 3,000 die from
foodborne diseases. From July 1, 2007,
through June 30, 2008, FDA oversaw 40
recalls of imported foods that were so
contaminated that the Agency deemed
them to be an imminent threat. We
expect that the adoption of FSVPs by
food importers will lead to a significant
reduction to the threat to public health
posed by unsafe imported food, though
we are still in the process of trying to
quantify the reduction in risk that will
occur through importer compliance
with the FSVP regulations.
Timetable:
Action
Date
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FR Cite
01/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
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Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Brian L. Pendleton,
Senior Policy Advisor, Department of
Health and Human Services, Food and
Drug Administration, Office of Policy,
WO32, Room 4245, 10903 New
Hampshire Avenue, Silver Spring, MD
20993–0002, Phone: 301 796–4614, Fax:
301 847–8616, Email:
brian.pendleton@fda.hhs.gov.
RIN: 0910–AG64.
HHS—FDA
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39. Accreditation of Third Parties To
Conduct Food Safety Audits and for
Other Related Purposes
Priority: Other Significant.
Legal Authority: Pub. L. 111–353, sec
307, FDA Food Safety Modernization
Act; Other sections of FDA Food Safety
Modernization Act, as appropriate.
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory, July
2012, Promulgate implementing
regulations. Per Public Law 111–353,
section 307(c)(5)(C), promulgate, within
18 months of enactment, implementing
regulations for accreditation of thirdparty auditors to conduct food safety
audits.
Abstract: The Food and Drug
Administration (FDA) is proposing
regulations relating to the accreditation
of third-party auditors to conduct food
safety audits of foreign entities,
including foreign facilities in the food
import supply chain. The proposed
regulations will include provisions to
protect against conflicts of interest
between accredited auditors and
audited entities, as described in section
307 of the FDA Food Safety
Modernization Act (FSMA), Public Law
111–353. As part of this rulemaking,
FDA may propose regulations relating to
the accreditation of third parties to
perform related activities, such as
conducting laboratory analyses of food,
authorized by other sections of FSMA.
Statement of Need: The use of
accredited third-party auditors to certify
high-risk food imports to assist in
ensuring the safety of food from foreign
origin entering U.S. commerce.
Accredited third-party auditors auditing
foreign process facilities may be viewed
as increasing FDA’s ‘‘coverage’’ of
foreign facilities that FDA may not have
adequate resources to inspect in a
particular year while using identified
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standards creating overall uniformity to
complete the task. Audits that result in
issuance of facility certificates will
provide FDA information about the
compliance status of the facility.
Additionally, auditors will be required
to submit audit reports that may be
reviewed by FDA for purposes of
compliance assessment and work
planning.
Summary of Legal Basis: Not later
than 2 years after the date of enactment,
establish a system for the recognition of
accreditation bodies that accredit thirdparty auditors, certifying that their
eligible entities meet the requirements,
directly accredit third-party auditors
should none be identified and
recognized by the 2-year date of
enactment, obtain a list of all accredited
third-party auditors and their agents
from recognized accreditation bodies,
and determine requirements for
regulatory audit reports while avoiding
unnecessary duplication of efforts and
costs.
Alternatives: FSMA described in
detail the framework for, and
requirements of, the accredited thirdparty auditor program. Alternatives
include certain oversight activities
required of recognized accreditation
bodies that accredit third-party auditors,
as distinguished from third-party
auditors directly accredited by FDA.
Another alternative relates to the nature
of the required standards and the degree
to which those standards are
prescriptive or flexible.
Anticipated Cost and Benefits: The
benefits of the proposed rule would
result from fewer cases of unsafe or
misbranded food entering U.S.
commerce. Additional benefits include
the increased flow of credible
information to FDA regarding the
compliance status of foreign firms and
their foods that are ultimately offered
for import Into the United States, which
information in turn would inform FDA’s
work planning for inspection of foreign
food facilities and might result in a
signal of possible problems with a
particular firm or its products, and with
sufficient signals, might raise questions
about the rigor of the food safety
regulatory system of the country of
origin.
The compliance costs of the proposed
rule would result from the additional
labor and capital required of
accreditation bodies seeking FDA
recognition and of third-party auditors
seeking accreditation to the extent that
will involve the assembling of
information for an application unique to
the FDA third-party program. The
compliance costs associated with
certification will be accounted for
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7723
separately under the costs associated
with participation In the foreign
supplier verification program and the
costs associated with mandatory
certification for high-risk food imports.
The third-party program is funded
through revenue neutral user fees,
which will be developed by FDA
through rulemaklng. User fee costs will
be accounted for in that rulemaklng.
Risks: FDA is proposing this rule to
provide greater assurance the food
offered for import into the United States
is safe and will not cause injury or
illness to animals or humans. The rule
would implement a program for
accrediting third-party auditors to
conduct food safety audits of foreign
food entities, including registered
foreign food facilities, and based on the
findings of the regulatory audit, to issue
certifications to foreign food entities
found to be in compliance with FDA
requirements. The certifications would
be used by importers seeking to
participate in the Voluntary Qualified
Importer Program for expedited review
and entry of product and would be a
means to provide assurance of
compliance as required by FDA based
on risk-related considerations. The rule
would apply to any foreign or domestic
accreditation body seeking FDA
recognition, any foreign or domestic
third-party auditor seeking
accreditation, any registered foreign
food facility or other foreign food entity
subject to a food safety audit (including
a regulatory audit conducted for
purposes of certification), and any
importer seeking to participate in the
Voluntary Qualified Importer Program.
Fewer cases of unsafe or misbranded
food entering U.S. commerce would
reduce the risk of serious illness and
death to humans and animals.
Timetable:
Action
Date
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FR Cite
02/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected:
Undetermined.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Charlotte A. Christin,
Senior Policy Advisor, Department of
Health and Human Services, Food and
Drug Administration, Office of Policy
WO32, Room 4234, 10903 New
Hampshire Avenue, Silver Spring, MD
20993, Phone: 301 796–4718, Fax: 301
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847–3541, Email:
charlotte.christin@fda.hhs.gov.
RIN: 0910–AG66
HHS—FDA
erowe on DSK2VPTVN1PROD with PROPOSALS2
Final Rule Stage
40. Infant Formula: Current Good
Manufacturing Practices; Quality
Control Procedures; Notification
Requirements; Records and Reports;
and Quality Factors
Priority: Other Significant.
Legal Authority: 21 U.S.C. 321; 21
U.S.C. 350a; 21 U.S.C. 371
CFR Citation: 21 CFR 106 and 107.
Legal Deadline: None.
Abstract: The Food and Drug
Administration (FDA) is revising its
infant formula regulations in 21 CFR
parts 106 and 107 to establish
requirements for current good
manufacturing practices (CGMP),
including audits; to establish
requirements for quality factors; and to
amend FDA’s quality control
procedures, notification, and record and
reporting requirements for infant
formula. FDA is taking this action to
improve the protection of infants who
consume infant formula products.
Statement of Need: The Agency
published a proposed rule on July 9,
1996, that would establish current good
manufacturing practice regulations,
quality control procedures, quality
factors, notification requirements,
records, and reports for the production
of infant formula. This proposal was
issued in response to the 1986
Amendments to the Infant Formula Act
of 1980. On April 28, 2003, FDA
reopened the comment period to update
comments on the proposal. The
comment was extended on June 27,
2003, and ended on August 26, 2003.
The comment period was reopened on
August 1, 2006, and ended on
September 15, 2006.
Summary of Legal Basis: The Infant
Formula Act of 1980 (the 1980 Act)
(Pub. L. 96–359) amended the Federal
Food, Drug, and Cosmetic Act (the Act)
to include section 412 (21 U.S.C. 350a).
This law is intended to improve
protection of infants consuming infant
formula products by establishing greater
regulatory control over the formulation
and production of infant formula. In
1982, FDA adopted infant formula recall
procedures in subpart D of 21 CFR part
107 of its regulations (47 FR 18832, Apr.
30, 1982), and infant formula quality
control procedures in subpart B of 21
CFR part 106 (47 FR 17016, Apr. 20,
1982). In 1985, FDA further
implemented the 1980 Act by
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establishing subparts B, C, and D in 21
CFR part 107 regarding the labeling of
infant formula, exempt infant formulas,
and nutrient requirements for infant
formula, respectively (50 FR 1833, Jan.
14, 1985; 50 FR 48183, Nov. 22, 1985;
and 50 FR 45106, Oct. 30, 1985).
In 1986, Congress, as part of the AntiDrug Abuse Act of 1986 (Pub. L. 99–
570) (the 1986 amendments), amended
section 412 of the act to address
concerns that had been expressed by
Congress and consumers about the 1980
Act and its implementation related to
the sufficiency of quality control testing,
CGMP, recordkeeping, and recall
requirements. The 1986 amendments:
(1) State that an infant formula is
deemed to be adulterated if it fails to
provide certain required nutrients, fails
to meet quality factor requirements
established by the Secretary (and, by
delegation, FDA), or if it is not
processed in compliance with the
CGMP and quality control procedures
established by the Secretary; (2) require
that the Secretary issue regulations
establishing requirements for quality
factors and CGMP, including quality
control procedures; (3) require that
infant formula manufacturers regularly
audit their operations to ensure that
those operations comply with CGMP
and quality control procedure
regulations; (4) expand the
circumstances in which firms must
make a submission to the Agency to
include when there is a major change in
an infant formula or a change that may
affect whether the formula is
adulterated; (5) specify the nutrient
quality control testing that must be done
on each batch of infant formula; (6)
modify the infant formula recall
requirements; and (7) give the Secretary
authority to establish requirements for
retention of records, including records
necessary to demonstrate compliance
with CGMP and quality control
procedures. In 1989, the Agency
implemented the provisions on recalls
(secs. 412(f) and (g) of the Act) by
establishing subpart E in 21 CFR part
107 (54 FR 4006, Jan. 27, 1989). In 1991,
the Agency implemented the provisions
on record and record retention
requirements by revising 21 CFR
106.100 (56 FR 66566, Dec. 24, 1991).
The Agency has already promulgated
regulations that respond to a number of
the provisions of the 1986 amendments.
The final rule would address additional
provisions of these amendments.
Alternatives: The 1986 amendments
require the Secretary (and, by
delegation, FDA) to establish, by
regulation, requirements for quality
factors and CGMPs, including quality
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control procedures. Therefore, there are
no alternatives to rulemaking.
Anticipated Cost and Benefits: FDA
estimates that the costs from the final
rule to producers of infant formula
would include first year and recurring
costs (e.g., administrative costs,
implementation of quality controls,
records, audit plans, and assurances of
quality factors in new infant formulas).
FDA anticipates that the primary
benefits would be a reduced risk of
illness due to Cronobacter sakazakii and
Salmonella spp in infant formula.
Additional benefits stem from the
quality factors requirements that would
assure the healthy growth of infants
consuming infant formula. Monetized
estimates of costs and benefits for this
final rule are not available at this time.
The analysis for the proposed rule
estimated costs of less than $1 million
per year. FDA was not able to quantify
benefits in the analysis for the proposed
rule.
Risks: Special controls for infant
formula manufacturing are especially
important because infant formula,
particularly powdered infant formula, is
an ideal medium for bacterial growth
and because infants are at high risk of
foodborne illness because of their
immature immune systems. In addition,
quality factors are of critical need to
assure that the infant formula supports
healthy growth in the first months of life
when infant formula may be an infant’s
sole source of nutrition. The provisions
of this rule will address weaknesses in
production that may allow
contamination of infant formula,
including, contamination with C.
sakazakii and Salmonella spp which can
lead to serious illness with devastating
sequelae and/or death. The provisions
would also assure that new infant
formulas support healthy growth in
infants.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Reopened.
NPRM Comment
Period Extended.
NPRM Comment
Period End.
NPRM Comment
Period Reopened.
NPRM Comment
Period End.
Final Action .........
07/09/96
12/06/96
61 FR 36154
04/28/03
68 FR 22341
06/27/03
68 FR 38247
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08/26/03
08/01/06
09/15/06
03/00/12
71 FR 43392
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Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Benson Silverman,
Department of Health and Human
Services, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition (HFS–850), 5100
Paint Branch Parkway, College Park, MD
20740, Phone: 240 402–1459, Email:
benson.silverman@fda.hhs.gov.
Related RIN: Split from 0910–AA04.
RIN: 0910–AF27
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HHS—FDA
41. Medical Device Reporting;
Electronic Submission Requirements
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 352, 360,
360i, 360j, 371, 374
CFR Citation: 21 CFR 803.
Legal Deadline: None.
Abstract: The Food and Drug
Administration (FDA) is amending its
postmarket medical device reporting
(MDR) regulations to require that
manufacturers, importers, and user
facilities submit mandatory reports of
medical device adverse events to the
Agency in an electronic format that FDA
can process, review, and archive. FDA
is taking this action to improve the
Agency’s systems for collecting and
analyzing postmarketing safety reports.
The proposed change would help the
Agency to more quickly review safety
reports and identify emerging public
health issues.
Statement of Need: The final rule
would require user facilities and
medical device manufacturers and
importers to submit medical device
adverse event reports in electronic
format instead of using a paper form.
FDA is taking this action to improve its
adverse event reporting program by
enabling it to more quickly receive and
process these reports.
Summary of Legal Basis: The Agency
has legal authority under section 519 of
the Federal Food, Drug, and Cosmetic
Act to require adverse event reports.
The final rule would require
manufacturers, importers, and user
facilities to change their procedures to
send reports of medical device adverse
events to FDA in electronic format
instead of using a hard copy form.
Alternatives: There are two
alternatives. The first alternative is to
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allow the voluntary submission of
electronic MDRs. If a substantial
number of reporters fail to voluntarily
submit electronic MDRs, FDA will not
obtain the benefits of standardized
formats and quicker access to medical
device adverse event data. The second
alternative is to allow small entities
more time to comply. This would
significantly postpone the benefits of
the rule; moreover, it would only delay,
rather than reduce or eliminate, the
costs of compliance.
Anticipated Cost and Benefits: The
principal benefit would be to public
health, due to the increased speed in the
processing and analysis of medical
device reports currently submitted
annually on paper. In addition,
requiring electronic submission would
reduce FDA annual operating costs and
generate industry savings.
The one-time costs are for modifying
standard operating procedures and
establishing electronic submission
capabilities. Annually recurring costs
include maintenance of electronic
submission capabilities, including
renewing the electronic certificate, and
for some firms, the incremental cost to
maintain high-speed Internet access.
Risks: None.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
08/21/09
11/19/09
74 FR 42203
03/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Nancy Pirt,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, Center for Devices
and Radiological Health, WO 66, Room
4438, 10903 New Hampshire Avenue,
Silver Spring, MD 20993, Phone: 301
796–6248, Fax: 301 847–8145, Email:
nancy.pirt@fda.hhs.gov.
RIN: 0910–AF86
HHS—FDA
42. Electronic Registration and Listing
for Devices
Priority: Other Significant.
Legal Authority: Pub. L. 110–85; Pub.
L. 107–188, sec 321; Pub. L. 107–250,
sec 207; 21 U.S.C. 360(a) through 360(j);
21 U.S.C. 360(p)
CFR Citation: 21 CFR 807.
Legal Deadline: None.
Abstract: This rule would codify the
requirements for electronic registration
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7725
and listing. However, for those
companies that do not have access to
the Web, FDA will offer an avenue by
which they can register, list, and update
information with a paper submission.
The rule also will amend part 807 to
reflect the timeframes for device
establishment registration and listing
established by sections 222 and 223 of
Food and Drug Administration
Amendment Act (FDAAA) and to reflect
the requirement in section 510(i) of the
Act, as amended by section 321 of the
Public Health Security and Bioterrorism
Preparedness and Response Act (BT
Act), that foreign establishments
provide FDA with additional pieces of
information as part of their registration.
Statement of Need: FDA is amending
the medical device establishment
registration and listing requirements
under 21 CFR part 807 to reflect the
electronic submission requirements in
section 510(p) of the Act, which was
added by section 207 of MDUFMA and
later amended by section 224 of
FDAAA. FDA also is amending 21 CFR
part 807 to reflect the requirements in
section 321 of the BT Act for foreign
establishments to furnish additional
information as part of their registration.
This rule will improve FDA’s device
establishment registration and listing
system and utilize the latest technology
in the collection of this information.
Summary of Legal Basis: The statutory
basis for our authority includes sections
510(a) through (j), 510(p), 701, 801, and
1003 of the Act.
Alternatives: The alternatives to this
rulemaking include not updating the
registration and listing regulations.
Because of the new FDAAA statutory
requirements and the advances in data
collection and transmission technology,
FDA believes this rulemaking is the
preferable alternative.
Anticipated Cost and Benefits: The
Agency believes that there may be some
one-time costs associated with the
rulemaking, which involve resource
costs of familiarizing users with the
electronic system. Recurring costs
related to submission of the information
by domestic firms would probably
remain the same or decrease because a
paper submission and postage is not
required. There might be some increase
in the financial burden on foreign firms
since they will have to supply
additional registration information as
required by section 321 of the BT Act.
Risks: None.
Timetable:.
Action
Date
FR Cite
NPRM ..................
03/26/10
75 FR 14510
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Action
Date
NPRM Comment
Period End.
Final Rule ............
FR Cite
06/24/10
05/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Nancy Pirt,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, Center for Devices
and Radiological Health, WO 66, Room
4438, 10903 New Hampshire Avenue,
Silver Spring, MD 20993, Phone: 301
796–6248, Fax: 301 847–8145, Email:
nancy.pirt@fda.hhs.gov.
RIN: 0910–AF88
erowe on DSK2VPTVN1PROD with PROPOSALS2
HHS—FDA
43. Food Labeling: Nutrition Labeling
for Food Sold in Vending Machines
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 321; 21
U.S.C. 343; 21 U.S.C. 371
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Food and Drug
Administration (FDA) published a
proposed rule in the Federal Register of
April 6, 2011 (72 FR 19238) to establish
requirements for nutrition labeling of
certain food items sold in certain
vending machines. FDA also proposed
the terms and conditions for vending
machine operators registering to
voluntarily be subject to the
requirements. FDA took this action to
carry out section 4205 of the Patient
Protection and Affordable Care Act
(‘‘Affordable Care Act’’ or ‘‘ACA’’),
which was signed into law on March 23,
2010.
Statement of Need: This rulemaking
was mandated by section 4205 of the
Patient Protection and Affordable Care
Act (Affordable Care Act).
Summary of Legal Basis: On March
23, 2010, the Affordable Care Act (Pub.
L. 111–148) was signed into law.
Section 4205 amended 403(q)(5) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by, among other things,
creating new clause (H) to require that
vending machine operators, who own or
operate 20 or more machines, disclose
calories for certain food items. FDA has
the authority to issue this rule under
sections 403(q)(5)(H) and 701(a) of the
FD&C Act (21 U.S.C. 343(q)(5)(H), and
371(a)). Section 701(a) of the FD&C Act
vests the Secretary of Health and
Human Services, and, by delegation, the
Food and Drug Administration (FDA)
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with the authority to issue regulations
for the efficient enforcement of the
FD&C Act.
Alternatives: Section 4205 of the
Affordable Care Act requires the
Secretary (and by delegation, the FDA)
to establish by regulation requirements
for calorie labeling of articles of food
sold from covered vending machines.
Therefore, there are no alternatives to
rulemaking. FDA has analyzed
alternatives that may reduce the burden
of the rulemaking, including analyzing
the benefits and costs of: Restricting the
flexibility of the format for calorie
disclosure, lengthening the compliance
time, and extending the coverage of the
rule to bulk vending machines without
selection buttons.
Anticipated Cost and Benefits: Any
vending machine operator operating
fewer than 20 machines may voluntarily
choose to be covered by the national
standard. It is anticipated that vending
machine operators that own or operate
20 or more vending machines will bear
costs associated with adding calorie
information to vending machines. FDA
estimates that the total cost of
complying with section 4205 of the
Affordable Care Act and this rulemaking
will be approximately $25.8 million
initially, with a recurring cost of
approximately $24 million.
Because comprehensive national data
for the effects of vending machine
labeling do not exist, FDA has not
quantified the benefits associated with
section 4205 of the Affordable Care Act
and this rulemaking. Some studies have
shown that some consumers consume
fewer calories when calorie content
information is displayed at the point of
purchase. Consumers will benefit from
having this important nutrition
information to assist them in making
healthier choices when consuming food
away from home. Given the very high
costs associated with obesity and its
associated health risks, FDA estimates
that if 0.02 percent of the adult obese
population reduces energy intake by at
least 100 calories per week, then the
benefits of Section 4205 of the
Affordable Care Act and this rulemaking
will be at least as large as the costs.
Risks: Americans now consume an
estimated one-third of their total
calories from foods prepared outside the
home and spend almost half of their
food dollars on such foods. This rule
will provide consumers with
information about the nutritional
content of food to enable them to make
healthier food choices, and may help
mitigate the trend of increasing obesity
in America.
Timetable:
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Fmt 4701
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Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
04/06/11
07/05/11
76 FR 19238
11/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Federal,
Local, State.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Agency Contact: Daniel Reese,
Department of Health and Human
Services, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition (HFS–820), 5100
Paint Branch Parkway, College Park, MD
20740, Phone: 240 402–2126, Email:
daniel.reese@fda.hhs.gov.
RIN: 0910–AG56
HHS—FDA
44. Food Labeling: Nutrition Labeling of
Standard Menu Items in Restaurants
and Similar Retail Food Establishments
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 21 U.S.C. 321; 21
U.S.C. 343; 21 U.S.C. 371
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Food and Drug
Administration (FDA) published a
proposed rule in the Federal Register of
April 6, 2011 (72 FR 19192), to establish
requirements for nutrition labeling of
standard menu items in chain
restaurants and similar retail food
establishments. FDA also proposed the
terms and conditions for restaurants and
similar retail food establishments
registering to voluntarily be subject to
the Federal requirements. FDA took this
action to carry out section 4205 of the
Patient Protection and Affordable Care
Act (‘‘Affordable Care Act’’ or ‘‘ACA’’),
which was signed into law on March 23,
2010.
Statement of Need: This rulemaking
was mandated by section 4205 of the
Patient Protection and Affordable Care
Act (Affordable Care Act).
Summary of Legal Basis: On March
23, 2010, the Affordable Care Act (Pub.
L. 111–148) was signed into law.
Section 4205 of the Affordable Care Act
amended 403(q)(5) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) by,
among other things, creating new clause
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
(H) to require that certain chain
restaurants and similar retail food
establishments with 20 or more
locations disclose certain nutrient
information for standard menu items.
FDA has the authority to issue this rule
under sections 403(a)(1), 403(q)(5)(H),
and 701(a) of the FD&C Act (21 U.S.C.
343(a)(1), 343(q)(5)(H), and 371(a)).
Section 701(a) of the FD&C Act vests the
Secretary of Health and Human
Services, and, by delegation, the Food
and Drug Administration (FDA) with
the authority to issue regulations for the
efficient enforcement of the FD&C Act.
Alternatives: Section 4205 of the
Affordable Care Act requires the
Secretary, and by delegation the FDA, to
establish by regulation requirements for
nutrition labeling of standard menu
items for covered restaurants and
similar retail food establishments.
Therefore, there are no alternatives to
rulemaking. FDA has analyzed
alternatives that may reduce the burden
of this rulemaking, including analyzing
the benefits and costs of expanding and
contracting the set of establishments
automatically covered by this rule and
shortening or lengthening the
compliance time relative to the
rulemaking.
Anticipated Cost and Benefits: Chain
restaurants and similar retail food
establishments operating in local
jurisdictions that impose different
nutrition labeling requirements will
benefit from having a uniform national
standard. Any restaurant or similar
retail food establishment with fewer
than 20 locations may voluntarily
choose to be covered by the national
standard. It is anticipated that chain
restaurants with 20 or more locations
will bear costs for adding nutrition
information to menus and menu boards.
FDA estimates that the total cost of
section 4205 and this rulemaking will
be approximately $80 million,
annualized over 10 years, with a low
annualized estimate of approximately
$33 million and a high annualized
estimate of approximately $125 million
over 10 years. These costs include an
initial cost of approximately $320
million with an annually recurring cost
of $45 million.
Because comprehensive national data
for the effects of menu labeling do not
exist, FDA has not quantified the
benefits associated with section 4205 of
the Affordable Care Act and this
rulemaking. Some studies have shown
that some consumers consume fewer
calories when menus have information
about calorie content displayed.
Consumers will benefit from having
important nutrition information for the
approximately 30 percent of calories
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15:08 Feb 10, 2012
Jkt 226001
consumed away from home. Given the
very high costs associated with obesity
and its associated health risks, FDA
estimates that if 0.6 percent of the adult
obese population reduces energy intake
by at least 100 calories per week, then
the benefits of section 4205 of the
Affordable Care Act and this rule will be
at least as large as the costs.
Risks: Americans now consume an
estimated one-third of their total
calories on foods prepared outside the
home and spend almost half of their
food dollars on such foods. Unlike
packaged foods that are labeled with
nutrition information, foods in
restaurants, for the most part, do not
have nutrition information that is
readily available when ordered. Dietary
intake data have shown that obese
Americans consume over 100 calories
per meal more when eating food away
from home rather than food at home.
This rule will provide consumers
information about the nutritional
content of food to enable them to make
healthier food choices and may help
mitigate the trend of increasing obesity
in America.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
04/06/11
07/05/11
76 FR 19192
11/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Federal,
Local, State.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Agency Contact: Geraldine A. June,
Supervisor, Product Evaluation and
Labeling Team, Department of Health
and Human Services, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition, (HFS–820), 5100
Paint Branch Parkway, College Park, MD
20740, Phone: 240 402–1802, Fax: 301
436–2636, Email:
geraldine.june@fda.hhs.gov.
RIN: 0910–AG57
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7727
HHS—CENTERS FOR MEDICARE &
MEDICAID SERVICES (CMS)
Proposed Rule Stage
45. Medicare and Medicaid Programs:
Reform of Hospital and Critical Access
Hospital Conditions of Participation
(CMS–3244–P)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1302; 42
U.S.C. 1395hh and 1395rr
CFR Citation: 42 CFR 482; 42 CFR
485.
Legal Deadline: None.
Abstract: This proposed rule would
revise the requirements that hospitals
and critical access hospitals (CAHs)
must meet to participate in the Medicare
and Medicaid programs. These changes
are necessary to reflect substantial
advances in health care delivery and in
patient safety knowledge and practices.
They are also an integral part of our
efforts to achieve broad-based
improvements in the quality of health
care furnished through Federal
programs and in patient safety, while at
the same time reducing procedural
burdens on providers.
Statement of Need: CMS is revising
many of the hospital CoPs to ensure that
they meet the needs of hospital and
CAH patients in an effective and
efficient manner. CMS is proposing
changes to reduce unnecessary,
obsolete, or burdensome regulations on
U.S. hospitals. This retrospective review
of existing regulations meets the
President’s Executive Order that all
Federal agencies identify such rules and
make proposals to ‘‘modify, streamline,
expand, or repeal them.’’ CMS is also
proposing additional quality and safety
requirements to protect patients.
Summary of Legal Basis: The
provisions that are included in this
proposed rule are necessary to
implement the requirements of
Executive Order 13563 ‘‘Improving
Regulations and Regulatory Review.’’
Alternatives: To date, nearly 90
specific reforms have been identified
and scheduled for action. These reforms
impact hospitals, physicians, home
health agencies, ambulance providers,
clinical labs, skilled nursing facilities,
intermediate care facilities, managed
care plans, Medicare Advantage
organizations, and States. Many of these
reforms will be included in proposed
rules that relate to particular categories
of regulations or types of providers.
Other reforms are being implemented
without the need for regulations.
This proposed rule includes reforms
that do not fit directly in other rules
scheduled for publication.
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Anticipated Cost and Benefits: This
proposed rule would reduce costs to
tens of thousands of physicians,
ambulatory surgical centers, End Stage
Renal Disease facilities, and other small
entities. Achieving the full scope of
potential savings will depend on future
decisions by hospitals, by State
regulators, and others. Many other
factors will influence long-term results.
We believe, however, that likely savings
and benefits will reach many billions of
dollars. Our primary estimate of the net
savings to hospitals from reductions in
regulatory requirements that we can
quantify at this time, offset by increases
in other regulatory costs, are
approximately $940 million a year.
Risks: None.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
10/24/11
12/23/11
76 FR 65891
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: CDR Scott Cooper,
Health Insurance Specialist, Department
of Health and Human Services, Centers
for Medicare & Medicaid Services,
Clinical Standards Group, Mail Stop
S3–05–15, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786–
9465, Email: scott.cooper@cms.hhs.gov.
RIN: 0938–AQ89
erowe on DSK2VPTVN1PROD with PROPOSALS2
HHS—CMS
46. Regulatory Provisions To Promote
Program Efficiency, Transparency, and
Burden Reduction (CMS–9070–P)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1302 and
1395hh and 44 U.S.C. 35
CFR Citation: 42 CFR 400, 405, 416,
418, 423; 42 CFR 424, 440, 442, 486,
494.
Legal Deadline: None.
Abstract: This proposed rule
identifies and proposes reforms in
Medicare and Medicaid regulations that
CMS has identified as unnecessary,
obsolete, or excessively burdensome on
health care providers and beneficiaries.
This proposed rule would increase the
ability of health care professionals to
devote resources to improving patient
care, by eliminating or reducing
requirements that impede quality
patient care or that divert providing
high quality patient care.
Statement of Need: In January 2011,
the President issued an Executive order
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that requires agencies to identify rules
that may be ‘‘outmoded, ineffective,
insufficient, or excessively burdensome,
and to modify, streamline, expand, or
repeal them in accordance with what
has been learned.’’ In accordance with
the Executive order, we identified
obsolete and unnecessarily burdensome
rules that could be eliminated or
reformed to achieve similar objectives,
with a particular focus on freeing up
resources that health care providers,
health plans, and States could use to
improve or enhance patient health and
safety. We examined policies and
practices not codified in rules that could
be changed or streamlined to achieve
better outcomes for patients while
reducing burden on providers of care.
We also sought to increase transparency
and become a better business partner.
Summary of Legal Basis: The
provisions that are included in this
proposed rule are necessary to
implement the requirements of
Executive Order 13563 ‘‘Improving
Regulations and Regulatory Review.’’
Alternatives: To date, nearly 90
specific reforms have been identified
and scheduled for action. These reforms
impact hospitals, physicians, home
health agencies, ambulance providers,
clinical labs, skilled nursing facilities,
intermediate care facilities, managed
care plans, Medicare Advantage
organizations, and States. Many of these
reforms will be included in proposed
rules that relate to particular categories
of regulations or types of providers.
Other reforms are being implemented
without the need for regulations. This
proposed rule includes reforms that do
not fit directly in other rules scheduled
for publication.
Anticipated Cost and Benefits: We
anticipate that the provider industry
and health professionals would
welcome the proposed changes and
reductions in burden. We also expect
that health professionals would
experience increased efficiencies and
resources to appropriately devote to
improving patient care, increasing
accessibility to care, and reducing
associated health care costs.
Risks: None.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
10/24/11
12/23/11
76 FR 65909
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
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Fmt 4701
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Government Levels Affected: Federal,
State.
Agency Contact: Michelle Shortt,
Director, Regulations Development
Group, OSORA, Department of Health
and Human Services, Centers for
Medicare & Medicaid Services, Mailstop
C4–26–05, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786–
4675, Email:
michelle.shortt@cms.hhs.gov.
RIN: 0938–AQ96
HHS—CMS
47. • Proposed Changes to Hospital
OPPS and CY 2013 Payment Rates; ASC
Payment System and CY 2013 Payment
Rates (CMS–1589–P) (Section 610
Review)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Sec 1833 of the
Social Security Act
CFR Citation: 42 CFR 410; 42 CFR
416; 42 CFR 419.
Legal Deadline: Final, Statutory,
November 1, 2012.
Abstract: This final rule would revise
the Medicare hospital outpatient
prospective payment system to
implement applicable statutory
requirements and changes arising from
our continuing experience with this
system. The proposed rule also
describes changes to the amounts and
factors used to determine payment rates
for services. In addition, the rule
proposes changes to the Ambulatory
Surgical Center Payment System list of
services and rates.
Statement of Need: Medicare pays
over 4,000 hospitals for outpatient
department services under the hospital
outpatient prospective payment system
(OPPS). The OPPS is based on groups of
clinically similar services called
ambulatory payment classification
groups (APCs). CMS annually revises
the APC payment amounts based on the
most recent claims data, proposes new
payment policies, and updates the
payments for inflation using the
hospital operating market basket. The
proposed rule solicits comments on the
proposed OPPS payment rates and new
policies. Medicare pays roughly 5,000
Ambulatory Surgical Centers (ASCs)
under the ASC payment system. CMS
annually revises the payment under the
ASC payment system, proposes new
policies, and updates payments for
inflation using the Consumer Price
Index for All Urban Consumers (CPI–U).
CMS will issue a final rule containing
the payment rates for the 2013 OPPS
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and ASC payment system at least 60
days before January 1, 2013.
Summary of Legal Basis: Section 1833
of the Social Security Act establishes
Medicare payment for hospital
outpatient services and ASC services.
The final rule revises the Medicare
hospital OPPS and ASC payment system
to implement applicable statutory
requirements. In addition, the proposed
and final rules describe changes to the
outpatient APC system, relative
payment weights, outlier adjustments,
and other amounts and factors used to
determine the payment rates for
Medicare hospital outpatient services
paid under the prospective payment
system, as well as changes to the rates
and services paid under the ASC
payment system. These changes would
be applicable to services furnished on or
after January 1, 2013.
Alternatives: None. This is a statutory
requirement.
Anticipated Cost and Benefits: Total
expenditures will be adjusted for CY
2013.
Risks: If this regulation is not
published timely, outpatient hospital
and ASC services will not be paid
appropriately beginning January 1,
2013.
Timetable:
Action
Date
NPRM ..................
physician fee schedule, as well as other
policy changes to payment under Part B.
These changes would be applicable to
services furnished on or after January 1.
Statement of Need: The statute
requires that we establish each year, by
regulation, payment amounts for all
physicians’ services furnished in all fee
schedule areas. This major proposed
rule would implement changes affecting
Medicare Part B payment to physicians
and other Part B suppliers. The final
rule has a statutory publication date of
November 1, 2012, and an
implementation date of January 1, 2013.
Summary of Legal Basis: Section 1848
of the Social Security Act (the Act)
establishes the payment for physician
services provided under Medicare.
Section 1848 of the Act imposes a
deadline of no later than November 1 for
publication of the final rule or final
physician fee schedule.
Alternatives: None. This implements a
statutory requirement.
Anticipated Cost and Benefits: Total
expenditures will be adjusted for CY
2013.
Risks: If this regulation is not
published timely, physician services
will not be paid appropriately,
beginning January 1, 2013.
Timetable:
Date
NPRM ..................
06/00/12
Action
06/00/12
FR Cite
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Federalism: Undetermined.
Agency Contact: Paula Smith, Health
Insurance Specialist, Department of
Health and Human Services, Centers for
Medicare & Medicaid Services, Mail
Stop C4–05–13, 7500 Security Blvd.,
Baltimore, MD 21244, Phone: 410 786–
4709, Email: paula.smith@cms.hhs.gov.
RIN: 0938–AR10
FR Cite
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Christina Ritter,
Director, Division of Practitioner
Services, Department of Health and
Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4–03–06,
7500 Security Blvd., Baltimore, MD
21244, Phone: 410 786–4636, Email:
christina.ritter@cms.hhs.gov.
RIN: 0938–AR11
HHS—CMS
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48. • Revisions to Payment Policies
Under the Physician Fee Schedule and
Part B for CY 2013 (CMS–1590–P)
(Section 610 Review)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Social Security Act,
secs 1102, 1871, 1848
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory,
November 1, 2012.
Abstract: This annual proposed rule
would revise payment polices under the
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HHS—CMS
49. • Changes to the Hospital Inpatient
an Long–Term Care Prospective
Payment System for FY 2013 (CMS–
1588–P) (Section 610 Review)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Sec 1886(d) of the
Social Security Act
CFR Citation: 42 CFR 412.
Legal Deadline: NPRM, Statutory,
April 1, 2012. Final, Statutory, August
1, 2012.
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Abstract: This annual major proposed
rule would revise the Medicare hospital
inpatient and long-term care hospital
prospective payment systems for
operating and capital-related costs. This
proposed rule would implement
changes arising from our continuing
experience with these systems.
Statement of Need: CMS annually
revises the Medicare hospital inpatient
prospective payment systems (IPPS) for
operating and capital-related costs to
implement changes arising from our
continuing experience with these
systems. In addition, we describe the
proposed changes to the amounts and
factors used to determine the rates for
Medicare hospital inpatient services for
operating costs and capital-related costs.
Also, CMS annually updates the
payment rates for the Medicare
prospective payment system (PPS) for
inpatient hospital services provided by
long-term care hospitals (LTCHs). The
proposed rule solicits comments on the
proposed IPPS and LTCH payment rates
and new policies. CMS will issue a final
rule containing the payment rates for
the FY 2013 IPPS and LTCHs at least 60
days before October 1, 2012.
Summary of Legal Basis: The Social
Security Act (the Act) sets forth a
system of payment for the operating
costs of acute care hospital inpatient
stays under Medicare Part A (Hospital
Insurance) based on prospectively set
rates. The Act requires the Secretary to
pay for the capital-related costs of
hospital inpatient and Long Term Care
stays under a PPS. Under these systems,
Medicare payment for hospital inpatient
and Long Term Care operating and
capital-related costs is made at
predetermined, specific rates for each
hospital discharge. These changes
would be applicable to services
furnished on or after October 1, 2012.
Alternatives: None. This implements a
statutory requirement.
Anticipated Cost and Benefits: Total
expenditures will be adjusted for FY
2013.
Risks: If this regulation is not
published timely, inpatient hospital and
LTCH services will not be paid
appropriately beginning October 1,
2012.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Agency Contact: Ankit Patel, Health
Insurance Specialist, Division of Acute
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Care, Department of Health and Human
Services, Centers for Medicare &
Medicaid Services, Hospital and
Ambulatory Policy Group, Mail Stop,
C4–25–11, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786–
4537, Email: ankit.patel@cms.hhs.gov.
RIN: 0938–AR12
HHS—CMS
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Final Rule Stage
50. Medicaid Eligibility Expansion
Under the Affordable Care Act of 2010
(CMS–2349–F)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 111–148, secs
1413, 1414, 2001, 2002, 2101, 2201
CFR Citation: 42 CFR 431, 435, 457.
Legal Deadline: Final, Statutory,
January 1, 2014.
Abstract: This rule implements
provisions of the Affordable Care Act
expanding access to health insurance
through improvements in Medicaid, the
establishment of American Health
Benefit Exchanges (‘‘Exchanges’’), and
coordination between Medicaid, the
Children’s Health Insurance Program
(CHIP), and Exchanges. This rule also
implements sections of the Affordable
Care Act related to Medicaid eligibility,
enrollment simplification, and
coordination.
Statement of Need: This rule expands
Medicaid eligibility, simplifies
Medicaid eligibility procedures, and
streamlines Medicaid enrollment
processes. It also coordinates eligibility
processes and policies with the
processes for premium tax credits for
Exchange coverage. Millions of
uninsured low-income persons who do
not have access to, or could not afford,
health insurance will obtain coverage.
Summary of Legal Basis: The
provisions that are included in this rule
are necessary to implement the
requirements of sections 1413, 1414,
2001, 2002, 2101, and 2201 of the
Affordable Care Act.
Alternatives: None. This is a statutory
requirement.
Anticipated Cost and Benefits: We
anticipate that this rule provides
significant benefits to low-income
individuals by expanding the
availability of affordable health
coverage. We expect that States may
incur short term increases in
administrative costs (depending on their
current systems and practices) but that
these costs will be wholly offset by
administrative savings over the longer
term.
Risks: None.
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Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
08/17/11
10/31/11
76 FR 51148
02/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Governmental
Jurisdictions.
Government Levels Affected: Federal,
Local, State, Tribal.
Agency Contact: Sarah DeLone,
Health Insurance Specialist, Department
of Health and Human Services, Centers
for Medicare & Medicaid Services, Mail
Stop S2–01–16, 7500 Security
Boulevard, Baltimore, MD 21244,
Phone: 410 786–0615, Email:
sarah.delone@cms.hhs.gov.
RIN: 0938–AQ62.
HHS—CMS
51. Establishment of Exchanges and
Qualified Health Plans Part I (CMS–
9989–F)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Affordable Care Act,
secs 1301 to 1343, secs 1401 to 1413
CFR Citation: 45 CFR 155 to 157.
Legal Deadline: Final, Statutory,
January 1, 2014.
Abstract: This rule implements the
new Affordable Insurance Exchanges
(‘‘Exchanges’’), consistent with title I of
the Affordable Care Act of 2010, referred
to collectively as the Affordable Care
Act. The Exchanges will provide
competitive marketplaces for
individuals and small employers to
directly compare available private
health insurance options on the basis of
price, quality, and other factors. The
Exchanges, which will become
operational by January 1, 2014, will
help enhance competition in the health
insurance market, improve choice of
affordable health insurance, and give
small businesses the same purchasing
clout as large businesses.
Statement of Need: A central aim of
Title I of the Affordable Care Act is to
expand access to health insurance
coverage through the establishment of
Exchanges. The number of uninsured
Americans is rising due to the lack of
affordable insurance, barriers to
insurance for people with pre-existing
conditions, and high prices due to
limited competition and market failures.
Millions of people without health
insurance use health care services for
which they do not pay, shifting the
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uncompensated cost of their care to
health care providers. Providers pass
much of this cost to insurance
companies, resulting in higher
premiums that make insurance
unaffordable to even more people. The
Affordable Care Act includes a number
of policies to address these problems,
including the creating of Affordable
Insurance Exchanges.
Summary of Legal Basis: This rule
implements the new Affordable
Insurance Exchanges consistent with
title I of the Affordable Care Act of 2010.
Alternatives: None. This is a statutory
requirement.
Anticipated Cost and Benefits: This
rule will help enhance competition in
the health insurance market, promote
the choice of affordable health
insurance, and give small businesses the
same purchasing clout as large
businesses. States seeking to operate an
Exchange will incur administrative
expenses as a result of implementing
and subsequently maintaining
Exchanges. There is no Federal
requirement that each State establish an
Exchange.
Risks: If this regulation is not
published, the Exchanges will not
become operational by January 1, 2014,
thereby violating the statute.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
07/15/11
09/28/11
76 FR 41866
02/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Federal,
State, Tribal.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Agency Contact: Alissa DeBoy,
Department of Health and Human
Services, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244,
Phone: 301 492–4428, Email:
alissa.deboy@cms.hhs.gov.
RIN: 0938–AQ67
HHS—CMS
52. • State Requirements for
Exchange—Reinsurance and Risk
Adjustments (CMS–9975–F)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 111–148, secs
1341 and 1342
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CFR Citation: 45 CFR 155, 156.
Legal Deadline: Final, Statutory,
January 1, 2014.
Abstract: This rule implements
requirements for States related to
reinsurance, risk corridors, and a
permanent risk adjustment. The goals of
these programs are to minimize negative
impacts of adverse selection inside the
Exchanges.
Statement of Need: This rule finalizes
guidelines for the transitional risksharing programs, reinsurance and risk
corridors, as well as for the risk
adjustment program that will continue
beyond the first 3 years of Exchange
operation. The purpose of these
programs is to protect health insurance
issuers from the negative effects of
adverse selection and to protect
consumers from increases in premiums
due to uncertainty for issuers.
Summary of Legal Basis: This rule
implements the new Affordable
Insurance Exchanges consistent with
title I of the Affordable Care Act of 2010.
Alternatives: None. This is a statutory
requirement.
Anticipated Cost and Benefits:
Payments through reinsurance, risk
adjustment, and risk corridors reduce
the increased risk of financial loss that
health insurance issuers might
otherwise expect to incur in 2014 due
to market reforms such as guaranteed
issue and the elimination of medical
underwriting. These payments reduce
the risk to the issuer and the issuer can
pass on a reduced risk premium to
enrollees. Administrative costs will vary
across States and health insurance
issuers depending on the sophistication
of technical infrastructure and prior
experience with data collection and risk
adjustment. States and issuers that
already have systems in place for data
collection and reporting will have
reduced administrative costs.
Risks: If this regulation is not
published, the Exchanges will not
become operational by January 1, 2014,
thereby violating the statute.
Timetable:
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
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Action
07/15/11
09/28/11
76 FR 41866
01/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Governmental
Jurisdictions.
Government Levels Affected: State.
Federalism: This action may have
federalism implications as defined in
EO 13132.
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Agency Contact: Alissa DeBoy, Health
Insurance Specialist, Center for
Consumer Information & Insurance
Oversight, Department of Health and
Human Services, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244,
Phone: 301 492–4428, Email:
alissa.deboy@cms.hhs.gov.
RIN: 0938–AR07
BILLING CODE 4150–24–P
DEPARTMENT OF HOMELAND
SECURITY (DHS)
Fall 2011 Statement of Regulatory
Priorities
The Department of Homeland
Security (DHS or Department) was
created in 2003 pursuant to the
Homeland Security Act of 2002, Public
Law 107–296. DHS has a vital mission:
To secure the Nation from the many
threats we face. This requires the
dedication of more than 225,000
employees in jobs that range from
aviation and border security to
emergency response, from cybersecurity
analyst to chemical facility inspector.
Our duties are wide-ranging, but our
goal is clear—keeping America safe.
Our mission gives us six main areas
of responsibility:
1. Prevent Terrorism and Enhance
Security,
2. Secure and Manage Our Borders,
3. Enforce and Administer our
Immigration Laws,
4. Safeguard and Secure Cyberspace,
5. Ensure Resilience to Disasters, and
6. Mature and Strengthen DHS.
In achieving these goals, we are
continually strengthening our
partnerships with communities, first
responders, law enforcement, and
government agencies—at the State,
local, tribal, Federal, and international
levels. We are accelerating the
deployment of science, technology, and
innovation in order to make America
more secure, and we are becoming
leaner, smarter, and more efficient,
ensuring that every security resource is
used as effectively as possible. For a
further discussion of our main areas of
responsibility, see the DHS Web site at
https://www.dhs.gov/xabout/
responsibilities.shtm.
The regulations we have summarized
below in the Department’s fall 2011
regulatory plan and in the agenda
support the Department’s responsibility
areas listed above. These regulations
will improve the Department’s ability to
accomplish its mission.
The regulations we have identified in
this year’s fall regulatory plan continue
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to address legislative initiatives
including, but not limited to, the
following acts: The Implementing
Recommendations of the 9/11
Commission Act of 2008 (9/11 Act),
Public Law 110–53 (Aug. 3, 2007); the
Post-Katrina Emergency Management
Reform Act of 2006 (PKEMRA), Public
Law 109–295 (Oct. 4, 2006); the
Consolidated Natural Resources Act of
2008 (CNRA), Public Law 110–220 (May
7, 2008); the Security and
Accountability for Every Port Act of
2006 (SAFE Port Act), Public Law 109–
347 (Oct. 13, 2006); and the
Consolidated Security, Disaster
Assistance, and Continuing
Appropriations Act, 2009, Public Law
110–329 (Sep. 30, 2008).
DHS strives for organizational
excellence and uses a centralized and
unified approach in managing its
regulatory resources. The Office of the
General Counsel manages the
Department’s regulatory program,
including the agenda and regulatory
plan. In addition, DHS senior leadership
reviews each significant regulatory
project to ensure that the project fosters
and supports the Department’s mission.
The Department is committed to
ensuring that all of its regulatory
initiatives are aligned with its guiding
principles to protect civil rights and
civil liberties, integrate our actions,
build coalitions and partnerships,
develop human resources, innovate, and
be accountable to the American public.
DHS is also committed to the
principles described in Executive
Orders 13563 and 12866 (as amended).
Both Executive orders direct agencies to
assess the costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. Many of
the regulations in DHS’ regulatory plan
support the Department’s efforts
pursuant to the DHS Final Plan for the
Retrospective Review of Existing
Regulations. DHS issued its final plan
on August 22, 2011.
Finally, the Department values public
involvement in the development of its
regulatory plan, agenda, and
regulations, and takes particular
concern with the impact its rules have
on small businesses. DHS and each of
its components continue to emphasize
the use of plain language in our notices
and rulemaking documents to promote
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a better understanding of regulations
and increased public participation in
the Department’s rulemakings.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), DHS
identified the following regulatory
actions in the Department’s Final Plan
for the Retrospective Review of Existing
Regulations (‘‘DHS Final Plan’’). DHS
has identified these regulatory actions
as associated with retrospective review
and analysis. You can view the DHS
Final Plan on www.regulations.gov by
searching for docket number DHS–
2011–0015. Some of the regulatory
actions on the below list may be
completed actions, which do not appear
in The Regulatory Plan. You can find
more information about these completed
rulemakings in past publications of the
Unified Agenda (search the Completed
Actions sections) on www.reginfo.gov.
Some of the entries on this list,
however, are active rulemakings. You
can find entries for these rulemakings
on www.regulations.gov.
Significantly Reduces
Burdens on Small
Businesses
RIN
Rule
1615–AB71 ................
Registration Requirement for Petitioners Seeking to File H–1B Petitions on Behalf of Aliens
Subject to Numerical Limitations.
Commonwealth of the Northern Mariana Islands Transitional Worker Classification ....................
Immigration Benefits Business Transformation, Increment I ..........................................................
Immigration Benefits Business Transformation: Nonimmigrants; Student and Exchange Visitor
Program.
Implementation of the 1995 Amendments to the International Convention on Standards of
Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978.
Updates to Maritime Security ..........................................................................................................
Elimination of TWIC for Certain Mariner Populations (Implementation of Section 809 of the
2010 Coast Guard Authorization Act).
Establishment of Global Entry Program ..........................................................................................
Closing of the Port of Whitetail, Montana .......................................................................................
Internet Publication of Administrative Seizure/Forfeiture Notices ...................................................
Aviation Security Infrastructure Fee (ASIF) ....................................................................................
Flight Training for Aliens and Other Designated Individuals; Security Awareness Training for
Flight School Employees.
Clarification of Eligibility Criteria for F and M Students and for Schools Certified by the Student
and Exchange Visitor Program To Enroll F and/or M Students.
1615–AB76 ................
1615–AB83 ................
1615–AB95 ................
1625–AA16 ................
1625–AB38 ................
TBD ............................
1651–AA73
1651–AA93
1651–AA94
1652–AA01
1652–AA35
................
................
................
................
................
1653–AA44 ................
The fall 2011 regulatory plan for DHS
includes regulations from DHS
components—including U.S.
Citizenship and Immigration Services
(USCIS), the U.S. Coast Guard (Coast
Guard), U.S. Customs and Border
Protection (CBP), the Federal Emergency
Management Agency (FEMA), the U.S.
Immigration and Customs Enforcement
(ICE), and the Transportation Security
Administration (TSA), which have
active regulatory programs. In addition,
it includes regulations from the
Department’s major offices and
directorates such as the National
Protection and Programs Directorate
(NPPD). Below is a discussion of the fall
2011 regulatory plan for DHS regulatory
components, as well as for DHS offices
and directorates.
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United States Citizenship and
Immigration Services
U.S. Citizenship and Immigration
Services (USCIS) administers
immigration benefits and services while
protecting and securing our homeland.
USCIS has a strong commitment to
welcoming individuals who seek entry
through the U.S. immigration system,
providing clear and useful information
regarding the immigration process,
promoting the values of citizenship, and
assisting those in need of humanitarian
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protection. Based on a comprehensive
review of the planned USCIS regulatory
agenda, USCIS will promulgate several
rulemakings to directly support these
commitments and goals.
Improvements to the Immigration
System. USCIS is currently engaged in
a multi-year transformation effort to
create a more efficient, effective, and
customer-focused organization by
improving our business processes and
technology. In the coming years, USCIS
will publish rules to facilitate that effort,
including rules that will remove
references to form numbers, form titles,
expired regulatory provisions, and
descriptions of internal procedure; will
mandate electronic filing in certain
circumstances; and will
comprehensively reorganize 8 CFR part
214. In addition, to streamline processes
and improve efficiency, USCIS plans to
revise its regulations governing appeals
and motions before the Administrative
Appeals Office. USCIS will also finalize
a final rule related to the extension of
immigration law to the Commonwealth
of the Northern Mariana Islands.
Requirements for Filing Motions and
Administrative Appeals. USCIS will
propose to revise the procedural
regulations governing appeals and
motions to reopen or reconsider before
its Administrative Appeals Office, and
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No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
to require that applicants and
petitioners exhaust administrative
remedies before seeking judicial review
of an unfavorable decision. The changes
proposed by the rule will streamline the
procedures before the Administrative
Appeals Office and improve the
efficiency of the adjudication process.
Regulations Related to the
Commonwealth of Northern Mariana
Islands. During 2009, USCIS issued
three regulations to implement the
extension of U.S. immigration law to the
Commonwealth of Northern Mariana
Islands (CNMI), as required under title
VII of the Consolidated Natural
Resources Act of 2008. During fiscal
year 2011, USCIS issued two final rules
related to the extension of the U.S.
immigration law to the CNMI. In fiscal
year 2012, USCIS will issue the
following CNMI final rule: The joint
USCIS/Department of Justice (DOJ)
regulation ‘‘Application of Immigration
Regulations to the CNMI.’’
Regulatory Changes Involving
Humanitarian Benefits. USCIS offers
protection to individuals who face
persecution by adjudicating
applications for refugees and asylees.
Other humanitarian benefits are
available to individuals who have been
victims of severe forms of trafficking or
criminal activity.
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Asylum and Withholding Definitions.
USCIS plans a regulatory proposal to
amend the regulations that govern
asylum eligibility and refugee status
determinations. The amendments are
expected to focus on portions of the
regulations that deal with
determinations of whether suffered or
feared persecution is on account of a
protected ground, the requirements for
establishing that the government is
unable or unwilling to protect the
applicant, and the definition of
membership in a particular social group.
This effort should provide greater clarity
and consistency in this important area
of the law.
Exception to the Persecutor Bar for
Asylum, Refugee, or Temporary
Protected Status, and Withholding of
Removal. In a joint rulemaking, DHS
and DOJ will propose amendments to
existing DHS and DOJ regulations to
resolve ambiguity in the statutory
language precluding eligibility for
asylum, refugee resettlement, temporary
protected status, and withholding or
removal of an applicant who ordered,
incited, assisted, or otherwise
participated in the persecution of
others. The proposed rule would
provide a limited exception for
persecutory actions taken by the
applicant under duress and would
clarify the required level of the
applicant’s knowledge of the
persecution.
‘‘T’’ and ‘‘U’’ Nonimmigrants. USCIS
plans additional regulatory initiatives
related to T nonimmigrants (victims of
trafficking), U nonimmigrants (victims
of criminal activity), and Adjustment of
Status for T and U status holders. By
promulgating additional regulations
related to these victims of specified
crimes or severe forms of human
trafficking, USCIS hopes to provide
greater consistency for these vulnerable
groups, their advocates, and the
community. These rulemakings will
contain provisions to adjust
documentary requirements for this
vulnerable population and provide
greater clarity to the law enforcement
community.
Application of the William
Wilberforce Trafficking Victims
Protection Act of 2008. In a joint
rulemaking, DHS and DOJ will propose
amendments to implement the William
Wilberforce Trafficking Victims
Protection Act of 2008 (TVPRA). Among
other things, this statute specified that
USCIS has initial jurisdiction over an
asylum application filed by an
unaccompanied alien child in removal
proceedings before an immigration
judge in DOJ. The agencies
implemented this legislation with
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interim procedures that the TVPRA
mandated within 90 days after
enactment. The proposed rule would
amend both agencies’ regulations to
finalize the procedures to determine
when an alien child is unaccompanied
and how jurisdiction is transferred to
USCIS for initial adjudication of the
child’s asylum application. In addition,
this rule would address adjustment of
status for special immigrant juveniles
and voluntary departure for
unaccompanied alien children in
removal proceedings.
United States Coast Guard
The U.S. Coast Guard (Coast Guard) is
a military, multi-mission, maritime
service of the United States and the only
military organization within DHS. It is
the principal Federal agency responsible
for maritime safety, security, and
stewardship, and delivers daily value to
the Nation through multi-mission
resources, authorities, and capabilities.
Effective governance in the maritime
domain hinges upon an integrated
approach to safety, security, and
stewardship. The Coast Guard’s policies
and capabilities are integrated and
interdependent, delivering results
through a network of enduring
partnerships. The Coast Guard’s ability
to field versatile capabilities and highlytrained personnel is one of the U.S.
Government’s most significant and
important strengths in the maritime
environment.
America is a maritime nation, and our
security, resilience, and economic
prosperity are intrinsically linked to the
oceans. Safety, efficient waterways, and
freedom of transit on the high seas are
essential to our well-being. The Coast
Guard is leaning forward, poised to
meet the demands of the modern
maritime environment. The Coast Guard
creates value for the public through
solid prevention and response efforts.
Activities involving oversight and
regulation, enforcement, maritime
presence, and public and private
partnership foster increased maritime
safety, security, and stewardship.
The statutory responsibilities of the
Coast Guard include ensuring marine
safety and security, preserving maritime
mobility, protecting the marine
environment, enforcing U.S. laws and
international treaties, and performing
search and rescue. The Coast Guard
supports the Department’s overarching
goals of mobilizing and organizing our
Nation to secure the homeland from
terrorist attacks, natural disasters, and
other emergencies. The rulemaking
projects identified for the Coast Guard
in the Unified Agenda, and the rules
appearing in the fall 2011 regulatory
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plan below, contribute to the fulfillment
of those responsibilities and reflect our
regulatory policies.
Implementation of the 1995
Amendments to the International
Convention on Standards of Training,
Certification, and Watchkeeping
(STCW) for Seafarers, 1978. The Coast
Guard proposed to amend its
regulations to implement changes to an
interim rule published on June 26, 1997.
These proposed amendments go beyond
changes found in the interim rule and
seek to more fully incorporate the
requirements of the STCW in the
requirements for the credentialing of
U.S. merchant mariners. The proposed
changes are primarily substantive and:
(1) Are necessary to continue to give full
and complete effect to the STCW
Convention; (2) incorporate lessons
learned from implementation of the
STCW through the interim rule and
through policy letters and Navigation
and Vessel Inspection Circulars (NVICs);
and (3) attempt to clarify regulations
that have generated confusion. The
Coast Guard published this proposal as
a Supplemental Notice of Proposed
Rulemaking (SNPRM) on August 1,
2011. The Coast Guard intends to
review and analyze comments received
on that SNPRM, and publish a
subsequent rule complying with the
requirements of the newly amended
STCW Convention. DHS included this
rulemaking in the DHS Final Plan for
the Retrospective Review of Existing
Regulations, which DHS released on
August 22, 2011.
Vessel Requirements for Notices of
Arrival and Departure, and Automatic
Identification System. The Coast Guard
intends to expand the applicability of
notice of arrival and departure (NOAD)
and automatic identification system
(AIS) requirements to include more
commercial vessels. This rule, once
final, would expand the applicability of
notice of arrival (NOA) requirements to
include additional vessels, establish a
separate requirement for vessels to
submit notices of departure (NOD) when
departing for a foreign port or place, set
forth a mandatory method for electronic
submission of NOA and NOD, and
modify related reporting content,
timeframes, and procedures. This rule
would also extend the applicability of
AIS requirements beyond Vessel Traffic
Service (VTS) areas to all U.S. navigable
waters and require additional
commercial vessels install and use AIS.
These changes are intended to improve
navigation safety, enhance Coast
Guard’s ability to identify and track
vessels, and heighten the Coast Guard’s
overall maritime domain awareness,
thus helping the Coast Guard address
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threats to maritime transportation safety
and security and mitigate the possible
harm from such threats.
Nontank Vessel Response Plans and
Other Vessel Response Plan
Requirements. The Coast Guard intends
to promulgate a rule to further protect
the Nation from the threat of oil spills
in U.S. waters, which supports the
strategic goals of protection of natural
resources and maritime mobility. The
rule, once final, would require owners
and operators of nontank vessels to
prepare and submit oil spill response
plans. The Federal Water Pollution
Control Act defines nontank vessels as
self-propelled vessels of 400 gross tons
or greater that operate on the navigable
waters of the United States, carry oil of
any kind as fuel for main propulsion,
and are not tank vessels. The rule would
specify the content of a response plan
and would address, among other issues,
the requirement that a plan for
responding to a worst case discharge
and a substantial threat of such a
discharge. Additionally, the rule would
require vessel owners and operators to
submit their vessel response plan
control number as part of already
required notice of arrival information.
Revision to Transportation Worker
Identification Credential (TWIC)
Requirements for Mariners. The Coast
Guard is developing revisions to its
merchant mariner credentialing
regulations, to implement changes made
by section 809 of the Coast Guard
Authorization Act of 2010. Section 809
eliminated the requirement for certain
mariner populations to obtain TWIC.
The Coast Guard is also considering
revising its regulations to provide an
exemption for certain fees associated
with merchant mariner credentialing for
those mariners not required to hold a
TWIC who may still be required to visit
a TWIC enrollment center to provide the
information necessary to obtain a
Merchant Mariner Credential. DHS
highlighted this rulemaking in the DHS
Final Plan for the Retrospective Review
of Existing Regulations, which DHS
released on August 22, 2011.
Offshore Supply Vessels of 6,000 or
more GT ITC. The Coast Guard
Authorization Act of 2010 (the Act)
removed the size limit on offshore
supply vessels (OSVs) and directed the
Coast Guard to issue, as soon as
practicable, regulations to implement
section 617 of the Act. As required by
the Act, this regulation would provide
for the safe carriage of oil, hazardous
substances, and individuals in addition
to crew on OSVs of at least 6,000 gross
tonnage as measured under the
International Convention on Tonnage
Measurement of Ships (6,000 GT ITC).
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In developing the regulations, the Coast
Guard is taking into account the
characteristics of offshore supply
vessels, their methods of operation, and
their service in support of exploration,
exploitation, or production of offshore
mineral or energy resources.
United States Customs and Border
Protection
U.S. Customs and Border Protection
(CBP) is the Federal agency principally
responsible for the security of our
Nation’s borders at and between the
ports of entry and at official crossings
into the United States. CBP must
accomplish its border security and
enforcement mission while facilitating
the flow of legitimate trade and travel.
The primary mission of CBP is its
homeland security mission; that is, to
prevent terrorists and terrorist weapons
from entering the United States. An
important aspect of this priority mission
involves improving security at our
borders and ports of entry, but it also
means extending our zone of security
beyond our physical borders.
CBP is also responsible for
administering laws concerning the
import and export of goods into and out
of the United States, and enforcing the
laws concerning the entry of persons
into and out of the United States. This
includes regulating and facilitating
international trade; collecting import
duties; enforcing U.S. trade,
immigration, and other laws of the
United States at our borders; inspecting
imports and exports; overseeing the
activities of persons and businesses
engaged in importing; enforcing the
laws concerning smuggling and
trafficking in contraband; apprehending
individuals attempting to enter the
United States illegally; protecting our
agriculture and economic interests from
harmful pests and diseases; conducting
inspections of all people, vehicles, and
cargo entering the United States;
enforcing export controls; and
protecting U.S. businesses from theft of
their intellectual property.
In carrying out its priority mission,
CBP’s goal is to facilitate the processing
of legitimate trade and people efficiently
without compromising security.
Consistent with its primary mission of
homeland security, CBP intends to
finalize several rules during the next
fiscal year that are intended to improve
security at our borders and ports of
entry. We have highlighted some of
these rules below.
Electronic System for Travel
Authorization (ESTA). On June 9, 2008,
CBP published an interim final rule
amending DHS regulations to
implement the Electronic System for
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Travel Authorization (ESTA) for aliens
who wish to enter the United States
under the Visa Waiver Program (VWP)
at air or sea ports of entry. This rule is
intended to fulfill the requirements of
section 711 of the Implementing
Recommendations of the 9/11
Commission Act of 2007 (9/11 Act). The
rule establishes ESTA and delineates
the data field DHS has determined will
be collected by the system. The rule
requires that each alien traveling to the
United States under the VWP must
obtain electronic travel authorization
via the ESTA in advance of such travel.
VWP travelers may obtain the required
ESTA authorization by electronically
submitting to CBP biographic and other
information as currently required by the
I–94W Nonimmigrant Alien Arrival/
Departure Form (I–94W). By Federal
Register notice dated November 13,
2008, the Secretary of Homeland
Security informed the public that ESTA
would become mandatory beginning
January 12, 2009. This means that all
VWP travelers must either obtain travel
authorization in advance of travel under
ESTA or obtain a visa prior to traveling
to the United States.
By shifting from a paper to an
electronic form and requiring the data in
advance of travel, CBP will be able to
determine before the alien departs for
the U.S. the eligibility of nationals from
VWP countries to travel to the United
States and to determine whether such
travel poses a law enforcement or
security risk. By modernizing the VWP,
the ESTA is intended to increase
national security and provide for greater
efficiencies in the screening of
international travelers by allowing for
vetting of subjects of potential interest
well before boarding, thereby reducing
traveler delays based on lengthy
processes at ports of entry. On August
9, 2010, CBP published an interim final
rule amending the ESTA regulations to
require ESTA applicants to pay a
congressionally mandated fee, which is
the sum of two amounts, a $10 travel
promotion fee for an approved ESTA
and a $4.00 operational fee for the use
of ESTA set by the Secretary of
Homeland Security to at least ensure the
recovery of the full costs of providing
and administering the ESTA system.
During the next fiscal year, CBP intends
to issue a final rule on ESTA and the
ESTA fee.
Importer Security Filing and
Additional Carrier Requirements. The
Security and Accountability for Every
Port Act of 2006 (SAFE Port Act) calls
for CBP to promulgate regulations to
require the electronic transmission of
additional data elements for improved
high-risk targeting. See Public Law 109–
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347, section 203 (October 13, 2006).
This includes appropriate security
elements of entry data for cargo destined
for the United States by vessel prior to
loading of such cargo on vessels at
foreign seaports. The SAFE Port Act
requires that the information collected
reasonably improve CBP’s ability to
identify high-risk shipments to prevent
smuggling and ensure cargo safety and
security.
On November 25, 2008, CBP
published an interim final rule
‘‘Importer Security Filing and
Additional Carrier Requirements,’’
amending CBP Regulations to require
carriers and importers to provide to CBP
via a CBP-approved electronic data
interchange system, information
necessary to enable CBP to identify
high-risk shipments to prevent
smuggling, and ensure cargo safety and
security. This rule, which became
effective on January 26, 2009, improves
CBP risk assessment and targeting
capabilities, facilitates the prompt
release of legitimate cargo following its
arrival in the United States, and assists
CBP in increasing the security of the
global trading system. The comment
period for the interim final rule
concluded on June 1, 2009. CBP is
analyzing comments and conducting a
structured review of certain flexibility
provided in the interim final rule. CBP
intends to publish a final rule during
the next fiscal year.
Implementation of the Guam-CNMI
Visa Waiver Program. CBP published an
interim final rule in November 2008
amending the DHS regulations to
replace the current Guam Visa Waiver
Program with a new Guam-CNMI Visa
Waiver program. This rule implements
portions of the Consolidated National
Resources Act of 2008 (CNRA), which
extends the immigration laws of the
United States to the Commonwealth of
the Northern Mariana Islands (CNMI)
and, among others things, provides for
a visa waiver program for travel to
Guam and the CNMI. The amended
regulations set forth the requirements
for nonimmigrant visitors who seek
admission for business or pleasure and
solely for entry into and stay on Guam
or the CNMI without a visa. The rule
also establishes six ports of entry in the
CNMI for purposes of administering and
enforcing the Guam-CNMI Visa Waiver
program. CBP intends to issue a final
rule during the next fiscal year.
Global Entry Program. In the fall of
2009, pursuant to section 7208(k) of the
Intelligence Reform and Terrorism
Prevention Act of 2004, as amended,
CBP issued a Notice of Proposed
Rulemaking (NPRM), proposing to
establish an international trusted
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traveler program, called Global Entry.
This voluntary program would allow
CBP to expedite clearance of preapproved, low-risk air travelers into the
United States. CBP has been operating
the Global Entry program as a pilot at
several airports since June 6, 2008.
Based on the successful operation of the
pilot, CBP proposed to establish Global
Entry as a permanent voluntary
regulatory program. CBP has evaluated
the public comments received in
response to the NPRM and intends to
issue a final rule during the next fiscal
year.
In the above paragraphs, DHS
discusses the CBP regulations that foster
DHS’s mission. CBP also issues
regulations related to the mission of the
Department of the Treasury. Under
section 403(1) of the Homeland Security
Act of 2002, the former U.S. Customs
Service, including functions of the
Secretary of the Treasury relating
thereto, transferred to the Secretary of
Homeland Security. As part of the
initial organization of DHS, the Customs
Service inspection and trade functions
were combined with the immigration
and agricultural inspection functions
and the Border Patrol and transferred
into CBP. It is noted that certain
regulatory authority of the United States
Customs Service relating to customs
revenue function was retained by the
Department of the Treasury (see the
Department of the Treasury regulatory
plan). In addition to its plans to
continue issuing regulations to enhance
border security, CBP, during fiscal year
2012, expects to continue to issue
regulatory documents that will facilitate
legitimate trade and implement the
trade benefit program. CBP regulations
regarding the customs revenue function
are discussed in the regulatory plan of
the Department of the Treasury.
Federal Emergency Management Agency
The mission of the Federal Emergency
Management Agency (FEMA) is to
support our citizens and first responders
to ensure that, as a Nation, we work
together to build, sustain, and improve
our capability to prepare for, protect
against, respond to, recover from, and
mitigate all hazards. In fiscal year 2012,
FEMA will continue to serve that
mission and promote the Department of
Homeland Security’s goals. In
furtherance of the Department and
Agency’s goals, in the upcoming fiscal
year, FEMA will work on regulations to
implement provisions of the PostKatrina Emergency Management Reform
Act of 2006 (PKEMRA) (Pub. L. 109–
295, Oct. 4, 2006) and to implement
lessons learned from past events.
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Public Assistance Program
Regulations. FEMA will work to revise
the Public Assistance Program
regulations in 44 CFR part 206 to reflect
changes made to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act by PKEMRA, the Pets
Evacuation and Transportation
Standards Act of 2006 (PETS Act) (Pub.
L. 109–308, Oct. 6, 2006), the Local
Community Recovery Act of 2006 (Pub.
L. 109–218, Apr. 20, 2006), and the
Security and Accountability for Every
Port Act of 2006 (SAFE Port Act) (Pub.
L. 109–347, Oct. 13, 2006), and to make
other substantive and nonsubstantive
clarifications and corrections to the
Public Assistance regulations. The
proposed changes would expand
eligibility to include performing arts
facilities and community arts centers
pursuant to section 688 of PKEMRA;
include education in the list of critical
services pursuant to section 689(h) of
PKEMRA, thus allowing private
nonprofit educational facilities to be
eligible for restoration funding; add
accelerated Federal assistance to
available assistance pursuant to section
681 of PKEMRA; include household
pets and service animals in essential
assistance pursuant to section 689 of
PKEMRA and section 4 of the PETS Act;
provide for expedited payments of grant
assistance for the removal of debris
pursuant to section 610 of the SAFE
Port Act; and allow for a contract to be
set aside for award based on a specific
geographic area pursuant to section 2 of
the Local Community Recovery Act of
2006. Other changes would include
adding or changing requirements to
improve and streamline the Public
Assistance grant application process.
Federal Law Enforcement Training
Center
The Federal Law Enforcement
Training Center (FLETC) does not have
any significant regulatory actions
planned for fiscal year 2012.
United States Immigration and Customs
Enforcement
ICE is the principal criminal
investigative arm of the Department of
Homeland Security and one of the three
Department components charged with
the civil enforcement of the Nation’s
immigration laws. Its primary mission is
to protect national security, public
safety, and the integrity of our borders
through the criminal and civil
enforcement of Federal law governing
border control, customs, trade, and
immigration.
During fiscal year 2012, ICE will
pursue rulemaking actions that improve
two critical subject areas: The detention
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of aliens who are subject to final orders
of removal and the processes for the
Student and Exchange Visitor Program
(SEVP).
Continued Detention of Aliens Subject
to Final Orders of Removal. ICE will
improve the post order custody review
process in a Final Rule related to the
continued detention of aliens subject to
final orders of removal in light of the
U.S. Supreme Court’s decisions in
Zadvydas v. Davis, 533 U.S. 678 (2001)
and Clark v. Martinez, 543 U.S. 371
(2005), as well as changes pursuant to
the enactment of the Homeland Security
Act of 2002. During fiscal year 2012, ICE
will also issue a companion Notice of
Proposed Rulemaking (NPRM) that will
allow the public an opportunity to
comment on new sections of the
custody determination process not
previously published for comment.
Processes for the Student and
Exchange Visitor Program. ICE will
improve SEVP processes by publishing
a final Optional Practical Training
(OPT) rule, which will respond to
comments on the OPT Interim Final
Rule (IFR). The IFR increased the
maximum period of OPT from 12
months to 29 months for nonimmigrant
students who have completed a science,
technology, engineering, or mathematics
degree and who accept employment
with employers who participate in
USCIS’s E-Verify employment
verification program.
National Protection and Programs
Directorate
The goal of the National Protection
and Programs Directorate (NPPD) is to
advance the Department’s risk-reduction
mission. Reducing risk requires an
integrated approach that encompasses
both physical and virtual threats and
their associated human elements.
Ammonium Nitrate Security Program.
The Secure Handling of Ammonium
Nitrate Act, section 563 of the Fiscal
Year 2008 Department of Homeland
Security Appropriations Act, Public
Law 110–161, amended the Homeland
Security Act of 2002 to provide DHS
with the authority to ‘‘regulate the sale
and transfer of ammonium nitrate by an
ammonium nitrate facility * * * to
prevent the misappropriation or use of
ammonium nitrate in an act of
terrorism.’’
The Secure Handling of Ammonium
Nitrate Act directs DHS to promulgate
regulations requiring potential buyers
and sellers of ammonium nitrate to
register with DHS. As part of the
registration process, the statute directs
DHS to screen registration applicants
against the Federal Government’s
Terrorist Screening Database. The
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statute also requires sellers of
ammonium nitrate to verify the
identities of those seeking to purchase
it; to record certain information about
each sale or transfer of ammonium
nitrate; and to report thefts and losses of
ammonium nitrate to DHS.
The Ammonium Nitrate Security
Program Notice of Proposed Rulemaking
proposes requirements that would
implement the Secure Handling of
Ammonium Nitrate Act. The rule would
aid the Federal Government in its efforts
to prevent the misappropriation of
ammonium nitrate for use in acts of
terrorism. By preventing such
misappropriation, this rule aims to limit
terrorists’ abilities to threaten the public
and to threaten the Nation’s critical
infrastructure and key resources. By
securing the Nation’s supply of
ammonium nitrate, it will be more
difficult for terrorists to obtain
ammonium nitrate materials for use in
terrorist acts.
On October 29, 2008, DHS published
an Advance Notice of Proposed
Rulemaking (ANPRM) for the Secure
Handling of Ammonium Nitrate
Program, and received a number of
public comments on that ANPRM. DHS
reviewed those comments and
published a Notice of Proposed
Rulemaking (NPRM) on August 3, 2011.
NPPD will accept public comment on
until December 1, 2011, after which
NPPD will review the public comments
and develop a Final Rule related to the
Security Handling of Ammonium
Nitrate Program.
Transportation Security Administration
The Transportation Security
Administration (TSA) protects the
Nation’s transportation systems to
ensure freedom of movement for people
and commerce. TSA is committed to
continuously setting the standard for
excellence in transportation security
through its people, processes, and
technology as we work to meet the
immediate and long-term needs of the
transportation sector.
In fiscal year 2012, TSA will promote
the DHS mission by emphasizing
regulatory efforts that allow TSA to
better identify, detect, and protect
against threats against various modes of
the transportation system, while
facilitating the efficient movement of
the traveling public, transportation
workers, and cargo.
General Aviation Security and Other
Aircraft Operator Security. TSA plans to
issue a Supplemental Notice of
Proposed Rulemaking (SNPRM) to
propose amendments to current aviation
transportation security regulations to
enhance the security of general aviation
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(GA) by expanding the scope of current
requirements and by adding new
requirements for certain GA aircraft
operators. To date, the Government’s
focus with regard to aviation security
generally has been on air carriers and
commercial operators. As vulnerabilities
and risks associated with air carriers
and commercial operators have been
reduced or mitigated, terrorists may
perceive that GA aircraft are more
vulnerable and may view them as
attractive targets. This rule would
enhance aviation security by requiring
operators of certain GA aircraft to adopt
a security program and to undertake
other security measures. TSA published
a Notice of Proposed Rulemaking on
October 30, 2008, and received over
7,000 public comments, generally
urging significant changes to the
proposal. The SNPRM will respond to
the comments and contain proposals on
addressing security in the GA sector.
Security Training for Surface Mode
Employees. TSA will propose
regulations to enhance the security of
several non-aviation modes of
transportation. In particular, TSA will
propose regulations requiring freight
railroad carriers, public transportation
agencies (including rail mass transit and
bus systems), passenger railroad
carriers, and over-the-road bus operators
to conduct security training for front
line employees. This regulation would
implement sections 1408 (Public
Transportation), 1517 (Freight
Railroads), and 1534(a) (Over the Road
Buses) of the Implementing
Recommendations of the 9/11
Commission Act of 2008 (9/11 Act),
Public Law 110–53 (Aug. 3, 2007). In
compliance with the definitions of
frontline employees in the pertinent
provisions of the 9/11 Act, the Notice of
Proposed Rulemaking (NPRM) would
define which employees are required to
undergo training. The NPRM would also
propose definitions for transportation
security-sensitive materials, as required
by section 1501 of the 9/11 Act.
Railroad Carrier Vulnerability
Assessment and Security Plans. TSA
will also propose regulations requiring
high-risk freight and passenger railroads
to conduct vulnerability selfassessments, as well as develop and
implement comprehensive security
plans. TSA would need to approve both
the vulnerability assessment and
security plan. This regulation,
implementing section 1512 of the 9/11
Act, would include proposed provisions
to identify which railroads would be
considered high-risk and include
proposed provisions about the
associated vulnerability assessment and
security planning requirements.
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Aircraft Repair Station Security. TSA
will finalize a rule requiring repair
stations that are certificated by the
Federal Aviation Administration under
14 CFR part 145 to adopt and
implement standard security programs
and to comply with security directives
issued by TSA. TSA issued an Notice of
Proposed Rulemaking (NPRM) on
November 18, 2009. The final rule will
also codify the scope of TSA’s existing
inspection program and could require
regulated parties to allow DHS officials
to enter, inspect, and test property,
facilities, and records relevant to repair
stations. This rulemaking action will
implement section 1616 of the 9/11 Act.
Standardized Vetting, Adjudication,
and Redress Process and Fees. TSA is
developing a proposed rule to revise
and standardize the procedures,
adjudication criteria, and fees for most
of the security threat assessments (STA)
of individuals that TSA conducts. DHS
is considering a proposal that would
include procedures for conducting STAs
for transportation workers from almost
all modes of transportation, including
those covered under the 9/11 Act. In
addition, TSA will propose equitable
fees to cover the cost of the STAs and
credentials for some personnel. TSA
plans to identify new efficiencies in
processing STAs and ways to streamline
existing regulations by simplifying
language and removing redundancies.
As part of this proposed rule, TSA
will propose revisions to the Alien
Flight Student Program (AFSP)
regulations. TSA published an interim
final rule for ASFP on September 20,
2004. TSA regulations require aliens
seeking to train at Federal Aviation
Administration-regulated flight schools
to complete an application and undergo
an STA prior to beginning flight
training. There are four categories under
which students currently fall; the nature
of the STA depends on the student’s
category. TSA is considering changes to
the AFSP that would improve equity
among fee payers and enable the
implementation of new technologies to
support vetting.
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United States Secret Service
The United States Secret Service does
not have any significant regulatory
actions planned for fiscal year 2012.
DHS Regulatory Plan for Fiscal Year
2012
A more detailed description of the
priority regulations that comprise DHS’s
fall 2011 regulatory plan follows.
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DHS—OFFICE OF THE SECRETARY
(OS)
Proposed Rule Stage
53. Secure Handling of Ammonium
Nitrate Program
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 2008 Consolidated
Appropriations Act, sec 563, subtitle J—
Secure Handling of Ammonium Nitrate,
Pub. L. 110–161
CFR Citation: 6 CFR 31.
Legal Deadline: NPRM, Statutory,
May 26, 2008, Publication of Notice of
Proposed Rulemaking.
Abstract: This rulemaking will
implement the December 2007
amendment to the Homeland Security
Act entitled ‘‘Secure Handling of
Ammonium Nitrate.’’ The amendment
requires the Department of Homeland
Security to ‘‘regulate the sale and
transfer of ammonium nitrate by an
ammonium nitrate facility * * * to
prevent the misappropriation or use of
ammonium nitrate in an act of
terrorism.’’
Statement of Need: Pursuant to
section 563 of the 2008 Consolidated
Appropriations Act, subtitle J—Secure
Handling of Ammonium Nitrate, Public
Law 110–161, the Department of
Homeland Security is required to
promulgate a rulemaking to create a
registration regime for certain buyers
and sellers of ammonium nitrate. The
rule, as proposed by this NPRM, would
create that regime, and would aid the
Federal Government in its efforts to
prevent the misappropriation of
ammonium nitrate for use in acts of
terrorism. By preventing such
misappropriation, this rule could limit
terrorists’ abilities to threaten the public
and to threaten the Nation’s critical
infrastructure and key resources. By
securing the Nation’s supply of
ammonium nitrate, it should be much
more difficult for terrorists to obtain
ammonium nitrate materials for use in
improvised explosive devices. As a
result, there is a direct value in the
deterrence of a catastrophic terrorist
attack using ammonium nitrate, such as
the Oklahoma City attack that killed
over 160 and injured 853 people.
Summary of Legal Basis: Section 563
of the 2008 Consolidated
Appropriations Act, subtitle J—Secure
Handling of Ammonium Nitrate, Public
Law 110–161, authorizes and requires
this rulemaking.
Alternatives: The Department
considered several alternatives when
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7737
developing the Ammonium Nitrate
Security Program proposed rule. The
alternatives considered were: (a)
Register individuals applying for an AN
Registered User Number using a paper
application (via facsimile or the U.S.
mail) rather than through in person
application at a local Cooperative
Extension office or only through a webbased portal; (b) verify AN Purchasers
through both an Internet based
verification portal and call center rather
than only a verification portal or call
center; (c) communicate with applicants
for an AN Registered User Number
through U.S. Mail rather than only
through email or a secure web-based
portal; (d) establish a specific capability
within the Department to receive,
process, and respond to reports of theft
or loss rather than leverage a similar
capability which already exists with the
ATF; (e) require AN Facilities to
maintain records electronically in a
central database provided by the
Department rather than providing
flexibility to the AN Facility to maintain
their own records either in paper or
electronically; (f) require agents to
register with the Department prior to the
sale or transfer of ammonium nitrate
involving an agent rather than allow
oral confirmation of the agent with the
AN Purchaser on whose behalf the agent
is working; and (g) exempt explosives
from this regulation rather than not
exempting them. As part of its notice of
proposed rulemaking, the Department
seeks public comment on the numerous
alternative ways in which the final
Secure Handling of Ammonium Nitrate
Program could carry out the
requirements of the Secure Handling of
Ammonium Nitrate Act.
Anticipated Cost and Benefits: The
Department estimates the number of
entities that purchase ammonium
nitrate to range from 64,950 to 106,200.
These purchasers include farms,
fertilizer mixers, farm supply
wholesalers and cooperatives (co-ops),
golf courses, landscaping services,
explosives distributors, mines, retail
garden centers, and lab supply
wholesalers. The Department estimates
the number of entities that sell
ammonium nitrate to be between 2,486
and 6,236, many of which are also
purchasers. These sellers include
ammonium nitrate fertilizer and
explosive manufacturers, fertilizer
mixers, farm supply wholesalers and coops, retail garden centers, explosives
distributors, fertilizer applicator
services, and lab supply wholesalers.
Individuals or firms that provide
transportation services within the
distribution chain may be categorized as
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sellers, agents, or facilities depending
upon their business relationship with
the other parties to the transaction. The
total number of potentially regulated
farms and other businesses ranges from
64,986 to 106,236 (including overlap
between the categories).
The cost of this proposed rule ranges
from $300 million to $1,041 million
over 10 years at a 7 percent discount
rate. The primary estimate is the mean
which is $670.6 million. For
comparison, at a 3 percent discount rate,
the cost of the program ranges from
$364 million to $1.3 billion with a
primary (mean) estimate of $814
million. The average annualized cost for
the program ranges from $43 million to
$148 million (with a mean of $96
million), also employing a 7 percent
discount rate.
Because the value of the benefits of
reducing risk of a terrorist attack is a
function of both the probability of an
attack and the value of the consequence,
it is difficult to identify the particular
risk reduction associated with the
implementation of this rule. These
elements and related qualitative benefits
include point of sale identification
requirements and requiring individuals
to be screened against the Terrorist
Screening Database (TSDB) resulting in
known bad actors being denied the
ability to purchase ammonium nitrate.
The Department of Homeland
Security aims to prevent terrorist attacks
within the United States and to reduce
the vulnerability of the United States to
terrorism. By preventing the
misappropriation or use of ammonium
nitrate in acts of terrorism, this
rulemaking will support the
Department’s efforts to prevent terrorist
attacks and to reduce the Nation’s
vulnerability to terrorist attacks. This
rulemaking is complementary to other
Department programs seeking to reduce
the risks posed by terrorism, including
the Chemical Facility Anti-Terrorism
Standards program (which seeks in part
to prevent terrorists from gaining access
to dangerous chemicals) and the
Transportation Worker Identification
Credential program (which seeks in part
to prevent terrorists from gaining access
to certain critical infrastructure), among
other programs.
Risks: Explosives containing
ammonium nitrate are commonly used
in terrorist attacks. Such attacks have
been carried out both domestically and
internationally. The 1995 Murrah
Federal Building attack in Oklahoma
City claimed the lives of 167 individuals
and demonstrated firsthand to America
how ammonium nitrate could be
misused by terrorists. In addition to the
Murrah Building attack, the Provisional
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Irish Republican Army used ammonium
nitrate as part of its London, England
bombing campaign in the early 1980s.
More recently, ammonium nitrate was
used in the 1998 East African Embassy
bombings and in November 2003
bombings in Istanbul, Turkey.
Additionally, since the events of 9/11,
stores of ammonium nitrate have been
confiscated during raids on terrorist
sites around the world, including sites
in Canada, England, India, and the
Philippines.
Timetable:
Action
Date
FR Cite
ANPRM ...............
Correction ............
ANPRM Comment
Period End.
NPRM ..................
Notice of Public
Meetings.
Notice of Public
Meetings.
NPRM Comment
Period End.
10/29/08
11/05/08
12/29/08
73 FR 64280
73 FR 65783
08/03/11
10/07/11
76 FR 46908
76 FR 62311
11/14/11
76 FR 70366
12/01/11
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Federalism: This action may have
federalism implications as defined in
EO 13132.
URL For More Information: www.
regulations.gov.
URL for Public Comments: www.
regulations.gov.
Agency Contact: Jon MacLaren,
Ammonium Nitrate Program Manager,
Department of Homeland Security,
Office of the Secretary, Infrastructure
Security Compliance Division (NPPD/
ISCD), Mail Stop 0610, 245 Murray Lane
SW., Arlington, VA 20598–0610, Phone:
703 235–5263, Email: jon.m.maclaren@
hq.dhs.gov.
RIN: 1601–AA52
DHS—U.S. CITIZENSHIP AND
IMMIGRATION SERVICES (USCIS)
Proposed Rule Stage
54. Asylum and Withholding
Definitions
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1103; 8
U.S.C. 1158; 8 U.S.C. 1226; 8 U.S.C.
1252; 8 U.S.C. 1282
CFR Citation: 8 CFR 2; 8 CFR 208.
Legal Deadline: None.
Abstract: This rule proposes to amend
Department of Homeland Security
regulations that govern asylum
eligibility. The amendments focus on
portions of the regulations that deal
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with the definitions of membership in a
particular social group, the
requirements for failure of State
protection, and determinations about
whether persecution is inflicted on
account of a protected ground. This rule
codifies long-standing concepts of the
definitions. It clarifies that gender can
be a basis for membership in a
particular social group. It also clarifies
that a person who has suffered or fears
domestic violence may under certain
circumstances be eligible for asylum on
that basis. After the Board of
Immigration Appeals published a
decision on this issue in 1999, Matter of
R–A–, Int. Dec. 3403 (BIA 1999), it
became clear that the governing
regulatory standards required
clarification. The Department of Justice
began this regulatory initiative by
publishing a proposed rule addressing
these issues in 2000.
Statement of Need: This rule provides
guidance on a number of key
interpretive issues of the refugee
definition used by adjudicators deciding
asylum and withholding of removal
(withholding) claims. The interpretive
issues include whether persecution is
inflicted on account of a protected
ground, the requirements for
establishing the failure of State
protection, and the parameters for
defining membership in a particular
social group. This rule will aid in the
adjudication of claims made by
applicants whose claims fall outside of
the rubric of the protected grounds of
race, religion, nationality, or political
opinion. One example of such claims
which often fall within the particular
social group ground concerns people
who have suffered or fear domestic
violence. This rule is expected to
consolidate issues raised in a proposed
rule in 2000 and to address issues that
have developed since the publication of
the proposed rule. This rule should
provide greater stability and clarity in
this important area of the law.
Summary of Legal Basis: The purpose
of this rule is to provide guidance on
certain issues that have arisen in the
context of asylum and withholding
adjudications. The 1951 Geneva
Convention relating to the Status of
Refugees contains the internationally
accepted definition of a refugee. United
States immigration law incorporates an
almost identical definition of a refugee
as a person outside his or her country
of origin ‘‘who is unable or unwilling to
return to, and is unable or unwilling to
avail himself or herself of the protection
of, that country because of persecution
or a well-founded fear of persecution on
account of race, religion, nationality,
membership in a particular social group,
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or political opinion.’’ Section 101(a)(42)
of the Immigration and Nationality Act.
Alternatives: A sizable body of
interpretive case law has developed
around the meaning of the refugee
definition. Historically, much of this
case law has addressed more traditional
asylum and withholding claims based
on the protected grounds of race,
religion, nationality, or political
opinion. In recent years, however, the
United States increasingly has
encountered asylum and withholding
applications with more varied bases,
related, for example, to an applicant’s
gender or sexual orientation. Many of
these new types of claims are based on
the ground of ‘‘membership in a
particular social group,’’ which is the
least well-defined of the five protected
grounds within the refugee definition.
On December 7, 2000, DOJ published
a proposed rule in the Federal Register
providing guidance on the definitions of
‘‘persecution’’ and ‘‘membership in a
particular social group.’’ Prior to
publishing a new proposed rule, the
Department will be considering how the
nexus between persecution and a
protected ground might be further
conceptualized; how membership in a
particular social group might be defined
and evaluated; and what constitutes a
State’s inability or unwillingness to
protect the applicant where the
persecution arises from a non-State
actor. This rule will provide guidance to
the following adjudicators: USCIS
asylum officers, Department of Justice
Executive Office for Immigration
Review (EOIR) immigration judges, and
members of the EOIR Board of
Immigration Appeals. The alternative to
publishing this rule would be to allow
the standards governing this area of law
to continue to develop piecemeal
through administrative and judicial
precedent. This approach has resulted
in inconsistent and confusing standards,
and the Department has therefore
determined that promulgation of the
new proposed rule is necessary.
Anticipated Cost and Benefits: By
providing a clear framework for key
asylum and withholding issues, we
anticipate that adjudicators will have
clear guidance, increasing
administrative efficiency and
consistency in adjudicating these cases.
The rule will also promote a more
consistent and predictable body of
administrative and judicial precedent
governing these types of cases. We
anticipate that this will enable
applicants to better assess their
potential eligibility for asylum, and to
present their claims more efficiently
when they believe that they may
qualify, thus reducing the resources
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spent on adjudicating claims that do not
qualify. In addition, a more consistent
and predictable body of law on these
issues will likely result in fewer
appeals, both administrative and
judicial, and reduce associated litigation
costs. The Department has no way of
accurately predicting how this rule will
impact the number of asylum
applications filed in the United States.
Based on anecdotal evidence and on the
reported experience of other nations
that have adopted standards under
which the results are similar to those we
anticipate for this rule, we do not
believe this rule will cause a change in
the number of asylum applications filed.
Risks: The failure to promulgate a
final rule in this area presents
significant risks of further inconsistency
and confusion in the law. The
Government’s interests in fair, efficient,
and consistent adjudications would be
compromised.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM ..................
12/07/00
01/22/01
65 FR 76588
05/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS No.
2092–00, Transferred from RIN 1115–
AF92.
Agency Contact: Ted Kim, Deputy
Chief, Asylum Division, Department of
Homeland Security, U.S. Citizenship
and Immigration Services, Office of
Refugee, Asylum, and International
Operations, Suite 3200, 20
Massachusetts Avenue NW.,
Washington, DC 20259, Phone: 202 272–
1614, Fax: 202 272–1994, Email: ted.
kim@dhs.gov.
RIN: 1615–AA41
DHS—USCIS
55. New Classification for Victims of
Criminal Activity; Eligibility for the U
Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C.
552a; 8 U.S.C. 1101; 8 U.S.C. 1101 note;
8 U.S.C. 1102
CFR Citation: 8 CFR 103; 8 CFR 204;
8 CFR 212; 8 CFR 214; 8 CFR 299.
Legal Deadline: None.
Abstract: This rule sets forth
application requirements for a new
nonimmigrant status. The U
classification is for non-U.S. Citizen/
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7739
Lawful Permanent Resident victims of
certain crimes who cooperate with an
investigation or prosecution of those
crimes. There is a limit of 10,000
principals per year.
This rule establishes the procedures
to be followed in order to petition for
the U nonimmigrant classifications.
Specifically, the rule addresses the
essential elements that must be
demonstrated to receive the
nonimmigrant classification, procedures
that must be followed to make an
application, and evidentiary guidance to
assist in the petitioning process. Eligible
victims will be allowed to remain in the
United States. The Trafficking Victims
Protection Reauthorization Act of 2008,
Public Law 110–457, made amendments
to the T nonimmigrant status provisions
of the Immigration and Nationality Act.
The Department will issue a proposed
rule to make the changes required by
recent legislation and to provide the
opportunity for notice and comment.
Statement of Need: This rule provides
requirements and procedures for aliens
seeking U nonimmigrant status. U
nonimmigrant classification is available
to alien victims of certain criminal
activity who assist government officials
in the investigation or prosecution of
that criminal activity. The purpose of
the U nonimmigrant classification is to
strengthen the ability of law
enforcement agencies to investigate and
prosecute such crimes as domestic
violence, sexual assault, and trafficking
in persons, while offering protection to
alien crime victims in keeping with the
humanitarian interests of the United
States.
Summary of Legal Basis: Congress
created the U nonimmigrant
classification in the Battered Immigrant
Women Protection Act of 2000
(BIWPA). Congress intended to
strengthen the ability of law
enforcement agencies to investigate and
prosecute cases of domestic violence,
sexual assault, trafficking of aliens, and
other crimes, while offering protection
to victims of such crimes. Congress also
sought to encourage law enforcement
officials to better serve immigrant crime
victims.
Alternatives: USCIS has identified
four alternatives, the first being chosen
for the rule:
1. USCIS would adjudicate petitions
on a first in, first out basis. Petitions
received after the limit has been reached
would be reviewed to determine
whether or not they are approvable, but
for the numerical cap. Approvable
petitions that are reviewed after the
numerical cap has been reached would
be placed on a waiting list and written
notice sent to the petitioner. Priority on
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the waiting list would be based upon
the date on which the petition is filed.
USCIS would provide petitioners on the
waiting list with interim relief until the
start of the next fiscal year in the form
of deferred action, parole, or a stay of
removal.
2. USCIS would adjudicate petitions
on a first in, first out basis, establishing
a waiting list for petitions that are
pending or received after the numerical
cap has been reached. Priority on the
waiting list would be based upon the
date on which the petition was filed.
USCIS would not provide interim relief
to petitioners whose petitions are placed
on the waiting list.
3. USCIS would adjudicate petitions
on a first in, first out basis. However,
new filings would be reviewed to
identify particularly compelling cases
for adjudication. New filings would be
rejected once the numerical cap is
reached. No official waiting list would
be established; however, interim relief
until the start of the next fiscal year
would be provided for some compelling
cases. If a case was not particularly
compelling, the filing would be denied
or rejected.
4. USCIS would adjudicate petitions
on a first in, first out basis. However,
new filings would be rejected once the
numerical cap is reached. No waiting
list would be established nor would
interim relief be granted.
Anticipated Cost and Benefits: USCIS
estimates the total annual cost of this
interim rule to applicants to be $6.2
million. This cost includes the
biometric services fee that petitioners
must pay to USCIS, the opportunity cost
of time needed to submit the required
forms, the opportunity cost of time
required for a visit to an Application
Support Center, and the cost of traveling
to an Application Support Center.
This rule will strengthen the ability of
law enforcement agencies to investigate
and prosecute such crimes as domestic
violence, sexual assault, and trafficking
in persons, while offering protection to
alien crime victims in keeping with the
humanitarian interests of the United
States.
Risks: In the case of witness
tampering, obstruction of justice, or
perjury, the interpretive challenge for
USCIS was to determine whom the
BIWPA was meant to protect, given that
these criminal activities are not targeted
against a person. Accordingly it was
determined that a victim of witness
tampering, obstruction of justice, or
perjury is an alien who has been
directly and proximately harmed by the
perpetrator of one of these three crimes,
where there are reasonable grounds to
conclude that the perpetrator
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principally committed the offense as a
means: (1) To avoid or frustrate efforts
to investigate, arrest, prosecute, or
otherwise bring him or her to justice for
other criminal activity; or (2) to further
his or her abuse or exploitation of, or
undue control over, the alien through
manipulation of the legal system.
Timetable:
Action
Date
FR Cite
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
NPRM ..................
09/17/07
10/17/07
72 FR 53013
11/17/07
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
Local, State.
Additional Information: Transferred
from RIN 1115–AG39.
Agency Contact: Laura M. Dawkins,
Chief, Family Immigration and Victim
Protection Division, Department of
Homeland Security, U.S. Citizenship
and Immigration Services, Suite 1200,
20 Massachusetts Avenue NW.,
Washington, DC 20529, Phone: 202 272–
1470, Fax: 202 272–1480, Email: laura.
dawkins@dhs.gov.
RIN: 1615–AA67
DHS—USCIS
56. Exception to the Persecution Bar for
Asylum, Refugee, and Temporary
Protected Status, and Withholding of
Removal
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1101; 8
U.S.C. 1103; 8 U.S.C. 1158; 8 U.S.C.
1226; Pub. L. 107–26; Pub. L. 110–229
CFR Citation: 8 CFR 1; 8 CFR 208; 8
CFR 244; 8 CFR 1244.
Legal Deadline: None.
Abstract: This joint rule proposes
amendments to Department of
Homeland Security (DHS) and
Department of Justice (DOJ) regulations
to describe the circumstances under
which an applicant will continue to be
eligible for asylum, refugee, or
temporary protected status, special rule
cancellation of removal under the
Nicaraguan Adjustment and Central
American Relief Act, and withholding
of removal, even if DHS or DOJ has
determined that the applicant’s actions
contributed, in some way, to the
persecution of others. The purpose of
this rule is to resolve ambiguity in the
statutory language precluding eligibility
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for asylum, refugee, and temporary
protected status of an applicant who
ordered, incited, assisted, or otherwise
participated in the persecution of
others. The proposed amendment would
provide a limited exception for actions
taken by the applicant under duress and
clarify the required levels of the
applicant’s knowledge of the
persecution.
Statement of Need: This rule resolves
ambiguity in the statutory language
precluding eligibility for asylum,
refugee, and temporary protected status
of an applicant who ordered, incited,
assisted, or otherwise participated in the
persecution of others. The proposed
amendment would provide a limited
exception for actions taken by the
applicant under duress and clarify the
required levels of the applicant’s
knowledge of the persecution.
Summary of Legal Basis: In Negusie v.
Holder, 129 S. Ct. 1159 (2009), the
Supreme Court addressed whether the
persecutor bar should apply where an
alien’s actions were taken under duress.
DHS believes that this is an appropriate
subject for rulemaking and proposes to
amend the applicable regulations to set
out its interpretation of the statute. In
developing this regulatory initiative,
DHS has carefully considered the
purpose and history behind enactment
of the persecutor bar, including its
international law origins and the
criminal law concepts upon which they
are based.
Alternatives: DHS did consider the
alternative of not publishing a
rulemaking on these issues. To leave
this important area of the law without
an administrative interpretation would
confuse adjudicators and the public.
Anticipated Cost and Benefits: The
programs affected by this rule exist so
that the United States may respond
effectively to global humanitarian
situations and assist people who are in
need. USCIS provides a number of
humanitarian programs and protection
to assist individuals in need of shelter
or aid from disasters, oppression,
emergency medical issues, and other
urgent circumstances. This rule will
advance the humanitarian goals of the
asylum/refugee program, and other
specialized programs. The main benefits
of such goals tend to be intangible and
difficult to quantify in economic and
monetary terms. These forms of relief
have not been available to certain
persecutors. This rule will allow an
exception to this bar from protection for
applicants who can meet the
appropriate evidentiary standard.
Consequently, this rule may result in a
small increase in the number of
applicants for humanitarian programs.
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To the extent a small increase in
applicants occurs, there could be
additional fee costs incurred by these
applicants.
Risks: If DHS were not to publish a
regulation, the public would face a
lengthy period of confusion on these
issues. There could also be inconsistent
interpretations of the statutory language,
leading to significant litigation and
delay for the affected public.
Timetable:
Action
Date
NPRM ..................
FR Cite
05/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Molly Groom, Office
of the Chief Counsel Department of
Homeland Security, U.S. Citizenship
and Immigration Services, 20
Massachusetts Avenue NW.,
Washington, DC 20259, Phone: 202 272–
1400, Fax: 202 272–1408, Email:
molly.groom@dhs.gov.
RIN: 1615–AB89
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DHS—USCIS
57. • Electronic Filing of Requests for
Immigration Benefits; Requiring an
Application To Change or Extend
Nonimmigrant Status To Be Filed
Electronically
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1101; 8
U.S.C. 1103; 8 U.S.C. 1151; 8 U.S.C.
1153
CFR Citation: 8 CFR 103; 8 CFR 204.
Legal Deadline: None.
Abstract: The Department of
Homeland Security (DHS) is proposing
regulations to govern the electronic
filing of requests for immigration benefit
requests with the U.S. Citizenship and
Immigration Services (USCIS). DHS also
proposes to mandate electronic
applications in the new Integrated
Operating Environment that is under
development, with limited exceptions,
for an Application to Extend/Change
Nonimmigrant Status from any
individual in the M, J, B–1, and B–2
classifications; change of status requests
to the F, M, J, B–1, or B–2
classifications; and reinstatement of
status requests in the F or M
classification.
Statement of Need: USCIS is in the
process of transforming its operations to
improve service, operational efficiency,
and national security. This rule will
allow USCIS to modernize its processes,
which will provide applicants and
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petitioners with better and faster
services and enhance the ability of
USCIS to process cases with greater
accuracy, security, and timeliness.
Summary of Legal Basis: Authority for
this rule falls within the broad authority
of the Secretary of Homeland Security to
administer DHS, the administration of
immigration and nationality laws, and
other delegated authority. See
Homeland Security Act of 2002, Public
Law 107–296 section 102 (Nov. 25,
2002), 6 U.S.C. 112, and the
Immigration and Nationality Act of
1952, as amended, section 103, 8 U.S.C.
1103.
The Government Paperwork
Elimination Act provides that, when
possible, Federal agencies are directed
to make available electronic forms and
provide for electronic filing and
submissions when conducting agency
business with the public. See Public
Law 105–277, section 1703 (Oct. 21,
1998), 44 U.S.C. 3504. GPEA also
establishes the means for the use and
acceptance of electronic signatures.
The INA provides a detailed list of
classes of nonimmigrant aliens. See,
e.g., INA sections 101(a)(15)(B), (C), (F),
and (M); 8 U.S.C. 1101(a)(15) (B), (C),
(F), and (M). The Secretary of Homeland
Security may authorize a change to any
other nonimmigrant classification in the
case of any alien who is lawfully
admitted to the United States as a
nonimmigrant, maintains his or her
lawful status, does not fall under certain
nonimmigrant visa categories that are
listed in the statute, and is not
inadmissible or whose inadmissibility
has been waived under the pertinent
sections of the immigration and
nationality laws of the United States.
See INA section 248(a); 8 U.S.C. 1258(a).
This rule is also proposed in
compliance with Executive Order 13571
‘‘Streamlining Service Delivery and
Improving Customer Service.’’ See
Executive Order No. 13571, 76 FR 24339
(Apr. 27, 2011). Executive Order 13571
tasks each Federal department and
agency with establishing an initiative
that uses technology to improve the
experience of individuals and entities
receiving services from that Federal
department or agency. See Executive
Order No. 13571, section 2(a).
Alternatives: DHS has examined the
alternative of maintaining paper
processing for applications to extend/
change status (Form I–539) and has
determined that the continuation of
legacy data systems and current
processes do not meet the need for
USCIS to modernize operations.
Anticipated Cost and Benefits: DHS is
proposing to mandate the electronic
filing of stand-alone Applications to
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Extend/Change Nonimmigrant Status.
Only a limited number of
nonimmigrants would be impacted by
this change. Specifically, those
individuals in the following
nonimmigrant classifications would be
required to file this application
electronically: B–1, B–2, F, M, or J. In
transforming its immigration benefit
processes into a paperless system, DHS
anticipates the following benefits:
• Streamlined operations
• More timely submission and
adjudication of the benefit requested
• Reduced requests for additional or
missing information
• Enhanced security for the applicant
• Enhanced customer service
For those applicants that do not
currently possess or have access to the
tools needed to submit immigration
benefit requests electronically—namely,
computer, Internet service, and a
scanner—this rule would result in
additional costs to these petitioners or
applicants. DHS is in the process of
examining the potential monetary costs
and benefits of the proposed rule.
Risks: Populations with no or limited
Internet access and individuals with no
or limited English proficiency may be
affected by this rule. This risk can be
mitigated by including a waiver process.
Timetable:
Action
Date
NPRM ..................
FR Cite
08/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Dan Konnerth, Policy
and Coordination Chief, Office of
Transformation Coordination,
Department of Homeland Security, U.S.
Citizenship and Immigration Services,
6th Floor, 633 Third Street NW.,
Washington, DC 20529, Phone: 202 233–
2381, Email: dan.konnerth@dhs.gov.
RIN: 1615–AB94
DHS—USCIS
58. • Immigration Benefits Business
Transformation: Nonimmigrants;
Student and Exchange Visitor Program
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 5 U.S.C.
552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8
U.S.C. 1103
CFR Citation: 8 CFR 103; 8 CFR 212;
8 CFR 214; 8 CFR 245; 8 CFR 248; 8 CFR
274a.
Legal Deadline: None.
Abstract: The Department of
Homeland Security (DHS) is amending
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its nonimmigrant regulations to enable
U.S. Citizenship and Immigration
Services (USCIS) to migrate from a
paper file-based, non-integrated systems
environment to an electronic, customerfocused, centralized case management
environment for benefit processing. This
rulemaking, the second in a series of
business transformation rules, primarily
focuses on 8 CFR part 214, reorganizes
and streamlines general information
relating to nonimmigrant classifications,
and relocates other information relating
to specific, individual nonimmigrant
classifications to a separate subpart for
each major nonimmigrant classification.
DHS is making these amendments
because part 214 contains more than 20
nonimmigrant classifications, and it has
become very large and complex to
navigate. This regulation will provide
the public with simpler, better
organized regulatory requirements for
each nonimmigrant classification and
facilitate future revisions.
Statement of Need: USCIS is in the
process of transforming its operations to
improve service, operational efficiency,
and national security. This rule will
provide the public with clearly written,
better organized regulatory requirements
for each nonimmigrant classification.
Summary of Legal Basis: The
Homeland Security Act of 2002, Public
Law 107–296, section 102, 116 Stat.
2135 (Nov. 25, 2002), 6 U.S.C. 112, and
the Immigration and Nationality Act of
1952 (INA), charge the Secretary of
Homeland Security (Secretary) with
administration and enforcement of the
immigration and nationality laws. See
INA section 103, 8 U.S.C. 1103.
This rule will significantly enhance
the ability of USCIS to fully implement
the Government Paperwork Elimination
Act (GPEA). See Public Law 105–277,
tit. XVII, section 1701 to 1710, 112 Stat.
2681 at 2681–749, (Oct. 21, 1998)
(codified at 44 U.S.C. 3504 & note).
GPEA provides that, when possible,
Federal agencies use electronic forms,
electronic filing, and electronic
submissions to conduct agency business
with the public. Id. The USCIS
modernization and transformation effort
will move its operations away from a
paper-based system to an electronic
environment wherever possible in an
effort to implement the requirements of
GPEA.
Alternatives: The regulations for the
more than 20 nonimmigrant
classifications are included in 8 CFR
214. As more nonimmigrant
classifications have been added to the
Act and as the statutory requirements
for existing classifications have become
more complex, sections within 8 CFR
214 have become increasingly difficult
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to read, comprehend and cite. DHS will
reorganize 8 CFR 214 to address this
lack of clarity.
Anticipated Cost and Benefits: DHS
will amend its regulations at 8 CFR part
214 to streamline and reorganize the
content into a more reader-friendly and
logical format. DHS is not making
substantive changes to the content or
requirements of existing regulations.
There are no additional costs
anticipated as a result of this
rulemaking.
Risks: This rule may initially lead to
confusion of those who are familiar with
the previous organization of 8 CFR 214.
USCIS can mitigate this risk by
informing the public of these changes.
Timetable:
Action
Date
NPRM ..................
FR Cite
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS# 2505–
11. This rule (RIN 1615–AB95) is
adopting the following three rules as
final rules: 1615–AA35, 1615–AA56,
and 1615–AA53.
Agency Contact: Dan Konnerth, Policy
and Coordination Chief, Office of
Transformation Coordination,
Department of Homeland Security, U.S.
Citizenship and Immigration Services,
6th Floor, 633 Third Street NW.,
Washington, DC 20529, Phone: 202 233–
2381, Email: dan.konnerth@dhs.gov.
RIN: 1615–AB95
DHS—USCIS
59. • Application of the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008
to Unaccompanied Alien Children
Seeking Asylum
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 110–457
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule implements the
provisions of the William Wilberforce
Trafficking Victims Protection
Reauthorization Act of 2008 (TVPRA),
Public Law 110–457, 122 Stat. 5074
(Dec. 23, 2008) relating to
unaccompanied alien children seeking
asylum. Specifically, the rule proposes
to amend Department of Homeland
Security and Department of Justice
regulations relating to asylum
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applications filed by unaccompanied
alien children. The rule will amend
both Departments’ regulations to reflect
that U.S. Citizenship and Immigration
Services (USCIS) has initial jurisdiction
over any asylum application filed by an
unaccompanied alien child. The rule
will also add new special procedures for
all children in interviews before USCIS
officers and for unaccompanied alien
children in proceedings before
immigration judges in the Executive
Office for Immigration Review.
Statement of Need: The TVPRA
mandated promulgation of regulations
taking into account the specialized
needs of unaccompanied alien children
and addressing both procedural and
substantive aspects of handling
unaccompanied alien children’s cases.
This rule will codify existing agency
guidance on the specialized needs of
unaccompanied alien children. The rule
will also codify agency guidance
implementing the TVPRA. Such
guidance has been in effect since March
2009 and, based on experience gained in
following the guidance, will be revised
in the rule.
Summary of Legal Basis: The purpose
of this rule is to comply with the
TVPRA mandate to promulgate
regulations taking into account the
specialized needs of unaccompanied
alien children and addressing both
procedural and substantive aspects of
handling unaccompanied alien
children’s cases.
Alternatives: N/A.
Anticipated Cost and Benefits:
Congress has given USCIS initial
jurisdiction over the asylum claims of
unaccompanied alien children. New
costs can accrue when EOIR
immigration judges transfer cases
involving unaccompanied alien minors
to USCIS for asylum interviews and
adjudication if USCIS does not grant the
asylum application and the case is
returned to EOIR for further
adjudication. This additional cost is
offset, however, when USCIS grants
such an application because the costs of
USCIS asylum adjudications are
generally much lower than the
processing of immigration court
applications for that benefit. In addition,
USCIS provides a non-adversarial
setting for asylum seeker interviews and
has recently developed extensive and
ongoing training in children’s issues.
These factors can assist unaccompanied
children in expressing their fear of
return to their native countries.
Unaccompanied alien children also
compose a uniquely vulnerable
population with often compelling
protection issues; therefore, affording
unaccompanied alien children every
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consideration in the asylum process
greatly benefits them. Finally, benefits
will also accrue because the regulation
will improve upon the process initially
implemented upon passage of the
TVPRA, incorporating lessons learned
and optimizing the procedures for
USCIS and EOIR.
Risks: N/A.
Timetable:
Action
Date
NPRM ..................
FR Cite
06/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Ted Kim, Deputy
Chief, Asylum Division, Department of
Homeland Security, U.S. Citizenship
and Immigration Services, Office of
Refugee, Asylum, and International
Operations, Suite 3200, 20
Massachusetts Avenue NW.,
Washington, DC 20259, Phone: 202 272–
1614, Fax: 202 272–1994, Email:
ted.kim@dhs.gov.
RIN: 1615–AB96
DHS—USCIS
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60. • Administrative Appeals Office:
Procedural Reforms To Improve
Efficiency
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C.
552a; 8 U.S.C. 1101; 8 U.S.C. 1103; 8
U.S.C. 1304; 6 U.S.C. 112
CFR Citation: 8 CFR 103; 8 CFR 204;
8 CFR 205; 8 CFR 210; 8 CFR 214; 8 CFR
245a; 8 CFR 320; 8 CFR 105 (new);
* * *.
Legal Deadline: None.
Abstract: This proposed rule revises
the requirements and procedures for the
filing of motions and appeals before the
Department’s U.S. Citizenship and
Immigration Services and its
Administrative Appeals Office. The
proposed changes are intended to
streamline the existing processes for
filing motions and appeals and will
reduce delays in the review and
appellate process. This rule also makes
additional changes necessitated by the
establishment of the Department of
Homeland Security and its components.
Statement of Need: This rule proposes
to make numerous changes to
streamline the current appeal and
motion processes which: (1) Will result
in cost savings to the Government,
applicants, and petitioners; and (2) will
provide for a more efficient use of
USCIS officer and clerical staff time, as
well as more uniformity with Board of
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Immigration Appeals appeal and motion
processes.
Summary of Legal Basis: 5 U.S.C. 301;
5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C.
1101 and note 1102, 1103, 1151, 1153,
1154, 1182, 1184, 1185 note (sec. 7209
of Pub. L. 108–458; title VII of Pub. L.
110–229), 1186a, 1187, 1221,1223, 1225
to 1227, 1255a, and 1255a note, 1281,
1282, 1301 to 1305, 1324a, 1356, 1372,
1379, 1409(c), 1443 to 1444, 1448, 1452,
1455, 1641, 1731 to 1732; 31 U.S.C.
9701; 48 U.S.C. 1901, 1931 note; section
643, Public Law 104–208, 110 Stat.
3009–708; section 141 of the Compacts
of Free Association with the Federated
States of Micronesia and the Republic of
the Marshall Islands, and with the
Government of Palau,; title VII of Public
Law 110–229; Public Law 107–296, 116
Stat. 2135 (6 U.S.C. 1 et seq.); Public
Law 82–414, 66 Stat. 173, 238, 254, 264;
title VII of Public Law 110–229; E.O.
12356.
Alternatives: The alternative to this
rule would be to continue under the
current process without change.
Anticipated Cost and Benefits: As a
result of streamlining the appeal and
motion process, USCIS anticipates
quantitative and qualitative benefits to
DHS and the public. We also anticipate
cost savings to DHS and applicants as a
result of the proposed changes.
Timetable:
Action
Date
NPRM ..................
FR Cite
03/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
Additional Information: Previously
1615–AB29 (CIS 2311–04), which was
withdrawn in 2007. DHS has included
this rule in its Final Plan for the
Retrospective Review of Existing
Regulations, which DHS issued on
August 22, 2011.
Agency Contact: William K Renwick,
Supervisory Citizenship and
Immigration Appeals Officer,
Department of Homeland Security, U.S.
Citizenship and Immigration Services,
Administrative Appeals Office,
Washington, DC 20529–2090, Phone:
703 224–4501, Email:
william.k.renwick@dhs.gov.
Related RIN: Duplicate of 1615–AB29.
RIN: 1615–AB98
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DHS—USCIS
Final Rule Stage
61. New Classification for Victims of
Severe Forms of Trafficking in Persons;
Eligibility for T Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C.
552a; 8 U.S.C. 1101 to 1104; 8 U.S.C.
1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8
U.S.C. 1201; 8 U.S.C. 1224 to 1227; 8
U.S.C. 1252 to 1252a; 22 U.S.C. 7101; 22
U.S.C. 7105
CFR Citation: 8 CFR 103; 8 CFR 212;
8 CFR 214; 8 CFR 274a; 8 CFR 299.
Legal Deadline: None.
Abstract: T classification was created
by 107(e) of the Victims of Trafficking
and Violence Protection Act of 2000
(VTVPA), Public Law 106–386. The T
nonimmigrant classification was
designed for eligible victims of severe
forms of trafficking in persons who aid
law enforcement with their
investigation or prosecution of the
traffickers, and who can establish that
they would suffer extreme hardship
involving unusual and severe harm if
they were removed from the United
States. The rule establishes application
procedures and responsibilities for the
Department of Homeland Security and
provides guidance to the public on how
to meet certain requirements to obtain T
nonimmigrant status. The Trafficking
Victims Protection Reauthorization Act
of 2008, Public Law 110–457, made
amendments to the T nonimmigrant
status provisions of the Immigration and
Naturalization Act. The Department will
issue another interim final rule to make
the changes required by recent
legislation and to provide the
opportunity for notice and comment.
Statement of Need: T nonimmigrant
status is available to eligible victims of
severe forms of trafficking in persons
who have complied with any reasonable
request for assistance in the
investigation or prosecution of acts of
trafficking in persons, and who can
demonstrate that they would suffer
extreme hardship involving unusual
and severe harm if removed from the
United States. This rule addresses the
essential elements that must be
demonstrated for classification as a T
nonimmigrant alien; the procedures to
be followed by applicants to apply for
T nonimmigrant status; and evidentiary
guidance to assist in the application
process.
Summary of Legal Basis: Section
107(e) of the Trafficking Victims
Protection Act (TVPA), Public Law 106–
386, as amended, established the T
classification to create a safe haven for
certain eligible victims of severe forms
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of trafficking in persons, who assist law
enforcement authorities in investigating
and prosecuting the perpetrators of
these crimes.
Alternatives: To develop a
comprehensive Federal approach to
identifying victims of severe forms of
trafficking in persons, to provide them
with benefits and services, and to
enhance the Department of Justice’s
ability to prosecute traffickers and
prevent trafficking in persons in the first
place, a series of meetings with
stakeholders were conducted with
representatives from key Federal
agencies; national, State, and local law
enforcement associations; non-profit,
community-based victim rights
organizations; and other groups.
Suggestions from these stakeholders
were used in the drafting of this
regulation.
Anticipated Cost and Benefits: There
is no cost to applicants associated with
this regulation. Applicants for T
nonimmigrant status do not pay
application or biometric fees.
The anticipated benefits of these
expenditures include: Assistance to
trafficked victims and their families,
prosecution of traffickers in persons,
and the elimination of abuses caused by
trafficking activities.
Benefits which may be attributed to
the implementation of this rule are
expected to be:
1. An increase in the number of cases
brought forward for investigation and/or
prosecution;
2. Heightened awareness by the law
enforcement community of trafficking in
persons;
3. Enhanced ability to develop and
work cases in trafficking in persons
cross-organizationally and multijurisdictionally, which may begin to
influence changes in trafficking
patterns.
Risks: There is a 5,000-person limit to
the number of individuals who can be
granted T–1 status per fiscal year.
Eligible applicants who are not granted
T–1 status due solely to the numerical
limit will be placed on a waiting list to
be maintained by U.S. Citizenship and
Immigration Services (USCIS).
To protect T–1 applicants and their
families, USCIS will use various means
to prevent the removal of T–1 applicants
on the waiting list, and their family
members who are eligible for derivative
T status, including its existing authority
to grant deferred action, parole, and
stays of removal.
Timetable:
Action
Date
FR Cite
Interim Final Rule
01/31/02
67 FR 4784
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Action
Date
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Interim Final Rule
FR Cite
03/04/02
04/01/02
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
Local, State.
Additional Information: CIS No.
2132–01; AG Order No. 2554–2002.
There is a related rulemaking, CIS No.
2170–01, the new U nonimmigrant
status (RIN 1615–AA67). Transferred
from RIN 1115–AG19.
Agency Contact: Laura M. Dawkins,
Chief, Family Immigration and Victim
Protection Division, Department of
Homeland Security, U.S. Citizenship
and Immigration Services, Suite 1200,
20 Massachusetts Avenue NW.,
Washington, DC 20529, Phone: 202 272–
1470, Fax: 202 272–1480, Email:
laura.dawkins@dhs.gov.
Related RIN: Related to 1615–AA67.
RIN: 1615–AA59
DHS—USCIS
62. Adjustment of Status to Lawful
Permanent Resident for Aliens in T and
U Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C.
552a; 8 U.S.C. 1101 to 1104; 8 U.S.C.
1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8
U.S.C. 1201; 8 U.S.C. 1224 to 1227; 8
U.S.C. 1252 to 1252a; 8 U.S.C. 1255; 22
U.S.C. 7101; 22 U.S.C. 7105
CFR Citation: 8 CFR 204; 8 CFR 214;
8 CFR 245.
Legal Deadline: None.
Abstract: This rule sets forth measures
by which certain victims of severe forms
of trafficking who have been granted T
nonimmigrant status and victims of
certain criminal activity who have been
granted U nonimmigrant status may
apply for adjustment to permanent
resident status in accordance with
Public Law 106–386, Victims of
Trafficking and Violence Protection Act
of 2000; and Public Law 109–162,
Violence Against Women and
Department of Justice Reauthorization
Act of 2005. The Trafficking Victims
Protection Reauthorization Act of 2008,
Public Law 110–457, made amendments
to the T nonimmigrant status provisions
of the Immigration and Naturalization
Act. The Department will issue another
interim final rule to make the changes
required by recent legislation and to
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provide the opportunity for notice and
comment.
Statement of Need: This regulation is
necessary to permit aliens in lawful T or
U nonimmigrant status to apply for
adjustment of status to that of lawful
permanent residents. T nonimmigrant
status is available to aliens who are
victims of a severe form of trafficking in
persons and who are assisting law
enforcement in the investigation or
prosecution of the acts of trafficking. U
nonimmigrant status is available to
aliens who are victims of certain crimes
and are being helpful to the
investigation or prosecution of those
crimes.
Summary of Legal Basis: This rule
implements the Victims of Trafficking
and Violence Protection Act of 2000
(VTVPA), Public Law 106–386, 114 Stat.
1464 (Oct. 28, 2000), as amended, to
permit aliens in lawful T or U
nonimmigrant status to apply for
adjustment of status to that of lawful
permanent residents.
Alternatives: USCIS did not consider
alternatives to managing T and U
applications for adjustment of status.
Ease of administration dictates that
adjustment of status applications from T
and U nonimmigrants would be best
handled on a first in, first out basis,
because that is the way applications for
T and U status are currently handled.
Anticipated Cost and Benefits: USCIS
uses fees to fund the cost of processing
applications and associated support
benefits. The fees to be collected
resulting from this rule will be
approximately $3 million in the first
year, $1.9 million in the second year,
and an average of about $32 million in
the third and subsequent years. To
estimate the new fee collections to be
generated by this rule, USCIS estimated
the fees to be collected for new
applications for adjustment of status
from T and U nonimmigrants and their
eligible family members. After that,
USCIS estimated fees from associated
applications that are required such as
biometrics, and others that are likely to
occur in direct connection with
applications for adjustment, such as
employment authorization or travel
authorization.
The anticipated benefits of these
expenditures include: Continued
assistance to trafficked victims and their
families, increased investigation and
prosecution of traffickers in persons,
and the elimination of abuses caused by
trafficking activities.
Benefits that may be attributed to the
implementation of this rule are expected
to be:
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1. An increase in the number of cases
brought forward for investigation and/or
prosecution;
2. Heightened awareness of
trafficking-in-persons issues by the law
enforcement community; and
3. Enhanced ability to develop and
work cases in trafficking in persons
cross-organizationally and multijurisdictionally, which may begin to
influence changes in trafficking
patterns.
Risks: Congress created the U
nonimmigrant status (‘‘U visa’’) to
provide immigration protection to crime
victims who assist in the investigation
and prosecution of those crimes.
Although there are no specific data on
alien crime victims, statistics
maintained by the Department of Justice
have shown that aliens, especially those
aliens without legal status, are often
reluctant to help in the investigation or
prosecution of crimes. U visas are
intended to help overcome this
reluctance and aid law enforcement
accordingly.
Timetable:
Action
Date
FR Cite
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Interim Final Rule
12/12/08
01/12/09
73 FR 75540
02/10/09
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
Local, State.
Additional Information: CIS No.
2134–01. Transferred from RIN 1115–
AG21.
Agency Contact: Laura M. Dawkins,
Chief, Family Immigration and Victim
Protection Division, Department of
Homeland Security, U.S. Citizenship
and Immigration Services, Suite 1200,
20 Massachusetts Avenue NW.,
Washington, DC 20529, Phone: 202 272–
1470, Fax: 202 272–1480, Email:
laura.dawkins@dhs.gov.
RIN: 1615–AA60
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DHS—USCIS
63. Application of Immigration
Regulations to the Commonwealth of
the Northern Mariana Islands
Priority: Other Significant.
Legal Authority: Pub. L. 110–229
CFR Citation: 8 CFR 208 and 209; 8
CFR 214 and 215; 8 CFR 217; 8 CFR 235;
8 CFR 248; 8 CFR 264; 8 CFR 274a.
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Legal Deadline: Final, Statutory,
November 28, 2009, Consolidated
Natural Resources Act (CNRA) of 2008.
Abstract: This final rule amends the
Department of Homeland Security
(DHS) and the Department of Justice
(DOJ) regulations to comply with the
Consolidated Natural Resources Act of
2008 (CNRA). The CNRA extends the
immigration laws of the United States to
the Commonwealth of the Northern
Mariana Islands (CNMI). This rule
finalizes the interim rule and
implements conforming amendments to
their respective regulations.
Statement of Need: This rule finalizes
the interim rule to conform existing
regulations with the CNRA. Some of the
changes implemented under the CNRA
affect existing regulations governing
both DHS immigration policy and
procedures and proceedings before the
immigration judges and the Board.
Accordingly, it is necessary to make
amendments both to the DHS
regulations and to the DOJ regulations.
The Secretary and the Attorney General
are making conforming amendments to
their respective regulations in this
single rulemaking document.
Summary of Legal Basis: Congress
extended the immigration laws of the
United States to the CNMI. The stated
purpose of the CNRA is to ensure
effective border control procedures, to
properly address national security and
homeland security concerns by
extending U.S. immigration law to the
CNMI (phasing-out the CNMI’s
nonresident contract worker program
while minimizing to the greatest extent
practicable the potential adverse
economic and fiscal effects of that
phase-out), to maximize the CNMI’s
potential for future economic and
business growth, and to assure worker
protections from the potential for abuse
and exploitation.
Anticipated Cost and Benefits: Costs:
The interim rule established basic
provisions necessary for the application
of the INA to the CNMI and updated
definitions and existing DHS and DOJ
regulations in areas that were confusing
or in conflict with how they are to be
applied to implement the INA in the
CNMI. As such, that rule made no
changes that had identifiable direct or
indirect economic impacts that could be
quantified.
Benefits: This final rule makes
additional regulatory changes in order
to lessen the adverse impacts of the
CNRA on employers and employees in
the CNMI and assist the CNMI in its
transition to the INA.
Timetable:
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Action
Date
FR Cite
Interim Final Rule
Interim Final Rule
Comment Period End.
Correction ............
Final Action .........
10/28/09
11/27/09
74 FR 55725
12/22/09
03/00/12
74 FR 67969
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS 2460–08.
Agency Contact: Kevin Cummings,
Branch Chief, Business and Trade
Services, Department of Homeland
Security, U.S. Citizenship and
Immigration Services, Second Floor,
Office of Program and Regulations
Development, 20 Massachusetts Avenue
NW., Washington, DC 20529, Phone:
202 272–1470, Fax: 202 272–1480,
Email: kevin.cummings@dhs.gov.
Related RIN: Related to 1615–AB76,
Related to 1615–AB75.
RIN: 1615–AB77
DHS—U.S. COAST GUARD (USCG)
Final Rule Stage
64. Implementation of the 1995
Amendments to the International
Convention on Standards of Training,
Certification, and Watchkeeping
(STCW) for Seafarers, 1978
Priority: Other Significant.
Legal Authority: 46 U.S.C. 2103; 46
U.S.C. chapters 71 and 73; DHS
Delegation No. 0170.1
CFR Citation: 46 CFR 10; 46 CFR 11;
46 CFR 12; 46 CFR 15.
Legal Deadline: None.
Abstract: The International Maritime
Organization (IMO) comprehensively
amended the International Convention
on Standards of Training, Certification,
and Watchkeeping (STCW) for
Seafarers, 1978, in 1995 and 2010. The
1995 amendments came into force on
February 1, 1997. This project
implements those amendments by
revising current rules to ensure that the
United States complies with their
requirements on: The training of
merchant mariners, the documenting of
their qualifications, and watch-standing
and other arrangements aboard seagoing
merchant ships of the United States. In
addition, the Coast Guard has identified
the need for additional changes to the
interim rule issued in 1997. This project
supports the Coast Guard’s broad role
and responsibility of maritime safety. It
also supports the roles and
responsibilities of the Coast Guard of
reducing deaths and injuries of crew
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members on domestic merchant vessels
and eliminating substandard vessels
from the navigable waters of the United
States. The Coast Guard published an
NPRM on November 17, 2009, and
Supplemental NPRM (SNPRM) on
March 23, 2010.
At a June 2010 diplomatic conference,
the IMO adopted additional
amendments to the STCW convention,
which change the minimum training
requirements for seafarers. In response
to feedback and to the adoption of those
amendments, the Coast Guard
developed a second Supplemental
NPRM to incorporate the 2010
Amendments into the 1990 interim rule.
Statement of Need: The Coast Guard
proposed to amend its regulations to
implement changes to its interim rule
published on June 26, 1997. These
proposed amendments go beyond
changes found in the interim rule and
seek to more fully incorporate the
requirements of the International
Convention on Standards of Training,
Certification and Watchkeeping for
Seafarers, 1978, as amended (STCW), in
the requirements for the credentialing of
United States merchant mariners. The
new changes are primarily substantive
and: (1) Are necessary to continue to
give full and complete effect to the
STCW Convention; (2) Incorporate
lessons learned from implementation of
the STCW through the interim rule and
through policy letters and NVICs; and
(3) Attempt to clarify regulations that
have generated confusion.
Summary of Legal Basis: The
authority for the Coast Guard to
prescribe, change, revise, or amend
these regulations is provided under 46
U.S.C. 2103 and 46 U.S.C. chapters 71
and 73; and Department of Homeland
Security Delegation No. 0170.1.
Alternatives: For each proposed
change, the Coast Guard has considered
various alternatives. We considered
using policy statements, but they are not
enforceable. We also considered taking
no action, but this does not support the
Coast Guard’s fundamental safety and
security mission. Additionally, we
considered comments made during our
1997 rulemaking to formulate our
alternatives. When we analyzed issues,
such as license progression and tonnage
equivalency, the alternatives chosen
were those that most closely met the
requirements of STCW.
Anticipated Cost and Benefits: In the
SNPRM, we estimated the annualized
cost of this rule over a 10-year period to
be $32.8 million per year at a 7 percent
discount rate. We estimate the total 10year cost of this rulemaking to be $230.7
million at a 7 percent discount rate and
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$274.3 million at a 3 percent discount
rate.
The changes in anticipated costs since
the publication of 2009 NPRM are due
to the 2010 amendments to the STCW
Convention: Medical examinations and
endorsements, leadership and
management skills, engine room
management training, tankerman
endorsements, safety refresher training
and able seafarer deck and engine
certification requirements. However,
there would be potential savings from
the costs of training requirements as the
Coast Guard would accept various
methods for demonstrating competence,
including the on-the-job training and
preservation of the ‘‘hawsepipe’’
programs.
We anticipate the primary benefit of
this rulemaking is to ensure that the
U.S. meets its obligations under the
STCW Convention. Another benefit is
an increase in vessel safety and a
resulting decrease in the risk of
shipping casualties.
Risks: No risks.
Timetable:
Action
Date
FR Cite
Notice of Meeting
Supplemental
NPRM Comment Period
End.
Notice of Inquiry ..
Comment Period
End.
NPRM ..................
Notice of Public
Meetings.
NPRM Comment
Period End.
Notice of Intent ....
Interim Final Rule
Interim Final Rule
Effective.
NPRM ..................
NPRM Comment
Period End.
Supplemental
NPRM.
Supplemental
NPRM.
Public Meeting
Notice.
Comment Period
End.
Final Action .........
08/02/95
09/29/95
60 FR 39306
11/13/95
01/12/96
60 FR 56970
03/26/96
04/08/96
61 FR 13284
61 FR 15438
07/24/96
02/04/97
06/26/97
07/28/97
62 FR 5197
62 FR 34505
11/17/09
02/16/10
74 FR 59353
03/23/10
75 FR 13715
08/01/11
76 FR 45908
08/02/11
76 FR 46217
09/30/11
01/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Additional Information: The docket
number for this rulemaking is USCG–
PO 00000
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2004–17914. The docket is located at
www.regulations.gov. The old docket
number is CGD 95–062.
Include Retrospective Review under
E.O. 13563.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Mark Gould, Project
Manager, CG–5221, Department of
Homeland Security, U.S. Coast Guard,
2100 Second Street SW., STOP 7126,
Washington, DC 20593–7126, Phone:
202 372–1409.
RIN: 1625–AA16
DHS—USCG
65. Vessel Requirements for Notices of
Arrival and Departure, and Automatic
Identification System
Priority: Other Significant.
Legal Authority: 33 U.S.C. 1223; 33
U.S.C. 1225; 33 U.S.C. 1231; 46 U.S.C.
3716; 46 U.S.C. 8502 and ch 701; sec
102 of Pub. L. 107–295; EO 1223
CFR Citation: 33 CFR 62; 33 CFR 66;
33 CFR 160; 33 CFR 161; 33 CFR 164;
33 CFR 165.
Legal Deadline: None.
Abstract: This rulemaking would
expand the applicability for Notice of
Arrival and Departure (NOAD) and
Automatic Identification System (AIS)
requirements. These expanded
requirements would better enable the
Coast Guard to correlate vessel AIS data
with NOAD data, enhance our ability to
identify and track vessels, detect
anomalies, improve navigation safety,
and heighten our overall maritime
domain awareness.
The NOAD portion of this rulemaking
could expand the applicability of the
NOAD regulations by changing the
minimum size of vessels covered below
the current 300 gross tons, require a
notice of departure when a vessel is
departing for a foreign port or place, and
mandate electronic submission of
NOAD notices to the National Vessel
Movement Center. The AIS portion of
this rulemaking would expand current
AIS carriage requirements for the
population identified in the Safety of
Life at Sea (SOLAS) Convention and the
Marine Transportation Marine
Transportation Security Act (MTSA) of
2002.
Statement of Need: There is no central
mechanism in place to capture vessel,
crew, passenger, or specific cargo
information on vessels less than or
equal to 300 gross tons (GT) intending
to arrive at or depart from U.S. ports
unless they are arriving with certain
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dangerous cargo (CDC) or at a port in the
7th Coast Guard District; nor is there a
requirement for vessels to submit
notification of departure information.
The lack of NOAD information of this
large and diverse population of vessels
represents a substantial gap in our
maritime domain awareness (MDA). We
can minimize this gap and enhance
MDA by expanding NOAD applicability
to vessels greater than 300 GT, all
foreign commercial vessels and all U.S.
commercial vessels coming from a
foreign port, and further enhance (and
corroborate) MDA by tracking those
vessels (and others) with AIS. This
information is necessary in order to
expand our MDA and provide Nation
maritime safety and security.
Summary of Legal Basis: This
rulemaking is based on congressional
authority provided in the Ports and
Waterways Safety Act and the Maritime
Transportation Security Act of 2002.
Alternatives: Our goal is to extend our
MDA and to identify anomalies by
correlating vessel NOAD data with AIS
data. NOAD and AIS information from
a greater number of vessels, as proposed
in this rulemaking, would expand our
MDA. We considered expanding NOAD
and AIS to even more vessels, but we
determined we needed additional
legislative authority to expand AIS
beyond what we propose in this
rulemaking; and that it was best to
combine additional NOAD expansion
with future AIS expansion. Although
not in conjunction with a proposed rule,
the Coast Guard sought comment
regarding expansion of AIS carriage to
other waters and other vessels not
subject to the current requirements (68
FR 39369, Jul. 1, 2003; USCG 2003–
14878; see also 68 FR 39355). Those
comments were reviewed and
considered in drafting this rule and are
available in this docket. To fulfill our
agency obligations, the Coast Guard
needs to receive AIS reports and NOADs
from vessels identified in this
rulemaking that currently are not
required to provide this information.
Policy or other non-binding statements
by the Coast Guard addressed to the
owners of these vessels would not
produce the information required to
sufficiently enhance our MDA to
produce the information required to
fulfill our Agency obligations.
Anticipated Cost and Benefits: This
rulemaking will enhance the Coast
Guard’s regulatory program by making it
more effective in achieving the
regulatory objectives, which, in this
case, is improved MDA. We provide
flexibility in the type of AIS system that
can be used, allowing for reduced cost
burden. This rule is also streamlined to
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correspond with Customs and Border
Protection’s APIS requirements, thereby
reducing unjustified burdens. We are
further developing estimates of cost and
benefit that were published in 2008. In
the 2008 NPRM, we estimated that both
segments of the proposed rule would
affect approximately 42,607 vessels. The
total number of domestic vessels
affected is approximately 17,323 and the
total number of foreign vessels affected
is approximately 25,284. We estimated
that the 10-year total present discounted
value or cost of the proposed rule to
U.S. vessel owners is between $132.2
and $163.7 million (7 and 3 percent
discount rates, respectively, 2006
dollars) over the period of analysis.
The Coast Guard believes that this
rule, through a combination of NOAD
and AIS, would strengthen and enhance
maritime security. The combination of
NOAD and AIS would create a
synergistic effect between the two
requirements. Ancillary or secondary
benefits exist in the form of avoided
injuries, fatalities, and barrels of oil not
spilled into the marine environment. In
the 2008 NPRM, we estimated that the
total discounted benefit (injuries and
fatalities) derived from 68 marine
casualty cases analyzed over an 8-year
data period from 1996 to 2003 for the
AIS portion of the proposed rule is
between $24.7 and $30.6 million using
$6.3 million for the value of statistical
life (VSL) at seven and three percent
discount rates, respectively. Just based
on barrels of oil not spilled, we expect
the AIS portion of the proposed rule to
prevent 22 barrels of oil from being
spilled annually.
Risks: Considering the economic
utility of U.S. ports, waterways, and
coastal approaches, it is clear that a
terrorist incident against our U.S.
Maritime Transportation System (MTS)
would have a direct impact on U.S.
users and consumers and could
potentially have a disastrous impact on
global shipping, international trade, and
the world economy. By improving the
ability of the Coast Guard both to
identify potential terrorists coming to
the United States while the terrorists are
far from our shores and to coordinate
appropriate responses and intercepts
before the vessel reaches a U.S. port,
this rulemaking would contribute
significantly to the expansion of MDA,
and consequently is instrumental in
addressing the threat posed by terrorist
actions against the MTS.
Timetable:
Action
Date
FR Cite
NPRM ..................
12/16/08
73 FR 76295
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Action
Date
FR Cite
Notice of Public
Meeting.
Notice of Second
Public Meeting.
NPRM Comment
Period End.
Notice of Second
Public Meeting
Comment Period End.
Final Rule ............
01/21/09
74 FR 3534
03/02/09
74 FR 9071
04/15/09
04/15/09
03/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: We have
indicated in past notices and
rulemaking documents, and it remains
the case that we have worked to
coordinate implementation of AIS
MTSA requirements with the
development of our ability to take
advantage of AIS data (68 FR 39355 and
39370, Jul. 1, 2003).
The docket number for this
rulemaking is USCG–2005–21869. The
docket can be found at
www.regulations.gov.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: LT Sharmine Jones,
Program Manager, Office of Vessel
Activities, Foreign and Offshore Vessel
Activities Div. (CG–5432), Department
of Homeland Security, U.S. Coast
Guard, 2100 2nd Street SW., STOP
7581, Washington, DC 20593–7581,
Phone: 202 372–1234, Email:
sharmine.n.jones@uscg.mil.
Jorge Arroyo, Project Manager, Office
of Navigation Systems CG–5531,
Department of Homeland Security, U.S.
Coast Guard, 2100 2nd Street SW.,
STOP 7683, Washington, DC 20593–
7683, Phone: 202 372–1563, Email:
jorge.arroyo@uscg.mil.
Related RIN: Related to 1625–AA93,
Related to 1625–AB28.
RIN: 1625–AA99
DHS—USCG
66. Nontank Vessel Response Plans and
Other Vessel Response Plan
Requirements
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: 3 U.S.C. 301 to 303;
33 U.S.C. 1223; 33 U.S.C. 1231; 33
U.S.C. 3121; 33 U.S.C. 1903; 33 U.S.C.
1908; 46 U.S.C. 6101
CFR Citation: 33 CFR 151; 33 CFR
155; 33 CFR 160.
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Legal Deadline: Final, Statutory, April
15, 2012, Coast Guard Authorization Act
of 2010.
Abstract: This rulemaking would
establish regulations requiring owners
or operators of nontank vessels to
prepare and submit oil spill response
plans. The Federal Water Pollution
Control Act defines nontank vessels as
self-propelled vessels of 400 gross tons
or greater that operate on the navigable
waters of the United States, carry oil of
any kind as fuel for main propulsion,
and are not tank vessels. The NPRM
proposed to specify the content of a
response plan, and among other issues,
address the requirement to plan for
responding to a worst case discharge
and a substantial threat of such a
discharge. Additionally, the NPRM
proposed to update International
Shipboard Oil Pollution Emergency
Plan (SOPEP) requirements that apply to
certain nontank vessels and tank
vessels. Finally, the NPRM proposed to
require vessel owners and operators to
submit their vessel response plan
control number as part of the notice of
arrival information. This project
supports the Coast Guard’s broad roles
and responsibilities of maritime
stewardship.
Statement of Need: This rule
implements the statutory requirement
for an owner or operator of a selfpropelled, nontank vessel of 400 gross
tons or greater, which operates on the
navigable waters of the United States, to
prepare and submit an oil spill response
plan to the Coast Guard. This rule
specifies the content of a vessel
response plan (VRP), including the
requirement to plan for responding to a
worst-case discharge (WCD) and a
substantial threat of such a discharge as
mandated in statute. The rule also
specifies the procedures for submitting
a VRP to the Coast Guard. This rule will
improve our Nation’s pollution response
planning and preparedness posture, and
help limit the environmental damage
resulting from nontank vessel marine
casualties.
Summary of Legal Basis: Section
311(j)(5) of the Federal Water Pollution
Control Act (FWPCA) (33 U.S.C.
1321(j)(5)), as amended by section 4202
of the Oil Pollution Act of 1990 (OPA
90) (Pub. L. 101–380, 104 Stat. 484); the
Coast Guard and Maritime
Transportation Act of 2004 (Pub. L.
108–293, 118 Stat. 102); and the Coast
Guard and Maritime Transportation Act
of 2006 (Pub. L. 109–241, 120 Stat. 516)
sets out the statutory mandate requiring
tank and nontank vessel owners or
operators to prepare and submit oil or
hazardous substance discharge response
plans for certain vessels operating on
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the navigable waters of the United
States.
Alternatives: In the development of
these regulations, the Coast Guard
considered four alternatives: Three
regulatory alternatives and one nonregulatory alternative. The alternatives
are—(1) Establish regulations for the
submission of NTVRPs to the USCG; (2)
amend the tank vessel response plan
(TVRP) regulations to incorporate
NTVRPs; (3) acceptance of flagapproved SOPEPs; and (4) provide
interpretive guidance through a USCG’s
Navigation and Vessel Inspection
Circular (NVIC).
Anticipated Cost and Benefits: We are
developing the cost and benefit
estimates associated with this step of
the rulemaking. The cost elements
associated with this rule include: (1)
Nontank vessel plan development,
maintenance, and submission; (2) the
service of an Oil Spill Response
Organization (OSRO); (3) the contract
with a Qualified Individual (QI) along
with a Spill Management Team; and (4)
training and exercises. We expect this
proposed rule to provide quantifiable
benefits in the form of barrels of oil not
spilled into the water in addition to
qualitative benefits, which include
improved preparedness and reaction to
an incident, including a worst-case
discharge and improved effectiveness of
onboard and shore-side response
activities.
In the 2009 NPRM, we estimated that
the rulemaking would affect about 2,951
U.S. flag vessels and 1,228 associated
planholders. We estimated the total 10year present value cost of the proposed
rule to U.S. flag nontank vessel owners
and operators to be about $111.4 million
at a 7 percent discount rate and $134.8
million at a 3 percent discount rate. We
found the training and exercise
requirements to be the most costly
element or over 90 percent of the total
discounted cost of the proposed rule for
vessel owners. We estimated the total
U.S. annualized cost of the proposed
rule over the 10-year period of analysis
to be about $15.8 million at both 7 and
3 percent discount rates.
Risks: Response plans are required by
statute. A response plan will not
prevent a discharge of oil, but it may
help minimize the discharge and
resulting damage to the environment.
We estimate the proposed rule would
prevent between 2,014 and 2,446 barrels
of oil from being spilled into the water
during the 10-year period of analysis.
Timetable:
Action
Date
FR Cite
NPRM ..................
08/31/09
74 FR 44970
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Action
Date
FR Cite
Public Meeting ....
NPRM Comment
Period End.
Final Rule ............
09/25/09
11/30/09
74 FR 48891
04/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: The docket
number for this rulemaking is USCG–
2008–1070. The docket can be found at
www.regulations.gov.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: LCDR Kevin B.
Ferrie, Project Manager, Department of
Homeland Security, U.S. Coast Guard,
2100 2nd Street SW., Stop 7581,
Washington, DC 20593–7581, Phone:
202 372–1000, Email:
kevin.b.ferrie@uscg.mil.
Related RIN: Related to 1625–AA19,
Related to 1625–AA26.
RIN: 1625–AB27
DHS—USCG
67. Offshore Supply Vessels of at Least
6000 GT ITC
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Pub. L. 111–281, sec
617
CFR Citation: Not Yet Determined.
Legal Deadline: Other, Statutory,
January 1, 2012, Coast Guard
Authorization Act of 2010.
Abstract: The Coast Guard
Authorization Act of 2010 removed the
size limit on offshore supply vessels
(OSVs). The Act also directed the Coast
Guard to issue, as soon as is practicable,
a regulation to implement section 617 of
the Act and to ensure the safe carriage
of oil, hazardous substances, and
individuals in addition to the crew on
vessels of at least 6,000 gross tonnage as
measured under the International
Convention on Tonnage Measurement of
Ships (6,000 GT ITC). Accordingly, the
Coast Guard’s rule will address design,
manning, carriage of personnel, and
related topics for OSVs of at least 6,000
GT ITC. This rulemaking will meet the
requirements of the Act and will
support the Coast Guard’s mission of
marine safety, security, and
stewardship.
Statement of Need: In section 617 of
Public Law 111–281, Congress removed
OSV tonnage limits and instructed the
Coast Guard to promulgate regulations
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to implement the amendments and
authorities of section 617. Additionally,
Congress directed the Coast Guard to
ensure the safe carriage of oil, hazardous
substances, and individuals in addition
to the crew on OSVs of at least 6,000 GT
ITC.
Summary of Legal Basis: The statutory
authority to promulgate these
regulations is found in section 617(f) of
Public Law 111–281.
Alternatives: The Coast Guard
Authorization Act removed OSV
tonnage limits and the Coast Guard will
examine alternatives during the
development of the regulatory analysis.
Anticipated Cost and Benefits: The
Coast Guard is currently developing a
regulatory impact analysis of regulations
that ensure the safe carriage of oil,
hazardous substances, and individuals
in addition to the crew on OSVs of at
least 6,000 GT ITC. A potential benefit
of this rulemaking is the ability of
industry to expand and take advantage
of new commercial opportunities in the
building of larger OSVs.
Risks: No risks.
Timetable:
Action
Date
Interim Final Rule
FR Cite
01/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Thomas L. Neyhart,
Program Manager, Department of
Homeland Security, U.S. Coast Guard,
2100 2nd Street SW., STOP 7126,
Washington, DC 20593–7126, Phone:
202 372–1360, Email:
thomas.l.neyhart@uscg.mil.
RIN: 1625–AB62
DHS—USCG
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68. • Revision to Transportation
Worker Identification Credential
(TWIC) Requirements for Mariners
Priority: Other Significant.
Legal Authority: sec 809 of the Coast
Guard Authorization Act of 2010, Pub.
L. 111–281, codified at 46 U.S.C.
70105(b)(2); 46 U.S.C. 2110(g)
CFR Citation: 46 CFR 10; 46 CFR 11;
46 CFR 12; 46 CFR 15.
Legal Deadline: None.
Abstract: This Policy Letter describes
both short-term and long-term steps that
the Coast Guard is taking to implement
the requirements of section 809 of Coast
Guard Authorization Act of 2010, Public
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Law 111–281. Section 809 excludes
certain mariners from the statutory
requirement to obtain and hold a
Transportation Worker Identification
Credential (TWIC) in order to receive a
Merchant Mariner Credential (MMC).
In the short-term, while working to
promulgate implementing regulations,
the Coast Guard is relaxing its
enforcement posture for mariners
without a valid TWIC who operate on
board vessels that do not have a security
plan. The Coast Guard is also altering its
policies to allow these mariners to
obtain a MMC without holding a valid
TWIC. Specifically, mariners already
hold or held a TWIC, and who no longer
require a TWIC, may skip the TWIC
enrollment process and apply for a
renewal MMC directly with a Regional
Examination Center (REC), in
accordance with title 46 CFR, section
10.209. However, mariners that are
being issued an initial MMC, or who
never held a TWIC, will need to enroll
for a TWIC at a TWIC enrollment center.
They will also have to pay all applicable
fees associated with getting a TWIC.
This is required because the TWIC
enrollment center is the only place
where the Coast Guard can obtain
biometric information (fingerprints)
from the applicant.
In the long-term, as part of a
rulemaking to promulgate implementing
regulations, the Coast Guard is
considering waiving a portion of the
fees for a MMC in order to compensate
the mariner for the cost of enrolling for
a TWIC. However, it is emphasized that
such action is contingent on the
promulgation of a regulation to adjust
the fee structure.
Statement of Need: The Coast Guard
is revising its merchant mariner
credentialing regulations to implement
changes made by section 809 of the
Coast Guard Authorization Act of 2010,
codified at 46 U.S.C. 70105(b)(2), which
reduces the population of mariners who
are required to obtain and hold a valid
Transportation Worker Identification
Credential (TWIC). Prior to section 809,
46 U.S.C. 70105(b)(2) required each
mariner required to hold an MMC
issued by the Coast Guard to also obtain
and hold a valid TWIC issued by the
Transportation Security Administration
(TSA). Section 809 removes this
requirement, and now a TWIC is
statutorily required if the mariner is
‘‘allowed unescorted access to a secure
area designated in a vessel security plan
approved under section 70103 of title 46
[U.S.C.]’’
The Coast Guard is revising the
applicability of the TWIC requirements
in Coast Guard merchant mariner
credentialing regulations as well as
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7749
revising some of its merchant mariner
credentialing processes contained in
Coast Guard regulations. Current Coast
Guard regulations in 46 CFR parts 10,
11, 12, and 15 contain the processes for
issuing an MMC that are intertwined
with TSA processes for issuing a TWIC.
The Coast Guard utilizes the TWIC
enrollment process to capture
information necessary to issue an MMC.
Although the Coast Guard is changing
some of its processes for obtaining an
MMC, some mariners no longer required
to hold a TWIC may still have to
complete the TWIC enrollment process
in order to provide information
necessary to obtain an MMC. For any
such mariner that must still go through
the TWIC enrollment process, including
paying the full TWIC enrollment fee, the
Coast Guard is revising its regulations to
exempt these mariners from paying a
portion of the MMC fees in order to
offset the TWIC fee and to minimize the
burden on those mariners of paying for
a TWIC when the mariner is no longer
statutorily required to hold one.
Summary of Legal Basis: The Coast
Guard’s statutory authority to
promulgate regulations addressing
TWIC requirements for mariners is
found in 46 U.S.C. 70105(a) and (b). The
Coast Guard’s statutory authority to
promulgate regulations addressing fee
exemptions is found in 46 U.S.C.
2110(g).
Alternatives: This rulemaking
implements section 809 of the 2010
Coast Guard Authorization Act. The
Coast Guard is currently evaluating the
alternatives as we complete the
Regulatory Impact Analysis.
Anticipated Cost and Benefits: This
rulemaking would provide certain
mariner populations a fee exemption
when applying or renewing an MMC.
These mariner populations would also
benefit from cost savings associated
with reduced travels to TWIC
enrollment centers.
Risks: No risks.
Timetable:
Action
Date
Interim Final Rule
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal.
Additional Information: DHS has
included this rule in its Final Plan for
the Retrospective Review of Existing
Regulations, which DHS issued on
August 22, 2011.
Agency Contact: Davis Breyer, Project
Manager, Department of Homeland
Security, U.S. Coast Guard, CG–5221,
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2100 2nd Street SW., Washington, DC
20593, Phone: 202 372–1445, Email:
davis.j.breyer@uscg.mil.
RIN: 1625–AB80
DHS—U.S. CUSTOMS AND BORDER
PROTECTION (USCBP)
Final Rule Stage
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69. Importer Security Filing and
Additional Carrier Requirements
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: Pub. L. 109–347, sec
203; 5 U.S.C. 301; 19 U.S.C. 66; 19
U.S.C. 1431; 19 U.S.C. 1433 to 1434; 19
U.S.C. 1624; 19 U.S.C. 2071 note; 46
U.S.C. 60105
CFR Citation: 19 CFR 4; 19 CFR 12.3;
19 CFR 18.5; 19 CFR 103.31a; 19 CFR
113; 19 CFR 123.92; 19 CFR 141.113; 19
CFR 146.32; 19 CFR 149; 19 CFR 192.14.
Legal Deadline: None.
Abstract: This interim final rule
implements the provisions of section
203 of the Security and Accountability
for Every Port Act of 2006. It amended
CBP Regulations to require carriers and
importers to provide to CBP, via a CBPapproved electronic data interchange
system, information necessary to enable
CBP to identify high-risk shipments to
prevent smuggling and insure cargo
safety and security. Under the rule,
importers and carriers must submit
specified information to CBP before the
cargo is brought into the United States
by vessel. This advance information will
improve CBP’s risk assessment and
targeting capabilities, assist CBP in
increasing the security of the global
trading system, and facilitate the prompt
release of legitimate cargo following its
arrival in the United States. The interim
final rule requested comments on those
required data elements for which CBP
provided certain flexibilities for
compliance and on the revised costs and
benefits and Regulatory Flexibility
Analysis. CBP plans to issue a final rule
after CBP completes a structured review
of the flexibilities and analyzes the
comments.
Statement of Need: Vessel carriers are
currently required to transmit certain
manifest information by way of the CBP
Vessel Automated Manifest System
(AMS) 24 hours prior to lading of
containerized and non-exempt break
bulk cargo at a foreign port. For the most
part, this is the ocean carrier’s or nonvessel operating common carrier’s
(NVOCC) cargo declaration. CBP
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analyzes this information to generate its
risk assessment for targeting purposes.
Internal and external government
reviews have concluded that more
complete advance shipment data would
produce even more effective and
vigorous cargo risk assessments. In
addition, pursuant to section 203 of the
Security and Accountability for Every
Port Act of 2006 (Pub. L. 109–347, 6
U.S.C. 943) (SAFE Port Act), the
Secretary of Homeland Security, acting
through the Commissioner of CBP, must
promulgate regulations to require the
electronic transmission of additional
data elements for improved high-risk
targeting, including appropriate security
elements of entry data for cargo destined
to the United States by vessel prior to
loading of such cargo on vessels at
foreign seaports.
Based upon its analysis, as well as the
requirements under the SAFE Port Act,
CBP is requiring the electronic
transmission of additional data for
improved high-risk targeting. Some of
these data elements are being required
from carriers (Container Status Messages
and Vessel Stow Plan) and others are
being required from ‘‘importers,’’ as that
term is defined for purposes of the
regulations.
This rule intends to improve CBP’s
risk assessment and targeting
capabilities and enables the agency to
facilitate the prompt release of
legitimate cargo following its arrival in
the United States. The information will
assist CBP in increasing the security of
the global trading system and, thereby,
reducing the threat to the United States
and world economy.
Summary of Legal Basis: Pursuant to
section 203 of the Security and
Accountability for Every Port Act of
2006 (Pub. L. 109–347, 6 U.S.C. 943)
(SAFE Port Act), the Secretary of
Homeland Security, acting through the
Commissioner of CBP, must promulgate
regulations to require the electronic
transmission of additional data elements
for improved high-risk targeting,
including appropriate security elements
of entry data for cargo destined to the
United States by vessel prior to loading
of such cargo on vessels at foreign
seaports.
Alternatives: CBP considered and
evaluated the following four
alternatives:
Alternative 1 (the chosen alternative):
Importer Security Filings and
Additional Carrier Requirements are
required. Bulk cargo is exempt from the
Importer Security Filing requirements;
Alternative 2: Importer Security
Filings and Additional Carrier
Requirements are required. Bulk cargo is
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not exempt from the Importer Security
Filing requirements;
Alternative 3: Only Importer Security
Filings are required. Bulk cargo is
exempt from the Importer Security
Filing requirements; and
Alternative 4: Only the Additional
Carrier Requirements are required.
Anticipated Cost and Benefits: When
the NPRM was published, CBP
estimated that approximately 11 million
import shipments conveyed by 1,000
different carrier companies operating
37,000 unique voyages or vessel-trips to
the United States will be subject to the
rule. Annualized costs range from $890
million to $7.0 billion (7 percent
discount rate over 10 years).
The annualized cost range estimate
resulted from varying assumptions
about the importers’ estimated security
filing transaction costs or fees charged
to the importers by the filing parties, the
potential for supply chain delays, and
the estimated costs to carriers for
transmitting additional data to CBP.
The regulation may increase the time
shipments are in transit, particularly for
shipments consolidated in containers.
For such shipments, the supply chain is
generally more complex and the
importer has less control of the flow of
goods and associated security filing
information. Foreign cargo consolidators
may be consolidating multiple
shipments from one or more shippers in
a container destined for one or more
buyers or consignees. In order to ensure
that the security filing data is provided
by the shippers to the importers (or their
designated agents) and is then
transmitted to and accepted by CBP in
advance of the 24-hour deadline,
consolidators may advance their cut-off
times for receipt of shipments and
associated security filing data.
These advanced cut-off times would
help prevent a consolidator or carrier
from having to unpack or unload a
container in the event the security filing
for one of the shipments contained in
the container is inadequate or not
accepted by CBP. For example,
consolidators may require shippers to
submit, transmit, or obtain CBP
approval of their security filing data
before their shipments are stuffed in the
container, before the container is sealed,
or before the container is delivered to
the port for lading. In such cases,
importers would likely have to increase
the times they hold their goods as
inventory, and thus incur additional
inventory carrying costs to sufficiently
meet these advanced cut-off times
imposed by their foreign consolidators.
The high end of the cost ranges
presented assumes an initial supply
chain delay of 2 days for the first year
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of implementation (2008) and a delay of
1 day for years 2 through 10 (2009 to
2017).
Ideally, the quantification and
monetization of the benefits of this
regulation would involve estimating the
current level of risk of a successful
terrorist attack, absent this regulation,
and the incremental reduction in risk
resulting from implementation of the
regulation. CBP would then multiply
the change by an estimate of the value
individuals place on such a risk
reduction to produce a monetary
estimate of direct benefits. However,
existing data limitations and a lack of
complete understanding of the true risks
posed by terrorists prevent us from
establishing the incremental risk
reduction attributable to this rule. As a
result, CBP has undertaken a ‘‘breakeven’’ analysis to inform
decisionmakers of the necessary
incremental change in the probability of
such an event occurring that would
result in direct benefits equal to the
costs of the proposed rule. CBP’s
analysis finds that the incremental costs
of this regulation are relatively small
compared to the median value of a
shipment of goods, despite the rather
large absolute estimate of present value
cost.
The benefit of this rule is the
improvement of CBP’s risk assessment
and targeting capabilities, while at the
same time, enabling CBP to facilitate the
prompt release of legitimate cargo
following its arrival in the United
States. The information will assist CBP
in increasing the security of the global
trading system, and thereby reducing
the threat to the United States and the
world economy.
Timetable:
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Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period End.
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Correction ............
Correction ............
Final Action .........
01/02/08
03/03/08
73 FR 90
02/01/08
73 FR 6061
03/18/08
11/25/08
01/26/09
73 FR 71730
06/01/09
07/14/09
12/24/09
10/00/12
74 FR 33920
74 FR 68376
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
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International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Christopher
Kennally, Acting Director, Cargo
Control, Office of Field Operations,
CBP, Department of Homeland Security,
U.S. Customs and Border Protection,
1300 Pennsylvania Avenue NW.,
Washington, DC 20229, Phone: 202 344–
2476, Email:
christopher.j.kennally@cbp.dhs.gov.
RIN: 1651–AA70
DHS—USCBP
70. Changes to the Visa Waiver
Program To Implement the Electronic
System for Travel Authorization
(ESTA) Program
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 8 U.S.C. 1103; 8
U.S.C. 1187
CFR Citation: 8 CFR 217.5.
Legal Deadline: None.
Abstract: This interim final rule
implements the Electronic System for
Travel Authorization (ESTA) for aliens
who travel to the United States under
the Visa Waiver Program (VWP) at air or
sea ports of entry. Under the rule, VWP
travelers are required to provide certain
biographical information to CBP
electronically before departing for the
United States. This allows CBP to
determine before their departure
whether these travelers are eligible to
travel to the United States under the
VWP and whether such travel poses a
security risk. The rule is intended to
fulfill the requirements of section 711 of
the Implementing recommendations of
the 9/11 Commission Act of 2007 (9/11
Act). In addition to fulfilling a statutory
mandate, the rule serves the twin goals
of promoting border security and
legitimate travel to the United States. By
modernizing the VWP, the ESTA is
intended to increase national security
and to provide for greater efficiencies in
the screening of international travelers
by allowing for vetting of subjects of
potential interest well before boarding,
thereby reducing traveler delays at the
ports of entry. CBP requested comments
on all aspects of the interim final rule
and plans to issue a final rule after
completion of the comment analysis.
Statement of Need: Section 711 of the
9/11 Act requires the Secretary of
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7751
Homeland Security, in consultation
with the Secretary of State, to develop
and implement a fully automated
electronic travel authorization system
that will collect biographical and other
information in advance of travel to
determine the eligibility of the alien to
travel to the United States, and to
determine whether such travel poses a
law enforcement or security risk. ESTA
is intended to fulfill these statutory
requirements.
Under this rule, VWP travelers
provide certain information to CBP
electronically before departing for the
United States. VWP travelers who
receive travel authorization under ESTA
are not required to complete the paper
Form I–94W when arriving on a carrier
that is capable of receiving and
validating messages pertaining to the
traveler’s ESTA status as part of the
traveler’s boarding status. By
automating the I–94W process and
establishing a system to provide VWP
traveler data in advance of travel, CBP
is able to determine the eligibility of
citizens and eligible nationals from
VWP countries to travel to the United
States and to determine whether such
travel poses a law enforcement or
security risk, before such individuals
begin travel to the United States. ESTA
provides for greater efficiencies in the
screening of international travelers by
allowing CBP to identify subjects of
potential interest before they depart for
the United States, thereby increasing
security and reducing traveler delays
upon arrival at U.S. ports of entry.
Summary of Legal Basis: The ESTA
program is based on congressional
authority provided under section 711 of
the Implementing Recommendations of
the 9/11 Commission Act of 2007 and
section 217 of the Immigration and
Nationality Act (INA).
Alternatives: CBP considered three
alternatives to this rule:
1. The ESTA requirements in the rule,
but with a $1.50 fee per each travel
authorization (more costly).
2. The ESTA requirements in the rule,
but with only the name of the passenger
and the admissibility questions on the
I–94W form (less burdensome).
3. The ESTA requirements in the rule,
but only for the countries entering the
VWP after 2009 (no new requirements
for VWP, reduced burden for newly
entering countries).
CBP determined that the rule provides
the greatest level of enhanced security
and efficiency at an acceptable cost to
traveling public and potentially affected
air carriers.
Anticipated Cost and Benefits: The
purpose of ESTA is to allow DHS and
CBP to establish the eligibility of certain
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foreign travelers to travel to the United
States under the VWP, and whether the
alien’s proposed travel to the United
States poses a law enforcement or
security risk. Upon review of such
information, DHS will determine
whether the alien is eligible to travel to
the United States under the VWP.
Costs to Air & Sea Carriers
CBP estimated that eight U.S.-based
air carriers and eleven sea carriers will
be affected by the rule. An additional 35
foreign-based air carriers and five sea
carriers will be affected. CBP concluded
that costs to air and sea carriers to
support the requirements of the ESTA
program could cost $137 million to $1.1
billion over the next 10 years depending
on the level of effort required to
integrate their systems with ESTA, how
many passengers they need to assist in
applying for travel authorizations, and
the discount rate applied to annual
costs.
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Costs to Travelers
ESTA will present new costs and
burdens to travelers in VWP countries
who were not previously required to
submit any information to the U.S.
Government in advance of travel to the
United States. Travelers from Roadmap
countries who become VWP countries
will also incur costs and burdens,
though these are much less than
obtaining a nonimmigrant visa (category
B1/B2), which is currently required for
short-term pleasure or business to travel
to the United States. CBP estimated that
the total quantified costs to travelers
will range from $1.1 billion to $3.5
billion depending on the number of
travelers, the value of time, and the
discount rate. Annualized costs are
estimated to range from $133 million to
$366 million.
Benefits
As set forth in section 711 of the
9/11 Act, it was the intent of Congress
to modernize and strengthen the
security of the Visa Waiver Program
under section 217 of the Immigration
and Nationality Act (INA, 8 U.S.C. 1187)
by simultaneously enhancing program
security requirements and extending
visa-free travel privileges to citizens and
eligible nationals of eligible foreign
countries that are partners in the war on
terrorism.
By requiring passenger data in
advance of travel, CBP may be able to
determine, before the alien departs for
the United States, the eligibility of
citizens and eligible nationals from
VWP countries to travel to the United
States under the VWP, and whether
such travel poses a law enforcement or
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security risk. In addition to fulfilling a
statutory mandate, the rule serves the
twin goals of promoting border security
and legitimate travel to the United
States. By modernizing the VWP, ESTA
is intended to both increase national
security and provide for greater
efficiencies in the screening of
international travelers by allowing for
the screening of subjects of potential
interest well before boarding, thereby
reducing traveler delays based on
potentially lengthy processes at U.S.
ports of entry.
CBP concluded that the total benefits
to travelers could total $1.1 billion to
$3.3 billion over the period of analysis.
Annualized benefits could range from
$134 million to $345 million.
In addition to these benefits to
travelers, CBP and the carriers should
also experience the benefit of not having
to administer the I–94W except in
limited situations. While CBP has not
conducted an analysis of the potential
savings, it should accrue benefits from
not having to produce, ship, and store
blank forms. CBP should also be able to
accrue savings related to data entry and
archiving. Carriers should realize some
savings as well, though carriers will still
have to administer the I–94 for those
passengers not traveling under the VWP
and the Customs Declaration forms for
all passengers aboard the aircraft and
vessel.
Timetable:
Action
Date
FR Cite
Interim Final Action.
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Notice—Announcing Date Rule
Becomes Mandatory.
Final Action .........
06/09/08
73 FR 32440
08/08/08
08/08/08
11/13/08
73 FR 67354
08/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Additional Information: https://www.
cbp.gov/xp/cgov/travel/id_visa/esta/.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Suzanne Shepherd,
Director, Electronic System for Travel
Authorization, Department of Homeland
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Security, U.S. Customs and Border
Protection, 1300 Pennsylvania Avenue
NW., Washington, DC 20229, Phone:
202 344–2073, Email: cbp.esta@dhs.gov.
Related RIN: Related to 1651–AA83.
RIN: 1651–AA72
DHS—USCBP
71. Establishment of Global Entry
Program
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1365b(k)(1);
8 U.S.C. 1365b(k)(3); 8 U.S.C. 1225; 8
U.S.C. 1185(b)
CFR Citation: 8 CFR 235; 8 CFR 103.
Legal Deadline: None.
Abstract: CBP already operates several
regulatory and non-regulatory
international registered traveler
programs, also known as trusted traveler
programs. In order to comply with the
Intelligence Reform Terrorism
Prevention Act of 2004 (IRPTA), CBP is
proposing to amend its regulations to
establish another international
registered traveler program called
Global Entry. The Global Entry program
would expedite the movement of lowrisk, frequent international air travelers
by providing an expedited inspection
process for pre-approved, pre-screened
travelers. These travelers would proceed
directly to automated Global Entry
kiosks upon their arrival in the United
States. This Global Entry Program, along
with the other programs that have
already been established, are consistent
with CBP’s strategic goal of facilitating
legitimate trade and travel while
securing the homeland. A pilot of
Global Entry has been operating since
June 6, 2008.
Statement of Need: CBP has been
operating the Global Entry program as a
pilot at several airports since June 6,
2008, and the pilot has been very
successful. As a result, there is a desire
on the part of the public that CBP
establish the program as a permanent
program, and expanded the program to
additional airports and to citizens from
other countries if possible. By
establishing this program, CBP will
make great strides toward facilitating
the movement of people in a more
efficient manner, thereby accomplishing
our strategic goal of balancing legitimate
travel with security. Through the use of
biometric and recordkeeping
technologies, the risk of terrorists
entering the United States would be
reduced. Improving security and
facilitating travel at the border, both of
which are accomplished by Global
Entry, are primary concerns within CBP
jurisdiction.
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Summary of Legal Basis: The Global
Entry program is based on section
7208(k) of the Intelligence Reform and
Terrorism Prevention Act of 2004
(IRTPA), as amended by section 565 of
the Consolidated Appropriations Act,
which requires the Secretary of
Homeland Security to create a program
to expedite the screening and processing
of pre-approved low risk air travelers
into the United States.
Anticipated Cost and Benefits: Global
Entry is a voluntary program that
provides a benefit to the public by
speeding the CBP processing time for
participating travelers. Travelers who
are otherwise admissible to the United
States will be able to enter or exit the
country regardless of whether they
participate in Global Entry. CBP
estimates that over a 5-year period,
250,000 enrollees will be processed (an
annual average of 50,000 individuals).
CBP estimates that each application will
require 40 minutes (0.67 hours) of the
enrollee’s time to search existing data
resources, gather the data needed, and
complete and review the application
form. Additionally, an enrollee will
experience an ‘‘opportunity cost of
time’’ to travel to an Enrollment Center
upon acceptance of the initial
application. We assume that 1 hour will
be required for this time spent at the
Enrollment Center and travel to and
from the Center, though we note that
during the pilot program, many
applicants coordinated their trip to an
Enrollment Center with their travel at
the airport. CBP has used 1 hour of
travel time so as not to underestimate
potential opportunity costs for enrolling
in the program. CBP used a value of
$28.60 for the opportunity cost for this
time, which is taken from the Federal
Aviation Administration’s ‘‘Economic
Values for FAA Investment and
Regulatory Decisions, A Guide.’’ (Jul. 3,
2007) This value is the weighted average
for U.S. business and leisure travelers.
For this evaluation, CBP assumed that
all enrollees will be U.S. citizens, U.S.
nationals, or Lawful Permanent
Residents.
Timetable:
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Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
11/19/09
01/19/10
74 FR 59932
12/00/11
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
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Additional Information: Includes
Retrospective Review under E.O. 13563.
URL for More Information:
www.globalentry.gov
Agency Contact: John P. Wagner,
Executive Director, Admissibility and
Passenger Programs, Department of
Homeland Security, U.S. Customs and
Border Protection, Office of Field
Operations, 1300 Pennsylvania Avenue
NW., Washington, DC 20229, Phone:
202 344–2118, Email:
john.p.wagner@cbp.dhs.gov.
RIN: 1651–AA73
DHS—USCBP
72. Implementation of the Guam-CNMI
Visa Waiver Program
Priority: Other Significant. Major
under 5 U.S.C. 801.
Legal Authority: Pub. L. 110–229, sec
702
CFR Citation: 8 CFR 100.4; 8 CFR
212.1; 8 CFR 233.5; 8 CFR 235.5; 19 CFR
4.7b; 19 CFR 122.49a
Legal Deadline: Final, Statutory,
November 4, 2008, Pub. L. 110–229.
Abstract: This rule amends
Department of Homeland Security
(DHS) regulations to implement section
702 of the Consolidated Natural
Resources Act of 2008 (CNRA). This law
extends the immigration laws of the
United States to the Commonwealth of
the Northern Mariana Islands (CNMI)
and provides for a joint visa waiver
program for travel to Guam and the
CNMI. This rule implements section 702
of the CNRA by amending the
regulations to replace the current Guam
Visa Waiver Program with a new GuamCNMI Visa Waiver Program. The
amended regulations set forth the
requirements for nonimmigrant visitors
who seek admission for business or
pleasure and solely for entry into and
stay on Guam or the CNMI without a
visa. This rule also establishes six ports
of entry in the CNMI for purposes of
administering and enforcing the GuamCNMI Visa Waiver Program.
Statement of Need: Currently, aliens
who are citizens of eligible countries
may apply for admission to Guam at a
Guam port of entry as nonimmigrant
visitors for a period of fifteen (15) days
or less, for business or pleasure, without
first obtaining a nonimmigrant visa,
provided that they are otherwise eligible
for admission. Section 702(b) of the
Consolidated Natural Resources Act of
2008 (CNRA), supersedes the Guam visa
waiver program by providing for a visa
waiver program for Guam and the
Commonwealth of the Northern Mariana
Islands (Guam-CNMI Visa Waiver
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7753
Program). Section 702(b) requires DHS
to promulgate regulations within 180
days of enactment of the CNRA to allow
nonimmigrant visitors from eligible
countries to apply for admission into
Guam and the CNMI, for business or
pleasure, without a visa, for a period of
authorized stay of no longer than 45
days.
Summary of Legal Basis: The GuamCNMI Visa Waiver Program is based on
congressional authority provided under
702(b) of the Consolidated Natural
Resources Act of 2008 (CNRA).
Alternatives: None.
Anticipated Cost and Benefits: The
most significant change for admission to
the CNMI as a result of the rule will be
for visitors from those countries who are
not included in either the existing U.S.
Visa Waiver Program or the Guam-CNMI
Visa Waiver Program established by the
rule. These visitors must apply for U.S.
visas, which require in-person
interviews at U.S. embassies or
consulates and higher fees than the
CNMI currently assesses for its visitor
entry permits. CBP anticipates that the
annual cost to the CNMI will be $6
million. These are losses associated
with the reduced visits from foreign
travelers who may no longer visit the
CNMI upon implementation of this rule.
In addition, we estimate Government
implementation costs of between $87
and 91 million over the 5-year period of
analysis.
The anticipated benefits of the rule
are enhanced security that will result
from the federalization of the
immigration functions in the CNMI.
Timetable:
Action
Date
FR Cite
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Technical Amendment; Change
of Implementation Date.
Final Action .........
01/16/09
01/16/09
74 FR 2824
03/17/09
05/28/09
74 FR 25387
10/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Erin Martin, Program
Manager, Office of Field Operations,
Department of Homeland Security, U.S.
Customs and Border Protection, 1300
Pennsylvania Avenue NW., Washington,
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DC 20229, Phone: 202 344–2728, Email:
erin.m.martin@dhs.gov.
Related RIN: Related to 1651–AA81.
RIN: 1651–AA77
DHS—TRANSPORTATION SECURITY
ADMINISTRATION (TSA)
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Proposed Rule Stage
73. General Aviation Security and
Other Aircraft Operator Security
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 6 U.S.C. 469; 18
U.S.C. 842; 18 U.S.C. 845; 46 U.S.C.
70102 to 70106; 46 U.S.C. 70117; 49
U.S.C. 114; 49 U.S.C. 114(f)(3); 49 U.S.C.
5103; 49 U.S.C. 5103a; 49 U.S.C. 40113;
49 U.S.C. 44901 to 44907; 49 U.S.C.
44913 to 44914; 49 U.S.C. 44916 to
44918; 49 U.S.C. 44932; 49 U.S.C. 44935
to 44936; 49 U.S.C. 44942; 49 U.S.C.
46105
CFR Citation: 49 CFR 1515; 49 CFR
1520; 49 CFR 1522; 49 CFR 1540; 49
CFR 1542; 49 CFR 1544; 49 CFR 1550.
Legal Deadline: None.
Abstract: On October 30, 2008, the
Transportation Security Administration
(TSA) issued a Notice of Proposed
Rulemaking (NPRM), proposing to
amend current aviation transportation
security regulations to enhance the
security of general aviation by
expanding the scope of current
requirements, and by adding new
requirements for certain large aircraft
operators and airports serving those
aircraft. TSA also proposed that all
aircraft operations, including corporate
and private charter operations, with
aircraft having a maximum certificated
takeoff weight (MTOW) above 12,500
pounds (large aircraft) be required to
adopt a large aircraft security program.
TSA also proposed to require certain
airports that serve large aircraft to adopt
security programs. TSA is preparing a
supplemental NPRM (SNPRM), which
will include a comment period for
public comments.
After considering comments received
on the NPRM and meeting with
stakeholders, TSA decided to revise the
original proposal to tailor security
requirements to the general aviation
industry. TSA is considering
alternatives to the following proposed
provisions in the SNPRM: (1) The type
of aircraft subject to TSA regulation; (2)
compliance oversight; (3) watch list
matching of passengers; (4) prohibited
items; (5) scope of the background check
requirements and the procedures used
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to implement the requirement; and (6)
other issues. Additionally, in the
SNPRM, TSA plans to propose security
measures for foreign aircraft operators.
U.S. and foreign operators would
implement commensurate measures
under the proposed rule.
Statement of Need: This rule would
enhance current security measures and
might apply security measures currently
in place for operators of certain types of
aircraft to operators of other aircraft,
including general aviation operators.
While the focus of TSA’s existing
aviation security programs has been on
air carriers and commercial operators,
TSA is aware that general aviation
aircraft of sufficient size and weight
may inflict significant damage and loss
of lives if they are hijacked and used as
missiles. TSA has current regulations
that apply to large aircraft operated by
air carriers and commercial operators,
including the twelve-five program, the
partial program, and the private charter
program. However, the current
regulations in 49 CFR part 1544 do not
cover all general aviation operations,
such as those operated by corporations
and individuals, and such operations do
not have the features that are necessary
to enhance security. Therefore, TSA is
preparing a SNPRM which proposes to
establish new security measures for
operators, including general aviation
operators, that are not covered under
TSA’s current regulations.
Summary of Legal Basis: 49 U.S.C.
114, 40113, 44903.
Alternatives: DHS considered
continuing to use voluntary guidance to
secure general aviation, but determined
that to ensure that each aircraft operator
maintains an appropriate level of
security, these security measures would
need to be mandatory requirements.
Anticipated Cost and Benefits: TSA
has not quantified benefits.
Unquantified benefits of this rule
include those in the areas of security
and quality governance. The rule would
enhance security by expanding the
mandatory use of security measures to
certain operators of large aircraft that are
not currently required to have a security
plan. These measures would deter
malicious individuals from perpetrating
acts that might compromise
transportation or national security by
using large aircraft for these purposes.
As stated above, TSA is revising this
proposed rule and preparing a SNPRM.
Aircraft operators, passengers, and TSA
would incur costs to comply with the
requirements of the proposed rule. TSA
is currently evaluating the costs of the
revised rule which will be published in
the SNPRM.
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TSA uses a break-even analysis to
assess the trade-off between the
beneficial effects of the SNPRM and the
costs of implementing the rulemaking.
This break-even analysis uses scenarios
extracted from the TSA Transportation
Sector Security Risk Assessment
(TSSRA) to determine the degree to
which the SNPRM must reduce the
overall risk of a terrorist attack in order
for the expected benefits of the SNPRM
to justify the estimated costs. For its
analyses, TSA uses scenarios with
varying levels of risk, but only details
the consequence estimates. To maintain
consistency, TSA developed the
analyses with a method similar to that
used for the break-even analyses
conducted in earlier DHS rules. After
estimating the total consequences of
each scenario by monetizing lives lost,
injuries incurred, capital replacement,
and clean-up, TSA will use this figure
and the annualized cost of the SNPRM
to calculate the frequency of attacks
averted in order for the SNPRM to break
even.
Risks: This rulemaking addresses the
national security risk of general aviation
aircraft being used as a weapon or as a
means to transport persons or weapons
that could pose a threat to the United
States.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Notice—NPRM
Comment Period Extended.
NPRM Extended
Comment Period End.
Notice—Public
Meetings; Requests for Comments.
Supplemental
NPRM.
10/30/08
12/29/08
73 FR 64790
11/25/08
73 FR 71590
02/27/09
12/28/08
73 FR 77045
09/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Additional Information: Public
Meetings held on: Jan. 6, 2009, at White
Plains, NY; Jan. 8, 2009, at Atlanta, GA;
Jan 16, 2009, at Chicago, IL; Jan. 23,
2009, at Burbank, CA; and Jan. 28, 2009,
at Houston, TX.
Additional Comment Sessions held in
Arlington, VA, on April 16, 2009, May
6, 2009, and June 15, 2009.
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URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Erik Jensen,
Assistant General Manager, General
Aviation Security, Department of
Homeland Security, Transportation
Security Administration, Office of
Transportation Sector Network
Management, TSA–28, HQ, E10–132S,
601 South 12th Street, Arlington, VA
20598–6028, Phone: 571 227–2154, Fax:
571 227–1923, Email:
erik.jensen@dhs.gov.
Thomas Philson, Deputy Director,
Regulatory and Economic Analysis,
Department of Homeland Security,
Transportation Security Administration,
Office of Transportation Sector Network
Management, TSA–28, HQ, E10–411N,
601 South 12th Street, Arlington, VA
20598–6028, Phone: 571 227–3236, Fax:
571 227–1362, Email:
thomas.philson@dhs.gov.
Denise Daniels, Attorney, Regulations
and Security Standards Division,
Department of Homeland Security,
Transportation Security Administration,
Office of the Chief Counsel, TSA–2, HQ,
E12–127S, 601 South 12th Street,
Arlington, VA 20598–6002, Phone: 571
227–3443, Fax: 571 227–1381, Email:
denise.daniels@dhs.gov.
Kiersten Ols, Attorney, Regulations
and Security Standards Division,
Department of Homeland Security,
Transportation Security Administration,
Office of the Chief Counsel, TSA–2, HQ,
E12–316N, 601 South 12th Street,
Arlington, VA 20598–6002, Phone: 571
227–2403, Fax: 571 227–1378, Email:
kiersten.ols@dhs.gov.
Related RIN: Related to 1652–AA03,
Related to 1652–AA04.
RIN: 1652–AA53
DHS—TSA
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74. Freight Railroads, Public
Transportation and Passenger
Railroads, and Over-the-Road Buses—
Security Training of Employees
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L.
110–53, secs 1408, 1517, and 1534
CFR Citation: 49 CFR 1520; 49 CFR
1570; 49 CFR 1580; 49 CFR 1582 (New);
49 CFR 1584 (New).
Legal Deadline: Final, Statutory,
November 1, 2007, Interim Rule for
public transportation agencies is due
90 days after date of enactment.
Final, Statutory, February 3, 2008,
Rule for railroads and over-the-road
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buses are due 6 months after date of
enactment.
Final, Statutory, August 3, 2008, Rule
for public transportation agencies is due
1 year after date of enactment.
According to section 1408 of Public
Law 110–53, Implementing
Recommendations of the 9/11
Commission Act of 2007 (Aug. 3, 2007;
121 Stat. 266), interim final regulations
for public transportation agencies are
due 90 days after the date of enactment
(Nov. 1, 2007), and final regulations are
due 1 year after the date of enactment
of this Act.
Abstract: The Transportation Security
Administration (TSA) will propose a
new regulation to improve the security
of freight railroads, public
transportation and passenger railroads,
and over-the-road buses in accordance
with the Implementing
Recommendations of the 9/11
Commission Act of 2007. This
rulemaking will propose general
requirements for the owner/operators of
a freight railroad, a public
transportation system or passenger
railroad, and over-the-road bus
operation determined by TSA to be
high-risk to develop and implement a
security training program to prepare
security-sensitive employees, including
frontline employees identified in
sections 1402 and 1501 of the Act, for
potential security threats and
conditions. The rulemaking will also
propose extending the security
coordinator and reporting security
incident requirements applicable to rail
operators under current 49 CFR part
1580 to the non-rail transportation
components of covered public
transportation agencies. In addition, the
rulemaking will also propose requiring
the affected over-the-road bus owner/
operators to identify security
coordinators and report security
incidents, similar to the requirements
for rail in current 49 CFR 1580. The
regulation will take into consideration
any current security training
requirements or best practices.
Statement of Need: A security training
program for freight railroads, public
transportation agencies and passenger
railroads, and over-the-road bus
operations is proposed to prepare freight
railroad security-sensitive employees,
public transportation and passenger
railroad security-sensitive employees,
and over-the-road bus security sensitive
employees for potential security threats
and conditions.
Summary of Legal Basis: 49 U.S.C.
114; sections 1408, 1517, and 1534 of
Public Law 110–53, Implementing
Recommendations of the 9/11
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Commission Act of 2007 (Aug. 3, 2007;
121 Stat. 266).
Alternatives: TSA is required by
statute to publish regulations requiring
security training programs for these
owner/operators. As part of its notice of
proposed rulemaking, TSA will seek
public comment on the alternative ways
in which the final rule could carry out
the requirements of the statute.
Anticipated Cost and Benefits: TSA
will estimate the costs that the freight
railroad systems, public transportation
agencies and passenger railroads, and
over-the-road bus (OTRB) entities
covered by this proposed rule would
incur following its implementation.
These costs will include estimates for
the following elements: (1) Creating or
modifying a security training program
and submitting it to TSA; (2) Training
(initial and recurrent) all securitysensitive employees; (3) Maintaining
records of employee training; (4) Being
available for inspections; (5) As
applicable, providing information on
security coordinators and alternates;
and (6) As applicable, reporting security
concerns. TSA will also estimate the
costs TSA itself would expect to incur
with the implementation of this rule.
TSA has not quantified benefits.
However, the primary benefit of the
Security Training NPRM will be to
enhance United States surface
transportation security by reducing the
vulnerability of freight railroad systems,
public transportation agencies, and
passenger railroads to terrorist activity
through the training of securitysensitive employees. TSA uses a breakeven analysis to assess the trade-off
between the beneficial effects of the
Security Training NPRM and the costs
of implementing the rulemaking. This
break-even analysis uses scenarios
extracted from the TSA Transportation
Sector Security Risk Assessment
(TSSRA) to determine the degree to
which the Security Training NPRM
must reduce the overall risk of a
terrorist attack in order for the expected
benefits of the NPRM to justify the
estimated costs. For its analyses, TSA
uses scenarios with varying levels of
risk, but only details the consequence
estimates. To maintain consistency,
TSA developed the analyses with a
method similar to that used for the
break-even analyses conducted in
earlier DHS rules.
After estimating the total consequence
of each scenario by monetizing lives
lost, injuries incurred, and capital
replacement and clean-up, TSA will use
this figure and the annualized cost of
the NPRM for freight rail, public
transportation and passenger rail, and
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OTRB operators to calculate a breakeven
annual likelihood of attack.
Risks: The Department of Homeland
Security aims to prevent terrorist attacks
within the United States and to reduce
the vulnerability of the United States to
terrorism. By providing for security
training for personnel, TSA intends in
this rulemaking to reduce the risk of a
terrorist attack on this transportation
sector.
Timetable:
Action
Date
NPRM ..................
FR Cite
05/00/12
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Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Local.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Scott Gorton, Policy
and Plans Branch Chief for Freight Rail,
Department of Homeland Security,
Transportation Security Administration,
Office of Transportation Sector Network
Management, TSA–28, HQ, E10–423N,
601 South 12th Street, Arlington, VA
20598–6028, Phone: 571 227–1251, Fax:
571 227–2930, Email:
scott.gorton@dhs.gov.
David Kasminoff, Sr. Counsel,
Regulations and Security Standards
Division, Department of Homeland
Security, Transportation Security
Administration, Office of the Chief
Counsel, TSA–2, HQ, E12–310N, 601
South 12th Street, Arlington, VA 20598–
6002, Phone: 571 227–3583, Fax: 571
227–1378, Email:
david.kasminoff@dhs.gov.
Steve Sprague, Highway Passenger,
Infrastructure and Licensing Branch
Chief, Highway and Motor Carrier
Programs, Department of Homeland
Security, Transportation Security
Administration, Office of Transportation
Sector Network Management, TSA–28,
HQ, E, 601 South 12th Street, Arlington,
VA 20598–6028, Phone: 571 227–1468,
Email: steve.sprague@dhs.gov.
Related RIN: Related to 1652–AA57,
Related to 1652–AA59.
RIN: 1652–AA55
DHS—TSA
75. Freight Railroads and Passenger
Railroads—Vulnerability Assessment
and Security Plan
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
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Legal Authority: 49 U.S.C. 114; Pub. L.
110–53, sec 1512
CFR Citation: 49 CFR 1520; 49 CFR
1570; 49 CFR 1580; 49 CFR 1582 (New).
Legal Deadline: Final, Statutory,
August 3, 2008, Rule for freight
railroads and passenger railroads is due
no later than 12 months after date of
enactment.
According to section 1512 of Public
Law 110–53, Implementing
Recommendations of the 9/11
Commission Act of 2007 (Aug. 3, 2007;
121 Stat. 266), a final regulation for
freight railroads and passenger railroads
is due no later than 12 months after the
date of enactment of the Act.
Abstract: The Transportation Security
Administration (TSA) will propose a
new regulation to improve the security
of freight railroads and passenger
railroads in accordance with the
Implementing Recommendations of the
9/11 Commission Act of 2007. This
rulemaking will propose thresholds for
which a risk determination can be made
to determine whether a freight railroad
and passenger railroad should be
considered ‘‘high risk.’’ The rulemaking
will also propose requirements for
vulnerability assessments and security
plans for owner/operators of those
railroads. The proposed requirements
include procedures for TSA’s review
and approval of these assessments and
plans, and recordkeeping requirements.
The regulation will take into
consideration any current security
assessment and planning requirements
or best practices.
Statement of Need: The rulemaking
will propose requirements for owner/
operators of high-risk freight railroads
and high-risk passenger railroads to
conduct vulnerability assessments and
carry-out security plans to address the
railroad carrier’s preparedness and
response for potential security threats
and conditions.
Summary of Legal Basis: 49 U.S.C.
114; section 1512 of Public Law 110–53,
Implementing Recommendations of the
9/11 Commission Act of 2007 (Aug. 3,
2007; 121 Stat. 266).
Alternatives: TSA is required by
statute to publish regulations requiring
vulnerability assessments and security
plans for owner/operators of high-risk
freight railroads and high-risk passenger
railroads. As part of its notice of
proposed rulemaking, TSA will seek
public comment on the alternative ways
in which the final rule could carry out
the requirements of the statute.
Anticipated Cost and Benefits: TSA
will estimate the costs that the freight
rail systems and passenger railroad
carriers covered by this proposed rule
would incur following its
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implementation. These costs will
include estimates for the following
elements: (1) Completing, modifying, or
updating a vulnerability assessment and
submitting it to TSA; (2) Developing,
modifying, or updating a security plan
and submitting it to TSA; (3)
Implementing a security plan; (4)
Maintaining records, including master
copies of the vulnerability assessment
and security plan and all plans or
documents referenced in the security
plan; and (5) Being available for
inspection.
The expected primary benefit of the
Vulnerability Assessment and Security
Plan NPRM will be to enhance U.S.
surface transportation security by
reducing vulnerability to terrorist
attacks in two different ways. First,
vulnerability assessments, as required in
this proposed rule, would identify
assets and infrastructure that are critical
to owner/operators and provide an
assessment of security risks that need to
be mitigated at these locations. Second,
in an effort to mitigate security risks,
security plans would help target
resources and mitigation strategies
toward security gaps in an owner/
operator’s specific freight or passenger
railroad operation to address the risks
identified by the vulnerability
assessments.
TSA has not quantified benefits. For
the purposes of this rulemaking, TSA
employs a break even analysis to
compare the cost of the risk reduction
resulting from the proposed rule with
the dollar value of the type of terrorist
attacks that could potentially be averted
due to the requirements in the proposed
rule. This provides a framework for
evaluating the tradeoff between program
costs and benefits. For purposes of this
analysis, TSA evaluates three scenarios
in the freight rail mode of surface
transportation and three scenarios in the
passenger railroad mode of surface
transportation covered by the proposed
rule. For each scenario, TSA calculates
a total monetary consequence from an
estimated statistical value of the human
casualties and capital replacement
resulting from the attack. TSA compared
an expected value of the monetary cost
of an attack to the each rail mode and
TSA’s annualized cost of conducting
vulnerability assessments and
implementing security plans,
discounted at 7 percent, to estimate how
often an attack of that nature would
need to be averted for the expected
benefits to equal estimated costs. For a
given level of pre-existing or baseline
risk of an attack, the calculation of the
break-even point—the reduction in
baseline risk for which the estimated
costs and expected benefits are equal—
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and a detailed description of each
scenario is presented in the regulatory
evaluation for this NPRM.
Risks: The Department of Homeland
Security aims to prevent terrorist attacks
within the United States and to reduce
the vulnerability of the United States to
terrorism. By providing for owner/
operators of high-risk freight railroads
and owner/operators of high-risk
passenger railroads to conduct
vulnerability assessments and adopt and
carry out security plans, TSA intends in
this rulemaking to reduce the risk of a
terrorist attack on the passenger rail
transportation sector.
Timetable:
DHS—TSA
76. Standardized Vetting, Adjudication,
and Redress Services
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L.
110–53, secs 1411, 1414, 1520, 1522,
1602; 6 U.S.C. 469
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Transportation Security
Administration (TSA) will propose new
regulations to revise and standardize the
procedures, adjudication criteria, and
fees for most of the security threat
assessments (STA) of individuals for
FR which TSA is responsible. In
Action
Date
Cite accordance with the Implementing
Recommendations of the 9/11
NPRM ........................... 09/00/12 ...... ...... Commission Act of 2007 (9/11 Act), the
scope of the rulemaking will include
Regulatory Flexibility Analysis
transportation workers from all modes
Required: Undetermined.
of transportation who are required to
undergo an STA in other regulatory
Government Levels Affected: Local.
programs, including certain aviation
Federalism: Undetermined.
workers and frontline employees for
URL for More Information:
public transportation agencies and
www.regulations.gov.
railroads.
In addition, TSA will propose fees to
URL for Public Comments:
cover the cost of the STAs, and
www.regulations.gov.
credentials for some personnel. TSA
Agency Contact: Scott Gorton, Policy
plans to improve efficiencies in
and Plans Branch Chief for Freight Rail, processing STAs and streamline existing
Department of Homeland Security,
regulations by simplifying language and
Transportation Security Administration, removing redundancies.
Office of Transportation Sector Network
As part of this proposed rule, TSA
Management, TSA–28, HQ, E10–423N,
will propose revisions to the Alien
601 South 12th Street, Arlington, VA
Flight Student Program (AFSP)
20598–6028, Phone: 571 227–1251, Fax: regulations. TSA published an interim
571 227–2930, Email:
final rule for ASFP on September 20,
scott.gorton@dhs.gov.
2004. TSA regulations require aliens
David Kasminoff, Sr. Counsel,
seeking to train at Federal Aviation
Regulations and Security Standards
Administration-regulated flight schools
Division, Department of Homeland
to complete an application and undergo
Security, Transportation Security
an STA prior to beginning flight
Administration, Office of the Chief
training. There are four categories under
Counsel, TSA–2, HQ, E12–310N, 601
which students currently fall; the nature
South 12th Street, Arlington, VA 20598– of the STA depends on the student’s
6002, Phone: 571 227–3583, Fax: 571
category. TSA is considering changes to
227–1378, Email:
the AFSP that would improve the equity
david.kasminoff@dhs.gov.
among fee payers and enable the
implementation of new technologies to
Morvarid Zolghadr, Branch Chief,
support vetting.
Policy and Plans, Mass Transit and
Statement of Need: Through this
Passenger Rail Security, Department of
rulemaking, TSA proposes to carry out
Homeland Security, Transportation
statutory mandates to perform security
Security Administration, Office of
threat assessments (STA) of certain
Transportation Sector Network
transportation workers pursuant to the
Management, TSA–28, E10–113S, 601
South 12th Street, Arlington, VA 20598– 9/11 Act. Also, TSA proposes to fully
satisfy 6 U.S.C. 469, which requires TSA
6028, Phone: 571 227–2957, Fax: 571
to fund security threat assessment and
227–0729, Email:
credentialing activities through user
morvarid.zolghadr@dhs.gov.
fees. The proposed rulemaking would
Related RIN: Related to 1652–AA58,
increase transportation security by
Related to 1652–AA60.
enhancing identification and
RIN: 1652–AA56
immigration verification standards,
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providing for more thorough vetting,
improving the reliability and
consistency of the vetting process, and
increasing fairness to vetted individuals
by providing more robust redress and
reducing redundant STA requirements.
Summary of Legal Basis: 49 U.S.C.
114(f): Under the Aviation and
Transportation Security Act (ATSA)
(Pub. L. 170–71, Nov. 19, 2001, 115 Stat.
597), TSA assumed responsibility to
oversee the vetting of certain aviation
workers. See 49 U.S.C. 44936.
Under the Maritime Transportation
Security Act (MTSA), (Pub. L. 107–295,
sec. 102, Nov. 25, 2002, 116 Stat. 2064),
codified at 46 U.S.C. 70105, TSA vets
certain merchant mariners and
individuals who require unescorted
access to secure areas of vessels and
maritime facilities.
Under the Uniting and Strengthening
America by Providing Appropriate
Tools Required to Intercept and
Obstruct Terrorism Act (USA PATRIOT
Act) (Pub. L. 107–56, Oct. 25, 2001, 115
Stat. 272), TSA vets individuals seeking
hazardous materials endorsements
(HME) to commercial driver’s licenses
(CDL) issued by the States.
In the Implementing
Recommendation of the 9/11
Commission Act of 2007 (Pub. L. 110–
53, Aug. 3, 2007, 121 Stat. 266),
Congress directed TSA to vet additional
populations of transportation workers,
including certain public transportation
and railroad workers.
In 6 U.S.C. 469, Congress directed
TSA to fund vetting and credentialing
programs through user fees.
Alternatives: TSA considered a
number of viable alternatives to lessen
the impact of the proposed on entities
deemed ‘‘small’’ by the Small Business
Administration (SBA) standards. This
included: (1) Extending phone preenrollment to populations eligible to
enroll via the web; and (2) changing the
current delivery and activation process
and instituting centralized activation of
biometric credentials that allow
applicants to receive their credentials
through the mail rather than returning
to the enrollment center to pick up the
credential. These alternatives are
discussed in detail in the rule and
regulatory evaluation.
Anticipated Cost and Benefits: TSA
conducted a regulatory evaluation to
estimate the costs regulated entities,
individuals, and TSA would incur to
comply with the requirements of the
NPRM. The NPRM would impose new
requirements for some individuals,
codify existing requirements not
included in the Code of Federal
Regulations (CFR), and modify current
STA requirements for many
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transportation workers. The primary
benefit of the NPRM would be that it
will improve TSA’s vetting product,
process, and structure by improving
STAs, increasing equity, decreasing
reliance on appropriated funds, and
improving reusability of STAs and
mitigating redundant STAs.
TSA has not quantified benefits. TSA
uses a break-even analysis to assess the
trade-off between the beneficial effects
of the NPRM and the costs of
implementing the rulemaking. This
break-even analysis uses scenarios from
the TSA Transportation Sector Security
Risk Assessment (TSSRA) to determine
the degree to which the NPRM must
reduce the overall risk of a terrorist
attack in order for the expected benefits
of the NPRM to justify the estimated
costs. For its analyses, TSA uses
scenarios with varying levels of risk, but
only details the consequence estimates.
To maintain consistency, TSA
developed the analyses with a method
similar to that used for the break-even
analyses conducted in earlier DHS rules.
After estimating the total consequences
of each scenario by monetizing lives
lost, injuries incurred, capital
replacement, and clean-up, TSA will
use this figure and the annualized cost
of the NPRM to calculate the frequency
of attacks averted in order for the NPRM
to break even.
TSA estimates that the total savings to
the alien flight students, over a 5-year
period, will be $18,107 at a 7 percent
discount rate.
Timetable:
Date
NPRM ..................
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Action
FR Cite
08/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Hao-y Tran
Froemling, Program Manager, Maritime
and Surface Credentialing, Department
of Homeland Security, Transportation
Security Administration, Office of
Transportation Threat Assessment and
Credentialing, TSA–19, HQ, E3–401N,
601 South 12th Street, Arlington, VA
20598–6019, Phone: 571 227–2782,
Email: hao-y.froemling@dhs.gov.
Thomas Philson, Deputy Director,
Regulatory and Economic Analysis,
Department of Homeland Security,
Transportation Security Administration,
Office of Transportation Sector Network
Management, TSA–28, HQ, E10–411N,
601 South 12th Street, Arlington, VA
20598–6028, Phone: 571 227–3236, Fax:
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571 227–1362, Email:
thomas.philson@dhs.gov.
John Vergelli, Attorney, Regulations
and Security Standards Division,
Department of Homeland Security,
Transportation Security Administration,
DHS, TSA, Office of the Chief Counsel,
TSA–2, HQ, E12–309N, 601 South 12th
Street, Arlington, VA 20598–6002,
Phone: 571 227–4416, Fax: 571 227–
1378, Email: john.vergelli@dhs.gov.
Related RIN: Related to 1652–AA35.
RIN: 1652–AA61
DHS—TSA
Final Rule Stage
77. Aircraft Repair Station Security
Priority: Other Significant. Major
under 5 U.S.C. 801.
Legal Authority: 49 U.S.C. 114; 49
U.S.C. 44924
CFR Citation: 49 CFR 1554.
Legal Deadline: Final, Statutory,
August 8, 2004, Rule within 240 days of
the date of enactment of Vision 100.
Final, Statutory, August 3, 2008, Rule
within 1 year after the date of enactment
of 9/11 Commission Act. Section
611(b)(1) of Vision 100—Century of
Aviation Reauthorization Act (Pub. L.
108–176; Dec. 12, 2003; 117 Stat. 2490),
codified at 49 U.S.C. 44924, requires
TSA issue ‘‘final regulations to ensure
the security of foreign and domestic
aircraft repair stations.’’ Section 1616 of
the Implementing Recommendations of
the 9/11 Commission Act of 2007 (Pub.
L. 110–531; Aug. 3, 2007; 21 Stat. 266)
requires TSA issue a final rule on
foreign repair station security.
Abstract: The Transportation Security
Administration (TSA) proposed to add a
new regulation to improve the security
of domestic and foreign aircraft repair
stations, as required by the section 611
of Vision 100—Century of Aviation
Reauthorization Act and section 1616 of
the 9/11 Commission Act of 2007. The
regulation proposed general
requirements for security programs to be
adopted and implemented by repair
stations certificated by the Federal
Aviation Administration (FAA). A
notice of proposed rulemaking (NPRM)
was published in the Federal Register
on November 18, 2009, requesting
public comments to be submitted by
January 19, 2010. The comment period
was extended to February 19, 2010, on
request of the stakeholders to allow the
aviation industry and other interested
entities and individuals additional time
to complete their comments.
TSA has coordinated its efforts with
the FAA throughout the rulemaking
process to ensure that the final rule does
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not interfere with FAA’s ability or
authority to regulate part 145 repair
station safety matters.
Statement of Need: The
Transportation Security Administration
(TSA) is proposing regulations to
improve the security of domestic and
foreign aircraft repair stations. The
NPRM proposed to require repair
stations that are certificated by the
Federal Aviation Administration to
adopt and carry out a security program.
The proposal will codify the scope of
TSA’s existing inspection program. The
proposal also provides procedures for
repair stations to seek review of any
TSA determination that security
measures are deficient.
Summary of Legal Basis: Section
611(b)(1) of Vision 100—Century of
Aviation Reauthorization Act (Pub. L.
108–176; Dec. 12, 2003; 117 Stat. 2490),
codified at 49 U.S.C. 44924, requires
TSA to issue ‘‘final regulations to ensure
the security of foreign and domestic
aircraft repair stations’’ within 240 days
from date of enactment of Vision 100.
Section 1616 of Public Law 110–53,
Implementing Recommendations of the
9/11 Commission Act of 2007 (Aug. 3,
2007; 121 Stat. 266) requires that the
FAA may not certify any foreign repair
stations if the regulations are not issued
within 1 year after the date of enactment
of the 9/11 Commission Act unless the
repair station was previously
certificated or is in the process of
certification.
Alternatives: TSA is required by
statute to publish regulations requiring
security programs for aircraft repair
stations. As part of its notice of
proposed rulemaking, TSA sought
public comment on the numerous
alternative ways in which the final rule
could carry out the requirements of the
statute.
Anticipated Cost and Benefits: TSA
anticipates costs to aircraft repair
stations mainly related to the
establishment of security programs,
which may include adding such
measures as access controls, a personnel
identification system, security
awareness training, the designation of a
security coordinator, employee
background verification, and
contingency plan.
The NPRM estimated the total 10-year
undiscounted cost of the program at
$344 million. The cost of the program,
annualized and discounted at 7 percent,
is $241 million. Security coordinator
and training costs represent the largest
portions of the program.
TSA has not quantified benefits.
However, a major line of defense against
an aviation-related terrorist act is the
prevention of explosives, weapons, and/
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or incendiary devices from getting on
board a plane. To date, efforts have been
primarily related to inspection of
baggage, passengers, and cargo, and
security measures at airports that serve
air carriers. With this rule, attention is
given to aircraft that are located at repair
stations, and to aircraft parts that are at
repair stations themselves, to reduce the
likelihood of an attack against aviation
and the country. Since repair station
personnel have direct access to all parts
of an aircraft, the potential exists for a
terrorist to seek to commandeer or
compromise an aircraft when the
aircraft is at one of these facilities.
Moreover, as TSA tightens security in
other areas of aviation, repair stations
increasingly may become attractive
targets for terrorist organizations
attempting to evade aviation security
protections currently in place.
TSA uses a break-even analysis to
assess the trade-off between the
beneficial effects of the final rule and
the costs of implementing the
rulemaking. This break-even analysis
uses three attack scenarios to determine
the degree to which the final rule must
reduce the overall risk of a terrorist
attack in order for the expected benefits
of the final rule to justify the estimated
costs. For its analyses, TSA uses
scenarios with varying levels of risk, but
only details the consequence estimates.
To maintain consistency, TSA
developed the analyses with a method
similar to that used for the break-even
analyses conducted in earlier DHS rules.
After estimating the total consequences
of each scenario by monetizing lives
lost, injuries incurred, and capital
replacement, TSA will use this figure
and the annualized cost of the final rule
to calculate the frequency of attacks
averted in order for the final rule to
break even.
Risks: The Department of Homeland
Security aims to prevent terrorist attacks
within the United States and to reduce
the vulnerability of the United States to
terrorism. By requiring security
programs for aircraft repair stations,
TSA will focus on preventing
unauthorized access to repair work and
to aircraft to prevent sabotage or
hijacking.
Timetable:
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Action
Date
FR Cite
Notice—Public
Meeting; Request for Comments.
Report to Congress.
NPRM ..................
NPRM Comment
Period End.
02/24/04
69 FR 8357
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Action
Date
FR Cite
NPRM Comment
Period Extended.
NPRM Extended
Comment Period End.
Final Rule ............
12/29/09
74 FR 68774
02/19/10
09/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Celio Young,
Program Manager, Repair Stations,
Department of Homeland Security,
Transportation Security Administration,
Office of Transportation Sector Network
Management, General Aviation
Division, TSA–28, HQ, E5, 601 South
12th Street, Arlington, VA 20598–6028,
Phone: 571 227–3580, Fax: 571 227–
1362, Email: celio.young@dhs.gov.
Thomas Philson, Deputy Director,
Regulatory and Economic Analysis,
Department of Homeland Security,
Transportation Security Administration,
Office of Transportation Sector Network
Management, TSA–28, HQ, E10–411N,
601 South 12th Street, Arlington, VA
20598–6028, Phone: 571 227–3236, Fax:
571 227–1362, Email:
thomas.philson@dhs.gov.
Linda L. Kent, Assistant Chief
Counsel, Regulations and Security
Standards Division, Department of
Homeland Security, Transportation
Security Administration, Office of the
Chief Counsel, TSA–2, HQ, E12–126S,
601 South 12th Street, Arlington, VA
20598–6002, Phone: 571 227–2675, Fax:
571 227–1381, Email:
linda.kent@dhs.gov.
RIN: 1652–AA38
DHS—U.S. IMMIGRATION AND
CUSTOMS ENFORCEMENT (USICE)
Proposed Rule Stage
78. Continued Detention of Aliens
Subject to Final Orders of Removal
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 8 U.S.C. 1103; 8
U.S.C. 1223; 8 U.S.C. 1227; 8 U.S.C.
1231; 8 U.S.C. 1253
CFR Citation: 8 CFR 241.
Legal Deadline: None.
Abstract: This notice of proposed
rulemaking (NPRM) is proposing to
amend the Department of Homeland
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7759
Security (DHS) regulatory provisions for
custody determinations for aliens in
immigration detention who are subject
to an administratively final order of
removal. The proposed amendment
would add a paragraph to 8 CFR
241.4(g) providing that U.S. Immigration
and Customs Enforcement (ICE) shall
have a reasonable period of time to
effectuate an alien’s removal where the
alien is not in immigration custody
when the order of removal becomes
administratively final. The proposed
rule would also clarify the removal
period time frame afforded to the agency
following an alien’s compliance with
his or her obligations regarding removal
subsequent to a period of obstruction or
failure to cooperate. The rule proposes
to make conforming changes to
241.13(b)(2). Lastly, the rule proposes to
add a paragraph to 8 CFR 241.13(b)(3)
to make clear that aliens certified by the
Secretary under section 236A of the
Immigration and Nationality Act, 8
U.S.C. 1226a, are not subject to the
provisions of 8 CFR 241.13, in
accordance with the separate detention
standard provided under the Act.
Statement of Need: The companion
final rule will improve the post order
custody review process in the final rule
related to the Detention of Aliens
Subject to Final Orders of Removal in
light of the U.S. Supreme Court’s
decisions in Zadvydas v. Davis, 533
U.S. 678 (2001), Clark v. Martinez, 543
U.S. 371 (2005) and conforming changes
as required by the enactment of the
Homeland Security Act of 2002 (HSA).
This notice of proposed rulemaking
(NPRM) will propose to amend 8 CFR
241.1(g) to provide for a new 90-day
removal period once an alien comes into
compliance with his or her obligation to
make timely application in good faith
for travel or other documents and not
conspire or act to prevent removal.
Anticipated Cost and Benefits: This
proposed rule will clarify the regulatory
provisions concerning the removal of
aliens that are subject to an
administratively final order of removal.
DHS does not anticipate there will be
cost impacts to the public as a result of
the rule.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Alexander Hartman,
Regulatory Coordinator, Department of
Homeland Security, U.S. Immigration
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and Customs Enforcement, 500 12th
Street SW., Washington, DC 20536,
Phone: 202 732–6202, Email:
alexander.hartman@dhs.gov.
Related RIN: Related to 1653–AA13.
RIN: 1653–AA60
DHS—USICE
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Final Rule Stage
79. Continued Detention of Aliens
Subject to Final Orders of Removal
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1103; 8
U.S.C. 1223; 8 U.S.C. 1227; 8 U.S.C.
1231; 8 U.S.C. 1253; * * *
CFR Citation: 8 CFR 241.
Legal Deadline: None.
Abstract: The U.S. Department of
Homeland Security is finalizing, with
amendments, the interim rule that was
published on November 14, 2001, by the
former Immigration and Naturalization
Service (Service). The interim rule
included procedures for conducting
custody determinations in light of the
U.S. Supreme Court’s decision in
Zadvydas v. Davis, 533 U.S. 678 (2001),
which held that the detention period of
certain aliens who are subject to a final
administrative order of removal is
limited under section 241(a)(6) of the
Immigration and Nationality Act (Act)
to the period reasonably necessary to
effect their removal. The interim rule
amended section 241.4 of title 8, Code
of Federal Regulations (CFR), in
addition to creating two new sections: 8
CFR 241.13 (establishing custody review
procedures based on the significant
likelihood of the alien’s removal in the
reasonably foreseeable future) and
241.14 (establishing custody review
procedures for special circumstances
cases). Subsequently, in the case of
Clark v. Martinez, 543 U.S. 371 (2005),
the Supreme Court clarified a question
left open in Zadvydas, and held that
section 241(a)(6) of the Act applies
equally to all aliens described in that
section. This rule amends the interim
rule to conform to the requirements of
Martinez. Further, the procedures for
custody determinations for post-removal
period aliens who are subject to an
administratively final order of removal,
and who have not been released from
detention or repatriated, have been
revised in response to comments
received and experience gained from
administration of the interim rule
published in 2001. This final rule also
makes conforming changes as required
by the enactment of the Homeland
Security Act of 2002 (HSA).
Additionally, certain portions of the
final rule were determined to require
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public comment and, for this reason,
have been developed into a separate/
companion notice of proposed
rulemaking; RIN 1653–AA60.
Statement of Need: This rule will
improve the post order custody review
process in the final rule related to the
Detention of Aliens Subject to Final
Orders of Removal in light of the U.S.
Supreme Court’s decisions in Zadvydas
v. Davis, 533 U.S. 678 (2001), Clark v.
Martinez, 543 U.S. 371 (2005) and
conforming changes as required by the
enactment of the Homeland Security
Act of 2002 (HSA). A companion notice
of proposed rulemaking (NPRM) will
propose to amend 8 CFR 241.1(g) to
provide for a new 90-day removal
period once an alien comes into
compliance with his or her obligation to
make timely application in good faith
for travel or other documents and not
conspire or act to prevent removal.
Anticipated Cost and Benefits: The
changes are administrative and
procedural in nature, and will not result
in cost impacts to the public. The
benefits of making these changes to the
regulations will allow for expedited
review of the post-order custody review
process.
Timetable:
Action
Date
FR Cite
Interim Final Rule
Interim Final Rule
Comment Period End.
Final Action .........
11/14/01
01/14/02
66 FR 56967
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: INS No.
2156–01. Transferred from RIN 1115–
AG29.
Agency Contact: Alexander Hartman,
Regulatory Coordinator, Department of
Homeland Security, U.S. Immigration
and Customs Enforcement, 500 12th
Street SW., Washington, DC 20536,
Phone: 202 732–6202, Email:
alexander.hartman@dhs.gov.
RIN: 1653–AA13
DHS—USICE
80. Extending Period for Optional
Practical Training by 17 Months for
F–1 Nonimmigrant Students With
STEM Degrees and Expanding the CapGap Relief for All F–1 Students With
Pending H–1B Petitions
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
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Legal Authority: 8 U.S.C. 1101 to
1103; 8 U.S.C. 1182; 8 U.S.C. 1184 to
1187; 8 U.S.C. 1221; 8 U.S.C. 1281 and
1282; 8 U.S.C. 1301 to 1305
CFR Citation: 8 CFR 214.
Legal Deadline: None.
Abstract: Currently, foreign students
in F–1 nonimmigrant status who have
been enrolled on a full-time basis for at
least one full academic year in a college,
university, conservatory, or seminary
certified by U.S. Immigration and
Custom Enforcement’s (ICE) Student
and Exchange Visitor Program (SEVP)
are eligible for 12 months of optional
practical training (OPT) to work for a
U.S. employer in a job directly related
to the student’s major area of study. The
maximum period of OPT is 29 months
for F–1 students who have completed a
science, technology, engineering, or
mathematics (STEM) degree and accept
employment with employers enrolled in
U.S. Citizenship and Immigration
Services’ (USCIS’) E-Verify employment
verification program. Employers of F–1
students with an extension of postcompletion OPT authorization must
report to the student’s designated school
official (DSO) within 48 hours after the
OPT student has been terminated from,
or otherwise leaves, his or her
employment with that employer prior to
end of the authorized period of OPT.
The final rule will respond to public
comments and may make adjustments to
the regulations.
Statement of Need: ICE will improve
SEVP processes by publishing the Final
Optional Practical Training (OPT) rule,
which will respond to comments on the
OPT interim final rule (IFR). The IFR
increased the maximum period of OPT
from 12 months to 29 months for
nonimmigrant students who have
completed a science, technology,
engineering, or mathematics (STEM)
degree and who accept employment
with employers who participate in the
U.S. Citizenship and Immigration
Services’ (USCIS’) E-Verify employment
verification program.
Alternatives: DHS is considering
several alternatives to the 17-month
extension of OPT and cap-gap
extension, ranging from taking no action
to further extension for a larger
populace. The interim final rule
addressed an immediate competitive
disadvantage faced by U.S. industries
and ameliorated some of the adverse
impacts on the U.S. economy. DHS
continues to evaluate both quantitative
and qualitative alternatives.
Anticipated Cost and Benefits: Based
on an estimated 12,000 students per
year that will receive an OPT extension
and an estimated 5,300 employers that
will need to enroll in E-Verify, DHS
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projects that this rule will cost students
approximately $1.49 million per year in
additional information collection
burdens, $4,080,000 in fees, and cost
employers $1,240,000 to enroll in
E-Verify and $168,540 per year
thereafter to verify the status of new
hires. However, this rule will increase
the availability of qualified workers in
science, technology, engineering, and
mathematical fields; reduce delays that
place U.S. employers at a disadvantage
when recruiting foreign job candidates,
thereby improving strategic and
resource planning capabilities; increase
the quality of life for participating
students, and increase the integrity of
the student visa program.
Timetable:
Action
Date
FR Cite
Interim Final Rule
Interim Final Rule
Comment Period End.
Final Rule ............
04/08/08
06/09/08
73 FR 18944
08/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
URL for More Information:
www.dhs.gov/sevis/.
Agency Contact: Sharon Snyder,
Acting Branch Chief, SEVP Policy,
Student and Exchange Visitor Program,
Department of Homeland Security, U.S.
Immigration and Customs Enforcement,
Potomac Center North, 500 12th Street
SW., Washington, DC 20024–6121,
Phone: 703 603–3415.
RIN: 1653–AA56
DHS—FEDERAL EMERGENCY
MANAGEMENT AGENCY (FEMA)
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Proposed Rule Stage
81. Update of FEMA’s Public Assistance
Regulations
Priority: Other Significant.
Legal Authority: 42 U.S.C. 5121 to
5207
CFR Citation: 44 CFR 206.
Legal Deadline: None.
Abstract: This proposed rule would
revise the Federal Emergency
Management Agency’s Public
Assistance program regulations. Many
of these changes reflect amendments
made to the Robert T. Stafford Disaster
Relief and Emergency Assistance Act by
the Post-Katrina Emergency
Management Reform Act of 2006 and
the Security and Accountability For
Every Port Act of 2006. The proposed
rule also proposes to reflect lessons
learned from recent events, and propose
further substantive and non-substantive
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clarifications and corrections to improve
upon the Public Assistance regulations.
This proposed rule is intended to
improve the efficiency and consistency
of the Public Assistance program, as
well as implement new statutory
authority by expanding Federal
assistance, improving the Project
Worksheet process, empowering
grantees, and improving State
Administrative Plans.
Statement of Need: The proposed
changes implement new statutory
authorities and incorporate necessary
clarifications and corrections to
streamline and improve the Public
Assistance program. Portions of FEMA’s
Public Assistance regulations have
become out of date and do not
implement all of FEMA’s available
statutory authorities. The current
regulations inhibit FEMA’s ability to
clearly articulate its regulatory
requirements, and the Public Assistance
applicants’ understanding of the
program. The proposed changes are
intended to improve the efficiency and
consistency of the Public Assistance
program.
Summary of Legal Basis: The legal
authority for the changes in this
proposed rule is contained in the Robert
T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C.
5121 to 5207, as amended by the PostKatrina Emergency Management Reform
Act of 2006, Public Law 109–295, the
Security and Accountability For Every
Port Act of 2006, 6 U.S.C. 901 note, the
Local Community Recovery Act of 2006,
Public Law 109–218, 120 Stat. 333, and
the Pets Evacuation and Transportation
Standards Act of 2006, Public Law 109–
308, 120 Stat. 1725.
Alternatives: One alternative is to
revise some of the current regulatory
requirements (such as application
deadlines) in addition to implementing
the amendments made to the Stafford
Act by (1) the Post-Katrina Emergency
Management Reform Act of 2006
(PKEMRA), Public Law 109–295, 120
Stat. 1394; (2) the Security and
Accountability For Every Port Act of
2006 (SAFE Port Act), Public Law 109–
347, 120 Stat. 1884; (3) the Local
Community Recovery Act of 2006,
Public Law 109–218, 120 Stat. 333; and
(4) the Pets Evacuation and
Transportation Standards Act of 2006
(PETS Act), Public Law 109–308, 120
Stat. 1725. Another alternative is to
expand funding by expanding force
account labor cost eligibility to Category
A Projects (debris removal).
Anticipated Cost and Benefits: The
proposed rule is expected to have
economic impacts on the public,
grantees, subgrantees, and FEMA. The
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expected benefits are a reduction in
property damages, societal losses, and
losses to local businesses, as well as
improved efficiency and consistency of
the Public Assistance program. FEMA
estimates the primary economic impact
of the proposed rule is the additional
transfer of funding from FEMA through
the Public Assistance program to
grantees and subgrantees that is
effectuated by this rulemaking.
Risks: This action does not adversely
affect public health, safety, or the
environment.
Timetable:
Action
Date
NPRM ..................
FR Cite
03/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: Federal,
Local, State, Tribal.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Agency Contact: Tod Wells, Recovery
Directorate, Department of Homeland
Security, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472–3100, Phone:
202 646–3936, Fax: 202 646–3363,
Email: tod.wells@dhs.gov.
RIN: 1660–AA51
BILLING CODE 9110–9B–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
Statement of Regulatory Priorities
The regulatory plan for the
Department of Housing and Urban
Development (HUD) for fiscal year (FY)
2012 highlights the most significant
regulations and policy initiatives that
HUD seeks to complete during the
upcoming fiscal year. As the Federal
agency that serves as the Nation’s
housing agency, HUD’s mission is to
create strong, sustainable, inclusive
communities and quality affordable
homes for all. HUD strives to meet the
challenges of this mission by focusing
on people and places through policies
and initiatives that address the unique
conditions and needs of communities.
For example, HUD recognizes that the
‘‘American Dream’’ no longer refers to a
singular vision of success, such as
owning a home, and, therefore, through
programs such as HUD’s Housing
Counseling program, HUD assists
individuals and families to make
decisions about owning or renting that
are financially appropriate to the
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individual or family.1 HUD also has
been placing greater focus on improving
locational outcomes for households
receiving rental assistance. HUD’s
Choice Neighborhood initiative
provides funding for plans that link
housing to schools, jobs, and affordable
transportation in order to transform
neighborhoods of concentrated poverty
into sustainable mixed-income
communities with well-functioning
services, public assets, and access to
opportunity. HUD’s Neighborhood
Stabilization Program helps
communities acquire, rehabilitate, and
resell foreclosed and abandoned
properties in order to more quickly
prevent decline in neighborhoods hardhit by the foreclosure process.
In addition to meeting the challenges
of HUD’s mission through revitalized
policies and initiatives, President
Obama challenged all agencies to
identify opportunities to significantly
improve near-term performance. These
opportunities were incorporated as key
outcome measures into HUD’s strategic
plan, representing challenging, nearterm, high-impact outcomes that reflect
HUD’s commitment to addressing some
of the most fundamental housing and
community challenges facing America.
Building on the directions to improve
performance, but on a longer-term basis,
President Obama issued Executive
Order 13563 entitled ‘‘Improving
Regulation and Regulatory Review.’’
Executive Order 13563 supplements and
reaffirms the rulemaking principles of
Executive Order 12866 ‘‘Regulatory
Planning and Review,’’ which include
identifying regulatory approaches that
reduce burden, considering the costs
and benefits of rules, and encouraging
public participation, but also directs
agencies to undertake a retrospective
analysis of rules that may be outmoded,
ineffective, insufficient, or excessively
burdensome, and to modify, streamline,
expand, or repeal such regulations as
appropriate. The Executive order
recognizes the significant role that
regulations play in protecting public
health, welfare, safety, and the
environment, and in promoting
economic growth, innovation,
competitiveness, and job creation, but
also that regulations cannot remain
stagnant. Agencies must frequently
review regulations to ensure that they
are meeting the challenges of today and
not addressing conditions, whether
housing, health, business, labor, or
1 This statement is based on language found on
page 4, paragraph 2, of the Introduction to HUD’s
FY 2010 to 2015 Strategic Plan. (See https://
portal.hud.gov/hudportal/documents/
huddoc?id=DOC_4436.pdf.)
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environmental, that are no longer
reflected in today’s economy. In this
regard, Executive Order 13563 directed
agencies to undertake periodic
retrospective review of their regulations,
and to develop, prepare, and post their
plans for retrospective review of rules.
HUD’s plan and that of all agencies can
be found at https://www.whitehouse.gov/
21stcenturygov/actions/21st-centuryregulatory-system. HUD’s semiannual
agenda of regulations includes the rules
highlighted in HUD’s retrospective
review of rules plans.
The rules highlighted in HUD’s
regulatory plan for FY 2011 reflect both
HUD’s continuing efforts to fulfill its
mission and improve performance,
including by addressing regulations that
necessitate update and modification.
HUD’s FY 2011 regulatory plan reflects
HUD’s retrospective review of the
regulations governing one of HUD’s
major mortgage insurance programs.
Another rule highlighted in this
regulatory plan revises the regulations
of another significant program to
address the unique conditions and
needs of participants in one of HUD’s
major assistance programs. The third
rule related to a significant HUD
program is designed to implement
flexibility provided by a recently
enacted statute.
Priority: Create Financially Sustainable
Homeownership Opportunities
HUD’s HECM program was
established by statute to assist in
alleviating economic hardship caused
by the increasing costs of health,
housing, and other needs at a time in
life when one’s income is reduced. The
HECM program, administered through
HUD’s Federal Housing Administration
(FHA), enables older homeowners to
withdraw some of the equity in their
home in the form of monthly payments
for life or a fixed term, or in a lump
sum, or through a line of credit. In
addition, the HECM mortgage can be
used to purchase a primary home when
the borrower is 62 years of age or older
and is able to use cash in hand, money
from the sale of assets, or money from
an allowable FHA funding source to pay
the difference between the reverse
mortgage and the sales price plus
closing costs for the property.
To be eligible for a HECM mortgage,
current homeowners must be 62 years of
age or older, own their home outright,
or have a low mortgage balance that can
be paid off at closing with proceeds
from the reverse mortgage. Homeowners
can only have one HECM at any one
time and the home must be their
principal residence. In addition, the
HECM can be used to purchase a
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primary home if the borrower is able to
pay the difference between the HECM
and the sales price and closing costs for
the property. The borrower remains the
owner of the home and may sell it and
move at any time, keeping the sales
proceeds that exceed the mortgage
balance. A borrower cannot be forced to
sell the home to pay off the mortgage,
even if the mortgage balance grows to
exceed the value of the property, unless
they fail to perform an obligation of the
mortgage.
As the Nation’s population has
increased in age, the attraction of the
HECM has increased as well. In 1990,
there were approximately 157 HECMs.
By 2008, there were more than 112,000
HECMs. The situation that HUD has
confronted recently with increasing
frequency is that HECM homeowners
are not paying property taxes,
insurance, and other property charges.
Payment of these items is the
responsibility of the homeowner, and
failure to pay places the homeowner in
default of its obligations under the
mortgage and makes the homeowner
vulnerable to loss of his or her home.
FHA-approved lenders are responsible
for keeping all tax and insurance
payments current, in compliance with
the HECM regulations. If homeowners
stop making payments, lenders are
allowed to access any remaining home
equity to pay taxes and insurance
premiums. Once homeowner funds are
exhausted, lenders are legally required
to advance their own funds for such
payments and seek reimbursement from
homeowners.
With the same recognition that
homeownership may not be the best
choice for every individual or family, a
HECM may not be the best choice for
every senior homeowner. The security
that the HECM program was designed to
bring to seniors may be lost if the senior
homeowner cannot maintain payment of
taxes and insurance payments.
Regulatory Action: Strengthening the
Home Equity Conversion Mortgage
(HECM) Program To Promote Sustained
Homeownership
To address this growing issue in the
HECM program, HUD proposes to
require FHA-approved mortgagees that
originate HECM mortgages to perform a
financial capacity and credit history
assessment of prospective HECM
mortgagors prior to loan approval and
closing. Mortgagees will be required to
evaluate whether the HECM mortgagor’s
cash flow and credit history support the
mortgagor’s ability to comply with the
obligations of the HECM and are
sufficient to meet recurring living
expenses. The proposed rule would also
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cap the amount of insurance benefits
paid in connection with a claim
involving amounts advanced by the
mortgagee on behalf of a HECM
mortgagor who fails to pay such
property charges when the HECM
proceeds have been exhausted, and
establish a new property inspection
requirement to insure that homes
secured with a HECM mortgage are
adequately maintained and meet
applicable property standards.
These changes to the HECM program
are necessary to ensure that senior
homeowners do not enter a program
seeking security in their later life only
to find themselves without a home.
Additionally, without such changes, the
HECM program will place the FHA
Insurance Fund at significant risk, with
the possible result being the
unavailability of HECMs in the future.
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Priority: Improve the Quality of
Affordable Rental Housing
In an era when more than one-third of
all American families rent their homes,
the current housing market does not
create and sustain a sufficient supply of
affordable rental homes, especially for
low-income households. In many
communities, affordable rental housing
does not exist without public support.
Despite significant improvements in
housing quality in recent decades, much
of America’s rental housing stock is not
energy efficient or even accessible to
people with disabilities, and pockets of
severely substandard housing remain
across the country. Even before the
recent recession, the number of
households with severe housing cost
burdens had increased substantially
since 2000, and homelessness among
families with children is a growing
problem throughout our Nation. When it
comes to strong, safe, and healthy
communities, lower-cost rental housing
is particularly scarce. As the lead
Federal housing agency, HUD will work
with its Federal, State, local, and private
partners to meet affordable and quality
rental housing needs for all.2 In this
regard, HUD will strengthen the
indicators by which HUD measures the
performance of public housing agencies
in administering its Section 8 rental
assistance program, referred to as the
Housing Choice Voucher program.
HUD’s Housing Choice Voucher
program is the Federal Government’s
major program for assisting very lowincome families, the elderly, and the
disabled to afford decent, safe, and
2 This
statement is taken from the first column of
page 19 of section 2 of HUD’s FY 2010 to 2015
Strategic Plan. (See https://portal.hud.gov/
hudportal/documents/huddoc?id=DOC_4436.pdf.)
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sanitary housing in the private market.
Since housing assistance is provided on
behalf of the family or individual,
participants are able to find their own
housing, including single-family homes,
townhouses, and apartments. The
participant is free to choose any housing
that meets the requirements of the
program and is not limited to units
located in subsidized housing projects.
Housing choice vouchers are
administered locally by public housing
agencies (PHAs). The PHAs receive
Federal funds from HUD to administer
the voucher program. A family that is
issued a housing voucher is responsible
for finding a suitable housing unit of the
family’s choice where the owner agrees
to rent under the program. Rental units
must meet minimum standards of health
and safety, as determined by the PHA.3
Through HUD’s Section Eight
Management Assessment Program
(SEMAP), HUD measures the
performance of PHAs in their
administration of the Housing Choice
Voucher program in key areas. The areas
of review indicate whether PHAs are
helping eligible families to afford decent
rental units at a reasonable subsidy cost.
SEMAP requires PHAs to undertake an
annual Housing Quality Standard (HQS)
inspection of units.
Regulatory Action: Tenant-Based Rental
Assistance; Improving Performance
Through a Strengthened SEMAP
HUD recognizes that SEMAP is more
process-oriented than results-oriented.
To make SEMAP a more effective
assessment tool, HUD is proposing to
revise the management indicators used
by HUD to measure the performance of
PHAs. For example, the proposed rule
would revise the indicator that
measures Section 8 voucher use to
encourage PHAs to maximize the
number of Section 8 families served.
Under this revised indicator, HUD will
not only consider the number of
vouchers available to a PHA, but also
the funds available to the PHA,
including budget authority and a
portion of reserves. HUD also proposes
to assume responsibility for conducting
the inspections used to measure a PHA’s
compliance with housing quality
standards (HQS). Currently, HUD
measures HQS compliance through a
reporting requirement for PHA selfconducted inspections. The proposed
rule would also establish a new
deconcentration indicator that will
evaluate the ability of Section 8 families
3 The information in this paragraph is taken from
HUD’s Web page on Housing Choice Vouchers
found at https://portal.hud.gov/hudportal/
HUD?src=/program_offices/public_indian_housing/
programs/hcv/about/fact_sheet.)
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7763
with children to access neighborhoods
with below-average poverty rates or
neighborhoods with above-average
schools.
Priority: Utilize Housing as a Platform
for Improving the Quality of Life
Stable housing, made possible with
HUD support, provides an ideal
platform for delivering a wide variety of
health and social services to improve
health, education, and economic
outcomes. HUD housing serves at least
two broad populations: People who are
in a position to markedly increase their
self-sufficiency and people who will
need long-term support (for example,
the frail elderly and people with severe
disabilities). For those individuals who
are able, increasing self-sufficiency
requires access to life-skills training,
wealth-creation and asset-building
opportunities, job training, and career
services. For those who need long-term
support, HUD housing will provide
access to income support and other
benefits that can enhance an
individual’s quality of life.
HUD’s Supportive Housing for
Persons with Disabilities Program
(Section 811) is a critical HUD program
that allows persons with disabilities to
live as independently as possible in the
community by increasing the supply of
rental housing with the availability of
supportive services. HUD increases the
supply of rental housing for persons
with disabilities by providing interestfree capital advances to nonprofit
sponsors to help them finance the
development of rental housing such as
independent living projects,
condominium units, and small group
homes with the availability of
supportive services for persons with
disabilities. The capital advance can
finance the construction, rehabilitation,
or acquisition with or without
rehabilitation of supportive housing.
The advance does not have to be repaid
as long as the housing remains available
for very low-income persons with
disabilities for at least 40 years. Over the
last several years, the Section 811
program has not been as effective as
desired because the underlying statutory
foundation for the program required
substantial reform and improvements to
meet the challenges of current market
conditions and reflect modern practices
with respect to production of housing.
The Frank Melville Supportive
Housing Investment Act of 2010 (Pub. L.
111–374) (Melville Act), which was
enacted on January 4, 2011, amended
section 811 of the Cranston-Gonzalez
National Affordable Housing Act (42
U.S.C. 8013), which authorizes the
supportive housing program for persons
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with disabilities (Section 811 program).
The Melville Act made significant
changes to the Section 811 program,
with one of the most significant changes
being the establishment of new project
rental assistance authority. This new
authority allows HUD to make Section
811 program operating assistance
available to State housing agencies and
similar organizations for the purposes of
granting funds to the development of
supportive housing for persons with
disabilities, and overseeing compliance
with the requirements applicable to
such housing.
Regulatory Action: Supportive Housing
for Persons With Disabilities:
Implementing New Project Rental
Assistance Authority
While the Melville Act makes many
important changes to the Section 811
program, HUD’s first priority is to
implement the requirements for the new
project rental assistance authority.
Project rental assistance has long been
Regulation
Identifier No.
(RIN)
part of eligible assistance for the Section
811 program, and the existing Section
811 program regulations provide that
project rental assistance is available for
operating costs. The new project rental
assistance provided by the Melville Act
offers another method of financing for
supportive housing for persons with
disabilities for projects that do not
receive capital advances. The new
project rental assistance is designed to
promote and facilitate the creation of
integrated supportive housing units,
which is achieved by making funds
available to State housing agencies and
other appropriate entities. As provided
by the Melville Act, projects eligible for
the new project rental assistance can be
either new or existing multifamily
housing projects.
HUD’s proposed rule establishes the
requirements and procedures that
would govern the eligibility and use of
the new project rental assistance
authority in HUD’s Section 811
program.
Retrospective Review of Agency
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in The Regulatory Plan.
However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov in the
Completed Actions section for that
agency. These rulemakings can also be
found on Regulations.gov. HUD’s
retrospective review plan can be found
at: https://portal.hud.gov/hudportal/
HUD?src=/program_offices/general_
counsel/Review_of_Regulations.
Title
Anticipated Reductions in Regulatory Burden
2502–AI92 ..........
Federal Housing Administration (FHA): Refinancing an Existing Cooperative Under Section 207 Pursuant to Section
223(f) of the National Housing Act; Final Rule.
2502–AJ03 .........
Streamlining Inspection and Warranty Requirements for Federal Housing Administration (FHA) Single Family Mortgage
Insurance: Removal of the FHA Inspector Roster and of
the 10-Year Protection Plan Requirements for High Loanto-Value Ratio Mortgages; Proposed Rule.
2502–AI91 ..........
Approval of Farm Credit System Lending Institutions in FHA
Mortgage Insurance Programs; Proposed Rule.
2502–AJ06 .........
Expansion of Eligibility of Nonprofit Organizations To Participate in FHA Single Family Mortgage Insurance Programs;
Proposed Rule.
2502–AJ02 .........
Federal Housing Administration (FHA) Single Family Mortgage Insurance: Removal of Requests for Alternative Mortgage Amounts; Proposed Rule.
Federal Housing Administration (FHA): Suspension of FHA’s
Regulation Placing Time Restrictions on Resale of FHA-Insured Property; Proposed Rule.
Federal Housing Administration (FHA): Suspension of Single
Family Mortgage Insurance for Military Impacted Areas;
Proposed Rule.
Federal Housing Administration (FHA): Approval of Lending
Institutions and Mortgagees—Alternative Reporting Requirements for Small Supervised Lenders.
• Removes a regulatory restriction on FHA refinancing of existing mortgage debt by owners of multifamily cooperative
projects, thus expanding the number of individuals eligible
to participate in FHA programs.
• Removes the regulations for the FHA Inspector Roster,
making it easier for lenders and borrowers to have inspections performed and streamlining the mortgage insurance
application process.
• Removes the outdated 10-year protection plan requirement
for high Loan-to-Value newly constructed single family
homes securing FHA-insured mortgages. This eliminates
an unnecessary layer of regulatory burden.
• Enables direct lending institutions of the Farm Credit System to seek approval as FHA mortgagees and lenders, removing a regulatory barrier to participation in FHA programs.
• Expands roster eligibility to include nonprofit organizations
created by State and local governments that qualify for tax
exemption under section 115 of the Internal Revenue
Code.
• Removes requirement that a nonprofit organization have a
voluntary board in order to be eligible for roster placement.
• Brings certainty to and streamlines the announced maximum mortgage amounts for each calendar year by removing a regulation that is no longer relevant.
• Removes permanent time restrictions on resale of FHA-insured properties, thus lifting burdensome regulatory impediments to receiving FHA mortgage insurance.
• Removes regulations for an underutilized program, streamlining the application process for FHA-insured.
2502–AI99 ..........
2502–AJ01 .........
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2502–AJ00 .........
2502–AI98 ..........
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Programs: Changes to Limitation on Distributions of
Project Funds and Adjustment of Initial Equity; Proposed
Rule.
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• Removes overly burdensome reporting requirements for
small lenders wishing to participate in FHA programs.
• Eliminates duplicative reporting requirements for lenders
who already report to other Federal agencies, thus reducing paperwork and minimizing the burden of the process of
becoming an FHA-approved.
• By reducing regulatory barriers, this change removes a
disincentive for nonprofit owners to promote affordable
housing.
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Regulation
Identifier No.
(RIN)
7765
Title
Anticipated Reductions in Regulatory Burden
2502–AI67 ..........
Streamlining Requirements Governing the Use of Funding for
Supportive Housing for the Elderly and Persons With Disabilities Programs; Proposed Rule.
2577–AC68 ........
Public Housing Assessment System (PHAS); Final Rule .......
2577–AC50 ........
Public Housing Capital Fund Program; Final Rule ..................
2577–AC88 ........
Streamlined Application Process in Public/Private Partnerships for Mixed-Finance Development of Public Housing
Units; Proposed Rule.
Revisions to the Consortia of Public Housing Agencies; Proposed Rule.
• Removes restrictions on the portions of developments not
funded through capital advances.
• Removes regulatory barriers on participations by creating
new exemptions to the conflict of interest provisions.
• Provides flexibility regarding amenities that may be provided in projects.
• Streamlines requirements for release of capital advance
funds upon completion.
• Consolidates assessment regulations in 24 CFR part 902.
• Removes outdated Public Housing Management Assessment Program (PHMAP) regulations at 24 CFR part 901.
• Streamlines public housing modernization requirements.
• Consolidates the modernization requirements for the public
housing programs in HUD’s Capital Fund Program regulations at 24 CFR part 905.
• Removes outdated parts 941, 968, 969, which currently
codify the legacy modernization program requirements.
• Reduces document submission burdens on Public Housing
Agencies (PHAs).
2577–AC89 ........
2577–AC87 ........
2577–AC86 ........
2577–AC76 ........
Removal of the Indian HOME Investment Partnerships Program Regulations; Final Rule.
Public Housing and Section 8 Programs: Housing Choice
Voucher—Improving Portability for Voucher Families Proposed Rule.
Revision to the Section 8 Management Assessment Program
(SEMAP) Lease-Up Indicator; Proposed Rule.
2506–AC26,
2506–AC29,
2506–AC31,
2506–AC32,
2506–AC33.
Implementation of the Homeless Emergency Assistance and
Rapid Transition to Housing Act of 2009 (HEARTH Act).
2501–AC94 ........
HOME Investment Partnerships—Improving Performance
and Accountability; Updating Property Standards and Instituting Energy Efficiency Standards.
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Aggregate Costs and Benefits
Executive Order 12866, as amended,
requires the agency to provide its best
estimate of the combined aggregate costs
and benefits of all regulations included
in the agency’s regulatory plan that will
be made effective in calendar year 2011.
HUD expects that neither the total
economic costs nor the total efficiency
gains will exceed $100 million. None of
the rules on HUD’s regulatory plan is
anticipated to have an economically
significant impact. The revisions
proposed to be made to HUD’s HECM
program are anticipated to strengthen
the program, keep seniors in their
homes, and protect the FHA Insurance
Fund, but the proposed changes are
prospective and are not expected to
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• Enables PHAs to establish cross-jurisdictional consortia
that would be treated as a single PHA, with a single jurisdiction and a single set of reporting and audit requirements, for purposes of administering the Housing Choice
Voucher program in a more streamlined and less burdensome fashion.
• Removes outdated regulations for the legacy Indian HOME
program.
• Removes the administrative burdens involved with processing portability requests.
• Removes complexity and administrative burden caused by
use of both the fiscal year and calendar year systems.
• Provides a critical synchronization of administration of the
voucher program, which will reduce program inefficiencies.
• Provides for consolidated grant application and administration to ease administrative burden and improve coordination among providers and, consequently, increase the effectiveness of responses to the needs of homeless persons.
• Provides for increased coordination and planning between
programs to better meet the needs of homeless persons.
• Modernizes the Continuum of Care program and Emergency Shelter Grants program.
• This proposed rule would update HUD’s program regulations to reflect current legal requirements with respect to
HOME projects.
result in an economic impact of $100
million or more annually. The changes
proposed to be made to the SEMAP
program are similarly designed to
strengthen the program and are
intended to have the Housing Choice
Voucher program be administered more
effectively and efficiently but will also
not result in an economic impact of
$100 million or more. Implementation
of the new project rental assistance
authority in the Section 811 program, as
authorized by the Melville Act, will
open up another source of financing for
supportive housing for persons with
disabilities but not at a level of $100
million or more.
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The Priority Regulations That Comprise
HUD’s Regulatory Plan
A more detailed description of the
priority regulations that comprise
HUD’s regulatory plan follows.
HUD—OFFICE OF HOUSING (OH)
Proposed Rule Stage
82. Federal Housing Administration
(FHA): Strengthening the Home Equity
Conversion Mortgages (HECM) Program
To Promote Sustained Homeownership
(FR–5353)
Priority: Other Significant.
Legal Authority: 12 U.S.C. 1715b,
1715z to 1720; 42 U.S.C. 3535(d)
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
CFR Citation: 24 CFR 206.19; 24 CFR
206.32; 24 CFR 206.25; 24 CFR 206.27;
24 CFR 206.29; 24 CFR 206.38.24; 24
CFR 206.51; 24 CFR 206.53; 24 CFR
206.105; 24 CFR 206.107; 24 CFR
206.124; 24 CFR 206.129; 24 CFR
206.140, 206.142; 24 CFR 206.203, 19;
24 CFR 206.58; 24 CFR 206.47.
Legal Deadline: None.
Abstract: HUD is taking another step
to reform and strengthen the mortgage
insurance functions and responsibilities
of the Federal Housing Administration
(FHA), and concomitantly protect the
individuals and families that use FHAmortgage products. This proposed rule
would revise the regulations governing
FHA’s Home Equity Conversion
Mortgage (HECM) program, which is
FHA’s reverse mortgage program that
enables senior homeowners who have
equity in their homes to withdraw a
portion of the accumulated equity. Most
significantly, this rule proposes to
require FHA-approved mortgagees that
originate HECM mortgages (HECM
mortgagees) to perform a financial
capacity and credit history assessment
of prospective HECM mortgagors prior
to loan approval and closing.
Mortgagees will be required to evaluate
whether the HECM mortgagor’s cash
flow and credit history support the
mortgagor’s ability to comply with the
obligations of the HECM and are
sufficient to meet recurring living
expenses. A mortgagee may deny the
HECM loan application if the
prospective mortgagor fails either the
financial capacity or credit history
assessment. As an alternative to
declining the HECM loan application,
the mortgagee may require the
establishment of a principal limit setaside for payment of property charges.
The proposed rule would also cap the
amount of insurance benefits paid in
connection with a claim involving
amounts advanced by the mortgagee on
behalf of a HECM mortgagor who fails
to pay such property charges when the
HECM proceeds have been exhausted
and establish a new property inspection
requirement to insure that home secured
with a HECM mortgage are adequately
maintained and meet applicable
property standards. The proposed rule
would also make several nonsubstantive changes to reflect the
statutory flexibility provided to HUD in
establishing the mortgage insurance
premiums for FHA-insured mortgages,
conform the regulations to existing HUD
interpretations and industry practices
regarding HECM program requirements,
and reduce administrative paperwork.
Statement of Need: HUD does not
currently require HECM mortgagees to
verify the mortgagor’s income, assets,
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and debt obligations. Neither do the
HECM regulations require a mortgagee
to assess the mortgagor’s credit history
and capacity to pay future living
expenses and meet all other future
financial obligations related to the
property under the HECM loan. Such a
financial capacity and credit history
assessment is a prudent underwriting
practice currently required by
mortgagees for FHA forward mortgage
products. Based on data available to
HUD, HECM delinquencies are growing
and occurring soon after origination.
This data also indicates that these
delinquencies are largely the result of
the failure of mortgagors to pay
recurring property charges. The
proposed rule would address these
concerns by requiring that mortgagees
determine whether the potential
mortgagor has the capacity to pay
recurring property charges and meet
recurring living expenses.
Summary of Legal Basis: The HECM
program is authorized under section 255
of the National Housing Act (12 U.S.C.
1715z to 1720). This rulemaking is
undertaken pursuant to the general
rulemaking authority granted to the
Secretary under section 7(d) of the
Department of HUD Act (42 U.S.C.
35335(d)), which authorizes the
Secretary to make ‘‘such rules and
regulations as may be necessary to carry
out his functions, powers, and duties.’’
In addition, the National Housing Act at
12 U.S.C. 1701c(a) uses the exact
wording in conferring general
rulemaking authority to the Secretary
for implementing the insured mortgage
programs authorized under the National
Housing Act.
Alternatives: Rulemaking is required
to ensure that the financial capacity and
credit history requirements are generally
applicable and enforceable by HUD.
Where appropriate, HUD will provide
mortgagees with flexibility in
determining the method for conducting
the required assessments and for
considering additional factors in
determining and verifying the financial
capacity and credit history of
prospective HECM mortgagors.
Anticipated Cost and Benefits: The
benefits of this rule would be the
reduced transaction costs and
externalities associated with
foreclosure. The costs of the rule would
be the additional administrative and
financial costs associated with carrying
out the required assessments.
Risks: This rule poses no risk to
public health, safety, or the
environment.
Timetable:
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Action
Date
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Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Kari B. Hill, Director,
Office of Single Family Program
Development, Department of Housing
and Urban Development, Office of
Housing, 451 7th Street SW.,
Washington, DC 20410, Phone: 202 708–
2121.
RIN: 2502–AI79
HUD—OH
83. • Supportive Housing for Persons
With Disabilities Implementing New
Project Rental Assistance Authority
(FR–5576)
Priority: Other Significant.
Legal Authority: 12 U.S.C. 1701q; 42
U.S.C. 1437f, 3535(d), and 8013
CFR Citation: 24 CFR 891.
Legal Deadline: None.
Abstract: This proposed rule
commences the rulemaking process to
implement the project rental assistance
authority as provided under the Frank
Melville Supportive Housing
Investment Act of 2010 (Pub. L. 111–
374) (Melville Act), which was enacted
on January 4, 2011. The Melville Act
amended section 811 of the CranstonGonzalez National Affordable Housing
Act (42 U.S.C. 8013), which authorizes
the supportive housing program for
persons with disabilities (Section 811
program). The Melville Act made
significant changes to the Section 811
program, with one of the most
significant changes being the
establishment of new project rental
assistance authority. This new authority
allows HUD to make Section 811
program operating assistance available
to State housing agencies and similar
organizations for the purposes of
granting funds to the development of
supportive housing for persons with
disabilities and overseeing compliance
with the requirements applicable to
such housing. This proposed rule
establishes the requirements and
procedures that would govern the
eligibility and use of project rental
assistance in HUD’s supportive housing
program for persons with disabilities.
Statement of Need: The Melville Act
makes many important reforms and
improvements to the Section 811
program. One of the most significant
new features introduced by the Melville
Act is the establishment of new project
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
rental assistance authority (section
811(b)(3) of the Cranston-Gonzalez
National Affordable Housing Act, as
amended by the Melville Act) that is
separate from the existing project rental
assistance under the Section 811
program that is available to cover
operating costs. Although the Melville
Act establishes the prerequisite
statutory framework, the full and
successful implementation of the new
project rental assistance authority
requires rulemaking. This proposed rule
addresses the need for rulemaking by
establishing the necessary policies,
procedures, and other requirements that
will govern the eligibility and use of
project rental assistance. HUD intends
to implement other changes made by the
Melville Act through separate
rulemaking.
Summary of Legal Basis: As noted, the
Melville Act amended section 811 of the
Cranston-Gonzalez National Affordable
Housing Act to establish new project
rental assistance authority. This
rulemaking is undertaken pursuant to
the general rulemaking authority
granted to the Secretary under section
7(d) of the Department of HUD Act (42
U.S.C. 35335(d)), which authorizes the
Secretary to make ‘‘such rules and
regulations as may be necessary to carry
out his functions, powers, and duties.’’
Alternatives: Rulemaking is required
to ensure that the new requirements and
procedures governing the eligibility and
use of project rental assistance are
generally applicable to participants in
HUD’s supportive housing program for
persons with disabilities and
enforceable by HUD.
Anticipated Cost and Benefits: The
new project rental assistance authority
offers another method of financing for
supportive housing for persons with
disabilities for projects that do not
receive capital advances. The new
authority is designed to promote and
facilitate the creation of integrated
supportive housing units, which is
achieved by making funds available to
State housing agencies and other
appropriate entities. While there may be
incremental costs associated with
compliance with the new requirements,
to the extent that program participants
incur such costs, it will be as a result
of their voluntary participation in the
project rental assistance component of
the Section 811 program. The benefits
are increased affordability of providing
housing for persons with disabilities.
Risks: This rule poses no risk to
public health, safety, or the
environment
Timetable:
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Action
Date
NPRM ..................
FR Cite
02/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Benjamin T. Metcalf,
Senior Advisor, Office of Multifamily
Houisng Programs, Department of
Housing and Urban Development, Office
of Housing, 451 7th Street SW.,
Washington, DC 20410, Phone: 202 708–
2495.
RIN: 2502–AJ10
HUD—OFFICE OF PUBLIC AND INDIAN
HOUSING (PIH)
Proposed Rule Stage
84. Tenant–Based Rental Assistance;
Improving Performance Through a
Strengthened Section 8 Management
Assessment Program (FR–5201)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 1437a,
1437c, 1437f; 42 U.S.C. 3535(d)
CFR Citation: 24 CFR 985.
Legal Deadline: None.
Abstract: SEMAP establishes the
management indicators used by HUD to
measure the performance of public
housing agencies (PHA) in key areas of
the Section 8 rental assistance programs
and to assign performance ratings. The
proposed rule would revise the
indicator that measures Section 8
voucher use to encourage PHAs to
maximize the number of Section 8
families served. Specifically, under this
revised indicator, HUD will not only
consider the number of vouchers
available to a PHA, but also the funds
available to the PHA, including budget
authority and a portion of reserves. HUD
also proposes to assume responsibility
for conducting the inspections used to
measure a PHA’s compliance with
housing quality standards (HQS).
Currently, HUD measures HQS
compliance through a reporting
requirement for PHA self-conducted
inspections. The proposed rule would
also establish a new deconcentration
indicator that will evaluate the ability of
Section 8 families with children to
access neighborhoods with belowaverage poverty rates or neighborhoods
with above-average schools.
Statement of Need: While the SEMAP
is currently an effective oversight tool,
HUD’s experience indicates that
modifications are needed to increase its
utility and to better reflect policy
priorities. The proposed regulatory
amendments address these needs. For
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7767
example, the change to the voucher
utilization indicator will allow HUD to
better assess whether PHAs are
maximizing their use of available
voucher authority and funds to assist
families. By assuming responsibility for
HQS inspections, HUD will be in a
better position to assess their quality
and accuracy. The new deconcentration
indicator addresses one of HUD’s
highest priorities; namely, improving
the housing and educational
opportunities afforded to families
receiving HUD assistance.
Summary of Legal Basis: The Section
8 rental assistance programs are
authorized under section 8 of the United
States Housing Act of 1937 (42 U.S.C.
1437f). This rulemaking is undertaken
pursuant to the general rulemaking
authority granted to the Secretary under
section 7(d) of the Department of HUD
Act (42 U.S.C. 35335(d)), which
authorizes the Secretary to make ‘‘such
rules and regulations as may be
necessary to carry out his functions,
powers, and duties.’’
Alternatives: Rulemaking is required
to ensure that revised SEMAP indicators
are generally applicable to all PHAs
administering Section 8 programs, and
are enforceable by HUD. Moreover, the
current SEMAP requirements are
codified in regulation and, therefore,
notice and comment rulemaking is
required for their revision.
Anticipated Cost and Benefits: There
may be some incremental administrative
costs borne by PHAs as a result of
revised indicators. The benefits are the
cost savings of no longer having to
conduct HQS inspections, resulting in a
net economic benefit. HUD will assume
the costs of conducting these
inspections, but these costs will be
balanced by the management and
operational benefits resulting from the
proposed SEMAP enhancements.
Moreover, HUD is considering whether
HQS inspections should be conducted
less frequently than on an annual basis,
in order to allow for the best use of
departmental resources.
Risks: This rule poses no risk to
public health, safety, or the
environment.
Timetable:
Action
Date
NPRM ..................
FR Cite
02/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Additional Information: Includes
retrospective review under Executive
Order 13563.
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Agency Contact: Laure Rawson,
Director, Housing Voucher Management
and Operations Division, Department of
Housing and Urban Development, Office
of Public and Indian Housing, 451 7th
Street SW., Washington, DC 20410,
Phone: 202 402–2425.
RIN: 2577–AC76
BILLING CODE 4210–67–P
DEPARTMENT OF THE INTERIOR (DOI)
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Statement of Regulatory Priorities
The Department of the Interior (DOI)
is the principal Federal steward of our
Nation’s public lands and resources,
including many of our cultural
treasures. DOI serves as trustee to Native
Americans and Alaska natives and is
responsible for relations with the island
territories under United States
jurisdiction. The Department manages
more than 500 million acres of Federal
lands, including 397 park units, 555
wildlife refuges, and approximately 1.7
billion of submerged offshore acres.
This includes some of the highest
quality renewable energy resources
available to help the United States
achieve the President’s goal of energy
independence, including geothermal,
solar, and wind.
The Department protects and recovers
endangered species; protects natural,
historic, and cultural resources;
manages water projects that are a
lifeline and economic engine for many
communities in the West; manages
forests and fights wildfires; manages
Federal energy resources; regulates
surface coal mining operations; reclaims
abandoned coal mines; educates
children in Indian schools; and provides
recreational opportunities for over 400
million visitors annually in the Nation’s
national parks, public lands, national
wildlife refuges, and recreation areas.
The DOI will continue to review and
update its regulations and policies to
ensure that they are effective and
efficient, and that they promote
accountability and sustainability. The
DOI will emphasize regulations and
policies that:
• Promote environmentally
responsible, safe, and balanced
development of renewable and
conventional energy on our public lands
and the Outer Continental Shelf (OCS);
• Use the best available science to
ensure that public resources are
protected, conserved, and used wisely;
• Adopt performance approaches
focused on achieving cost-effective,
timely results;
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• Improve the nation-to-nation
relationship with American Indian
tribes;
• Promote partnerships with States,
tribes, local governments, other groups,
and individuals to achieve common
goals;
• Promote transparency, fairness,
accountability, and the highest ethical
standards while maintaining
performance goals.
Major Regulatory Areas
The DOI bureaus implement
congressionally mandated programs
through their regulations. Some of these
regulatory programs include:
• Developing onshore and offshore
energy, including renewable, minerals,
oil and gas, and other energy resources;
• Regulating surface coal mining and
reclamation operations on public and
private lands;
• Managing migratory birds and
preserving marine mammals and
endangered species;
• Managing dedicated lands, such as
national parks, wildlife refuges,
National Landscape Conservation
System lands, and American Indian
trust lands;
• Managing public lands open to
multiple use;
• Managing revenues from American
Indian and Federal minerals;
• Fulfilling trust and other
responsibilities pertaining to American
Indians;
• Managing natural resource damage
assessments; and
• Managing assistance programs.
Regulatory Policy
How DOI Regulatory Priorities Support
the President’s Energy, Resource
Management, Environmental
Sustainability, and Economic Recovery
Goals
The DOI’s regulatory programs seek to
operate programs transparently,
efficiently, and cooperatively while
maximizing protection of our land,
resources, and environment in a fiscally
responsible way by:
(1) Protecting Natural, Cultural, and
Heritage Resources
The Department’s mission includes
protecting and providing access to our
Nation’s natural and cultural heritage
and honoring our trust responsibilities
to tribes. We are committed to this
mission and to applying laws and
regulations fairly and effectively. Our
priorities include protecting public
health and safety, restoring and
maintaining public lands, protecting
threatened and endangered species,
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ameliorating land- and resourcemanagement problems on public lands,
and ensuring accountability and
compliance with Federal laws and
regulations.
The Bureau of Land Management
(BLM) Wildlife Program continues to
focus on maintaining and managing
wildlife habitat to ensure self-sustaining
populations and a natural abundance
and diversity of wildlife resources on
public lands. The BLM-managed lands
are vital to game species and hundreds
of species of non-game mammals,
reptiles, and amphibians. In order to
provide for long-term protection of
wildlife resources, especially given
other mandated land use requirements,
the Wildlife Program supports
aggressive habitat conservation and
restoration activities, many funded by
partnerships with Federal, State, and
non-governmental organizations. For
instance, the Wildlife Program is
restoring wildlife habitat across a multistate region to support species that
depend upon sagebrush vegetation.
Projects are tailored to address regional
issues such as fire (as in the western
portion of the sagebrush biome) or
habitat degradation and loss (as in the
eastern portion of the sagebrush biome).
Additionally, BLM undertakes habitat
improvement projects in partnership
with a variety of stakeholders and
consistent with State fish and game
wildlife action plans and local working
group plans.
The National Park Service (NPS) is
working with BLM and the U.S. Fish
and Wildlife Service (FWS) to finalize a
rule implementing Public Law 106–206,
which directs the Secretary to establish
a system of location fees for commercial
filming and still photography activities
on public lands. While commercial
filming and still photography are
generally allowed on Federal lands,
managing this activity through a
permitting process will minimize
damage to cultural or natural resources
and interference with other visitors to
the area. This regulation would
standardize location fee rates and
collection for all DOI agencies.
The NPS is proposing a new winter
use rule for Yellowstone National Park.
This rule is proposed to replace an
interim rule that expired at the end of
the 2010 to 2011 winter season and that
was recently reauthorized for the
current (2011–2012) winter season. It
would allow a variety of winter uses for
visitors while protecting park resources
by establishing maximum numbers of
snowmobiles and snowcoaches
permitted in the Park on a given day. It
would also require most snowmobiles
and snowcoaches operating in the Park
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to meet air and sound emission
requirements and would require a
commercial guide. The NPS intends to
publish a final rule by mid-November
2012.
The NPS is prepared to publish final
rules for Off Road Vehicle use at Cape
Hatteras National Seashore and bicycle
routes at Mammoth Cave National Park.
Proposed rules for bicycle routes are
pending for other park areas. These
rules would manage use to protect and
preserve natural and cultural resources,
and natural processes, and provide a
variety of safe visitor experiences while
minimizing conflicts among various
users.
(2) Sustainably Using Energy, Water,
and Natural Resources
The BLM has identified
approximately 20.6 million acres of
public land with wind energy potential
in the 11 western States and
approximately 29.5 million acres with
solar energy potential in the six
southwestern States. There are over 140
million acres of public land in western
States and Alaska with geothermal
resource potential. There is also
significant wind and wave potential in
our offshore waters. The National
Renewable Energy Lab, a Department of
Energy national laboratory, has
identified more than 1,000 gigawatts of
wind potential off the Atlantic coast—
roughly equivalent to the Nation’s
existing installed electric generating
capacity—and more than 900 gigawatts
of wind potential off the Pacific Coast.
Because public lands are extensive and
widely distributed, the Department has
an important role, in consultation with
Federal, State, regional, and local
authorities, in approving and building
new transmission lines that are crucial
to deliver renewable energy to
America’s homes and businesses.
Since the beginning of the Obama
Administration, the Department has
focused on renewable energy issues and
has established priorities for
environmentally responsible
development of renewable energy on
public lands and the OCS. Industry has
started to respond by investing in
development of wind farms off the
Atlantic seacoast and solar, wind, and
geothermal energy facilities throughout
the west. Power generation from these
new energy sources produces virtually
no greenhouse gases and, when done in
an environmentally sensitive manner,
harnesses with minimum impact
abundant renewable energy that nature
itself provides. The Department will
continue its intra- and interdepartmental efforts to move forward
with the environmentally responsible
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review and permitting of renewable
energy projects on public lands.
The Secretary issued his first
Secretarial Order on March 11, 2009,
making renewable energy on public
lands and the OCS top priorities at the
Department. These remain top
priorities. In implementing these
priorities through its regulations, the
Department will continue to create jobs
and contribute to a healthy economy
while protecting our signature
landscapes, natural resources, wildlife,
and cultural resources.
(3) Empowering People and
Communities
The Department strongly encourages
public participation in the regulatory
process. For example, every year the
FWS establishes migratory bird hunting
seasons in partnership with flyway
councils composed of State fish and
wildlife agencies. The FWS also holds a
series of public meetings to give other
interested parties, including hunters
and other groups, opportunities to
participate in establishing the upcoming
season’s regulations.
Similarly, the BLM uses Resource
Advisory Councils made up of affected
parties to help prepare land
management plans and regulations.
The NPS has begun revising its rules
on non-Federal development of gas and
oil in units of the National Park System.
Of the approximately 700 gas and oil
wells in 13 NPS units, 55 percent, or
385 wells, are exempt from current
regulations. The NPS is revising the
regulations to improve protection of
NPS resources. The NPS actively sought
public input into designing the rule and
published an Advance Notice of
Proposed Rulemaking with a comment
period from November 15, 2009,
through January 25, 2010. Interested
members of the public were able to
make suggestions for the content of the
rule, which NPS will consider in
writing the proposed rule. After
developing a proposed rule, NPS will
solicit further public comment. The NPS
expects to publish a proposed rule in
2012.
In October 2010, NPS published an
interim final rule with request for
comments revising the former
regulations for management of
demonstrations and the sale or
distribution of printed matter in most
areas of the National Park System to
allow a small-group exception to permit
requirements. In essence, under specific
criteria, demonstrations, and the sale or
distribution of printed matter involving
25 or fewer persons may be held in
designated areas, without first obtaining
a permit; i.e. making it easier for
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individuals and small groups to express
their views. The NPS has analyzed the
comments and expects to publish a final
rule in early 2012.
Retrospective Review of Regulations
President Obama’s Executive Order
13563 directs agencies to make the
regulatory system work better for the
American public. Regulations should
‘‘* * * protect public health, welfare,
safety, and our environment while
promoting economic growth,
innovation, competitiveness, and job
creation.’’ DOI’s plan for retrospective
regulatory review identifies specific
efforts to relieve regulatory burdens, add
jobs to the economy, and make
regulations work better for the American
public while protecting our
environment and resources. The DOI
plan seeks to strengthen and maintain a
culture of retrospective review by
consolidating all regulatory review
requirements 1 into DOI’s annual
regulatory plan. DOI has selected the
following regulatory efforts to focus on
over the next 2 years:
• Oil and Gas Royalty Valuation
Rules (Office of Natural Resources
Revenue)—DOI is exploring a simplified
market-based approach to arrive at the
value of oil and gas for royalty purposes
that could dramatically reduce
accounting and paperwork requirements
and costs on industry and better ensure
proper royalty valuation by creating a
more transparent royalty calculation
method.
• Endangered Species Act Rules (Fish
and Wildlife Service)—The Fish and
Wildlife Service (FWS), working in
conjunction with the National Marine
Fisheries Service, will revise and update
the ESA implementing regulations and
policies to improve conservation
effectiveness, reduce administrative
burden, enhance clarity and consistency
for impacted stakeholders and agency
staff, and encourage partnerships,
innovation, and cooperation. FWS has
already proposed a rule on May 17,
2011, that would minimize the
requirements for written descriptions of
critical habitat boundaries in favor of
map and Internet-based descriptions.
FWS anticipates issuing the final rule in
the spring of 2012. Additionally, FWS
will develop proposed rules and/or
policies to amend existing regulations
related to:
• Habitat conservation plans;
1 DOI conducts regulatory review under
numerous statutes, Executive orders, memoranda,
and policies, including but not limited to the
Regulatory Flexibility Act of 1980 (RFA), the Small
Business Regulatory Enforcement Fairness Act of
1996 (SBREFA), Executive Orders 12866 and 13563,
and the DOI Departmental Manual.
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• Safe harbor agreements;
• Candidate conservation agreements;
• The process and procedures for
designation of critical habitat;
• Section 7 consultation to revise the
definition of ‘‘destruction or adverse
modification’’ of critical habitat; and
• Issuance of incidental take permits
during section 7 consultation.
• Commercial Filming on Public Land
Rules—This joint effort between the
National Park Service (NPS), Fish and
Wildlife Service (FWS), Bureau of Land
Management (BLM), Bureau of
Reclamation (BOR), and Bureau of
Indian Affairs (BIA) will create
consistent regulations and a unified fee
schedule for commercial filming and
still photography on public land. It will
provide the commercial filming
industry with a predictable fee for using
Federal lands, while earning the
Government a fair return for the use of
that land.
• Offshore Energy Safety and
Environmental Rules (BSEE)—In the
wake of the Deepwater Horizon oil spill,
DOI immediately instituted regulatory
reforms that strengthened the protection
of workers’ health and safety and
enhanced environmental safeguards.
The Bureau of Safety and
Environmental Enforcement (BSEE),
formerly part of the Bureau of Ocean
Energy Management, Regulation, and
Enforcement (BOEMRE) is now
considering ways to apply ‘‘safety case’’type performance standards, such as
those widely applied internationally, to
the U.S. offshore drilling regulatory
regime. A hybrid combination of
performance-based and prescriptive
standards will provide flexibility to
adapt to changing technologies and
increasingly complex operational
conditions, while maintaining worker
and environmental protections.
• Leasing (BIA)—BIA is amending its
leasing regulations to eliminate the need
to follow multiple cross-references in
the regulations. The amendments will
also delete the requirement for BIA
review of permits, which some view as
unjustified and excessively
burdensome.
• Land Classification Regulations
(BLM)—BLM is amending its regulations
to remove obsolete land classification
regulations and consolidate these
regulations into the existing planning
system regulations. These changes will
benefit the public by consolidating all
land use decisions into one systematic
process.
DOI bureaus work to make our
regulations easier to comply with and
understand. Our regulatory process
ensures that bureaus share ideas on how
to reduce regulatory burdens while
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meeting the requirements of the laws
they enforce and improving their
stewardship of the environment and
resources. Results include:
• Effective stewardship of our
Nation’s resources in a way that is
responsive to the needs of small
businesses;
• Increased benefits per dollars spent
by carefully evaluating the economic
effects of planned rules; and
• Improved compliance and
transparency by use of plain language in
our regulations and guidance
documents.
Bureaus and Offices Within DOI
The focus of DOI’s major regulatory
bureaus and offices is summarized
below.
Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA)
administers and manages 56 million
acres of land held in trust by the United
States for Indians and Indian tribes,
providing services to approximately 1.9
million Indians and Alaska Natives, and
maintaining a government-togovernment relationship with the 565
federally recognized Indian tribes. The
BIA’s mission is to enhance the quality
of life, to promote economic
opportunity, and to carry out the
responsibility to protect and improve
the trust assets of American Indians,
Indian tribes, and Alaska Natives, as
well as to provide quality education
opportunities to students in Indian
schools.
In the coming year, BIA will continue
its regulatory focus on improved
management of trust responsibilities
and promotion of economic
development in Indian communities. In
addition, BIA will focus on updating
Indian education regulations and on
other regulatory changes to increase
transparency in support of the
President’s Open Government Initiative.
With the input of tribal leaders,
individual Indian beneficiaries, and
other subject matter experts, BIA has
been examining better ways to serve its
beneficiaries. The American Indian
Probate Reform Act of 2004 (AIPRA)
made clear that regulatory changes were
necessary. BIA has promulgated
regulations implementing the probaterelated provisions of AIPRA and will
now focus on regulations to implement
other AIPRA provisions related to
managing Indian land.
The focus on promoting economic
development in Indian communities is
a core component of BIA’s mission.
Economic development initiatives can
attract businesses to Indian
communities that provide jobs and fund
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services that support the health and
well-being of tribal members. Economic
development can enable tribes to attain
self-sufficiency, strengthen their
governments, and reduce crime.
Indian education is a top priority of
the Assistant Secretary for Indian
Affairs. BIA will review Indian
education regulations to ensure that
they adequately support efforts to
provide students of BIA-funded schools
with the best education possible.
Finally, BIA’s regulatory focus on
increasing transparency implements the
President’s Open Government Initiative.
BIA will ensure that all regulations that
it drafts or revises meet high standards
of readability and accurately and clearly
describe BIA processes.
BIA’s regulatory priorities are to:
• Develop regulations to meet the
Indian trust reform goals for land
consolidation and land use
management.
BIA is amending regulations affecting
land title and records, conveyances of
trust or restricted land, leasing, grazing,
trespass, rights-of-way, and energy and
minerals. These regulatory changes will
help the Department better serve
beneficiaries and will standardize
procedures for consistent execution of
fiduciary responsibilities across the BIA.
• Identify and develop regulatory
changes necessary for improved Indian
education.
BIA is reviewing regulations
addressing grants to tribally controlled
community colleges and other Indian
education regulations. The review will
identify provisions that need to be
updated to comply with applicable
statutes and ensure that the proper
regulatory framework is in place to
support students of Bureau-funded
schools.
• Develop regulatory changes to
reform the process for Federal
acknowledgment of Indian tribes.
Over the years, BIA has received
significant comments from American
Indian groups and members of Congress
on the Federal acknowledgment
process. Most of these comments claim
that the current process is cumbersome
and overly restrictive. The BIA is
reviewing the Federal acknowledgment
regulations to determine if any
regulatory changes are appropriate.
• Revise regulations governing
administrative appeals and other
processes to increase transparency.
The BIA is making a concentrated
effort to improve the readability and
precision of its regulations. Because
trust beneficiaries often turn to the
regulations for guidance on how a given
BIA process works, BIA is ensuring that
each revised regulation is written as
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clearly as possible and accurately
reflects the current organization of the
Bureau. A few of the regulations BIA
will be focusing this effort on include
the regulation governing administrative
appeals (25 CFR part 2), the land use
management regulations mentioned
above, and regulations addressing
various Indian services.
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The Bureau of Land Management
The BLM manages the 245-millionacre National System of Public Lands,
located primarily in the western States,
including Alaska, and the 700-millionacre subsurface mineral estate located
throughout the Nation. BLM’s complex
multiple-use mission affects the lives of
a great number of Americans, including
those who live near and visit the public
lands, as well as millions of Americans
who benefit from commodities, such as
minerals, energy, or timber, produced
from the lands’ rich resources.
The BLM’s multiple-use mission
conserves the lands’ natural and
cultural resources and sustains the
health and productivity of the public
lands for the use and enjoyment of
present and future generations. The
BLM manages such varied uses as
energy and mineral development,
outdoor recreation, livestock grazing,
and forestry and woodlands products.
The BLM has identified the following
three areas of regulatory priorities.
• Energy Independence
• Treasured Landscapes
• Native American Nations
The summaries that follow explain
how these three areas promote the BLM
mission and the priorities of the
Department.
Energy Independence
BLM manages more Federal land than
any other agency—more than 245
million surface acres and 700 million
subsurface acres of mineral estate. Thus,
it plays a key role in ensuring that the
Nation’s energy needs are met by
managing both Federal renewable and
non-renewable sources of energy. The
BLM is analyzing proposals for
increasing renewable energy
development on public lands. The BLM
will manage these proposals to assure
they proceed in an environmentally and
fiscally sound way that protects our
natural resources and critical wildlife
habitat for such species as the sage
grouse and lynx. These projects will
create environmentally friendly jobs and
help sustain the quality of life that
Americans enjoy today.
Another BLM priority is siting and
authorizing transmission corridors to
assist the national effort to move
renewable energy from production sites
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to market. The BLM has already
designated more than 5,000 miles of
energy transport corridors. The BLM
will authorize rights-of-way across
public lands through these energy
transport corridors to allow
development of transmission lines.
Treasured Landscapes
Protecting the landscapes of the
National System of Public Lands
involves numerous BLM programs as
the agency moves toward a holistic,
landscape-level approach to managing
multiple public land uses. The BLM
also engages partners interested in
working on a broader scale across
jurisdictional lines to achieve a common
landscape vision. For the past several
years, BLM, which manages the largest
amount and the greatest diversity of fish
and wildlife habitat of any Federal
agency, has focused on restoring healthy
landscapes in a number of ways,
including:
• Reducing the number of wild horses
and burros on public lands, particularly
in areas most affected by drought and
wildfire. Maintaining the wild horse
and burro population at appropriate
management levels is critical in the
effort to conserve forage resources that
also sustain native wildlife and
livestock.
• Restoring habitat for sensitive, rare,
threatened, and endangered species,
such as sage grouse, desert tortoise, and
salmon.
• Supporting greater biodiversity
through noxious weed and invasive
species treatments to bring back native
plants.
• Improving water quality by
restoring riparian areas and protecting
watersheds. Enhanced water quality
aids in the restoration of habitat for fish
and other aquatic and riparian species.
• Conducting post-fire recovery
efforts to promote healthy landscapes
and discourage the spread of invasive
species.
Native American Nations
BLM consults with Indian tribes on a
government-to-government basis under
multiple authorities and is continually
working to assess and improve its tribal
consultation practices. The BLM held
listening sessions throughout the West
on this important issue in 2009 and
2010 and received many valuable
comments. BLM has continued its
efforts to improve its tribal consultation
practices by participating with the
Department in multiple listening
sessions with tribes throughout the
country.
The Native American Graves
Protection and Repatriation Act
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(NAGPRA), enacted in 1990, addresses
the rights of lineal descendants, Indian
tribes, and Native Hawaiian
organizations to certain Native
American human remains, funerary
objects, associated funerary objects,
sacred objects, and objects of cultural
patrimony with which they are
affiliated. The statute and implementing
regulations represent a careful balance
between the legitimate interests of lineal
descendants, Indian tribes, and Native
Hawaiian organizations to control the
remains of their ancestors and cultural
property and the legitimate public
interests in scientific and educational
information associated with the human
remains and cultural items.
BLM is complying with the new
NAGPRA regulations, including
inventorying and repatriating human
remains and other cultural items that
are in BLM museum collections. BLM
also consults with Indian tribes on
implementing appropriate actions when
human remains and other cultural items
subject to NAGPRA are inadvertently
discovered or intentionally excavated
on the public lands.
Additionally, BLM, in cooperation
with the Bureau of Indian Affairs, helps
tribes and individual Indian allottees
develop their solid and fluid mineral
resources. BLM is responsible for
development, product measurement,
and inspection and enforcement of
extracting operations of the mineral
estate on trust properties.
BLM’s Regulatory Priorities
The BLM’s regulatory focus is
directed primarily by the priorities of
the President and Congress, which
include:
• Generating jobs and promoting a
healthy economy by facilitating
domestic production of various sources
of energy, including biomass, wind,
solar, and other alternative sources.
• Providing for a wide variety of
public uses while maintaining the longterm health and diversity of the land.
• Preserving significant natural,
cultural, and historic resource values.
• Understanding the arid, semi-arid,
arctic, and other ecosystems that BLM
manages.
• Using the best scientific and
technical information to make resource
management decisions.
• Understanding the needs of the
people who use and enjoy BLMmanaged public lands and providing
them with quality service.
• Securing the recovery of a fair
return for using publicly owned
resources, and avoiding the creation of
long-term liabilities for American
taxpayers.
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• Resolving problems and
implementing decisions in cooperation
with other agencies, states, tribal
governments, and the public.
In developing regulations, BLM
recognizes the need to ensure
communication, coordination, and
consultation with the public, including
affected interests, tribes, and other
stakeholders. BLM also works to draft
regulations that are easy for the public
to understand and that provide clarity to
those most affected by them.
The BLM’s specific regulatory
priorities include:
• Revising onshore oil and gas
operating standards.
The BLM expects to publish rules to
revise several existing onshore oil and
gas operating orders and propose one
new onshore order. Onshore orders
establish requirements and minimum
standards and provide standard
operating procedures. The orders are
binding on operating rights owners and
operators of Federal and Indian (except
the Osage Nation) oil and gas leases and
on all wells and facilities on state or
private lands committed to Federal
agreements. The BLM is responsible for
ensuring that oil or gas produced and
sold from Federal or Indian leases is
accurately measured for quantity and
quality. The volume and quality of oil
or gas sold from leases is key to
determining the proper royalty to be
paid by the lessee to the Office of
Natural Resources Revenue. Existing
Onshore Orders Number 3, 4, and 5
would be revised to use new industry
standards so that they reflect current
operating procedures and to require that
proper verification and accounting
practices are used consistently. New
Onshore Order Number 9 would cover
waste prevention and beneficial use.
The revisions would ensure that proper
royalties are paid on oil and gas
removed from Federal and Trust lands.
• Revising coal-management
regulations.
The BLM plans to publish a proposed
rule to amend the coal-management
regulations that pertain to the
administration of Federal coal leases
and logical mining units. The rule
would primarily implement provisions
of the Energy Policy Act of 2005 that
pertain to administering coal leases. The
rule also would clarify the royalty rate
applicable to continuous highwall
mining, a new coal-mining method in
use on some Federal coal leases.
• Publishing rules on paleontological
resources preservation.
The 2009 omnibus public lands law
included provisions on permitting for
the collection of paleontological
resources. The BLM and the National
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Park Service are co-leads of a team with
the U.S. Forest Service that will be
drafting a paleontological resources
rule. The rule would address the
protection of paleontological resources
and how BLM would permit the
collection of these resources. The rule
would also address other issues such as
administering permits, casual collection
of rocks and minerals, hobby collection
of common invertebrate plants and
fossils, and civil and criminal penalties
for violation of these rules.
• Amending rules on royalty rate
increases for new Federal Onshore
Competitive Oil and Gas Leases.
The BLM will consider amending its
oil and gas regulations to set higher
royalty rates for new Federal onshore
competitive oil and gas leases issued on
or after the effective date of the rule.
This rule would revise existing
regulations by increasing royalty rates
based on the options set out in the
proposed rule.
The Bureau of Ocean Energy
Management, Regulation, and
Enforcement
The Bureau of Ocean Energy
Management, Regulation, and
Enforcement (BOEMRE) replaced the
former Minerals Management Service
(MMS). On October 1, 2011, BOEMRE
was reorganized and divided into two
new Bureaus, under the Assistant
Secretary for Land and Minerals
Management:
(1) The Bureau of Ocean Energy
Management (BOEM) now functions as
the resource manager for the
conventional and renewable energy and
mineral resources on the OCS. It fosters
environmentally responsible and
appropriate development of the OCS for
both conventional and renewable energy
and mineral resources in an efficient
and effective manner that ensures fair
market value for the rights conveyed.
(2) The Bureau of Safety and
Environmental Enforcement (BSEE)
applies independent regulation,
oversight, and enforcement powers to
promote and enforce safety in offshore
energy exploration and production
operations and ensure that potentially
negative environmental impacts on
marine ecosystems and coastal
communities are appropriately
considered and mitigated.
Our regulatory focus for fiscal year
2012 is directed by Presidential and
legislative priorities that emphasize
contributing to America’s energy
supply, protecting the environment, and
ensuring a fair return for taxpayers for
energy production from Federal and
Indian lands.
BOEM’s regulatory priorities are to:
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• Finalize Regulations for Leasing of
Sulphur or Oil and Gas and Bonding
Requirements in the Outer Continental
Shelf
This final rule updates and
streamlines the existing OCS leasing
regulations and clarifies implementation
of the Federal Oil and Gas Royalty
Simplification and Fairness Act of 1996.
This final rule reorganizes leasing
requirements to communicate more
effectively the leasing process, as it has
evolved over the years. This final rule
makes changes to 30 CFR parts 250, 256,
and 260 that relate to the oil and gas
leasing and bonding requirements.
BSEE’s regulatory priorities are to:
• Establish Additional Requirements
for Safety Measures for Drilling and
Other Well Operations for Oil and Gas
This will be an Advance Notice of
Proposed Rulemaking to address
recommendations from the ‘‘Increased
Safety Measures for Energy
Development on the Outer Continental
Shelf’’ report that were not covered by
an Interim Final Rule BOEMRE, BSEE’s
predecessor, published on October 14,
2010. The safety measures
recommendations include additional
requirements for blowout preventers,
remotely operated vehicles, secondary
control systems, and cement evaluation
techniques. Detailed responses to the
questions and ideas posed in this
Advance Notice of Proposed
Rulemaking would allow BSEE to
develop more comprehensive
regulations, if needed, and have a better
understanding of the impacts.
• Revise Regulations on Safety and
Environmental Management Programs
for Offshore Operations and Facilities
This rulemaking proposes to revise 30
CFR part 250 (subpart S) regulations to
require operators to develop and
implement additional provisions in
their Safety and Environmental
Management Systems (SEMS) programs
for oil, gas, and sulphur operations in
the Outer Continental Shelf (OCS).
These revisions pertain to developing
and implementing: (1) Stop work
authority, (2) ultimate work authority,
(3) requiring employee participation in
the development and implementation of
SEMS programs, and (4) establishing
requirements for reporting unsafe
working conditions. In addition, this
proposed rule (5) requires independent
third parties to conduct audits of
operators’ SEMS programs and (6)
establishes further requirements relating
to conducting job safety analyses (JSA)
for activities identified in an operator’s
SEMS program. BSEE believes that these
new requirements will further reduce
the likelihood of accidents, injuries, and
spills in connection with OCS activities,
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by requiring OCS operators to
specifically address issues associated
with human behavior as it applies to
their SEMS program.
• Develop additional rules and
regulations as a result of ongoing
reviews of BSEE’s offshore regulatory
regime.
Several investigations and reviews of
BOEMRE, now BSEE, have been and are
being conducted by various agencies
and entities—including the Safety
Oversight Board, the Office of Inspector
General, the President’s Deepwater
Horizon Commission, the National
Academy of Engineering, and the joint
BOEMRE/United States Coast Guard
(USCG) investigation of Deepwater
Horizon. Some of these investigations
and reviews focus narrowly on the
Deepwater Horizon explosion; others
are broader in focus and include many
aspects of the current regulatory system.
BSEE expects that recommendations for
regulatory changes—both substantive
and procedural—will be generated by
these investigations and reviews, and
will need to be reviewed, analyzed, and
potentially incorporated in new or
modified regulations. The Secretary
established the Ocean Energy Safety
Advisory Committee to provide advice
on matters related to drilling and
workplace safety, and spill containment
and response. This Committee is
expected to make recommendations for
new or modified regulations.
Office of Natural Resources Revenue
The revenue responsibilities of the
former MMS now are located in the
Office of Natural Resources Revenue
(ONRR), which will continue to collect,
account for, and disburse revenues from
Federal offshore energy and mineral
leases and from onshore mineral leases
on Federal and Indian lands. The
program operates nationwide and is
primarily responsible for timely and
accurate collection, distribution, and
accounting for revenues associated with
mineral and energy production. The
regulatory program of ONRR seeks to:
• Simplify valuation regulations.
ONRR plans to simplify the
regulations at 30 CFR part 1206 for
establishing the value for royalty
purposes of (1) oil and natural gas
produced from Federal leases; and (2)
coal and geothermal resources produced
from Federal and Indian leases.
Additionally, the proposed rules would
consolidate sections of the regulations
common to all minerals, such as
definitions and instructions regarding
how a payor should request a valuation
determination. ONRR published
Advance Notices of Proposed
Rulemaking (ANPRMs) to initiate the
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rulemaking process and to obtain input
from interested parties.
• Finalize debt collection regulations.
ONRR is preparing regulations
governing collection of delinquent
royalties, rentals, bonuses, and other
amounts due under Federal and Indian
oil, gas, and other mineral leases. The
regulations would include provisions
for administrative offset and would
clarify and codify the provisions of the
Debt Collection Act of 1982 and the
Debt Collection Improvement Act of
1996.
• Continue to meet Indian trust
responsibilities.
ONRR has a trust responsibility to
accurately collect and disburse oil and
gas royalties on Indian lands. ONRR
will increase royalty certainty by
addressing oil valuation for Indian lands
through a negotiated rulemaking process
involving key stakeholders.
Office of Surface Mining Reclamation
and Enforcement
The Office of Surface Mining
Reclamation and Enforcement (OSM)
was created by the Surface Mining
Control and Reclamation Act of 1977
(SMCRA). Under SMCRA, OSM has two
principal functions. They are:
• The regulation of surface coal
mining and reclamation operations; and
• The reclamation and restoration of
abandoned coal mine lands.
In enacting SMCRA, Congress
directed OSM to ‘‘strike a balance
between protection of the environment
and agricultural productivity and the
Nation’s need for coal as an essential
source of energy.’’ In response to its
statutory mandate, OSM has sought to
develop and maintain a stable
regulatory program that is safe, costeffective, and environmentally sound. A
stable regulatory program ensures that
the coal mining industry has clear
guidelines for operation and
reclamation, and that citizens know
how the program is being implemented.
OSM’s Federal regulatory program
sets minimum requirements for
obtaining a permit for surface and
underground coal mining operations,
sets performance standards for those
operations, requires reclamation of
lands and waters disturbed by mining,
and requires enforcement to ensure that
the standards are met.
OSM is the primary regulatory
authority for SMCRA enforcement until
a State or Indian tribe develops its own
regulatory program, which is no less
effective than the Federal program.
When a State or Indian tribe achieves
‘‘primacy,’’ it assumes direct
responsibility for permitting, inspection,
and enforcement activities under its
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federally approved regulatory program.
Today, 24 of the 26 coal-producing
States have primacy. In the 2006
amendments to SMCRA, Indian tribes
with coal resources were provided the
opportunity to assume primacy. No
tribes have done so to date, although
three tribes have expressed an interest
in submitting a tribal program.
OSM’s regulatory priorities for the
coming year will focus on:
• Stream Protection.
Protect streams from the adverse
effects of surface coal mining
operations; and
• Coal Combustion Residues
Establish Federal standards for the
beneficial use of coal combustion
residues on active and abandoned coal
mines.
U.S. Fish and Wildlife Service
The mission of the U.S. Fish and
Wildlife Service (FWS) is to work with
others to conserve, protect, and enhance
fish, wildlife, and plants and their
habitats for the continuing benefit of the
American people. FWS also helps
ensure a healthy environment for people
by providing opportunities for
Americans to enjoy the outdoors and
our shared natural heritage.
FWS fulfills its responsibilities
through a diverse array of programs that:
• Protect and recover endangered and
threatened species;
• Monitor and manage migratory
birds;
• Restore native aquatic populations
and nationally significant fisheries;
• Enforce Federal wildlife laws and
regulate international trade;
• Conserve and restore wildlife
habitat such as wetlands;
• Help foreign governments conserve
wildlife through international
conservation efforts;
• Distribute Federal funds to States,
territories, and tribes for fish and
wildlife conservation projects; and
• Manage the almost 150-million-acre
National Wildlife Refuge System, which
includes 555 National Wildlife Refuges
and which protects and conserves fish
and wildlife and their habitats and
allows the public to engage in outdoor
recreational activities.
Critical challenges to the work of FWS
include global climate change; shortages
of clean water suitable for wildlife;
invasive species that are harmful to our
fish, wildlife, and plant resources and
their habitats; and the alienation of
children and adults from the natural
world. To address these challenges,
FWS has identified six priorities:
• The National Wildlife Refuge
System—conserving our lands and
resources;
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• Landscape conservation—working
with others;
• Migratory birds—conservation and
management;
• Threatened and endangered
species—achieving recovery and
preventing extinction;
• Connecting people with nature—
ensuring the future of conservation; and
• Aquatic species—the National Fish
Habitat Action Plan (a plan that brings
public and private partners together to
restore U.S. waterways to sustainable
health).
To carry out these priorities, FWS has
a large regulatory agenda that will,
among other things:
• List, delist, and reclassify species
on the Lists of Endangered and
Threatened Wildlife and Plants and
designate critical habitat for certain
listed species;
• Update our regulations to carry out
the Convention on International Trade
in Wild Fauna and Flora;
• Manage migratory bird populations;
• Administer the subsistence program
for harvest of fish and wildlife in
Alaska;
• Update our regulations governing
the Wildlife and Sport Fish Restoration
Program; and
• Set forth hunting and sport fishing
regulations for the National Wildlife
Refuge System.
Additionally, FWS is working with
the National Oceanic and Atmospheric
Administration and the Environmental
Protection Agency, via a contract with
the National Research Council (NRC), to
review scientific issues associated with
the Federal Insecticide, Fungicide, and
Rodenticide Act. Once the NRC’s report
is completed, the agencies will work
together to develop an approach that
produces efficient, scientifically
defensible biological evaluations
protective of listed species.
Further, the FWS’ Regional Directors
and/or Ecological Services State
Supervisors or Project leaders will be
meeting with their State counterparts to
discuss the role of State agencies in ESA
initiatives to enhance their involvement
in implementing the ESA’s provisions.
National Park Service
The NPS preserves unimpaired the
natural and cultural resources and
values within almost 400 units of the
National Park System encompassing
nearly 84 million acres of lands and
waters for the enjoyment, education,
and inspiration of this and future
generations. The NPS also cooperates
with partners to extend the benefits of
natural and resource conservation and
outdoor recreation throughout the
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To achieve this mission the NPS
adheres to the following guiding
principles:
• Excellent Service: Providing the
best possible service to park visitors and
partners.
• Productive Partnerships:
Collaborating with Federal, State, tribal,
and local governments, private
organizations, and businesses to work
toward common goals.
• Citizen Involvement: Providing
opportunities for citizens to participate
in the decisions and actions of the
National Park Service.
• Heritage Education: Educating park
visitors and the general public about
their history and common heritage.
• Outstanding Employees:
Empowering a diverse workforce
committed to excellence, integrity, and
quality work.
• Employee Development: Providing
developmental opportunities and
training so employees have the ‘‘tools to
do the job’’ safely and efficiently.
• Wise Decisions: Integrating social,
economic, environmental, and ethical
considerations into the decisionmaking
process.
• Effective Management: Instilling a
performance management philosophy
that fosters creativity, focuses on results,
and requires accountability at all levels.
• Research and Technology:
Incorporating research findings and new
technologies to improve work practices,
products, and services.
The NPS Division of Regulations and
Special Park Uses provides agency
coordination for a variety of activities
that directly affect the management of
visitor use and resource protection
within the National Park System to
carry out this mission. Our regulatory
priorities include among other issues:
Revising existing regulations
pertaining to:
• Commercial Film and Related
Activities
• Solid Waste Disposal
• Non-Federal Oil and Natural Gas
Rights
• Rights-of-Way
Establishing rules related to:
• Collection of Natural Products by
Members of Federally Recognized
Tribes for Traditional and Cultural
Purposes
• Managing Winter Use at
Yellowstone NP
• Managing Off Road Vehicle Use and
Bicycling
• Implementation of the Native
American Graves Protection and
Repatriation Act
• Establishing Standards and
Procedures for Disposition of
Archeological Materials
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Bureau of Reclamation
The Bureau of Reclamation’s mission
is to manage, develop, and protect water
and related resources in an
environmentally and economically
sound manner in the interest of the
American public. To accomplish this
mission, Reclamation employs
management, engineering, and science
to achieve effective and
environmentally sensitive solutions.
Reclamation projects provide:
Irrigation water service, municipal and
industrial water supply, hydroelectric
power generation, water quality
improvement, groundwater
management, fish and wildlife
enhancement, outdoor recreation, flood
control, navigation, river regulation and
control, system optimization, and
related uses. Reclamation has continued
to focus on increased security at its
facilities.
The Reclamation regulatory program
focus in fiscal year 2012 is to ensure
that its mission and laws that require
regulatory actions are carried out
expeditiously, efficiently, and with an
emphasis on cooperative problem
solving by implementing two newly
authorized programs:
• Rural Water Supply Program
Title I of Public Law 109–451
authorizes the establishment of a rural
water supply program to enable the
Bureau of Reclamation to coordinate
with rural communities throughout the
Western United States to identify their
potable water supply needs and
evaluate options for meeting those
needs. Under the Act, Reclamation is
finalizing a rule that will define how it
will identify and work with eligible
rural communities. Reclamation
published an interim final rule on
November 17, 2008, and expects to
publish a Second Notice of Proposed
Rulemaking in 2012 that will address
comments received from the public.
• Loan Guarantees
Title II of Public Law 109–451
authorizes the Secretary of the Interior,
through the Bureau of Reclamation, to
issue loan guarantees to assist in
financing: (a) Rural water supply
projects, (b) extraordinary maintenance
and rehabilitation of Reclamation
project facilities, and (c) improvements
to infrastructure directly related to
Reclamation projects. This new program
will provide an additional funding
option to help western communities and
water managers to cost effectively meet
their water supply and maintenance
needs. Under the Act, Reclamation is
working with the Office of Management
and Budget to publish a rule that will
establish criteria for administering the
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loan guarantee program. Reclamation
published a proposed rule on October 6,
2008, and expects to publish a Second
Notice of Proposed Rulemaking in 2012
that will address comments received
from the public.
BILLING CODE 4310–10–P
DEPARTMENT OF JUSTICE (DOJ)
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Statement of Regulatory Priorities
The mission of the Department of
Justice is to enforce the law and defend
the interests of the United States
according to the law, to ensure public
safety against threats foreign and
domestic, to provide Federal leadership
in preventing and controlling crime, to
seek just punishment for those guilty of
unlawful behavior, and to ensure fair
and impartial administration of justice
for all Americans. In carrying out its
mission, the Department is guided by
four core values: (1) Equal justice under
the law; (2) honesty and integrity; (3)
commitment to excellence; and (4)
respect for the worth and dignity of each
human being. The Department of Justice
is primarily a law-enforcement agency,
not a regulatory agency; it carries out its
principal investigative, prosecutorial,
and other enforcement activities
through means other than the regulatory
process.
The Department of Justice’s key
regulatory priority is the Prison Rape
Elimination Act (PREA) rulemaking
which will establish national standards
for the prevention, detection, reduction,
and punishment of prison rape. The
regulatory priorities of the Department
also include initiatives in the areas of
civil rights, criminal justice, and
immigration. These initiatives are
summarized below. In addition, several
other components of the Department
carry out important responsibilities
through the regulatory process.
Although their regulatory efforts are not
separately discussed in this overview of
the regulatory priorities, those
components have key roles in
implementing the Department’s antiterrorism and law enforcement
priorities.
Prison Rape Elimination
Pursuant to the Prison Rape
Elimination Act of 2003 (PREA or the
‘‘Act’’), 42 U.S.C. section 15601 et seq.,
the Department is drafting regulations to
adopt national standards for the
prevention, detection, reduction, and
punishment of prison rape. On February
3, 2011, the Department published for
public comment a Notice of Proposed
Rulemaking setting forth comprehensive
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national standards for the detection,
prevention, reduction, and punishment
of prison rape in prisons, jails, lockups,
community confinement facilities, and
juvenile facilities operated by
Department of Justice, State, local, and
private agencies. See 76 FR 6248 (Feb.
3, 2011). In developing these proposed
standards, the Department benefited
from the findings and recommendations
of the National Prison Rape Elimination
Commission (NPREC), which had
undertaken a comprehensive legal and
factual study of the penological,
physical, mental, medical, social, and
economic impacts of prison sexual
assaults on government functions and
on the communities and social
institutions in which they operate. The
Department received over 1,300 public
comments in response to the proposed
rule, reviewed and analyzed those
comments, and drafted the final rule for
submission to OMB. PREA mandates
that the national standards shall be
based upon the independent judgment
of the Attorney General, after giving due
consideration to the recommended
national standards provided by the
Commission * * * and being informed
by such data, opinions, and proposals
that the Attorney General determines to
be appropriate to consider.’’ The Act
further provides that the Department
‘‘shall not establish a national standard
* * * that would impose substantial
additional costs compared to the costs
presently expended by Federal, State,
and local prison authorities.’’
The Department worked with an
outside contractor to assess the costs
imposed by its proposed rule and to
support a Regulatory Impact Assessment
that will accompany the final rule. Once
the rulemaking process has been
completed, the Department’s PREA
standards will constitute the most
comprehensive and assertive approach
ever undertaken in this country to
combating sexual abuse against persons
who are incarcerated
Civil Rights
In September 2010, the Department
published its final rules amending its
regulations implementing title II and
title III of the Americans with
Disabilities Act (ADA). Title II prohibits
disability based discrimination by
public entities. Title III prohibits
disability based discrimination by
public accommodations and certain
testing entities, and requires commercial
facilities to be constructed or altered in
compliance with the ADA accessibility
standards. These key regulations adopt
revised ADA Standards for Accessible
Design and address certain important
policy issues. During the course of this
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rulemaking, the Department became
aware of the need to promulgate
regulations in four additional subject
matter areas—the accessibility of
emergency call center services (Next
Generation 9–1–1), captioning and
video description in movie theaters,, use
of accessible Web sites, and accessible
equipment and furniture. On July 26,
2010, the Department published an
advance notice of proposed rulemaking
(ANPRM) for each of these subject areas.
The comment period for these ANPRMs
closed on January 24, 2011. In addition
to soliciting written public comments,
the Department held public hearings on
the ANPRMs in November and
December 2010 and January 2011. The
subject matter of these ANPRMs will be
the focus of the Civil Rights Division’s
regulatory activities for FY 2012, as well
as FY 2013. The Department also plans
to propose amendments to its ADA
regulations and its section 504
regulations to implement the ADA
Amendments Act of 2008, which took
effect on January 1, 2009.
The subjects addressed in the
ANPRMs published on July 26, 2010,
included:
Next Generation 9–1–1. This ANPRM
sought information on possible
revisions to the Department’s regulation
to ensure direct access to Next
Generation 9–1–1 (NG 9–1–1) services
for individuals with disabilities. In
1991, the Department of Justice
published a regulation to implement
title II of the Americans with
Disabilities Act of 1990 (ADA). That
regulation requires public safety
answering points (PSAPs) to provide
direct access to persons with disabilities
who use analog telecommunication
devices for the deaf (TTYs), 28 CFR
35.162. Since that rule was published,
there have been major changes in the
types of communications technology
used by the general public and by
people who have disabilities that affect
their hearing or speech. Many
individuals with disabilities now use
the Internet and wireless text devices as
their primary modes of
telecommunications. At the same time,
PSAPs are planning to shift from analog
telecommunications technology to new
Internet-Protocol (IP)-enabled NG 9–1–1
services that will provide voice and data
(such as text, pictures, and video)
capabilities. As PSAPs transition from
the analog systems to the new
technologies, it is essential people with
communication disabilities will be able
to use the new systems. Therefore, the
Department published this ANPRM to
begin to develop appropriate regulatory
guidance for PSAPs that are making this
transition. The Department is in the
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process of completing its review of the
approximately 146 public comments it
received in response to its NG 9–1–1
ANPRM and expects to publish an
NPRM addressing accessibility of NG 9–
1–1 in FY 2012.
Captioning and Video Description in
Movie Theaters. Title III of the ADA
requires public accommodations to take
‘‘such steps as may be necessary to
ensure that no individual with a
disability is treated differently because
of the absence of auxiliary aids and
services, unless the covered entity can
demonstrate that taking such steps
would cause a fundamental alteration or
would result in an undue burden.’’ 42
U.S.C. section 12182(b)(2)(A)(iii). Both
open and closed captioning and audio
recordings are examples of auxiliary
aids and services that should be
provided by places of public
accommodations, 28 CFR section
36.303(b)(1)–(2). The Department stated
in the preamble to its 1991 rule that
‘‘[m]ovie theaters are not required * * *
to present open-captioned films,’’ 28
CFR part 36, app. C (2011), but it did
not address closed captioning and video
description in movie theaters.
Since 1991, there have been many
technological advances in the area of
closed captioning and video description
for first-run movies. In June 2008, the
Department issued a Notice of Proposed
Rulemaking (NPRM) to revise the ADA
title III regulation, 73 FR 34466, in
which the Department stated that it was
considering options for requiring that
movie theater owners or operators
exhibit movies that are captioned or that
provide video (narrative) description.
The Department received numerous
comments urging the Department to
issue captioning and video description
regulations. The Department is
persuaded that such regulations are
appropriate. The Department issued an
ANPRM on July 26, 2010, to obtain
more information regarding issues
raised by commenters; to seek comment
on technical questions that arose from
the Department’s research; and to learn
more about the status of digital
conversion. In addition, the Department
sought information regarding whether
other technologies or areas of interest
(e.g., 3D) have developed or are in the
process of development that either
would replace or augment digital
cinema or make any regulatory
requirements for captioning and video
description more difficult or expensive
to implement. The Department received
approximately 1171 public comments in
response to its movie captioning and
video description ANPRM. The
Department is in the process of
completing its review of these
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comments and expects to publish an
NPRM addressing captioning and video
description in movie theaters in FY
2012.
Web Site Accessibility. The Internet as
it is known today did not exist when
Congress enacted the ADA, yet today
the World Wide Web plays a critical
role in the daily personal, professional,
civic, and business life of Americans.
The ADA’s expansive
nondiscrimination mandate reaches
goods and services provided by public
accommodations and public entities
using Internet Web sites. Being unable
to access Web sites puts individuals at
a great disadvantage in today’s society,
which is driven by a dynamic electronic
marketplace and unprecedented access
to information. On the economic front,
electronic commerce, or ‘‘e-commerce,’’
often offers consumers a wider selection
and lower prices than traditional,
‘‘brick-and-mortar’’ storefronts, with the
added convenience of not having to
leave one’s home to obtain goods and
services. For individuals with
disabilities who experience barriers to
their ability to travel or to leave their
homes, the Internet may be their only
way to access certain goods and
services. Beyond goods and services,
information available on the Internet
has become a gateway to education,
socializing, and entertainment.
The Internet is also dramatically
changing the way that governmental
entities serve the public. Public entities
are increasingly providing their
constituents access to government
services and programs through their
web sites. Through government web
sites, the public can obtain information
or correspond with local officials
without having to wait in line or be
placed on hold. They can also pay fines,
apply for benefits, renew State-issued
identification, register to vote, file taxes,
request copies of vital records, and
complete numerous other everyday
tasks. The availability of these services
and information online not only makes
life easier for the public but also often
enables governmental entities to operate
more efficiently and at a lower cost.
The ADA’s promise to provide an
equal opportunity for individuals with
disabilities to participate in and benefit
from all aspects of American civic and
economic life will be achieved in
today’s technologically advanced
society only if it is clear to State and
local governments, businesses,
educators, and other public
accommodations that their web sites
must be accessible. Consequently, the
Department is considering amending its
regulations implementing title II and
title III of the ADA to require public
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entities and public accommodations
that provide products or services to the
public through Internet web sites to
make their sites accessible to and usable
by individuals with disabilities.
In particular, the Department’s
ANPRM on Web site accessibility
sought public comment regarding what
standards, if any, it should adopt for
Web site accessibility, whether the
Department should adopt coverage
limitations for certain entities, like
small businesses, and what resources
and services are available to make
existing web sites accessible to
individuals with disabilities. The
Department also solicited comments on
the costs of making Web sites accessible
and on the existence of any other
effective and reasonably feasible
alternatives to making Web sites
accessible. The Department received
approximately 440 public comments
and is in the process of reviewing these
comments. The Department anticipates
publishing separate NPRMs addressing
Web site accessibility pursuant to titles
II and III of the ADA in FY 2013.
Equipment and Furniture. Both title II
and title III of the ADA require covered
entities to make reasonable
modifications in their programs or
services to facilitate participation by
persons with disabilities. In addition,
covered entities are required to ensure
that people are not excluded from
participation because facilities are
inaccessible or because the entity has
failed to provide auxiliary aids. The use
of accessible equipment and furniture is
often critical to an entity’s ability to
provide a person with a disability equal
access to its services. Changes in
technology have resulted in the
development and improved availability
of accessible equipment and furniture
that benefit individuals with
disabilities. Consequently, it is easier
now to specify appropriate accessibility
standards for such equipment and
furniture, as the 2010 ADA Standards
do for several types of fixed equipment
and furniture, including ATMs, washing
machines, dryers, tables, benches, and
vending machines. To the extent that
ADA standards apply requirements for
fixed equipment and furniture, the
Department will look to those standards
for guidance on accessibility standards
for equipment and furniture that are not
fixed. The ANPRM sought information
about other categories of equipment,
including beds in accessible guest
rooms, and medical equipment and
furniture. The Department received
approximately 420 comments in
response to its ANPRM and is in the
process of reviewing these comments.
The Department has decided to publish
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in FY 2012 a separate NPRM pursuant
to title III of the ADA on beds in
accessible guest rooms and a more
detailed ANPRM pursuant to titles II
and III of the ADA that focuses solely on
accessible medical equipment and
furniture. The remaining items of
equipment and furniture addressed in
the 2010 ANPRM will be the subject of
an NPRM that the Department
anticipates publishing in FY 2013.
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Federal Habeas Corpus Review
Procedures in Capital Cases
Pursuant to the USA PATRIOT
Improvement and Reauthorization Act
of 2005, on December 11, 2008, the
Department promulgated a final rule to
implement certification procedures for
States seeking to qualify for the
expedited Federal habeas corpus review
procedures in capital cases under
chapter 154 of title 28 of the United
States Code. On February 5, 2009, the
Department published in the Federal
Register a notice soliciting further
public comment on all aspects of the
December 2008 final rule. (74 FR 6131)
As the Department reviewed the
comments submitted in response to the
February 2009 notice, it considered
further the statutory requirements
governing the regulatory
implementation of the chapter 154
certification procedures. The Attorney
General determined that chapter 154
reasonably could be construed to allow
the Attorney General greater discretion
in making certification determinations
than the December 2008 regulations
allowed. Accordingly, the Department
published a notice in the Federal
Register on May 25, 2010, proposing to
remove the December 2008 regulations
pending the completion of a new
rulemaking process. The Department
finalized the removal of the December
2008 regulations on November 23, 2010.
The Department published an NPRM in
the Federal Register on March 3, 2011,
proposing a new rule and seeking public
input on the certification procedure for
chapter 154 and the standards the
Attorney General will apply in making
certification decisions. The comment
period for the proposed new rule closed
on June 1, 2011.
Criminal Law Enforcement
For the most part, the Department’s
criminal law enforcement components
do not rely on the rulemaking process
to carry out their assigned missions. The
Federal Bureau of Investigation (FBI),
for example, is responsible for
protecting and defending the United
States against terrorist and foreign
intelligence threats, upholding and
enforcing the criminal laws of the
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United States, and providing leadership
and criminal justice services to Federal,
State, municipal, and international
agencies and partners. Only in very
limited contexts does the FBI rely on
rulemaking. For example, the FBI is
currently updating its National Instant
Criminal Background Check System
regulations to allow criminal justice
agencies to conduct background checks
prior to the return of firearms.
Bureau of Alcohol, Tobacco, Firearms
and Explosives (ATF) Initiatives. ATF
issues regulations to enforce the Federal
laws relating to the manufacture and
commerce of firearms and explosives.
ATF’s mission and regulations are
designed to, among other objectives,
curb illegal traffic in, and criminal use
of, firearms, and to assist State, local,
and other Federal law enforcement
agencies in reducing crime and
violence. ATF will continue, as a
priority during fiscal year 2012, to seek
modifications to its regulations
governing commerce in firearms and
explosives. ATF plans to issue final
regulations implementing the provisions
of the Safe Explosives Act, title XI,
subtitle C, of Public Law 107–296, the
Homeland Security Act of 2002 (enacted
Nov. 25, 2002).
Pursuant to Executive Order 13563
‘‘Improving Regulation and Regulatory
Review,’’ ATF is initiating a rulemaking
proceeding to amend existing
regulations and extend the term of
import permits for firearms,
ammunition, and defense articles from 1
year to 2 years. The additional time will
allow importers sufficient time to
complete the importation of an
authorized commodity before the permit
expires and eliminate the need for
importers to submit new and
duplicative import applications. ATF
believes that extending the term of
import permits will result in substantial
cost and time savings for both ATF and
industry. ATF also has begun a
rulemaking process that will lead to
promulgation of a revised set of
regulations (27 CFR part 771) governing
the procedure and practice for
disapproval of applications for
explosives licenses or permits.
Drug Enforcement Administration
(DEA) Initiatives. DEA is the primary
agency responsible for coordinating the
drug law enforcement activities of the
United States. DEA also assists in the
implementation of the President’s
National Drug Control Strategy. DEA’s
mission is to enforce U.S. controlled
substance laws and regulations and
bring to the criminal and civil justice
system those organizations and
individuals involved in the growing,
manufacturing, or distribution of
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controlled substances and listed
chemicals appearing in or destined for
illicit traffic in the United States,
including organizations that use drug
trafficking proceeds to finance
terrorism. A strategic component of the
DEA’s law enforcement mission is the
diversion control program (DCP). The
DCP carries out the mandates of the
Controlled Substances and Chemical
Diversion and Trafficking Acts. DEA
drafts and publishes the implementing
regulations for these statutes in title 21
of the Code of Federal Regulations
(CFR), parts 1300 to 1321. The CSA,
together with these regulations, are
designed to prevent, detect, and
eliminate the diversion of controlled
substances and listed chemicals into the
illicit market while ensuring a sufficient
supply of controlled substances and
listed chemicals for legitimate medical,
scientific, research, and industrial
purposes.
In 2011, the President declared a
national epidemic of prescription drug
abuse, which has emphasized the
importance of the Department’s
regulatory role with respect to
controlled substances. DEA has initiated
National Take-Back events to purge
America’s home medicine cabinets of
unwanted and unused drugs, as well as
assisting in other strategies and
increased enforcement to address doctor
shopping and pill mills. DEA schedules
new and emerging substances for
control under the CSA to protect public
health and safety. During fiscal year
2012, among other regulatory reviews
and initiatives, DEA plans to propose
regulations implementing the Secure
and Responsible Drug Disposal Act of
2010 (Pub. L. 111–273). DEA also plans
to issue final regulations on electronic
prescriptions for controlled substances
subsequent to an Interim Final Rule
currently in effect, which provides
practitioners with the option of writing
prescriptions for controlled substances
electronically and permits pharmacies
to receive, dispense, and archive
electronic prescriptions for controlled
substances.
Bureau of Prisons Initiatives. The
Federal Bureau of Prisons issues
regulations to enforce the Federal laws
relating to its mission: to protect society
by confining offenders in the controlled
environments of prisons and
community-based facilities that are safe,
humane, cost-efficient, and
appropriately secure, and that provide
work and other self-improvement
opportunities to assist offenders in
becoming law-abiding citizens. During
the next 12 months, in addition to other
regulatory objectives aimed at
accomplishing its mission, the Bureau
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will continue its ongoing efforts to:
streamline regulations, eliminating
unnecessary language and improving
readability; improve disciplinary
procedures through a revision of the
subpart relating to the disciplinary
process; reduce the introduction of
contraband through various means, such
as clarifying drug and alcohol
surveillance testing programs; protect
the public from continuing criminal
activity committed within prison; and
enhance the Bureau’s ability to more
closely monitor the communications of
high-risk inmates.
Immigration
On March 1, 2003, pursuant to the
Homeland Security Act of 2002 (HSA),
the responsibility for immigration
enforcement and for providing
immigration-related services and
benefits, such as naturalization and
work authorization, was transferred
from the Justice Department’s
Immigration and Naturalization Service
(INS) to the Department of Homeland
Security (DHS). However, the
immigration judges and the Board of
Immigration Appeals (Board) in the
Executive Office for Immigration
Review (EOIR) remain part of the
Department of Justice. The immigration
judges adjudicate approximately
300,000 cases each year to determine
whether aliens should be removed from
the United States or should be granted
some form of relief from removal. The
Board has jurisdiction over appeals from
the decisions of immigration judges, as
well as other matters. Accordingly, the
Attorney General has a continuing role
in the conduct of removal hearings, the
granting of relief from removal, and
custody determinations regarding the
detention of aliens pending completion
of removal proceedings. The Attorney
General also is responsible for civil
litigation and criminal prosecutions
relating to the immigration laws.
In several pending rulemaking
actions, the Department is working to
revise and update the regulations
relating to removal proceedings in order
to improve the efficiency and
effectiveness of the hearings. In
furtherance of these goals, the
Department is drafting a regulation to
improve the recognition and
accreditation process for organizations
and representatives that appear in
immigration proceedings. With the
assistance of DHS, the Department is
also drafting a regulation pursuant to
the William Wilberforce Trafficking
Victims Protection Reauthorization Act
of 2008 to implement procedures that
take into account the specialized needs
of unaccompanied alien children in
removal proceedings. In addition, the
Department is considering regulatory
action to address mental incompetency
issues in removal proceedings. Finally,
in response to Executive Order 13653,
the Department is retrospectively
reviewing EOIR’s regulations to
eliminate regulations that unnecessarily
duplicate DHS’s regulations and update
outdated references to the pre-2002
immigration system.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in The Regulatory Plan.
However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov in the
Completed Actions section for that
agency. These rulemakings can also be
found on Regulations.gov. The final
Justice Department plan can be found at:
https://www.justice.gov/open/doj-rrfinal-plan.pdf.
Title
Description
1140–AA42 ........
Importation of Arms, Ammunition and Implements of War and
Machine Guns, Destructive Devices, and Certain Other
Firearms; Extending the Term of Import Permits’’.
1117–AB34 ........
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RIN
Establishment of Quotas Required by the Controlled Substances Act’’.
The regulations in 27 CFR 447 and 479 generally provide
that firearms, ammunition, and defense articles may not be
imported into the United States except pursuant to a permit. Section 447.43 provides that import permits are valid
for one year from their issuance date. I ATF will consider
whether these regulations could be revised to achieve the
same regulatory objective in a manner that is less burdensome for both industry and ATF.
The regulations in 21 CFR parts 1303 and 1315 apply
quotas to registered manufacturers of Schedule I and II
controlled substances and certain List I chemicals. The
quotas are intended to control the available quantities of
the basic ingredients needed for the manufacture of certain
substances, to reduce the risk of diversion while ensuring
sufficient availability to satisfy the legitimate needs of the
United States. DEA will explore strategies to modernize
the quota system to achieve greater efficiency and effectiveness and reduce the burden on applicants. Although
the Department expects that manufacturers and the DEA
will benefit from enhanced efficiency and a reduction in paperwork, it cannot quantify the burden and cost reductions
until the working group identifies the specific changes it will
implement.
DOJ—LEGAL ACTIVITIES (LA)
Final Rule Stage
85. National Standards To Prevent,
Detect, and Respond to Prison Rape
Priority: Economically Significant.
Major under 5 U.S.C. 801.
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Legal Authority: 5 U.S.C. 301; 28
U.S.C. 509; 28 U.S.C. 510; 42 U.S.C.
15607
CFR Citation: 28 CFR 115.
Legal Deadline: Final, Statutory, June
23, 2010. 42 U.S.C. section 15607
directed the Attorney General to
promulgate a final rule within 1 year
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after receiving the report and
recommendations of the National Prison
Rape Elimination Commission.
Abstract: In the Prison Rape
Elimination Act of 2003 (PREA), Public
Law 108–79, codified at 42 U.S.C.
sections 15601 to 15609, Congress
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directed the Attorney General to
‘‘publish a final rule adopting national
standards for the detection, prevention,
reduction, and punishment of prison
rape.’’ 42 U.S.C. section 15607(a)(1).
The statute further directed that the
Attorney General ‘‘shall not establish a
national standard * * * that would
impose substantial additional costs
compared to the costs presently
expended by Federal, State, and local
prison authorities.’’ 42 U.S.C. section
15607(a)(3). In accordance with PREA,
the Department is drafting a final rule
setting forth national standards for
enhancing the prevention, detection,
and response to sexual abuse in
confinement settings. The Department
published a Notice of Proposed
Rulemaking on February 3, 2011 (see 76
FR 6248), identifying the proposed
standards, and it received over 1,300
public comments in response.
Statement of Need: Many of the
evidentiary and public policy bases for
the final rule are set forth in the statute,
in which Congress set forth 15 findings
relating to the prevalence of prison rape
and its impact on society. See 42 U.S.C.
section 15601. In summary, prison rape
is a widespread problem that causes
significant harm to its victims and
imposes significant costs to society as a
whole. Given the violent, destructive,
reprehensible, and illegal nature of rape
and sexual abuse in any setting, strong
measures are needed to combat its
prevalence in correctional settings.
Tolerance of sexual abuse of prisoners
in the government’s custody is
incompatible with American values.
Summary of Legal Basis: PREA states
that the Attorney General ‘‘shall publish
a final rule adopting national standards
for the detection, prevention, reduction,
and punishment of prison rape.’’ 42
U.S.C. section 15607(a)(1). The
standards ‘‘shall be based upon the
independent judgment of the Attorney
General, after giving due consideration
to the recommended national standards
provided by the [National Prison Rape
Elimination] Commission * * *, and
being informed by such data, opinions,
and proposals that the Attorney General
determines to be appropriate to
consider.’’ Id. section 15607(a)(2) and
(a)(3). In June 2009, the Commission
forwarded to the Attorney General a
lengthy report describing its findings
and recommending national standards.
Alternatives: Given the specific
direction of Congress, the Department is
obligated to issue a rule that
promulgates national standards to
combat prison rape. PREA also gives the
Attorney General the option of
‘‘providing a list of improvements for
consideration by correctional facilities,’’
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to the extent that a particular national
standard would impose substantial
additional costs compared to the costs
presently expended by Federal, State,
and local prison authorities. 42 U.S.C.
section 15607(a)(3). The Department has
received input from numerous
stakeholders concerning the
development of the national standards
and, as part of the development process,
considered a wide range of proposals
and alternatives. These proposals
include the standards recommended by
the Commission, as well as alternative
approaches proposed by various public
stakeholders.
Anticipated Cost and Benefits: In
directing the Attorney General to
promulgate national standards that
would ‘‘eliminate’’ prison rape by
enhancing its prevention, detection,
reduction, and punishment, Congress
understood that Federal, State, and local
agencies (as well as private entities) that
operate inmate confinement facilities
and that adopt the standards would
likely have to incur costs to come into,
and remain in, compliance with the
standards. However, any such costs
more than outweighed by the benefits of
avoiding prison rape. Prevention of
prison rape has benefits that can be
monetized, as well as benefits that
cannot be monetized. The monetized
benefits inure primarily to the victims of
prison sexual abuse (which number over
200,000 per year) and include the costs
of medical and mental health care
treatment as well as pain, suffering, and
diminished quality of life, among other
factors. For the most serious category of
prison sexual abuse, the Department’s
Initial Regulatory Impact Assessment
(IRIA) accompanying the Notice of
Proposed Rulemaking estimated the cost
per adult victim as ranging from
$200,000 to $300,000. Correspondingly,
the IRIA estimated that if all affected
agencies adopt the standards, full
compliance with the standards would
cost, in the aggregate, over half a billion
dollars a year when annualized over 15
years. Using a breakeven analysis, this
means that the standards would have to
result in the avoidance of approximately
2 percent or less of the baseline number
of annual prison sexual abuse victims
for the costs of full compliance to breakeven with the monetized benefits of the
standards. This does not include the
many non-monetizable benefits of
prison rape avoidance, which include
benefits for victims, for inmates who are
not victims, for families of inmates, for
prison administrators and staff, and for
society at large. The final rule will
include a final Regulatory Impact
Assessment.
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Risks: The final rule is intended to
carry out the intent of Congress to
eliminate prison rape. The risks from
the failure to promulgate the final rule
are primarily that inmates in Federal,
State, and local facilities would
continue to be at a higher risk of sexual
assault than they would be if the final
rule is not promulgated.
Timetable:
Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
NPRM Comment
Period End.
Final Action .........
03/10/10
05/10/10
75 FR 11077
02/03/11
04/04/11
76 FR 6248
02/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Governmental
Jurisdictions, Organizations.
Government Levels Affected: Federal,
Local, State.
Federalism: This action may have
federalism implications as defined in
EO 13132.
URL for Public Comments:
regulations.gov.
Agency Contact: Robert Hinchman,
Senior Counsel, Office of Legal Policy,
Department of Justice, Room 4252, 950
Pennsylvania Avenue NW., Washington,
DC 20530, Phone: 202 514–8059, Fax:
202 353–2371, Email:
robert.hinchman@usdoj.gov
RIN: 1105–AB34
BILLING CODE 4410–BP–P
DEPARTMENT OF LABOR
Fall 2011 Statement of Regulatory
Priorities
The Department of Labor’s fall 2011
agenda continues Secretary Solis’ vision
of Good Jobs for Everyone. It also renews
the Labor Department’s commitment to
efficient and effective regulation
through the review and modification of
our existing regulations, consistent with
Executive Order 13563 (‘‘E.O. 13563’’).
The Labor Department’s vision of a
‘‘good job’’ includes jobs that:
• Increase workers’ incomes and
narrow wage and income inequality;
• Assure workers are paid their wages
and overtime;
• Are in safe and healthy workplaces,
and fair and diverse workplaces;
• Provide workplace flexibility for
family and personal care-giving;
• Improve health benefits and
retirement security for all workers; and
• Assure workers have a voice in the
workplace.
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The Department continues to use a
variety of mechanisms to achieve the
goal of Good Jobs for Everyone,
including increased enforcement
actions, increased education and
outreach, and regulatory actions that
foster compliance. At the same time, the
Department is enhancing the efficiency
and effectiveness of its efforts through
targeted regulatory actions designed to
improve compliance while reducing
regulatory burdens. The Department’s
Plan/Prevent/Protect and Openness and
Transparency compliance strategies and
the implementation of E.O. 13563 create
unifying themes that seek to foster a
new calculus that strengthens
protections for workers. By requiring
employers and other regulated entities
to take full ownership over their
adherence to Department regulations
and promoting greater openness and
transparency to put workers in a better
position to judge whether their
workplace is one that values health and
safety, work-life balance, and diversity,
the Department seeks to significantly
increase compliance. The increased
effectiveness of this compliance strategy
will enable the Department to achieve
the Good Jobs for Everyone goal in a
regulatory environment that is more
efficient and less burdensome.
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Plan/Prevent/Protect Compliance
Strategy
The Department has already
published several regulatory actions
toward the completion of requirements
that employers develop programs to
address specific issues of worker
protection, security, and equity. Some of
these issues have included controlling
the spread of infectious diseases,
examining work areas in underground
coal mines for mandatory violations,
and identifying patterns of violations in
mines. The collection of regulatory
actions in the Department’s Plan/
Prevent/Protect strategy is designed to
ensure employers and other regulated
entities are in full compliance with the
law every day, not just when
Department inspectors come calling. As
announced with the spring 2010
regulatory agenda, this strategy requires
employers and other regulated entities
to:
‘‘Plan’’: Create a plan for identifying
and remediating risks of legal violations
and other risks to workers; for example,
a plan to inspect their workplaces for
safety hazards that might injure or kill
workers. Workers will be given
opportunities to participate in the
creation of the plans. In addition, the
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plans would be made available to
workers so they can fully understand
them and help to monitor their
implementation.
‘‘Prevent’’: Thoroughly and
completely implement the plan in a
manner that prevents legal violations.
The plan cannot be a mere paper
process. This will not be an exercise in
drafting a plan only to put it on a shelf.
The plan must be fully implemented.
‘‘Protect’’: Verify on a regular basis
that the plan’s objectives are being met.
The plan must actually protect workers
from health and safety risks and other
violations of their workplace rights.
Employers and other regulated
entities who fail to take these steps to
comprehensively address the risks,
hazards, and inequities in their
workplaces will be considered out of
compliance with the law and, may be
subject to remedial action. However,
employers, unions, and others who
follow the Department’s Plan/Prevent/
Protect strategy will assure compliance
with employment laws before Labor
Department enforcement personnel
arrive at their doorsteps. Most
important, they will assure that workers
get the safe, healthy, diverse, familyfriendly, and fair workplaces they
deserve.
In the fall 2011 regulatory agenda, the
Occupational Safety and Health
Administration (OSHA), Mine Safety
and Health Administration (MSHA),
and the Office of Federal Contract
Compliance Programs (OFCCP) will all
propose regulatory actions furthering
the Department’s implementation of the
Plan/Prevent/Protect strategy.
Openness and Transparency: Tools for
Achieving Compliance
Greater openness and transparency
continues to be central to the
Department’s compliance and regulatory
strategies. The fall 2011 regulatory plan
demonstrates the Department’s
continued commitment to conducting
the people’s business with openness
and transparency, not only as good
Government and stakeholder
engagement strategies, but as important
means to achieve compliance with the
employment laws administered and
enforced by the Department. Openness
and transparency will not only enhance
agencies’ enforcement actions but will
encourage greater levels of compliance
by the regulated community and
enhance awareness among workers of
their rights and benefits. When
employers, unions, workers, advocates,
and members of the public have greater
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access to information concerning
workplace conditions and expectations,
then we all become partners in the
endeavor to create Good Jobs for
Everyone.
Worker Protection Responsiveness
The Department believes Plan/
Prevent/Protect and increased Openness
and Transparency will result in
improvements to worker health and
safety. However, when the Department
identifies specific hazards and risks to
worker health, safety, security, or
fairness, we will utilize our regulatory
powers to limit the risk to workers. The
fall 2011 regulatory plan includes
examples of such regulatory initiatives
to address such specific concerns.
MSHA is planning regulatory
initiatives to respond to specific health
and safety needs of workers: (1) MSHA
plans to finalize the standard Lowering
Miners’ Exposure to Coal Mine Dust,
including Continuous Personal Dust
Monitors in April 2012; and (2) MSHA
plans to finalize the rule covering
Examinations of Work Areas in
Underground Coal Mines in March
2012.
Workers across many industries face
serious hazards from vehicles perform
backing maneuvers and from equipment
that can pin, crush, or strike. OSHA and
MSHA will both publish regulatory
actions concerning these hazards.
Crystalline silica exposure is one of
the most serious hazards workers face.
OSHA and MSHA are both proposing to
address worker exposures to crystalline
silica through the promulgation and
enforcement of a comprehensive health
standard.
Retrospective Review of Existing Rules
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in The Regulatory Plan.
However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov in the
Completed Actions section for that
agency. These rulemakings can also be
found on Regulations.gov. The final
agency plans can be found at: https://
www.dol.gov/regulations/EO13563
Plan.pdf.
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Whether It Is Expected to Significantly
Reduce Burdens on
Small Businesses
Regulatory Identifier No.
Title of Rulemaking
1218–AC20 ..................................
1218–AC34 ..................................
1218–AC64; 1218–AC65 .............
Hazard Communication ................................................................................................
Bloodborne Pathogens .................................................................................................
Updating OSHA Standards Based on National Consensus Standards—Acetylene
and Personal Protective Equipment.
Standard Improvement Project—Phase IV (SIP IV) .....................................................
Cranes and Derricks in Construction: Revision to Digger Derricks’ Requirements .....
Review/Lookback of OSHA Chemical Standards .........................................................
Criteria and Procedures for Proposed Assessment of Civil Penalties (Part 100) .......
Sex Discrimination Guidelines ......................................................................................
Amendment of Abandoned Plan Program ....................................................................
Equal Employment Opportunity in Apprenticeship and Training, Amendment of Regulations.
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1218–AC67
1218–AC75
1218–AC74
1219–AB72
1250–AA05
1210–AB47
1205–AB59
..................................
..................................
..................................
...................................
...................................
...................................
...................................
The fall 2011 regulatory agenda aims
to achieve more efficient and less
burdensome regulation through our
renewed commitment to conduct
retrospective reviews of regulations. On
January 18, 2011, the President issued
Executive Order (E.O.) 13563 entitled
‘‘Improving Regulation and Regulatory
Review.’’ The E.O. aims to ‘‘strike the
right balance’’ between what is needed
to protect health, welfare, safety, and
the environment for all Americans, and
what we need to foster economic
growth, job creation, and
competitiveness.
In August 2011, as part of a
Governmentwide response to E.O.
13563, the Department published its
Plan for Retrospective Analysis of
Existing Rules, which identifies several
burden-reducing review projects. For
example, OSHA’s Standards
Improvement Project III (SIP III)
rulemaking achieved a 1.9 million
burden hour reduction, and we
anticipate that OSHA’s SIP IV project
will similarly yield savings for
employers. OSHA’s Hazard
Communication/Globally Harmonized
System for Classification and Labeling
of Chemicals proposal has estimated
savings for employers ranging from $585
million to $792.7 million. Based on
preliminary estimates, EBSA’s
Abandoned Plan Program amendments
may reduce costs by approximately
$1.12 million. These projects estimate
monetized savings that would eliminate
roughly between $580 to $790 million
in annual regulatory burdens.
The Plan also formalizes the
development of this semiannual
regulatory agenda as a system through
which the Department identifies
potential regulations for review. This
regulatory agenda provides public
notice of the Department’s intention to
initiate or continue work on
approximately 10 review projects; more
than 13 percent of all of the
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Department’s planned regulatory
actions.
Occupational Safety and Health
Administration (OSHA)
OSHA’s regulatory program is
designed to help workers and employers
identify hazards in the workplace,
prevent the occurrence of injuries and
adverse health effects, and communicate
with the regulated community regarding
hazards and how to effectively control
them. Long-recognized health hazards
and emerging hazards place American
workers at risk of serious disease and
death and are initiatives on OSHA’s
regulatory agenda. In addition to
targeting specific hazards, OSHA is
focusing on systematic processes that
will modernize the culture of safety in
America’s workplaces and retrospective
review projects that will update
regulations and reduce burdens on
regulated communities. OSHA’s
retrospective review projects under
E.O.13563 include consideration of the
Bloodborne Pathogens standard,
updating consensus standards, phase IV
of OSHA’s standard improvement
project (SIP IV), and reviewing various
permissible exposure levels.
Plan/Prevent/Protect
Infectious Diseases
OSHA is considering the need for
regulatory action to address the risk to
workers exposed to infectious diseases
in healthcare and other related high-risk
environments. OSHA is interested in all
routes of infectious disease transmission
in healthcare settings not already
covered by its bloodborne pathogens
standard (e.g. contact, droplet, and
airborne). The Agency is particularly
concerned by studies that indicate that
transmission of infectious diseases to
both patients and healthcare workers
may be occurring as a result of
incomplete adherence to recognized, but
voluntary, infection control measures.
The Agency is considering an approach
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7781
Yes.
No.
No.
To be
No.
To be
To be
To be
Yes.
To be
determined.
determined.
determined.
determined.
determined.
that would combine elements of the
Department’s Plan/Prevent/Protect
strategy with established infection
control practices. The Agency received
strong stakeholder participation in
response to its May 2010 request for
information and July 2011 stakeholder
meetings.
In 2007, the healthcare and social
assistance sector as a whole had 16.5
million employees. Healthcare
workplaces can range from small,
private practices of physicians to
hospitals that employ thousands of
workers. In addition, healthcare is
increasingly being provided in other
settings such as nursing homes, freestanding surgical and outpatient centers,
emergency care clinics, patients’ homes,
and pre-hospitalization emergency care
settings. OSHA is concerned with the
movement of healthcare delivery from
the traditional hospital setting, with its
greater infrastructure and resources to
effectively implement infection control
measures, into more diverse and smaller
workplace settings with less
infrastructure and fewer resources, but
with an expanding worker population.
Injury and Illness Prevention Program
(12P2)
OSHA’s Injury and Illness Prevention
Program is the prototype for the
Department’s Plan/Prevent/Protect
strategy. OSHA’s first step in this
important rulemaking was to hold
stakeholder meetings. Stakeholder
meetings were held in East Brunswick,
New Jersey; Dallas, Texas; Washington,
DC; and Sacramento, California,
beginning in June 2010 and ending in
August 2010. More than 200
stakeholders participated in these
meetings, and in addition, nearly 300
stakeholders attended as observers. The
proposed rule will explore requiring
employers to provide their employees
with opportunities to participate in the
development and implementation of an
injury and illness prevention program,
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including a systematic process to
proactively and continuously address
workplace safety and health hazards.
This rule will involve planning,
implementing, evaluating, and
improving processes and activities that
promote worker safety and health
hazards. OSHA has substantial evidence
showing that employers that have
implemented similar injury and illness
prevention programs have significantly
reduced injuries and illnesses in their
workplaces. The new rule would build
on OSHA’s existing Safety and Health
Program Management Guidelines and
lessons learned from successful
approaches and best practices that have
been applied by companies
participating in OSHA’s Voluntary
Protection Program and Safety and
Health Achievement Recognition
Program, and similar industry and
international initiatives.
Openness and Transparency
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Modernizing Recordkeeping
OSHA held informal meetings to
gather information from experts and
stakeholders regarding the modification
of its current injury and illness data
collection system that will help the
agency, employers, employees,
researchers, and the public prevent
workplace injuries and illnesses, as well
as support President Obama’s Open
Government Initiative. Under the
proposed rule, OSHA will explore
requiring employers to electronically
submit to the Agency data required by
part 1904 (Recording and Reporting
Occupational Injuries). The proposed
rule will enable OSHA to conduct data
collections ranging from the periodic
collection of all part 1904 data from a
handful of employers to the annual
collection of summary data from many
employers. OSHA learned from
stakeholders that most large employers
already maintain their part 1904 data
electronically; as a result, electronic
submission will constitute a minimal
burden on these employers, while
providing a wealth of data to help
OSHA, employers, employees,
researchers, and the public prevent
workplace injuries and illnesses. The
proposed rule also does not add to or
change the recording criteria or
definitions in part 1904. The proposed
rule only modifies employers’
obligations to transmit information from
these records to OSHA.
Whistleblower Protection Regulations
The ability of workers to speak out
and exercise their legal rights without
fear of retaliation is essential to many of
the legal protections and safeguards that
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all Americans value. Whether the goal is
the safety of our food, drugs, or
workplaces, the integrity of our
financial system, or the security of our
transportation systems, whistleblowers
have been essential to ensuring that our
laws are fully and fairly executed. In the
fall regulatory agenda, OSHA proposes
to issue procedural rules that will
establish consistent and transparent
procedures for the filing of
whistleblower complaints under eight
statutes. They include procedures for
handling employee retaliation
complaints filed under the:
• National Transit System Security
Act, and Federal Railroad Safety Act, as
amended by the Implementing
Recommendations of the 9/11
Commission Act
• Surface Transportation Assistance
Act, as amended by the Implementing
Recommendations of the 9/11
Commission Act
• Consumer Product Safety
Improvement Act
• Consumer Financial Protection Act
of 2010, and section 1057 of the DoddFrank Wall Street Reform and Consumer
Protection Act of 2010
• Sarbanes Oxley Act, as amended by
section 922 (b) and (c) and section 929A
of the Dodd-Frank Wall Street Reform
and Consumer Protection Act
• Affordable Care Act
• Seaman’s Protection Act
• FDA Food Safety Modernization
Act
These procedural rules will
strengthen OSHA’s enforcement of its
whistleblower program by providing
specific timeframes and guidance for
filing a complaint with OSHA, issuing
a finding, avenues of appeal, and
allowable remedies. OSHA is committed
to its whistleblower program and to
ensuring that all America’s workers
have a voice in the workplace.
Addressing Targeted Hazards
Silica
In order to target one of the most
serious hazards workers face, OSHA is
proposing to address worker exposures
to crystalline silica through the
promulgation and enforcement of a
comprehensive health standard.
Exposure to silica causes silicosis, a
debilitating respiratory disease, and may
cause cancer, other chronic respiratory
diseases, and renal and autoimmune
disease as well. The seriousness of the
health hazards associated with silica
exposure is demonstrated by the large
number of fatalities and disabling
illnesses that continue to occur. Over
2 million workers are exposed to
crystalline silica in general industry,
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construction, and maritime industries.
Reducing these hazardous exposures
through promulgation and enforcement
of a comprehensive health standard will
contribute to OSHA’s goal of reducing
occupational fatalities and illnesses. As
a part of the Secretary’s strategy for
securing safe and healthy workplaces,
MSHA will also utilize information
provided by OSHA to undertake
regulatory action related to silica
exposure in mines.
Preventing Backover Injuries and
Fatalities
Workers across many industries face a
serious hazard when vehicles perform
backing maneuvers, especially vehicles
with an obstructed view to the rear.
OSHA is collecting information on this
hazard and researching emerging
technologies that may help to reduce
this risk. NIOSH reports, for example,
that one-half of the fatalities involving
construction equipment occur while the
equipment is backing. Backing accidents
cause at least 60 occupational deaths
per year. Emerging technologies that
address the risks of backing operations
include cameras, radar, and sonar—to
help view or detect the presence of
workers on foot in blind areas—and new
monitoring technology, such as tagbased warning systems that use radio
frequency (RFID) and magnetic field
generators on equipment to detect
electronic tags worn by workers. Along
with MSHA, which is developing
regulations concerning Proximity
Detection Systems, and based on
information collected and the Agency’s
review and research, the Agency may
consider rulemaking as an appropriate
measure to address this source of
employee risk.
E.O. 13563
Hazard Communication/Globally
Harmonized System for Classification
and Labeling of Chemicals
The proposed modifications in its
NPRM concerning the HCS are expected
to benefit employers in two primary
ways. First, the harmonization of hazard
classifications, safety data sheet (SDSs)
formats, and warning labels will yield
substantial savings to businesses, once
the standard is fully implemented. On
the producer side, fewer different SDSs
will have to be produced for affected
chemicals, and many SDSs will be able
to be produced at lower cost due to
harmonization and standardization.
Second, for users, OSHA expects that
they will see reductions in operating
costs due to the decreased number of
SDSs, the standardization of SDSs that
will make it easier to locate information
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and determine handling requirements,
and other factors related to
simplification and uniformity that will
improve workplace efficiency. Finally,
OSHA estimates that the revisions to the
HCS will result in reductions in the cost
of training employees on the HCS in
future periods because standardized
SDS and label formats will reduce the
amount of time needed to familiarize
employees with the HCS and fewer
systems will have to be taught since all
producers will be using the same
system.
OSHA’s preliminary estimate is that
establishing a harmonized system for
the classification and labeling of
chemicals will create a substantial
annualized savings for employers
ranging from $585 million to $792.7
million. The majority of these benefits
will be realized through increases in
productivity for health and safety
managers, as well as for logistics
personnel with savings ranging from
$475.2 million to $569 million.
Simplifying requirements for hazard
communication training are estimated to
provide savings up to $285.3 million.
Additionally, establishing uniform
safety data sheets and labels will save
between $16 million and $32.2 million.
OSHA plans to publish the final rule in
2012. This rulemaking is economically
significant with an estimated annual
cost of over $200 million.
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Bloodborne Pathogens
OSHA will undertake a review of the
Bloodborne Pathogen Standard in
accordance with the requirements of the
Regulatory Flexibility Act, section 5 of
Executive Order 12866, and E.O. 13563.
The review will consider the continued
need for the rule; whether the rule
overlaps, duplicates, or conflicts with
other Federal, State or local regulations;
and the degree to which technology,
economic conditions, or other factors
may have changed since the rule was
evaluated.
Updating OSHA Standards Based on
National Consensus Standards—
Acetylene and Personal Protective
Equipment Standards
Under section 6(a) of the OSH Act,
during the first 2 years of the Act, the
Agency was directed to adopt national
consensus standards as OSHA
standards. In the more than 40 years
since these standards were adopted by
OSHA, the organizations responsible for
these consensus standards have issued
updated versions of these standards.
However, in most cases, OSHA has not
revised its regulations to reflect later
editions of the consensus standards.
This project is part of a multi-year
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project to update OSHA standards that
are based on consensus standards.
Standard Improvement Project—Phase
IV (SIP IV)
OSHA’s Standards Improvement
Projects (SIPs) are intended to remove or
revise duplicative, unnecessary, and
inconsistent safety and health
standards. The Agency has published
three earlier final standards to remove
unnecessary provisions, thus reducing
costs or paperwork burden on affected
employers. The Agency believes that
these standards have reduced the
compliance costs and eliminated or
reduced the paperwork burden for a
number of its standards. The Agency
only considers such changes to its
standards so long as they do not
diminish employee protections. The
Agency is initiating a fourth rulemaking
effort to identify unnecessary or
duplicative provisions or paperwork
requirements that is limited solely to its
construction standards in 29 CFR 1926.
Cranes and Derricks in Construction:
Revision to Digger Derricks’
Requirements
OSHA published its final Cranes and
Derricks in Construction Standard in
August 2010. Edison Electric Institute
(EEI) filed a petition for review
challenging several aspects of the
standard, including the scope of the
exemption for digger derricks. As part of
the settlement agreement with EEI,
OSHA agreed to publish a direct final
rule expanding the scope of a partial
exemption for work by digger derricks.
In the direct final rule, OSHA will
revise the scope provision on digger
derricks as an exemption for all work
done by digger derricks covered by
subpart V of 29 CFR 1926.
Review—Lookback of OSHA Chemical
Standards
The majority of OSHA’s Permissible
Exposure Limits (PELs) were adopted in
1971 under section 6(a) of the OSH Act,
and only a few have been successfully
updated since that time. There is
widespread agreement among industry,
labor, and professional occupational
safety and health organizations that
OSHA’s PELs are outdated and need
revising in order to take into account
newer scientific data that indicates that
significant occupational health risks
exist at levels below OSHA’s current
PELs. In 1989, OSHA issued a final
standard that lowered PELs for over 200
chemicals and added PELs for 164.
However, the final rule was challenged
and ultimately vacated by the 11th
Circuit Court of Appeals in 1991 citing
deficiencies in OSHA’s analyses. Since
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that time, OSHA has made attempts to
examine its outdated PELs in light of the
Court’s 1991 decision. Most recently,
OSHA sought input through a
stakeholder meeting and web forum to
discuss various approaches that might
be used to address its outdated PELs. As
part of the Department’s Regulatory
Review and Lookback Efforts, OSHA is
developing a Request for Information
(RFI), seeking input from the public to
help the Agency identify effective ways
to address occupational exposure to
chemicals.
Mine Safety and Health Administration
(MSHA)
The Mine Safety and Health
Administration is the worker protection
agency focused on the prevention of
death, disease, and injury from mining
and the promotion of safe and healthful
workplaces for the Nation’s miners. The
Department believes that every worker
has a right to a safe and healthy
workplace. Workers should never have
to sacrifice their lives for their
livelihood, and all workers deserve to
come home to their families at the end
of their shift safe and whole. MSHA’s
approach to reducing workplace
fatalities and injuries includes
promulgating and enforcing mandatory
health and safety standards. MSHA’s
retrospective review projects under E.O.
13563 addresses revising the process for
proposing civil penalties.
Plan/Prevent/Protect
Examinations of Work Areas in
Underground Coal Mines for Violations
of Mandatory Health or Safety
Standards
MSHA plans to issue a proposed rule
to address section 303(d) of the Federal
Mine Safety and Health Act that
requires mine operators to conduct
examinations, in areas where miners
work or travel, to address violations of
standards. The final rule would assure
that underground coal mine operators
find and fix violations during pre-shift,
supplemental, on-shift, and weekly
examinations, thereby improving health
and safety for miners.
Respirable Crystalline Silica Standard
The Agency’s regulatory actions also
exemplify a commitment to protecting
the most vulnerable populations while
assuring broad-based compliance.
Health hazards are pervasive in both
coal and metal/nonmetal mines,
including surface and underground
mines and large and small mines. As
mentioned previously, as part of the
Secretary’s strategy for securing safe and
healthy workplaces, both MSHA and
OSHA will be undertaking regulatory
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actions related to silica. Overexposure
to crystalline silica can result in some
miners developing silicosis, an
irreversible but preventable lung
disease, which ultimately may be fatal.
In its proposed rule, MSHA plans to
follow the recommendations of the
Secretary of Labor’s Advisory
Committee on the Elimination of
Pneumoconiosis Among Coal Mine
Workers, the National Institute for
Occupational Safety and Health
(NIOSH), and other groups to address
the exposure limit for respirable
crystalline silica. As another example of
intra-departmental collaboration, MSHA
intends to consider OSHA’s work on the
health effects of occupational exposure
to silica and OSHA’s risk assessment in
developing the appropriate standard for
the mining industry.
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Proximity Detection Systems for
Continuous Mining Machines in
Underground Coal Mines
MSHA published a proposed rule to
address the danger that miners face
when working near continuous mining
machines in underground coal mines.
MSHA has concluded, from
investigations of accidents involving
mobile equipment and other reports,
that action was necessary to protect
miners. From 1984 to 2011, there have
been 31 fatalities resulting from
crushing and pinning accidents
involving continuous mining machines.
Continuous mining machines can pin,
crush, or strike a miner working near
the equipment. Proximity detection
technology can prevent these types of
accidents. Proximity detection systems
can be installed on mining machinery to
detect the presence of personnel or
equipment within a certain distance of
the machine. The rule would strengthen
the protection for underground miners
by reducing the potential for pinning,
crushing, or striking hazards associated
with working close to continuous
mining machines.
Proximity Detection Systems for Mobile
Machines in Underground Mines
MSHA plans to publish a proposed
rule to require underground coal mine
operators to equip shuttle cars, coal
hauling machines, continuous haulage
systems, and scoops with proximity
detection systems. Miners working near
these machines face pinning, crushing,
and striking hazards that have resulted,
and continue to result, in accidents
involving life threatening injuries and
death. The proposal would strengthen
protections for miners by reducing the
potential for pinning, crushing, or
striking accidents in underground
mines.
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Openness and Transparency
Pattern of Violations
MSHA has determined that the
existing pattern criteria and procedures
contained in 30 CFR part 104 do not
reflect the statutory intent for section
104(e) of the Federal Mine Safety and
Health Act of 1977 (Mine Act). The
legislative history of the Mine Act
explains that Congress intended the
pattern of violations to be an
enforcement tool for operators who have
demonstrated a disregard for the health
and safety of miners. These mine
operators, who have a chronic history of
persistent significant and substantial
(S&S) violations, needlessly expose
miners to the same hazards again and
again. This indicates a serious safety
and health management problem at a
mine. The goal of the pattern of
violations final rule is to compel
operators to manage health and safety
conditions so that the root causes of S&S
violations are found and fixed before
they become a hazard to miners. The
final rule would reflect statutory intent,
simplify the pattern of violations
criteria, and improve consistency in
applying the pattern of violations
criteria.
MSHA developed an online service
that enables mine operators, miners, and
others to monitor a mining operation to
determine if the mine could be
approaching a potential pattern of
violations. The web tool contains the
specific criteria that MSHA uses to
review a mine for a potential pattern of
violations. The pattern of violations
monitoring tool promotes openness and
transparency in government.
Notification of Legal Identity
The existing requirements do not
provide sufficient information for
MSHA to identify all of the mine
‘‘operators’’ responsible for operator
safety and health obligations under the
Federal Mine Safety and Health Act of
1977, as amended. This proposed
regulation would expand the
information required to be submitted to
MSHA to create more transparent and
open records that would allow the
Agency to better identify and focus on
the most egregious or persistent
violators and more effectively deter
future violations by imposing penalties
and other remedies on those violators.
Addressing Targeted Hazards
Lowering Miners’ Exposure to Coal
Mine Dust, Including Continuous
Personal Dust Monitors
MSHA will continue its regulatory
action related to preventing Black Lung
disease. Data from the NIOSH indicate
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increased prevalence of coal workers
pneumoconiosis (CWP) ‘‘clusters’’ in
several geographical areas, particularly
in the Southern Appalachian Region.
MSHA published a notice of proposed
rulemaking to address continued risk to
coal miners from exposure to respirable
coal mine dust. This regulatory action is
part of MSHA’s Comprehensive Black
Lung Reduction Strategy for reducing
miners’ exposure to respirable dust.
This strategy includes enhanced
enforcement, education and training,
and health outreach and collaboration.
E.O. 13563
Criteria and Procedures for Proposed
Assessment of Civil Penalties (Part 100)
MSHA plans to publish a proposed
rule to revise the process for proposing
civil penalties. The assessment of civil
penalties is a key component in MSHA’s
strategy to enforce safety and health
standards. The Congress intended that
the imposition of civil penalties would
induce mine operators to be proactive in
their approach to mine safety and
health, and take necessary action to
prevent safety and health hazards before
they occur. MSHA believes that the
procedures for assessing civil penalties
can be revised to improve the efficiency
of the Agency’s efforts and to facilitate
the resolution of enforcement issues.
Office of Federal Contract Compliance
Programs (OFCCP)
Through the work of the Office of
Federal Contract Compliance Programs,
DOL ensures that contractors and
subcontractors doing business with the
Federal Government at nearly 200,000
establishments take affirmative action to
create fair and diverse workplaces.
OFCCP also combats discrimination
based on race, color, religion, sex,
national origin, disability, or status as a
protected veteran by ensuring that
Federal contractors recruit, hire, train,
promote, terminate, and compensate
workers in a non-discriminatory
manner. DOL, through OFCCP, protects
workers, promotes diversity and
enforces civil rights laws.
Plan/Prevent/Protect
Construction Contractor Affirmative
Action Requirements
OFCCP will publish a proposed rule
that would enhance the effectiveness of
the affirmative action programs of
Federal and federally assisted
construction contractors and
subcontractors. The proposed rule
would strengthen affirmative action
programs particularly in the areas of
recruitment, training, and
apprenticeships. The proposed rule
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would also provide contractors and
subcontractors the tools to assess their
progress and appropriately tailor their
affirmative action plans. The proposed
rule would also allow contractors and
subcontractors to focus on their
affirmative action obligations earlier in
the contracting process. OFCCP is
coordinating with the Employment and
Training Administration (ETA), which
is developing a proposed regulation
revising the equal opportunity
regulatory framework under the
National Apprenticeship Act.
E.O. 13563
Sex Discrimination Guidelines
The Office of Federal Contract
Compliance Programs (OFCCP) is
charged with enforcing Executive Order
11246, as amended, which prohibits
Federal Government contractors and
subcontractors from discriminating
against individuals in employment on
the basis of race, color, sex, religion, or
national origin, and requires them to
take affirmative action. OFCCP
regulations at 41 CFR part 60–20 set
forth the interpretations and guidelines
for implementing Executive Order
11246, as amended, in regard to
promoting and ensuring equal
opportunities for all persons employed
or seeking employment with
Government contractors and
subcontractors without regard to sex.
This nondiscrimination requirement
also applies to contractors and
subcontractors performing under
federally assisted construction
contracts. The guidance in part 60–20 is
more than 30 years old and warrants a
regulatory lookback. OFCCP will issue a
Notice of Proposed Rulemaking to create
sex discrimination regulations that
reflect the current state of the law in this
area.
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Employee Benefits Security
Administration (EBSA)
The Employee Benefits Security
Administration (EBSA) is responsible
for administering and enforcing the
fiduciary, reporting and disclosure, and
health coverage provisions of title I of
the Employee Retirement Income
Security Act of 1974 (ERISA). This
includes recent amendments and
additions to ERISA enacted in the
Pension Protection Act of 2006, as well
as new health coverage provisions
under the Patient Protection and
Affordable Care Act of 2010 (the
Affordable Care Act). EBSA’s regulatory
plan initiatives are intended to improve
health benefits and retirement security
for workers in every type of job at every
income level. EBSA is charged with
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protecting approximately 140 million
Americans covered by an estimated
718,000 private retirement plans, 2.5
million health plans, and similar
numbers of other welfare benefit plans,
which together hold $6.7 trillion in
assets.
EBSA will continue to issue guidance
implementing the health reform
provisions of the Affordable Care Act to
help provide better quality health care
for American workers and their families.
EBSA’s regulations reduce
discrimination in health coverage,
promote better access to quality
coverage, and protect the ability of
individuals and businesses to keep their
current health coverage. Many
regulations are joint rulemakings with
the Departments of Health and Human
Services and the Treasury.
Using regulatory changes to produce
greater openness and transparency is an
integral part of EBSA’s contribution to
a departmentwide compliance strategy.
These efforts will not only enhance
EBSA’s enforcement toolbox but will
encourage greater levels of compliance
by the regulated community and
enhance awareness among workers of
their rights and benefits. Several
proposals from the EBSA agenda
expand disclosure requirements,
substantially enhancing the availability
of information to employee benefit plan
participants and beneficiaries and
employers, and strengthening the
retirement security of America’s
workers. EBSA’s retrospective review
project under E.O.13563 is Abandoned
Plan Program amendments.
Addressing Targeted Issues of Employee
Benefits
Health Reform Implementation
Since the passage of health care
reform, EBSA has helped put the
employment-based health provisions
into action. Working with HHS and
Treasury, EBSA has issued regulations
covering issues such as the elimination
of preexisting condition exclusions for
children under age 19, internal and
external appeals of benefit denials, the
extension of coverage for children up to
age 26, and a ban on rescissions (which
are retroactive terminations of health
care coverage). These regulations will
eventually impact up to 138 million
Americans in employer-sponsored
plans. EBSA will continue its work in
this regard, to ensure a smooth
implementation of the legislation’s
market reforms, minimizing disruption
to existing plans and practices, and
strengthening America’s health care
system.
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Enhancing Participant Protections
EBSA will re-propose amendments to
its regulations to clarify the
circumstances under which a person
will be considered a ‘‘fiduciary’’ when
providing investment advice to
retirement plans and other employee
benefit plans and participants and
beneficiaries of such plans. The
amendments would take into account
current practices of investment advisers
and the expectations of plan officials
and participants who receive
investment advice. This initiative is
intended to assure retirement security
for workers in all jobs regardless of
income level by ensuring that financial
advisers and similar persons are
required to meet ERISA’s standards of
care when providing the investment
advice that is relied upon by millions of
plan sponsors and workers.
Lifetime Income Options
EBSA, in 2010, published a request
for information concerning steps it can
take by regulation, or otherwise, to
encourage the offering of lifetime
annuities or similar lifetime benefit
distribution options for participants and
beneficiaries of defined contribution
plans. EBSA also held a hearing with
the Department of the Treasury and
Internal Revenue Service to further
explore these possibilities. This
initiative is intended to assure
retirement security for workers in all
jobs regardless of income level by
helping to ensure that participants and
beneficiaries have the benefit of their
plan savings throughout retirement.
EBSA now has established a public
record which supports further
consideration or action in a number of
areas including pension benefit
statements, participant education, and
fiduciary guidance. With regard to
pension benefit statements specifically,
EBSA is working on a proposed rule
under ERISA section 105 that would
require or facilitate the presentation of
a participant’s accrued benefits; i.e., the
participant’s account balance, as a
lifetime income stream of payments, in
addition to presenting the benefits as an
account balance.
Promoting Openness and Transparency
In addition to its health care reform
and participant protection initiatives
discussed above, EBSA is pursuing a
regulatory program that, as reflected in
the Unified Agenda, is designed to
encourage, foster, and promote
openness, transparency, and
communication with respect to the
management and operations of pension
plans, as well as participant rights and
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benefits under such plans. Among other
things, EBSA will be issuing a final rule
addressing the requirement that
administrators of defined benefit
pension plans annually disclose the
funding status of their plan to the plan’s
participants and beneficiaries (RIN
1210–AB18). In addition, EBSA will be
finalizing amendments to the disclosure
requirements applicable to plan
investment options, including Qualified
Default Investment Alternatives, to
better ensure that participants
understand the operations and risks
associated with investments in target
date funds (RIN 1210–AB38). A
complete listing of EBSA’s regulatory
initiatives (both Plan and non-Plan
items) is provided in the Unified
Agenda portion of this document.
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E.O. 13563
Abandoned Plan Program Amendment
In 2006, the Department published
regulations that facilitate the
termination and winding up of 401(k)type retirement plans that have been
abandoned by their plan sponsors. The
regulation establishes a streamlined
program under which plans are
terminated with very limited
involvement of EBSA regional offices.
EBSA now has 6 years of experience
with this program and believes certain
changes would improve the overall
efficiency of the program and increase
its usage.
EBSA intends to revise the regulations
to expand the program to include plans
of businesses in liquidation proceedings
to reflect recent changes in the U.S.
Bankruptcy Code. The Department
believes that this expansion has the
potential to substantially reduce
burdens on these plans and bankruptcy
trustees. Plans of businesses in
liquidation currently do not have the
option of using the streamlined
termination and winding-up procedures
under the program. This is true even
though bankruptcy trustees, pursuant to
the Bankruptcy Code, can have a legal
duty to administer the plan. Thus,
bankruptcy trustees, who often are
unfamiliar with applicable fiduciary
requirements and plan-termination
procedures, presently have little in the
way of a blueprint or guide for
efficiently terminating and winding up
such plans. Expanding the program to
cover these plans will allow eligible
bankruptcy trustees to use the
streamlined termination process to
better discharge its obligations under
the law. The use of streamlined
procedures will reduce the amount of
time and effort it would take ordinarily
to terminate and wind up such plans.
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The expansion also will eliminate
Government filings ordinarily required
of terminating plans. Participation in
the program will reduce the overall cost
of terminating and winding up such
plans, which will result in larger benefit
distributions to participants and
beneficiaries in such plans.
EBSA preliminarily estimates that
approximately 165 additional plans will
benefit from the amended abandoned
plans regulation and accompanying
class exemption. EBSA expects that the
cost burden reduction that will result
from this initiative will be
approximately $1.12 million.
Please note that this preliminary
estimate only reflects short-term burden
reduction costs for bankruptcy trustees
to terminate plans under the rule. EBSA
expects substantial benefits will accrue
to participants and beneficiaries covered
by these plans, because their account
balances will be maximized for two
primary reasons. First, prompt, efficient
termination of these plans will
eliminate future administrative
expenses charged to the plans that
otherwise would diminish plan assets.
Second, by following the specific
standards and procedures set forth in
the rule, the Department expects that
overall plan termination costs will be
reduced due to increased efficiency.
Office of Labor-Management Standards
(OLMS)
The Office of Labor-Management
Standards (OLMS) administers and
enforces most provisions of the LaborManagement Reporting and Disclosure
Act of 1959 (LMRDA). The LMRDA
promotes labor-management
transparency by requiring unions,
employers, labor-relations consultants,
and others to file reports, which are
publicly available. The LMRDA
includes provisions protecting union
member rights to participate in their
union’s governance, to run for office and
fully exercise their union citizenship, as
well as procedural safeguards to ensure
free and fair union elections. Besides
enforcing these provisions, OLMS also
ensures the financial accountability of
unions, their officers and employees,
through enforcement and voluntary
compliance efforts. Because of these
activities, OLMS better ensures that
workers have a more effective voice in
the governance of their unions, which in
turn affords them a more effective voice
in their workplaces. OLMS also
administers Executive Order 13496,
which requires Federal contractors to
notify their employees concerning their
rights to organize and bargain
collectively under Federal labor laws.
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Openness and Transparency
Persuader Agreements: Employer and
Labor Relations Consultant Reporting
Under the LMRDA
OLMS published a proposed
regulatory initiative in June 2011, which
is a transparency regulation intended to
provide workers with information
critical to their effective participation in
the workplace. The proposed
regulations would better implement the
public disclosure objectives of the
LMRDA in situations where an
employer engages a consultant in order
to persuade employees concerning their
rights to organize and bargain
collectively. Under LMRDA section 203,
an employer must report any agreement
or arrangement with a consultant to
persuade employees concerning their
rights to organize and collectively
bargain, or to obtain certain information
concerning activities of employees or a
labor organization in connection with a
labor dispute involving the employer.
The consultant is also required to report
such an agreement or arrangement with
an employer. Statutory exceptions to
these reporting requirements are set
forth in LMRDA section 203(c), which
provides, in part, that employers and
consultants are not required to file a
report by reason of the consultant’s
giving or agreeing to give ‘‘advice’’ to
the employer. The Department in its
proposal reconsidered the current
policy concerning the scope of the
‘‘advice’’ exception. When workers have
the necessary information about
arrangements that have been made by
their employer to persuade them
whether or not to form, join, or assist a
union, they are better able to make a
more informed choice about
representation.
Form LM–30: Labor Organization
Officer and Employee Conflict-ofInterest Reporting
OLMS published a final rule in
October 2011 revising the Form LM–30
Labor Organization Officer and
Employee Report, which discloses
actual or likely conflicts between the
financial interests of a union official and
the interests of the union. In addition to
seeking greater transparency of actual or
likely conflicts of interest, this rule is
also a burden reduction regulation.
Employment and Training
Administration (ETA)
The Employment and Training
Administration (ETA) administers and
oversees programs that prepare workers
for good jobs at good wages by
providing high quality job training,
employment, labor market information,
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and income maintenance services
through its national network of OneStop centers. The programs within ETA
promote pathways to economic
independence for individuals and
families. Through several laws, ETA is
charged with administering numerous
employment and training programs
designed to assist the American worker
in developing the knowledge, skills, and
abilities that are sought after in the 21st
century’s economy. ETA plans a
retrospective review of the Rounding
Rule for the Total Unemployment Rate
Benefits Trigger.
Addressing Targeted Concerns of
Workers
Temporary Non-Agricultural
Employment of H–2B Aliens in the
United States
As part of the Department’s foreign
labor certification responsibilities, ETA
certifies whether U.S. workers capable
of performing the jobs for which
employers are seeking foreign workers
are available and whether the
employment of foreign workers will
adversely affect the wages and working
conditions of U.S. workers similarly
employed. Through the Wage and Hour
Division (WHD), the Department
enforces compliance with the
conditions of an approved temporary
labor certification.
This rulemaking seeks to ensure that
only those employers who demonstrate
a real temporary need for foreign
workers will have access to H–2B
workers. The rule also will seek to
provide U.S. workers with greater access
to the jobs employers wish to fill with
temporary H–2B workers through more
robust recruitment by employers to
demonstrate the unavailability of U.S.
workers and through the creation of a
national, electronic job registry. The
rule will explore strengthening existing
worker enforcement to ensure adequate
protections for both U.S. and H–2B
workers. The rulemaking will include
greater transparency and openness to
provide U.S. workers with greater
information and access to job
opportunities.
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E.O. 13563
Equal Employment Opportunity in
Apprenticeship and Training,
Amendment of Regulations
The revision of the National
Apprenticeship Act Equal Opportunity
in Apprenticeship and Training (EEO)
regulations is a critical element in the
Department’s vision to promote and
expand registered apprenticeship
opportunities in the 21st Century while
safeguarding the welfare and safety of
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all apprentices. In October 2008, ETA
issued a final rule updating 29 CFR part
29, the regulatory framework for
registration of apprenticeship programs
and apprentices, and administration of
the National Apprenticeship System.
The companion EEO regulations, 29
CFR part 30, have not been amended
since 1978. ETA proposes to update part
30 EEO in the Apprenticeship and
Training regulations to ensure that they
act in concert with the 2008 revised part
29 rule. The proposed EEO regulations
also will further Secretary Solis’ vision
of good jobs for everyone by ensuring
that apprenticeship program sponsors
develop and fully implement
nondiscrimination and affirmative
action efforts that provide equal
opportunity for all applicants to
apprenticeship and apprentices,
regardless of race, gender, national
origin, color, religion, or disability.
DOL—OFFICE OF FEDERAL
CONTRACT COMPLIANCE
PROGRAMS (OFCCP)
Proposed Rule Stage
86. Construction Contractors’
Affirmative Action Requirements
Priority: Other Significant.
Legal Authority: Sec. 201, 202, 205,
211, 301, 302, and 303 of E.O. 11246, as
amended; 30 FR 12319; 32 FR 14303, as
amended by E.O. 12086
CFR Citation: 41 CFR 60–1; 41 CFR
60–4.
Legal Deadline: None.
Abstract: The regulations
implementing the affirmative action
obligations of construction contractors
under Executive Order 11246, as
amended, were last revised in 1980.
Recent data show that disparities in the
representation of women and racial
minorities continue to exist in on-site
construction occupations in the
construction industry. This Notice of
Proposed Rulemaking (NPRM) would
revise 41 CFR part 60–1 and 60–4 by
removing outdated regulatory
provisions, proposing a new method for
establishing affirmative action goals,
and proposing other revisions to the
affirmative action requirements that
reflect the realities of the labor market
and employment practices in the
construction industry today.
Statement of Need: These regulations,
last revised in 1980, have proven
ineffective at making meaningful
progress in the employment of women
and certain minorities in the
construction industry. Analysis of 2006
to 2008 ACS data for 27 on-site
construction occupations reveals a
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significant disparity between the
percentage of women in construction
occupations in the construction
industry and the percentage of women
in construction occupations in all other
industries. The representation of
African Americans in the construction
industry is substantially less than would
be expected given their representation
in all other industries. For example, in
23 of the 27 occupations analyzed,
disparities were found in the
representation of African Americans.
The NPRM would remove outdated
regulatory provisions, propose a new
method for establishing affirmative
action goals, and propose other
revisions to the affirmative action
requirements that reflect the realities of
the labor market and employment
practices in the construction industry
today.
Summary of Legal Basis: This action
is not required by statute or court order.
Legal Authority: Sections 201, 202, 205,
211, 301, 302, and 303 of E.O. 11246, as
amended; 30 FR 12319; 32 FR 14303, as
amended by E.O. 12086.
Alternatives: Regulatory alternatives
will be addressed as the NPRM is
developed.
Anticipated Cost and Benefits: The
proposed rule would adopt a new
framework for implementing affirmative
action requirements in the construction
industry and proposes standards for
designating projects ‘‘mega construction
projects.’’ There may be some additional
costs to contractors as a result of the
increased scope of required actions. The
benefits would likely include increased
diversity in construction workplaces
and increased opportunities for women
and minorities to obtain on-site
construction jobs. Recent reports on the
national unemployment rate show
significantly higher unemployment in
these populations than in others. The
African American unemployment rate is
at record high numbers. More detailed
cost and benefit analyses will be made
as the NPRM is developed. Data all
show significant underrepresentation of
these groups in the construction
industry.
Risks: Failure to provide updated
regulations may impede the equal
opportunity rights of some workers in
protected classes.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
Federalism: Undetermined.
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Agency Contact: Debra A. Carr,
Director, Division of Policy, Planning,
and Program Development, Department
of Labor, Office of Federal Contract
Compliance Programs, Room C3325, 200
Constitution Avenue NW., Washington,
DC 20210, Phone: 202 693–0103, TDD
Phone: 202 693–1337, Fax: 202 693–
1304, Email: ofccp-public@dol.gov.
Related RIN: Previously reported as
1215–AB81.
RIN: 1250–AA01
DOL—OFFICE OF LABORMANAGEMENT STANDARDS (OLMS)
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Final Rule Stage
87. Persuader Agreements: Employer
and Labor Relations Consultant
Reporting Under the LMRDA
Priority: Other Significant.
Legal Authority: 29 U.S.C. 433; 29
U.S.C. 438
CFR Citation: 29 CFR 405; 29 CFR
406.
Legal Deadline: None.
Abstract: The Department published a
notice and comment rulemaking seeking
consideration of a revised interpretation
of section 203(c) of the LaborManagement Reporting and Disclosure
Act (LMRDA). That statutory provision
creates an ‘‘advice’’ exemption from
reporting requirements that apply to
employers and other persons in
connection with persuading employees
about the right to organize and bargain
collectively. A revised interpretation
would narrow the scope of the advice
exemption.
Statement of Need: The Department of
Labor proposed a regulatory initiative to
better implement the public disclosure
objectives of the Labor-Management
Reporting and Disclosure Act (LMRDA)
regarding employer-consultant
agreements to persuade employees
concerning their rights to organize and
bargain collectively. Under LMRDA
section 203, an employer must report
any agreement or arrangement with a
third party consultant to persuade
employees as to their collective
bargaining rights or to obtain certain
information concerning the activities of
employees or a labor organization in
connection with a labor dispute
involving the employer. The consultant
also is required to report concerning
such an agreement or arrangement with
an employer. Statutory exceptions to
these reporting requirements are set
forth in LMRDA section 203(c), which
provides, in part, that employers and
consultants are not required to file a
report by reason of the consultant’s
giving or agreeing to give ‘‘advice’’ to
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the employer. The Department’s
proposal stated that its current policy
concerning the scope of the ‘‘advice
exception’’ is overbroad and that a
narrower construction would better
allow for the employer and consultant
reporting intended by the LMRDA. The
proposal stated that regulatory action is
needed to provide workers with
information critical to their effective
participation in the workplace.
Summary of Legal Basis: This
proposed rulemaking is authorized
under U.S.C. sections 433 and 438 and
applies to regulations at 29 CFR part 405
and 29 CFR part 406.
Alternatives: Alternatives will be
developed and considered in the course
of notice and comment rulemaking.
Anticipated Cost and Benefits:
Anticipated costs and benefits of this
proposed regulatory initiative have not
been assessed and will be determined at
a later date, as appropriate.
Risks: This action does not affect
public health, safety, or the
environment.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period End.
Final Action .........
06/21/11
08/22/11
76 FR 36178
07/29/11
76 FR 45480
09/21/11
08/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
URL for More Information:
www.olms.dol.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Andrew R. Davis,
Chief, Division of Interpretations and
Standards, Office of Labor-Management
Standards, Department of Labor, Office
of Labor-Management Standards, Room
N–5609, FP Building, 200 Constitution
Avenue NW., Washington, DC 20210,
Phone: 202 693–1254, Fax: 202 693–
1340, Email: davis.andrew@dol.gov.
Related RIN: Previously reported as
1215–AB79.
RIN: 1245–AA03
DOL—EMPLOYMENT AND TRAINING
ADMINISTRATION (ETA)
Proposed Rule Stage
88. Equal Employment Opportunity in
Apprenticeship Amendment of
Regulations
Priority: Other Significant.
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Legal Authority: Sec. 1, 50 Stat 664, as
amended (29 U.S.C. 50; 40 U.S.C. 276c;
5 U.S.C. 301); Reorganization Plan No.
14 of 1950, 64 Stat. 1267 (5 U.S.C. app.
p. 534)
CFR Citation: 29 CFR 30 (Revision).
Legal Deadline: None.
Abstract: Revisions to the equal
opportunity regulatory framework for
the National Apprenticeship Act are a
critical element in the Department’s
vision to promote and expand
Registered Apprenticeship
opportunities in the 21st century while
continuing to safeguard the welfare and
safety of apprentices. In October 2008,
the Agency issued a Final Rule updating
regulations for Apprenticeship Programs
and Labor Standards for Registration.
These regulations, codified at title 29
Code of Federal Regulations (CFR) part
29, had not been updated since 1977.
The companion regulations, 29 CFR part
30, Equal Employment Opportunity
(EEO) in Apprenticeship and Training,
have not been amended since 1978.
The Agency now proposes to update
29 CFR part 30 to ensure that the
National Registered Apprenticeship
System is consistent and in alignment
with EEO law, as it has developed since
1978, and recent revisions to 29 CFR
part 29. This second phase of regulatory
updates will ensure that Registered
Apprenticeship is positioned to
continue to provide economic
opportunity for millions of Americans
while keeping pace with these new
requirements.
Statement of Need: Federal
regulations for Equal Employment
Opportunity (EEO) in Apprenticeship
have not been updated since 1978.
Updates to these regulations are
necessary to ensure that DOL regulatory
requirements governing the National
Registered Apprenticeship System are
consistent with the current state of EEO
law and recent revisions to 29 CFR part
29.
Summary of Legal Basis: These
regulations are authorized by the
National Apprenticeship Act of 1937 (29
U.S.C. 50) and the Copeland Act (40
U.S.C. 276c). These regulations will set
forth policies and procedures to
promote equality of opportunity in
apprenticeship programs registered with
the U.S. Department of Labor or in State
Apprenticeship Agencies recognized by
the U.S. Department of Labor.
Alternatives: The public will be
afforded an opportunity to provide
comments on the proposed amendment
to Apprenticeship EEO regulations
when the Department publishes a
Notice of Proposed Rulemaking (NPRM)
in the Federal Register. A Final Rule
will be issued after analysis and
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incorporation of public comments to the
NRPM.
Anticipated Cost and Benefits: The
proposed changes are thought to raise
‘‘novel legal or policy issues’’ but are
not economically significant within the
context of Executive Order 12866 and
are not a ‘‘major rule’’ under section 804
of the Small Business Regulatory
Enforcement Fairness Act.
Risks: This action does not affect the
public health, safety, or the
environment.
Timetable:
Action
Date
NPRM ..................
FR Cite
02/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
State, Tribal.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
Agency Contact: John V. Ladd, Office
of Apprenticeship, Department of Labor,
Employment and Training
Administration, Room N5311, FP
Building, 200 Constitution Avenue NW.,
Washington, DC 20210, Phone: 202 693–
2796, Fax: 202 693–3799, Email:
ladd.john@dol.gov.
RIN: 1205–AB59
DOL—ETA
Final Rule Stage
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89. Labor Certification Process and
Enforcement for Temporary
Employment in Occupations Other
Than Agriculture or Registered Nursing
in the United States (H–2B Workers)
Priority: Other Significant.
Legal Authority: 8 U.S.C.
1101(a)(15)(H)(ii)(B)); 8 U.S.C.
1184(c)(1); 8 CFR 214.2(h)
CFR Citation: 20 CFR 655.
Legal Deadline: None.
Abstract: The Department published a
Notice of Proposed Rulemaking (NPRM)
on March 18, 2011. The public comment
period closed on May 17, 2011. The
Department of Homeland Security
(DHS) regulations require employers to
apply for a temporary labor certification
from the Department of Labor before H–
2B petitions may be approved. DOL
certifies that there are not sufficient U.S.
worker(s) who are capable of performing
the temporary services or labor at the
time of an application for a visa, and
that the employment of the H–2B
workers will not adversely affect the
wages and working conditions of
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similarly employed U.S. workers. This
NPRM proposed to re-engineer the H–
2B program in order to enhance
transparency and strengthen program
integrity and protections of both U.S.
workers and H–2B workers.
Statement of Need: The Department
has determined that a new rulemaking
effort is necessary for the H–2B
program. The policy underpinnings of
the current regulation; e.g., streamlining
the H–2B process to defer many
determinations of program compliance
until after an application has been
adjudicated do not provide an adequate
level of protection for either U.S. or
foreign workers. The proposed rule
seeks to enhance worker protections and
increase the availability of job
opportunities to qualified U.S. workers.
Summary of Legal Basis: The
Department of Labor’s authority to
revise these regulations derives from 8
U.S.C. 1101(a)(15)(H)(ii)(B), 8 U.S.C.
1184(c)(1), and 8 CFR 214.2(h).
Alternatives: The public was afforded
an opportunity to provide comments on
the proposed regulatory changes when
the Department published the NPRM in
the Federal Register. A final rule will be
issued after analysis of, and response to,
public comments.
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated
costs of this regulatory action have been
provided in the NPRM. The Department
of Labor sought information on potential
additional or actual costs from
employers and other interested parties
through the NPRM in order to better
assess the costs and benefits of the
proposed provisions of the program.
The proposed changes are thought to
raise ‘‘novel legal or policy issues’’ but
are not economically significant within
the context of Executive Order 12866
and are not a ‘‘major rule’’ under section
804 for the Small Business Regulatory
Enforcement Fairness Act.
Risks: This action does not affect the
public health, safety, or the
environment.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
03/18/11
05/17/11
76 FR 15130
01/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: State.
Agency Contact: William L. Carlson,
Ph.D., Administrator, Office of Foreign
Labor Certification, Department of
Labor, Employment and Training
Administration, Room C–4312, FP
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Building, 200 Constitution Avenue NW.,
Washington, DC 20210, Phone: 202 693–
3010, Email: carlson.william@dol.gov.
RIN: 1205–AB58
DOL—EMPLOYEE BENEFITS
SECURITY ADMINISTRATION (EBSA)
Proposed Rule Stage
90. Definition of ‘‘Fiduciary’’
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 29 U.S.C. 1002;
ERISA sec 3(21); 29 U.S.C. 1135; ERISA
sec 505
CFR Citation: 29 CFR 2510.3–21(c).
Legal Deadline: None.
Abstract: This rulemaking would
amend the regulatory definition of the
term ‘‘fiduciary’’ set forth at 29 CFR
2510.3–21(c) to more broadly define as
employee benefit plan fiduciaries
persons who render investment advice
to plans for a fee within the meaning of
section 3(21) of ERISA. The amendment
would take into account current
practices of investment advisers and the
expectations of plan officials and
participants who receive investment
advice.
Statement of Need: This rulemaking is
needed to bring the definition of
‘‘fiduciary’’ into line with investment
advice practices and to recast the
current regulation to better reflect
relationships between investment
advisers and their employee benefit
plan clients. The current regulation may
inappropriately limit the types of
investment advice relationships that
should give rise to fiduciary duties on
the part of the investment adviser.
Summary of Legal Basis: Section 505
of ERISA provides that the Secretary
may prescribe such regulations as she
finds necessary and appropriate to carry
out the provisions of title I of the Act.
Regulation 29 CFR 2510.3–21(c) defines
the term fiduciary for certain purposes
under section 3(21) of ERISA.
Alternatives: Alternatives will be
considered following a determination of
the scope and nature of the regulatory
guidance needed by the public.
Anticipated Cost and Benefits:
Preliminary estimates of the anticipated
costs and benefits will be developed, as
appropriate, following a determination
regarding the alternatives to be
considered.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
10/22/10
01/20/11
75 FR 65263
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Action
Date
Second NPRM ....
FR Cite
05/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Agency Contact: Jeffrey J. Turner,
Chief, Division of Regulations, Office of
Regulations and Interpretations,
Department of Labor, Employee Benefits
Security Administration, 200
Constitution Avenue NW., Room N–
5655, FP Building, Washington, DC
20210, Phone: 202 693–8500.
RIN: 1210–AB32
DOL—MINE SAFETY AND HEALTH
ADMINISTRATION (MSHA)
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Proposed Rule Stage
91. Respirable Crystalline Silica
Priority: Other Significant.
Legal Authority: 30 U.S.C. 811
CFR Citation: 30 CFR 58.
Legal Deadline: None.
Abstract: Current standards limit
exposures to quartz (crystalline silica) in
respirable dust. The metal and nonmetal
mining industry standard is based on
the 1973 American Conference of
Governmental Industrial Hygienists
(ACGIH) Threshold Limit Values
formula: 10 mg/m3 divided by the
percentage of quartz plus 2.
Overexposure to crystalline silica can
result in some miners developing
silicosis, an irreversible but preventable
lung disease, which ultimately may be
fatal. The formula is designed to limit
exposures to 0.1 mg/m3 (100 mg) of
silica. NIOSH recommends a 50 mg/m3
exposure limit for respirable crystalline
silica. MSHA will publish a proposed
rule to address miners’ exposure to
respirable crystalline silica.
Statement of Need: MSHA standards
are outdated; current regulations may
not protect workers from developing
silicosis. Evidence indicates that miners
continue to develop silicosis. MSHA’s
proposed regulatory action exemplifies
the Agency’s commitment to protecting
the most vulnerable populations while
assuring broad-based compliance.
MSHA will regulate based on sound
science to eliminate or reduce the
hazards with the broadest and most
serious consequences. MSHA intends to
use OSHA’s work on the health effects
and risk assessment, adapting it as
necessary for the mining industry.
Summary of Legal Basis:
Promulgation of this standard is
authorized by section 101 of the Federal
Mine Safety and Health Act of 1977.
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Alternatives: This rulemaking would
improve health protection from that
afforded by the existing standards.
MSHA will consider alternative
methods of addressing miners’
exposures based on the capabilities of
the sampling and analytical methods.
Anticipated Cost and Benefits: MSHA
will prepare estimates of the anticipated
costs and benefits associated with the
proposed rule.
Risks: For over 70 years, toxicology
information and epidemiological studies
have shown that exposure to respirable
crystalline silica presents potential
health risks to miners. These potential
adverse health effects include simple
silicosis and progressive massive
fibrosis (lung scarring). Evidence
indicates that exposure to silica may
cause cancer. MSHA believes that the
health evidence forms a reasonable basis
for reducing miners’ exposures to
respirable crystalline silica.
Timetable:
Action
Date
NPRM ..................
FR Cite
05/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Local,
State.
URL for More Information:
www.msha.gov/regsinfo.htm.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Roslyn B. Fontaine,
Acting Director, Office of Standards,
Regulations, and Variances, Department
of Labor, Mine Safety and Health
Administration, 1100 Wilson Boulevard,
Room 2350, Arlington, VA 22209–3939,
Phone: 202 693–9440, Fax: 202 693–
9441, Email: fontaine.roslyn@dol.gov.
RIN: 1219–AB36
DOL—MSHA
92. Criteria and Procedures for
Proposed Assessment of Civil Penalties
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: 30 U.S.C. 815; 30
U.S.C. 820; 30 U.S.C. 957
CFR Citation: 30 CFR 100.
Legal Deadline: None.
Abstract: MSHA will develop a
proposed rule to revise the process for
proposing civil penalties. The
assessment of civil penalties is a key
component in MSHA’s strategy to
enforce safety and health standards. The
Congress intended that the imposition
of civil penalties would induce mine
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operators to be proactive in their
approach to mine safety and health, and
take necessary action to prevent safety
and health hazards before they occur.
MSHA believes that the procedures for
assessing civil penalties can be revised
to improve the efficiency of the
Agency’s efforts and to facilitate the
resolution of enforcement issues.
Statement of Need: Section 110(a) of
the Federal Mine Safety and Health Act
of 1977 (Mine Act) requires MSHA to
assess a civil penalty for a violation of
a mandatory health or safety standard or
violation of any provision of the Mine
Act. The mine operator has 30 days
from receipt of the proposed assessment
to contest it before the Federal Mine
Safety and Health Review Commission
(Commission), an independent
adjudicatory agency established under
the Mine Act. A proposed assessment
that is not contested within 30 days
becomes a final order of the
Commission. A proposed assessment
that is contested within 30 days
proceeds to the Commission for
adjudication. The proposed rule would
promote consistency, objectivity, and
efficiency in the proposed assessment of
civil penalties.
When issuing citations or orders,
inspectors are required to evaluate
safety and health conditions and make
decisions about the statutory criteria
related to assessing penalties. The
proposed changes in the measures of the
evaluation criteria would result in fewer
areas of disagreement and earlier
resolution of enforcement issues. The
proposal would require conforming
changes to the Mine Citation/Order form
(MSHA Form 7000–3).
Summary of Legal Basis: Section 104
of the Mine Act requires MSHA to issue
citations or orders to mine operators for
any violations of a mandatory health or
safety standard, rule, order, or
regulation promulgated under the Mine
Act. Sections 105 and 110 of the Mine
Act provide for assessment of these
penalties.
Alternatives: The proposal would
include several alternatives in the
preamble and requests comments on
them.
Anticipated Cost and Benefits: MSHA
will prepare estimates of the anticipated
costs and benefits in a preliminary
regulatory economic analysis to
accompany the proposed rule.
Risks: MSHA’s existing procedures for
assessing civil penalties can be revised
to improve the efficiency of the
Agency’s efforts and to facilitate the
resolution of enforcement issues. In the
overwhelming majority of contested
cases before the Commission, the issue
is not whether a violation occurred.
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Rather, the parties disagree on the
gravity of the violation, the degree of
mine operator negligence, and other
criterion. The proposed changes should
result in fewer areas of disagreement
and earlier resolution of enforcement
issues, which should result in fewer
contests of violations or proposed
assessments.
Timetable:
Action
Date
NPRM ..................
FR Cite
02/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.msha.gov/regsinfo.htm.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Roslyn B. Fontaine,
Acting Director, Office of Standards,
Regulations, and Variances, Department
of Labor, Mine Safety and Health
Administration, 1100 Wilson Boulevard,
Room 2350, Arlington, VA 22209–3939,
Phone: 202 693–9440, Fax: 202 693–
9441, Email: fontaine.roslyn@dol.gov.
RIN: 1219–AB72
Statement of Need: Mining is one of
the most hazardous industries in this
country. Miners continue to be injured
or killed resulting from pinning,
crushing, or striking accidents involving
mobile equipment. Equipment is
available to help prevent accidents that
cause debilitating injuries and
accidental death.
Summary of Legal Basis:
Promulgation of this standard is
authorized by section 101(a) of the
Federal Mine Safety and Health Act of
1977, as amended by the Mine
Improvement and New Emergency
Response Act of 2006.
Alternatives: No reasonable
alternatives to this regulation would be
as comprehensive or as effective in
eliminating hazards and preventing
injuries.
Anticipated Cost and Benefits: MSHA
will develop a preliminary regulatory
economic analysis to accompany the
proposed rule.
Risks: The lack of proximity detection
systems on mobile equipment in
underground mines contributes to a
higher incidence of debilitating injuries
and accidental deaths.
Timetable:
Action
DOL—MSHA
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93. • Proximity Detection Systems for
Mobile Machines in Underground
Mines
Priority: Other Significant.
Legal Authority: 30 U.S.C. 811
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: MSHA will develop a
proposed rule to address the hazards
that miners face when working near
mobile equipment in underground
mines. MSHA has concluded, from
investigations or accidents involving
mobile equipment and other reports,
that action is needed to protect miner
safety. Mobile equipment can pin,
crush, or strike a miner working near
the equipment. Proximity detection
technology can prevent these types of
accidents. The proposed rule would
strengthen the protection for
underground miners by reducing the
potential of pinning, crushing, or
striking hazards associated with
working close to mobile equipment. As
part of the Secretary’s strategy for
securing safe and healthy workplaces,
the OSHA will also undertake
regulatory action related to reducing
injuries and fatalities to workers in close
proximity to moving equipment and
vehicles.
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Date
FR Cite
Request for Information.
RFI Comment Period Ended.
NPRM ..................
02/01/10
75 FR 5009
04/02/10
01/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.msha.gov/regsinfo.htm.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Roslyn B. Fontaine,
Acting Director, Office of Standards,
Regulations, and Variances, Department
of Labor, Mine Safety and Health
Administration, 1100 Wilson Boulevard,
Room 2350, Arlington, VA 22209–3939,
Phone: 202 693–9440, Fax: 202 693–
9441, Email: fontaine.roslyn@dol.gov.
Related RIN: Related to 1219–AB65.
RIN: 1219–AB78
DOL—MSHA
Final Rule Stage
94. Lowering Miners’ Exposure to Coal
Mine Dust, Including Continuous
Personal Dust Monitors
Priority: Other Significant
Legal Authority: 30 U.S.C. 811; 30
U.S.C. 813(h)
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CFR Citation: 30 CFR 70; 30 CFR 71;
30 CFR 72; 30 CFR 75; 30 CFR 90
Legal Deadline: None
Abstract: The Federal Coal Mine
Health and Safety Act of 1969
established the first comprehensive
respirable dust standards for coal mines.
These standards were designed to
reduce the incidence of coal workers’
pneumoconiosis (CWP or black lung)
and silicosis and eventually eliminate
these diseases. While significant
progress has been made toward
improving the health conditions in our
Nation’s coal mines, miners continue to
be at risk of developing occupational
lung disease, according to the National
Institute for Occupational Safety and
Health (NIOSH). In September 1995,
NIOSH issued a Criteria Document in
which it recommended that the
respirable coal mine dust permissible
exposure limit (PEL) be cut in half. In
February 1996, the Secretary of Labor
convened a Federal Advisory
Committee on the Elimination of
Pneumoconiosis Among Coal Miners
(Advisory Committee) to assess the
adequacy of MSHA’s current program
and standards to control respirable dust
in underground and surface coal mines,
as well as other ways to eliminate black
lung and silicosis among coal miners.
The Committee represented the labor,
industry and academic communities.
The Committee submitted its report to
the Secretary of Labor in November
1996, with the majority of the
recommendations unanimously
supported by the Committee members.
The Committee recommended a number
of actions to reduce miners’ exposure to
respirable coal mine dust. This final
rule is an important element in MSHA’s
Comprehensive Black Lung Reduction
Strategy (Strategy) to ‘‘End Black Lung
Now.’’
Statement of Need: Comprehensive
respirable dust standards for coal mines
were designed to reduce the incidence,
and eventually eliminate, CWP and
silicosis. While significant progress has
been made toward improving the health
conditions in our Nation’s coal mines,
miners remain at risk of developing
occupational lung disease, according to
NIOSH. Recent NIOSH data indicates
increased prevalence of CWP ‘‘clusters’’
in several geographical areas,
particularly in the Southern
Appalachian Region.
Summary of Legal Basis:
Promulgation of this regulation is
authorized by the Federal Mine Safety
and Health Act of 1977 as amended by
the Mine Improvement and New
Emergency Response Act of 2006.
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Alternatives: MSHA is considering
amendments, revisions, and additions to
existing standards.
Anticipated Cost and Benefits: MSHA
will develop a regulatory economic
analysis to accompany the final rule.
Risks: Respirable coal dust is one of
the most serious occupational hazards
in the mining industry. Occupational
exposure to excessive levels of
respirable coal mine dust can cause coal
workers’ pneumoconiosis and silicosis,
which are potentially disabling and can
cause death. MSHA is pursuing both
regulatory and nonregulatory actions to
eliminate these diseases through the
control of coal mine respirable dust
levels in mines and reduction of miners’
exposure. MSHA developed a risk
assessment to accompany the proposed
rule.
Timetable:
Date
FR Cite
NPRM ..................
Notice of Public
Hearings; Corrections.
NPRM—Rescheduling of Public
Hearings; Correction.
NPRM Comment
Period End.
Public Hearing .....
Public Hearing .....
Public Hearing .....
Public Hearing .....
Public Hearing .....
Public Hearing .....
Public Hearing .....
NPRM Comment
Period Extended.
Request for Comment.
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period End.
Final Rule ............
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Action
10/19/10
11/15/10
75 FR 64412
75 FR 69617
11/30/10
75 FR 73995
02/28/10
12/07/10
01/11/11
01/13/11
01/25/11
02/08/11
02/10/11
02/15/11
01/14/11
76 FR 2617
03/08/11
76 FR 12648
05/02/11
05/04/11
76 FR 25277
05/31/11
05/27/11
76 FR 30878
06/20/11
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.msha.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Roslyn B. Fontaine,
Acting Director, Office of Standards,
Regulations, and Variances, Department
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of Labor, Mine Safety and Health
Administration, 1100 Wilson Boulevard,
Room 2350, Arlington, VA 22209–3939,
Phone: 202 693–9440, Fax: 202 693–
9441, Email: fontaine.roslyn@dol.gov.
RIN: 1219–AB64
machines in underground coal mines
contributes to a higher incidence of
debilitating injuries and accidental
deaths.
Timetable:
Action
DOL—MSHA
95. Proximity Detection Systems for
Continuous Mining Machines in
Underground Coal Mines
Priority: Other Significant.
Legal Authority: 30 U.S.C. 811
CFR Citation: 30 CFR 75.1732.
Legal Deadline: None.
Abstract: The Mine Safety and Health
Administration (MSHA) will develop a
final rule to address hazards that miners
face when working near continuous
mining machines in underground coal
mines. MSHA has concluded, from
investigations of accidents involving
continuous mining machines and other
reports, that action is necessary to
protect miners. Continuous mining
machines can pin, crush, or strike a
miner working near the equipment.
Proximity detection technology can
prevent these types of accidents. The
final rule would strengthen the
protection for underground coal miners
by reducing the potential of pinning,
crushing, or striking hazards associated
with working close to continuous
mining machines. As a part of the
Secretary’s strategy for securing safe and
healthy workplaces, the OSHA will also
undertake regulatory action related to
reducing injuries and fatalities to
workers in close proximity to moving
equipment and vehicles.
Statement of Need: Mining is one of
the most hazardous industries in this
country. Miners continue to be injured
or killed resulting from pinning,
crushing, or striking accidents involving
mobile equipment. Equipment is
available to help prevent accidents that
cause debilitating injuries and
accidental death.
Summary of Legal Basis:
Promulgation of this standard is
authorized by section 101(a) of the
Federal Mine Safety and Health Act of
1977, as amended by the Mine
Improvement and New Emergency
Response Act of 2006.
Alternatives: No reasonable
alternatives to this regulation would be
as comprehensive or as effective in
eliminating hazards and preventing
injuries.
Anticipated Cost and Benefits: MSHA
will develop a regulatory economic
analysis to accompany the final rule.
Risks: The lack of proximity detection
systems on continuous mining
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Date
FR Cite
Request for Information (RFI).
RFI Comment Period Ended.
NPRM ..................
Notice of Public
Hearing.
NPRM Comment
Period End.
Final Action .........
02/01/10
75 FR 5009
04/02/10
08/31/11
10/12/11
76 FR 54163
76 FR 63238
11/14/11
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.msha.gov/reginfo.htm.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Roslyn B. Fontaine,
Acting Director, Office of Standards,
Regulations, and Variances, Department
of Labor, Mine Safety and Health
Administration, 1100 Wilson Boulevard,
Room 2350, Arlington, VA 22209–3939,
Phone: 202 693–9440, Fax: 202 693–
9441, Email: fontaine.roslyn@dol.gov.
RIN: 1219–AB65
DOL—MSHA
96. Pattern of Violations
Priority: Other Significant.
Legal Authority: 30 U.S.C. 814(e); 30
U.S.C. 957
CFR Citation: 30 CFR 104.
Legal Deadline: None.
Abstract: MSHA is preparing a final
rule to revise the Agency’s existing
regulation for pattern of violations
contained in 30 CFR part 104. MSHA
has determined that the existing pattern
criteria and procedures do not reflect
the statutory intent for section 104(e) of
the Federal Mine Safety and Health Act
of 1977 (Mine Act) that operators
manage health and safety conditions at
mines so that the root causes of
significant and substantial (S&S)
violations are addressed before they
become a hazard to the health and safety
of miners. The legislative history of the
Mine Act explains that Congress
intended the pattern of violations tool to
be used for operators who have
demonstrated a disregard for the health
and safety of miners. The final rule
would reflect statutory intent, simplify
the pattern of violations criteria, and
improve consistency in applying the
patterns of violations criteria.
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Statement of Need: The pattern of
violations provision was a new
enforcement tool in the Mine Act. The
Mine Act places the ultimate
responsibility for ensuring the safety
and health of miners on mine operators.
The goal of the pattern of violations
proposed rule is to compel operators to
manage health and safety conditions so
that the root causes of S&S violations
are found and fixed before they become
a hazard to miners. MSHA’s existing
regulation is not consistent with the
language, purpose, and legislative
history of the Mine Act and hinders the
Agency’s use of pattern of violations to
identify chronic violators who thumb
their noses at the law by a continuing
cycle of citation and abatement.
Summary of Legal Basis:
Promulgation of this standard is
authorized by sections 104(e) and 508 of
the Federal Mine Safety and Health Act
of 1977.
Alternatives: MSHA will consider
alternative criteria for determining
when a pattern of significant and
substantial violations exists in order to
improve health and safety conditions in
mines and provide protection for
miners. Congress provided the Secretary
with broad discretion in determining
criteria, recognizing that MSHA may
need to modify the criteria as Agency
experience dictates.
Anticipated Cost and Benefits: MSHA
will develop a regulatory economic
analysis to accompany the final rule.
Risks: Mine operators with a chronic
history of persistent serious violations
needlessly expose miners to the same
hazards again and again. These
operators demonstrate a disregard for
the safety and health of miners; this
indicates a serious safety and health
management problem at the mine. The
existing regulation has not been
effective in reducing repeated risks to
miners at these mines.
Timetable:
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Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period End.
Notice of Public
Hearing and
Extension of
Comment Period.
Notice of Public
Hearing and
Extension of
Comment Period.
02/02/11
04/04/11
76 FR 5719
04/04/11
76 FR 18467
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05/04/11
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76 FR 25277
76 FR 35801
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Action
Date
NPRM Comment
Period End.
Comment Period
End.
Final Action .........
FR Cite
06/30/11
08/01/11
04/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.msha.gov/regsinfo.htm.
URL for Public Comments: https://
www.regulations.gov.
Agency Contact: Roslyn B. Fontaine,
Acting Director, Office of Standards,
Regulations, and Variances, Department
of Labor, Mine Safety and Health
Administration, 1100 Wilson Boulevard,
Room 2350, Arlington, VA 22209–3939,
Phone: 202 693–9440, Fax: 202 693–
9441, Email: fontaine.roslyn@dol.gov.
RIN: 1219–AB73
DOL—MSHA
97. Examination of Work Areas in
Underground Coal Mines for Violations
of Mandatory Health or Safety
Standards
Priority: Other Significant.
Legal Authority: 30 U.S.C. 811; 30
U.S.C. 961
CFR Citation: 30 CFR 75.
Legal Deadline: None.
Abstract: In the ever changing mine
environment, it is critical that
hazardous conditions be recognized and
abated quickly. Additionally, other
conditions that could develop into a
hazard if left uncorrected must also be
eliminated. Operator examinations for
hazards and violations of mandatory
health or safety standards are mandated
in the Mine Act and are a critical
component of an effective safety and
health program for underground mines.
While this requirement was previously
included in regulations, the 1992 final
rule addressing ventilation in
underground coal mines only included
the requirement that the mine
examiners look for hazardous
conditions. The 1992 rule omitted from
the standard the text taken from the
Mine Act requiring examinations for
violations of mandatory health or safety
standards during preshift examinations.
The final rule will revise existing
standards for preshift, supplemental,
on-shift, and weekly examinations to
address violations of mandatory health
or safety standards.
Statement of Need: Underground coal
mines usually present harsh and hostile
working environments, and the
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ventilation system is the most vital life
support system in underground mining.
A properly operating ventilation system
is essential for maintaining a safe and
healthful working environment.
Examinations of work areas that include
the ventilation system are the first line
of defense for miners working in
underground coal mines and are
necessary to protect miners. Conditions
in underground coal mines change
rapidly—roof that appears adequately
supported can quickly deteriorate and
fall; stoppings can crush out and shortcircuit air currents; conveyor belts can
become misaligned or belt roller
bearings can fail, resulting in an ignition
source; and methane can accumulate in
areas where it may not have been
detected.
Diligent compliance with safety and
health standards and safety-conscious
work practices provide a substantial
measure of protection against mine
accidents and emergencies. To assure
optimum safety of miners, it is
imperative that operators find violations
of health or safety standards, correct
them, and record corrective actions
taken.
Summary of Legal Basis:
Promulgation of this regulation is
authorized by sections 101 and 303
(d)(1) and (f) of the Federal Mine Safety
and Health Act of 1977.
Alternatives: The proposal included
several alternatives in the preamble and
requested comments on them.
Anticipated Cost and Benefits: MSHA
estimated that the proposed rule would
cost $15.3 million yearly and result in
net benefits of $6.0 million yearly.
Risks: Failure to conduct adequate
examinations to identify, report, and
correct hazardous conditions and
violations of health and safety standards
has resulted in serious accidents and
fatalities. Lack of adequate ventilation
in underground mines has resulted in
fatalities from asphyxiation and
explosions.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM Extension
of Comment
Period.
NPRM Comment
Period End.
Notice of Public
Hearing and
Extension of
Comment Period.
NPRM Comment
Period End.
12/27/10
02/25/11
75 FR 81165
03/01/11
76 FR 11187
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05/04/11
06/30/11
76 FR 25277
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Action
Date
FR Cite
Notice of Public
Hearing and
Extension of
Comment Period.
NPRM Comment
Period End.
Final Action .........
06/20/11
76 FR 35801
08/01/11
03/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
URL for More Information:
www.msha.gov/regsinfo.htm.
Agency Contact: Roslyn B. Fontaine,
Acting Director, Office of Standards,
Regulations, and Variances, Department
of Labor, Mine Safety and Health
Administration, 1100 Wilson Boulevard,
Room 2350, Arlington, VA 22209–3939,
Phone: 202 693–9440, Fax: 202 693–
9441, Email: fontaine.roslyn@dol.gov.
Related RIN: Related to 1219–AB71.
RIN: 1219–AB75
DOL—OCCUPATIONAL SAFETY AND
HEALTH ADMINISTRATION (OSHA)
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Prerule Stage
98. Infectious Diseases
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 5 U.S.C. 533; 29
U.S.C. 657 and 658; 29 U.S.C. 660; 29
U.S.C. 666; 29 U.S.C. 669; 29 U.S.C. 673
CFR Citation: 29 CFR 1910.
Legal Deadline: None.
Abstract: Employees in health care
and other high-risk environments face
long-standing infectious diseases
hazards such as tuberculosis (TB),
varicella disease (chickenpox, shingles),
and measles (rubeola), as well as new
and emerging infectious disease threats,
such as Severe Acute Respiratory
Syndrome (SARS) and pandemic
influenza. Health care workers and
workers in related occupations, or who
are exposed in other high-risk
environments, are at increased risk of
contracting TB, SARS, MRSA, and other
infectious diseases that can be
transmitted through a variety of
exposure routes. OSHA is concerned
about the ability of employees to
continue to provide health care and
other critical services without
unreasonably jeopardizing their health.
OSHA is considering the need for a
standard to ensure that employers
establish a comprehensive infection
control program and control measures to
protect employees from infectious
disease exposures to pathogens that can
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cause significant disease. Workplaces
where such control measures might be
necessary include: Health care,
emergency response, correctional
facilities, homeless shelters, drug
treatment programs, and other
occupational settings where employees
can be at increased risk of exposure to
potentially infectious people. A
standard could also apply to
laboratories, which handle materials
that may be a source of pathogens, and
to pathologists, coroners’ offices,
medical examiners, and mortuaries.
OSHA published an RFI on May 6,
2010, the comment period closed on
August 4, 2010.
Statement of Need: In 2007, the
healthcare and social assistance sector
as a whole had 16.5 million employees.
Healthcare workplaces can range from
small private practices of physicians to
hospitals that employ thousands of
workers. In addition, healthcare is
increasingly being provided in other
settings such as nursing homes, freestanding surgical and outpatient centers,
emergency care clinics, patients’ homes,
and prehospitalization emergency care
settings. The Agency is particularly
concerned by studies that indicate that
transmission of infectious diseases to
both patients and healthcare workers
may be occurring as a result of
incomplete adherence to recognized, but
voluntary, infection control measures.
Another concern is the movement of
healthcare delivery from the traditional
hospital setting, with its greater
infrastructure and resources to
effectively implement infection control
measures, into more diverse and smaller
workplace setting with less
infrastructure and fewer resources, but
with an expanding worker population.
Summary of Legal Basis: The
Occupational Safety and Health Act of
1970 authorizes the Secretary of Labor
to set mandatory occupational safety
and health standards to assure safe and
healthful working conditions for
working men and women (29 U.S.C.
651).
Alternatives: The alternative to the
proposed rulemaking would be to take
no regulatory action.
Anticipated Cost and Benefits: The
estimates of the costs and benefits are
still under development.
Risks: Analysis of risks is still under
development.
Timetable:
Action
Date
FR Cite
Request for Information (RFI).
RFI Comment Period End.
05/06/10
75 FR 24835
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Action
Date
Analyze Comments.
Stakeholder Meetings.
Initiate SBREFA ..
FR Cite
12/30/10
07/29/11
03/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Dorothy Dougherty,
Acting Director, Directorate of
Evaluation and Analysis, Department of
Labor, Occupational Safety and Health
Administration, Room N–3641, FP
Building, 200 Constitution Avenue NW.,
Washington, DC 20210, Phone: 202 693–
2400, Fax: 202 693–1641, Email:
dougherty.dorothy@dol.gov.
RIN: 1218–AC46
DOL—OSHA
99. Injury and Illness Prevention
Program
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 29 U.S.C. 653; 29
U.S.C. 655(b); 29 U.S.C. 657
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: OSHA is developing a rule
requiring employers to implement an
Injury and Illness Prevention Program. It
involves planning, implementing,
evaluating, and improving processes
and activities that protect employee
safety and health. OSHA has substantial
data on reductions in injuries and
illnesses from employers who have
implemented similar effective
processes. The Agency currently has
voluntary Safety and Health Program
Management Guidelines (54 FR 3904 to
3916), published in 1989. An injury and
illness prevention rule would build on
these guidelines as well as lessons
learned from successful approaches and
best practices under OSHA’s Voluntary
Protection Program Safety and Health
Achievement Recognition Program and
similar industry and international
initiatives such as American National
Standards Institute/American Industrial
Hygiene Association Z10 and
Occupational Health and Safety
Assessment Series 18001.
Statement of Need: There are
approximately 5,000 workplace
fatalities and approximately 3.5 million
serious workplace injuries every year.
There are also many workplace illnesses
caused by exposure to common
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
chemical, physical, and biological
agents. OSHA believes that an injury
and illness prevention program is a
universal intervention that can be used
in a wide spectrum of workplaces to
dramatically reduce the number and
severity of workplace injuries. Such
programs have been shown to be
effective in many workplaces in the
United States and internationally.
Summary of Legal Basis: The
Occupational Safety and Health Act of
1970 authorizes the Secretary of Labor
to set mandatory occupational safety
and health standards to assure safe and
healthful working conditions for
working men and women (29 U.S.C.
651).
Alternatives: The alternatives to this
rulemaking would be to issue guidance,
recognition programs, or allow for the
States to develop individual regulations.
OSHA has used voluntary approaches to
address the need, including publishing
Safety and Health Program Management
Guidelines in 1989. In addition, OSHA
has two recognition programs, the
Voluntary Protection Program (known
as VPP), and the Safety and Health
Achievement Recognition Program
(known as SHARP). These programs
recognize workplaces with effective
safety and health programs. Several
States have issued regulations that
require employers to establish effective
safety and health programs.
Anticipated Cost and Benefits: The
scope of the proposed rulemaking and
the costs and benefits are still under
development for this regulatory action.
Risks: A detailed risk analysis is
underway.
Timetable:
Date
Stakeholder Meetings.
Initiate SBREFA ..
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Action
FR Cite
06/03/10
01/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Dorothy Dougherty,
Acting Director, Directorate of
Evaluation and Analysis, Department of
Labor, Occupational Safety and Health
Administration, Room N–3641, FP
Building, 200 Constitution Avenue NW.,
Washington, DC 20210, Phone: 202 693–
2400, Fax: 202 693–1641, Email:
dougherty.dorothy@dol.gov.
RIN: 1218–AC48
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DOL—OSHA
Proposed Rule Stage
100. Occupational Exposure to
Crystalline Silica
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect State, local or tribal governments.
Legal Authority: 29 U.S.C. 655(b); 29
U.S.C. 657
CFR Citation: 29 CFR 1910; 29 CFR
1915; 29 CFR 1917; 29 CFR 1918; 29
CFR 1926.
Legal Deadline: None.
Abstract: Crystalline silica is a
significant component of the earth’s
crust, and many workers in a wide range
of industries are exposed to it, usually
in the form of respirable quartz or, less
frequently, cristobalite. Chronic silicosis
is a uniquely occupational disease
resulting from exposure of employees
over long periods of time (10 years or
more). Exposure to high levels of
respirable crystalline silica causes acute
or accelerated forms of silicosis that are
ultimately fatal. The current OSHA
permissible exposure limit (PEL) for
general industry is based on a formula
proposed by the American Conference
of Governmental Industrial Hygienists
(ACGIH) in 1968 (PEL = 10mg/cubic
meter/(% silica + 2), as respirable dust).
The current PEL for construction and
shipyards (derived from ACGIH’s 1970
Threshold Limit Value) is based on
particle counting technology, which is
considered obsolete. NIOSH and ACGIH
recommend 50mg/m3 and 25mg/m3
exposure limits, respectively, for
respirable crystalline silica.
Both industry and worker groups have
recognized that a comprehensive
standard for crystalline silica is needed
to provide for exposure monitoring,
medical surveillance, and worker
training. ASTM International has
published recommended standards for
addressing the hazards of crystalline
silica. The Building Construction Trades
Department of the AFL–CIO has also
developed a recommended
comprehensive program standard. These
standards include provisions for
methods of compliance, exposure
monitoring, training, and medical
surveillance.
Statement of Need: Workers are
exposed to crystalline silica dust in
general industry, construction, and
maritime industries. Industries that
could be particularly affected by a
standard for crystalline silica include:
Foundries, industries that have abrasive
blasting operations, paint manufacture,
glass and concrete product manufacture,
brick making, china and pottery
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manufacture, manufacture of plumbing
fixtures, and many construction
activities including highway repair,
masonry, concrete work, rock drilling,
and tuckpointing. The seriousness of the
health hazards associated with silica
exposure is demonstrated by the
fatalities and disabling illnesses that
continue to occur. In 2005, the most
recent year for which data is available,
silicosis was identified on 161 death
certificates as an underlying or
contributing cause of death. It is likely
that many more cases have occurred
where silicosis went undetected. In
addition, the International Agency for
Research on Cancer has designated
crystalline silica as carcinogenic to
humans, and the National Toxicology
Program has concluded that respirable
crystalline silica is a known human
carcinogen. Exposure to crystalline
silica has also been associated with an
increased risk of developing
tuberculosis and other nonmalignant
respiratory diseases, as well as renal and
autoimmune diseases. Exposure studies
and OSHA enforcement data indicate
that some workers continue to be
exposed to levels of crystalline silica far
in excess of current exposure limits.
Congress has included compensation of
silicosis victims on Federal nuclear
testing sites in the Energy Employees’
Occupational Illness Compensation
Program Act of 2000. There is a
particular need for the Agency to
modernize its exposure limits for
construction and shipyard workers, and
to address some specific issues that will
need to be resolved to propose a
comprehensive standard.
Summary of Legal Basis: The legal
basis for the proposed rule is a
preliminary determination that workers
are exposed to a significant risk of
silicosis and other serious disease and
that rulemaking is needed to
substantially reduce the risk. In
addition, the proposed rule will
recognize that the PELs for construction
and maritime are outdated and need to
be revised to reflect current sampling
and analytical technologies.
Alternatives: Over the past several
years, the Agency has attempted to
address this problem through a variety
of non-regulatory approaches, including
initiation of a Special Emphasis
Program on silica in October 1997,
sponsorship with NIOSH and MSHA of
the National Conference to Eliminate
Silicosis, and dissemination of guidance
information on its Web site.
Anticipated Cost and Benefits: The
scope of the proposed rulemaking and
estimates of the costs and benefits are
still under development.
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Risks: A detailed risk analysis is
under way.
Timetable:
Action
Date
Completed
SBREFA Report.
Initiated Peer Review of Health
Effects and
Risk Assessment.
Completed Peer
Review.
NPRM ..................
FR Cite
12/19/03
05/22/09
01/24/10
02/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Agency Contact: Dorothy Dougherty,
Acting Director, Directorate of
Evaluation and Analysis, Department of
Labor, Occupational Safety and Health
Administration, Room N–3641, FP
Building, 200 Constitution Avenue NW.,
Washington, DC 20210, Phone: 202 693–
2400, Fax: 202 693–1641, Email:
dougherty.dorothy@dol.gov.
RIN: 1218–AB70
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DOL—OSHA
101. Improve Tracking of Workplace
Injuries and Illnesses
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 29 U.S.C. 657
CFR Citation: 29 CFR 1904.
Legal Deadline: None.
Abstract: OSHA is proposing changes
to its reporting system for occupational
injuries and illnesses. An updated and
modernized reporting system would
enable a more efficient and timely
collection of data and would improve
the accuracy and availability of the
relevant records and statistics. This
proposal involves modification to 29
CFR part 1904.41 to expand OSHA’s
legal authority to collect and make
available injury and illness information
required under part 1904.
Statement of Need: The collection of
establishment specific injury and illness
data in electronic format on a timely
basis is needed to help OSHA,
employers, employees, researchers, and
the public more effectively prevent
workplace injuries and illnesses, as well
as support President Obama’s Open
Government Initiative to increase the
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ability of the public to easily find,
download, and use the resulting dataset
generated and held by the Federal
Government.
Summary of Legal Basis: The
Occupational Safety and Health Act of
1970 authorizes the Secretary of Labor
to develop and maintain an effective
program of collection, compilation, and
analysis of occupational safety and
health statistics (29 U.S.C. 673).
Alternatives: The alternative to the
proposed rulemaking would be to take
no regulatory action.
Anticipated Cost and Benefits: The
estimates of the costs and benefits are
still under development.
Risks: Analysis of risks is still under
development.
Timetable:
Action
Date
FR Cite
Stakeholder Meetings.
Comment Period
End.
NPRM ..................
05/25/10
75 FR 24505
06/18/10
02/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Dorothy Dougherty,
Acting Director, Directorate of
Evaluation and Analysis, Department of
Labor, Occupational Safety and Health
Administration, Room N–3641, FP
Building, 200 Constitution Avenue NW.,
Washington, DC 20210, Phone: 202 693–
2400, Fax: 202 693–1641, Email:
dougherty.dorothy@dol.gov.
RIN: 1218–AC49
DOL—OSHA
Final Rule Stage
102. Hazard Communication
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 29 U.S.C. 655(b); 29
U.S.C. 657
CFR Citation: 29 CFR 1910.1200; 29
CFR 1915.1200; 29 CFR 1917.28; 29 CFR
1918.90; 29 CFR 1926.59; 29 CFR
1928.21.
Legal Deadline: None.
Abstract: OSHA’s Hazard
Communication Standard (HCS)
requires chemical manufacturers and
importers to evaluate the hazards of the
chemicals they produce or import, and
prepare labels and material safety data
sheets to convey the hazards and
associated protective measures to users
of the chemicals. All employers with
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hazardous chemicals in their
workplaces are required to have a
hazard communication program,
including labels on containers, material
safety data sheets (MSDS), and training
for employees. Within the United States
(U.S.), there are other Federal agencies
that also have requirements for
classification and labeling of chemicals
at different stages of the life cycle.
Internationally, there are a number of
countries that have developed similar
laws that require information about
chemicals to be prepared and
transmitted to affected parties. These
laws vary with regard to the scope of
substances covered, definitions of
hazards, the specificity of requirements
(e.g., specification of a format for
MSDSs), and the use of symbols and
pictograms. The inconsistencies
between the various laws are substantial
enough that different labels and safety
data sheets must often be used for the
same product when it is marketed in
different nations.
The diverse and sometimes
conflicting national and international
requirements can create confusion
among those who seek to use hazard
information. Labels and safety data
sheets may include symbols and hazard
statements that are unfamiliar to readers
or not well understood. Containers may
be labeled with such a large volume of
information that important statements
are not easily recognized. Development
of multiple sets of labels and safety data
sheets is a major compliance burden for
chemical manufacturers, distributors,
and transporters involved in
international trade. Small businesses
may have particular difficulty in coping
with the complexities and costs
involved.
As a result of this situation, and in
recognition of the extensive
international trade in chemicals, there
has been a long-standing effort to
harmonize these requirements and
develop a system that can be used
around the world. In 2003, the United
Nations adopted the Globally
Harmonized System of Classification
and Labeling of Chemicals (GHS).
Countries are now adopting the GHS
into their national regulatory systems.
OSHA published the NPRM on
September 30, 2009, and held public
hearings in Washington, DC, and
Pittsburgh, PA, in March 2010. The
record closed on June 1, 2010.
Statement of Need: Multiple sets of
requirements for labels and safety data
sheets present a compliance burden for
U.S. manufacturers, distributors, and
transports involved in international
trade. The comprehensibility of hazard
information and worker safety will be
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enhanced as the GHS will: (1) Provide
consistent information and definitions
for hazardous chemicals; (2) address
stakeholder concerns regarding the need
for a standardized format for material
safety data sheets; and (3) increase
understanding by using standardized
pictograms and harmonized hazard
statements. The increase in
comprehensibility and consistency will
reduce confusion and thus improve
worker safety and health. In addition,
the adoption of the GHS would facilitate
international trade in chemicals, reduce
the burdens caused by having to comply
with differing requirements for the same
product, and allow companies that have
not had the resources to deal with those
burdens to be involved in international
trade. This is particularly important for
small producers who may be precluded
currently from international trade
because of the compliance resources
required to address the extensive
regulatory requirements for
classification and labeling of chemicals.
Thus, every producer is likely to
experience some benefits from domestic
harmonization, in addition to the
benefits that will accrue to producers
involved in international trade. Several
nations, including the European Union,
have adopted the GHS with an
implementation schedule through 2015.
U.S. manufacturers, employers, and
employees will be at a disadvantage in
the event that our system of hazard
communication is not in compliance
with the GHS.
Summary of Legal Basis: The
Occupational Safety and Health Act of
1970 authorizes the Secretary of Labor
to set mandatory occupational safety
and health standards to assure safe and
healthful working conditions for
working men and women (29 U.S.C.
651).
Alternatives: The alternative to the
proposed rulemaking would be to take
no regulatory action.
Anticipated Cost and Benefits: The
estimates of the costs and benefits are
still under development.
Risks: OSHA’s risk analysis is under
development.
Timetable:
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Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
Complete Peer
Review of Economic Analysis.
NPRM ..................
NPRM Comment
Period End.
Hearing ................
Hearing ................
09/12/06
11/13/06
71 FR 53617
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03/02/10
03/31/10
15:08 Feb 10, 2012
Date
Post Hearing
Comment Period End.
Final Action .........
FR Cite
06/01/10
02/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: Local,
State.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Agency Contact: Dorothy Dougherty,
Acting Director, Directorate of
Evaluation and Analysis, Department of
Labor, Occupational Safety and Health
Administration, Room N–3641, FP
Building, 200 Constitution Avenue NW.,
Washington, DC 20210, Phone: 202 693–
2400, Fax: 202 693–1641, Email:
dougherty.dorothy@dol.gov.
RIN: 1218–AC20
BILLING CODE 4510–04–P
DEPARTMENT OF TRANSPORTATION
(DOT)
Introduction: Department Overview and
Summary of Regulatory Priorities
The Department of Transportation
(DOT) consists of 10 operating
administrations and the Office of the
Secretary, each of which has statutory
responsibility for a wide range of
regulations. DOT regulates safety in the
aviation, motor carrier, railroad, motor
vehicle, commercial space, and pipeline
transportation areas. DOT also regulates
aviation consumer and economic issues
and provides financial assistance for
programs involving highways, airports,
public transportation, the maritime
industry, railroads, and motor vehicle
safety. The Department writes
regulations to carry out a variety of
statutes ranging from the Americans
With Disabilities Act to the Uniform
Time Act. Finally, DOT develops and
implements a wide range of regulations
that govern internal programs such as
acquisitions and grants, access for the
disabled, environmental protection,
energy conservation, information
technology, occupational safety and
health, property asset management,
seismic safety, and the use of aircraft
and vehicles.
The Department’s Regulatory Priorities
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The Department’s regulatory priorities
respond to the challenges and
opportunities we face. Our mission
generally is as follows:
The national objectives of general
welfare, economic growth and stability,
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and the security of the United States
require the development of
transportation policies and programs
that contribute to providing fast, safe,
efficient, and convenient transportation
at the lowest cost consistent with those
and other national objectives, including
the efficient use and conservation of the
resources of the United States.
To help us achieve our mission, we
have five strategic goals:
• Safety: Improve public health and
safety by reducing transportation-related
fatalities and injuries.
• State of Good Repair: Ensure the
U.S. proactively maintains its critical
transportation infrastructure in a state of
good repair.
• Economic Competitiveness:
Promote transportation policies and
investments that bring lasting and
equitable economic benefits to the
Nation and its citizens.
• Livable Communities: Foster livable
communities through place-based
policies and investments that increase
transportation choices and access to
transportation services.
• Environmental Sustainability:
Advance environmentally sustainable
policies and investments that reduce
carbon and other harmful emissions
from transportation sources.
In identifying our regulatory priorities
for the next year, the Department
considered its mission and goals and
focused on a number of factors,
including the following:
• The relative risk being addressed
• Requirements imposed by statute or
other law
• Actions on the National
Transportation Safety Board ‘‘Most
Wanted List’’
• The costs and benefits of the
regulations
• The advantages of nonregulatory
alternatives
• Opportunities for deregulatory
action
• The enforceability of any rule,
including the effect on agency resources
This regulatory plan identifies the
Department’s regulatory priorities—the
16 pending rulemakings chosen from
among the dozens of significant
rulemakings listed in the Department’s
broader regulatory agenda that the
Department believes will merit special
attention in the upcoming year. The
rules included in the regulatory plan
embody the Department’s focus on our
strategic goals.
The regulatory plan reflects the
Department’s primary focus on safety—
a focus that extends across several
modes of transportation. For example:
• The Federal Aviation
Administration (FAA) will continue its
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efforts to implement safety management
systems.
• The Federal Motor Carrier Safety
Administration (FMCSA) continues its
work to strengthen the requirements for
Electronic On-Board Recorders.
• The FMCSA will continue its work
to revise motor carrier safety fitness
procedures.
• The National Highway Traffic
Safety Administration (NHTSA) will
continue its rulemaking to reduce death
and injury resulting from incidents
involving motorcoaches.
We are taking actions to address other
important issues. For example:
• The NHTSA is engaged in a major
rulemaking to address fuel economy
standards for passenger cars and light
trucks.
• The Office of the Secretary of
Transportation (OST) remains focused
on aviation consumer rulemaking
designed to further safeguard the
interests of consumers flying the
Nation’s skies.
Each of the rulemakings in the
regulatory plan is described below in
detail. In order to place them in context,
we first review the Department’s
regulatory philosophy and our
initiatives to educate and inform the
public about transportation safety
issues. We then describe the role of the
Department’s regulatory process and
other important regulatory initiatives of
OST and of each of the Department’s
components. Since each transportation
‘‘mode’’ within the Department has its
own area of focus, we summarize the
regulatory priorities of each mode and
of OST, which supervises and
coordinates modal initiatives and has its
own regulatory responsibilities, such as
consumer protection in the aviation
industry.
• The Department’s Regulatory
Philosophy and Initiatives
The Department has adopted a
regulatory philosophy that applies to all
its rulemaking activities. This
philosophy is articulated as follows:
DOT regulations must be clear, simple,
timely, fair, reasonable, and necessary.
They will be issued only after an
appropriate opportunity for public
comment, which must provide an equal
chance for all affected interests to
participate, and after appropriate
consultation with other governmental
entities. The Department will fully
consider the comments received. It will
assess the risks addressed by the rules
and their costs and benefits, including
the cumulative effects. The Department
will consider appropriate alternatives,
including nonregulatory approaches. It
will also make every effort to ensure
that regulation does not impose
unreasonable mandates.
The Department stresses the
importance of conducting high-quality
rulemakings in a timely manner and
reducing the number of old
rulemakings. To implement this, the
Department has required the following
actions: (1) Regular meetings of senior
DOT officials to ensure effective policy
leadership and timely decisions, (2)
effective tracking and coordination of
rulemakings, (3) regular reporting, (4)
early briefings of interested officials, (5)
regular training of staff, and (6) adequate
allocations of resources. The
Department has achieved significant
success because of this effort. It allows
the Department to use its resources
more effectively and efficiently.
The Department’s regulatory policies
and procedures provide a
comprehensive internal management
and review process for new and existing
regulations and ensure that the
Secretary and other appropriate
appointed officials review and concur in
all significant DOT rules. DOT
continually seeks to improve its
regulatory process. A few examples
include: The Department’s development
of regulatory process and related
training courses for its employees; its
use of an electronic, Internet-accessible
docket that can also be used to submit
comments electronically; a ‘‘list serve’’
that allows the public to sign up for
email notification when the Department
issues a rulemaking document; creation
of an electronic rulemaking tracking and
coordination system; the use of direct
final rulemaking; the use of regulatory
negotiation; a continually expanding
Internet page that provides important
regulatory information, including
‘‘effects’’ reports and status reports
(https://regs.dot.gov/); and the continued
exploration and use of Internet blogs
and other Web 2.0 technology to
increase and enhance public
participation in its rulemaking process.
In addition, the Department continues
to engage in a wide variety of activities
to help cement the partnerships
between its agencies and its customers
that will produce good results for
transportation programs and safety. The
Department’s agencies also have
established a number of continuing
partnership mechanisms in the form of
rulemaking advisory committees.
• Retrospective Review of Existing
Regulations
In accordance with Executive Order
(E.O.) 13563 ‘‘Improving Regulation and
Regulatory Review,’’ the Department
actively engaged in a special
retrospective review of our existing
rules to determine whether they need to
be revised or revoked. This review was
in addition to those reviews in
accordance with section 610 of the
Regulatory Flexibility Act, Executive
Order 12866, and the Department’s
Regulatory Policies and Procedures. As
part of this effort, we also reviewed our
processes for determining what rules to
review and ensuring the rules are
effectively reviewed. As a result of the
review, we identified many rules for
expedited review and changes to our
retrospective review process. Our
retrospective review plan in response to
E.O. 13563 can be found at
www.regs.dot.gov; the results of the
review of our rules can also be found
there and in appendix D to our
regulatory agenda.
• Each rulemaking initiated as a
result of the retrospective review is
included in the list below with a
Regulation Identification Number (RIN)
to assist in following the action through
the rulemaking process. Additionally, at
the end of each title, existing
rulemaking actions will be been
identified by adding ‘‘RRR’’ and those
that are new will be indicated by
‘‘RRR*’’.
Likely Potential for
Positive Effects on Small
Businesses
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RIN
Title
2120–AJ94 ........
2120–AJ97 ........
2120–AK00 .......
2120–AK01 .......
Enhanced Flight Vision System (EFVS) (RRR*) ..................................................................................
14 CFR Part 16; Rules of Practice for Federally-Assisted Airport Enforcement Proceedings (RRR*)
Medical Certificate Endorsement Issue (RRR*)
Combined Drug and Alcohol Testing Programs for Operators Conducting Commercial Air Tours
(RRR*).
CAT III Definitions (RRR*).
National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for
Streets and Highways; Engineering Judgments (RRR).
2120–AK03 .......
2125–AF41 .......
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Likely Potential for
Positive Effects on Small
Businesses
RIN
Title
2125–AF43 .......
National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for
Streets and Highways; Compliance Dates Revision (RRR*).
Pedestrian Safety Global Technical Regulation (GTR) (RRR*) ...........................................................
Federal Motor Vehicle Standard No. 108; Lamps, reflective devices, and associated equipment—
Color Boundaries (RRR*).
Federal Motor Vehicle Safety Standard No. 108; Lamps, reflective devices, and associated equipment—Reconsideration (RRR*).
FMVSS No. 126, Petition for Reconsideration of Electronic Stability Control (ESC) (RRR*).
Part 571 FMVSS No. 205, Glazing Materials, GTR (RRR*) ................................................................
Amend FMVSS No. 210 to Incorporate the Use of a New Force Application Device (RRR*).
Training Standards for Railroad Employees (RRR).
Locomotive Safety Standards Amendments (RRR) .............................................................................
Positive Train Control Systems Amendments (RRR*).
Major Capital Investment Projects (RRR).
Cargo Preference (RRR).
MARAD NEPA Procedures (RRR*).
Transportation Priority Allocation System, Part 341 (RRR*).
Administrative Claims, Part 327 (RRR*).
Operating Differential Subsidy and Construction Differential Subsidy Programs (RRR*).
Foreign Transfer Regulations (RRR*).
War Risk Ship Valuation (RRR*).
Hazardous Materials: Minor Editorial Corrections and Clarifications (RRR*).
Hazardous Materials: Miscellaneous Amendments (RRR*) ................................................................
Hazardous Materials: Miscellaneous Amendments; Petitions for Rulemaking (RRR*) .......................
Hazardous Materials: Miscellaneous Pressure Vessel Requirements (DOT Spec Cylinders)
(RRR*).
Hazardous Materials: Reverse Logistics (RRR*) .................................................................................
Hazardous Materials: Incorporation of Certain Special Permits and Competent Authorities into the
HMR (RRR*).
2127–AK98 .......
2127–AK99 .......
2127–AL00 .......
2127–AL02
2127–AL03
2127–AL05
2130–AC06
2130–AC16
2130–AC27
2132–AB02
2133–AB74
2133–AB77
2133–AB78
2133–AB79
2133–AB80
2133–AB81
2133–AB82
2137–AE77
2137–AE78
2137–AE79
2137–AE80
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
2137–AE81 .......
2137–AE82 .......
Y
Y
Y
Y
Y
Y
Y
Y
Y
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* Some of the entries on this list may be completed actions, which do not appear in The Regulatory Plan/Agenda. However, more information
can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for
DOT.
The Department will also continue its
efforts to use advances in technology to
improve its rulemaking management
process. For example, the Department
created an effective tracking system for
significant rulemakings to ensure that
either rules are completed in a timely
manner or delays are identified and
fixed. Through this tracking system, a
monthly status report is generated. To
make its efforts more transparent, the
Department has made this report
Internet accessible at www.regs.dot.gov,
as well as through a list-serve. By doing
this, the Department is providing
valuable information concerning our
rulemaking activity and is providing
information necessary for the public to
evaluate the Department’s progress in
meeting its commitment to completing
quality rulemakings in a timely manner.
The Department continues to place
great emphasis on the need to complete
high-quality rulemakings by involving
senior departmental officials in regular
meetings to resolve issues
expeditiously.
Office of the Secretary of Transportation
(OST)
The Office of the Secretary (OST)
oversees the regulatory process for the
Department. OST implements the
Department’s regulatory policies and
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procedures and is responsible for
ensuring the involvement of top
management in regulatory
decisionmaking. Through the General
Counsel’s office, OST is also responsible
for ensuring that the Department
complies with the Administrative
Procedure Act, Executive Order 12866
(Regulatory Planning and Review),
DOT’s Regulatory Policies and
Procedures, and other legal and policy
requirements affecting rulemaking.
Although OST’s principal role concerns
the review of the Department’s
significant rulemakings, this office has
the lead role in the substance of projects
concerning aviation economic rules and
other rules that affect multiple elements
of the Department.
OST provides guidance and training
regarding compliance with regulatory
requirements and process for use by
personnel throughout the Department.
OST also plays an instrumental role in
the Department’s efforts to improve our
economic analyses; risk assessments;
regulatory flexibility analyses; other
related analyses; and data quality,
including peer reviews.
OST also leads and coordinates the
Department’s response to the Office of
Management and Budget’s (OMB)
intergovernmental review of other
agencies’ significant rulemaking
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documents and to Administration and
congressional proposals that concern
the regulatory process. The General
Counsel’s office works closely with
representatives of other agencies, OMB,
the White House, and congressional
staff to provide information on how
various proposals would affect the
ability of the Department to perform its
safety, infrastructure, and other
missions.
During fiscal year 2012, OST will
continue to focus its efforts on
enhancing airline passenger protections
by requiring carriers to adopt various
consumer service practices under the
following rulemaking initiatives:
• Accessibility of Carrier Web sites
and Ticket Kiosks (2105–AD96)
• Enhancing Airline Passenger
Protections III (2105–AE11)
• Carrier-Supplied Medical Oxygen,
Accessible In-Flight Entertainment
Systems, Service Animals, and
Accessible Lavatories on Single-Aisle
Aircraft (2105–AE12).
OST will also continue its efforts to
help coordinate the activities of several
operating administrations that advance
various departmental efforts that
support the Administration’s initiatives
on promoting safety, stimulating the
economy and creating jobs, sustaining
and building America’s transportation
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infrastructure, and improving livability
for the people and communities who
use transportation systems subject to the
Department’s policies.
Federal Aviation Administration (FAA)
The Federal Aviation Administration
is charged with safely and efficiently
operating and maintaining the most
complex aviation system in the world.
It is guided by Destination 2025—a
transformation of the Nation’s aviation
system in which air traffic will move
safely, swiftly, efficiently, and
seamlessly around the globe. Our vision
is to develop new systems and to
enhance a culture that increases the
safety, reliability, efficiency, capacity,
and environmental performance of our
aviation system. To meet our vision will
require enhanced skills, clear
communication, strong leadership,
effective management, innovative
technology, new equipment, advanced
system oversight, and global integration.
FAA activities that may lead to
rulemaking in fiscal year 2012 include
continuing to:
• Promote and expand safety
information-sharing efforts, such as
FAA-industry partnerships and datadriven safety programs that prioritize
and address risks before they lead to
accidents. Specifically, FAA will
continue implementing Commercial
Aviation Safety Team projects related to
controlled flight into terrain, loss of
control of an aircraft, uncontained
engine failures, runway incursions,
weather, pilot decisionmaking, and
cabin safety. Some of these projects may
result in rulemaking and guidance
materials.
• Work cooperatively to harmonize
the U.S. aviation regulations with those
of other countries, without
compromising rigorous safety standards.
The differences worldwide in
certification standards, practice and
procedures, and operating rules must be
identified and minimized to reduce the
regulatory burden on the international
aviation system. The differences
between the FAA regulations and the
requirements of other nations impose a
heavy burden on U.S. aircraft
manufacturers and operators, some of
which are small businesses.
Standardization should help the U.S.
aerospace industry remain
internationally competitive. The FAA
continues to publish regulations based
on recommendations of Aviation
Rulemaking Committees that are the
result of cooperative rulemaking
between the U.S. and other countries.
• Develop and implement Safety
Management Systems (SMS) where
these systems will improve safety of
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aviation and aviation-related activities.
An SMS proactively identifies potential
hazards in the operating environment,
analyzes the risks of those hazards, and
encourages mitigation prior to an
accident or incident. In its most general
form, an SMS is a set of decisionmaking
tools that can be used to plan, organize,
direct, and control activities in a
manner that enhances safety.
FAA top regulatory priorities for 2011
through 2012 include:
• Qualification, Service, and Use of
Crewmembers and Aircraft Dispatchers
(2120–AJ00)
• Helicopter Air Ambulance and
Commercial Helicopter Safety Initiatives
and Miscellaneous Amendments (2120–
AJ53)
• Congestion Management for
LaGuardia Airport, John F. Kennedy
International Airport, and Newark
Liberty International Airport (2120–
AJ89)
• Safety Management System for
Certificate Holders Operating Under 14
CFR Part 121 (2120–AJ86)
The Crewmember and Aircraft
Dispatcher Training rulemaking would:
• Reduce human error and improve
performance;
• Enhance traditional training
programs through the use of flight
simulation training devices for flight
crewmembers; and
• Include additional training in areas
critical to safety.
The Air Ambulance and Commercial
Helicopter rulemaking would:
• Codify current agency guidance
• Address National Transportation
Safety Board recommendations;
• Provide certificate holders and
pilots with tools and procedures that
will aid in reducing accidents,
including potential equipage
requirements; and
• Amend all part 135 commercial
helicopter operations regulations to
include pilot training and alternate
airport weather minimums.
The Congestion Management
rulemaking for LaGuardia Airport, John
F. Kennedy International Airport, and
Newark Liberty International Airport
would:
• Replace the orders limiting
scheduled operations at John F.
Kennedy International Airport (JFK),
limiting scheduled operations at
Newark Liberty International Airport
(EWR), and limiting scheduled and
unscheduled operations at LaGuardia
Airport (LGA); and
• Provide a longer-term and
comprehensive approach to congestion
management at JFK, EWR, and LGA
The Safety Management System for
Certificate Holders Operating Under 14
CFR Part 121 rulemaking would:
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• Require certain certificate holders
to develop and implement an SMS;
• Propose a general framework from
which a certificate holder can build its
SMS; and
• Conform to International Civil
Aviation Organization Annexes and
adopt several National Transportation
Safety Board recommendations.
Federal Highway Administration
(FHWA)
The Federal Highway Administration
(FHWA) carries out the Federal highway
program in partnership with State and
local agencies to meet the Nation’s
transportation needs. The FHWA’s
mission is to improve continually the
quality and performance of our Nation’s
highway system and its intermodal
connectors.
Consistent with this mission, the
FHWA will continue:
• With ongoing regulatory initiatives
in support of its surface transportation
programs;
• To implement legislation in the
least burdensome and restrictive way
possible; and
• To pursue regulatory reform in
areas where project development can be
streamlined or accelerated, duplicative
requirements can be consolidated,
recordkeeping requirements can be
reduced or simplified, and the
decisionmaking authority of our State
and local partners can be increased.
FHWA’s top regulatory priority for the
fiscal year is to address the rulemaking
actions outlined in the DOT Plan for
Implementation of Executive Order
13563. In particular, FHWA will
undertake two rulemakings that propose
changes to the Manual on Uniform
Traffic Control Devices (MUTCD). The
first of these rulemakings (RIN 2125–
AF41, Engineering Judgment) would
clarify the use of engineering judgment
and studies in the application of traffic
control devices. A separate rulemaking
(RIN 2125–AF43, Compliance Dates
Revision) would revise the compliance
dates for certain requirements in the
MUTCD. Consistent with the principles
outlined in Executive Order 13563, the
FHWA anticipates these actions would
provide clarity and needed flexibility, as
well as reduce burdens on State and
local governments. We believe our
approach in both rulemakings is
consistent with the requirements of
Executive Order 13563, including its
emphasis on consideration of benefits
and costs (sections 1(a) and 1(b)), its
requirement of an open exchange of
information with stakeholders (section
2(a)), and, in particular, its call for
retrospective analysis of existing rules,
including streamlining and modification
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to make such rules less burdensome
(section 6). These rulemakings are also
consistent with a Presidential
Memorandum regarding Administrative
Flexibility, which calls for reducing
burdens and promoting flexibility for
State and local governments.
Federal Motor Carrier Safety
Administration (FMCSA)
The mission of the Federal Motor
Carrier Safety Administration (FMCSA)
is to reduce crashes, injuries, and
fatalities involving commercial trucks
and buses. A strong regulatory program
is a cornerstone of FMCSA’s compliance
and enforcement efforts to advance this
safety mission. FMCSA develops new
and more effective safety regulations
based on three core priorities: Raising
the bar for entry, maintaining high
standards, and removing high-risk
behavior. In addition to Agency-directed
regulations, FMCSA develops
regulations mandated by Congress, such
as the Safe, Accountable, Flexible, and
Efficient Transportation Equity Act: A
Legacy for Users (SAFETEA–LU).
FMCSA regulations establish standards
for motor carriers, drivers, vehicles, and
State agencies receiving certain motor
carrier safety grants and issuing
commercial drivers’ licenses.
FMCSA’s regulatory plan for FY 2012
includes completion of a number of
rulemakings that are high priorities for
the Agency because they would have a
positive impact on safety. Among the
rulemakings included in the plan are:
(1) Carrier Safety Fitness Determination
(RIN 2126–AB11) and (2) National
Registry of Certified Medical Examiners
(RIN 2126–AA97).
Together, these priority rules could
help to substantially improve
commercial motor vehicle (CMV) safety
on our Nation’s highways by improving
FMCSA’s ability to provide safety
oversight of motor carriers and drivers.
In FY 2012, FMCSA will continue its
work on the Comprehensive Safety
Analysis (CSA). The CSA initiative will
improve the way FMCSA identifies and
conducts carrier compliance and
enforcement operations over the coming
years. CSA’s goal is to improve large
truck and bus safety by assessing a
wider range of safety performance data
from a larger segment of the motor
carrier industry through an array of
progressive compliance interventions.
FMCSA anticipates that the impacts of
CSA and its associated rulemaking to
put into place a new safety fitness
standard will enable the Agency to
prohibit ‘‘unfit’’ carriers from operating
on the Nation’s highways (the Carrier
Safety Fitness Determination (RIN
2126–AB11)) and will contribute further
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to the Agency’s overall goal of
decreasing CMV-related fatalities and
injuries.
Also in FY 2012, FMCSA plans to
issue a final rule on the National
Registry of Certified Medical Examiners
(RIN 2126–AA97) to establish training
and testing requirements for healthcare
professionals who issue medical
certificates to CMV drivers.
In order to manage its rulemaking
agenda, FMCSA continues to involve
senior Agency leaders at the earliest
stages of its rulemakings and continues
to refine its regulatory development
process. The Agency also holds senior
executives accountable for meeting
deadlines for completing rulemakings.
National Highway Traffic Safety
Administration
The statutory responsibilities of the
National Highway Traffic Safety
Administration (NHTSA) relating to
motor vehicles include reducing the
number of, and mitigating the effects of,
motor vehicle crashes and related
fatalities and injuries; providing safety
performance information to aid
prospective purchasers of vehicles,
child restraints, and tires; and
improving automotive fuel efficiency.
NHTSA pursues policies that encourage
the development of nonregulatory
approaches when feasible in meeting its
statutory mandates. It issues new
standards and regulations or
amendments to existing standards and
regulations when appropriate. It ensures
that regulatory alternatives reflect a
careful assessment of the problem and a
comprehensive analysis of the benefits,
costs, and other impacts associated with
the proposed regulatory action. Finally,
it considers alternatives consistent with
the Administration’s regulatory
principles.
NHTSA continues to focus on the
high-priority vehicle safety issue of
motorcoaches and their occupants, and
will publish several notices in fiscal
year 2012 to that end. NHTSA will issue
a final rule to require the installation of
lap/shoulder belts in newly
manufactured motorcoaches in
accordance with NHTSA’s 2007
Motorcoach Safety Plan and DOT’s 2009
departmental Motorcoach Safety Action
Plan. NHTSA is also considering
proposing new Federal motor vehicle
safety standards (FMVSS) for
motorcoach rollover structural integrity
requirements, as well as requirements
for electronic stability control systems
for motorcoaches and truck tractors.
Together, these three rulemaking actions
will address 12 recommendations
issued by the National Transportation
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7801
Safety Board related to motorcoach
safety.
In fiscal year 2012, NHTSA will
continue its efforts to reduce domestic
dependency on foreign oil in
accordance with the Energy
Independence and Security Act (EISA)
of 2007 by publishing, in conjunction
with the Environmental Protection
Agency (EPA), a joint final rule setting
corporate average fuel economy (CAFE)
standards for light trucks and passenger
cars for model years 2017 and beyond.
To further enhance the safety of
passenger vehicles and pedestrians,
NHTSA is considering proposing, in
response to the Pedestrian Safety
Enhancement Act of 2010, a FMVSS to
provide a means of alerting blind and
other pedestrians of motor vehicle
operation.
In addition to numerous programs
that focus on the safe performance of
motor vehicles, the Agency is engaged
in a variety of programs to improve
driver and occupant behavior. These
programs emphasize the human aspects
of motor vehicle safety and recognize
the important role of the States in this
common pursuit. NHTSA has identified
two high-priority areas: Safety belt use
and impaired driving. To address these
issue areas, the Agency is focusing
especially on three strategies—
conducting highly visible, wellpublicized enforcement; supporting
prosecutors who handle impaired
driving cases and expanding the use of
DWI/Drug Courts, which hold offenders
accountable for receiving and
completing treatment for alcohol abuse
and dependency; and adopting alcohol
screening and brief intervention by
medical and health care professionals.
Other behavioral efforts encourage child
safety-seat use; combat excessive speed
and aggressive driving; improve
motorcycle, bicycle, and pedestrian
safety; and provide consumer
information to the public.
Federal Railroad Administration (FRA)
FRA’s current regulatory program
contains numerous mandates resulting
from the Rail Safety Improvement Act of
2008 (RSIA08), as well as actions
supporting the Department’s HighSpeed Rail Strategic Plan. RSIA08 alone
has resulted in at least 20 rulemaking
actions, which are competing for limited
resources to meet statutory deadlines.
FRA has prioritized these rulemakings
according to the greatest effect on safety,
as well as expressed congressional
interest, and will work to complete as
many rulemakings as possible prior to
their statutory deadlines. Revised
timelines for completion of unfinished
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regulations will be forwarded to
Congress for consideration.
Through the Railroad Safety Advisory
Committee (RSAC), FRA is working to
complete many of the RSIA08 actions
that include developing requirements
for train conductor certification,
roadway worker protection, track safety,
alcohol and drug testing of
maintenance-of-way personnel, and
training for railroad employees. Other
RSAC-supported actions that advance
high-speed passenger rail include
proposed revisions to the Track Safety
Standards dealing with vehicle-track
interaction. FRA is also initiating a
rulemaking related to the development
of railroad risk reduction and system
safety programs, which will be a multiyear effort due to the underlying
statutory requirements that must be
undertaken prior to the issuance of any
final rule. Finally, FRA will be engaging
in two rulemaking proceedings to
address various issues related to the
implementation of positive train control
systems. FRA expects these regulatory
actions to provide substantial benefits to
the industry while ensuring the safe and
effective implementation of the
technology.
Federal Transit Administration (FTA)
FTA helps communities support
public transportation by making grants
of Federal funding for transit vehicles,
construction of transit facilities, and
planning and operation of transit and
other transit-related purposes. FTA
regulatory activity implements the laws
that apply to recipients’ uses of Federal
funding and the terms and conditions of
FTA grant awards. FTA policy regarding
regulations is to:
• Provide maximum benefit to the
mobility of the Nation’s citizens and the
connectivity of transportation
infrastructure;
• Provide maximum local discretion;
• Ensure the most productive use of
limited Federal resources;
• Protect taxpayer investments in
public transportation;
• Incorporate principles of sound
management into the grant management
process.
As the needs for public transportation
have changed over the years, the Federal
transit programs have grown in number
and complexity. FTA’s regulatory
priorities for the coming year will reflect
the mandates of the Agency’s
authorization statute, including, most
notably, the Major Capital Investments
(RIN 2132–AB02) ‘‘New Starts’’
program. The New Starts program is the
main source of discretionary Federal
funding for construction of rapid rail,
light rail, commuter rail, and other
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forms of transit infrastructure. FTA also
anticipates amending its regulations
governing recipients’ management of
major capital projects and its Bus
Testing rule.
Maritime Administration (MARAD)
The Maritime Administration
(MARAD) administers Federal laws and
programs to promote and strengthen the
U.S. merchant marine to meet the
economic and security needs of the
Nation. To that end, MARAD’s efforts
are focused upon ensuring a strong
American presence in the domestic and
international trades and to expanding
maritime opportunities for American
businesses and workers.
MARAD’s regulatory objectives and
priorities reflect the Agency’s
responsibility for ensuring the
availability of a U.S. merchant marine
that can provide water transportation
services for American shippers and
consumers and, in times of war or
national emergency, for the U.S. armed
forces. Major program areas include the
following: Maritime Security, Voluntary
Intermodal Sealift Agreement, National
Defense Reserve Fleet and the Ready
Reserve Force, Maritime Guaranteed
Loan Financing, United States Merchant
Marine Academy, Mariner Education
and Training Support, and Deepwater
Port Licensing. Additionally, MARAD
will continue its monitoring and
enforcement of U.S. cargo preference
laws and implementation of MARAD’s
newest program, the ‘‘America’s Marine
Highways Program.’’ To date, the
Department has identified marine
corridors, and grants have been awarded
under the America’s Marine Highways
Program.
MARAD’s primary regulatory
activities in fiscal year 2012 will be to
update existing cargo preference-related
regulations, to continue the update of
existing regulations as part of the
Department’s Retrospective Regulatory
Review effort, and to propose new
regulations where appropriate.
Pipeline and Hazardous Materials
Safety Administration (PHMSA)
The Pipeline and Hazardous Materials
Safety Administration (PHMSA) has
responsibility for rulemaking under two
programs. Through the Associate
Administrator for Hazardous Materials
Safety, PHMSA administers regulatory
programs under Federal hazardous
materials transportation law and the
Federal Water Pollution Control Act, as
amended by the Oil Pollution Act of
1990. Through the Associate
Administrator for Pipeline Safety,
PHMSA administers regulatory
programs under the Federal pipeline
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safety laws and the Federal Water
Pollution Control Act, as amended by
the Oil Pollution Act of 1990.
PHMSA will continue to work toward
the reduction of deaths and injuries
associated with the transportation of
hazardous materials by all
transportation modes, including
pipeline. We will concentrate on the
prevention of high-risk incidents
identified through the findings of the
National Transportation Safety Board
and PHMSA’s evaluation of
transportation incident data. PHMSA
will use all available Agency tools to
assess data; evaluate alternative safety
strategies, including regulatory
strategies as necessary and appropriate;
target enforcement efforts; and enhance
outreach, public education, and training
to promote safety outcomes.
PHMSA will be considering whether
changes are needed to the regulations
covering hazardous liquid onshore
pipelines. In particular, PHMSA is
considering whether it should extend
regulation to certain pipelines currently
exempt from regulation; whether other
areas along a pipeline should either be
identified for extra protection or be
included as additional highconsequence areas (HCAs) for integrity
management (IM) protection; whether to
establish and/or adopt standards and
procedures for minimum lead detection
requirements for all pipelines; whether
to require the installation of emergency
flow restricting devices (EFRDs) in
certain areas; whether revised valve
spacing requirements are needed on
new construction or existing pipelines;
whether repair timeframes should be
specified for pipeline segments in areas
outside the HCAs that are assessed as
part of the IM; and whether to establish
and/or adopt standards and procedures
for improving the methods of
preventing, detecting, assessing, and
remediating stress corrosion cracking
(SCC) in hazardous liquid pipeline
systems.
Additionally, PHMSA will consider
whether or not to revise the
requirements in the pipeline safety
regulations addressing integrity
management principles for gas
transmission pipelines. Specifically,
PHMSA will be reviewing the definition
of an HCA (including the concept of a
potential impact radius), the repair
criteria for both HCA and non-HCA
areas, requiring the use of automatic and
remote-controlled shutoff valves, valve
spacing, and whether applying the
integrity management program
requirements to additional areas would
mitigate the need for class location
requirements.
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Research and Innovative Technology
Administration (RITA)
The Research and Innovative
Technology Administration (RITA)
seeks to identify and facilitate solutions
to the challenges and opportunities
facing America’s transportation system
through:
• Coordination, facilitation, and
review of the Department’s research and
development programs and activities;
• Providing multi-modal expertise in
transportation and logistics research,
analysis, strategic planning, systems
engineering and training;
• Advancement, and research and
development, of innovative
technologies, including intelligent
transportation systems;
• Comprehensive transportation
statistics research, analysis, and
reporting;
• Managing education and training in
transportation and national
transportation-related fields; and
• Managing the activities of the John
A. Volpe National Transportation
Systems Center.
Through its Bureau of Transportation
Statistics, Office of Airline Information,
RITA collects, compiles, analyzes, and
makes accessible information on the
Nation’s air transportation system. RITA
collects airline financial, traffic, and
operating statistical data, including ontime flight performance data that
highlight long tarmac times and
chronically late flights. This information
gives the Government consistent and
comprehensive economic and market
data on airline operations that are used
in supporting policy initiatives and
administering the Department’s
mandated aviation responsibilities,
including negotiating international
bilateral aviation agreements, awarding
international route authorities,
performing airline and industry status
evaluations, supporting air service to
small communities, setting Alaskan
Bush Mail rates, and meeting
international treaty obligations.
Through its Intelligent Transportation
Systems Joint Program Office (ITS/JPO),
RITA conducts research and
demonstrations and, as appropriate,
may develop new regulations, in
coordination with OST and other DOT
operating administrations, to enable
deployment of ITS research and
technology results. This office collects
and disseminates benefits and costs
information resulting from ITS-related
research along with direct measurement
of the deployment of ITS nationwide.
These efforts support market
assessments for emerging market sectors
that would be cost-prohibitive for
industry to absorb alone. Such
information is widely consumed by the
community of stakeholders to determine
their deployment needs.
The ITS Architecture and Standards
Programs develop and maintain a
National ITS Architecture; develop
open, non-proprietary interface
standards to facilitate rapid and
economical adoption of nationally
interoperable ITS technologies; and
cooperate to harmonize ITS standards
internationally. These standards are
incorporated into DOT operating
administration regulatory activities
when appropriate.
Through its Volpe National
Transportation Systems Center, RITA
provides a comprehensive range of
engineering expertise, and qualitative
and quantitative assessment services,
focused on applying, maintaining, and
increasing the technical body of
knowledge to support DOT operating
administration regulatory activities.
Through its Transportation Safety
Institute, RITA designs, develops,
conducts, and evaluates training and
technical assistance programs in
transportation safety and security to
support DOT operating administration
regulatory implementation and
enforcement activities.
RITA’s regulatory priorities are to
assist OST and all DOT operating
administrations in updating existing
regulations by applying research,
technology, and analytical results; to
provide reliable information to
transportation system decisionmakers;
and to provide safety regulation
implementation and enforcement
training.
QUANTIFIABLE COSTS AND BENEFITS OF RULEMAKINGS ON THE 2011 TO 2012 DOT REGULATORY PLAN
[This chart does not account for non-quantifiable benefits, which are often substantial]
Title
Stage
Quantifiable
Costs
Discounted
2007 $
(Millions)
Accessibility of Carrier Websites and Ticket Kiosks.
Enhancing Airline Passenger Protections
III.
Air Carrier Access Act (ACAA) ..................
FR (TBD) ....................................................
TBD ..................
TBD
SNPRM 08/12 ............................................
TBD ..................
TBD
SNPRM 06/12 ............................................
TBD ..................
TBD
Total for OST .......................................................................................................................................
0 .......................
0
FR (TBD) ....................................................
FR 07/12 ....................................................
222.9 ................
225 ...................
199.1
275
FR 07/12 ....................................................
NPRM 05/12 ...............................................
375.5 ................
TBD ..................
500.8
TBD
Total for FAA .......................................................................................................................................
823.4 ................
974.9
FR 02/12 ....................................................
575 ...................
1,199
NPRM 04/12 ...............................................
19 .....................
324
Total for FMCSA .................................................................................................................................
594 ...................
1,523
Agency/RIN No.
OST:
2105–AD96
2105–AE11
2105–AE12
FAA:
2120–AJ00
2120–AJ53
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2120–AJ86
2120–AJ89
FMCSA:
2126–AA97
2126–AB11
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Part 121, subparts N and O .......................
Helicopter Safety Initiatives and Misc
Amendments.
SMS for part 121 ........................................
NY Congestion Management .....................
National Registry of Certified Medical Examiners.
Carrier Safety Fitness Determination .........
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Quantifiable
Benefits
Discounted
2007 $
(Millions)
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QUANTIFIABLE COSTS AND BENEFITS OF RULEMAKINGS ON THE 2011 TO 2012 DOT REGULATORY PLAN—Continued
[This chart does not account for non-quantifiable benefits, which are often substantial]
Title
Stage
Quantifiable
Costs
Discounted
2007 $
(Millions)
Seat Belts on Motorcoaches ......................
CAFE 2017 and Beyond ............................
Sound for Hybrid and Electric Vehicles .....
Motorcoach Rollover Structural Integrity ....
Electronic Stability Control Systems for
Heavy Vehicles.
FR 07/12 ....................................................
FR (TBD) ....................................................
NPRM 07/12 ...............................................
NPRM 04/12 ...............................................
NPRM 01/12 ...............................................
26.8–27.9 .........
TBD ..................
TBD ..................
TBD ..................
TBD ..................
17.5–96.9
TBD
TBD
TBD
TBD
Total for NHTSA ..................................................................................................................................
26.8–27.9 .........
17.5–96.9
NPRM 01/12 ...............................................
TBD ..................
TBD
Total for FTA .......................................................................................................................................
0 .......................
0
05/12 ..........................................................
TBD ..................
TBD
Total for MARAD .................................................................................................................................
0 .......................
0
Total for DOT ......................................................................................................................................
1,444.2–1,445.3
2,515.4–2,594.8
Agency/RIN No.
NHTSA:
2127–AK56
2127–AK79
2127–AK93
2127–AK96
2127–AK97
Quantifiable
Benefits
Discounted
2007 $
(Millions)
FTA:
2132–AB02
MARAD:
2133–AB74
Major Capital Investment Projects .............
Cargo Preference .......................................
Notes: Costs and benefits of rulemakings
may be forecast over varying periods.
Although the forecast periods will be the
same for any given rulemaking, comparisons
between proceedings should be made
cautiously.
Costs and benefits are generally
discounted at a 7 percent discount rate
over the period analyzed.
The Department of Transportation
generally assumes that there are
economic benefits to avoiding a fatality
of $6.2 million. That economic value is
included as part of the benefits
estimates shown in the chart. As noted
above, we have not included the nonquantifiable benefits.
DOT—OFFICE OF THE SECRETARY
(OST)
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Proposed Rule Stage
103. + Accessibility of Carrier Web Sites
and Ticket Kiosks
Priority: Other Significant.
Legal Authority: 49 U.S.C. 41702; 49
U.S.C. 47105; 49 U.S.C. 41712
CFR Citation: 14 CFR 382.
Legal Deadline: None.
Abstract: This rulemaking was
divided into two successive Air Carrier
Access Act (ACAA) rulemakings. This
one, as well as the second rulemaking
(2105–AE12), address issues raised in
another rulemaking RIN 2105–AD92.
This rulemaking would consider: (1)
The cost and technical issues involved
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in requiring carrier Web site
accessibility and (2) whether automated
kiosks operated by carriers at airports
and elsewhere should be required to be
accessible. After the public comment
periods, we intend to consolidate the
final decisions in this rulemaking and
RIN 2105–AE12 into one document.
Statement of Need: This rulemaking
proposes to provide greater
accommodations for individuals with
disabilities in accessing automated
kiosks at U.S. airports and Web sites
operated by U.S. and foreign air carriers
and their ticket agents. Automated
kiosks are widely used by U.S. and
foreign air carriers at airports to provide
customer services (e.g., boarding pass
and bag tag printing). Also, today’s
passengers increasingly rely on air
travel Web sites for information about
airline services, making reservations,
and obtaining discounted airfares.
Currently, neither airlines nor airports
are required to make airport kiosks
accessible to passengers with
disabilities. Also, not all air travel
information and services available to the
public on Web sites are accessible to
people with disabilities. Only DOT can
protect air travelers with disabilities as
states are preempted from regulating in
these areas and no private right of action
exists for airline consumers to enforce
the Air Carrier Access Act.
Summary of Legal Basis: The legal
basis for the proposed rule is the Air
Carrier Access Act, which prohibits
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discrimination in airline service on the
basis of disability, and section 504 of
the Rehabilitation Act of 1973, which
requires accessibility in airport terminal
facilities that receive Federal financial
assistance.
Alternatives: Since May 2008, the
Department has attempted to address
the problem of inaccessible Web sites by
requiring U.S. and foreign air carriers to
make discounted, Web-based fares and
amenities available to passengers who
self-identify as being unable to use an
airline’s inaccessible Web site due to
their disability. The Department has
also tried to address the problem of
inaccessible kiosks by requiring U.S.
and foreign air carriers to make
equivalent service available to
passengers with a disability who cannot
readily use a carrier’s automated kiosk
due to their disability. Disability
advocacy groups have repeatedly
expressed opposition to these interim
solutions as they do not enable them to
independently access and use airlines’
Web sites or kiosks.
Anticipated Cost and Benefits:
Preliminary estimates show that the
present value of net benefits of the
requirement to ensure the accessibility
of automated airport kiosks to be $70.4
million over the 10-year period from
2013 through 2022, using a 7 percent
discount rate. With respect to the
proposed requirements to ensure air
travel Web site accessibility, our
preliminary regulatory evaluation
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estimates the expected present value of
net benefits at $48.5 million over the
period from 2013 through 2022, using
the 7 percent discount rate.
Risks: N/A
Timetable:
Action
Date
FR Cite
SNPRM ...............
SNPRM Comment
Period End.
Extension of
Comment Period and Clarification of Proposed Rule.
Supplemental
NPRM Comment Period
End.
09/26/11
11/25/11
76 FR 59307
11/21/11
76 FR 71914
01/09/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Robert C. Ashby,
Deputy Assistant General Counsel for
Regulation and Enforcement,
Department of Transportation, Office of
the Secretary, Room W94–302, 1200
New Jersey Avenue SE., Washington,
DC 20590, Phone: 202 366–4723, TDD
Phone: 202 755–7687, Email:
bob.ashby@ost.dot.gov.
Related RIN: Related to 2105–AE12.
RIN: 2105–AD96
DOT—OST
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104. • + Enhancing Airline Passenger
Protections III
Priority: Other Significant.
Legal Authority: 49 U.S.C. 41712; 49
U.S.C. 40101; 49 U.S.C. 41702
CFR Citation: 14 CFR 244; 14 CFR
250; 14 CFR 253; 14 CFR 259; 14 CFR
399.
Legal Deadline: None.
Abstract: This rulemaking would
address the following issues: (1)
Whether the Department should require
a marketing carrier to provide assistance
to its code-share partner when a flight
operated by the code-share partner
experiences a lengthy tarmac delay; (2)
whether the Department should
enhance disclosure requirements on
code-share operations, including
requiring on-time performance data,
reporting of certain data code-share
operations, and codifying the statutory
amendment of 49 U.S.C. 41712(c)
regarding Web site schedule disclosure
of code-share operations; (3) whether
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the Department should expand the ontime performance ‘‘reporting carrier’’
pool to include smaller carriers; (4)
whether the Department should require
travel agents to adopt minimum
customer service standards in relation to
the sale of air transportation; (5)
whether the Department should require
ticket agents to disclose the carriers
whose tickets they sell or do not sell
and information regarding any incentive
payments they receive in connection
with the sale of air transportation; (6)
whether the Department should require
ticket agents to disclose any preferential
display of individual fares or carriers in
the ticket agent’s Internet displays; (7)
whether the Department should require
additional or special disclosures
regarding certain substantial fees; e.g.,
oversize or overweight baggage fees; (8)
whether the Department should prohibit
post-purchase price increase for all
services and products not purchased
with the ticket or whether it is sufficient
to prohibit post-purchase prices
increases for baggage charges that
traditionally have been included in the
ticket price; and (9) whether the
Department should require that
ancillary fees be displayed through all
sale channels.
Statement of Need: On April 25, 2011,
the Department of Transportation
published in the Federal Register a final
rule on Enhancing Airline Passenger
Protections (76 FR 23110). Among other
requirements, the rule contains several
requirements for U.S. and foreign air
carriers, ticket agents, and other sellers
of air transportation to disclose to
consumers the cost of certain ancillary
services. The rule requires disclosure
through various methods. One issue the
rulemaking requested comment on was
whether the Department should require
information regarding the cost of airline
ancillary services to be displayed
through Global Distribution Systems in
order to enhance transparency of such
fees to consumers. Because the
Department lacked critical information
on the issue, the Department deferred
the issue to this rulemaking. This
rulemaking will address that issue as
well as several other airline consumer
protection proposals.
Summary of Legal Basis: The
Department has authority and
responsibility under 49 U.S.C. section
41712, in concert with 49 U.S.C. 40101
and 49 U.S.C. section 41702, to protect
consumers from unfair and deceptive
practices and to ensure safe and
adequate service in air transportation.
Alternatives: One alternative would
be to take no regulatory action. Also,
various regulatory alternatives will be
developed and the public will be
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7805
afforded an opportunity to provide
comments when the Department
publishes the proposed rule in the
Federal Register.
Anticipated Cost and Benefits: TBD
Risks: The risk of not taking
regulatory action would be the
continuation of a system where
passengers cannot determine the true
cost of their air travel.
Timetable:
Action
Supplemental
NPRM.
Date
FR Cite
08/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Blane A. Workie,
Attorney, Department of Transportation,
Office of the Secretary, 1200 New Jersey
Avenue SE., Washington, DC 20590,
Phone: 202 366–9342, TDD Phone: 202
755–7687, Fax: 202 366–7152, Email:
blane.workie@ost.dot.gov.
Related RIN: Related to 2105–AD72,
Related to 2105–AD92.
RIN: 2105–AE11
DOT—OST
105. • + Carrier-Supplied Medical
Oxygen, Accessible In-Flight
Entertainment Systems, Service
Animals, and Accessible Labatories on
Single Aisle Aircraft
Priority: Other Significant.
Legal Authority: 49 U.S.C. 41702; 49
U.S.C. 41712; 49 U.S.C. 47105
CFR Citation: 14 CFR 382.
Legal Deadline: None.
Abstract: This rulemaking is the one
of two successive Air Carrier Access Act
(ACAA) rulemakings that address issues
raised in another rulemaking: RIN 2105–
AD92. The second rulemaking is RIN
2105–AD96. This rulemaking action
would consider (1) whether there are
safety-related reasons for excluding
service animals other than dogs that
may be specific to foreign carriers; (2)
whether the cost of requiring carriers to
supply free in-flight medical oxygen
would create an undue burden; and (3)
whether providing high-contrast
captioning on in-flight entertainment
displays is technically and
economically feasible. It would also
address accessible lavatories on singleaisle aircraft and a rulemaking petition
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from the Psychiatric Service Dog Society
to eliminate provisions allowing carriers
to require documentation and 48 hours
advance notice for users of psychiatric
service animals, and miscellaneous
service animal issues. After the public
comment periods, we intend to
consolidate the final decisions in this
rulemaking and RIN 2105–AD96 into
one document.
Statement of Need: This rulemaking
action would examine whether the
Department should require carriers to
provide in-flight medical oxygen,
captioning on in-flight entertainment
(IFE) systems, and accessible lavatories
on single-aisle aircraft to provide
individuals with disabilities greater
access to air travel. Currently, few
airlines make in-flight medical oxygen
available to passengers and as a result
individuals who are dependent on
medical oxygen but cannot use portable
oxygen concentrators are having
difficulty traveling by air. Also,
passengers who are deaf or hard-ofhearing have strongly advocated for
captioning of IFE systems, arguing that
the in-flight entertainment that is
available to other passengers should
also be available to them. Lavatories on
single-aisle aircraft have also become a
matter of interest to the Department as
more and more single-aisle aircraft are
used for longer flights and the absence
of accessible lavatories makes travel
difficult for passengers with disabilities.
This rulemaking action will also
address whether to amend the existing
regulation, which allows airlines to
require users of psychiatric and
emotional support service animals to
provide documentation and advance
notice of their planned travel with a
service animal. An advocacy group
representing users of psychiatric service
dogs has filed a petition for rulemaking
stating that the notice and medical
documentation requirements stigmatize
and discriminate against people with
mental disabilities, and asking that it be
repealed.
Summary of Legal Basis: This legal
basis for the proposed rule is the Air
Carrier Access Act (ACAA), which
prohibits discrimination in airline
service on the basis of disability.
Alternatives: Regulatory alternatives
will be developed and the public will be
afforded an opportunity to provide
comments when the Department
publishes the proposed rule in the
Federal Register.
Anticipated Cost and Benefits:
Estimates of costs and benefits are under
development.
Risks: N/A.
Timetable:
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Action
Supplemental
NPRM.
Date
FR Cite
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Robert C. Ashby,
Deputy Assistant General Counsel for
Regulation and Enforcement,
Department of Transportation, Office of
the Secretary, Room W94–302, 1200
New Jersey Avenue SE., Washington,
DC 20590, Phone: 202 366–4723, TDD
Phone: 202 755–7687, Email:
bob.ashby@ost.dot.gov.
Related RIN: Split from 2105–AD96.
RIN: 2105–AE12
DOT—FEDERAL AVIATION
ADMINISTRATION (FAA)
Proposed Rule Stage
106. + Qualification, Service, and Use of
Crewmembers and Aircraft Dispatchers
Priority: Other Significant.
Legal Authority: 49 U.S.C. 106(g); 49
U.S.C. 40113; 49 U.S.C. 40119; 49 U.S.C.
44101; 49 U.S.C. 44701; 49 U.S.C.
44702; 49 U.S.C. 44705; 49 U.S.C. 44709
to 44711; 49 U.S.C. 44713; 49 U.S.C.
44716; 49 U.S.C. 44717; 49 U.S.C.
44722; 49 U.S.C. 44901; 49 U.S.C.
44903; 49 U.S.C. 44904; 49 U.S.C.
44912; 49 U.S.C. 46105
CFR Citation: 14 CFR 119; 14 CFR
121; 14 CFR 135; 14 CFR 142; 14 CFR
65.
Legal Deadline: None.
Abstract: This rulemaking would
amend the regulations for crewmember
and dispatcher training programs in
domestic, flag, and supplemental
operations. The rulemaking would
enhance traditional training programs
by requiring the use of flight simulation
training devices for flight crewmembers
and including additional training
requirements in areas that are critical to
safety. The rulemaking would also
reorganize and revise the qualification
and training requirements. The changes
are intended to contribute to reducing
aviation accidents.
Statement of Need: This rulemaking is
part of the FAA’s efforts to reduce fatal
accidents in which human error was a
major contributing cause. The changes
would reduce human error and improve
performance among flight
crewmembers, flight attendants, and
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Fmt 4701
Sfmt 4702
aircraft dispatchers. National
Transportation Safety Board (NTSB)
investigations identified several areas of
inadequate training that were the
probable cause of an accident. This
rulemaking contains changes to address
the causes and factors identified by the
NTSB.
Summary of Legal Basis: The FAA’s
authority to issue rules on aviation
safety is found in title 49 of the United
States Code. This rulemaking is
promulgated under the authority
described in 49 U.S.C. 44701(a)(5),
which requires the Administrator to
promulgate regulations and minimum
standards for other practices, methods,
and procedures necessary for safety in
air commerce and national security.
Alternatives: During the Notice of
Proposed Rulemaking (NPRM) phase,
the FAA did not find any significant
alternatives in accordance with 5 U.S.C.
section 603(d). The FAA will again
review alternatives at the final rule
phase.
Anticipated Cost and Benefits: The
FAA is developing the costs and
benefits of this rulemaking
Risks: The FAA will review specific
risks associated with this rulemaking.
Timetable:
Action
Date
FR Cite
NPRM ..................
Proposed Rule;
Notice of Public
Meeting.
NPRM Comment
Period Extended.
NPRM Comment
Period End.
Extended NPRM
Comment Period End.
Supplemental
NPRM.
Supplemental
NPRM Comment Period
End.
Supplemental
NPRM Comment Period Extended.
Extended Supplemental NPRM
Comment Period End.
Analyzing Comments.
01/12/09
03/12/09
74 FR 1280
74 FR 10689
04/20/09
74 FR 17910
05/12/09
08/10/09
05/20/11
76 FR 29336
07/19/11
06/23/11
76 FR 36888
09/19/11
01/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: For flight
crewmember information contact James
K. Sheppard, for flight attendant
information contact Nancy Lauck
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Claussen, and for aircraft dispatcher
information contact Leo Hollis, Air
Carrier Training Branch (AFS–210),
Flight Standards Service, Federal
Aviation Administration, 800
Independence Avenue SW.,
Washington, DC 20591; telephone 202
267 8166.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Nancy L. Claussen,
Federal Aviation Administration,
Department of Transportation, Federal
Aviation Administration, 800
Independence Avenue SW.,
Washington, DC 20591, Phone: 202 267–
8166, Email: nancy.claussen@faa.gov.
RIN: 2120–AJ00
DOT—FAA
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107. + New York Congestion
Management Rule for LaGuardia
Airport, John F. Kennedy International
Airport, and Newark Liberty
International Airport
Priority: Other Significant.
Legal Authority: 49 U.S.C. 106(g); 49
U.S.C. 40103; 49 U.S.C. 40106; 49 U.S.C.
40109; 49 U.S.C. 40113; 49 U.S.C.
44502; 49 U.S.C. 44514; 49 U.S.C.
44701; 49 U.S.C. 44719; 49 U.S.C. 46301
CFR Citation: 14 CFR 93.
Legal Deadline: None.
Abstract: This rulemaking would
replace the current temporary orders
limiting scheduled operations at
LaGuardia Airport, John F. Kennedy
International Airport, and Newark
Liberty International Airport with a
more permanent rule to address the
issues of congestion and delay at the
New York area´s three major commercial
airports, while also promoting fair
access and competition. The rulemaking
would help ensure that congestion and
delays are managed by limiting
scheduled and unscheduled operations.
The rulemaking would also establish a
secondary market for U.S. and foreign
air carriers to buy, sell, trade, and lease
slots amongst each other at each of the
three airports. This would allow carriers
serving or seeking to serve the New
York area airports to exchange slots as
their business models and strategic
goals require.
Statement of Need: This rulemaking
would replace the current temporary
orders limiting scheduled operations at
LaGuardia Airport, John F. Kennedy
International Airport, and Newark
Liberty International Airport with a
more permanent rule to address the
issues of congestion and delay at the
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New York area’s three major commercial
airports, while also promoting fair
access and competition. The rulemaking
would help ensure that congestion and
delays are managed by limiting
scheduled and unscheduled operations.
The rulemaking would also establish a
secondary market for U.S. and foreign
air carriers to buy, sell, trade, and lease
slots amongst each other at each of the
three airports. This would allow carriers
serving or seeking to serve the New
York area airports to exchange slots as
their business models and strategic
goals require.
Summary of Legal Basis: This
rulemaking is promulgated under the
authority described in subtitle VII, part
A, subpart I, sections 40101, 40103,
40105, and 41712. The Secretary of
Transportation (Secretary) is the head of
the DOT and has broad oversight of
significant FAA decisions. See 49 U.S.C.
102 and 106. In addition, under 49
U.S.C. 41712, the Secretary has the
authority to investigate and prohibit
unfair and deceptive practices and
unfair methods of competition in air
transportation or the sale of air
transportation.
The FAA has broad authority under
49 U.S.C. 40103 to regulate the use of
the navigable airspace of the United
States. This section authorizes the FAA
to develop plans and policy for the use
of navigable airspace and to assign the
use the FAA deems necessary for safe
and efficient utilization. It further
directs the FAA to prescribe air traffic
rules and regulations governing the
efficient utilization of navigable
airspace. Not only is the FAA required
to ensure the efficient use of navigable
airspace, but it must do so in a manner
that does not effectively shut out
potential operators at the airport and in
a manner that acknowledges
competitive market forces.
These authorities empower the DOT
to ensure the efficient utilization of
airspace by limiting the number of
scheduled and unscheduled aircraft
operations at JFK, EWR, and LGA, while
balancing between promoting
competition and recognizing historical
investments in the airport and the need
to provide continuity. They also
authorize the DOT to investigate the
transfer of slots and to limit or prohibit
anti-competitive transfers.
Alternatives: The FAA considered two
alternatives. The first alternative was to
simply extend the existing orders. This
alternative was rejected because the
FAA wanted to increase competition by
making slots available to more
operators. The FAA believes these
operators are likely to be small entities.
The second alternative was to remove
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7807
the existing orders. This alternative
results in unacceptable delay costs from
the increase in operations.
Anticipated Cost and Benefits: TBD
Risks: The FAA will review specific
risks associated with this rulemaking.
Timetable:
Action
Date
NPRM ..................
FR Cite
05/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Molly W. Smith,
Federal Aviation Administration,
Department of Transportation, Federal
Aviation Administration, 800
Independence Avenue SW.,
Washington, DC 20591, Phone: 202 267–
3344, Email: molly.w.smith@faa.gov.
RIN: 2120–AJ89
DOT—FAA
Final Rule Stage
108. + Air Ambulance and Commercial
Helicopter Operations; Safety
Initiatives and Miscellaneous
Amendments
Priority: Other Significant.
Legal Authority: 49 U.S.C. 106(g); 49
U.S.C. 1155; 49 U.S.C. 40101 to 40103;
49 U.S.C. 40120; 49 U.S.C. 41706; 49
U.S.C. 41721; 49 U.S.C. 44101; 49 U.S.C.
44106; 49 U.S.C. 44111; 49 U.S.C.
46306; 49 U.S.C. 46315; 49 U.S.C.
46316; 49 U.S.C. 46504; 49 U.S.C.
46506; 49 U.S.C. 46507; 49 U.S.C.
47122; 49 U.S.C. 47508; 49 U.S.C. 47528
to 47531
CFR Citation: 14 CFR 1; 14 CFR 135;
14 CFR 91.
Legal Deadline: None.
Abstract: This rulemaking would
change equipment and operating
requirements for commercial helicopter
operations, including many specifically
for helicopter air ambulance operations.
This rulemaking is necessary to increase
crew, passenger, and patient safety. The
intended effect is to implement National
Transportation Safety Board, Aviation
Rulemaking Committee, and internal
FAA recommendations.
Statement of Need: Since 2002, there
has been an increase in fatal helicopter
air ambulance accidents. The FAA has
undertaken initiatives to address
common factors that contribute to
helicopter air ambulance accidents,
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including issuing notices, handbook
bulletins, operations specifications, and
advisory circulars (ACs). This rule
would codify many of those initiatives,
as well as several NTSB and part 125/
135 Aviation Rulemaking Committee
recommendations. In addition, the
House of Representatives and the Senate
introduced legislation in the 111th
Congress and in earlier sessions that
would address several of the issues
raised in this rulemaking.
Summary of Legal Basis: This
rulemaking is promulgated under the
authority described in 49 U.S.C.
44701(a)(4), which requires the
Administrator to promulgate regulations
in the interest of safety for the
maximum hours or periods of service of
airmen and other employees of air
carriers, and 49 U.S.C. 44701(a)(5),
which requires the Administrator to
promulgate regulations and minimum
standards for other practices, methods,
and procedures necessary for safety in
air commerce and national security.
Alternatives: Alternative One: The
alternative would change the
compliance date from 3 years to 4 years
after the effective rule date to install all
required pieces of equipment. This
would help small business owners cope
with the burden of the expenses because
they would be able to integrate these
pieces of equipment over a longer
period of time. This alternative is not
preferred because it would delay safety
enhancements.
Alternative Two: The alternative
would exclude the HTAWS unit from
this proposal. Although this alternative
would reduce annualized costs to small
air ambulance operators by
approximately 12 percent and the ratio
of annualized cost to annual revenue
would decrease from a range of between
1.76 percent and 1.88 percent to a range
of between 1.55 percent and 1.65
percent, the annualized cost would still
be significant for all 35 small air
ambulance operators. The alternative
not only does not eliminate the problem
for a substantial number of small
entities, but also would reduce safety.
The HTAWS is an outstanding tool for
situational awareness in all aspects of
flying, including day, night, and
instrument meteorological conditions.
Therefore the FAA believes that this
equipment is a significant enhancement
for safety.
Alternative Three: The alternative
would increase the requirement of
certificate holders from 10 to 15
helicopters or more that are engaged in
helicopter air ambulance operations to
have an Operations Control Center. The
FAA believes that operators with 10 or
more helicopters engaged in air
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ambulance operations would cover 66
percent of the total population of the air
ambulance fleet in the U.S. The FAA
believes that operators with 15 or more
helicopters would decrease the coverage
of the population to 50 percent.
Furthermore, complexity issues arise
and considerably increase with
operators of more than 10 helicopters.
All alternatives above are not
considered to be acceptable by the FAA
in accordance with 5 U.S.C. 603(c).
Anticipated Cost and Benefits: The
FAA is currently developing costs and
benefits.
Risks: Helicopter air ambulance
operations have several characteristics
that make them unique, including that
they are not limited to airport locations
for picking up and dropping off
patients, but may pick up a person at a
roadside accident scene and transport
him or her directly to a hospital.
Helicopter air ambulance operations are
also often time-sensitive. A helicopter
air ambulance flight may be crucial to
getting a donor organ or critically ill or
injured patient to a medical facility as
efficiently as possible. Additionally,
patients generally are not able to choose
the helicopter air ambulance company
that provides them with transportation.
Despite the fact that there are unique
aspects to helicopter air ambulance
operations, they remain, at their core,
air transportation. Accordingly, the FAA
has the responsibility for ensuring the
safety of these operations.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
10/12/10
01/10/11
75 FR 62640
07/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Alberta Brown, Air
Transportation Division, Department of
Transportation, Federal Aviation
Administration, 800 Independence
Avenue SW., Washington, DC 20591,
Phone: 202 267–8321.
RIN: 2120–AJ53
DOT—FAA
109. + Safety Management Systems for
Certificate Holders (Section 610
Review)
Priority: Other Significant.
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Legal Authority: 49 U.S.C. 106(g); 49
U.S.C. 40113; 49 U.S.C. 40119; 49 U.S.C.
41706; 49 U.S.C. 44101; 49 U.S.C.
44701; 49 U.S.C. 44702; 49 U.S.C.
44705; 49 U.S.C. 44709 to 44711; 49
U.S.C. 44713; 49 U.S.C. 44716; 49 U.S.C.
44717; 49 U.S.C. 44722; 49 U.S.C. 46105
CFR Citation: 14 CFR 121.
Legal Deadline: NPRM, Statutory,
October 29, 2010.
Final, Statutory, July 30, 2012, Final
Rule.
Congress passed Public Law 111–216
that instructs FAA to conduct a
rulemaking to require all part 121 air
carriers to implement a Safety
Management System (SMS). This act
further states that FAA shall consider at
a minimum each of the following as part
of the SMS rulemaking: (1) An Aviation
Safety Action Program (ASAP); (2) a
Flight Operations Quality Assurance
Program (FOQA); (3) a Line Operations
Safety Audit (LOSA); and (4) an
Advance Qualifications Program.
Abstract: This rulemaking would
require each certificate holder operating
under 14 CFR part 121 to develop and
implement a Safety Management System
(SMS) to improve the safety of its
aviation related activities. A SMS is a
comprehensive, process-oriented
approach to managing safety throughout
an organization. An SMS includes an
organization-wide safety policy; formal
methods for identifying hazards,
controlling, and continually assessing
risk and safety performance; and
promotion of a safety culture. SMS
stresses not only compliance with
technical standards but increased
emphasis on the overall safety
performance of the organization.
Statement of Need: Passage of the
Airline Safety and FAA Extension Act
of 2010 (Pub. L. 111–216), section 215
‘‘Safety Management System’’ directs
the Administrator to conduct a
rulemaking to require all part 121 air
carriers to implement a safety
management system (SMS). The Act
requires an NPRM within 90 days and
a final rule not later than 24 months
from enactment of Public Law 111–216.
Summary of Legal Basis: Airline
Safety and Federal Aviation
Administration Extension Act of 2010
(Pub. L. 111–216), section 215, signed
by President on August 1, 2010.
Alternatives: The Rulemaking Team
considered including parts 135 (air
carriers) and 145 (repair stations) to the
rule but did not because of time
restraints.
Anticipated Cost and Benefits: Costs
and benefits of this final rule are still in
development. An initial cost estimate
for SMS implementation over 3 years is
$270,000 (small carrier), $373,950
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(medium carrier), and $1,135,500 (large
carrier) with total cost for 90 part 121
carriers of $52,276,200. However, given
the flexibility of SMS, and expected
safety improvements, benefits are
expected to exceed costs.
Risks: Commercial air carrier accident
rate in the U.S. has remained relatively
constant over the past 10 years.
However, the recent trend of hazards
include many that could have been
mitigated or eliminated had a
structured, organization-wide approach
to managing air carriers’ operations been
in place.
SMS is a comprehensive, processoriented approach to managing safety
throughout an organization, and stresses
not only compliance with technical
standards but increased emphasis on the
overall safety performance of the
organization.
The potential reduction of risks
would be averted causalities, aircraft
damage, and accident investigation
costs by identifying safety issues and
spotting trends before they result in a
near-miss, incident, or accident.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period Extended.
NPRM Comment
Period End.
Extended NPRM
Comment Period End.
Final Rule ............
11/05/10
01/31/11
75 FR 68224
76 FR 5296
02/03/11
03/07/11
07/00/12
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Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Scott VanBuren,
Department of Transportation, Federal
Aviation Administration, 800
Independence Avenue SW.,
Washington, DC 20591, Phone: 202 494–
8417, Email: scott.vanburen@faa.gov.
Related RIN: Split from 2120–AJ15.
RIN: 2120–AJ86
DOT—FEDERAL MOTOR CARRIER
SAFETY ADMINISTRATION (FMCSA)
Proposed Rule Stage
110. + Carrier Safety Fitness
Determination
Priority: Economically Significant.
Major under 5 U.S.C. 801.
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Unfunded Mandates: Undetermined.
Legal Authority: Sec 4009 of TEA–21
CFR Citation: 49 CFR 385.
Legal Deadline: None.
Abstract: This rulemaking would
revise 49 CFR part 385, Safety Fitness
Procedures, in accordance with the
Agency’s major new initiative,
Comprehensive Safety Analysis (CSA).
CSA is a new operational model FMCSA
plans to implement that is designed to
help the Agency carry out its
compliance and enforcement programs
more efficiently and effectively.
Currently, the safety fitness rating of a
motor carrier is determined based on the
results of a very labor intensive
compliance review conducted at the
carrier’s place of business. Aside from
roadside inspections and new audits,
the compliance review is the Agency’s
primary intervention. Under CSA,
FMCSA would propose to implement a
broader array of progressive
interventions, some of which allow
FMCSA to make contact with more
carriers. Through this rulemaking
FMCSA would establish safety fitness
determinations based on safety data
from crashes, inspections, and violation
history rather than just the standard
compliance review. This will enable the
Agency to assess the safety performance
of a greater segment of the motor carrier
industry with the goal of further
reducing large truck and bus crashes
and fatalities.
Statement of Need: Because of the
time and expense associated with the
on-site compliance review, only a small
fraction of carriers (approximately
12,000) receive a safety fitness
determination each year. Since the
current safety fitness determination
process is based exclusively on the
results of an on-site compliance review,
the great majority of carriers subject to
FMCSA jurisdiction do not receive a
timely determination of their safety
fitness.
The proposed methodology for
determining motor carrier safety fitness
should correct the deficiencies of the
current process. In correcting these
deficiencies, FMCSA has made a
concerted effort to develop a
‘‘transparent’’ method for the Safety
Fitness Determination (SFD) that would
allow each motor carrier to understand
fully how FMCSA established that
carrier’s specific SFD.
Summary of Legal Basis: This rule is
based primarily on the authority of 49
U.S.C. 31144, which directs the
Secretary of Transportation to
‘‘determine whether an owner or
operator is fit to operate a commercial
motor vehicle’’ and to ‘‘maintain by
regulation a procedure for determining
PO 00000
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Fmt 4701
Sfmt 4702
7809
the safety fitness of an owner or
operator.’’ This statute was first enacted
as part of the Motor Carrier Safety Act
of 1984, section 215, Public Law 98–
554, 98 Stat. 2844 (Oct. 30, 1984).
The proposed rule also relies on the
provisions of 49 U.S.C. 31133, which
gives the Secretary ‘‘broad
administrative powers to assist in the
implementation’’ of the provisions of
the Motor Carrier Safety Act now found
in chapter 311 of title 49, U.S.C. These
powers include, among others, authority
to conduct inspections and
investigations, compile statistics,
require production of records and
property, prescribe recordkeeping and
reporting requirements and to perform
other acts considered appropriate. These
powers are used to obtain the data used
by the Safety Management System and
by the proposed new methodology for
safety fitness determinations.
Under 49 CFR 1.73(g), the Secretary
has delegated the authority to carry out
the functions in subchapters I, III, and
IV of chapter 311, title 49, U.S.C., to the
FMCSA Administrator. Sections 31133
and 31144 are part of subchapter III of
chapter 311.
Alternatives: The Agency has been
considering only two alternatives: The
no-action alternative and the proposal.
Anticipated Cost and Benefits: The
Agency has estimated the crashreduction benefit from the change to the
proposed safety fitness determination
process to be about $441 million
annually. The total cost is estimated at
$13 million annually. Net benefits are
about $428 million annually.
Risks: A risk of incorrectly identifying
a compliant carrier as non-compliant—
and consequently subjecting the carrier
to unnecessary expenses—has been
analyzed and has been found to be
negligible under the process being
proposed.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: David Miller,
Regulatory Development Division,
Department of Transportation, Federal
Motor Carrier Safety Administration,
1200 New Jersey Avenue SE.,
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Washington, DC 20590, Phone: 202 366–
5370, Email: fmcsaregs@dot.gov.
RIN: 2126–AB11
DOT—FMCSA
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Final Rule Stage
111. + National Registry of Certified
Medical Examiners
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: Pub. L. 109–59
(2005), sec 4116
CFR Citation: 49 CFR 390; 49 CFR
391.
Legal Deadline: Final, Statutory,
August 10, 2006.
Abstract: This rulemaking would
establish training, testing, and
certification standards for medical
examiners responsible for certifying that
interstate commercial motor vehicle
(CMV) drivers meet established physical
qualifications standards; provide a
database (or National Registry) of
medical examiners that meet the
prescribed standards for use by motor
carriers, drivers, and Federal and State
enforcement personnel in determining
whether a medical examiner is qualified
to conduct examinations of interstate
truck and bus drivers; and require
medical examiners to transmit
electronically to FMCSA the name of
the driver and a numerical identifier for
each driver that is examined. The
rulemaking would also establish the
process by which medical examiners
that fail to meet or maintain the
minimum standards would be removed
from the National Registry. This action
is in response to section 4116 of Safe,
Accountable, Flexible, Efficient,
Transportation Equity Act: A Legacy for
Users (SAFETEA–LU).
Statement of Need: In enacting the
Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for
Users (SAFETEA–LU) (Pub. L. 109–59,
Aug. 10, 2005), Congress recognized the
need to improve the quality of the
medical certification of drivers.
SAFETEA–LU addresses the
requirement for medical examiners to
receive training in physical examination
standards and be listed on a national
registry of medical examiners as one
step toward improving the quality of the
commercial motor vehicle (CMV) driver
physical examination process and the
medical fitness of CMV drivers to
operate CMVs. The safety impact will
result from ensuring that medical
examiners have completed training and
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testing to demonstrate that they fully
understand FMCSA’s physical
qualifications standards and are capable
of applying those standards
consistently, thereby decreasing the
likelihood that a medically unqualified
driver may obtain a medical certificate.
Summary of Legal Basis: The
fundamental legal basis for the National
Registry program comes from 49 U.S.C.
31149(d), which requires FMCSA to
establish and maintain a current
national registry of medical examiners
that are qualified to perform
examinations of CMV drivers and to
issue medical certificates. FMCSA is
required to remove from the registry any
medical examiner who fails to meet or
maintain qualifications established by
FMCSA. In addition, in developing its
regulations, FMCSA must consider both
the effect of driver health on the safety
of CMV operations and the effect of
such operations on driver health, 49
U.S.C. 31136(a).
Alternatives: The rulemaking is
statutorily mandated. Thus, the Agency
must establish the National Registry.
Anticipated Cost and Benefits: We
estimated 10-year costs (discounted at 7
percent) at $700,783 million, total
benefits at $1,144,961 million, and net
benefits over 10 years at $444,177
million.
Risks: FMCSA has not yet fully
assessed the risks that might be
associated with this activity.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
12/01/08
01/30/09
73 FR 73129
02/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Dr. Mary D. Gunnels,
Director, Office of Medical Programs,
Department of Transportation, Federal
Motor Carrier Safety Administration,
1200 New Jersey Avenue SE.,
Washington, DC 20590, Phone: 202 366–
4001, Email: maggi.gunnels@dot.gov.
RIN: 2126–AA97
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DOT—NATIONAL HIGHWAY TRAFFIC
SAFETY ADMINISTRATION (NHTSA)
Proposed Rule Stage
112. + Passenger Car and Light Truck
Corporate Average Fuel Economy
Standards MYS 2017 and Beyond
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 49 U.S.C. 32902;
Delegation of Authority at 49 CFR 1.50
CFR Citation: 49 CFR 533.
Legal Deadline: Final, Statutory, April
1, 2015.
Abstract: This rulemaking would
establish Corporate Average Fuel
Economy (CAFE) standards for light
trucks and passenger cars for model
years 2017 and beyond. This rulemaking
would respond to requirements of the
Energy Policy and Conservation Act, as
amended by the Energy Independence
and Security Act of 2007. The statute
requires that CAFE standards be
prescribed separately for passenger
automobiles and non-passenger
automobiles to achieve a combined fleet
fuel economy of at least 35 mpg by
model year 2020. For model years 2021
and beyond, the statute requires that the
average fuel economy required to be
attained by each fleet of passenger and
non-passenger automobiles be the
maximum feasible for each model year.
The law requires the standards be set at
least 18 months prior to the start of the
model year. On May 21, 2010, President
Obama issued a memorandum directing
NHTSA and EPA to conduct a joint
rulemaking (NHTSA regulating fuel
economy and EPA regulating
greenhouse gas emissions), and to issue
a Notice of Intent to Issue a Proposed
Rule (NOI) by September 30, 2010.
Statement of Need: This rulemaking
would respond to requirements of the
Energy Policy and Conservation Act, as
amended by the Energy Independence
and Security Act of 2007. The statute
requires that corporate average fuel
economy standards be prescribed
separately for passenger automobiles
and non-passenger automobiles to
achieve a combined fleet fuel economy
of at least 35 mpg by model year 2020.
For model years 2021 and beyond, the
statute requires that the average fuel
economy required to be attained by each
fleet of passenger and non-passenger
automobiles be the maximum feasible
for each model year. The law requires
the standards be set at least 18 months
prior to the start of the model year, and
for model year 2017, standards must be
set by April 1, 2015. On May 21, 2010,
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President Obama issued a memorandum
directing NHTSA and EPA to conduct
joint rulemaking, with NHTSA
regulating fuel economy and EPA
regulating greenhouse gas emissions.
Summary of Legal Basis: Section
32910(d) of title 49 of the United States
Code provides that the Administrator
may prescribe regulations necessary to
carry out his duties under chapter 329,
Automobile Fuel Economy.
Alternatives: The Agency is not
pursuing any alternatives.
Anticipated Cost and Benefits: The
costs and benefits of the potential
changes addressed in this action have
not yet been assessed.
Risks: Depending upon how
manufacturers use weight reduction to
meet the fuel economy standards, there
is a potential impact on motor vehicle
safety. The 2010 NHTSA analysis shows
that a 100-pound reduction in weight,
while keeping footprint constant,
decreases the fatality rate for light trucks
over 3,870 pounds but increases the
fatality rate for light trucks less than
3,870 pounds and for all passenger cars.
An interagency team from DOT, EPA,
and DOE are further examining this
issue.
Timetable:
Date
FR Cite
Notice of Intent
(NOI).
NOI Comment
Period End.
Supplemental NOI
NPRM ..................
NPRM Comment
Period End.
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Action
10/13/10
75 FR 62739
10/31/10
12/08/10
12/01/11
01/30/12
75 FR 76337
76 FR 74854
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
Energy Effects: Statement of Energy
Effects planned as required by Executive
Order 13211.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: James Tamm, Fuel
Economy Division Chief, Department of
Transportation, National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC
20590, Phone: 202 493–0515, Email:
james.tamm@dot.gov.
Related RIN: Duplicate of 2060–
AQ54.
RIN: 2127–AK79
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DOT—NHTSA
Action
113. • + Sound for Hybrid and Electric
Vehicles
Priority: Other Significant.
Legal Authority: 49 U.S.C. 30111; 49
U.S.C. 30115; 49 U.S.C. 30117; 49 U.S.C.
30166; 49 U.S.C. 322; Delegation of
Authority at 49 CFR 1.50
CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Statutory, July
5, 2012, Initiate rulemaking.
Final, Statutory, January 3, 2014.
Legislation requires the Secretary of
Transportation to initiate rulemaking by
July 2012 and issue a final rule not later
than January 2014.
Abstract: This rulemaking would
respond to The Pedestrian Safety
Enhancement Act of 2010, which directs
the Secretary of Transportation to study
and establish a motor vehicle safety
standard that provides for a means of
alerting blind and other pedestrians of
motor vehicle operation. NHTSA is
conducting research in this area and has
not yet developed an estimate for the
potential costs and benefits associated
with this rulemaking action.
Statement of Need: The Pedestrian
Safety Enhancement Act of 2010, signed
into law on January 4, 2011, directs the
Secretary to study and establish a motor
vehicle safety standard that provides for
a means of alerting blind and other
pedestrians of motor vehicle operation.
Prior to that, in June 2008, NHTSA held
a public meeting to provide a forum for
interested parties to discuss the issue of
quieter cars and established a docket
(Docket No. NHTSA–2008–0108) to
collect information on the issue.
Subsequently, the Agency developed
and initiated a research plan to identify
the critical safety scenarios in which
quieter vehicles may pose a hazard to
blind and other pedestrians; identify
and evaluate various countermeasures
to address the safety problem; and
support the development of a
specification for an artificial vehicle
sound.
Summary of Legal Basis: Section
30111, title 49 of the U.S.C. states that
the Secretary shall prescribe motor
vehicle safety standards.
Alternatives: The Agency is not
pursuing any alternatives.
Anticipated Cost and Benefits: The
costs and benefits of the potential
changes addressed in this action have
not yet been assessed.
Risks: The Agency believes that there
are no significant risks associated with
this rulemaking and that only beneficial
outcomes will occur.
Timetable:
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Date
NPRM ..................
7811
FR Cite
07/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Marisol Medri,
Safety Engineer, Department of
Transportation, National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC
20590, Phone: 202 366–6987, Email:
marisol.medri@dot.gov.
RIN: 2127–AK93
DOT—NHTSA
114. • + Motorcoach Rollover
Structural Integrity
Priority: Other Significant.
Legal Authority: 49 U.S.C. 30111; 49
U.S.C. 30115; 49 U.S.C. 30117; 49 U.S.C.
30166; 49 U.S.C. 322; Delegation of
Authority at 49 CFR 1.50
CFR Citation: 49 CFR 571.
Legal Deadline: None.
Abstract: This rulemaking would
promulgate a new FMVSS for rollover
structural integrity requirements for
motorcoaches. In August 2007, NHTSA
published a motorcoach safety plan
identifying four specific priority items:
Seat belts on motorcoaches, rollover
structural integrity, emergency
evacuation, and fire safety. The DOT
published a comprehensive motorcoach
safety action plan in November 2009
that reiterated NHTSA’s motorcoach
safety priorities. This rulemaking also
addresses six recommendations issued
by the NTSB on motorcoach roof
strength and structural integrity.
Statement of Need: Over the 10-year
period between 1999 and 2008, there
were 54 fatal motorcoach crashes
resulting in 186 fatalities. During this
period, on average, 16 fatalities have
occurred annually to occupants of
motorcoaches in crash and rollover
events, with about 2 of these fatalities
being drivers and 14 being passengers.
However, while motorcoach
transportation overall is safe, when
serious crashes of this vehicle type do
occur, they can cause a significant
number of fatal or serious injuries
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
during a single event, particularly when
occupants are ejected. This action is
consistent with our detailed plans for
improving motorcoach passenger
protection, laid out in NHTSA’s
Approach to Motorcoach Safety 2007
and the Department of Transportation
2009 Motorcoach Action Plan (Docket
No. NHTSA–2007–28793), as well as the
Agency’s Vehicle Safety and Fuel
Economy Rulemaking and Research
Priority Plan 2011 to 2013 (Docket No.
NHTSA–2009–0108), and is responsive
to six recommendations issued by the
National Transportation Safety Board.
Summary of Legal Basis: Section
30111, title 49 of the U.S.C. states that
the Secretary shall prescribe motor
vehicle safety standards.
Alternatives: The Agency is not
pursuing any alternatives.
Anticipated Cost and Benefits: The
costs and benefits of the potential
changes addressed in this action have
not yet been assessed.
Risks: The Agency believes that there
are no significant risks associated with
this rulemaking and that only beneficial
outcomes will occur.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Shashi Kuppa, Chief,
Special Vehicles and Systems Division,
Department of Transportation, National
Highway Traffic Safety Administration,
1200 New Jersey Avenue SE.,
Washington, DC 20590, Phone: 202 366–
3827, Fax: 202 493–7002, Email:
shashi.kuppa@dot.gov.
RIN: 2127–AK96
DOT—NHTSA
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115. • + Electronic Stability Control
Systems for Heavy Vehicles
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 49 U.S.C. 30111; 49
U.S.C. 30115; 49 U.S.C. 30117; 49 U.S.C.
30166; 49 U.S.C. 322; Delegation of
Authority at 49 CFR 1.50
CFR Citation: 49 CFR 571.
Legal Deadline: None.
Abstract: This rulemaking would
promulgate a new Federal standard that
would require stability control systems
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on truck tractors and motorcoaches that
address both rollover and loss of control
crashes, after an extensive research
program to evaluate the available
technologies, an evaluation of the costs
and benefits, and a review of
manufacturer’s product plans. Rollover
and loss of control crashes involving
heavy vehicles is a serious safety issue
that is responsible for 304 fatalities and
2,738 injuries annually. They are also a
major cause of traffic tie-ups, resulting
in millions of dollars of lost
productivity and excess energy
consumption each year. Suppliers and
truck and motorcoach manufacturers
have developed stability control
technology for heavy vehicles to
mitigate these types of crashes. Our
preliminary estimate produces an
effectiveness range of 37 to 56 percent
against single-vehicle tractor-trailer
rollover crashes and 3 to 14 percent
against loss of control crashes that result
from skidding on the road surface. With
these effectiveness estimates, annually,
we estimate 29 to 66 lives would be
saved, 517 to 979 MAIS 1 to 5 injuries
would be reduced, and 810 to 1,693
crashes that involved property damage
only would be eliminated. Additionally,
it would save $10 to $26 million in
property damage and travel delays.
Based on the technology unit costs and
affected vehicles, we estimate
technology costs would be $55 to $107
million, annually. However, the costs
savings from reducing travel delay and
property damage would produce net
benefits of $128 to $372 million.
Statement of Need: Rollover and loss
of control crashes involving heavy
vehicles is a serious safety issue that is
responsible for 304 fatalities and 2,738
injuries annually. They are also a major
cause of traffic tie-ups, resulting in
millions of dollars of lost productivity
and excess energy consumption each
year. This action is consistent with our
detailed plans for improving
motorcoach passenger protection, laid
out in NHTSA’s Approach to
Motorcoach Safety 2007 and the
Department of Transportation 2009
Motorcoach Action Plan (Docket No.
NHTSA–2007–28793), as well as the
Agency’s Vehicle Safety and Fuel
Economy Rulemaking and Research
Priority Plan 2011 to 2013 (Docket No.
NHTSA–2009–0108), and is responsive
to two recommendations issued by the
National Transportation Safety Board.
Summary of Legal Basis: Section
30111, title 49 of the U.S.C. states that
the Secretary shall prescribe motor
vehicle safety standards.
Alternatives: The Agency is not
pursuing any alternatives.
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Anticipated Cost and Benefits: The
costs and benefits of the potential
changes addressed in this action have
not yet been assessed.
Risks: The Agency believes that there
are no significant risks associated with
this rulemaking and that only beneficial
outcomes will occur.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: George Soodoo,
Chief, Vehicle Safety Dynamics Division
(NVS–122), Department of
Transportation, National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC
20590, Phone: 202 366–2720, Fax: 202
366–4329, Email:
george.soodoo@dot.gov.
RIN: 2127–AK97
DOT—NHTSA
Final Rule Stage
116. + Require Installation of Seat Belts
on Motorcoaches, FMVSS No. 208
Priority: Other Significant.
Legal Authority: 49 U.S.C. 30111; 49
U.S.C. 30115; 49 U.S.C. 30117; 49 U.S.C.
30166; 49 U.S.C. 322; Delegation of
Authority at 49 CFR 1.50
CFR Citation: 49 CFR 571.208; 49 CFR
571.3.
Legal Deadline: None.
Abstract: This rulemaking would
require the installation of lap/shoulder
belts in newly manufactured
motorcoaches. Specifically, this
rulemaking would establish a new
definition for motorcoaches in 49 CFR
part 571.3. It would also amend Federal
Motor Vehicle Safety Standard No. 208
‘‘Occupant Crash Protection’’ to require
the installation of lap/shoulder belts at
all driver and passenger seating
positions. It would also require the
installation of lap/shoulder belts at
driver seating positions of large school
buses in FMVSS no. 208. This
rulemaking responds, in part, to
recommendations made by the National
Transportation Safety Board for
improving bus safety.
Statement of Need: Over the 10-year
period between 1999 and 2008, there
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were 54 fatal motorcoach crashes
resulting in 186 fatalities. During this
period, on average, 16 fatalities have
occurred annually to occupants of
motorcoaches in crash and rollover
events, with about 2 of these fatalities
being drivers and 14 being passengers.
However, while motorcoach
transportation overall is safe, when
serious crashes of this vehicle type do
occur, they can cause a significant
number of fatal or serious injuries
during a single event, particularly when
occupants are ejected.
Summary of Legal Basis: Section
30111, title 49 of the U.S.C., states that
the Secretary shall prescribe motor
vehicle safety standards.
Alternatives: In addition to the
proposed installation of lap/shoulder
belts in all passenger seating positions
on motorcoaches, the Agency is also
pursuing improvements to motorcoach
rollover structural integrity, fire safety,
electronic stability control, and
emergency egress to improve occupant
protection. Our detailed plans for
improving motorcoach passenger
protection can be found in NHTSA’s
Approach to Motorcoach Safety 2007
and the Department of Transportation
2009 Motorcoach Action Plan (Docket
No. NHTSA–2007–28793), as well as the
Agency’s Vehicle Safety and Fuel
Economy Rulemaking and Research
Priority Plan 2011 to 2013 (Docket No.
NHTSA–2009–0108).
The Agency also alternatively
evaluated proposing the installation of
lap belts in all passenger seating
positions on motorcoaches and is
seeking comments on the issue of
retrofitting older motorcoaches with seat
belts.
Anticipated Cost and Benefits: The
anticipated total costs are expected to be
$25.8 million for the 2,000 new
motorcoaches produced each year, plus
added fuel costs. The Agency estimates
the proposal has the potential to save 1
to 8 fatalities and 144 to 794 non-fatal
injuries annually assuming a range of
seat belt use between 15 and 83 percent.
The cost per equivalent life saved at a
7 percent discount rate is estimated to
range from $1.8 to $9.9 million, based
on an assumed seat belt use rate
between 83 percent and 15 percent,
respectively.
Risks: The Agency believes there are
no substantial risks to this rulemaking,
and that only beneficial outcomes will
occur as the industry moves to reduce
injuries of motorcoach occupants.
Timetable:
Action
Date
FR Cite
NPRM ..................
08/18/10
75 FR 50958
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Action
Date
NPRM Comment
Period End.
Final Rule ............
FR Cite
10/18/10
07/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: David Sutula, Safety
Standards Engineer, Department of
Transportation, National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC
20590, Phone: 202 366–3273, Fax: 202
366–4329, Email: david.sutula@dot.gov.
RIN: 2127–AK56
DOT—FEDERAL TRANSIT
ADMINISTRATION (FTA)
Proposed Rule Stage
117. + Major Capital Investment
Projects (RRR)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 49 U.S.C. 5309
CFR Citation: 49 CFR 611.
Legal Deadline: Final, Statutory, April
7, 2006.
Abstract: This rulemaking would
make changes to the regulations that
govern the New Starts discretionary
funding program authorized by 49
U.S.C. 5309. FTA´s initial rulemaking
on this subject (RIN 2132–AA81),
initiated to meet the statutory deadline,
was terminated as the result of
subsequent congressional action
prohibiting FTA from issuing a rule.
Statement of Need: Section 3011 of
the Safe, Accountable, Flexible,
Efficient Transportation Equity Act: A
Legacy for Users (SAFETEA–LU) made
a number of changes to 49 U.S.C. 5309,
which authorizes the Federal Transit
Administration’s (FTA) fixed guideway
capital investment grant program known
as ‘‘New Starts.’’ SAFETEA–LU also
created a new category of major capital
investments that have a total project
cost of less than $250 million, and that
are seeking less than $75 million in
section 5309 major capital investment
funds. This rulemaking proposes to
implement those changes and a number
of other changes that FTA believes will
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improve the process for evaluating
major capital investment projects.
Summary of Legal Basis: Section
5309, title 49 of the United States Code,
requires the Secretary to promulgate
regulations for the evaluation and
selection of major capital investment
projects that have a total project cost of
less than $250 million, and that are
seeking less than $75 million in section
5309 major capital investment funds.
Alternatives: This rulemaking is
mandated by section 3011 of SAFETEA–
LU, so there is not an alternative to
pursuing rulemaking. Within the
rulemaking process, FTA has already
issued and has received comments on
an Advance Notice of Proposed
Rulemaking that will inform the various
options FTA might pursue in the Notice
of Proposed Rulemaking.
Anticipated Cost and Benefits: The
single largest change in the New Starts
program is the creation in SAFETEA–
LU of the ‘‘Small Starts’’ program. Over
the first 10 years of the Small Starts
program, the cumulative impact of
transfer from New Starts to Small Starts
will likely be $1.9 Billion, with a Net
Present Value of $1.311 Billion using a
discount rate of 7 percent. This effect is
difficult to characterize in terms of cost
or benefit, as it simply represents a
‘‘transfer of a transfer’’ from one
governmental entity to another.
Risks: The proposed rulemaking
provides a framework for a discretionary
grant program; it does not propose to
regulate other than for applicants for
Federal funds. As such, the rulemaking
poses no risks for the regulated
community, other than for the risks
inherent in pursuing Federal funds that
might not be awarded if a project fails
to satisfy the eligibility and evaluation
criteria in the proposed regulatory
structure.
Timetable:
Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
06/03/10
08/02/10
75 FR 31383
01/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: Includes
Retrospective Review under E.O. 13563.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Christopher
VanWyk, Attorney Advisor, Department
of Transportation, Federal Transit
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Administration, 1200 New Jersey
Avenue SE., Washington, DC 20590,
Phone: 202 366–1733, Email:
christopher.vanwyk@fta.dot.gov.
RIN: 2132–AB02
DOT—MARITIME ADMINISTRATION
(MARAD)
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Proposed Rule Stage
118. + Regulations To Be Followed by
All Departments, Agencies, and
Shippers Having Responsibility to
Provide a Preference for U.S.-Flag
Vessels in the Shipment of Cargoes on
Ocean Vessels
Priority: Other Significant.
Legal Authority: 49 CFR 1.66; 46 app
U.S.C. 1101; 46 app U.S.C. 1241; 46
U.S.C. 2302 (e)(1); Pub. L. 91–469
CFR Citation: 46 CFR 381.
Legal Deadline: None.
Abstract: This rulemaking would
revise and clarify the Cargo Preference
rules that have not been revised
substantially since 1971. Revisions
would include an updated purpose and
definitions section along with the
removal of obsolete provisions. This
rulemaking also would establish a new
part 383 of the Cargo Preference
regulations. This rulemaking would
cover Public Law 110–417, section
3511, National Defense Authorization
Act for FY 2009 changes to the cargo
preference rules, which have not been
substantially revised since 1971. The
rulemaking also would include
compromise, assessment, mitigation,
settlement, and collection of civil
penalties. Originally the agency had two
separate rulemakings in process under
RIN 2133–AB74 and 2133–AB75. RIN
2133–AB74 would have revised existing
regulations and RIN 2133–AB75 would
have established a new part 383:
Guidance and Civil Penalties and
implement Public Law 110–417, section
3511, National Defense Authorization
Act for FY 2009. MARAD has decided
it would be more efficient to merge both
efforts under one; RIN 2133–AB75 has
been merged with this action.
Statement of Need: On September 4,
2009, the USDA, MARAD, and USAID
entered into a MOU regarding the
proper implementation of the Cargo
Preference Act. The MOU establishes
procedures and standards by which
owners and operators of oceangoing
cargo ships may seek to designate each
of their vessels as either a dry bulk
carrier or a dry cargo liner, according to
specified service-based criteria. With
the help of OMB, these agencies are in
the process of negotiating updates to the
comprehensive cargo preference rule,
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which has not been significantly
changed since 1971.
Summary of Legal Basis: The Cargo
Preference Act requires that Federal
agencies take necessary and practicable
steps to ensure that privately owned
U.S.-flag vessels transport at least 50
percent of the gross tonnage of cargo
sponsored under Federal programs to
the extent such vessels are available at
fair and reasonable rates for commercial
vessels of the U.S., in a manner that will
ensure a fair and reasonable
participation of commercial vessels of
the U.S. in those cargoes by geographic
areas. 46 U.S.C. 55305(b). An additional
25 percent of gross tonnage of certain
food assistance programs is to be
transported in accordance with the
requirements of 46 U.S.C. 55314.
Alternatives: TBD.
Anticipated Cost and Benefits: TBD.
Risks: TBD.
Timetable:
Action
Date
NPRM ..................
FR Cite
05/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL for More Information:
www.regulations.gov.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Christine Gurland,
Department of Transportation, Maritime
Administration, 1200 New Jersey
Avenue SE., Washington, DC 20590,
Phone: 202 366–5157, Email:
christine.gurland@dot.gov.
Related RIN: Related to 2133–AB75.
RIN: 2133–AB74
BILLING CODE 4910–9X–P
DEPARTMENT OF THE TREASURY
Statement of Regulatory Priorities
The primary missions of the
Department of the Treasury are:
• To promote prosperous and stable
American and world economies,
including promoting domestic economic
growth and maintaining our Nation’s
leadership in global economic issues,
supervising national banks and thrift
institutions, and helping to bring
residents of distressed communities into
the economic mainstream.
• To manage the Government’s
finances by protecting the revenue and
collecting the correct amount of revenue
under the Internal Revenue Code,
overseeing customs revenue functions,
financing the Federal Government and
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managing its fiscal operations, and
producing our Nation’s coins and
currency.
• To safeguard the U.S. and
international financial systems from
those who would use these systems for
illegal purposes or to compromise U.S.
national security interests, while
keeping them free and open to
legitimate users.
Consistent with these missions, most
regulations of the Department and its
constituent bureaus are promulgated to
interpret and implement the laws as
enacted by the Congress and signed by
the President. It is the policy of the
Department to comply with applicable
requirements to issue a notice of
proposed rulemaking and carefully
consider public comments before
adopting a final rule. Also, in particular
cases, the Department invites interested
parties to submit views on rulemaking
projects while a proposed rule is being
developed.
In response to the events of
September 11, 2001, the President
signed the USA PATRIOT Act of 2001
into law on October 26, 2001. Since
then, the Department has accorded the
highest priority to developing and
issuing regulations to implement the
provisions in this historic legislation
that target money laundering and
terrorist financing. These efforts, which
will continue during the coming year,
are reflected in the regulatory priorities
of the Financial Crimes Enforcement
Network (FinCEN).
To the extent permitted by law, it is
the policy of the Department to adhere
to the regulatory philosophy and
principles set forth in Executive Orders
12866 and 13563 and to develop
regulations that maximize aggregate net
benefits to society while minimizing the
economic and paperwork burdens
imposed on persons and businesses
subject to those regulations.
Office of Financial Stability
On October 3, 2008, the President
signed the Emergency Economic
Stabilization Act of 2008 (EESA) (Pub.
L. 110–334). Section 101(a) of EESA
authorizes the Secretary of the Treasury
to establish a Troubled Asset Relief
Program (TARP) to ‘‘purchase, and to
make and fund commitments to
purchase, troubled assets from any
financial institution, on such terms and
conditions as are determined by the
Secretary, and in accordance with this
Act and policies and procedures
developed and published by the
Secretary.’’
EESA provides authority to issue
regulations and guidance to implement
the program. Regulations and guidance
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required by EESA include conflicts of
interest, executive compensation, and
tax guidance. The Secretary is also
charged with establishing a program
that will guarantee principal of, and
interest on, troubled assets originated or
issued prior to March 14, 2008.
The Department has issued guidance
and regulations and will continue to
provide program information through
the next year. Regulatory actions taken
to date include:
Executive compensation. In October
2008, the Department issued an interim
final rule that set forth executive
compensation guidelines for the TARP
Capital Purchase Program (73 FR
62205). Related tax guidance on
executive compensation was announced
in IRS Notice 2008–94. In addition,
among other EESA tax guidance, the IRS
issued interim guidance regarding loss
corporation and ownership changes in
Notice 2008–100, providing that any
shares of stock owned by the
Department of the Treasury under the
Capital Purchase Program will not be
considered to cause Treasury’s
ownership in such corporation to
increase. On June 15, 2009, the
Department issued a revised interim
final rule that sets forth executive
compensation guidelines for all TARP
program participants (74 FR 28394),
implementing amendments to the
executive compensation provisions of
EESA made by the American Recovery
and Reinvestment Act of 2009 (Pub.
L.111–5). Public comments on the
revised interim final rule regarding
executive compensation were due by
August 14, 2009, and will be considered
as part of the process of issuing a final
rule on this subject.
Conflicts of interest. On January 21,
2009, the Department issued an interim
final rule providing guidance on
conflicts of interest pursuant to section
108 of EESA (74 FR 3431). Comments
on the interim final rule, which were
due by March 23, 2009, will be
considered as part of the process of
issuing a final rule. A final rule was
published on October 3, 2011.
The Department will continue
implementing the EESA authorities to
restore capital flows to the consumers
and businesses that form the core of the
Nation’s economy.
Terrorism Risk Insurance Program
Office
The Terrorism Risk Insurance Act of
2002 (TRIA) was signed into law on
November 26, 2002. The law, which was
enacted as a consequence of the events
of September 11, 2001, established a
temporary Federal reinsurance program
under which the Federal Government
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shares the risk of losses associated with
certain types of terrorist acts with
commercial property and casualty
insurers. The Act, originally scheduled
to expire on December 31, 2005, was
extended to December 31, 2007, by the
Terrorism Risk Insurance Extension Act
of 2005 (TRIEA). The Act has since been
extended to December 31, 2014, by the
Terrorism Risk Insurance Program
Reauthorization Act of 2007 (TRIPRA).
The Office of the Assistant Secretary
for Financial Institutions is responsible
for developing and promulgating
regulations implementing TRIA, as
extended and amended by TRIEA and
TRIPRA. The Terrorism Risk Insurance
Program Office, which is part of the
Office of the Assistant Secretary for
Financial Institutions, is responsible for
operational implementation of TRIA.
The purposes of this legislation are to
address market disruptions, ensure the
continued widespread availability and
affordability of commercial property
and casualty insurance for terrorism
risk, and to allow for a transition period
for the private markets to stabilize and
build capacity while preserving State
insurance regulation and consumer
protections.
Over the past year, the Office of the
Assistant Secretary has issued proposed
rules implementing changes authorized
by TRIA as revised by TRIPRA. The
following regulations should be
published by December 31, 2011:
Final Netting. This final rule would
establish procedures by which, after the
Secretary has determined that claims for
the Federal share of insured losses
arising from a particular Program Year
shall be considered final, a final netting
of payments to or from insurers will be
accomplished.
Affiliates. This proposed rule would
make changes to the definition of
‘‘affiliate’’ to conform to the language in
the statute.
Civil Penalty. This proposed rule
would establish procedures by which
the Secretary may assess civil penalties
against any insurer that the Secretary
determines, on the record after an
opportunity for a hearing, has violated
provisions of the Act.
Treasury will continue the ongoing
work of implementing TRIA and
carrying out revised operations as a
result of the TRIPRA-related regulation
changes.
Customs Revenue Functions
The Homeland Security Act of 2002
(the Act) provides that the Secretary of
the Treasury retains sole legal authority
over the customs revenue functions. The
Act also authorizes the Secretary of the
Treasury to delegate any of the retained
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authority over customs revenue
functions to the Secretary of Homeland
Security. By Treasury Department Order
No. 100–16, the Secretary of the
Treasury delegated to the Secretary of
Homeland Security authority to
prescribe regulations pertaining to the
customs revenue functions subject to
certain exceptions. This Order further
provided that the Secretary of the
Treasury retained the sole authority to
approve such regulations.
During the past fiscal year, among the
customs-revenue function regulations
issued was an interim rule (76 FR 692)
on January 6, 2011, which implemented
the preferential tariff treatment and
other customs-related provisions of the
United States-Oman Free Trade
Agreement Implementation Act. CBP
plans to finalize this rulemaking in the
first half of FY 2012.
On March 17, 2011, CBP also issued
a final rule (76 FR 14575) that adopted,
with some changes, the interim
amendments to the CBP regulations
relating to the country of origin of
textile and apparel products. These
amendments were necessitated, in part,
by the expiration of the Agreement on
Textile and Clothing and the resulting
elimination of quotas on the entry of
textile and apparel products from World
Trade Organizations (WTO) members.
The primary regulatory change
consisted of the elimination of the
requirement that a textile declaration be
submitted for every importation of
textile and apparel products.
This past fiscal year, consistent with
the practice of continuing to move
forward with Customs Modernization
provisions of the North American Free
Trade Implementation Act to improve
its regulatory procedures and consistent
with the goals of Executive Orders
12866 and 13563, Treasury and CBP
finalized on August 17, 2011 (76 FR
50883), the March 2010 proposal and
pertaining to how CBP issues courtesy
notices of liquidation to importers of
record whose entry summaries are filed
in the Automated Broker Interface (ABI).
In an effort to streamline the notification
process and reduce CBP’s printing and
mailing costs, the final rule provides
that all ABI filers (importers of record
and brokers who file as the agent of an
importer of record) will receive
electronic courtesy notices beginning
September 30, 2011. Importers of record
whose entries are not filed through the
ABI will continue to receive paper
courtesy notices of liquidation. In
addition, every importer of record with
an Automated Commercial Environment
(ACE) Account can now monitor the
liquidation of its entries by using the
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reporting tool in the ACE Secure Data
Portal Account.
On August 19, 2011, Treasury and
CBP published a proposal (76 FR 51914)
to amend the CBP regulations to extend
the time period after the date of entry
for an applicant to file the certification
documentation required for duty-free
treatment of certain visual and auditory
material of an educational, scientific, or
cultural character under chapter 98 of
the Harmonized Tariff Schedule of the
United States.
On September 2, 2011, Treasury and
CBP adopted as a final rule (76 FR
54691) only the portion of its July 25,
2008, proposal for amending the
country of origin rules codified in part
102 of the CBP regulations applicable to
five specific product areas; namely, pipe
fittings and flanges, greeting cards, glass
optical fiber, rice preparations, and
certain textile and apparel products,
but, in the light of the public comments
received, it did not adopt the proposal
to establish uniform rules governing
CBP determinations of the country of
origin of imported merchandise.
During fiscal year 2012, CBP and
Treasury plan to give priority to the
following regulatory matters involving
the customs revenue functions:
Trade Act of 2002’s preferential trade
benefit provisions. Treasury and CBP
plan to make permanent several interim
regulations that implement the trade
benefit provisions of the Trade Act of
2002.
Free Trade Agreements. Treasury and
CBP also plan to issue interim
regulations this fiscal year to implement
the preferential trade benefit provisions
of the United States-Singapore Free
Trade Agreement Implementation Act.
Treasury and CBP also expect to issue
interim regulations implementing the
preferential trade benefit provisions of
the United States-Australia Free Trade
Agreement Implementation Act and the
United States-Peru Free Trade
Agreement Implementation Act.
Customs and Border Protection’s
Bond Program. Treasury and CBP plan
to publish a final rule amending the
regulations to reflect the centralization
of the continuous bond program at
CBP’s Revenue Division. The changes
proposed would support CBP’s bond
program by ensuring an efficient and
uniform approach to the approval,
maintenance, and periodic review of
continuous bonds, as well as
accommodating the use of information
technology and modern business
practices.
Use of Sampling Methods and
Offsetting of Overpayments and OverDeclarations in CBP Audits. Treasury
and CBP plan to publish a final rule
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amending the regulations to add
provisions for using sampling methods
in CBP audits and for the offsetting of
overpayments and over-declarations
when an audit involves a calculation of
lost duties, taxes, or fees or monetary
penalties under 19 U.S.C. 1592.
Financial Crimes Enforcement Network
As chief administrator of the Bank
Secrecy Act (BSA), the Financial Crimes
Enforcement Network (FinCEN) is
responsible for developing and
implementing regulations that are the
core of the Department’s anti-money
laundering and counter-terrorism
financing efforts. FinCEN’s
responsibilities and objectives are
linked to, and flow from, that role. In
fulfilling this role, FinCEN seeks to
enhance U.S. national security by
making the financial system
increasingly resistant to abuse by money
launderers, terrorists and their financial
supporters, and other perpetrators of
crime.
The Secretary of the Treasury,
through FinCEN, is authorized by the
BSA to issue regulations requiring
financial institutions to file reports and
keep records that are determined to
have a high degree of usefulness in
criminal, tax, or regulatory matters or in
the conduct of intelligence or counterintelligence activities to protect against
international terrorism. The BSA also
authorizes requiring designated
financial institutions to establish antimoney laundering programs and
compliance procedures. To implement
and realize its mission, FinCEN has
established regulatory objectives and
priorities to safeguard the financial
system from the abuses of financial
crime, including terrorist financing,
money laundering, and other illicit
activity. These objectives and priorities
include: (1) Issuing, interpreting, and
enforcing compliance with regulations
implementing the BSA; (2) supporting,
working with, and as appropriate,
overseeing compliance examination
functions delegated to other Federal
regulators; (3) managing the collection,
processing, storage, and dissemination
of data related to the BSA; (4)
maintaining a Governmentwide access
service to that same data and for
network users with overlapping
interests; (5) conducting analysis in
support of policymakers, law
enforcement, regulatory and intelligence
agencies, and the financial sector; and
(6) coordinating with and collaborating
on anti-terrorism and anti-money
laundering initiatives with domestic law
enforcement and intelligence agencies,
as well as foreign financial intelligence
units.
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During fiscal year 2011, FinCEN
issued the following regulatory actions:
Reorganization of BSA Rules. On
October 26, 2010, FinCEN issued a final
rule re-designating and reorganizing the
BSA regulations in a new chapter,
chapter X, within the Code of Federal
Regulations. The regulations are now
organized in a more consistent and
intuitive structure that more easily
allows financial institutions to identify
their specific regulatory requirements
under the BSA. In reorganizing the
regulations, FinCEN has made BSA
rules more accessible, easier to research,
and easier to understand. The change
promotes the goals of the BSA to protect
the financial system from criminal
abuse by facilitating compliance by
regulated financial institutions.
Confidentiality of Suspicious Activity
Reports. On November 23, 2010,
FinCEN issued a final rule clarifying the
non-disclosure provisions with respect
to the regulations pertaining to the
confidentiality of suspicious activity
reports (SARs). In conjunction with this
notice, FinCEN finalized two pieces of
guidance (SAR Sharing with Affiliates
for depository institutions and SAR
Sharing with Affiliates for securities and
futures industry entities), which permit
certain financial institutions to share
SARs with their U.S. affiliates that are
also subject to SAR reporting
requirements. The regulations and the
guidance pieces promote the protection
of SAR information while seeking to
ensure that all appropriate parties have
access to SARs. Allowing information
sharing among affiliates also will help
financial institutions protect themselves
from abuses of financial crime, support
overarching industry efforts to
strengthen enterprise-wide risk
management, and promote the reporting
of even more useful information to
FinCEN and law enforcement
investigators.
Non-Bank Residential Mortgage
Lenders and Originators. On December
9, 2010, FinCEN issued a Notice of
Proposed Rulemaking (NPRM) to solicit
public comment on the application of
anti-money laundering (AML) program
and SAR regulations to a specific subset of loan and finance companies; i.e.,
non-bank residential mortgage lenders
and originators. The proposed
regulations would close a regulatory gap
that allows other originators, such as
mortgage brokers and mortgage lenders
not affiliated with banks, to avoid
having AML and SAR obligations. Based
on its ongoing work supporting criminal
investigators and prosecutors in
combating mortgage fraud, FinCEN
believes that this regulatory measure
will help mitigate some of the
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vulnerabilities that criminals have
exploited. This NPRM was informed by
comments received following an
Advance Notice of Proposed
Rulemaking issued in July 2009.
FinCEN has a final rule to implement
the proposed regulations in clearance
and hopes to issue it prior to the end of
FY 2011.
Imposition of Special Measure
Against Lebanese Canadian Bank SAL
as a Financial Institution of Primary
Money Laundering Concern. On
February 10, 2011, FinCEN issued a
finding that the Lebanese Canadian
Bank SAL is a financial institution of
primary money laundering concern
under section 311 of the USA PATRIOT
Act for the bank’s role in facilitating the
money laundering activities of an
international narcotics trafficking and
money laundering network.
Concurrently, FinCEN issued a Notice of
Proposed Rulemaking to impose the
fifth special measure against the bank.
The fifth special measure prohibits or
conditions the opening or maintaining
of correspondent or payable-through
accounts for the designated institution
by U.S. financial institutions. These
actions are intended to protect the U.S.
financial system from the illicit
proceeds flowing through the bank and
to deprive this international narcotics
trafficking and money laundering
network of its preferred access point
into the formal financial system.
FBAR Requirements. On February 24,
2011, working with the Department of
Treasury, Office of Tax Policy, and the
Internal Revenue Service, FinCEN,
issued a final rule that amended the
BSA implementing regulations
regarding the filing of Reports of Foreign
Bank and Financial Accounts (FBARs).
The FBAR form is used to report a
financial interest in, or signature or
other authority over, one or more
financial accounts in foreign countries.
With slight modifications, the final rule
adopted the proposed changes
contained in the February 26, 2010,
NPRM. FBARs are used in conjunction
with SARs, CTRs, and other BSA reports
to provide law enforcement and
regulatory investigators with valuable
information to fight fraud, money
laundering, tax evasion, and other
financial crime.
Comprehensive Iran Sanctions,
Accountability, and Divestment Act of
2010 Reporting Requirements Under
Section 104(e). As a result of a
congressional mandate to prescribe
regulations under the Comprehensive
Iran Sanctions, Accountability, and
Divestment Act of 2010 (CISADA), on
May 2, 2011, FinCEN issued an NPRM
to impose a reporting requirement that
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would be invoked, as necessary, to elicit
information valuable in the
implementation of CISADA and would
work in tandem with other financial
provisions of CISADA to isolate Iran’s
Islamic Revolutionary Guard Corps and
financial institutions designated by the
U.S. Government in connection with
Iran’s proliferation of weapons of mass
destruction (WMD) or WMD delivery
systems or in connection with its
support for international terrorism.
FinCEN published a final rule to
implement the proposed regulations on
October 11, 2011.
Money Services Businesses—
Definitions and Other Regulations. On
July 21, 2011, FinCEN issued a final rule
revising the definitions for money
services businesses (MSBs) to delineate
more clearly the scope of entities
regulated as MSBs, incorporating
previously issued administrative rulings
and guidance with regard to MSBs, and
ensuring that certain foreign-located
persons engaging in MSB activities
within the United States are subject to
BSA rules. The rule enables entities to
determine in a more predictable and
straightforward way whether they are
operating as MSBs subject to BSA
regulations. In clarifying that foreign
entities conducting MSB activities in
the United State are required to register,
FinCEN recognizes that the Internet and
other technological advances make it
increasingly possible for persons to offer
MSB services in the United States from
foreign locations and seeks to ensure
that the BSA rules apply to all persons
engaging in MSB activities within the
United States, regardless of their
physical location.
Withdrawal of the Finding of Primary
Money Laundering Concern and the
Final Rule Against VEF Banka. On July
26, 2011, FinCEN withdrew its April
2005 final rule and finding under
section 311 of the USA PATRIOT Act.
FinCEN withdrew its finding that VEF
Banka was a financial institution of
primary money laundering concern.
FinCEN also withdrew the final rule
against VEF Banka that imposed a
special measure prohibiting U.S.
financial institutions from, directly or
indirectly, opening or maintaining
correspondent accounts in the United
States for VEF Banks.
Prepaid Access—Regulatory
Framework for Activity Previously
Referred to as Stored Value. On July 29,
2011, FinCEN issued a final rule
establishing a more comprehensive
regulatory framework for non-bank
prepaid access. The rule puts in place
suspicious activity reporting, and
customer and transactional information
collection requirements on providers
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and sellers of certain types of prepaid
access similar to other categories of
MSBs. It addresses regulatory gaps that
have resulted from the proliferation of
prepaid access innovations over the last
12 years and their increasing use as an
accepted payment method. The
regulations also provide a balance to
provide law enforcement with the
information needed to attack money
laundering, terrorist financing, and
other illicit transactions through the
financial system, without hindering
innovation and the many legitimate uses
and societal benefits prepaid access
offers.
Renewal of Existing Rules. FinCEN
renewed without change a number of
information collections associated with
the following existing requirements:
Additional records to be made and
retained by banks (31 CFR 1020.410 and
1010.430); records to be made and
retained by financial institutions (31
CFR 1010.410 and 1010.430); purchases
of bank checks and drafts, cashier’s
checks, money orders and traveler’s
checks (31 CFR 1010.415 and 1010.430);
reports of certain domestic coin and
currency transactions (31 CFR 1010.370
and 1010.410(d)); reports of transactions
with foreign financial agencies (31 CFR
1010.360); additional records to be
made and retained by casinos (31 CFR
1021.410 and 1010.430); additional
records to be made and retained by
brokers or dealers in securities (31 CFR
1023.410 and 1010.430); additional
records to be made and retained by
currency dealers or exchangers (31 CFR
1022.410 and 1010.430); special rules
for casinos (31 CFR 1021.210,
1021.410(b) and 1010.430); and
correspondent accounts for foreign shell
banks and recordkeeping and
termination of correspondent accounts
(31 CFR 1010.630 and 1010.670).
Administrative Rulings and Written
Guidance. FinCEN published 6
administrative rulings and written
guidance pieces, and provided 39
responses to written inquiries/
correspondence (as of August 2011)
interpreting the BSA and providing
clarity to regulated industries. FinCEN
anticipates issuing an additional 10
pieces by the end of FY 2011.
FinCEN’s regulatory priorities for
fiscal year 2012 include finalizing any
initiatives mentioned above that are not
finalized by fiscal year end, as well as
the following projects:
Amendment to the BSA Regulations—
Definition of Monetary Instrument. On
October 17, 2011, FinCEN published an
NPRM to address the mandate in the
Credit Card Accountability,
Responsibility, and Disclosure Act of
2009, which authorizes regulations
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regarding international transport of
prepaid access devices because of the
potential to substitute prepaid access for
cash and other monetary instruments as
a means to smuggle the proceeds of
illegal activity into and out of the
United States.
Anti-Money Laundering Program and
SAR Requirements for Housing
Government-Sponsored Enterprises.
FinCEN plans to issue an NPRM that
would define certain housing
government-sponsored enterprises as
financial institutions for the purpose of
requiring them to establish anti-money
laundering programs and report
suspicious activity to FinCEN pursuant
to the BSA.
Anti-Money Laundering Program and
SAR Requirements for Investment
Advisers. FinCEN is researching and
developing an NPRM that would
prescribe minimum standards for antimoney laundering programs to be
established by certain investment
advisers and to require such investment
advisers to report suspicious activity to
FinCEN.
Customer Due Diligence
Requirements. FinCEN is developing an
advance notice of proposed rulemaking
to solicit public comment on a wide
range of questions pertaining to the
development of a customer due
diligence (CDD) regulation that would
clarify, consolidate, and strengthen
existing CDD obligations for financial
institutions and also incorporate the
collection of beneficial ownership
information into the CDD framework.
Anti-Money Laundering Program for
State-Chartered Credit Unions and
Other Depository Institutions without a
Federal Functional Regulator. Pursuant
to section 352 of the USA PATRIOT Act,
certain financial institutions are
required to establish AML programs.
Continued from prior fiscal years,
FinCEN is researching and developing
rulemaking to require State-chartered
credit unions and other depository
institutions without a Federal functional
regulator to implement AML programs.
Cross Border Electronic Transmittal of
Funds. On September 27, 2010, FinCEN
issued a Notice of Proposed Rulemaking
(NPRM) in conjunction with the
feasibility study prepared pursuant to
the Intelligence Reform and Terrorism
Prevention Act of 2004 concerning the
issue of obtaining information about
certain cross-border funds transfers and
transmittals of funds. As FinCEN
continues to develop the system to
receive, store, and use this data, FinCEN
may publish another NPRM prior to
issuing a final rule.
Other Requirements. FinCEN also will
continue to issue proposed and final
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rules pursuant to section 311 of the USA
PATRIOT Act, as appropriate. Finally,
FinCEN expects to propose various
technical and other regulatory
amendments in conjunction with its
ongoing, comprehensive review of
existing regulations to enhance
regulatory efficiency.
Internal Revenue Service
The Internal Revenue Service (IRS),
working with the Office of Tax Policy,
promulgates regulations that interpret
and implement the Internal Revenue
Code and related tax statutes. The
purpose of these regulations is to carry
out the tax policy determined by
Congress in a fair, impartial, and
reasonable manner, taking into account
the intent of Congress, the realities of
relevant transactions, the need for the
Government to administer the rules and
monitor compliance, and the overall
integrity of the Federal tax system. The
goal is to make the regulations practical
and as clear and simple as possible.
Most IRS regulations interpret tax
statutes to resolve ambiguities or fill
gaps in the tax statutes. This includes
interpreting particular words, applying
rules to broad classes of circumstances,
and resolving apparent and potential
conflicts between various statutory
provisions.
During fiscal year 2012, the IRS will
accord priority to the following
regulatory projects:
Deduction and Capitalization of Costs
for Tangible Assets. Section 162 of the
Internal Revenue Code allows a current
deduction for ordinary and necessary
expenses paid or incurred in carrying on
any trade or business. Under section
263(a) of the Code, no immediate
deduction is allowed for amounts paid
out for new buildings or for permanent
improvements or betterments made to
increase the value of any property or
estate. Those expenditures are capital
expenditures that generally may be
recovered only in future taxable years,
as the property is used in the taxpayer’s
trade or business. It often is not clear
whether an amount paid to acquire,
produce, or improve property is a
deductible expense or a capital
expenditure. Although existing
regulations provide that a deductible
repair expense is an expenditure that
does not materially add to the value of
the property or appreciably prolong its
life, the IRS and Treasury believe that
additional clarification is needed to
reduce uncertainty and controversy in
this area. In August 2006, the IRS and
Treasury issued proposed regulations in
this area and received numerous
comments. In March 2008, the IRS and
Treasury withdrew the 2006 proposed
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regulations and issued new proposed
regulations, which have generated
relatively few comments. The IRS and
Treasury intend to finalize those
regulations.
Arbitrage Investment Restrictions on
Tax-Exempt Bonds. The arbitrage
investment restrictions on tax-exempt
bonds under section 148 generally limit
issuers from investing bond proceeds in
higher-yielding investments. Treasury
and the IRS plan to issue proposed
regulations to address selected current
issues involving the arbitrage
restrictions, including guidance on the
issue price definition used in the
computation of bond yield, working
capital financings, grants, investment
valuation, modifications and
terminations of qualified hedging
transactions, and selected other issues.
Guidance on the Tax Treatment of
Distressed Debt. A number of tax issues
relating to the amount, character, and
timing of income, expense, gain, or loss
on distressed debt remain unresolved.
In addition, the tax treatment of
distressed debt, including distressed
debt that has been modified, may affect
the qualification of certain entities for
tax purposes or result in additional
taxes on the investors in such entities,
such as regulated investment
companies, real estate investment trusts
(REITs), and real estate mortgage
investment conduits. During fiscal year
2011, Treasury and the IRS have
addressed some of these issues through
published guidance, including (1) a
revenue procedure providing relief for
certain modifications of distressed
mortgage loans held by a REIT and (2)
final regulations clarifying that the
deterioration in the financial condition
of the issuer of a modified debt
instrument is not taken into account to
determine whether the instrument is
debt or equity. Treasury and the IRS
plan to address more of these issues in
published guidance.
Elective Deferral of Certain Business
Discharge of Indebtedness Income. In
the recent economic downturn, many
business taxpayers realized income as a
result of modifying the terms of their
outstanding indebtedness or refinancing
on terms subjecting them to less risk of
default. The American Recovery and
Reinvestment Act of 2009 includes a
special relief provision allowing for the
elective deferral of certain discharge of
indebtedness income realized in 2009
and 2010. The provision, section 108(i)
of the Code, is complicated and many of
the details will have to be supplied
through regulatory guidance. On August
9, 2009, Treasury and the IRS issued
Revenue Procedure 2009–37 that
prescribes the procedure for making the
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election. On August 13, 2010, Treasury
and the IRS published temporary and
proposed regulations (TD 9497 and TD
9498) in the Federal Register. These
regulations provide additional guidance
on such issues as the types of
indebtedness eligible for the relief,
acceleration of deferred amounts, the
operation of the provision in the context
of flow-through entities, the treatment of
the discharge for the purpose of
computing earnings and profits, and the
operation of a provision of the statute
deferring original issue discount
deductions with respect to related
refinancings. Treasury and the IRS
intend to finalize those regulations.
Regulation of Tax Return Preparers.
In June 2009, the IRS launched a
comprehensive review of the tax return
preparer program with the intent to
propose a set of recommendations to
ensure uniform and high ethical
standards of conduct for all tax return
preparers and to increase taxpayer
compliance. The IRS published findings
and recommendations in Publication
4832, Return Preparer Review. In the
report, the IRS recommended increased
oversight of the tax return preparer
industry, including but not limited to,
mandatory preparer tax identification
number (PTIN) registration and usage,
competency testing, continuing
education requirements, and ethical
standards for all tax return preparers. As
part of a multi-step effort to increase
oversight of Federal tax return
preparers, Treasury and the IRS
published in 2010 final regulations: 1)
Authorizing the IRS to require tax return
preparers who prepare all or
substantially all of a tax return for
compensation after December 31, 2010,
to use PTINs as the preparer’s
identifying number on all tax returns
and refund claims that they prepare and
2) setting the user fee for obtaining a
PTIN at $50 plus a third-party vendor’s
fee. On June 3, 2011, Treasury and IRS
published final regulations amending
Circular 230, which established
registered tax return preparers as a new
category of tax practitioner and
extended the ethical rules for tax
practitioners to any individual who is a
tax return preparer. Treasury and the
IRS intend to publish additional
guidance in 2011 and 2012 to
specifically support the tax return
preparer program and operations,
including regulations that establish user
fees for the return preparer competency
examination and regulations that
provide additional rules with respect to
the PTIN. Treasury and the IRS also
intend to publish regulations under
Circular 230, which will include
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amendments to the opinion
requirements.
Penalties. Congress amended several
penalty provisions in the Internal
Revenue Code in the past several years
and Treasury and the IRS intend to
publish a number of guidance projects
in 2011 addressing these new or
amended penalty provisions.
Specifically, Treasury and the IRS
intend to publish in 2011 proposed
regulations under sections 6662, 6662A,
and 6664, to provide further guidance
on the circumstances under which a
taxpayer could be subject to the
accuracy-related penalty on
underpayments or reportable
transaction understatements and the
reasonable cause exception, including
clarifying that a taxpayer may not rely
upon written advice to establish a
reasonable cause and good faith defense
if the advice states that it cannot be used
for the purpose of avoiding penalties.
Treasury and the IRS also intend to
publish: (1) Proposed regulations under
section 6676 regarding the penalty
related to an erroneous claim for refund
or credit; (2) final regulations under
section 6707A addressing whether the
penalty for failure to disclose reportable
transactions applies, before the
temporary regulations expire in
September 2011; and (3) temporary and
proposed regulations under section
6707A addressing statutory changes to
the method of computing the section
6707A penalty, which occurred after
existing temporary regulations were
published.
Basis Reporting. Section 403 of the
Energy Improvement and Extension Act
of 2008 (Pub. L. 110–343), enacted on
October 3, 2008, added sections 6045(g),
6045h, 6045A, and 6045B to the Internal
Revenue Code. Section 6045(g) provides
that every broker required to file a
return with the Service under section
6045(a) showing the gross proceeds
from the sale of a covered security must
include in the return the customer’s
adjusted basis in the security and
whether any gain or loss with respect to
the security is long-term or short-term.
Section 6045(h) extends the basis
reporting requirement in section 6045(g)
and the gross proceeds reporting
requirement in section 6045(a) to
options that are granted or acquired on
or after January 1, 2013. Section 6045A
provides that a broker and any other
specified person (transferor) that
transfers custody of a covered security
to a receiving broker must furnish to the
receiving broker a written statement that
allows the receiving broker to satisfy the
basis reporting requirements of section
6045(g). The transferor must furnish the
statement to the receiving broker within
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15 days after the date of the transfer or
at a later time provided by the Secretary.
Section 6045B requires issuers of
specified securities to make a return
relating to organizational actions that
affect the basis of the security. Final
regulations implementing these
provisions for sales of stock were
published on October 18, 2010.
Treasury and the IRS plan to issue
proposed regulations implementing
these provisions for options and sales or
exchanges of debt instruments.
Information Reporting for Foreign
Accounts of U.S. Persons. In March
2010, chapter 4 (sections 1471 to 1474)
was added to subtitle A of the Internal
Revenue Code as part of the Hiring
Incentives to Restore Employment Act
(HIRE Act) (Pub. L. 111–147). Chapter 4
was enacted to address concerns with
offshore tax evasion and generally
requires foreign financial institutions
(FFIs) to enter into an agreement (FFI
Agreement) with the IRS to report
information regarding certain financial
accounts of U.S. persons and foreign
entities with significant U.S. ownership.
An FFI that does not enter into an FFI
Agreement generally will be subject to
a withholding tax on the gross amount
of certain payments from U.S. sources,
as well as the proceeds from disposing
of certain U.S. investments. Treasury
and the IRS published Notice 2010–60,
Notice 2011–34, and Notice 2011–53,
which provides preliminary guidance
and requests comments on the most
important and time-sensitive issues
under chapter 4. Treasury and the IRS
expect to follow up on these notices
with regulations and a model FFI
Agreement in this fiscal year. These
regulations will address numerous
issues, notably the definition of FFI, the
due diligence required of withholding
agents and FFIs in identifying U.S.
accountholders, and the requirements
for reporting U.S. accounts.
Withholding on Certain Dividend
Equivalent Payments Under Notional
Principal Contracts. The HIRE act also
added section 871(l) to the Code (now
sec. 871(m)), which designates certain
substitute dividend payments in
security lending and sale-repurchase
transactions and dividend-referenced
payments made under certain notional
principal contracts as U.S.-source
dividends for Federal tax purposes. In
response to this legislation, on May 20,
2010, the IRS issued Notice 2010–46,
addressing the requirements for
determining the proper withholding in
connection with substitute dividends
paid in foreign-to-foreign security
lending and sale-repurchase
transactions. The IRS and Treasury
intend to issue regulations to implement
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the provisions of this Notice, as well as
regulations addressing cases where
dividend equivalents should be found to
arise in connection with notional
principal contracts and other financial
derivatives.
New International Tax Provisions of
the Education, Jobs, and Medicaid
Assistance Act. On August 10, 2010, the
Education, Jobs, and Medicaid
Assistance Act of 2010 (Pub. L. 111–
226) was signed into law. The new law
includes a significant package of
international tax provisions, including
limitations on the availability of foreign
tax credits in certain cases where U.S.
tax law and foreign tax law provide
different rules for recognizing income
and gain, and in cases where income
items treated as foreign source under
certain tax treaties would otherwise be
sourced in the United States. The
legislation also limits the ability of
multinationals to reduce their U.S. tax
burdens by using a provision intended
to prevent corporations from avoiding
U.S. income tax on repatriated corporate
earnings. Other new provisions under
this legislation limit the ability of
multinational corporations to use
acquisitions of related party stock to
avoid U.S. tax on what would otherwise
be taxable distributions of dividends.
The statute also includes a new
provision intended to tighten the rules
under which interest expense is
allocated between U.S.- and foreignsource incomes within multinational
groups of related corporations when a
foreign corporation has significant
amounts of U.S.-source income that is
effectively connected with a U.S.
business. Treasury and the IRS expect to
issue guidance on most of these
provisions.
Guidance on Tax-Related Health Care
Provisions. On March 23, 2010, the
President signed the Patient Protection
and Affordable Care Act of 2010 (Pub.
L. 111–148) and on March 30, 2010, the
President signed the Health Care and
Education Reconciliation Act of 2010
(Pub. L. 111–152) (referred to
collectively as the Affordable Care Act
(ACA)). The ACA’s comprehensive
reform of the health insurance system
affects individuals, families, employers,
health care providers, and health
insurance providers. The ACA provides
authority for Treasury and the IRS to
issue regulations and other guidance to
implement tax provisions in the ACA,
some of which are effective immediately
and some of which will become
effective over the next several years.
Since enactment of the ACA, Treasury
and the IRS, together with the
Department of Health and Human
Services and the Department of Labor,
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have issued a series of temporary and
proposed regulations implementing
various provisions of the ACA related to
individual and group market reforms. In
the past year, Treasury and IRS also
have issued temporary and proposed
regulations addressing the fee on
branded prescription drug sales under
section 9008 of the ACA and proposed
regulations on the premium assistance
tax credit under section 36B of the
Code. In addition, Treasury and the IRS
have issued guidance on specific ACA
provisions, including guidance on the
treatment of certain nonprofit health
insurers (section 833 of the Code), the
credit for small employers that provide
health insurance coverage (section 45R
of the Code), the adoption credit
(section 36C of the Code), information
reporting to employees of the cost of
employer sponsored health coverage
(section 6051(a)(14) of the Code), and
additional requirements for tax-exempt
hospitals (section 501(r) of the Code).
Providing additional guidance to
implement tax provisions of the ACA is
a priority for Treasury and the IRS.
Office of the Comptroller of the
Currency (Including Former Office of
Thrift Supervision)
The Office of the Comptroller of the
Currency (OCC) was created by
Congress to charter national banks, to
oversee a nationwide system of banking
institutions, and to assure that national
banks are safe and sound, competitive
and profitable, and capable of serving in
the best possible manner the banking
needs of their customers.
Pursuant to title III of the Dodd-Frank
Wall Street Reform and Consumer
Protection Act, all functions of the
Office of Thrift Supervision (OTS)
relating to Federal savings associations,
including rulemaking authority, were
transferred to the OCC on July 21, 2011.
The OCC seeks to assure a banking
system in which national banks and
Federal savings associations soundly
manage their risks, maintain the ability
to compete effectively with other
providers of financial services, meet the
needs of their communities for credit
and financial services, comply with
laws and regulations, and provide fair
access to financial services and fair
treatment of their customers.
Significant rules issued during fiscal
year 2011 include:
Incentive-Based Compensation
Arrangements: Section 956 of the DoddFrank Act requires the banking agencies,
the National Credit Union
Administration (NCUA), the Securities
and Exchange Commission (SEC), and
the Federal Housing Finance Agency
(FHFA), to jointly prescribe regulations
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or guidance prohibiting any types of
incentive-based payment arrangement,
or any feature of any such arrangement,
that the regulators determine encourages
inappropriate risks by covered financial
institutions by providing an executive
officer, employee, director, or principal
shareholder with excessive
compensation, fees or benefits, or that
could lead to material financial loss to
the covered financial institution. The
Act also requires such agencies to
jointly prescribe regulations or guidance
requiring each covered financial
institution to disclose to its regulator the
structure of all incentive-based
compensation arrangements offered by
such institution sufficient to determine
whether the compensation structure
provides any officer, employee, director,
or principal shareholder with excessive
compensation or could lead to material
financial loss to the institution. The
agencies issued an NPRM on April 14,
2011. 76 FR 21170. Work on a final rule
is underway.
Retail Foreign Exchange
Transactions: The OCC adopted a final
rule authorizing national banks, Federal
branches and agencies of foreign banks,
and their operating subsidiaries to
engage in off-exchange transactions in
foreign currency with retail customers.
It describes various requirements with
which national banks, Federal branches
and agencies of foreign banks, and their
operating subsidiaries must comply to
conduct such transactions. It is
necessary pursuant to amendments by
the Dodd-Frank Act to the Commodity
Exchange Act (CEA) that provide that a
United States financial institution for
which there is a Federal regulatory
agency shall not enter into, or offer to
enter into, a transaction described in
section 2(c)(2)(B)(i)(I) of the CEA with a
retail customer except pursuant to a rule
or regulation of a Federal regulatory
agency allowing the transaction under
such terms and conditions as the
Federal regulatory agency shall
prescribe a retail forex rule. This final
rule was issued on July 14, 2011. 76 FR
41375. Work on an interim final rule to
cover savings associations is underway.
Credit Risk Retention. The banking
agencies, Securities and Exchange
Commission, Federal Housing Finance
Agency, and the Department of Housing
and Urban Development proposed rules
to implement the credit risk retention
requirements of section 15G of the
Securities Exchange Act of 1934 (15.
U.S.C. section 78o-11), as added by
section 941 of the Dodd-Frank Wall
Street Reform and Consumer Protection
Act. Section 15G generally requires the
securitizer of asset-backed securities to
retain not less than 5 percent of the
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credit risk of the assets collateralizing
the asset-backed securities. Section 15G
includes a variety of exemptions from
these requirements, including an
exemption for asset-backed securities
that are collateralized exclusively by
residential mortgages that qualify as
‘‘qualified residential mortgages,’’ as
such term is defined by the Agencies by
rule. This NPRM was published on
April 29, 2011. 76 FR 24090. Work on
a final rule is underway.
Margin and Capital Requirements for
Covered Swap Entities. The banking
agencies, Farm Credit Administration,
and the Federal Housing Finance
Agency issued a proposed rule to
establish minimum margin and capital
requirements for registered swap
dealers, major swap participants,
security-based swap dealers, and major
security-based swap participants for
which one of the Agencies is the
prudential regulator. This proposed rule
implements sections 731 and 764 of the
Dodd-Frank Wall Street Reform and
Consumer Protection Act, which require
the Agencies to adopt rules jointly to
establish capital requirements and
initial and variation margin
requirements for such entities on all
non-cleared swaps and non-cleared
security-based swaps in order to offset
the greater risk to such entities and the
financial system arising from the use of
swaps and security-based swaps that are
not cleared. This NPRM was published
on May 11, 2011. 76 FR 27564. Work on
a final rule is underway.
OTS Integration; Dodd-Frank
Implementation. The OCC adopted
amendments to its regulations governing
organization and functions, availability
and release of information, postemployment restrictions for senior
examiners, and assessment of fees to
incorporate the transfer of certain
functions of the Office of Thrift
Supervision (OTS) to the OCC pursuant
to title III of the Dodd-Frank Wall Street
Reform and Consumer Protection Act.
The OCC also amended its rules
pertaining to preemption and visitorial
powers to implement various sections of
the Act; change in control of credit card
banks and trust banks to implement
section 603 of the Act; and deposittaking by uninsured Federal branches to
implement section 335 of the Act. This
final rule was effective and published
on July 21, 2011. 76 FR 43549.
Republication of Regulations in
Connection with OTS Integration
Pursuant to Dodd-Frank. Pursuant to
title III of the Dodd-Frank Wall Street
Reform and Consumer Protection Act,
all functions of the Office of Thrift
Supervision relating to Federal savings
associations and rulemaking authority
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of the OTS relating to all savings
associations were transferred to the OCC
on July 21, 2011 (transfer date). In order
to facilitate the OCC’s enforcement and
administration of former OTS rules and
to make appropriate changes to these
rules to reflect OCC supervision of
Federal savings associations as of the
transfer date, the OCC republished, with
nomenclature and other technical
changes, those OTS regulations
currently found at 12 CFR chapter V for
which the OCC has authority to
promulgate and will enforce as of the
transfer date. The republished
regulations are recodified with the
OCC’s regulations in chapter I at 12 CFR
100 et seq., effective on the transfer
date. The republished regulations will
supersede the OTS regulations in
chapter V for purposes of OCC
supervision and regulation of Federal
savings associations, and for certain
rules for purposes of the FDIC’s
supervision of State savings
associations. This interim final rule was
published on August 9, 2011. 76 FR
48950.
Prohibition and Restrictions on
Proprietary Trading and Certain
Interests In, and Relationships with,
Hedge Funds and Private Equity Funds.
The banking agencies, the Securities
and Exchange Commission, and the
Commodity Futures Trading
Commission, issued a proposed rule
that would implement section 619 of
Dodd-Frank, which contains certain
prohibitions and restrictions on the
ability of banking entities and nonbank
financial companies supervised by the
Federal Reserve Board to engage in
proprietary trading and have certain
investments in, or relationships with,
hedge funds or private equity funds.
Section 619 is commonly referred to as
the ‘‘Volcker Rule.’’
Community Reinvestment Act
Regulations (12 CFR part 25). The
banking agencies issued final
regulations to revise provisions of their
rules implementing the Community
Reinvestment Act. The agencies
proposed revising the term ‘‘community
development’’ to include loans,
investments, and services by financial
institutions that support, enable, or
facilitate projects or activities that meet
the criteria described in section
2301(c)(3) of the Housing and Economic
Recovery Act of 2008 (HERA) and are
conducted in designated target areas
identified in plans approved by the U.S.
Department of Housing and Urban
Development under the Neighborhood
Stabilization Program (NSP), established
by HERA. This final rule was published
on December 20, 2010 (75 FR 79278).
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Community Reinvestment Act
Regulations (12 CFR part 25). On
August 14, 2008, the Higher Education
Opportunity Act (HEOA) was enacted
into law (Pub. L. 110–315, 122 Stat.
3078). Section 1031 of the HEOA
revised the Community Reinvestment
Act (CRA) to require the banking
agencies, when evaluating a bank’s
record of meeting community credit
needs, to consider, as a factor, low-cost
education loans provided by the bank to
low-income borrowers. The banking
agencies issued a final rule to
implement section 1031 of the HEOA. In
addition, the rule incorporates into the
banking agencies’ rules statutory
language that allows them to consider as
a factor when evaluating a bank’s record
of meeting community credit needs
capital investment, loan participation,
and other ventures undertaken by
nonminority- and nonwomen-owned
financial institutions in cooperation
with minority- and women-owned
financial institutions and low-income
credit unions. A final rule was
published on October 10, 2010 (75 FR
61035).
Standards Governing the Release of a
Suspicious Activity Report (12 CFR part
4). Confidentiality of Suspicious Activity
Reports (12 CFR part 21). The OCC and
OTS separately issued final regulations
governing the release of non-public OCC
or OTS information set forth in 12 CFR
part 4, subpart C, and section 510.5.
These final rules clarify that the
decision to release a suspicious activity
report (SAR) will be governed by the
standards set forth in amendments to
the SAR regulations, that are part of
separate, but simultaneously issued,
final rulemakings discussed below.
These final rules were published on
December 3, 2010. 75 FR 75574, 75583.
The OCC’s and OTS’s final regulations
implementing the Bank Secrecy Act
governing the confidentiality of a
suspicious activity report (SAR): Clarify
the scope of the statutory prohibition on
the disclosure by an institution of a
SAR; address the statutory prohibition
on the disclosure by the government of
a SAR as that prohibition applies to the
OCC’s or OTS’s standards governing the
disclosure of SARs; clarify that the
exclusive standard applicable to the
disclosure of a SAR, or any information
that would reveal the existence of a
SAR, by the OCC or OTS, is to fulfill
official duties consistent with the
purposes of the BSA; and modify the
safe harbor provision in its rules to
include changes made by the USA
PATRIOT Act. These final rules are
based upon a similar rule prepared by
the Financial Crimes Enforcement
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Network (FinCEN). These final rules
were issued on December 3, 2010. 75 FR
75576, 75586.
Risk-Based Capital Guidelines;
Revising Transitional Floors for
Advanced Approaches Rule (12 CFR
part 3). The Federal banking agencies
issued a notice of proposed rulemaking
and final rule to revise the transitional
floors in the advanced approaches riskbased capital rule to preclude a decline
in a banking organization’s risk-based
capital requirements during the
transition period. Under the revisions,
the capital floors used by a banking
organization subject to the advanced
approaches during its first, second, and
third transitional floor periods are 100
percent of the bank’s tier 1 and total
risk-based capital requirements
computed under the agencies’ general
risk-based capital rules. The NPRM was
published on December 30, 2010. 75 FR
82317. The final rule was issued on June
28, 2011. 76 FR 37620. OTS issued a
parallel proposal on March 8, 2011, but
did not issue a final rule. 76 FR 12611.
Regulatory priorities for fiscal year
2012 include, in addition to those listed
above that have not yet been finalized,
the following:
Strengthening Tier 1 Capital Other
Capital Enhancements, Standardized
Approach (Basel III). (12 CFR part 3).
The banking agencies currently are
working jointly on rules to implement
provisions in the Dodd-Frank Wall
Street Reform and Consumer Protection
Act (Dodd-Frank) and to update capital
standards to maintain and improve
consistency in agency rules. These rules
include revisions to implement the
International Convergence of Capital
Management and Capital Standards: A
Revised Framework (Basel II
Framework). The Federal banking
agencies plan to amend their current
capital rules, including revisions to the
definition of Tier 1 capital and the
leverage capital ratio. This rule would
implement a comprehensive set of
revisions issued by the Basel Committee
in December 2010 to amend the Basel II
Capital Framework. Key components of
the rule include: Revisions to the
definition of Tier 1, the addition of a
capital conservation buffer, the addition
of a countercyclical buffer, revisions to
counterparty credit risk requirements
(includes central counterparties), a new
international leverage ratio, and new
liquidity ratio requirements. In addition,
this rule includes the rule entitled
Alternatives to the Use of Credit Ratings
in the Risk-Based Capital Guidelines of
the Federal Banking Agencies (12 CFR
part 3). Section 939A of the Dodd-Frank
Act directs all Federal agencies to
review, no later than 1 year after
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enactment, any regulation that requires
the use of an assessment of creditworthiness of a security or money
market instrument and any references to
or requirements in regulations regarding
credit ratings. The agencies are also
required to remove references or
requirements of reliance on credit
ratings and to substitute an alternative
standard of credit-worthiness. The
agencies issued an ANPRM describing
the areas in their risk-based capital
standards where the agencies rely on
credit ratings, as well as the Basel
Committee on Banking Supervision’s
recent amendments to the Basel Accord,
which could affect those standards and
requested comment on potential
alternatives to the use of credit ratings.
The ANPRM was published on August
25, 2010 (75 FR 52283).
Risk-Based Capital Standards: Market
Risk: The banking agencies issued a
notice of proposed rulemaking to revise
their market risk capital rules to modify
their scope to better capture positions
for which the market risk capital rules
are appropriate; reduce procyclicality in
market risk capital requirements,
enhance the rules’ sensitivity to risks
that are not adequately captured under
current regulatory measurement
methodologies; and increase
transparency through enhanced
disclosures. This NPRM was published
on January 11, 2011. 76 FR 1890. Work
on a final rule is underway.
Alternatives to the Use of External
Credit Ratings in the Regulations of the
OCC (12 CFR parts 1, 16, and 28).
Section 939A of the Dodd-Frank Wall
Street Reform and Consumer Protection
Act directs all Federal agencies to
review, no later than 1 year after
enactment, any regulation that requires
the use of an assessment of creditworthiness of a security or money
market instrument and any references to
or requirements in regulations regarding
credit ratings. The agencies are also
required to remove references or
requirements of reliance on credit
ratings and to substitute an alternative
standard of credit-worthiness. Through
an advanced notice of proposed
rulemaking (ANPRM), the OCC sought
to gather information as it begins to
review its regulations pursuant to the
Dodd-Frank Act. It described the areas
where the OCC’s regulations, other than
those that establish regulatory capital
requirements, currently rely on credit
ratings; sets forth the considerations
underlying such reliance; and requests
comment on potential alternatives to the
use of credit ratings. Work on an NPRM
is underway. The ANPRM was
published on August 13, 2010 (75 FR
49423). OTS published a parallel
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ANPRM on October 14, 2010 (75 FR
63107).
Recordkeeping Requirements for
Securities Activities: The Gramm-LeachBliley Act requires the banking agencies
to adopt recordkeeping requirements
sufficient to facilitate and demonstrate
compliance with the exceptions to the
definitions of ‘‘broker’’ or ‘‘dealer’’ for
banks in the Securities Exchange Act of
1934. Work on an NPRM is underway.
Integration of Savings Association
Supervision. Pursuant to the transfer of
OTS functions relating to Federal
savings associations to the OCC, the
OCC plans to issue one or more
rulemakings resulting from our review
of OCC rules applicable to banks and/
or savings associations that will
consolidate our rules and establish, to
the extent practicable, consistent
regulations for national banks and
federal savings associations.
Lending Limits for Derivative
Transactions. Section 610 of the DoddFrank Act amends the lending limit, 12
U.S.C. section 84, to apply it to any
credit exposure to a person arising from
a derivative transaction and certain
other transactions between the bank and
the person. The amendment is effective
1 year after the transfer date, July 21,
2012. The OCC plans to issue a rule that
will amend our lending limit regulation
set forth at 12 CFR part 32 to conform
to this new requirement.
Annual Stress Test (12 CFR part 46).
This regulation will implement 12
U.S.C. 5365(i) that requires annual
stress testing to be conducted by
financial companies with total
consolidated assets of more than $10
billion and establishes a definition of
stress test, methodologies for
conducting stress tests, and reporting
and disclosure requirements.
Collective Investment Funds. This
notice of proposed rulemaking will
update the regulation of short-term
investment funds (STIFs), a type of
collective investment fund permissible
under OCC regulations, through the
addition of STIF eligibility requirements
to ensure the safety of STIFs and to
mitigate financial systemic risks.
Alcohol and Tobacco Tax and Trade
Bureau
The Alcohol and Tobacco Tax and
Trade Bureau (TTB) issues regulations
to enforce Federal laws relating to
alcohol, tobacco, firearms, and
ammunition taxes and relating to
commerce involving alcohol beverages
and industrial alcohol. TTB’s mission
and regulations are designed to:
(1) Regulate with regard to the
issuance of permits and authorizations
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to operate in the alcohol and tobacco
industries;
(2) Assure the collection of all
alcohol, tobacco, and firearms and
ammunition taxes, and obtain a high
level of voluntary compliance with all
laws governing those industries; and
(3) Suppress commercial bribery,
consumer deception, and other
prohibited practices in the alcohol
beverage industry.
The Federal Alcohol Administration
Act and the Internal Revenue Code
authorize regulations for the labeling of
wine, distilled spirits, and malt
beverages, which should, among other
things, ensure that labels provide the
consumer with adequate information as
to the identity and quality of the
product. In July 2007, in response to a
petition for rulemaking from a consumer
advocacy group and comments received
in response to a 2005 advance notice of
proposed rulemaking, TTB published a
proposed rule concerning the inclusion
of a statement of calories, carbohydrates,
fat, and protein per serving in a serving
facts panel on wine, beer, and distilled
spirits labels. The proposed rule also
invited public comments on the
extension of alcohol content labeling
requirements to all alcohol beverages,
which currently apply only to some
alcohol beverages. TTB is continuing to
evaluate the cost burden to industry and
benefits to consumers.
In addition to the regulatory action
described above, in FY 2012, TTB plans
to give priority to the following
regulatory matters:
As described in greater detail below,
in FY 2012 TTB plans to continue its
Regulations Modernization Project
concerning its Specially Denatured and
Completely Denatured Alcohol
regulations, Labeling Requirement
regulations, Export regulations, and
Beer regulations.
Revision to Specially Denatured and
Completely Denatured Alcohol
Regulations: TTB plans to propose
changes to regulations for specially
denatured alcohol (SDA) and
completely denatured alcohol (CDA)
that would result in cost savings for
both TTB and regulated industry
members. Under the authority of the
Internal Revenue Code of 1986, TTB
regulates denatured alcohol that is unfit
for beverage use, and which may be
removed from a regulated distilled
spirits plant without payment of tax.
SDA and CDA are widely used in the
American fuel, medical, and
manufacturing sectors. The industrial
alcohol industry far exceeds the
beverage alcohol industry in size and
scope, and it is a rapidly growing
industry in the United States. Some
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concerns have been raised that the
current regulations may create
significant roadblocks for industry
members in getting products to the
marketplace quickly and efficiently.
TTB is proposing to reclassify certain
SDA formulas as CDA and to issue new
general-use formulas for articles made
with SDA so that industry members
would less frequently need to seek
formula approval from TTB and fewer
TTB resources would need to be
devoted to formula review. TTB
estimates that these proposed changes
would result in an 80 percent reduction
in the formula approval submissions
currently required from industry
members and would reduce total annual
paperwork burden hours on affected
industry members from 2,415 to 517
hours. The reduction in formula
submissions will enable TTB to redirect
its resources to address backlogs that
exist in other areas of TTB’s mission
activities, such as analyzing compliance
samples for industrial/fuel alcohol to
protect the revenue and working with
industry to test and approve new and
more environmentally friendly
denaturants. Other proposed changes
would remove unnecessary regulatory
burdens and update the regulations to
align them with current industry
practice.
CHIPRA Final Rule: TTB will make
final a temporary rule to amend
regulations promulgated under the
Children’s Health Insurance Program
Reauthorization Act of 2009 (CHIPRA).
The Act provides enforcement
mechanisms to assist in preventing the
diversion of tobacco materials to illegal
manufacturers, and the regulations
implement these enforcement
mechanisms. A 3-year temporary rule
was published in June of 2009 to
continue the implementation of these
CHIPRA provisions, a final rule must be
published by June 2012 to meet the
requirements of 26 U.S.C. 7805
regarding the expiration of temporary
rules.
Revisions to the Labeling
Requirements (parts 4 (Wine), 5
(Distilled Spirits), and 7 (Malt
Beverages)): The Federal Alcohol
Administration Act requires that alcohol
beverages introduced in interstate or
foreign commerce have a label issued
and approved under regulations
prescribed by the Secretary of the
Treasury. In connection with E.O.
13563, TTB has near-term plans to
revise the regulations concerning the
approval of labels for distilled spirits,
wine, and malt beverages to reduce the
cost to TTB of reviewing and approving
an ever increasing number of
applications for label approval (well
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over 130,000 per year). Currently, the
review and approval process requires a
staff of at least 13 people for the preapproval of labels in addition to
management review. These regulatory
changes, to be developed with industry
input, also are intended to accelerate the
approval process, which shall result in
the regulated industries being able to
bring products to market faster.
Selected Revisions of Export
Regulations (part 28): TTB has
identified selected sections of its export
regulations (part 28) that should be
amended to assist industry members in
complying with the regulations. Current
regulations require industry members to
obtain documents and follow
procedures that are outdated and not
entirely consistent with current industry
practices regarding exportation. Under
its regulatory authority, TTB routinely
provides exceptions to these regulatory
provisions. Revising these regulations
will provide industry members with
clear and up-to-date procedures for
removal of alcohol for exportation
without having to pay excise taxes
(under the Internal Revenue Code,
beverage alcohol may be removed from
the premises of a distilled spirits plant
for exportation without payment of tax),
thus increasing their willingness and
ability to export their products.
Revisions to the Alcohol Fuel Plant
Regulations: TTB’s alcohol fuel plant
regulations (within part 19) need to be
revised to reflect the current state of the
alcohol fuel industry. Alcohol produced
at a TTB-approved alcohol fuel plant
may be removed from the plant without
payment of tax if properly denatured
and used only for fuel. Primarily
focused on the development of smaller
capacity plants, the alcohol fuel plant
regulations were initially drafted to
promote growth in the industry and to
provide minimal permitting,
recordkeeping, reporting, and bonding
requirements. In the United States, there
are currently over 1,400 permitted
ethanol fuel plants that produced over
9 billion gallons of ethanol for fuel use
in 2010. Fewer than 200 of the largest
fuel ethanol plants produce 8 billion
gallons of fuel ethanol. The significant
growth of the industry, especially the
largest capacity plants, since the
previous issuance of the applicable
regulations has resulted in potential
risks to the revenue not currently
addressed in the regulations. If just 1
percent of this alcohol were diverted for
beverage use, the tax loss would
approximate $2.4 billion. Current
reporting requirements for certain plants
are not sufficient to provide adequate
information to TTB to monitor industry
compliance and to identify removals of
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alcohol that should be subject to tax;
alcohol removed for beverage purposes
or without proper denaturation may go
unnoticed. TTB is also considering
other changes, such as the addition of
provisions regarding the disposition of
by-products of the production process,
which would update the regulations to
reflect current industry practice.
Revision of the Part 17 Regulations,
‘‘Drawback on Taxpaid Distilled Spirits
Used in Manufacturing Nonbeverage
Products,’’ To Allow Self-Certification of
Nonbeverage Product Formulas: TTB is
considering revisions to the part 17
regulations governing nonbeverage
products made with taxpaid distilled
spirits. These nonbeverage products
include foods, medicines, and flavors.
The revisions would practically
eliminate the need for TTB to formally
approve nonbeverage product formulas
by proposing to allow for selfcertification of such formulas. The
changes would result in significant cost
savings for an important industry which
currently must obtain formula approval
from TTB, and some savings for TTB,
which must review and take action to
approve or disapprove each formula.
Estimating the specific savings to TTB is
premature as this rulemaking project is
in the early stages of internal
deliberation.
Revisions to the Beer Regulations
(part 25): Under the Internal Revenue
Code, TTB regulates activities at
breweries. The regulations of title 27 of
the Code of Federal Regulations, part 25,
address the qualification of breweries,
bonds and taxation, removals without
payment of tax, and records and
reporting. The brewery regulations were
last revised in 1986 and need to be
updated to reflect changes to the
industry, including the increased
number of small (‘‘craft’’) brewers. TTB
plans to issue an advance notice of
proposed rulemaking soliciting
comments regarding potential ways to
decrease the regulatory burden on
industry members (e.g., streamlining
and/or reducing the reporting and
recordkeeping requirements for the
industry, which includes many small
businesses) and increase efficiency for
both the industry and TTB. TTB intends
to develop and propose specific
regulatory changes after consideration of
comments received.
Revisions to Distilled Spirits Plant
Reporting Requirements: TTB will
propose to revise regulations in part 19
and replace the current four report
forms used by distilled spirits plants to
report their operations on a monthly
basis with two new report forms that
would be submitted on a monthly basis
(plants that qualify to file taxes on a
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quarterly basis would submit the new
reports on a quarterly basis). This
project, which was included in the
President’s FY 2012 budget for TTB as
a cost saving item, would address
numerous concerns and desires for
improved reporting by the distilled
spirits industry and result in cost
savings to the industry and TTB by
significantly reducing the number of
monthly plant operations reports that
must be completed and filed by industry
members and processed by TTB. TTB
preliminarily estimates that this project
would result in an annual savings of
approximately 23,218 paperwork
burden hours (or 11.6 staff years) for
industry members and 629 processing
hours (or 0.3 staff years) and $12,442
per year for TTB in contractor time. In
addition, TTB estimates that this project
would save staff time (approximately 3
staff years) costing $300, as a result of
more efficient and effective processing
of reports and the use of report data to
reconcile industry member tax accounts.
Bureau of the Public Debt
The Bureau of the Public Debt (BPD)
has responsibility for borrowing the
money needed to operate the Federal
Government and accounting for the
resulting debt, regulating the primary
and secondary Treasury securities
markets, and ensuring that reliable
systems and processes are in place for
buying and transferring Treasury
securities.
BPD administers regulations: (1)
Governing transactions in Government
securities by Government securities
brokers and dealers under the
Government Securities Act of 1986
(GSA), as amended; (2) Implementing
Treasury’s borrowing authority,
including rules governing the sale and
issue of savings bonds, marketable
Treasury securities, and State and local
government securities; (3) Setting out
the terms and conditions by which
Treasury may buy back and redeem
outstanding, unmatured marketable
Treasury securities through debt
buyback operations; (4) Governing
securities held in Treasury’s retail
systems; and (5) Governing the
acceptability and valuation of collateral
pledged to secure deposits of public
monies and other financial interests of
the Federal Government.
During fiscal year 2012, BPD will
accord priority to the following
regulatory projects:
Over-the-Counter Savings Bonds. In
December 2011, BPD anticipates issuing
a rule ending the sale of definitive
(paper) savings bonds.
Savings Bond Paying Agent
Regulations. BPD plans to issue a final
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rule amending the savings bond paying
agent regulations (31 CFR parts 321,
330) to provide for the conversion from
use of the EZ Clear system to Check 21
in processing savings bonds redeemed
at financial institutions.
Eliminating Credit Rating References.
In compliance with the Dodd-Frank
Wall Street Reform and Consumer
Protection Act, BPD, on behalf of
Treasury (Financial Markets), plans to
amend the Government Securities Act
regulations (17 CFR chapter IV) to
eliminate references to credit ratings
from Treasury’s liquid capital rule.
Financial Management Service
The Financial Management Service
(FMS) issues regulations to improve the
quality of Government financial
management and to administer its
payments, collections, debt collection,
and Governmentwide accounting
programs. For fiscal year 2012, FMS’s
regulatory plan includes the following
priorities:
Debt Collection Authorities Under the
Debt Collection Improvement Act. The
Debt Collection Improvement Act of
1996 authorizes Federal agencies to
publish or otherwise publicly
disseminate information regarding the
identity of persons owing delinquent
nontax debts to the United States for the
purpose of collecting the debts,
provided certain criteria are met. FMS is
proposing to amend its regulation to
establish the procedures Federal
agencies must follow before publishing
information about delinquent debtors
and the standards for determining when
use of this debt collection remedy is
appropriate.
Federal Government Participation in
the Automated Clearing House. FMS
recently amended its regulation
governing the use of the Automated
Clearing House (ACH) system by
Federal agencies. The amendments
adopt, with some exceptions, the 2009
ACH Rules published by NACHA—The
Electronic Payments Association
(NACHA), as the rules governing the use
of the ACH Network by Federal
agencies. FMS issued this rule to
address changes that NACHA made to
the ACH Rules since the publication of
NACHA’s 2007 ACH Rules book. These
changes include new requirements to
identify all international payment
transactions using a new Standard Entry
Class Code and to include certain
information in the ACH record
sufficient to allow the receiving
financial institution to identity the
parties to the transaction and to allow
transactions to be screened for
compliance with for Office of Foreign
Assets Control (OFAC) requirements.
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In addition, the amendments require
financial institutions to provide limited
account-related customer information
related to the reclamation of post-death
benefit payments as permitted under the
Payment Transactions Integrity Act of
2008. The amendments also allow
Federal payments to be delivered to
pooled or master accounts established
by nursing facilities for residents of
those facilities or held by religious
orders whose members have taken vows
of poverty.
Indorsement and Payment of Checks
Drawn on the United States Treasury.
By amending our regulation governing
the indorsement and payment of checks
drawn on the United States Treasury,
Treasury has the authority to direct
Federal Reserve Banks to debit a
financial institution’s reserve account at
the financial institution’s servicing
Federal Reserve Bank for all check
reclamations that the financial
institution has not protested. Financial
institutions continue to have the right to
file a protest with FMS if they believe
a proposed reclamation is in error.
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Domestic Finance—Office of the Fiscal
Assistant Secretary (OFAS)
The Office of the Fiscal Assistant
Secretary develops policy for and
oversees the operations of the financial
infrastructure of the Federal
Government, including payments,
collections, cash management,
financing, central accounting, and
delinquent debt collection.
Anti-Garnishment. On February 23,
2011, the Treasury published an interim
final rule and request for public
comment with the Office of Personnel
Management, the Railroad Retirement
Board, the Social Security
Administration, and Veterans Affairs.
Treasury plans to promulgate a final
rule, with the Federal benefit agencies,
in the next several months to give force
and effect to various benefit agency
statutes that exempt Federal benefits
from garnishment. Typically, upon
receipt of a garnishment order from a
State court, financial institutions will
freeze an account as they perform due
diligence in complying with the order.
The joint final rule will address this
practice of account freezes to ensure
that benefit recipients have access to a
certain amount of lifeline funds while
garnishment orders or other legal
processes are resolved or adjudicated.
The rule will provide financial
institutions with specific administrative
instructions to carry out upon receipt of
a garnishment order. The final rule will
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apply to financial institutions, but is not
expected to have specific provisions for
consumers, debt collectors, or banking
regulators. However, the banking
regulators would enforce the policy in
cases of non-compliance by means of
their general authorities.
Community Development Financial
Institutions Fund
The Community Development
Financial Institutions Fund (Fund) was
established by the Community
Development Banking and Financial
Institutions Act of 1994 (12 U.S.C. 4701
et seq.). The primary purpose of the
CDFI Fund is to promote economic
revitalization and community
development through the following
programs: The Community
Development Financial Institutions
(CDFI) Program, the Bank Enterprise
Award (BEA) Program, the Native
American CDFI Assistance (NACA)
Program, and the New Markets Tax
Credit (NMTC) Program. In addition, the
CDFI Fund administers the Financial
Education and Counseling Pilot Program
(FEC), the Capital Magnet Fund (CMF),
and the CDFI Bond Guarantee Program
(BGP).
In fiscal year (FY) 2012, the CDFI
Fund will publish Interim regulations
implementing the CDFI Bond Guarantee
Program (BGP). The BGP was
established through the Small Business
Jobs Act of 2010 and authorizes the
Secretary of the Treasury (through the
CDFI Fund) to guarantee the full amount
of notes or bonds, including the
principal, interest, and call premiums,
issued to finance or refinance loans to
certified CDFIs for eligible community
or economic development purposes for
a period not to exceed 30 years. The
bonds or notes will support CDFI
lending and investment by providing a
source of long-term, patient capital to
CDFIs. In accordance with Federal
credit policy, the Federal Financing
Bank (FFB), a body corporate and
instrumentality of the United States
Government under the general
supervision and direction of the
Secretary of the Treasury, will finance
obligations that are 100 percent
guaranteed by the United States, such as
the bonds or notes to be issued by
Qualified Issuers under the BGP.
In FY 2012, subject to funding
availability, the Fund will provide
awards through the following programs:
Community Development Financial
Institutions (CDFI) Program. Through
the CDFI Program, the CDFI Fund will
provide technical assistance grants and
financial assistance awards to financial
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7825
institutions serving distressed
communities.
Native American CDFI Assistance
(NACA) Program. Through the NACA
Program, the CDFI Fund will provide
technical assistance grants and financial
assistance awards to promote the
development of CDFIs that serve Native
American, Alaska Native, and Native
Hawaiian communities.
Bank Enterprise Award (BEA)
Program. Through the BEA Program, the
CDFI Fund will provide financial
incentives to encourage insured
depository institutions to engage in
eligible development activities and to
make equity investments in CDFIs.
New Markets Tax Credit (NMTC)
Program. Through the NMTC Program,
the CDFI Fund will provide allocations
of tax credits to qualified community
development entities (CDEs). The CDEs
in turn provide tax credits to private
sector investors in exchange for their
investment dollars; investment proceeds
received by the CDEs are to be used to
make loans and equity investments in
low-income communities. The CDFI
Fund administers the NMTC Program in
coordination with the Office of Tax
Policy and the Internal Revenue Service.
CDFI Bond Guarantee Program (BGP).
Through the BGP, the CDFI Fund will
select Qualified Issuers of federally
guaranteed bonds, the bond proceeds
will be used to make or refinance loans
to certified CDFIs. The bonds must be a
minimum of $100 million and may have
terms of up to 30 years. The CDFI Fund
is authorized to award up to $1 billion
in guarantees per fiscal year through FY
2014.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in ‘‘The Regulatory Plan.’’
However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov in the
Completed Actions section for that
agency. These rulemakings can also be
found on Regulations.gov. Treasury’s
final plan can be found at:
www.treasury.gov/open.
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RIN
Title
1545–BF40 ................................................
Definitions and Special Rules Regarding Accuracy-Related Penalties on Underpayments and Reportable Transaction Understatements and the Reasonable Cause Exception.
Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages.
Revision of American Viticultural Area Regulations.
Revision of Distilled Spirits Plant Regulations.
Proposed Revisions to SDA and CDA Formulas Regulations.
Implementation of Statutory Amendments Requiring the Qualification of Manufacturers and Importers
of Processed Tobacco and Other Amendments.
Exportation of Alcohol.
Proposed Revisions to Distilled Spirits for Fuel Use and Alcohol Fuel Plant Regulations.
Self-Certification of Nonbeverage Product Formulas.
Self-Certification of Nonbeverage Product Formulas.
Proposed Revisions to Beer Regulations.
Revisions to Distilled Spirits Plant Operations Reports and Regulations.
Courtesy Notice of Liquidation.
TARP Conflicts of Interest.
1513–AB07
1513–AB39
1513–AA23
1513–AB59
1513–AB72
...............................................
...............................................
...............................................
...............................................
...............................................
1513–AA00
1513–AB62
1513–AB35
1513–AB35
1513–AB05
1513–AB89
1515–AD67
1505–AC05
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
BILLING CODE 4810–25–P
DEPARTMENT OF VETERANS
AFFAIRS (VA)
Statement of Regulatory Priorities
The Department of Veterans Affairs
(VA) administers benefit programs that
recognize the important public
obligations to those who served this
Nation. VA’s regulatory responsibility is
almost solely confined to carrying out
mandates of the laws enacted by
Congress relating to programs for
veterans and their beneficiaries. VA’s
major regulatory objective is to
implement these laws with fairness,
justice, and efficiency.
Most of the regulations issued by VA
involve at least one of three VA
components: The Veterans Benefits
Administration, the Veterans Health
Administration, and the National
Cemetery Administration. The primary
mission of the Veterans Benefits
Administration is to provide highquality and timely nonmedical benefits
to eligible veterans and their
beneficiaries. The primary mission of
the Veterans Health Administration is to
provide high-quality health care on a
timely basis to eligible veterans through
its system of medical centers, nursing
homes, domiciliaries, and outpatient
medical and dental facilities. The
primary mission of the National
Cemetery Administration is to bury
eligible veterans, members of the
Reserve components, and their
dependents in VA National Cemeteries
and to maintain those cemeteries as
national shrines in perpetuity as a final
tribute of a grateful Nation to honor the
memory and service of those who
served in the Armed Forces.
VA Regulatory Priorities
VA’s regulatory priorities include a
special project to undertake a
comprehensive review and
improvement of its existing regulations.
The first portion of this project is
devoted to reviewing, reorganizing, and
rewriting the VA’s compensation and
pension regulations found in 38 CFR
part 3. The goal of the Regulation
Rewrite Project is to improve the clarity
and logical consistency of these
regulations in order to better inform
veterans and their family members of
their entitlements.
A second VA regulatory priority
includes a new caregiver benefits
program provided by VA. This rule
implements title I of the Caregivers and
Veterans Omnibus Health Services Act
of 2010, which was signed into law on
May 5, 2010. The purpose of the new
caregiver benefits program is to provide
certain medical, travel, training, and
financial benefits to caregivers of certain
veterans and servicemembers who were
seriously injured in the line of duty on
or after September 11, 2001.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in The Regulatory Plan.
However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov in the
Completed Actions section for that
agency. These rulemakings can also be
found on Regulations.gov. The final
agency plans can be found at: https://
www.va.gov/ORPM/docs/RegMgmt_VA_
EO13563_RegRevPlan20110810.docx.
Significantly reduce
burdens on small
businesses
RIN
Title
2900–AO13* .....
VA Compensation and Pension Regulation Rewrite Project ...................................................................
No.
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* Consolidating Proposed Rules: 2900–AL67, AL70, AL71, AL72, AL74, AL76, AL82, AL83, AL84, AL87, AL88, AL89, AL94, AL95, AM01,
AM04, AM05, AM06, AM07, AM16.
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
VA
Proposed Rule Stage
119. • VA Compensation and Pension
Regulation Rewrite Project
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Priority: Other Significant. Major
under 5 U.S.C. 801.
Legal Authority: 38 U.S.C. 501
CFR Citation: 38 CFR 3; 38 CFR 5.
Legal Deadline: None.
Abstract: Since 2004, the Department
of Veterans Affairs (V) has published 20
Notices of Proposed Rulemaking to
reorganize and rewrite its compensation
and pension regulations in a logical,
claimant-focused, and user-friendly
format. The intended effect of the
proposed revisions was to assist
claimants, beneficiaries, and VA
personnel in locating and understanding
these regulations. Several veterans
service organizations have requested
that VA republish all these regulations
together to allow the public another
opportunity to comment. This proposed
rule would provide that opportunity.
Statement of Need: Many current VA
regulations on compensation and
pension benefits are disorganized and
confusing. This rulemaking will make
these regulations much easier to find,
read, understand, and apply.
Summary of Legal Basis: 38 CFR
501(a).
Alternatives: The only alternative
would be for VA to amend the
regulations in part 3 on a piecemeal
basis.
Anticipated Cost and Benefits: The
cost of publishing the new regulations
in the Federal Register as a proposed
and then as a final rule, plus the cost of
publishing the regulations in the Code
of Federal Regulations, is anticipated to
be $281,316. There will be
administrative costs to update VA
publications with the new regulation
citations, and the cost of a short training
program for VA adjudication employees
regarding the new regulations. These
costs should be more than offset by
improved efficiency resulting from the
use of part 5 and by the benefits
inherent in providing both VA
employees and veterans with
regulations they can more readily
understand.
Risks: Not applicable.
Timetable:
Action
Date
NPRM ..................
FR Cite
10/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
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URL for Public Comments:
www.regulations.gov.
Agency Contact: William F. Russo,
Office of Regulation Policy and
Management, Department of Veterans
Affairs, 810 Vermont Avenue NW.,
Washington, DC 20420, Phone: 202 461–
4902, Email: bill.russo@va.gov.
Related RIN: Related to 2900–AL67,
Related to 2900–AL70, Related to 2900–
AL71, Related to 2900–AL72, Related to
2900–AL74, Related to 2900–AL76,
Related to 2900–AL82, Related to 2900–
AL83, Related to 2900–AL84, Related to
2900–AL87, Related to 2900–AL88,
Related to 2900–AL89, Related to 2900–
AL94, Related to 2900–AL95, Related to
2900–AM01, Related to 2900–AM04,
Related to 2900–AM05, Related to
2900–AM06, Related to 2900–AM07,
Related to 2900–AM16.
RIN: 2900–AO13
Alternatives: There is no alternative;
VA is required to implement the
Caregivers Act.
Anticipated Cost and Benefits: The
costs are described in detail in the
Impact Analysis. The estimated costs
associated with this regulation are
$69,044,469.40 for FY 2011 and
$777,060,923.18 over a 5-year period.
These include costs associated with the
implementation and development of the
Caregiver Support Program. The benefit
is that by enabling and encouraging
family members to serve as Caregivers,
we hope to prevent the need to place
these Veterans and Servicemembers in
higher complexity treatment settings,
and instead ensure that those who wish
to, may continue to live in their homes
with their families and loved ones.
Risks: Not applicable.
Timetable:
Action
VA
Final Rule Stage
120. Caregivers Program
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 38 U.S.C. 501; 38
U.S.C. 1720G
CFR Citation: 38 CFR 17.38; 38 CFR
71.
Legal Deadline: None.
Abstract: This document promulgates
Department of Veterans Affairs (VA)
interim final regulations concerning a
new caregivers benefits program
provided by VA. This rule implements
title I of the Caregivers and Veterans
Omnibus Health Services Act of 2010,
Public Law 111–163, which was signed
into law on May 5, 2010. The purpose
of the caregivers benefits program is to
provide certain medical, travel, training,
and financial benefits to caregivers of
veterans and certain servicemembers
who were seriously injured in the line
of duty on or after September 11, 2001.
Statement of Need: This document
adopts as final Department of Veterans
Affairs (VA) interim final regulations
concerning Caregiver benefits provided
by VA. The rule implements title I of the
Caregivers and Veterans Omnibus
Health Services Act of 2010 (Caregivers
Act), which was signed into law on May
5, 2010. The purpose of the Caregiver
benefits program is to provide certain
medical, travel, training, and financial
benefits to Caregivers of certain
Veterans and Servicemembers who were
seriously injured during service on or
after September 11, 2001.
Summary of Legal Basis: 38 U.S.C.
111(e) and 1720G.
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Date
FR cite
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Final Action .........
05/05/11
05/05/11
76 FR 26148
07/05/11
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Ethan Kalett,
Director, VHA Regulations, Department
of Veterans Affairs, 810 Vermont
Avenue NW., Room 675Q, Washington,
DC 20420, Phone: 202 461–7633, Email:
ethan.kalett@va.gov.
RIN: 2900–AN94
BILLING CODE 8320–01–P
ARCHITECTURAL AND
TRANSPORTATION BARRIERS
COMPLIANCE BOARD
Statement of Regulatory and
Deregulatory Priorities
The Architectural and Transportation
Barriers Compliance Board (Access
Board) is an Independent Federal
agency established by section 502 of the
Rehabilitation Act (29 U.S.C. 792). The
Access Board is responsible for
developing accessibility guidelines and
standards under various laws to ensure
that individuals with disabilities have
access to and use of buildings and
facilities, transportation vehicles, and
information and communication
technology. Other Federal agencies
adopt the accessibility guidelines and
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
standards issued by the Access Board as
mandatory requirements for entities
under their jurisdiction.
The item in this regulatory plan is
entitled ‘‘Accessibility Standards for
Medical Diagnostic Equipment.’’
Section 4203 of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148, 124 Stat. 570) amended title V of
the Rehabilitation Act, which
establishes rights and protections for
individuals with disabilities, by adding
section 510. Section 510 of the
Rehabilitation Act (29 U.S.C. 794f)
requires the Access Board, in
consultation with the Commissioner of
the Food and Drug Administration, to
issue standards that contain minimum
technical criteria to ensure that medical
diagnostic equipment, used in or in
conjunction with medical settings such
as physicians’ offices, clinics,
emergency rooms, and hospitals, are
accessible to and usable by individuals
with disabilities. The statute provides
that the standards must allow for
independent access to and use of the
equipment by individuals with
disabilities to the maximum extent
possible. The statute lists examination
tables, examination chairs, weight
scales, mammography equipment, and
other imaging equipment as examples of
equipment to which the standards will
apply. However, this list is not
exclusive and the statute covers any
equipment commonly used by health
professionals for diagnostic purposes.
The statute does not cover medical
devices used for monitoring or treating
medical conditions such as glucometers
and infusion pumps.
Section 510 of the Rehabilitation Act
requires the standards to be issued not
later than 24 months after the enactment
of the Patient Protection and Affordable
Care Act. The Patient Protection and
Affordable Care Act was enacted on
March 23, 2010. Accordingly, the
statutory deadline for issuing the
standards is March 23, 2012.
The Access Board has considered
alternatives proposed by stakeholders at
public hearings and identified in
research. In addition, the Access Board
has consulted closely with the
Department of Justice and the Food and
Drug Administration in the
development of these draft standards.
The Access Board has also considered
approaches contained in the Association
for the Advancement of Medical
Instrumentation’s ANSI/AAMI HE
75:2009, ‘‘Human factors engineering—
Design of medical devices’’ in
developing the proposed standards.
ANSI/AAMI HE 75 is a recommended
practice that provides guidance on
human factors design principles for
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medical devices. Chapter 16 of ANSI/
AAMI HE 75 provides guidance on
accessibility for patients and health care
professionals with disabilities. Chapter
16 of ANSI/AAMI HE 75 is available at:
https://www.aami.org/he75/. The
proposed standards do not reference the
guidance in chapter 16 of ANSI/AAMI
HE 75 because the guidance is not
mandatory. The Access Board seeks to
promote harmonization of its standards
and guidelines with voluntary
consensus standards and plans to
participate in future revisions to ANSI/
AAMI HE 75.
The Access Board is seeking input
from the public on costs and benefits
associated with these standards. Section
510 of the Rehabilitation Act does not
address who is required to comply with
the standards. Compliance with the
standards is not mandatory unless other
agencies adopt the standards as
mandatory requirements for entities
under their jurisdiction. In July 2010,
the Department of Justice issued an
advance notice of proposed rulemaking
(ANPRM) announcing that it was
considering amending its Americans
With Disabilities Act (ADA) regulations
to ensure that equipment and furniture
are accessible to individuals with
disabilities. See 75 FR 43452 (July 26,
2010). The ANPRM noted that the ADA
has always required the provision of
accessible equipment and furniture, and
that the Department has entered into
settlement agreements with medical
care providers requiring them to provide
accessible medical equipment. The
ANPRM stated that when the Access
Board has issued accessibility standards
for medical diagnostic equipment, the
Department would consider adopting
the standards in its ADA regulations.
The ANPRM also stated that if the
Department adopts the Access Board’s
accessibility standards for medical
diagnostic equipment, it would develop
scoping requirements that specify the
minimum number of accessible types of
equipment required for different
medical settings.
The rule is intended to reduce health
and safety risks to individuals with
disabilities by making medical
diagnostic equipment accessible.
ATBCB
Proposed Rule Stage
121. Accessibility Standards for
Medical Diagnostic Equipment
Priority: Other Significant.
Legal Authority: 29 U.S.C. 794(f)
CFR Citation: 30 CFR 1197 (New).
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Fmt 4701
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Legal Deadline: Final, Statutory,
March 22, 2012, 29 U.S.C. 794(f).
Abstract: This regulation will
establish minimum technical criteria to
ensure that medical equipment used for
diagnostic purposes by health
professionals in (or in conjunction with)
physician’s offices, clinics, emergency
rooms, hospitals, and other medical
settings is accessible to and usable by
individuals with disabilities.
Statement of Need: The Access Board
is required to issue accessibility
standards for medical diagnostic
equipment by section 510 of the
Rehabilitation Act. The standards will
reduce health and safety risks to
individuals with disabilities by making
medical diagnostic equipment
accessible.
Summary of Legal Basis: Section 4203
of the Patient Protection and Affordable
Care Act (Pub. L. 111–148, 124 Stat.
570) amended title V of the
Rehabilitation Act, which establishes
rights and protections for individuals
with disabilities by adding section 510.
Section 510 of the Rehabilitation Act (29
U.S.C. 794f) requires the Access Board,
in consultation with the Commissioner
of the Food and Drug Administration, to
issue standards that contain minimum
technical criteria to ensure that medical
diagnostic equipment used in or in
conjunction with medical settings such
as physicians’ offices, clinics,
emergency rooms, and hospitals are
accessible to and usable by individuals
with disabilities. The statute provides
that the standards must allow for
independent access to and use of the
equipment by individuals with
disabilities to the maximum extent
possible. The statute lists examination
tables, examination chairs, weight
scales, mammography equipment, and
other imaging equipment as examples of
equipment to which the standards will
apply. However, this list is not
exclusive and the statute covers any
equipment commonly used by health
professionals for diagnostic purposes.
The statute does not cover medical
devices used for monitoring or treating
medical conditions such as glucometers
and infusion pumps.
Alternatives: The Access Board has
considered alternatives proposed by
stakeholders at public hearings and
identified in research. In addition, the
Access Board has consulted closely with
the Department of Justice and the Food
and Drug Administration in the
development of these draft standards.
The Access Board has also considered
approaches contained in the Association
for the Advancement of Medical
Instrumentation’s ANSI/AAMI HE
75:2009, ‘‘Human factors engineering—
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Design of medical devices’’ in
developing the proposed standards.
ANSI/AAMI HE 75 is a recommended
practice that provides guidance on
human factors design principles for
medical devices. Chapter 16 of ANSI/
AAMI HE 75 provides guidance on
accessibility for patients and health care
professionals with disabilities. Chapter
16 of ANSI/AAMI HE 75 is available at:
https://www.aami.org/he75/. The
proposed standards do not reference the
guidance in chapter 16 of ANSI/AAMI
HE 75 because the guidance is not
mandatory. The Access Board seeks to
promote harmonization of its standards
and guidelines with voluntary
consensus standards and plans to
participate in future revisions to ANSI/
AAMI HE 75.
Anticipated Cost and Benefits: The
Access Board is seeking input from the
public on costs and benefits associated
with these standards. Section 510 of the
Rehabilitation Act does not address who
is required to comply with the
standards. Compliance with the
standards is not mandatory unless other
agencies adopt the standards as
mandatory requirements for entities
under their jurisdiction. In July 2010,
the Department of Justice issued an
advance notice of proposed rulemaking
(ANPRM) announcing that it was
considering amending its ADA
regulations to ensure that equipment
and furniture are accessible to
individuals with disabilities. See 75 FR
43452 (Jul. 26, 2010). The ANPRM
noted that the ADA has always required
the provision of accessible equipment
and furniture, and that the Department
has entered into settlement agreements
with medical care providers requiring
them to provide accessible medical
equipment. The ANPRM stated that
when the Access Board has issued
accessibility standards for medical
diagnostic equipment, the Department
would consider adopting the standards
in its ADA regulations. The ANPRM
also stated that, if the Department
adopts the Access Board’s accessibility
standards for medical diagnostic
equipment, it would develop scoping
requirements that specify the minimum
number of accessible types of
equipment required for different
medical settings.
Risks: The rule is intended to reduce
health and safety risks to individuals
with disabilities by making medical
diagnostic equipment accessible.
Timetable:
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Action
Date
FR Cite
Notice of Public
Information
Meeting.
NPRM ..................
NPRM Comment
Period End.
06/22/10
75 FR 35439
02/00/12
04/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
URL for More Information:
www.access-board.gov/medicalequipment.htm.
URL for Public Comments:
www.regulations.gov.
Agency Contact: James Raggio,
General Counsel, Architectural and
Transportation Barriers Compliance
Board, 1331 F Street NW., Suite 1000,
Washington, DC 20004–1111, Phone:
202 272–0040, TDD Phone: 202 272–
0062, Fax: 202 272–0081, Email:
raggio@access-board.gov.
RIN: 3014–AA40
BILLING CODE 8150–01–P
7829
EPA has removed over a billion tons of
pollution from the air and produced
hundreds of billions of dollars in
benefits for the American people. For
example:
• The number of Americans receiving
water that meets health standards has
gone from 79 percent in 1993 to 92
percent in 2008.
• EPA has also helped realize a 60
percent reduction in the dangerous air
pollutants that cause smog, acid rain,
lead poisoning, and more since the
passage of the Clean Air Act in 1970.
Innovations like smokestack scrubbers
and catalytic converters in automobiles
have helped this process.
• Today, new cars are 98 percent
cleaner in terms of smog-forming
pollutants than they were in 1970.
• Meanwhile, American families and
businesses have gone from recycling
about 10 percent of trash in 1980 to
more than 33 percent in 2008. Eightythree million tons of trash are recycled
annually—the equivalent of cutting
greenhouse gas emissions from more
than 33 million automobiles.
Highlights of EPA’s Regulatory Plan
ENVIRONMENTAL PROTECTION
AGENCY (EPA)
Statement of Priorities
Overview
The U.S. Environmental Protection
Agency (EPA) was created on December
2, 1970, when Americans across the
Nation took up a call for cleaner air,
safer water, and unpolluted land. For
the past 4 decades, EPA has confronted
health and environmental challenges,
fostered innovations, and cleaned up
pollution in the places where people
live, work, play, and learn.
The EPA remains strongly committed
to protecting health and the
environment through:
• Taking action on climate change;
• Improving air quality;
• Assuring the safety of chemicals;
• Cleaning up our communities;
• Protecting America’s waters;
• Expanding the conversation on
environmentalism and working for
environmental justice; and
• Building strong State and tribal
partnerships.
EPA and its Federal, State, local, and
community partners have made
enormous progress in protecting the
Nation’s health and environment. From
reducing mercury and other toxic air
pollution from power plants to doubling
the fuel economy of our cars and trucks,
the Agency is working to save tens of
thousands of lives each year. Further,
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EPA’s 40 years of environmental and
health protection demonstrate our
Nation’s ability to create jobs while we
clean our air, water, and land. Clean air,
clean water, and healthy workers are all
essential to American businesses.
Moreover, innovations in clean
technology are creating new jobs right
now. Addressing climate change calls
for coordinated national and global
efforts to research alternative fuels and
other emission reduction technologies
and requires strong partnerships across
economic sectors and around the world.
Similarly, energy consumption and
higher costs underscore the need to
promote alternative energy sources and
invest in new technologies.
Seven Guiding Priorities
The EPA’s success depends on
supporting innovation and creativity in
both what we do and how we do it. To
guide the Agency’s efforts,
Administrator Lisa P. Jackson has
established seven guiding priorities.
These priorities are enumerated in the
list that follows, along with recent
progress and future objectives for each.
1. Taking Action on Climate Change
While the EPA stands ready to help
Congress craft strong, science-based
climate legislation that addresses the
spectrum of issues, the Agency will
deploy existing regulatory tools as they
are available and warranted. Using the
Clean Air Act, EPA will continue to
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
3. Assuring the Safety of Chemicals
5. Protecting America’s Waters
2. Improving Air Quality
Since passage of the Clean Air Act
Amendments in 1990, nationwide air
quality has improved significantly for
the six criteria air pollutants for which
there are national ambient air quality
standards. Long-term exposure to air
pollution can cause cancer and damage
to the immune, neurological,
reproductive, cardiovascular, and
respiratory systems.
Reviewing and Implementing Air
Quality Standards. Despite progress,
millions of Americans still live in areas
that exceed one or more of the national
standards. Ground-level ozone and
particle pollution still present
challenges in many areas of the country.
This year’s regulatory plan describes
efforts to review the primary National
Ambient Air Quality Standards
(NAAQS) for particulates.
Tier 3 Vehicle and Fuel Standards.
EPA plans to propose new vehicle
emission and fuel standards to further
reduce NOX, PM, and air toxics. These
standards will address the Energy
Independence and Security Act (EISA)
‘‘anti-backsliding’’ provision, which
requires the Agency to assess the air
quality impacts of renewable fuel
mandates and take steps to mitigate
them. These standards will also help
states to achieve air quality standards.
Cleaner Air From Improved
Technology. EPA continues to address
toxic air pollution under authority of
the Clean Air Act Amendments of 1990.
The centerpiece of this effort is the
‘‘Maximum Achievable Control
Technology’’ (MACT) program, which
requires that all major sources of a given
type use emission controls that better
reflect the current state of the art.
One of EPA’s highest priorities is to
make significant and long-overdue
progress in assuring the safety of
chemicals. Using sound science as a
compass, EPA protects individuals,
families, and the environment from
potential risks of pesticides and other
chemicals.
Enhancing EPA’s Current Chemicals
Management Program Under the Toxic
Substances Control Act. EPA continues
to target priority chemicals for action
and to identify both concerns that the
chemicals may present and actions the
Agency will take to address those
concerns. EPA is undertaking a range of
actions to address potential risks,
including establishing for the first time
criteria for the use of TSCA’s section
5(b)(4) authority and proposing actions
under TSCA to gather additional
information on nanoscale chemical
materials.
Enhancing Agricultural Worker
Protection and Strengthening Pesticide
Applicator Safety. EPA is developing a
proposal to strengthen the existing
agricultural worker protection
regulation, which is designed to protect
agricultural farm workers and pesticide
handlers by improving pesticide safety
training for workers and protections
from exposure during work activities.
This proposal will also address key
environmental justice concerns for a
population that is disproportionately
affected by pesticide exposure. In
addition, EPA expects to propose
changes to the existing regulations for
certifying the competency of pesticide
applicators to apply pesticides safely.
Both of these rules also aim to protect
child and adolescent agricultural
workers.
4. Cleaning Up Communities
We have made considerable progress
in cleaning up many of America’s
waters, but water quality and
enforcement programs face on-going
challenges. These challenges demand
both traditional and innovative
strategies.
Clean Water Protection. After U.S.
Supreme Court decisions in SWANCC
and Rapanos, the scope of ‘‘waters of the
U.S.’’ protected under all CWA
programs has been an issue of
considerable debate and uncertainty.
The Act has a single definition for
‘‘waters of the United States.’’ As a
result, these decisions affect the
geographic scope of all CWA programs.
SWANCC and Rapanos did not
invalidate the current regulatory
definition of ‘‘waters of the United
States.’’ U.S. EPA and the U.S. Army
Corps of Engineers are developing a
proposed rule for determining whether
a water is protected by the Clean Water
Act.
Concentrated Animal Feeding
Operations. EPA proposed a regulation
that would collect information about
concentrated animal feeding operations
(CAFOs). CAFOs are a significant source
of nutrient pollution and pathogens in
U.S. watersheds. The information that
would be collected under the proposed
rule would allow EPA to increase water
quality protection through better
implementation of the NPDES
permitting program for CAFOs. The
proposed regulation would apply to all
permitted and unpermitted CAFOs. EPA
co-proposed a regulation that would
only collect information from CAFOs in
targeted areas, if EPA determined such
collection was necessary based on
specified factors, such as water quality
concerns.
Streamlining. EPA intends to review
the regulations that apply to the
issuance of National Pollutant Discharge
Elimination System (NPDES) permits,
which are the wastewater permits that
facility operators must obtain before
they discharge pollutants to any water
of the United States. EPA plans to
update specific elements of the existing
NPDES in order to better harmonize
regulations and application forms,
improve permit documentation and
transparency, and provide clarifications
to the existing regulations.
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develop greenhouse gas standards for
both mobile and stationary sources.
Greenhouse Gas Emission Standards
for Automobiles and Trucks. Last year,
EPA issued joint regulations with the
National Highway Traffic Safety
Administration that will improve fuel
economy and reduce GHG emissions
from light-duty vehicles for the 2012 to
2016 model years and from heavy-duty
engines and vehicles. Building on that
success, the two agencies are now
developing a rule that will require
further improvements in light-duty
vehicles for the model years 2017 to
2025.
Greenhouse Gas Emission Standards
for Power Plants. In 2012, EPA will also
continue to develop common-sense
solutions for reducing greenhouse gas
emissions from large stationary sources
like power plants.
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EPA supports urban, suburban, and
rural community goals of improving
environmental, human health, and
quality-of-life outcomes through
partnerships that also promote
economic opportunities, energy
efficiency, and revitalized
neighborhoods. Sustainable
communities balance their economic
and natural assets so that the diverse
needs of local residents can be met now
and in the future with limited
environmental impacts. EPA
accomplishes these outcomes by
working with communities, other
Federal agencies, States, and national
experts to develop and encourage
development strategies that have better
outcomes for air quality, water quality,
and land preservation and
revitalization.
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6. Expanding the Conversation on
Environmentalism and Working for
Environmental Justice
Environmental Justice in Rulemaking.
EPA released ‘‘Plan EJ 2014’’ in
September 2011. This Plan, which
marks the 20th anniversary of the
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signing of Executive Order 12898 on
environmental justice, is EPA’s
overarching strategy for advancing
environmental justice. It seeks to protect
the environment and health in
overburdened communities, empower
communities to take action to improve
their health and environment, and
establish partnerships with local, State,
tribal, and Federal governments, and
organizations to achieve healthy and
sustainable communities. The Plan is an
important and positive step toward
meeting EPA Administrator Lisa P.
Jackson’s priority to work for
environmental justice and protect the
health and safety of communities that
have been disproportionately impacted
by pollution.
Children’s Health. EPA continues to
lead efforts to protect children from
environmental health risks, in
accordance with Executive Order 13045.
To accomplish this, EPA intends to use
a variety of approaches, including
regulation, enforcement, research,
outreach, community-based programs,
and partnerships to protect pregnant
women, infants, children, and
adolescents from environmental and
human health hazards.
7. Building Strong State and Tribal
Partnerships
EPA’s success depends more than
ever on working with increasingly
capable and environmentally conscious
partners. While the Agency works with
the States and tribes on the day-to-day
mission of environmental protection,
declining tax revenues and fiscal
challenges are pressuring State agencies
and tribal governments to do more with
fewer resources. EPA is supportive of
State and tribal capacity to ensure that
programs are consistently delivered
nationwide. This provides EPA and its
intergovernmental partners with an
opportunity to further strengthen their
working relationship and, thereby, more
effectively pursue their shared goal of
2060–AQ86 ...............................................
2060–AQ54 ...............................................
2060–AQ41 ...............................................
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2060–AO60 ...............................................
2060–AR00 ...............................................
2070–AJ20 ................................................
2070–AJ63 ................................................
2040–AF25 ................................................
2050–AG50 ...............................................
2060–AP64 ...............................................
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protecting the Nation’s environment and
public health.
Recognizing the Right of Tribes as
Sovereign Nations. In FY 2009, EPA
Administrator Jackson reaffirmed the
Agency’s Indian Policy, which
recognizes that the United States has a
unique legal relationship with tribal
governments based on treaties, statutes,
Executive orders, and court decisions.
EPA recognizes the right of tribes as
sovereign governments to selfdetermination and acknowledges the
Federal Government’s trust
responsibility to tribes.
*
*
*
*
*
The priorities described above will
guide EPA’s work in the years ahead.
They are built around the challenges
and opportunities inherent in our
mission to protect health and the
environment for all Americans. This
mission is carried out by respecting
EPA’s core values of science,
transparency, and the rule of law.
Within these parameters, EPA carefully
considers the impacts its regulatory
actions will have on society.
Retrospective Review of Existing
Regulations
Just as today’s economy is vastly
different from that of 40 years before,
EPA’s regulatory program is evolving to
recognize the progress that has already
been made in environmental protection
and to incorporate new technologies
and approaches that allow us to
accomplish our mission more efficiently
and effectively. A central goal,
consistent with January’s Executive
Order 13563, is to identify methods for
reducing unjustified burdens and costs.
In August, EPA released a plan for
periodically reviewing EPA’s existing
regulations. The Agency intends to
apply the principles and directives of
EO 13563 to both retrospective reviews
of existing regulations and the
development of new regulations. As
called for by Executive Order 13563,
7831
EPA intends to seek ways ‘‘to determine
whether * * * regulations should be
modified, streamlined, expanded, or
repealed so as to make the Agency’s
regulatory program more effective or
less burdensome in achieving the
regulatory objectives.’’
The EPA’s Final Plan for
Retrospective Reviews of Existing
Regulations (Retrospective Review Plan)
describes a large number of burdenreducing, cost-saving reforms, including
35 priority initiatives. Some of these
have recently been completed; others
are in process; still others are in their
earliest stages. The potential economic
savings are significant. For example, a
recently proposed rule may eliminate
redundant air pollution control
requirements now imposed on gas
stations; that rule would save $87
million annually. Taken as a whole,
recent reforms, already finalized or
formally proposed, are anticipated to
save up to $1.5 billion over the next 5
years. Other reforms described in the
Retrospective Review Plan, including
efforts to streamline requirements and to
move to electronic reporting, could save
more.
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulation Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in EPA’s final
Retrospective Review Plan. Some of the
entries on this list may be completed
actions, which do not appear in The
Regulatory Plan. However, more
information can be found about these
completed rulemakings in past
publications of the Unified Agenda on
Reginfo.gov in the Completed Actions
section for the Agency. These
rulemakings can also be found on
Regulations.gov. The final Agency plan
can be found at: https://www.epa.gov/
regdarrt/retrospective/.
Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards.
Joint Rulemaking To Establish 2017 and Later Model Year Light Duty Vehicle GHG Emissions and
CAFE Standards.
Risk and Technology Review for National Emission Standards for Hazardous Air Pollutants From the
Pulp and Paper Industry.
New Source Performance Standards (NSPS) Review Under CAA Section 111(b)(1)(B).
Uniform Standards for Equipment Leaks and Ancillary Systems, Closed Vent Systems and Control
Devices, Storage Vessels and Transfer Operations, and Wastewater Operations.
Pesticides; Certification of Pesticide Applicators.
TSCA Reporting Requirements; Minor Revisions.
National Pollutant Discharge Elimination System (NPDES) Application and Program Updates Rule.
Oil Pollution Prevention: Spill Prevention, Control, and Countermeasure Rule Requirements—
Amendments for Milk Containers.
Clean Alternative Fuel Vehicle and Engine Conversions.
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Rules Expected To Affect Small Entities
By better coordinating small business
activities, EPA aims to improve its
technical assistance and outreach
efforts, minimize burdens to small
2060–AR13 ...............................................
2060–AP52 ...............................................
2060–AQ86 ...............................................
2070–AJ56 ................................................
2070–AJ44 ................................................
2050–AG61 ...............................................
2040–AF13 ................................................
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Proposed Rule Stage
122. Risk and Technology Review for
National Emission Standards for
Hazardous Air Pollutants From the
Pulp and Paper Industry
Priority: Other Significant.
Legal Authority: Clean Air Act sec 112
CFR Citation: 40 CFR 63.440 to
63.459.
Legal Deadline: NPRM, Judicial,
December 15, 2011, Consent decree
deadline completed.
Final, Judicial, July 31, 2012, Consent
decree deadline.
Abstract: Section 112(f)(2) of the
Clean Air Act (CAA) directs EPA to
conduct risk assessments on each source
category subject to maximum achievable
control technology (MACT) standards
and to determine if additional standards
are needed to reduce residual risks, to
be completed 8 years after
promulgation. Section 112(d)(6) of the
CAA requires EPA to review and revise
the MACT standards as necessary,
taking into account developments in
practices, processes, and control
technologies, to be done at least every
8 years. The National Emission
Standards for Hazardous Air Pollutants
(NESHAP) for the Pulp and Paper
Industry (subpart S) was promulgated in
1998 and also has not been reviewed.
This action will propose those
amendments.
Statement of Need: The National
Emission Standard for Hazardous Air
Pollutants (NESHAP) in the Pulp and
Paper Category was promulgated April
15, 1998 and codified as subpart S in 40
CFR parts 63.440 to 63.459. Section
112(f)(2) of the Clean Air Act (CAA)
directs EPA to conduct risk assessments
on each source category subject to
maximum achievable control
technology (MACT) standards, and to
determine if additional standards are
needed to reduce residual risks, to be
completed 8 years after promulgation.
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Retrospective Review Tracker (https://
www.epa.gov/regdarrt/) at any time.
This Plan includes a number of rules
that may be of particular interest to
small entities:
National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial,
and Institutional Boilers and Process Heaters; Proposed Reconsideration.
National Emission Standards for Hazardous Air Pollutants From Coal- and Oil-fired Electric Utility
Steam Generating Units and Standards of Performance for Electric Utility Steam Generating Units.
Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards.
Lead; Renovation, Repair, and Painting Program for Public and Commercial Buildings.
Formaldehyde Emissions From Pressed Wood Products.
Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in the
Hard Rock Mining Industry.
Stormwater Regulations Revision To Address Discharges from Developed Sites.
EPA
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businesses in its regulations, and
simplify small businesses’ participation
in its voluntary programs. Actions that
may affect small entities can be tracked
on EPA’s Regulatory Development and
Section 112(d)(6) of the CAA requires
EPA to review and revise the MACT
standards as necessary, taking into
account developments in practices,
processes and control technologies, to
be done at least every 8 years.
Summary of Legal Basis: EPA has
signed a consent agreement that directs
it to propose a Risk and Technology
Review rule (RTR) to address the
requirements of Sections 112(f)(2) and
(d)(6) by December 15, 2011 and
promulgate a final RTR rule for this
category by July 31, 2012.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
Timetable:
Action
Date
FR Cite
NPRM ..................
Final Action .........
12/27/11
08/00/12
76 FR 81328
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: Local,
State, Tribal.
Additional Information: Docket
number EPA–HQ–OAR–2007–0544.
Agency Contact: Bill Schrock,
Environmental Protection Agency, Air
and Radiation, E143–03, Research
Triangle Park, NC 27711, Phone: 919
541–5432, Fax: 919 541–3470, Email:
schrock.bill@epa.gov.
Robin Dunkins, Environmental
Protection Agency, Air and Radiation,
E143–03, Research Triangle Park, NC
27711, Phone: 919 541–5335, Fax: 919
541–3470.
RIN: 2060–AQ41
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EPA
123. Joint Rulemaking To Establish
2017 and Later Model Year Light Duty
Vehicle GHG Emissions and CAFE
Standards
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Pub. L.
104–4.
Legal Authority: 42 U.S.C. 7401 to
7671q
CFR Citation: 40 CFR 86 and 600
Legal Deadline: None.
Abstract: The Environmental
Protection Agency (EPA) and the
National Highway Traffic Safety
Administration (NHTSA), on behalf of
the Department of Transportation, have
proposed a joint rulemaking on GHG
and CAFE standards for model years
2017 to 2025 light-duty vehicles. This
action represents a continuation of a
coordinated National Program under the
Clean Air Act (CAA) and the Energy
Policy and Conservation Act (EPCA), as
amended by the Energy Independence
and Security Act (EISA), to improve fuel
efficiency and to reduce greenhouse gas
(GHG) emissions of light-duty vehicles.
On July 29, 2011, President Obama
announced a historic agreement with 13
automakers and the State of California
to pursue 2017 to 2025 standards. This
announcement was accompanied by a
joint Supplemental Notice of Intent,
issued by EPA and NHTSA, which
outlined the standards and other key
program elements the agencies intend to
propose in the upcoming rulemaking.
EPA and NHTSA intend to propose that
automobile manufacturers meet a model
year 2025 CO2 standard of 163 grams/
mile, which is equivalent to 54.5 miles
per gallon if the standard were achieved
with fuel economy technologies alone.
This latest notice followed a September
30, 2010, joint Notice of Intent that
provided an initial assessment of
potential levels of stringency for 2017 to
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2025 standards, an Interim Joint
Technical Assessment Report published
jointly by EPA, NHTSA, and the
California Resources Board in
September 2010, and a November 30,
2010, Supplemental Notice
summarizing key stakeholder
comments.
Statement of Need: EPA has found
that emissions of greenhouse gases
(GHGs) from new motor vehicles cause
or contribute to pollution that may
reasonably be anticipated to endanger
public health and welfare. Light-duty
vehicles emit four GHGs—carbon
dioxide (CO2), methane (CH4), nitrous
oxide (NOX), and hydrofluorocarbons
(HFCs)—and are responsible for nearly
60 percent of all mobile-source GHGs.
On May 21, 2010, the President called
on the EPA and NHTSA, in close
coordination with California, to begin
the next phase of the National Clean Car
Program and propose new standards for
model years 2017 to 2025, in response
to the urgent and closely intertwined
challenges faced by our Nation of
dependence on oil, energy security, and
global climate change. This rulemaking
would provide significant additional
reductions in GHGs from future lightduty vehicles and fuel efficiency
improvements.
Summary of Legal Basis: The Clean
Air Act section 202(a)(1) states that
‘‘The Administrator shall by regulation
prescribe (and from time to time revise)
in accordance with the provisions of
this section, standards applicable to the
emissions of any air pollutant from any
class or classes of new motor vehicles or
new motor vehicle engines, which in his
judgment cause, or contribute to, air
pollution, which may reasonably be
anticipated to endanger public health or
welfare.’’ Section 202(a) covers lightduty vehicles. In April 2007, the
Supreme Court found in Massachusetts
v. EPA that greenhouse gases fit well
within the Act’s capacious definition of
‘‘air pollutant’’ and that EPA has
statutory authority to regulate emission
of such gases from new motor vehicles.
Lastly, in December 2009, EPA
published two findings (74 FR 66496)
that emissions of GHGs from new motor
vehicles and motor vehicle engines
contribute to air pollution, and that the
air pollution may reasonably be
anticipated to endanger public health
and welfare.
Alternatives: The rulemaking
proposal includes an evaluation of
regulatory alternatives that can be
considered in addition to the Agency’s
primary proposal. In addition, the
proposal includes tools such as
averaging, banking, and trading of
emissions credits and other flexibilities
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for alternative approaches for
compliance with the proposed program.
Anticipated Cost and Benefits: The
standards under consideration are
projected to reduce GHGs by
approximately 2 billion metric tons and
save 4 billion barrels of oil over the
lifetime of MY 2017 to 2025 vehicles.
These standards would have significant
benefits to American consumers by
reducing the costs they would pay to
fuel these more efficient vehicles.
Risks: The failure to set new GHG
standards for light-duty vehicles would
increase the risk of unacceptable climate
change impacts.
Timetable:
Action
Date
FR Cite
Notice of Intent ....
Supplemental Notice of Intent.
2nd Supplemental
Notice of Intent.
NPRM ..................
Final Action .........
10/13/10
12/08/10
75 FR 62739
75 FR 76337
08/09/11
76 FR 48758
12/01/11
08/00/12
76 FR 74854
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Additional Information: EPA Docket
information: EPA–HQ–OAR–2010–
0799.
Sectors Affected: 811198 All Other
Automotive Repair and Maintenance;
336111 Automobile Manufacturing;
423110 Automobile and Other Motor
Vehicle Merchant Wholesalers; 811112
Automotive Exhaust System Repair;
811111 General Automotive Repair;
441120 Used Car Dealers.
Agency Contact: Robin Moran,
Environmental Protection Agency, Air
and Radiation, NVFEL, Ann Arbor, MI
48105, Phone: 734 214–4781, Fax: 734
214–4816, Email: moran.robin@epa.gov.
Chris Lieske, Environmental
Protection Agency, Air and Radiation,
NVFEL, Ann Arbor, MI 48105, Phone:
734 214–4584, Fax: 734 214–4816,
Email: lieske.christopher@epa.gov.
RIN: 2060–AQ54
EPA
124. Petroleum Refinery Sector Risk
and Technology Review And NSPS
Priority: Economically Significant.
Major under 5 U.S.C. 801.
PO 00000
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Legal Authority: Clean Air Act secs
111 and 112
CFR Citation: 40 CFR 60 and 63.
Legal Deadline: NPRM, Judicial,
December 10, 2011, Settlement
Agreement. Final, Judicial, November
10, 2012, Settlement Agreement.
Abstract: This action is the Petroleum
Refining Sector Rulemaking, which will
address our obligation to perform Risk
and Technology Reviews (RTR) for
Petroleum Refinery MACT 1 and 2
source categories and will address
issues related to the reconsideration of
Petroleum Refinery New Source
Performance Standards (NSPS) subpart
Ja.
EPA entered into a settlement
agreement with multiple litigants on
December 23, 2010. The settlement
agreement requires EPA to propose
standards of performance for GHGs for
affected facilities at refineries that are
subject to NSPS subparts J and Ja
(Petroleum Refineries, including flares,
process heaters, fluid catalytic cracking
units, fluid cokers, delayed cokers, and
sulfur recovery plants), subpart Db
(Industrial-Commercial-Institutional
Steam Generating Units [Boilers]),
subpart Dc (Small IndustrialCommercial-Institutional Steam
Generating Units), subpart GGG
(Equipment Leaks of VOC in Petroleum
Refineries; e.g., leaking equipment
components such as pumps, valves,
flanges), and subpart QQQ (VOC
Emissions from Petroleum Refinery
Wastewater Systems; e.g., drain systems
and oil water separators) and to propose
emissions guidelines for GHGs from
existing affected facilities at refineries in
the source categories covered by those
NSPS subparts. The settlement also
requires EPA to propose to address
remaining issues raised in a petition
filed in response to the June 24, 2008,
promulgation of amendments to the
Refinery NSPS subpart J and new
standards of performance for subpart Ja,
and to propose standards, as necessary,
to address the RTR review for the 2002
Refinery MACT II standards. The
settlement requires EPA to issue final
standards for the NSPS and RTR
reviews by November 10, 2012. This
settlement agreement is currently under
negotiation.
In this action, we will also conduct
RTR reviews for the two Petroleum
Refinery MACT. We will use
information obtained through a
comprehensive information collection
process to address The MACT and NSPS
reviews. Uniform standards (for heat
exchangers, equipment leaks, storage
vessels and transfer operations; control
devices and closed-vent systems) are
being developed in separate actions and
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
will specify work practices, equipment
standards, and monitoring,
recordkeeping, and reporting
requirements. The refinery sector MACT
and NSPS are expected to reference the
uniform standards. Later, chemical
sector MACT and NSPS will also
reference the uniform standards, which
will ensure that requirements are
consistent, to the extent appropriate,
across the chemical sectors.
Statement of Need: Under the
‘‘technology review’’ provision of CAA
section 112, EPA is required to review
maximum achievable control
technology (MACT) standards and to
revise them ‘‘as necessary (taking into
account developments in practices,
processes, and control technologies)’’ no
less frequently than every 8 years.
Under the ‘‘residual risk’’ provision of
CAA section 112, EPA must evaluate the
MACT standards within 8 years after
promulgation and promulgate standards
if required to provide an ample margin
of safety to protect public health or
prevent an adverse environmental
effect. Section 111(b)(1)(B) of the CAA
mandates that EPA review and, if
appropriate, revise existing NSPS every
8 years.
Summary of Legal Basis: CAA
sections 111 and 112.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: EPA is
currently assessing the costs and
benefits associated with this action.
Risks: EPA is currently assessing risks
for this action.
Timetable:
Date
NPRM ..................
Final Action .........
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Action
FR Cite
12/00/11
12/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: Federal,
Local, State.
Additional Information: Action
described in RIN 2060–AQ28 (NSPS
reconsideration issues) will be included
in this action. EPA Docket information:
EPA–HQ–OAR–2010–0682.
Sectors Affected: 32411 Petroleum
Refineries.
URL for More Information: https://
www.epa.gov/ttn/atw/petrefine/
petrefpg.html.
Agency Contact: Brenda Shine,
Environmental Protection Agency, Air
and Radiation, E143–01, Research
Triangle Park, NC 27711, Phone: 919
541–3608, Fax: 919 541–0246, Email:
shine.brenda@epamail.epa.gov.
Penny Lassiter, Environmental
Protection Agency, Air and Radiation,
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E1430–01, Research Triangle Park, NC
27711, Phone: 919 541–5396, Fax: 919
541–0246, Email:
lassiter.penny@epamail.epa.gov.
RIN: 2060–AQ75
EPA
125. Control of Air Pollution From
Motor Vehicles: Tier 3 Motor Vehicle
Emission and Euel Standards
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: CAA 202(a) and
211(v)
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule will establish new
standards for light-duty vehicles and
their fuels in order to reduce emissions
of criteria and toxic pollutants and their
impact on air quality and health. This
action will set forth a comprehensive
approach toward regulating motor
vehicles for non-greenhouse gas
pollutants, as requested by a May 2010
Presidential memorandum.
Statement of Need: States are working
to attain National Ambient Air Quality
Standards for ozone, PM, and NOX.
Light-duty vehicles are responsible for a
significant portion of the precursors to
these pollutants and are large
contributors to ambient air toxic
pollution. For example, without future
controls, by 2014 light-duty vehicles are
projected to contribute 25 percent of
nationwide mobile-source NOX, 40
percent of nationwide mobile-source
VOC, and 10 percent nationwide
mobile-source PM. Importantly, by 2020
mobile sources are expected to be as
much as 50 percent of the inventories
for some individual urban areas without
future controls. Light-duty vehicles also
contribute about half of the 2030 mobile
source inventory of toxics; the 2002
National-Scale Air Toxics Assessment
showed that mobile sources were
responsible for over 50 percent of cancer
risk and over 80 percent of noncancer
hazard. Clearly, there is a need for
tighter light-duty vehicle standards and
fuel standards as part of a
comprehensive approach to reducing
pollution from motor vehicles.
Renewable fuels are recognized to pose
potential air quality concerns, and EPA
has a mandate to address them under
Clean Air Act section 211(q) and 211(v).
Specifically, both EPAct of 2005 and
EISA (2007) amended the CAA to
require EPA to determine adverse air
quality impacts of renewable fuels and
to implement appropriate measures to
mitigate these impacts to the greatest
extent achievable.
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Summary of Legal Basis: The Clean
Air Act, section 202(a)(1), states ‘‘The
Administrator shall by regulation
prescribe (and from time to time revise)
in accordance with the provisions of
this section, standards applicable to the
emission of any air pollutant from any
class, or class of new motor vehicles or
new motor vehicle engines, which in his
judgment cause, or contribute to, air
pollution which may be reasonably be
anticipated to endanger public health or
welfare.’’ Section 202(a) covers all onhighway vehicles, including medium
and heavy-duty trucks. EPA is also
using its authority under section 211(c)
of the Clean Air Act to address gasoline
sulfur controls, section 211(h) to
address Reid Vapor Pressure, and
section 211(v), which requires that the
Administrator promulgate fuel
regulations to implement appropriate
measures to mitigate, to the greatest
extent achievable, and considering the
results of the anti-backsliding study
completed under section 211(v)(1), any
adverse impacts on air quality as a
results of the renewable volumes or
make a determination that no such
measures are necessary.
Alternatives: The rulemaking
proposal will include an evaluation of
regulatory alternatives that can be
considered in addition to the Agency’s
primary proposal.
Anticipated Cost and Benefits:
Detailed analysis of economy-wide cost
impacts, emissions reductions, and
societal benefits will be performed
during the rulemaking process.
Risks: The failure to set new Tier 3
vehicle/fuel standards will adversely
impact the population living in
nonattainment areas, where reductions
from the Tier 3 rule are needed to help
attain and maintain the ozone and PM
NAAQS (and to mitigate adverse effects
of renewable fuels). Also, without the
new Tier 3 vehicle/fuel standards, the
sizeable population living, working, and
going to school near roads will continue
to be exposed to higher levels of air
toxics, which is a current environmental
justice and children’s health concern.
Timetable:
Action
Date
NPRM ..................
Final Action .........
FR Cite
03/00/12
10/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: EPA Docket
information: EPA–HQ–OAR–2011–
0135. Includes Retrospective Review
under E.O. 13563.
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Sectors Affected: 811198 All Other
Automotive Repair and Maintenance;
336111 Automobile Manufacturing;
811112 Automotive Exhaust System
Repair; 336311 Carburetor, Piston,
Piston Ring, and Valve Manufacturing;
336312 Gasoline Engine and Engine
Parts Manufacturing; 336120 Heavy
Duty Truck Manufacturing; 336112
Light Truck and Utility Vehicle
Manufacturing; 454312 Liquefied
Petroleum Gas (Bottled Gas) Dealers;
541690 Other Scientific and Technical
Consulting Services; 324110 Petroleum
Refineries; 484220 Specialized Freight
(except Used Goods) Trucking, Local;
484230 Specialized Freight (except
Used Goods) Trucking, Long-Distance.
Agency Contact: Catherine Yanca,
Environmental Protection Agency, Air
and Radiation, NVFEL S87, Ann Arbor,
MI 48105, Phone: 734 214–4769, Email:
yanca.catherine@epamail.epa.gov.
Kathryn Sargeant, Environmental
Protection Agency, Air and Radiation,
NVFEL S77, Ann Arbor, MI 48105,
Phone: 734 214–4441, Email:
sargeant.kathryn@epamail.epa.gov.
RIN: 2060–AQ86
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EPA
126. Greenhouse Gas New Source
Performance Standard for Electric
Generating Units for New Sources
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: CAA 111
CFR Citation: 40 CFR 60.
Legal Deadline: NPRM, Judicial,
September 30, 2011. Final, Judicial, May
25, 2012.
Abstract: This action will amend the
electric generating units (EGUs) New
Source Performance Standard and add a
section 111(b) greenhouse gas (GHG)
standard for new and modified
facilities.
Statement of Need: EPA entered into
settlement agreement with multiple
State and environmental petitioners on
December 21, 2010, to establish
standards of performance for GHGs for
new EGUs and emissions guidelines for
GHGs from existing EGUs.
Summary of Legal Basis: Clean Air
Act, section 111.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
Timetable:
Action
Date
NPRM ..................
01/00/12
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7835
Under the ‘‘residual risk’’ provision of
CAA section 112, EPA must evaluate the
Final Action .........
06/00/12
MACT standards within 8 years after
promulgation and promulgate standards
Regulatory Flexibility Analysis
if required to provide an ample margin
Required: No.
of safety to protect public health or
Small Entities Affected: No.
prevent an adverse environmental
Government Levels Affected:
effect. Section 111(b)(1)(B) of the CAA
Undetermined.
mandates that EPA review and, if
Federalism: Undetermined.
appropriate, revise existing NSPS every
Energy Effects: Statement of Energy
8 years. EPA will also remove startup,
Effects planned as required by Executive shutdown, and malfunction exemptions
Order 13211.
for these source categories, as required
Additional Information: EPA Docket
by recent court decisions.
Statement of Need: This action
information: EPA–HQ–OAP–2011–0660.
addresses EPA’s statutory obligations to
Sectors Affected: 221 Utilities.
perform Risk and Technology Reviews
Agency Contact: Christian Fellner,
(RTR) and NSPS reviews for chemical
Environmental Protection Agency, Air
sector MACT. It will address Clean Air
and Radiation, D243–01, Research
Act (CAA) section 112(f)(2) to conduct
Triangle Park, NC 27711, Phone: 919
residual risk reviews, section 112(d)(6)
541–4003, Fax: 919 541–5450, Email:
to conduct technology reviews, and
fellner.christian@epamail.epa.gov.
section 111(b)(1)(B) to conduct NSPS
Brian Shrager, Environmental
reviews for multiple chemical sector
Protection Agency, Air and Radiation,
source categories. Under the
D243–01, Research Triangle Park, NC
‘‘technology review’’ provision of CAA
27711, Phone: 919 541–7689, Fax: 919
section 112, EPA is required to review
541–5450, Email:
maximum achievable control
shrager.brian@epa.gov.
technology (MACT) standards and to
RIN: 2060–AQ91
revise them ‘‘as necessary (taking into
account developments in practices,
processes, and control technologies)’’ no
EPA
less frequently than every 8 years.
127. • National Emission Standards for Under the ‘‘residual risk’’ provision of
CAA section 112, EPA must evaluate the
Hazardous Air Pollutant Emissions:
MACT standards within 8 years after
Group IV Polymers and Resins,
Pesticide Active Ingredient Production, promulgation and promulgate standards
if required to provide an ample margin
and Polyether Polyols Production Risk
of safety to protect public health or
and Technology Review
prevent an adverse environmental
Priority: Other Significant.
effect. Under the CAA section 111, EPA
Legal Authority: Clean Air Act secs
must evaluate NSPS requirements and,
111 and 112.
if appropriate, revise existing NSPS
CFR Citation: 40 CFR 60 and 63.
every 8 years.
Legal Deadline: NPRM, Judicial,
Summary of Legal Basis: CAA
November 30, 2011. Final, Judicial,
sections 111 and 112.
November 30, 2012.
Alternatives: Unavailable.
Abstract: In this action, EPA will
Anticipated Cost and Benefits: We are
perform risk and technology reviews for currently estimating the costs and
three National Emission Standards for
benefits associated with this action.
Hazardous Air Pollutants (NESHAP).
Risks: We are currently assessing the
These NESHAP are under a deadline
risks associated with this action.
consent decree for proposal in
Timetable:
November 2011 and promulgation in
November 2012: Group IV Polymers and
Action
Date
FR Cite
Resins, Pesticide Active Ingredient
NPRM ..................
01/09/12 77 FR 1268
Production, and Polyether Polyols
NPRM Comment
03/09/12
Production. Clean Air Act (CAA)
Period End.
sections 112(f)(2) and 112(d)(6) require
Final Action .........
11/00/12
EPA to conduct residual risk and
technology reviews. Under the
Regulatory Flexibility Analysis
‘‘technology review’’ provision of CAA
Required: No.
section 112, EPA is required to review
Small Entities Affected: No.
maximum achievable control
Government Levels Affected: Federal,
technology (MACT) standards and to
Local, State, Tribal.
revise them ‘‘as necessary (taking into
Sectors Affected: 325 Chemical
account developments in practices,
Manufacturing.
processes, and control technologies)’’ no
Agency Contact: Nick Parsons,
less frequently than every 8 years.
Environmental Protection Agency, Air
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and Radiation, E143–01, Research
Triangle Park, NC 27711, Phone: 919
541–5372, Fax: 919 541–0246, Email:
parsons.nick@epamail.epa.gov.
Penny Lassiter, Environmental
Protection Agency, Air and Radiation,
E1430–01, Research Triangle Park, NC
27711, Phone: 919 541–5396, Fax: 919
541–0246, Email:
lassiter.penny@epamail.epa.gov.
RIN: 2060–AR02
EPA
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128. • National Emission Standards for
Hazardous Air Pollutants for Major
Sources: Industrial, Commercial, and
Institutional Boilers and Process
Heaters; Proposed Reconsideration
Priority: Other Significant. Major
under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect State, local or tribal governments
and the private sector.
Legal Authority: Clean Air Act sec 112
CFR Citation: 40 CFR 63.
Legal Deadline: None.
Abstract: EPA estimates the total
national capital cost for the proposed
reconsideration rule to be
approximately $5.4 billion in the year
2015, with a total national annual cost
of $1.5 billion in the year 2015. The
annual cost, which considers fuel
savings, includes control device
operation and maintenance, as well as
monitoring, recordkeeping, reporting,
and performance testing. EPA estimates
that implementation of the rulemaking,
as proposed, would reduce nationwide
emissions from major source boilers and
process heaters by: 1,000 to 3,600
pounds per year of mercury, 2,200 tpy
of non-mercury metals, 37,000 tpy of
HCl, 41,000 tpy of PM, 560,000 tpy of
SO2, and 4,700 tpy of volatile organic
compounds. These emissions reductions
would lead to the following annual
health benefits. In 2015, this rule will
protect public health by avoiding 3,100
to 8,000 premature deaths, 2,000 cases
of chronic bronchitis, 4,900 nonfatal
heart attacks, 5,350 hospital and
emergency room visits, 4,600 cases of
acute bronchitis, 390,000 days when
people miss work, 51,000 cases of
aggravated asthma, and 96,000 acute
respiratory symptoms. The monetized
value of the benefits ranges from $27
billion to $67 billion in 2015—
outweighing the costs by at least $25
billion.
Statement of Need: As a result of the
vacatur of the Industrial Boiler MACT,
the Agency will develop another
rulemaking under CAA section 112,
which will reduce hazardous air
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pollutant (HAP) emissions from this
source category. Recent court decisions
on other CAA section 112 rules will be
considered in developing this
regulation.
Summary of Legal Basis: Clean Air
Act, section 112.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: EPA
estimates the total national capital cost
for the final rule to be approximately
$9.5 billion in the year 2013, with a
total national annual cost of $2.9 billion
in the year 2013. The annual cost,
which considers fuel savings, includes
control device operation and
maintenance as well as monitoring,
recordkeeping, reporting, and
performance testing. EPA estimates that
implementation of the rulemaking, as
proposed, would reduce nationwide
emissions from major source boilers and
process heaters by: 15,000 pounds per
year of mercury, 3,200 tons per year
(tpy) of non-mercury metals, 37,000 tpy
of HCl, 50,000 tpy of PM, 340,000 tpy
of SO2, 722 grams per year of dioxin,
and 1,800 tpy of volatile organic
compounds. These emissions reductions
would lead to the following annual
health benefits. In 2013, this rule will
protect public health by avoiding 1,900
to 4,800 premature deaths, 1,300 cases
of chronic bronchitis, 3,000 nonfatal
heart attacks, 3,200 hospital and
emergency room visits, 3,000 cases of
acute bronchitis, 250,000 days when
people miss work, 33,000 cases of
aggravated asthma, and 1,500,000 acute
respiratory symptoms. The monetized
value of the benefits ranges from $17
billion to $41 billion in 2013—
outweighing the costs by at least $14
billion.
Risks: Not yet determined.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
12/23/11
02/21/12
76 FR 80598
04/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: Federal,
Local, State, Tribal.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Additional Information: Split from
RIN 2060–AQ25. Split from RIN 2060–
AM44. This rulemaking combines the
area source rulemaking for boilers and
the rulemaking for reestablishing the
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vacated NESHAP for boilers and process
heaters. EPA Docket information: EPA–
HQ–OAR–2002–0058.
Sectors Affected: 325 Chemical
Manufacturing; 611 Educational
Services; 322 Paper Manufacturing; 221
Utilities; 321 Wood Product
Manufacturing.
Agency Contact: Brian Shrager,
Environmental Protection Agency, Air
and Radiation, D243–01, Research
Triangle Park, NC 27711, Phone: 919
541–7689, Fax: 919 541–5450, Email:
shrager.brian@epa.gov.
Robert J Wayland, Environmental
Protection Agency, Air and Radiation,
D243–01, Research Triangle Park, NC
27711, Phone: 919 541–1045, Fax: 919
541–5450, Email:
wayland.robertj@epamail.epa.gov.
RIN: 2060–AR13
EPA
129. • National Emission Standards for
Hazardous Air Pollutants for Area
Sources: Industrial, Commercial, and
Institutional Boilers; Reconsideration
and Proposed Rule Amendments
Priority: Other Significant.
Legal Authority: Clean Air Act sec 112
CFR Citation: 40 CFR 63.
Legal Deadline: Other, Statutory,
April 30, 2012, Tentative date for
promulgation of amendments to the
rule.
Abstract: On March 21, 2011, EPA
issued a final rule establishing
standards for emissions of hazardous air
pollutants from boilers located at area
sources. EPA also issued on March 21,
2011, a Notice of Reconsideration listing
four issues for which additional
opportunity for public review and
comment should be obtained.
Subsequently, we received petitions to
reconsider and clarify and amend
certain applicability and
implementation provisions of the final
rule. This action will propose the
amendments after we analyze the
information submitted in the petitions.
Statement of Need: Section
307(d)(7)(B) of the CAA requires EPA to
convene a proceeding for
reconsideration of the rule if a person
raising an objection to the rule can
demonstrate to EPA that it was
impracticable to raise such objection
within the period for public comment or
if the grounds for such objection arose
after the period for public comment, and
if such objection is of central relevance
to the outcome of the rule.
Summary of Legal Basis: Clean Air
Act, section 112.
Alternatives: Not yet determined.
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Anticipated Cost and Benefits: Cost
and benefits numbers for the Boiler Area
Source Rule (subpart JJJJJJ) are as
follows.
Proposal: Total annualized costs =
$1.0 billion. Total net monetized
benefits = $0.5 billion to $1.9 billion
(3% discount rate), $0.4 billion to $1.7
billion (7% discount rate). Nonmonetized Benefits = 39,000 tons of
carbon monoxide, 130 tons of HCl, 5
tons of HF, 0.75 tons of mercury, 250
tons of other metals, 470 grams of
dioxins/furans. Additionally, health
effects from NO2 and SO2 exposure
diminish, as well as ecosystem effects
and visibility impairment.
Final: Total annualized costs = $535
million. Total net monetized benefits =
¥$280 million to $30 million (3%
discount rate), ¥$300 million to ¥$20
million (7% discount rate). Nonmonetized Benefits = 1,100 tons of
carbon monoxide, 340 tons of HCl, 8
tons of HF, 90 pounds of mercury, 320
tons of other metals, <1 gram of dioxins/
furans (TEQ), health effects from SO2
exposure, ecosystem effects, visibility
impairment.
Risks: Not yet determined.
Timetable:
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
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Action
12/23/11
02/21/12
76 FR 80532
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
Local, State, Tribal.
Additional Information: Split from
RIN 2060–AM44. Related to RIN 2060–
AQ25. EPA Docket information: EPA–
HQ–OAR–2006–0790.
Sectors Affected: 611 Educational
Services; 62 Health Care and Social
Assistance; 44–45 Retail Trade; 321
Wood Product Manufacturing.
Agency Contact: Jim Eddinger,
Environmental Protection Agency, Air
and Radiation, D243–01, Research
Triangle Park, NC 27711, Phone: 919
541–5426, Email: eddinger.jim@epa.gov.
Robert J Wayland, Environmental
Protection Agency, Air and Radiation,
D243–01, Research Triangle Park, NC
27711, Phone: 919 541–1045, Fax: 919
541–5450, Email:
wayland.robertj@epamail.epa.gov.
RIN: 2060–AR14
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EPA
130. • Standards of Performance for
New Stationary Sources and Emission
Guidelines for Existing Sources:
Commercial and Industrial Solid Waste
Incineration Units; Reconsideration
and Proposed Amendments
Priority: Other Significant.
Legal Authority: 42 U.S.C. 7401 et seq.
CFR Citation: 40 CFR 60; 40 CFR 62.
Legal Deadline: None.
Abstract: On March 21, 2011, EPA
issued a final rule establishing new
source performance standards and
emission guidelines for commercial and
industrial solid waste incineration
units. EPA also issued on March 21,
2011, a Notice of Reconsideration listing
issues for which additional opportunity
for public review and comment should
be obtained. Subsequently, we received
more than 15 petitions to reconsider,
clarify, and amend certain provisions of
the final rule. This action will propose
the amendments after we analyze the
information submitted in the petitions.
Statement of Need: As a result of the
vacatur of the CISWI definition and the
remand of the CISWI rule, the Agency
will develop another rulemaking under
CAA section 129 that will reduce
hazardous air pollutant (HAP) emissions
from this source category. Recent court
decisions on other rules will be
considered in developing this
regulation.
Summary of Legal Basis: Clean Air
Act, section 129.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: EPA
estimates the total national capital cost
for the final rule to be approximately
$706 million in the year 2013, with a
total national annual cost of $280
million in the year 2013. The annual
cost, which considers fuel savings,
includes control device operation and
maintenance as well as monitoring,
recordkeeping, reporting, and
performance testing. EPA estimates that
implementation of the rulemaking, as
proposed, would reduce nationwide
emissions from commercial and
industrial solid waste incineration units
by: 5,700 tons per year (tpy) of acid
gases (i.e., hydrogen chloride and sulfur
dioxide), 1,600 tpy of particulate matter,
23,000 tpy of carbon monoxide, 5,700
tpy of nitrogen oxides, and 5.5 tpy of
metals (i.e., lead, cadmium, and
mercury) and dioxins/furans. These
emissions reductions would lead to the
following annual health benefits. In
2013, this rule will protect public health
by avoiding 40 to 100 premature deaths,
27 cases of chronic bronchitis, 64
nonfatal heart attacks, 68 hospital and
emergency room visits, 65 cases of acute
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bronchitis, 1,350 cases of respiratory
symptoms, 5,300 days when people
miss work or school, 700 cases of
aggravated asthma, and 31,000 days
when people must restrict their
activities. The monetized value of the
benefits ranges from $360 to $870
million in 2013—outweighing the costs
by at least $80 million.
Risks: Not yet determined.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
12/23/11
02/21/12
76 FR 80452
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: Split from
RIN 2060–AO12. EPA Docket
information: EPA–HQ–OAR–2003–
0119.
Sectors Affected: 325 Chemical
Manufacturing; 334 Computer and
Electronic Product Manufacturing; 3254
Pharmaceutical and Medicine
Manufacturing; 321 Wood Product
Manufacturing.
Agency Contact: Toni Jones,
Environmental Protection Agency, Air
and Radiation, E143–03, Research
Triangle Park, NC 27711, Phone: 919
541–0316, Fax: 919 541–3470, Email:
jones.toni@epamail.epa.gov.
Charlene Spells, Environmental
Protection Agency, Air and Radiation,
E–143–05, Research Triangle Park, NC
27711, Phone: 919 541–5255, Fax: 919
541–3470, Email:
spells.charlene@epa.gov.
RIN: 2060–AR15
EPA
131. NPDES Electronic Reporting Rule
Priority: Other Significant.
Legal Authority: CWA secs 304(i) and
501(a), 33 U.S.C. 1314(i) and 1361(a)
CFR Citation: 40 CFR 123, 403, and
501.
Legal Deadline: None.
Abstract: The EPA has responsibility
to ensure that the Clean Water Act’s
(CWA) National Pollutant Discharge
Elimination System (NPDES) program is
effectively and consistently
implemented across the country. This
regulation would identify the essential
information that EPA needs to receive
electronically, primarily from NPDES
permittees with some data required
from NPDES agencies (NPDESauthorized States, territories, and tribes)
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
to manage the national NPDES
permitting and enforcement program.
Through this regulation, EPA seeks to
ensure that such facility-specific
information would be readily available,
accurate, timely, and nationally
consistent on the facilities that are
regulated by the NPDES program.
In the past, EPA primarily obtained
this information from the Permit
Compliance System (PCS). However, the
evolution of the NPDES program since
the inception of PCS has created an
increasing need to better reflect a more
complete picture of the NPDES program
and the diverse universe of regulated
sources. In addition, information
technology has advanced significantly
so that PCS no longer meets EPA’s
national needs to manage the full scope
of the NPDES program or the needs of
individual States that use PCS to
implement and enforce the NPDES
program.
Statement of Need: As the NPDES
program and information technology
have evolved in the past several
decades, the Permit Compliance System
(PCS)—EPA’s NPDES national data
system, which has been in use since
1985—has become increasingly
ineffective in meeting the full scope of
EPA’s and individual States’ needs to
manage, direct, oversee, and report on
the implementation and enforcement of
the NPDES program. Therefore, a
NPDES component of EPA’s existing
Integrated Compliance Information
System (ICIS), ICIS–NPDES, was
designed and constructed based upon
EPA and State input to manage data for
the full breadth of the NPDES program.
This rulemaking would identify
essential NPDES-specific information
EPA needs to receive from NPDES
agencies (authorized States and tribes,
as well as EPA regions). This
information would be sought in a format
compatible with the new NPDES
component of the Integrated
Compliance Information System (ICIS)
in order to better enable EPA to ensure
the protection of public health and the
environment, effectively manage the
national NPDES permitting and
enforcement program, identify and
address environmental problems, and
ultimately replace PCS. This action
would be of interest primarily to NPDES
permittees, NPDES-authorized States,
and to the public at large, which would
ultimately have increased access to this
NPDES information.
Summary of Legal Basis: In 1972,
Congress passed the Clean Water Act to
‘‘restore and maintain the chemical,
physical, and biological integrity of the
Nation’s waters.’’ 33 U.S.C. 1251(a). The
Clean Water Act established a
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comprehensive program for protecting
and restoring our Nation’s waters. The
Clean Water Act prohibits the discharge
of pollutants from a point source to
waters of the United States except when
authorized by a National Pollutant
Discharge Elimination System (NPDES)
permit. The Clean Water Act established
the NPDES permit program to authorize
and regulate the discharges of pollutants
to waters of the United States. EPA has
issued comprehensive regulations that
implement the NPDES program at 40
CFR parts 122 to 125, 129 to 133, 136,
and subpart N.
Under the NPDES permit program,
point sources subject to regulation may
discharge pollutants to waters of the
United States subject to the terms and
conditions of an NPDES permit. With
very few exceptions (40 CFR 122.3),
point sources require NPDES permit
authorization to discharge, including
both municipal and industrial
discharges. NPDES permit authorization
may be provided under an individual
NPDES permit, which is developed after
a process initiated by a permit
application (40 CFR 122.21), or under a
general NPDES permit, which among
other things, applies to one or more
categories of dischargers (e.g., oil and
gas facilities, seafood processors) with
the same or substantially similar types
of operations and the same effluent
limitations, operating conditions, or
standards for sewage sludge use or
disposal.
The U.S. Environmental Protection
Agency has the primary responsibility
to ensure that the NPDES program is
effectively and consistently
implemented across the country, thus
ensuring that public health and
environmental protection goals of the
CWA are met. Many States and some
territories have received authorization
to implement and enforce the NPDES
program, and EPA works with its State
partners to ensure effective program
implementation and enforcement. CWA
section 304(i)(2) directs EPA to
promulgate guidelines establishing the
minimum procedural and other
elements of a State, territory, or tribal
NPDES program, including monitoring
requirements; reporting requirements
(including procedures to make
information available to the public);
enforcement provisions; and funding,
personnel qualifications, and manpower
requirements [CWA sec. 304(i)(2)].
EPA published NPDES State, territory,
and tribal program regulations under
CWA section 304(i)(2) at 40 CFR part
123. Among other things, the part 123
regulations specify NPDES program
requirements for permitting, compliance
evaluation programs, enforcement
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authority, sharing of information,
transmission of information to EPA, and
noncompliance and program reporting
to EPA.
This proposed rulemaking may add
some specificity to those particular
regulations regarding what NPDES
information is required to be submitted
to EPA by States and may modify other
regulations to require electronic
reporting of NPDES information by
NPDES permittees to the States and
EPA.
Alternatives: For this proposed
rulemaking, EPA has determined that
the need for EPA’s receipt of such
NPDES information exists. If, for
whatever reason, electronic reporting by
permittees is not a feasible option for
certain NPDES information, the obvious
alternative would be for EPA to require
States to provide that information to
EPA. The States already receive that
information from the permittees, and
therefore, they have the information that
EPA seeks.
Within the rulemaking process itself,
various alternatives are under
consideration based on the feasibility of
particular electronic reporting options.
For example, EPA may consider
establishing requirements for electronic
reporting of discharge monitoring
reports by NPDES permittees. Under
this proposed rulemaking, EPA may
consider establishing similar
requirements for any or all of the
following types of NPDES information:
Notices of Intent to discharge (for
facilities seeking coverage under general
permits), permitting information
(including permit applications), various
program reports (e.g., pretreatment
compliance reports from approved local
pretreatment programs, annual reports
from concentrated animal feeding
operations, biosolids reports, sewage
overflow incident reports, annual
reports for pesticide applicators, annual
reports for municipal stormwater
systems), and annual compliance
certifications.
Some States might also raise the
possibility of supplying only summarylevel information to EPA rather than
facility-specific information to EPA.
Based upon considerable experience,
EPA considers such alternative nonfacility-specific data to be insufficient to
meet its needs, except in very particular
situations or reports.
One alternative that EPA may
consider for rule implementation is
whether third-party vendors may be
better equipped to develop and modify
such electronic reporting tools than
EPA.
Anticipated Cost and Benefits: The
economic analysis for this proposed
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rulemaking has not yet been completed;
therefore, the dollar values of estimated
costs and benefits are not yet known.
However, some generalizations can still
be made regarding expectations. EPA
anticipates that electronic reporting of
discharge monitoring reports (DMRs) by
NPDES permittees will provide
significant data entry cost savings for
States and EPA. These discharge
monitoring reports are already required
to be submitted by NPDES permittees to
States and EPA, which in turn currently
enter that information into the State
NPDES data system or EPA’s national
NPDES data system. These discharge
monitoring reports contain significant
amounts of information regarding
pollutants discharged, identified
concentrations and quantities of
pollutants, discharge locations, etc.
Through electronic reporting by
permittees, States and EPA will no
longer have associated data entry costs
to enter this information. Electronic
reporting by NPDES permittees of other
NPDES information (such as notices of
intent to discharge or various program
reports) may also yield considerable
data entry savings to the States and
EPA. In addition, some States have been
able to quantify savings by the
permittees to electronically report their
NPDES information using existing
electronic reporting tools. Such savings
are being examined in the economic
analysis process for this rulemaking.
Additional benefits of this rule will
likely include improved transparency of
information regarding the NPDES
program, improved information
regarding the national NPDES program,
improved targeting of resources and
enforcement based on identified
program needs and noncompliance
problems, and ultimately improved
protection of public health and the
environment.
Some NPDES information will need to
be reported by States to EPA; therefore,
there will be some data entry costs
associated with that information, but it
will likely be far less than the savings
that will be realized by States through
electronic reporting by NPDES
permittees. In addition, EPA will likely
have sizable costs to develop tools for
electronic reporting by permittees, as
well as operation and maintenance costs
associated with those tools.
Risks: Given the scope of this
proposed rulemaking, the most
significant risks associated with this
effort may be those if EPA does not
proceed with this rulemaking. At this
point, EPA does not receive sufficient
NPDES information from the States to
be able to fully assess the
implementation of the national NPDES
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program nor the smaller subprograms.
Such information is not currently
required by EPA from the States, and
the lack of such reporting requirements
perpetuates this problem. Furthermore,
EPA does not have facility-specific
information regarding most of the
facilities regulated under the NPDES
program, and therefore, EPA cannot
easily identify potential implementation
problems or noncompliance problems.
This lack of information may adversely
impact EPA’s ability to better ensure the
protection of public health and the
environment, nationally and locally.
A potential risk associated with this
rule may involve EPA efforts to develop
electronic reporting tools for use by
permittees. The costs associated with
the internal development of such tools,
possibly for multiple types of NPDES
information from various types of
NPDES permittees, and the future costs
of operation and maintenance may be
substantial for EPA, possibly impacting
the availability of funding for other
purposes. Furthermore, EPA would also
need to determine the feasibility of
ensuring that the electronic tools can be
flexible enough to meet state needs and
work well with State data systems.
Problems in the development and
maintenance of these electronic tools
could pose significant risks for the
effective implementation of this rule.
Timetable:
Action
Date
FR Cite
Notice—Public
Meeting.
Notice—Public
Meeting 2.
NPRM ..................
Final Action .........
07/01/10
75 FR 38068
06/23/11
76 FR 36919
12/00/11
09/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: State.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Additional Information: SAN No.
5251.
URL for More Information: https://
www.regulations.gov/exchange/topic/
npdes
Agency Contact: Andrew Hudock,
Environmental Protection Agency,
Office of Enforcement and Compliance
Assurance, 2222A, Washington, DC
20460, Phone: 202 564–6032, Email:
hudock.andrew@epamail.epa.gov.
John Dombrowski, Environmental
Protection Agency, Office of
Enforcement and Compliance
Assurance, 2222A, Washington, DC
20460, Phone: 202 566–0742, Email:
dombrowski.john@epamail.epa.gov.
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RIN: 2020–AA47
EPA
132. Pesticides; Certification of
Pesticide Applicators
Priority: Other Significant.
Legal Authority: 7 U.S.C. 136; 7 U.S.C.
136i; 7 U.S.C. 136w
CFR Citation: 40 CFR 171; 40 CFR
156.
Legal Deadline: None.
Abstract: EPA is proposing change to
the Federal regulations under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) that guide the
certified pesticide applicator program
(40 CFR 171). Change is sought to
strengthen the regulations to better
protect pesticide applicators and the
public and the environment from harm
due to pesticide exposure. The possible
need for change arose from EPA
discussions with key stakeholders. EPA
has been in extensive discussions with
stakeholders since 1997 when the
Certification and Training Assessment
Group (CTAG) was established. CTAG is
a forum used by regulatory and
academic stakeholders to discuss the
current state of, and the need for
improvements in, the national certified
pesticide applicator program.
Throughout these extensive interactions
with stakeholders, EPA has learned of
the potential need for changes to the
regulation.
Statement of Need: These regulations
have been in place since 1972. Since
then, many States have advanced the
existing requirements to better protect
applicators, the public, and the
environment. The Agency is proposing
revisions to establish a more protective
national standard.
Summary of Legal Basis: 7 U.S.C. 136
through 7 U.S.C. 136y.
Alternatives: The Agency has
developed mechanisms to improve
applicator trainers and make training
materials more accessible. The Agency
has also developed nationally relevant
training and certification materials to
preserve State resources.
Anticipated Cost and Benefits: Costs
and benefits from the proposed rule are
being prepared.
Risks: Applicators are at risk from
exposure to pesticides they handle for
their work. The public and the
environment may also be at risk from
misapplication by non-competent
applicators. Revisions to the regulations
are expected to minimize these risks by
ensuring the competency of certified
applicators.
Timetable:
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Action
Date
NPRM ..................
FR Cite
10/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: Federal,
Local, State, Tribal.
Additional Information: EPA Docket
information: EPA–HQ–OPP–2005–0561.
Sectors Affected: 9241 Administration
of Environmental Quality Programs; 112
Animal Production; 111 Crop
Production; 1132 Forest Nurseries and
Gathering of Forest Products; 32532
Pesticide and Other Agricultural
Chemical Manufacturing; 5617 Services
to Buildings and Dwellings; 115
Support Activities for Agriculture and
Forestry.
URL for More Information: https://
www.epa.gov/pesticides/health/
worker.htm.
Agency Contact: Kathy Davis,
Environmental Protection Agency,
Office of Chemical Safety and Pollution
Prevention, 7506P, Washington, DC
20460, Phone: 703 308–7002, Fax: 703
308–2962, Email: davis.kathy@epa.gov.
Richard Pont, Environmental
Protection Agency, Office of Chemical
Safety and Pollution Prevention, 7506P,
Washington, DC 20460, Phone: 703 305–
6448, Fax: 703 308–2962, Email:
pont.richard@epa.gov.
RIN: 2070–AJ20
EPA
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133. Pesticides; Agricultural Worker
Protection Standard Revisions
Priority: Other Significant.
Legal Authority: 7 U.S.C. 136; 7 U.S.C.
136w
CFR Citation: 40 CFR 170.
Legal Deadline: None.
Abstract: EPA is developing a
proposal under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
to revise the Federal regulations guiding
agricultural worker protection (40 CFR
170). The changes under consideration
are intended to improve agricultural
workers’ ability to protect themselves
from potential exposure to pesticides
and pesticide residues. In addition, EPA
is proposing to make adjustments to
improve and clarify current
requirements and facilitate enforcement.
Other changes sought are to bring
hazard communication requirements
more in line with OSHA requirements
and make improvements to pesticide
safety training, with improved worker
safety the intended outcome. The
potential need for change arose from
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EPA discussions with key stakeholders
beginning in 1996 and continuing
through 2004. EPA held nine public
meetings throughout the country, during
which the public submitted written and
verbal comments on issues of their
concern. In 2000 through 2004, EPA
held meetings where invited
stakeholders identified their issues and
concerns with the regulations.
Statement of Need: Stakeholders have
identified gaps in the protections in the
current regulation. Revisions to the rule
are necessary to better protect
agricultural workers and pesticide
handlers from unreasonable adverse
effects of pesticide exposure.
Summary of Legal Basis: 7 U.S.C. 136
through 7 U.S.C. 136y.
Alternatives: Wherever deficiencies in
the existing regulation could be
adequately addressed through nonregulatory means, EPA has done so. For
example, the Agency has developed
improved training materials that are
sector-specific and in multiple
languages; improved capacity for
outreach; a train-the-trainer program;
health care practitioner (HCP) curricula
to train HCPs on pesticide exposure
identification and treatment; and a
bilingual manual for HCPs to use in
identifying pesticide poisonings. The
Agency also provides financial support
for pesticide safety training.
Anticipated Cost and Benefits:
Incremental costs to agricultural
employers are expected to increase as a
result of revised requirements for
training, notification, and other
protections. Incremental costs to
commercial pesticide handler
employers are expected to decrease.
Benefits will accrue to workers’ and
handlers’ health, and improved
protection of children is expected to be
realized from the proposed revisions.
Risks: Agricultural workers and
pesticide handlers are at risk from
pesticide exposure through their work
activities, and may put their families at
risk of secondary exposure. In order to
address exposure risks to workers,
pesticide handlers, and their families,
the Agency is proposing revisions
identified by stakeholders and the
public.
Timetable:
Action
Date
NPRM ..................
07/00/12
Final Action .........
FR Cite
To Be Determined
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: Federal,
State, Tribal.
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Additional Information: EPA Docket
information: EPA–HQ–OPP–2005–0561.
Sectors Affected: 111 Crop
Production; 32532 Pesticide and Other
Agricultural Chemical Manufacturing;
115 Support Activities for Agriculture
and Forestry.
URL for More Information: https://
www.epa.gov/pesticides/health/
worker.htm.
Agency Contact: Kathy Davis,
Environmental Protection Agency,
Office of Chemical Safety and Pollution
Prevention, 7506P, Washington, DC
20460, Phone: 703 308–7002, Fax: 703
308–2962, Email: davis.kathy@epa.gov.
Richard Pont, Environmental Protection
Agency, Office of Chemical Safety and
Pollution Prevention, 7506P,
Washington, DC 20460, Phone: 703 305–
6448, Fax: 703 308–2962, Email:
pont.richard@epa.gov.
RIN: 2070–AJ22
EPA
134. Formaldehyde; Third-Party
Certification Framework for the
Formaldehyde Standards for Composite
Wood Products
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 15 U.S.C. 2697;
TSCA sec 601
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory,
January 1, 2013.
Abstract: In 2008, EPA initiated a
proceeding under Toxics Substance and
Control Act (TSCA) to investigate risks
posed by formaldehyde emitted from
pressed wood products. An advance
notice of proposed rulemaking
(ANPRM) sought to engage stakeholders
to contribute to obtaining a better
understanding of the available control
technologies and approaches, industry
practices, and the implementation of
California’s formaldehyde emission
limits. Subsequently, EPA developed an
industry survey to obtain more
information on these ANPRM topics and
continued to assess the hazards of and
exposures to formaldehyde emissions
from pressed wood products. On July 7,
2010, the Formaldehyde Standards for
Composite Wood Products Act was
enacted. This law amends TSCA to
establish specific formaldehyde
emission limits for hardwood plywood,
particleboard, and medium-density
fiberboard, which limits are identical to
the California emission limits for these
products. The law further requires EPA
to promulgate implementing regulations
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by January 1, 2013. This rulemaking
covers the mandate for EPA to
promulgate regulations to address
requirements for accrediting bodies and
third-party certifiers. A separate
regulatory agenda entry (RIN 2070-tbd)
covers the mandate for EPA to
promulgate regulations to implement
the statutory formaldehyde emission
standards for hardwood plywood,
medium-density fiberboard, and
particleboard sold, supplied, offered for
sale, or manufactured (including
imported) in the United States.
Statement of Need: EPA is concerned
about the human health risks that may
be presented by exposure to
formaldehyde emissions from composite
wood products, because formaldehyde
is a probable human carcinogen and an
eye, nose, and throat irritant.
Summary of Legal Basis: TSCA title
VI
Alternatives: TSCA title VI establishes
national formaldehyde emission limits
for hardwood plywood, particleboard,
and medium-density fiberboard, and
EPA has not been given the authority to
change the limits. However, EPA will
evaluate various implementation
alternatives during the course of this
rulemaking.
Anticipated Cost and Benefits: EPA is
currently evaluating the costs and
benefits of this action.
Risks: EPA is currently evaluating the
risks presented by exposure to
formaldehyde emissions in excess of the
statutory limits.
Timetable:
Date
FR Cite
ANPRM ...............
ANPRM: Extension of Comment Period.
NPRM ..................
Final Action .........
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Action
12/03/08
01/30/09
73 FR 73620
74 FR 5632
02/00/12
01/00/13
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Additional Information: EPA
publication information: ANPRM—
https://www.regulations.gov/search/
Regs/home.html#documentDetail?R=
09000064807cabb2; EPA Docket
information: ANPRM stage: EPA–HQ–
OPPT–2008–0627; NPRM Stage: EPA–
HQ–OPPT–2011–0380
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Sectors Affected: 325199 All Other
Basic Organic Chemical Manufacturing;
423110 Automobile and Other Motor
Vehicle Merchant Wholesalers; 4441
Building Material and Supplies Dealers;
42321 Furniture Merchant Wholesalers;
4421 Furniture Stores; 337 Furniture
and Related Product Manufacturing;
42331 Lumber, Plywood, Millwork, and
Wood Panel Merchant Wholesalers;
45393 Manufactured (Mobile) Home
Dealers; 321991 Manufactured Home
(Mobile Home) Manufacturing; 336213
Motor Home Manufacturing; 423390
Other Construction Material Merchant
Wholesalers; 325211 Plastics Material
and Resin Manufacturing; 321992
Prefabricated Wood Building
Manufacturing; 441210 Recreational
Vehicle Dealers; 336214 Travel Trailer
and Camper Manufacturing; 3212
Veneer, Plywood, and Engineered Wood
Product Manufacturing.
URL for More Information: https://
www.epa.gov/opptintr/chemtest/
formaldehyde/.
Agency Contact: Cindy Wheeler,
Environmental Protection Agency,
Office of Chemical Safety and Pollution
Prevention, 7404T, Washington, DC
20460, Phone: 202 566–0484, Email:
wheeler.cindy@epa.gov.
Lynn Vendinello, Environmental
Protection Agency, Office of Chemical
Safety and Pollution Prevention, 7404T,
Washington, DC 20460, Phone: 202 566–
0514, Email: vendinello.lynn@epa.gov.
RIN: 2070–AJ44
EPA
135. Mercury; Regulation of Use in
Certain Products
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 15 U.S.C. 2605
CFR Citation: 40 CFR 750.
Legal Deadline: None.
Abstract: Elemental mercury is well
documented as a toxic, environmentally
persistent substance that is
atmospherically transported on a local,
regional, and global scale. In addition,
mercury can be environmentally
transformed into methylmercury, which
bioaccumulates, biomagnifies, and is
highly toxic. EPA conducted a
preliminary analysis of the costs,
advantages, and disadvantages
associated with mercury-free
alternatives to certain mercurycontaining products, and made a
preliminary judgment that effective and
economically feasible alternatives exist.
These mercury-containing products
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include switches, relays/contactors,
flame sensors, and button cell batteries.
Therefore, EPA is evaluating whether an
action (or combination of actions) under
Toxic Substances Control Act (TSCA) is
appropriate for mercury used in such
products. As appropriate, such an
action(s) would involve a group(s) of
these products. Specifically, EPA will
determine whether the continued use of
mercury in one or more of these
products would pose an unreasonable
risk to human health and the
environment.
Statement of Need: Elemental
mercury is well documented as a toxic,
environmentally persistent substance
that is atmospherically transported on a
local, regional, and global scale. In
addition, mercury can be
environmentally transformed into
methylmercury, which bioaccumulates,
biomagnifies, and is highly toxic.
Human health risks associated with
elemental mercury and methylmercury
are well documented. Humans can be
exposed to mercury in products directly
through inhalation of elemental mercury
vapor and indirectly through ingestion
of fish contaminated with
methylmercury. EPA conducted a
preliminary analysis of the costs,
advantages, and disadvantages
associated with mercury-free
alternatives to certain mercurycontaining products, and made a
preliminary judgment that effective and
economically feasible alternatives exist.
In its initial analysis of mercury in
certain products, EPA considered
mercury’s well-documented toxicity,
persistence, ability to bioaccumulate,
ability to be environmentally
transformed into methylmercury, and its
demonstrated ability to be transported
globally, as well as locally. EPA also
considered the availability of effective
and economically feasible alternatives
for mercury in certain products. EPA
believes manufacturing, processing, use,
or disposal of elemental mercury in
these products may result in significant
potential for human and environmental
exposures to elemental mercury and
methylmercury.
Summary of Legal Basis: EPA is
evaluating whether an action (or
combination of actions) under Toxic
Substances Control Act (TSCA), 15
U.S.C. 2601 et seq., is appropriate for
mercury used in certain products. TSCA
provides EPA with authority to require
reporting, recordkeeping, and testing
requirements, and restrictions relating
to chemical substances and/or mixtures.
Specifically, section 4 authorizes EPA to
require testing of chemicals by
manufacturers, importers, and
processors where risks or exposures of
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concern are found. Section 5 authorizes
EPA to require prior notice by
manufacturers, importers, and
processors when it identifies a
‘‘significant new use’’ that could result
in exposures to, or releases of, a
substance of concern. Section 6 gives
EPA the authority to protect against
unreasonable risk of injury to health or
the environment from chemical
substances. If EPA finds that there is a
reasonable basis to conclude that the
chemical’s manufacture, processing,
distribution, use or disposal presents an
unreasonable risk, EPA may by rule take
action to: Prohibit or limit manufacture,
processing, or distribution in commerce;
prohibit or limit the manufacture,
processing, or distribution in commerce
of the chemical substance above a
specified concentration; require
adequate warnings and instructions
with respect to use, distribution, or
disposal; require manufacturers or
processors to make and retain records;
prohibit or regulate any manner of
commercial use; prohibit or regulate any
manner of disposal; and/or require
manufacturers or processors to give
notice of the unreasonable risk of injury,
and to recall products if required.
Section 8 authorizes EPA to require
reporting and recordkeeping by persons
who manufacture, import, process, and/
or distribute chemical substances in
commerce.
Alternatives: EPA conducted a
preliminary analysis of the costs,
advantages, and disadvantages
associated with mercury-free
alternatives to certain mercurycontaining products, and made a
preliminary judgment that effective and
economically feasible alternatives exist.
Anticipated Cost and Benefits: As part
of the economic, exposure, and risk
assessment to support the current
action, EPA is conducting a
comprehensive use-substitute analysis
and industry profile that will consider
the costs and benefits of an action (or
combination of actions) under Toxic
Substances Control Act (TSCA). Those
assessments consider the costs of
mercury-containing and mercury-free
alternatives and the impact that any
action would have on potentially
affected stakeholders, including
economic, human health, and
environmental criteria.
Risks: As part of the economic,
exposure, and risk assessment to
support the current action, EPA is
conducting a comprehensive usesubstitute analysis and industry profile
that will consider the risks associated
with an action (or combination of
actions) under Toxic Substances Control
Act (TSCA). Those assessments consider
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the relative toxicity and other
considerations associated with mercuryfree alternatives to mercury-containing
products and the impact that any action
would have on potentially affected
stakeholders, including economic,
human health, and environmental
criteria.
Timetable:
Action
Date
NPRM ..................
FR Cite
10/00/12
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Additional Information: SAN No.
5312.
Sectors Affected: 325188 All Other
Basic Inorganic Chemical
Manufacturing.
URL for More Information: https://
www.epa.gov/mercury/.
Agency Contact: Thomas Groeneveld,
Environmental Protection Agency,
Office of Chemical Safety and Pollution
Prevention, 7404T, Washington, DC
20460, Phone: 202 566–1188, Fax: 202
566–0469, Email:
groeneveld.thomas@epa.gov.
Lynn Vendinello, Environmental
Protection Agency, Office of Chemical
Safety and Pollution Prevention, 7404T,
Washington, DC 20460, Phone: 202 566–
0514, Email: vendinello.lynn@epa.gov.
RIN: 2070–AJ46
EPA
136. Lead; Renovation, Repair, and
Painting Program for Public and
Commercial Buildings
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 15 U.S.C. 2682(c)(3)
CFR Citation: 40 CFR 745.
Legal Deadline: Other, Judicial, April
22, 2010, Advance Notice of Proposed
Rulemaking, deadline from settlement
agreement.
NPRM, Judicial, June 15, 2012,
Deadline from settlement agreement and
subsequent renegotiation with litigants.
Final, Judicial, February 15, 2014,
Deadline from settlement agreement and
subsequent renegotiation with litigants.
Abstract: Section 402(c)(3) of the
Toxic Substances Control Act (TSCA)
requires EPA to regulate renovation or
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remodeling activities in target housing
(most pre-1978 housing), pre-1978
public buildings, and commercial
buildings that create lead-based paint
hazards. On April 22, 2008, EPA issued
a final rule to address lead-based paint
hazards created by these activities in
target housing and child-occupied
facilities built before 1978 (childoccupied facilities are a subset of public
and commercial buildings or facilities
where children under age 6 spend a
great deal of time). The 2008 rule
established requirements for training
renovators, other renovation workers,
and dust sampling technicians; for
certifying renovators, dust sampling
technicians, and renovation firms; for
accrediting providers of renovation and
dust sampling technician training; for
renovation work practices; and for
recordkeeping. This new rulemaking
will address renovation or remodeling
activities in the remaining buildings
described in TSCA section 402(c)(3):
Public buildings built before 1978 and
commercial buildings that are not childoccupied facilities. On May 6, 2010,
EPA announced the commencement of
proceedings to propose lead-safe work
practices and other requirements for
renovations on the exteriors of public
and commercial buildings and to
determine whether lead-based paint
hazards are created by interior
renovation, repair, and painting projects
in public and commercial buildings. For
those renovations in the interiors of
public and commercial buildings that
create lead-based paint hazards, EPA
will propose regulations to address
these hazards.
Statement of Need: This rulemaking is
being undertaken in response to a
settlement agreement and is designed to
help insure that individuals and firms
conducting renovation, repair, and
painting activities in and on public and
commercial buildings will do so in a
way that safeguards the environment
and protects the health of building
occupants and nearby residents,
especially children under 6 years old.
Lead is known to cause deleterious
health effects on multiple organ systems
through diverse mechanisms of action
in both adults and children. This array
of health effects includes effects on
heme biosynthesis and related
functions, neurological development
and function, reproduction and physical
development, kidney function,
cardiovascular function, and immune
function. EPA has conducted several
studies and reviewed additional
information that indicates that the
renovation of buildings containing leadbased paint can create health hazards in
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the form of lead-based paint dust under
typical industry work practices.
Summary of Legal Basis: Section
402(c)(3) of the Toxic Substances
Control Act (TSCA) requires EPA to
regulate renovation or remodeling
activities that create lead-based paint
hazards in target housing, public
buildings built before 1978, and
commercial buildings.
Alternatives: For those activities that
EPA determines create lead-based paint
hazards, EPA will evaluate options to
address the hazards. These options are
likely to include different combinations
of work practices and worker training
and certification.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
Timetable:
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
Final Action .........
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05/06/10
07/06/10
75 FR 24848
06/00/12
02/00/14
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Additional Information: EPA
publication information: ANPRM—
https://www.regulations.gov/search/
Regs/home.html#documentDetail?R=
0900006480ae7eb8; EPA Docket
information: EPA–HQ–OPPT–2010–
0173.
Sectors Affected: 236 Construction of
Buildings; 921 Executive, Legislative,
and Other General Government Support;
561210 Facilities Support Services; 531
Real Estate; 238 Specialty Trade
Contractors.
URL for More Information: https://
www.epa.gov/lead/pubs/
renovation.htm.
Agency Contact: Hans Scheifele,
Environmental Protection Agency,
Office of Chemical Safety and Pollution
Prevention, 7404T, Washington, DC
20460, Phone: 202 564–3122, Email:
scheifele.hans@epa.gov.
Cindy Wheeler, Environmental
Protection Agency, Office of Chemical
Safety and Pollution Prevention, 7404T,
Washington, DC 20460, Phone: 202 566–
0484, Email: wheeler.cindy@epa.gov.
RIN: 2070–AJ56
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EPA
137. Revisions to the National Oil and
Hazardous Substances Pollution
Contingency Plan; Subpart J Product
Schedule Listing Requirements
Priority: Other Significant.
Legal Authority: 33 U.S.C. 1321(d)(2);
33 U.S.C. 1321(b)(3); CWA 311(d)(2)
CFR Citation: 40 CFR 300; 40 CFR
110.
Legal Deadline: None.
Abstract: EPA is considering
proposing revisions to subpart J of the
National Contingency Plan (NCP). The
Clean Water Act requires EPA to
prepare a schedule of dispersants, other
chemicals, and other spill mitigating
devices and substances, if any, that may
be used in carrying out the NCP. Under
subpart J, respondents wishing to add a
product to the Product Schedule must
submit technical product data to EPA.
The Agency is considering revisions to
subpart J to clarify and/or change the
effectiveness and toxicity testing
protocols required for adding a product
to the Schedule. These changes, if
finalized, will help ensure protection of
the environment when these products
are used to clean up and mitigate oil
spills (1) into or upon navigable waters,
adjoining shorelines, or the waters of
the contiguous zone, or (2) which may
affect natural resources belonging to or
under the exclusive management
authority of the United States. Further,
the Agency is considering proposed
changes to 40 CFR 110.4 regarding the
use of dispersants.
Statement of Need: The
unprecedented use of dispersants on the
surface and in the subsea during the
2010 Deepwater Horizon oil spill in the
Gulf of Mexico raised many questions
about dispersant efficacy, toxicity,
environmental fate, and monitoring. The
public and officials working at local,
State, and Federal levels expressed
concerns regarding the effects of
dispersant use on the ecosystem. These
concerns require a review of the product
toxicity and efficacy testing and
application in the current subpart J
regulatory requirements. Additionally,
the large-scale submission of oilmitigating technologies through the
Interagency Alternative Technology
Assessment Program (IATAP) as a result
of this incident also highlights the need
to re-evaluate the current subpart J
regulations, particularly the technical
data requirements.
Summary of Legal Basis: The Federal
Water Pollution Control Act (FWPCA)
requires the President to prepare and
publish a National Contingency Plan
(NCP) for the removal of oil and
hazardous substances. In turn, the
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President delegated the authority to
implement this section of the FWPCA to
EPA through Executive Order 12777 (56
FR 54757; Oct. 22, 1991). Section
311(d)(2)(G)(i) of the FWPCA (a.k.a.,
Clean Water Act), as amended by the
OPA, requires that the NCP include a
schedule identifying ‘‘dispersants, other
chemicals, and other spill mitigating
devices and substances, if any, that may
be used in carrying out’’ the NCP.
Currently, the use of dispersants, other
chemicals, and other oil spill mitigating
devices and substances (e.g.,
bioremediation agents) to respond to oil
spills in U.S. waters is governed by
subpart J of the NCP (40 CFR part 300
series 900).
Alternatives: To be determined.
Anticipated Cost and Benefits: To be
determined.
Risks: To be determined.
Timetable:
Action
Date
NPRM ..................
08/00/12
Final Action .........
FR Cite
To Be Determined
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: Federal,
Local, State, Tribal.
Additional Information: Includes
Retrospective Review under E.O.13563.
Sectors Affected: 3251 Basic Chemical
Manufacturing; 325 Chemical
Manufacturing; 3259 Other Chemical
Product and Preparation Manufacturing;
54 Professional, Scientific, and
Technical Services.
URL for More Information:
www.epa.gov/oilspill.
Agency Contact: William Nichols,
Environmental Protection Agency, Solid
Waste and Emergency Response, 5104A,
Washington, DC 20460, Phone: 202 564–
1970, Fax: 202 564–2625, Email:
nichols.nick@epa.gov.
Leigh DeHaven, Environmental
Protection Agency, Solid Waste and
Emergency Response, 5104A,
Washington, DC 20460, Phone: 202 564–
1974, Fax: 202 564–2625, Email:
dehaven.leigh@epa.gov.
RIN: 2050–AE87
EPA
138. Stormwater Regulations Revision
To Address Discharges From Developed
Sites
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 1251 et seq.
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CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Judicial,
December 15, 2011, Chesapeake Bay
Settlement Agreement, May 10, 2010,
Fowler v. U.S. EPA, No. 1:09–CV–
00005–CKK (D. D.C) modified by
agreement 10/04/2011. Final, Judicial,
November 19, 2012, Chesapeake Bay
Settlement Agreement, May 10, 2010,
Fowler v. U.S. EPA, No. 1:09–CV–
00005–CKK (D. D.C.).
Abstract: Stormwater discharge from
developed areas is a major cause of
degradation of surface waters. This is
true for both conveyance of pollutants
and the erosive power of increased
stormwater flow rates and volumes.
Current stormwater regulations were
promulgated in 1990 and 1999. In 2006,
the Office of Water asked the National
Research Council (NRC) to review the
stormwater program and recommend
ways to strengthen it. The NRC Report,
which was finalized in October 2008,
found that the current stormwater
program ‘‘* * * is not likely to
adequately control stormwater’s
contribution to waterbody impairment’’
and recommended that EPA take action
to address the harmful effects of
stormwater flow. This proposed action
would establish requirements for, at
minimum, managing stormwater
discharges from newly developed and
re-developed sites, to reduce the amount
of pollutants in stormwater discharges
entering receiving waters by reducing
the discharge of excess stormwater. EPA
may take other actions to implement
improved control of stormwater
pollution and more efficient rainwater
use. The Phase I and Phase II MS4
regulations might also be combined and
amended, and may include provisions
for better managing existing discharges.
Statement of Need: Section 402(p) of
the Clean Water Act requires EPA to
regulate certain stormwater discharges.
Stormwater is a primary contributor of
water quality impairment. There is a
need to strengthen the stormwater
program’s effectiveness by reducing
pollutant loading from currently
regulated and unregulated stormwater
discharges and preserving surface water
health and integrity. This action was
informed by the 2006 National Research
Council report.
Summary of Legal Basis: Section
402(p) of the Clean Water Act requires
EPA to regulate certain discharges from
stormwater in order to protect water
quality.
Alternatives: To be determined.
Anticipated Cost and Benefits: To be
determined.
Risks: To be determined.
Timetable:
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Action
Date
NPRM ..................
Final Action .........
FR Cite
01/00/12
11/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Federal,
Local, State.
Federalism: Undetermined.
Additional Information: EPA Docket
information: EPA–HQ–OW–2009–0817.
URL for More Information:
www.epa.gov/npdes/stormwater/
rulemaking.
Agency Contact: Connie Bosma,
Environmental Protection Agency,
Water, 4203M, Washington, DC 20460,
Phone: 202 564–6773, Fax: 202 564–
6431, Email: bosma.connie@epa.gov.
Janet Goodwin, Environmental
Protection Agency, Water, 4303T,
Washington, DC 20460, Phone: 202 566–
1060, Email:
goodwin.janet@epamail.epa.gov.
RIN: 2040–AF13
EPA
139. Effluent Limitations Guidelines
and Standards for the Steam Electric
Power Generating Point Source
Category
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 1311; 33
U.S.C. 1314; 33 U.S.C. 1316; 33 U.S.C.
1317; 33 U.S.C. 1318; 33 U.S.C. 1342; 33
U.S.C. 1361
CFR Citation: 40 CFR 423 revision.
Legal Deadline: NPRM, Judicial, July
23, 2012, Consent Decree. Final,
Judicial, January 31, 2014, Consent
Decree.
Abstract: EPA establishes national
technology-based regulations, called
effluent guidelines, to reduce discharges
of pollutants from industries to waters
of the U.S. These requirements are
incorporated into National Pollutant
Discharge Elimination System (NPDES)
discharge permits issued by EPA and
States, and through the national
pretreatment program. The steam
electric effluent guidelines apply to
steam electric power plants using
nuclear or fossil fuels, such as coal, oil,
and natural gas. There are about 1,200
nuclear- and fossil-fueled steam electric
power plants nationwide;
approximately 500 of these power
plants are coal fired. In a study
completed in 2009, EPA found that the
current regulations, which were last
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updated in 1982, do not adequately
address the pollutants being discharged
and have not kept pace with changes
that have occurred in the electric power
industry over the last 3 decades. The
rulemaking will address discharges from
ash ponds and flue gas desulfurization
(FGD) air pollution controls, as well as
other power plant waste streams. Power
plant discharges can have major impacts
on water quality, including reduced
organism abundance and species
diversity, contamination of drinking
water sources, and other effects.
Pollutants of concern include metals
(e.g., mercury, arsenic and selenium),
nutrients, and total dissolved solids.
Statement of Need: EPA’s decision to
proceed with a rulemaking was
announced on September 15, 2009. EPA
reviewed wastewater discharges from
power plants and the treatment
technologies available to reduce
pollutant discharges, which
demonstrated the need to update the
current effluent guidelines (40 CFR
423). The current regulations, which
were last updated in 1982, do not
adequately address the pollutants being
discharged and have not kept pace with
changes that have occurred in the
electric power industry over the last 3
decades. Steam electric power plants are
responsible for a significant amount of
the toxic pollutant loadings discharged
to surface waters by point sources, and
coal ash ponds and flue gas
desulfurization (FGD) systems are the
source of much of these pollutants.
Summary of Legal Basis: Section
301(b)(2) of the Clean Water Act
requires EPA to promulgate effluent
limitations for categories of point
sources, using technology-based
standards, that govern the sources’
discharge of certain pollutants. 33
U.S.C. section 1311(b). Section 304(b) of
the Act directs EPA to develop effluent
limitations guidelines (ELGs) that
identify certain technologies and control
measures available to achieve effluent
reductions for each point source
category, specifying factors to be taken
into account in identifying those
technologies and control measures. 33
U.S.C. section 1314(b). Since the 1970s,
EPA has formulated effluent limitations
and ELGs in tandem through a single
administrative process. Am. Frozen
Food Inst. v. Train, 539 F.2d 107 (D.C.
Cir. 1976). The CWA also requires EPA
to perform an annual review of existing
ELGs and to revise them, if appropriate.
33 U.S.C. section 1314(b); see also 33
U.S.C. section 1314(m)(1)(A). EPA
originally established effluent
limitations and guidelines for the steam
electric generating industry in 1974 and
last updated them in 1982. 47 FR 52290
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(Nov. 19, 1982). As described above,
EPA determined the existing regulations
do not adequately address the pollutants
being discharged and that revisions are
appropriate.
Alternatives: To be determined.
Anticipated Cost and Benefits: To be
determined.
Risks: To be determined.
Timetable:
Action
Date
NPRM ..................
Final Action .........
FR Cite
08/00/12
03/00/14
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Additional Information: EPA Docket
information: EPA–HQ–OW–2009–0819.
Sectors Affected: 221112 Fossil Fuel
Electric Power Generation; 221113
Nuclear Electric Power Generation.
URL for More Information: https://
water.epa.gov/scitech/wastetech/guide/
steam_index.cfm.
Agency Contact: Ronald Jordan,
Environmental Protection Agency,
Water, 4303T, Washington, DC 20460,
Phone: 202 566–1003, Fax: 202 566–
1053, Email:
jordan.ronald@epamail.epa.gov.
Jezebele Alicea, Environmental
Protection Agency, Water, 4303T,
Washington, DC 20460, Phone: 202 566–
1755, Fax: 202 566–1053, Email:
alicea.jezebele@epamail.epa.gov.
RIN: 2040–AF14
EPA
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140. National Pollutant Discharge
Elimination System (NPDES)
Concentrated Animal Feeding
Operation (CAFO) Reporting Rule
Priority: Other Significant.
Legal Authority: 33 U.S.C. 1251(a); 33
U.S.C. 1311(a); 33 U.S.C. 1342; 33
U.S.C. 1362(14); 33 U.S.C. 1318(a); 33
U.S.C. 1319
CFR Citation: 40 CFR 122.
Legal Deadline: None.
Abstract: EPA proposed a regulation
that would collect information about
concentrated animal feeding operations
(CAFOs). CAFOs are a significant source
of nutrient pollution and pathogens in
U.S. watersheds. The information that
would be collected under the proposed
rule would allow EPA to increase water
quality protection through better
implementation of the NPDES
permitting program for CAFOs. The
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proposed regulation would apply to all
permitted and unpermitted CAFOs. EPA
co-proposed a regulation that would
only collect information from CAFOs in
targeted areas, if EPA determined such
collection was necessary based on
specified factors, such as water quality
concerns.
Statement of Need: The proposed rule
would collect facility-specific
information about CAFOs to help
inform watershed management
activities. This will enhance EPA’s
ability to effectively implement the
NPDES program.
Summary of Legal Basis: The
proposed rule would collect facilityspecific information about CAFOs to
help inform watershed management
activities. This will enhance EPA’s
ability to effectively implement the
NPDES program and reduce pathogens
from CAFOs.
Alternatives: EPA proposed a number
of alternatives including relying on
existing information to collect
information from CAFOs.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
10/21/11
01/19/12
76 FR 65431
07/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected:
Undetermined.
Agency Contact: Becky Mitschele,
Environmental Protection Agency,
Water, 4203M, Washington, DC 20460,
Phone: 202 564–6418, Email:
mitschele.becky@epamail.epa.gov.
George Utting, Environmental
Protection Agency, Water, 4203M,
Washington, DC 20460, Phone: 202 564–
0744, Email:
utting.george@epamail.epa.gov.
RIN: 2040–AF22
7845
elements of the existing National
Pollutant Discharge Elimination System
(NPDES) in order to better harmonize
regulations and application forms,
improve permit documentation and
transparency and provide clarifications
to the existing regulations. In this effort,
EPA plans to address application,
permitting, monitoring, and reporting
requirements that have become obsolete
or outdated due to programmatic,
technical, or other changes that have
occurred over the past 35 years.
Specifically, EPA plans to focus on
revising the NPDES permit application
forms to specifically include all final
Agency data standards, improving the
consistency between the application
forms, and updating the applications to
better reflect current program practices,
and specifically to incorporate new
program areas into the forms (e.g., Clean
Water Act section 316(b) requirements
for cooling water intake structures). EPA
also plans to address other program
elements, including permit
documentation, EPA State permit
objection, and public participation
procedures to improve the quality and
transparency of permit development. As
an example of a regulation which could
be proposed to change to reduce burden,
as well as improve transparency and
public access to information, EPA is
considering whether to revise the public
notice requirements to allow a State to
post notices of draft NPDES permits and
other permit actions under the Clean
Water Act on their State agency Web
sites in lieu of traditional newspaper
posting.
Statement of Need: Certain
application, permitting, monitoring, and
reporting requirements need to be
updated to reflect programmatic and
technical changes that have occurred
over the past 35 years.
Summary of Legal Basis: 33 U.S.C.
1251 et seq.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
Timetable:
Action
Date
EPA
NPRM ..................
Final Action .........
03/00/12
10/00/12
141. National Pollutant Discharge
Elimination System (NPDES)
Application and Program Updates Rule
Priority: Other Significant.
Legal Authority: 33 U.S.C. 1251 et seq.
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: EPA plans to propose
regulations that would update specific
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
Local, State, Tribal.
Agency Contact: Kathryn Kelley,
Environmental Protection Agency,
Water, 4203M, Washington, DC 20460,
Phone: 202 564–7004, Fax: 202 564–
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9544, Email:
kelley.kathryn@epamail.epa.gov.
David Hair, Environmental Protection
Agency, Water, 4203M, Washington, DC
20460, Phone: 202 564–2287, Fax: 202
564–9544, Email:
hair.david@epamail.epa.gov.
RIN: 2040–AF25
EPA
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Final Rule Stage
142. Review of the Secondary National
Ambient Air Quality Standards for
Oxides of Nitrogen and Oxides of Sulfur
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 7408; 42
U.S.C. 7409
CFR Citation: 40 CFR 50.
Legal Deadline: NPRM, Judicial, July
12, 2011.
Final, Judicial, March 20, 2012, The
court has approved the amendments to
the consent decree incorporating the
revised dates.
Abstract: Under the Clean Air Act,
EPA is required to review and, if
appropriate, revise the air quality
criteria for the primary (health-based)
and secondary (welfare-based) national
ambient air quality standards (NAAQS)
every 5 years. On October 11, 1995, EPA
published a final rule not to revise
either the primary or secondary NAAQS
for nitrogen dioxide (NO2). On May 22,
1996, EPA published a final decision
that revisions of the primary and
secondary NAAQS for sulfur dioxide
(SO2) were not appropriate at that time,
aside from several minor technical
changes. On December 9, 2005, EPA’s
Office of Research and Development
(ORD) initiated the current periodic
review of NO2 air quality criteria with
a call for information in the Federal
Register (FR). On May 3, 2006, ORD
initiated the current periodic review of
SO2 air quality criteria with a call for
information in the FR. Subsequently,
the decision was made to review the
oxides of nitrogen and the oxides of
sulfur together, rather than individually,
with respect to a secondary welfare
standard for NO2 and SO2. This decision
derives from the fact that NO2, SO2, and
their associated transformation products
are linked from an atmospheric
chemistry perspective, as well as from
an environmental effects perspective,
most notably in the case of secondary
aerosol formation and acidification in
ecosystems. This review includes the
preparation of an Integrated Science
Assessment (ISA), Risk/Exposure
Assessment (REA), and a Policy
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Assessment Document (PAD) by EPA,
with opportunities for review by EPA’s
Clean Air Scientific Advisory
Committee and the public. These
documents inform the Administrator’s
proposed decision as to whether to
retain or revise the standards. It should
be noted that this review will be limited
to only the secondary standards; the
primary standards for SO2 and NO2
were reviewed separately. The ISA,
REA, and PAD have been completed,
and a notice of proposed rulemaking
was signed on July 12, 2011. The court
ordered date for the final rule to be
signed is March 20, 2012.
Statement of Need: As established in
the Clean Air Act, the national ambient
air quality standards for oxides of
nitrogen and oxides of sulfur are to be
reviewed every 5 years.
Summary of Legal Basis: Section 109
of the Clean Air Act (42 U.S.C. 7409)
directs the Administrator to propose
and promulgate ‘‘primary’’ and
‘‘secondary’’ national ambient air
quality standards for pollutants
identified under section 108 (the
‘‘criteria’’ pollutants). The ‘‘primary’’
standards are established for the
protection of public health, while
‘‘secondary’’ standards are to protect
against public welfare or ecosystem
effects.
Alternatives: The main alternatives for
the Administrator’s decision on the
review of the national ambient air
quality standards for oxides of nitrogen
and oxides of sulfur are whether to
retain or revise the existing standards.
Anticipated Cost and Benefits: The
Clean Air Act makes clear that the
economic and technical feasibility of
attaining standards are not to be
considered in setting or revising the
NAAQS, although such factors may be
considered in the development of State
plans to implement the standards.
Accordingly, the Agency prepares cost
and benefit information in order to
provide States information that may be
useful in considering different
implementation strategies for meeting
proposed or final standards. Cost and
benefit information is not developed to
support a NAAQS rulemaking until
sufficient policy and scientific
information is available to narrow
potential options for the form and level
associated with any potential revisions
to the standard. Therefore, work on
developing the plan for conducting the
cost and benefit analysis will generally
start 11⁄2 to 2 years following the start
of a NAAQS review.
Risks: During the course of this
review, risk assessments may be
conducted to evaluate public welfare
risks associated with retention or
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revision of the NOx/SOx secondary
standards.
Timetable:
Action
Date
FR Cite
NPRM ..................
Notice—Public
Meeting.
Final Action .........
08/01/11
08/08/11
76 FR 46084
76 FR 48073
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
Local, State, Tribal.
Additional Information: EPA
publication information: NPRM—https://
www.regulations.gov/#!document
Detail;D=EPA_FRDOC_0001–10843;
EPA Docket information: EPA–HQ–
OAR–2007–1145.
Agency Contact: Rich Scheffe,
Environmental Protection Agency, Air
and Radiation, C304–02, Research
Triangle Park, NC 27711, Phone: 919
541–4650, Fax: 919 541–0237, Email:
scheffe.rich@epa.gov.
Karen Martin, Environmental
Protection Agency, Air and Radiation,
C504–06, Research Triangle Park, NC
27711, Phone: 919 541–5274, Fax: 919
541–0237, Email: martin.karen@
epamail.epa.gov.
RIN: 2060–AO72
EPA
143. National Emission Standards for
Hazardous Air Pollutants From Coaland Oil-Fired Electric Utility Steam
Generating Units and Standards of
Performance for Electric Utility Steam
Generating Units
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect State, local or tribal governments
and the private sector.
Legal Authority: Clean Air Act sec
112(d); Clean Air Act sec 111(b)
CFR Citation: 40 CFR 63; 40 CFR 60,
subpart Da.
Legal Deadline: NPRM, Judicial,
March 16, 2011, No later than March 16,
2011, EPA shall sign for publication in
the Federal Register a notice of
proposed rulemaking.
Final, Judicial, December 16, 2011, No
later than December 16, 2011, EPA shall
sign for publication in the Federal
Register a notice of final rulemaking.
Abstract: On May 18, 2005 (70 FR
28606), EPA published a final rule
requiring reductions in emissions of
mercury from Electric Utility Steam
Generating Units. That rule was vacated
on February 8, 2008, by the U.S. Court
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of Appeals for the District of Columbia
Circuit. As a result of that vacatur, coaland oil-fired electric utility steam
generating units remain on the list of
sources that must be regulated under
section 112 of the Clean Air Act (CAA).
The Agency will develop standards
under CAA section 112(d), which will
reduce hazardous air pollutant (HAP)
emissions from this source category.
Recent court decisions on other CAA
section 112(d) rules will be considered
in developing this regulation. The rule
was proposed on May 3, 2011 (76 FR
24976).
Under this action, EPA also proposed
amendments to the criteria pollutant
new source performance standards
(NSPS) for utilities. On February 27,
2006, EPA promulgated amendments to
the utility NSPS and was subsequently
sued by multiple state attorney general
offices and environmental
organizations. On September 2, 2009,
EPA was granted a voluntary remand
without vacatur of the 2006
amendments. Combining the two rules
in a single action provides interested
parties the opportunity to provide
comments on the combined
requirements of the two rules. It also
avoids double-counting either costs or
environmental benefits of the separate
rules.
Statement of Need: Section
112(n)(1)(A) of the Clean Air Act
required EPA to conduct a study of the
hazards to public health resulting from
emissions of hazardous air pollutants
from electric utility steam generating
units and, after considering the results
of that study, determine whether it was
appropriate and necessary to regulate
such units under section 112. The study
was completed in 1998, and, in
December 2000, EPA determined that it
was appropriate and necessary to
regulate coal- and oil-fired electric
utility steam generating units and added
such units to the list of sources for
which standards must be developed
under section 112. The February 8,
2008, vacatur of the May 18, 2005, Clean
Air Mercury Rule and March 29, 2005,
section 112(n) revision rule (which had
removed such sources from the list)
resulted in the requirement to regulate
under section 112 being reinstated.
Summary of Legal Basis: Clean Air
Act, section 112.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: EPA
estimates that this final rule will yield
annual monetized benefits (in 2007$) of
between $37 to $90 billion using a 3
percent discount rate and $33 to $81
billion using a 7 percent discount rate.
The great majority of the estimates are
attributable to co-benefits from 4,200 to
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11,000 fewer PM2.5-related premature
mortalities. The monetized benefits
from reductions in mercury emissions,
calculated only for children exposed to
recreationally caught freshwater fish,
are expected to be $0.004 to $0.006
billion in 2016 using a 3 percent
discount rate and $0.0005 to $0.001
billion using a 7 percent discount rate.
The annual social costs, approximated
by the compliance costs, are $9.6 billion
(2007$) and the annual monetized net
benefits are $27 to $80 billion using 3
percent discount rate or $24 to $71
billion using a 7 percent discount rate.
The benefits outweigh costs by between
3 to 1 or 9 to 1 depending on the benefit
estimate and discount rate used.
Risks: Not yet determined.
Timetable:
Action
Date
FR Cite
Public Hearing
Notice.
NPRM ..................
NPRM Comment
Period Extended.
Final Action .........
04/28/11
76 FR 23768
05/03/11
07/01/11
76 FR 24976
76 FR 38590
12/00/11
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Federal,
Local, State, Tribal.
Federalism: This action may have
federalism implications as defined in
EO 13132.
Energy Effects: Statement of Energy
Effects planned as required by Executive
Order 13211.
Additional Information: EPA
publication information: NPRM—https://
www.regulations.gov/
#!documentDetail;D=EPA-HQ-OAR2009-0234-2910; EPA Docket
information: EPA–HQ–OAR–2009–
0234, EPA–HQ–OAR–2005–0031.
Sectors Affected: 221112 Fossil Fuel
Electric Power Generation.
Agency Contact: Bill Maxwell,
Environmental Protection Agency, Air
and Radiation, D243–01, Research
Triangle Park, NC 27711, Phone: 919
541–5430, Fax: 919 541–5450, Email:
maxwell.bill@epa.gov.
Robert J Wayland, Environmental
Protection Agency, Air and Radiation,
D243–01, Research Triangle Park, NC
27711, Phone: 919 541–1045, Fax: 919
541–5450, Email:
wayland.robertj@epamail.epa.gov.
RIN: 2060–AP52
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EPA
144. Oil and Natural Gas Sector—New
Source Performance Standards and
National Emission Standards for
Hazardous Air Pollutants
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 7411; 42
U.S.C. 7412
CFR Citation: 40 CFR 60; 40 CFR 63.
Legal Deadline: NPRM, Judicial, July
28, 2011, Consent Decree entered 02/04/
2010, 3-month extension granted 1/11/
11, new 3-month extension granted on
4/18/2011. Final, Judicial, April 3, 2012,
Consent Decree deadline.
Abstract: New Source Performance
Standards (NSPS) regulate criteria
pollutants from new stationary sources.
Two NSPS (subparts KKK and LLL) for
the oil and natural gas industry were
promulgated in 1985. Section 111 of the
Clean Air Act (CAA) requires that NSPS
be reviewed every 8 years and revised
as appropriate. National Emission
Standards for Hazardous Air Pollutants
(NESHAP) regulate hazardous air
pollutants (HAP) from new and existing
stationary sources. Two NESHAP
(subparts HH and HHH) for the oil and
natural gas industry were promulgated
in 1999. Section 112 of the CAA
requires that NESHAP be reviewed
every 8 years and revised as
appropriate. In addition, section 112(f)
requires that each category regulated
under section 112(d) be reviewed to
ensure that such regulations provide for
an ample margin of safety to protect
public health (i.e., address ‘‘residual
risk’’ for each category). This action will
include the required reviews under
sections 111 and 112. Because the
existing regulations are narrow in scope,
the reviews will include consideration
of broadening the scope of operations
and emission points covered by the
NSPS and MACT.
Statement of Need: Not yet
determined.
Summary of Legal Basis: Not yet
determined.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: For the
NSPS, the annual costs are estimated at
$738 million. After taking into account
the value of the natural gas and
condensate recovered, there would be a
net savings of $45 million annually. For
the NESHAP, the annual costs of
compliance will be $16 million. EPA
estimates benefits for the VOCs 540,000
tons per year, or about 25 percent
reduction overall; for methane, 3.4
million tpy, which is equal to 65 million
metric tons of carbon dioxide equivalent
(CO2e), which is a reduction of about 26
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percent; and for air toxics, 38,000 tons,
or a reduction of nearly 30 percent.
Risks: Not yet determined.
Timetable:
Action
Date
FR Cite
NPRM ..................
Notice—Public
Meeting.
Final Action .........
08/23/11
08/26/11
76 FR 52738
76 FR 53371
03/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: EPA
publication information: NPRM—https://
www.regulations.gov/
#!documentDetail;D=EPA-HQ-OAR2010-0505-0002; EPA Docket
information: EPA–HQ–OAR–2010–
0505.
URL for More Information: https://
epa.gov/airquality/oilandgas/.
Agency Contact: Bruce Moore,
Environmental Protection Agency, Air
and Radiation, E143–01, Research
Triangle Park, NC 27711, Phone: 919
541–5460, Fax: 919 541–0246, Email:
moore.bruce@epamail.epa.gov.
David Cozzie, Environmental
Protection Agency, Air and Radiation,
1200 Pennsylvania Ave., NW.,
Washington, DC 20460, Phone: 919 541–
5356, Email: cozzie.david@epa.gov.
RIN: 2060–AP76
EPA
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145. Criteria and Standards for Cooling
Water Intake Structures
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Pub. L.
104–4.
Legal Authority: CWA 101; CWA 301;
CWA 304; CWA 308; CWA 316; CWA
401; CWA 402; CWA 501; CWA 510
CFR Citation: 40 CFR 122; 40 CFR
125.
Legal Deadline: NPRM, Judicial,
March 28, 2011.
Final, Judicial, July 27, 2012.
Abstract: Section 316(b) of the Clean
Water Act (CWA) requires EPA to
ensure that the location, design,
construction, and capacity of cooling
water intake structures reflect the best
technology available (BTA) for
minimizing adverse environmental
impacts. Phase II, for existing electric
generating plants that use at least 50
MGD of cooling water, was completed
in July 2004. Industry and
environmental stakeholders challenged
the Phase II regulations. On review, the
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U.S. Court of Appeals for the Second
Circuit remanded several key
provisions.
In July 2007, EPA suspended the
Phase II rule following the decision in
the Second Circuit. Several parties
petitioned the U.S. Supreme Court to
review that decision, and the Supreme
Court granted the petitions, limited to
the issue of whether the Clean Water
Act authorized EPA to consider the
relationship of costs and benefits in
establishing section 316(b) standards.
On April 1, 2009, the Supreme Court
reversed the Second Circuit, finding that
the Agency may consider cost-benefit
analysis in its decisionmaking, but not
holding that the Agency must consider
costs and benefits in these decisions.
In June 2006, EPA promulgated the
Phase III regulation, covering existing
electric generating plants using less than
50 MGD of cooling water, new offshore
oil and gas facilities, and all existing
manufacturing facilities. Petitions to
review this rule were filed in the U.S.
Court of Appeals for the Fifth Circuit. In
July 2010, the U.S. Court of Appeals for
the Fifth Circuit issued a decision
upholding EPA’s rule for new offshore
oil and gas extraction facilities. Further,
the court granted the request of EPA and
environmental petitioners in the case to
remand the existing facility portion of
the rule back to the Agency for further
rulemaking. EPA expects this new
rulemaking would apply to the
approximately 1,200 existing electric
generating and manufacturing plants.
The Fifth Circuit also affirmed that EPA
may consider costs in relation to
benefits but is not required to do so.
EPA entered into a settlement with
the plaintiffs in two lawsuits related to
section 316(b) rulemakings. Under the
settlement agreement, as modified, EPA
agreed to sign a notice of a proposed
rulemaking implementing section 316(b)
of the CWA at existing facilities no later
than March 28, 2011, and to sign a
notice taking final action on the
proposed rule no later than July 27,
2012. Plaintiffs agreed to seek dismissal
of both their suits, subject to a request
to reopen the Cronin proceeding in the
event EPA failed to meet the agreed
deadlines.
EPA’s proposed regulation includes
uniform controls at all existing facilities
to prevent fish from being trapped
against screens (impingement), sitespecific controls for existing facilities
other than new units to prevent fish
from being drawn through cooling
systems (entrainment), and uniform
controls equivalent to closed cycle
cooling for new units at existing
facilities (also entrainment). Other
regulatory options analyzed included
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similar uniform impingement controls
and progressively more stringent
requirements for entrainment controls.
Another option considered would
impose the uniform impingement
controls only for facilities withdrawing
50 million or more gallons per day of
cooling water, with site-specific
impingement controls for facilities
withdrawing less than 50 million
gallons per day.
Statement of Need: In the absence of
national regulations, NPDES permit
writers have developed requirements to
implement section 316(b) on a case-bycase basis. This may result in a range of
different requirements, and in some
cases, delays in permit issuance or
reissuance. This regulation may have
substantial ecological benefits.
Summary of Legal Basis: The Clean
Water Act requires EPA to establish best
technology available standards to
minimize adverse environmental
impacts from cooling water intake
structures. On February 16, 2004, EPA
took final action on regulations
governing cooling water intake
structures at certain existing power
producing facilities under section 316(b)
of the Clean Water Act (Phase II rule).
69 FR 41576 (Jul. 9, 2004). These
regulations were challenged, and the
Second Circuit remanded several
provisions of the Phase II rule on
various grounds. Riverkeeper, Inc., v.
EPA, 475F.3d83, (2d Cir., 2007). EPA
suspended most of the rule in response
to the remand. 72 FR 37107 (Jul. 9,
2007). The remand of Phase III does not
change permitting requirements for
these facilities. Until the new rule is
issued, permit directors continue to
issue permits on a case-by-case, Best
Professional Judgment basis for Phase II
facilities.
Alternatives: This analysis will cover
various sizes and types of potentially
regulated facilities and control
technologies. EPA is considering
whether to regulate on a national basis,
by subcategory, by broad water body
category, or some other basis.
Anticipated Cost and Benefits: The
technologies under consideration in this
rulemaking are similar to the
technologies considered for the original
Phase II and Phase III rules, and costs
have been updated to 2009. The annual
social costs associated with EPA’s
proposed regulation are $384 million,
plus an additional $15 million in costs
associated with the new units provision.
The annual social costs of the other
options ranged from $327 million to
$4.63 billion. EPA monetized only a
portion of the expected annual benefits
of the rule, amounting to $18 million.
The monetized benefits for the other
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options ranged from $17 to $126
million. EPA is also conducting a stated
preference survey to provide a more
comprehensive estimate of the
monetized benefits and expects to
publish a notice of data availability with
these results around the end of 2011.
Risks: Cooling water intake structures
may pose significant risks for aquatic
ecosystems.
Timetable:
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Reopening Public
Comment Period.
Reopening Comment Period
End.
Final Action .........
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Action
04/20/11
07/19/11
76 FR 22174
07/20/11
76 FR 43230
08/18/11
07/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: Federal,
Local, State.
Additional Information: EPA
publication information: NPRM—https://
www.regulations.gov/#!documentDetail;
EPA Docket information: EPA–HQ–
OW–2008–0667.
Sectors Affected: 336412 Aircraft
Engine and Engine Parts Manufacturing;
332999 All Other Miscellaneous
Fabricated Metal Product
Manufacturing; 321999 All Other
Miscellaneous Wood Product
Manufacturing; 324199 All Other
Petroleum and Coal Products
Manufacturing; 326299 All Other
Rubber Product Manufacturing; 331521
Aluminum Die-Casting Foundries;
331524 Aluminum Foundries (except
Die-Casting); 331315 Aluminum Sheet,
Plate, and Foil Manufacturing; 311313
Beet Sugar Manufacturing; 31321
Broadwoven Fabric Mills; 311312 Cane
Sugar Refining; 32731 Cement
Manufacturing; 61131 Colleges,
Universities, and Professional Schools;
33312 Construction Machinery
Manufacturing; 333922 Conveyor and
Conveying Equipment Manufacturing;
331525 Copper Foundries (except DieCasting); 339914 Costume Jewelry and
Novelty Manufacturing; 211111 Crude
Petroleum and Natural Gas Extraction;
321912 Cut Stock, Resawing Lumber,
and Planing; 332211 Cutlery and
Flatware (except Precious)
Manufacturing; 31214 Distilleries;
221121 Electric Bulk Power
Transmission and Control; 221122
Electric Power Distribution; 331112
Electrometallurgical Ferroalloy Product
Manufacturing; 31332 Fabric Coating
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Mills; 333111 Farm Machinery and
Equipment Manufacturing; 311225 Fats
and Oils Refining and Blending; 221112
Fossil Fuel Electric Power Generation;
332212 Hand and Edge Tool
Manufacturing; 33251 Hardware
Manufacturing; 221111 Hydroelectric
Power Generation; 21221 Iron Ore
Mining; 331111 Iron and Steel Mills;
22121 Natural Gas Distribution; 211112
Natural Gas Liquid Extraction; 221113
Nuclear Electric Power Generation;
332323 Ornamental and Architectural
Metal Work Manufacturing; 221119
Other Electric Power Generation;
332618 Other Fabricated Wire Product
Manufacturing; 332439 Other Metal
Container Manufacturing; 332919 Other
Metal Valve and Pipe Fitting
Manufacturing; 321918 Other Millwork
(including Flooring); 312229 Other
Tobacco Product Manufacturing; 333923
Overhead Traveling Crane, Hoist, and
Monorail System Manufacturing; 32212
Paper Mills; 32213 Paperboard Mills;
32411 Petroleum Refineries; 325992
Photographic Film, Paper, Plate, and
Chemical Manufacturing; 333315
Photographic and Photocopying
Equipment Manufacturing; 212391
Potash, Soda, and Borate Mineral
Mining; 332117 Powder Metallurgy Part
Manufacturing; 331312 Primary
Aluminum Production; 331419 Primary
Smelting and Refining of Nonferrous
Metal (except Copper and Aluminum);
3221 Pulp, Paper, and Paperboard Mills;
333911 Pump and Pumping Equipment
Manufacturing; 33651 Railroad Rolling
Stock Manufacturing; 321219
Reconstituted Wood Product
Manufacturing; 54171 Research and
Development in the Physical,
Engineering, and Life Sciences; 326192
Resilient Floor Covering Manufacturing;
331221 Rolled Steel Shape
Manufacturing; 322291 Sanitary Paper
Product Manufacturing; 321113
Sawmills; 331492 Secondary Smelting,
Refining, and Alloying of Nonferrous
Metal (except Copper and Aluminum);
337215 Showcase, Partition, Shelving,
and Locker Manufacturing; 321212
Softwood Veneer and Plywood
Manufacturing; 311222 Soybean
Processing; 22133 Steam and AirConditioning Supply; 331222 Steel Wire
Drawing; 111991 Sugar Beet Farming;
11193 Sugarcane Farming; 311311
Sugarcane Mills; 326211 Tire
Manufacturing (except Retreading);
31221 Tobacco Stemming and Redrying;
311221 Wet Corn Milling.
URL for More Information: https://
water.epa.gov/lawsregs/lawsguidance/
cwa/316b/index.cfm.
Agency Contact: Paul Shriner,
Environmental Protection Agency,
Water, 4303T, Washington, DC 20460,
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7849
Phone: 202 566–1076, Email:
shriner.paul@epamail.epa.gov.
Julie Hewitt, Environmental
Protection Agency, Water, 4303T,
Washington, DC 20460, Phone: 202 566–
1031, Email:
hewitt.julie@epamail.epa.gov.
RIN: 2040–AE95
BILLING CODE 6560–50–P
EQUAL EMPLOYMENT OPPORTUNITY
COMMISSION (EEOC)
Statement of Regulatory and
Deregulatory Priorities
The mission of the Equal Employment
Opportunity Commission (EEOC,
Commission, or agency) is to ensure
equality of opportunity in employment
by vigorously enforcing seven Federal
statutes. These statutes are: Title VII of
the Civil Rights Act of 1964, as amended
(prohibits employment discrimination
on the basis of race, color, sex, religion,
or national origin); the Equal Pay Act of
1963, as amended (makes it illegal to
pay unequal wages to men and women
performing substantially equal work at
the same establishment, unless the
difference is attributable to a bona fide
seniority, merit, or incentive system, or
to a factor other than sex); the Age
Discrimination in Employment Act of
1967 (ADEA) as amended (prohibits
employment discrimination based on
age of 40 or older); titles I and V of the
Americans with Disabilities Act, as
amended, and sections 501 and 505 of
the Rehabilitation Act, as amended
(prohibits employment discrimination
based on disability); title II of the
Genetic Information Nondiscrimination
Act (GINA) (prohibits employment
discrimination based on genetic
information and limits acquisition and
disclosure of genetic information); and
section 304 of the Government
Employee Rights Act of 1991 (protects
certain previously exempt State and
local government employees from
employment discrimination on the basis
of race, color, religion, sex, national
origin, age, disability, or genetic
information).
The item in this Regulatory Plan is
entitled ‘‘Disparate Impact and
Reasonable Factors Other Than Age
Under the Age Discrimination in
Employment Act.’’ This item previously
appeared as two separate items titled
‘‘Disparate Impact Burden of Proof
Under the Age Discrimination in
Employment Act’’ (RIN 3046–AA76)
and ‘‘Reasonable Factors Other Than
Age Under the Age Discrimination in
Employment Act’’ (RIN 3046–AA87).
These two items have been merged, and
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a final rule will be issued addressing the
issues covered in both (appearing under
RIN 3046–AA76).
Prior to the Supreme Court’s decision
in Smith v. City of Jackson, 544 U.S. 228
(2005), Commission regulations
interpreted the ADEA to require
employers to prove that actions that had
an age-based disparate impact were
justified as a business necessity.
Although the Court, in Smith, agreed
with the EEOC that disparate impact
claims were recognizable under the
ADEA, it held that the defense was not
business necessity but reasonable
factors other than age (RFOA). The
Smith Court did not specify whether the
employer or employee bore the burden
of proof on the RFOA defense.
On March 31, 2008, the Commission
issued a Notice of Proposed Rulemaking
(NPRM) to conform Commission ADEA
regulations to Smith, also taking the
position that the employer bore the
burden of proving the defense. Because
current EEOC regulations do not define
the meaning of ‘‘RFOA,’’ the NPRM
asked whether regulations should
provide more information on the
meaning of ‘‘reasonable factors other
than age’’ and, if so, what the
regulations should say. 73 FR 16807
(March 31, 2008). Subsequently, the
Supreme Court held in Meacham v.
Knolls Atomic Laboratory, 554 U.S. 84,
128 S. Ct. 2395 (2008), that employers
have the RFOA burdens of production
and persuasion. After consideration of
the public comments, and in light of the
Supreme Court decisions, the
Commission issued a second NPRM on
February 18, 2010, to address the scope
of the RFOA defense. A final rule will
be issued addressing the topics covered
in both NPRMs and conforming to both
Smith and Meacham. The rule will not
have a significant impact on small
businesses because, among other
reasons, their employment actions
generally will not affect individuals in
numbers sufficient to raise questions of
disparate impact.
This item is highlighted in EEOC’s
Plan for Retrospective Review of
Significant Regulations, developed
pursuant to Executive Order 13563.
Consistent with section 4(c) of
Executive Order 12866, this statement
was reviewed and approved by the
Chair of the Agency. The statement has
not been reviewed or approved by the
other members of the Commission.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
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(RINs) have been identified as
associated with retrospective review
and analysis in the EEOC’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in The Regulatory Plan.
However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov. These
rulemakings can also be found on
Regulations.gov. The final agency plans
can be found at: https://www.eeoc.gov/
laws/regulations/retro_review_plan_
final.cfm.
RIN: 3046–AA76
Disparate Impact and Reasonable
Factors Other Than Age Under the Age
Discrimination in Employment Act
This rulemaking is not expected to
alter burdens on small businesses.
RIN: 3046–AA73
Federal Sector Equal Employment
Opportunity Complaint Processing
This rulemaking does not apply to
small businesses. It applies only to the
Federal Government.
EEOC
Final Rule Stage
146. Disparate Impact and Reasonable
Factors Other Than Age Under the Age
Discrimination in Employment Act
Priority: Other Significant.
Legal Authority: 29 U.S.C. 628
CFR Citation: 29 CFR 1625.7(d).
Legal Deadline: None.
Abstract: Prior to the Supreme Court’s
decision in Smith v. City of Jackson, 544
U.S. 228 (2005), Commission
regulations interpreted the ADEA to
require employers to prove that actions
that had an age-based disparate impact
were justified as a business necessity.
Although the Court, in Smith, agreed
with the EEOC that disparate impact
claims were cognizable under the
ADEA, it held that the defense was not
business necessity but reasonable
factors other than age (RFOA). The
Smith Court did not specify whether the
employer or employee bore the burden
of proof on the RFOA defense.
On March 31, 2008, the Commission
issued a Notice of Proposed Rulemaking
(NPRM) to conform Commission ADEA
regulations to Smith, also taking the
position that the employer bore the
burden of proving the defense. Because
current EEOC regulations do not define
the meaning of ‘‘RFOA,’’ the NPRM also
asked whether regulations should
provide more information on the
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meaning of ‘‘reasonable factors other
than age’’ and, if so, what the
regulations should say. 73 FR 16807
(March 31, 2008). Subsequently, the
Supreme Court held in Meacham v.
Knolls Atomic Laboratory, 554 U.S. 84,
128 S. Ct. 2395 (2008), that employers
have the RFOA burdens of production
and persuasion. After consideration of
the public comments, and in light of the
Supreme Court decisions, the
Commission issued a second NPRM on
February 18, 2010 to address the scope
of the RFOA defense. A final rule will
be issued addressing the issues covered
in both NPRMs and conforming to both
Smith and Meacham.
The RIN associated with the NPRM
titled ‘‘Reasonable Factors Other Than
Age Under the Age Discrimination in
Employment Act’’ (RIN 3046–AA87) has
been merged with this item (RIN 3046–
AA76), which will be the RIN used to
identify the final rule.
Statement of Need: Current EEOC
regulations interpret the ADEA as
prohibiting an employment practice that
has a disparate impact on individuals
within the protected age group unless it
is justified as a business necessity. The
Supreme Court’s holding in Smith v.
City of Jackson validated the
Commission’s position that disparate
impact analysis applies in ADEA cases.
The holding, however, differed from the
Commission’s position that the business
necessity test was the appropriate
standard for determining the lawfulness
of a practice that had an age-based
disparate impact. The EEOC is revising
its regulation to reflect the Smith
decision. Moreover, as noted above, a
related item (RIN #3046–AA87) entitled
‘‘Reasonable Factors Other Than Age
Under the Age Discrimination in
Employment Act’’ has been merged with
this item. In this final rule, the EEOC is
also revising its regulations to address
the scope of the RFOA defense.
Summary of Legal Basis: The ADEA
authorizes the EEOC ‘‘to issue such
rules and regulations it may consider
necessary or appropriate for carrying out
this chapter * * *.’’ 29 U.S.C. section
628.
Alternatives: The Commission has
considered all alternatives proposed by
the public comments.
Anticipated Cost and Benefits: Based
on the information currently available,
the EEOC does not anticipate that the
rule will have significant economic
effects. The purpose of the rule is to
help explain the implications of recent
Supreme Court decisions and the type
of conduct that would support an RFOA
defense in court. It therefore does not
directly require any action on the part
of covered entities.
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The regulation makes clear that the
employer’s burden is to prove the
RFOA, rather than the more stringent
business necessity, defense. Further, the
rule instructs covered entities what to
do if they want to ensure that their
practices are based on reasonable factors
other than age. The rule does not
expand the coverage of the ADEA to
additional employers or employees, and
does not include reporting,
recordkeeping, or other requirements for
compliance. Costs would result
primarily from voluntary modifications
to covered entities’ business practices
made to protect against disparate-impact
liability. Modifications may include
performing disparate impact analyses of
business practices before they are
adopted, providing guidance to
decisionmakers on how to implement
the practice, and evaluating other
options to mitigate harm. The costs will
be minimal, because these actions are
required, for purposes of establishing
the RFOA defense, only to the extent
that a reasonable employer would
perform them under the circumstances.
Many covered entities already routinely
perform them. To the extent that the
regulation motivates employers to take
additional actions, free resources
minimize the cost of doing so.
This revision, informed by the
comments of stakeholders, will be
beneficial to courts, employers, and
employees seeking to interpret,
understand, and comply with the
ADEA.
Risks: The rule does not affect risks to
public health, safety, or the
environment.
Timetable:
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
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Action
03/31/08
05/30/08
73 FR 16807
12/00/11
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: Federal,
Local, State, Tribal.
Additional Information: Includes
Retrospective Review under E.O. 13563.
Agency Contact: Dianna B. Johnston,
Senior Attorney Advisor, Office of Legal
Counsel, Equal Employment
Opportunity Commission, 131 M Street
NE., Washington, DC 20507, Phone: 202
663–4657, Fax: 202 663–4679, Email:
dianna.johnston@eeoc.gov.
Lyn McDermott, Senior Attorney
Advisor, Office of Legal Counsel, Equal
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Employment Opportunity Commission,
131 M Street NE., Washington, DC
20507, Phone: 202 663–4663, Fax: 202
663–4679, Email:
lyn.mcdermott@eeoc.gov.
Related RIN: Related to 3046–AA87.
RIN: 3046–AA76
BILLING CODE 6570–01–P
FINANCIAL STABILITY OVERSIGHT
COUNCIL (FSOC)
Statement of Regulatory Priorities
Title I, subtitle A, of the Dodd-Frank
Wall Street Reform and Consumer
Protection Act (‘‘Dodd-Frank’’ or ‘‘Act’’)
established the Financial Stability
Oversight Council (FSOC or Council).
The purpose of the FSOC is to identify
risks to the financial stability of the
United States that could arise from the
material financial distress or failure, or
ongoing activities, of large,
interconnected bank holding companies
or nonbank financial companies. In
addition, the Council is responsible for
promoting market discipline and
responding to emerging risks to the
stability of the United States financial
system. The duties of the FSOC are set
forth in section 112(a)(2) of the Act. The
FSOC consists of 10 voting members
and 5 non-voting members, who serve
in an advisory capacity. The Secretary
of the Treasury serves as Chairperson.
Dodd-Frank provides the FSOC with
authority to issue certain regulations to
carry out the business of the Council
and for certain other purposes. In
October 2011, the FSOC issued a revised
notice of proposed rulemaking with
guidance on the framework that the
Council will apply when considering
the designation of nonbank financial
companies that will be subject to
consolidated supervision by the Federal
Reserve and enhanced prudential
standards. In fiscal year 2012, the
Council will approve a rule, which will
be issued by the Secretary of the
Treasury, outlining an assessment
schedule to collect assessments from
bank holding companies with greater
than $50bn in total assets and non-bank
financial companies supervised by the
FRB, to provide for the total expenses of
the Office of Financial Research and the
Council. Additionally, the Council will
issue a final rule to implement the
Freedom of Information Act that will set
forth procedures for requesting access to
FSOC records.
Over the next several months, the
FSOC and its members will continue
efforts to issue regulations, policies, and
guidance mandated by the Act and to
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7851
take other actions necessary to
effectively carry out the Act.
BILLING CODE 4810–25–P
GENERAL SERVICES
ADMINISTRATION (GSA)
I. Mission and Overview
GSA oversees the business of the
Federal Government. GSA’s acquisition
solutions supplies Federal purchasers
with cost-effective, high-quality
products and services from commercial
vendors. GSA provides workplaces for
Federal employees and oversees the
preservation of historic Federal
properties. GSA helps keep the Nation
safe by providing tools, equipment, and
non-tactical vehicles to the U.S.
military, and providing State and local
governments with law enforcement
equipment, firefighting and rescue
equipment, and disaster recovery
products and services.
GSA serves the public by delivering
services directly to its Federal
customers through the Federal
Acquisition Service (FAS), the Public
Buildings Service (PBS), and the Office
of Governmentwide Policy (OGP). GSA
has a continuing commitment to its
Federal customers and the U.S.
taxpayers by providing those services in
the most cost-effective manner possible.
Federal Acquisition Service (FAS)
FAS is the lead organization for
procurement of products and services
(other than real property) for the Federal
Government. The FAS organization
leverages the buying power of the
Government by consolidating Federal
agencies requirements for common
goods and services. FAS provides a
range of high-quality and flexible
acquisition services that increase overall
Government effectiveness and
efficiency. FAS business operations are
organized into four business portfolios
based on the product or service
provided to customer agencies:
Integrated Technology Services (ITS);
Assisted Acquisition Services (AAS);
General Supplies and Services (GSS);
and Travel, Motor Vehicles and Card
Services (TMVCS). The FAS portfolio
structure enables GSA and FAS to
provide best value services, products,
and solutions to its customers by
aligning resources around key functions.
Public Buildings Service (PBS)
PBS is the largest public real estate
organization in the United States,
providing facilities and workspace
solutions to more than 60 Federal
agencies. PBS aims to provide a superior
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workplace for the Federal worker and
superior value for the U.S. taxpayer.
Balancing these two objectives is PBS’
greatest management challenge. PBS’
activities fall into two broad areas. The
first is space acquisition through both
leases and construction. PBS translates
general needs into specific
requirements, marshals the necessary
resources, and delivers the space
necessary to meet the respective
missions of its Federal clients. The
second area is management of space.
This involves making decisions on
maintenance, servicing tenants, and
ultimately, deciding when and how to
dispose of a property at the end of its
useful life.
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Office of Governmentwide Policy (OGP)
OGP sets Governmentwide policy in
the areas of personal and real property,
travel and transportation, information
technology, regulatory information, and
use of Federal advisory committees.
OGP also helps direct how all Federal
supplies and services are acquired as
well as GSA’s own acquisition
programs. OGP’s regulatory function
fully incorporates the provisions of the
President’s priorities and objectives
under Executive Order 12866 and 13563
with policies covering acquisition,
travel, and property and management
practices to promote efficient
Government operations. OGP’s strategic
direction is to ensure that
Governmentwide policies encourage
agencies to develop and utilize the best,
most cost effective management
practices for the conduct of their
specific programs. To reach the goal of
improving Governmentwide
management of property, technology,
and administrative services, OGP builds
and maintains a policy framework by (1)
incorporating the requirements of
Federal laws, Executive orders, and
other regulatory material into policies
and guidelines; (2) facilitating
Governmentwide reform to provide
Federal managers with business-like
incentives and tools and flexibility to
prudently manage their assets; (3)
identifying, evaluating, and promoting
best practices to improve efficiency of
management processes; and (4)
performing ongoing analysis if existing
rules that may be obsolete, unnecessary,
unjustified, excessively burdensome, or
counterproductive. In regard to the
retrospective analysis of existing rules,
GSA’s plan (dated Aug. 18, 2011) has
been approved by OMB.
OGP’s policy regulations are
described in the following subsections:
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Office of Travel, Transportation, and
Asset Management (Federal Travel
Regulation)
Federal Travel Regulation (FTR)
enumerates the travel and relocation
policy for all title 5 executive agency
employees. The Code of Federal
Regulations (CFR) is available at
www.gpoaccess.gov/cfr. Each version is
updated as official changes are
published in the Federal Register (FR).
FR publications and complete versions
of the FTR are available at www.gsa.gov/
ftr.
The FTR is the regulation contained
in 41 Code of Federal Regulations (CFR),
chapters 300 through 304, that
implements statutory requirements and
executive branch policies for travel by
Federal civilian employees and others
authorized to travel at Government
expense.
The Administrator of General Services
promulgates the FTR to: (a) Interpret
statutory and other policy requirements
in a manner that balances the need to
ensure that official travel is conducted
in a responsible manner with the need
to minimize administrative costs and (b)
communicate the resulting policies in a
clear manner to Federal agencies and
employees.
Office of Travel, Transportation, and
Asset Management (Federal
Management Regulation)
Federal Management Regulation
(FMR) establishes policy for aircraft,
transportation, personal property, and
mail management. The FMR is the
successor regulation to the Federal
Property Management Regulation
(FPMR), and it contains updated
regulatory policies originally found in
the FPMR. However, it does not contain
FPMR material that describes how to do
business with the GSA.
Office of Acquisition Policy (Federal
Acquisition Regulation and GSA
Acquisition Regulation Manual)
GSA helps provide to the public and
the Federal buying community the
updating and maintaining of the rule
book for all Federal agency
procurements, the Federal Acquisition
Regulation (FAR). This is achieved
through its extensive involvement with
the Federal Acquisition Regulatory
(FAR) Council. The FAR Council is
comprised of senior representation from
the Office of Federal Procurement
Policy (OFPP), National Aeronautics
and Space Administration (NASA), the
Department of Defense (DoD), and GSA.
The FAR Council directs the writing
of the FAR cases, which is
accomplished, in part, by teams of
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expert FAR analysts. All changes to the
FAR are accompanied by review and
analysis of public comment. Public
comments play an important role in
clarifying and enhancing this
rulemaking process. The regulatory
agenda pertaining to changes to the FAR
are outside the scope of this discussion
as GSA cannot speak on behalf of the
FAR Council.
GSA’s internal rules and practices on
how it buys goods and services from its
business partners are covered by the
General Services Administration
Acquisition Manual (GSAM) and the
General Services Administration
Acquisition Regulation (GSAR). The
GSAM is closely related to the FAR as
it supplements areas of the FAR where
GSA has additional and unique
regulatory requirements. Office of
Acquisition Policy writes and revises
the GSAM and the GSAR. The size and
scope of the FAR are substantially larger
than the GSAR. In effect, the GSAR and
the GSAM adds to the FAR by providing
additional guidance to GSA officials and
its business partners.
Federal Acquisition Regulation (FAR):
The FAR was established to codify
uniform policies for acquisition of
supplies and services by executive
agencies. It is issued and maintained
jointly, pursuant to the Office of Federal
Procurement Policy (OFPP)
Reauthorization Act, under the statutory
authorities granted to the Secretary of
Defense, Administrator of General
Services, and the Administrator,
National Aeronautics and Space
Administration. Statutory authorities to
issue and revise the FAR have been
delegated to the procurement executives
in Department of Defense (DoD), GSA,
and National Aeronautics and Space
Administration (NASA).
GSA Acquisition Regulation Manual
(GSAM) along with Acquisition Letters:
The GSAM incorporates the GSAR, as
well as internal agency acquisition
policy. The rules that require
publication fall into two major
categories:
• Those that affect GSA’s business
partners (e.g., prospective offerors and
contractors).
• Those that apply to acquisition of
leasehold interests in real property. The
FAR does not apply to leasing actions.
GSA establishes regulations for lease of
real property under the authority of 40
U.S.C. 490 note.
GSA Acquisition Regulation (GSAR):
The GSAR establishes agency
acquisition rules and guidance, which
contains agency acquisition policies and
practices, contract clauses, solicitation
provisions, and forms that control the
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relationship between GSA and
contractors and prospective contractors.
• Migrating supply and procurement
policy from the FPMR to the FMR.
II. Statement of Regulatory and
Deregulatory Priorities
GSAR Regulatory Priorities
FTR Regulatory Priorities
In fiscal year 2012, GSA plans to
amend the FTR by:
• Revising the Relocation Income Tax
(RIT) Allowance; amending coverage on
family relocation;
• Amending the calculations
regarding the commuted rate for
employee-managed household goods
shipments; and
• Removing the Privately Owned
Vehicle (POV) rates from the FTR;
amending reimbursement for employees
staying in their privately owned homes/
condos while on TDY.
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FMR Regulatory Priorities
In fiscal year 2012, GSA plans to
amend the FMR by:
• Revising rules regarding
management of government aircraft;
• Revising rules regarding mail
management;
• Amending coverage in motor
vehicle management by revising the
definition of ‘‘motor vehicle rental’’;
• Migrating the provisions of the
Federal Property Management
Regulations (FPMR) regarding purchase
of new motor vehicles to the FMR;
• Migrating the provisions of the
Interagency Fleet Management Systems
from the Federal Property Management
Regulations (FPMR) into the FMR;
• Incorporating the requirements of
the Presidential Memorandum on
Federal Fleet Performance of May 24,
2011, that all agencies develop annual
vehicle allocation methodologies to
rightsize their fleets and that by fiscal
year 2015 all light duty vehicles
acquired be alternatively fueled;
• Amending transportation
management regulations by revising
coverage on open skies agreements,
obligation authority, and training for
civilian transportation officers, and
transportation data collection;
• Amending Transportation
Management and Audit by revising the
requirements regarding the refund of
unused and expired tickets;
• Publishing procedures for handling
the transfer of title for vehicles to
donees via State Agencies for Surplus
Property; removing activities related to
the Federal Asset Sales program, which
initiated the program (policies began
rulemaking process in fiscal year 2011);
• Removing aircraft, aircraft-related
parts, fire control equipment, and
guided missiles from the exchange/sale
prohibited list; and
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GSA plans, in fiscal year 2012, to
finalize the rewrite of the GSAR to
maintain consistency with the Federal
Acquisition Regulation (FAR) and to
implement streamlined and innovative
acquisition procedures that contractors,
offerors, and GSA contracting personnel
can utilize when entering into and
administering contractual relationships.
Currently, there are only a few parts of
the GSAR rewrite effort still
outstanding.
GSA is clarifying the GSAR by—
• Providing consistency with the
FAR;
• Eliminating coverage that
duplicates the FAR or creates
inconsistencies within the GSAR;
• Correcting inappropriate references
listed to indicate the basis for the
regulation;
• Rewriting sections that have
become irrelevant because of changes in
technology or business processes or that
place unnecessary administrative
burdens on contractors and the
Government;
• Streamlining or simplifying the
regulation;
• Rolling up coverage from the
services and regions/zones that should
be in the GSAR;
• Providing new and/or augmented
coverage; and
• Deleting unnecessary burdens on
small businesses.
Specific GSAR cases that the agency
plans to address in FY 2012 and 2013
include:
• The rewrite of GSAM part 515,
Contracting by Negotiation.
• The rewrite of GSAM part 538,
Federal Supply Schedule Contracting.
• The rewrite of GSAM part 536,
Construction and A/E Contracts.
These cases are more fully described
in the Agency’s approved Final Plan for
Retrospective Analysis of Existing Rules
(Aug. 18, 2011), created in response to
Executive Order 13563.
Regulations of Concern to Small
Businesses
FAR and GSAR rules are relevant to
small businesses who do or wish to do
business with the Federal Government.
Approximately 18,000 businesses, most
of whom are small, have GSA schedule
contracts. GSA assists its small
businesses by providing assistance
through its Office of Small Business
Utilization. In addition, GSA
extensively utilizes its regional
resources, within FAS and PBS, to
provide grass-roots outreach to small
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7853
business concerns, through hosting such
outreach events, or participating in a
vast array of other similar presentations
hosted by others.
Regulations Which Promote Open
Government and Disclosure
While there are currently no
regulations which promote open
Government and disclosure, all
Government contract spend transactions
are available online through Federal
Procurement Data System-Next
Generation (FPDS–NG).
Regulations Required by Statute or
Court Order
GSA plans to publish FTR Case 2011–
308; Payment of Expenses Connected
with the Death of Certain Employees in
FY 2012. Presidential Memorandum
‘‘Delegation Under Section 2(a) of the
Special Agent Samuel Hicks Families of
Fallen Heroes Act’’, dated September
12, 2011, delegates to the Administrator
of General Services the authority to
issues regulations under Public Law
111–178, the Special Agent Samuel
Hicks Families of Fallen Heroes Act,
codified at 5 U.S.C. 5724d, relating to
the payment of certain expenses when
a covered employee dies as a result of
injuries sustained in the performance of
his or her official duties. GSA is
amending the FTR to establish policy
for the transportation of the immediate
family, household goods, personal
effects, and one privately owned vehicle
of a covered employee whose death
occurred as a result of personal injury
sustained while in the performance of
the employee’s duty as defined by the
agency.
Regulation Required by Office of
Federal Procurement Policy (OFPP)
A FAR case will be necessary to
implement OFPP Policy Letter 11–01;
Performance of Inherently
Governmental and Critical Functions.’’
Updates will be provided in the Spring
Regulatory Agenda.
III. Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (January 18, 2011),
the following Regulatory Identifier
Numbers (RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in The Regulatory Plan.
However, more information can be
found about these completed
rulemakings in past publications of the
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Note: The GSAR cases do not specifically
provide relief to small businesses or
additional administrative flexibility to state,
local or tribal governments. However, we do
believe that updating and clarifying the
regulation will benefit all contractors (and
Schedule users).
Unified Agenda on Reginfo.gov in the
Completed Actions section for that
agency. These rulemakings can also be
found on Regulations.gov. The final
agency plans can be found at:
www.gsa.gov/improvingregulations.
FAR Rules
• 9000–AL93 FAR Case 2007–012;
Requirements for Acquisitions Pursuant
to Multiple-Award Contracts; yes, this
rule increases competition which will
benefit small businesses.
• 9000–AL46 FAR Case 2008–025;
Preventing Personal Conflicts of Interest
for Contractor Employees Performing
Acquisition Functions; no specific
impact on small businesses.
• 9000–AL82 FAR Case 2011–001;
Organizational Conflicts of Interest; no
specific impact on small businesses.
• 9000–AL88 FAR Case 2011–004;
Socioeconomic Program Parity; this
rule, implementing Section 1347 of the
Small Business Jobs Act of 2010,
specifically impacts small businesses;
however, no overall negative impact is
expected.
• 9000–AM12 FAR Case 2011–024;
Set-Asides for Small Business; yes, this
rule, implementing Section 1331 of the
Small Business Jobs Act of 2010, will
increase opportunities for small
business contractors authorizing
agencies to set aside more work for
small businesses under multiple award
contracts.
GSAR Rules
• 3090–A177 GSAR Case 2006–
G507; Rewrite of GSAR Part 538,
Federal Supply Schedule Contracting.
• 3090–A176 GSAR Case 2008–
G506; Rewrite of GSAR Part 515,
Contracting by Negotiation.
• 3090–A181 GSAR Case 2008–
G509; Rewrite of GSAR Part 536,
Construction and A/E Contracts.
BILLING CODE 6820–34–P
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION (NASA)
Statement of Regulatory Priorities
NASA continues to implement
programs according to its 2011 Strategic
Plan, released in February 2011.
NASA’s mission is to ‘‘Drive advances
in science, technology, and exploration
to enhance knowledge, education,
innovation, economic vitality, and
stewardship of the Earth.’’ The 2011
Strategic Plan guides NASA’s program
activities through a framework of the
following six strategic goals:
• Goal 1: Extend and sustain human
activities across the solar system.
• Goal 2: Expand scientific
understanding of Earth and the universe
in which we live.
• Goal 3: Create innovative new space
technologies for our exploration,
science, and economic future.
• Goal 4: Advance aeronautics
research for societal benefit.
• Goal 5: Enable program and
institutional capabilities to conduct
NASA’s aeronautics and space
activities.
• Goal 6: Share NASA with the
public, educators, and students to
provide opportunities to participate in
our mission, foster innovation, and
contribute to a strong national economy.
In the decades since Congress enacted
the National Aeronautics and Space Act
of 1958, NASA has challenged its
scientific and engineering capabilities in
pursuing its mission, generating
tremendous results and benefits for
humankind. NASA will continue to
push scientific and technical boundaries
in pursuing of these goals.
The Federal Acquisition Regulation
(FAR), 48 CFR chapter 1, contains
procurement regulations that apply to
NASA and other Federal agencies.
NASA implements and supplements
FAR requirements through the NASA
FAR Supplement (NFS), 48 CFR chapter
18. NASA will review and update the
entire NFS. During the second half of
FY 2012 with projected completion of
January 2013, NASA will report these
regulatory actions in the spring 2012
Unified Agenda. Concurrently, we will
continue to make routine changes to the
NFS to implement NASA initiatives and
Federal procurement policy.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13579 ‘‘Regulation and
Independent Regulatory Agencies’’ (Jul.
11, 2011), the following Regulation
Identifier Numbers (RINs) have been
identified as associated with
retrospective review and analysis in
NASA’s final retrospective review of
regulations plan. Some of these entries
on this list may be completed actions,
which do not appear in The Regulatory
Plan. However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov in the
Completed Actions section for NASA.
These rulemakings can also be found on
Regulations.gov. NASA’s final plans can
be found at https://www.nasa.gov/open.
Regulation
Identifier No.
Title
2700–AD56 ...............................................
2700–AD60 ...............................................
NASA Grant and Cooperative Agreement Handbook, Delete Requirement for U.S. Citizenship.
NASA Grant and Cooperative Agreement: Change Procedures for Letter of Credit Advance Payments.
NASA Grant Handbook, Payment of Profit and/or Management Expenses on Cooperative Agreements.
Non Procurement Rule, Suspension and Debarment.
NASA, Contract Adjustment Board.
NASA Grant and Cooperative Agreement Handbook: Update, Streamline and Reorganize.
Use of NASA Airfield Facilities by Aircraft Not Operated for the Benefit of the Federal Government.
Small Business Policy.
Space Flight.
Inventions and Contributions.
Information Security Protection.
Claims for Patent and Copyright Infringement.
Procedures for Implementing the National Environmental Policy Act.
Tracking and Data Relay Satellite System.
Delegation of authority to license the use of Centennial of Flight Commission name, Delegation of
authority of certain civil rights functions to Department of Health, Education, and Welfare, and
Care and use of animals in the conduct of NASA activities—REPEALS.
Collection of Civil Claims of the United States Arising Out of the Activities of NASA.
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2700–AD79 ...............................................
2700–AD81
2700–AD82
2700–AD94
2700–AD96
2700–AD97
2700–AD98
2700–AD51
2700–AD61
2700–AD63
2700–AD71
2700–AD72
2700–AD78
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2700–AD83 ...............................................
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Regulation
Identifier No.
2700–AD84
2700–AD85
2700–AD86
2700–AD87
2700–AD88
2700–AD89
2700–AD90
2700–AD91
2700–AD92
2700–AD95
2700–AD99
2700–AE00
Title
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
...............................................
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Research Misconduct.
Accessibility Standards for New Construction and Alterations in Federally-Assisted Programs.
Privacy Act—NASA Regulations.
Space Flight Mission Critical Systems Personnel Reliability Program.
Aeronautics and Space—Statement of Organization and General Information.
Security Program; Arrest Authority and Use of Force by NASA Security Force Personnel.
Inspection of Persons and Personal Effects at NASA Installations or on NASA’s Property.
NASA Security Areas.
Information Security Program—NASA Regulations.
Delegations and Designations.
Duty-Free Entry of Space Articles.
National Space Grant College and Fellowship Program.
Abstracts for regulations to be
amended or repealed between October
2011 and October 2012 are reported in
the fall 2011 edition of Unified Agenda
of Federal Regulatory and Deregulation
actions.
BILLING CODE 7510–13–P
NATIONAL ARCHIVES AND RECORDS
ADMINISTRATION (NARA)
Statement of Regulatory Priorities
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Overview
The National Archives and Records
Administration (NARA) issues
regulations directed to other Federal
agencies and to the public. Records
management regulations directed to
Federal agencies concern the proper
management and disposition of Federal
records. Through the Information
Security Oversight Office (ISOO), NARA
also issues Governmentwide regulations
concerning information security
classification and declassification
programs. NARA regulations directed to
the public address access to and use of
our historically valuable holdings,
including archives, donated historical
materials, Nixon Presidential materials,
and Presidential records. NARA also
issues regulations relating to the
National Historical Publications and
Records Commission (NHPRC) grant
programs.
NARA has three regulatory priorities
for fiscal year 2012, which are included
in The Regulatory Plan.
The first is a continuation of the
previous fiscal year’s update to NARA’s
regulations related to declassification of
classified national security information
in records transferred to NARA’s legal
custody. The rule incorporates changes
resulting from promulgation of
Executive Order 13526, Classified
National Security Information. These
changes include establishing procedures
for the automatic declassification of
records in NARA’s legal custody and
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revising requirements for
reclassification of information to meet
the provisions of E.O. 13526. Executive
Order 13526 also created the National
Declassification Center (NDC) with a
mission to align people, processes, and
technologies to advance the
declassification and public release of
historically valuable permanent records
while maintaining national security.
The Notice of Proposed Rulemaking was
published on July 8, 2011.
The second priority is NARA’s
revisions to the Federal records
management regulations found at 36
CFR chapter XII, subchapter B, to
include the Electronic Records Archives
(ERA). ERA is NARA’s system that
Federal agencies use to draft new
records retention schedules for records,
officially submit those schedules for
approval by NARA, request the transfer
of records to NARA for accessioning or
pre-accessioning, and submit electronic
records for storage in the ERA electronic
records repository. The revisions will
cover provisions in 36 CFR parts 1220,
1225, 1226, and 1235.
The third priority is NARA’s revisions
to its Freedom of Information Act
(FOIA) regulations, clarifying the
applicability of the FOIA to categories of
records in NARA’s holdings.
officially submit those schedules for
approval by NARA, request the transfer
of records to NARA for accessioning or
pre-accessioning, and submit electronic
records for storage in the ERA electronic
records repository. The revisions will
cover provisions in 36 CFR parts 1220,
1225, 1226, and 1235.
Statement of Need: NARA will revise
the Federal records management
regulations found at 36 CFR chapter XII,
subchapter B, to include the Electronic
Records Archives (ERA). ERA is
NARA’s system that Federal agencies
use to draft new records retention
schedules for records, officially submit
those schedules for approval by NARA,
request the transfer of records to NARA
for accessioning or pre-accessioning,
and submit electronic records for
storage in the ERA electronic records
repository. The revisions will cover
provisions in 36 CFR parts 1220, 1225,
1226, and 1235.
Summary of Legal Basis: 44 U.S.C.
2107(2).
Alternatives: None.
Anticipated Cost and Benefits: None.
Risks: None.
Timetable:
Action
NPRM ..................
NARA
Proposed Rule Stage
147. • Federal Records Management;
Electronic Records Archives (ERA)
Priority: Other Significant.
Legal Authority: 44 U.S.C. 2107
CFR Citation: 36 CFR 1235.
Legal Deadline: None.
Abstract: The National Archives and
Records proposes to revise the Federal
records management regulations found
at 36 CFR chapter XII, subchapter B, to
include the Electronic Records Archives
(ERA). ERA is NARA’s system that
Federal agencies use to draft new
records retention schedules for records,
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Date
FR Cite
04/00/12
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: Federal.
URL for Public Comments:
regulations.gov.
Agency Contact: Laura McCarthy,
National Archives and Records
Administration, 8601 Adelphi Road,
College Park, MD 20740, Phone: 301
837–3023, Email:
laura.mccarthy@nara.gov.
RIN: 3095–AB74
BILLING CODE 7515–01–P
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OFFICE OF PERSONNEL
MANAGEMENT (OPM)
Recruitment, Relocation, and Retention
Incentives
Statement of Regulatory Priorities
In OPM’s continuing effort to improve
the administration and oversight of
recruitment, relocation, and retention
incentives, OPM anticipates issuing
final regulations to improve oversight of
group recruitment incentive
determinations and all retention
incentives, add succession planning to
the list of factors that an agency may
consider before approving a retention
incentive, and provide that OPM may
require data on recruitment, relocation,
and retention incentives from agencies
on an annual basis. These regulations
will help support OPM’s efforts to
ensure agencies actively manage their
incentive programs so that they
continue to be cost-effective
compensation tools.
The Office of Personnel
Management’s mission is to ensure the
Federal Government has an effective
civilian workforce. OPM fulfills that
mission by, among other things,
providing human capital advice and
leadership for the President and Federal
agencies; delivering human resources
policies, products, and services; and
holding agencies accountable for their
human capital practices. OPM’s 2011
regulatory priorities are designed to
support these activities.
Pay System for Senior Professionals
(SL/ST)
OPM proposes to amend rules for
setting and adjusting pay of senior-level
(SL) and scientific and professional (ST)
employees. The Senior Professional
Performance Act of 2008 changed pay
for these employees by eliminating their
previous entitlement to locality pay and
providing instead for rates of basic pay
up to the rate payable for level III of the
Executive Schedule (EX–III), or if the
employee is under a certified
performance appraisal system, the rate
payable for level II of the Executive
Schedule (EX–II). Consistent with this
statutory emphasis on performancebased pay, these regulations will
provide more flexible rules for agencies
to set and adjust pay for SL and ST
employees based primarily upon
individual performance, contribution to
the agency’s performance, or both, as
determined under a rigorous
performance appraisal system.
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Managing Senior Executive Performance
OPM proposes to revise the
regulations addressing the performance
management of Senior Executives to
provide for a Governmentwide appraisal
system built around the Executive Core
Qualifications and agency mission
results. During fiscal year 2011, the
President’s Management Council (PMC)
sponsored several workgroups to
address various SES-related issues. One
of the recommendations from the work
group on SES appraisal system
certification, and supported by the PMC,
the Chief Human Capital Officers
Council, OPM, and OMB, was the
creation of a Governmentwide appraisal
system for the SES to support and
facilitate interagency consistency and
mobility of this Governmentwide corps.
The new regulations will provide a
common structure and basic
requirements, while allowing flexibility
to address agency-specific needs.
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Benefits for Reservists and Their Family
Members
OPM anticipates issuing final
regulations to implement section
565(b)(1) of the National Defense
Authorization Act (NDAA) for Fiscal
Year (FY) 2010 (Pub. L. 111–84, Oct. 28,
2009) that amends the Family and
Medical Leave Act (FMLA) provisions at
5 U.S.C. 6381 to 6383 to add qualifying
exigencies to the circumstances or
events that entitle Federal employees to
up to 12 administrative workweeks of
FMLA unpaid leave during any 12month period. The final regulations
would amend OPM’s current regulations
at part 630, subpart L, to cover
qualifying exigencies when the spouse,
son, daughter, or parent of the employee
is on covered active duty in the Armed
Forces or has been notified of an
impending call or order to covered
active duty. OPM proposes eight
categories of qualifying exigencies:
Short-notice deployments, military
events and related activities, childcare
and school activities, financial and legal
arrangements, counseling, rest and
recuperation, post-deployment
activities, and additional activities not
encompassed in the other categories
when the agency and employee agree
they qualify as exigencies, including the
timing and duration of the leave.
Suitability Reinvestigations
OPM anticipates issuing final
regulations modifying suitability
regulations to assist agencies in carrying
out new requirements to reinvestigate
individuals in public trust positions
under Executive Order 13488, Granting
Reciprocity on Excepted Service and
Federal Contractor Employee Fitness
and Reinvestigating Individuals in
Positions of Public Trust, to ensure their
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continued employment is appropriate.
The proposed rule was originally
published on November 3, 2009, at 74
FR 56747, with the comment period
ending on January 4, 2010. A new notice
was provided on November 5, 2010, at
75 FR 68222 to provided additional
information relative to the scope of
reinvestigations for public trust
positions in order to allow for further
comment as to reinvestigation
frequency.
Designation of National Security
Position
OPM anticipates issuing final
regulations regarding designation of
national security positions. The
proposed rule was published on
December 14, 2010, at 75 FR 77783, as
one of a number of initiatives OPM has
undertaken to simplify and streamline
the system of Federal Government
investigative and adjudicative processes
to make them more efficient and as
equitable as possible. The purpose of
the revised rule is to clarify the
requirements and procedures agencies
should observe when designating
national security positions as required
under Executive Order 10450, Security
Requirements for Government
Employment. The regulations will
clarify the categories of positions, which
by virtue of the nature of their duties
have the potential to bring about a
material adverse impact on the national
security, whether or not the positions
require access to classified information.
The regulations also will acknowledge,
for greater clarity, complementary
requirements set forth in part 731,
Suitability, so that every position is
properly designated with regard to both
public trust risk and national security
sensitivity considerations. Finally, the
rule will clarify when reinvestigation of
individuals in national security
positions is required.
Pathways
OPM proposes to issue regulations
based on the Executive Order (E.O.)
13562 ‘‘Recruiting and Hiring Students
and Recent Graduates’’ issued December
27, 2010. This E.O. established the
concept of Pathways Programs to
promote employment opportunities for
students and recent graduates in the
Federal workforce, as well as provides
an exception to the competitive hiring
rules. The Pathways Programs consist of
three discrete excepted service
internships programs for students and
recent graduates: The Internship
Program; the Recent Graduates Program;
and the Presidential Management
Fellows Program. The E.O. also
established a new excepted service
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Schedule D in the Code of Federal
Regulation (5 CFR).
Hiring Reform—Recruitment, Selection,
and Placement (General) Job
Announcement and Applicant
Notification
OPM proposes to amend the
regulations concerning the content of a
job announcement. We are also
proposing to add regulations to require
Federal agencies to notify applicants at
key stages in the hiring process; to
require agencies to use alternative valid
assessment tools, excluding lengthy
written essays or narratives of
knowledge, skills, and abilities/
competencies, and to require agencies to
´
´
accept cover letters and resumes as the
initial application for a Federal job.
With these changes, OPM plans to
streamline the Federal hiring process
and improve an applicant’s experience.
Schedule A—Elimination of Job
Readiness Certification for People With
Disabilities
OPM proposes to amend its
regulations on the appointment of
persons with mental retardation, severe
physical disabilities, or psychiatric
disabilities. The proposed changes will
eliminate the certification of job
readiness requirement for people with
mental retardation, severe physical
disabilities, or psychiatric disabilities
using the Schedule A appointment
authority.
Noncompetitive Appointment of Certain
Former Overseas Employees
OPM is issuing a proposed regulation
to clarify that an employee’s same-sex
domestic partner qualifies and should
be treated as a family member for
purposes of eligibility for
noncompetitive appointments based on
overseas employment, as provided in
section 315.608 of title 5, Code of
Federal Regulations. These regulations
implemented, in part, a June 2, 2010,
Presidential Memorandum by providing
same-sex domestic partners with the
same employment opportunities that
opposite-sex spouses of Federal
employees receive under 5 CFR 315.608.
Multi-State Exchanges; Implementations
for Affordable Care Act Provisions
The U.S. Office of Personnel
Management (OPM) is proposing to
implement regulations for the
provisions of the Affordable Care Act of
2010 in order for OPM to contract with
at least two multi-State plans for the
Affordable Insurance Exchanges to be
offered in 2014.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in The Regulatory Plan.
However, more information can be
found about these completed
rulemakings in past publications of the
Unified Agenda on Reginfo.gov in the
Completed Actions section for that
agency. These rulemakings can also be
found on Regulations.gov. The final
agency plans can be found at: https://
www.opm.gov/open/.
Small Business
Impact
RIN
Title
3206–AL93 ................
3206–AM00 ...............
3206–AM18 ...............
3206–AM20 ...............
3206–AM24 ...............
Absence and Leave; Sick Leave .....................................................................................................
Recruitment, Selection, and Placement (General) Job Announcement and Applicant Notification
Personnel Management in Agencies; Employee Surveys ..............................................................
Presumption of Insurable Interest for Same-Sex Domestic Partners .............................................
Regulatory Requirements for Alcoholism and Drug Abuse Programs and Services for Federal
Civilian Employees.
Designation of National Security Positions .....................................................................................
Change in Definitions; Evacuation Pay and the Separate Maintenance Allowance at Johnston
Island.
Excepted Service, Career and Career-Conditional Employment; and Pathways Programs ..........
Noncompetitive Appointment of Certain Former Overseas Employees .........................................
Agency Use of Appropriated Funds for Child Care Costs for Lower Income Employees .............
Federal Employees Health Benefits Program; Community-Rated Health Plans ............................
Retirement Systems Modernization ................................................................................................
3206–AM27 ...............
3206–AM31 ...............
3206–AM34 ...............
3206–AM35 ...............
3206–AL36 ................
3206–AM39 ...............
3206–AM45 ...............
BILLING CODE 6325–44–P
PENSION BENEFIT GUARANTY
CORPORATION (PBGC)
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Statement of Regulatory and
Deregulatory Priorities
The Pension Benefit Guaranty
Corporation (PBGC) protects the
pensions of about 44 million people in
about 27,500 private-sector defined
benefit plans. PBGC receives no funds
from general tax revenues. Operations
are financed by insurance premiums,
investment income, assets from pension
plans trusteed by PBGC, and recoveries
from the companies formerly
responsible for the trusteed plans.
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To carry out these functions, PBGC
issues regulations on such matters as
termination, payment of premiums,
reporting and disclosure, and
assessment and collection of employer
liability. The Corporation is committed
to issuing simple, understandable,
flexible, and timely regulations to help
affected parties.
PBGC intends that its regulations
(new and existing) implement the law in
ways that do not impede the
maintenance of existing defined benefit
plans or the establishment of new plans.
Thus, in developing new regulations
and reviewing existing regulations, the
focus, to the extent possible, is to avoid
placing burdens on plans, employers,
and participants, and to ease and
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N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
simplify employer compliance. In
particular, PBGC strives to meet the
needs of small businesses that sponsor
defined benefit plans.
PBGC develops its regulations in
accordance with the principles set forth
in Executive Order 13563 ‘‘Improving
Regulation and Regulatory Review’’
(Jan. 18, 2011) and PBGC’s Plan for
Regulatory Review (Regulatory Review
Plan), which can be found at
www.pbgc.gov/documents/plan-forregulatory-review.pdf. This Statement of
Regulatory and Deregulatory Priorities
reflects the initial results of the
Regulatory Review Plan.
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PBGC Insurance Programs
PBGC administers two insurance
programs for privately defined benefit
plans under title IV of the Employee
Retirement Income Security Act of 1974
(ERISA): A single-employer plan
termination insurance program and a
multiemployer plan insolvency
insurance program.
• Single-Employer Program. Under
the single-employer program, when a
plan terminates with insufficient assets
to cover all plan benefits (distress and
involuntary terminations), PBGC pays
plan benefits that are guaranteed under
title IV. PBGC also pays nonguaranteed
plan benefits to the extent funded by
plan assets or recoveries from
employers.
• Multiemployer Program. The
smaller multiemployer program covers
about 1,500 collectively bargained plans
involving more than one unrelated
employer. PBGC provides financial
assistance (in the form of a loan) to the
plan if the plan is unable to pay benefits
at the guaranteed level. Guaranteed
benefits are less than single-employer
guaranteed benefits.
At the end of fiscal year 2010, PBGC
had a $23 billion deficit in its insurance
programs.
Regulatory Objectives and Priorities
PBGC’s regulatory objectives and
priorities are developed in the context
of the Corporation’s statutory purposes:
• To encourage voluntary private
pension plans;
• To provide for the timely and
uninterrupted payment of pension
benefits; and
• To keep premiums at the lowest
possible levels.
Pensions and the statutory framework
in which they are maintained and
terminated are inherently complex.
Despite this inherent complexity, PBGC
is committed to issuing simple,
understandable, flexible, and timely
regulations and other guidance that do
not impose undue burdens that could
impede maintenance or establishment of
defined benefit plans.
Through its regulations and other
guidance, PBGC strives to minimize
burdens on plans, plan sponsors, and
plan participants; simplify filing;
provide relief for small businesses and
Title
plans; and assist plans in complying
with applicable requirements. To
enhance policymaking through
collaboration, PBGC also plans to
expand opportunities for public
participation in rulemaking (see Open
Government and Public Participation
below).
PBGC’s current regulatory objectives
and priorities are to reconsider two
proposed regulations, continue to
provide targeted relief in certain
premium situations, and complete
implementation of the Pension
Protection Act of 2006 (PPA 2006).
PBGC will streamline requirements and
reduce unjustified burdens as much as
possible in its planned rulemakings.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Department’s final
retrospective review of regulations plan.
The proposals are described below.
RIN
Effect on Small Business
1212–AB06
Liability for Termination of Single-Employer Plans; Treatment of Substantial Cessation of Operations; ERISA section 4062(e).
Assessment of and Relief From Information Penalties .............................................
Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets ...
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Reportable Events; Pension Protection Act of 2006 .................................................
1212–AB20
1212–AB04
1212–AA55
Reportable events. PPA 2006 affected
certain provisions in the PBGC’s
reportable events regulation (part 4043),
which requires employers to notify
PBGC of certain plan or corporate
events. In November 2009, PBGC
published a proposed rule to conform
the regulation to the PPA 2006 changes
and make other changes.1 In response to
Executive Order 13563 and comments
on the non-PPA provisions of the
proposed rule, PBGC decided to repropose the rule. PBGC is trying to take
advantage of other existing reporting
requirements and methods to avoid
burdening companies and plans. PBGC
is also considering how to implement
stakeholder suggestions that different
reporting requirements should apply in
circumstances where the risk to PBGC is
low or compliance is especially
burdensome. PBGC expects that the new
proposal will more effectively target
troubled plans while reducing burden
for healthy plans and sponsors. The
target date for publication of a new
proposed rule is March 2012.
ERISA section 4062(e). The statutory
provision requires reporting of, and
liability for, certain substantial
cessations of operations by employers
that maintain single-employer plans. In
August 2010, PBGC issued a proposed
rule to provide guidance on the
applicability and enforcement of section
4062(e).2 In light of comments, PBGC is
reconsidering its 2010 proposed rule. In
particular, PBGC is considering
reducing the reporting burden and tying
4062(e) to actual risk through the same
approaches being considered for
reportable events. The target date for
publication of a new proposed rule is
June 2012.
Information penalty policy. PBGC
plans to amend its regulation on Rules
for Administrative Review of Agency
Decisions (part 4003) to cover
information penalties under ERISA
section 4071. This amendment, which
1 74 FR 61248 (Nov. 23, 2009), www.pbgc.gov/
Documents/E9-28056.pdf.
2 75 FR 48283 (Aug. 10, 2010), www.pbgc.gov/
Documents/2010-19627.pdf.
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Expected to reduce burden on small
business.
Expected to reduce burden on small
business.
No significant effect on burden.
Undetermined.
was part of an earlier proposed rule,
would make the process for assessing
and reviewing information penalties
more transparent and consistent with
other agency determinations. The target
date for publication of a final rule is
January 2012.
Changes in other regulations to
improve plan and PBGC administration.
PBGC will review selected aspects its
regulations on Benefits Payable in
Terminated Single-Employer Plans (part
4022), Allocation of Assets in SingleEmployer Plans (part 4044) and
Withdrawal Liability for Multiemployer
Plans (Subchapter I) and Insolvency,
Reorganization, Termination, and Other
Rules Applicable to Multiemployer
Plans (Subchapter J) to eliminate
obsolete provisions, simplify language,
and fill in gaps where guidance would
be helpful to the public and the relevant
operating departments. See the
Regulatory Review Plan for details.
Premium Payment Relief
PBGC is granting relief in three types
of situations under its premium
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regulations.3 PBGC decided to grant this
relief as a result of its regulatory review
under Executive Order 13563 and in
response to comments from premium
payers and pension professionals. In
that same spirit, PBGC is considering
revising its premium penalty policy—
appendix to PBGC’s regulation on
Payment of Premiums (part 4007)—to be
more flexible in the case of clerical or
administrative errors generally and is
already taking steps in this direction.
Such changes could remove undue
penalty burdens on plan sponsors where
there is minimal risk to the pension
insurance system or intent to evade
regulatory requirements. See Small
Businesses for a possible regulatory
initiative affecting small businesses and
plans.
PPA 2006 Implementation
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Cash balance plans. PPA 2006
changed the rules for determining
benefits in cash balance plans and other
statutory hybrid plans. In October 2011,
PBGC published a proposed rule
implementing the changes in both
PBGC-trusteed plans and in plans that
close out in the private sector. PBGC
expects to finalize the proposal in 2012.
Missing participants. Currently,
PBGC’s Missing Participants Program
applies only to terminating singleemployer defined benefit plans insured
by PBGC. PPA 2006 expanded the
program to cover single-employer plans
sponsored by professional service
employers with fewer than 25
employees, multiemployer defined
benefit plans, and 401(k) and other
defined contribution plans. PBGC is
developing a proposed rule to
implement the expansion and
streamline the existing program. The
target date for publication of the
proposed rule is June 2012.
Shutdown benefits. Under PPA 2006,
the phase-in period for the guarantee of
a benefit payable solely by reason of an
‘‘unpredictable contingent event,’’ such
as a plant shutdown, starts no earlier
than the date of the shutdown or other
unpredictable contingent event. PBGC
published a proposed rule
implementing this statutory change in
3 76 FR 57082 (Sep. 15, 2011), www.pbgc.gov/
Documents/2011–23692.pdf. For 2011 and later
plan years, PBGC is waiving premium penalties
assessed solely because payments are late by not
more than 7 calendar days. For 2010 and later plan
years, PBGC is providing relief similar to, but more
expansive than, the relief provided in 2010 under
Technical Update 10–2: Variable Rate Premiums;
Alternative Premium Funding Target Elections; Box
5 Relief. For 2008 and 2009 plan years, PBGC is
waiving premium penalties for late premiums in
connection with certain errors in connection with
alternative premium funding target elections.
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March 20114 and received one
comment. The target date for
publication of a final rule is May 2012.
Commercial airline plans. Under PPA
2006, there are special rules for
commercial airline plans that elected
the PPA 2006 17-year funding relief and
terminate within 10 years of the
election. The amount of benefits
guaranteed in such plans is fixed as of
the first plan year to which funding
relief applies, with plan assets first
allocated to the amount of guaranteed
benefits lost due to the new rules. The
target date for a proposed rule
implementing these rules is June 2012.
Owner-participant benefits. ERISA
contains special guarantee and asset
allocation rules that apply to ownerparticipants in terminating underfunded
plans. PPA 2006 simplified these rules
and applied them only to majority (50%
or more) owners, as opposed to
substantial (10% or more) owners, as
was the case previously. The target date
for publication of a proposed rule
implementing these changes is June
2012.
Other Regulations
DC to DB plan rollovers. PBGC is
developing a proposed rule to address
title IV treatment of rollovers from
defined contribution plans to defined
benefit plans, including asset allocation
and guarantee limits. The target date for
publication of this proposed rule is May
2012.
ERISA section 4010. In response to
comments, PBGC has begun reviewing
its regulation on Annual Financial and
Actuarial Information Reporting (part
4010) and the related e-filing
application to consider ways of
reducing reporting burden, without
forgoing receipt of critical information.
PBGC is considering waiving reporting
for plans that must file 4010 information
solely based on (1) the conditions for a
statutory lien resulting from missed
required contributions totaling over one
million dollars being met or (2)
outstanding funding waivers totaling
over one million dollars. Waiving such
reporting would reduce the compliance
and cost burden on plan sponsors;
PBGC can obtain some information
similar to that reported under section
4010 from other sources, such as
reportable events filings. PBGC is also
considering other changes to section
4010 reporting that would further
reduce burden for financially sound
companies, by taking into account
company financial health and targeting
reporting more closely to the risk of
4 76 FR 13304 (Mar. 11, 2011), www.pbgc.gov/
Documents/2011-5696.pdf .
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plan termination; such changes might
require legislative action.
Small Businesses
PBGC takes into account the special
needs and concerns of small businesses
in making policy. A large percentage of
the plans insured by PBGC are small or
maintained by small employers. PBGC
is considering several proposed rules
that will focus on small businesses:
Small plan premium due date. The
premium due date for plans with fewer
than 100 participants is 4 months after
year-end (April 30 for calendar year
plans). PBGC has heard that some small
plans with year-end valuation dates
have difficulty meeting the filing
deadline because such plans
traditionally do not complete their
actuarial valuation for funding purposes
until after the premium due date. In
light of this concern, PBGC will review
part 4007 to determine whether changes
could be made that would enable small
plans to streamline their premium
valuation procedures and thereby
reduce actuarial fees. PBGC will
consider several options (e.g., extending
the due date or permitting the use of
prior-year data).
Missing participants. See Missing
participants under PPA 2006
Implementation above. Expansion of the
program will benefit small businesses
closing out terminating plans.
Owner-participant benefits. See
Owner-participant benefits under PPA
2006 Implementation above. These rules
primarily affect small businesses.
Open Government and Public
Participation
PBGC views public participation as
very important to regulatory
development and review. For example,
PBGC’s current efforts to reduce
regulatory burden are in substantial part
a response to public comments.
Regulatory projects discussed above,
such as reportable events, ERISA section
4062(e), and ERISA section 4010,
highlight PBGC’s customer-focused
efforts to reduce regulatory burden.
PBGC’s Regulatory Review Plan sets
forth ways to expand opportunities for
public participation in the regulatory
process. For example, PBGC plans to
hold public hearings as it develops
major regulations, so that the agency has
a better understanding of the needs and
concerns of plan administrators and
plan sponsors.
Further, PBGC plans to provide
additional means for public
involvement, including online town hall
meetings, social media, and continuing
opportunity for public comment on
PBGC’s Web site.
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PBGC also invites comments on the
Regulatory Review Plan on an ongoing
basis as we engage in the review
process. Comments should be sent to
regs.comments@pbgc.gov.
PBGC will continue to look for ways
to further improve its regulations.
BILLING CODE 7709–01–P
U.S. SMALL BUSINESS
ADMINISTRATION (SBA)
Statement of Regulatory Priorities
Overview
The mission of the U.S. Small
Business Administration (SBA) is to
maintain and strengthen the Nation’s
economy by enabling the establishment
and viability of small businesses and by
assisting in economic recovery of
communities after disasters. In carrying
out this mission, SBA strives to improve
the economic and regulatory
environment for small businesses,
including those in areas that have
significantly higher unemployment and
lower income levels than the Nation’s
averages and those in traditionally
underserved markets. The Agency
serves as a guarantor of small business
loans and provides management and
technical assistance to existing or
potential small business owners to help
them grow, sustain, or start their
businesses. The Agency also provides
direct financial assistance to
communities that have experienced
catastrophes. This assistance is a critical
factor in rebuilding the communities
and their devastated economies. SBA’s
regulatory policy encompasses these
objectives and is implemented primarily
through several core program offices:
Office of Capital Access, Office of
Government Contracting and Business,
Office of Entrepreneurial Development,
and Office of Disaster Assistance. Other
offices, such as the Office of Veterans
Business Development and Office of
Native American Affairs, also play a role
in developing and shaping Agency
regulatory policy that affects veterans,
American Indians, Alaska Natives,
Native Hawaiians, and the indigenous
people of Guam and American Samoa.
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Reducing Burden on Small Businesses
SBA strives to develop regulations
that, to the extent possible, reduce or
eliminate the burden on the public,
especially its core constituents—small
businesses. The Agency’s regulatory
process generally includes an
assessment of the relative costs and
benefits of the regulations, as required
by Executive Order 12866 ‘‘Regulatory
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Planning and Review’’ and Executive
Order 13563, as well as an analysis
under the Regulatory Flexibility Act of
whether regulations will have a
significant economic impact on small
businesses or small entities. Where
practicable or feasible, SBA also
analyzes whether there are alternative
approaches to a proposed regulation
that would be more beneficial to the
public. SBA’s program offices are
particularly invested in finding ways to
reduce the burden imposed by the
Agency’s loan, innovation, and
procurement programs. As a result, SBA
is exploring various electronic options
for doing business with the Agency,
including: E-applications for financial
assistance, participation in Government
contracting and surety bond assistance
programs, as well as submission of loan
data. Along those lines, SBA is
analyzing the following initiatives that
would streamline and simplify the
process for participating in the various
SBA programs:
• Single Electronic Lender
Application for 7(a) Loan Programs
There is potential for process
improvement by adopting a single eapplication for all SBA 7(a) guaranteed
loans. This would reduce the paperwork
burden on lenders (which in turn
impacts small business borrowers) and
will result in greater lender
participation, particularly small
community banks, credit unions, and
rural lenders. These lenders usually
support small businesses that seek
relatively small amounts of capital to
grow and succeed; hence, additional
small, community lender-partners will
potentially lead to increasing the
amount of small-dollar loans flowing to
small businesses. This e-application
could add value by reducing the screen
out rate currently experienced during
the loan application process and could
improve the timeliness of delivering
loan approvals and hence delivery of
loan proceeds to small businesses.
• Uniform SBIR Portal for
Information and Solicitations
For the Small Business Innovation
Research program, there is no one form
or database for applying for the program
and submitting proposals. Often, there
are multiple systems for a single
submission—e.g., eRA Commons
(Electronic Research Administration
NIH Web site) and Grants.gov—in
addition to the lack of uniformity across
the participating 11 agencies in the
program. The goal of the project would
be to create a common, simple
application form that ports over
application data into the agencies’
application systems on an as-needed
basis. This would not replace other
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application systems, but it would be a
common form that ports data over more
simply to multiple application systems.
In addition to the technology solution,
the business process of narrowing and
simplifying into a common base of
information can be open-sourced to
multiple agencies, as they may navigate
the same challenges of common
applicants for different programs.
• Single Uniform Certification for
SBA Contracting Programs
SBA will analyze the regulatory
changes required and implications of
developing and implementing a single
certification process for common
information collected across its small
business contracting programs, such as
the 8(a) Business Development,
HUBZone, Women-Owned Small
Business, Service-Disabled VeteranOwned Small Business, and other Small
Business Programs.
• Automated Credit Decision Model
for 7(a) Loan Program
For loans of less than $250,000, SBA
could develop an optional credit scoring
methodology to be used by SBA lender
partners in their underwriting process,
which could result in lowering the
lenders’ cost of delivering capital to
borrowers and would likely expand
their interest in making low-dollar
loans. This initiative may also attract
additional lenders (e.g., small
community banks, credit unions, and
rural lenders) to become SBA partners
and increase credit availability for small
businesses.
• Government Contracting Program
Eligibility Web Site
SBA will analyze the feasibility of
building a one-stop Web site for small
businesses to input basic information
about their business (e.g., number of
employees, revenues, ownership (e.g.,
women-owned, service-disabled
veteran-owned, minority owned)) to
determine contracting and loan
programs they may be eligible for, as
well as help identify local district
offices and resource partners in their
area. This would make it easier for the
public to access and participate in
Federal small business programs.
• Integrated Certification and
Program Management System
SBA will review development of a
system that will allow the certification
and program management (e.g., reviews,
protests) processes to be done
electronically for the 8(a) and HUBZone
programs. The system is also planned to
be developed to allow for future
additions for other programs such as the
Women-Owned Small Business Federal
Contract Program and the ServiceDisabled Veteran-Owned Small
Business program. This system would
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enable easier access to the small
business programs and reduce the
amount of paperwork submitted to SBA
by applicants.
• Auto-Approve Disaster Loans Based
on Credit Scores
Private industry approves a
substantial number of loans through
credit scoring to reduce the cost of
underwriting. The portfolio analysis
that is being currently completed
indicates that the performance of loans
to borrowers with a FICO score that is
greater than 725 have limited risk.
Changing this process would allow SBA
more flexibility to design a loan
approval that is in line with current
private-sector practices and reduce the
processing cost for lower-dollar disaster
loans.
• Automated Process of Receiving
Insurance Recovery Information
Under the disaster loan program, loan
eligibility is based on the
uncompensated disaster loss. Being able
to automate the insurance recovery
information would enhance our ability
to ensure that insurance proceeds are
addressed and no duplication of
benefits occurs as a result of insurance
recovery after loan approval. This
would reduce the possibility that
disaster victims will be asked to repay
erroneously disbursed Federal disaster
benefits.
Openness and Transparency
SBA is committed to developing
regulations that are clear, simple, and
easily understood. In addition,
consistent with the President’s mandate,
SBA continues to promote transparency,
collaboration, and public participation
in its rulemakings. To that end, SBA
routinely solicits comments on its
regulations, even those that are not
subject to the public notice and
comment requirement under the
Administrative Procedure Act, and
where appropriate, the Agency consults
with other Federal agencies or other
entities that the regulation might affect.
In addition, in compliance with
Executive Order 13563 ‘‘Improving
Regulation and Regulatory Review’’
(Jan. 18, 2011), SBA invited the public
to take an active role in helping SBA to
develop a plan for conducting a
retrospective review of the Agency’s
regulations, including identification of
rules that are obsolete, unnecessary, or
excessively burdensome to the public.
The final plan is available on SBA’s
Open Government Web site at https://
www.sba.gov/content/sba-final-planretrospective-analysis-existing-rules-0.
SBA also conducted several public
meetings throughout diverse areas of the
country to solicit feedback on the
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Agency’s development and
implementation of various rules
required by the Small Business Jobs Act
of 2010. The Agency will determine
how the comments can inform the rules
identified in this plan and the agenda
overall, particularly those rules that
concern Government contracting
programs and activities. Information on
the completed SBJA Tour can be found
at www.sba.gov/jobsacttour.
Finally, as part of the White House’s
Startup America initiative, SBA and
representatives from other agencies met
with small business entrepreneurs in
eight different cities across the country
to solicit ideas and suggestions for
reducing barriers and for regulations
that foster a more supportive
environment for entrepreneurship and
innovation. As SBA develops its
regulations, the relevant ideas and
suggestions will be incorporated into
the rules or used to inform the process
generally. Information on the Startup
America meetings can be found at
www.sba.gov/content/startup-americareducing-barriers-roundtables.
Regulatory Framework
The SBA FY 2011 to FY 2016 strategic
plan serves as the foundation for the
regulations that the Agency will develop
during the next 12 months. This
strategic plan proposes three primary
strategic goals: (1) Growing businesses
and creating jobs; (2) building an SBA
that meets needs of today’s and
tomorrow’s small businesses; and (3)
serving as the voice for small business.
In order to achieve these goals SBA will,
among other objectives, focus on:
• Expanding access to capital through
SBA’s extensive lending network;
• Ensuring Federal contracting goals
are met or exceeded by collaborating
across the Federal Government to
expand opportunities for small
businesses and strengthen the integrity
of the Federal contracting data and
certification process;
• Ensuring that SBA’s disaster
assistance resources for businesses,
nonprofit organizations, homeowners,
and renters can be deployed quickly,
effectively, and efficiently;
• Strengthening SBA’s relevance to
high-growth entrepreneurs and small
businesses to more effectively drive
innovation and job creation; and
• Mitigating risk to taxpayers and
improving program oversight.
Regulatory Priority
As reported in the SBA’s fall 2011
regulatory agenda, the Agency plans to
publish several regulations during the
coming year that are designed to achieve
these goals. During this time, SBA’s
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7861
highest regulatory priority will focus on
implementing changes to the regulations
or policy directives regarding (1)
Multiple award contracts and small
business set-asides; (2) Small Business
Innovation and Research (SBIR)
Program; (3) Small Business Technology
Transfer (STTR) Program; and (4)
´ ´
Mentor-Protege Opportunities for the
HUBZone, Women-Owned Small
Business (WOSB) Contracting, and
Service-Disabled Veteran-Owned Small
Business (SDVOSB) Programs.
(1) Multiple Award Contracts and
Small Business Set-Asides: SBA intends
to implement authorities provided by
section 1331 of the Small Business Jobs
Act that would allow Federal agencies
to set aside a part or parts of multiple
awards contracts for small business
concerns; set aside orders placed against
multiple award contracts for small
business concerns; and reserve one or
more contract awards for small business
concerns under full and open
competition in certain circumstances.
Allowing small businesses to gain
access to multiple award contracts
through prime contract awards or
through set-asides off the orders of the
prime contracts should increase Federal
contracting opportunities for such
businesses.
(2) Small Business Innovation and
Research (SBIR) Program: The SBIR
Policy Directive has been identified as
one of the initial candidates for review
under SBA’s Retrospective Review Plan
under E.O. 13563. This review is also in
step with a White House initiative,
Innovation and Entrepreneurial
Working Group (IEWG), to share best
practices and improve the SBIR and
STTR Programs. One of the issues
highlighted during these discussions is
the need to clarify the SBIR data rights
afforded to SBIR awardees and the
Federal Government. SBA has also
worked with small businesses that have
had difficulty protecting their SBIR Data
Rights as a result of misunderstandings
by the procuring agencies of the
Government’s rights to such data. This
confusion has resulted in disagreements
between parties and, in some cases, the
confusion about data rights may have
resulted in small businesses shying
away from the SBIR Program. As a
result, SBA believes that there is critical
need to update the SBIR Policy
Directive to set clear guidelines for
determining the right of the parties to
the SBIR data. Accordingly, SBA plans
to update the SBIR Policy Directive to,
among other things, revise the
definitions relating to SBIR data and
clarify the rights of the SBIR awardees
and the Federal Government to such
data. SBA believes that clarifications to
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the directive regarding SBIR data rights
will benefit both small businesses and
the agencies and further could lead to
an increase in responses to SBIR
solicitations and savings of
administrative costs.
(3) Small Business Technology
Transfer (STTR) Program: As identified
in the Retrospective Review Plan
required by E.O. 13563, SBA also plans
to conduct a comprehensive review of
the existing STTR Program Policy
Directive, which has not been updated
since 2005. Many elements of the STTR
program are designed and intended to
be identical to those of the SBIR
program. The SBA is therefore planning
to update the STTR Policy Directive to
maintain the appropriate consistency
with the SBIR program. As with the
SBIR program, SBA also expects to
make several amendments to the STTR
Policy Directive that will reduce
confusion for both small businesses and
the Federal agencies that make awards
under the program, especially on the
issue of data rights. Possible benefits
include a potential increase in
responses to STTR solicitations and
savings of administrative costs as a
result of fewer informational inquiries
and disputes.
´ ´
(4) Small Business Mentor-Protege
Programs: SBA currently has a mentor´ ´
protege program for the 8(a) Business
Development Program that is intended
to enhance the capabilities of the
´ ´
protege and to improve its ability to
successfully compete for Federal
contracts. The Small Business Jobs Act
authorized SBA to use this model to
´ ´
establish similar mentor-protege
programs for the Service Disabled
Veteran-Owned, HUBZone and WomenOwned Small Business Programs. This
authority is consistent with
recommendations issued by an
interagency task force created by
President Obama on Federal Contracting
Opportunities for Small Businesses.
Among other things, the task force
´ ´
recommended that mentor-protege
programs should be promoted through a
new Governmentwide framework to
give small businesses the opportunity to
develop under the wing of experienced
large businesses in an expanded Federal
procurement arena. During the next 12
months, SBA will make it a priority to
issue regulations establishing the three
´ ´
newly authorized mentor-protege
programs and set out the standards for
´ ´
participating as a mentor or protege in
each. As is the case with the current
´ ´
mentor-protege program, the various
RIN
................
................
................
................
................
................
................
................
3245–AG28
3245–AG29
3245–AG30
3245–AG36
3245–AG37
3245–AG38
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in the Agency’s final
retrospective review of regulations plan.
Some of these entries on this list may
be completed actions, which do not
appear in the Regulatory Plan. However,
more information can be found about
these completed rulemakings in past
publications of the Unified Agenda on
Regingo.gov in the Completed Actions
section for that agency. These
rulemakings can also be found on
Regulations.gov. The final agency
retrospective review plan can be found
at: https://www.sba.gov/about-sbaservices/open-government.
Small Business
Burden Reduction
................
................
................
................
................
................
Small Business Technology Transfer (STTR) Policy Directive .......................................................
Small Business Innovation Research (SBIR) Program Policy Directive .........................................
504 Regulatory Enhancements .......................................................................................................
Small Business Size Standards: Professional, Scientific, and Technical Services ........................
Small Business Size Standards: Transportation and Warehousing Industries ..............................
Small Business Size Standards for Utilities Industries ...................................................................
Small Business Size Standards; Information ..................................................................................
Small Business Size Standards; Administrative and Support, Waste Management and Remediation Services Industries.
Small Business Size Standards: Real Estate, Rental and Leasing Industries ...............................
Small Business Size Standards: Educational Services Industries .................................................
Small Business Size Standards: Health Care and Social Assistance Services Industries ............
Small Business Size Standards: Arts, Entertainment, and Recreation ..........................................
Small Business Size Standards: Construction ................................................................................
Small Business HUBZone Program ................................................................................................
SBA
Proposed Rule Stage
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Retrospective Review of Existing
Regulations
Title of Rulemaking
3245–AF45
3245–AF84
3245–AG04
3245–AG07
3245–AG08
3245–AG25
3245–AG26
3245–AG27
148. Small Business Technology
Transfer (STTR) Policy Directive
Priority: Other Significant.
Legal Authority: 15 U.S.C. 638(p)
CFR Citation: None.
Legal Deadline: None.
Abstract: SBA plans to propose
amendments to the 2005 STTR Program
Policy Directive. These proposed
amendments bring the text up to date on
issues, including the changes to
program eligibility made by the SBA in
2005 and an adjustment to award
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forms of assistance that a mentor will be
´ ´
expected to provide to a protege include
technical and/or management
assistance; financial assistance in the
form of equity investment and/or loans;
subcontracts and/or assistance in
performing prime contracts with the
Government in the form of joint venture
arrangements.
15:08 Feb 10, 2012
Jkt 226001
guideline amounts consistent with the
adjustments to the SBIR award amounts
made in 2008, and they seek to add
clarity to areas such as STTR data rights
and incorporate several miscellaneous
corrections to the text.
Statement of Need: SBA is proposing
to clarify SBIR data rights and make
several necessary updates to the SBIR
Policy Directive. Many elements of the
STTR program are designed and
intended to be identical to those of the
SBIR program. SBA is therefore
planning to update the STTR Policy
Directive to maintain the appropriate
consistency with the SBIR program.
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YES.
YES.
YES.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
N/A.
YES.
Summary of Legal Basis: Small
Business Technology Transfer Act of
1992 (STTR Act), Public Law 102–564
(codified at 15 U.S.C. 638). The STTR
Act requires the SBA to ‘‘issue a policy
directive for the general conduct of the
STTR Programs within the Federal
Government.’’ 15 U.S.C. 638(p)(1).
Alternatives: Not applicable.
Anticipated Cost and Benefits: SBA
believes that bringing the STTR Policy
Directive up to date to conform with the
SBIR Program Policy Directive will
reduce confusion and benefit both small
businesses and the agencies. The
possible benefits include a potential
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increase in responses to STTR
solicitations and savings of
administrative costs as a result of fewer
informational inquiries and disputes.
Ultimately, SBA believes there will be
negligible costs to the Federal
Government with respect to the award
and monitoring of STTR funding
agreements as a result of this rule.
Risks: Not applicable.
Timetable:
Action
Date
NPRM ..................
FR Cite
03/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Additional Information: Includes
Retrospective Review under Executive
Order 13563 with small business burden
reduction.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Edsel M. Brown Jr.,
Assistant Director, Office of Innovation,
Small Business Administration, 409
Third Street SW., Washington, DC
20416, Phone: 202 205–6450, Email:
edsel.brown@sba.gov.
RIN: 3245–AF45
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SBA
149. Small Business Innovation
Research (SBIR) Program Policy
Directive
Priority: Other Significant.
Legal Authority: 15 U.S.C. 638(j)
CFR Citation: None.
Legal Deadline: None.
Abstract: SBA plans to update the
SBIR Policy Directive to revise the
definitions relating to SBIR data, add
several new definitions, and clarify the
rights in such SBIR data afforded to
SBIR awardees and the Federal
Government. In addition, the SBA
proposes to clarify other parts of the
Directive relating to Phase I, II, and III
awards and the definition of Small
Business Concern.
Statement of Need: The White
House’s Innovation and Entrepreneurial
Working Group (IEWG) is supporting an
initiative to share best practices and
improve the SBIR and Small Business
Technology Transfer (STTR) Programs.
During sessions concerning this
initiative, SBA have discussed the issue
of SBIR data rights and the need for
clarification. In addition, SBA has
worked with small businesses that have
had difficulty protecting their SBIR data
rights as a result of misunderstandings
by the procuring agencies of the
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Government’s rights to such data. As a
result, SBA believes that the directive
must be clarified.
SBA is also proposing to amend the
definition of Small Business Concern.
SBA amended this definition in 13 CFR
section 121.702 of its regulations, at 69
FR 70185 (Dec. 3, 2004). SBA is
updating language in the Policy
Directive to reflect the current definition
as set forth in the regulations.
Summary of Legal Basis: The Small
Business Innovation Development Act
of 1982 requires the SBA to ‘‘issue
policy directives for the general conduct
of the SBIR programs within the Federal
Government.’’ 15 U.S.C. 638(j)(1).
Alternatives: In clarifying SBIR data
rights in the Directive, SBA considered
using terms as defined in the sections of
the FAR and DFARS that address SBIR
data rights. However, SBA determined
that some of the terms were not
consistent with SBIR policy and other
terms could be used with modification.
For other proposed updates to the
Directive, alternatives were not
applicable.
Anticipated Cost and Benefits: SBA
believes that clarifications to the
directive regarding SBIR data rights will
benefit both small businesses and the
agencies. It is our understanding that
there is a misunderstanding of or
confusion surrounding the rights in data
of each party to an SBIR Funding
Agreement. This confusion has resulted
in disagreements between parties. In
some cases, the confusion about data
rights may have resulted in small
businesses shying away from the SBIR
Program. Therefore, the potential
benefits include a potential increase in
responses to SBIR solicitations and
savings of administrative costs as a
result of fewer disputes. Ultimately,
SBA believes there will be negligible
costs to the Federal Government with
respect to the award and monitoring of
SBIR funding agreements as a result of
this rule.
Risks: Not applicable.
Timetable:
Action
Date
NPRM ..................
FR Cite
03/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Additional Information: Includes
Retrospective Review under Executive
Order 13563 with small business burden
reduction.
Agency Contact: Edsel M. Brown Jr.,
Assistant Director, Office of Innovation,
Small Business Administration, 409
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Third Street SW., Washington, DC
20416, Phone: 202 205–6450, Email:
edsel.brown@sba.gov.
RIN: 3245–AF84
SBA
150. Acquisition Process: Task and
Delivery Order Contracts, Bundling,
Consolidation
Priority: Other Significant.
Legal Authority: Pub. L. 111–240, sec
1311, 1312, 1313, 1331
CFR Citation: 13 CFR 121, 124 to 127,
134.
Legal Deadline: Final, Statutory,
September 27, 2011, SBA, with Office of
Federal Procurement Policy, must issue
guidance by September 27, 2011, under
section 1331.
Abstract: The U.S. Small Business
Administration (SBA) is proposing
regulations that will establish guidance
under which Federal agencies may set
aside part of a multiple award contract
for small business concerns, set aside
orders placed against multiple award
contracts for small business concerns,
and reserve one or more awards for
small business concerns under full and
open competition for a multiple award
contract. These regulations will apply to
small businesses, including those small
businesses eligible for SBA’s
socioeconomic programs. The U.S.
Small Business Administration is
proposing regulations that will set forth
a Governmentwide policy on bundling,
which will address teams and joint
ventures of small businesses and the
requirement that each Federal agency
must publish on its Web site the
rationale for any bundled contract. In
addition, the proposed regulations will
address contract consolidation and the
limitations on the use of such
consolidation in Federal procurement to
include ensuring that the head of a
Federal agency may not carry out a
consolidated contract over $2 million
unless the Senior Procurement
Executive or Chief Acquisition Officer
ensures that market research has been
conducted and determines that the
consolidation is necessary and justified.
Statement of Need: The law
recognizes that many small businesses
were losing Federal contract
opportunities when agencies issue
multiple award contracts. This will
improve small business participation in
the acquisition process and provide
clear direction to contracting officers by
authorizing small business set-asides in
multiple-award contracts.
Summary of Legal Basis: The Small
Business Jobs Act of 2010, Public Law
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111–240, section 1331, requires the SBA
to issue regulations implementing this
provision within one year from the date
of enactment.
Alternatives: SBA has not yet
determined the costs resulting from this
regulation.
Anticipated Cost and Benefits: This
provision will allow small businesses to
gain access to multiple award contracts
through prime contract awards or
through set-asides of the orders of the
prime contracts. This should increase
opportunities for small businesses.
Risks: Not applicable.
Timetable:
Action
Date
NPRM ..................
FR Cite
12/00/11
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Agency Contact: Dean R. Koppel,
Assistant Director, Office of Policy and
Research, Small Business
Administration, 409 Third Street SW.,
Washington, DC 20416, Phone: 202 205–
7322, Fax: 202 481–1540, Email:
dean.koppel@sba.gov.
RIN: 3245–AG20
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SBA
151. Small Business Jobs Act: Small
´ ´
Business Mentor-Protege Programs
Priority: Other Significant.
Legal Authority: Pub. L. 111–240
CFR Citation: 13 CFR 124; 13 CFR
125; 13 CFR 126; 13 CFR 127.
Legal Deadline: None.
Abstract: SBA currently has a mentor´ ´
protege program for the 8(a) Business
Development Program that is intended
to enhance the capabilities of the
´ ´
protege and to improve its ability to
successfully compete for Federal
contracts. The Small Business Jobs Act
authorized SBA to use this model to
´ ´
establish similar mentor-protege
programs for the Service Disabled
Veteran-Owned, HUBZone, and
Women-Owned Small Federal Contract
Business Programs. This authority is
consistent with recommendations
issued by an interagency task force
created by President Obama on Federal
Contracting Opportunities for Small
Businesses. During the next 12 months,
SBA will make it a priority to issue
regulations establishing the three newly
´ ´
authorized mentor-protege programs
and set out the standards for
´ ´
participating as a mentor or protege in
each. As is the case with the current
´ ´
mentor-protege program, the various
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forms of assistance that a mentor will be
´ ´
expected to provide to a protege include
technical and/or management
assistance; financial assistance in the
form of equity investment and/or loans;
subcontracts; and/or assistance in
performing prime contracts with the
Government in the form of joint venture
arrangements.
Statement of Need: Congress
determined that the SBA-administered
´ ´
mentor-protege program currently
available to 8(a) BD participants is a
valuable tool for all small business
concerns and authorized SBA to
´ ´
establish mentor protege programs for
the HUBZone SBC, Service Disabled
Veteran-Owned SBCs, and WomenOwned Small Business programs SBCs.
This authority is consistent with
recommendations issued by an
interagency task force created by
President Obama on Federal Contracting
Opportunities for Small Businesses.
Among other things, the task force
´ ´
recommended that mentor-protege
programs should be promoted through a
new Governmentwide framework to
give small businesses the opportunity to
develop under the wing of experienced
large businesses in an expanded Federal
procurement arena.
Summary of Legal Basis: The Small
Business Jobs Act of 2010, Public Law
No 111–240, section 1337(b)(3),
authorizes SBA to establish mentor´ ´
protege programs for HUBZone SBC,
Service Disabled Veteran-Owned SBCs,
and Women-Owned Small Business
programs SBCs.
Alternatives: At this point, SBA
believes that the best option for
implementing the authority is to create
a regulatory scheme that is similar to the
´ ´
existing mentor-protege program.
Anticipated Cost and Benefits: SBA
has not yet quantified the costs
associated with this rule. However,
program participants, particularly the
´ ´
proteges, would be able to leverage the
mentoring opportunities as a form of
business development assistance that
could enhance their capabilities to
successfully compete for contracts in
and out of the Federal contracting arena.
This assistance may include technical
and/or management assistance; financial
assistance in the form of equity
investments and/or loans; subcontracts;
and/or assistance in performing prime
contracts with the Government in the
form of joint venture arrangements.
Risks: None identified.
Timetable:
Action
Date
NPRM ..................
01/00/12
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Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Dean R. Koppel,
Assistant Director, Office of Policy and
Research, Small Business
Administration, 409 Third Street SW.,
Washington, DC 20416, Phone: 202 205–
7322, Fax: 202 481–1540, Email:
dean.koppel@sba.gov.
RIN: 3245–AG24
BILLING CODE 8025–01–P
SOCIAL SECURITY ADMINISTRATION
(SSA)
Statement of Regulatory Priorities
We administer the Retirement,
Survivors, and Disability Insurance
programs under title II of the Social
Security Act (Act), the Supplemental
Security Income (SSI) program under
title XVI of the Act, and the Special
Veterans Benefits program under title
VIII of the Act. As directed by Congress,
we also assist in administering portions
of the Medicare program under title
XVIII of the Act. Our regulations codify
the requirements for eligibility and
entitlement to benefits and our
procedures for administering these
programs. Generally, our regulations do
not impose burdens on the private
sector or on State or local governments,
except for the States’ disability
determination services. We fully fund
the disability determination services in
advance or by way of reimbursement for
necessary costs in making disability
determinations.
The six entries in our regulatory plan
(plan) represent issues of major
importance to the Agency. We describe
the individual initiatives more fully in
the attached plan.
Improving the Disability Process
Since the continued improvement of
the disability program is of vital concern
to us, we have five initiatives in the
plan addressing disability-related
issues. They include:
• A proposed rule that will modify
the requirement to recontact medical
source(s) first when we need to resolve
an inconsistency or insufficiency in the
evidence;
• A proposed rule that will allow
adjudicators the discretion to proceed to
the fifth step of the sequential process
for assessing disability when we have
insufficient information regarding a
claimant’s past relevant work history;
• Three proposed rules updating the
medical listings used to determine
disability—evaluating respiratory
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
system disorders, mental disorders, and
hematological disorders. The revisions
reflect our adjudicative experience and
advances in medical knowledge,
diagnosis, and treatment.
Enhance Public Service
We will revise our rules to establish
a 12-month time limit for the
withdrawal of an old-age benefits
application. The final rules will permit
only one withdrawal per lifetime.
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (Jan. 18, 2011), the
following Regulatory Identifier Numbers
(RINs) have been identified as
associated with retrospective review
and analysis in our final retrospective
review of regulations plan. Some of
these entries on this list may be
completed actions, which do not appear
in The Regulatory Plan. However, more
information can be found about these
completed rulemakings in past
publications of the Unified Agenda on
Reginfo.gov in the Completed Actions
section for that agency. These
rulemakings can also be found on
Regulations.gov. The final agency plans
can be found at: https://
www.socialsecurity.gov/open/
regsreview/EO-13563-Final-Plan.html.
Expected to
Significantly Reduce
Burdens on Small
Businesses
RIN
Title
0960–AF35 .................
0960–AF58 .................
0960–AF69 .................
0960–AF88 .................
0960–AG21 ................
0960–AG28 ................
0960–AG38 ................
0960–AG65 ................
0960–AG71 ................
0960–AG74 ................
0960–AG91 ................
0960–AH03 ................
0960–AH04 ................
Revised Medical Criteria for Evaluating Neurological Impairments ...............................................
Revised Medical Criteria for Evaluating Respiratory System Disorders ........................................
Revised Medical Criteria for Evaluating Mental Disorders .............................................................
Revised Medical Criteria for Evaluating Hematological Disorders .................................................
New Medical Criteria for Evaluating Language and Speech Disorders .........................................
Revised Medical Criteria for Evaluating Growth Impairments ........................................................
Revised Medical Criteria for Evaluating Musculoskeletal Disorders ..............................................
Revised Medical Criteria for Evaluating Digestive Disorders .........................................................
Revised Medical Criteria for Evaluating Immune (HIV) System Disorders ....................................
Revised Medical Criteria for Evaluating Cardiovascular Disorders ................................................
Revised Medical Criteria for Evaluating Skin Disorders .................................................................
Revised Medical Criteria for Evaluating Genitourinary Disorders ..................................................
Revised Medical Criteria for Evaluating Congenital Disorders That Affect Multiple Body Systems.
Revised Medical Criteria for Evaluating Visual Disorders ..............................................................
0960–AH28 ................
SSA
Proposed Rule Stage
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152. Revised Medical Criteria for
Evaluating Respiratory System
Disorders (859P)
Priority: Other Significant. Major
under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 402; 42
U.S.C. 405(a); 42 U.S.C. 405(b); 42
U.S.C. 405(d) to 405(h); 42 U.S.C. 416(i);
42 U.S.C. 421(a); 42 U.S.C. 421(i); 42
U.S.C. 423; 42 U.S.C. 902(a)(5); 42
U.S.C. 1381a; 42 U.S.C. 1382c; 42 U.S.C.
1383; 42 U.S.C. 1383b
CFR Citation: 20 CFR 404.1500, app 1.
Legal Deadline: None.
Abstract: Sections 3.00 and 103.00,
Respiratory System, of appendix 1 to
subpart P of part 404 of our regulations
describe respiratory system disorders
that we consider severe enough to
prevent an individual from doing any
gainful activity or that cause marked
and severe functional limitations for a
child claiming SSI payments under title
XVI. We are proposing to revise these
sections to ensure that the medical
evaluation criteria are up to date and
consistent with the latest advances in
medical knowledge and treatment.
Statement of Need: These proposed
regulations are necessary to update the
Respiratory System listings to reflect
advances in medical knowledge,
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treatment, and methods of evaluating
respiratory disorders. The changes
would ensure that determinations of
disability have a sound medical basis,
that claimants receive equal treatment
through the use of specific criteria, and
that people who are disabled can be
readily identified and awarded benefits
if all other factors of entitlement or
eligibility are met.
Summary of Legal Basis:
Administrative—not required by statute
or court order.
Alternatives: We considered not
revising the listings and continuing to
use our current criteria. However, we
believe that proposing these revisions is
preferable because of the medical
advances that have been made in
treating and evaluating respiratory
diseases and because of our adjudicative
experience.
Anticipated Cost and Benefits:
Estimated costs—low.
Risks: None.
Timetable:
Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
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70 FR 19358
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Required: No.
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No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: Includes
Retrospective Review under E.O. 13563.
URL for Public Comments: www.
regulations.gov.
Agency Contact: Cheryl A. Williams,
Director, Social Security
Administration, Office of Medical
Listings Improvement, 6401 Security
Boulevard, Baltimore, MD 21235–6401,
Phone: 410 965–1020.
Joshua B. Silverman, Social Insurance
Specialist, Regulations Writer, Social
Security Administration, Office of
Regulations, 6401 Security Boulevard,
Baltimore, MD 21235–6401, Phone: 410
594–2128.
RIN: 0960–AF58
SSA
153. Revised Medical Criteria for
Evaluating Hematological Disorders
(974P)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 402; 42
U.S.C. 405(a); 42 U.S.C. 405(b); 42
U.S.C. 405(d) to 405(h); 42 U.S.C. 416(i);
42 U.S.C. 421(a); 42 U.S.C. 421(i); 42
U.S.C. 423; 42 U.S.C. 902(a)5); 42 U.S.C.
1381a; 42 U.S.C. 1382c; 42 U.S.C. 1383;
42 U.S.C. 1383b
CFR Citation: 20 CFR 404.1500, app 1.
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / The Regulatory Plan
Legal Deadline: None.
Abstract: Sections 7.00 and 107.00,
Hematological Disorders, of appendix 1
to subpart P of part 404 of our
regulations, describe hematological
disorders that we consider severe
enough to prevent a person from
performing any gainful activity or that
cause marked and severe functional
limitation for a child claiming
Supplemental Security Income
payments under title XVI. We are
proposing to revise the criteria in these
sections to ensure that the medical
evaluation criteria are up to date and
consistent with the latest advances in
medical knowledge and treatment.
Statement of Need: These proposed
regulations are necessary to update the
hematological listings to reflect
advances in medical knowledge,
treatment, and methods of evaluating
hematological disorders. The changes
ensure that determinations of disability
have a sound medical basis, that
claimants receive equal treatment
through the use of specific criteria, and
that people who are disabled can be
readily identified and awarded benefits
if all other factors of entitlement or
eligibility are met.
Summary of Legal Basis:
Administrative—not required by statute
or court order.
Alternatives: We considered not
revising the listings or making only
minor technical changes and continuing
to use our current criteria. However, we
believe that proposing these revisions is
preferable because of the medical
advances that have been made in
treating and evaluating these types of
impairments.
Anticipated Cost and Benefits:
Estimated savings—low.
Risks: None.
Timetable:
Date
NPRM ..................
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Action
FR Cite
03/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: Includes
Retrospective Review under E.O. 13563.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Cheryl A. Williams,
Director, Social Security
Administration, Office of Medical
Listings Improvement, 6401 Security
Boulevard, Baltimore, MD 21235–6401,
Phone: 410 965–1020.
Helen Droddy, Social Insurance
Specialist, Regulations Writer, Social
Security Administration, Office of
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Regulations, 6401 Security Boulevard,
Baltimore, MD 21235–6401, Phone: 410
965–1483.
RIN: 0960–AF88
SSA
not reflect state-of-the-art medical
knowledge and technology.
Anticipated Cost and Benefits:
Savings estimates for fiscal years 2010
to 2018: (in millions of dollars) OASDI–
315, SSI–370.
Risks: None.
Timetable:
Final Rule Stage
154. Revised Medical Criteria for
Evaluating Mental Disorders (886F)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 402; 42
U.S.C. 405(a); 42 U.S.C. 405(b); 42
U.S.C. 405(d) to 42 U.S.C. 405(h); 42
U.S.C. 416(i); 42 U.S.C. 421(a); 42 U.S.C.
421(h); 42 U.S.C. 421(i); 42 U.S.C. 423;
42 U.S.C. 902(a)(5); 42 U.S.C. 1381a; 42
U.S.C. 1382c; 42 U.S.C. 1383; 42 U.S.C.
1383b
CFR Citation: 20 CFR 404.1500, app 1;
20 CFR 404.1520a; 20 CFR 416.920a; 20
CFR 416.934.
Legal Deadline: None.
Abstract: Sections 12.00 and 112.00,
Mental Disorders, of appendix 1 to
subpart P of part 404 of our regulations
describe those mental impairments that
we consider severe enough to prevent a
person from doing any gainful activity,
or that cause marked and severe
functional limitations for a child
claiming Supplemental Security Income
payments under title XVI. We will
revise the criteria in these sections to
ensure that the medical evaluation
criteria are up to date and consistent
with the latest advances in medical
knowledge and treatment.
Statement of Need: These regulations
are necessary to update the listings for
evaluating mental disorders to reflect
advances in medical knowledge,
treatment, and methods of evaluating
these disorders. The changes will ensure
that determinations of disability have a
sound medical basis, that claimants
receive equal treatment through the use
of specific criteria, and that people who
are disabled can be readily identified
and awarded benefits if all other factors
of entitlement or eligibility are met.
Summary of Legal Basis:
Administrative—not required by statute
or court order.
Alternatives: We considered not
revising the listings or making only
minor technical changes. However, we
believe that these revisions are
preferable because of the medical
advances that have been made in
treating and evaluating these types of
disorders. We have not
comprehensively revised the current
listings in over 15 years. Medical
advances in disability evaluation and
treatment and our program experience
make clear that the current listings do
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Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
NPRM Comment
Period End.
NPRM ..................
NPRM Comment
Period End.
Final Action .........
03/17/03
06/16/03
68 FR 12639
08/19/10
11/17/10
75 FR 51336
11/24/10
12/09/10
75 FR 71632
03/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: Includes
Retrospective Review under E.O. 13563.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Cheryl A. Williams,
Director, Social Security
Administration, Office of Medical
Listings Improvement, 6401 Security
Boulevard, Baltimore, MD 21235–6401,
Phone: 410 965–1020.
Fran O. Thomas, Social Insurance
Specialist, Regulations Writer, Social
Security Administration, Office of
Regulations, 6401 Security Boulevard,
Baltimore, MD 21235–6401, Phone: 410
966–9822.
RIN: 0960–AF69
SSA
155. How We Collect and Consider
Evidence of Disability (3487P)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 402; 42
U.S.C. 405(a); 42 U.S.C. 405(d)(h); 42
U.S.C. 416(i); 42 U.S.C. 421(a); 42 U.S.C.
421(i); 42 U.S.C. 421(m); 42 U.S.C. 421
note; 42 U.S.C. 422(c); 42 U.S.C. 423; 42
U.S.C. 423 note; 42 U.S.C. 425; 42
U.S.C. 902(a)(5); 42 U.S.C. 1382; 42
U.S.C. 1382c; 42 U.S.C. 1382h; 42 U.S.C.
1382h note; 42 U.S.C. 1383(a); 42 U.S.C.
1383(c); 42 U.S.C. 1383(d)(1); 42 U.S.C.
1383(p); 42 U.S.C. 1383b
CFR Citation: 20 CFR 404.1512; 20
CFR 404.1519a; 20 CFR 404.1520; 20
CFR 404.1520b (New); 20 CFR 404.1527;
20 CFR 416.912; 20 CFR 416.919a; 20
CFR 416.920; 20 CFR 416.920b (New);
20 CFR 416.927.
Legal Deadline: None.
Abstract: We propose to modify the
requirement to recontact your medical
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source(s) first when we need to resolve
an inconsistency or insufficiency in the
evidence he or she provided. Depending
on the nature of the inconsistency or
insufficiency, there may be other, more
appropriate sources from whom we
could obtain the information we need.
By giving adjudicators more flexibility
in determining how best to obtain this
information, we will be able to make a
determination or decision on disability
claims more quickly and efficiently in
certain situations. Eventually, our need
to recontact your medical source(s) in
many situations will be significantly
reduced as a result of our efforts to
improve the evidence collection process
through the increased utilization of
Health Information Technology (HIT).
Statement of Need: The final rule
would modify the requirement to
recontact a claimant’s medical source(s)
first when we need to resolve an
inconsistency or insufficiency in the
evidence he or she provided. Depending
on the nature of the inconsistency or
insufficiency, there may be other, more
appropriate sources from whom we
could obtain the information we need.
By giving adjudicators more flexibility
in determining how best to obtain this
information, we will be able to make a
determination or decision on disability
claims more quickly and efficiently in
certain situations.
Summary of Legal Basis:
Administrative—not required by statute
or court order.
Alternatives: We could have chosen
not to make these changes at all.
However, the Integrated Disability
Process workgroup recommended these
changes, and we know from the
intercomponent review process that our
adjudicators support them. The changes
affect the process of collecting and
considering evidence, and we believe
that this final rule represents our best
course of action.
Anticipated Cost and Benefits: These
changes will have only a negligible net
effect on the projected level of OASDI
and Federal SSI benefit outlays.
Risks: None.
Timetable:
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Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
04/12/11
06/13/11
76 FR 20282
SSA
156. Amendments to Regulations
Regarding Withdrawals of Applications
and Voluntary Suspension of Benefits
(3573F)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 402; 42
U.S.C. 402(i); 42 U.S.C. 402(j); 42 U.S.C.
402(o); 42 U.S.C. 402(p); 42 U.S.C.
402(r); 42 U.S.C. 403(a); 42 U.S.C.
403(b); 42 U.S.C. 405(a); 42 U.S.C. 416;
42 U.S.C. 416(i)(2); 42 U.S.C. 423; 42
U.S.C. 423(b); 42 U.S.C. 425; 42 U.S.C.
428(a) to 428(e); 42 U.S.C. 902(a)(5)
CFR Citation: 20 CFR 404.313; 20 CFR
404.640.
Legal Deadline: None.
Abstract: We will modify our
regulations to establish a 12-month time
limit for the withdrawal of an old age
benefits application. We will also
permit only one withdrawal per
lifetime. These changes will limit the
voluntary suspension of benefits only to
those benefits disbursed in future
months.
Statement of Need: We are under a
clear congressional mandate to protect
the Trust Funds. It is crucial that we
change our current policies that have
the effect of allowing beneficiaries to
withdraw applications or suspend
benefits and use benefits from the Trust
Funds as something akin to an interestfree loan.
Summary of Legal Basis:
Discretionary.
Alternatives: None.
Anticipated Cost and Benefits: Not yet
determined.
Risks: None.
Timetable:
Action
Date
FR Cite
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Final Action .........
12/08/10
12/08/10
75 FR 76256
01/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL for Public Comments:
www.regulations.gov.
VerDate Mar<15>2010
Agency Contact: Janet Truhe, Social
Insurance Specialist, Social Security
Administration, Office of Disability
Programs, 6401 Security Boulevard,
Baltimore, MD 21235–6401, Phone: 410
966–7203.
Brian Rudick, Social Insurance
Specialist, Regulations Writer, Social
Security Administration, Office of
Regulations, 6401 Security Boulevard,
Baltimore, MD 21235–6401, Phone: 410
965–7102.
RIN: 0960–AG89
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Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected:
Undetermined.
Agency Contact: Deidre Bemister,
Social Insurance Specialist, Social
Security Administration, Office of
Information Security Programs,
Baltimore, MD 21235–6401, Phone: 410
966–6223.
Helen Droddy, Social Insurance
Specialist, Regulations Writer, Social
Security Administration, Office of
Regulations, 6401 Security Boulevard,
Baltimore, MD 21235–6401, Phone: 410
965–1483.
RIN: 0960–AH07
SSA
157. Expedited Vocational Assessment
Under the Sequential Evaluation
Process (3684P)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 402; 42
U.S.C. 405(a) to 405(b); 42 U.S.C. 405(d)
to 405(h); 42 U.S.C. 416(i); 42 U.S.C.
421(a); 42 U.S.C. 421(i); 42 U.S.C. 421(j);
42 U.S.C. 421(m); 42 U.S.C. 421 note; 42
U.S.C. 422(c); 42 U.S.C. 423; 42 U.S.C.
423 note; 42 U.S.C. 425; 42 U.S.C.
902(a)(5); 42 U.S.C. 902 note; 42 U.S.C.
1382; 42 U.S.C. 1382c; 42 U.S.C. 1382h;
42 U.S.C. 1382h note; 42 U.S.C. 1383(a);
42 U.S.C. 1383(c); 42 U.S.C. 1383(d)(i);
42 U.S.C. 1383(p); 42 U.S.C. 1383b
CFR Citation: 404.1505; 404.1520;
404.1545; 404.1560; 404.1565; 404.1569;
404.1594; 416.905; 416.920; 416.945;
416.960; 416.965; 416.969; 416.987;
416.994.
Legal Deadline: None.
Abstract: We propose to give
adjudicators the discretion to proceed to
the fifth step of the sequential
evaluation process for assessing
disability when we have insufficient
information about a claimant’s past
relevant work history to make the
findings required for step 4. If an
adjudicator finds at step 5 that a
claimant may be unable to adjust to
other work existing in the national
economy, the adjudicator would return
to the fourth step to develop the
claimant’s work history and make a
finding about whether the claimant can
perform his or her past relevant work.
This proposed new process would not
disadvantage any claimant or change the
ultimate conclusion about whether a
claimant is disabled, but it would
promote administrative efficiency and
help us make more timely disability
determinations and decisions.
Statement of Need: This expedited
process will shorten case processing
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time, give our adjudicators more
flexibility to assess disability claims,
and assist in reducing the disability
backlog.
Summary of Legal Basis:
Administrative—not required by statute
or court order.
Alternatives: Undetermined at this
time.
Anticipated Cost and Benefits:
Undetermined at this time.
Risks: None.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Action .........
09/13/11
11/14/11
76 FR 56357
09/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL for Public Comments:
www.regulations.gov.
Agency Contact: Janet Truhe, Social
Insurance Specialist, Social Security
Administration, Office of Disability
Programs, 6401 Security Boulevard,
Baltimore, MD 21235–6401, Phone: 410
966–7203.
Joshua B. Silverman, Social Insurance
Specialist, Regulations Writer, Social
Security Administration, Office of
Regulations, 6401 Security Boulevard,
Baltimore, MD 21235–6401, Phone: 410
594–2128.
RIN: 0960–AH26
BILLING CODE 4191–02–P
BUREAU OF CONSUMER FINANCIAL
PROTECTION
Statement of Regulatory Priorities 1
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A. CFPB Purposes and Functions
The Bureau of Consumer Financial
Protection (CFPB) was established as an
independent bureau of the Federal
Reserve System by the Dodd-Frank Wall
Street Reform and Consumer Protection
Act (Pub. L. 111–203, 124 Stat. 1376)
(Dodd-Frank Act). Pursuant to the Act,
the CFPB has rulemaking, supervisory,
enforcement, and other authorities
relating to consumer financial products
and services. Among these are the
consumer financial protection
authorities that transferred to the CPFB
from seven Federal agencies on the
designated transfer date, July 21, 2011.
1 This Statement of Regulatory Priorities
(Statement) supplements the semiannual regulatory
agenda that is being published contemporaneously.
The CFPB is submitting this Statement on a
voluntary basis.
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These authorities include the ability to
issue regulations under more than a
dozen Federal consumer financial laws.
As provided in section 1021 of the
Dodd-Frank Act, the purpose of the
CFPB is to implement and enforce
Federal consumer financial laws
consistently for the purpose of ensuring
that all consumers have access to
markets for consumer financial products
and services and that such markets are
fair, transparent, and competitive. The
CFPB is authorized to exercise its
authorities for the purpose of ensuring
that:
(1) Consumers are provided with
timely and understandable information
to make responsible decisions about
transactions involving consumer
financial products and services;
(2) Consumers are protected from
unfair, deceptive, or abusive acts and
practices and from discrimination;
(3) Outdated, unnecessary, or unduly
burdensome regulations concerning
consumer financial products and
services are regularly identified and
addressed in order to reduce
unwarranted regulatory burdens;
(4) Federal consumer financial law is
enforced consistently, without regard to
status as a depository institution, in
order to promote fair competition; and
(5) Markets for consumer financial
products and services operate
transparently and efficiently to facilitate
access and innovation.
B. Immediate Regulatory Priorities
The CFPB is working on a wide range
of initiatives to address issues in
markets for consumer financial products
and services that are not reflected in this
notice because the Unified Agenda is
limited to rulemaking activities. With
regard to the exercise of its rulemaking
authorities, as reflected in the CFPB’s
semiannual regulatory agenda, the
CFPB’s immediate focus is on
completing various rulemakings that are
mandated by the Dodd-Frank Act and
resolving a handful of proposals that
had been issued by the transferor
agencies prior to July 21, 2011. In
addition, the CFPB must issue a number
of procedural rules relating to the standup of the CFPB as an independent
regulatory agency.
The semiannual regulatory agenda
provides more detailed descriptions of
individual rulemaking projects. The
CFPB is particularly focused on meeting
the rulemaking deadlines set forth in the
Dodd-Frank Act, in order to provide
certainty to consumers, financial
services providers, and the broader
economy. These rules include:
• Regulations governing international
money transfers (remittances) under the
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Electronic Fund Transfer Act. These
regulations concern disclosures, error
resolution procedures, and other topics.
The Board of Governors of the Federal
Reserve System issued a Notice of
Proposed Rulemaking concerning these
rules in May 2011, and the CFPB now
has responsibility for finalizing this
rulemaking, as appropriate. Final rules
on certain topics are required by January
21, 2012.
• An initial rule determining which
nondepository covered persons are
subject to the CFPB’s supervision
authority as ‘‘larger participant[s]’’ of
‘‘other markets’’ for consumer financial
products and services. The Dodd-Frank
Act vests the CFPB with authority to
examine all sizes of nondepository
financial services providers engaged in
mortgage lending and certain related
services, payday lending, and private
student lending. It also authorizes
examinations of a ‘‘larger participant of
a market for other consumer financial
products or services,’’ as defined by the
rule. An initial rule defining who is a
larger participant in these other markets
is required by July 21, 2012.
• Consolidated mortgage loan
disclosures and related rules under the
Truth in Lending Act and Real Estate
Settlement Procedures Act. The DoddFrank Act requires the CFPB to develop
consolidated mortgage loan disclosures
to satisfy the requirements of both the
Truth in Lending Act and Real Estate
Settlement Procedures Act. The DoddFrank Act also imposes certain new
disclosure requirements, and the CFPB
inherits proposals to amend Truth in
Lending Act regulations relating to
mortgage loan disclosures that were
issued by the Board of Governors of the
Federal Reserve System in August 2009
and September 2010. The consolidated
disclosures proposal is required by July
21, 2012.
• Regulations defining lenders’
obligations to assess borrowers’ ability
to repay mortgage loans, including
certain protections from liability for
‘‘qualified mortgages.’’ The Dodd-Frank
Act requires lenders to make a
reasonable, good faith determination of
applicants’ ability to repay closed-end
mortgage loans. ‘‘Qualified mortgages’’
as defined under the Act and by
regulation receive certain protections
from liability. The Board of Governors
of the Federal Reserve System issued a
Notice of Proposed Rulemaking
concerning these rules in May 2011, and
the CFPB now has responsibility for
finalizing this rulemaking, as
appropriate. Although the statutory
deadline for final rules is January 2013,
this rulemaking is a particular priority
for the CFPB because it impacts basic
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underwriting practices and serves as a
building block for other Dodd-Frank Act
rulemakings.
• Regulations to implement other
requirements concerning mortgage
origination and servicing under title XIV
of the Dodd-Frank Act. As described in
more detail in the individual agenda
entries, these regulations will address a
variety of origination and servicing
practices, including loan originator
compensation and anti-steering rules,
restrictions on high-cost loans,
maintenance of escrow accounts and
other servicing practices, and (on an
interagency basis) various regulations
concerning appraisals. Final rules are
required by January 21, 2013.
In carrying out these mandates, the
CFPB is focused on developing clear,
simple disclosures that will give
consumers the information they need to
determine which consumer financial
products and services best meet their
needs while avoiding unwarranted
regulatory burdens on industry. The
CFPB has made the consolidation of
mortgage disclosure forms a priority
because streamlining the existing,
overlapping forms could significantly
benefit both consumers and industry
members alike.
Because the CFPB is at an early stage
of its operations, it is still in the process
of assessing the need and resources
available for additional substantive
rulemakings beyond those listed in its
fall 2011 agenda. The CFPB expects to
include any such projects that it
realistically anticipates considering
before October 2012 in its spring 2012
agenda.
BILLING CODE 4810–AM–P
CONSUMER PRODUCT SAFETY
COMMISSION (CPSC)
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Statement of Regulatory Priorities
The U.S. Consumer Product Safety
Commission is charged with protecting
the public from unreasonable risks of
death and injury associated with
consumer products. To achieve this
goal, the Commission:
• Develops mandatory product safety
standards or banning rules when other,
less restrictive efforts are inadequate to
address a safety hazard, or where
required by statute;
• Obtains repair, replacement, or
refund of the purchase price for
defective products that present a
substantial product hazard;
• Develops information and
education campaigns about the safety of
consumer products;
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• Directs staff to participate in the
development or revision of voluntary
product safety standards; and
• Follows congressional mandates to
enact specific regulations.
Unless directed otherwise by
congressional mandate, when deciding
which of these approaches to take in
any specific case, the Commission
gathers and analyzes the best available
data about the nature and extent of the
risk presented by the product. The
Commission’s rules require the
Commission to consider, among other
factors, the following criteria when
deciding the level of priority for any
particular project:
• Frequency and severity of injury;
• Causality of injury;
• Chronic illness and future injuries;
• Costs and benefits of Commission
action;
• Unforeseen nature of the risk;
• Vulnerability of the population at
risk; and
• Probability of exposure to the
hazard.
Significant Regulatory Actions
Currently, the Commission is
considering two rules that would
constitute ‘‘significant regulatory
actions’’ under the definition of that
term in Executive Order 12866:
1. Flammability Standard for
Upholstered Furniture
Under section 4 of the Flammable
Fabrics Act (FFA), the Commission may
issue a flammability standard or other
regulation for a product of interior
furnishing if the Commission
determines that such a standard is
needed to adequately protect the public
against unreasonable risk of the
occurrence of fire leading to death or
personal injury, or significant property
damage. The Commission’s regulatory
proceeding could result in several
actions, one of which could be the
development of a mandatory standard
requiring that upholstered furniture
meet mandatory labeling requirements,
resist ignition, or meet other
performance criteria under test
conditions specified in the standard.
2. Testing and Certification Rule
Section 102(d)(2) of the CPSIA, as
amended by H.R. 2715, requires the
Commission to: (1) Initiate by regulation
a program by which a manufacturer or
private labeler may label a consumer
product as complying with the
certification requirements of section
102(a) of the CPSIA and (2) establish
protocols and standards (i) for ensuring
that a children’s product tested for
compliance with an applicable
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children’s product safety rule is subject
to testing periodically and when there
has been a material change in the
product’s design or manufacturing
process, including the sourcing of
component parts; (ii) for the testing of
representative samples to ensure
continued compliance; (iii) for verifying
that a children’s product tested by a
conformity assessment body complies
with applicable children’s product
safety rules; and (iv) for safeguarding
against the exercise of undue influence
on a third party conformity assessment
body by a manufacturer or private
labeler.
BILLING CODE 6355–01–P
FEDERAL TRADE COMMISSION (FTC)
Statement of Regulatory Priorities
I. Regulatory Priorities
Background
The Federal Trade Commission
(‘‘FTC’’ or ‘‘Commission’’) is an
independent agency charged by its
enabling statute, the Federal Trade
Commission Act, with protecting
American consumers from ‘‘unfair
methods of competition’’ and ‘‘unfair or
deceptive acts or practices’’ in the
marketplace. The Commission strives to
ensure that consumers benefit from a
vigorously competitive marketplace.
The Commission’s work is rooted in a
belief that competition, based on
truthful and non-misleading
information about products and
services, brings the best choice of
products and services at the lowest
prices for consumers.
The Commission pursues its goal of
promoting competition in the
marketplace through two different, but
complementary, approaches. Unfair or
deceptive acts or practices injure both
consumers and honest competitors alike
and undermine competitive markets.
Through its consumer protection
activities, the Commission seeks to
ensure that consumers receive accurate,
truthful, and non-misleading
information in the marketplace. At the
same time, for consumers to have a
choice of products and services at
competitive prices and quality, the
marketplace must be free from
anticompetitive business practices.
Thus, the second part of the
Commission’s basic mission—antitrust
enforcement—is to prohibit
anticompetitive mergers or other
anticompetitive business practices
without unduly interfering with the
legitimate activities of businesses. These
two complementary missions make the
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Commission unique insofar as it is the
Nation’s only Federal agency to be given
this combination of statutory authority
to protect consumers.
The Commission is, first and
foremost, a law enforcement agency. It
pursues its mandate primarily through
case-by-case enforcement of the Federal
Trade Commission Act and other
statutes. In addition, the Commission is
also charged with the responsibility of
issuing and enforcing regulations under
a number of statutes. Most notably,
pursuant to the FTC Act, the
Commission currently has in place 16
trade regulation rules. Other examples
include the regulations enforced
pursuant to credit and financial
statutes 1 and to energy laws.2 The
Commission also has adopted a number
of voluntary industry guides. Most of
the regulations and guides pertain to
consumer protection matters and are
intended to ensure that consumers
receive the information necessary to
evaluate competing products and make
informed purchasing decisions.
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Commission Initiatives
The Commission protects consumers
through a variety of tools, including
both regulatory and non-regulatory
approaches. To that end, it has
encouraged industry self-regulation,
developed a corporate leniency policy
for certain rule violations, and
established compliance partnerships
where appropriate.
As detailed below, help for consumers
in financial distress, health care,
consumer privacy and data security, and
evolving technology and innovation
continue to be at the forefront of the
Commission’s consumer protection and
competition programs. By subject area,
the FTC discusses the major workshops,
reports,3 and initiatives pursued since
the 2010 Regulatory Plan was
published.
(a) Help for Consumers in Financial
Distress. Historic levels of consumer
debt, increased unemployment, and an
unprecedented downturn in the housing
and mortgage markets have contributed
to high rates of consumer bankruptcies
and mortgage loan delinquency and
1 For example, the Fair Credit Reporting Act (15
U.S.C. sections 1681 to 1681(u), as amended) and
the Gramm-Leach-Bliley Act (Pub. L. 106–102, 113
Stat.1338, codified in relevant part at 15 U.S.C.
sections 6801 to 6809 and sections 6821 to 6827,
as amended).
2 For example, the Energy Policy Act of 1992 (106
Stat. 2776, codified in scattered sections of the U.S.
Code, particularly 42 U.S.C. section 6201 et seq.
and the Energy Independence and Security Act of
2007 (EISA)).
3 The FTC also prepares a number of annual and
periodic reports on the statutes it administers.
These are not discussed in this plan.
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foreclosure. Debt relief services have
proliferated in recent years as the
economy has declined and greater
numbers of consumers hold debts they
cannot pay. On August 10, 2010, the
Commission published a final rule
amending the Telemarketing Sales Rule
to protect consumers from deceptive or
abusive practices in the telemarketing of
debt relief services. 75 FR 48458. On
October 27, 2010, the Commission
issued a policy statement staying
enforcement of the debt relief provisions
of the TSR against companies offering
tax relief services; i.e., services offered
to renegotiate, settle, or alter the terms
of obligation between a consumer and a
taxing entity.
The recent national mortgage crisis
has launched an industry of companies
purporting, for a fee, to obtain mortgage
loan modifications or other relief for
consumers facing foreclosure. The
Commission and other law enforcement
have also taken action against mortgage
companies that harm consumers
through their advertising and servicing
practices. The Commission initiated and
completed rulemakings to protect
distressed homeowners, one relating to
Mortgage Assistance Relief Services
(‘‘MARS’’) and another relating to
Mortgage Acts and Practices (‘‘MAP’’)Advertising, through the life cycle of the
mortgage loan.4 The Commission ceased
work on a pending NPRM for MAP–
Servicing on July 21, 2011, and other
MAP rules, when the legal authority to
promulgate rulemaking transferred to
the new Consumer Financial Protection
Bureau pursuant to the Dodd-Frank
Wall Street Reform Act of 2010.
In December 2009, the Commission
issued compulsory information requests
to nine of the Nation’s largest debt
buying companies, requiring them to
produce information about their
practices in buying and selling
consumer debt. These nine companies
collectively purchased about 75 percent
of the debt sold in the United States in
2008. The Commission is using the
information for a study of the debt
buying industry. In recent years, debt
buyers have become a significant part of
the debt collection system. In February
2009, the Commission issued a report,
based on an agency debt collection
workshop, in which it found major
problems in the flow of information
among creditors, debt buyers, and
collection agencies. The Commission
issued the compulsory information
requests to determine whether the
practice of debt buying is contributing
to these problems and, more generally,
to obtain a better understanding of the
role of debt buyers in the debt collection
system. The Agency plans to report its
findings in early 2012.
In 2011, Commission staff initiated an
outreach project to inform various
advocacy and educational/research
organizations about the litigation
research and recommendations in the
Commission’s July 2010 roundtable
report entitled ‘‘Repairing a Broken
System: Protecting Consumers in Debt
Collection Litigation and Arbitration.’’ 5
Some State reform efforts have been
motivated by the Commission’s
recommendations, and the project has
created opportunities for FTC staff to
discuss the Commission’s findings and
recommendations with groups and
individuals who work on these issues.
The underlying 2010 report concluded
that the system for resolving consumer
debt collection disputes is broken and
recommended significant litigation and
arbitration reforms to improve efficiency
and fairness to consumers.
On April 28, 2011, the Commission
held a workshop, ‘‘Debt Collection 2.0:
Protecting Consumers as Technologies
Change.’’ The workshop addressed the
impact of technological advances on the
debt collection system, the resulting
consumer protection concerns, and the
need for responsive policy changes.
Technologies discussed included the
tools collectors use to locate consumers
and their assets; changing modes of
collector-consumer communications,
such as mobile phones, auto-dialers,
and electronic mail; the software that
collectors use to manage information
about consumers and debts; and
collector use of social media
applications. The workshop featured a
diverse group of speakers, including
consumer advocates, academics,
technologists, law enforcers, and
industry representatives. Staff officials
are drafting a document highlighting the
workshop’s key findings and their
policy implications.
On July 20, 2011, in response to
concerns about possible unfair,
deceptive, or abusive practices by
certain debt collectors, the Commission
finalized a policy statement clarifying
that the Agency will not take
enforcement action under the Fair Debt
Collection Practices Act (FDCPA) or the
FTC Act against companies that are
attempting to collect the debts of
deceased consumers, if the companies
communicate with someone who is
authorized to pay debts from the estate
of the deceased. 76 FR 44915 (Jul. 27,
2011). The policy statement also
4 See Mortgage Loans Rule under Rulemakings
and Studies Required by Statute, infra.
5 The report is available at https://www.ftc.gov/os/
2010/07/debtcollectionreport.pdf.
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emphasizes that debt collectors may not
mislead relatives to believe that they are
personally liable for a deceased
consumer’s debts or use other deceptive
or abusive tactics.
(b) Health Care. The FTC continues to
work to end anticompetitive settlement
deals featuring payments by branded
drug firms to a generic competitor to
keep generic drugs off the market (so
called, ‘‘pay for delay’’ agreements). The
Commission has a two-pronged
approach to ending these
anticompetitive pay-for-delay
agreements: Active support for
legislation to ban harmful pay-for-delay
agreements—one example being the
proposed legislation that Senate
Judiciary Committee recently
approved 6—and Federal court
challenges to invalidate individual
agreements. The FTC currently has three
cases in active litigation.7 An FTC Staff
Report issued during FY 2010 found a
record number (31) of potential pay for
delay agreements.8
The Commission also studied the
competitive impact of authorized
generics, which are generic versions of
drugs sold by the branded company. On
August 31, 2011, the Commission issued
a final report on authorized generic
drugs, finding that when branded
pharmaceutical companies introduce an
authorized generic version of their
brand-name drug, it can reduce both
retail and wholesale drug prices during
the first 6 months of competition. The
report also found that authorized
generics have a substantial effect on the
revenues of competing generic firms.
Over the longer term, by lowering
expected profits for generic competitors,
the introduction of an authorized
generic could affect a generic drug
company’s decision to challenge patents
on branded drug products with low
sales. However, the report concludes
that in spite of this, patent challenges by
generic competitors remain robust even
on drugs with low sales.
Additionally, the FTC is playing an
active role in health care reform. The
FTC and the Department of Justice’s
Antitrust Division (the Antitrust
Agencies) are working with the Centers
for Medicare & Medicaid Services (CMS)
and the Office of the Inspector General
6 S.27, ‘‘Preserve Access to Affordable Generics
Act.’’
7 FTC v. Watson Pharm., Inc., No. 10–12729–DD
(11th Cir. argued May 13, 2011); FTC v. Cephalon,
Inc., No. 2:08–CV–02141 (E.D. Pa. argued Oct. 21,
2009); Brief for FTC as Amicus Curiae Supporting
Plaintiffs, In re K-Dur Antitrust Litig., Nos. 10–2077,
10–2078, 10–2079 (3d Cir. filed May 18, 2011).
8 The Report on ‘‘Pay-for-Delay: How Drug
Company Pay-Offs Cost Consumers Billions’’ can be
found at https://www.ftc.gov/os/2010/01/100112pay
fordelayrpt.pdf.
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of the Department of Health and Human
Services (HHS OIG) to implement
provisions of the Patient Protection and
Affordable Care Act (the Act), Public
Law 111–48 (2010), that provide for the
formation of Accountable Care
Organizations (ACOs) under a new
Shared Savings Program. That program
encourages health care providers to
create integrated, efficient health care
delivery systems that can improve the
quality of health care services and lower
health care costs. The purpose of this
interagency project is to develop well
coordinated rules and policy guidance
that avoid conflicting or duplicative
requirements and encourage the
formation of pro-competitive, legally
compliant Shared Savings Program
ACOs.
In April 2011, the Antitrust Agencies
jointly proposed an enforcement policy
statement to provide the antitrust
guidance providers need to form procompetitive ACOs that will participate
in both the Shared Savings Program and
commercial markets. At the same time,
CMS issued its proposed rules for
Shared Savings ACOs, and HHS OIG
issued its proposed policy guidance.
After working with CMS and HHS OIG
to revise these documents in light of
public comments, the Agencies issued
on October 20, 2011, the final version of
a joint policy statement detailing how
the agencies will enforce U.S. antitrust
laws with respect to new ACOs.
(c) Privacy Challenges to Consumers
Posed by Technology and Business
Practices. During 2009 to 2010, the
Commission hosted a series of
roundtables to explore the privacy
issues and challenges associated with
21st century technology and business
practices to determine how best to
protect consumer privacy while
supporting beneficial uses of
information and technological
innovation. In December 2010, the FTC
staff issued a preliminary privacy
report 9 proposing a framework that
promotes privacy by design,
transparency, consumer choice, and
business innovation. The report is
intended to inform policymakers,
including Congress, as they develop
solutions, policies, and potential laws
governing privacy, and to guide and
motivate industry as it develops more
robust and effective best practices and
self-regulatory guidelines. The report
suggests implementation of a ‘‘Do Not
9 See ‘‘Federal Trade Commission (Bureau of
Consumer Protection), A Preliminary FTC Staff
Report on Protecting Consumer Privacy in an Era
of Rapid Change: A Proposed Framework for
Businesses and Policymakers’’ (Dec. 1, 2010) at
https://www.ftc.gov/os/2010/12/101201privacy
report.pdf.
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Track’’ mechanism, so consumers can
control the collection of data about their
online searching and browsing
activities. Since the release of the report,
self-regulatory efforts have progressed
and several companies have come
forward with ideas and innovations to
enhance consumer choice and online
privacy. FTC Staff are closely watching
these initiatives.
(d) Children’s Identity Theft. The FTC
and the Office for Victims of Crime
(OVC), Office of Justice Programs, U.S.
Department of Justice, held a forum on
July 12, 2011, which explored the
nature of child identity theft, including
foster care identity theft and identity
theft within families, with the goal of
advising parents and victims on how to
prevent the crime and how to resolve
child identity theft problems. The
Agencies have released educational
materials for public distribution.
(e) Food Marketing to Children. In an
effort to combat childhood obesity—the
most serious health crisis facing today’s
youth—a working group of four Federal
agencies on April 28, 2011, released for
public comment a set of proposed
voluntary non-regulatory principles that
can be used by industry as a guide for
marketing food to children. The
Interagency Working Group on Food
Marketed to Children, comprised of the
FTC, the Food and Drug Administration,
the Centers for Disease Control and
Prevention, and the Department of
Agriculture, was established by a
provision in the FY 2009 Omnibus
Appropriations Act (H.R. 1105) and is
charged with conducting a study and
developing recommendations for
nutritional standards for foods marketed
to children ages 17 and under. The
working group also held a half-day
forum on May 24, 2011, to provide
stakeholders with a chance to comment
in person. The comment period closed
July 14, 2011, with approximately
29,000 comments submitted. Members
of the Interagency Working Group are
sharing responsibility for reviewing the
comments on the proposed principles.
Comments pertaining to the proposed
nutrition principles, including those
about the food categories identified in
the principles, are being reviewed
primarily by the CDC, FDA, and USDA.
Comments relating to the marketing
aspects of the recommended principles,
as well as general comments, are being
reviewed primarily by the FTC. The
Working Group will make final
recommendations in a pending report to
Congress.
Following OMB approval on July 8,
2010, on August 12, 2010, the
Commission issued information
requests to 48 major food, beverage
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manufacturers, and quick-service
restaurant companies about spending
and marketing activities targeting
children and adolescents, as well as
nutritional information for food and
beverage products that the companies
market to these young consumers. The
study will advance the Commission’s
understanding of how food industry
promotional dollars targeted to children
and adolescents are allocated, the types
of activities and marketing techniques
the food industry uses to market its
products to children and adolescents,
and the extent to which self-regulatory
efforts are succeeding in improving the
nutritional quality of foods advertised to
children and adolescents. The Bureau of
Consumer Protection is analyzing the
data and preparing a report, which is
expected to be released sometime in late
2011 or early 2012.
(f) Alcohol Advertising. Regarding
advertising for beverage alcohol
products, the Commission issued on
September 8, 2010, compulsory
information requests requiring three
mid-sized suppliers to provide
information about advertising and
marketing practices and compliance
with self-regulatory guidelines. The
Commission has reviewed the three
companies’ responses and
communicated with them about the
results. This procedure is consistent
with a 2008 commitment by the
Commission to conduct small studies of
industry self-regulation in years when
no major study was underway. Further,
in early 2011, the Commission began the
process of seeking Office of
Management and Budget approval,
under the Paperwork Reduction Act, to
conduct another major study of alcohol
marketing and self-regulation; that study
will evaluate the advertising practices of
the major alcohol suppliers. The
Commission will also continue to
promote the ‘‘We Don’t Serve Teens’’
consumer education program,
supporting the legal drinking age.10
(g) Gasoline Prices. On September 1,
2011, the Commission issued a Bureau
of Economics staff report examining
trends in the petroleum industry and
how they have affected gasoline prices
between 2005 and early 2011.11 It
concludes that while a broad range of
factors influence the price of gasoline,
worldwide crude oil prices continue to
be the main driver of what Americans
pay at the pump. The report spells out
10 More information can be found at https://
www.dontserveteens.gov/.
11 See ‘‘Federal Trade Commission Bureau of
Economics: Gasoline Price Changes and the
Petroleum Industry: An Update,’’ September 2011,
at https://www.ftc.gov/os/2011/09/110901gasoline
pricereport.pdf.
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the factors that determine what
consumers pay for gas, and why prices
seem to ‘‘rocket up’’ but ‘‘feather down’’
(in other words, why prices increase
faster in response to cost increases than
they fall in response to cost decreases).
In addition to the price of crude oil, by
far and away the largest factor in
gasoline prices, the report looks at
factors such as refinery profit margins;
and the possible impact of futures
speculation on oil and gas prices.
(h) Financing of Motor Vehicles. The
Commission is holding a series of
roundtable events to gather information
on possible consumer protection issues
that may arise in the sale, lease, or
financing of motor vehicles. For many
consumers, buying or leasing a car is
their most expensive financial
transaction aside from owning a home.
With prices averaging more than
$28,000 for a new vehicle and $14,000
for a used vehicle from a dealer, most
consumers seek to lease or finance the
purchase of a new or used car.
Financing obtained at a dealership may
provide benefits for many consumers,
such as convenience, special
manufacturer-sponsored programs,
access to a variety of banks and
financial entities, or access to credit
otherwise unavailable to a buyer.
Dealer-arranged financing, however, can
be a complicated, opaque process and
could potentially involve unfair or
deceptive practices.
The first event took place in Detroit,
Michigan, on April 12, 2011. The FTC’s
second motor vehicle roundtable took
place in San Antonio, Texas on August
2–3, 2011. Dates for future additional
roundtables will be posted on the FTC
Web site at https://www.ftc.gov.
(i) Fraud Forum Surveys. The FTC’s
Bureau of Economics continues to
conduct fraud surveys and related
research on consumer susceptibility to
fraud. For example, the FTC is
conducting an exploratory study during
2011 on consumer susceptibility to
fraudulent and deceptive marketing.
This research is intended to further the
FTC’s mission of protecting consumers
from unfair and deceptive marketing.
The FTC also submitted a clearance
request for a second study with the
OMB, proposing to survey consumer
experiences with consumer fraud.
Neither study is intended to lead to
enforcement actions; rather, study
results may aid the FTC’s efforts to
better target its enforcement actions and
consumer education initiatives, and
improve future fraud surveys.
(j) Protecting Consumers from CrossBorder Harm. The FTC continues to
protect American consumers from fraud
by making greater use of the tools
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provided by the U.S. SAFE WEB Act.
The FTC has used the Act to cooperate
with its foreign law enforcement
counterparts in investigations and
enforcement actions involving Internet
fraud and other technological abuses
and deceptive schemes that victimize
U.S. consumers. During the past year,
the FTC added to its U.S. SAFE WEB
scorecard by sharing information in
response to nine requests from five
foreign law enforcement agencies. It also
issued twelve civil investigative
demands on behalf of two foreign
agencies in three investigations. In
many of these cases, the foreign
agencies investigated conduct that
directly harms U.S. consumers. In
others, the FTC’s assistance has led to
reciprocal assistance in other FTC
investigations. Given the success of the
U.S. SAFE WEB Act, the Commission
continues to recommend that Congress
repeal the Act’s seven-year sunset
provision before it expires in 2013.
Significant consumer protection
developments this year include the
launch of the Asia-Pacific Economic
Cooperation Cross-Border Privacy
Enforcement Arrangement, and a new
asset recovery initiative with Federal
and provincial Canadian law enforcers.
This year the Agency also worked with
its counterparts in the Global Privacy
Enforcement Network, a group of
privacy enforcement agencies around
the globe, to launch the organization’s
Web site, which provides a platform for
the participants to interact. The
Commission was also instrumental in
the development of the Organization for
Economic Cooperation and
Development’s new Consumer Policy
Toolkit, which was released at an event
hosted by the FTC featuring Karen
Kornbluh, U.S. Ambassador to the
OECD.
The FTC also stepped up its efforts to
reduce Internet-related fraud by
convening, with the FBI, a roundtable
discussion for law enforcement
agencies, domain name registrars, and
Internet registries to discuss measures to
curb malicious Internet conduct. Law
enforcement officials from the United
States, Brazil, Canada, Switzerland, and
the United Kingdom met with U.S.based and foreign domain name
registrars and four Internet registries to
discuss measures to curtail domain
name abuse.
(k) Journalism and the Internet. In
2009 to 2010, the FTC began a project
to examine how the Internet has
transformed the competitive dynamics
of the news media landscape. The
Agency first held a series of exploratory
workshops, seeking expert views and
public comments on varied aspects of
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the challenges and new opportunities
facing the news industry. The Agency
continues to analyze the issues
discussed at those workshops and
elsewhere, including the economics of
journalism in a digital world, new
business and non-profit models for
journalism, and potential changes to a
variety of Government policies,
including antitrust, copyright, and tax
policy, relevant to journalism. The
Agency plans to release a report in late
fall 2011.
(l) Intellectual Property. After a series
of eight hearings on the Evolving
Intellectual Property (IP) Marketplace
since the issuance of the FTC’s October
2003 report ‘‘To Promote Innovation:
The Proper Balance of Competition and
Patent Law and Policy,’’ the
Commission released a report in March
2011, ‘‘The Evolving IP Marketplace
Aligning Patent Notice and Remedies
with Competition,’’ that recommends
improvements to policies affecting
patent notice and remedies for patent
infringement. Specifically, the report
recommends improving policies
relevant to the patent notice function
through actions by the courts and the
Patent and Trademark Office. Clear
notice of what a patent covers promotes
innovation by encouraging
collaboration, technology transfer, and
design-around. The report suggests
notice mechanisms to improve the
public’s ability to identify relevant
patents, to understand the scope of
patent claims, and to predict the breadth
of claims that are likely to emerge from
patent applications. The report also
explains that patent remedies that align
compensation of patent holders with the
economic value of their patented
inventions are important for both
innovation and competition. Patent
damages that under-compensate
patentees for infringement can deter
innovation, but overcompensation can
lead to higher prices and encourage
speculation in patent rights, which also
deters innovation. Finally, the report
makes recommendations to courts that
would ground damages calculations and
injunction analysis in economic
principles that recognize competition
among patented technologies.
(m) Self-Regulatory and Compliance
Initiatives with Industry. The
Commission continues to engage
industry in compliance partnerships in
at least two areas involving the funeral
and franchise industries. Specifically,
the Commission’s Funeral Rule
Offender Program, conducted in
partnership with the National Funeral
Directors Association, is designed to
educate funeral home operators found
in violation of the requirements of the
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Funeral Rule, 16 CFR 453, so that they
can meet the rule’s disclosure
requirements. More than 350 funeral
homes have participated in the program
since its inception in 1996.
In addition, the Commission
established the Franchise Rule
Alternative Law Enforcement Program
in partnership with the International
Franchise Association (IFA), a nonprofit
organization that represents both
franchisors and franchisees. This
program is designed to assist franchisors
found to have a minor or technical
violation of the Franchise Rule, 16 CFR
436, in complying with the rule.
Violations involving fraud or other
section 5 violations are not candidates
for referral to the program. The IFA
teaches the franchisor how to comply
with the rule and monitors its business
for a period of years. Where appropriate,
the program offers franchisees the
opportunity to mediate claims arising
from the law violations. Since December
1998, 21 companies have agreed to
participate in the program.
Effect of the Consumer Financial
Protection Act of 2010
On July 21, 2010, President Obama
signed into law the ‘‘Dodd-Frank Wall
Street Reform and Consumer Protection
Act,’’ Public Law 111–203. Title X of the
statute, known as the Consumer
Financial Protection Act of 2010 (or the
Consumer Financial Protection Act),
created a new Bureau of Consumer
Financial Protection (‘‘CFPB’’) within
the Board of Governors of the Federal
Reserve System (‘‘Federal Reserve
Board’’). Most of the FTC’s rulemaking
authority under certain ‘‘enumerated
consumer laws’’ was transferred to the
CFPB on July 21, 2011. These laws
include all or most of the rulemaking
authority under the Truth in Lending
Act, the Fair Credit Reporting Act
(including the Fair and Accurate Credit
Transactions Act of 2003 (‘‘FACTA’’)),
the Gramm-Leach-Bliley Act, the Equal
Credit Opportunity Act, the Electronic
Funds Transfer Act, the Federal Deposit
Insurance Corporation Improvement Act
of 1991, and the Omnibus
Appropriations Act of 2009. Therefore,
the Commission removed the following
nine matters from its regulatory review
schedule because authority to modify or
repeal them were transferred to the
CFPB: Disclosure Requirements for
Depository Institutions Lacking Federal
Deposit Insurance, 16 CFR part 320;
Mortgage Assistance Relief Services
Rule, 16 CFR part 322; Statements of
General Policy or Interpretations [of the
Fair Credit Reporting Act Rules], 16 CFR
part 600; [Identity Theft] Definitions, 16
CFR part 603; Free Annual File
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Disclosures Rule, 16 CFR part 610
Prohibition Against Circumventing
Treatment as a Nationwide Consumer
Reporting Agency, 16 CFR part 611;
Duration of Active Duty Alerts, 16 CFR
part 613; Appropriate Proof of Identity,
16 CFR part 614; and Procedures for
State Application for Exemption From
the Provisions of the [Federal Debt
Collection Practices] Act, 16 CFR part
901.2. Further information on the
impact of the Consumer Financial
Protection Act on the Commission’s
rulemakings, studies, and guidelines is
discussed below.
Rulemakings and Studies Required by
Statute
Congress has enacted laws requiring
the Commission to undertake
rulemakings and studies. This section
discusses required rules and studies.
The final actions section below
describes actions taken on the required
rulemakings and studies since the 2010
Regulatory Plan was published.
FACTA Rules. The Commission has
already issued nearly all of the rules
required by FACTA. These rules are
codified in several parts of 16 CFR 600
et seq., amending or supplementing
regulations relating to the Fair Credit
Reporting Act. The enforcement of the
Red Flags Rule (or Identity Theft Rule),
16 CFR 681, was delayed by the
Commission from its initial effective
date of November 1, 2008, until January
1, 2011, pending clarification by
Congress. The ‘‘Red Flag Program
Clarification Act of 2010’’ (or the Act),
Public Law 111–319, was signed into
law on December 18, 2010. The
Commission and the banking agencies
expect to revise the Red Flags Rule to
implement the Act by the spring of
2012.
FACTA Studies. On March 27, 2009,
the Commission issued compulsory
information requests to the nine largest
private providers of homeowner’s
insurance in the Nation. The purpose
was to help the FTC collect data for its
study on the effects of credit-based
scores in the homeowners’ insurance
market, a study mandated by section
215 of the FACTA. During the summer
of 2009 these nine insurers submitted
responses to the Commission’s requests.
FTC staff has reviewed the large policylevel data files included in these
submissions and has identified a sample
set of data to be used for the study. Staff
expects to prepare and submit the report
to Congress before the end of 2012. The
data collection phase of the study
should be completed by March 2012.
This study is not affected by the
Consumer Financial Protection Act.
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The FTC is also conducting a national
study of the accuracy of consumer
reports in connection with section 319
of the FACTA. This study is a followup to the Commission’s two previous
pilot studies that were undertaken to
evaluate a potential design for a national
study. Section 319 requires the FTC to
study the accuracy and completeness of
information in consumers’ credit reports
and to consider methods for improving
the accuracy and completeness of such
information. Section 319 of the Act also
requires the Commission to issue a
series of biennial reports to Congress
over a period of 11 years.12 A major
report on the study, which is presently
in the field, is due by December 2012.
This study is also not affected by the
Consumer Financial Protection Act.
Mortgage Loans Rules, 16 CFR 321,
322: Section 626 of the Omnibus
Appropriations Act of 2009 directed the
Commission to initiate a rulemaking
proceeding with respect to mortgage
loans and prescribed that any violation
of the Rule shall be treated as a violation
of a rule under section 18 of the FTC
Act regarding unfair or deceptive acts or
practices. On June 1, 2009, the
Commission published an ANPRM in
two parts: (1) Mortgage Assistance Relief
Services (practices of entities providing
assistance to consumers in modifying
mortgage loans or avoiding foreclosure)
(or MARS), 74 FR 26,130, and (2)
Mortgage Acts and Practices through the
life cycle of the mortgage loan (i.e., loan
advertising, marketing, origination,
appraisals, and servicing) (or MAP), 74
FR 26,118.
• MARS—After issuing an NPRM on
March 10, 2010, the Commission
published a MARS final rule. 75 FR
75092 (Dec. 1, 2011). The final MARS
rule prohibits providers of these
services from making false or
misleading claims, mandates that
providers disclose certain information
about these services, bars the collection
of advance fees for these services,
prohibits persons from providing
substantial assistance or support to an
entity they know or consciously avoid
knowing is engaged in a violation of
these rules, and imposes recordkeeping
and compliance requirements. All
provisions of the rule except the
advance-fee ban became effective
December 29, 2010. The advance-fee
12 See Federal Trade Commission Reports to
Congress under Sections 318 and 319 of the Fair
and Accurate Credit Transactions Act of 2003;
available at https://www.ftc.gov/reports/FACTACT/
FACTAct_Report_2006.pdf (December 2006 Report),
https://www.ftc.gov/opa/2008/12/factareport.shtm
(December 2008 Report) and
https://www.ftc.gov/os/2011/01/1101factareport.pdf
(December 2010 Report).
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ban provisions became effective January
31, 2011. Additionally, on July 15, 2011,
the FTC issued a stay of enforcement
stating that the Agency would forbear
from enforcing the MARS Rule, with the
exception of the prohibition on
misrepresentations, against real estate
professionals who assist consumers in
negotiating or obtaining short sales.
• MAP-Advertising—After issuing an
NPRM on September 30, 2010, the
Commission announced a final rule for
MAP-Advertising on July 19, 2011. 76
FR 43826. The final rule prohibits
misrepresentation in commercial
communications regarding any term of a
mortgage credit product and imposes
certain recordkeeping requirements. The
rule became effective on August 19,
2011.
• MAP-Servicing—The Commission
ceased work on a pending NPRM for
MAP-Servicing on July 21, 2011. On
that date, the Commission’s rulemaking
authority for all of the MAP rules under
the Omnibus Appropriations Act of
2009 was transferred to the CFPB.
Rule Concerning Disclosures
Regarding Energy Consumption and
Water Use of Certain Home Appliances
and Other Products Required Under the
Energy Policy and Conservation Act
(Appliance Labeling Rule), 16 CFR 305:
Under direction from Congress to
examine the effectiveness of light bulb
labels, the FTC introduced a new
‘‘Lighting Facts’’ label in July 2010 for
medium screw-base light bulbs. 75 FR
41696. On July 22, 2011, the
Commission announced an NPRM
seeking comment on expanding the
‘‘Lighting Facts’’ label coverage to
additional bulb types and a specific test
procedure for light-emitting diode (LED)
bulbs. During November 2011, the
Commission will issue an ANPRM
seeking comment on disclosures to help
consumers, distributors, contractors,
and installers easily determine whether
a specific furnace, central air
conditioner, or heat pump meets the
applicable new Department of Energy
efficiency standard for the regions
where it will be installed. The
Commission will seek comment on the
content, location, and format of such
disclosures. As part of this effort, the
Commission staff will hold a public
meeting with the Department of Energy
(DOE) to discuss possible disclosures.
The statutory deadline for the
Commission to issue regional efficiency
standards is 15 months after DOE issued
their final efficiency standards on
October 25, 2011. 76 FR at 37408.
Section 325 of the Energy
Independence and Security Act of 2007
provides the Commission with the
authority to promulgate energy labeling
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rules for consumer electronics. On
October 27, 2010, the Commission
announced it was issuing a final rule
that will require televisions
manufactured after May 10, 2011, to
display EnergyGuide labels that include
information on estimated yearly energy
and the cost range compared to similar
models. Staff anticipates sending a
recommendation to the Commission by
December 2011 regarding a proposed
notice of rulemaking for other consumer
electronics.
Retrospective Review of Existing
Regulations
In 1992, the Commission
implemented a program to review its
rules and guides regularly. The
Commission’s review program is
patterned after provisions in the
Regulatory Flexibility Act, 5 U.S.C. 601
to 612. Under the Commission’s
program, rules have been reviewed on a
ten-year schedule. For many rules, this
has resulted in more frequent reviews
than is generally required by section 610
of the Regulatory Flexibility Act. This
program is also broader than the review
contemplated under the Regulatory
Flexibility Act, because it provides the
Commission with an ongoing systematic
approach for seeking information about
the costs and benefits of its rules and
guides and whether there are changes
that could minimize any adverse
economic effects, not just a ‘‘significant
economic impact upon a substantial
number of small entities.’’ 5 U.S.C. 610.
As part of its continuing ten-year
review plan, the Commission examines
the effect of rules and guides on small
businesses and on the marketplace in
general. These reviews may lead to the
revision or rescission of rules and
guides to ensure that the Commission’s
consumer protection and competition
goals are achieved efficiently and at the
least cost to business. In a number of
instances, the Commission has
determined that existing rules and
guides were no longer necessary nor in
the public interest. Most of the matters
currently under review pertain to
consumer protection and are intended
to ensure that consumers receive the
information necessary to evaluate
competing products and make informed
purchasing decisions. Pursuant to this
program, the Commission has rescinded
37 rules and guides promulgated under
the FTC’s general authority and updated
dozens of other since the early 1990s.
In light of Executive Orders 13563
and 13579, the FTC has taken a fresh
look at its longstanding regulatory
review process. The Commission is
taking a number of steps to ease burdens
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on business and promote transparency
in its regulatory review program:
• The Commission recently issued a
revised 10-year review schedule (see
next paragraph below) and is
accelerating the review of a number of
rules and guides in response to recent
changes in technology and the
marketplace. More than a third of the
Commission’s 66 rules and guides will
be under review, or will have just been
reviewed, by the end of 2011.
• The Commission is requesting
public comment on the effectiveness of
its regulatory review program and
suggestions for its improvement.
• The FTC has launched a Web page
at https://www.ftc.gov/regreview that will
serve as a one-stop shop for the public
to obtain information and provide
comments on individual rules and
guides under review as well as the
Commission’s regulatory review
program generally.
Pursuant to section 2 of Executive
Order 13579 ‘‘Regulation and
Independent Regulatory Agencies’’ (Jul.
11, 2011), the following Regulatory
Identifier Numbers (RINs) have been
identified as associated with
retrospective review and analysis in the
FTC’s regulatory review plan. The table
includes rulemakings that the Agency
expects to issue in proposed or final
form during the upcoming year. Each
entry includes the title of the
rulemaking subject to the Agency’s
retrospective analysis, the RIN and
whether it is expected to reduce
burdens on small businesses. The
regulatory review plan can be found at:
www.ftc.gov.
Regulatory
Identifier Nos.
(RIN)
Rule
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Business Opportunity Rule, 16 CFR 437 ................................................................................................
Trade Regulation Rule Concerning Cooling Off Period for Sales Made at Homes or at Certain Other
Locations, 16 CFR 429.
Children’s Online Privacy Protection Rule, 16 CFR 312 ........................................................................
In addition, the Commission’s tenyear periodic review for 2011 includes
the following rules and guides (76 FR
41151, July 13, 2011):
(1) Guides for Advertising of
Warranties and Guaranties, 16 CFR 239;
(2) Rules and Regulations under the
Wool Products Labeling Act of 1939, 16
CFR part 300;
(3) Fur Products Labeling Act Rules,
16 CFR 301;
(4) Rules and Regulations under the
Textile Fiber Products Identification
Act, 16 CFR part 303;
(5) Rule on Retail Food Store
Advertising and Marketing Practices
(Unavailability Rule), 16 CFR 424;
(6) Interpretations of Magnuson-Moss
Warranty Act, 16 CFR 700;
(7) Disclosure of Written Consumer
Product Warranty Terms and
Conditions, 16 CFR 701;
(8) Pre-Sale Availability of Written
Warranty Terms, 16 CFR 702;
(9) Informal Dispute Settlement
Procedures, 16 CFR 703; and
(10) [Hart-Scott-Rodino Antitrust
Improvements Act] Coverage Rules, 16
CFR part 801.
Due to resource constraints, the
Commission is postponing review of the
following matters previously scheduled
for 2011 review: Administrative
Interpretations, General Policy
Statements, and Enforcement Policy
Statements, 16 CFR part 14; the Guides
for the Jewelry, Precious Metals, and
Pewter Industries, 16 CFR part 23; the
Preservation of Consumers’ Claims and
Defenses Rule [Holder in Due Course
Rule], 16 CFR part 433; and the Credit
Practices Rule, 16 CFR part 444.
Furthermore, consistent with the goal
of reducing unnecessary burdens,
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within and outside the Government,
Commission staff officials are in the
process of identifying reports required
by statute as well as statutes themselves
that appear to be of limited value, but
that divert business or Commission
resources from more pressing work.
Thus far, staff preliminarily has
identified two reports that do not appear
to be useful. The first is a report,
required annually, on concentration in
the ethanol market. The Commission
has found each year that the market is
extremely unconcentrated, and that
entry is easy and ongoing. Therefore,
this report seems to provide little useful
information. The second report is
prepared by the Commission together
with the Department of Justice and the
Department of Education, and simply
describes actions taken to address
scholarship scams. Though stopping
scholarship scams is an important
priority, the report appears to provide
little valuable information. The
Commission will make appropriate
recommendations to Congress at the
conclusion of its review.
Ongoing Rule and Guide Reviews
The Commission is continuing review
of a number of rules and guides, which
are discussed first under (a) Rules and
then (b) Guides.
(a) Rules
Labeling Requirements for Alternative
Fuels and Alternative Fueled Vehicles
Rule (‘‘Alternative Fuel Rule’’), 16 CFR
309. The Alternative Fuel Rule, which
became effective on November 20, 1995,
and was last reviewed in 2004, requires
disclosure of appropriate cost and
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7875
Expected to Reduce
Burdens on Small
Business
(Yes/No)
3084–AB04
3084–AB10
Yes.
Yes.
3084–AB20
No.
benefit information to enable consumers
to make reasonable purchasing choices
and comparisons between non-liquid
alternative fuels, as well as alternativefueled vehicles. On June 1, 2011, the
Commission requested comments on the
rule, as part of the Commission’s
systematic review of all current
Commission rules and guides. The
Commission also sought comment on
whether to merge its alternative fueled
vehicle (AFV) labels with fuel economy
labels proposed by the Environmental
Protection Agency (EPA) and the
National Highway Traffic Safety
Administration (NHTSA), add new
definitions for AFVs contained in recent
legislation, and change labeling
requirements for used AFVs. The
comment period closed on July 25,
2011, and staff is reviewing the
comments. On June 1, 2011, the
Commission also postponed any
amendments to its Guide Concerning
Fuel Economy Advertising for New
Automobiles upon completion of
ongoing review by the Environmental
Protection Agency and the National
Highway Traffic Safety Administration
of current fuel economy labeling
requirements and the Commission’s
accelerated regulatory review of its own
Alternative Fuel Rule. 76 FR 31467.
Telemarketing Sales Rule (TSR).
Caller ID—The Commission issued an
advance notice of proposed rulemaking
on December 15, 2010, requesting
public comment on provisions of the
Telemarketing Sales Rule concerning
caller identification services and
disclosure of the identity of the seller or
telemarketer responsible for
telemarketing calls. 75 FR 78,179. The
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comment period closed on January 28,
2011. The Commission solicited
comments on whether changes should
be made to the TSR to reflect the current
use and capabilities of Caller ID
technologies. In particular, the
Commission is interested in whether the
TSR should be amended to better
achieve the objectives of the Caller ID
provisions—including enabling
consumers and law enforcement to use
Caller ID information to identify entities
responsible for illegal telemarketing
practices. Staff is reviewing the
comments and anticipates making a
recommendation to the Commission by
April 2012.
Business Opportunity Rule. Regarding
the Business Opportunity Rule, the
Commission issued an NPRM (71 FR
19,054, Apr. 12, 2006) and a revised
NPRM (73 FR 16,110, Mar. 26, 2008),
then later held a workshop on June 1,
2009, to explore changes to the
proposed rule, including the
effectiveness of a proposed disclosure
form. On October 28, 2010, the
Commission released a staff report
recommending that coverage of the
FTC’s Business Opportunity Rule be
expanded to include work-at-home
opportunities such as envelope stuffing,
medical billing, and product assembly,
many of which have not been covered
before. 75 FR 68,559 (Nov. 8, 2010). FTC
staff also recommended streamlining the
disclosures required by the Business
Opportunity Rule so that companies or
individuals selling business
opportunities make important
disclosures to consumers on a simple,
easy-to-read document. If adopted, the
changes will make it less burdensome
for legitimate sellers to comply with the
Rule, while still protecting consumers
from ‘‘widespread and persistent’’
business opportunity fraud. Public
comments on the staff report were
accepted until January 18, 2011. Staff
anticipates Commission action relating
to a proposed final rule by the end of
2011.
Children’s Online Privacy Protection
Rule (‘‘COPPA Rule’’), 16 CFR 312. The
COPPA Rule requires operators of Web
sites, and online service providers
directed at children under 13
(operators), with certain exceptions, to
obtain verifiable parental consent before
collecting, using, or disclosing personal
information from or about children
under the age of 13. An operator must
make reasonable efforts, in light of
available technology, to ensure that the
person providing consent is the child’s
parent. The Commission issued an
ANPRM requesting comments on the
Rule as part of the systematic regulatory
review process. 75 FR 17089 (Apr. 5,
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2010). The Commission held a public
roundtable on the Rule on June 2, 2010,
and the comment period, as extended,
ended on July 12, 2010. On September
15, 2011, the Commission announced it
was proposing modifications to the Rule
in five areas to respond to changes in
online technology, including in the
mobile marketplace, and, where
appropriate, to streamline the Rule:
Definitions, including the definitions of
‘‘personal information’’ and
‘‘collection,’’ parental notice, parental
consent mechanisms, confidentiality
and security of children’s personal
information, and the role of selfregulatory ‘‘safe harbor’’ programs. 76
FR 59804. In addition, the Commission
also proposed adding a new provision
addressing data retention and deletion.
The comment period will close on
November 28, 2011.
Mail or Telephone Order Merchandise
Rule. The Mail Order Rule, 16 CFR 435,
requires that, when sellers advertise
merchandise, they must have a
reasonable basis for stating or implying
that they can ship within a certain time.
On September 30, 2011,13 the
Commission published a NPRM
proposing to: clarify that the Rule covers
all orders placed over the Internet;
revise the Rule to allow sellers to
provide refunds and refund notices by
any means at least as fast and reliable
as first class mail; clarify sellers’
obligations when buyers use payment
systems not enumerated in the Rule;
and require that refunds be made with
seven working days for purchases made
using third-party credit cards. 76 FR
60765. The comment period closes on
December 14, 2011.
Used Car Rule. The Used Motor
Vehicle Trade Regulation Rule (‘‘Used
Car Rule’’), 16 CFR 455, sets out the
general duties of a used vehicle dealer;
requires that a completed Buyers Guide
be posted at all times on the side
window of each used car a dealer offers
for sale; and mandates disclosure of
whether the vehicle is covered by a
warranty and, if so, the type and
duration of the warranty coverage, or
whether the vehicle is being sold ‘‘as
is—no warranty.’’ The Commission
published a notice seeking public
comments on the effectiveness and
impact of the rule. 73 FR 42285 (Jul. 21,
2008). The notice seeks comments on a
range of issues including, among others,
whether a bilingual Buyers Guide would
be useful or practicable, as well as what
form such a Buyers Guide should take.
13 Please see Final Action section for information
about a separate FR Notice that announces that the
Commission is retaining MOTR with minor
technical corrections.
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Second, the notice seeks comments on
possible changes to the Buyers Guide
that reflect new warranty products, such
as certified used car warranties, that
have become increasingly popular since
the rule was last reviewed. Finally, the
notice seeks comments on other issues
including the continuing need for the
rule and its economic impact, the effect
of the rule on deception in the used car
market, and the rule’s interaction with
other regulations. The comment period,
as extended and then reopened, ended
on June 15, 2009. Staff anticipates
sending a recommendation to the
Commission by the end of 2011.
Cooling-Off Rule. The Cooling-Off
Rule requires that a consumer be given
a 3-day right to cancel certain sales
greater than $25.00 that occur at a place
other than a seller’s place of business.
The rule also requires a seller to notify
buyers orally of the right to cancel, to
provide buyers with a dated receipt or
copy of the contract containing the
name and address of the seller and
notice of cancellation rights, and to
provide buyers with forms which buyers
may use to cancel the contract. An
ANPRM seeking comment was
published on April 21, 2009. 74 FR
18170. The comment period, as
extended, ended on September 25, 2009.
74 FR 36972 (Jul. 27, 2009). Staff
prepared a recommendation for the
Commission and anticipates publication
of an NPRM by the end of 2011.
Negative Option Rule. The Negative
Option Rule governs the operation of
prenotification subscription plans.
Under these plans, sellers ship
merchandise automatically to their
subscribers and bill them for the
merchandise within a prescribed time.
The rule protects consumers by
requiring the disclosure of the terms of
membership clearly and conspicuously
and establishes procedures for
administering the subscription plans.
An ANPRM was published on May 14,
2009, 74 FR 22720, and the comment
period closed on July 27, 2009. On
August 7, 2009, the Commission
reopened and extended the comment
period until October 13, 2009. 74 FR
40121. Staff anticipates sending a
recommendation to the Commission by
the end of 2011.
Pay-Per-Call Rule. The Commission’s
review of the Pay-Per-Call Rule, 16 CFR
308, is continuing. The Commission has
held workshops to discuss proposed
amendments to this rule, including
provisions to combat telephone bill
‘‘cramming’’—inserting unauthorized
charges on consumers’ phone bills—and
other abuses in the sale of products and
services that are billed to the telephone
including voicemail, 900-number
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services, and other telephone based
information and entertainment services.
The most recent workshop focused on
the use of 800 and other toll-free
numbers to offer pay-per-call services,
the scope of the rule, the dispute
resolution process, the requirements for
a pre-subscription agreement, and the
need for obtaining express authorization
from consumers before placing charges
on their telephone bills. The review
record has remained open to encourage
additional comments on expansion of
the rule’s coverage. Staff expects to
prepare a recommendation for the
Commission by December 2012.
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(b) Guides
Guides for the Use of Environmental
Marketing Claims (Green Guides), 16
CFR 260: After holding three public
workshops, analyzing public comments,
and studying consumer perceptions of
certain environmental claims, the
Commission announced on October 6,
2010, proposed revisions to the Green
Guides to help marketers avoid making
misleading environmental claims. The
proposed changes are designed to
update the Guides and make them easier
for companies to understand and use.
The changes to the Green Guides
include new guidance on marketers’ use
of product certifications and seals of
approval, ‘‘renewable energy’’ claims,
‘‘renewable materials’’ claims, and
‘‘carbon offset’’ claims. The comment
period closed on December 10, 2010.
The staff is currently reviewing 338
non-duplicate comments and
anticipates sending a recommendation
to the Commission by the end of 2011.
Vocational Schools Guides. The
Commission sought public comments
on its Private Vocational and Distance
Education Schools Guides, commonly
known as the Vocational Schools
Guides. 74 FR 37973 (Jul. 30, 2009).
Issued in 1972 and most recently
amended in 1998 to add a provision
addressing misrepresentations related to
post-graduation employment, the guides
advise businesses offering vocational
training courses—either on the school’s
premises or through distance education,
such as correspondence courses or the
Internet—how to avoid unfair and
deceptive practices in the advertising,
marketing, or sale of their courses. The
comment period closed on October 16,
2009. Staff is reviewing comments and
anticipates sending a recommendation
to the Commission by the end of 2011.
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Final Actions 14
Since the publication of the 2010
Regulatory Plan, the Commission has
issued the following final rules or taken
other actions to terminate rulemaking
proceedings.
FACTA Risk-Based Pricing Rule. After
the Commission issued a risk-based
pricing rule jointly with the Federal
Reserve, 75 FR 2724 (Jan. 15, 2010), the
Dodd-Frank Act subsequently amended
the Fair Credit Reporting Act to require
that this risk-based pricing notice
include a credit score if one was used.
After issuing an NPRM, the Agencies
published final rules requiring creditors
to disclose credit score information to
consumers when a credit score is used
in setting or adjusting the terms of
credit. 76 FR 41602 (Jul. 15, 2011).
Hart-Scott-Rodino Rules. For the HartScott-Rodino Premerger Notification
Rules (HSR Rules), 16 CFR 801 to 803),
the Commission in conjunction with the
Antitrust Division, Department of
Justice, published a final rule on July
19, 2011, streamlining the HSR Form
and capturing new information that will
help the Agencies conduct their initial
review of a proposed transaction’s
competitive impact. 76 FR 42471. These
final rules were effective August 18,
2011.
Fuel Ratings Rule. The Fuel Ratings
Rule sets out a uniform method for
determining the octane rating of
gasoline from the refiner through the
chain of distribution to the point of
retail sale. The rule enables consumers
to buy gasoline with an appropriate
octane rating for their vehicle and
establishes standard procedures for
determining, certifying, and posting
octane ratings. After notice and
comment, 75 FR 12,470 (Mar. 16, 2010),
on April 8, 2011, the Commission
issued amendments to the rule that
allow an alternative octane rating
method and made other minor changes.
76 FR 19684. The effective date for the
amendments was May 31, 2011. The
Commission declined to issue final
ethanol labeling amendments at that
time, but is currently considering this
for possible further action.
Mail or Telephone Order Merchandise
Rule. The Mail Order Rule, 16 CFR 435,
requires that, when sellers advertise
merchandise, they must have a
reasonable basis for stating or implying
that they can ship within a certain time.
During 2007, the Commission sought
comments about non-substantive
changes to the rule to bring it into
conformity with changing conditions;
including consumers’ usage of means
other than the telephone to access the
Internet when ordering, consumers
paying for merchandise by demand draft
or debit card, and merchants using
alternative methods to make prompt
rule-required refunds. 72 FR 51728
(Sep. 11, 2007). On September 30,
2011,15 the Commission announced it
was retaining MTOR. 76 FR 60715.
Based on previous Rule proceedings and
after reviewing public comments
received regarding the Rule’s overall
costs, benefits, and regulatory and
economic impact, the Commission
concluded that the Rule continues to
benefit consumers and the Rule’s
benefits outweigh its costs. For clarity,
the Commission reorganized the Rule by
alphabetizing the definitions at the
beginning of the Rule.
14 Other final actions can be found under
Rulemakings and Studies Required by Statute,
supra.
15 Please see Ongoing Rule and Guide Reviews
section above for information on a separate FR
Notice proposing amendments to MOTR.
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Summary
In both content and process, the FTC’s
ongoing and proposed regulatory
actions are consistent with the
President’s priorities. The actions under
consideration inform and protect
consumers, while minimizing the
regulatory burdens on businesses. The
Commission will continue working
toward these goals. The Commission’s
10-year review program is patterned
after provisions in the Regulatory
Flexibility Act and complies with the
Small Business Regulatory Enforcement
Fairness Act of 1996. The Commission’s
10-year program also is consistent with
section 5(a) of Executive Order 12866,
which directs executive branch agencies
to develop a plan to reevaluate
periodically all of their significant
existing regulations. 58 FR 51735 (Sep.
30, 1993). In addition, the final rules
issued by the Commission continue to
be consistent with the President’s
Statement of Regulatory Philosophy and
Principles, Executive Order 12866,
section 1(a), which directs agencies to
promulgate only such regulations as are,
inter alia, required by law or are made
necessary by compelling public need,
such as material failures of private
markets to protect or improve the health
and safety of the public.
The Commission continues to identify
and weigh the costs and benefits of
proposed actions and possible
alternative actions, and to receive the
broadest practicable array of comment
from affected consumers, businesses,
and the public at large. In sum, the
Commission’s regulatory actions are
aimed at efficiently and fairly promoting
the ability of ‘‘private markets to protect
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or improve the health and safety of the
public, the environment, or the wellbeing of the American people.’’
Executive Order 12866, section 1.
II. Regulatory Actions
The Commission has no proposed
rules that would be a ‘‘significant
regulatory action’’ under the definition
in Executive Order 12866.16
BILLING CODE 6750–01–P
NATIONAL INDIAN GAMING
COMMISSION (NIGC)
Statement of Regulatory Priorities
In 1988, Congress adopted the Indian
Gaming Regulatory Act (IGRA) (Pub. L.
100–497, 102 Stat. 2475) with a primary
purpose of providing ‘‘a statutory basis
for the operation of gaming by Indian
tribes as a means of promoting tribal
economic development, self-sufficiency,
and strong tribal governments.’’ IGRA
established the National Indian Gaming
Commission (NIGC or the Commission)
to protect such gaming, amongst other
things, as a means of generating tribal
revenue.
At its core, Indian gaming is a
function of sovereignty exercised by
tribal governments. In addition, the
Federal Government maintains a
government-to-government relationship
with the tribes—a responsibility of the
NIGC. Thus, while the Agency is
committed to strong regulation of Indian
gaming, the Commission is equally
committed to strengthening
government-to-government relations by
engaging in meaningful consultation
with tribes to fulfill IGRA’s intent. The
NIGC’s vision is to adhere to principles
of good government, including
transparency to promote Agency
accountability and fiscal responsibility,
to operate consistently to ensure
fairness and clarity in the
administration of IGRA, and to respect
the responsibilities of each sovereign in
order to fully promote tribal economic
development, self-sufficiency, and
strong tribal governments. The NIGC is
fully committed to working with tribes
to ensure the integrity of the industry by
exercising its regulatory responsibilities
through technical assistance,
compliance, and enforcement activities.
Retrospective Review of Existing
Regulations
As an independent regulatory agency,
the NIGC has been performing a
RIN
Title
3141–AA15 ..................................
3141–AA–27 ................................
3141–AA40 ..................................
3141–AA43 ..................................
3141–AA44 ..................................
3141–AA45 ..................................
3141–AA46 ..................................
3141–AA47 ..................................
3141–AA48 ..................................
3141–AA49 ..................................
3141–AA50 ..................................
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retrospective review of its existing
regulations well before Executive Order
13579 was issued on July 11, 2011. The
NIGC, however, recognizes the
importance of E.O. 13579 and its
regulatory review is being conducted in
the spirit of E.O. 13579, to identify those
regulations that may be outmoded,
ineffective, insufficient, or excessively
burdensome and to modify, streamline,
expand, or repeal them in accordance
with input from the public. In addition,
as required by Executive Order 13175,
the Commission has been conducting
government-to-government
consultations with tribes regarding each
regulation’s relevancy, consistency in
application, and limitations or barriers
to implementation, based on the tribes’
experiences. The consultation process is
also intended to result in the
identification of areas for improvement
and needed amendments, if any, new
regulations, and the possible repeal of
outdated regulations.
The following Regulatory Identifier
Numbers (RINs) have been identified as
associated with the review:
Tribal Background Investigations and Licensing.
Class II and Class III Minimum Internal Control Standards and Class II Minimum Technical Standards.
Fees.
Definitions.
Self Regulation of Class II.
Review and Approval of Pre-Existing Ordinances or Resolutions.
Management Contracts.
Appeal Proceedings Before the Commission.
Facility License Notifications, Renewals, and Submissions.
Issuance of Investigation Completion Letters.
Enforcement Regulations.
More specifically, the NIGC is
reviewing and considering revising its
existing regulations in the following
areas: (i) Tribal background
investigations and licensing, in order to
streamline the process for submitting
information to the NIGC; (ii) minimum
internal control standards (MICS) and
minimum technical standards for
gaming equipment used in the play of
Class II games, in order to respond to
changing technologies in the industry
and to ensure that the MICS and
technical standards remain relevant and
appropriate; (iii) requirements for
obtaining a self-regulation certification
for Class II gaming; (iv) appeals of the
Chair’s actions on ordinances,
management contracts, notices of
violations (NOV), civil fine assessments,
and closure orders, in order to clarify
the appeals process for the regulated
community; (v) facility licensing
notifications, renewals, and
submissions; (vi) monitoring and
investigations; (vii) fees, in order to
allow for the calculation of fees based
on each tribe’s fiscal year (instead of
calendar year) and to require quarterly
fee payments instead of semiannual
payments, to ensure fingerprint fees
reflect the true cost of fingerprint
processing by providing for the annual
review and adjustment of fees, and to
implement a late payment system in
lieu of NOVs for late submissions of fees
and utilizing the NOV system only in
rare instances; and (viii) enforcement, in
order to provide for pre-enforcement
procedures.
The NIGC is also currently
considering promulgating new
regulations: (i) Concerning a definition
of the term ‘‘sole proprietary interest’’
with regard to the conduct of gaming on
16 Section 3(f) of the Executive order defines a
regulatory action to be ‘‘significant’’ if it is likely
to result in a rule that may:
(1) Have an annual effect on the economy of $100
million or more or adversely affect in a material
way the economy; a sector of the economy;
productivity; competition; jobs; the environment;
public health or safety; or State, local, or tribal
governments or communities;
(2) Create a serious inconsistency or otherwise
interfere with an action taken or planned by another
agency;
(3) Materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs, or
the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out
of legal mandates, the President’s priorities, or the
principles set forth in this Executive order.
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Indian lands, in order to reduce
uncertainty surrounding the types of
development, consulting, financing, and
lease agreements tribes may enter into
with regard to their gaming activities;
and (ii) that would give preference to
qualified Indian-owned business when
purchasing goods or services needed to
carry out the Commission’s duties.
Lastly, the NIGC has issued a Notice of
Proposed Rulemaking repealing the
regulation on the review and approval
of gaming ordinances enacted by tribes
prior to the existence of the
Commission, as such ordinances may no
longer exist and thus there is no further
need for this regulation. The NIGC
anticipates that the ongoing
consultations with regulated tribes will
continue to play an important role in
the development of the NIGC’s
rulemaking efforts.
BILLING CODE 7565–01–P
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U.S. NUCEAR REGULATORY
COMMISSION
Fiscal Year 2011 Regulatory Plan
Statement of Regulatory Priorities
Under the authority of the Atomic
Energy Act of 1954, as amended, and
the Energy Reorganization Act of 1974,
as amended, the U.S. Nuclear
Regulatory Commission (NRC) regulates
the possession and use of source,
byproduct, and special nuclear material.
The NRC’s regulatory mission is to
ensure that civilian uses of nuclear
materials and facilities are carried out in
a manner that will protect public health
and safety and the environment and that
will not be inimical to the common
defense and security of the United
States. The NRC regulates the operation
of nuclear power plants and fuel cycle
plants; the safeguarding of nuclear
materials from theft and sabotage; the
safe transport, storage, and disposal of
radioactive materials and wastes; the
decommissioning and safe release for
other uses of licensed facilities that are
no longer in operation; and the medical,
industrial, and research applications of
nuclear material. In addition, the NRC
licenses the import and export of
radioactive materials.
As part of its regulatory process, the
NRC routinely conducts comprehensive
regulatory analyses that examine the
costs and benefits of contemplated
regulations. The NRC has developed
internal procedures and programs to
ensure that it imposes only necessary
requirements on its licensees and to
review existing regulations to determine
whether the requirements imposed are
still necessary.
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The NRC’s fiscal year (FY) 2011
regulatory plan is not indicative of all
rulemakings ongoing in FY 2011. The
NRC anticipates publication of one
major rule in FY 2011.
The NRC will update its requirement
to recover approximately 90 percent of
its budget authority in FY 2011, not
including amounts appropriated from
the Nuclear Waste Fund, amounts
appropriated for Waste Incidental to
Reprocessing, and amounts
appropriated for generic homeland
security activities (nonfee items),
through fees to NRC licensees and
applicants. The NRC receives 10 percent
of its budget authority (not including
nonfee items) from the general fund
each year to pay for the cost of Agency
activities that do not provide a direct
benefit to NRC licensees, such as
international assistance and Agreement
State activities (as defined under section
274 of the Atomic Energy Act of 1954,
as amended).
The NRC’s other significant regulatory
priorities for FY 2012 and beyond
includes the following:
• Revise the environmental
protection requirements for renewing
nuclear power plant operating licenses.
• Develop performance-based
acceptance criteria for fuel cladding
performance during loss-of-coolant
accidents at nuclear power plants.
• Certify new designs for nuclear
power plants and amend existing
approved designs.
• Specify the requirements for a sitespecific analysis to demonstrate
compliance with low-level waste
disposal performance objectives, and
the technical requirements needed for
this analysis.
• Amend the regulations that govern
the medical use of byproduct material
related to reporting and notifications of
medical events to clarify requirements
for permanent implant branchytherapy.
• Expand the options for independent
storage of spent nuclear fuel by
amending and approving new spent fuel
storage cask designs.
• Revise the fitness-for-duty
requirements specific to drug and
alcohol testing of employees working at
nuclear power plants and other licensed
facilities, and amend the fatigue
management requirements pertaining to
personnel who perform quality control
and quality verification functions.
• Put in place security requirements
for Category 1 and Category 2 quantities
of radioactive material.
In addition to the previously stated
priorities, additional regulatory
priorities may be required due to: (1)
Recommendations from a task force
established to examine the NRC’s
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regulatory requirements, programs,
processes, and implementation in light
of information from the Fukushima
Daiichi site in Japan, following the
March 11, 2011, earthquake and
tsunami; and (2) other emerging events.
NRC
Proposed Rule Stage
158. Medical Use of Byproduct
Material—Amendments/Medical Event
Definition [NRC–2008–0071]
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 35.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations
that govern medical use of byproduct
material related to reporting and
notifications of medical events to clarify
requirements for permanent implant
branchytherapy.
Statement of Need: The U.S. Nuclear
Regulatory Commission (NRC) is
proposing to amend its regulations to
change the criteria for defining a
medical event (ME) for permanent
implant brachytherapy from dose-based
to activity-based.
Several medical use events involving
therapeutic use of byproduct material in
2003, as well as advice from the
Advisory Committee on the Medical Use
of Isotopes (ACMUI), prompted the
reconsideration of the appropriateness
and adequacy of the regulations
regarding MEs and written directives
(WDs).
A proposed rule was published in the
Federal Register on August 6, 2008 (73
FR 45635), for public comment. Most of
the 57 comment letters received
primarily opposed parts of the
rulemaking. During fall of 2008, a
substantial number of MEs involving
permanent implant brachytherapy were
reported to the NRC. Based on its
evaluation of this information,
including an independent analysis by
an NRC medical consultant, the staff
developed a re-proposed rule in SECY–
10–0062, ‘‘Re-proposed Rule: Medical
Use of Byproduct Material—
Amendments/Medical Event
Definitions,’’ dated May 18, 2010, for
Commission approval.
In SRM–SECY–10–0062, dated
August 10, 2010, the Commission
disapproved the staff’s recommendation
to publish the re-proposed rule. Instead,
the Commission directed the staff to
work closely with the ACMUI and the
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broader medical and stakeholder
community to develop event definitions
that will protect the interests of patients,
allow physicians the flexibility to take
actions that they deem medically
necessary, while continuing to enable
the agency to detect failures in process,
procedure, and training, as well as any
misapplication of byproduct materials
by authorized users. Additionally, the
staff was directed to hold a series of
stakeholder workshops to discuss issues
associated with the ME definition. The
staff plans to expand this part 35
rulemaking to: Modify preceptor
attestation requirements, consider
extending grandfathering to certain
certified individuals (Ritenour petition
PRM–35–20), and to consider other
issues that have developed in
implementation of the current
regulations. The NRC intends to merge
this proposed rule with RIN 3150–AI63,
Preceptor Attestation Requirements
(NRC–2009–0175).
Summary of Legal Basis: 42 U.S.C.
2201; 42 U.S.C. 5841.
Alternatives: As an alternative to the
rulemaking, the NRC staff considered
the ‘‘no-action’’ alternative. Under this
option the NRC would not modify part
35, and the medical events would
continue to be considered under dosebased criteria than the activity-based
criteria for the permanent brachytherapy
implants.
Anticipated Cost and Benefits: The
NRC is in the process of preparing a
regulatory analysis to support this
rulemaking. The analysis examines the
costs and benefits of the alternatives
considered by the NRC. The analysis
will be available as part of the
rulemaking package.
Timetable:
Action
Date
FR Cite
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period End.
Second NPRM ....
02/15/08
02/26/08
73 FR 8830
08/06/08
10/20/08
73 FR 45635
10/06/08
73 FR 58063
11/07/08
Washington, DC 20555–0001, Phone:
301 415–0253, Email:
edward.lohr@nrc.gov.
Related RIN: Merged with 3150–AI63.
RIN: 3150–AI26
NRC
NRC
159. Fitness-for-Duty Programs [NRC–
2009–0090]
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 2201; 41
U.S.C. 5841
CFR Citation: 10 CFR 26.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations to
ensure that personnel who actually
perform independent quality control/
verification (QC/QV) checks under the
licensee’s NRC-approved quality
assurance program are subject to the
same part 26, subpart I, provisions as
operating personnel identified in
section 26.4(a)(1). The proposed rule
would also consider requests the
Commission received in Petitions for
Rulemaking 26–3, 26–5, and 26–6. Part
26, subpart I, currently does not include
QC/QV personnel as covered workers
for fatigue management. Also, petitions
for rulemaking have raised additional
concerns from affected stakeholders. A
detailed regulatory analysis will be
performed per NRC processes which
detail the costs and benefits associated
with the proposed rule. This regulatory
analysis will be published with the
proposed rule.
Statement of Need: Part 26, subpart I,
currently does not include QC/QV
personnel as covered workers for fatigue
management. Also, petitions for
rulemaking have raised additional
concerns from affected stakeholders.
Anticipated Cost and Benefits: A
detailed regulatory analysis will be
performed per NRC processes which
detail the costs and benefits associated
with the proposed rule. This regulatory
analysis will be published with the
proposed rule.
Timetable:
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Action
09/00/12
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Edward M. Lohr,
Nuclear Regulatory Commission, Office
of Federal and State Materials and
Environmental Management Programs,
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Washington, DC 20555–0001, Phone:
301 415–1619, Email:
scott.sloan@nrc.gov.
RIN: 3150–AI58
FR Cite
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Scott C. Sloan,
Nuclear Regulatory Commission, Office
of Nuclear Reactor Regulation,
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160. U.S. Evolutionary Power Reactor
(EPR) Design Certification Amendment
[NRC–2010–0132]
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 52.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations to
part 52 by issuing a new appendix for
the initial certification of the U.S.
Evolutionary Power Reactor standard
plant design. Applicants or licensees
intending to construct and operate a
nuclear power plant using the EPR
design may do so by referencing this
design certification rule.
Statement of Need: The U.S. Nuclear
Regulatory Commission (NRC or the
Commission) is amending its
regulations to certify an amendment to
the U.S. Evolutionary Power Reactor
(U.S. EPR) standard plant design. This
action is necessary so that applicants or
licensees intending to construct and
operate a U.S. EPR design may do so by
referencing this design certification rule.
The applicant for certification of the
amendment to the U.S. EPR design is
AREVA Nuclear Power.
A design certification amendment
does not establish standards or
requirements with which all licensees
must comply. Rather, design
certifications (and amendments thereto)
are Commission approvals of specific
nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
combined licenses. Furthermore, design
certification rulemakings are initiated
by an applicant for a design certification
(or amendments thereto), rather than the
NRC. As a result, there is no monetary
impact for this final rule.
Alternatives: The NRC has not
prepared alternatives for this rule. The
NRC evaluates alternatives for
rulemakings that establish generic
regulatory requirements applicable to all
licensees. Design certifications (and
amendments thereto) are not generic
rulemakings in the sense that design
certifications (and amendments thereto)
do not establish standards or
requirements with which all licensees
must comply. Rather, design
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certifications (and amendments thereto)
are Commission approvals of specific
nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
COLs. Furthermore, design certification
rulemakings are initiated by an
applicant for a design certification (or
amendments thereto), rather than the
NRC. Preparation of alternatives in this
circumstance would not be useful
because the design to be certified is
proposed by the applicant rather than
the NRC.
Anticipated Cost and Benefits: The
NRC has not prepared a regulatory
analysis for this rule. The NRC prepares
regulatory analyses for rulemakings that
establish generic regulatory
requirements applicable to all licensees.
Design certifications (and amendments
thereto) are not generic rulemakings in
the sense that design certifications (and
amendments thereto) do not establish
standards or requirements with which
all licensees must comply. Rather,
design certifications (and amendments
thereto) are Commission approvals of
specific nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
COLs. Furthermore, design certification
rulemakings are initiated by an
applicant for a design certification (or
amendments thereto), rather than the
NRC. Preparation of a regulatory
analysis in this circumstance would not
be useful because the design to be
certified is proposed by the applicant
rather than the NRC. For these reasons,
the Commission concludes that
preparation of a regulatory analysis is
neither required nor appropriate.
Timetable:
Action
Date
NPRM ..................
FR Cite
06/00/12
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Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Fred Schofer,
Nuclear Regulatory Commission, Office
of New Reactors, Washington, DC
20555–0001, Phone: 301 415–5682,
Email: fred.schofer@nrc.gov.
RIN: 3150–AI82
NRC
161. Disposal of Unique Waste Streams
[NRC–2011–0012]
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
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Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 61.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations to
require operating and future low-level
radioactive waste disposal facilities to
conduct a performance assessment and
an intruder assessment, to demonstrate
compliance with performance objectives
in 10 CFR part 61 to enhance safe
disposal of low-level radioactive waste.
These analyses will identify any
additional measures that would enhance
adequate protection of public health and
safety. The NRC is also proposing
additional changes to the current
regulations to reduce ambiguity,
facilitate implementation, and to better
align the requirements with current
health and safety standards. This rule
would affect existing and future lowlevel radioactive waste disposal
facilities that are regulated by the NRC
and the Agreement States.
Statement of Need: The U.S. Nuclear
Regulatory Commission (NRC) is
proposing to amend its regulations to
require low-level radioactive waste
(LLRW) disposal facilities to conduct
site-specific analyses to demonstrate
compliance with the performance
objectives. Although the NRC believes
that part 61 is adequate to protect public
health and safety, requiring a sitespecific analysis to demonstrate
compliance with the performance
objectives would enhance the safe
disposal of LLRW and would provide
added assurance that waste streams not
considered in the part 61 technical basis
comply with the part 61 performance
objectives. Further, these analyses
would identify any additional measures
that would be prudent to implement,
and these amendments would improve
the efficiency of the regulations by
making changes to reduce ambiguity,
facilitate implementation, and better
align the requirements with the current
and more modern health and safety
regulations. This rulemaking would
correct ambiguities and provide added
assurance that LLRW disposal continues
to meet the performance objectives in
part 61.
Summary of Legal Basis: 42 U.S.C.
2201; 42 U.S.C. 5841.
Alternatives: As an alternative to the
rulemaking, the NRC staff considered
the ‘‘no-action’’ alternative. Under this
option the NRC would not modify part
61, no long-term analyses would be
required, no period of performance
would be specified, and no intruder
assessment would be required.
Anticipated Cost and Benefits: The
NRC is in the process of preparing a
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regulatory analysis to support this
rulemaking. The analysis examines the
costs and benefits of the alternatives
considered by the NRC. The analysis
will be available as part of the
rulemaking package.
Risks: Not conducting this rulemaking
would allow the ambiguities in the part
61 regulations to continue and would
not provide the added assurance that
disposal of the waste streams not
considered in the part 61 technical basis
comply with the part 61 performance
objectives.
Timetable:
Action
Date
FR Cite
Preliminary Proposed Rule
Language.
Comment Period
End.
NPRM ..................
05/03/11
76 FR 24831
06/18/11
04/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Andrew G. Carrera,
Nuclear Regulatory Commission, Office
of Federal and State Materials and
Environmental Management Programs,
Washington, DC 20555–0001, Phone:
301 415–1078, Email:
andrew.carrera@nrc.gov.
RIN: 3150–AI92
NRC
162. • Revision of Fee Schedules: Fee
Recovery for FY 2012 [NRC–2011–0207]
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 170; 10 CFR
171.
Legal Deadline: Final, Statutory,
September 30, 2012.
The Omnibus Budget Reconciliation
Act of 1990 (OBRA–90), as amended,
requires that the NRC recover
approximately 90 percent of its budget
authority in fiscal year (FY) 2012, less
the amounts appropriated from the
Nuclear Waste Fund, amounts
appropriated for Waste Incidental to
Reprocessing, and amounts
appropriated for generic homeland
security activities (non-fee items). The
OBRA–90 requires that the fees for FY
2010 must be collected by September
30, 2012.
Abstract: This proposed rule would
amend the Commission’s licensing,
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inspection, and annual fees charged to
its applicants and licensees. The
amendments would implement the
Omnibus Budget Reconciliation Act of
1990 (OBRA–90), as amended, which
requires that the NRC recover
approximately 90 percent of its budget
authority in fiscal year (FY) 2012, less
the amounts appropriated from the
Nuclear Waste Fund, and for Waste
Incidental to Reprocessing, and generic
homeland security activities.
Based on the FY 2012 NRC budget
sent to Congress, the NRC’s required fee
recovery amount for the FY 2012 budget
is approximately $909.5 million. After
accounting for carryover and billing
adjustments, the total amount to be
recovered through fees is approximately
$908.5 million.
Statement of Need: This rulemaking
would amend the licensing, inspection,
and annual fees charged to NRC
licensees and applicants for an NRC
license. The amendments are necessary
to recover approximately 90 percent of
the NRC budget authority for FY 2012,
less the amounts appropriated for nonfee items. The OBRA–90, as amended,
requires that the NRC accomplish the 90
percent recovery through the assessment
of fees. The NRC assesses two types of
fees to recover its budget authority.
License and inspection fees are assessed
under the authority of the Independent
Offices Appropriation Act of 1952
(IOAA) to recover the costs of providing
individually identifiable services to
specific applicants and licensees (10
CFR part 170). IOAA requires that the
NRC recover the full cost to the NRC of
all identifiable regulatory services that
each applicant or licensee receives. The
NRC recovers generic and other
regulatory costs not recovered from fees
imposed under 10 CFR part 170 through
the assessment of annual fees under the
authority of OBRA–90 (10 CFR part
171). Annual fee charges are consistent
with the guidance in the Conference
Committee Report on OBRA–90 that the
NRC assess the annual charge under the
principle that licensees who require the
greatest expenditure of the Agency’s
resources should pay the greatest annual
fee.
Summary of Legal Basis: The OBRA–
90 requires that the fees for FY 2012
must be collected by September 30,
2012.
Alternatives: Because this action is
mandated by statute and the fees must
be assessed through rulemaking, the
NRC did not consider alternatives to
this action.
Anticipated Cost and Benefits: The
cost to NRC licensees is approximately
90 percent of the NRC FY 2012 budget
authority less the amounts appropriated
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for non-fee items. The dollar amount to
be billed as fees to NRC applicants and
licensees for FY 2012 is approximately
$909.5 million.
Risks: Not applicable.
Timetable:
Action
Date
NPRM ..................
FR Cite
02/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: Local,
State.
Federalism: Undetermined.
Agency Contact: Renu Suri, Nuclear
Regulatory Commission, Office of the
Chief Financial Officer, Washington, DC
20555–0001, Phone: 301 415–0161,
Email: renu.suri@nrc.gov.
RIN: 3150–AJ03
NRC
Final Rule Stage
163. Risk-Informed Changes to Loss-ofCoolant Accident Technical
Requirements [NRC–2004–0006]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 50; 10 CFR 52.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations to
allow for a risk-informed alternative to
the present loss-of-coolant accident
break size. This rulemaking would
address a petition for rulemaking
submitted by the Nuclear Energy
Institute (NEI) (PRM–50–75). The final
rule was provided to the Commission on
December 10, 2010, in SECY–10–0161.
The NRC staff provided an initial
draft final rule to the Advisory
Committee on Reactor Safeguards
(ACRS) on October 16, 2006. After
reviewing the draft rule, the ACRS
informed the Commission of numerous
technical and policy concerns and
recommended that the rule not be
issued. The staff prepared a Commission
paper (SECY–07–0082; May 16, 2007) to
inform the Commission of the impact of
the ACRS recommendations and to
request guidance before proceeding with
the rule. The Commission provided its
guidance in a Staff Requirements
Memorandum on August 10, 2007. On
April 1, 2008, the staff provided an
updated rule schedule to the
Commission. In a meeting on August 6,
2008, selected NRC managers approved
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the staff’s recommended resolution of
the open issues related to the final rule.
The staff prepared draft rule language
incorporating the new positions into the
rule and adding additional requirements
for defense-in depth for pipe breaks
larger than the transition break size. The
OGC reviewed the revised rule language
and recommended that portions of the
rule be re-noticed to provide an
opportunity for public comments on
some of the new rule requirements. In
a meeting on October 8, 2008, NRC
managers decided to repropose the
entire rule. On December 18, 2008, the
EDO signed a memorandum informing
the Commission that the staff will renotice the section 50.46a rule for
additional public comments in August
2009. The staff discussed the revised
proposed rule with the ACRS on May
6–7, 2009, and then published the rule
on August 10, 2009 (74 FR 40006). On
September 24, 2009, in response to a
request from NEI, the NRC extended the
public comment period by 120 days to
close on January 22, 2010 (74 FR 48667).
The NRC evaluated the public
comments and prepared draft final rule
language, which was posted on
Regulations.gov on May 12, 2010. A
public meeting was held on June 4,
2010, to discuss resolution of public
comments and the draft rule language.
The staff discussed the rule with the
ACRS in September and October of
2010. In its letter of October 20, 2010,
the ACRS concluded that the rule was
an acceptable alternative for operating
reactors. The final rule was provided to
the Commission on December 10, 2010
(SECY–10–0161).
Statement of Need: This rulemaking
would codify alternative requirements
for ECCS at nuclear power reactors by
using risk information to refine ECCS
requirements based on the likelihood of
pipe breaks of various sizes. The rule
would divide all coolant piping breaks
currently considered in emergency core
cooling requirements into two size
groups: Breaks up to and including a
‘‘transition’’ size, and breaks larger than
the transition size up to the largest pipe
in the reactor coolant system. Selection
of the transition size was based upon
pipe break frequency estimates and
associated uncertainties. Because pipe
breaks in the smaller size group are
considered more likely, they would be
analyzed using existing criteria for
ensuring that the reactor core stays cool
during and after an accident. Larger
breaks are considered less likely and
would be analyzed with less
conservative methods. Plants would still
have to mitigate the effects of breaking
the largest pipe and maintain core
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cooling. Under the draft final rule,
power plant operators could make plant
design changes that could enhance
safety and/or provide operational
benefits. The rule includes risk
acceptance criteria to ensure that
modified designs would continue to
provide adequate protection of public
health and safety.
Alternatives: The alternative is for the
NRC not to issue these requirements.
The alternative would not allow
operators of nuclear power plants to
have the increased design and
operational flexibility that would be
allowed by these risk-informed
requirements.
Anticipated Cost and Benefits: There
are no costs or benefits associated with
this alternative rule for licensees who
choose not to implement it. For the
licensees who do choose to comply with
the alternative requirements, if they
request to increase power generation at
their facilities and eliminate the need
for fast-starting of emergency diesel
generators, they would need to invest an
estimated overall total of approximately
$445 to $1,221 million (in 2008$ @ 3
percent discount rate) for plant
modifications and staff support. Total
estimated NRC cost associated with
implementing the alternative
requirements and reviewing licensees’
design change requests at these facilities
would be approximately $22 to $24
million (in 2008$ @ 3 percent discount
rate). Substantial net benefits would
result after subtracting both licensee and
NRC costs from the benefits that
licensees would obtain from making
these plant modifications. The total
cumulative net benefits are estimated to
range from $279 to $2,876 million (in
2008$ @ 3 percent discount rate).
Risks: The rule would allow plant
design and operational changes which
could result in small but acceptable
increases in risk. Specific acceptance
criteria for risk increases are contained
in the rule which limit overall risk
increases to very small amounts.
Allowable risk increases under this rule
are consistent with the current risk
increase guidelines specified in
Regulatory Guide 1.174, ‘‘An Approach
for Using Probabilistic Risk Assessment
in Risk-informed Decisions on PlantSpecific Changes to the Licensing
Basis.’’
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
11/07/05
02/06/06
70 FR 67597
01/25/06
71 FR 4061
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Action
Date
NPRM Comment
Period End.
Supplemental
NPRM.
Supplemental
NPRM Comment Period
End.
Supplemental
NPRM Comment Period Extended.
Supplemental
NPRM Extended Comment Period
End.
Final Rule ............
03/08/06
08/10/09
FR Cite
74 FR 40006
09/24/09
10/07/09
74 FR 51522
01/22/10
09/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Richard F. Dudley,
Nuclear Regulatory Commission, Office
of Nuclear Reactor Regulation,
Washington, DC 20555–0001, Phone:
301 415–1116, Email:
richard.dudley@nrc.gov.
RIN: 3150–AH29
NRC
164. Physical Protection of Byproduct
Material [NRC–2008–0120]
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 30; 10 CFR 32;
10 CFR 33; 10 CFR 34; 10 CFR 35; 10
CFR 37; 10 CFR 39; 10 CFR 51; 10 CFR
71; 10 CFR 73.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations to
put in place security requirements for
the use of Category 1 and Category 2
quantities of radioactive material. The
objective is to ensure that effective
security measures are in place to
prevent the dispersion of radioactive
material for malevolent purposes. The
proposed amendment would also
address background investigations and
access controls, enhanced security for
use, and transportation security for
Category 1 and Category 2 quantities of
radioactive material. This rulemaking
subsumes RIN 3150–AI56,
‘‘Requirements for Fingerprinting and
Criminal History Record Checks for
Unescorted Access to Radioactive
Material and Other Property (part 37).’’
Statement of Need: The objective of
this rule is to provide reasonable
assurance of preventing the theft or
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diversion of category 1 and category 2
quantities of radioactive material by
establishing generally applicable
security requirements similar to those
previously imposed on certain licensees
by the NRC orders. Although a security
order is legally binding on the licensee
receiving the order, a rule makes
requirements generally applicable to all
licensees. In addition, notice and
comment rulemaking allows for public
participation and is an open process.
This rulemaking places the security
requirements for use of category 1 and
category 2 quantities of radioactive
material into the regulations.
Summary of Legal Basis: Atomic
Energy Act of 1954, as amended.
Alternatives: NRC could continue to
regulate the security aspects for these
facilities by Commission order. This
alternative would not significantly
reduce the burden as the majority of the
cost is associated with the order
requirements.
Anticipated Cost and Benefits: This
final rule will result in maximum
annual impact to the economy of
approximately $17.9 million (using a
7% discount rate, annualizing the onetime costs over 20 years, and adding
these ‘‘annualized’’ one-time costs to the
annual costs) or $24.4 million (using a
3% discount rate). The Office of
Management and Budget has indicated
that the annual cost of the orders should
be included in the annual impact to the
economy calculation. The estimated
annual cost to the industry using the
pre-order was $111.6 million. Therefore,
this final rule is considered a major rule
as defined by the Congressional Review
Act.
The qualitative values of the rule are
associated with safeguard and security
considerations of the decreased risk of
a security-related event, such as theft or
diversion of radioactive material and
subsequent use for unauthorized
purposes. Increasing the security of
high-risk radioactive material decreases
this risk and increases the common
defense and security of the Nation.
Other qualitative values that are
positively affected by the decreased risk
of a security-related event include
public and occupational health due to
an accident or event and the risk of
damage to on-site and off-site property.
In addition, regulatory efficiency is
enhanced by the rule.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
06/15/10
10/13/10
75 FR 33901
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Action
Date
FR Cite
NPRM Comment
Period Extended.
NPRM Comment
Period Extended End.
Final Rule ............
10/08/10
75 FR 62330
01/18/11
Action
06/00/12
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Local,
State.
Federalism: Undetermined.
Agency Contact: Merri L. Horn,
Nuclear Regulatory Commission, Office
of Federal and State Materials and
Environmental Management Programs,
Washington, DC 20555–0001, Phone:
301 415–8126, Email:
merri.horn@nrc.gov.
RIN: 3150–AI12
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NRC
165. Environmental Effect of Renewing
the Operating License of a Nuclear
Power Plant [NRC–2008–0608]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 51.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations
that provide the environmental
protection requirements for renewing
nuclear power plant operating licenses.
The regulations require that licensees
consider the impact that the licensing
action could have on the human
environment.
Statement of Need: The Nuclear
Regulatory Commission (NRC) is
amending its environmental protection
regulations by updating the
Commission’s 1996 findings on the
environmental effect of renewing the
operating license of a nuclear power
plant. The rule redefines the number
and scope of the environmental impact
issues which must be addressed by the
NRC during license renewal
environmental reviews. The rule also
incorporates lessons learned and
knowledge gained from license renewal
environmental reviews conducted by
the NRC since 1996.
Summary of Legal Basis: NRC’s
environmental protection regulations
are in 10 CFR part 51, and implement
section 102(2) of the National
Environmental Policy Act of 1969
(NEPA).
Anticipated Cost and Benefits: A
detailed regulatory analysis was
VerDate Mar<15>2010
published with the proposed rule, and
can be accessed in ADAMS at
ML090260568.
Timetable:
15:08 Feb 10, 2012
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Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Extended
Comment Period End.
Final Rule ............
07/31/09
10/14/09
74 FR 38117
10/07/09
74 FR 51522
01/12/10
06/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Stewart Schneider,
Nuclear Regulatory Commission, Office
of Nuclear Reactor Regulation,
Washington, DC 20555–0001, Phone:
301 415–4123, Email:
stewart.schneider@nrc.gov.
RIN: 3150–AI42
NRC
166. AP1000 Design Certification
Amendment [NRC–2010–0131]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 52.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations for
the AP1000 design certification to
replace combined license information
and design acceptance criteria with
specific design information, address
compliance with the aircraft impact
assessment rule, and incorporate design
improvements resulting from detailed
design efforts. Applicants or licensees
intending to construct and operate a
nuclear power plant using the AP1000
design as amended may do so by
referencing this design certification rule.
Statement of Need: The U.S. Nuclear
Regulatory Commission (NRC or
Commission) is amending its
regulations to certify an amendment to
the AP1000 standard plant design. The
purpose of the amendment is to replace
the combined license (COL) information
items and design acceptance criteria
(DAC) with specific design information,
address the effects of the impact of a
large commercial aircraft, incorporate
design improvements, and increase
standardization of the design. This
action is necessary so that applicants or
licensees intending to construct and
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operate an AP1000 design may do so by
referencing this design certification rule
(DCR), and need not demonstrate in its
application the safety of the certified
design as amended.
The applicant for certification of the
amendment to the AP1000 design is
Westinghouse Electric Company, LLC
(Westinghouse).
A design certification amendment
does not establish standards or
requirements with which all licensees
must comply. Rather, design
certifications (and amendments thereto)
are Commission approvals of specific
nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
combined licenses. Furthermore, design
certification rulemakings are initiated
by an applicant for a design certification
(or amendments thereto), rather than the
NRC. As a result, there is no monetary
impact for this final rule.
Alternatives: The NRC has not
prepared alternatives for this rule. The
NRC evaluates alternatives for
rulemakings that establish generic
regulatory requirements applicable to all
licensees. Design certifications (and
amendments thereto) are not generic
rulemakings in the sense that design
certifications (and amendments thereto)
do not establish standards or
requirements with which all licensees
must comply. Rather, design
certifications (and amendments thereto)
are Commission approvals of specific
nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
COLs. Furthermore, design certification
rulemakings are initiated by an
applicant for a design certification (or
amendments thereto), rather than the
NRC. Preparation of alternatives in this
circumstance would not be useful
because the design to be certified is
proposed by the applicant rather than
the NRC.
Anticipated Cost and Benefits: The
NRC has not prepared a regulatory
analysis for this rule. The NRC prepares
regulatory analyses for rulemakings that
establish generic regulatory
requirements applicable to all licensees.
Design certifications (and amendments
thereto) are not generic rulemakings in
the sense that design certifications (and
amendments thereto) do not establish
standards or requirements with which
all licensees must comply. Rather,
design certifications (and amendments
thereto) are Commission approvals of
specific nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
COLs. Furthermore, design certification
rulemakings are initiated by an
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applicant for a design certification (or
amendments thereto), rather than the
NRC. Preparation of a regulatory
analysis in this circumstance would not
be useful because the design to be
certified is proposed by the applicant
rather than the NRC. For these reasons,
the Commission concludes that
preparation of a regulatory analysis is
neither required nor appropriate.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
02/24/11
05/10/11
76 FR 10269
12/00/11
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Serita Sanders,
Nuclear Regulatory Commission, Office
of New Reactors, Washington, DC
20555–0001, Phone: 301 415–2956,
Email: serita.sanders@nrc.gov.
RIN: 3150–AI81
NRC
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167. U.S. Advanced Boiling Water
Reactor (ABWR) Aircraft Impact Design
Certification Amendment [NRC–2010–
0134]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 52.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations in
appendix A ‘‘Design Certification Rule
for the U.S. Advanced Boiling Water
Reactor’’ to 10 CFR part 52 ‘‘Licenses,
Certifications, and Approvals for
Nuclear Power Plants’’ to comply with
10 CFR 50.150 ‘‘Aircraft Impact
Assessment.’’ Applicants or licensees
intending to construct and operate a
nuclear power plant using the ABWR
design may comply with 10 CFR 50.150
by referencing the amended design
certification rule.
Statement of Need: The U.S. Nuclear
Regulatory Commission (NRC or the
Commission) is amending its
regulations to certify an amendment to
the U.S. Advanced Boiling Water
Reactor (U.S. ABWR) standard plant
design to comply with the NRC’s aircraft
impact assessment (AIA) regulations.
This action allows applicants or
licensees intending to construct and
operate a U.S. ABWR to comply with
the NRC’s AIA regulations by
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referencing the amended design
certification rule (DCR). The applicant
for certification of the amendment to the
U.S. ABWR design is STP Nuclear
Operating Company (STPNOC).
A design certification amendment
does not establish standards or
requirements with which all licensees
must comply. Rather, design
certifications (and amendments thereto)
are Commission approvals of specific
nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
combined licenses. Furthermore, design
certification rulemakings are initiated
by an applicant for a design certification
(or amendments thereto), rather than the
NRC. As a result, there is no monetary
impact for this final rule.
Alternatives: The NRC has not
prepared alternatives for this rule. The
NRC evaluates alternatives for
rulemakings that establish generic
regulatory requirements applicable to all
licensees. Design certifications (and
amendments thereto) are not generic
rulemakings in the sense that design
certifications (and amendments thereto)
do not establish standards or
requirements with which all licensees
must comply. Rather, design
certifications (and amendments thereto)
are Commission approvals of specific
nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
COLs. Furthermore, design certification
rulemakings are initiated by an
applicant for a design certification (or
amendments thereto), rather than the
NRC. Preparation of alternatives in this
circumstance would not be useful
because the design to be certified is
proposed by the applicant rather than
the NRC.
Anticipated Cost and Benefits: The
NRC has not prepared a regulatory
analysis for this rule. The NRC prepares
regulatory analyses for rulemakings that
establish generic regulatory
requirements applicable to all licensees.
Design certifications (and amendments
thereto) are not generic rulemakings in
the sense that design certifications (and
amendments thereto) do not establish
standards or requirements with which
all licensees must comply. Rather,
design certifications (and amendments
thereto) are Commission approvals of
specific nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
COLs. Furthermore, design certification
rulemakings are initiated by an
applicant for a design certification (or
amendments thereto), rather than the
NRC. Preparation of a regulatory
analysis in this circumstance would not
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be useful because the design to be
certified is proposed by the applicant
rather than the NRC. For these reasons,
the Commission concludes that
preparation of a regulatory analysis is
neither required nor appropriate.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
01/20/11
04/05/11
76 FR 3540
12/00/11
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Fred Schofer,
Nuclear Regulatory Commission, Office
of New Reactors, Washington, DC
20555–0001, Phone: 301 415–5682,
Email: fred.schofer@nrc.gov.
RIN: 3150–AI84
NRC
168. Economic Simplified BoilingWater Reactor (ESBWR) Design
Certification [NRC–2010–0135]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 52.
Legal Deadline: None.
Abstract: The proposed rule would
amend the Commission’s regulations to
part 52 by issuing a new appendix for
the initial certification of the ESBWR
standard plant design. Applicants or
licensees intending to construct and
operate a nuclear power plant using the
ESBWR design may do so by referencing
this design certification rule.
Statement of Need: The U.S. Nuclear
Regulatory Commission (NRC or the
Commission) is amending its
regulations to certify an amendment to
the Economic Simplified Boiling-Water
Reactor (ESBWR) standard plant design.
This action is necessary so that
applicants or licensees intending to
construct and operate an ESBWR design
may do so by referencing this design
certification rule (DCR). The applicant
for certification of the amendment to the
ESBWR design is GE-Hitachi Nuclear
Energy.
A design certification amendment
does not establish standards or
requirements with which all licensees
must comply. Rather, design
certifications (and amendments thereto)
are Commission approvals of specific
nuclear power plant designs by
rulemaking, which then may be
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voluntarily referenced by applicants for
combined licenses. Furthermore, design
certification rulemakings are initiated
by an applicant for a design certification
(or amendments thereto), rather than the
NRC. As a result, there is no monetary
impact for this final rule.
Alternatives: The NRC has not
prepared alternatives for this rule. The
NRC evaluates alternatives for
rulemakings that establish generic
regulatory requirements applicable to all
licensees. Design certifications (and
amendments thereto) are not generic
rulemakings in the sense that design
certifications (and amendments thereto)
do not establish standards or
requirements with which all licensees
must comply. Rather, design
certifications (and amendments thereto)
are Commission approvals of specific
nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
COLs. Furthermore, design certification
rulemakings are initiated by an
applicant for a design certification (or
amendments thereto), rather than the
NRC. Preparation of alternatives in this
circumstance would not be useful
because the design to be certified is
proposed by the applicant rather than
the NRC.
Anticipated Cost and Benefits: The
NRC has not prepared a regulatory
analysis for this rule. The NRC prepares
regulatory analyses for rulemakings that
establish generic regulatory
requirements applicable to all licensees.
Design certifications (and amendments
thereto) are not generic rulemakings in
the sense that design certifications (and
amendments thereto) do not establish
standards or requirements with which
all licensees must comply. Rather,
design certifications (and amendments
thereto) are Commission approvals of
specific nuclear power plant designs by
rulemaking, which then may be
voluntarily referenced by applicants for
COLs. Furthermore, design certification
rulemakings are initiated by an
applicant for a design certification (or
amendments thereto), rather than the
NRC. Preparation of a regulatory
analysis in this circumstance would not
be useful because the design to be
certified is proposed by the applicant
rather than the NRC. For these reasons,
the Commission concludes that
preparation of a regulatory analysis is
neither required nor appropriate.
Timetable:
Action
Date
FR Cite
NPRM ..................
NPRM Comment
Period End.
03/24/11
06/07/11
76 FR 16549
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15:08 Feb 10, 2012
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Action
Date
Final Rule ............
FR Cite
02/00/12
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: George M. Tartal,
Nuclear Regulatory Commission, Office
of New Reactors, Washington, DC
20555–0001, Phone: 301 415–0016,
Email: george.tartal@nrc.gov.
RIN: 3150–AI85
NRC
169. List of Approved Spent Fuel
Storage Casks—MAGNASTOR,
Revision 2 [NRC–2011–0008]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 2201; 42
U.S.C. 5841
CFR Citation: 10 CFR 72.
Legal Deadline: None.
Abstract: The direct final rule amends
the Commission’s regulations by
revising the MAGNASTOR System to
include Amendment No. 2 to the
Certificate of Compliance. Amendment
No. 2 will include changes to allow: The
addition of various boron-10 areal
densities for use with Pressurized Water
Reactor and Boiling Water Reactor
baskets; correction of the code reference
in Table 2.1–2 of the Final Safety
Analysis Report, table entitled ‘‘ASME
Code Alternatives for MAGNASTOR®
components;’’ change of transportable
storage canister surface contamination
limits for loose contamination; and
other changes in appendices A and B of
the technical specification to
incorporate minor editorial corrections.
This direct final rule allows the holders
of power reactor operating licenses to
store spent fuel in this approved cask
system under a general license.
Statement of Need: On March 22,
2010, and as supplemented on March
30, March 31, June 8, July 1, November
10, and November 19, 2010, and April
22 and May 17, 2011, NAC, the holder
of CoC No. 1031, submitted an
application to the NRC that requested an
amendment to CoC No. 1031.
Specifically, NAC requested changes to
revise: TS 3.3.2 to reduce the
transportable storage canister removable
surface contamination limits; TS 4.1.1 to
add various boron-10 areal densities for
use with Pressurized Water Reactor and
Boiling Water Reactor baskets and to
replace the fuel tube orthogonal pitch
with the minimum fuel tube outer
diagonal dimension; Table 2.1–2,
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‘‘ASME Code Alternatives for
MAGNASTOR® components,’’ of the
Final Safety Analysis Report to correct
the code reference; and appendices A
and B of the TSs to make editorial
corrections.
As documented in the SER, the NRC
staff performed a detailed safety
evaluation of the proposed CoC
amendment request and found that an
acceptable safety margin is maintained.
In addition, the NRC staff has
determined that there continues to be
reasonable assurance that public health
and safety will be adequately protected.
This direct final rule revises the
MAGNASTOR® System listing in 10
CFR 72.214 by adding Amendment No.
2 to CoC No. 1031. The amendment
consists of the changes previously
described, as set forth in the revised
CoC and TSs. The revised TSs are
identified in the SER. The amended
MAGNASTOR® System cask design,
when used under the conditions
specified in the CoC, the TSs, and NRC
regulations, will meet the requirements
of 10 CFR part 72; thus, adequate
protection of public health and safety
will continue to be ensured. When this
direct final rule becomes effective,
persons who hold a general license
under 10 CFR 72.210 may load spent
nuclear fuel into MAGNASTOR®
System casks that meet the criteria of
Amendment No. 2 to CoC No. 1031
under 10 CFR 72.212.
Summary of Legal Basis: This rule is
limited to the changes contained in
Amendment No. 2 to CoC No. 1031 and
does not include other aspects of the
MAGNASTOR® System. The NRC is
using the ‘‘direct final rule procedure’’
to issue this amendment because it
represents a limited and routine change
to an existing CoC that is expected to be
noncontroversial. Adequate protection
of public health and safety continues to
be ensured.
Alternatives: The alternative to this
action is to withhold approval of
Amendment No. 2 and to require any 10
CFR part 72 general licensee seeking to
load spent nuclear fuel into
MAGNASTOR® System casks under the
changes described in Amendment No. 2
to request an exemption from the
requirements of 10 CFR 72.212 and
72.214. Under this alternative, each
interested 10 CFR part 72 licensee
would have to prepare, and the NRC
would have to review, a separate
exemption request, thereby increasing
the administrative burden upon the
NRC and the costs to each licensee.
Anticipated Cost and Benefits:
Approval of the direct final rule is
consistent with previous NRC actions.
Further, as documented in the SER and
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the environmental assessment, the
direct final rule will have no adverse
effect on public health and safety or the
environment. This direct final rule has
no significant identifiable impact or
benefit on other Government agencies.
Based on this regulatory analysis, the
NRC concludes that the requirements of
the direct final rule are commensurate
with the NRC’s responsibilities for
public health and safety and the
common defense and security. For these
VerDate Mar<15>2010
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reasons, the Commission concludes that
preparation of a regulatory analysis is
neither required nor appropriate.
Timetable:
Action
Date
Direct Final Rule
FR Cite
12/00/11
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
PO 00000
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Government Levels Affected: None.
Agency Contact: Gregory Trussell,
Nuclear Regulatory Commission, Office
of Federal and State Materials and
Environmental Management Programs,
Washington, DC 20555–0001, Phone:
301 415–6445, Email: gregory.trussell@
nrc.gov.
RIN: 3150–AI91
[FR Doc. 2012–1620 Filed 2–10–12; 8:45 am]
BILLING CODE 7590–01–P
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Vol. 77
Monday,
No. 29
February 13, 2012
Part III
Department of Agriculture
erowe on DSK2VPTVN1PROD with PROPOSALS2
Semiannual Regulatory Agenda
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Agencies
[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Unknown Section]
[Pages 7664-7889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1620]
[[Page 7663]]
Vol. 77
Monday,
No. 29
February 13, 2012
Part II
Regulatory Information Service Center
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Introduction to the Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
Federal Register / Vol. 77 , No. 29 / Monday, February 13, 2012 / The
Regulatory Plan
[[Page 7664]]
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REGULATORY INFORMATION SERVICE CENTER
Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions
AGENCY: Regulatory Information Service Center.
ACTION: Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions.
-----------------------------------------------------------------------
SUMMARY: The Regulatory Flexibility Act requires that agencies publish
semiannual regulatory agendas in the Federal Register describing
regulatory actions they are developing that may have a significant
economic impact on a substantial number of small entities (5 U.S.C.
602). Executive Order 12866 ``Regulatory Planning and Review,'' signed
September 30, 1993 (58 FR 51735), and Office of Management and Budget
memoranda implementing section 4 of that Order establish minimum
standards for agencies' agendas, including specific types of
information for each entry.
The Unified Agenda of Federal Regulatory and Deregulatory Actions
(Unified Agenda) helps agencies fulfill these requirements. All Federal
regulatory agencies have chosen to publish their regulatory agendas as
part of the Unified Agenda.
Editions of the Unified Agenda prior to fall 2007 were printed in
their entirety in the Federal Register. Beginning with the fall 2007
edition, the Internet is the basic means for conveying regulatory
agenda information to the maximum extent legally permissible. The
complete Unified Agenda for fall 2011, which contains the regulatory
agendas for 59 Federal agencies, is available to the public at https://reginfo.gov.
The fall 2011 Unified Agenda publication appearing in the Federal
Register consists of agency regulatory flexibility agendas, in
accordance with the publication requirements of the Regulatory
Flexibility Act. Agency regulatory flexibility agendas contain only
those Agenda entries for rules that are likely to have a significant
economic impact on a substantial number of small entities and entries
that have been selected for periodic review under section 610 of the
Regulatory Flexibility Act.
ADDRESSES: Regulatory Information Service Center (MI), General Services
Administration, One Constitution Square, 1275 First Street NE., 651A,
Washington, DC 20417.
FOR FURTHER INFORMATION CONTACT: For further information about specific
regulatory actions, please refer to the agency contact listed for each
entry.
To provide comment on or to obtain further information about this
publication, contact: John C. Thomas, Executive Director, Regulatory
Information Service Center (MI), General Services Administration, One
Constitution Square, 1275 First Street NE., 642, Washington, DC 20417,
202 482-7340. You may also send comments to us by email at:
RISC@gsa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
Introduction to the Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
I. What Are the Regulatory Plan and the Unified Agenda?
II. Why Are the Regulatory Plan and the Unified Agenda Published?
III. How Are the Regulatory Plan and the Unified Agenda Organized?
IV. What Information Appears for Each Entry?
V. Abbreviations
VI. How Can Users Get Copies of the Plan and the Agenda?
Introduction to the Fall 2011 Regulatory Plan
AGENCY REGULATORY PLANS
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of Housing and Urban Development
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Department of Veterans Affairs
Other Executive Agencies
Architectural and Transportation Barriers Compliance Board
Environmental Protection Agency
Equal Employment Opportunity Commission
Financial Stability Oversight Council
General Services Administration
National Aeronautics and Space Administration
National Archives and Records Administration
Office of Personnel Management
Pension Benefit Guaranty Corporation
Small Business Administration
Social Security Administration
Independent Regulatory Agencies
Consumer Financial Protection Bureau
Consumer Product Safety Commission
Federal Trade Commission
National Indian Gaming Commission
Nuclear Regulatory Commission
AGENCY AGENDAS
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Other Executive Agencies
Architectural and Transportation Barriers Compliance Board
Environmental Protection Agency
General Services Administration
National Aeronautics and Space Administration
Small Business Administration
Joint Authority
Department of Defense/General Services Administration/National
Aeronautics and Space Administration (Federal Acquisition
Regulation)
Independent Regulatory Agencies
Consumer Financial Protection Bureau
Federal Communications Commission
Federal Deposit Insurance Corporation
Federal Reserve System
Nuclear Regulatory Commission
Securities and Exchange Commission
Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions
I. What Is the Unified Agenda?
The Unified Agenda provides information about regulations that the
Government is considering or reviewing. The Unified Agenda has appeared
in the Federal Register twice each year since 1983 and has been
available online since 1995. To further the objective of using modern
technology to deliver better service to the American people for lower
cost, beginning with the fall 2007 edition, the Internet is the basic
means for conveying regulatory agenda information to the maximum extent
legally permissible. The complete Unified Agenda is available to the
public at https://reginfo.gov. The online Unified Agenda offers flexible
search tools and will soon offer access to the entire historic Unified
Agenda database.
The fall 2011 Unified Agenda publication appearing in the Federal
Register consists of agency regulatory flexibility agendas, in
accordance with the publication requirements of the Regulatory
Flexibility Act. Agency regulatory flexibility agendas contain only
those Agenda entries for rules that are likely to have a significant
economic impact on a substantial number of small
[[Page 7665]]
entities and entries that have been selected for periodic review under
section 610 of the Regulatory Flexibility Act. Printed entries display
only the fields required by the Regulatory Flexibility Act. Complete
agenda information for those entries appears, in a uniform format, in
the online Unified Agenda at https://reginfo.gov.
These publication formats meet the publication mandates of the
Regulatory Flexibility Act and Executive Order 12866, as well as move
the Agenda process toward the goal of e-Government, at a substantially
reduced printing cost compared with prior editions. The current format
does not reduce the amount of information available to the public, but
it does limit most of the content of the Agenda to online access. The
complete online edition of the Unified Agenda includes regulatory
agendas from 59 Federal agencies. Agencies of the United States
Congress are not included.
The following agencies have no entries identified for inclusion in
the printed regulatory flexibility agenda. An asterisk (*) indicates
agencies that appear in The Regulatory Plan. The regulatory agendas of
these agencies are available to the public at https://reginfo.gov.
Department of Housing and Urban Development*
Department of State
Department of Veterans Affairs*
Agency for International Development
Commission on Civil Rights
Committee for Purchase From People Who Are Blind or Severely
Disabled
Corporation for National and Community Service
Court Services and Offender Supervision Agency for the District of
Columbia
Equal Employment Opportunity Commission*
Federal Mediation and Conciliation Service
Financial Stability Oversight Council*
Institute of Museum and Library Services
National Archives and Records Administration*
National Endowment for the Humanities
National Science Foundation
Office of Government Ethics
Office of Management and Budget
Office of Personnel Management*
Peace Corps
Pension Benefit Guaranty Corporation*
Railroad Retirement Board
Selective Service System
Social Security Administration*
Commodity Futures Trading Commission
Consumer Product Safety Commission*
Farm Credit Administration
Federal Energy Regulatory Commission
Federal Housing Finance Agency
Federal Maritime Commission
Federal Trade Commission*
National Credit Union Administration
National Indian Gaming Commission*
National Labor Relations Board
Postal Regulatory Commission
Surface Transportation Board
The Regulatory Information Service Center (the Center) compiles the
Unified Agenda for the Office of Information and Regulatory Affairs
(OIRA), part of the Office of Management and Budget. OIRA is
responsible for overseeing the Federal Government's regulatory,
paperwork, and information resource management activities, including
implementation of Executive Order 12866. The Center also provides
information about Federal regulatory activity to the President and his
Executive Office, the Congress, agency managers, and the public.
The activities included in the Agenda are, in general, those that
will have a regulatory action within the next 12 months. Agencies may
choose to include activities that will have a longer timeframe than 12
months. Agency agendas also show actions or reviews completed or
withdrawn since the last Unified Agenda. Executive Order 12866 does not
require agencies to include regulations concerning military or foreign
affairs functions or regulations related to agency organization,
management, or personnel matters.
Agencies prepared entries for this publication to give the public
notice of their plans to review, propose, and issue regulations. They
have tried to predict their activities over the next 12 months as
accurately as possible, but dates and schedules are subject to change.
Agencies may withdraw some of the regulations now under development,
and they may issue or propose other regulations not included in their
agendas. Agency actions in the rulemaking process may occur before or
after the dates they have listed. The Unified Agenda does not create a
legal obligation on agencies to adhere to schedules in this publication
or to confine their regulatory activities to those regulations that
appear within it.
II. Why Is the Unified Agenda Published?
The Unified Agenda helps agencies comply with their obligations
under the Regulatory Flexibility Act and various Executive orders and
other statutes.
Regulatory Flexibility Act
The Regulatory Flexibility Act requires agencies to identify those
rules that may have a significant economic impact on a substantial
number of small entities (5 U.S.C. 602). Agencies meet that requirement
by including the information in their submissions for the Unified
Agenda. Agencies may also indicate those regulations that they are
reviewing as part of their periodic review of existing rules under the
Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272
entitled ``Proper Consideration of Small Entities in Agency
Rulemaking,'' signed August 13, 2002 (67 FR 53461), provides additional
guidance on compliance with the Act.
Executive Order 12866
Executive Order 12866 entitled ``Regulatory Planning and Review,''
signed September 30, 1993 (58 FR 51735), requires covered agencies to
prepare an agenda of all regulations under development or review. The
Order also requires that certain agencies prepare annually a regulatory
plan of their ``most important significant regulatory actions,'' which
appears as part of the fall Unified Agenda. Executive Order 13497,
signed January 30, 2009 (74 FR 6113), revoked the amendments to
Executive Order 12866 that were contained in Executive Order 13258 and
Executive Order 13422.
Executive Order 13132
Executive Order 13132 entitled ``Federalism,'' signed August 4,
1999 (64 FR 43255), directs agencies to have an accountable process to
ensure meaningful and timely input by State and local officials in the
development of regulatory policies that have ``federalism
implications'' as defined in the Order. Under the Order, an agency that
is proposing a regulation with federalism implications, which either
preempt State law or impose nonstatutory unfunded substantial direct
compliance costs on State and local governments, must consult with
State and local officials early in the process of developing the
regulation. In addition, the agency must provide to the Director of the
Office of Management and Budget a federalism summary impact statement
for such a regulation, which consists of a description of the extent of
the agency's prior consultation with State and local officials, a
summary of their concerns and the agency's position supporting the need
to issue the regulation, and a statement of the extent to which those
concerns have been met. As part of this effort, agencies include in
their submissions for the Unified Agenda information on whether their
regulatory actions may have an effect on the various levels of
government and whether those actions have federalism implications.
Executive Order 13563
Executive Order 13563 entitled ``Improving Regulation and
Regulatory Review,'' signed January 18, 2011, supplements and reaffirms
the
[[Page 7666]]
principles, structures, and definitions governing contemporary
regulatory review that were established in Executive Order 12866, which
includes the general principles of regulation and public participation,
and orders integration and innovation in coordination across agencies;
flexible approaches where relevant, feasible, and consistent with
regulatory approaches; scientific integrity in any scientific or
technological information and processes used to support the agencies'
regulatory actions; and retrospective analysis of existing regulations.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II)
requires agencies to prepare written assessments of the costs and
benefits of significant regulatory actions ``that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more * * * in any 1 year *
* *.'' The requirement does not apply to independent regulatory
agencies, nor does it apply to certain subject areas excluded by
section 4 of the Act. Affected agencies identify in the Unified Agenda
those regulatory actions they believe are subject to title II of the
Act.
Executive Order 13211
Executive Order 13211 entitled ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use,'' signed
May 18, 2001 (66 FR 28355), directs agencies to provide, to the extent
possible, information regarding the adverse effects that agency actions
may have on the supply, distribution, and use of energy. Under the
Order, the agency must prepare and submit a Statement of Energy Effects
to the Administrator of the Office of Information and Regulatory
Affairs, Office of Management and Budget, for ``those matters
identified as significant energy actions.'' As part of this effort,
agencies may optionally include in their submissions for the Unified
Agenda information on whether they have prepared or plan to prepare a
Statement of Energy Effects for their regulatory actions.
Small Business Regulatory Enforcement Fairness Act
The Small Business Regulatory Enforcement Fairness Act (Pub. L.
104-121, title II) established a procedure for congressional review of
rules (5 U.S.C. 801 et seq.), which defers, unless exempted, the
effective date of a ``major'' rule for at least 60 days from the
publication of the final rule in the Federal Register. The Act
specifies that a rule is ``major'' if it has resulted, or is likely to
result, in an annual effect on the economy of $100 million or more or
meets other criteria specified in that Act. The Act provides that the
Administrator of OIRA will make the final determination as to whether a
rule is major.
III. How Is the Unified Agenda Organized?
Agency regulatory flexibility agendas are printed in a single daily
edition of the Federal Register. A regulatory flexibility agenda is
printed for each agency whose agenda includes entries for rules which
are likely to have a significant economic impact on a substantial
number of small entities or rules that have been selected for periodic
review under section 610 of the Regulatory Flexibility Act. Each
printed agenda appears as a separate part. The parts are organized
alphabetically in four groups: Cabinet departments; other executive
agencies; the Federal Acquisition Regulation, a joint authority; and
independent regulatory agencies. Agencies may in turn be divided into
subagencies. Each agency's part of the Agenda contains a preamble
providing information specific to that agency. Each printed agency
agenda has a table of contents listing the agency's printed entries
that follow.
The online, complete Unified Agenda contains the preambles of all
participating agencies. Unlike the printed edition, the online Agenda
has no fixed ordering. In the online Agenda, users can select the
particular agencies whose agendas they want to see. Users have broad
flexibility to specify the characteristics of the entries of interest
to them by choosing the desired responses to individual data fields. To
see a listing of all of an agency's entries, a user can select the
agency without specifying any particular characteristics of entries.
Each entry in the Agenda is associated with one of five rulemaking
stages. The rulemaking stages are:
1. Prerule Stage--actions agencies will undertake to determine
whether or how to initiate rulemaking. Such actions occur prior to a
Notice of Proposed Rulemaking (NPRM) and may include Advance Notices of
Proposed Rulemaking (ANPRMs) and reviews of existing regulations.
2. Proposed Rule Stage--actions for which agencies plan to publish
a Notice of Proposed Rulemaking as the next step in their rulemaking
process or for which the closing date of the NPRM Comment Period is the
next step.
3. Final Rule Stage--actions for which agencies plan to publish a
final rule or an interim final rule or to take other final action as
the next step.
4. Long-Term Actions--items under development but for which the
agency does not expect to have a regulatory action within the 12 months
after publication of this edition of the Unified Agenda. Some of the
entries in this section may contain abbreviated information.
5. Completed Actions--actions or reviews the agency has completed
or withdrawn since publishing its last agenda. This section also
includes items the agency began and completed between issues of the
Agenda.
Long-Term Actions are rulemakings reported during the publication
cycle that are outside of the required 12-month reporting period for
which the Agenda was intended. Completed Actions in the publication
cycle are rulemakings that are ending their lifecycle either by
Withdrawal or completion of the rulemaking process. Therefore, the
Long-Term and Completed RINs do not represent the ongoing, forward-
looking nature intended for reporting developing rulemakings in the
Agenda pursuant to Executive Order 12866, section 4(b) and 4(c). To
further differentiate these two stages of rulemaking in the Unified
Agenda from active rulemakings, Long-Term and Completed Actions are
reported separately from active rulemakings, which can be any of the
first three stages of rulemaking listed above. A separate search
function is provided on reginfo.gov to search for Completed and Long-
Term Actions apart from each other and active RINs.
A bullet () preceding the title of an entry indicates that
the entry is appearing in the Unified Agenda for the first time.
In the printed edition, all entries are numbered sequentially from
the beginning to the end of the publication. The sequence number
preceding the title of each entry identifies the location of the entry
in this edition. The sequence number is used as the reference in the
printed table of contents. Sequence numbers are not used in the online
Unified Agenda because the unique Regulation Identifier Number (RIN) is
able to provide this cross-reference capability.
Editions of the Unified Agenda prior to fall 2007 contained several
indexes, which identified entries with various characteristics. These
included regulatory actions for which agencies believe that the
Regulatory Flexibility Act may require a Regulatory Flexibility
Analysis, actions selected for periodic review under section 610(c) of
the Regulatory Flexibility Act, and actions
[[Page 7667]]
that may have federalism implications as defined in Executive Order
13132 or other effects on levels of government. These indexes are no
longer compiled, because users of the online Unified Agenda have the
flexibility to search for entries with any combination of desired
characteristics. The online edition retains the Unified Agenda's
subject index based on the Federal Register Thesaurus of Indexing
Terms. In addition, online users have the option of searching Agenda
text fields for words or phrases.
IV. What Information Appears for Each Entry?
All entries in the online Unified Agenda contain uniform data
elements including, at a minimum, the following information:
Title of the Regulation--a brief description of the subject of the
regulation. In the printed edition, the notation ``Section 610 Review''
following the title indicates that the agency has selected the rule for
its periodic review of existing rules under the Regulatory Flexibility
Act (5 U.S.C. 610(c)). Some agencies have indicated completions of
section 610 reviews or rulemaking actions resulting from completed
section 610 reviews. In the online edition, these notations appear in a
separate field.
Priority--an indication of the significance of the regulation.
Agencies assign each entry to one of the following five categories of
significance.
(1) Economically Significant
As defined in Executive Order 12866, a rulemaking action that will
have an annual effect on the economy of $100 million or more or will
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. The definition of an ``economically significant'' rule is
similar but not identical to the definition of a ``major'' rule under 5
U.S.C. 801 (Pub. L. 104-121). (See below.)
(2) Other Significant
A rulemaking that is not Economically Significant but is considered
Significant by the agency. This category includes rules that the agency
anticipates will be reviewed under Executive Order 12866 or rules that
are a priority of the agency head. These rules may or may not be
included in the agency's regulatory plan.
(3) Substantive, Nonsignificant
A rulemaking that has substantive impacts but is neither
Significant, nor Routine and Frequent, nor Informational/
Administrative/Other.
(4) Routine and Frequent
A rulemaking that is a specific case of a multiple recurring
application of a regulatory program in the Code of Federal Regulations
and that does not alter the body of the regulation.
(5) Informational/Administrative/Other
A rulemaking that is primarily informational or pertains to agency
matters not central to accomplishing the agency's regulatory mandate
but that the agency places in the Unified Agenda to inform the public
of the activity.
Major--whether the rule is ``major'' under 5 U.S.C. 801 (Pub. L.
104-121) because it has resulted or is likely to result in an annual
effect on the economy of $100 million or more or meets other criteria
specified in that Act. The Act provides that the Administrator of the
Office of Information and Regulatory Affairs will make the final
determination as to whether a rule is major.
Unfunded Mandates--whether the rule is covered by section 202 of
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act
requires that, before issuing an NPRM likely to result in a mandate
that may result in expenditures by State, local, and tribal
governments, in the aggregate, or by the private sector of more than
$100 million in 1 year, agencies, other than independent regulatory
agencies, shall prepare a written statement containing an assessment of
the anticipated costs and benefits of the Federal mandate.
Legal Authority--the section(s) of the United States Code (U.S.C.)
or Public Law (Pub. L.) or the Executive order (E.O.) that authorize(s)
the regulatory action. Agencies may provide popular name references to
laws in addition to these citations.
CFR Citation--the section(s) of the Code of Federal Regulations
that will be affected by the action.
Legal Deadline--whether the action is subject to a statutory or
judicial deadline, the date of that deadline, and whether the deadline
pertains to an NPRM, a Final Action, or some other action.
Abstract--a brief description of the problem the regulation will
address; the need for a Federal solution; to the extent available,
alternatives that the agency is considering to address the problem; and
potential costs and benefits of the action.
Timetable--the dates and citations (if available) for all past
steps and a projected date for at least the next step for the
regulatory action. A date displayed in the form 12/00/11 means the
agency is predicting the month and year the action will take place but
not the day it will occur. In some instances, agencies may indicate
what the next action will be, but the date of that action is ``To Be
Determined.'' ``Next Action Undetermined'' indicates the agency does
not know what action it will take next.
Regulatory Flexibility Analysis Required--whether an analysis is
required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
because the rulemaking action is likely to have a significant economic
impact on a substantial number of small entities as defined by the Act.
Small Entities Affected--the types of small entities (businesses,
governmental jurisdictions, or organizations) on which the rulemaking
action is likely to have an impact as defined by the Regulatory
Flexibility Act. Some agencies have chosen to indicate likely effects
on small entities even though they believe that a Regulatory
Flexibility Analysis will not be required.
Government Levels Affected--whether the action is expected to
affect levels of government and, if so, whether the governments are
State, local, tribal, or Federal.
International Impacts--whether the regulation is expected to have
international trade and investment effects, or otherwise may be of
interest to the Nation's international trading partners.
Federalism--whether the action has ``federalism implications'' as
defined in Executive Order 13132. This term refers to actions ``that
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.''
Independent regulatory agencies are not required to supply this
information.
Included in the Regulatory Plan--whether the rulemaking was
included in the agency's current regulatory plan published in fall
2010.
Agency Contact--the name and phone number of at least one person in
the agency who is knowledgeable about the rulemaking action. The agency
may also provide the title, address, fax number, email address, and TDD
for each agency contact.
Some agencies have provided the following optional information:
[[Page 7668]]
RIN Information URL--the Internet address of a site that provides
more information about the entry.
Public Comment URL--the Internet address of a site that will accept
public comments on the entry. Alternatively, timely public comments may
be submitted at the Governmentwide e-rulemaking site, https://www.regulations.gov.
Additional Information--any information an agency wishes to include
that does not have a specific corresponding data element.
Compliance Cost to the Public--the estimated gross compliance cost
of the action.
Affected Sectors--the industrial sectors that the action may most
affect, either directly or indirectly. Affected sectors are identified
by North American Industry Classification System (NAICS) codes.
Energy Effects--an indication of whether the agency has prepared or
plans to prepare a Statement of Energy Effects for the action, as
required by Executive Order 13211 ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use,'' signed May
18, 2001 (66 FR 28355).
Related RINs--one or more past or current RIN(s) associated with
activity related to this action, such as merged RINs, split RINs, new
activity for previously completed RINs, or duplicate RINs.
Some agencies that participated in the fall 2010 edition of The
Regulatory Plan have chosen to include the following information for
those entries that appeared in the Plan:
Statement of Need--a description of the need for the regulatory
action.
Summary of the Legal Basis--a description of the legal basis for
the action, including whether any aspect of the action is required by
statute or court order.
Alternatives--a description of the alternatives the agency has
considered or will consider as required by section 4(c)(1)(B) of
Executive Order 12866.
Anticipated Costs and Benefits--a description of preliminary
estimates of the anticipated costs and benefits of the action.
Risks--a description of the magnitude of the risk the action
addresses, the amount by which the agency expects the action to reduce
this risk, and the relation of the risk and this risk reduction effort
to other risks and risk reduction efforts within the agency's
jurisdiction.
V. Abbreviations
The following abbreviations appear throughout this publication:
ANPRM--An Advance Notice of Proposed Rulemaking is a preliminary
notice, published in the Federal Register, announcing that an agency is
considering a regulatory action. An agency may issue an ANPRM before it
develops a detailed proposed rule. An ANPRM describes the general area
that may be subject to regulation and usually asks for public comment
on the issues and options being discussed. An ANPRM is issued only when
an agency believes it needs to gather more information before
proceeding to a notice of proposed rulemaking.
CFR--The Code of Federal Regulations is an annual codification of
the general and permanent regulations published in the Federal Register
by the agencies of the Federal Government. The Code is divided into 50
titles, each title covering a broad area subject to Federal regulation.
The CFR is keyed to and kept up to date by the daily issues of the
Federal Register.
EO--An Executive order is a directive from the President to
Executive agencies, issued under constitutional or statutory authority.
Executive orders are published in the Federal Register and in title 3
of the Code of Federal Regulations.
FR--The Federal Register is a daily Federal Government publication
that provides a uniform system for publishing Presidential documents,
all proposed and final regulations, notices of meetings, and other
official documents issued by Federal agencies.
FY--The Federal fiscal year runs from October 1 to September 30.
NPRM--A Notice of Proposed Rulemaking is the document an agency
issues and publishes in the Federal Register that describes and
solicits public comments on a proposed regulatory action. Under the
Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a
minimum:
A statement of the time, place, and nature of the public
rulemaking proceeding;
A reference to the legal authority under which the rule is
proposed; and
Either the terms or substance of the proposed rule or a
description of the subjects and issues involved.
PL (or Pub. L.)--A public law is a law passed by Congress and
signed by the President or enacted over his veto. It has general
applicability, unlike a private law that applies only to those persons
or entities specifically designated. Public laws are numbered in
sequence throughout the 2-year life of each Congress; for example, Pub.
L. 112-4 is the fourth public law of the 112th Congress.
RFA--A Regulatory Flexibility Analysis is a description and
analysis of the impact of a rule on small entities, including small
businesses, small governmental jurisdictions, and certain small not-
for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601
et seq.) requires each agency to prepare an initial RFA for public
comment when it is required to publish an NPRM and to make available a
final RFA when the final rule is published, unless the agency head
certifies that the rule would not have a significant economic impact on
a substantial number of small entities.
RIN--The Regulation Identifier Number is assigned by the Regulatory
Information Service Center to identify each regulatory action listed in
the Unified Agenda, as directed by Executive Order 12866 (section
4(b)). Additionally, OMB has asked agencies to include RINs in the
headings of their Rule and Proposed Rule documents when publishing them
in the Federal Register, to make it easier for the public and agency
officials to track the publication history of regulatory actions
throughout their development.
Seq. No.--The sequence number identifies the location of an entry
in the printed edition of the Unified Agenda. Note that a specific
regulatory action will have the same RIN throughout its development but
will generally have different sequence numbers if it appears in
different printed editions of the Unified Agenda. Sequence numbers are
not used in the online Unified Agenda.
U.S.C.--The United States Code is a consolidation and codification
of all general and permanent laws of the United States. The U.S.C. is
divided into 50 titles, each title covering a broad area of Federal
law.
VI. How Can Users Get Copies of the Agenda?
Copies of the Federal Register issue containing the printed edition
of the Unified Agenda (agency regulatory flexibility agendas) are
available from the Superintendent of Documents, U.S. Government
Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone:
202 512-1800 or 1 866 512-1800 (toll-free).
Copies of individual agency materials may be available directly
from the agency or may be found on the agency's Web site. Please
contact the particular agency for further information.
All editions of The Regulatory Plan and the Unified Agenda of
Federal
[[Page 7669]]
Regulatory and Deregulatory Actions since fall 1995 are available in
electronic form at https://reginfo.gov, along with flexible search
tools.
In accordance with regulations for the Federal Register, the
Government Printing Office's GPO FDsys Web site contains copies of the
Agendas and Regulatory Plans that have been printed in the Federal
Register. These documents are available at https://www.fdsys.gov.
Dated: December 19, 2011.
John C. Thomas,
Director.
Introduction to the Fall 2011 Regulatory Plan
Executive Order 12866, issued in 1993, requires the annual
production of a Unified Regulatory Agenda and Regulatory Plan. It does
so to promote transparency--or in the words of the Executive Order
itself, ``to have an effective regulatory program, to provide for
coordination of regulations, to maximize consultation and the
resolution of potential conflicts at an early stage, to involve the
public and its State, local, and tribal officials in regulatory
planning, and to ensure that new or revised regulations promote the
President's priorities and the principles set forth in this Executive
order.''
The requirements of Executive Order 12866 were reaffirmed in
Executive Order 13563, issued in 2011. Consistent with Executive Orders
13563 and 12866, we are now providing the Unified Regulatory Agenda and
the Regulatory Plan for public scrutiny and review. Such scrutiny and
review are closely connected with the general goal, central to
Executive Order 13563, of promoting public participation in the
rulemaking process.
It is important to understand that the Agenda and Plan are intended
merely to serve as a preliminary statement, for public understanding
and assessment, of regulatory and deregulatory policies and priorities
that are now under contemplation. This preliminary statement often
includes a number of rules that are not issued in the following year
and that may well not be issued at all. This year, we have taken
several new steps to clarify the purposes and uses of the Agenda and
Plan and to improve its presentation. Among other things, we have
narrowed the list of ``active rulemakings'' to rules that are not
merely under some form of contemplation but that also have at least
some possibility of issuance over the next year. We have also made it
easier to understand which rules are active rulemakings rather than
long-term actions or completed actions. But it remains true that rules
on this list, designed among other things ``to involve the public and
its State, local, and tribal officials in regulatory planning,'' must
undergo serious internal and external scrutiny before they are issued--
and that there are rules on the list that may never be issued.
In this light, it should be clear that this preliminary statement
of policies and priorities has extremely important limitations. No
regulatory action can be made effective until it has gone through
legally required processes, including those that involve public
scrutiny and review. For this reason, the inclusion of a regulatory
action here does not necessarily mean that it will be finalized or even
proposed. Any proposed or final action must satisfy the requirements of
relevant statutes, Executive Orders, and Presidential Memoranda. Those
requirements, public comments, and new information may or may not lead
an agency to go forward with an action that is currently under
contemplation and that is included here. For example, the directives of
Executive Order 13563, emphasizing the importance of careful
consideration of costs and benefits, may lead an agency to decline to
proceed with a regulatory action that is presented here.
It is also important to note that under Executive Order 12866,
whether a regulation counts as ``economically significant'' is not an
adequate measure of whether it imposes high costs on the private
sector. Economically significant actions may impose small costs or even
no costs. For example, regulations may count as economically
significant not because they impose significant costs, but because they
confer large benefits. Moreover, many regulations count as economically
significant not because they impose significant regulatory costs on the
private sector, but because they involve transfer payments as required
or authorized by law.
It should be observed that the number of economically significant
actions listed as under active consideration here--138--is lower than
the corresponding figure for Spring 2011 (149) and for Fall 2010 (140).
It is notable that the number of such rules has not grown even taking
account of rules implementing the Affordable Care Act and the Wall
Street Reform and Consumer Protection Act. We also note that the net
benefits of regulation were unusually high in Fiscal Year 2011 (well
over $50 billion for the year alone). In addition, the aggregate costs
for that year (under $8 billion) were lower than in Fiscal Year 2010
and were not out of line with those in recent years, including during
the Bush Administration.
With these notes and qualifications, the Regulatory Plan provides a
list of important regulatory actions that are now under contemplation
for issuance in proposed or final form during the upcoming fiscal year.
In contrast, the Unified Agenda is a more inclusive list, including
numerous ministerial actions and routine rulemakings, as well as long-
term initiatives that agencies do not plan to complete in the coming
year.
We hope that public scrutiny of the Regulatory Plan and the Unified
Agenda might help ensure, in the words of Executive Order 13563, a
regulatory system that protects ``public health, welfare, safety, and
our environment while promoting economic growth, innovation,
competitiveness, and job creation.''
As discussed below, a large number of significant recent steps have
been taken, consistent with Executive Order 13563, to reduce regulatory
costs and ensure that our regulatory system is consistent with
promoting growth and job creation. At the same time, a number of steps
have been taken to promote public health, welfare, safety, and our
environment. It is important to emphasize that the net benefits of
recent rules, including the monetized benefits, are high--over the
first two fiscal years of this Administration, in excess of $35
billion. Rules have been issued and initiatives have been undertaken
that are saving lives on the highways and in workplaces; reducing air
and water pollution, preventing thousands of deaths in the process;
increasing fuel economy, thus saving money while reducing pollution;
making both trains and planes safer; increasing energy efficiency,
saving billions of dollars while increasing energy security; combating
childhood obesity; and creating a ``race to the top'' in education.
Consider, as merely one example, the fact that in 2010, the rates of
roadway fatalities and injuries fell to their lowest recorded levels
and to their lowest numbers since 1949. The decrease is attributable,
in part, to a range of regulatory actions and to private-public
partnerships that have increased safety.
Since President Reagan's Executive Order 12291, issued in 1981, a
principal focus of the Office of Information and Regulatory Affairs,
and of regulatory policy in general, has been on maximizing net
benefits. In this Administration, agencies and OMB have worked together
to issue a number of rules for which the benefits exceed the costs, and
by a large margin. Consider the following figure:
[[Page 7670]]
[GRAPHIC] [TIFF OMITTED] TP13FE12.000
These figures reflect the numbers for 2009 and 2010. As noted, the
net benefits for 2011 are expected to be unusually high (in excess of
$50 billion); they will be discussed in detail in the 2012 Report to
Congress on the Benefits and Costs of Federal Regulations.
The recent steps build on a great deal of new learning about
regulation. As a result of conceptual and empirical advances, we know
far more than during the New Deal and the Great Society. We have also
learned much since the 1980s and 1990s. These lessons have informed the
Administration's efforts to protect public health and safety while also
promoting economic growth and job creation. Eight points are
particularly important:
1. We are now equipped with state-of-the-art techniques for
anticipating, cataloguing, and monetizing the consequences of
regulation, including both benefits and costs.
2. We know that risks are part of systems, and that efforts to
reduce a certain risk may increase other risks, perhaps even deadly
ones, thus producing ancillary harms--and that efforts to reduce a
certain risk may reduce other risks, perhaps even deadly ones, thus
producing ancillary benefits.
3. We know that flexible, innovative approaches, maintaining
freedom of choice and respecting heterogeneity and the fact that one
size may not fit all, are often desirable, both because they preserve
liberty and because they frequently cost less.
4. We know that large benefits can come from seemingly modest and
small steps, including simplification of regulatory requirements,
provision of information, and sensible default rules, such as automatic
enrollment for retirement savings.
5. We know, more clearly than ever before, that it is important to
allow public participation in the design of rules, because members of
the public have valuable information about likely effects, existing
problems, creative solutions, and possible unintended consequences.
6. We know that if carefully designed, disclosure policies can
promote informed choices and save both money and lives.
7. We know that intuitions and anecdotes are unreliable, and that
advance testing of the effects of rules, as through pilot programs or
randomized controlled experiments, can be highly illuminating.
8. We know that it is important to explore the effects of
regulation in the real world, to learn whether they are having
beneficial consequences or producing unintended harm. We need to
consult, and to learn from, those who are affected by rules.
Executive Order 13563 draws on these understandings and emphasizes
the importance of protecting ``public health, welfare, safety, and our
environment while promoting economic growth, innovation,
competitiveness, and job creation.'' Executive Order 13563 explicitly
points to the need for predictability and for certainty, and for use of
the least burdensome tools for achieving regulatory ends. It indicates
that agencies ``must take into account benefits and costs, both
quantitative and qualitative.'' It explicitly draws attention to the
need to measure and to improve ``the actual results of regulatory
requirements''--a clear reference to the importance of retrospective
evaluation.
Executive Order 13563 reaffirms the principles, structures, and
definitions in Executive Order 12866, which has long governed
regulatory review. In addition, it endorses, and quotes, a number of
[[Page 7671]]
provisions of that Executive Order that specifically emphasize the
importance of considering costs--including the requirement that to the
extent permitted by law, agencies should not proceed in the absence of
a reasoned determination that the benefits justify the costs.
Importantly, Executive Order 13563 directs agencies ``to use the best
available techniques to quantify anticipated present and future
benefits and costs as accurately as possible.'' This direction reflects
a strong emphasis on quantitative analysis as a means of improving
regulatory choices and increasing transparency.
Among other things, Executive Order 13563 sets out five sets of
requirements to guide regulatory decision making:
Public participation. Agencies are directed to promote
public participation, in part by making supporting documents available
on Regulations.gov in order to promote transparency and public comment.
Executive Order 13563 also directs agencies, where feasible and
appropriate, to engage the public, including affected stakeholders,
before rulemaking is initiated.
Integration and innovation. Agencies are directed to
attempt to reduce ``redundant, inconsistent, or overlapping''
requirements, in part by working with one another to simplify and
harmonize rules. This important provision is designed to reduce
confusion, redundancy, and excessive cost. An important goal of
simplification and harmonization is to promote rather than to hamper
innovation, which is a foundation of both growth and job creation.
Different offices within the same agency might work together to
harmonize their rules; different agencies might work together to
achieve the same objective. Such steps can also promote predictability
and certainty.
Flexible approaches. Agencies are directed to identify and
consider flexible approaches to regulatory problems, including
warnings, appropriate default rules, and disclosure requirements. Such
approaches may ``reduce burdens and maintain flexibility and freedom of
choice for the public.'' In certain settings, they may be far
preferable to mandates and bans, precisely because they maintain
freedom of choice and reduce costs. The reference to ``appropriate
default rules'' signals the possibility that important social goals can
be obtained through simplification--as, for example, in the form of
automatic enrollment, direct certification, or reduced paperwork
burdens.
Science. Agencies are directed to promote scientific
integrity, and in a way that ensures a clear separation between
judgments of science and judgments of policy.
Retrospective analysis of existing rules. Agencies are
directed to produce preliminary plans to engage in retrospective
analysis of existing significant regulations to determine whether they
should be modified, streamlined, expanded, or repealed.
Executive Order 13563 addresses both the ``flow'' of new
regulations that are under development and the ``stock'' of existing
regulations that are already in place. Executive Order 13563 emphasizes
the importance of promoting predictability, of carefully considering
costs, of choosing the least burdensome approach, and of selecting the
most flexible, least costly tools. In addition, Executive Order 13563
calls for careful reassessment, based on empirical analysis. It is
understood that the prospective analysis required by Executive Order
13563 may depend on a degree of speculation and that the actual costs
and benefits of a regulation may be lower or higher than what was
anticipated when the rule was originally developed. It is also
understood that circumstances may change in a way that requires
reconsideration of regulatory requirements. After retrospective
analysis has been undertaken, agencies will be in a position to
reevaluate existing rules and to streamline, modify, or eliminate those
that do not make sense in their current form.
In August 2011, over two dozen agencies released final plans to
remove what the President has called unjustified rules and ``absurd and
unnecessary paperwork requirements that waste time and money.'' Over
the next five years, billions of dollars in savings are anticipated
from just a few initiatives from the Department of Transportation, the
Department of Labor, the Department of Health and Human Services, and
the Environmental Protection Agency. And all in all, the plans'
initiatives will save tens of millions of hours in annual paperwork
burdens on individuals, businesses, and state and local governments.
The plans span over 800 pages and offer more than 500 proposals.
Some plans list well over 50 reforms. Many of the proposals focus on
small business. Indeed, a number of the initiatives are specifically
designed to reduce burdens on small business and to enable them to do
what they do best, which is to create jobs. Some of the proposed
initiatives represent a fundamental rethinking of how things have long
been done--as, for example, with numerous efforts to move from paper to
electronic reporting. For both private and public sectors, those
efforts can save a great deal of money. Over the next five years, the
Department of Treasury's paperless initiative will be saving $400
million and 12 million pounds of paper.
Many of the reforms will have a significant economic impact:
The Occupational Safety and Health Administration has
announced a final rule that will remove over 1.9 million annual hours
of redundant reporting burdens on employers and save more than $40
million in annual costs. Businesses will no longer be saddled with the
obligation to fill out unnecessary government forms, meaning that their
employees will have more time to be productive and do their real work.
To eliminate unjustified economic burdens on railroads,
the Department of Transportation is reconsidering parts of a rule that
requires railroads to install equipment on trains. DOT has proposed to
refine the requirements so that the equipment is installed only where
it is really needed on grounds of safety. DOT expects initial savings
of up to $325 million, with total 20-year savings of up to $755
million.
EPA has proposed to eliminate the obligation for many
states to require air pollution vapor recovery systems at local gas
stations, on the ground that modern vehicles already have effective air
pollution control technologies. The anticipated annual savings are $87
million.
The Departments of Commerce and State are undertaking a
series of steps to eliminate unnecessary barriers to exports, including
duplicative and unnecessary regulatory requirements, thus reducing the
cumulative burden and uncertainty faced by American companies and their
trading partners. These steps will make it a lot easier for American
companies to reach new markets, increasing our exports while creating
jobs here at home.
To promote flexibility, the Department of Health and Human
Services has proposed two rules, and finalized another, to reduce
burdensome regulatory requirements now placed on hospitals and doctors.
These reforms are expected to save more than $1 billion annually.
The regulatory lookback is not merely a one-time exercise. Regular
reporting, about recent progress and coming initiatives, is required.
The goal is to change the regulatory culture to ensure that rules on
the books are reevaluated and are effective, cost-justified, and based
on the best available science. By creating regulatory review teams at
agencies, we will continue to examine what is working and what is not
and to
[[Page 7672]]
eliminate unjustified and outdated regulations.
In addition to looking back at existing regulations, we are looking
forward to ensure that future regulations are well-justified. Executive
Order 13563 provides critical guidance with its emphasis on careful
consideration of costs and benefits, public participation, integration
and innovation, flexible approaches, and science. These requirements
are meant to produce a regulatory system that draws on recent learning,
that is driven by evidence, and that is suited to the distinctive
circumstances of the twenty-first century.
Department of Agriculture
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
1............................. Wholesale Pork Reporting 0581-AD07 Proposed Rule Stage.
Program.
2............................. National Organic Program: 0581-AD17 Proposed Rule Stage.
Sunset Review for
Nutrient Vitamins and
Minerals (NOP-10-0083).
3............................. Animal Welfare; 0579-AC02 Proposed Rule Stage.
Regulations and
Standards for Birds.
4............................. Plant Pest Regulations; 0579-AC98 Proposed Rule Stage.
Update of General
Provisions.
5............................. Importation of Live Dogs. 0579-AD23 Final Rule Stage.
6............................. Animal Disease 0579-AD24 Final Rule Stage.
Traceability.
7............................. Supplemental Nutrition 0584-AD88 Proposed Rule Stage.
Assistance Program: Farm
Bill of 2008 Retailer
Sanctions.
8............................. National School Lunch and 0584-AE09 Proposed Rule Stage.
School Breakfast
Programs: Nutrition
Standards for All Foods
Sold in School, as
Required by the Healthy,
Hunger-Free Kids Act of
2010.
9............................. WIC: Electronic Benefit 0584-AE21 Proposed Rule Stage.
Transfer (EBT)
Implementation.
10............................ Nutrition Standards in 0584-AD59 Final Rule Stage.
the National School
Lunch and School
Breakfast Programs.
11............................ Direct Certification of 0584-AD60 Final Rule Stage.
Children in Food Stamp
Households and
Certification of
Homeless, Migrant, and
Runaway Children for
Free Meals.
12............................ Eligibility, 0584-AD87 Final Rule Stage.
Certification, and
Employment and Training
Provisions of the Food,
Conservation, and Energy
Act of 2008.
13............................ Supplemental Nutrition 0584-AE07 Final Rule Stage.
Assistance Program:
Nutrition Education and
Obesity Prevention Grant.
14............................ Prior Labeling Approval 0583-AC59 Proposed Rule Stage.
System: Generic Label
Approval.
15............................ Product Labeling: Use of 0583-AD30 Proposed Rule Stage.
the Voluntary Claim
``Natural'' on the
Labeling of Meat and
Poultry Products.
16............................ New Poultry Slaughter 0583-AD32 Proposed Rule Stage.
Inspection.
17............................ Electronic Imported 0583-AD39 Proposed Rule Stage.
Product Inspection
Application and
Certification of
Imported Product and
Foreign Establishments;
Amendments to Facilitate
the Public Health
Information System
(PHIS).
18............................ Electronic Export 0583-AD41 Proposed Rule Stage.
Application and
Certification as a
Reimbursable Service and
Flexibility in the
Requirements for
Official Export
Inspection Marks,
Devices, and
Certificates.
19............................ Performance Standards for 0583-AC46 Final Rule Stage.
the Production of
Processed Meat and
Poultry Products;
Control of Listeria
Monocytogenes in Ready-
To-Eat Meat and Poultry
Products.
20............................ Notification, 0583-AD34 Final Rule Stage.
Documentation, and
Recordkeeping
Requirements for
Inspected Establishments.
----------------------------------------------------------------------------------------------------------------
Department of Commerce
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
21............................ Revisions to the Export 0694-AF17 Final Rule Stage.
Administration
Regulations (EAR):
Control of Military
Vehicles and Related
Items That the President
Determines do not
Warrant Control on the
United States Munitions
List.
22............................ Fishery Management Plan 0648-AS65 Proposed Rule Stage.
for Regulating Offshore
Marine Aquaculture in
the Gulf of Mexico.
23............................ Reducing Disturbances to 0648-AU02 Proposed Rule Stage.
Hawaiian Spinner
Dolphins From Human
Interactions.
24............................ Designation of Critical 0648-AY54 Proposed Rule Stage.
Habitat for the North
Atlantic Right Whale.
25............................ Regulatory Amendments To 0648-BA89 Proposed Rule Stage.
Implement the Shark
Conservation Act and
Revise the Definition of
Illegal, Unreported, and
Unregulated Fishing.
----------------------------------------------------------------------------------------------------------------
Department of Education
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
26............................ Title IV of the Higher 1840-AD05 Proposed Rule Stage.
Education Act of 1965,
as Amended.
----------------------------------------------------------------------------------------------------------------
[[Page 7673]]
Department of Energy
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
27............................ Energy Efficiency 1904-AB57 Proposed Rule Stage.
Standards for Battery
Chargers and External
Power Supplies.
28............................ Energy Conservation 1904-AB86 Proposed Rule Stage.
Standards for Walk-In
Coolers and Walk-In
Freezers.
29............................ Energy Efficiency 1904-AC11 Proposed Rule Stage.
Standards for
Manufactured Housing.
30............................ Energy Conservation 1904-AC15 Proposed Rule Stage.
Standards for ER, BR,
and Small Diameter
Incandescent Reflector
Lamps.
31............................ Energy Efficiency 1904-AB50 Final Rule Stage.
Standards for
Fluorescent Lamp
Ballasts.
----------------------------------------------------------------------------------------------------------------
Department of Health and Human Services
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
32............................ Health Information 0991-AB82 Proposed Rule Stage.
Technology: New and
Revised Standards,
Implementation
Specifications, and
Certification Criteria
for Electronic Health
Record Technology.
33............................ Electronic Submission of 0910-AC52 Proposed Rule Stage.
Data From Studies
Evaluating Human Drugs
and Biologics.
34............................ Current Good 0910-AG10 Proposed Rule Stage.
Manufacturing Practice
and Hazard Analysis and
Risk-Benefit Preventive
Controls for Food for
Animals.
35............................ Unique Device 0910-AG31 Proposed Rule Stage.
Identification.
36............................ Produce Safety Regulation 0910-AG35 Proposed Rule Stage.
37............................ Hazard Analysis and Risk- 0910-AG36 Proposed Rule Stage.
Based Preventive
Controls.
38............................ Foreign Supplier 0910-AG64 Proposed Rule Stage.
Verification Program.
39............................ Accreditation of Third 0910-AG66 Proposed Rule Stage.
Parties to Conduct Food
Safety Audits and for
Other Related Purposes.
40............................ Infant Formula: Current 0910-AF27 Final Rule Stage.
Good Manufacturing
Practices; Quality
Control Procedures;
Notification
Requirements; Records
and Reports; and Quality
Factors.
41............................ Medical Device Reporting; 0910-AF86 Final Rule Stage.
Electronic Submission
Requirements.
42............................ Electronic Registration 0910-AF88 Final Rule Stage.
and Listing for Devices.
43............................ Food Labeling: Nutrition 0910-AG56 Final Rule Stage.
Labeling for Food Sold
in Vending Machines.
44............................ Food Labeling: Nutrition 0910-AG57 Final Rule Stage.
Labeling of Standard
Menu Items in
Restaurants and Similar
Retail Food
Establishments.
45............................ Medicare and Medicaid 0938-AQ89 Proposed Rule Stage.
Programs: Reform of
Hospital and Critical
Access Hospital
Conditions of
Participation (CMS-3244-
P).
46............................ Regulatory Provisions To 0938-AQ96 Proposed Rule Stage.
Promote Program
Efficiency,
Transparency, and Burden
Reduction (CMS-9070-P).
47............................ Proposed Changes to 0938-AR10 Proposed Rule Stage.
Hospital OPPS and CY
2013 Payment Rates; ASC
Payment System and CY
2013 Payment Rates (CMS-
1589-P).
48............................ Revisions to Payment 0938-AR11 Proposed Rule Stage.
Policies Under the
Physician Fee Schedule
and Part B for CY 2013
(CMS-1590-P).
49............................ Changes to the Hospital 0938-AR12 Proposed Rule Stage.
Inpatient an Long-Term
Care Prospective Payment
System for FY 2013 (CMS-
1588-P).
50............................ Medicaid Eligibility 0938-AQ62 Final Rule Stage.
Expansion Under the
Affordable Care Act of
2010 (CMS-2349-F).
51............................ Establishment of 0938-AQ67 Final Rule Stage.
Exchanges and Qualified
Health Plans Part I (CMS-
9989-F).
52............................ State Requirements for 0938-AR07 Final Rule Stage.
Exchange--Reinsurance
and Risk Adjustments
(CMS-9975-F).
----------------------------------------------------------------------------------------------------------------
Department of Homeland Security
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
53............................ Secure Handling of 1601-AA52 Proposed Rule Stage.
Ammonium Nitrate Program.
54............................ Asylum and Withholding 1615-AA41 Proposed Rule Stage.
Definitions.
55............................ New Classification for 1615-AA67 Proposed Rule Stage.
Victims of Criminal
Activity; Eligibility
for the U Nonimmigrant
Status.
56............................ Exception to the 1615-AB89 Proposed Rule Stage.
Persecution Bar for
Asylum, Refugee, and
Temporary Protected
Status, and Withholding
of Removal.
57............................ Electronic Filing of 1615-AB94 Proposed Rule Stage.
Requests for Immigration
Benefits; Requiring an
Application To Change or
Extend Nonimmigrant
Status To Be Filed
Electronically.
58............................ Immigration Benefits 1615-AB95 Proposed Rule Stage.
Business Transformation:
Nonimmigrants; Student
and Exchange Visitor
Program.
59............................ Application of the 1615-AB96 Proposed Rule Stage.
William Wilberforce
Trafficking Victims
Protection
Reauthorization Act of
2008 to Unaccompanied
Alien Children Seeking
Asylum.
60............................ Administrative Appeals 1615-AB98 Proposed Rule Stage.
Office: Procedural
Reforms To Improve
Efficiency.
61............................ New Classification for 1615-AA59 Final Rule Stage.
Victims of Severe Forms
of Trafficking in
Persons; Eligibility for
T Nonimmigrant Status.
[[Page 7674]]
62............................ Adjustment of Status to 1615-AA60 Final Rule Stage.
Lawful Permanent
Resident for Aliens in T
and U Nonimmigrant
Status.
63............................ Application of 1615-AB77 Final Rule Stage.
Immigration Regulations
to the Commonwealth of
the Northern Mariana
Islands.
64............................ Implementation of the 1625-AA16 Final Rule Stage.
1995 Amendments to the
International Convention
on Standards of
Training, Certification,
and Watchkeeping (STCW)
for Seafarers, 1978.
65............................ Vessel Requirements for 1625-AA99 Final Rule Stage.
Notices of Arrival and
Departure, and Automatic
Identification System.
66............................ Nontank Vessel Response 1625-AB27 Final Rule Stage.
Plans and Other Vessel
Response Plan
Requirements.
67............................ Offshore Supply Vessels 1625-AB62 Final Rule Stage.
of At Least 6000 GT ITC.
68............................ Revision to 1625-AB80 Final Rule Stage.
Transportation Worker
Identification
Credential (TWIC)
Requirements for
Mariners.
69............................ Importer Security Filing 1651-AA70 Final Rule Stage.
and Additional Carrier
Requirements.
70............................ Changes to the Visa 1651-AA72 Final Rule Stage.
Waiver Program To
Implement the Electronic
System for Travel
Authorization (ESTA)
Program.
71............................ Establishment of Global 1651-AA73 Final Rule Stage.
Entry Program.
72............................ Implementation of the 1651-AA77 Final Rule Stage.
Guam-CNMI Visa Waiver
Program.
73............................ General Aviation Security 1652-AA53 Proposed Rule Stage.
and Other Aircraft
Operator Security.
74............................ Freight Railroads, Public 1652-AA55 Proposed Rule Stage.
Transportation and
Passenger Railroads, and
Over-the-Road Buses--
Security Training of
Employees.
75............................ Freight Railroads and 1652-AA56 Proposed Rule Stage.
Passenger Railroads--
Vulnerability Assessment
and Security Plan.
76............................ Standardized Vetting, 1652-AA61 Proposed Rule Stage.
Adjudication, and
Redress Services.
77............................ Aircraft Repair Station 1652-AA38 Final Rule Stage.
Security.
78............................ Continued Detention of 1653-AA60 Proposed Rule Stage.
Aliens Subject to Final
Orders of Removal.
79............................ Continued Detention of 1653-AA13 Final Rule Stage.
Aliens Subject to Final
Orders of Removal.
80............................ Extending Period for 1653-AA56 Final Rule Stage.
Optional Practical
Training by 17 Months
for F-1 Nonimmigrant
Students With STEM
Degrees and Expanding
the CAP-GAP Relief for
All F-1 Students With
Pending H-1B Petitions.
81............................ Update of FEMA's Public 1660-AA51 Proposed Rule Stage.
Assistance Regulations.
----------------------------------------------------------------------------------------------------------------
Department of Housing and Urban Development
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
82............................ Federal Housing 2502-AI79 Proposed Rule Stage.
Administration (FHA):
Strengthening the Home
Equity Conversion
Mortgages (HECM) Program
to Promote Sustained
Homeownership (FR-5353).
83............................ Supportive Housing for 2502-AJ10 Proposed Rule Stage.
Persons With
Disabilities
Implementing New Project
Rental Assistance
Authority (FR-5576).
84............................ Tenant-Based Rental 2577-AC76 Proposed Rule Stage.
Assistance; Improving
Performance Through a
Strengthened Section 8
Management Assessment
Program (FR-5201).
----------------------------------------------------------------------------------------------------------------
Department of Justice
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
85............................ National Standards to 1105-AB34 Final Rule Stage.
Prevent, Detect, and
Respond to Prison Rape.
----------------------------------------------------------------------------------------------------------------
Department of Labor
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
86............................ Construction Contractors' 1250-AA01 Proposed Rule Stage.
Affirmative Action
Requirements.
87............................ Persuader Agreements: 1245-AA03 Final Rule Stage.
Employer and Labor
Relations Consultant
Reporting Under the
LMRDA.
88............................ Equal Employment 1205-AB59 Proposed Rule Stage.
Opportunity in
Apprenticeship Amendment
of Regulations.
89............................ Labor Certification 1205-AB58 Final Rule Stage.
Process and Enforcement
for Temporary Employment
in Occupations Other
Than Agriculture or
Registered Nursing in
the United States (H-2B
Workers).
90............................ Definition of 1210-AB32 Proposed Rule Stage.
``Fiduciary''.
91............................ Respirable Crystalline 1219-AB36 Proposed Rule Stage.
Silica.
92............................ Criteria and Procedures 1219-AB72 Proposed Rule Stage.
for Proposed Assessment
of Civil Penalties.
93............................ Proximity Detection 1219-AB78 Proposed Rule Stage.
Systems for Mobile
Machines in Underground
Mines.
[[Page 7675]]
94............................ Lowering Miners' Exposure 1219-AB64 Final Rule Stage.
to Coal Mine Dust,
Including Continuous
Personal Dust Monitors.
95............................ Proximity Detection 1219-AB65 Final Rule Stage.
Systems for Continuous
Mining Machines in
Underground Coal Mines.
96............................ Pattern of Violations.... 1219-AB73 Final Rule Stage.
97............................ Examination of Work Areas 1219-AB75 Final Rule Stage.
in Underground Coal
Mines for Violations of
Mandatory Health or
Safety Standards.
98............................ Infectious Diseases...... 1218-AC46 Prerule Stage.
99............................ Injury and Illness 1218-AC48 Prerule Stage.
Prevention Program.
100........................... Occupational Exposure to 1218-AB70 Proposed Rule Stage.
Crystalline Silica.
101........................... Improve Tracking of 1218-AC49 Proposed Rule Stage.
Workplace Injuries and
Illnesses.
102........................... Hazard Communication..... 1218-AC20 Final Rule Stage.
----------------------------------------------------------------------------------------------------------------
Department of Transportation
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
103........................... Accessibility of Carrier 2105-AD96 Proposed Rule Stage.
Websites and Ticket
Kiosks.
104........................... Enhancing Airline 2105-AE11 Proposed Rule Stage.
Passenger Protections
III.
105........................... Carrier-Supplied Medical 2105-AE12 Proposed Rule Stage.
Oxygen, Accessible In-
Flight Entertainment
Systems, Service
Animals, and Accessible
Lavatories on Single-
Aisle Aircraft.
106........................... Qualification, Service, 2120-AJ00 Proposed Rule Stage.
and Use of Crewmembers
and Aircraft Dispatchers.
107........................... New York Congestion 2120-AJ89 Proposed Rule Stage.
Management Rule for
LaGuardia Airport, John
F. Kennedy International
Airport, and Newark
Liberty International
Airport.
108........................... Air Ambulance and 2120-AJ53 Final Rule Stage.
Commercial Helicopter
Operations; Safety
Initiatives and
Miscellaneous Amendments.
109........................... Safety Management Systems 2120-AJ86 Final Rule Stage.
for Certificate Holders.
110........................... Carrier Safety Fitness 2126-AB11 Proposed Rule Stage.
Determination.
111........................... National Registry of 2126-AA97 Final Rule Stage.
Certified Medical
Examiners.
112........................... Passenger Car and Light 2127-AK79 Proposed Rule Stage.
Truck Corporate Average
Fuel Economy Standards
MYs 2017 and Beyond.
113........................... Sound for Hybrid and 2127-AK93 Proposed Rule Stage.
Electric Vehicles.
114........................... Motorcoach Rollover 2127-AK96 Proposed Rule Stage.
Structural Integrity.
115........................... Electronic Stability 2127-AK97 Proposed Rule Stage.
Control Systems for
Heavy Vehicles.
116........................... Require Installation of 2127-AK56 Final Rule Stage.
Seat Belts on
Motorcoaches, FMVSS No.
208.
117........................... Major Capital Investment 2132-AB02 Proposed Rule Stage.
Projects (RRR).
118........................... Regulations To Be 2133-AB74 Proposed Rule Stage.
Followed by All
Departments, Agencies,
and Shippers Having
Responsibility To
Provide a Preference for
U.S.-Flag Vessels in the
Shipment of Cargoes on
Ocean Vessels.
----------------------------------------------------------------------------------------------------------------
Department of Veterans Affairs
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
119........................... VA Compensation and 2900-AO13 Proposed Rule Stage.
Pension Regulation
Rewrite Project.
120........................... Caregivers Program....... 2900-AN94 Final Rule Stage.
----------------------------------------------------------------------------------------------------------------
Architectural and Transportation Barriers Compliance Board
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
121........................... Accessibility Standards 3014-AA40 Proposed Rule Stage.
for Medical Diagnostic
Equipment.
----------------------------------------------------------------------------------------------------------------
Environmental Protection Agency
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
122........................... Risk and Technology 2060-AQ41 Proposed Rule Stage.
Review for National
Emission Standards for
Hazardous Air Pollutants
From the Pulp and Paper
Industry.
123........................... Joint Rulemaking To 2060-AQ54 Proposed Rule Stage.
Establish 2017 and Later
Model Year Light Duty
Vehicle GHG Emissions
and CAFE Standards.
124........................... Petroleum Refinery Sector 2060-AQ75 Proposed Rule Stage.
Risk and Technology
Review and NSPS.
125........................... Control of Air Pollution 2060-AQ86 Proposed Rule Stage.
From Motor Vehicles:
Tier 3 Motor Vehicle
Emission and Fuel
Standards.
[[Page 7676]]
126........................... Greenhouse Gas New Source 2060-AQ91 Proposed Rule Stage.
Performance Standard for
Electric Generating
Units for New Sources.
127........................... National Emission 2060-AR02 Proposed Rule Stage.
Standards for Hazardous
Air Pollutant Emissions:
Group IV Polymers and
Resins, Pesticide Active
Ingredient Production,
and Polyether Polyols
Production Risk and
Technology Review.
128........................... National Emission 2060-AR13 Proposed Rule Stage.
Standards for Hazardous
Air Pollutants for Major
Sources: Industrial,
Commercial, and
Institutional Boilers
and Process Heaters;
Proposed Reconsideration.
129........................... National Emission 2060-AR14 Proposed Rule Stage.
Standards for Hazardous
Air Pollutants for Area
Sources: Industrial,
Commercial, and
Institutional Boilers;
Reconsideration and
Proposed Rule Amendments.
130........................... Standards of Performance 2060-AR15 Proposed Rule Stage.
for New Stationary
Sources and Emission
Guidelines for Existing
Sources: Commercial and
Industrial Solid Waste
Incineration Units;
Reconsideration and
Proposed Amendments.
131........................... NPDES Electronic 2020-AA47 Proposed Rule Stage.
Reporting Rule.
132........................... Pesticides; Certification 2070-AJ20 Proposed Rule Stage.
of Pesticide Applicators.
133........................... Pesticides; Agricultural 2070-AJ22 Proposed Rule Stage.
Worker Protection
Standard Revisions.
134........................... Formaldehyde; Third-Party 2070-AJ44 Proposed Rule Stage
Certification Framework
for the Formaldehyde
Standards for Composite
Wood Products.
135........................... Mercury; Regulation of 2070-AJ46 Proposed Rule Stage.
Use in Certain Products.
136........................... Lead; Renovation, Repair, 2070-AJ56 Proposed Rule Stage.
and Painting Program for
Public and Commercial
Buildings.
137........................... Revisions to the National 2050-AE87 Proposed Rule Stage.
Oil and Hazardous
Substances Pollution
Contingency Plan;
Subpart J Product
Schedule Listing
Requirements.
138........................... Stormwater Regulations 2040-AF13 Proposed Rule Stage.
Revision To Address
Discharges From
Developed Sites.
139........................... Effluent Limitations 2040-AF14 Proposed Rule Stage.
Guidelines and Standards
for the Steam Electric
Power Generating Point
Source Category.
140........................... National Pollutant 2040-AF22 Proposed Rule Stage.
Discharge Elimination
System (NPDES)
Concentrated Animal
Feeding Operation (CAFO)
Reporting Rule.
141........................... National Pollutant 2040-AF25 Proposed Rule Stage.
Discharge Elimination
System (NPDES)
Application and Program
Updates Rule.
142........................... Review of the Secondary 2060-AO72 Final Rule Stage.
National Ambient Air
Quality Standards for
Oxides of Nitrogen and
Oxides of Sulfur.
143........................... National Emission 2060-AP52 Final Rule Stage.
Standards for Hazardous
Air Pollutants From Coal-
and Oil-Fired Electric
Utility Steam Generating
Units and Standards of
Performance for Electric
Utility Steam Generating
Units.
144........................... Oil and Natural Gas 2060-AP76 Final Rule Stage.
Sector--New Source
Performance Standards
and National Emission
Standards for Hazardous
Air Pollutants.
145........................... Criteria and Standards 2040-AE95 Final Rule Stage.
for Cooling Water Intake
Structures.
----------------------------------------------------------------------------------------------------------------
Equal Employment Opportunity Commission
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
146........................... Disparate Impact and 3046-AA76 Final Rule Stage.
Reasonable Factors Other
Than Age Under the Age
Discrimination in
Employment Act.
----------------------------------------------------------------------------------------------------------------
National Archives and Records Administration
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
147........................... Federal Records 3095-AB74 Proposed Rule Stage.
Management; Electronic
Records Archives (ERA).
----------------------------------------------------------------------------------------------------------------
Small Business Administration
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
148........................... Small Business Technology 3245-AF45 Proposed Rule Stage.
Transfer (STTR) Policy
Directive.
149........................... Small Business Innovation 3245-AF84 Proposed Rule Stage.
Research (SBIR) Program
Policy Directive.
150........................... Acquisition Process: Task 3245-AG20 Proposed Rule Stage.
and Delivery Order
Contracts, Bundling,
Consolidation.
151........................... Small Business Jobs Act: 3245-AG24 Proposed Rule Stage.
Small Business Mentor-
Prot[eacute]g[eacute]
Programs.
----------------------------------------------------------------------------------------------------------------
[[Page 7677]]
Social Security Administration
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
152........................... Revised Medical Criteria 0960-AF58 Proposed Rule Stage.
for Evaluating
Respiratory System
Disorders (859P).
153........................... Revised Medical Criteria 0960-AF88 Proposed Rule Stage.
for Evaluating
Hematological Disorders
(974P).
154........................... Revised Medical Criteria 0960-AF69 Final Rule Stage.
for Evaluating Mental
Disorders (886F).
155........................... How We Collect and 0960-AG89 Final Rule Stage.
Consider Evidence of
Disability (3487P).
156........................... Amendments to Regulations 0960-AH07 Final Rule Stage.
Regarding Withdrawals of
Applications and
Voluntary Suspension of
Benefits (3573F).
157........................... Expedited Vocational 0960-AH26 Final Rule Stage.
Assessment Under the
Sequential Evaluation
Process (3684P).
----------------------------------------------------------------------------------------------------------------
Nuclear Regulatory Commission
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
158........................... Medical Use of Byproduct 3150-AI26 Proposed Rule Stage.
Material--Amendments/
Medical Event Definition
[NRC-2008-0071].
159........................... Fitness-For-Duty Programs 3150-AI58 Proposed Rule Stage.
[NRC-2009-0090].
160........................... U.S. Evolutionary Power 3150-AI82 Proposed Rule Stage.
Reactor (EPR) Design
Certification Amendment
[NRC-2010-0132].
161........................... Disposal of Unique Waste 3150-AI92 Proposed Rule Stage.
Streams [NRC-2011-0012].
162........................... Revision of Fee 3150-AJ03 Proposed Rule Stage.
Schedules: Fee Recovery
for FY 2012 [NRC-2011-
0207].
163........................... Risk-Informed Changes to 3150-AH29 Final Rule Stage.
Loss-of-Coolant Accident
Technical Requirements
[NRC-2004-0006].
164........................... Physical Protection of 3150-AI12 Final Rule Stage.
Byproduct Material [NRC-
2008-0120].
165........................... Environmental Effect of 3150-AI42 Final Rule Stage.
Renewing the Operating
License of a Nuclear
Power Plant [NRC-2008-
0608].
166........................... AP1000 Design 3150-AI81 Final Rule Stage.
Certification Amendment
[NRC-2010-0131].
167........................... U.S. Advanced Boiling 3150-AI84 Final Rule Stage.
Water Reactor (ABWR)
Aircraft Impact Design
Certification Amendment
[NRC-2010-0134].
168........................... Economic Simplified 3150-AI85 Final Rule Stage.
Boiling-Water Reactor
(ESBWR) Design
Certification [NRC-2010-
0135].
169........................... List of Approved Spent 3150-AI91 Final Rule Stage.
Fuel Storage Casks--
MAGNASTOR, Revision 2
[NRC-2011-0008].
----------------------------------------------------------------------------------------------------------------
BILLING CODE 6820-27-P
DEPARTMENT OF AGRICULTURE (USDA)
Statement of Regulatory Priorities
USDA's focus in 2012 will be on programs that create/save jobs,
particularly in rural America, while identifying and taking action on
those programs that could be modified, streamlined, and simplified, or
reporting burdens reduced, particularly with the public's access to
USDA programs. In addition, USDA's regulatory efforts in the coming
year will be focused on achieving the Department's goals identified in
the Department's Strategic Plan for 2010 to 2015.
Assist rural communities to create prosperity so they are
self-sustaining, re-populating, and economically thriving. USDA is the
leading advocate for rural America. The Department supports rural
communities and enhances quality of life for rural residents by
improving their economic opportunities, community infrastructure,
environmental health, and the sustainability of agricultural
production. The common goal is to help create thriving rural
communities with good jobs where people want to live and raise
families, and where children have economic opportunities and a bright
future.
Ensure that all of America's children have access to safe,
nutritious, and balanced meals. A plentiful supply of safe and
nutritious food is essential to the well-being of every family and the
healthy development of every child in America. USDA provides nutrition
assistance to children and low-income people who need it and works to
improve the healthy eating habits of all Americans, especially
children. In addition, the Department safeguards the quality and
wholesomeness of meat, poultry, and egg products and addresses and
prevents loss and damage from pests and disease outbreaks.
Ensure our national forests and private working lands are
conserved, restored, and made more resilient to climate change, while
enhancing our water resources. America's prosperity is inextricably
linked to the health of our lands and natural resources. Forests,
farms, ranches, and grasslands offer enormous environmental benefits as
a source of clean air, clean and abundant water, and wildlife habitat.
These lands generate economic value by supporting the vital agriculture
and forestry sectors, attracting tourism and recreation visitors,
sustaining green jobs, and producing ecosystem services, food, fiber,
timber and non-timber products, and energy. They are also of immense
social importance, enhancing rural quality of life, sustaining scenic
and culturally important landscapes, and providing opportunities to
engage in outdoor activity and reconnect with the land.
Help America promote agricultural production and
biotechnology exports as America works to increase food security. A
productive agricultural sector is critical to increasing global food
security. For many crops, a substantial portion of domestic production
is bound for overseas markets. USDA helps American farmers and ranchers
use efficient, sustainable production, biotechnology, and other
emergent technologies to enhance food security around the world and
find export markets for their products.
[[Page 7678]]
Important regulatory activities supporting the accomplishment of
these goals in 2012 will include the following:
Rural Development and Renewable Energy. USDA priority
regulatory actions for the Rural Development mission will be to revise
regulations for the Business and Industry Guaranteed Loan Program,
Rural Development's flagship job creation and capital expansion
business program, and finalize regulations for the bioenergy programs.
USDA will continue to promote sustainable economic
opportunities to create jobs in rural communities through the purchase
and use of biobased products through the BioPreferred[supreg] program.
USDA will continue to designate groups of biobased products to receive
procurement preference from Federal agencies and contractors.
BioPreferred has made serious efforts to minimize burdens on small
business by providing a standard mechanism for product testing, an
online application process, and individual assistance for small
manufacturers when needed. Both the Federal preferred procurement and
the certified label parts of the program are voluntary, and both are
designed to assist biobased businesses in securing additional sales.
Nutrition Assistance. As changes are made to the nutrition
assistance programs, USDA will work to foster actions that ensure
access to program benefits, improve program integrity, improve diets
and healthy eating through nutrition education, and promote physical
activity consistent with the national effort to reduce obesity. In
support of these activities in 2012, the Food and Nutrition Service
(FNS) plans to publish the final rule regarding the nutrition standards
in the school meals programs; finalize a rule updating the WIC food
packages; and establish permanent rules for the Fresh Fruit and
Vegetable Program. FNS will continue to work to implement rules that
minimize participant and vendor fraud in its nutrition assistance
programs.
Food Safety. In the area of food safety, USDA will
continue to develop science-based regulations that improve the safety
of meat, poultry, and processed egg products in the least burdensome
and most cost-effective manner. Regulations will be revised to address
emerging food safety challenges, streamlined to remove excessively
prescriptive regulations, and updated to be made consistent with hazard
analysis and critical control point principles. In 2012, the Food
Safety and Inspection Service (FSIS) plans to propose regulations to
establish new systems for poultry slaughter inspection, requirements
for federally inspected egg product plants to develop and implement
hazard analysis and critical control point systems and sanitation
standard operating procedures, and finalize regulations on catfish
inspection. To assist small entities to comply with food safety
requirements, the FSIS will continue to collaborate with other USDA
agencies and State partners in the enhanced small business outreach
program.
Farm Loans, Disaster Designation, and Environmental
Compliance. USDA will work to ensure a strong U.S. agricultural system
through farm income support and farm loan programs. In addition, USDA
will streamline the disaster designation process and update and
consolidate the environmental compliance regulations.
Forestry and Conservation. In the conservation area, USDA
plans to finalize regulations that would provide financial assistance
grants to local governments, tribal governments, and nonprofit
organizations to establish community forests by acquiring and
protecting private forestlands.
Marketing and Regulatory Programs. USDA will work to
support the organic sector and continue regulatory work to protect the
health and value of U.S. agricultural and natural resources. USDA will
also implement regulations to enhance enforcement of the Packers and
Stockyards Act. In addition, USDA plans to finalize acceptable animal
disease traceability standards. Regarding plant health, USDA
anticipates revising the permitting of movement of plant pests and
biological control organisms. For the Animal Welfare Act, USDA will
propose specific standards for the humane care of birds and finalize
specific standards for the humane care of dogs imported for resale.
Retrospective Review and Executive Order 13563
In January 2011, President Obama issued Executive Order (E.O.)
13563 on Improving Regulation and Regulatory Review. As part of this
E.O., agencies were asked to review existing rules that may be
outmoded, ineffective, insufficient, or excessively burdensome, and to
modify, streamline, expand, or repeal them accordingly. Reducing the
regulatory burden on the American people and our trading partners is a
priority for USDA, and we will continually work to improve the
effectiveness of our existing regulations. As a result of our
regulatory review efforts in 2011, USDA will make regulatory changes in
2012, including the following:
Labeling--Generic Approval and Regulations Consolidation. FSIS is
developing a rule that will expand the circumstances in which the
labels of meat and poultry products will be deemed to be generically
approved by FSIS. The rule will reduce duplication and streamline the
regulations on this subject by combining them into a single part of the
Code of Federal Regulations (CFR);
Electronic Export Application and Certification Fee. FSIS is
planning a rule to provide for the electronic transmittal of foreign
establishment certifications between FSIS and foreign governments. The
rule will consolidate four inspection certificates (meat, meat by-
products, poultry, and egg products) into one certificate. The
rulemaking is intended, in part, to accommodate the Agency's electronic
Public Health Information System.
Environmental Compliance. The Farm Service Agency (FSA) will
consolidate and update the environmental compliance regulations to
ensure regulations are consistent and current for all FSA programs and
remove obsolete regulations;
National Environmental Policy Act (NEPA) Streamlining. The Natural
Resources and Environment mission area and the Forest Service (FS), in
cooperation with the Council on Environmental Quality (CEQ), is
considering a series of initiatives to improve and streamline the NEPA
process as it applies to FS projects;
Rural Energy for America Program. This new program will modify the
existing grant and guaranteed loan program for renewable energy system
(RES) and energy efficiency improvement (EEI) projects. In addition, it
would add a grant program for RES feasibility studies and a grant
program for energy audits and renewable energy development assistance.
This rulemaking will streamline the process for smaller grants,
lessening the burden to the customer. It will also make the guaranteed
portion of the rule consistent with other programs Rural Development
(RD) manages and allow applications to be accepted year around;
Business and Industry Loan Guaranteed Program. RD plans to rewrite
the regulations, which will result in improved efficiency and
effectiveness of the program, fewer errors because the guidelines and
requirements will be clearer, and items will be more easily found in a
better organized volume of regulations; and
Water and Waste Loans and Grants. RD will update the operations
aspects of
[[Page 7679]]
the loan and grant program to reduce the burden on the borrower.
Reducing the Paperwork Burden on Customers and Executive Order 13563
USDA has continued to make substantial progress in realizing the
goal of the Paperwork Reduction Act. For example, the Farm and Foreign
Agricultural Services (FFAS) mission area will reduce the paperwork
burden on program participants by consolidating the information
collections required to participate in farm programs administered by
FSA and the Federal crop insurance program administered by the Risk
Management Agency (RMA).
FFAS will evaluate methods to simplify and standardize, to the
extent practical, acreage reporting processes, program dates, and data
definitions across the various USDA programs and agencies. FFAS expects
to allow producers to use information from their farm-management and
precision agriculture systems for reporting production, planted and
harvested acreage, and other key information needed to participate in
USDA programs. FFAS will also streamline the collection of producer
information by FSA and RMA with the agricultural production information
collected by National Agricultural Statistics Service.
These process changes will allow for program data that is common
across agencies to be collected once and utilized or redistributed to
Agency programs in which the producer chooses to participate. FFAS
plans to implement the Acreage and Crop Reporting Streamlining
Initiative (ACRSI) in an incremental approach starting in late 2012
with a pilot in Kansas for growers of winter wheat when OMB approves
the information collection. Full implementation is planned for 2013.
When specific changes are identified, FSA and RMA will make any
required conforming changes in their respective regulations.
Increasingly, USDA is providing electronic alternatives to its
traditionally paper-based customer transactions. As a result, customers
increasingly have the option to electronically file forms and other
documentation online, allowing them to choose when and where to conduct
business with USDA.
For example, Rural Development continues to review its regulations
to determine which application procedures for Business Programs,
Community Facilities Programs, Energy Programs, and Water and
Environmental Programs can be streamlined and its requirements
synchronized. RD is approaching the exercise from the perspective of
the people it serves, by communicating with stakeholders on two common
areas of regulation that can provide the basis of reform.
The first area provides support for entrepreneurship and business
innovation. This initiative would provide for the streamlining and
reformulating of the Business & Industry Loan Guarantee Program and the
Intermediary Relending Program--the first such overhauls in over 20
years. The second area would provide for streamlining programs being
made available to municipalities, tribes, and non-profit organizations;
specifically Water and Waste Disposal, Community Facilities, and Rural
Business Enterprise Grants, plus programs such as Electric and
Telecommunications loans that provide basic community needs. This
regulatory reform initiative has the potential to significantly reduce
the burden to respondents (lenders and borrowers).
To the extent practicable, each reform initiative will consist of a
common application and uniform documentation requirements making it
easier for constituency groups to apply for multiple programs. In
addition, there will be associated regulations for each program that
will contain program specific information.
Natural Resources Conservation Service will also improve the
delivery of technical and financial assistance by simplifying customer
access to NRCS' technical and financial assistance programs,
streamlining the delivery and timeliness of conservation assistance to
clients, and enhancing the technical quality of its conservation
planning and services. The streamlining initiatives will allow NRCS
field staff to spend more time on conservation planning in the field
with customers, reduce the time needed to implement cost-share
contracts, and provide more flexibility for customers to work with NRCS
in different ways. NRCS estimates that this initiative has the
potential to reduce the amount of time required for producers to
participate in USDA's conservation programs by almost 800,000 hours
annually. This includes efficiencies from reduced paperwork, data entry
by the client, and reduced travel time to and from the local office to
complete forms and other administrative tasks. Improvements being
considered include the following:
Providing an online portal that will allow customers to
apply for programs or services, review their plans and contracts, view
and assess natural resource information specifically about their farm,
evaluate the costs and benefits for various conservation treatment
alternatives, notify NRCS of installed practices, and check on contract
payments at their convenience;
Creating an e-customer profile that will improve customer
service by allowing the client to view, finalize, and electronically
sign documents using remote electronic signature, on-site rather than
at a local office;
Providing clients with more timely and specific
information on alternative conservation treatments, including the
environmental benefits of their planned and applied practices;
Accelerating payments to clients; and
Simplifying conservation plan documents to more
specifically address client needs and goals.
Major Regulatory Priorities
This document represents summary information on prospective
significant regulations as called for in E.O.s 12866 and 13563. The
following USDA agencies are represented in this regulatory plan, along
with a summary of their mission and key regulatory priorities in 2012:
Food and Nutrition Service
Mission: FNS increases food security and reduces hunger in
partnership with cooperating organizations by providing children and
low-income people access to food, a healthful diet, and nutrition
education in a manner that supports American agriculture and inspires
public confidence.
Priorities: In addition to responding to provisions of legislation
authorizing and modifying Federal nutrition assistance programs, FNS'
2012 regulatory plan supports USDA's Strategic Goal ``Ensure that all
of America's children have access to safe, nutritious, and balanced
meals,'' and its two related objectives:
Access to Nutritious Food. This objective represents FNS's efforts
to improve nutrition by providing access to program benefits (food
consumed at home, school meals, commodities) and distributing State
administrative funds to support program operations. To advance this
objective, FNS plans to publish a final rule of the 2008 Farm Bill that
ensures access to SNAP benefits and addresses other eligibility,
certification, employment, and training issues. An interim rule,
implementing provisions of the Child Nutrition and WIC Reauthorization
Act of 2004 to establish automatic eligibility for homeless children
for school meals, further supports this objective.
Promote Healthy Diet and Physical Activity Behaviors. This
objective represents FNS' efforts to improve the
[[Page 7680]]
diets of its clients through nutrition education, support the national
effort to reduce obesity by promoting healthy eating and physical
activity, and to ensure that program benefits meet appropriate
standards to effectively improve nutrition for program participants. In
support of this objective, FNS plans to publish the final rule
regarding the nutrition standards in the school meals programs,
finalize a rule updating the WIC food packages, and establish permanent
rules for the Fresh Fruit and Vegetable Program, which currently
operates in a select number of schools in each State, the District of
Columbia, Guam, Puerto Rico, and the Virgin Islands.
Food Safety and Inspection Service
Mission: FSIS is responsible for ensuring that meat, poultry, egg,
and catfish products in interstate and foreign commerce are wholesome,
not adulterated, and properly marked, labeled, and packaged.
Priorities: FSIS is committed to developing and issuing science-
based regulations intended to ensure that meat, poultry, egg, and
catfish products are wholesome and not adulterated or misbranded. FSIS
regulatory actions support the objective to protect public health by
ensuring that food is safe under USDA's goal to ensure access to safe
food. To reduce the number of foodborne illnesses and increase program
efficiencies, FSIS will continue to review its existing authorities and
regulations to ensure that it can address emerging food safety
challenges, to streamline excessively prescriptive regulations, and to
revise or remove regulations that are inconsistent with the FSIS'
hazard analysis and critical control point (HACCP) regulations. FSIS is
also working with the Food and Drug Administration (FDA) to improve
coordination and increase the effectiveness of inspection activities.
FSIS' priority initiatives are as follows:
[rtarr8] Rulemakings that support initiatives of the President's
Food Safety Working Group:
Poultry Slaughter Inspection. Based on the
Administration's top-to-bottom review of food safety activities, the
Food Safety and Inspection Service will issue regulations that will
prevent thousands of food-borne illnesses by more clearly focusing FSIS
inspection activities on improving food safety, streamline poultry
inspections, and reduce Government spending.
Revision of Egg Products Inspection Regulations. FSIS is
planning to propose requirements for federally inspected egg product
plants to develop and implement HACCP systems and sanitation standard
operating procedures. FSIS will be proposing pathogen reduction
performance standards for egg products and will remove prescriptive
requirements for egg product plants.
[rtarr8] Initiatives that provide for disclosure or that enable
economic growth. FSIS plans to issue two rules to promote disclosure of
information to the public or that provide flexibility for the adoption
of new technologies:
Product Labeling; Use of the Voluntary Claim ``Natural''
in the Labeling of Meat and Poultry Products. FSIS will propose to
amend the meat and poultry products regulations to define the
conditions under which the voluntary claim ``natural'' may be used on
meat and poultry product labeling.
Food Ingredients and Sources of Radiation Listed and
Approved for Use in the Production of Meat and Poultry Products. FSIS
will propose to amend its food ingredient regulations to provide for
the use under certain conditions of benzoic acid, sodium propionate, or
sodium benzoate.
Notification, Documentation, and Recordkeeping Requirements for
Inspected Establishments. As authorized by the 2008 Farm Bill, FSIS
will issue final regulations that will require establishments that are
subject to inspection to promptly notify FSIS when an adulterated or
misbranded product received by or originating from the establishment
has entered into commerce. The regulations also will require the
establishments to prepare and maintain current procedures for the
recall of all products produced and shipped by the establishments and
to document each reassessment of the establishments' process control
plans.
Catfish Inspection. FSIS is developing final regulations to
implement provisions of the 2008 Farm Bill provisions that make catfish
an amenable species under the Federal Meat Inspection Act (FMIA).
Public Health Information System. To support its food safety
inspection activities, FSIS is implementing the Public Health
Information System (PHIS). PHIS, which is user-friendly and Web-based,
will replace many of FSIS' current systems and automate many business
processes. PHIS also will improve FSIS' ability to systematically
verify the effectiveness of foreign food safety systems and enable
greater exchange of information between FSIS and other Federal agencies
(such as U.S. Customs and Border Protection) involved in tracking
cross-border movement of import and export shipments of meat, poultry,
and processed egg products. To facilitate the implementation of some
PHIS components, FSIS is proposing to provide for electronic export and
import application and certification processes as alternatives to the
current paper-based systems for these certifications.
Other Planned Initiatives. FSIS plans to finalize a February 2001
proposed rule to establish food safety performance standards for all
processed ready-to-eat (RTE) meat and poultry products and for
partially heat-treated meat and poultry products that are not ready-to-
eat. Some provisions of the proposal addressed post-lethality
contamination of RTE products with Listeria monocytogenes. In June
2003, FSIS published an interim final rule requiring establishments to
prevent L. monocytogenes contamination of RTE products. FSIS has
carefully reviewed its economic analysis of the interim final rule and
is planning to affirm the interim rule as a final rule with changes.
FSIS Small Business Implications. The great majority of businesses
regulated by FSIS are small businesses. Some of the regulations listed
above substantially affect small businesses. FSIS conducts a small
business outreach program that provides critical training, access to
food safety experts, and information resources (such as compliance
guidance and questions and answers on various topics) in forms that are
uniform, easily comprehended, and consistent. FSIS collaborates in this
effort with other USDA agencies and cooperating State partners. For
example, FSIS makes plant owners and operators aware of loan programs,
available through USDA's Rural Business and Cooperative programs, to
help them in upgrading their facilities. FSIS employees meet with small
and very small plant operators to learn more about their specific needs
and provide joint training sessions for small and very small plants and
FSIS employees.
Animal and Plant Health Inspection Service
Mission: A major part of the mission of the Animal and Plant Health
Inspection Service (APHIS) is to protect the health and value of
American agricultural and natural resources. APHIS conducts programs to
prevent the introduction of exotic pests and diseases into the U.S. and
conducts surveillance, monitoring, control, and eradication programs
for pests and diseases in this country. These activities enhance
agricultural productivity and competitiveness and contribute to the
national economy and the public health. APHIS also conducts programs to
ensure the humane handling, care,
[[Page 7681]]
treatment, and transportation of animals under the Animal Welfare Act.
Priorities: With respect to animal health, APHIS is continuing work
to revise its regulations concerning bovine spongiform encephalopathy
(BSE) to provide a more comprehensive and universally applicable
framework for the importation of certain animals and products. In the
area of plant health, APHIS is in the midst of a revision to its
regulations for the importation and interstate movement of plant pests
and biological control organisms to clarify the factors that would be
considered when assessing the risks associated with the movement of
certain organisms, facilitate the movement of regulated organisms and
articles in a manner that also protects U.S. agriculture, and address
gaps in the current regulations. APHIS also plans to propose standards
for the humane handling, care, treatment, and transportation of birds
covered under the Animal Welfare Act.
Additional information about APHIS and its programs is available on
the Internet at https://www.aphis.usda.gov.
Agricultural Marketing Service
Mission: The Agricultural Marketing Service (AMS) provides
marketing services to producers, manufacturers, distributors,
importers, exporters, and consumers of food products. The AMS also
manages the Government's food purchases, supervises food quality
grading, maintains food quality standards, and supervises the Federal
research and promotion programs.
Priorities: AMS' priority items for the next year include
rulemaking that impact the organic industry, as well as the wholesale
pork industry. Rulemakings the Agency intends to initiate within the
next 12 months include:
Sunset Review (2012)--Nutrient Vitamins and Minerals. On March 26,
2010, the National Organic Program (NOP) issued an Advanced Notice of
Proposed Rulemaking (ANPRM) announcing the National Organic Standards
Board's (NOSB) sunset review of exempted and prohibited substances
codified at the National List of Allowed and Prohibited Substances of
the NOP regulations. This review included a listing for ``Nutrient
vitamins and minerals'' scheduled to sunset on October 21, 2012. AMS
intends to publish a proposed rule to address a recommendation
submitted by the NOSB for this listing. This proposed rule would
continue the exemption (use) for nutrient vitamins and minerals for 5
years after the October 21, 2012, sunset date. This proposed rule would
amend the annotation for nutrient vitamins and minerals to correct an
inaccurate cross reference to U.S. Food and Drug Administration (FDA)
regulations as AMS determined that the current exemption for the use of
nutrient vitamins and minerals in organic products in the NOP
regulations is inaccurate. In effect, the proposed amendment would
clarify what synthetic substances are allowed as nutrient vitamins and
minerals in organic products. Further, the NOP regulations do not
correctly provide for the fortification of infant formula that would
meet FDA requirements. This proposed rule would incorporate the correct
FDA citation with respect to the addition of required vitamins and
minerals to organic infant formula.
Livestock Mandatory Reporting; Establishing Regulations for
Wholesale Pork. As directed by the 2008 Farm Bill, the Secretary
conducted a study to determine advantages, drawbacks, and potential
implementation issues associated with adopting mandatory wholesale pork
reporting. The report from this study concluded that negotiated
wholesale pork price reporting is thin and becoming thinner and found
some degree of support for moving to mandatory price reporting exists
at every segment of the industry interviewed. That study also concluded
that the benefits likely would exceed the cost of moving from a
voluntary to a mandatory reporting program for wholesale pork.
Subsequently, the Mandatory Price Reporting Act of 2010 (2010
Reauthorization Act) (Pub. L. 111-239), was signed into law on
September 28, 2010, and reauthorized Livestock Mandatory Reporting for
5 years and added a provision for mandatory reporting of wholesale pork
cuts. The 2010 Reauthorization Act directed the Secretary to engage in
negotiated rulemaking to make required regulatory changes for mandatory
wholesale pork reporting.
Further, the 2010 Reauthorization Act directed the Secretary to
establish a Committee that represented the spectrum of interests within
the pork industry, as well as related stakeholders, to ensure all
parties had input into the regulatory framework. Specifically, the
statute required that the Committee include representatives from (i)
organizations representing swine producers; (ii) organizations
representing packers of pork, processors of pork, retailers of pork,
and buyers of wholesale pork; (iii) Department of Agriculture; and (iv)
interested parties that participate in swine or pork production.
The Agricultural Marketing Service (AMS) convened the Wholesale
Pork Reporting Negotiated Rulemaking Committee (Committee) through
notice in the Federal Register on January 26, 2011. The Committee met
three times over the period February through May of 2011 to develop the
regulatory framework necessary to implement a mandatory program of
wholesale pork reporting.
The regulatory text developed by the Committee will serve as the
primary basis for the proposed rule, consistent with both the intent of
Congress and the Negotiated Rulemaking Act. It is important to note
that the Committee reached consensus on all items included in the
proposed rule--where consensus was defined by the Committee bylaws as
being unanimous agreement. Therefore, AMS is confident the proposed
rule to implement wholesale pork reporting will be met with little or
no resistance from the industry members who will be required to report
under the mandatory system.
Grain Inspection, Packers, and Stockyards Administration
Mission: The Grain Inspection, Packers, and Stockyards
Administration (GIPSA) facilitates the marketing of livestock, poultry,
meat, cereals, oilseeds, and related agricultural products and promotes
fair and competitive trading practices for the overall benefit of
consumers and American agriculture. GIPSA's activities contribute
significantly to USDA's goal to increase prosperity in rural areas by
supporting a competitive agricultural system.
Priorities: GIPSA intends to issue a final rule that will define
practices or conduct that are unfair, unjustly discriminatory, or
deceptive, and/or that represent the making or giving of an undue or
unreasonable preference or advantage, and ensure that producers and
growers can fully participate in any arbitration process that may arise
relating to livestock or poultry contracts. This regulation is being
finalized in accordance with the authority granted to the Secretary by
the Packers and Stockyards Act of 1921 and with the requirements of
sections 11005 and 11006 of the 2008 Farm Bill.
Farm Service Agency
Mission: FSA's mission is to equitably serve all farmers, ranchers,
and agricultural partners through the delivery of effective, efficient
agricultural programs, which contributes to two USDA goals: Assist
rural communities in creating prosperity so they are self-sustaining,
re-
[[Page 7682]]
populating, and economically thriving; and enhance the Nation's natural
resource base by assisting owners and operators of farms and ranches to
conserve and enhance soil, water, and related natural resources. FSA
supports the first goal by stabilizing farm income, providing credit to
new or existing farmers and ranchers who are temporarily unable to
obtain credit from commercial sources, and helping farm operations
recover from the effects of disaster. FSA supports the second goal by
administering several conservation programs directed toward
agricultural producers. The largest program is the Conservation Reserve
Program (CRP), which protects nearly 32 million acres of
environmentally sensitive land.
Priorities: Farm Loan Programs. FSA will develop and issue
regulations to amend programs for farm operating loans, down payment
loans, and emergency loans to include socially disadvantaged farmers,
increase loan limits, loan size, funding targets, interest rates, and
graduating borrowers to commercial credit. In addition, FSA will
further streamline normal loan servicing activities and reduce burden
on borrowers while still protecting the loan security.
Disaster Designation. FSA will revise the disaster designation
process to streamline it and reduce the burden on States and tribes
requesting disaster designations. One result may be fewer delays in
delivering disaster assistance to help farm operations recover from the
effects of disaster.
Forest Service
Mission: The mission of the Forest Service is to sustain the
health, productivity, and diversity of the Nation's forests and
rangelands to meet the needs of present and future generations. This
includes protecting and managing National Forest System lands,
providing technical and financial assistance to States, communities,
and private forest landowners, and developing and providing scientific
and technical assistance and scientific exchanges in support of
international forest and range conservation. FS' regulatory priorities
support the accomplishment of USDA's goal to ensure our national
forests are conserved, restored, and made more resilient to climate
change, while enhancing our water resources.
Priorities: Special Areas; State-Specific Inventoried Roadless Area
Management: Colorado. FS planned final rulemaking would establish a
State-specific rule to provide management direction for conserving and
managing inventoried roadless areas on National Forest System lands in
the State of Colorado.
Land Management Planning Rule. FS is required to issue rulemaking
for National Forest System land management planning under 16 U.S.C.
1604. The first planning rule was adopted in 1979, and amended in 1982.
FS published a new planning rule on April 21, 2008 (73 FR 21468). On
June 30, 2009, the United States District Court for the Northern
District of California invalidated FS' 2008 Planning Rule published at
36 CFR 219 based on violations of NEPA and the Endangered Species Act
in the rulemaking process. The District Court vacated the 2008 rule,
enjoined USDA from further implementing it, and remanded it to USDA for
further proceedings. USDA has determined that the 2000 planning rule is
now in effect, including its transition provisions as amended in 2002
and 2003, and as clarified by interpretative rules issued in 2001 and
2004, which allows the use of the provisions of the 1982 planning rule
to amend or revise plans. FS is now in the 2000 planning rule
transition period. FS published a proposed planning rule on February
14, 2011 (76 FR 8480). The final rule is expected to be published
December 2011. In so doing, FS plans to correct deficiencies that have
been identified over two decades of forest planning and update planning
procedures to reflect contemporary collaborative planning practices.
Community Forest and Open Space Conservation Program. The purpose
of the Community Forest Program is to achieve community benefits
through financial assistance grants to local governments, tribal
governments, and nonprofit organizations to establish community forests
by acquiring and protecting private forestlands. Community forest
benefits are specified in the authorizing statute and include economic
benefits from sustainable forest management, natural resource
conservation, forest-based educational programs, model forest
stewardship activities, and recreational opportunities.
Rural Business-Cooperative Service
Mission: Promoting a dynamic business environment in rural America
is the goal of the Rural Business-Cooperative Service (RBS). Business
Programs works in partnership with the private sector and the
community-based organizations to provide financial assistance and
business planning, and helps fund projects that create or preserve
quality jobs and/or promote a clean rural environment. The financial
resources are often leveraged with those of other public and private
credit source lenders to meet business and credit needs in under-served
areas. Recipients of these programs may include individuals,
corporations, partnerships, cooperatives, public bodies, nonprofit
corporations, Indian tribes, and private companies. The mission of
Cooperative Programs of RBS is to promote understanding and use of the
cooperative form of business as a viable organizational option for
marketing and distributing agricultural products.
Priorities: In support USDA's goal to increase the prosperity of
rural communities, RBS regulatory priorities will facilitate
sustainable renewable energy development and enhance the opportunities
necessary for rural families to thrive economically. RBS' priority will
be to publish regulations to fully implement the 2008 Farm Bill. This
includes promulgating regulations for the Biorefinery Assistance
Program (sec. 9003), the Repowering Assistance Program (sec. 9004), the
Bioenergy Program for Advanced Biofuels (sec. 9005), and the Rural
Microentrepreneur Assistance Program (RMAP). RBS has been administering
sections 9003, 9004, and 9005 through the use of Notices of Funds
Availability and Notices of Contract Proposals. Revisions to the Rural
Energy for America Program (sec. 9007) will be made to incorporate
Energy Audits and Renewable Energy Development Assistance and
Feasibility Studies for Rural Energy Systems as eligible grant
purposes, as well as other Farm Bill initiatives and various technical
changes throughout the rule. In addition, revisions to the Business and
Industry Guaranteed Loan Program will be made to implement 2008 Farm
Bill provisions and other program initiatives. These rules will
minimize program complexity and burden on the public while enhancing
program delivery and RBS oversight.
Rural Utilities Service
Mission: The mission of the Rural Utilities Service (RUS) is to
improve the quality of life in rural America by providing investment
capital for the deployment of critical rural utilities
telecommunications, electric, and water and waste disposal
infrastructure. Financial assistance is provided to rural utilities,
municipalities, commercial corporations, limited liability companies,
public utility districts, Indian tribes, and cooperative, non-profit,
limited-dividend, or mutual associations. The public-private
partnership, which is forged between RUS and these industries, results
in billions of dollars in rural infrastructure
[[Page 7683]]
development and creates thousands of jobs for the American economy.
Priorities: RUS' regulatory priorities will be to achieve the
President's goal to bring affordable broadband to all rural Americans.
To accomplish this, RUS will continue to improve the Broadband Program
established by the 2002 Farm Bill. The 2002 Farm Bill authorized RUS to
approve loans and loan guarantees for the costs of construction,
improvement, and acquisition of facilities and equipment for broadband
service in eligible rural communities. The 2008 Farm Bill significantly
changed the statutory requirements of the Broadband Loan Program. As
such, RUS issued an interim rule to implement the statutory changes and
requested comments on the section of the rule that was not part of the
proposed rule published in May 2007. Comments were received and the
agency will analyze the comments and finalize the rule.
Departmental Management
Mission: Departmental Management's mission is to provide management
leadership to ensure that USDA administrative programs, policies,
advice, and counsel meet the needs of USDA program organizations,
consistent with laws and mandates, and provide safe and efficient
facilities and services to customers.
Priorities: In support of the Department's goal to increase rural
prosperity, USDA's departmental management will finalize regulations to
revise the BioPreferred program guidelines to continue adding
designated product categories to the preferred procurement program,
including intermediates and feedstocks and finished products made of
intermediates and feedstocks.
Aggregate Costs and Benefits
USDA will ensure that its regulations provide benefits that exceed
costs but is unable to provide an estimate of the aggregated impacts of
its regulations. Problems with aggregation arise due to differing
baselines, data gaps, and inconsistencies in methodology and the type
of regulatory costs and benefits considered. Some benefits and costs
associated with rules listed in the regulatory plan cannot currently be
quantified as the rules are still being formulated. For 2012, USDA's
focus will be to implement the changes to programs in such a way as to
provide benefits while minimizing program complexity and regulatory
burden for program participants.
USDA--Agricultural Marketing Service (AMS)
Proposed Rule Stage
1. Wholesale Pork Reporting Program
Priority: Other Significant.
Legal Authority: 7 U.S.C. 1635 to 1636
CFR Citation: 7 CFR 59.
Legal Deadline: Final, Statutory, March 28, 2012.
With the passage of S. 3656, the Mandatory Price Reporting Act of
2010, the Secretary of Agriculture is required to amend chapter 3 of
subtitle B of the Agricultural Marketing Act of 1946 by adding a new
section for mandatory reporting of wholesale pork cuts. To make these
amendments, the Secretary was directed to promulgate a final rule no
later than 1\1/2\ years after the date of the enactment of the Act.
Accordingly, a final rule will be promulgated by March 28, 2012.
Abstract: On September 15, 2010, Congress passed the Mandatory
Price Reporting Act of 2010 reauthorizing Livestock Mandatory Reporting
for 5 years and adding a provision for mandatory reporting of wholesale
pork cuts. The Act was signed by the President on September 28, 2010.
Congress directed the Secretary to engage in negotiated rulemaking to
make required regulatory changes for mandatory wholesale pork
reporting. Further, Congress required that the negotiated rulemaking
committee include representatives from (i) organizations representing
swine producers; (ii) organizations representing packers of pork,
processors of pork, retailers of pork, and buyers of wholesale pork;
(iii) the Department of Agriculture; and (iv) interested parties that
participate in swine or pork production.
Statement of Need: Implementation of mandatory pork reporting is
required by Congress. Congress delegated responsibility to the
Secretary for determining what information is necessary and
appropriate. The Food, Conservation, and Energy Act of 2008 (Pub. L.
110-234) directed the Secretary to conduct a study to determine
advantages, drawbacks, and potential implementation issues associated
with adopting mandatory wholesale pork reporting. The report from this
study generally concluded that voluntary wholesale pork price reporting
is thin and becoming thinner, and some degree of support for moving to
mandatory price reporting exists at every segment of the industry
interviewed. The report was delivered to Congress on March 25, 2010.
Summary of Legal Basis: Livestock Mandatory Reporting is authorized
under the Agricultural Marketing Act (7 U.S.C. 1635 to 1636). The
Livestock and Seed Program of USDA's Agricultural Marketing Service has
day-to-day responsibility for collecting and disseminating LMR data.
Alternatives: There are no alternatives, as this rulemaking is a
matter of law based on the Mandatory Price Reporting Act of 2010.
Anticipated Cost and Benefits: Estimation of costs will follow the
previous methodology used in earlier Livestock Mandatory Reporting
rulemaking. The focus of the cost estimation is the burden placed on
reporting companies in providing pork marketing data to the Livestock
and Seed Program. Previous rulemaking cost estimates of boxed beef
reporting of similar data found the burden to be an annual total of 65
hours in additional reporting requirements per firm. Because no
official USDA grade standards are used in the marketing of pork, and
there are fewer cutting styles, the burden for pork reporting firms in
comparison with beef reporting firms could be lower. However, the
impact is not truly known at this stage.
Risks: Implementing wholesale pork reporting presents few risks to
the Agency and the impacted industry. Members of the industry who
served on the negotiated rulemaking committee expressed some concern
with reporting prices under a different reporting basis than what is
used for voluntary pork reporting. However, ultimately the committee
reached consensus on having prices reporting on both an FOB Omaha and
FOB Plant basis in order to reduce market volatility.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Changes to Livestock Mandatory 11/24/10 75 FR 71568
Reporting.
Wholesale Pork Reporting; Notice of 01/26/11 76 FR 4554
Meeting.
NPRM................................ 02/00/12
Final Action........................ 10/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Michael P. Lynch, Department of Agriculture,
Agricultural Marketing Service, 14th and Independence Avenue SW.,
Washington, DC 20250, Phone: 202 720-6231.
RIN: 0581-AD07
[[Page 7684]]
USDA--AMS
2. National Organic Program: Sunset Review for Nutrient
Vitamins and Minerals (NOP-10-0083)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 7 U.S.C. 6501
CFR Citation: 7 CFR 205.
Legal Deadline: None.
Abstract: This proposed rule would address a recommendation
submitted to the Secretary of Agriculture (Secretary) by the National
Organic Standards Board (NOSB) on April 29, 2011. The recommendation
pertains to the 2012 Sunset Review of the listing for nutrient vitamins
and minerals on the U.S. Department of Agriculture's (USDA) National
List of Allowed and Prohibited Substances (National List). As
recommended by the NOSB, the proposed rule would continue the exemption
(use) for nutrient vitamins and minerals for 5 years after the October
21, 2012, sunset date. In addition, the proposed rule would amend the
annotation to correct an inaccurate cross reference to U.S. Food and
Drug Administration regulations. The proposed amendment to the
annotation would clarify what synthetic substances are allowed as
nutrient vitamins and minerals in organic products labeled as
``organic'' or ``made with organic (specified ingredients or food
group(s)).''
Statement of Need: The Agricultural Marketing Service (AMS) has
determined that the current exemption for the use of nutrient vitamins
and minerals in organic products in the National Organic Program (NOP)
regulations (7 CFR part 205) is inaccurate. The proposed rule would
amend the annotation for nutrient vitamins and minerals to correct an
inaccurate cross reference to U.S. Food and Drug Administration (FDA)
regulations. In effect, the proposed amendment would clarify what
synthetic substances are allowed as nutrient vitamins and minerals in
organic products. Further, the NOP regulations do not correctly provide
for the fortification of infant formula that would meet FDA
requirements. This proposed rule would incorporate the correct FDA
citation with respect to the addition of required vitamins and minerals
to organic infant formula.
Summary of Legal Basis: This proposed rule would address a
recommendation submitted to the Secretary of Agriculture by the
National Organic Standards Board (NOSB) on April 29, 2011, to continue
the exemption for nutrient vitamins and minerals in organic products as
provided by the NOP National List of Allowed and Prohibited Substances
(National List). The Organic Foods Production Act of 1990 (OFPA)
authorizes the Secretary to amend the National List based on proposed
amendments developed by the NOSB. The Sunset Provision, in section
6517(e) of the OFPA, provides that no exemption or prohibition on the
National List will remain valid after 5 years unless the exemption or
prohibition has been reviewed and the Secretary renews the listing. The
exemption for nutrient vitamins and minerals is scheduled to sunset on
October 21, 2012.
Alternatives: AMS considered two alternatives to this proposed
rulemaking: (1) Renew the existing listing for nutrient vitamins and
minerals or (2), in lieu of a rule, issue guidance stating NOP's intent
to interpret the current listing for nutrient vitamins and minerals as
proposed in this action. AMS determined that neither alternative is
viable as both would retain a regulatory provision that is inaccurate
and remains vulnerable to misinterpretations of what substances are
permitted in organic products.
Anticipated Cost and Benefits: This proposed rule would establish a
finite list of essential and required vitamins and minerals for use in
organic food and infant formula. The action addresses the requests of a
broad spectrum of public commenters for clarification on the parameters
for adding nutrient vitamins and minerals to organic products and is
expected to reduce the submission of consumer complaints alleging the
unlawful addition of substances to organic products. This proposed rule
would also provide more certainty to certifying agents and organic
operations in determining whether substances are acceptable for use in
organic products. Further, this proposed action also would foster
greater transparency by ensuring that exemptions for the use of
vitamins, minerals, and other nutrients are subject to National Organic
Standards Board (NOSB) evaluation in accordance with the criteria
established in OFPA.
This action could directly impact a subset of certified organic
operations, which add substances to organic products that are not
essential vitamins and minerals for human nutrition (21 CFR 101.9) or
required vitamins and minerals for infant formula (21 CFR 107.100 or
107.10), as enumerated by FDA regulation. AMS believes the impacts will
be concentrated within five categories of organic products in which
nutrient supplementation has been more prevalent: Infant formula, baby
food, milk, breakfast cereal, and pet food. The proposed rule could
indirectly impact producers who supply organic agricultural commodities
to affected product categories. However, AMS expects that there will be
opportunities for producers to divert organic agricultural products to
other purchasers to buffer the impact of any disruption to the
manufacture of certain processed organic products as a result of this
proposed action.
There are several impact mitigation factors which are expected to
reduce the costs of complying with this proposed action. AMS is
proposing a 2-year implementation phase, which is intended to provide
time for NOSB to consider petitions for substances that are affected by
this action and for AMS to conclude any rulemaking to add substances to
the National List. The implementation phase would also provide entities
the time to explore reformulation of affected products. Further, if
some products are discontinued as a result of this proposed rule, AMS
anticipates that some consumers will purchase, as an alternative, an
organic product within the same category rather than a nonorganic
product.
Risks: For the 2-year implementation phase to function as a
mitigation measure, the timeframe may be tight to complete the review
of petitions received by publication of this proposed rule and for any
rulemaking action recommended by NOSB. Therefore, AMS has requested
comments on the length of the implementation phase as part of this
proposed rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/12/12 77 FR 1980
NPRM Comment Period End............. 03/12/12 .......................
Final Action........................ 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Local, State.
Agency Contact: Melissa R. Bailey, Director, Standards Division,
Department of Agriculture, Agricultural Marketing Service, Washington,
DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email:
melissa.bailey@usda.gov.
Related RIN: Split from 0581-AC96.
RIN: 0581-AD17
[[Page 7685]]
USDA--ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)
Proposed Rule Stage
3. Animal Welfare; Regulations and Standards for Birds
Priority: Other Significant.
Legal Authority: 7 U.S.C. 2131 to 2159
CFR Citation: 9 CFR 1 to 3.
Legal Deadline: None.
Abstract: APHIS intends to establish standards for the humane
handling, care, treatment, and transportation of birds other than birds
bred for use in research.
Statement of Need: The Farm Security and Rural Investment Act of
2002 amended the definition of animal in the Animal Welfare Act (AWA)
by specifically excluding birds, rats of the genus Rattus, and mice of
the genus Mus, bred for use in research. While the definition of animal
in the regulations contained in 9 CFR part 1 has excluded rats of the
genus Rattus and mice of the genus Mus bred for use in research, that
definition has also excluded all birds (i.e., not just those birds bred
for use in research). In line with this change to the definition of
animal in the AWA, APHIS intends to establish standards in 9 CFR part 3
for the humane handling, care, treatment, and transportation of birds
other than those birds bred for use in research and to revise the
regulations in 9 CFR parts 1 and 2 to make them applicable to birds.
Summary of Legal Basis: The Animal Welfare Act (AWA) authorizes the
Secretary of Agriculture to promulgate standards and other requirements
governing the humane handling, care, treatment, and transportation of
certain animals by dealers, research facilities, exhibitors, operators
of auction sales, and carriers and immediate handlers. Animals covered
by the AWA include birds that are not bred for use in research.
Alternatives: To be identified.
Anticipated Cost and Benefits: Benefits of the rule would stem from
improvements in the humane handling and care of birds by affected
dealers, exhibitors, carriers, and intermediate handlers. At a minimum,
these entities would be required to satisfy certain reporting
provisions and undergo periodic compliance inspections by APHIS--
measures that they are not subject to now with respect to birds.
Regulated entities, therefore, may incur certain costs because of the
proposed rule. Most facilities that use birds in research, such as
pharmaceutical companies, universities, and research institutes, would
not be affected. Retail pet stores could be affected to the extent that
regulatory costs are passed on to them by breeders and other suppliers.
Most entities affected by the proposal are likely to be small in
size, based on Small Business Administration standards. We have not
been able to conduct a comprehensive analysis of the rule's potential
economic impact because of the paucity of available data on the
affected industries. APHIS welcomes public comment that would permit a
more complete assessment of the proposed rule's impact.
Risks: Not applicable.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/12 .......................
NPRM Comment Period End............. 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Additional Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
Agency Contact: Johanna Briscoe, Veterinary Medical Officer and
Avian Specialist, Animal Care, Department of Agriculture, Animal and
Plant Health Inspection Service, 4700 River Road, Unit 84, Riverdale,
MD 20737-1234, Phone: 301 734-0658.
RIN: 0579-AC02
USDA--APHIS
4. Plant Pest Regulations; Update of General Provisions
Priority: Other Significant.
Legal Authority: 7 U.S.C. 450; 7 U.S.C. 2260; 7 U.S.C. 7701 to
7772; 7 U.S.C. 7781 to 7786; 7 U.S.C. 8301 to 8817; 19 U.S.C. 136; 21
U.S.C. 111; 21 U.S.C. 114a; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 42
U.S.C. 4331 and 4332
CFR Citation: 7 CFR 318 and 319; 7 CFR 330; 7 CFR 352.
Legal Deadline: None.
Abstract: We are proposing to revise our regulations regarding the
movement of plant pests. We are proposing to regulate the movement of,
not only plant pests, but also biological control organisms and
associated articles. We are proposing risk-based criteria regarding the
movement of biological control organisms and are proposing to exempt
certain types of plant pests from permitting requirements for their
interstate movement and movement for environmental release. We are also
proposing to revise our regulations regarding the movement of soil and
to establish regulations governing the biocontainment facilities in
which plant pests, biological control organisms, and associated
articles are held. This proposed rule replaces a previously published
proposed rule, which we are withdrawing as part of this document. This
proposal would clarify the factors that would be considered when
assessing the risks associated with the movement of certain organisms,
facilitate the movement of regulated organisms and articles in a manner
that also protects U.S. agriculture, and address gaps in the current
regulations.
Statement of Need: APHIS is preparing a proposed rule to revise its
regulations regarding the movement of plant pests. The revised
regulations would address the importation and interstate movement of
plant pests, biological control organisms, and associated articles, and
the release into the environment of biological control organisms. The
revision would also address the movement of soil and establish
regulations governing the biocontainment facilities in which plant
pests, biological control organisms, and associated articles are held.
This proposal would clarify the factors that would be considered when
assessing the risks associated with the movement of certain organisms,
facilitate the movement of regulated organisms and articles in a manner
that also protects U.S. agriculture, and address gaps in the current
regulations.
Summary of Legal Basis: Under section 411(a) of the Plant
Protection Act (PPA), no person shall import, enter, export, or move in
interstate commerce any plant pest, unless the importation, entry,
exportation, or movement is authorized under a general or specific
permit and in accordance with such regulations as the Secretary of
Agriculture may issue to prevent the introduction of plant pests into
the United States or the dissemination of plant pests within the United
States.
Under section 412 of the PPA, the Secretary may restrict the
importation or movement in interstate commerce of biological control
organisms by requiring the organisms to be accompanied by a permit
authorizing such movement and by subjecting the organisms to quarantine
conditions or other remedial measures deemed necessary to prevent the
spread of plant pests or noxious weeds. That same section of the PPA
also gives the Secretary explicit authority to regulate the movement of
associated articles.
Alternatives: The alternatives we considered were taking no action
at this time or implementing a comprehensive
[[Page 7686]]
risk reduction plan. This latter alternative would be characterized as
a broad risk mitigation strategy that could involve various options
such as increased inspection, regulations specific to a certain
organism or group of related organisms, or extensive biocontainment
requirements.
We decided against the first alternative because leaving the
regulations unchanged would not address the needs identified
immediately above. We decided against the latter alternative, because
available scientific information, personnel, and resources suggest that
it would be impracticable at this time.
Anticipated Cost and Benefits: To be determined.
Risks: Unless we issue such a proposal, the regulations will not
provide a clear protocol for obtaining permits that authorize the
movement and environmental release of biological control organisms.
This, in turn, could impede research to explore biological control
options for various plant pests and noxious weeds known to exist within
the United States, and could indirectly lead to the further
dissemination of such pests and weeds.
Moreover, unless we revise the soil regulations, certain provisions
in the regulations will not adequately address the risk to plants,
plant parts, and plant products within the United States that such soil
might present.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Intent To Prepare an 10/20/09 74 FR 53673
Environmental Impact Statement.
Notice Comment Period End........... 11/19/09 .......................
NPRM................................ 05/00/12 .......................
NPRM Comment Period End............. 07/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Organizations.
Government Levels Affected: Local, State, Tribal.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Additional Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
Agency Contact: Shirley Wager--Page Chief, Pest Permitting Branch,
Plant Health Programs, PPQ, Department of Agriculture, Animal and Plant
Health Inspection Service, 4700 River Road, Unit 131, Riverdale, MD
20737-1236, Phone: 301 734-8453.
RIN: 0579-AC98
USDA--APHIS
Final Rule Stage
5. Importation of Live Dogs
Priority: Other Significant.
Legal Authority: 7 U.S.C. 2148
CFR Citation: 9 CFR 1 and 2.
Legal Deadline: None.
Abstract: This rulemaking would amend the Animal Welfare Act (AWA)
regulations to regulate dogs imported for resale as required by a
recent amendment to the AWA. Importation of dogs for resale would be
prohibited unless the dogs are in good health, have all necessary
vaccinations, and are 6 months of age or older. This proposal would
also reflect the exemptions provided in the amendment to the AWA for
dogs imported for research purposes or veterinary treatment and for
dogs legally imported into the State of Hawaii from the British Isles,
Australia, Guam, or New Zealand.
Statement of Need: The Food, Conservation, and Energy Act of 2008
mandates that the Secretary of Agriculture promulgate regulations to
implement and enforce new provisions of the Animal Welfare Act (AWA)
regarding the importation of dogs for resale. In line with the changes
to the AWA, APHIS intends to amend the regulations in 9 CFR parts 1 and
2 to regulate the importation of dogs for resale.
Summary of Legal Basis: The Food, Conservation, and Energy Act of
2008 (Pub. L. 110-246, signed into law on Jun. 18, 2008) added a new
section to the Animal Welfare Act (7 U.S.C. 2147) to restrict the
importation of live dogs for resale. As amended, the AWA now prohibits
the importation of dogs into the United States for resale unless the
Secretary of Agriculture determines that the dogs are in good health,
have received all necessary vaccinations, and are at least 6 months of
age. Exceptions are provided for dogs imported for research purposes or
veterinary treatment. An exception to the 6-month age requirement is
also provided for dogs that are lawfully imported into Hawaii for
resale purposes from the British Isles, Australia, Guam, or New Zealand
in compliance with the applicable regulations of Hawaii, provided the
dogs are vaccinated, are in good health, and are not transported out of
Hawaii for resale purposes at less than 6 months of age.
Alternatives: To be identified.
Anticipated Cost and Benefits: To be determined.
Risks: Not applicable.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/01/11 76 FR 54392
NPRM Comment Period End............. 10/31/11 .......................
Final Rule.......................... 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Additional Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
Agency Contact: Gerald Rushin, Veterinary Medical Officer, Animal
Care, Department of Agriculture, Animal and Plant Health Inspection
Service, 4700 River Road, Unit 84, Riverdale, MD 20737-1234, Phone: 301
734-0954.
RIN: 0579-AD23
USDA--APHIS
6. Animal Disease Traceability
Priority: Other Significant.
Legal Authority: 7 U.S.C. 8305
CFR Citation: 9 CFR 90.
Legal Deadline: None.
Abstract: This rulemaking would establish a new part in the Code of
Federal Regulations containing minimum national identification and
documentation requirements for livestock moving interstate. The
proposed regulations specify approved forms of official identification
for each species covered under this rulemaking but would allow such
livestock to be moved interstate with another form of identification,
as agreed upon by animal health officials in the shipping and receiving
States or tribes. The purpose of the new regulations is to improve our
ability to trace livestock in the event that disease is found.
Statement of Need: Preventing and controlling animal disease is the
cornerstone of protecting American animal agriculture. While ranchers
and farmers work hard to protect their animals and their livelihoods,
there is never a guarantee that their animals will be spared from
disease. To support their efforts, USDA has enacted regulations to
prevent, control, and eradicate disease, and to increase foreign and
domestic confidence in the safety of animals and animal products.
Traceability helps give
[[Page 7687]]
that reassurance. Traceability does not prevent disease, but knowing
where diseased and at-risk animals are, where they have been, and when,
is indispensable in emergency response and in ongoing disease programs.
The primary objective of these proposed regulations is to improve our
ability to trace livestock in the event that disease is found in a
manner that continues to ensure the smooth flow of livestock in
interstate commerce.
Summary of Legal Basis: Under the Animal Health Protection Act (7
U.S.C. 8301 et seq.), the Secretary of Agriculture may prohibit or
restrict the interstate movement of any animal to prevent the
introduction or dissemination of any pest or disease of livestock, and
may carry out operations and measures to detect, control, or eradicate
any pest or disease of livestock. The Secretary may promulgate such
regulations as may be necessary to carry out the Act.
Alternatives: As part of its ongoing efforts to safeguard animal
health, APHIS initiated implementation of the National Animal
Identification System (NAIS) in 2004. More recently, the Agency
launched an effort to assess the level of acceptance of NAIS through
meetings with the Secretary, listening sessions in 14 cities, and
public comments. Although there was some support for NAIS, the vast
majority of participants were highly critical of the program and of
USDA's implementation efforts. The feedback revealed that NAIS has
become a barrier to achieving meaningful animal disease traceability in
the United States in partnership with America's producers.
The option we are proposing pertains strictly to interstate
movement and gives States and tribes the flexibility to identify and
implement the traceability approaches that work best for them.
Anticipated Cost and Benefits: A workable and effective animal
traceability system would enhance animal health programs, leading to
more secure market access and other societal gains. Traceability can
reduce the cost of disease outbreaks, minimizing losses to producers
and industries by enabling current and previous locations of
potentially exposed animals to be readily identified. Trade benefits
can include increased competitiveness in global markets generally, and
when outbreaks do occur, the mitigation of export market losses through
regionalization. Markets benefit through more efficient and timely
epidemiological investigation of animal health issues.
Other societal benefits include improved animal welfare during
natural disasters.
The main economic effect of the rule is expected to be on the beef
and cattle industry. For other species such as horses and other equine
species, poultry, sheep and goats, swine, and captive cervids, APHIS
would largely maintain and build on the identification requirements of
existing disease program regulations.
Costs of an animal traceability system would include those for tags
and interstate certificates of veterinary inspection (ICVIs) or other
movement documentation, for animals moved interstate. Incremental costs
incurred are expected to vary depending upon a number of factors,
including whether an enterprise does or does not already use eartags to
identify individual cattle. For many operators, costs of official
animal identification and ICVIs would be similar, respectively, to
costs associated with current animal identification practices and the
in-shipment documentation currently required by individual States. To
the extent that official animal identification and ICVIs would simply
replace current requirements, the incremental costs of the rule for
private enterprises would be minimal.
Risks: This rulemaking is being undertaken to address the animal
health risks posed by gaps in the existing regulations concerning
identification of livestock being moved interstate. The current lack of
a comprehensive animal traceability program is impairing our ability to
trace animals that may be infected with disease.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/11/11 76 FR 50082
NPRM Comment Period End............. 11/09/11 .......................
Final Rule.......................... 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: State, Tribal.
Additional Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
Agency Contact: Neil Hammerschmidt, Program Manager, Animal Disease
Traceability, VS, Department of Agriculture, Animal and Plant Health
Inspection Service, 4700 River Road, Unit 46, Riverdale, MD 20737-1231,
Phone: 301 734-5571.
RIN: 0579-AD24
USDA--FOOD AND NUTRITION SERVICE (FNS)
Proposed Rule Stage
7. Supplemental Nutrition Assistance Program: Farm Bill of 2008
Retailer Sanctions
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 110-246
CFR Citation: 7 CFR 276.
Legal Deadline: None.
Abstract: This proposed rule would implement provisions under
section 4132 of the Food, Conservation, and Energy Act of 2008, also
referred to as the Farm Bill of 2008. Under section 4132, the
Department of Agriculture's Food and Nutrition Service (FNS) is
provided with greater authority and flexibility when sanctioning retail
or wholesale food stores that violate Supplemental Nutrition Assistance
Program (SNAP) rules. Specifically, the Department is authorized to
assess a civil penalty and to disqualify a retail or wholesale food
store authorized to participate in SNAP. Previously, the Department
could assess a civil penalty or disqualification but not both. Section
4132 also eliminates the minimum disqualification period, which was
previously set at 6 months.
Statement of Need: This proposed rule would implement provisions
under section 4132 of the Food, Conservation, and Energy Act of 2008,
also referred to as the Farm Bill of 2008. Under section 4132, the
Department of Agriculture's Food and Nutrition Service (FNS) is
provided with greater authority and flexibility when sanctioning retail
or wholesale food stores that violate Supplemental Nutrition Assistance
Program (SNAP) rules. Specifically, the Department is authorized to
assess a civil penalty and to disqualify a retail or wholesale food
store authorized to participate in SNAP. Previously, the Department
could assess a civil penalty or disqualification, but not both. Section
4132 also eliminates the minimum disqualification period, which was
previously set at 6 months. In addition to implementing statutory
provisions, this rule proposes to provide a clear administrative
penalty when an authorized retailer or wholesale food store redeems a
SNAP participant's program benefits without the knowledge of the
participant. All program benefits are issued through the Electronic
Benefits Transfer (EBT) system. The EBT system establishes data that
may be used to identify fraud committed by retail food stores. While
stealing program benefits could be prosecuted under current statute,
program
[[Page 7688]]
regulations do not provide a clear penalty for these thefts. The
proposed rule would establish an administrative penalty for such thefts
equivalent to the penalty for trafficking in program benefits, which is
the permanent disqualification of a retailer or wholesale food store
from SNAP participation. Finally, the Department proposes to identify
additional administrative retail violations and the associated sanction
that would be imposed against the retail food store for committing the
violation. For instance, to maintain integrity, FNS requires retail and
wholesale food stores to key enter EBT card data in the presence of the
actual EBT card. The proposed rule would codify this requirement and
identify the specific sanction that would be imposed if retail food
stores are found to be in violation.
Summary of Legal Basis: Section 4132, Food, Conservation, and
Energy Act of 2008 (Pub. L. 110-246).
Alternatives: Because this proposed rule is under development,
alternatives are not yet articulated.
Anticipated Cost and Benefits: Because this proposed rule is under
development, anticipated costs and benefits have not yet been
articulated.
Risks: The risk that retail or wholesale food stores will violate
SNAP rules, or continue to violate SNAP rules, is expected to be
reduced by refining program sanctions for participating retailers and
wholesalers.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Additional Information: Note: This RIN replaces the previously
issued RIN 0584-AD78.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584-AD88
USDA--FNS
8. National School Lunch and School Breakfast Programs:
Nutrition Standards for All Foods Sold in School, as Required by the
Healthy, Hunger-Free Kids Act of 2010
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 111-296
CFR Citation: 7 CFR 210; 7 CFR 220.
Legal Deadline: None.
Abstract: This proposed rule would codify the following provisions
of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) as
appropriate, under 7 CFR parts 210 and 220.
Section 203 requires schools participating in the National School
Lunch Program to make available to children free of charge, as
nutritionally appropriate, potable water for consumption in the place
where meals are served during meal service.
Section 208 requires the Secretary to promulgate proposed
regulations to establish science-based nutrition standards for all
foods sold in schools not later than December 13, 2011. The nutrition
standards would apply to all food sold outside the school meal
programs, on the school campus, and at any time during the school day.
(11-004)
Statement of Need: This proposed rule would codify the following
provisions of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the
Act) as appropriate, under 7 CFR parts 210 and 220.
Section 203 requires schools participating in the National School
Lunch Program to make available to children free of charge, as
nutritionally appropriate, potable water for consumption in the place
where meals are served during meal service.
Section 208 requires the Secretary to promulgate proposed
regulations to establish science-based nutrition standards for all
foods sold in schools not later than December 13, 2011. The nutrition
standards would apply to all food sold outside the school meal
programs, on the school campus, and at any time during the school day.
Summary of Legal Basis: There is no existing regulatory requirement
to make water available where meals are served. Regulations at 7 CFR
parts 210.11 direct State agencies and school food authorities to
establish such rules or regulations necessary to control the sale of
foods in competition with lunches served under the NSLP. Such rules or
regulations shall prohibit the sale of foods of minimal nutritional
value in the food service areas during the lunch periods. The sale of
other competitive foods may, at the discretion of the State agency and
school food authority, be allowed in the food service area during the
lunch period only if all income from the sale of such foods accrues to
the benefit of the nonprofit school food service or the school or
student organizations approved by the school. State agencies and school
food authorities may impose additional restrictions on the sale of and
income from all foods sold at any time throughout schools participating
in the Program.
Alternatives: None.
Anticipated Cost and Benefits: Expected Costs Analysis and
Budgetary Effects Statement: The Congressional Budget Office determined
these provisions would incur no Federal costs.
Expected Benefits of the Proposed Action: The provisions in this
proposed rulemaking would result in better nutrition for all school
children.
Risks: None known.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Governmental Jurisdictions.
Government Levels Affected: Local, State.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584-AE09
USDA--FNS
9. WIC: Electronic Benefit Transfer (EBT) Implementation
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 111-296
CFR Citation: 7 CFR 246.
Legal Deadline: NPRM, Statutory, October 1, 2020, Require all WIC
State agencies to implement EBT Statewide.
Abstract: This proposed rule would revise and expand regulations
regarding WIC EBT at 7 CFR 246 and implement statutory provisions
related to EBT as defined in the Healthy, Hunger-Free Kids Act of 2010,
Public Law 11-296. The EBT requirements addressed in the proposed rule
would promote improved access to Program benefits, standardize EBT
operations, and establish
[[Page 7689]]
implementation guidelines and timeframes.
Statement of Need: This proposed rule would revise and expand
regulations regarding WIC EBT at 7 CFR 246 and implement statutory
provisions related to EBT as defined in the Healthy, Hunger-Free Kids
Act of 2010, Public Law 11-296. The EBT requirements addressed in the
proposed rule would promote improved access to program benefits,
standardize EBT operations, and establish implementation guidelines and
timeframes.
WIC EBT has been an ongoing effort within the WIC community for
several years. The proposed rule would address the following:
Set forth the definition of EBT.
Require all WIC State agencies to implement EBT statewide
by October 1, 2020.
Require State agencies to submit status reports
demonstrating their progress toward Statewide EBT implementation.
Revise the current provision regarding the imposition of
EBT costs to vendors to include: (1) The formation of cost-sharing
criteria associated with any equipment or system not solely dedicated
to EBT; (2) the allowance of the payment of fees imposed by a third-
party processor for EBT transactions; (3) the disallowance of the
payment of interchange fees; (4) clarification of EBT cost impositions
after Statewide implementation; (5) elimination of the requirement for
State agencies to fund ongoing maintenance costs for vendors using
multi-function EBT equipment; and (6) require vendors to demonstrate
the capability to accept program benefits electronically prior to
authorization after Statewide implementation of EBT.
Establish minimum lane coverage guidelines for vendor
equipment, as set forth in the operating rules, and require State
agencies to provide the necessary EBT-only equipment if vendors do not
wish to acquire multi-function equipment.
Require that EBT technical standards and operating rules
be established and adhered to by State agencies.
Require all State agencies to use the universal product
code database.
Summary of Legal Basis: Healthy, Hunger-Free Kids Act of 2010 (Pub.
L. 111-296).
Alternatives: None.
Anticipated Cost and Benefits: Expected Costs Analysis and
Budgetary Effects Statement:
FNS estimates costs of approximately $30 to $60 million per fiscal
year (as reflected in the program's budget) for State agencies to
comply with the mandate. The costs will vary depending on
implementation activity and are expected to decline as more State
agencies adopt WIC EBT.
Expected Benefits of the Proposed Action: The EBT requirements
addressed in the proposed rule would promote improved access to program
benefits, standardize EBT operations, and establish implementation
guidelines and timeframes.
Risks: None known.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584-AE21
USDA--FNS
Final Rule Stage
10. Nutrition Standards in the National School Lunch and School
Breakfast Programs
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 108-265, sec 103
CFR Citation: 7 CFR 210; 7 CFR 220.
Legal Deadline: None.
Abstract: Public Law 108-265 requires the Secretary to issue
regulations that reflect specific recommendations for increased
consumption of foods and food ingredients in school nutrition programs
based on the most recent Dietary Guidelines for Americans.
The current regulations require that reimbursable meals offered by
schools meet the applicable recommendations of the Dietary Guidelines
for Americans. This rule would revise the regulations on meal patterns
and nutrition standards to ensure that school meals reflect the 2005
Dietary Guidelines for Americans (04-017).
Statement of Need: This final rule will implement the requirement
in section 201 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L.
111-296) (the Act) that USDA promulgate regulations to update the meal
patterns and nutrition standards for school lunches and breakfasts
based on recommendations made by the Institute of Medicine (IOM). USDA
issued a proposed rule on January 13, 2011. The Act requires USDA to
issue interim or final regulations not later than 18 months after
promulgation of the proposed regulation.
This final rule will implement meal patterns and nutrition
standards recommended by IOM in its report ``School Meals: Building
Blocks for Healthy Children.'' In addition, the final rule will address
the comments submitted by the public in response to USDA's proposed
rule.
Summary of Legal Basis: The meal patterns and nutrition standards
for school lunches and breakfast are established in 7 CFR 210.10 and 7
CFR 220.8, respectively. State agencies monitor compliance with the
meal patterns and nutrition standards through program reviews
authorized in 7 CFR 210.19.
Alternatives: None.
Anticipated Cost and Benefits: Expected Costs Analysis and
Budgetary Effects Statement:
While there are no increased Federal costs associated with
implementation of this final rule, the Act provides schools that comply
with the new meal requirements with an increased Federal reimbursement.
The Act also provides Federal funding for training, technical
assistance, certification, and oversight activities related to
compliance with this rule. It is expected that the total costs of
compliance with the final rule will exceed $100 million per year.
Expected Benefits of the Proposed Action: The final rule is
projected to make substantial improvements to the meals served daily in
over 101,000 schools nationwide to more than 31 million children. It
will align school meals with national nutrition guidelines and help
safeguard the health of school children.
Risks: None known.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/13/11 76 FR 2494
NPRM Comment Period End............. 04/13/11 .......................
Final Action........................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State.
Federalism: This action may have federalism implications as defined
in EO 13132.
[[Page 7690]]
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584-AD59
USDA--FNS
11. Direct Certification of Children in Food Stamp Households and
Certification of Homeless, Migrant, and Runaway Children for Free Meals
Priority: Other Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 108-265, sec 104
CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 225; 7 CFR
226; 7 CFR 245.
Legal Deadline: None.
Abstract: In response to Public Law 108-265, which amended the
Richard B. Russell National School Lunch Act, 7 CFR 245, Determining
Eligibility for Free and Reduced Price Meals and Free Milk in Schools,
is amended to establish categorical (automatic) eligibility for free
meals and free milk upon documentation that a child is (1) homeless as
defined by the McKinney-Vento Homeless Assistance Act; (2) a runaway
served by grant programs under the Runaway and Homeless Youth Act; or
(3) migratory as defined in section 1309(2) of the Elementary and
Secondary Education Act. The rule also requires phase-in of mandatory
direct certification for children who are members of households
receiving benefits from the Supplemental Nutrition Assistance Program
and continues discretionary direct certification for other
categorically eligible children (04-018).
Statement of Need: The changes made to the Richard B. Russell
National School Lunch Act concerning direct certification are intended
to improve program access, reduce paperwork, and improve the accuracy
of the delivery of free meal benefits. This regulation will implement
the statutory changes and provide State agencies and local educational
agencies with the policies and procedures to conduct mandatory and
discretionary direct certification.
Summary of Legal Basis: These changes are being made in response to
provisions in Public Law 108-265.
Alternatives: None; statutory requirements.
Anticipated Cost and Benefits: This regulation will reduce
paperwork, target benefits more precisely, and will improve program
access of eligible school children.
Risks: This regulation may require adjustments to existing computer
systems to more readily share information between schools and
assistance agencies.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 04/25/11 76 FR 22785
Interim Final Rule Effective........ 06/24/11 .......................
Interim Final Rule Comment Period 10/24/11 .......................
End.
Final Rule.......................... 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
james.herbert@fns.usda.gov.
Related RIN: Merged with 0584-AD62.
RIN: 0584-AD60
USDA--FNS
12. Eligibility, Certification, and Employment and Training Provisions
of the Food, Conservation, and Energy Act of 2008
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 110-246; Pub. L. 104-121
CFR Citation: 7 CFR 273.
Legal Deadline: None.
Abstract: This proposed rule would amend the regulations governing
the Supplemental Nutrition Assistance Program (SNAP) to implement
provisions from the Food, Conservation, and Energy Act of 2008 (Pub. L.
110-246) (FCEA) concerning the eligibility and certification of SNAP
applicants and participants and SNAP employment and training. In
addition, this proposed rule would revise the SNAP regulations
throughout 7 CFR part 273 to change the program name from the Food
Stamp Program to SNAP and to make other nomenclature changes as
mandated by the FCEA. The statutory effective date of these provisions
was October 1, 2008. Food and Nutrition Service (FNS) is also proposing
two discretionary revisions to SNAP regulations to provide State
agencies options that are currently available only through waivers.
These provisions would allow State agencies to average student work
hours and to provide telephone interviews in lieu of face-to-face
interviews. FNS anticipates that this rule would impact the associated
paperwork burdens (08-006).
Statement of Need: This proposed rule would amend the regulations
governing SNAP to implement provisions from the FCEA concerning the
eligibility and certification of SNAP applicants and participants and
SNAP employment and training. In addition, this proposed rule would
revise the SNAP regulations throughout 7 CFR part 273 to change the
program name from the Food Stamp Program to SNAP and to make other
nomenclature changes as mandated by the FCEA. The statutory effective
date of these provisions was October 1, 2008. FNS is also proposing two
discretionary revisions to SNAP regulations to provide State agencies
options that are currently available only through waivers. These
provisions would allow State agencies to average student work hours and
to provide telephone interviews in lieu of face-to-face interviews. FNS
anticipates that this rule would impact the associated paperwork
burdens.
Summary of Legal Basis: Food, Conservation, and Energy Act of 2008
(Pub. L. 110-246).
Alternatives: Most aspects of the rule are non-discretionary and
tie to explicit, specific requirements for SNAP in the FCEA. However,
FNS did consider alternatives in implementing section 4103 of the FCEA,
Elimination of Dependent Care Deduction Caps. FNS considered whether to
limit deductible expenses to costs paid directly to the care provider
or whether to permit households to deduct other expenses associated
with dependent care in addition to the direct costs. FNS chose to allow
households to deduct the cost of transportation to and from the
dependent care provider and the cost of separately identified activity
fees that are associated with dependent care. Section 4103 signaled an
important shift in congressional recognition that dependent care costs
constitute major expenses for working households. In addition, it was
noted during the floor discussion in both houses of Congress prior to
passage of the FCEA that some States already counted transportation
costs as part of dependent care expenditures.
Anticipated Cost and Benefits: The estimated total SNAP costs to
the Government of the FCEA provisions implemented in the rule are
estimated to be $831 million in FY 2010 and
[[Page 7691]]
$5.619 billion over the 5 years FY 2010 through FY 2014. These impacts
are already incorporated into the President's budget baseline.
There are many potential societal benefits of this rule. Some
provisions may make some households newly eligible for SNAP benefits.
Other provisions may increase SNAP benefits for certain households.
Certain provisions in the rule will reduce the administrative burden
for households and State agencies.
Risks: The statutory changes and discretionary ones under
consideration would streamline program operations. The changes are
expected to reduce the risk of inefficient operations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/04/11 76 FR 25414
NPRM Comment Period End............. 07/05/11 .......................
Final Action........................ 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Local, State.
Agency Contact: Kevin Kwon, Chief, Planning and Regulatory Affairs
Branch, Department of Agriculture, Food and Nutrition Service, 10th
Floor, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-
0800, Email: kevin.kwon@fns.usda.gov.
RIN: 0584-AD87
USDA--FNS
13. Supplemental Nutrition Assistance Program: Nutrition
Education and Obesity Prevention Grant
Priority: Other Significant.
Legal Authority: Pub. L. 111-296
CFR Citation: 7 CFR 272.
Legal Deadline: Final, Statutory, January 1, 2012, Pub. L. 111-296
Abstract: [Pub. L. 111-296, The Healthy, Hunger-Free Kids Act of
2001, title II; Reducing Childhood Obesity and Improving the Diets of
Children, subtitle D; Miscellaneous, sec. 241.] The Nutrition Education
and Obesity Prevention Grant Program amends the Food and Nutrition Act
of 2008 to replace the current nutrition education program under the
Act with a program providing grants to States for the implementation of
a nutrition education and obesity prevention program that promotes
healthy food choices consistent with the most recent Dietary Guidelines
for Americans.
Statement of Need: The Nutrition Education and Obesity Prevention
Grant Program rule amends the Food and Nutrition Act of 2008 to replace
the current nutrition education program under the Act with a program
providing grants to States for the implementation of a nutrition
education and obesity prevention program that promotes healthy food
choices consistent with the most recent Dietary Guidelines for
Americans. This rule will implement all requirements of the law. It
makes eligible for program participation: (1) Supplemental Nutrition
Assistance Program (SNAP) participants, (2) participants in the school
lunch or breakfast programs, and (3) individuals who reside in low-
income communities or are low-income individuals. The rule continues
commitment to serving low-income populations while focusing on the
issue of obesity, a priority of this Administration. It ensures that
interventions implemented as part of State nutrition education plans
recognize the constrained resources of the eligible population.
The rule requires activities be science-based and outcome-driven
and provides for accountability and transparency through State plans.
It will require coordination and collaboration among Federal agencies
and stakeholders, including the Centers for Disease Control and
Prevention, the public health community, the academic and research
communities, nutrition education practitioners, representatives of
State and local governments, and community organizations that serve the
low-income populations. The rule allows for 100 percent Federal
funding, and States will not have to provide matching funds. The grant
funding will be based on 2009 expenditures. For 3 years after
enactment, States will receive grant funds based on their level of
funds expended for the 2009 base year with funds indexed for inflation
thereafter. The new funding structure is phased in over a 7-year
period. From fiscal year 2014 forward, funds will be allocated based on
a formula that considers participation.
Summary of Legal Basis: Section 241, Healthy, Hunger-Free Kids Act
of 2010 (Pub. L. 111-296).
Alternatives: None.
Anticipated Cost and Benefits: Expected Costs Analysis and
Budgetary Effects Statement:
The action allows for 100 percent Federal funding which gives
States more flexibility to target services where they can be most
effective without the constraints of a State match. For 3 years after
enactment, States will receive grant funds based on their level of
funds expended for the 2009 base year with funds indexed for inflation
thereafter. The new funding structure is phased in over a 7-year
period. From fiscal year 2014 forward, funds will be allocated based on
a formula that considers participation.
Expected Benefits of the Proposed Action: This regulatory action
seeks to improve the effectiveness of the program and make it easier
for the States to administer, while still allowing funding to grow. It
allows for 100 percent Federal funding, which gives States more
flexibility to target services where they can be most effective without
the constraints of a State match. It allows grantees to adopt
individual and group-based nutrition education, as well as community
and public health approaches. It allows coordinated services to be
provided to participants in all the Federal food assistance programs
and to other low-income persons.
Risks: None known.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: State.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
james.herbert@fns.usda.gov.
RIN: 0584-AE07
USDA--FOOD SAFETY AND INSPECTION SERVICE (FSIS)
Proposed Rule Stage
14. Prior Labeling Approval System: Generic Label Approval
Priority: Other Significant.
Legal Authority: 21 U.S.C. 451 to 470; 21 U.S.C. 601 to 695
CFR Citation: 9 CFR 317; 9 CFR 327; 9 CFR 381; 9 CFR 412.
Legal Deadline: None.
Abstract: This rulemaking will continue an effort initiated several
years ago by amending FSIS' regulations to expand the types of labeling
that are generically approved. FSIS plans to propose that the
submission of labeling for approval prior to use be limited to certain
types of labeling, as specified in the regulations. In addition, FSIS
plans to reorganize and amend the regulations by consolidating the
nutrition labeling rules that currently are stated separately
[[Page 7692]]
for meat and poultry products (in part 317, subpart B, and part 381,
subpart Y, respectively) and by amending their provisions to set out
clearly various circumstances under which these products are
misbranded.
Statement of Need: Expanding the types of labeling that are
generically approved would permit Agency personnel to focus their
resources on evaluating only those claims or special statements that
have health and safety or economic implications. This would essentially
eliminate the time needed for FSIS personnel to evaluate labeling
features and allocate more time for staff to work on other duties and
responsibilities. A major advantage of this proposal is that it is
consistent with FSIS' current regulatory approach, which separates
industry and Agency responsibilities.
Summary of Legal Basis: 21 U.S.C. 457 and 607.
Alternatives: FSIS considered several options. The first was to
expand the types of labeling that would be generically approved and
consolidate into one part all of the labeling regulations applicable to
products regulated under the FMIA and PPIA and the policies currently
contained in FSIS Directive 7220.1, Revision 3. The second option FSIS
considered was to consolidate only the meat and poultry regulations
that are similar and to expand the types of generically approved
labeling that can be applied by Federal and certified foreign
establishments. The third option, and the one favored by FSIS, was to
amend the prior labeling approval system in an incremental three-phase
approach.
Anticipated Cost and Benefits: The proposed rule would permit the
Agency to realize an estimated discounted cost savings of $2.9 million
over 10 years. The proposed rule would be beneficial because it would
streamline the generic labeling process, while imposing no additional
cost burden on establishments. Consumers would benefit because industry
would have the ability to introduce products into the marketplace more
quickly.
Risks: None
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/05/11 76 FR 75809
NPRM Comment Period End............. 02/03/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Jeff Canavan, Labeling and Program Delivery
Division, Department of Agriculture, Food Safety and Inspection
Service, Patriots Plaza 3, 8th Floor, 8-146, Stop 5273, 1400
Independence Avenue SW., Washington, DC 20250-5273, Phone: 301 504-
0878, Fax: 301 504-0872, Email: jeff.canavan@fsis.usda.gov.
RIN: 0583-AC59
USDA--FSIS
15. Product Labeling: Use of the Voluntary Claim ``Natural'' on the
Labeling of Meat and Poultry Products
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.
CFR Citation: 9 CFR 317; 9 CFR 381.
Legal Deadline: None.
Abstract: The Food Safety and Inspection Service (FSIS) is
proposing to amend the Federal meat and poultry products inspection
regulations to define the conditions under which it will permit the
voluntary claim ``natural'' to be used in the labeling of meat and
poultry products. FSIS is also proposing that label approval requests
for labels that contain ``natural'' claims include documentation to
demonstrate that the products meet the criteria to bear a ``natural''
claim. FSIS is proposing to require that meat or poultry products meet
these conditions to qualify for a ``natural'' claim to make the claim
more meaningful to consumers.
Statement of Need: A codified ``natural'' claim definition will
reduce uncertainty about which products qualify to be labeled as
``natural'' and will increase consumer confidence in the claim. A
codified ``natural'' definition that clearly articulates the criteria
that meat and poultry products must meet to qualify to be labeled as
``natural'' will make the Agency's approval of ``natural'' claims more
transparent and will allow the Agency to review labels that contain
``natural'' claims in a more efficient and consistent manner. A
codified ``natural'' definition will also make the claim more
meaningful to consumers.
Summary of Legal Basis: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et
seq.
Alternatives: The Agency has considered not proceeding with
rulemaking and maintaining the existing policy guidance on ``natural''
claims and using that policy guidance to evaluate ``natural'' claims on
a case-by-case basis. The Agency has also considered alternative
definitions of ``natural'' and establishing separate codified
definitions of ``natural,'' ``natural * * * minimally processed,'' and
``natural * * * minimally processed/all natural ingredients.''
Anticipated Cost and Benefits: FSIS anticipates that a clear and
simple definition of ``natural'' will minimize cognitive costs to
consumers. FSIS also anticipates benefits from a consistent USDA policy
on ``natural'' claims. FSIS anticipates costs to establishments to
change their labels or change their production practices.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 09/14/09 74 FR 46951
ANPRM Comment Period End............ 11/13/09
NPRM................................ 09/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Rosalyn Murphy-Jenkins, Director, Labeling and
Program Delivery Division, Department of Agriculture, Food Safety and
Inspection Service, Patriots Plaza 3, 8th Floor, Room 8-148, Stop 5273,
1400 Independence Avenue SW, Washington, DC 20250-5273, Phone: 301 504-
0878, Fax: 301 504-0872, Email: rosalyn.murphy-jenkins@fsis.usda.gov.
RIN: 0583-AD30
USDA--FSIS
16. New Poultry Slaughter Inspection
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 451 et seq.
CFR Citation: 9 CFR 381.66; 9 CFR 381.67; 9 CFR 381.76; 9 CFR
381.83; 9 CFR 381.91; 9 CFR 381.94.
Legal Deadline: None.
Abstract: FSIS is proposing a new inspection system for young
poultry slaughter establishments that would facilitate public health-
based inspection. This new system would be available initially only to
young chicken and turkey slaughter establishments. Establishments that
slaughter broilers, fryers, roasters, and Cornish game hens (as defined
in 9 CFR 381.170) would be considered as ``young chicken
establishments.'' FSIS is also proposing to revoke the provisions that
allow young chicken slaughter establishments to operate under the
current Streamlined Inspection System (SIS) or the New Line Speed
(NELS) Inspection System, and to revoke the New Turkey Inspection
System (NTIS). FSIS anticipates that this proposed rule would provide
the framework for action
[[Page 7693]]
to provide public health-based inspection in all establishments that
slaughter amenable poultry species.
Under the proposed new system, young chicken slaughter
establishments would be required to sort chicken carcasses and to
conduct other activities to ensure that carcasses are not adulterated
before they enter the chilling tank.
Statement of Need: Because of the risk to the public health
associated with pathogens on young chicken carcasses, FSIS is proposing
a new inspection system that would allow for more effective inspection
of young chicken carcasses, would allow the Agency to more effectively
allocate its resources, would encourage industry to more readily use
new technology, and would include new performance standards to reduce
pathogens.
This proposed rule is an example of regulatory reform because it
would facilitate technological innovation in young chicken slaughter
establishments. It would likely result in more cost-effective dressing
of young chickens that are ready to cook or ready for further
processing. Similarly, it would likely result in more efficient and
effective use of Agency resources.
Summary of Legal Basis: 21 U.S.C. 451 to 470.
Alternatives: FSIS considered the following options in developing
this proposal:
(1) No action.
(2) Propose to implement HACCP-based Inspection Models Pilot in
regulations.
(3) Propose to establish a mandatory, rather than a voluntary, new
inspection system for young chicken slaughter establishments.
Anticipated Cost and Benefits: Not publicly available at this time.
Risks: Salmonella and other pathogens are present on a substantial
portion of poultry carcasses inspected by FSIS. Foodborne salmonella
cause a large number of human illnesses that at times lead to
hospitalization and even death. There is an apparent relationship
between human illness and prevalence levels for salmonella in young
chicken carcasses. FSIS believes that through better allocation of
inspection resources and the use of performance standards, it would be
able to better address the prevalence of salmonella and other pathogens
in young chickens.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator,
Office of Policy and Program Development, Department of Agriculture,
Food Safety and Inspection Service, 1400 Independence Avenue SW.,
Washington, DC 20250, Phone: 202 205-0495, Fax: 202 401-1760, Email:
daniel.engeljohn@fsis.usda.gov.
RIN: 0583-AD32
USDA--FSIS
17. Electronic Imported Product Inspection Application and
Certification of Imported Product and Foreign Establishments;
Amendments To Facilitate the Public Health Information System (PHIS)
Priority: Other Significant.
Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
to 695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to
470); Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056)
CFR Citation: 9 CFR 304.3; 9 CFR 327.2 and 327.4; 9 CFR 381.196 to
381.198; 9 CFR 590.915 and 590.920.
Legal Deadline: None.
Abstract: FSIS is proposing to amend the meat, poultry, and egg
products import inspection regulations to provide for an electronic
import inspection application, and electronic imported product foreign
inspection and foreign establishment certification system. FSIS is also
proposing to delete the ``streamlined'' import inspection procedures
for Canadian product. In addition, the Agency is proposing that
official import inspection establishment must develop, implement, and
maintain written Sanitation SOPs, as provided in 9 CFR 416.11 through
416.17. FSIS is also announcing that it is discontinuing its practice
of conducting imported product reinspection based on a foreign
government's guarantee.
Statement of Need: FSIS is proposing these regulations to provide
for the electronic import system, which will be available through the
Agency's Public Health Information System (PHIS), a computerized, Web-
based inspection information system. The import system will enable
applicants to electronically submit and track import inspection
applications that are required for all commercial entries of FSIS-
regulated products imported into the U.S. FSIS inspection program
personnel will be able to access the PHIS system to assign appropriate
imported product inspection activities. The electronic import system
will also facilitate the imported product foreign inspection and annual
foreign establishment certifications by providing immediate and direct
electronic government-to-government exchange of information. The Agency
is proposing to delete the Canadian streamlined import inspection
procedures because they have not been in use since 1990 and are
obsolete. Sanitation SOPs are written procedures establishments
develop, implement, and maintain to prevent direct contamination or
adulteration of meat or poultry products. To ensure that imported meat
and poultry products do not become contaminated while undergoing
reinspection prior to entering the U.S., FSIS is proposing to clarify
that official import inspection establishments must develop written
Sanitation SOPs.
Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470;
21 U.S.C. 1031 to 1056.
Alternatives: The use of the electronic import system is voluntary.
The Agency will continue to accept and process paper import inspection
applications, and foreign establishment and imported product foreign
inspection certificates. The Canadian streamlined import inspection
procedures are not currently in use. Proposing Sanitation SOPs in
official import inspection establishments will prevent direct
contamination or adulteration of product. Therefore, no alternatives
were considered.
Anticipated Cost and Benefits: Under this proposed rule, the
industry will have the option of filing inspection applications
electronically and submitting electronic imported foreign inspection
product and establishment certificates through the PHIS. Since the
electronic option is voluntary, applicants and the foreign countries
that choose to file electronically will do so only if the benefits
outweigh the cost. Sanitation SOPs are a condition of approval for
official import inspection establishments and as a requirement for
official import inspection establishments to continue to operate under
Federal inspection. The proposed rule will clarify that official import
inspection establishments must have developed written Sanitation SOPs
before being granted approval and that existing official import
inspection establishments must meet Sanitation SOP requirements. Since,
in practice, FSIS has always expected official import inspection
establishments to maintain Sanitation SOPs during the reinspection of
imported products, the proposed amendment for these
[[Page 7694]]
sanitation requirements will have little, if any, cost impact on the
industry.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Mary Stanley, Director, International Policy
Division Office of Policy and Program, Department of Agriculture, Food
Safety and Inspection Service, Room 2125, 1400 Independence Avenue SW.,
Washington, DC 20250, Phone: 202 720-0287.
RIN: 0583-AD39
USDA--FSIS
18. Electronic Export Application and Certification as a Reimbursable
Service and Flexibility in the Requirements for Official Export
Inspection Marks, Devices, and Certificates
Priority: Other Significant.
Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
to 695); Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470);
Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056)
CFR Citation: 9 CFR 312.8; 9 CFR 322.1 and 322.2; 9 CFR 350.7; 9
CFR 362.5; 9 CFR 381.104 to 381.106; 9 CFR 590.407; 9 CFR 592.20 and
592.500.
Legal Deadline: None.
Abstract: The Food Safety and Inspection Service (FSIS) is
proposing to amend the meat, poultry, and egg product inspection
regulations to provide an electronic export application and
certification system. The electronic export application and
certification system will be a component of the Agency's Public Health
Information System (PHIS). The export component of PHIS will be
available as an alternative to the paper-based application and
certification process. FSIS is proposing to charge users for the use of
the proposed system. FSIS is proposing to establish a formula for
calculating the fee. FSIS is also proposing to provide establishments
that export meat, poultry, and egg products with flexibility in the
official export inspection marks, devices, and certificates. In
addition, FSIS is proposing egg product export regulations that
parallel the meat and poultry export regulations.
Statement of Need: FSIS is proposing these regulations to
facilitate the electronic processing of export applications and
certificates through the Public Health Information System (PHIS), a
computerized, Web-based inspection information system. The current
export application and certification regulations provide only for a
paper-based process. This proposed rule will provide this electronic
export system as a reimbursable certification service charged to the
exporter.
Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470;
21 U.S.C. 1031 to 1056; 7 U.S.C. 1622(h).
Alternatives: The electronic export applications and certification
system is being proposed as a voluntary service; therefore, exporters
have the option of continuing to use the current paper-based system.
Therefore, no alternatives were considered.
Anticipated Cost and Benefits: FSIS is proposing to charge
exporters an application fee for the electronic system. Automating the
export application and certification process will facilitate the
exportation of U.S. meat, poultry, and egg products by streamlining and
automating the processes that are in use while ensuring that foreign
regulatory requirements are met. The cost to an exporter would depend
on the number of electronic applications submitted. An exporter that
submits only a few applications per year would not be likely to
experience a significant economic impact. Under this proposal,
inspection personnel workload is reduced through the elimination of the
physical handling and processing of applications and certificates. When
an electronic government-to-government system interface or data
exchange is used, fraudulent transactions, such as false alterations
and reproductions, will be significantly reduced, if not eliminated.
The electronic export system is designed to ensure authenticity,
integrity, and confidentiality. Exporters will be provided a more
efficient and effective application and certification process. The
proposed egg product export regulations provide the same export
requirements across all products regulated by FSIS and consistency in
the export application and certification process. The total annual
paperwork burden to egg processing industry to fill out the paper-based
export application is approximately $32,340 per year for a total of 924
hours a year. The average establishment burden would be 11 hours, and
$385.00 per establishment.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Dr. Ron Jones, Assistant Administrator, Office of
International Affairs, Department of Agriculture, Food Safety and
Inspection Service, 1400 Independence Avenue SW., Washington, DC 20250,
Phone: 202 720-3473.
RIN: 0583-AD41
USDA--FSIS
Final Rule Stage
19. Performance Standards for the Production of Processed Meat and
Poultry Products; Control of Listeria Monocytogenes in Ready-to-Eat
Meat and Poultry Products
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 451 et seq.; 21 U.S.C. 601 et seq.
CFR Citation: 9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR
319; 9 CFR 320; 9 CFR 325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430;
9 CFR 431.
Legal Deadline: None.
Abstract: FSIS has proposed to establish pathogen reduction
performance standards for all ready-to-eat (RTE) and partially heat-
treated meat and poultry products, and measures, including testing, to
control Listeria monocytogenes in RTE products. The performance
standards spell out the objective level of pathogen reduction that
establishments must meet during their operations in order to produce
safe products, but allow the use of customized, plant-specific
processing procedures other than those prescribed in the earlier
regulations. With HACCP, food safety performance standards give
establishments the incentive and flexibility to adopt innovative,
science-based food safety processing procedures and controls, while
providing objective, measurable standards that can be verified by
Agency inspectional oversight. This set of performance
[[Page 7695]]
standards will include and be consistent with standards already in
place for certain ready-to-eat meat and poultry products.
Statement of Need: Although FSIS routinely samples and tests some
ready-to-eat products for the presence of pathogens prior to
distribution, there are no specific regulatory pathogen reduction
requirements for most of these products. The proposed performance
standards are necessary to help ensure the safety of these products;
give establishments the incentive and flexibility to adopt innovative,
science-based food safety processing procedures and controls; and
provide objective, measurable standards that can be verified by Agency
oversight.
Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470.
Alternatives: As an alternative to all of the proposed
requirements, FSIS considered taking no action. As alternatives to the
proposed performance standard requirements, FSIS considered end-product
testing and requiring ``use-by'' date labeling on ready-to-eat
products.
Anticipated Cost and Benefits: Benefits are expected to result from
fewer contaminated products entering commercial food distribution
channels as a result of improved sanitation and process controls and
in-plant verification. FSIS believes that the benefits of the rule
would exceed the total costs of implementing its provisions. FSIS
currently estimates net benefits from the 2003 interim final rule at
$470 to $575 million, with annual recurring costs at $150.4 million, if
FSIS discounts the capital cost at 7 percent. FSIS is continuing to
analyze the potential impact of the other provisions of the proposal.
The other main provisions of the proposed rule are: Lethality
performance standards for Salmonella and E. coli O157:H7 and
stabilization performance standards for C. perfringens that firms must
meet when producing RTE meat and poultry products. Most of the costs of
these requirements would be associated with one-time process
performance validation in the first year of implementation of the rule
and with revision of HACCP plans. Benefits are expected to result from
the entry into commercial food distribution channels of product with
lower levels of contamination resulting from improved in-plant process
verification and sanitation. Consequently, there will be fewer cases of
foodborne illness.
Risks: Before FSIS published the proposed rule, FDA and FSIS had
estimated that each year L. monocytogenes caused 2,540 cases of
foodborne illness, including 500 fatalities. The Agencies estimated
that about 65.3 percent of these cases, or 1660 cases and 322 deaths
per year, were attributable to RTE meat and poultry products. The
analysis of the interim final rule on control of L. monocytogenes
conservatively estimated that implementation of the rule would lead to
an annual reduction of 27.3 deaths and 136.7 illnesses at the median.
FSIS is continuing to analyze data on production volume and Listeria
controls in the RTE meat and poultry products industry and is using the
FSIS risk assessment model for L. monocytogenes to determine the likely
risk reduction effects of the rule. Preliminary results indicate that
the risk reductions being achieved are substantially greater than those
estimated in the analysis of the interim rule.
FSIS is also analyzing the potential risk reductions that might be
achieved by implementing the lethality and stabilization performance
standards for products that would be subject to the proposed rule. The
risk reductions to be achieved by the proposed rule and that are being
achieved by the interim rule are intended to contribute to the Agency's
public health protection effort.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/27/01 66 FR 12590
NPRM Comment Period End............. 05/29/01 .......................
NPRM Comment Period Extended........ 07/03/01 66 FR 35112
NPRM Comment Period Extended End.... 09/10/01 .......................
Interim Final Rule.................. 06/06/03 68 FR 34208
Interim Final Rule Effective........ 10/06/03 .......................
Interim Final Rule Comment Period 01/31/05 .......................
End.
NPRM Comment Period Reopened........ 03/24/05 70 FR 15017
NPRM Comment Period Reopened End.... 05/09/05 .......................
Affirmation of Interim Final Rule... 01/00/12 .......................
Final Action........................ 09/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator,
Office of Policy and Program Development,Department of Agriculture,
Food Safety and Inspection Service, 1400 Independence Avenue SW.,
Washington, DC 20250, Phone: 202 205-0495, Fax: 202 401-1760, Email:
daniel.engeljohn@fsis.usda.gov.
RIN: 0583-AC46
USDA--FSIS
20. Notification, Documentation, and Recordkeeping Requirements for
Inspected Establishments
Priority: Other Significant.
Legal Authority: 21 U.S.C. 612 to 613; 21 U.S.C. 459
CFR Citation: 9 CFR 417.4; 9 CFR 418.
Legal Deadline: None.
Abstract: The Food Safety and Inspection Service (FSIS) has
proposed to require establishments subject to inspection under the
Federal Meat Inspection Act and the Poultry Products Inspection Act to
promptly notify the Secretary of Agriculture that an adulterated or
misbranded product received by or originating from the establishment
has entered into commerce, if the establishment believes or has reason
to believe that this has happened. FSIS has also proposed to require
these establishments to: (1) Prepare and maintain current procedures
for the recall of all products produced and shipped by the
establishment and (2) document each reassessment of the process control
plans of the establishment.
Statement of Need: The Food, Conservation, and Energy Act of 2008
(Pub. L. 110-246, sec. 11017), known as the 2008 Farm Bill, amended the
Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection
Act (PPIA) to require establishments subject to inspection under these
Acts to promptly notify the Secretary that an adulterated or misbranded
product received by or originating from the establishment has entered
into commerce, if the establishment believes or has reason to believe
that this has happened. Section 11017 also requires establishments
subject to inspection under the FMIA and PPIA to: (1) Prepare and
maintain current procedures for the recall of all products produced and
shipped by the establishment and (2) document each reassessment of the
process control plans of the establishment.
Summary of Legal Basis: 21 U.S.C. 612 and 613; 21 U.S.C. 459, and
Public Law 110-246, section 11017.
Alternatives: The option of no rulemaking is unavailable.
Anticipated Cost and Benefits: Approximate costs: $5.0 million for
[[Page 7696]]
labor and costs; $5.2 million for first-year costs; $0.7 million
average costs adjusted with a 3.0 percent inflation rate for following
years. Total approximate costs: $10.2 million. The average cost of this
final rule to small entities is expected to be less than 1/10 of 1 cent
of meat and poultry food products per annum. Therefore, FSIS has
determined that this rule will not have a significant economic impact
on a substantial number of small entities. Approximate benefits:
Benefits have not been monetized because quantified data on benefits
attributable to this final rule are not available. Non-monetary
benefits include improved protection of the public health, improved
HACCP plans, and improved recall effectiveness.
Risks: In preparing regulations on the shipment of adulterated meat
and poultry products by meat and poultry establishments, the
preparation and maintenance of procedures for recalled products
produced and shipped by establishments, and the documentation of each
reassessment of the process control plans by the establishment, the
Agency considered any risks to public health or other pertinent risks
associated with these actions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/25/10 75 FR 14361
NPRM Comment Period End............. 05/24/10 .......................
Final Action........................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Victoria Levine, Program Analyst, Policy Issuances
Division, Department of Agriculture, Food Safety and Inspection
Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202
720-5627, Fax: 202 690-0486, Email: victoria.levine@fsis.usda.gov.
RIN: 0583-AD34
BILLING CODE 3410-90-P
DEPARTMENT OF COMMERCE (DOC)
Statement of Regulatory and Deregulatory Priorities
Established in 1903, the Department of Commerce is one of the
oldest Cabinet-level agencies in the Federal Government. The
Department's mission is to create the conditions for economic growth
and opportunity by promoting innovation, entrepreneurship,
competitiveness, and environmental stewardship. Commerce has 12
operating units, which are responsible for managing a diverse portfolio
of programs and services, ranging from trade promotion and economic
development assistance to broadband and the National Weather Service.
The Department touches Americans daily, in many ways--making
possible the daily weather reports and survey research; facilitating
technology that all of us use in the workplace and in the home each
day; supporting the development, gathering, and transmission of
information essential to competitive business; enabling the diversity
of companies and goods found in America's and the world's marketplace;
and supporting environmental and economic health for the communities in
which Americans live.
Commerce has a clear and compelling vision for itself, for its role
in the Federal Government, and for its roles supporting the American
people, now and in the future. To achieve this vision, the Department
works in partnership with businesses, universities, communities, and
workers to:
Innovate by creating new ideas through cutting-edge
science and technology from advances in nanotechnology, to ocean
exploration, to broadband deployment, and by protecting American
innovations through the patent and trademark system;
Support entrepreneurship and commercialization by enabling
community development and strengthening minority businesses and small
manufacturers;
Maintain U.S. economic competitiveness in the global
marketplace by promoting exports, ensuring a level playing field for
U.S. businesses, and ensuring that technology transfer is consistent
with our Nation's economic and security interests;
Provide effective management and stewardship of our
Nation's resources and assets to ensure sustainable economic
opportunities; and
Make informed policy decisions and enable better
understanding of the economy by providing accurate economic and
demographic data.
The Department is a vital resource base, a tireless advocate, and
Cabinet-level voice for job creation.
The Regulatory Plan tracks the most important regulations that
implement these policy and program priorities, several of which involve
regulation of the private sector by the Department.
Responding to the Administration's Regulatory Philosophy and Principles
The vast majority of the Department's programs and activities do
not involve regulation. Of the Department's 12 primary operating units,
only the National Oceanic and Atmospheric Administration (NOAA) will be
planning actions that are considered the ``most important'' significant
preregulatory or regulatory actions for FY 2012. During the next year,
NOAA plans to publish four rulemaking actions that are designated as
regulatory plan actions. The Bureau of Industry and Security (BIS) will
also publish rulemaking actions designated as regulatory plan actions.
Further information on these actions is provided below.
The Department has a long-standing policy to prohibit the issuance
of any regulation that discriminates on the basis of race, religion,
gender, or any other suspect category and requires that all regulations
be written so as to be understandable to those affected by them. The
Secretary also requires that the Department afford the public the
maximum possible opportunity to participate in departmental
rulemakings, even where public participation is not required by law.
National Oceanic and Atmospheric Administration
NOAA establishes and administers Federal policy for the
conservation and management of the Nation's oceanic, coastal, and
atmospheric resources. It provides a variety of essential environmental
and climate services vital to public safety and to the Nation's
economy, such as weather forecasts, drought forecasts, and storm
warnings. It is a source of objective information on the state of the
environment. NOAA plays the lead role in achieving the Departmental
goal of promoting stewardship by providing assessments of the global
environment.
Recognizing that economic growth must go hand-in-hand with
environmental stewardship, the Department, through NOAA, conducts
programs designed to provide a better understanding of the connections
between environmental health, economics, and national security.
Commerce's emphasis on ``sustainable fisheries'' is designed to boost
long-term economic growth in a vital sector of the U.S. economy while
conserving the resources in the public trust and minimizing any
economic dislocation necessary to ensure long-term economic growth. The
Department is where business and environmental interests
[[Page 7697]]
intersect, and the classic debate on the use of natural resources is
transformed into a ``win-win'' situation for the environment and the
economy.
Three of NOAA's major components, the National Marine Fisheries
Service (NMFS), the National Ocean Service (NOS), and the National
Environmental Satellite, Data, and Information Service (NESDIS),
exercise regulatory authority.
NMFS oversees the management and conservation of the Nation's
marine fisheries, protects threatened and endangered marine and
anadromous species and marine mammals, and promotes economic
development of the U.S. fishing industry. NOS assists the coastal
States in their management of land and ocean resources in their coastal
zones, including estuarine research reserves; manages the national
marine sanctuaries; monitors marine pollution; and directs the national
program for deep-seabed minerals and ocean thermal energy. NESDIS
administers the civilian weather satellite program and licenses private
organizations to operate commercial land-remote sensing satellite
systems.
The Department, through NOAA, has a unique role in promoting
stewardship of the global environment through effective management of
the Nation's marine and coastal resources and in monitoring and
predicting changes in the Earth's environment, thus linking trade,
development, and technology with environmental issues. NOAA has the
primary Federal responsibility for providing sound scientific
observations, assessments, and forecasts of environmental phenomena on
which resource management, adaptation, and other societal decisions can
be made.
In the environmental stewardship area, NOAA's goals include:
Rebuilding and maintaining strong U.S. fisheries by using market-based
tools and ecosystem approaches to management; increasing the
populations of depleted, threatened, or endangered species and marine
mammals by implementing recovery plans that provide for their recovery
while still allowing for economic and recreational opportunities;
promoting healthy coastal ecosystems by ensuring that economic
development is managed in ways that maintain biodiversity and long-term
productivity for sustained use; and modernizing navigation and
positioning services. In the environmental assessment and prediction
area, goals include: Understanding climate change science and impacts,
and communicating that understanding to government and private sector
stakeholders enabling them to adapt; continually improving the National
Weather Service; implementing reliable seasonal and interannual climate
forecasts to guide economic planning; providing science-based policy
advice on options to deal with very long-term (decadal to centennial)
changes in the environment; and advancing and improving short-term
warning and forecast services for the entire environment.
Magnuson-Stevens Fishery Conservation and Management Act
Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens Act) rulemakings concern the conservation and management of
fishery resources in the U.S. Exclusive Economic Zone (generally 3-200
nautical miles). Among the several hundred rulemakings that NOAA plans
to issue in FY 2012, a number of the preregulatory and regulatory
actions will be significant. The exact number of such rulemakings is
unknown, since they are usually initiated by the actions of eight
regional Fishery Management Councils (FMCs) that are responsible for
preparing fishery management plans (FMPs) and FMP amendments, and for
drafting implementing regulations for each managed fishery. NOAA issues
regulations to implement FMPs and FMP amendments. Once a rulemaking is
triggered by an FMC, the Magnuson-Stevens Act places stringent
deadlines upon NOAA by which it must exercise its rulemaking
responsibilities. FMPs and FMP amendments for Atlantic highly migratory
species, such as bluefin tuna, swordfish, and sharks, are developed
directly by NOAA, not by FMCs.
FMPs address a variety of issues including maximizing fishing
opportunities on healthy stocks, rebuilding overfished stocks, and
addressing gear conflicts. One of the problems that FMPs may address is
preventing overcapitalization (preventing excess fishing capacity) of
fisheries. This may be resolved by market-based systems such as catch
shares, which permit shareholders to harvest a quantity of fish and
which can be traded on the open market. Harvest limits based on the
best available scientific information, whether as a total fishing limit
for a species in a fishery or as a share assigned to each vessel
participant, enable stressed stocks to rebuild. Other measures include
staggering fishing seasons or limiting gear types to avoid gear
conflicts on the fishing grounds and establishing seasonal and area
closures to protect fishery stocks.
The FMCs provide a forum for public debate and, using the best
scientific information available, make the judgments needed to
determine optimum yield on a fishery-by-fishery basis. Optional
management measures are examined and selected in accordance with the
national standards set forth in the Magnuson-Stevens Act. This process,
including the selection of the preferred management measures,
constitutes the development, in simplified form, of an FMP. The FMP,
together with draft implementing regulations and supporting
documentation, is submitted to NMFS for review against the national
standards set forth in the Magnuson-Stevens Act, in other provisions of
the Act, and other applicable laws. The same process applies to
amending an existing approved FMP.
Marine Mammal Protection Act
The Marine Mammal Protection Act of 1972 (MMPA) provides the
authority for the conservation and management of marine mammals under
U.S. jurisdiction. It expressly prohibits, with certain exceptions, the
take of marine mammals. Exceptions allow for permitting the collection
of wild animals for scientific research or public display or to enhance
the survival of a species or stock. NMFS initiates rulemakings under
the MMPA to establish a management regime to reduce marine mammal
mortalities and injuries as a result of interactions with fisheries.
The MMPA also established the Marine Mammal Commission, which makes
recommendations to the Secretaries of the Departments of Commerce and
the Interior and other Federal officials on protecting and conserving
marine mammals. The Act underwent significant changes in 1994 to allow
for takings incidental to commercial fishing operations, to provide
certain exemptions for subsistence and scientific uses, and to require
the preparation of stock assessments for all marine mammal stocks in
waters under U.S. jurisdiction.
Endangered Species Act
The Endangered Species Act of 1973 (ESA) provides for the
conservation of species that are determined to be ``endangered'' or
``threatened,'' and the conservation of the ecosystems on which these
species depend. The ESA authorizes both NMFS and the Fish and Wildlife
Service (FWS) to jointly administer the provisions of the MMPA. NMFS
manages marine and ``anadromous'' species, and FWS manages land and
freshwater species. Together, NMFS and FWS work to protect critically
imperiled species from extinction. Of the 1,310 listed species
[[Page 7698]]
found in part or entirely in the United States and its waters, NMFS has
jurisdiction over approximately 60 species. NMFS' rulemaking actions
are focused on determining whether any species under its responsibility
is an endangered or threatened species and whether those species must
be added to the list of protected species. NMFS is also responsible for
designating, reviewing, and revising critical habitat for any listed
species. In addition, under the ESA's procedural framework, Federal
agencies consult with NMFS on any proposed action authorized, funded,
or carried out by that agency that may affect one of the listed species
or designated critical habitat, or is likely to jeopardize proposed
species or adversely modify proposed critical habitat that is under
NMFS' jurisdiction.
NOAA's Regulatory Plan Actions
While most of the rulemakings undertaken by NOAA do not rise to the
level necessary to be included in the Department's regulatory plan,
NMFS is undertaking four actions that rise to the level of ``most
important'' of the Department's significant regulatory actions and thus
are included in this year's regulatory plan. The four actions implement
provisions of the Magnuson-Stevens Fishery Conservation and Management
Act, as reauthorized in 2006. The third action may be of particular
interest to international trading partners as it concerns the
Certification of Nations Whose Fishing Vessels are Engaged in Illegal,
Unreported, and Unregulated Fishing or Bycatch of Protected Living
Marine Resources. A description of the four regulatory plan actions is
provided below.
1. Fishery Management Plan for Regulating Offshore Marine
Aquaculture in the Gulf of Mexico (0648-AS65): In January 2009, the
Gulf of Mexico Fishery Management Council approved the Aquaculture
Fishery Management Plan, which authorizes NMFS to issue permits to
culture species managed by the Council (except shrimp and corals). This
was the first time a regional Fishery Management Council approved a
comprehensive regulatory program for offshore aquaculture in U.S.
Federal waters. On September 3, 2009, the Aquaculture Fishery
Management Plan entered into effect by operation of law and Dr.
Lubchenco announced that NOAA would develop a new National Aquaculture
Policy, which would provide context for the Aquaculture Fishery
Management Plan. On June 9, 2011, NOAA released the final National
Aquaculture Policy and announced that the Agency will move forward with
the rulemaking to implement the Aquaculture Fishery Management Plan.
The Aquaculture Plan has received regional and national media attention
and was challenged in two lawsuits. Although the lawsuits were
dismissed, additional legal challenges are anticipated when the final
rule is issued. A vocal coalition of environmental, non-governmental
organizations and fishermen's groups opposed to marine aquaculture has
been actively following the process. Others, including some fishing and
seafood groups, support the Aquaculture Fishery Management Plan.
2. Amend the Definition of Illegal, Unreported, and Unregulated
Fishing Under the High Seas Driftnet Fishing Moratorium Protection Act
to Include International Provisions of the Shark Conservation Act
(0648-BA89): As required under the international provisions of the
Shark Conservation Act, the rule would amend the identification and
certification procedures under the High Seas Driftnet Fishing
Moratorium Protection to include the identification of a foreign nation
whose fishing vessels engaged during the preceding calendar year in
fishing activities in areas beyond any national jurisdiction that
target or incidentally catch sharks if that nation has not adopted a
regulatory program to provide for the conservation of sharks that is
comparable to that of the United States, taking into account different
conditions. NMFS also intends to amend the regulatory definition of
``illegal, unreported, and unregulated (IUU) fishing'' for purposes of
the identification and certification procedures under the Moratorium
Protection Act.
3. Critical Habitat for North Atlantic Right Whale (0648-AY54): In
1994, NMFS designated critical habitat for the northern right whale in
the North Atlantic Ocean. This critical habitat designation includes
portions of Cape Cod Bay and Stellwagen Bank, the Great South Channel,
and waters adjacent to the coasts of Georgia and Florida. In 2008, NMFS
published final determinations listing right whales in the North
Atlantic and North Pacific as separate endangered species under the ESA
and initiated work on new critical habitat designations triggered by
these 2008 listings. On October 1, 2009, NMFS received a petition from
the Center for Biological Diversity, Defenders of Wildlife, Humane
Society of the United States, Ocean Conservancy, and the Whale and
Dolphin Conservation Society to revise the designated critical habitat
of the North Atlantic right whale. The petition seeks an expansion of
the areas designated as critical feeding and calving habitats and also
seeks to include a migratory corridor as part of the critical habitat
designation. On October 6, 2010, NMFS published a 90-day finding and
12-month determination stating the intent to proceed with publishing a
proposed rule to revise critical habitat.
4. Reduce Disturbance to Hawaiian Spinner Dolphins from Human
Interactions (0648-AU02): Spinner dolphins are being disturbed in their
natural resting habitats by human activities, which may be altering the
dolphins' normal behavioral patterns. NMFS is proposing time-area
closures to protect the essential resting habitat of spinner dolphins
and to reduce the human activities that cause unauthorized taking of
these dolphins under the Marine Mammal Protection Act and its
implementing regulations. The proposed rule lists time-area closures
including four bays on the island of Hawaii, and one on the island of
Maui. Adaptive management strategies will be used to monitor the
effectiveness of the proposed rule and allow for necessary
improvements. This proposed action will set a precedent for NMFS'
management of wildlife viewing activities. This proposed action
represents the first proposal by NMFS to use regulated area closures to
reduce harassment of non-ESA listed marine mammals resulting from
activities aimed at viewing and interacting with these animals.
At this time, NOAA is unable to determine the aggregate cost of the
identified Regulatory Plan actions as several of these actions are
currently under development.
Bureau of Industry and Security
The Bureau of Industry and Security (BIS) advances U.S. national
security, foreign policy, and economic objectives by maintaining and
strengthening adaptable, efficient, and effective export control and
treaty compliance systems, as well as by administering programs to
prioritize certain contracts to promote the national defense and to
protect and enhance the defense industrial base.
In August 2009, the President directed a broad-based interagency
review of the U.S. export control system with the goal of strengthening
national security and the competitiveness of key U.S. manufacturing and
technology sectors by focusing on the current threats and adapting to
the changing economic and technological landscape. In August 2010, the
President outlined an approach under which agencies that administer
export controls will apply
[[Page 7699]]
new criteria for determining what items need to be controlled and a
common set of policies for determining when an export license is
required. The control list criteria are to be based on transparent
rules, which will reduce the uncertainty faced by our Allies, U.S.
industry and its foreign customers, and will allow the Government to
erect higher walls around the most sensitive export items in order to
enhance national security.
Under the President's approach, agencies will apply the criteria
and revise the lists of munitions and dual use items that are
controlled for export so that they:
Are ``tiered'' to distinguish the types of items that should be
subject to stricter or more permissive levels of control for different
destinations, end-uses, and end-users;
Create a ``bright line'' between the two current control lists to
clarify jurisdictional determinations and reduce government and
industry uncertainty about whether particular items are subject to the
control of the State Department or the Commerce Department; and
Are structurally aligned so that they potentially can be combined
into a single list of controlled items.
BIS' current regulatory plan action is designed to implement the
initial phase of the President's directive.
Major Programs and Activities
BIS administers four sets of regulations. The Export Administration
Regulations (EAR) regulate exports and reexports to protect national
security, foreign policy, and short supply interests. The EAR also
regulates participation of U.S. persons in certain boycotts
administered by foreign governments. The National Defense Industrial
Base Regulations provide for prioritization of certain contracts and
allocations of resources to promote the national defense, require
reporting of foreign government-imposed offsets in defense sales, and
address the effect of imports on the defense industrial base. The
Chemical Weapons Convention Regulations implement declaration,
reporting, and on-site inspection requirements in the private sector
necessary to meet United States treaty obligations under the Chemical
Weapons Convention treaty. The Additional Protocol Regulations
implement similar requirements with respect to an agreement between the
United States and the International Atomic Energy Agency.
BIS also has an enforcement component with eight field offices in
the United States. BIS export control officers are also stationed at
several U.S. embassies and consulates abroad. BIS works with other U.S.
Government agencies to promote coordinated U.S. Government efforts in
export controls and other programs. BIS participates in U.S. Government
efforts to strengthen multilateral export control regimes and to
promote effective export controls through cooperation with other
governments.
BIS' Regulatory Plan Actions
As the agency responsible for leading the administration and
enforcement of the U.S. dual-use export control system, BIS plays a
central role in the Administration's efforts to fundamentally reform
the export control system. Changing what we control, how we control it,
and how we enforce and manage our controls will help strengthen our
national security by focusing our efforts on controlling the most
critical products and technologies, and by enhancing the
competitiveness of key U.S. manufacturing and technology sectors.
In FY 2011, BIS took several steps to implement the President's
Export Control Reform Initiative. BIS published a final rule (76 FR
35276, June 16, 2011) implementing a license exception that authorizes
exports, reexports, and transfers to destinations that do not pose a
national security concern, provided certain safeguards against
diversion to other destinations are taken. BIS also proposed a rule
that provides a framework for controlling militarily less significant
defense articles, largely generic parts and components, on the Commerce
Control List (CCL) rather than the United States Munitions List. In the
immediate future, BIS will work with other agencies to implement
transfers of such items to the CCL and to make the CCL a more positive
list. Looking further ahead BIS will work with other agencies to place
items on the CCL into one of three tiers, corresponding to different
levels of sensitivity.
Tier 1 will include the most sensitive items. These are items that
provide a critical military or intelligence advantage to the United
States and are available almost exclusively from the United States, or
are items that are a weapon of mass destruction.
Tier 2 will include items that are sensitive but not as sensitive,
as those in Tier 1. These are items that provide a substantial military
or intelligence advantage to the United States and are available almost
exclusively from either the United States or our partners and allies.
Tier 3 will include items that are less sensitive than those in
Tier 2. These items will be those that provide a significant military
or intelligence advantage but are available more broadly. BIS will also
be developing other rules to implement additional aspects of the export
control reform as those aspects are identified and decided.
Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (Jan. 18, 2011), the following
Regulatory Identifier Numbers (RINs) have been identified as associated
with retrospective review and analysis in the Department's final
retrospective review of regulations plan. Accordingly, the Agency is
reviewing these rules to determine whether action under E.O. 13563 is
appropriate. Some of these entries on this list may be completed
actions, which do not appear in The Regulatory Plan. However, more
information can be found about these completed rulemakings in past
publications of the Unified Agenda on Reginfo.gov in the Completed
Actions section for the Agency. These rulemakings can also be found on
Regulations.gov. The final Agency retrospective analysis plan can be
found at: https://open.commerce.gov/sites/default/files/Commerce%20Plan%20for%20Retrospective%20Analysis%20of%20Existing%20Rules%20-%202011-08-22%20Final.pdf.
------------------------------------------------------------------------
Expected To Significantly
RIN Title Reduce Burdens on Small
Businesses?
------------------------------------------------------------------------
0610-AA66.................. Revisions to Yes.
EDA's
Regulations.
0625-AA81.................. Foreign Trade Yes.
Zones.
0648-AN55.................. Amendments 61/
61/13/8 to
Implement
Major
Provisions of
the American
Fisheries Act.
0648-AL92.................. Western Alaska
Community
Development
Quota Program.
[[Page 7700]]
0648-AP12.................. Atlantic Yes.
Mackerel,
Squid and
Butterfish
Fisheries;
Framework
Adjustment 2.
0648-AO62.................. Reef Fish Yes.
Fishery of the
Gulf of
Mexico:
Charter Vessel
and Headboat
Permit
Moratorium.
0648-AL41.................. Nearshore Area
Closures
Around
American Samoa
by Vessels
More Than 50
Feet in Length.
0648-AP78.................. Fisheries of
the
Northeastern
United States:
Northeast
Multispecies
Fishery.
0648-AN75.................. Pelagic
Longline Gear
Restrictions,
Seasonal Area
Closure, and
Other Sea
Turtle
Mitigation
Measures.
0648-AP37.................. Atlantic
Herring
Fishery; 2002
Specifications.
0648-AO35.................. Measures To
Reduce the
Incidental
Catch of
Seabirds in
the Hawaii
Pelagic
Longline
Fishery.
0648-AP76.................. Atlantic Deep-
Sea Red Crab
Fishery
Management
Plan.
0648-AP39.................. Pacific Coast
Groundfish
Fishery:
Experimental
Setnet
Sablefish
Landings To
Qualify
Limited Entry
Sablefish-
Endorsed
permits for
Tier
Assignment.
0648-AO20.................. Fisheries of Yes.
the Exclusive
Economic Zone
off Alaska:
Revisions to
Recordkeeping
and Reporting
Requirements.
0648-AQ05.................. Extend the
Interim
Groundfish
Observer
Program
Through
December 31,
2007, and
Amend
Regulations
for the North
Pacific
Groundfish
Observer
Program.
0648-AN88.................. Taking of
Marine Mammals
Incidental to
Commercial
Fishing
Operations:
Atlantic Large
Whale Take
Reduction Plan
Regulations.
0648-AK23.................. Fisheries Off
West Coast
States and in
the Western
Pacific:
Precious
Corals
Fisheries;
Harvest
Quotas,
Definitions,
Size Limits,
Gear
Restrictions,
and Bed
Classification.
0648-AP21.................. Implementation
of the Shark
Finning
Prohibition
Act.
0648-AP49.................. Atlantic Highly
Migratory
Species;
Pelagic
Longline
Fishery; Shark
Gillnet
Fishery: Sea
Turtle and
Whale
Protection
Measures.
0648-AM40.................. License
Limitation
Program for
Groundfish of
the Bering Sea
and Aleutian
Islands Area.
0648-AP79.................. Prohibition of
Non-pelagic
Trawl Gear in
Cook Inlet in
the Gulf of
Alaska.
0648-AO69.................. Fisheries Off
the West Coast
States and in
the Western
Pacific;
Pacific Coast
Groundfish
Fishery:
Annual
Specifications
and Management
Measures.
0648-AK70.................. Fisheries of
the Exclusive
Economic Zone
Off Alaska:
Individual
Fishing Quota
Program.
0648-AP81.................. Sea Turtle
Conservation
Measures of
the Pound Net
Fishery in
Virginia
Waters.
0648-AP17.................. Take of Four
Threatened
Evolutionarily
Significant
Units of West
Coast Salmon.
0648-AP68.................. Atlantic Large
Whale Seasonal
Area
Management
Program.
0648-AN29.................. Regulations
Governing the
Approach to
Humpback
Whales in
Alaska.
0648-AK50.................. Fisheries of
the Exclusive
Economic Zone
Off Alaska:
Improved
Individual
Fishing Quota
Program.
0648-AM72.................. Western Alaska
Community
Development
Quota Program.
0648-AN23.................. Fisheries of
the Exclusive
Economic Zone
Off Alaska:
Revisions to
Definition of
Length Overall
of a Vessel.
0648-AL95.................. Fisheries of
the Exclusive
Economic Zone
Off Alaska:
License
Limitation
Program.
0648-AO02.................. Atlantic
Coastal
Fisheries
Cooperative
Management Act
Provisions:
Horseshoe Crab
Fishery--Close
d Area.
0648-AF87.................. Fisheries of
the
Northeastern
United States:
Fishery
Management
Plan for
Tilefish.
0648-AN27.................. Pacific Coast
Groundfish
Fishery:
Groundfish
Observer
Program.
0648-AL51.................. West Coast
Salmon
Fisheries:
Amendment 14.
0648-AO41.................. Pacific Coast
Groundfish
Fishery:
Amendment 13.
0648-AO97.................. Pacific Coast
Groundfish
Fishery:
Amendment 14.
0648-AO42.................. International
Fisheries
Regulations:
Pacific Tuna
Fisheries.
0648-BA42.................. Fisheries of
the
Northeastern
United States;
Tilefish Cost
Recovery
Regulatory
Amendment.
0648-BA06.................. Fisheries of Yes.
the Caribbean,
Gulf of
Mexico, and
South
Atlantic; Reef
Fish Fishery
of the Gulf of
Mexico;
Emergency Rule
To Authorize
Re-Opening the
Recreational
Red Snapper
Season.
0694-AF03.................. Export Control
Reform
Initiative:
Strategic
Trade
Authorization
License
Exception.
0694-AF17.................. Revisions to Yes.
the Export
Administration
Regulations
(EAR): Control
of Items the
President
Determines No
Longer Warrant
Control Under
the United
States
Munitions List
(USML).
------------------------------------------------------------------------
DOC--BUREAU OF INDUSTRY AND SECURITY (BIS)
Final Rule Stage
21. Revisions to the Export Administration Regulations (EAR): Control
of Military Vehicles and Related Items That the President Determines Do
Not Warrant Control on the United States Munitions List
Priority: Other Significant.
Legal Authority: 10 U.S.C. 7420; 10 U.S.C. 7430(e); 15 U.S.C.
1824a; 22 U.S.C. 287c; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; 30 U.S.C. 185(s); 42 U.S.C. 2139a; 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 50 U.S.C. 1701 et seq.; 50 U.S.C. 2401 et
seq.; 50 U.S.C. 5; EO 12058; EO 12851; EO 12938; EO 12947; EO 13026; EO
13099; EO 13222; EO 13224; 22 U.S.C. 2151 note; 22 U.S.C. 3201 et seq.;
EO 11912; EO 12002; EO 12214; EO 12854; EO 12918; EO 12918; EO 12981;
EO 13020; EO 13338; 30 U.S.C. 185(u)
CFR Citation: 15 CFR 740; 15 CFR 743; 15 CFR 744; 15 CFR 748; 15
CFR 774; 15 CFR 730; 15 CFR 732; 15 CFR 738; 15 CFR 742; 15 CFR 746; 15
CFR 756; 15 CFR 762; 15 CFR 770; 15 CFR 772.
Legal Deadline: None.
Abstract: In August 2009, President Obama directed a fundamental
review of the U.S. Export control system be conducted. This review
included a fundamental review of the two primary control lists of the
U.S. Export control system; i.e., the Commerce Control List (CCL) and
the United States Munitions List (USML). In December 2010, the
Departments of Commerce and State each published an Advanced Notice of
Proposed Rulemaking (ANPRM)
[[Page 7701]]
requesting public comments on creating more ``positive'' and clear
control lists and recommendations for how items listed on the two
control lists could be tiered based on criteria developed during the
Export Control Reform (ECR) initiative.
An integral part of creating a ``positive'' USML requires a proper
control structure be put into place under the EAR to appropriately
control the less significant items moved from the USML to the CCL,
which is the subject of this proposed rule. This rule outlines the
control structure developed under the ECR initiative to ensure
appropriate controls are in place for these less significant items
moved from the USML to the CCL.
Statement of Need: This rule is needed to describe how items that
no longer warrant ITAR control--but, because they are specially
designed for military applications, warrant some degree of control--
will be made subject to the EAR and listed on the CCL. In particular,
this rule establishes the framework within which items that are
transferred from the ITAR to the EAR will be identified in and
controlled by the EAR. Such ready identification is needed to allow for
public understanding of the changes and to facilitate executive branch
compliance with the requirements to notify Congress when items are
removed from the ITAR. Such controls are needed to accomplish the
national security and foreign policy objectives of controlling
transfers of military items, which includes complying with statutory
and international obligations to prevent the transfer of such items to
certain countries, end uses, and end users.
Summary of Legal Basis: The Export Administration Act of 1979, as
amended, authorizes the President to prohibit or curtail exports for
national security or foreign policy reasons. Section 3(1) of that Act
provides that ``It is the policy of the United States to minimize
uncertainties in export control policy and to encourage trade with all
countries with which the United States has diplomatic or trading
relations, except those countries with which such trade has been
determined by the President to be against the national interest.''
Although the Export Administration Act of 1979 (EAA), as amended,
expired on August 20, 2001, Executive Order 13222 of August 17, 2001 (3
CFR, 2001 Comp., p. 783 (2002)) as extended by Notice of August 12,
2010, 75 FR 50681 (Aug. 16, 2010) continues the EAR in effect under the
International Emergency Economic Powers Act (IEEPA). The EAA and the
IEEPA provide the President with the discretion to tailor controls,
such as through the use of license exceptions and the creation of
country groups in the implementing regulations, over different types of
items based on their significance or other factors relevant to the
national interest.
The Arms Export Control Act (22 U.S.C. 2778) gives the President
the authority to identify any item as a ``defense article.'' The list
of ``defense articles'' is identified on the U.S. Munitions List (USML)
of the International Traffic in Arms Regulations (ITAR) (22 CFR chapter
I, subchapter M). Section 38(f) of the AECA requires the President to
periodically review the list of defense articles and determine which,
if any, should be removed from the list. Section 38(f) authorizes the
President to remove defense articles from the USML and control them
under other statutory and regulatory authorities, such as the export
control regulations administered by the Commerce Department, after
completing a 30-day congressional notification.
Alternatives: BIS considered several alternative regulatory
structures for the items that would be moved from the ITAR to the EAR,
including creating a separate Commerce Munitions List in the EAR and
attempting to insert all items transferred into the existing ECCN
structure. BIS selected the ``600 series'' structure because it
provided the best balance between ease of use and the need to readily
identify items moved or to be moved from the ITAR to the EAR for
congressional notification purposes. A separate Commerce Munitions List
would have readily identified items moved from the ITAR, but would have
required the public to consult two lists to assess whether license
requirements applied to a particular item. Attempting to place all
transferred items within the existing ECCN structure would have
minimized the number of ECCNs to be consulted but would have unduly
obscured the ITAR origin of the transferred items.
Anticipated Cost and Benefits: The underlying policy motivation for
the reform effort is not a traditional economic cost/benefit analysis.
Rather, it is a national security effort. When the Administration first
began to consider how the export control system should be reformed to
enhance national security, it did not take into account whether there
would be particular economic benefits or costs. After conducting the
review, the Administration ultimately determined that our national
security will be strengthened if (i) our export control system allows
for more interoperability with our NATO and other close allies; (ii)
our industrial base is enhanced by, for example, reducing the current
incentives created by the export control rules for foreign companies to
design out or avoid U.S.-origin content; and (iii) our resources are
more focused on controlling or prohibiting, as needed, the items that
provide at least a significant military or intelligence advantage to
the United States. Items made subject to the EAR as a result of this
rule generally would require a license to all destinations except
Canada and exporters, reexporters and transferors would incur the costs
associated with applying for such licenses. BIS would need additional
resources to review the additional licenses and to handle the related
compliance activities that will accompany the planned change in
jurisdictional status of items. The net burden on the government and
that the government imposes on industry, however, would be
substantially reduced because this rule would apply to items that
currently are subject to strict, generally inflexible ITAR license
requirements that impose many collateral compliance burdens and costs
on exporters and the U.S. Government. BIS believes that replacing such
ITAR license requirements with the more flexible EAR license
requirements is not likely to result in any net increase in costs.
However, the benefits of the move would be substantial, although not
readily quantifiable.
Risks: Not all items currently subject to the ITAR are appropriate
for movement to the EAR. Care must be taken to ensure that large
sophisticated weapons and other inherently military items (as opposed
to items unique to defense articles merely because of a change in form
or fit) are not moved to the EAR. BIS believes that the ongoing
interagency review process is adequate to guard against any transfers
contrary to national security and foreign policy interests. At the same
time, one must consider the risks of not transferring to the EAR
defense articles that no longer warrant ITAR controls. These risks
include continued excessive costs to exporters in complying with
unnecessarily restrictive rules, continued disincentives for defense
manufacturers to use U.S. origin parts and components, and continued
excessive costs associated with supplying allied armed forces with U.S.
origin parts and components. BIS believes that this rule sets up a
structure for controls that will allow for the appropriate balance
between the risks of
[[Page 7702]]
continuing the status quo and the risks of unwarranted relaxation of
controls.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/15/11 76 FR 41958
NPRM Comment Period End............. 09/13/11 .......................
Final Rule.......................... 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Timothy Mooney, Export Policy Analyst, Department
of Commerce, Bureau of Industry and Security, 14th Street and
Pennsylvania Avenue NW., Washington, DC 20230, Phone: 202 482-3371,
Fax: 202 482-3355, Email: timothy.mooney@bis.doc.gov.
Related RIN: Merged with 0694-AF09.
RIN: 0694-AF17
DOC--NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION (NOAA)
Proposed Rule Stage
22. Fishery Management Plan for Regulating Offshore Marine Aquaculture
in the Gulf of Mexico
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1801 et seq.
CFR Citation: 50 CFR 622.
Legal Deadline: None.
Abstract: The purpose of this fishery management plan (FMP) is to
develop a regional permitting process for regulating and promoting
environmentally sound and economically sustainable aquaculture in the
Gulf of Mexico (Gulf) exclusive economic zone. This FMP consists of ten
actions, each with an associated range of management alternatives,
which would facilitate the permitting of an estimated 5 to 20 offshore
aquaculture operations in the Gulf over the next 10 years, with an
estimated annual production of up to 64 million pounds. By establishing
a regional permitting process for aquaculture, the Gulf of Mexico
Fishery Management Council will be positioned to achieve their primary
goal of increasing maximum sustainable yield and optimum yield of
federal fisheries in the Gulf by supplementing harvest of wild caught
species with cultured product.
Statement of Need: Demand for protein is increasing in the United
States and commercial wild-capture fisheries will not likely be
adequate to meet this growing demand. Aquaculture is one method to meet
current and future demands for seafood. Supplementing the harvest of
domestic fisheries with cultured product will help the U.S. meet
consumers' growing demand for seafood and may reduce the Nation's
dependence on seafood imports.
Currently, the U.S. imports over 80 percent of the seafood consumed
in the country, and the annual U.S. seafood trade deficit is at an all
time high of over $9 billion.
Summary of Legal Basis: Magnuson-Stevens Fishery Conservation and
Management Act, 16 U.S.C. 1801 et seq.
Alternatives: The Council's Aquaculture FMP includes 10 actions,
each with an associated range of alternatives. These actions and
alternatives are collectively intended to establish a regional
permitting process for offshore aquaculture. Management actions in the
FMP include: (1) Aquaculture permit requirements, eligibility, and
transferability; (2) duration aquaculture permits are effective; (3)
aquaculture application requirements, operational requirements, and
restrictions; (4) species allowed for aquaculture; (5) allowable
aquaculture systems; (6) marine aquaculture siting requirements and
conditions; (7) restricted access zones for aquaculture facilities; (8)
recordkeeping and reporting requirements; (9) biological reference
points and status determination criteria; and (10) framework procedures
for modifying biological reference points and regulatory measures.
Anticipated Cost and Benefits: Environmental and social/economic
costs and benefits are described in detail in the Council's Aquaculture
FMP. Potential benefits include: establishing a rigorous review process
for reviewing and approving/denying aquaculture permits; increasing
optimum yield by supplementing the harvest of wild domestic fisheries
with cultured products; and reducing the nation's dependence on
imported seafood. Anticipated costs include increased administration
and oversight of an aquaculture permitting process, and potential
negative environmental impacts to wild marine resources. Approval of an
aquaculture permitting system may also benefit fishing communities by
creating new jobs or impact fishing communities if cultured products
economically displace domestic seafood.
Risks: National offshore aquaculture legislation has also been
previously proposed by the Administration. This action may reduce the
need for uniform national legislation and allow aquaculture regulations
to vary by region.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Availability (NOA)........ 06/04/09 74 FR 26829
NOA Comment Period End.............. 08/03/09 .......................
NPRM................................ 12/00/11 .......................
Final Action........................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Roy E. Crabtree, Southeast Regional Administrator,
Department of Commerce, National Oceanic and Atmospheric
Administration, 263 13th Avenue South, St. Petersburg, FL 33701, Phone:
727 824-5305, Fax: 727 824-5308, Email: roy.crabtree@noaa.gov.
RIN: 0648-AS65
DOC--NOAA
23. Reducing Disturbances to Hawaiian Spinner Dolphins From Human
Interactions
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1361 et seq.
CFR Citation: 50 CFR 216.
Legal Deadline: None.
Abstract: The National Marine Fisheries Service proposes
regulations to protect the essential resting habitat of wild spinner
dolphins (Stenella longirostris) in the main Hawaiian Islands, and to
reduce the human activities that may cause ``take,'' as defined in the
Marine Mammal Protection Act (MMPA) and its implementing regulations,
or from other actions that otherwise adversely affect the dolphins, by
proposing time-area closures in four bays on the island of Hawaii, and
one on the island of Maui.
Statement of Need: NMFS is concerned about the cumulative impacts
on Hawaiian spinner dolphin populations from human interactions. Human
interactions with dolphins in their resting habitats has increased over
the past decade, with spinner dolphins now being the target of viewing
or swim-with-wild-dolphins tours on a daily basis. Because spinner
dolphins routinely use the same habitats, and stay in the bays for most
of the day to rest, these same animals may be disturbed multiple times
per day from the multiple tours that seek these animals daily. The
unauthorized taking of spinner dolphins is occurring at these
[[Page 7703]]
bays, with many adverse impacts as a result including: behavioral
changes, shorter resting periods, and displacement from primary resting
habitats. By protecting the essential resting habitat of the spinner
dolphins, NMFS proposes to prevent the taking of these animals.
Summary of Legal Basis: All marine mammals are protected under the
Marine Mammal Protection Act (MMPA). NMFS is proposing these
regulations pursuant to its rulemaking authority under MMPA 16 U.S.C.
1361 et seq.; 16 U.S.C. 1372 et seq., which generally prohibits the
take of any marine mammals; and 16 U.S.C. 1382 et seq.
Alternatives:
1. No Action.
2. Regulate human behaviors and activities.
3. Implement time-area closures in specified spinner dolphin
resting habitats.
4. Combine limits on specified human behaviors with time-area
closures.
5. Full closure of all identified spinner dolphin resting habitats.
6. Codify the West Hawaii Voluntary Standards for Marine Tourism.
Anticipated Cost and Benefits: The primary benefit of this action
would be to reduce the unauthorized taking of spinner dolphins in their
primary resting habitat. These animals are being disturbed in an area
that is significant to their health, reproduction and survival.
Managing the amount of interactions humans can have with spinner
dolphins will help protect the animals in their natural environment.
Costs with this proposed rule would affect humans as their use of these
particular bays would be limited. Commercial tour operators, kayak
companies, and spiritual retreat operators may be negatively
economically impacted. The public at large would not be allowed to
engage in activities in the closure areas, and they may therefore
associate a cost with this proposed action.
Risks: No risks to public health, safety or the environment were
identified with implementation of this rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 12/12/05 70 FR 73426
ANPRM Comment Period End............ 01/11/06 .......................
NPRM................................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Melissa Andersen. Fishery Biologist, Management,
Department of Commerce, National Oceanic and Atmospheric
Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone:
301 713-2322, Fax: 301 713-2521, Email: melissa.andersen@noaa.gov.
RIN: 0648-AU02
DOC--NOAA
24. Designation of Critical Habitat for the North Atlantic Right Whale
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1361 et seq.; 16 U.S.C. 1531 to 1543
CFR Citation: 50 CFR 226; 50 CFR 229.
Legal Deadline: None.
Abstract: In June 1970, the northern right whale was listed as
endangered under the Endangered Species Conservation Act, the precursor
to the Endangered Species Act (ESA) (35 FR 8495; codified at 50 CFR
17.11). Subsequently, right whales were listed as endangered under the
ESA in 1973, and as depleted under the Marine Mammal Protection Act
(MMPA) the same year. In 1994, NMFS designated critical habitat for the
northern right whale, a single species thought at the time to include
right whales in both the north Atlantic and the North Pacific.
In 2006, NMFS published a comprehensive right whale status review
that concluded that recent genetic data provided unequivocal support to
distinguish three right whale lineages (including the southern right
whale) as separate phylogenetic species (Rosenbaum et al. 2000).
Rosenbaum et al. (2000), concluded that the right whale should be
regarded as the following three separate species: (1) The North
Atlantic right whale (Eubalaena glacialis) ranging in the North
Atlantic Ocean; (2) the North Pacific right whale (Eubalaena japonica),
ranging in the North Pacific Ocean; and (3) the southern right whale
(Eubalaena australis), historically ranging throughout the southern
hemisphere's oceans.
Based on these findings, NMFS published a proposed and final
determination listing right whales in the North Atlantic and North
Pacific as separate endangered species under the ESA (71 FR 77704, Dec.
27, 2006; 73 FR 12024, Mar. 6, 2008). Based on the new listing
determination, NMFS is required by the ESA to designate critical
habitat separately for both the North Atlantic right whale and the
North Pacific right whale.
In April 2008, a final critical habitat determination was published
for the North Pacific right whale (73 FR 19000; Apr. 8, 2008). At this
time, NMFS is preparing a proposal to designate critical habitat for
the North Atlantic right whale.
Statement of Need: Under section 4 of the Endangered Species Act,
NOAA Fisheries is required to designate critical habitat for newly
listed species.
Summary of Legal Basis: Endangered Species Act.
Alternatives: Because this rule is presently in the beginning
stages of development, no alternatives have been formulated or analyzed
at this time.
Anticipated Cost and Benefits: Because this rule is presently in
the beginning stages of development, no analysis has been completed at
this time to assess costs and benefits.
Risks: Loss of critical habitat for a species listed as protected
under the ESA and MMPA, as well as potential loss of right whales due
to habitat loss.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Marta Nammack, Office of Protected Resources,
Department of Commerce, National Oceanic and Atmospheric
Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone:
301 713-1401, Fax: 301 427-2523, Email: marta.nammack@noaa.gov.
RIN: 0648-AY54
DOC--NOAA
25. Regulatory Amendments To Implement the Shark Conservation Act and
Revise the Definition of Illegal, Unreported, and Unregulated Fishing
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1826d to 1826k
CFR Citation: 50 CFR 300.
Legal Deadline: Final, Statutory, January 4, 2012, The rule needs
to be published by December 4, 2011, due to the 30-day delay in
effectiveness.
Abstract: NMFS is amending identification and certification
procedures under the High Seas Driftnet Fishing Moratorium Protection
Act to help achieve shark conservation in international fisheries. NMFS
must identify nations whose fishing vessels
[[Page 7704]]
have engaged in high seas fisheries targeting or incidentally catching
sharks not subject to a regulatory program for the conservation of
sharks comparable to that of the United States, taking into account
different conditions, as required under the Shark Conservation Act
(Pub. L. 111-348). NMFS would subsequently certify whether identified
nations have adopted regulatory programs governing the conservation of
sharks that are comparable to U.S. programs, taking into account
different conditions, and established management plans for sharks. The
absence of sufficient steps may lead to prohibitions on the importation
of certain fisheries products into the United States and other
measures.
NMFS is also amending the regulatory definition of ``illegal,
unreported, and unregulated fishing'' under the High Seas Driftnet
Fishing Moratorium Protection Act.
The procedures for identification and certification would entail a
multilateral approach of consultations and negotiations with other
nations to achieve shark conservation.
This action is not expected to have adverse economic impacts, and
any such impacts would be well below the economic threshold of impact
pursuant to E.O. 12866. In addition, there are no novel legal or policy
issues associated with this action since identification and
certification procedures have already been established in regulations
(50 CFR part 300). However, this action is significant under the
meaning of E.O. 12866 because it could lead to trade restrictive
measures applied against foreign nations.
Statement of Need: These regulatory amendments are required to
implement the international provisions of the Shark Conservation Act to
identify and certify nations whose vessels are engaged in shark finning
and/or fishing for sharks in a manner that is not consistent with
international management efforts. Additionally, this rule would revise
the definition of Illegal, Unreported, and Unregulated (IUU) Fishing in
response to comments on a prior rulemaking (0648-AV51) that set out the
regulatory definition of IUU fishing.
Summary of Legal Basis: Shark Conservation Act (Pub. L. 111-348)
and 16 U.S.C. 1826d to 1826k.
Alternatives: This action is categorically excluded from analysis
under the National Environmental Policy Act because the proposed action
is the promulgation of regulations of an administrative, financial,
legal, technical, or procedural nature and the environmental effects of
which are too broad, speculative, or conjectural to lend themselves to
meaningful analysis and for which any potential cumulative effects are
negligible. Consequently, no alternatives were analyzed.
Anticipated Cost and Benefits: This action is not expected to have
adverse economic impacts, and any such impacts would be well below the
economic threshold of impact pursuant to E.O. 12866. Potential
benefits, if any, would be indirect and accrue to internationally
managed fisheries by strengthening Regional Fishery Management
Organizations and by restricting U.S. market access through prohibiting
illegally harvested fishery products.
Risks: There are no novel legal or policy issues associated with
this action since identification and certification procedures have
already been established in regulations (50 CFR part 300). However,
this action is significant under the meaning of E.O. 12866 because it
could lead to trade restrictive measures applied against foreign
nations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/11 .......................
Final Action........................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Christopher Rogers, Division Chief, Department of
Commerce, National Oceanic and Atmospheric Administration, 1315 East-
West Highway, Silver Spring, MD 20910, Phone: 301 713-9090, Fax: 301
713-9106, Email: christopher.rogers@noaa.gov.
RIN: 0648-BA89
BILLING CODE 3510-12-P
DEPARTMENT OF DEFENSE
Statement of Regulatory Priorities
Background
The Department of Defense (DoD) is the largest Federal department,
consisting of 3 Military departments (Army, Navy, and Air Force), 10
Unified Combatant Commands, 14 Defense Agencies, and 10 DoD Field
Activities. It has 1,434,450 military personnel and 782,386 civilians
assigned as of March 31, 2011, and over 200 large and medium
installations in the continental United States, U. S. territories, and
foreign countries. The overall size, composition, and dispersion of
DoD, coupled with an innovative regulatory program, presents a
challenge to the management of the Defense regulatory efforts under
Executive Order (E.O.) 12866 ``Regulatory Planning and Review'' of
September 30, 1993.
Because of its diversified nature, DoD is affected by the
regulations issued by regulatory agencies such as the Departments of
Energy, Health and Human Services, Housing and Urban Development,
Labor, Transportation, and the Environmental Protection Agency. In
order to develop the best possible regulations that embody the
principles and objectives embedded in E.O. 12866, there must be
coordination of proposed regulations among the regulatory agencies and
the affected DoD components. Coordinating the proposed regulations in
advance throughout an organization as large as DoD is straightforward,
yet a formidable undertaking.
DoD is not a regulatory agency, but occasionally it issues
regulations that have an effect on the public. These regulations, while
small in number compared to the regulating agencies, can be significant
as defined in E.O. 12866. In addition, some of DoD's regulations may
affect the regulatory agencies. DoD, as an integral part of its
program, not only receives coordinating actions from the regulating
agencies, but coordinates with the agencies that are affected by its
regulations as well.
Overall Priorities
The Department needs to function at a reasonable cost, while
ensuring that it does not impose ineffective and unnecessarily
burdensome regulations on the public. The rulemaking process should be
responsive, efficient, cost-effective, and both fair and perceived as
fair. This is being done in DoD while reacting to the contradictory
pressures of providing more services with fewer resources. The
Department of Defense, as a matter of overall priority for its
regulatory program, fully incorporates the provisions of the
President's priorities and objectives under Executive Order (E.O.)
12866.
Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review (January 18, 2011), the following
Regulatory Identifier Numbers (RINs) have been identified as associated
with retrospective review and analysis in the Department's final
[[Page 7705]]
retrospective review of regulations plan. All are of particular
interest to small businesses. Some of these entries on this list may be
completed actions, which do not appear in The Regulatory Plan. However,
more information can be found about these completed rulemakings in past
publications of the Unified Agenda on Reginfo.gov in the Completed
Actions section for that agency. These rulemakings can also be found on
Regulations.gov. The final agency plans can be found at: https://www.regulations.gov/exchange/topic/eo-13563
0750-AH19--Accelerated Payments to Small Business (DFARS
Case 2011-D008)
0750-AH44--Extension of DoD Mentor-Prot[eacute]g[eacute]
Pilot Program (DFARS Case 2011-D050)
0750-AH45--Deletion of Text Implementing 10 U.S.C. 2323
(DFARS Case 2011-D038)
Administration Priorities
1. Rulemakings That Are Expected To Have High Net Benefits Well in
Excess of Costs
The Department plans to--
Finalize the DFARS rule to permit offerors to propose an
alternative line item structure to reflect the offeror's business
practices for selling and billing commercial items, and initial
provisioning of spares for weapon systems. This rule should prevent
misalignment of line item structure in receipt documents and invoices,
which causes manual intervention and can delay payment;
Finalize the DFARS rule to conduct discussions prior to
contract award for source selections of $100 million or more. A DoD
study showed a significant positive correlation between high-dollar
source selections that were conducted without discussions and protests
sustained. This rule should reduce the number of protests filed and
their resultant costs to contractors and the Government; and
Finalize the DFARS rule to implement section 866 of the
National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011
establishing a pilot program to acquire military purpose
nondevelopmental items. This pilot program is designed to test whether
the streamlined procedures, similar to those available for commercial
items, can serve as an effective incentive for nontraditional defense
contractors to (1) channel investment and innovation into areas that
are useful to DoD and (2) provide items developed exclusively at
private expense to meet validated military requirements. (2011-D034)
2. Rulemakings That Promote Open Government and Use Disclosure as a
Regulatory Tool
The Department plans to--
Finalize the Federal Acquisition Regulation (FAR) to
inform contractors of the statutory requirement of section 3010 of
Public Law 111-212, to make Federal Awardee Performance and Integrity
Information System information, excluding past performance reviews,
available to the public;
Finalize the FAR rule that implements section 743 of
Division C of the Fiscal Year 2010 Consolidated Appropriations Act,
which requires agencies to develop inventories of their service
contacts, including number and work location of contractor employees;
Finalize the FAR rule to establish standard evaluation
factors and rating scales for documenting contractor performance;
Finalize the FAR rule that implements the Federal Funding
Accountability and Transparency Act of 2006, which requires the Office
of Management and Budget (OMB) to establish a free, public, Web site
containing full disclosure of all Federal contract award information.
This rule requires contractors to report executive compensation and
first-tier subcontractor awards on unclassified contracts expected to
be $25,000 or more, except contracts with individuals;
Finalize the FAR rule that implements section 811 of the
NDAA for FY 2010, which requires a written justification and approval
prior to awarding a sole-source contract in an amount over $20 million
under the 8(a) program; and
Finalize the DFARS rule to implement section 814 of the
NDAA for FY 2010, which imposed additional reporting requirements for
awards of single task and delivery-order contracts.
3. Rulemakings That Streamline Regulations and Reduce Unjustified
Burdens
The Department plans to--
Finalize the DFARS rule to remove the requirement to use
DD Forms 2626 and 2631 to report past performance information for
construction and architect-engineer services and to instead provide the
performance reports electronically;
Finalize the DFARS rule to amend the definition of
``qualifying country end product'' to make it comparable to the change
in the definition of ``domestic end product'' by waiving the component
test for qualifying country end products;
Finalize the DFARS rule to update appendix F, Material
Inspection and Receiving Report, to incorporate procedures for using
the electronic Wide Area WorkFlow (WAWF) Receiving Report, which is
required for use in most contracts in lieu of the DD Form 250. WAWF is
the electronic tool for documenting receipt and acceptance of supplies
and services and for electronic invoicing; and
Finalize the rule for DFARS coverage of patents, data, and
copyrights, which significantly reduces the amount of regulatory text
and the number of required clauses.
4. Efforts To Minimize Burdens on Small Businesses
Of interest to Small Businesses are regulations to--
Finalize the DFARS rule to accelerate payments to all DoD
small business contractors.
5. Rules To Be Modified, Streamlined, Expanded, or Repealed To Make the
Agency's Regulatory Program More Effective or Less Burdensome in
Achieving the Regulatory Objectives
DFARS Case 2011-D028--Removes component test for COTS
items that are qualifying country end products. Require only
determination of country of origin of the COTS item, not the components
of the COTS item.
DFARS Case 2011-D013--Only One Offer. Motivate effective
competition by driving behavior to allow sufficient time for submission
of offers.
DFARS Case 2011-D008--Accelerate Small Business Payments.
Accelerate payments to all small businesses, not just small
disadvantaged businesses.
DFARS Case 2010-D018--Responsibility and Liability for
Government Property. Includes fixed-price contracts that are awarded on
the basis of adequate competition on the list of contract types whereby
contractors are not held liable for loss of Government property.
DFARS Case 2010-D001--Patents, Data, and Copyrights.
Rewrite of DFARS part 227, Patents, Data, and Copyrights.
DFARS Case 2009-D026--Multiyear Contracting. Comprehensive
review of DFARS subpart 217.1 to simplify and clarify the coverage of
multiyear acquisition.
Specific DoD Priorities
For this regulatory plan, there are six specific DoD priorities,
all of which reflect the established regulatory
[[Page 7706]]
principles. In those areas where rulemaking or participation in the
regulatory process is required, DoD has studied and developed policy
and regulations that incorporate the provisions of the President's
priorities and objectives under the Executive order.
DoD has focused its regulatory resources on the most serious
environmental, health, and safety risks. Perhaps most significant is
that each of the priorities described below promulgates regulations to
offset the resource impacts of Federal decisions on the public or to
improve the quality of public life, such as those regulations
concerning acquisition, security, energy projects, education, and
health affairs.
1. Defense Procurement and Acquisition Policy
The Department of Defense continuously reviews the DFARS and
continues to lead Government efforts to--
Revise the DFARS to specify circumstances under which the
U.S. Government needs to obtain data other than certified cost or
pricing data from Canadian contractors via the Canadian Commercial
Corporation.
Revise the DFARS to provide detailed guidance and
instruction to DoD contracting officers for the use of DoD's
performance-based payments analysis tool when contemplating the use of
performance-based payments on new fixed-price type contracts.
Revise the DFARS to implement a DoD Better Buying Power
initiative by providing a proposal-adequacy checklist in a provision to
ensure offerors take responsibility for providing thorough, accurate,
and complete proposals.
Revise the DFARS to address standards and structures for
the safeguarding of unclassified DoD information.
Revise the DFARS to implement the DoD Better Buying Power
initiative to address acquisitions using competitive procedures in
which only one offer is received. With some exceptions, the contracting
officer must resolicit for an additional period of at least 30 days, if
the solicitation allowed fewer than 30 days for receipt of proposals
and only one offer is received. If a period of at least 30 days was
allowed for receipt of proposals, the contracting officer must
determine prices to be fair and reasonable through price or cost
analysis or enter negotiations with the offeror.
Revise the DFARS to implement a DoD Better Buying Power
initiative by requiring contractors to submit annual technical
descriptions for their independent research and development projects.
Revise the DFARS to establish means for cleared
contractors, who have unclassified U.S. Government information resident
on or transiting through contractor information systems, to share cyber
threat information.
Revise the FAR to implement section 841 of the National
Defense Authorization Act for FY 2009, which required a review of the
FAR coverage on organizational conflicts of interest (OCIs).
Finalize the DFARS rule to clarify DoD policy regarding
the definition and administration of contractor business systems to
improve the effectiveness of DCMA/DCAA oversight of contractor business
systems;
Finalize the DFARS rule to implement a DoD Better Buying
Power initiative to increase the use of fixed-price incentive (firm
target) contracts;
2. Logistics and Materiel Readiness, Department of Defense
The Department of Defense published or plans to publish rules on
contractors supporting the military in contingency operations:
Final Rule: Private Security Contractors (PSCs) Operating
in Contingency Operations, Combat Operations or Other Significant
Military Operations. In order to meet the mandate of section 862 of the
2008 National Defense Authorization Act (NDAA) (as amended by section
813 (b) of the 2010 NDAA and section 832 of the 2011 NDAA), this rule
establishes policy, assigns responsibilities, and provides procedures
for the regulation of the selection, accountability, training,
equipping, and conduct of personnel performing private security
functions under a covered contract during contingency operations,
combat operations, or other significant military operations. It also
assigns responsibilities and establishes procedures for incident
reporting, use of and accountability for equipment, rules for the use
of force, and a process for administrative action or the removal, as
appropriate, of PSCs and PSC personnel. DoD published an interim final
rule on July 17, 2009 (74 FR 34690 to 34694), with an effective date of
July 17, 2009. The comment period ended August 31, 2009. DoD, in
coordination with the Department of State and the United States Agency
for International Development, prepared a final rule, which included
the responses to the public comments, and incorporated changes to the
interim final rule, where appropriate. The final rule also incorporated
the legislative changes required by section 813 (b) of the 2010 NDAA
and section 832 of the 2011 NDAA. The final rule was published August
11, 2011 (76 FR 49650), with an effective date of September 12, 2011.
Interim Final Rule: Operational Contract Support. This
rule will incorporate the latest changes and lessons learned into
policy and procedures for operational contract support (OCS), including
OCS program management, contract support integration, and the
integration of DoD contractor personnel into contingency operations
outside the United States. DoD anticipates publishing the interim final
rule in the first or second quarter of FY 2012.
3. Installations and Environment, Department of Defense
The Department of Defense will publish a rule regarding the process
for evaluating the impact of certain types of structures on military
operations and readiness:
Interim Final Rule: This rule implements policy, assigns
responsibilities, and prescribes procedures for the establishment and
operation of a process for evaluation of proposed projects submitted to
the Secretary of Transportation under section 44718 of title 49, United
States Code. The evaluation process is established for the purpose of
identifying any adverse impact of proposed projects on military
operations and readiness, minimizing or mitigating such adverse
impacts, and determining if any such projects pose an unacceptable risk
to the national security of the United States. The rule also includes
procedures for the operation of a central DoD siting clearinghouse to
facilitate both informal and formal reviews of proposed projects. This
rule was required by section 358 of Public Law 111-383. DoD anticipates
publishing an interim final rule in fourth quarter of FY 2011.
4. Military Community and Family Policy, Department of Defense
The Department of Defense plans to publish a final rule to
implement policy, assign responsibilities, and prescribe procedures for
the operation of voluntary education programs within DoD:
Final Rule: Voluntary Education Programs. In this rule,
the Department of Defense (DoD) implements policy, assigns
responsibilities, and prescribes procedures for the operation of
voluntary education programs within DoD. Several of the subject areas
in this rule include: Procedures for Service members participating in
education
[[Page 7707]]
programs; guidelines for establishing, maintaining, and operating
voluntary education programs including, but not limited to, instructor-
led courses offered on-installation and off-installation, as well as
via distance learning; procedures for obtaining on-base voluntary
education programs and services; minimum criteria for selecting
institutions to deliver higher education programs and services on
military installations; the establishment of a DoD Voluntary Education
Partnership Memorandum of Understanding (MOU) between DoD and
educational institutions receiving tuition assistance payments; and
procedures for other education programs for Service members and their
adult family members. The new requirement for a signed MOU with DoD
from participating educational institutions will be effective January
1, 2012. The Department published a proposed rule on August 6, 2010 (75
FR 47504 to 47514). The comment period ended October 10, 2010, which
contained a total of 110 comments. Several comments from the general
public were accepted, including suggestions to clarify terms such as
``one single tuition rate'' and a ``needs assessment.'' DoD anticipates
publishing the final rule during the first quarter of FY 2012.
5. Health Affairs, Department of Defense
The Department of Defense is able to meet its dual mission of
wartime readiness and peacetime health care by operating an extensive
network of medical treatment facilities. This network includes DoD's
own military treatment facilities supplemented by civilian health care
providers, facilities, and services under contract to DoD through the
TRICARE program. TRICARE is a major health care program designed to
improve the management and integration of DoD's health care delivery
system. The program's goal is to increase access to health care
services, improve health care quality, and control health care costs.
The TRICARE Management Activity has published or plans to publish
the following rules:
Final rule on TRICARE: Reimbursement of Sole Community
Hospitals and Adjustment to Reimbursement of Critical Access Hospitals.
The rule implements the statutory provision in 10 United States Code
1079(j)(2) that TRICARE payment methods for institutional care shall be
determined to the extent practicable in accordance with the same
reimbursement rules as those that apply to payments to providers of
services of the same type under Medicare. This rule implements a
reimbursement methodology similar to that furnished to Medicare
beneficiaries for services provided by sole community hospitals. It is
projected that implementation of this rule will result in a health care
savings of $31 million per year with proposed phase-in period and an
estimated initial start-up cost of $200,000. Any on-going
administrative costs would be minimal and there are no applicable risks
to the public. The proposed rule was published July 5, 2011 (76 FR
39043). The comment period ended on September 6, 2011. DoD anticipates
publishing a final rule in the second quarter of FY 2012.
Final rule on TRICARE: TRICARE Young Adult. The purpose of
this interim final rule is to establish the TRICARE Young Adult program
implementing section 702 of the Ike Skelton NDAA for FY 2011 (Pub. L.
111-383) to provide medical coverage to unmarried children under the
age of 26 who no longer meet the age requirements for TRICARE
eligibility (age 21, or 23 if enrolled in a full-time course of study
at an institution of higher learning approved by the Secretary of
Defense) and who are not eligible for medical coverage from an eligible
employer-sponsored plan (as defined in section 5000A(f)(2) of the
Internal Revenue Code of 1986). If qualified, they can purchase TRICARE
Standard/Extra or TRICARE Prime benefits coverage. The particular
TRICARE plan available depends on the military sponsor's eligibility
and the availability of the TRICARE plan in the dependent's geographic
location. It is projected that implementation of this rule will result
in an estimated initial start-up cost of $3,000,000. Premiums are
designed to cover the anticipated health care costs, as well as ongoing
administrative costs. The interim final rule was published April 27,
2011 (76 FR 23479), with an immediate effective date. The comment
period ended June 27, 2011. DoD anticipates publishing a final rule in
the first quarter of FY 2012.
6. Personnel and Readiness, Department of Defense
The Department of Defense will publish a rule regarding Service
Academies:
Final Rule: Service Academies. This rule establishes
policy, assigns responsibilities, and prescribes procedures for
Department of Defense oversight of the Service Academies.
Administrative costs are negligible and benefits are clear, concise
rules that enable the Secretary of Defense to insure that the Service
Academies are efficiently operated and meet the needs of the armed
forces. The proposed rule was published October 18, 2007 (72 FR 59053),
and included policy that has since changed. The final rule,
particularly the explanation of separation policy, will reflect recent
changes in the Don't Ask, Don't Tell policy. DoD anticipates publishing
the final rule in the second quarter of FY 2012.
BILLING CODE 5001-06-P
DEPARTMENT OF EDUCATION (DOE)
Statement of Regulatory Priorities
I. Introduction
The U.S. Department of Education (Department) supports States,
local communities, institutions of higher education, and others in
improving education nationwide and in helping to ensure that all
Americans receive a quality education. We provide leadership and
financial assistance pertaining to education at all levels to a wide
range of stakeholders and individuals, including State educational
agencies, local school districts, providers of early learning programs,
elementary and secondary schools, institutions of higher education,
career and technical schools, nonprofit organizations, postsecondary
students, members of the public, families, and many others. These
efforts are helping to ensure that all children and students from pre-
kindergarten through grade 12 will be ready for, and succeed in,
postsecondary education and that students attending postsecondary
institutions are prepared for a profession or career.
We also vigorously monitor and enforce the implementation of
Federal civil rights laws in educational programs and activities that
receive Federal financial assistance, and support innovative programs,
research and evaluation activities, technical assistance, and the
dissemination of research and evaluation findings to improve the
quality of education.
Overall, the laws, regulations, and programs we administer will
affect nearly every American during his or her life. Indeed, in the
2011 to 2012 school year, about 55 million students will attend an
estimated 99,000 elementary and secondary schools in approximately
13,800 public school districts, and about 21 million students will
enroll in degree-granting postsecondary schools. All of these students
may benefit from some degree of financial assistance or support from
the Department.
[[Page 7708]]
In developing and implementing regulations, guidance, technical
assistance, and monitoring related to our programs, we are committed to
working closely with affected persons and groups. Specifically, we work
with a broad range of interested parties and the general public
including families, students, and educators; State, local, and tribal
governments; and neighborhood groups, community-based early learning
programs, elementary and secondary schools, colleges, rehabilitation
service providers, adult education providers, professional
associations, advocacy organizations, businesses, and labor
organizations.
We also continue to seek greater and more useful public
participation in our rulemaking activities through the use of
transparent and interactive rulemaking procedures and new technologies.
If we determine that it is necessary to develop regulations, we seek
public participation at the key stages in the rulemaking process. We
invite the public to submit comments on all proposed regulations
through the Internet or by regular mail.
To facilitate the public's involvement, we participate in the
Federal Docketing Management System (FDMS), an electronic single
Governmentwide access point (www.regulations.gov) that enables the
public to submit comments on different types of Federal regulatory
documents and read and respond to comments submitted by other members
of the public during the public comment period. This system provides
the public with the opportunity to submit comments electronically on
any notice of proposed rulemaking or interim final regulations open for
comment, as well as read and print any supporting regulatory documents.
We are continuing to streamline information collections, reduce the
burden on information providers involved in our programs, and make
information easily accessible to the public.
II. Regulatory Priorities
A. American Recovery and Reinvestment Act of 2009
On February 17, 2009, President Obama signed into law the American
Recovery and Reinvestment Act of 2009 (ARRA), historic legislation
designed, in part, to invest in critical sectors, including education.
ARRA laid the foundation for education reform by supporting investments
in innovative strategies that are most likely to lead to improved
results for students, long-term gains in school and school system
capacity, and increased productivity and effectiveness. ARRA provided
funding for several key discretionary grant programs, including the
Race to the Top Fund and the Investing in Innovation Fund (i3)
programs.
The Race to the Top Fund program, the largest competitive education
grant program in U.S. history, is designed to provide incentives to
States to implement system-changing reforms that result in improved
student achievement, narrowed achievement gaps, and increased high
school graduation and college enrollment rates. Congress authorized and
provided $4.35 billion for ARRA in 2010, and the Department awarded
approximately $4 billion in Race to the Top State grant funds in two
phases. The Department awarded $600 million to Delaware and Tennessee
under the Race to the Top Phase 1 competition and approximately $3.4
billion to the winners of the Phase 2 competition: The District of
Columbia, Florida, Georgia, Hawaii, Maryland, Massachusetts, New York,
North Carolina, Ohio, and Rhode Island.
In announcing the winners of the Race to the Top Phase 2
competition, the Secretary noted that ``[we] had many more competitive
applications than money to fund them in this round'' and expressed the
hope that any Race to the Top funding included in the Department's FY
2011 appropriations would be available for Race to the Top Phase 3
awards. In particular, there were nine finalists in the Phase 2
competition that did not receive funding despite submitting bold and
ambitious plans for comprehensive reforms and innovations in their
systems of elementary and secondary education. These nine finalists
were: Arizona, California, Colorado, Illinois, Kentucky, Louisiana, New
Jersey, Pennsylvania, and South Carolina.
On April 15, 2011, President Obama signed into law Public Law 112-
10, the Department of Defense and Full-Year Continuing Appropriations
Act, 2011 (FY 2011 Appropriations Act), which made $698.6 million
available for the Race to the Top Fund, authorized the Secretary to
make awards on ``the basis of previously submitted applications,'' and
amended ARRA to permit the Secretary to make grants for improving early
childhood care and learning under the program.
Race to the Top--Early Learning Challenge (RTT-ELC). On May 25,
2011, Secretary Duncan and the Secretary of Health and Human Services,
Kathleen Sebelius, announced the RTT-ELC, a new $500 million State-
level grant competition to be held in 2011 and authorized under ARRA
and the FY 2011 Appropriations Act. The Departments of Education and
Health and Human Services are administering this competition jointly.
At its core is a strong commitment by the Administration to stimulate a
national effort to make sure all children enter kindergarten ready to
succeed. Through the RTT-ELC, the Administration seeks to help close
the achievement gap between children with high needs and their peers by
supporting State efforts to build strong systems of early learning and
development that provide increased access to high-quality programs for
the children who need it most. This competition represents an
unprecedented opportunity for States to focus deeply on their early
learning and development systems for children from birth through age
five. It is an opportunity to build a more unified approach to
supporting young children and their families--an approach that
increases access to high-quality early learning and development
programs and services, and helps ensure that children enter
kindergarten with the skills, knowledge, and dispositions toward
learning that they need to be successful.
The Departments of Education and Health and Human Services have
published requirements for the FY 2011 competition and will complete
the competition and make awards by the end of 2011.
Race to the Top Phase 3. On May 25, 2011, the Department also
announced that approximately $200 million of the FY 2011 Race to the
Top funds would be made available to some or all of the nine unfunded
finalists from the 2010 Race to the Top Phase 2 competition. The
Department recognizes that $200 million is not sufficient to support
full implementation of the plans submitted during the Phase 2
competition, and therefore believes that making these funds available
to the remaining nine finalists is the best way to create incentives
for these States to carry out the bold reforms proposed in their
applications. We have issued final eligibility requirements for the
nine unfunded finalists to apply for Race to the Top Phase 3 funds.
B. Elementary and Secondary Education Act of 1965, as Amended
In 2010, the Administration released the Blueprint for Reform: The
Reauthorization of the Elementary and Secondary Education Act, the
President's plan for revising the Elementary and Secondary Education
Act of 1965 (ESEA) and replacing the No Child Left Behind Act of 2001
(NCLB). The blueprint can be found at the following Web site: https://
www2.ed.
[[Page 7709]]
gov/policy/elsec/leg/blueprint/.
We look forward to congressional reauthorization of the ESEA that
will build on many of the reforms States and LEAs will be implementing
under the ARRA grant programs. In the interim, we may propose
amendments to our current regulations implementing the ESEA.
Additionally, as we continue to work with Congress on
reauthorization of the ESEA, we are currently implementing a plan to
provide flexibility on certain provisions of current law for States and
school districts that are willing to embrace reform. The mechanisms we
are implementing will ensure continued accountability and commitment to
quality education for all students while at the same time providing
States and school districts with increased flexibility to implement
State and local reforms to improve student achievement.
C. Higher Education Act of 1965, as Amended
Changes to the FFEL and Direct Loan Programs. On March 30, 2010,
the President signed into law the Health Care and Education
Reconciliation Act of 2010, Public Law 111-152, title II of which is
the SAFRA Act. SAFRA made a number of changes to the Federal student
financial aid programs under title IV of the Higher Education Act of
1965, as amended (HEA). One of the most significant changes made by
SAFRA is that it ended new loans under the Federal Family Education
Loan (FFEL) Program authorized by title IV, part B, of the HEA as of
July 1, 2010.
On May 5, 2011, ED announced through a notice in the Federal
Register that it was beginning a negotiated rulemaking process to
streamline the loan program regulations by repealing unnecessary FFEL
Program regulations and incorporating and modifying necessary
requirements within the Direct Loan Program regulations, as
appropriate. ED held four public hearings in May 2011 to obtain public
feedback on proposed amendments, as well as on possible amendments to
other ED regulations, including those governing income-based and
income-contingent loan repayment plans and loan discharges based on the
total and permanent disability of the borrower. Based on the feedback
received from these hearings, ED will soon form a negotiated rulemaking
committee to consider proposed amendments and intends to conduct these
negotiations in 2012.
Approval of New Gainful Employment Programs. Over the last 2 years,
the Department has conducted two significant rulemakings to enhance its
program integrity regulations related to the title IV, student aid
programs. As part of this effort, on October 29, 2010, the Department
issued regulations that included requirements for an institution to
notify the Department before offering a new educational program that
provides training leading to gainful employment in a recognized
occupation (Gainful Employment--New Programs). The Department
established the notification requirement out of concern that some
institutions might attempt to circumvent proposed regulations regarding
gainful employment standards by adding new programs before those
standards could take effect. The Department explained that the
notification process requirements were intended to remain in effect
until the final regulations that established eligibility measures for
gainful employment programs would take effect.
We published the final regulations establishing the gainful
employment eligibility measures on June 13, 2011 (Gainful Employment--
Debt Measures). In those regulations, the Department established
measures for gainful employment programs that are intended to identify
the worst performing programs. We believe that when these new
regulations go into effect on July 1, 2013, the notification process
for all new gainful employment programs established in the Gainful
Employment--New Programs final regulations will no longer be needed.
Accordingly, the Department has issued a new NPRM, which among other
changes, proposes to reduce burden for institutions by amending the
Gainful Employment--New Programs final regulations to establish a
smaller group of gainful employment programs for which an institution
must obtain approval from the Department.
Title II of the HEA. The Secretary intends to develop regulations
under title II of the HEA to streamline the program, institutional, and
State report cards; prescribe data quality standards to ensure
reliability, validity, and accuracy of the data submitted; and
establish standards for identifying low-performing teacher preparation
programs.
D. Individuals With Disabilities Education Act
We have issued final regulations that revise the regulations
implementing the Early Intervention Program for Infants and Toddlers
with Disabilities authorized under part C of the Individuals with
Disabilities Education Act (IDEA) to make changes needed for the
appropriate implementation of the early intervention program. The final
part C regulations incorporate provisions from the 2004 amendments to
part C of the IDEA. Additionally, the final regulations provide States
with flexibility in some areas, while ensuring State accountability to
improve results, and needed services for infants and toddlers with
disabilities and their families.
The Department has also issued a notice of proposed rulemaking to
revise the regulations implementing the Assistance to States for the
Education of Children with Disabilities program authorized under part B
of the IDEA and intends to issue final regulations in the coming year.
Specifically, over the last 6 months, we engaged in a review of one
particular provision of the part B regulations, relating to the use of
public benefits or insurance to pay for services provided to children
under part B. IDEA and the part B regulations allow public agencies to
use public benefits or insurance (e.g., Medicaid) to provide or pay for
services required under part B with the consent of the parent of a
child who is enrolled in a public benefits or insurance program. Public
insurance is an important source of financial support for services
required under part B. With respect to the use of public insurance, our
current regulations specifically provide that a public agency must
obtain parental consent each time access to public benefits or
insurance is sought.
We are now proposing to amend the regulations to provide that,
instead of having to obtain parental consent each time access to public
benefits or insurance is sought, the public agency responsible for
providing special education and related services to a child would be
required, before accessing a child's or parent's public benefits or
insurance, to provide written notification to the child's parents. The
notification would inform parents of their rights under the part B
regulations regarding the use of public benefits or insurance to pay
for part B services, including information about the limitations on a
public agency's billing of public benefits or insurance programs, as
well as parents' rights under the Family Educational Rights and Privacy
Act and IDEA to consent prior to the disclosure of personally
identifiable information.
We are proposing these amendments to reduce unnecessary burden on a
public agency's ability to access public benefits or insurance in
appropriate circumstances but still maintain critical parent
protections, and we do this for
[[Page 7710]]
several reasons. Specifically, we are mindful of the importance of
ensuring that parents have sufficient information to make decisions
about a public agency's use of their public benefits or insurance and
the disclosure of their child's educational records for that purpose.
At the same time, these proposed amendments are designed to address the
concern expressed to the Department by many State personnel and other
interested parties that, since the publication of the part B
regulations in 2006, the inability to obtain parental consent has
contributed to public agencies' failure to claim all of the Federal
financial assistance available for part B services covered under
Medicaid. In addition, public agencies have expressed concern over
using limited resources and the significant administrative burden of
obtaining parental consent for the use of Medicaid and other public
benefits or insurance each time that access to public benefits or
insurance is sought. Consequently, many of these parties have requested
that the Department remove the parental consent requirement.
E. Family Educational Rights and Privacy Act
Given the President's emphasis on improving the collection and use
of data as a key element of educational reform, we intend to issue
final regulations in the coming year to amend our current regulations
for the Family Educational Rights and Privacy Act of 1974 (FERPA) to
ensure that States are able to effectively establish and expand robust
statewide longitudinal data systems while protecting student privacy.
F. Other Potential Regulatory Activities
Congress may reauthorize the Adult Education and Family Literacy
Act (AEFLA) (title II of the Workforce Investment Act of 1998) and the
Rehabilitation Act of 1973 (title IV of the Workforce Investment Act of
1998). The Administration is working with Congress to ensure that any
changes to these laws (1) improve the State grant and other programs
providing assistance for adult education under the AEFLA and for
vocational rehabilitation and independent living services for persons
with disabilities under the Rehabilitation Act of 1973; and (2) provide
greater accountability in the administration of programs under both
statutes. Changes to our regulations may be necessary as a result of
the reauthorization of these two statutes.
III. Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (Jan. 18, 2011), the following
Regulatory Identifier Numbers (RINs) have been identified as associated
with retrospective review and analysis in the Department's final
retrospective review of regulations plan. Some of the entries on this
list may be completed actions, which do not appear in The Regulatory
Plan. However, more information can be found about these completed
rulemakings in past publications of the Unified Agenda on Reginfo.gov
in the Completed Actions section for that agency. These rulemakings can
also be found on Regulations.gov. The final agency plans can be found
at: https://www2.ed.gov/about/open.html.
------------------------------------------------------------------------
Do we expect this
rulemaking to
RIN Title of significantly reduce
Rulemaking burden on small
businesses?
------------------------------------------------------------------------
1820-AB64.................. Assistance to No.
States for the
Education of
Children With
Disabilities.
1840-AD01.................. High School No.
Equivalency
Program and
College
Assistance
Migrant
Program, the
Federal TRIO
Programs, and
Gaining Early
Awareness, and
Readiness for
Undergraduate
Program.
1848-AD02.................. Program No.
Integrity
Issues.
1840-AD05.................. Title IV of the No.
Higher
Education Act
of 1965, as
Amended.
1840-AD06.................. Program No.
Integrity:
Gainful
Employment--Me
asures.
1840-AD08.................. Titles III and No.
V of the
Higher
Education Act
of 1965, as
Amended.
1840-AD10.................. Application and Yes.
Approval
Process for
New Programs.
1880-AA86.................. Family No.
Educational
Rights and
Privacy.
1880-AA84.................. The Freedom of No.
Information
Act.
1890-AA14.................. Direct Grant No.
Programs and
Definitions
That Apply to
Department
Regulations.
1890-AA16.................. Department of No.
Education
Acquisition
Regulations.
------------------------------------------------------------------------
IV. Principles for Regulating
Over the next year, other regulations may be needed because of new
legislation or programmatic changes. In developing and promulgating
regulations we follow our Principles for Regulating, which determine
when and how we will regulate. Through consistent application of the
following principles, we have eliminated unnecessary regulations and
identified situations in which major programs could be implemented
without regulations or with limited regulatory action.
In deciding when to regulate, we consider the following:
Whether regulations are essential to promote quality and
equality of opportunity in education.
Whether a demonstrated problem cannot be resolved without
regulation.
Whether regulations are necessary to provide a legally
binding interpretation to resolve ambiguity.
Whether entities or situations subject to regulation are
similar enough that a uniform approach through regulation would be
meaningful and do more good than harm.
Whether regulations are needed to protect the Federal
interest; that is, to ensure that Federal funds are used for their
intended purpose and to eliminate fraud, waste, and abuse.
In deciding how to regulate, we are mindful of the following
principles:
Regulate no more than necessary.
Minimize burden, to the extent possible, and promote
multiple approaches to meeting statutory requirements if possible.
Encourage coordination of federally funded activities with
State and local reform activities.
Ensure that the benefits justify the costs of regulating.
To the extent possible, establish performance objectives
rather than specify compliance behavior.
Encourage flexibility, to the extent possible, and as
needed to enable institutional forces to achieve desired results.
[[Page 7711]]
ED--OFFICE OF POSTSECONDARY EDUCATION (OPE)
Proposed Rule Stage
26. Title IV of the Higher Education Act of 1965, as Amended
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 20 U.S.C. 1070a; 20 U.S.C. 1071 to 1087-4; 20
U.S.C. 1087a to 1087j; 20 U.S.C. 1098e; Pub. L. 111-152
CFR Citation: 34 CFR chapter VI.
Legal Deadline: None.
Abstract: The Secretary proposes to amend the title IV, HEA student
assistance regulations to (1) reflect that, as of July 1, 2010, under
title II of the Health Care and Education Reconciliation Act of 2010
(the SAFRA Act), no new Federal Family Education Loan Program loans
will be made and (2) to reflect other changes to improve the
effectiveness and efficiency of the student loan programs, particularly
with regard to the discharge of loans for persons with total and
permanent disabilities.
Statement of Need: These regulations are needed to reflect the
provisions of the SAFRA Act (title II of the Health Care and Education
Reconciliation Act of 2010) and to reflect other amendments to the HEA
resulting from the SAFRA Act.
Summary of Legal Basis: Health Care and Education Reconciliation
Act of 2010, Public Law 111-152.
Alternatives: The Department is still developing these proposed
regulations; our discussion of alternatives will be included in the
notice of proposed rulemaking.
Anticipated Cost and Benefits: Estimates of the costs and benefits
are currently under development and will be included in the notice of
proposed rulemaking.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
URL for Public Comments: www.regulations.gov.
Agency Contact: David Bergeron, Department of Education, Office of
Postsecondary Education, Room 8022, 1990 K Street NW., Washington, DC
20006, Phone: 202 502-7815, Email: david.bergeron@ed.gov.
RIN: 1840-AD05
BILLING CODE 4000-01-P
DEPARTMENT OF ENERGY (DOE)
Fall 2011 Statement of Regulatory and Deregulatory Priorities
The Department of Energy (Department or DOE) makes vital
contributions to the Nation's welfare through its activities focused on
improving national security, energy supply, energy efficiency,
environmental remediation, and energy research. The Department's
mission is to:
Promote dependable, affordable, and environmentally sound
production and distribution of energy;
Advance energy efficiency and conservation;
Provide responsible stewardship of the Nation's nuclear
weapons;
Provide a responsible resolution to the environmental
legacy of nuclear weapons production;
Strengthen U.S. scientific discovery, economic
competitiveness, and improving quality of life through innovations in
science and technology.
The Department's regulatory activities are essential to achieving
its critical mission and to implementing major initiatives of the
President's National Energy Policy. Among other things, the Regulatory
Plan and the Unified Agenda contain the rulemakings the Department will
be engaged in during the coming year to fulfill the Department's
commitment to meeting deadlines for issuance of energy conservation
standards and related test procedures. The Regulatory Plan and Unified
Agenda also reflect the Department's continuing commitment to cut
costs, reduce regulatory burden, and increase responsiveness to the
public.
Energy Efficiency Program for Consumer Products and Commercial
Equipment
The Energy Policy and Conservation Act (EPCA) requires DOE to set
appliance efficiency standards at levels that achieve the maximum
improvement in energy efficiency that is technologically feasible and
economically justified. The standards already published in 2011 have an
estimated net benefit to the Nation of up to $16.6 billion over 30
years. By 2045, these standards are expected to save enough energy to
operate all U.S. homes for more than 7 months.
The Department continues to follow its schedule for setting new
appliance efficiency standards. These rulemakings are expected to save
American consumers billions of dollars in energy costs. The schedule
outlines how DOE will address the various appliance standards
rulemakings necessary to meet statutory requirements established in
EPCA, the Energy Policy Act of 2005 (EPACT 2005), and the Energy
Independence and Security Act of 2007 (EISA 2007).
The overall plan for implementing the schedule is contained in the
Report to Congress under section 141 of EPACT 2005 that was released on
January 31, 2006. This plan was last updated in the August 2011 report
to Congress and now includes the requirements of the Energy
Independence and Security Act of 2007 (EISA 2007). The reports to
Congress are posted at: https://www.eere.energy.gov/buildings/appliance_standards/schedule_setting.html. The August 2011 report
identifies all products for which DOE has missed the deadlines
established in EPCA (42 U.S.C. section 6291 et seq.). It also describes
the reasons for such delays and the Department's plan for expeditiously
prescribing new or amended standards. Information and timetables
concerning these actions can also be found in the Department's
regulatory agenda, which is posted online at: www.reginfo.gov.
Estimate of Combined Aggregate Costs and Benefits
The regulatory actions included in this regulatory plan are
expected to provide significant benefits to the Nation for product
categories including: Fluorescent lamp ballasts, manufactured housing,
battery chargers and external power supplies, walk-in coolers and
freezers, and incandescent reflector lamps. DOE believes that the
benefits to the Nation of the proposed energy standards for fluorescent
lamp ballasts (energy savings, consumer average lifecycle cost savings,
national net present value increase, and emission reductions) outweigh
the costs (loss of industry net present value and life-cycle cost
increases for some consumers). DOE estimates that these regulations
will produce an energy savings between 3.7 and 6.3 quads over 30 years.
The benefit to the Nation will be between $8.1 billion (7% discount
rate) and $24.7 billion (3% discount rate). DOE believes that the
proposed energy standards for manufactured housing, battery chargers
and external power supplies, walk-in coolers and freezers, and
incandescent reflector lamps will also be beneficial to the Nation.
However, because DOE has not yet proposed candidate standard levels for
this equipment, DOE cannot provide an estimate of combined aggregate
costs and benefits for these actions. DOE will, however, in compliance
with all applicable law, issue standards that provide the maximum
energy savings that are technologically feasible and economically
justified. Estimates of
[[Page 7712]]
energy savings will be provided when DOE issues the notices of proposed
rulemaking for this equipment.
DOE--ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE)
Proposed Rule Stage
27. Energy Efficiency Standards for Battery Chargers and External Power
Supplies
Priority: Economically Significant. Major status under 5 U.S.C. 801
is undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 6295(u)
CFR Citation: 10 CFR 430.
Legal Deadline: Final, Statutory, July 1, 2011.
Abstract: In addition to the existing general definition of
``external power supply,'' the Energy Independence and Security Act of
2007 (EISA) defines a ``Class A external power supply'' and sets
efficiency standards for those products. EISA directs DOE to publish a
final rule to determine whether the standards set for Class A external
power supplies should be amended. EISA also requires DOE to issue a
final rule prescribing energy conservation standards for battery
chargers, if technologically feasible and economically justified.
Statement of Need: The Energy Policy and Conservation Act (EPCA)
requires minimum energy standards for appliances, which has the effect
of eliminating inefficient appliances and equipment from the market.
Summary of Legal Basis: Title III of EPCA sets forth a variety of
provisions designed to improve energy efficiency. Part A of title III
(42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program
for Consumer Products other than Automobiles. EPCA directs DOE to
conduct a rulemaking to establish energy conservation standards for
battery chargers or determine that no energy conservation standard is
technically feasible and economically justified (42 U.S.C. 6295
(u)(1)(E)(i) and (ii)).
In addition to the existing general definition of ``external power
supply,'' EPCA defines a ``Class A external power supply'' (42 U.S.C.
6291(36)(C)) and sets efficiency standards for those products (42
U.S.C. 6295(u)(3)). EPCA directs DOE to publish a final rule to
determine whether amended standards should be set for Class A external
power supplies, or new standards set for other classes of external
power supplies. If such determination is positive, DOE must include any
amended or new standards as part of that final rule.
DOE is bundling the two requirements to establish energy
conservation standards for battery chargers and to consider amended or
new standards for external power supplies into a single rulemaking.
Alternatives: The statute requires the Department to conduct
rulemakings to review standards and to revise standards to achieve the
maximum improvement in energy efficiency that the Secretary determines
is technologically feasible and economically justified. In making this
determination, the Department conducts a thorough analysis of the
alternative standard levels, including the existing standard, based on
the criteria specified by the statute.
Anticipated Cost and Benefits: Because DOE has not yet proposed
candidate standard levels for this equipment, DOE cannot provide an
estimate of combined aggregate costs and benefits for these actions.
DOE will, however, in compliance with all applicable law, issue
standards that provide the maximum energy savings that are
technologically feasible and economically justified. Estimates of
energy savings will be provided when DOE issues the notices of proposed
rulemaking for this equipment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice: Public Meeting, Framework 06/04/09 74 FR 26816
Document Availability.
Comment Period End.................. 07/20/09 .......................
Notice: Public Meeting, Data 09/15/10 75 FR 56021
Availability.
Comment Period End.................. 10/15/10 .......................
Final Rule (Technical Amendment).... 09/19/11 76 FR 57897
NPRM................................ 12/00/11 .......................
Final Action........................ 07/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local, State.
Federalism: Undetermined.
URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/battery_external.html.
Agency Contact: Victor Petrolati, Office of Building Technologies
Program, EE-2J, Department of Energy, Energy Efficiency and Renewable
Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202
586-4549, Email: victor.petrolati@ee.doe.gov.
Related RIN: Related to 1904-AB75.
RIN: 1904-AB57
DOE--EE
28. Energy Conservation Standards for Walk-In Coolers and Walk-In
Freezers
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 6313(f)(4)
CFR Citation: 10 CFR 431.
Legal Deadline: Final, Statutory, January 1, 2012.
Abstract: The Energy Independence and Security Act of 2007
amendments to the Energy Policy and Conservation Act require that DOE
establish maximum energy consumption levels for walk-in coolers and
walk-in freezers.
Statement of Need: The Energy Policy and Conservation Act requires
minimum energy efficiency standards for appliances, which has the
effect of eliminating inefficient appliances and equipment from the
market.
Summary of Legal Basis: Section 312 of the Energy Independence and
Security Act of 2007 (EISA) establishes definitions and standards for
walk-in coolers and walk-in freezers. EISA directs DOE to establish
performance-based standards not later than January 1, 2012 (42 U.S.C.
6313 (f)(4)).
Alternatives: The statute requires the Department to conduct
rulemakings to review standards and to revise standards to achieve the
maximum improvement in energy efficiency that the Secretary determines
is technologically feasible and economically justified. In making this
determination, the Department conducts a thorough analysis of the
alternative standard levels, including the existing standard, based on
the criteria specified by the statute.
Anticipated Cost and Benefits: Because DOE has not yet proposed
candidate standard levels for this equipment, DOE cannot provide an
estimate of combined aggregate costs and benefits for these actions.
DOE will, however, in compliance with all applicable law, issue
standards that provide the maximum energy savings that are
technologically feasible and economically justified. Estimates of
energy savings will be provided when DOE issues the notice of proposed
rulemaking for this equipment.
Timetable:
[[Page 7713]]
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice: Public Meeting, Framework 01/06/09 74 FR 411
Document Availability.
Notice: Public Meeting, Data 04/05/10 75 FR 17080
Availability.
Comment Period End.................. 05/20/10 .......................
NPRM................................ 12/00/11 .......................
Final Action........................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local, State.
Federalism: Undetermined.
Additional Information: Comments pertaining to this rule may be
submitted electronically to WICF-2008-STD-0015@ee.doe.gov.
URL for More Information: www.eere.energy.gov/buildings/appliance_standards/commercial/wicf.html.
URL for Public Comments: www.regulations.gov.
Agency Contact: Charles Llenza, Office of Building Technologies
Program, EE-2J, Department of Energy, Energy Efficiency and Renewable
Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202
586-2192, Email: charles.llenza@ee.doe.gov.
Related RIN: Related to 1904-AB85.
RIN: 1904-AB86
DOE--EE
29. Energy Efficiency Standards for Manufactured Housing
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 17071
CFR Citation: 10 CFR 460.
Legal Deadline: Final, Statutory, December 19, 2011.
Abstract: The rule would establish energy efficiency standards for
manufactured housing and a system to ensure compliance with, and
enforcement of, the standards.
Statement of Need: The Energy Independence and Security Act
requires increased energy efficiency standards for manufactured
housing.
Summary of Legal Basis: Section 413 of the Energy Independence and
Security Act of 2007 (EISA), 42 U.S.C. 17071, directs DOE to develop
and publish energy standards for manufactured housing.
Alternatives: The statute requires DOE to conduct a rulemaking to
establish standards to achieve the maximum improvement in energy
efficiency that the Secretary determines is technologically feasible
and economically justified. In making this determination, DOE conducts
a thorough analysis of the alternative standard levels, including the
existing standard, based on the criteria specified by the statute.
Anticipated Cost and Benefits: Because DOE has not yet proposed
candidate standard levels, DOE cannot provide an estimate of combined
aggregate costs and benefits for these actions. DOE will, however, in
compliance with all applicable law, issue standards that provide the
increased energy savings that are technologically feasible and
economically justified. Estimates of energy savings will be provided
when DOE issues the notice of proposed rulemaking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 02/22/10 75 FR 7556
ANPRM Comment Period End............ 03/24/10 .......................
NPRM................................ 02/00/12 .......................
Final Action........................ 12/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
URL for More Information: www.energycodes.gov/status/mfg_housing.stm.
URL for Public Comments: www.regulations.gov.
Agency Contact: Ronald B. Majette, Program Manager, Office of
Building Technologies Program, EE-2J, Department of Energy, Energy
Efficiency and Renewable Energy, 1000 Independence Avenue SW.,
Washington, DC 20585, Phone: 202 586-7935, Email:
ajett.majette@hq.doe.gov.
RIN: 1904-AC11
DOE--EE
30. Energy Conservation Standards for ER, BR, and Small Diameter
Incandescent Reflector Lamps
Priority: Other Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 6291(30)(C)(ii) and (F); 42 U.S.C.
6295(i)
CFR Citation: 10 CFR 430.
Legal Deadline: None.
Abstract: Amendments to Energy Policy and Conservation Act (EPCA)
in the Energy Independence and Security Act of 2007 (EISA) amended the
energy conservation standards to extend coverage to certain classes of
IRL that had previously been outside the statutory definition of
``incandescent reflector lamp'' although these lamps were excluded from
the statutory standard levels. However, EISA 2007 authorized DOE to
amend these standards if such amendments were warranted. Specifically,
as amended, EPCA exempted certain small diameter, ellipsoidal reflector
(ER) and bulged reflector (BR) lamps from standards. In June 2009, DOE
published a final rule amending existing standards for IRL. In earlier
stages of the June 2009 rulemaking, DOE had interpreted its authority
with regard to IRL as limited to amending congressionally established
standard levels only, and not to the exemptions set by Congress for
certain explicitly identified small diameter ER and BR lamps, commonly
used in track lighting and recessed cans. On further review, DOE has
concluded that DOE has authority to establish efficiency standards for
these currently exempt small diameter ER and BR lamps. However, as a
practical matter, DOE could not consider these lamps as part of the
previous rulemaking because it had not conducted the requisite analyses
to set appropriate standard levels. Pursuant to EPCA, DOE is now
conducting a rulemaking as to energy conservation standards for certain
incandescent reflector lamps (IRL) that have ER or BR bulb shapes, and
for certain IRL with diameters less than 2.25 inches.
Statement of Need: The Energy Policy and Conservation Act requires
minimum energy efficiency standards for appliances, which has the
effect of eliminating inefficient appliances and equipment from the
market.
Summary of Legal Basis: Section 322 of the Energy Independence and
Security Act of 2007 (EISA) establishes definitions and standards for
ER, BR, and BPAR incandescent reflector lamps. (42 U.S.C. 6291(54) to
6291(56), 42 U.S.C. 6295 (i)) Furthermore, section 305 of EISA directs
DOE to, not later than 6 years after issuance of any final rule
establishing or amending a standard, publish either a notice of
determination that standards do not need to be amended or a notice of
proposed rulemaking including new proposed standards. (42 U.S.C. 6295
(m))
Alternatives: The statute requires the Department to conduct
rulemakings to review standards and to revise standards to achieve the
maximum improvement in energy efficiency that the Secretary determines
is technologically feasible and
[[Page 7714]]
economically justified. In making this determination, the Department
conducts a thorough analysis of the alternative standard levels,
including the existing standard, based on the criteria specified by the
statute.
Anticipated Cost and Benefits: Because DOE has not yet proposed
candidate standard levels for this equipment, DOE cannot provide an
estimate of combined aggregate costs and benefits for these actions.
DOE will, however, in compliance with all applicable law, issue
standards that provide the maximum energy savings that are
technologically feasible and economically justified. Estimates of
energy savings will be provided when DOE issues the notice of proposed
rulemaking for this equipment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice: Public Meeting, Framework 05/03/10 75 FR 23191
Document Availability.
Comment Period End.................. 06/17/10 .......................
NPRM................................ 12/00/11 .......................
Final Action........................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/incandescent_lamps.html.
URL for Public Comments: www.regulations.gov.
Agency Contact: Lucy Debutts, Office of Building Technologies
Program, EE-2J, Department of Energy, Energy Efficiency and Renewable
Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202
287-1604, Email: lucy.debutts@ee.doe.gov.
Related RIN: Related to 1904-AA92.
RIN: 1904-AC15
DOE--EE
Final Rule Stage
31. Energy Efficiency Standards for Fluorescent Lamp Ballasts
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 42 U.S.C. 6295(g)
CFR Citation: 10 CFR 430.
Legal Deadline: Final, Judicial, October 28, 2011.
Abstract: DOE is reviewing and updating energy efficiency
standards, as required by the Energy Policy and Conservation Act, to
reflect technological advances. All amended energy efficiency standards
must be technologically feasible and economically justified. This is
the second review of the statutory standards for fluorescent lamp
ballasts.
Statement of Need: The Energy Policy and Conservation Act requires
minimum energy efficiency standards for appliances, which has the
effect of eliminating inefficient appliances and equipment from the
market.
Summary of Legal Basis: The Energy Policy and Conservation Act
(EPCA) of 1975 (42 U.S.C. 6291 to 6309) established an energy
conservation program for major household appliances. Amendments to EPCA
in the National Appliance Energy Conservation Amendments of 1988 (NAECA
1988) established energy conservation standards for fluorescent lamp
ballasts. These amendments also required that DOE (1) conduct two
rulemaking cycles to determine whether these standards should be
amended, and (2) for each rulemaking cycle, determine whether the
standards in effect for fluorescent lamp ballasts should be amended to
apply to additional fluorescent lamp ballasts. (42 U.S.C. 6295(g)(7)(A)
and (B)). On September 19, 2000, DOE published a final rule in the
Federal Register, which completed the first rulemaking cycle to amend
energy conservation standards for fluorescent lamp ballasts. 65 FR
56740. This rulemaking encompasses DOE's second cycle of review to
determine whether the standards in effect for fluorescent lamp ballasts
should be amended and whether the standards should be applicable to
additional fluorescent lamp ballasts.
Alternatives: The statute requires DOE to conduct rulemakings to
review standards and to revise standards to achieve the maximum
improvement in energy efficiency that the Secretary determines is
technologically feasible and economically justified. In making this
determination, DOE conducts a thorough analysis of the alternative
standard levels, including the existing standard, based on the criteria
specified by the statute.
Anticipated Cost and Benefits: DOE believes that the benefits to
the Nation from energy standards for fluorescent lamp ballasts (energy
savings, consumer average lifecycle cost (LCC) savings, national net
present value (NPV) increase, and emission reductions) outweigh the
burdens (loss of NPV and LCC increases of some small electric motor
users). DOE estimates that energy savings from electricity will be
between 3.7 and 6.3 quads over 30 years and the benefits to the Nation
will be between $8.1 and $24.7 billion.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice: Public Meeting, Framework 01/22/08 73 FR 3653
Document Availability.
Notice: Public Meetings, Data 03/24/10 75 FR 14319
Availability.
NPRM................................ 04/11/11 76 FR 20090
NPRM Comment Period End............. 06/11/11 .......................
Notice of Data Availability (NODA); 08/24/11 76 FR 52892
Request for Comments.
NODA Comment Period End............. 09/14/11 .......................
Final Action........................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local, State.
Federalism: This action may have federalism implications as defined
in EO 13132.
URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/fluorescent_lamp_ballasts.html
URL for Public Comments: www.regulations.gov.
Agency Contact: Tina Kaarsberg, Office of Building Technologies
Program, EE-2J, Department of Energy, Energy Efficiency and Renewable
Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202
287-1393, Email: tina.kaarsberg@ee.doe.gov.
Related RIN: Related to 1904-AB77, Related to 1904-AA99.
RIN: 1904-AB50
BILLING CODE 6450-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Statement of Regulatory Priorities for FY 2012
The Department of Health and Human Services is the Federal
Government's principal agency charged with protecting the health of all
Americans and providing essential human services, especially for those
least able to help
[[Page 7715]]
themselves. The Department operates more than 300 programs covering a
wide spectrum of activities, manages almost a quarter of all Federal
outlays, and administers more grant dollars than all other Federal
agencies combined. The Department's major program responsibilities
include: Medicare and Medicaid; control and prevention of communicable
and chronic disease; support for public health preparedness and
emergency response; biomedical research; substance abuse and mental
health treatment and prevention; assuring safe and effective drugs,
devices, and other medical products; protecting the food supply;
assistance to low-income families; the Head Start program; and
improving access to health care services to the uninsured, isolated, or
medically vulnerable. Currently, the Department is the principal agency
charged with implementing one of the President's signature
achievements--transformative health care reform through the Affordable
Care Act of 2010.
To implement this vast program portfolio, the Department develops
an active regulatory agenda each year, driven largely by statutory
mandates and interactions with stakeholders. The President also called
upon Federal agencies to reform the regulatory process in his January
18, 2011, Executive Order 13563 ``Improving Regulation and Regulatory
Review.'' A key directive in that Executive order was to require
agencies to conduct an inventory of existing regulations to determine
whether such regulations should be modified, streamlined, expanded, or
repealed to make an agency's regulatory scheme more effective or less
burdensome in achieving its programmatic objectives.
With these regulatory drivers in mind, Secretary Kathleen Sebelius
has worked with HHS agencies to craft a regulatory agenda that reflects
her commitments to implementing meaningful health care reform, access
to health care coverage, and high value health care services that are
safe and effective for all Americans. The agenda also reflects her
other strategic initiatives, which include securing and maintaining
health care coverage for all Americans; improving quality and patient
safety; more rapidly responding to adverse events; implementing a 21st
century food safety system; helping Americans achieve and maintain
healthy living habits; advancing scientific research; and streamlining
regulations to reduce the regulatory burden on industry and States.
Within this agenda, the Secretary has also been mindful of the need to
reform the ongoing regulatory process through retrospective review of
existing regulations, and this agenda reflects her commitment to that
review by incorporating some of the most significant burden reduction
reforms across all Federal agencies. In fact, of the $10 billion in
savings from retrospective regulatory review across all Federal
agencies announced by the Administrator of the Office of Information
and Regulatory Affairs, $5 billion was attributable to regulations
contained within this Department's current regulatory agenda.
What follows is an overview of the Department's regulatory
priorities for FY 2012 and some of the regulations on the agenda that
best exemplify these priorities.
Making Health Insurance Coverage More Secure for Those Who Have
Insurance and Extending Coverage to the Uninsured
As a result of the Affordable Care Act, the Department is making
affordable health care coverage more stable and secure through
insurance market reforms designed to protect consumers against
unreasonable insurance premium increases, provide them with more
comprehensive and understandable information with which to make
decisions, and enable eligible consumers to receive financial support
for health insurance easily and seamlessly. In 2014, all people who
suffer from chronic conditions will no longer be excluded from
insurance coverage or charged higher premiums because of a pre-existing
condition or medical history.
Already, insurers are prohibited from putting lifetime dollar
limits and restrictive annual caps on what they will pay for health
care services needed by the people they insure, ensuring that those
people have access to medical care throughout their lives, especially
when it is most needed. HHS is working with States to help identify and
put a stop to unreasonable health insurance premium rate increases and
will require new health plans to implement a comprehensive appeals
process for those beneficiaries who have been denied coverage or
payment by the insurance plan. New health insurers will also be
required to spend the majority of health insurance premiums on medical
care and health care quality improvement, not on administration and
overhead. As well, the Affordable Care Act is providing reimbursement
to employers that offer health benefits to early retirees, providing
insurance coverage through the Pre-existing Condition Insurance Plan to
people who would otherwise be locked out of the insurance market
because of their pre-existing health conditions, and requiring plans
that offer dependent coverage to make that coverage available to young
adults up to age 26.
Moving forward this year, the Department will continue to implement
the Affordable Care Act to promote consumer protections, improve
quality and safety, provide incentives for more efficient care
delivery, and slow the growth of health care costs. The Centers for
Medicare & Medicaid Services (CMS) will finalize three rules that will
expand access to health insurance and provide consumers with better
options and information about insurance:
CMS will issue standards for the establishment of the
Affordable Insurance Exchanges (Exchanges) to provide competitive
marketplaces for individuals and small employers to directly compare
available private health insurance options on the basis of price and
quality. These Exchanges will help enhance competition in the health
insurance market, improve choice of affordable health insurance, and
give small businesses the same purchasing clout as large businesses.
Another rule helps to make coverage more secure by
offsetting market uncertainty and risk selection to maintain the
viability of Exchanges. Under risk adjustment, HHS, in consultation
with the States, will establish criteria and methods to be used by
States in determining the actuarial risk of plans within a State to
minimize the negative effects of adverse selection. Under reinsurance,
all health insurance issuers, and third-party administrators on behalf
of self-insured group health plans, will contribute to a nonprofit
reinsurance entity to support reinsurance payments to individual market
issuers that cover high risk individuals.
To extend health insurance to greater numbers of low-
income people, Medicaid eligibility in 2014 will expand to cover adults
under the age of 65 earning up to 133 percent of the Federal poverty
level, and those who earn above that level may be eligible for tax
credits through the Exchanges to help pay their premiums. New,
simplified procedures for determining Medicaid, CHIP, and tax credit
eligibility will be forthcoming in 2012. CMS will simplify eligibility
rules to make it easier for eligible individuals and families to obtain
premium tax credits and Medicaid coverage, including ensuring that
Medicaid uses the same eligibility standards as other insurance
affordability programs available through the Exchange, as directed by
law. The rule further outlines how Medicaid and CHIP will coordinate
closely with the Exchange,
[[Page 7716]]
including sharing data to ensure that individuals are determined
eligible for the appropriate insurance affordability program regardless
of where an applicant submits the application.
Improving Health Care Quality and Patient Safety
Across America and for all Americans, the Department is working to
improve patient outcomes, ensure patient safety, promote efficiency and
accountability, encourage shared responsibility, and reduce health care
costs. Through improved administrative processes, reforms, innovations,
and additional information to support consumer decisionmaking, HHS is
supporting high-value, safe, and effective care across health care
settings and in the community.
In 2011, the Department published a key regulation to advance this
priority--the final rule for Accountable Care Organizations. This rule
establishes a system of shared savings for qualified organizations that
deliver primary care services to a given patient population. The
objective is to promote accountability and shared responsibility for
the delivery of care, especially to those with co-morbidities of
chronic health problems in order to prevent unnecessary and costly in-
patient hospital care, reduce health care acquired conditions, and
improve the quality of life for those individuals. This rule serves as
a companion to additional demonstration programs designed to explore
alternative services delivery and payment systems that are being
sponsored by the new Center for Medicare and Medicaid Innovation.
Several more key regulations are on the agenda to move forward in
meeting these quality and patient safety goals:
CMS is implementing value-based purchasing programs
throughout its payment structure in order to reward hospitals and other
health care providers for delivering high-quality care, rather than
just a high volume of services. The payment rules scheduled for
publication this year will reflect a mix of standards, processes,
outcomes, and patient experience of care measures, including measures
of care transition and changes in patient functional status.
The Department continues to encourage health care
providers to become meaningful users of health information technology
(IT) by accelerating health IT adoption and promoting electronic health
records to help improve the quality of health care, reduce costs, and
ultimately, improve health outcomes. Electronic health records and
health information exchange can help clinicians provide higher quality
and safer care for their patients. By adopting electronic health
records in a meaningful way, clinicians will know more about their
patients to better coordinate and improve the quality of patient care,
and they can make better decisions about treatments and conditions.
Improving Response to Adverse Events
In a related activity, the FDA will be proposing a new rule to
establish a unique identification system for medical devices in order
to track a device from pre-market application through distribution and
use. This system will allow FDA and other public health entities to
track individual devices so that when an adverse event occurs,
epidemiologists can quickly track down and identify other users of the
device to provide guidance and recommendations on what steps to take to
prevent additional adverse actions.
Implementing a 21st Century Food Safety System
The Food Safety Modernization Act of 2010, signed into law by the
President in January 2011, directs the Food and Drug Administration
(FDA), working with a wide range of public and private partners, to
build a new system of food safety oversight--one focused on applying
the best available science and good common sense to prevent the
problems that can make people sick. In implementing that Act, the
Department's goal is to shift emphasis from removing unsafe products
from the market place to keeping unsafe food from entering commerce in
the first place.
FDA will propose several new rules to establish a robust, enhanced
food safety program.
FDA will propose regulations establishing preventive
controls in the manufacture and distribution of human foods and of
animal feeds. These regulations will constitute the heart of the food
safety program by instituting, for the first time, good manufacturing
practices for the manufacture and distribution of food products to
ensure that those products are safe for consumption and will not cause
or spread disease.
Perhaps most anticipated in light of food borne illnesses
occurring in 2011, FDA will introduce a rule addressing produce safety
to ensure that produce sold in the marketplace meets rigorous safety
standards. The regulation will set enforceable, science-based standards
for the safe production and harvesting of fresh produce at the farm and
the packing house to minimize the risk of serious adverse health
consequences.
In another proposed rule, FDA will require food importers
to have a foreign supplier verification program that will be adequate
to provide assurances that each foreign supplier produces food in a
manner that provides the same level of protection as required for
domestic production under the Food Drug and Cosmetic Act.
FDA will establish a program to accredit third-party
auditors to conduct food safety audits of foreign entities. Such a
program will relieve importers of having to establish such programs
themselves and, instead, allow them to contract with an accredited
auditor to meet the audit requirements.
Empowering Americans To Make Healthy Choices in the Marketplace
Roughly two-thirds of adults and one-third of children in the
United States are overweight or obese, increasing their risk for
chronic diseases, including heart disease, type 2 diabetes, certain
cancers, stroke, and arthritis. Almost 10 percent of all medical
spending is used to treat obesity-related conditions. In order to
reverse the obesity epidemic, HHS is employing a comprehensive approach
that includes both clinical and public health strategies and touches
people where they live, work, learn, and play.
To help advance this agenda, FDA will finalize two rules aimed at
empowering consumers to make healthy eating choices. The rules require
nutrition labeling on standard menu items in restaurants and similar
retail food establishments, as well as on food sold in vending
machines. One rule will require restaurants and similar retail food
establishments with 20 or more locations to list calorie content
information for standard menu items on restaurant menus and menu
boards, including drive-through menu boards. Other nutrient
information--total calories, fat, saturated fat, cholesterol, sodium,
total carbohydrates, sugars, fiber and total protein--would have to be
made available in writing upon request. The other rule will require
vending machine operators who own or operate 20 or more vending
machines to disclose calorie content for some items. The Department
anticipates that such information will ensure that patrons of chain
restaurants and vending machines have nutritional information about the
food they are consuming.
Two additional rules will also improve dietary information
available to consumers. One is a revision to the nutrition and
supplement facts labels. Much of the information found on the Nutrition
Facts label has not been updated since 1993 when mandatory
[[Page 7717]]
nutrition labeling of food was first required. The aim of the proposed
revision is to provide updated and easier to read nutrition information
on the label to help consumers maintain healthy dietary practices. The
other proposed rule will focus on the serving sizes of foods that can
reasonably consumed in one serving. This rule would amend the labeling
regulations to provide updated reference amounts for certain food
categories with new consumption data derived from the current National
Health and Nutrition Survey.
Advancing Scientific Research
To effectively address the challenges the Department faces in
crafting the best, evidence-based approaches to advance health services
delivery, protect the public health, ensure essential human services,
promote biomedical research, and ensure the availability of safe
medical and food products, the Department must rely on research. The
lynchpin of this research is found in the ethical rules governing
research on human subjects.
In a major undertaking, the Department is in the process of
reviewing and revising those ethical rules, commonly referred to as the
Common Rule. The Common Rule serves to guide researchers and
investigators in the Department, but also throughout the Federal
Government, in the conduct and protocols for doing research on human
subjects. The proposed revisions will be designed to better protect
human subjects who are involved in research, while facilitating
research and reducing burden, delay, and ambiguity for investigators.
Streamlining Regulations To Reduce Regulatory Burdens
Consistent with the President's Executive Order 13563, the
Department continues its commitment to reducing the regulatory burden
on the health care industry through the use of modern technology. As
part of this effort, FDA will advance several rules designed to reduce
the reporting and data submission requirements from manufacturers of
drugs and medical devices.
In one such rule, FDA will permit manufacturers, importers, and
users of medical devices to submit reports of adverse events to the FDA
electronically. This proposed change will not only reduce the paper
reporting burden on industry, but also allow FDA to more quickly review
safety reports and identify emerging public health issues. Under
another proposed rule, FDA would revise existing regulations to allow
clinical study data and bioequivalence data for new drug applications
and biological license applications to be provided electronically.
Again, this rule will reduce the reporting burden on industry and also
permit FDA to more readily process and review applications.
CMS is also engaged in regulatory reduction and streamlining
activities. Of particular note are several rules on conditions of
participation for hospitals and other providers. The most comprehensive
of these rules is the one reducing regulatory burdens on hospitals,
which is expected to save as much as $940 million annually over the
next 5 years. This rule will implement changes to hospital conditions
of participation to reflect substantial advances in health care
delivery and patient safety knowledge and practices.
HHS--OFFICE OF THE SECRETARY (OS)
Proposed Rule Stage
32. Health Information Technology: New and Revised Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 300jj-14
CFR Citation: 45 CFR 170.
Legal Deadline: None.
Abstract: The final rule that established the initial set of
standards, implementation specifications, and certification criteria
was published in the Federal Register on July 28, 2010. The initial set
represented the first round of an incremental approach to adopting
future sets of standards, implementation specifications, and
certification criteria to enhance electronic health record (EHR)
interoperability, functionality, and utility. Under the authority
provided by section 3004 of the Public Health Service Act (PHSA), this
notice of proposed rulemaking would propose that the Secretary adopt
revisions to the initial set as well as new standards, implementation
specifications and certification criteria. The proposed new and revised
standards, implementation specifications, and certification criteria
would establish the technical capabilities that certified EHR
technology would need to include to support meaningful use under the
CMS Medicare and Medicaid EHR Incentive Programs.
Statement of Need: The final rule that established the initial set
of standards, implementation specifications, and certification criteria
was published in the Federal Register on July 28, 2010. The initial set
represented the first round of an incremental approach to adopting
future sets of standards, implementation specifications, and
certification criteria for electronic health record (EHR) technology.
In a notice of proposed rulemaking, the Secretary would propose new and
revised standards, implementation specifications, and certification
criteria that would establish the technical capabilities that certified
EHR technology would need to include in order to support meaningful use
under the CMS Medicare and Medicaid EHR Incentive Programs.
Summary of Legal Basis: Under the authority provided by section
3004 of the Public Health Service Act (PHSA), the Secretary would
propose to adopt revisions to the initial set of standards,
implementation specifications, and certification criteria and propose
new standards, implementation specifications and certification
criteria.
Alternatives: No alternatives are available because eligible
professionals, eligible hospitals, and critical access hospitals under
the CMS Medicare and Medicaid EHR Incentive Programs are required to
demonstrate meaningful use of certified EHR technology. This rule
ensures that the certification requirements necessary to support the
achievement of meaningful use Stage 2 keep pace with the changes to the
requirements in the CMS Medicare and Medicaid EHR Incentive Programs.
Anticipated Cost and Benefits: EHR technology developers seeking
certification are expected to incur costs related to EHR technology
redesign, reprogramming, and new capability development. Benefits
include greater standardization and increased EHR technology
interoperability and functionality.
Risks: Absent a rulemaking, it is unlikely that currently certified
EHR technology would include the requisite capacities to support an
eligible professional's, eligible hospital's, or critical access
hospital's achievement of meaningful use under the CMS Medicare and
Medicaid EHR Incentive Programs.
Timetable:
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Action Date FR Cite
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Regulatory Flexibility Analysis Required: Undetermined.
[[Page 7718]]
Government Levels Affected: None.
Agency Contact: Steven Posnack, Policy Analyst, Department of
Health and Human Services, Office of the Secretary, Office of the
National Coordinator for Health Information Technology, 200
Independence Avenue SW., Washington, DC 20201, Phone: 202 690-7151.
RIN: 0991-AB82
HHS--FOOD AND DRUG ADMINISTRATION (FDA)
Proposed Rule Stage
33. Electronic Submission of Data From Studies Evaluating Human Drugs
and Biologics
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262
CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR
314.96.
Legal Deadline: None.
Abstract: The Food and Drug Administration is proposing to amend
the regulations governing the format in which clinical study data and
bioequivalence data are required to be submitted for new drug
applications (NDAs), biological license applications (BLAs), and
abbreviated new drug applications (ANDAs). The proposal would revise
our regulations to require that data submitted for NDAs, BLAs, and
ANDAs, and their supplements and amendments, be provided in an
electronic format that FDA can process, review, and archive.
Statement of Need: Before a drug is approved for marketing, FDA
must determine that the drug is safe and effective for its intended
use. This determination is based in part on clinical study data and
bioequivalence data that are submitted as part of the marketing
application. Study data submitted to FDA in electronic format have
generally been more efficient to process and review.
FDA's proposed rule would address the submission of study data in a
standardized electronic format. Electronic submission of study data
would improve patient safety and enhance health care delivery by
enabling FDA to process, review, and archive data more efficiently.
Standardization would also enhance the ability to share study data and
communicate results. Investigators and industry would benefit from the
use of standards throughout the lifecycle of a study--in data
collection, reporting, and analysis. The proposal would work in concert
with ongoing Agency and national initiatives to support increased use
of electronic technology as a means to improve patient safety and
enhance health care delivery.
Summary of Legal Basis: Our legal authority to amend our
regulations governing the submission and format of clinical study data
and bioequivalence data for human drugs and biologics derives from
sections 505 and 701 of the Act (21 U.S.C. 355 and 371) and section 351
of the Public Health Service Act (42 U.S.C. 262).
Alternatives: FDA considered issuing a guidance document outlining
the electronic submission and the standardization of study data, but
not requiring electronic submission of the data in the standardized
format. This alternative was rejected because the Agency would not
fully benefit from standardization until it became the industry
standard, which could take up to 20 years.
We also considered a number of different implementation scenarios,
from shorter to longer time-periods. The 2-year time-period was
selected because the Agency believes it would provide ample time for
applicants to comply without too long a delay in the effective date. A
longer time-period would delay the benefit from the increased
efficiencies, such as standardization of review tools across
applications, and the incremental cost savings to industry would be
small.
Anticipated Cost and Benefits: Standardization of clinical data
structure, terminology, and code sets will increase the efficiency of
the Agency review process. FDA estimates that the costs resulting from
the proposal would include substantial one-time costs, additional waves
of one-time costs as standards mature, and possibly some annual
recurring costs. One-time costs would include, among other things, the
cost of converting data to standard structures, terminology, and cost
sets (i.e., purchase of software to convert data); the cost of
submitting electronic data (i.e., purchase of file transfer programs);
and the cost of installing and validating the software and training
personnel. Additional annual recurring costs may result from software
purchases and licensing agreements for use of proprietary
terminologies. The proposal could result in many long-term benefits
associated with reduced time for preparing applications, including
reduced preparation costs and faster time to market for beneficial
products. In addition, the proposed rule would improve patient safety
through faster, more efficient, comprehensive and accurate data review,
as well as enhanced communication among sponsors and clinicians.
Risks: None.
Timetable:
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Action Date FR Cite
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NPRM................................ 03/00/12 .......................
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Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Martha Nguyen, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3471, Fax: 301
847-8440, Email: martha.nguyen@fda.hhs.gov.
RIN: 0910-AC52
HHS--FDA
34. Current Good Manufacturing Practice and Hazard Analysis and Risk-
Benefit Preventive Controls for Food for Animals
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350e; 21 U.S.C. 371; 21
U.S.C. 374; 42 U.S.C. 264; Pub. L. 110-85, sec 1002(a)(2); Pub. L. 111-
353
CFR Citation: 21 CFR 228.
Legal Deadline: Final, Statutory, September 27, 2009, FDA is
directed to issue proposed and final regulations under FDA Amendments
Act by the statutory deadline.
The legal deadline for FDA under the Food Safety and Modernization
Act to promulgate regulations is July 2012.
Abstract: The Food and Drug Administration (FDA) is proposing
regulations for preventive controls for animal feed ingredients and
mixed animal feed to provide greater assurance that marketed animal
feed ingredients and mixed feeds intended for all animals, including
pets, are safe. This action is being taken as part of the FDA's Animal
Feed Safety System initiative. This action is also being taken to carry
out the requirements of the Food and Drug Administration Amendments Act
of 2007, under section 1002(a), and the Food Safety Modernization Act
of 2010 (FSMA), under section 103.
Statement of Need: Regulatory oversight of the animal food industry
has traditionally been limited and
[[Page 7719]]
focused on a few known safety issues, so there could be potential human
and animal health problems that remain unaddressed. The massive pet
food recall due to adulteration of pet food with melamine and cyanuric
acid in 2007 is a prime example. The actions taken by two protein
suppliers in China affected a large number of pet food suppliers in the
United States and created a nationwide problem. By the time the cause
of the problem was identified, melamine and cyanuric acid contaminated
ingredients resulted in the adulteration of millions of individual
servings of pet food. Congress passed FSMA which the President signed
into law on January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding
section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive
Controls. In enacting FSMA, Congress sought to improve the safety of
food in the United States by taking a risk-based approach to food
safety, emphasizing prevention. Section 418 of the FD&C Act requires
owners, operators, or agents in charge of food facilities to develop
and implement a written plan that describes and documents how their
facility will implement the hazard analysis and preventive controls
required by this section.
Summary of Legal Basis: FDA's authority for issuing this rule is
provided in FSMA (Pub. L. 111-353), which amended the FD&C Act by
establishing section 418, which directed FDA to publish implementing
regulations. FSMA also amended section 301 of the FD&C Act to add
301(uu) that states the operation of a facility that manufactures,
processes, packs, or holds food for sale in the United States if the
owner, operator, or agent in charge of such facility is not in
compliance with section 418 of the FD&C Act is a prohibited act.
Further authority comes from section 1002(a) of title X of the FDAAA of
2007 (21 U.S.C. 2102) requiring the Secretary to update standards for
the processing of pet food.
FDA is also issuing this rule under the general requirements of
section 402 of the FD&C Act (21 U.S.C. 342) for adulterated food.
In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a))
authorizes the Agency to issue regulations for the efficient
enforcement of the Act.
Alternatives: The 2011 FSMA limited the Agency's flexibility to
exclude many requirements. It described in detail its requirements for
subpart C, concerning the hazard analysis and risk-based preventive
controls part of the proposed rule. Alternatives include certain
requirements listed in subpart B concerning operations and practices.
Anticipated Cost and Benefits: The benefits of the proposed rule
would result from fewer cases of contaminated animal food ingredients
or finished animal food products. Discovering contaminated food
ingredients before they are used in a finished product would reduce the
number of recalls of contaminated animal food products. Benefits would
include reduced medical treatment costs for animals and humans, reduced
loss of market value of live animals, reduced loss of animal
companionship, and reduced loss in value of animal food products. More
stringent requirements for animal food manufacturing would maintain
public confidence in the safety of animal foods and protect animal and
human health. FDA lacks sufficient data to quantify the benefits of the
proposed rule.
The compliance costs of the proposed rule would result from the
additional labor and capital required to perform the hazard analyses,
write and implement the preventive controls, monitor and verify the
preventive controls, take corrective actions if preventive controls
fail to prevent feeds from becoming contaminated, and implement
requirements from the operations and practices section.
Risks: FDA is proposing this rule to provide greater assurance that
food intended for animals is safe and will not cause illness or injury
to animals or humans. This rule would implement a risk-based,
preventive controls food safety system intended to prevent animal food
containing hazards, which may cause illness or injury to animals or
humans, from entering into the food supply. The rule would apply to
domestic and imported animal food (including raw materials and
ingredients). Fewer cases of animal food contamination would (1) reduce
the risk of serious illness and death to animals, (2) reduce the risk
of adverse health effects to humans handling animal food, and (3)
reduce the risk of consuming human food from animals that consumed
contaminated food.
Timetable:
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Action Date FR Cite
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Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Kim Young, Deputy Director, Division of Compliance,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519
Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email:
kim.young@fda.hhs.gov.
RIN: 0910-AG10
HHS--FDA
35. Unique Device Identification
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Not Yet Determined
CFR Citation: 21 CFR 16; 21 CFR 801; 21 CFR 803; 21 CFR 806; 21 CFR
810; 21 CFR 814; 21 CFR 820; 21 CFR 821; 21 CFR 822.
Legal Deadline: None.
Abstract: The Food and Drug Administration Amendments Act of 2007
(FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding
section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to
promulgate regulations establishing a unique identification system for
medical devices requiring the label of medical devices to bear a unique
identifier, unless FDA specifies an alternative placement or provides
for exceptions. The unique identifier must adequately identify the
device through distribution and use, and may include information on the
lot or serial number.
Statement of Need: A unique device identification system will help
reduce medical errors; will allow FDA, the healthcare community, and
industry to more rapidly review and organize adverse event reports;
identify problems relating to a particular device (even down to a
particular lot or batch, range of serial numbers, or range of
manufacturing or expiration dates); and thereby allow for more rapid,
effective, corrective actions that focus sharply on the specific
devices that are of concern.
Summary of Legal Basis: Section 519(f) of the FD&C Act (added by
sec. 226 of the Food and Drug Administration Amendments Act of 2007)
directs the Secretary to promulgate regulations establishing a unique
device identification (UDI) system for medical devices, requiring the
label of devices to bear a unique identifier that will adequately
identify the device through its distribution and use.
Alternatives: FDA considered several alternatives that would allow
certain
[[Page 7720]]
requirements of the proposed rule to vary, such as the required
elements of a UDI and the scope of affected devices.
Anticipated Cost and Benefits: FDA estimates that the affected
industry would incur one-time and recurring costs, including
administrative costs, to change and print labels that include the
required elements of a UDI, costs to purchase equipment to print and
verify the UDI, and costs to purchase software and integrate and
validate the UDI into existing IT systems. FDA anticipates that
implementation of a UDI system would help improve the efficiency and
accuracy of medical device recalls and medical device adverse event
reporting. The proposed rule would also standardize how medical devices
are identified and contribute to future potential public health
benefits of initiatives aimed at optimizing the use of automated
systems in healthcare. Most of these benefits, however, require
complementary developments and innovations in the private and public
sectors.
Risks: This rule is intended to substantially eliminate existing
obstacles to the consistent identification of medical devices used in
the United States. By providing the means to rapidly and accurately
identify a device and key attributes that affect its safe and effective
use, the rule would reduce medical errors that result from
misidentification of a device or confusion concerning its appropriate
use. The rule will fulfill a statutory directive to establish a unique
device identification system.
Timetable:
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Action Date FR Cite
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NPRM................................ 01/00/12 .......................
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Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: John J. Crowley, Senior Advisor for Patient Safety,
Department of Health and Human Services, Food and Drug Administration,
Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 980-1936, Email:
jay.crowley@fda.hhs.gov.
RIN: 0910-AG31
HHS--FDA
36. Produce Safety Regulation
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42
U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)
CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Statutory, January 4, 2012, Proposed rule not
later than 12 months after the date of enactment of the Food Safety
Modernization Act.
Abstract: The Food Safety Modernization Act requires the Secretary
to establish and publish science-based minimum standards for the safe
production and harvesting of those types of fruits and vegetables,
including specific mixes or categories of fruits and vegetables, that
are raw agricultural commodities for which the Secretary has determined
that such standards minimize the risk of serious adverse health
consequences or death. FDA is proposing to promulgate regulations
setting enforceable standards for fresh produce safety at the farm and
packing house. The purpose of the proposed rule is to reduce the risk
of illness associated with contaminated fresh produce. The proposed
rule will be based on prevention-oriented public health principles and
incorporate what we have learned in the past decade since the Agency
issued general good agricultural practice guidelines entitled ``Guide
to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables'' (GAPs Guide). The proposed rule also will reflect comments
received on the Agency's 1998 update of its GAPs guide and its July
2009 draft commodity specific guidances for tomatoes, leafy greens, and
melons. Although the proposed rule will be based on recommendations
that are included in the GAPs guide, FDA does not intend to make the
entire guidance mandatory. FDA's proposed rule would, however, set out
clear standards for implementation of modern preventive controls. The
proposed rule also would emphasize the importance of environmental
assessments to identify hazards and possible pathways of contamination
and provide examples of risk reduction practices recognizing that
operators must tailor their preventive controls to particular hazards
and conditions affecting their operations. The requirements of the
proposed rule would be scale appropriate and commensurate with the
relative risks and complexity of individual operations. FDA intends to
issue guidance to assist industry in complying with the requirements of
the new regulation.
Statement of Need: FDA is taking this action to meet the
requirements of the FSMA and to address the food safety challenges
associated with fresh produce and thereby protect the public health.
Data indicate that between 1973 and 1997, outbreaks of foodborne
illness in the U.S. associated with fresh produce increased in absolute
numbers and as a proportion of all reported foodborne illness
outbreaks. The Agency issued general good agricultural practice
guidelines for fresh fruits and vegetables over a decade ago.
Incorporating prevention-oriented public heath principles and
incorporating what we have learned in the past decade into a regulation
is a critical step in establishing standards for the growing,
harvesting, packing, and storing of produce and reducing the foodborne
illness attributed to fresh produce.
Summary of Legal Basis: FDA is relying on the amendments to the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), provided by
section 105 of the Food Safety Modernization Act (codified primarily in
sec. 419 of the FD&C Act (21 U.S.C. 350h)). FDA's legal basis also
derives in part from sections 402(a)(4) and 701(a) of the FD&C Act (21
U.S.C. 342(a)(4) and 371(a)). FDA also intends to rely on section 361
of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives
FDA authority to promulgate regulations to control the spread of
communicable disease.
Alternatives: Section 105 of the Food Safety Modernization Act
requires FDA to conduct this rulemaking.
Anticipated Cost and Benefits: FDA estimates that the costs to more
than 300,000 domestic and foreign producers and packers of fresh
produce from the proposal would include one-time costs (e.g., new tools
and equipment) and recurring costs (e.g., monitoring, training,
recordkeeping). FDA anticipates that the benefits would be a reduction
in foodborne illness and deaths associated with fresh produce.
Monetized estimates of costs and benefits are not available at this
time.
Risks: This regulation would directly and materially advance the
Federal Government's substantial interest in reducing the risks for
illness and death associated with foodborne infections associated with
the consumption of fresh produce. Less restrictive and less
comprehensive approaches have not been sufficiently effective in
reducing the problems addressed by this
[[Page 7721]]
regulation. FDA anticipates that the regulation would lead to a
significant decrease in foodborne illness associated with fresh produce
consumed in the U.S.
Timetable:
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Action Date FR Cite
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NPRM................................ 01/00/12 .......................
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Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Samir Assar, Supervisory Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Office of Food Safety,
5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636,
Email: samir.assar@fda.hhs.gov.
RIN: 0910-AG35
HHS--FDA
37. Hazard Analysis and Risk-Based Preventive Controls
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub.
L. 111-353 (signed on Jan. 4, 2011)
CFR Citation: 21 CFR 110.
Legal Deadline: Final, Statutory, July 4, 2012, Final rule must be
published no later than 18 months after the date of enactment of the
FDA Food Safety Modernizaton Act.
Not later than 9 months after the date of enactment of the FDA Food
Safety Modernization Act.
Abstract: The Food and Drug Administration (FDA) Food Safety
Modernization Act (the FSMA) requires the Secretary of Health and Human
Services to promulgate regulations to establish science-based minimum
standards for conducting a hazard analysis, documenting hazards,
implementing preventive controls, and documenting the implementation of
the preventive controls; and to define the terms ``small business'' and
``very small business.'' The FSMA also requires the Secretary to
promulgate regulations with respect to activities that constitute on-
farm packing or holding of food that is not grown, raised, or consumed
on a farm or another farm under the same ownership and activities that
constitute on farm manufacturing or processing of food that is not
grown, raised, or consumed on a farm or another farm under the same
ownership.
FDA is proposing to amend its current good manufacturing practice
(CGMP) regulations (21 CFR part 110) for manufacturing, packing, or
holding human food to require food facilities to develop and implement
a written food safety plan. This proposed rule would require a food
facility to have and implement preventive controls to significantly
minimize or prevent the occurrence of hazards that could affect food
manufactured, processed, packed, or held by the facility and to provide
assurances that such food will not be adulterated under section 402 or
misbranded under section 403(w).
Statement of Need: FDA is taking this action to meet the
requirements of the FSMA and to better address changes that have
occurred in the food industry and thereby protect public health.
FDA last updated its food CGMP regulations for the manufacturing,
packing, or holding of human food in 1986. Modernizing these food CGMP
regulations to address risk-based preventive controls and more
explicitly address issues such as environmental pathogens, food
allergens, mandatory employee training, and sanitation of food contact
surfaces, would be a critical step in raising the standards for food
production and distribution. By amending 21 CFR 110 to modernize good
manufacturing practices, the agency could focus the attention of food
processors on measures that have been proven to significantly reduce
the risk of food-borne illness. An amended regulation also would allow
the agency to better focus its regulatory efforts on ensuring industry
compliance with controls that have a significant food safety impact.
Summary of Legal Basis: FDA is relying on section 103 of the FSMA.
FDA is also relying on sections 402(a)(3), (a)(4) and 701(a) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
342(a)(3), (a)(4), and 371(a)). Under section 402(a)(3) of the FD&C
Act, a food is adulterated if it consists in whole or in part of any
filthy, putrid, or decomposed substance, or if it is otherwise unfit
for food. Under section 402(a)(4), a food is adulterated if it has been
prepared, packed, or held under unsanitary conditions whereby it may
have become contaminated with filth or may have been rendered injurious
to health. Under section 701(a) of the FD&C Act, FDA is authorized to
issue regulations for the efficient enforcement of the FD&C Act. FDA's
legal basis also derives from section 361 of the Public Health Service
Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate
regulations to control the spread of communicable disease.
Alternatives: An alternative to this rulemaking is not to update
the CGMP regulations, and instead issue separate regulations to
implement the FDA Food Safety Modernization Act.
Anticipated Cost and Benefits: FDA estimates that the costs from
the proposal to domestic and foreign producers and packers of processed
foods would include new one-time costs (e.g., adoption of written food
safety plans, setting up training programs, implementing allergen
controls, and purchasing new tools and equipment) and recurring costs
(e.g., auditing and monitoring suppliers of sensitive raw materials and
ingredients, training employees, and completing and maintaining records
used throughout the facility). FDA anticipates that the benefits would
be a reduced risk of food-borne illness and death from processed foods
and a reduction in the number of safety related recalls.
Risks: This regulation will directly and materially advance the
Federal Government's substantial interest in reducing the risks for
illness and death associated with food-borne infections. Less
restrictive and less comprehensive approaches have not been effective
in reducing the problems addressed by this regulation. The regulation
will lead to a significant decrease in foodborne illness in the U.S.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
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Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: John F. Sheehan, Director, Office of Food Safety,
Division of Plant and Dairy Food Safety, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition (HFS-315), 5100 Paint Branch Parkway, College Park,
MD 20740, Phone: 240 402-1488, Fax: 301 436-2632, Email:
john.sheehan@fda.hhs.gov.
[[Page 7722]]
RIN: 0910-AG36
HHS--FDA
38. Foreign Supplier Verification Program
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Title III, sec 301 of FDA Food Safety
Modernization Act, Pub. L. 111-353, establishing sec 805 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act)
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory, January 4, 2012.
Abstract: The proposed rule would establish regulations concerning
the content of foreign supplier verification programs. The regulations
will require that each importer have a foreign supplier verification
program that is adequate to provide assurances that each foreign
supplier produces food in compliance with: (1) Processes and procedures
that provide the same level of public health protection as those
required under section 418 (concerning hazard analysis and risk-based
preventative controls) or section 419 (concerning produce safety
standards) of the FD&C Act; and (2) sections 402 (concerning
adulteration) and 403(w) (concerning major food allergens) of the FD&C
Act. In promulgating the foreign supplier verification regulations, we
will, as appropriate, take into account differences among importers and
types of imported foods, including differences related to the level of
risk posed by an imported food. Methods of foreign supplier
verification may include monitoring records for shipments, lot-by-lot
certifications of compliance, annual on-site inspections, checking the
hazard analysis and risk-based preventive control plans of foreign
suppliers, and periodically testing and sampling shipments.
Statement of Need: The proposed rule is needed to help improve the
safety of food that is imported into the United States. Imported food
products have increased dramatically over the last several decades.
Data indicate that about 15% of the U.S. food supply is imported. FSMA
provides the Agency with additional tools and authorities to help
ensure that imported foods are safe for U.S. consumers. Included among
these tools and authorities is a requirement that importers perform
risk-based foreign supplier verification activities to verify that the
food they import is produced in compliance with U.S. requirements and
is not adulterated or misbranded. This proposed rule on the content of
foreign supplier verification program (FSVPs) sets forth the proposed
steps that food importers would be required to take to fulfill their
responsibility to ensure the safety of the food they bring into this
country.
Summary of Legal Basis: Section 805(c) of the FD&C Act (21 U.S.C.
384a(c)) directs FDA, not later than 1 year after the date of enactment
of FSMA, to issue regulations on the content of FSVPs. Section
805(c)(4) states that verification activities under such programs may
include monitoring records for shipments, lot-by-lot certification of
compliance, annual onsite inspections, checking the hazard analysis and
risk-based preventive control plans of foreign suppliers, and
periodically testing and sampling shipments of imported products.
Section 301(b) of FSMA amends section 301 of the FD&C Act (21 U.S.C.
331) by adding section 301(zz), which designates as a prohibited act
the importation or offering for importation of a food if the importer
(as defined in section 805) does not have in place an FSVP in
compliance with section 805. In addition, section 301(c) of FSMA amends
section 801(a) of the FD&C Act (21 U.S.C. 381(a)) by stating that an
article of food being imported or offered for import into the United
States shall be refused admission if it appears from an examination of
a sample of such an article or otherwise that the importer is in
violation of section 805.
Alternatives: We are considering a range of alternative approaches
to the requirements for foreign supplier verification activities. These
might include: (1) Establishing a general requirement that importers
determine and conduct whatever verification activity that would
adequately address the risks associated with the foods they import; (2)
allowing importers to choose from a list of possible verification
mechanisms, such as the activities listed in section 805(c)(4) of the
FD&C Act; (3) requiring importers to conduct particular verification
activities for certain types of foods or risks (e.g., for high-risk
foods) but allowing flexibility in verification activities for other
types of foods or risks; and (4) specifying use of a particular
verification activity for each particular kind of food or risk. To the
extent possible while still ensuring that verification activities are
adequate to ensure that foreign suppliers are producing food in
accordance with U.S. requirements, we will seek to give importers the
flexibility to choose verification procedures that are appropriate to
adequately address the risks associated with the importation of a
particular food.
Anticipated Cost and Benefits: We have not yet quantified the cost
and benefits for this proposed rule. However, the available information
suggests that the costs will be significant. Our preliminary analysis
of FY10 OASIS data suggests that this rule will cover about 60,000
importers, 240,000 unique combinations of importers and foreign
suppliers, and 540,000 unique combinations of importers, products, and
foreign suppliers. These numbers imply that provisions that require
activity for each importer, each unique combination of importer and
foreign supplier, or each unique combination of importer, product, and
foreign supplier will generate significant costs. An example of a
provision linked to combinations of importers and foreign suppliers
would be a requirement to conduct a verification activity, such as an
onsite audit, under certain conditions. The cost of onsite audits will
depend in part on whether foreign suppliers can provide the same onsite
audit results to different importers or whether every importer will
need to take some action with respect to each of their foreign
suppliers. The benefits of this proposed rule will consist of the
reduction of adverse health events linked to imported food that could
result from compliance with the FSVP requirements. We have not yet
estimated the benefits of the rule.
Risks: As stated above, about 15 percent of the U.S. food supply is
imported, and many of these imported foods are high-risk commodities.
According to recent data from the Centers for Disease Control and
Prevention, each year, about 48 million Americans get sick, 128,000 are
hospitalized, and 3,000 die from foodborne diseases. From July 1, 2007,
through June 30, 2008, FDA oversaw 40 recalls of imported foods that
were so contaminated that the Agency deemed them to be an imminent
threat. We expect that the adoption of FSVPs by food importers will
lead to a significant reduction to the threat to public health posed by
unsafe imported food, though we are still in the process of trying to
quantify the reduction in risk that will occur through importer
compliance with the FSVP regulations.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
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Regulatory Flexibility Analysis Required: Undetermined.
[[Page 7723]]
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Brian L. Pendleton, Senior Policy Advisor,
Department of Health and Human Services, Food and Drug Administration,
Office of Policy, WO32, Room 4245, 10903 New Hampshire Avenue, Silver
Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email:
brian.pendleton@fda.hhs.gov.
RIN: 0910-AG64.
HHS--FDA
39. Accreditation of Third Parties To Conduct Food Safety Audits and
for Other Related Purposes
Priority: Other Significant.
Legal Authority: Pub. L. 111-353, sec 307, FDA Food Safety
Modernization Act; Other sections of FDA Food Safety Modernization Act,
as appropriate.
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory, July 2012, Promulgate
implementing regulations. Per Public Law 111-353, section 307(c)(5)(C),
promulgate, within 18 months of enactment, implementing regulations for
accreditation of third-party auditors to conduct food safety audits.
Abstract: The Food and Drug Administration (FDA) is proposing
regulations relating to the accreditation of third-party auditors to
conduct food safety audits of foreign entities, including foreign
facilities in the food import supply chain. The proposed regulations
will include provisions to protect against conflicts of interest
between accredited auditors and audited entities, as described in
section 307 of the FDA Food Safety Modernization Act (FSMA), Public Law
111-353. As part of this rulemaking, FDA may propose regulations
relating to the accreditation of third parties to perform related
activities, such as conducting laboratory analyses of food, authorized
by other sections of FSMA.
Statement of Need: The use of accredited third-party auditors to
certify high-risk food imports to assist in ensuring the safety of food
from foreign origin entering U.S. commerce. Accredited third-party
auditors auditing foreign process facilities may be viewed as
increasing FDA's ``coverage'' of foreign facilities that FDA may not
have adequate resources to inspect in a particular year while using
identified standards creating overall uniformity to complete the task.
Audits that result in issuance of facility certificates will provide
FDA information about the compliance status of the facility.
Additionally, auditors will be required to submit audit reports that
may be reviewed by FDA for purposes of compliance assessment and work
planning.
Summary of Legal Basis: Not later than 2 years after the date of
enactment, establish a system for the recognition of accreditation
bodies that accredit third-party auditors, certifying that their
eligible entities meet the requirements, directly accredit third-party
auditors should none be identified and recognized by the 2-year date of
enactment, obtain a list of all accredited third-party auditors and
their agents from recognized accreditation bodies, and determine
requirements for regulatory audit reports while avoiding unnecessary
duplication of efforts and costs.
Alternatives: FSMA described in detail the framework for, and
requirements of, the accredited third-party auditor program.
Alternatives include certain oversight activities required of
recognized accreditation bodies that accredit third-party auditors, as
distinguished from third-party auditors directly accredited by FDA.
Another alternative relates to the nature of the required standards and
the degree to which those standards are prescriptive or flexible.
Anticipated Cost and Benefits: The benefits of the proposed rule
would result from fewer cases of unsafe or misbranded food entering
U.S. commerce. Additional benefits include the increased flow of
credible information to FDA regarding the compliance status of foreign
firms and their foods that are ultimately offered for import Into the
United States, which information in turn would inform FDA's work
planning for inspection of foreign food facilities and might result in
a signal of possible problems with a particular firm or its products,
and with sufficient signals, might raise questions about the rigor of
the food safety regulatory system of the country of origin.
The compliance costs of the proposed rule would result from the
additional labor and capital required of accreditation bodies seeking
FDA recognition and of third-party auditors seeking accreditation to
the extent that will involve the assembling of information for an
application unique to the FDA third-party program. The compliance costs
associated with certification will be accounted for separately under
the costs associated with participation In the foreign supplier
verification program and the costs associated with mandatory
certification for high-risk food imports. The third-party program is
funded through revenue neutral user fees, which will be developed by
FDA through rulemaklng. User fee costs will be accounted for in that
rulemaklng.
Risks: FDA is proposing this rule to provide greater assurance the
food offered for import into the United States is safe and will not
cause injury or illness to animals or humans. The rule would implement
a program for accrediting third-party auditors to conduct food safety
audits of foreign food entities, including registered foreign food
facilities, and based on the findings of the regulatory audit, to issue
certifications to foreign food entities found to be in compliance with
FDA requirements. The certifications would be used by importers seeking
to participate in the Voluntary Qualified Importer Program for
expedited review and entry of product and would be a means to provide
assurance of compliance as required by FDA based on risk-related
considerations. The rule would apply to any foreign or domestic
accreditation body seeking FDA recognition, any foreign or domestic
third-party auditor seeking accreditation, any registered foreign food
facility or other foreign food entity subject to a food safety audit
(including a regulatory audit conducted for purposes of certification),
and any importer seeking to participate in the Voluntary Qualified
Importer Program. Fewer cases of unsafe or misbranded food entering
U.S. commerce would reduce the risk of serious illness and death to
humans and animals.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
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Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Undetermined.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Charlotte A. Christin, Senior Policy Advisor,
Department of Health and Human Services, Food and Drug Administration,
Office of Policy WO32, Room 4234, 10903 New Hampshire Avenue, Silver
Spring, MD 20993, Phone: 301 796-4718, Fax: 301
[[Page 7724]]
847-3541, Email: charlotte.christin@fda.hhs.gov.
RIN: 0910-AG66
HHS--FDA
Final Rule Stage
40. Infant Formula: Current Good Manufacturing Practices; Quality
Control Procedures; Notification Requirements; Records and Reports; and
Quality Factors
Priority: Other Significant.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 350a; 21 U.S.C. 371
CFR Citation: 21 CFR 106 and 107.
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) is revising its
infant formula regulations in 21 CFR parts 106 and 107 to establish
requirements for current good manufacturing practices (CGMP), including
audits; to establish requirements for quality factors; and to amend
FDA's quality control procedures, notification, and record and
reporting requirements for infant formula. FDA is taking this action to
improve the protection of infants who consume infant formula products.
Statement of Need: The Agency published a proposed rule on July 9,
1996, that would establish current good manufacturing practice
regulations, quality control procedures, quality factors, notification
requirements, records, and reports for the production of infant
formula. This proposal was issued in response to the 1986 Amendments to
the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the
comment period to update comments on the proposal. The comment was
extended on June 27, 2003, and ended on August 26, 2003. The comment
period was reopened on August 1, 2006, and ended on September 15, 2006.
Summary of Legal Basis: The Infant Formula Act of 1980 (the 1980
Act) (Pub. L. 96-359) amended the Federal Food, Drug, and Cosmetic Act
(the Act) to include section 412 (21 U.S.C. 350a). This law is intended
to improve protection of infants consuming infant formula products by
establishing greater regulatory control over the formulation and
production of infant formula. In 1982, FDA adopted infant formula
recall procedures in subpart D of 21 CFR part 107 of its regulations
(47 FR 18832, Apr. 30, 1982), and infant formula quality control
procedures in subpart B of 21 CFR part 106 (47 FR 17016, Apr. 20,
1982). In 1985, FDA further implemented the 1980 Act by establishing
subparts B, C, and D in 21 CFR part 107 regarding the labeling of
infant formula, exempt infant formulas, and nutrient requirements for
infant formula, respectively (50 FR 1833, Jan. 14, 1985; 50 FR 48183,
Nov. 22, 1985; and 50 FR 45106, Oct. 30, 1985).
In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (Pub.
L. 99-570) (the 1986 amendments), amended section 412 of the act to
address concerns that had been expressed by Congress and consumers
about the 1980 Act and its implementation related to the sufficiency of
quality control testing, CGMP, recordkeeping, and recall requirements.
The 1986 amendments: (1) State that an infant formula is deemed to be
adulterated if it fails to provide certain required nutrients, fails to
meet quality factor requirements established by the Secretary (and, by
delegation, FDA), or if it is not processed in compliance with the CGMP
and quality control procedures established by the Secretary; (2)
require that the Secretary issue regulations establishing requirements
for quality factors and CGMP, including quality control procedures; (3)
require that infant formula manufacturers regularly audit their
operations to ensure that those operations comply with CGMP and quality
control procedure regulations; (4) expand the circumstances in which
firms must make a submission to the Agency to include when there is a
major change in an infant formula or a change that may affect whether
the formula is adulterated; (5) specify the nutrient quality control
testing that must be done on each batch of infant formula; (6) modify
the infant formula recall requirements; and (7) give the Secretary
authority to establish requirements for retention of records, including
records necessary to demonstrate compliance with CGMP and quality
control procedures. In 1989, the Agency implemented the provisions on
recalls (secs. 412(f) and (g) of the Act) by establishing subpart E in
21 CFR part 107 (54 FR 4006, Jan. 27, 1989). In 1991, the Agency
implemented the provisions on record and record retention requirements
by revising 21 CFR 106.100 (56 FR 66566, Dec. 24, 1991).
The Agency has already promulgated regulations that respond to a
number of the provisions of the 1986 amendments. The final rule would
address additional provisions of these amendments.
Alternatives: The 1986 amendments require the Secretary (and, by
delegation, FDA) to establish, by regulation, requirements for quality
factors and CGMPs, including quality control procedures. Therefore,
there are no alternatives to rulemaking.
Anticipated Cost and Benefits: FDA estimates that the costs from
the final rule to producers of infant formula would include first year
and recurring costs (e.g., administrative costs, implementation of
quality controls, records, audit plans, and assurances of quality
factors in new infant formulas). FDA anticipates that the primary
benefits would be a reduced risk of illness due to Cronobacter
sakazakii and Salmonella spp in infant formula. Additional benefits
stem from the quality factors requirements that would assure the
healthy growth of infants consuming infant formula. Monetized estimates
of costs and benefits for this final rule are not available at this
time. The analysis for the proposed rule estimated costs of less than
$1 million per year. FDA was not able to quantify benefits in the
analysis for the proposed rule.
Risks: Special controls for infant formula manufacturing are
especially important because infant formula, particularly powdered
infant formula, is an ideal medium for bacterial growth and because
infants are at high risk of foodborne illness because of their immature
immune systems. In addition, quality factors are of critical need to
assure that the infant formula supports healthy growth in the first
months of life when infant formula may be an infant's sole source of
nutrition. The provisions of this rule will address weaknesses in
production that may allow contamination of infant formula, including,
contamination with C. sakazakii and Salmonella spp which can lead to
serious illness with devastating sequelae and/or death. The provisions
would also assure that new infant formulas support healthy growth in
infants.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/09/96 61 FR 36154
NPRM Comment Period End............. 12/06/96
NPRM Comment Period Reopened........ 04/28/03 68 FR 22341
NPRM Comment Period Extended........ 06/27/03 68 FR 38247
NPRM Comment Period End............. 08/26/03
NPRM Comment Period Reopened........ 08/01/06 71 FR 43392
NPRM Comment Period End............. 09/15/06
Final Action........................ 03/00/12
------------------------------------------------------------------------
[[Page 7725]]
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Benson Silverman, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College Park,
MD 20740, Phone: 240 402-1459, Email: benson.silverman@fda.hhs.gov.
Related RIN: Split from 0910-AA04.
RIN: 0910-AF27
HHS--FDA
41. Medical Device Reporting; Electronic Submission Requirements
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374
CFR Citation: 21 CFR 803.
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) is amending its
postmarket medical device reporting (MDR) regulations to require that
manufacturers, importers, and user facilities submit mandatory reports
of medical device adverse events to the Agency in an electronic format
that FDA can process, review, and archive. FDA is taking this action to
improve the Agency's systems for collecting and analyzing postmarketing
safety reports. The proposed change would help the Agency to more
quickly review safety reports and identify emerging public health
issues.
Statement of Need: The final rule would require user facilities and
medical device manufacturers and importers to submit medical device
adverse event reports in electronic format instead of using a paper
form. FDA is taking this action to improve its adverse event reporting
program by enabling it to more quickly receive and process these
reports.
Summary of Legal Basis: The Agency has legal authority under
section 519 of the Federal Food, Drug, and Cosmetic Act to require
adverse event reports. The final rule would require manufacturers,
importers, and user facilities to change their procedures to send
reports of medical device adverse events to FDA in electronic format
instead of using a hard copy form.
Alternatives: There are two alternatives. The first alternative is
to allow the voluntary submission of electronic MDRs. If a substantial
number of reporters fail to voluntarily submit electronic MDRs, FDA
will not obtain the benefits of standardized formats and quicker access
to medical device adverse event data. The second alternative is to
allow small entities more time to comply. This would significantly
postpone the benefits of the rule; moreover, it would only delay,
rather than reduce or eliminate, the costs of compliance.
Anticipated Cost and Benefits: The principal benefit would be to
public health, due to the increased speed in the processing and
analysis of medical device reports currently submitted annually on
paper. In addition, requiring electronic submission would reduce FDA
annual operating costs and generate industry savings.
The one-time costs are for modifying standard operating procedures
and establishing electronic submission capabilities. Annually recurring
costs include maintenance of electronic submission capabilities,
including renewing the electronic certificate, and for some firms, the
incremental cost to maintain high-speed Internet access.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/21/09 74 FR 42203
NPRM Comment Period End............. 11/19/09
Final Action........................ 03/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: nancy.pirt@fda.hhs.gov.
RIN: 0910-AF86
HHS--FDA
42. Electronic Registration and Listing for Devices
Priority: Other Significant.
Legal Authority: Pub. L. 110-85; Pub. L. 107-188, sec 321; Pub. L.
107-250, sec 207; 21 U.S.C. 360(a) through 360(j); 21 U.S.C. 360(p)
CFR Citation: 21 CFR 807.
Legal Deadline: None.
Abstract: This rule would codify the requirements for electronic
registration and listing. However, for those companies that do not have
access to the Web, FDA will offer an avenue by which they can register,
list, and update information with a paper submission. The rule also
will amend part 807 to reflect the timeframes for device establishment
registration and listing established by sections 222 and 223 of Food
and Drug Administration Amendment Act (FDAAA) and to reflect the
requirement in section 510(i) of the Act, as amended by section 321 of
the Public Health Security and Bioterrorism Preparedness and Response
Act (BT Act), that foreign establishments provide FDA with additional
pieces of information as part of their registration.
Statement of Need: FDA is amending the medical device establishment
registration and listing requirements under 21 CFR part 807 to reflect
the electronic submission requirements in section 510(p) of the Act,
which was added by section 207 of MDUFMA and later amended by section
224 of FDAAA. FDA also is amending 21 CFR part 807 to reflect the
requirements in section 321 of the BT Act for foreign establishments to
furnish additional information as part of their registration. This rule
will improve FDA's device establishment registration and listing system
and utilize the latest technology in the collection of this
information.
Summary of Legal Basis: The statutory basis for our authority
includes sections 510(a) through (j), 510(p), 701, 801, and 1003 of the
Act.
Alternatives: The alternatives to this rulemaking include not
updating the registration and listing regulations. Because of the new
FDAAA statutory requirements and the advances in data collection and
transmission technology, FDA believes this rulemaking is the preferable
alternative.
Anticipated Cost and Benefits: The Agency believes that there may
be some one-time costs associated with the rulemaking, which involve
resource costs of familiarizing users with the electronic system.
Recurring costs related to submission of the information by domestic
firms would probably remain the same or decrease because a paper
submission and postage is not required. There might be some increase in
the financial burden on foreign firms since they will have to supply
additional registration information as required by section 321 of the
BT Act.
Risks: None.
Timetable:.
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/26/10 75 FR 14510
[[Page 7726]]
NPRM Comment Period End............. 06/24/10 .......................
Final Rule.......................... 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: nancy.pirt@fda.hhs.gov.
RIN: 0910-AF88
HHS--FDA
43. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) published a
proposed rule in the Federal Register of April 6, 2011 (72 FR 19238) to
establish requirements for nutrition labeling of certain food items
sold in certain vending machines. FDA also proposed the terms and
conditions for vending machine operators registering to voluntarily be
subject to the requirements. FDA took this action to carry out section
4205 of the Patient Protection and Affordable Care Act (``Affordable
Care Act'' or ``ACA''), which was signed into law on March 23, 2010.
Statement of Need: This rulemaking was mandated by section 4205 of
the Patient Protection and Affordable Care Act (Affordable Care Act).
Summary of Legal Basis: On March 23, 2010, the Affordable Care Act
(Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other
things, creating new clause (H) to require that vending machine
operators, who own or operate 20 or more machines, disclose calories
for certain food items. FDA has the authority to issue this rule under
sections 403(q)(5)(H) and 701(a) of the FD&C Act (21 U.S.C.
343(q)(5)(H), and 371(a)). Section 701(a) of the FD&C Act vests the
Secretary of Health and Human Services, and, by delegation, the Food
and Drug Administration (FDA) with the authority to issue regulations
for the efficient enforcement of the FD&C Act.
Alternatives: Section 4205 of the Affordable Care Act requires the
Secretary (and by delegation, the FDA) to establish by regulation
requirements for calorie labeling of articles of food sold from covered
vending machines. Therefore, there are no alternatives to rulemaking.
FDA has analyzed alternatives that may reduce the burden of the
rulemaking, including analyzing the benefits and costs of: Restricting
the flexibility of the format for calorie disclosure, lengthening the
compliance time, and extending the coverage of the rule to bulk vending
machines without selection buttons.
Anticipated Cost and Benefits: Any vending machine operator
operating fewer than 20 machines may voluntarily choose to be covered
by the national standard. It is anticipated that vending machine
operators that own or operate 20 or more vending machines will bear
costs associated with adding calorie information to vending machines.
FDA estimates that the total cost of complying with section 4205 of the
Affordable Care Act and this rulemaking will be approximately $25.8
million initially, with a recurring cost of approximately $24 million.
Because comprehensive national data for the effects of vending
machine labeling do not exist, FDA has not quantified the benefits
associated with section 4205 of the Affordable Care Act and this
rulemaking. Some studies have shown that some consumers consume fewer
calories when calorie content information is displayed at the point of
purchase. Consumers will benefit from having this important nutrition
information to assist them in making healthier choices when consuming
food away from home. Given the very high costs associated with obesity
and its associated health risks, FDA estimates that if 0.02 percent of
the adult obese population reduces energy intake by at least 100
calories per week, then the benefits of Section 4205 of the Affordable
Care Act and this rulemaking will be at least as large as the costs.
Risks: Americans now consume an estimated one-third of their total
calories from foods prepared outside the home and spend almost half of
their food dollars on such foods. This rule will provide consumers with
information about the nutritional content of food to enable them to
make healthier food choices, and may help mitigate the trend of
increasing obesity in America.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/06/11 76 FR 19238
NPRM Comment Period End............. 07/05/11 .......................
Final Action........................ 11/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Governmental Jurisdictions.
Government Levels Affected: Federal, Local, State.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Daniel Reese, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park,
MD 20740, Phone: 240 402-2126, Email: daniel.reese@fda.hhs.gov.
RIN: 0910-AG56
HHS--FDA
44. Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) published a
proposed rule in the Federal Register of April 6, 2011 (72 FR 19192),
to establish requirements for nutrition labeling of standard menu items
in chain restaurants and similar retail food establishments. FDA also
proposed the terms and conditions for restaurants and similar retail
food establishments registering to voluntarily be subject to the
Federal requirements. FDA took this action to carry out section 4205 of
the Patient Protection and Affordable Care Act (``Affordable Care Act''
or ``ACA''), which was signed into law on March 23, 2010.
Statement of Need: This rulemaking was mandated by section 4205 of
the Patient Protection and Affordable Care Act (Affordable Care Act).
Summary of Legal Basis: On March 23, 2010, the Affordable Care Act
(Pub. L. 111-148) was signed into law. Section 4205 of the Affordable
Care Act amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by, among other things, creating new clause
[[Page 7727]]
(H) to require that certain chain restaurants and similar retail food
establishments with 20 or more locations disclose certain nutrient
information for standard menu items. FDA has the authority to issue
this rule under sections 403(a)(1), 403(q)(5)(H), and 701(a) of the
FD&C Act (21 U.S.C. 343(a)(1), 343(q)(5)(H), and 371(a)). Section
701(a) of the FD&C Act vests the Secretary of Health and Human
Services, and, by delegation, the Food and Drug Administration (FDA)
with the authority to issue regulations for the efficient enforcement
of the FD&C Act.
Alternatives: Section 4205 of the Affordable Care Act requires the
Secretary, and by delegation the FDA, to establish by regulation
requirements for nutrition labeling of standard menu items for covered
restaurants and similar retail food establishments. Therefore, there
are no alternatives to rulemaking. FDA has analyzed alternatives that
may reduce the burden of this rulemaking, including analyzing the
benefits and costs of expanding and contracting the set of
establishments automatically covered by this rule and shortening or
lengthening the compliance time relative to the rulemaking.
Anticipated Cost and Benefits: Chain restaurants and similar retail
food establishments operating in local jurisdictions that impose
different nutrition labeling requirements will benefit from having a
uniform national standard. Any restaurant or similar retail food
establishment with fewer than 20 locations may voluntarily choose to be
covered by the national standard. It is anticipated that chain
restaurants with 20 or more locations will bear costs for adding
nutrition information to menus and menu boards. FDA estimates that the
total cost of section 4205 and this rulemaking will be approximately
$80 million, annualized over 10 years, with a low annualized estimate
of approximately $33 million and a high annualized estimate of
approximately $125 million over 10 years. These costs include an
initial cost of approximately $320 million with an annually recurring
cost of $45 million.
Because comprehensive national data for the effects of menu
labeling do not exist, FDA has not quantified the benefits associated
with section 4205 of the Affordable Care Act and this rulemaking. Some
studies have shown that some consumers consume fewer calories when
menus have information about calorie content displayed. Consumers will
benefit from having important nutrition information for the
approximately 30 percent of calories consumed away from home. Given the
very high costs associated with obesity and its associated health
risks, FDA estimates that if 0.6 percent of the adult obese population
reduces energy intake by at least 100 calories per week, then the
benefits of section 4205 of the Affordable Care Act and this rule will
be at least as large as the costs.
Risks: Americans now consume an estimated one-third of their total
calories on foods prepared outside the home and spend almost half of
their food dollars on such foods. Unlike packaged foods that are
labeled with nutrition information, foods in restaurants, for the most
part, do not have nutrition information that is readily available when
ordered. Dietary intake data have shown that obese Americans consume
over 100 calories per meal more when eating food away from home rather
than food at home. This rule will provide consumers information about
the nutritional content of food to enable them to make healthier food
choices and may help mitigate the trend of increasing obesity in
America.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/06/11 76 FR 19192
NPRM Comment Period End............. 07/05/11 .......................
Final Action........................ 11/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Governmental Jurisdictions.
Government Levels Affected: Federal, Local, State.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Geraldine A. June, Supervisor, Product Evaluation
and Labeling Team, Department of Health and Human Services, Food and
Drug Administration, Center for Food Safety and Applied Nutrition,
(HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone:
240 402-1802, Fax: 301 436-2636, Email: geraldine.june@fda.hhs.gov.
RIN: 0910-AG57
HHS--CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)
Proposed Rule Stage
45. Medicare and Medicaid Programs: Reform of Hospital and Critical
Access Hospital Conditions of Participation (CMS-3244-P)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr
CFR Citation: 42 CFR 482; 42 CFR 485.
Legal Deadline: None.
Abstract: This proposed rule would revise the requirements that
hospitals and critical access hospitals (CAHs) must meet to participate
in the Medicare and Medicaid programs. These changes are necessary to
reflect substantial advances in health care delivery and in patient
safety knowledge and practices. They are also an integral part of our
efforts to achieve broad-based improvements in the quality of health
care furnished through Federal programs and in patient safety, while at
the same time reducing procedural burdens on providers.
Statement of Need: CMS is revising many of the hospital CoPs to
ensure that they meet the needs of hospital and CAH patients in an
effective and efficient manner. CMS is proposing changes to reduce
unnecessary, obsolete, or burdensome regulations on U.S. hospitals.
This retrospective review of existing regulations meets the President's
Executive Order that all Federal agencies identify such rules and make
proposals to ``modify, streamline, expand, or repeal them.'' CMS is
also proposing additional quality and safety requirements to protect
patients.
Summary of Legal Basis: The provisions that are included in this
proposed rule are necessary to implement the requirements of Executive
Order 13563 ``Improving Regulations and Regulatory Review.''
Alternatives: To date, nearly 90 specific reforms have been
identified and scheduled for action. These reforms impact hospitals,
physicians, home health agencies, ambulance providers, clinical labs,
skilled nursing facilities, intermediate care facilities, managed care
plans, Medicare Advantage organizations, and States. Many of these
reforms will be included in proposed rules that relate to particular
categories of regulations or types of providers. Other reforms are
being implemented without the need for regulations.
This proposed rule includes reforms that do not fit directly in
other rules scheduled for publication.
[[Page 7728]]
Anticipated Cost and Benefits: This proposed rule would reduce
costs to tens of thousands of physicians, ambulatory surgical centers,
End Stage Renal Disease facilities, and other small entities. Achieving
the full scope of potential savings will depend on future decisions by
hospitals, by State regulators, and others. Many other factors will
influence long-term results. We believe, however, that likely savings
and benefits will reach many billions of dollars. Our primary estimate
of the net savings to hospitals from reductions in regulatory
requirements that we can quantify at this time, offset by increases in
other regulatory costs, are approximately $940 million a year.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/24/11 76 FR 65891
NPRM Comment Period End............. 12/23/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: CDR Scott Cooper, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards Group, Mail Stop S3-05-15, 7500
Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9465, Email:
scott.cooper@cms.hhs.gov.
RIN: 0938-AQ89
HHS--CMS
46. Regulatory Provisions To Promote Program Efficiency, Transparency,
and Burden Reduction (CMS-9070-P)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1302 and 1395hh and 44 U.S.C. 35
CFR Citation: 42 CFR 400, 405, 416, 418, 423; 42 CFR 424, 440, 442,
486, 494.
Legal Deadline: None.
Abstract: This proposed rule identifies and proposes reforms in
Medicare and Medicaid regulations that CMS has identified as
unnecessary, obsolete, or excessively burdensome on health care
providers and beneficiaries. This proposed rule would increase the
ability of health care professionals to devote resources to improving
patient care, by eliminating or reducing requirements that impede
quality patient care or that divert providing high quality patient
care.
Statement of Need: In January 2011, the President issued an
Executive order that requires agencies to identify rules that may be
``outmoded, ineffective, insufficient, or excessively burdensome, and
to modify, streamline, expand, or repeal them in accordance with what
has been learned.'' In accordance with the Executive order, we
identified obsolete and unnecessarily burdensome rules that could be
eliminated or reformed to achieve similar objectives, with a particular
focus on freeing up resources that health care providers, health plans,
and States could use to improve or enhance patient health and safety.
We examined policies and practices not codified in rules that could be
changed or streamlined to achieve better outcomes for patients while
reducing burden on providers of care. We also sought to increase
transparency and become a better business partner.
Summary of Legal Basis: The provisions that are included in this
proposed rule are necessary to implement the requirements of Executive
Order 13563 ``Improving Regulations and Regulatory Review.''
Alternatives: To date, nearly 90 specific reforms have been
identified and scheduled for action. These reforms impact hospitals,
physicians, home health agencies, ambulance providers, clinical labs,
skilled nursing facilities, intermediate care facilities, managed care
plans, Medicare Advantage organizations, and States. Many of these
reforms will be included in proposed rules that relate to particular
categories of regulations or types of providers. Other reforms are
being implemented without the need for regulations. This proposed rule
includes reforms that do not fit directly in other rules scheduled for
publication.
Anticipated Cost and Benefits: We anticipate that the provider
industry and health professionals would welcome the proposed changes
and reductions in burden. We also expect that health professionals
would experience increased efficiencies and resources to appropriately
devote to improving patient care, increasing accessibility to care, and
reducing associated health care costs.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/24/11 76 FR 65909
NPRM Comment Period End............. 12/23/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations.
Government Levels Affected: Federal, State.
Agency Contact: Michelle Shortt, Director, Regulations Development
Group, OSORA, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Mailstop C4-26-05, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-4675, Email:
michelle.shortt@cms.hhs.gov.
RIN: 0938-AQ96
HHS--CMS
47. Proposed Changes to Hospital OPPS and CY 2013 Payment
Rates; ASC Payment System and CY 2013 Payment Rates (CMS-1589-P)
(Section 610 Review)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Sec 1833 of the Social Security Act
CFR Citation: 42 CFR 410; 42 CFR 416; 42 CFR 419.
Legal Deadline: Final, Statutory, November 1, 2012.
Abstract: This final rule would revise the Medicare hospital
outpatient prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system. The proposed rule also describes changes to the amounts
and factors used to determine payment rates for services. In addition,
the rule proposes changes to the Ambulatory Surgical Center Payment
System list of services and rates.
Statement of Need: Medicare pays over 4,000 hospitals for
outpatient department services under the hospital outpatient
prospective payment system (OPPS). The OPPS is based on groups of
clinically similar services called ambulatory payment classification
groups (APCs). CMS annually revises the APC payment amounts based on
the most recent claims data, proposes new payment policies, and updates
the payments for inflation using the hospital operating market basket.
The proposed rule solicits comments on the proposed OPPS payment rates
and new policies. Medicare pays roughly 5,000 Ambulatory Surgical
Centers (ASCs) under the ASC payment system. CMS annually revises the
payment under the ASC payment system, proposes new policies, and
updates payments for inflation using the Consumer Price Index for All
Urban Consumers (CPI-U). CMS will issue a final rule containing the
payment rates for the 2013 OPPS
[[Page 7729]]
and ASC payment system at least 60 days before January 1, 2013.
Summary of Legal Basis: Section 1833 of the Social Security Act
establishes Medicare payment for hospital outpatient services and ASC
services. The final rule revises the Medicare hospital OPPS and ASC
payment system to implement applicable statutory requirements. In
addition, the proposed and final rules describe changes to the
outpatient APC system, relative payment weights, outlier adjustments,
and other amounts and factors used to determine the payment rates for
Medicare hospital outpatient services paid under the prospective
payment system, as well as changes to the rates and services paid under
the ASC payment system. These changes would be applicable to services
furnished on or after January 1, 2013.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: Total expenditures will be adjusted
for CY 2013.
Risks: If this regulation is not published timely, outpatient
hospital and ASC services will not be paid appropriately beginning
January 1, 2013.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Federalism: Undetermined.
Agency Contact: Paula Smith, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4-05-13, 7500 Security Blvd., Baltimore,
MD 21244, Phone: 410 786-4709, Email: paula.smith@cms.hhs.gov.
RIN: 0938-AR10
HHS--CMS
48. Revisions to Payment Policies Under the Physician Fee
Schedule and Part B for CY 2013 (CMS-1590-P) (Section 610 Review)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Social Security Act, secs 1102, 1871, 1848
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory, November 1, 2012.
Abstract: This annual proposed rule would revise payment polices
under the physician fee schedule, as well as other policy changes to
payment under Part B. These changes would be applicable to services
furnished on or after January 1.
Statement of Need: The statute requires that we establish each
year, by regulation, payment amounts for all physicians' services
furnished in all fee schedule areas. This major proposed rule would
implement changes affecting Medicare Part B payment to physicians and
other Part B suppliers. The final rule has a statutory publication date
of November 1, 2012, and an implementation date of January 1, 2013.
Summary of Legal Basis: Section 1848 of the Social Security Act
(the Act) establishes the payment for physician services provided under
Medicare. Section 1848 of the Act imposes a deadline of no later than
November 1 for publication of the final rule or final physician fee
schedule.
Alternatives: None. This implements a statutory requirement.
Anticipated Cost and Benefits: Total expenditures will be adjusted
for CY 2013.
Risks: If this regulation is not published timely, physician
services will not be paid appropriately, beginning January 1, 2013.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Christina Ritter, Director, Division of
Practitioner Services, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Mail Stop C4-03-06, 7500 Security
Blvd., Baltimore, MD 21244, Phone: 410 786-4636, Email:
christina.ritter@cms.hhs.gov.
RIN: 0938-AR11
HHS--CMS
49. Changes to the Hospital Inpatient an Long-Term Care
Prospective Payment System for FY 2013 (CMS-1588-P) (Section 610
Review)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Sec 1886(d) of the Social Security Act
CFR Citation: 42 CFR 412.
Legal Deadline: NPRM, Statutory, April 1, 2012. Final, Statutory,
August 1, 2012.
Abstract: This annual major proposed rule would revise the Medicare
hospital inpatient and long-term care hospital prospective payment
systems for operating and capital-related costs. This proposed rule
would implement changes arising from our continuing experience with
these systems.
Statement of Need: CMS annually revises the Medicare hospital
inpatient prospective payment systems (IPPS) for operating and capital-
related costs to implement changes arising from our continuing
experience with these systems. In addition, we describe the proposed
changes to the amounts and factors used to determine the rates for
Medicare hospital inpatient services for operating costs and capital-
related costs. Also, CMS annually updates the payment rates for the
Medicare prospective payment system (PPS) for inpatient hospital
services provided by long-term care hospitals (LTCHs). The proposed
rule solicits comments on the proposed IPPS and LTCH payment rates and
new policies. CMS will issue a final rule containing the payment rates
for the FY 2013 IPPS and LTCHs at least 60 days before October 1, 2012.
Summary of Legal Basis: The Social Security Act (the Act) sets
forth a system of payment for the operating costs of acute care
hospital inpatient stays under Medicare Part A (Hospital Insurance)
based on prospectively set rates. The Act requires the Secretary to pay
for the capital-related costs of hospital inpatient and Long Term Care
stays under a PPS. Under these systems, Medicare payment for hospital
inpatient and Long Term Care operating and capital-related costs is
made at predetermined, specific rates for each hospital discharge.
These changes would be applicable to services furnished on or after
October 1, 2012.
Alternatives: None. This implements a statutory requirement.
Anticipated Cost and Benefits: Total expenditures will be adjusted
for FY 2013.
Risks: If this regulation is not published timely, inpatient
hospital and LTCH services will not be paid appropriately beginning
October 1, 2012.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Agency Contact: Ankit Patel, Health Insurance Specialist, Division
of Acute
[[Page 7730]]
Care, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Hospital and Ambulatory Policy Group, Mail Stop, C4-
25-11, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
4537, Email: ankit.patel@cms.hhs.gov.
RIN: 0938-AR12
HHS--CMS
Final Rule Stage
50. Medicaid Eligibility Expansion Under the Affordable Care Act of
2010 (CMS-2349-F)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 111-148, secs 1413, 1414, 2001, 2002,
2101, 2201
CFR Citation: 42 CFR 431, 435, 457.
Legal Deadline: Final, Statutory, January 1, 2014.
Abstract: This rule implements provisions of the Affordable Care
Act expanding access to health insurance through improvements in
Medicaid, the establishment of American Health Benefit Exchanges
(``Exchanges''), and coordination between Medicaid, the Children's
Health Insurance Program (CHIP), and Exchanges. This rule also
implements sections of the Affordable Care Act related to Medicaid
eligibility, enrollment simplification, and coordination.
Statement of Need: This rule expands Medicaid eligibility,
simplifies Medicaid eligibility procedures, and streamlines Medicaid
enrollment processes. It also coordinates eligibility processes and
policies with the processes for premium tax credits for Exchange
coverage. Millions of uninsured low-income persons who do not have
access to, or could not afford, health insurance will obtain coverage.
Summary of Legal Basis: The provisions that are included in this
rule are necessary to implement the requirements of sections 1413,
1414, 2001, 2002, 2101, and 2201 of the Affordable Care Act.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: We anticipate that this rule
provides significant benefits to low-income individuals by expanding
the availability of affordable health coverage. We expect that States
may incur short term increases in administrative costs (depending on
their current systems and practices) but that these costs will be
wholly offset by administrative savings over the longer term.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/17/11 76 FR 51148
NPRM Comment Period End............. 10/31/11
Final Action........................ 02/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Governmental Jurisdictions.
Government Levels Affected: Federal, Local, State, Tribal.
Agency Contact: Sarah DeLone, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop S2-01-16, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-0615, Email:
sarah.delone@cms.hhs.gov.
RIN: 0938-AQ62.
HHS--CMS
51. Establishment of Exchanges and Qualified Health Plans Part I (CMS-
9989-F)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Affordable Care Act, secs 1301 to 1343, secs 1401
to 1413
CFR Citation: 45 CFR 155 to 157.
Legal Deadline: Final, Statutory, January 1, 2014.
Abstract: This rule implements the new Affordable Insurance
Exchanges (``Exchanges''), consistent with title I of the Affordable
Care Act of 2010, referred to collectively as the Affordable Care Act.
The Exchanges will provide competitive marketplaces for individuals and
small employers to directly compare available private health insurance
options on the basis of price, quality, and other factors. The
Exchanges, which will become operational by January 1, 2014, will help
enhance competition in the health insurance market, improve choice of
affordable health insurance, and give small businesses the same
purchasing clout as large businesses.
Statement of Need: A central aim of Title I of the Affordable Care
Act is to expand access to health insurance coverage through the
establishment of Exchanges. The number of uninsured Americans is rising
due to the lack of affordable insurance, barriers to insurance for
people with pre-existing conditions, and high prices due to limited
competition and market failures. Millions of people without health
insurance use health care services for which they do not pay, shifting
the uncompensated cost of their care to health care providers.
Providers pass much of this cost to insurance companies, resulting in
higher premiums that make insurance unaffordable to even more people.
The Affordable Care Act includes a number of policies to address these
problems, including the creating of Affordable Insurance Exchanges.
Summary of Legal Basis: This rule implements the new Affordable
Insurance Exchanges consistent with title I of the Affordable Care Act
of 2010.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: This rule will help enhance
competition in the health insurance market, promote the choice of
affordable health insurance, and give small businesses the same
purchasing clout as large businesses. States seeking to operate an
Exchange will incur administrative expenses as a result of implementing
and subsequently maintaining Exchanges. There is no Federal requirement
that each State establish an Exchange.
Risks: If this regulation is not published, the Exchanges will not
become operational by January 1, 2014, thereby violating the statute.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/15/11 76 FR 41866
NPRM Comment Period End............. 09/28/11
Final Action........................ 02/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses, Governmental Jurisdictions.
Government Levels Affected: Federal, State, Tribal.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Alissa DeBoy, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 301 492-4428, Email:
alissa.deboy@cms.hhs.gov.
RIN: 0938-AQ67
HHS--CMS
52. State Requirements for Exchange--Reinsurance and Risk
Adjustments (CMS-9975-F)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 111-148, secs 1341 and 1342
[[Page 7731]]
CFR Citation: 45 CFR 155, 156.
Legal Deadline: Final, Statutory, January 1, 2014.
Abstract: This rule implements requirements for States related to
reinsurance, risk corridors, and a permanent risk adjustment. The goals
of these programs are to minimize negative impacts of adverse selection
inside the Exchanges.
Statement of Need: This rule finalizes guidelines for the
transitional risk-sharing programs, reinsurance and risk corridors, as
well as for the risk adjustment program that will continue beyond the
first 3 years of Exchange operation. The purpose of these programs is
to protect health insurance issuers from the negative effects of
adverse selection and to protect consumers from increases in premiums
due to uncertainty for issuers.
Summary of Legal Basis: This rule implements the new Affordable
Insurance Exchanges consistent with title I of the Affordable Care Act
of 2010.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: Payments through reinsurance, risk
adjustment, and risk corridors reduce the increased risk of financial
loss that health insurance issuers might otherwise expect to incur in
2014 due to market reforms such as guaranteed issue and the elimination
of medical underwriting. These payments reduce the risk to the issuer
and the issuer can pass on a reduced risk premium to enrollees.
Administrative costs will vary across States and health insurance
issuers depending on the sophistication of technical infrastructure and
prior experience with data collection and risk adjustment. States and
issuers that already have systems in place for data collection and
reporting will have reduced administrative costs.
Risks: If this regulation is not published, the Exchanges will not
become operational by January 1, 2014, thereby violating the statute.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/15/11 76 FR 41866
NPRM Comment Period End............. 09/28/11
Final Action........................ 01/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Governmental Jurisdictions.
Government Levels Affected: State.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Alissa DeBoy, Health Insurance Specialist, Center
for Consumer Information & Insurance Oversight, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4428, Email:
alissa.deboy@cms.hhs.gov.
RIN: 0938-AR07
BILLING CODE 4150-24-P
DEPARTMENT OF HOMELAND SECURITY (DHS)
Fall 2011 Statement of Regulatory Priorities
The Department of Homeland Security (DHS or Department) was created
in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-
296. DHS has a vital mission: To secure the Nation from the many
threats we face. This requires the dedication of more than 225,000
employees in jobs that range from aviation and border security to
emergency response, from cybersecurity analyst to chemical facility
inspector. Our duties are wide-ranging, but our goal is clear--keeping
America safe.
Our mission gives us six main areas of responsibility:
1. Prevent Terrorism and Enhance Security,
2. Secure and Manage Our Borders,
3. Enforce and Administer our Immigration Laws,
4. Safeguard and Secure Cyberspace,
5. Ensure Resilience to Disasters, and
6. Mature and Strengthen DHS.
In achieving these goals, we are continually strengthening our
partnerships with communities, first responders, law enforcement, and
government agencies--at the State, local, tribal, Federal, and
international levels. We are accelerating the deployment of science,
technology, and innovation in order to make America more secure, and we
are becoming leaner, smarter, and more efficient, ensuring that every
security resource is used as effectively as possible. For a further
discussion of our main areas of responsibility, see the DHS Web site at
https://www.dhs.gov/xabout/responsibilities.shtm.
The regulations we have summarized below in the Department's fall
2011 regulatory plan and in the agenda support the Department's
responsibility areas listed above. These regulations will improve the
Department's ability to accomplish its mission.
The regulations we have identified in this year's fall regulatory
plan continue to address legislative initiatives including, but not
limited to, the following acts: The Implementing Recommendations of the
9/11 Commission Act of 2008 (9/11 Act), Public Law 110-53 (Aug. 3,
2007); the Post-Katrina Emergency Management Reform Act of 2006
(PKEMRA), Public Law 109-295 (Oct. 4, 2006); the Consolidated Natural
Resources Act of 2008 (CNRA), Public Law 110-220 (May 7, 2008); the
Security and Accountability for Every Port Act of 2006 (SAFE Port Act),
Public Law 109-347 (Oct. 13, 2006); and the Consolidated Security,
Disaster Assistance, and Continuing Appropriations Act, 2009, Public
Law 110-329 (Sep. 30, 2008).
DHS strives for organizational excellence and uses a centralized
and unified approach in managing its regulatory resources. The Office
of the General Counsel manages the Department's regulatory program,
including the agenda and regulatory plan. In addition, DHS senior
leadership reviews each significant regulatory project to ensure that
the project fosters and supports the Department's mission.
The Department is committed to ensuring that all of its regulatory
initiatives are aligned with its guiding principles to protect civil
rights and civil liberties, integrate our actions, build coalitions and
partnerships, develop human resources, innovate, and be accountable to
the American public.
DHS is also committed to the principles described in Executive
Orders 13563 and 12866 (as amended). Both Executive orders direct
agencies to assess the costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety effects, distributive impacts,
and equity). Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. Many of the regulations in DHS'
regulatory plan support the Department's efforts pursuant to the DHS
Final Plan for the Retrospective Review of Existing Regulations. DHS
issued its final plan on August 22, 2011.
Finally, the Department values public involvement in the
development of its regulatory plan, agenda, and regulations, and takes
particular concern with the impact its rules have on small businesses.
DHS and each of its components continue to emphasize the use of plain
language in our notices and rulemaking documents to promote
[[Page 7732]]
a better understanding of regulations and increased public
participation in the Department's rulemakings.
Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (Jan. 18, 2011), DHS identified the
following regulatory actions in the Department's Final Plan for the
Retrospective Review of Existing Regulations (``DHS Final Plan''). DHS
has identified these regulatory actions as associated with
retrospective review and analysis. You can view the DHS Final Plan on
www.regulations.gov by searching for docket number DHS-2011-0015. Some
of the regulatory actions on the below list may be completed actions,
which do not appear in The Regulatory Plan. You can find more
information about these completed rulemakings in past publications of
the Unified Agenda (search the Completed Actions sections) on
www.reginfo.gov. Some of the entries on this list, however, are active
rulemakings. You can find entries for these rulemakings on
www.regulations.gov.
------------------------------------------------------------------------
Significantly Reduces
RIN Rule Burdens on Small
Businesses
------------------------------------------------------------------------
1615-AB71.................. Registration No.
Requirement
for
Petitioners
Seeking to
File H-1B
Petitions on
Behalf of
Aliens Subject
to Numerical
Limitations.
1615-AB76.................. Commonwealth of No.
the Northern
Mariana
Islands
Transitional
Worker
Classification.
1615-AB83.................. Immigration No.
Benefits
Business
Transformation
, Increment I.
1615-AB95.................. Immigration No.
Benefits
Business
Transformation
:
Nonimmigrants;
Student and
Exchange
Visitor
Program.
1625-AA16.................. Implementation No.
of the 1995
Amendments to
the
International
Convention on
Standards of
Training,
Certification,
and
Watchkeeping
(STCW) for
Seafarers,
1978.
1625-AB38.................. Updates to No.
Maritime
Security.
TBD........................ Elimination of No.
TWIC for
Certain
Mariner
Populations
(Implementatio
n of Section
809 of the
2010 Coast
Guard
Authorization
Act).
1651-AA73.................. Establishment No.
of Global
Entry Program.
1651-AA93.................. Closing of the No.
Port of
Whitetail,
Montana.
1651-AA94.................. Internet No.
Publication of
Administrative
Seizure/
Forfeiture
Notices.
1652-AA01.................. Aviation No.
Security
Infrastructure
Fee (ASIF).
1652-AA35.................. Flight Training No.
for Aliens and
Other
Designated
Individuals;
Security
Awareness
Training for
Flight School
Employees.
1653-AA44.................. Clarification No.
of Eligibility
Criteria for F
and M Students
and for
Schools
Certified by
the Student
and Exchange
Visitor
Program To
Enroll F and/
or M Students.
------------------------------------------------------------------------
The fall 2011 regulatory plan for DHS includes regulations from DHS
components--including U.S. Citizenship and Immigration Services
(USCIS), the U.S. Coast Guard (Coast Guard), U.S. Customs and Border
Protection (CBP), the Federal Emergency Management Agency (FEMA), the
U.S. Immigration and Customs Enforcement (ICE), and the Transportation
Security Administration (TSA), which have active regulatory programs.
In addition, it includes regulations from the Department's major
offices and directorates such as the National Protection and Programs
Directorate (NPPD). Below is a discussion of the fall 2011 regulatory
plan for DHS regulatory components, as well as for DHS offices and
directorates.
United States Citizenship and Immigration Services
U.S. Citizenship and Immigration Services (USCIS) administers
immigration benefits and services while protecting and securing our
homeland. USCIS has a strong commitment to welcoming individuals who
seek entry through the U.S. immigration system, providing clear and
useful information regarding the immigration process, promoting the
values of citizenship, and assisting those in need of humanitarian
protection. Based on a comprehensive review of the planned USCIS
regulatory agenda, USCIS will promulgate several rulemakings to
directly support these commitments and goals.
Improvements to the Immigration System. USCIS is currently engaged
in a multi-year transformation effort to create a more efficient,
effective, and customer-focused organization by improving our business
processes and technology. In the coming years, USCIS will publish rules
to facilitate that effort, including rules that will remove references
to form numbers, form titles, expired regulatory provisions, and
descriptions of internal procedure; will mandate electronic filing in
certain circumstances; and will comprehensively reorganize 8 CFR part
214. In addition, to streamline processes and improve efficiency, USCIS
plans to revise its regulations governing appeals and motions before
the Administrative Appeals Office. USCIS will also finalize a final
rule related to the extension of immigration law to the Commonwealth of
the Northern Mariana Islands.
Requirements for Filing Motions and Administrative Appeals. USCIS
will propose to revise the procedural regulations governing appeals and
motions to reopen or reconsider before its Administrative Appeals
Office, and to require that applicants and petitioners exhaust
administrative remedies before seeking judicial review of an
unfavorable decision. The changes proposed by the rule will streamline
the procedures before the Administrative Appeals Office and improve the
efficiency of the adjudication process.
Regulations Related to the Commonwealth of Northern Mariana
Islands. During 2009, USCIS issued three regulations to implement the
extension of U.S. immigration law to the Commonwealth of Northern
Mariana Islands (CNMI), as required under title VII of the Consolidated
Natural Resources Act of 2008. During fiscal year 2011, USCIS issued
two final rules related to the extension of the U.S. immigration law to
the CNMI. In fiscal year 2012, USCIS will issue the following CNMI
final rule: The joint USCIS/Department of Justice (DOJ) regulation
``Application of Immigration Regulations to the CNMI.''
Regulatory Changes Involving Humanitarian Benefits. USCIS offers
protection to individuals who face persecution by adjudicating
applications for refugees and asylees. Other humanitarian benefits are
available to individuals who have been victims of severe forms of
trafficking or criminal activity.
[[Page 7733]]
Asylum and Withholding Definitions. USCIS plans a regulatory
proposal to amend the regulations that govern asylum eligibility and
refugee status determinations. The amendments are expected to focus on
portions of the regulations that deal with determinations of whether
suffered or feared persecution is on account of a protected ground, the
requirements for establishing that the government is unable or
unwilling to protect the applicant, and the definition of membership in
a particular social group. This effort should provide greater clarity
and consistency in this important area of the law.
Exception to the Persecutor Bar for Asylum, Refugee, or Temporary
Protected Status, and Withholding of Removal. In a joint rulemaking,
DHS and DOJ will propose amendments to existing DHS and DOJ regulations
to resolve ambiguity in the statutory language precluding eligibility
for asylum, refugee resettlement, temporary protected status, and
withholding or removal of an applicant who ordered, incited, assisted,
or otherwise participated in the persecution of others. The proposed
rule would provide a limited exception for persecutory actions taken by
the applicant under duress and would clarify the required level of the
applicant's knowledge of the persecution.
``T'' and ``U'' Nonimmigrants. USCIS plans additional regulatory
initiatives related to T nonimmigrants (victims of trafficking), U
nonimmigrants (victims of criminal activity), and Adjustment of Status
for T and U status holders. By promulgating additional regulations
related to these victims of specified crimes or severe forms of human
trafficking, USCIS hopes to provide greater consistency for these
vulnerable groups, their advocates, and the community. These
rulemakings will contain provisions to adjust documentary requirements
for this vulnerable population and provide greater clarity to the law
enforcement community.
Application of the William Wilberforce Trafficking Victims
Protection Act of 2008. In a joint rulemaking, DHS and DOJ will propose
amendments to implement the William Wilberforce Trafficking Victims
Protection Act of 2008 (TVPRA). Among other things, this statute
specified that USCIS has initial jurisdiction over an asylum
application filed by an unaccompanied alien child in removal
proceedings before an immigration judge in DOJ. The agencies
implemented this legislation with interim procedures that the TVPRA
mandated within 90 days after enactment. The proposed rule would amend
both agencies' regulations to finalize the procedures to determine when
an alien child is unaccompanied and how jurisdiction is transferred to
USCIS for initial adjudication of the child's asylum application. In
addition, this rule would address adjustment of status for special
immigrant juveniles and voluntary departure for unaccompanied alien
children in removal proceedings.
United States Coast Guard
The U.S. Coast Guard (Coast Guard) is a military, multi-mission,
maritime service of the United States and the only military
organization within DHS. It is the principal Federal agency responsible
for maritime safety, security, and stewardship, and delivers daily
value to the Nation through multi-mission resources, authorities, and
capabilities.
Effective governance in the maritime domain hinges upon an
integrated approach to safety, security, and stewardship. The Coast
Guard's policies and capabilities are integrated and interdependent,
delivering results through a network of enduring partnerships. The
Coast Guard's ability to field versatile capabilities and highly-
trained personnel is one of the U.S. Government's most significant and
important strengths in the maritime environment.
America is a maritime nation, and our security, resilience, and
economic prosperity are intrinsically linked to the oceans. Safety,
efficient waterways, and freedom of transit on the high seas are
essential to our well-being. The Coast Guard is leaning forward, poised
to meet the demands of the modern maritime environment. The Coast Guard
creates value for the public through solid prevention and response
efforts. Activities involving oversight and regulation, enforcement,
maritime presence, and public and private partnership foster increased
maritime safety, security, and stewardship.
The statutory responsibilities of the Coast Guard include ensuring
marine safety and security, preserving maritime mobility, protecting
the marine environment, enforcing U.S. laws and international treaties,
and performing search and rescue. The Coast Guard supports the
Department's overarching goals of mobilizing and organizing our Nation
to secure the homeland from terrorist attacks, natural disasters, and
other emergencies. The rulemaking projects identified for the Coast
Guard in the Unified Agenda, and the rules appearing in the fall 2011
regulatory plan below, contribute to the fulfillment of those
responsibilities and reflect our regulatory policies.
Implementation of the 1995 Amendments to the International
Convention on Standards of Training, Certification, and Watchkeeping
(STCW) for Seafarers, 1978. The Coast Guard proposed to amend its
regulations to implement changes to an interim rule published on June
26, 1997. These proposed amendments go beyond changes found in the
interim rule and seek to more fully incorporate the requirements of the
STCW in the requirements for the credentialing of U.S. merchant
mariners. The proposed changes are primarily substantive and: (1) Are
necessary to continue to give full and complete effect to the STCW
Convention; (2) incorporate lessons learned from implementation of the
STCW through the interim rule and through policy letters and Navigation
and Vessel Inspection Circulars (NVICs); and (3) attempt to clarify
regulations that have generated confusion. The Coast Guard published
this proposal as a Supplemental Notice of Proposed Rulemaking (SNPRM)
on August 1, 2011. The Coast Guard intends to review and analyze
comments received on that SNPRM, and publish a subsequent rule
complying with the requirements of the newly amended STCW Convention.
DHS included this rulemaking in the DHS Final Plan for the
Retrospective Review of Existing Regulations, which DHS released on
August 22, 2011.
Vessel Requirements for Notices of Arrival and Departure, and
Automatic Identification System. The Coast Guard intends to expand the
applicability of notice of arrival and departure (NOAD) and automatic
identification system (AIS) requirements to include more commercial
vessels. This rule, once final, would expand the applicability of
notice of arrival (NOA) requirements to include additional vessels,
establish a separate requirement for vessels to submit notices of
departure (NOD) when departing for a foreign port or place, set forth a
mandatory method for electronic submission of NOA and NOD, and modify
related reporting content, timeframes, and procedures. This rule would
also extend the applicability of AIS requirements beyond Vessel Traffic
Service (VTS) areas to all U.S. navigable waters and require additional
commercial vessels install and use AIS. These changes are intended to
improve navigation safety, enhance Coast Guard's ability to identify
and track vessels, and heighten the Coast Guard's overall maritime
domain awareness, thus helping the Coast Guard address
[[Page 7734]]
threats to maritime transportation safety and security and mitigate the
possible harm from such threats.
Nontank Vessel Response Plans and Other Vessel Response Plan
Requirements. The Coast Guard intends to promulgate a rule to further
protect the Nation from the threat of oil spills in U.S. waters, which
supports the strategic goals of protection of natural resources and
maritime mobility. The rule, once final, would require owners and
operators of nontank vessels to prepare and submit oil spill response
plans. The Federal Water Pollution Control Act defines nontank vessels
as self-propelled vessels of 400 gross tons or greater that operate on
the navigable waters of the United States, carry oil of any kind as
fuel for main propulsion, and are not tank vessels. The rule would
specify the content of a response plan and would address, among other
issues, the requirement that a plan for responding to a worst case
discharge and a substantial threat of such a discharge. Additionally,
the rule would require vessel owners and operators to submit their
vessel response plan control number as part of already required notice
of arrival information.
Revision to Transportation Worker Identification Credential (TWIC)
Requirements for Mariners. The Coast Guard is developing revisions to
its merchant mariner credentialing regulations, to implement changes
made by section 809 of the Coast Guard Authorization Act of 2010.
Section 809 eliminated the requirement for certain mariner populations
to obtain TWIC. The Coast Guard is also considering revising its
regulations to provide an exemption for certain fees associated with
merchant mariner credentialing for those mariners not required to hold
a TWIC who may still be required to visit a TWIC enrollment center to
provide the information necessary to obtain a Merchant Mariner
Credential. DHS highlighted this rulemaking in the DHS Final Plan for
the Retrospective Review of Existing Regulations, which DHS released on
August 22, 2011.
Offshore Supply Vessels of 6,000 or more GT ITC. The Coast Guard
Authorization Act of 2010 (the Act) removed the size limit on offshore
supply vessels (OSVs) and directed the Coast Guard to issue, as soon as
practicable, regulations to implement section 617 of the Act. As
required by the Act, this regulation would provide for the safe
carriage of oil, hazardous substances, and individuals in addition to
crew on OSVs of at least 6,000 gross tonnage as measured under the
International Convention on Tonnage Measurement of Ships (6,000 GT
ITC). In developing the regulations, the Coast Guard is taking into
account the characteristics of offshore supply vessels, their methods
of operation, and their service in support of exploration,
exploitation, or production of offshore mineral or energy resources.
United States Customs and Border Protection
U.S. Customs and Border Protection (CBP) is the Federal agency
principally responsible for the security of our Nation's borders at and
between the ports of entry and at official crossings into the United
States. CBP must accomplish its border security and enforcement mission
while facilitating the flow of legitimate trade and travel. The primary
mission of CBP is its homeland security mission; that is, to prevent
terrorists and terrorist weapons from entering the United States. An
important aspect of this priority mission involves improving security
at our borders and ports of entry, but it also means extending our zone
of security beyond our physical borders.
CBP is also responsible for administering laws concerning the
import and export of goods into and out of the United States, and
enforcing the laws concerning the entry of persons into and out of the
United States. This includes regulating and facilitating international
trade; collecting import duties; enforcing U.S. trade, immigration, and
other laws of the United States at our borders; inspecting imports and
exports; overseeing the activities of persons and businesses engaged in
importing; enforcing the laws concerning smuggling and trafficking in
contraband; apprehending individuals attempting to enter the United
States illegally; protecting our agriculture and economic interests
from harmful pests and diseases; conducting inspections of all people,
vehicles, and cargo entering the United States; enforcing export
controls; and protecting U.S. businesses from theft of their
intellectual property.
In carrying out its priority mission, CBP's goal is to facilitate
the processing of legitimate trade and people efficiently without
compromising security. Consistent with its primary mission of homeland
security, CBP intends to finalize several rules during the next fiscal
year that are intended to improve security at our borders and ports of
entry. We have highlighted some of these rules below.
Electronic System for Travel Authorization (ESTA). On June 9, 2008,
CBP published an interim final rule amending DHS regulations to
implement the Electronic System for Travel Authorization (ESTA) for
aliens who wish to enter the United States under the Visa Waiver
Program (VWP) at air or sea ports of entry. This rule is intended to
fulfill the requirements of section 711 of the Implementing
Recommendations of the 9/11 Commission Act of 2007 (9/11 Act). The rule
establishes ESTA and delineates the data field DHS has determined will
be collected by the system. The rule requires that each alien traveling
to the United States under the VWP must obtain electronic travel
authorization via the ESTA in advance of such travel. VWP travelers may
obtain the required ESTA authorization by electronically submitting to
CBP biographic and other information as currently required by the I-94W
Nonimmigrant Alien Arrival/Departure Form (I-94W). By Federal Register
notice dated November 13, 2008, the Secretary of Homeland Security
informed the public that ESTA would become mandatory beginning January
12, 2009. This means that all VWP travelers must either obtain travel
authorization in advance of travel under ESTA or obtain a visa prior to
traveling to the United States.
By shifting from a paper to an electronic form and requiring the
data in advance of travel, CBP will be able to determine before the
alien departs for the U.S. the eligibility of nationals from VWP
countries to travel to the United States and to determine whether such
travel poses a law enforcement or security risk. By modernizing the
VWP, the ESTA is intended to increase national security and provide for
greater efficiencies in the screening of international travelers by
allowing for vetting of subjects of potential interest well before
boarding, thereby reducing traveler delays based on lengthy processes
at ports of entry. On August 9, 2010, CBP published an interim final
rule amending the ESTA regulations to require ESTA applicants to pay a
congressionally mandated fee, which is the sum of two amounts, a $10
travel promotion fee for an approved ESTA and a $4.00 operational fee
for the use of ESTA set by the Secretary of Homeland Security to at
least ensure the recovery of the full costs of providing and
administering the ESTA system. During the next fiscal year, CBP intends
to issue a final rule on ESTA and the ESTA fee.
Importer Security Filing and Additional Carrier Requirements. The
Security and Accountability for Every Port Act of 2006 (SAFE Port Act)
calls for CBP to promulgate regulations to require the electronic
transmission of additional data elements for improved high-risk
targeting. See Public Law 109-
[[Page 7735]]
347, section 203 (October 13, 2006). This includes appropriate security
elements of entry data for cargo destined for the United States by
vessel prior to loading of such cargo on vessels at foreign seaports.
The SAFE Port Act requires that the information collected reasonably
improve CBP's ability to identify high-risk shipments to prevent
smuggling and ensure cargo safety and security.
On November 25, 2008, CBP published an interim final rule
``Importer Security Filing and Additional Carrier Requirements,''
amending CBP Regulations to require carriers and importers to provide
to CBP via a CBP-approved electronic data interchange system,
information necessary to enable CBP to identify high-risk shipments to
prevent smuggling, and ensure cargo safety and security. This rule,
which became effective on January 26, 2009, improves CBP risk
assessment and targeting capabilities, facilitates the prompt release
of legitimate cargo following its arrival in the United States, and
assists CBP in increasing the security of the global trading system.
The comment period for the interim final rule concluded on June 1,
2009. CBP is analyzing comments and conducting a structured review of
certain flexibility provided in the interim final rule. CBP intends to
publish a final rule during the next fiscal year.
Implementation of the Guam-CNMI Visa Waiver Program. CBP published
an interim final rule in November 2008 amending the DHS regulations to
replace the current Guam Visa Waiver Program with a new Guam-CNMI Visa
Waiver program. This rule implements portions of the Consolidated
National Resources Act of 2008 (CNRA), which extends the immigration
laws of the United States to the Commonwealth of the Northern Mariana
Islands (CNMI) and, among others things, provides for a visa waiver
program for travel to Guam and the CNMI. The amended regulations set
forth the requirements for nonimmigrant visitors who seek admission for
business or pleasure and solely for entry into and stay on Guam or the
CNMI without a visa. The rule also establishes six ports of entry in
the CNMI for purposes of administering and enforcing the Guam-CNMI Visa
Waiver program. CBP intends to issue a final rule during the next
fiscal year.
Global Entry Program. In the fall of 2009, pursuant to section
7208(k) of the Intelligence Reform and Terrorism Prevention Act of
2004, as amended, CBP issued a Notice of Proposed Rulemaking (NPRM),
proposing to establish an international trusted traveler program,
called Global Entry. This voluntary program would allow CBP to expedite
clearance of pre-approved, low-risk air travelers into the United
States. CBP has been operating the Global Entry program as a pilot at
several airports since June 6, 2008. Based on the successful operation
of the pilot, CBP proposed to establish Global Entry as a permanent
voluntary regulatory program. CBP has evaluated the public comments
received in response to the NPRM and intends to issue a final rule
during the next fiscal year.
In the above paragraphs, DHS discusses the CBP regulations that
foster DHS's mission. CBP also issues regulations related to the
mission of the Department of the Treasury. Under section 403(1) of the
Homeland Security Act of 2002, the former U.S. Customs Service,
including functions of the Secretary of the Treasury relating thereto,
transferred to the Secretary of Homeland Security. As part of the
initial organization of DHS, the Customs Service inspection and trade
functions were combined with the immigration and agricultural
inspection functions and the Border Patrol and transferred into CBP. It
is noted that certain regulatory authority of the United States Customs
Service relating to customs revenue function was retained by the
Department of the Treasury (see the Department of the Treasury
regulatory plan). In addition to its plans to continue issuing
regulations to enhance border security, CBP, during fiscal year 2012,
expects to continue to issue regulatory documents that will facilitate
legitimate trade and implement the trade benefit program. CBP
regulations regarding the customs revenue function are discussed in the
regulatory plan of the Department of the Treasury.
Federal Emergency Management Agency
The mission of the Federal Emergency Management Agency (FEMA) is to
support our citizens and first responders to ensure that, as a Nation,
we work together to build, sustain, and improve our capability to
prepare for, protect against, respond to, recover from, and mitigate
all hazards. In fiscal year 2012, FEMA will continue to serve that
mission and promote the Department of Homeland Security's goals. In
furtherance of the Department and Agency's goals, in the upcoming
fiscal year, FEMA will work on regulations to implement provisions of
the Post-Katrina Emergency Management Reform Act of 2006 (PKEMRA) (Pub.
L. 109-295, Oct. 4, 2006) and to implement lessons learned from past
events.
Public Assistance Program Regulations. FEMA will work to revise the
Public Assistance Program regulations in 44 CFR part 206 to reflect
changes made to the Robert T. Stafford Disaster Relief and Emergency
Assistance Act by PKEMRA, the Pets Evacuation and Transportation
Standards Act of 2006 (PETS Act) (Pub. L. 109-308, Oct. 6, 2006), the
Local Community Recovery Act of 2006 (Pub. L. 109-218, Apr. 20, 2006),
and the Security and Accountability for Every Port Act of 2006 (SAFE
Port Act) (Pub. L. 109-347, Oct. 13, 2006), and to make other
substantive and nonsubstantive clarifications and corrections to the
Public Assistance regulations. The proposed changes would expand
eligibility to include performing arts facilities and community arts
centers pursuant to section 688 of PKEMRA; include education in the
list of critical services pursuant to section 689(h) of PKEMRA, thus
allowing private nonprofit educational facilities to be eligible for
restoration funding; add accelerated Federal assistance to available
assistance pursuant to section 681 of PKEMRA; include household pets
and service animals in essential assistance pursuant to section 689 of
PKEMRA and section 4 of the PETS Act; provide for expedited payments of
grant assistance for the removal of debris pursuant to section 610 of
the SAFE Port Act; and allow for a contract to be set aside for award
based on a specific geographic area pursuant to section 2 of the Local
Community Recovery Act of 2006. Other changes would include adding or
changing requirements to improve and streamline the Public Assistance
grant application process.
Federal Law Enforcement Training Center
The Federal Law Enforcement Training Center (FLETC) does not have
any significant regulatory actions planned for fiscal year 2012.
United States Immigration and Customs Enforcement
ICE is the principal criminal investigative arm of the Department
of Homeland Security and one of the three Department components charged
with the civil enforcement of the Nation's immigration laws. Its
primary mission is to protect national security, public safety, and the
integrity of our borders through the criminal and civil enforcement of
Federal law governing border control, customs, trade, and immigration.
During fiscal year 2012, ICE will pursue rulemaking actions that
improve two critical subject areas: The detention
[[Page 7736]]
of aliens who are subject to final orders of removal and the processes
for the Student and Exchange Visitor Program (SEVP).
Continued Detention of Aliens Subject to Final Orders of Removal.
ICE will improve the post order custody review process in a Final Rule
related to the continued detention of aliens subject to final orders of
removal in light of the U.S. Supreme Court's decisions in Zadvydas v.
Davis, 533 U.S. 678 (2001) and Clark v. Martinez, 543 U.S. 371 (2005),
as well as changes pursuant to the enactment of the Homeland Security
Act of 2002. During fiscal year 2012, ICE will also issue a companion
Notice of Proposed Rulemaking (NPRM) that will allow the public an
opportunity to comment on new sections of the custody determination
process not previously published for comment.
Processes for the Student and Exchange Visitor Program. ICE will
improve SEVP processes by publishing a final Optional Practical
Training (OPT) rule, which will respond to comments on the OPT Interim
Final Rule (IFR). The IFR increased the maximum period of OPT from 12
months to 29 months for nonimmigrant students who have completed a
science, technology, engineering, or mathematics degree and who accept
employment with employers who participate in USCIS's E-Verify
employment verification program.
National Protection and Programs Directorate
The goal of the National Protection and Programs Directorate (NPPD)
is to advance the Department's risk-reduction mission. Reducing risk
requires an integrated approach that encompasses both physical and
virtual threats and their associated human elements.
Ammonium Nitrate Security Program. The Secure Handling of Ammonium
Nitrate Act, section 563 of the Fiscal Year 2008 Department of Homeland
Security Appropriations Act, Public Law 110-161, amended the Homeland
Security Act of 2002 to provide DHS with the authority to ``regulate
the sale and transfer of ammonium nitrate by an ammonium nitrate
facility * * * to prevent the misappropriation or use of ammonium
nitrate in an act of terrorism.''
The Secure Handling of Ammonium Nitrate Act directs DHS to
promulgate regulations requiring potential buyers and sellers of
ammonium nitrate to register with DHS. As part of the registration
process, the statute directs DHS to screen registration applicants
against the Federal Government's Terrorist Screening Database. The
statute also requires sellers of ammonium nitrate to verify the
identities of those seeking to purchase it; to record certain
information about each sale or transfer of ammonium nitrate; and to
report thefts and losses of ammonium nitrate to DHS.
The Ammonium Nitrate Security Program Notice of Proposed Rulemaking
proposes requirements that would implement the Secure Handling of
Ammonium Nitrate Act. The rule would aid the Federal Government in its
efforts to prevent the misappropriation of ammonium nitrate for use in
acts of terrorism. By preventing such misappropriation, this rule aims
to limit terrorists' abilities to threaten the public and to threaten
the Nation's critical infrastructure and key resources. By securing the
Nation's supply of ammonium nitrate, it will be more difficult for
terrorists to obtain ammonium nitrate materials for use in terrorist
acts.
On October 29, 2008, DHS published an Advance Notice of Proposed
Rulemaking (ANPRM) for the Secure Handling of Ammonium Nitrate Program,
and received a number of public comments on that ANPRM. DHS reviewed
those comments and published a Notice of Proposed Rulemaking (NPRM) on
August 3, 2011. NPPD will accept public comment on until December 1,
2011, after which NPPD will review the public comments and develop a
Final Rule related to the Security Handling of Ammonium Nitrate
Program.
Transportation Security Administration
The Transportation Security Administration (TSA) protects the
Nation's transportation systems to ensure freedom of movement for
people and commerce. TSA is committed to continuously setting the
standard for excellence in transportation security through its people,
processes, and technology as we work to meet the immediate and long-
term needs of the transportation sector.
In fiscal year 2012, TSA will promote the DHS mission by
emphasizing regulatory efforts that allow TSA to better identify,
detect, and protect against threats against various modes of the
transportation system, while facilitating the efficient movement of the
traveling public, transportation workers, and cargo.
General Aviation Security and Other Aircraft Operator Security. TSA
plans to issue a Supplemental Notice of Proposed Rulemaking (SNPRM) to
propose amendments to current aviation transportation security
regulations to enhance the security of general aviation (GA) by
expanding the scope of current requirements and by adding new
requirements for certain GA aircraft operators. To date, the
Government's focus with regard to aviation security generally has been
on air carriers and commercial operators. As vulnerabilities and risks
associated with air carriers and commercial operators have been reduced
or mitigated, terrorists may perceive that GA aircraft are more
vulnerable and may view them as attractive targets. This rule would
enhance aviation security by requiring operators of certain GA aircraft
to adopt a security program and to undertake other security measures.
TSA published a Notice of Proposed Rulemaking on October 30, 2008, and
received over 7,000 public comments, generally urging significant
changes to the proposal. The SNPRM will respond to the comments and
contain proposals on addressing security in the GA sector.
Security Training for Surface Mode Employees. TSA will propose
regulations to enhance the security of several non-aviation modes of
transportation. In particular, TSA will propose regulations requiring
freight railroad carriers, public transportation agencies (including
rail mass transit and bus systems), passenger railroad carriers, and
over-the-road bus operators to conduct security training for front line
employees. This regulation would implement sections 1408 (Public
Transportation), 1517 (Freight Railroads), and 1534(a) (Over the Road
Buses) of the Implementing Recommendations of the 9/11 Commission Act
of 2008 (9/11 Act), Public Law 110-53 (Aug. 3, 2007). In compliance
with the definitions of frontline employees in the pertinent provisions
of the 9/11 Act, the Notice of Proposed Rulemaking (NPRM) would define
which employees are required to undergo training. The NPRM would also
propose definitions for transportation security-sensitive materials, as
required by section 1501 of the 9/11 Act.
Railroad Carrier Vulnerability Assessment and Security Plans. TSA
will also propose regulations requiring high-risk freight and passenger
railroads to conduct vulnerability self-assessments, as well as develop
and implement comprehensive security plans. TSA would need to approve
both the vulnerability assessment and security plan. This regulation,
implementing section 1512 of the 9/11 Act, would include proposed
provisions to identify which railroads would be considered high-risk
and include proposed provisions about the associated vulnerability
assessment and security planning requirements.
[[Page 7737]]
Aircraft Repair Station Security. TSA will finalize a rule
requiring repair stations that are certificated by the Federal Aviation
Administration under 14 CFR part 145 to adopt and implement standard
security programs and to comply with security directives issued by TSA.
TSA issued an Notice of Proposed Rulemaking (NPRM) on November 18,
2009. The final rule will also codify the scope of TSA's existing
inspection program and could require regulated parties to allow DHS
officials to enter, inspect, and test property, facilities, and records
relevant to repair stations. This rulemaking action will implement
section 1616 of the 9/11 Act.
Standardized Vetting, Adjudication, and Redress Process and Fees.
TSA is developing a proposed rule to revise and standardize the
procedures, adjudication criteria, and fees for most of the security
threat assessments (STA) of individuals that TSA conducts. DHS is
considering a proposal that would include procedures for conducting
STAs for transportation workers from almost all modes of
transportation, including those covered under the 9/11 Act. In
addition, TSA will propose equitable fees to cover the cost of the STAs
and credentials for some personnel. TSA plans to identify new
efficiencies in processing STAs and ways to streamline existing
regulations by simplifying language and removing redundancies.
As part of this proposed rule, TSA will propose revisions to the
Alien Flight Student Program (AFSP) regulations. TSA published an
interim final rule for ASFP on September 20, 2004. TSA regulations
require aliens seeking to train at Federal Aviation Administration-
regulated flight schools to complete an application and undergo an STA
prior to beginning flight training. There are four categories under
which students currently fall; the nature of the STA depends on the
student's category. TSA is considering changes to the AFSP that would
improve equity among fee payers and enable the implementation of new
technologies to support vetting.
United States Secret Service
The United States Secret Service does not have any significant
regulatory actions planned for fiscal year 2012.
DHS Regulatory Plan for Fiscal Year 2012
A more detailed description of the priority regulations that
comprise DHS's fall 2011 regulatory plan follows.
DHS--OFFICE OF THE SECRETARY (OS)
Proposed Rule Stage
53. Secure Handling of Ammonium Nitrate Program
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 2008 Consolidated Appropriations Act, sec 563,
subtitle J--Secure Handling of Ammonium Nitrate, Pub. L. 110-161
CFR Citation: 6 CFR 31.
Legal Deadline: NPRM, Statutory, May 26, 2008, Publication of
Notice of Proposed Rulemaking.
Abstract: This rulemaking will implement the December 2007
amendment to the Homeland Security Act entitled ``Secure Handling of
Ammonium Nitrate.'' The amendment requires the Department of Homeland
Security to ``regulate the sale and transfer of ammonium nitrate by an
ammonium nitrate facility * * * to prevent the misappropriation or use
of ammonium nitrate in an act of terrorism.''
Statement of Need: Pursuant to section 563 of the 2008 Consolidated
Appropriations Act, subtitle J--Secure Handling of Ammonium Nitrate,
Public Law 110-161, the Department of Homeland Security is required to
promulgate a rulemaking to create a registration regime for certain
buyers and sellers of ammonium nitrate. The rule, as proposed by this
NPRM, would create that regime, and would aid the Federal Government in
its efforts to prevent the misappropriation of ammonium nitrate for use
in acts of terrorism. By preventing such misappropriation, this rule
could limit terrorists' abilities to threaten the public and to
threaten the Nation's critical infrastructure and key resources. By
securing the Nation's supply of ammonium nitrate, it should be much
more difficult for terrorists to obtain ammonium nitrate materials for
use in improvised explosive devices. As a result, there is a direct
value in the deterrence of a catastrophic terrorist attack using
ammonium nitrate, such as the Oklahoma City attack that killed over 160
and injured 853 people.
Summary of Legal Basis: Section 563 of the 2008 Consolidated
Appropriations Act, subtitle J--Secure Handling of Ammonium Nitrate,
Public Law 110-161, authorizes and requires this rulemaking.
Alternatives: The Department considered several alternatives when
developing the Ammonium Nitrate Security Program proposed rule. The
alternatives considered were: (a) Register individuals applying for an
AN Registered User Number using a paper application (via facsimile or
the U.S. mail) rather than through in person application at a local
Cooperative Extension office or only through a web-based portal; (b)
verify AN Purchasers through both an Internet based verification portal
and call center rather than only a verification portal or call center;
(c) communicate with applicants for an AN Registered User Number
through U.S. Mail rather than only through email or a secure web-based
portal; (d) establish a specific capability within the Department to
receive, process, and respond to reports of theft or loss rather than
leverage a similar capability which already exists with the ATF; (e)
require AN Facilities to maintain records electronically in a central
database provided by the Department rather than providing flexibility
to the AN Facility to maintain their own records either in paper or
electronically; (f) require agents to register with the Department
prior to the sale or transfer of ammonium nitrate involving an agent
rather than allow oral confirmation of the agent with the AN Purchaser
on whose behalf the agent is working; and (g) exempt explosives from
this regulation rather than not exempting them. As part of its notice
of proposed rulemaking, the Department seeks public comment on the
numerous alternative ways in which the final Secure Handling of
Ammonium Nitrate Program could carry out the requirements of the Secure
Handling of Ammonium Nitrate Act.
Anticipated Cost and Benefits: The Department estimates the number
of entities that purchase ammonium nitrate to range from 64,950 to
106,200. These purchasers include farms, fertilizer mixers, farm supply
wholesalers and cooperatives (co-ops), golf courses, landscaping
services, explosives distributors, mines, retail garden centers, and
lab supply wholesalers. The Department estimates the number of entities
that sell ammonium nitrate to be between 2,486 and 6,236, many of which
are also purchasers. These sellers include ammonium nitrate fertilizer
and explosive manufacturers, fertilizer mixers, farm supply wholesalers
and co-ops, retail garden centers, explosives distributors, fertilizer
applicator services, and lab supply wholesalers. Individuals or firms
that provide transportation services within the distribution chain may
be categorized as
[[Page 7738]]
sellers, agents, or facilities depending upon their business
relationship with the other parties to the transaction. The total
number of potentially regulated farms and other businesses ranges from
64,986 to 106,236 (including overlap between the categories).
The cost of this proposed rule ranges from $300 million to $1,041
million over 10 years at a 7 percent discount rate. The primary
estimate is the mean which is $670.6 million. For comparison, at a 3
percent discount rate, the cost of the program ranges from $364 million
to $1.3 billion with a primary (mean) estimate of $814 million. The
average annualized cost for the program ranges from $43 million to $148
million (with a mean of $96 million), also employing a 7 percent
discount rate.
Because the value of the benefits of reducing risk of a terrorist
attack is a function of both the probability of an attack and the value
of the consequence, it is difficult to identify the particular risk
reduction associated with the implementation of this rule. These
elements and related qualitative benefits include point of sale
identification requirements and requiring individuals to be screened
against the Terrorist Screening Database (TSDB) resulting in known bad
actors being denied the ability to purchase ammonium nitrate.
The Department of Homeland Security aims to prevent terrorist
attacks within the United States and to reduce the vulnerability of the
United States to terrorism. By preventing the misappropriation or use
of ammonium nitrate in acts of terrorism, this rulemaking will support
the Department's efforts to prevent terrorist attacks and to reduce the
Nation's vulnerability to terrorist attacks. This rulemaking is
complementary to other Department programs seeking to reduce the risks
posed by terrorism, including the Chemical Facility Anti-Terrorism
Standards program (which seeks in part to prevent terrorists from
gaining access to dangerous chemicals) and the Transportation Worker
Identification Credential program (which seeks in part to prevent
terrorists from gaining access to certain critical infrastructure),
among other programs.
Risks: Explosives containing ammonium nitrate are commonly used in
terrorist attacks. Such attacks have been carried out both domestically
and internationally. The 1995 Murrah Federal Building attack in
Oklahoma City claimed the lives of 167 individuals and demonstrated
firsthand to America how ammonium nitrate could be misused by
terrorists. In addition to the Murrah Building attack, the Provisional
Irish Republican Army used ammonium nitrate as part of its London,
England bombing campaign in the early 1980s. More recently, ammonium
nitrate was used in the 1998 East African Embassy bombings and in
November 2003 bombings in Istanbul, Turkey. Additionally, since the
events of 9/11, stores of ammonium nitrate have been confiscated during
raids on terrorist sites around the world, including sites in Canada,
England, India, and the Philippines.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 10/29/08 73 FR 64280
Correction.......................... 11/05/08 73 FR 65783
ANPRM Comment Period End............ 12/29/08 .......................
NPRM................................ 08/03/11 76 FR 46908
Notice of Public Meetings........... 10/07/11 76 FR 62311
Notice of Public Meetings........... 11/14/11 76 FR 70366
NPRM Comment Period End............. 12/01/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Federalism: This action may have federalism implications as defined
in EO 13132.
URL For More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Jon MacLaren, Ammonium Nitrate Program Manager,
Department of Homeland Security, Office of the Secretary,
Infrastructure Security Compliance Division (NPPD/ISCD), Mail Stop
0610, 245 Murray Lane SW., Arlington, VA 20598-0610, Phone: 703 235-
5263, Email: jon.m.maclaren@hq.dhs.gov.
RIN: 1601-AA52
DHS--U.S. CITIZENSHIP AND IMMIGRATION SERVICES (USCIS)
Proposed Rule Stage
54. Asylum and Withholding Definitions
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1158; 8 U.S.C. 1226; 8
U.S.C. 1252; 8 U.S.C. 1282
CFR Citation: 8 CFR 2; 8 CFR 208.
Legal Deadline: None.
Abstract: This rule proposes to amend Department of Homeland
Security regulations that govern asylum eligibility. The amendments
focus on portions of the regulations that deal with the definitions of
membership in a particular social group, the requirements for failure
of State protection, and determinations about whether persecution is
inflicted on account of a protected ground. This rule codifies long-
standing concepts of the definitions. It clarifies that gender can be a
basis for membership in a particular social group. It also clarifies
that a person who has suffered or fears domestic violence may under
certain circumstances be eligible for asylum on that basis. After the
Board of Immigration Appeals published a decision on this issue in
1999, Matter of R-A-, Int. Dec. 3403 (BIA 1999), it became clear that
the governing regulatory standards required clarification. The
Department of Justice began this regulatory initiative by publishing a
proposed rule addressing these issues in 2000.
Statement of Need: This rule provides guidance on a number of key
interpretive issues of the refugee definition used by adjudicators
deciding asylum and withholding of removal (withholding) claims. The
interpretive issues include whether persecution is inflicted on account
of a protected ground, the requirements for establishing the failure of
State protection, and the parameters for defining membership in a
particular social group. This rule will aid in the adjudication of
claims made by applicants whose claims fall outside of the rubric of
the protected grounds of race, religion, nationality, or political
opinion. One example of such claims which often fall within the
particular social group ground concerns people who have suffered or
fear domestic violence. This rule is expected to consolidate issues
raised in a proposed rule in 2000 and to address issues that have
developed since the publication of the proposed rule. This rule should
provide greater stability and clarity in this important area of the
law.
Summary of Legal Basis: The purpose of this rule is to provide
guidance on certain issues that have arisen in the context of asylum
and withholding adjudications. The 1951 Geneva Convention relating to
the Status of Refugees contains the internationally accepted definition
of a refugee. United States immigration law incorporates an almost
identical definition of a refugee as a person outside his or her
country of origin ``who is unable or unwilling to return to, and is
unable or unwilling to avail himself or herself of the protection of,
that country because of persecution or a well-founded fear of
persecution on account of race, religion, nationality, membership in a
particular social group,
[[Page 7739]]
or political opinion.'' Section 101(a)(42) of the Immigration and
Nationality Act.
Alternatives: A sizable body of interpretive case law has developed
around the meaning of the refugee definition. Historically, much of
this case law has addressed more traditional asylum and withholding
claims based on the protected grounds of race, religion, nationality,
or political opinion. In recent years, however, the United States
increasingly has encountered asylum and withholding applications with
more varied bases, related, for example, to an applicant's gender or
sexual orientation. Many of these new types of claims are based on the
ground of ``membership in a particular social group,'' which is the
least well-defined of the five protected grounds within the refugee
definition.
On December 7, 2000, DOJ published a proposed rule in the Federal
Register providing guidance on the definitions of ``persecution'' and
``membership in a particular social group.'' Prior to publishing a new
proposed rule, the Department will be considering how the nexus between
persecution and a protected ground might be further conceptualized; how
membership in a particular social group might be defined and evaluated;
and what constitutes a State's inability or unwillingness to protect
the applicant where the persecution arises from a non-State actor. This
rule will provide guidance to the following adjudicators: USCIS asylum
officers, Department of Justice Executive Office for Immigration Review
(EOIR) immigration judges, and members of the EOIR Board of Immigration
Appeals. The alternative to publishing this rule would be to allow the
standards governing this area of law to continue to develop piecemeal
through administrative and judicial precedent. This approach has
resulted in inconsistent and confusing standards, and the Department
has therefore determined that promulgation of the new proposed rule is
necessary.
Anticipated Cost and Benefits: By providing a clear framework for
key asylum and withholding issues, we anticipate that adjudicators will
have clear guidance, increasing administrative efficiency and
consistency in adjudicating these cases. The rule will also promote a
more consistent and predictable body of administrative and judicial
precedent governing these types of cases. We anticipate that this will
enable applicants to better assess their potential eligibility for
asylum, and to present their claims more efficiently when they believe
that they may qualify, thus reducing the resources spent on
adjudicating claims that do not qualify. In addition, a more consistent
and predictable body of law on these issues will likely result in fewer
appeals, both administrative and judicial, and reduce associated
litigation costs. The Department has no way of accurately predicting
how this rule will impact the number of asylum applications filed in
the United States. Based on anecdotal evidence and on the reported
experience of other nations that have adopted standards under which the
results are similar to those we anticipate for this rule, we do not
believe this rule will cause a change in the number of asylum
applications filed.
Risks: The failure to promulgate a final rule in this area presents
significant risks of further inconsistency and confusion in the law.
The Government's interests in fair, efficient, and consistent
adjudications would be compromised.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/07/00 65 FR 76588
NPRM Comment Period End............. 01/22/01 .......................
NPRM................................ 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS No. 2092-00, Transferred from RIN 1115-
AF92.
Agency Contact: Ted Kim, Deputy Chief, Asylum Division, Department
of Homeland Security, U.S. Citizenship and Immigration Services, Office
of Refugee, Asylum, and International Operations, Suite 3200, 20
Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1614,
Fax: 202 272-1994, Email: ted.kim@dhs.gov.
RIN: 1615-AA41
DHS--USCIS
55. New Classification for Victims of Criminal Activity; Eligibility
for the U Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8
U.S.C. 1101 note; 8 U.S.C. 1102
CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 212; 8 CFR 214; 8 CFR
299.
Legal Deadline: None.
Abstract: This rule sets forth application requirements for a new
nonimmigrant status. The U classification is for non-U.S. Citizen/
Lawful Permanent Resident victims of certain crimes who cooperate with
an investigation or prosecution of those crimes. There is a limit of
10,000 principals per year.
This rule establishes the procedures to be followed in order to
petition for the U nonimmigrant classifications. Specifically, the rule
addresses the essential elements that must be demonstrated to receive
the nonimmigrant classification, procedures that must be followed to
make an application, and evidentiary guidance to assist in the
petitioning process. Eligible victims will be allowed to remain in the
United States. The Trafficking Victims Protection Reauthorization Act
of 2008, Public Law 110-457, made amendments to the T nonimmigrant
status provisions of the Immigration and Nationality Act. The
Department will issue a proposed rule to make the changes required by
recent legislation and to provide the opportunity for notice and
comment.
Statement of Need: This rule provides requirements and procedures
for aliens seeking U nonimmigrant status. U nonimmigrant classification
is available to alien victims of certain criminal activity who assist
government officials in the investigation or prosecution of that
criminal activity. The purpose of the U nonimmigrant classification is
to strengthen the ability of law enforcement agencies to investigate
and prosecute such crimes as domestic violence, sexual assault, and
trafficking in persons, while offering protection to alien crime
victims in keeping with the humanitarian interests of the United
States.
Summary of Legal Basis: Congress created the U nonimmigrant
classification in the Battered Immigrant Women Protection Act of 2000
(BIWPA). Congress intended to strengthen the ability of law enforcement
agencies to investigate and prosecute cases of domestic violence,
sexual assault, trafficking of aliens, and other crimes, while offering
protection to victims of such crimes. Congress also sought to encourage
law enforcement officials to better serve immigrant crime victims.
Alternatives: USCIS has identified four alternatives, the first
being chosen for the rule:
1. USCIS would adjudicate petitions on a first in, first out basis.
Petitions received after the limit has been reached would be reviewed
to determine whether or not they are approvable, but for the numerical
cap. Approvable petitions that are reviewed after the numerical cap has
been reached would be placed on a waiting list and written notice sent
to the petitioner. Priority on
[[Page 7740]]
the waiting list would be based upon the date on which the petition is
filed. USCIS would provide petitioners on the waiting list with interim
relief until the start of the next fiscal year in the form of deferred
action, parole, or a stay of removal.
2. USCIS would adjudicate petitions on a first in, first out basis,
establishing a waiting list for petitions that are pending or received
after the numerical cap has been reached. Priority on the waiting list
would be based upon the date on which the petition was filed. USCIS
would not provide interim relief to petitioners whose petitions are
placed on the waiting list.
3. USCIS would adjudicate petitions on a first in, first out basis.
However, new filings would be reviewed to identify particularly
compelling cases for adjudication. New filings would be rejected once
the numerical cap is reached. No official waiting list would be
established; however, interim relief until the start of the next fiscal
year would be provided for some compelling cases. If a case was not
particularly compelling, the filing would be denied or rejected.
4. USCIS would adjudicate petitions on a first in, first out basis.
However, new filings would be rejected once the numerical cap is
reached. No waiting list would be established nor would interim relief
be granted.
Anticipated Cost and Benefits: USCIS estimates the total annual
cost of this interim rule to applicants to be $6.2 million. This cost
includes the biometric services fee that petitioners must pay to USCIS,
the opportunity cost of time needed to submit the required forms, the
opportunity cost of time required for a visit to an Application Support
Center, and the cost of traveling to an Application Support Center.
This rule will strengthen the ability of law enforcement agencies
to investigate and prosecute such crimes as domestic violence, sexual
assault, and trafficking in persons, while offering protection to alien
crime victims in keeping with the humanitarian interests of the United
States.
Risks: In the case of witness tampering, obstruction of justice, or
perjury, the interpretive challenge for USCIS was to determine whom the
BIWPA was meant to protect, given that these criminal activities are
not targeted against a person. Accordingly it was determined that a
victim of witness tampering, obstruction of justice, or perjury is an
alien who has been directly and proximately harmed by the perpetrator
of one of these three crimes, where there are reasonable grounds to
conclude that the perpetrator principally committed the offense as a
means: (1) To avoid or frustrate efforts to investigate, arrest,
prosecute, or otherwise bring him or her to justice for other criminal
activity; or (2) to further his or her abuse or exploitation of, or
undue control over, the alien through manipulation of the legal system.
Timetable:
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Action Date FR Cite
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Interim Final Rule.................. 09/17/07 72 FR 53013
Interim Final Rule Effective........ 10/17/07 .......................
Interim Final Rule Comment Period 11/17/07 .......................
End.
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Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal, Local, State.
Additional Information: Transferred from RIN 1115-AG39.
Agency Contact: Laura M. Dawkins, Chief, Family Immigration and
Victim Protection Division, Department of Homeland Security, U.S.
Citizenship and Immigration Services, Suite 1200, 20 Massachusetts
Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-
1480, Email: laura.dawkins@dhs.gov.
RIN: 1615-AA67
DHS--USCIS
56. Exception to the Persecution Bar for Asylum, Refugee, and Temporary
Protected Status, and Withholding of Removal
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1158; 8
U.S.C. 1226; Pub. L. 107-26; Pub. L. 110-229
CFR Citation: 8 CFR 1; 8 CFR 208; 8 CFR 244; 8 CFR 1244.
Legal Deadline: None.
Abstract: This joint rule proposes amendments to Department of
Homeland Security (DHS) and Department of Justice (DOJ) regulations to
describe the circumstances under which an applicant will continue to be
eligible for asylum, refugee, or temporary protected status, special
rule cancellation of removal under the Nicaraguan Adjustment and
Central American Relief Act, and withholding of removal, even if DHS or
DOJ has determined that the applicant's actions contributed, in some
way, to the persecution of others. The purpose of this rule is to
resolve ambiguity in the statutory language precluding eligibility for
asylum, refugee, and temporary protected status of an applicant who
ordered, incited, assisted, or otherwise participated in the
persecution of others. The proposed amendment would provide a limited
exception for actions taken by the applicant under duress and clarify
the required levels of the applicant's knowledge of the persecution.
Statement of Need: This rule resolves ambiguity in the statutory
language precluding eligibility for asylum, refugee, and temporary
protected status of an applicant who ordered, incited, assisted, or
otherwise participated in the persecution of others. The proposed
amendment would provide a limited exception for actions taken by the
applicant under duress and clarify the required levels of the
applicant's knowledge of the persecution.
Summary of Legal Basis: In Negusie v. Holder, 129 S. Ct. 1159
(2009), the Supreme Court addressed whether the persecutor bar should
apply where an alien's actions were taken under duress. DHS believes
that this is an appropriate subject for rulemaking and proposes to
amend the applicable regulations to set out its interpretation of the
statute. In developing this regulatory initiative, DHS has carefully
considered the purpose and history behind enactment of the persecutor
bar, including its international law origins and the criminal law
concepts upon which they are based.
Alternatives: DHS did consider the alternative of not publishing a
rulemaking on these issues. To leave this important area of the law
without an administrative interpretation would confuse adjudicators and
the public.
Anticipated Cost and Benefits: The programs affected by this rule
exist so that the United States may respond effectively to global
humanitarian situations and assist people who are in need. USCIS
provides a number of humanitarian programs and protection to assist
individuals in need of shelter or aid from disasters, oppression,
emergency medical issues, and other urgent circumstances. This rule
will advance the humanitarian goals of the asylum/refugee program, and
other specialized programs. The main benefits of such goals tend to be
intangible and difficult to quantify in economic and monetary terms.
These forms of relief have not been available to certain persecutors.
This rule will allow an exception to this bar from protection for
applicants who can meet the appropriate evidentiary standard.
Consequently, this rule may result in a small increase in the number of
applicants for humanitarian programs.
[[Page 7741]]
To the extent a small increase in applicants occurs, there could be
additional fee costs incurred by these applicants.
Risks: If DHS were not to publish a regulation, the public would
face a lengthy period of confusion on these issues. There could also be
inconsistent interpretations of the statutory language, leading to
significant litigation and delay for the affected public.
Timetable:
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Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Molly Groom, Office of the Chief Counsel Department
of Homeland Security, U.S. Citizenship and Immigration Services, 20
Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1400,
Fax: 202 272-1408, Email: molly.groom@dhs.gov.
RIN: 1615-AB89
DHS--USCIS
57. Electronic Filing of Requests for Immigration Benefits;
Requiring an Application To Change or Extend Nonimmigrant Status To Be
Filed Electronically
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1151; 8
U.S.C. 1153
CFR Citation: 8 CFR 103; 8 CFR 204.
Legal Deadline: None.
Abstract: The Department of Homeland Security (DHS) is proposing
regulations to govern the electronic filing of requests for immigration
benefit requests with the U.S. Citizenship and Immigration Services
(USCIS). DHS also proposes to mandate electronic applications in the
new Integrated Operating Environment that is under development, with
limited exceptions, for an Application to Extend/Change Nonimmigrant
Status from any individual in the M, J, B-1, and B-2 classifications;
change of status requests to the F, M, J, B-1, or B-2 classifications;
and reinstatement of status requests in the F or M classification.
Statement of Need: USCIS is in the process of transforming its
operations to improve service, operational efficiency, and national
security. This rule will allow USCIS to modernize its processes, which
will provide applicants and petitioners with better and faster services
and enhance the ability of USCIS to process cases with greater
accuracy, security, and timeliness.
Summary of Legal Basis: Authority for this rule falls within the
broad authority of the Secretary of Homeland Security to administer
DHS, the administration of immigration and nationality laws, and other
delegated authority. See Homeland Security Act of 2002, Public Law 107-
296 section 102 (Nov. 25, 2002), 6 U.S.C. 112, and the Immigration and
Nationality Act of 1952, as amended, section 103, 8 U.S.C. 1103.
The Government Paperwork Elimination Act provides that, when
possible, Federal agencies are directed to make available electronic
forms and provide for electronic filing and submissions when conducting
agency business with the public. See Public Law 105-277, section 1703
(Oct. 21, 1998), 44 U.S.C. 3504. GPEA also establishes the means for
the use and acceptance of electronic signatures.
The INA provides a detailed list of classes of nonimmigrant aliens.
See, e.g., INA sections 101(a)(15)(B), (C), (F), and (M); 8 U.S.C.
1101(a)(15) (B), (C), (F), and (M). The Secretary of Homeland Security
may authorize a change to any other nonimmigrant classification in the
case of any alien who is lawfully admitted to the United States as a
nonimmigrant, maintains his or her lawful status, does not fall under
certain nonimmigrant visa categories that are listed in the statute,
and is not inadmissible or whose inadmissibility has been waived under
the pertinent sections of the immigration and nationality laws of the
United States. See INA section 248(a); 8 U.S.C. 1258(a).
This rule is also proposed in compliance with Executive Order 13571
``Streamlining Service Delivery and Improving Customer Service.'' See
Executive Order No. 13571, 76 FR 24339 (Apr. 27, 2011). Executive Order
13571 tasks each Federal department and agency with establishing an
initiative that uses technology to improve the experience of
individuals and entities receiving services from that Federal
department or agency. See Executive Order No. 13571, section 2(a).
Alternatives: DHS has examined the alternative of maintaining paper
processing for applications to extend/change status (Form I-539) and
has determined that the continuation of legacy data systems and current
processes do not meet the need for USCIS to modernize operations.
Anticipated Cost and Benefits: DHS is proposing to mandate the
electronic filing of stand-alone Applications to Extend/Change
Nonimmigrant Status. Only a limited number of nonimmigrants would be
impacted by this change. Specifically, those individuals in the
following nonimmigrant classifications would be required to file this
application electronically: B-1, B-2, F, M, or J. In transforming its
immigration benefit processes into a paperless system, DHS anticipates
the following benefits:
Streamlined operations
More timely submission and adjudication of the benefit
requested
Reduced requests for additional or missing information
Enhanced security for the applicant
Enhanced customer service
For those applicants that do not currently possess or have access
to the tools needed to submit immigration benefit requests
electronically--namely, computer, Internet service, and a scanner--this
rule would result in additional costs to these petitioners or
applicants. DHS is in the process of examining the potential monetary
costs and benefits of the proposed rule.
Risks: Populations with no or limited Internet access and
individuals with no or limited English proficiency may be affected by
this rule. This risk can be mitigated by including a waiver process.
Timetable:
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Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Dan Konnerth, Policy and Coordination Chief, Office
of Transformation Coordination, Department of Homeland Security, U.S.
Citizenship and Immigration Services, 6th Floor, 633 Third Street NW.,
Washington, DC 20529, Phone: 202 233-2381, Email: dan.konnerth@dhs.gov.
RIN: 1615-AB94
DHS--USCIS
58. Immigration Benefits Business Transformation:
Nonimmigrants; Student and Exchange Visitor Program
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 5 U.S.C. 552; 5 U.S.C. 552a; 8
U.S.C. 1101; 8 U.S.C. 1103
CFR Citation: 8 CFR 103; 8 CFR 212; 8 CFR 214; 8 CFR 245; 8 CFR
248; 8 CFR 274a.
Legal Deadline: None.
Abstract: The Department of Homeland Security (DHS) is amending
[[Page 7742]]
its nonimmigrant regulations to enable U.S. Citizenship and Immigration
Services (USCIS) to migrate from a paper file-based, non-integrated
systems environment to an electronic, customer-focused, centralized
case management environment for benefit processing. This rulemaking,
the second in a series of business transformation rules, primarily
focuses on 8 CFR part 214, reorganizes and streamlines general
information relating to nonimmigrant classifications, and relocates
other information relating to specific, individual nonimmigrant
classifications to a separate subpart for each major nonimmigrant
classification. DHS is making these amendments because part 214
contains more than 20 nonimmigrant classifications, and it has become
very large and complex to navigate. This regulation will provide the
public with simpler, better organized regulatory requirements for each
nonimmigrant classification and facilitate future revisions.
Statement of Need: USCIS is in the process of transforming its
operations to improve service, operational efficiency, and national
security. This rule will provide the public with clearly written,
better organized regulatory requirements for each nonimmigrant
classification.
Summary of Legal Basis: The Homeland Security Act of 2002, Public
Law 107-296, section 102, 116 Stat. 2135 (Nov. 25, 2002), 6 U.S.C. 112,
and the Immigration and Nationality Act of 1952 (INA), charge the
Secretary of Homeland Security (Secretary) with administration and
enforcement of the immigration and nationality laws. See INA section
103, 8 U.S.C. 1103.
This rule will significantly enhance the ability of USCIS to fully
implement the Government Paperwork Elimination Act (GPEA). See Public
Law 105-277, tit. XVII, section 1701 to 1710, 112 Stat. 2681 at 2681-
749, (Oct. 21, 1998) (codified at 44 U.S.C. 3504 & note). GPEA provides
that, when possible, Federal agencies use electronic forms, electronic
filing, and electronic submissions to conduct agency business with the
public. Id. The USCIS modernization and transformation effort will move
its operations away from a paper-based system to an electronic
environment wherever possible in an effort to implement the
requirements of GPEA.
Alternatives: The regulations for the more than 20 nonimmigrant
classifications are included in 8 CFR 214. As more nonimmigrant
classifications have been added to the Act and as the statutory
requirements for existing classifications have become more complex,
sections within 8 CFR 214 have become increasingly difficult to read,
comprehend and cite. DHS will reorganize 8 CFR 214 to address this lack
of clarity.
Anticipated Cost and Benefits: DHS will amend its regulations at 8
CFR part 214 to streamline and reorganize the content into a more
reader-friendly and logical format. DHS is not making substantive
changes to the content or requirements of existing regulations. There
are no additional costs anticipated as a result of this rulemaking.
Risks: This rule may initially lead to confusion of those who are
familiar with the previous organization of 8 CFR 214. USCIS can
mitigate this risk by informing the public of these changes.
Timetable:
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Action Date FR Cite
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Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS 2505-11. This rule (RIN 1615-
AB95) is adopting the following three rules as final rules: 1615-AA35,
1615-AA56, and 1615-AA53.
Agency Contact: Dan Konnerth, Policy and Coordination Chief, Office
of Transformation Coordination, Department of Homeland Security, U.S.
Citizenship and Immigration Services, 6th Floor, 633 Third Street NW.,
Washington, DC 20529, Phone: 202 233-2381, Email: dan.konnerth@dhs.gov.
RIN: 1615-AB95
DHS--USCIS
59. Application of the William Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008 to Unaccompanied Alien Children
Seeking Asylum
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 110-457
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule implements the provisions of the William
Wilberforce Trafficking Victims Protection Reauthorization Act of 2008
(TVPRA), Public Law 110-457, 122 Stat. 5074 (Dec. 23, 2008) relating to
unaccompanied alien children seeking asylum. Specifically, the rule
proposes to amend Department of Homeland Security and Department of
Justice regulations relating to asylum applications filed by
unaccompanied alien children. The rule will amend both Departments'
regulations to reflect that U.S. Citizenship and Immigration Services
(USCIS) has initial jurisdiction over any asylum application filed by
an unaccompanied alien child. The rule will also add new special
procedures for all children in interviews before USCIS officers and for
unaccompanied alien children in proceedings before immigration judges
in the Executive Office for Immigration Review.
Statement of Need: The TVPRA mandated promulgation of regulations
taking into account the specialized needs of unaccompanied alien
children and addressing both procedural and substantive aspects of
handling unaccompanied alien children's cases. This rule will codify
existing agency guidance on the specialized needs of unaccompanied
alien children. The rule will also codify agency guidance implementing
the TVPRA. Such guidance has been in effect since March 2009 and, based
on experience gained in following the guidance, will be revised in the
rule.
Summary of Legal Basis: The purpose of this rule is to comply with
the TVPRA mandate to promulgate regulations taking into account the
specialized needs of unaccompanied alien children and addressing both
procedural and substantive aspects of handling unaccompanied alien
children's cases.
Alternatives: N/A.
Anticipated Cost and Benefits: Congress has given USCIS initial
jurisdiction over the asylum claims of unaccompanied alien children.
New costs can accrue when EOIR immigration judges transfer cases
involving unaccompanied alien minors to USCIS for asylum interviews and
adjudication if USCIS does not grant the asylum application and the
case is returned to EOIR for further adjudication. This additional cost
is offset, however, when USCIS grants such an application because the
costs of USCIS asylum adjudications are generally much lower than the
processing of immigration court applications for that benefit. In
addition, USCIS provides a non-adversarial setting for asylum seeker
interviews and has recently developed extensive and ongoing training in
children's issues. These factors can assist unaccompanied children in
expressing their fear of return to their native countries.
Unaccompanied alien children also compose a uniquely vulnerable
population with often compelling protection issues; therefore,
affording unaccompanied alien children every
[[Page 7743]]
consideration in the asylum process greatly benefits them. Finally,
benefits will also accrue because the regulation will improve upon the
process initially implemented upon passage of the TVPRA, incorporating
lessons learned and optimizing the procedures for USCIS and EOIR.
Risks: N/A.
Timetable:
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Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Ted Kim, Deputy Chief, Asylum Division, Department
of Homeland Security, U.S. Citizenship and Immigration Services, Office
of Refugee, Asylum, and International Operations, Suite 3200, 20
Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1614,
Fax: 202 272-1994, Email: ted.kim@dhs.gov.
RIN: 1615-AB96
DHS--USCIS
60. Administrative Appeals Office: Procedural Reforms To
Improve Efficiency
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8
U.S.C. 1103; 8 U.S.C. 1304; 6 U.S.C. 112
CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 205; 8 CFR 210; 8 CFR
214; 8 CFR 245a; 8 CFR 320; 8 CFR 105 (new); * * *.
Legal Deadline: None.
Abstract: This proposed rule revises the requirements and
procedures for the filing of motions and appeals before the
Department's U.S. Citizenship and Immigration Services and its
Administrative Appeals Office. The proposed changes are intended to
streamline the existing processes for filing motions and appeals and
will reduce delays in the review and appellate process. This rule also
makes additional changes necessitated by the establishment of the
Department of Homeland Security and its components.
Statement of Need: This rule proposes to make numerous changes to
streamline the current appeal and motion processes which: (1) Will
result in cost savings to the Government, applicants, and petitioners;
and (2) will provide for a more efficient use of USCIS officer and
clerical staff time, as well as more uniformity with Board of
Immigration Appeals appeal and motion processes.
Summary of Legal Basis: 5 U.S.C. 301; 5 U.S.C. 552; 5 U.S.C. 552a;
8 U.S.C. 1101 and note 1102, 1103, 1151, 1153, 1154, 1182, 1184, 1185
note (sec. 7209 of Pub. L. 108-458; title VII of Pub. L. 110-229),
1186a, 1187, 1221,1223, 1225 to 1227, 1255a, and 1255a note, 1281,
1282, 1301 to 1305, 1324a, 1356, 1372, 1379, 1409(c), 1443 to 1444,
1448, 1452, 1455, 1641, 1731 to 1732; 31 U.S.C. 9701; 48 U.S.C. 1901,
1931 note; section 643, Public Law 104-208, 110 Stat. 3009-708; section
141 of the Compacts of Free Association with the Federated States of
Micronesia and the Republic of the Marshall Islands, and with the
Government of Palau,; title VII of Public Law 110-229; Public Law 107-
296, 116 Stat. 2135 (6 U.S.C. 1 et seq.); Public Law 82-414, 66 Stat.
173, 238, 254, 264; title VII of Public Law 110-229; E.O. 12356.
Alternatives: The alternative to this rule would be to continue
under the current process without change.
Anticipated Cost and Benefits: As a result of streamlining the
appeal and motion process, USCIS anticipates quantitative and
qualitative benefits to DHS and the public. We also anticipate cost
savings to DHS and applicants as a result of the proposed changes.
Timetable:
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Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Additional Information: Previously 1615-AB29 (CIS 2311-04), which
was withdrawn in 2007. DHS has included this rule in its Final Plan for
the Retrospective Review of Existing Regulations, which DHS issued on
August 22, 2011.
Agency Contact: William K Renwick, Supervisory Citizenship and
Immigration Appeals Officer, Department of Homeland Security, U.S.
Citizenship and Immigration Services, Administrative Appeals Office,
Washington, DC 20529-2090, Phone: 703 224-4501, Email:
william.k.renwick@dhs.gov.
Related RIN: Duplicate of 1615-AB29.
RIN: 1615-AB98
DHS--USCIS
Final Rule Stage
61. New Classification for Victims of Severe Forms of Trafficking in
Persons; Eligibility for T Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 to
1104; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1201; 8
U.S.C. 1224 to 1227; 8 U.S.C. 1252 to 1252a; 22 U.S.C. 7101; 22 U.S.C.
7105
CFR Citation: 8 CFR 103; 8 CFR 212; 8 CFR 214; 8 CFR 274a; 8 CFR
299.
Legal Deadline: None.
Abstract: T classification was created by 107(e) of the Victims of
Trafficking and Violence Protection Act of 2000 (VTVPA), Public Law
106-386. The T nonimmigrant classification was designed for eligible
victims of severe forms of trafficking in persons who aid law
enforcement with their investigation or prosecution of the traffickers,
and who can establish that they would suffer extreme hardship involving
unusual and severe harm if they were removed from the United States.
The rule establishes application procedures and responsibilities for
the Department of Homeland Security and provides guidance to the public
on how to meet certain requirements to obtain T nonimmigrant status.
The Trafficking Victims Protection Reauthorization Act of 2008, Public
Law 110-457, made amendments to the T nonimmigrant status provisions of
the Immigration and Naturalization Act. The Department will issue
another interim final rule to make the changes required by recent
legislation and to provide the opportunity for notice and comment.
Statement of Need: T nonimmigrant status is available to eligible
victims of severe forms of trafficking in persons who have complied
with any reasonable request for assistance in the investigation or
prosecution of acts of trafficking in persons, and who can demonstrate
that they would suffer extreme hardship involving unusual and severe
harm if removed from the United States. This rule addresses the
essential elements that must be demonstrated for classification as a T
nonimmigrant alien; the procedures to be followed by applicants to
apply for T nonimmigrant status; and evidentiary guidance to assist in
the application process.
Summary of Legal Basis: Section 107(e) of the Trafficking Victims
Protection Act (TVPA), Public Law 106-386, as amended, established the
T classification to create a safe haven for certain eligible victims of
severe forms
[[Page 7744]]
of trafficking in persons, who assist law enforcement authorities in
investigating and prosecuting the perpetrators of these crimes.
Alternatives: To develop a comprehensive Federal approach to
identifying victims of severe forms of trafficking in persons, to
provide them with benefits and services, and to enhance the Department
of Justice's ability to prosecute traffickers and prevent trafficking
in persons in the first place, a series of meetings with stakeholders
were conducted with representatives from key Federal agencies;
national, State, and local law enforcement associations; non-profit,
community-based victim rights organizations; and other groups.
Suggestions from these stakeholders were used in the drafting of this
regulation.
Anticipated Cost and Benefits: There is no cost to applicants
associated with this regulation. Applicants for T nonimmigrant status
do not pay application or biometric fees.
The anticipated benefits of these expenditures include: Assistance
to trafficked victims and their families, prosecution of traffickers in
persons, and the elimination of abuses caused by trafficking
activities.
Benefits which may be attributed to the implementation of this rule
are expected to be:
1. An increase in the number of cases brought forward for
investigation and/or prosecution;
2. Heightened awareness by the law enforcement community of
trafficking in persons;
3. Enhanced ability to develop and work cases in trafficking in
persons cross-organizationally and multi-jurisdictionally, which may
begin to influence changes in trafficking patterns.
Risks: There is a 5,000-person limit to the number of individuals
who can be granted T-1 status per fiscal year. Eligible applicants who
are not granted T-1 status due solely to the numerical limit will be
placed on a waiting list to be maintained by U.S. Citizenship and
Immigration Services (USCIS).
To protect T-1 applicants and their families, USCIS will use
various means to prevent the removal of T-1 applicants on the waiting
list, and their family members who are eligible for derivative T
status, including its existing authority to grant deferred action,
parole, and stays of removal.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 01/31/02 67 FR 4784
Interim Final Rule Effective........ 03/04/02 .......................
Interim Final Rule Comment Period 04/01/02 .......................
End.
Interim Final Rule.................. 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal, Local, State.
Additional Information: CIS No. 2132-01; AG Order No. 2554-2002.
There is a related rulemaking, CIS No. 2170-01, the new U nonimmigrant
status (RIN 1615-AA67). Transferred from RIN 1115-AG19.
Agency Contact: Laura M. Dawkins, Chief, Family Immigration and
Victim Protection Division, Department of Homeland Security, U.S.
Citizenship and Immigration Services, Suite 1200, 20 Massachusetts
Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-
1480, Email: laura.dawkins@dhs.gov.
Related RIN: Related to 1615-AA67.
RIN: 1615-AA59
DHS--USCIS
62. Adjustment of Status to Lawful Permanent Resident for Aliens in T
and U Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 to
1104; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1201; 8
U.S.C. 1224 to 1227; 8 U.S.C. 1252 to 1252a; 8 U.S.C. 1255; 22 U.S.C.
7101; 22 U.S.C. 7105
CFR Citation: 8 CFR 204; 8 CFR 214; 8 CFR 245.
Legal Deadline: None.
Abstract: This rule sets forth measures by which certain victims of
severe forms of trafficking who have been granted T nonimmigrant status
and victims of certain criminal activity who have been granted U
nonimmigrant status may apply for adjustment to permanent resident
status in accordance with Public Law 106-386, Victims of Trafficking
and Violence Protection Act of 2000; and Public Law 109-162, Violence
Against Women and Department of Justice Reauthorization Act of 2005.
The Trafficking Victims Protection Reauthorization Act of 2008, Public
Law 110-457, made amendments to the T nonimmigrant status provisions of
the Immigration and Naturalization Act. The Department will issue
another interim final rule to make the changes required by recent
legislation and to provide the opportunity for notice and comment.
Statement of Need: This regulation is necessary to permit aliens in
lawful T or U nonimmigrant status to apply for adjustment of status to
that of lawful permanent residents. T nonimmigrant status is available
to aliens who are victims of a severe form of trafficking in persons
and who are assisting law enforcement in the investigation or
prosecution of the acts of trafficking. U nonimmigrant status is
available to aliens who are victims of certain crimes and are being
helpful to the investigation or prosecution of those crimes.
Summary of Legal Basis: This rule implements the Victims of
Trafficking and Violence Protection Act of 2000 (VTVPA), Public Law
106-386, 114 Stat. 1464 (Oct. 28, 2000), as amended, to permit aliens
in lawful T or U nonimmigrant status to apply for adjustment of status
to that of lawful permanent residents.
Alternatives: USCIS did not consider alternatives to managing T and
U applications for adjustment of status. Ease of administration
dictates that adjustment of status applications from T and U
nonimmigrants would be best handled on a first in, first out basis,
because that is the way applications for T and U status are currently
handled.
Anticipated Cost and Benefits: USCIS uses fees to fund the cost of
processing applications and associated support benefits. The fees to be
collected resulting from this rule will be approximately $3 million in
the first year, $1.9 million in the second year, and an average of
about $32 million in the third and subsequent years. To estimate the
new fee collections to be generated by this rule, USCIS estimated the
fees to be collected for new applications for adjustment of status from
T and U nonimmigrants and their eligible family members. After that,
USCIS estimated fees from associated applications that are required
such as biometrics, and others that are likely to occur in direct
connection with applications for adjustment, such as employment
authorization or travel authorization.
The anticipated benefits of these expenditures include: Continued
assistance to trafficked victims and their families, increased
investigation and prosecution of traffickers in persons, and the
elimination of abuses caused by trafficking activities.
Benefits that may be attributed to the implementation of this rule
are expected to be:
[[Page 7745]]
1. An increase in the number of cases brought forward for
investigation and/or prosecution;
2. Heightened awareness of trafficking-in-persons issues by the law
enforcement community; and
3. Enhanced ability to develop and work cases in trafficking in
persons cross-organizationally and multi-jurisdictionally, which may
begin to influence changes in trafficking patterns.
Risks: Congress created the U nonimmigrant status (``U visa'') to
provide immigration protection to crime victims who assist in the
investigation and prosecution of those crimes. Although there are no
specific data on alien crime victims, statistics maintained by the
Department of Justice have shown that aliens, especially those aliens
without legal status, are often reluctant to help in the investigation
or prosecution of crimes. U visas are intended to help overcome this
reluctance and aid law enforcement accordingly.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 12/12/08 73 FR 75540
Interim Final Rule Effective........ 01/12/09 .......................
Interim Final Rule Comment Period 02/10/09 .......................
End.
Interim Final Rule.................. 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal, Local, State.
Additional Information: CIS No. 2134-01. Transferred from RIN 1115-
AG21.
Agency Contact: Laura M. Dawkins, Chief, Family Immigration and
Victim Protection Division, Department of Homeland Security, U.S.
Citizenship and Immigration Services, Suite 1200, 20 Massachusetts
Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-
1480, Email: laura.dawkins@dhs.gov.
RIN: 1615-AA60
DHS--USCIS
63. Application of Immigration Regulations to the Commonwealth of the
Northern Mariana Islands
Priority: Other Significant.
Legal Authority: Pub. L. 110-229
CFR Citation: 8 CFR 208 and 209; 8 CFR 214 and 215; 8 CFR 217; 8
CFR 235; 8 CFR 248; 8 CFR 264; 8 CFR 274a.
Legal Deadline: Final, Statutory, November 28, 2009, Consolidated
Natural Resources Act (CNRA) of 2008.
Abstract: This final rule amends the Department of Homeland
Security (DHS) and the Department of Justice (DOJ) regulations to
comply with the Consolidated Natural Resources Act of 2008 (CNRA). The
CNRA extends the immigration laws of the United States to the
Commonwealth of the Northern Mariana Islands (CNMI). This rule
finalizes the interim rule and implements conforming amendments to
their respective regulations.
Statement of Need: This rule finalizes the interim rule to conform
existing regulations with the CNRA. Some of the changes implemented
under the CNRA affect existing regulations governing both DHS
immigration policy and procedures and proceedings before the
immigration judges and the Board. Accordingly, it is necessary to make
amendments both to the DHS regulations and to the DOJ regulations. The
Secretary and the Attorney General are making conforming amendments to
their respective regulations in this single rulemaking document.
Summary of Legal Basis: Congress extended the immigration laws of
the United States to the CNMI. The stated purpose of the CNRA is to
ensure effective border control procedures, to properly address
national security and homeland security concerns by extending U.S.
immigration law to the CNMI (phasing-out the CNMI's nonresident
contract worker program while minimizing to the greatest extent
practicable the potential adverse economic and fiscal effects of that
phase-out), to maximize the CNMI's potential for future economic and
business growth, and to assure worker protections from the potential
for abuse and exploitation.
Anticipated Cost and Benefits: Costs: The interim rule established
basic provisions necessary for the application of the INA to the CNMI
and updated definitions and existing DHS and DOJ regulations in areas
that were confusing or in conflict with how they are to be applied to
implement the INA in the CNMI. As such, that rule made no changes that
had identifiable direct or indirect economic impacts that could be
quantified.
Benefits: This final rule makes additional regulatory changes in
order to lessen the adverse impacts of the CNRA on employers and
employees in the CNMI and assist the CNMI in its transition to the INA.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 10/28/09 74 FR 55725
Interim Final Rule Comment Period 11/27/09
End.
Correction.......................... 12/22/09 74 FR 67969
Final Action........................ 03/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS 2460-08.
Agency Contact: Kevin Cummings, Branch Chief, Business and Trade
Services, Department of Homeland Security, U.S. Citizenship and
Immigration Services, Second Floor, Office of Program and Regulations
Development, 20 Massachusetts Avenue NW., Washington, DC 20529, Phone:
202 272-1470, Fax: 202 272-1480, Email: kevin.cummings@dhs.gov.
Related RIN: Related to 1615-AB76, Related to 1615-AB75.
RIN: 1615-AB77
DHS--U.S. COAST GUARD (USCG)
Final Rule Stage
64. Implementation of the 1995 Amendments to the International
Convention on Standards of Training, Certification, and Watchkeeping
(STCW) for Seafarers, 1978
Priority: Other Significant.
Legal Authority: 46 U.S.C. 2103; 46 U.S.C. chapters 71 and 73; DHS
Delegation No. 0170.1
CFR Citation: 46 CFR 10; 46 CFR 11; 46 CFR 12; 46 CFR 15.
Legal Deadline: None.
Abstract: The International Maritime Organization (IMO)
comprehensively amended the International Convention on Standards of
Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978,
in 1995 and 2010. The 1995 amendments came into force on February 1,
1997. This project implements those amendments by revising current
rules to ensure that the United States complies with their requirements
on: The training of merchant mariners, the documenting of their
qualifications, and watch-standing and other arrangements aboard
seagoing merchant ships of the United States. In addition, the Coast
Guard has identified the need for additional changes to the interim
rule issued in 1997. This project supports the Coast Guard's broad role
and responsibility of maritime safety. It also supports the roles and
responsibilities of the Coast Guard of reducing deaths and injuries of
crew
[[Page 7746]]
members on domestic merchant vessels and eliminating substandard
vessels from the navigable waters of the United States. The Coast Guard
published an NPRM on November 17, 2009, and Supplemental NPRM (SNPRM)
on March 23, 2010.
At a June 2010 diplomatic conference, the IMO adopted additional
amendments to the STCW convention, which change the minimum training
requirements for seafarers. In response to feedback and to the adoption
of those amendments, the Coast Guard developed a second Supplemental
NPRM to incorporate the 2010 Amendments into the 1990 interim rule.
Statement of Need: The Coast Guard proposed to amend its
regulations to implement changes to its interim rule published on June
26, 1997. These proposed amendments go beyond changes found in the
interim rule and seek to more fully incorporate the requirements of the
International Convention on Standards of Training, Certification and
Watchkeeping for Seafarers, 1978, as amended (STCW), in the
requirements for the credentialing of United States merchant mariners.
The new changes are primarily substantive and: (1) Are necessary to
continue to give full and complete effect to the STCW Convention; (2)
Incorporate lessons learned from implementation of the STCW through the
interim rule and through policy letters and NVICs; and (3) Attempt to
clarify regulations that have generated confusion.
Summary of Legal Basis: The authority for the Coast Guard to
prescribe, change, revise, or amend these regulations is provided under
46 U.S.C. 2103 and 46 U.S.C. chapters 71 and 73; and Department of
Homeland Security Delegation No. 0170.1.
Alternatives: For each proposed change, the Coast Guard has
considered various alternatives. We considered using policy statements,
but they are not enforceable. We also considered taking no action, but
this does not support the Coast Guard's fundamental safety and security
mission. Additionally, we considered comments made during our 1997
rulemaking to formulate our alternatives. When we analyzed issues, such
as license progression and tonnage equivalency, the alternatives chosen
were those that most closely met the requirements of STCW.
Anticipated Cost and Benefits: In the SNPRM, we estimated the
annualized cost of this rule over a 10-year period to be $32.8 million
per year at a 7 percent discount rate. We estimate the total 10-year
cost of this rulemaking to be $230.7 million at a 7 percent discount
rate and $274.3 million at a 3 percent discount rate.
The changes in anticipated costs since the publication of 2009 NPRM
are due to the 2010 amendments to the STCW Convention: Medical
examinations and endorsements, leadership and management skills, engine
room management training, tankerman endorsements, safety refresher
training and able seafarer deck and engine certification requirements.
However, there would be potential savings from the costs of training
requirements as the Coast Guard would accept various methods for
demonstrating competence, including the on-the-job training and
preservation of the ``hawsepipe'' programs.
We anticipate the primary benefit of this rulemaking is to ensure
that the U.S. meets its obligations under the STCW Convention. Another
benefit is an increase in vessel safety and a resulting decrease in the
risk of shipping casualties.
Risks: No risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Meeting................... 08/02/95 60 FR 39306
Supplemental NPRM Comment Period End 09/29/95
Notice of Inquiry................... 11/13/95 60 FR 56970
Comment Period End.................. 01/12/96
NPRM................................ 03/26/96 61 FR 13284
Notice of Public Meetings........... 04/08/96 61 FR 15438
NPRM Comment Period End............. 07/24/96
Notice of Intent.................... 02/04/97 62 FR 5197
Interim Final Rule.................. 06/26/97 62 FR 34505
Interim Final Rule Effective........ 07/28/97
NPRM................................ 11/17/09 74 FR 59353
NPRM Comment Period End............. 02/16/10
Supplemental NPRM................... 03/23/10 75 FR 13715
Supplemental NPRM................... 08/01/11 76 FR 45908
Public Meeting Notice............... 08/02/11 76 FR 46217
Comment Period End.................. 09/30/11
Final Action........................ 01/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Additional Information: The docket number for this rulemaking is
USCG-2004-17914. The docket is located at www.regulations.gov. The old
docket number is CGD 95-062.
Include Retrospective Review under E.O. 13563.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Mark Gould, Project Manager, CG-5221, Department of
Homeland Security, U.S. Coast Guard, 2100 Second Street SW., STOP 7126,
Washington, DC 20593-7126, Phone: 202 372-1409.
RIN: 1625-AA16
DHS--USCG
65. Vessel Requirements for Notices of Arrival and Departure, and
Automatic Identification System
Priority: Other Significant.
Legal Authority: 33 U.S.C. 1223; 33 U.S.C. 1225; 33 U.S.C. 1231; 46
U.S.C. 3716; 46 U.S.C. 8502 and ch 701; sec 102 of Pub. L. 107-295; EO
1223
CFR Citation: 33 CFR 62; 33 CFR 66; 33 CFR 160; 33 CFR 161; 33 CFR
164; 33 CFR 165.
Legal Deadline: None.
Abstract: This rulemaking would expand the applicability for Notice
of Arrival and Departure (NOAD) and Automatic Identification System
(AIS) requirements. These expanded requirements would better enable the
Coast Guard to correlate vessel AIS data with NOAD data, enhance our
ability to identify and track vessels, detect anomalies, improve
navigation safety, and heighten our overall maritime domain awareness.
The NOAD portion of this rulemaking could expand the applicability
of the NOAD regulations by changing the minimum size of vessels covered
below the current 300 gross tons, require a notice of departure when a
vessel is departing for a foreign port or place, and mandate electronic
submission of NOAD notices to the National Vessel Movement Center. The
AIS portion of this rulemaking would expand current AIS carriage
requirements for the population identified in the Safety of Life at Sea
(SOLAS) Convention and the Marine Transportation Marine Transportation
Security Act (MTSA) of 2002.
Statement of Need: There is no central mechanism in place to
capture vessel, crew, passenger, or specific cargo information on
vessels less than or equal to 300 gross tons (GT) intending to arrive
at or depart from U.S. ports unless they are arriving with certain
[[Page 7747]]
dangerous cargo (CDC) or at a port in the 7th Coast Guard District; nor
is there a requirement for vessels to submit notification of departure
information. The lack of NOAD information of this large and diverse
population of vessels represents a substantial gap in our maritime
domain awareness (MDA). We can minimize this gap and enhance MDA by
expanding NOAD applicability to vessels greater than 300 GT, all
foreign commercial vessels and all U.S. commercial vessels coming from
a foreign port, and further enhance (and corroborate) MDA by tracking
those vessels (and others) with AIS. This information is necessary in
order to expand our MDA and provide Nation maritime safety and
security.
Summary of Legal Basis: This rulemaking is based on congressional
authority provided in the Ports and Waterways Safety Act and the
Maritime Transportation Security Act of 2002.
Alternatives: Our goal is to extend our MDA and to identify
anomalies by correlating vessel NOAD data with AIS data. NOAD and AIS
information from a greater number of vessels, as proposed in this
rulemaking, would expand our MDA. We considered expanding NOAD and AIS
to even more vessels, but we determined we needed additional
legislative authority to expand AIS beyond what we propose in this
rulemaking; and that it was best to combine additional NOAD expansion
with future AIS expansion. Although not in conjunction with a proposed
rule, the Coast Guard sought comment regarding expansion of AIS
carriage to other waters and other vessels not subject to the current
requirements (68 FR 39369, Jul. 1, 2003; USCG 2003-14878; see also 68
FR 39355). Those comments were reviewed and considered in drafting this
rule and are available in this docket. To fulfill our agency
obligations, the Coast Guard needs to receive AIS reports and NOADs
from vessels identified in this rulemaking that currently are not
required to provide this information. Policy or other non-binding
statements by the Coast Guard addressed to the owners of these vessels
would not produce the information required to sufficiently enhance our
MDA to produce the information required to fulfill our Agency
obligations.
Anticipated Cost and Benefits: This rulemaking will enhance the
Coast Guard's regulatory program by making it more effective in
achieving the regulatory objectives, which, in this case, is improved
MDA. We provide flexibility in the type of AIS system that can be used,
allowing for reduced cost burden. This rule is also streamlined to
correspond with Customs and Border Protection's APIS requirements,
thereby reducing unjustified burdens. We are further developing
estimates of cost and benefit that were published in 2008. In the 2008
NPRM, we estimated that both segments of the proposed rule would affect
approximately 42,607 vessels. The total number of domestic vessels
affected is approximately 17,323 and the total number of foreign
vessels affected is approximately 25,284. We estimated that the 10-year
total present discounted value or cost of the proposed rule to U.S.
vessel owners is between $132.2 and $163.7 million (7 and 3 percent
discount rates, respectively, 2006 dollars) over the period of
analysis.
The Coast Guard believes that this rule, through a combination of
NOAD and AIS, would strengthen and enhance maritime security. The
combination of NOAD and AIS would create a synergistic effect between
the two requirements. Ancillary or secondary benefits exist in the form
of avoided injuries, fatalities, and barrels of oil not spilled into
the marine environment. In the 2008 NPRM, we estimated that the total
discounted benefit (injuries and fatalities) derived from 68 marine
casualty cases analyzed over an 8-year data period from 1996 to 2003
for the AIS portion of the proposed rule is between $24.7 and $30.6
million using $6.3 million for the value of statistical life (VSL) at
seven and three percent discount rates, respectively. Just based on
barrels of oil not spilled, we expect the AIS portion of the proposed
rule to prevent 22 barrels of oil from being spilled annually.
Risks: Considering the economic utility of U.S. ports, waterways,
and coastal approaches, it is clear that a terrorist incident against
our U.S. Maritime Transportation System (MTS) would have a direct
impact on U.S. users and consumers and could potentially have a
disastrous impact on global shipping, international trade, and the
world economy. By improving the ability of the Coast Guard both to
identify potential terrorists coming to the United States while the
terrorists are far from our shores and to coordinate appropriate
responses and intercepts before the vessel reaches a U.S. port, this
rulemaking would contribute significantly to the expansion of MDA, and
consequently is instrumental in addressing the threat posed by
terrorist actions against the MTS.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/16/08 73 FR 76295
Notice of Public Meeting............ 01/21/09 74 FR 3534
Notice of Second Public Meeting..... 03/02/09 74 FR 9071
NPRM Comment Period End............. 04/15/09 .......................
Notice of Second Public Meeting 04/15/09 .......................
Comment Period End.
Final Rule.......................... 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: We have indicated in past notices and
rulemaking documents, and it remains the case that we have worked to
coordinate implementation of AIS MTSA requirements with the development
of our ability to take advantage of AIS data (68 FR 39355 and 39370,
Jul. 1, 2003).
The docket number for this rulemaking is USCG-2005-21869. The
docket can be found at www.regulations.gov.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: LT Sharmine Jones, Program Manager, Office of
Vessel Activities, Foreign and Offshore Vessel Activities Div. (CG-
5432), Department of Homeland Security, U.S. Coast Guard, 2100 2nd
Street SW., STOP 7581, Washington, DC 20593-7581, Phone: 202 372-1234,
Email: sharmine.n.jones@uscg.mil.
Jorge Arroyo, Project Manager, Office of Navigation Systems CG-
5531, Department of Homeland Security, U.S. Coast Guard, 2100 2nd
Street SW., STOP 7683, Washington, DC 20593-7683, Phone: 202 372-1563,
Email: jorge.arroyo@uscg.mil.
Related RIN: Related to 1625-AA93, Related to 1625-AB28.
RIN: 1625-AA99
DHS--USCG
66. Nontank Vessel Response Plans and Other Vessel Response Plan
Requirements
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: 3 U.S.C. 301 to 303; 33 U.S.C. 1223; 33 U.S.C.
1231; 33 U.S.C. 3121; 33 U.S.C. 1903; 33 U.S.C. 1908; 46 U.S.C. 6101
CFR Citation: 33 CFR 151; 33 CFR 155; 33 CFR 160.
[[Page 7748]]
Legal Deadline: Final, Statutory, April 15, 2012, Coast Guard
Authorization Act of 2010.
Abstract: This rulemaking would establish regulations requiring
owners or operators of nontank vessels to prepare and submit oil spill
response plans. The Federal Water Pollution Control Act defines nontank
vessels as self-propelled vessels of 400 gross tons or greater that
operate on the navigable waters of the United States, carry oil of any
kind as fuel for main propulsion, and are not tank vessels. The NPRM
proposed to specify the content of a response plan, and among other
issues, address the requirement to plan for responding to a worst case
discharge and a substantial threat of such a discharge. Additionally,
the NPRM proposed to update International Shipboard Oil Pollution
Emergency Plan (SOPEP) requirements that apply to certain nontank
vessels and tank vessels. Finally, the NPRM proposed to require vessel
owners and operators to submit their vessel response plan control
number as part of the notice of arrival information. This project
supports the Coast Guard's broad roles and responsibilities of maritime
stewardship.
Statement of Need: This rule implements the statutory requirement
for an owner or operator of a self-propelled, nontank vessel of 400
gross tons or greater, which operates on the navigable waters of the
United States, to prepare and submit an oil spill response plan to the
Coast Guard. This rule specifies the content of a vessel response plan
(VRP), including the requirement to plan for responding to a worst-case
discharge (WCD) and a substantial threat of such a discharge as
mandated in statute. The rule also specifies the procedures for
submitting a VRP to the Coast Guard. This rule will improve our
Nation's pollution response planning and preparedness posture, and help
limit the environmental damage resulting from nontank vessel marine
casualties.
Summary of Legal Basis: Section 311(j)(5) of the Federal Water
Pollution Control Act (FWPCA) (33 U.S.C. 1321(j)(5)), as amended by
section 4202 of the Oil Pollution Act of 1990 (OPA 90) (Pub. L. 101-
380, 104 Stat. 484); the Coast Guard and Maritime Transportation Act of
2004 (Pub. L. 108-293, 118 Stat. 102); and the Coast Guard and Maritime
Transportation Act of 2006 (Pub. L. 109-241, 120 Stat. 516) sets out
the statutory mandate requiring tank and nontank vessel owners or
operators to prepare and submit oil or hazardous substance discharge
response plans for certain vessels operating on the navigable waters of
the United States.
Alternatives: In the development of these regulations, the Coast
Guard considered four alternatives: Three regulatory alternatives and
one non-regulatory alternative. The alternatives are--(1) Establish
regulations for the submission of NTVRPs to the USCG; (2) amend the
tank vessel response plan (TVRP) regulations to incorporate NTVRPs; (3)
acceptance of flag-approved SOPEPs; and (4) provide interpretive
guidance through a USCG's Navigation and Vessel Inspection Circular
(NVIC).
Anticipated Cost and Benefits: We are developing the cost and
benefit estimates associated with this step of the rulemaking. The cost
elements associated with this rule include: (1) Nontank vessel plan
development, maintenance, and submission; (2) the service of an Oil
Spill Response Organization (OSRO); (3) the contract with a Qualified
Individual (QI) along with a Spill Management Team; and (4) training
and exercises. We expect this proposed rule to provide quantifiable
benefits in the form of barrels of oil not spilled into the water in
addition to qualitative benefits, which include improved preparedness
and reaction to an incident, including a worst-case discharge and
improved effectiveness of onboard and shore-side response activities.
In the 2009 NPRM, we estimated that the rulemaking would affect
about 2,951 U.S. flag vessels and 1,228 associated planholders. We
estimated the total 10-year present value cost of the proposed rule to
U.S. flag nontank vessel owners and operators to be about $111.4
million at a 7 percent discount rate and $134.8 million at a 3 percent
discount rate. We found the training and exercise requirements to be
the most costly element or over 90 percent of the total discounted cost
of the proposed rule for vessel owners. We estimated the total U.S.
annualized cost of the proposed rule over the 10-year period of
analysis to be about $15.8 million at both 7 and 3 percent discount
rates.
Risks: Response plans are required by statute. A response plan will
not prevent a discharge of oil, but it may help minimize the discharge
and resulting damage to the environment. We estimate the proposed rule
would prevent between 2,014 and 2,446 barrels of oil from being spilled
into the water during the 10-year period of analysis.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/31/09 74 FR 44970
Public Meeting...................... 09/25/09 74 FR 48891
NPRM Comment Period End............. 11/30/09 .......................
Final Rule.......................... 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: The docket number for this rulemaking is
USCG-2008-1070. The docket can be found at www.regulations.gov.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: LCDR Kevin B. Ferrie, Project Manager, Department
of Homeland Security, U.S. Coast Guard, 2100 2nd Street SW., Stop 7581,
Washington, DC 20593-7581, Phone: 202 372-1000, Email:
kevin.b.ferrie@uscg.mil.
Related RIN: Related to 1625-AA19, Related to 1625-AA26.
RIN: 1625-AB27
DHS--USCG
67. Offshore Supply Vessels of at Least 6000 GT ITC
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Pub. L. 111-281, sec 617
CFR Citation: Not Yet Determined.
Legal Deadline: Other, Statutory, January 1, 2012, Coast Guard
Authorization Act of 2010.
Abstract: The Coast Guard Authorization Act of 2010 removed the
size limit on offshore supply vessels (OSVs). The Act also directed the
Coast Guard to issue, as soon as is practicable, a regulation to
implement section 617 of the Act and to ensure the safe carriage of
oil, hazardous substances, and individuals in addition to the crew on
vessels of at least 6,000 gross tonnage as measured under the
International Convention on Tonnage Measurement of Ships (6,000 GT
ITC). Accordingly, the Coast Guard's rule will address design, manning,
carriage of personnel, and related topics for OSVs of at least 6,000 GT
ITC. This rulemaking will meet the requirements of the Act and will
support the Coast Guard's mission of marine safety, security, and
stewardship.
Statement of Need: In section 617 of Public Law 111-281, Congress
removed OSV tonnage limits and instructed the Coast Guard to promulgate
regulations
[[Page 7749]]
to implement the amendments and authorities of section 617.
Additionally, Congress directed the Coast Guard to ensure the safe
carriage of oil, hazardous substances, and individuals in addition to
the crew on OSVs of at least 6,000 GT ITC.
Summary of Legal Basis: The statutory authority to promulgate these
regulations is found in section 617(f) of Public Law 111-281.
Alternatives: The Coast Guard Authorization Act removed OSV tonnage
limits and the Coast Guard will examine alternatives during the
development of the regulatory analysis.
Anticipated Cost and Benefits: The Coast Guard is currently
developing a regulatory impact analysis of regulations that ensure the
safe carriage of oil, hazardous substances, and individuals in addition
to the crew on OSVs of at least 6,000 GT ITC. A potential benefit of
this rulemaking is the ability of industry to expand and take advantage
of new commercial opportunities in the building of larger OSVs.
Risks: No risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Thomas L. Neyhart, Program Manager, Department of
Homeland Security, U.S. Coast Guard, 2100 2nd Street SW., STOP 7126,
Washington, DC 20593-7126, Phone: 202 372-1360, Email:
thomas.l.neyhart@uscg.mil.
RIN: 1625-AB62
DHS--USCG
68. Revision to Transportation Worker Identification
Credential (TWIC) Requirements for Mariners
Priority: Other Significant.
Legal Authority: sec 809 of the Coast Guard Authorization Act of
2010, Pub. L. 111-281, codified at 46 U.S.C. 70105(b)(2); 46 U.S.C.
2110(g)
CFR Citation: 46 CFR 10; 46 CFR 11; 46 CFR 12; 46 CFR 15.
Legal Deadline: None.
Abstract: This Policy Letter describes both short-term and long-
term steps that the Coast Guard is taking to implement the requirements
of section 809 of Coast Guard Authorization Act of 2010, Public Law
111-281. Section 809 excludes certain mariners from the statutory
requirement to obtain and hold a Transportation Worker Identification
Credential (TWIC) in order to receive a Merchant Mariner Credential
(MMC).
In the short-term, while working to promulgate implementing
regulations, the Coast Guard is relaxing its enforcement posture for
mariners without a valid TWIC who operate on board vessels that do not
have a security plan. The Coast Guard is also altering its policies to
allow these mariners to obtain a MMC without holding a valid TWIC.
Specifically, mariners already hold or held a TWIC, and who no longer
require a TWIC, may skip the TWIC enrollment process and apply for a
renewal MMC directly with a Regional Examination Center (REC), in
accordance with title 46 CFR, section 10.209. However, mariners that
are being issued an initial MMC, or who never held a TWIC, will need to
enroll for a TWIC at a TWIC enrollment center. They will also have to
pay all applicable fees associated with getting a TWIC. This is
required because the TWIC enrollment center is the only place where the
Coast Guard can obtain biometric information (fingerprints) from the
applicant.
In the long-term, as part of a rulemaking to promulgate
implementing regulations, the Coast Guard is considering waiving a
portion of the fees for a MMC in order to compensate the mariner for
the cost of enrolling for a TWIC. However, it is emphasized that such
action is contingent on the promulgation of a regulation to adjust the
fee structure.
Statement of Need: The Coast Guard is revising its merchant mariner
credentialing regulations to implement changes made by section 809 of
the Coast Guard Authorization Act of 2010, codified at 46 U.S.C.
70105(b)(2), which reduces the population of mariners who are required
to obtain and hold a valid Transportation Worker Identification
Credential (TWIC). Prior to section 809, 46 U.S.C. 70105(b)(2) required
each mariner required to hold an MMC issued by the Coast Guard to also
obtain and hold a valid TWIC issued by the Transportation Security
Administration (TSA). Section 809 removes this requirement, and now a
TWIC is statutorily required if the mariner is ``allowed unescorted
access to a secure area designated in a vessel security plan approved
under section 70103 of title 46 [U.S.C.]''
The Coast Guard is revising the applicability of the TWIC
requirements in Coast Guard merchant mariner credentialing regulations
as well as revising some of its merchant mariner credentialing
processes contained in Coast Guard regulations. Current Coast Guard
regulations in 46 CFR parts 10, 11, 12, and 15 contain the processes
for issuing an MMC that are intertwined with TSA processes for issuing
a TWIC. The Coast Guard utilizes the TWIC enrollment process to capture
information necessary to issue an MMC. Although the Coast Guard is
changing some of its processes for obtaining an MMC, some mariners no
longer required to hold a TWIC may still have to complete the TWIC
enrollment process in order to provide information necessary to obtain
an MMC. For any such mariner that must still go through the TWIC
enrollment process, including paying the full TWIC enrollment fee, the
Coast Guard is revising its regulations to exempt these mariners from
paying a portion of the MMC fees in order to offset the TWIC fee and to
minimize the burden on those mariners of paying for a TWIC when the
mariner is no longer statutorily required to hold one.
Summary of Legal Basis: The Coast Guard's statutory authority to
promulgate regulations addressing TWIC requirements for mariners is
found in 46 U.S.C. 70105(a) and (b). The Coast Guard's statutory
authority to promulgate regulations addressing fee exemptions is found
in 46 U.S.C. 2110(g).
Alternatives: This rulemaking implements section 809 of the 2010
Coast Guard Authorization Act. The Coast Guard is currently evaluating
the alternatives as we complete the Regulatory Impact Analysis.
Anticipated Cost and Benefits: This rulemaking would provide
certain mariner populations a fee exemption when applying or renewing
an MMC. These mariner populations would also benefit from cost savings
associated with reduced travels to TWIC enrollment centers.
Risks: No risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal.
Additional Information: DHS has included this rule in its Final
Plan for the Retrospective Review of Existing Regulations, which DHS
issued on August 22, 2011.
Agency Contact: Davis Breyer, Project Manager, Department of
Homeland Security, U.S. Coast Guard, CG-5221,
[[Page 7750]]
2100 2nd Street SW., Washington, DC 20593, Phone: 202 372-1445, Email:
davis.j.breyer@uscg.mil.
RIN: 1625-AB80
DHS--U.S. CUSTOMS AND BORDER PROTECTION (USCBP)
Final Rule Stage
69. Importer Security Filing and Additional Carrier Requirements
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: Pub. L. 109-347, sec 203; 5 U.S.C. 301; 19 U.S.C.
66; 19 U.S.C. 1431; 19 U.S.C. 1433 to 1434; 19 U.S.C. 1624; 19 U.S.C.
2071 note; 46 U.S.C. 60105
CFR Citation: 19 CFR 4; 19 CFR 12.3; 19 CFR 18.5; 19 CFR 103.31a;
19 CFR 113; 19 CFR 123.92; 19 CFR 141.113; 19 CFR 146.32; 19 CFR 149;
19 CFR 192.14.
Legal Deadline: None.
Abstract: This interim final rule implements the provisions of
section 203 of the Security and Accountability for Every Port Act of
2006. It amended CBP Regulations to require carriers and importers to
provide to CBP, via a CBP-approved electronic data interchange system,
information necessary to enable CBP to identify high-risk shipments to
prevent smuggling and insure cargo safety and security. Under the rule,
importers and carriers must submit specified information to CBP before
the cargo is brought into the United States by vessel. This advance
information will improve CBP's risk assessment and targeting
capabilities, assist CBP in increasing the security of the global
trading system, and facilitate the prompt release of legitimate cargo
following its arrival in the United States. The interim final rule
requested comments on those required data elements for which CBP
provided certain flexibilities for compliance and on the revised costs
and benefits and Regulatory Flexibility Analysis. CBP plans to issue a
final rule after CBP completes a structured review of the flexibilities
and analyzes the comments.
Statement of Need: Vessel carriers are currently required to
transmit certain manifest information by way of the CBP Vessel
Automated Manifest System (AMS) 24 hours prior to lading of
containerized and non-exempt break bulk cargo at a foreign port. For
the most part, this is the ocean carrier's or non-vessel operating
common carrier's (NVOCC) cargo declaration. CBP analyzes this
information to generate its risk assessment for targeting purposes.
Internal and external government reviews have concluded that more
complete advance shipment data would produce even more effective and
vigorous cargo risk assessments. In addition, pursuant to section 203
of the Security and Accountability for Every Port Act of 2006 (Pub. L.
109-347, 6 U.S.C. 943) (SAFE Port Act), the Secretary of Homeland
Security, acting through the Commissioner of CBP, must promulgate
regulations to require the electronic transmission of additional data
elements for improved high-risk targeting, including appropriate
security elements of entry data for cargo destined to the United States
by vessel prior to loading of such cargo on vessels at foreign
seaports.
Based upon its analysis, as well as the requirements under the SAFE
Port Act, CBP is requiring the electronic transmission of additional
data for improved high-risk targeting. Some of these data elements are
being required from carriers (Container Status Messages and Vessel Stow
Plan) and others are being required from ``importers,'' as that term is
defined for purposes of the regulations.
This rule intends to improve CBP's risk assessment and targeting
capabilities and enables the agency to facilitate the prompt release of
legitimate cargo following its arrival in the United States. The
information will assist CBP in increasing the security of the global
trading system and, thereby, reducing the threat to the United States
and world economy.
Summary of Legal Basis: Pursuant to section 203 of the Security and
Accountability for Every Port Act of 2006 (Pub. L. 109-347, 6 U.S.C.
943) (SAFE Port Act), the Secretary of Homeland Security, acting
through the Commissioner of CBP, must promulgate regulations to require
the electronic transmission of additional data elements for improved
high-risk targeting, including appropriate security elements of entry
data for cargo destined to the United States by vessel prior to loading
of such cargo on vessels at foreign seaports.
Alternatives: CBP considered and evaluated the following four
alternatives:
Alternative 1 (the chosen alternative): Importer Security Filings
and Additional Carrier Requirements are required. Bulk cargo is exempt
from the Importer Security Filing requirements;
Alternative 2: Importer Security Filings and Additional Carrier
Requirements are required. Bulk cargo is not exempt from the Importer
Security Filing requirements;
Alternative 3: Only Importer Security Filings are required. Bulk
cargo is exempt from the Importer Security Filing requirements; and
Alternative 4: Only the Additional Carrier Requirements are
required.
Anticipated Cost and Benefits: When the NPRM was published, CBP
estimated that approximately 11 million import shipments conveyed by
1,000 different carrier companies operating 37,000 unique voyages or
vessel-trips to the United States will be subject to the rule.
Annualized costs range from $890 million to $7.0 billion (7 percent
discount rate over 10 years).
The annualized cost range estimate resulted from varying
assumptions about the importers' estimated security filing transaction
costs or fees charged to the importers by the filing parties, the
potential for supply chain delays, and the estimated costs to carriers
for transmitting additional data to CBP.
The regulation may increase the time shipments are in transit,
particularly for shipments consolidated in containers. For such
shipments, the supply chain is generally more complex and the importer
has less control of the flow of goods and associated security filing
information. Foreign cargo consolidators may be consolidating multiple
shipments from one or more shippers in a container destined for one or
more buyers or consignees. In order to ensure that the security filing
data is provided by the shippers to the importers (or their designated
agents) and is then transmitted to and accepted by CBP in advance of
the 24-hour deadline, consolidators may advance their cut-off times for
receipt of shipments and associated security filing data.
These advanced cut-off times would help prevent a consolidator or
carrier from having to unpack or unload a container in the event the
security filing for one of the shipments contained in the container is
inadequate or not accepted by CBP. For example, consolidators may
require shippers to submit, transmit, or obtain CBP approval of their
security filing data before their shipments are stuffed in the
container, before the container is sealed, or before the container is
delivered to the port for lading. In such cases, importers would likely
have to increase the times they hold their goods as inventory, and thus
incur additional inventory carrying costs to sufficiently meet these
advanced cut-off times imposed by their foreign consolidators. The high
end of the cost ranges presented assumes an initial supply chain delay
of 2 days for the first year
[[Page 7751]]
of implementation (2008) and a delay of 1 day for years 2 through 10
(2009 to 2017).
Ideally, the quantification and monetization of the benefits of
this regulation would involve estimating the current level of risk of a
successful terrorist attack, absent this regulation, and the
incremental reduction in risk resulting from implementation of the
regulation. CBP would then multiply the change by an estimate of the
value individuals place on such a risk reduction to produce a monetary
estimate of direct benefits. However, existing data limitations and a
lack of complete understanding of the true risks posed by terrorists
prevent us from establishing the incremental risk reduction
attributable to this rule. As a result, CBP has undertaken a ``break-
even'' analysis to inform decisionmakers of the necessary incremental
change in the probability of such an event occurring that would result
in direct benefits equal to the costs of the proposed rule. CBP's
analysis finds that the incremental costs of this regulation are
relatively small compared to the median value of a shipment of goods,
despite the rather large absolute estimate of present value cost.
The benefit of this rule is the improvement of CBP's risk
assessment and targeting capabilities, while at the same time, enabling
CBP to facilitate the prompt release of legitimate cargo following its
arrival in the United States. The information will assist CBP in
increasing the security of the global trading system, and thereby
reducing the threat to the United States and the world economy.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/02/08 73 FR 90
NPRM Comment Period End............. 03/03/08 .......................
NPRM Comment Period Extended........ 02/01/08 73 FR 6061
NPRM Comment Period End............. 03/18/08 .......................
Interim Final Rule.................. 11/25/08 73 FR 71730
Interim Final Rule Effective........ 01/26/09 .......................
Interim Final Rule Comment Period 06/01/09 .......................
End.
Correction.......................... 07/14/09 74 FR 33920
Correction.......................... 12/24/09 74 FR 68376
Final Action........................ 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Christopher Kennally, Acting Director, Cargo
Control, Office of Field Operations, CBP, Department of Homeland
Security, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue
NW., Washington, DC 20229, Phone: 202 344-2476, Email:
christopher.j.kennally@cbp.dhs.gov.
RIN: 1651-AA70
DHS--USCBP
70. Changes to the Visa Waiver Program To Implement the Electronic
System for Travel Authorization (ESTA) Program
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1187
CFR Citation: 8 CFR 217.5.
Legal Deadline: None.
Abstract: This interim final rule implements the Electronic System
for Travel Authorization (ESTA) for aliens who travel to the United
States under the Visa Waiver Program (VWP) at air or sea ports of
entry. Under the rule, VWP travelers are required to provide certain
biographical information to CBP electronically before departing for the
United States. This allows CBP to determine before their departure
whether these travelers are eligible to travel to the United States
under the VWP and whether such travel poses a security risk. The rule
is intended to fulfill the requirements of section 711 of the
Implementing recommendations of the 9/11 Commission Act of 2007 (9/11
Act). In addition to fulfilling a statutory mandate, the rule serves
the twin goals of promoting border security and legitimate travel to
the United States. By modernizing the VWP, the ESTA is intended to
increase national security and to provide for greater efficiencies in
the screening of international travelers by allowing for vetting of
subjects of potential interest well before boarding, thereby reducing
traveler delays at the ports of entry. CBP requested comments on all
aspects of the interim final rule and plans to issue a final rule after
completion of the comment analysis.
Statement of Need: Section 711 of the 9/11 Act requires the
Secretary of Homeland Security, in consultation with the Secretary of
State, to develop and implement a fully automated electronic travel
authorization system that will collect biographical and other
information in advance of travel to determine the eligibility of the
alien to travel to the United States, and to determine whether such
travel poses a law enforcement or security risk. ESTA is intended to
fulfill these statutory requirements.
Under this rule, VWP travelers provide certain information to CBP
electronically before departing for the United States. VWP travelers
who receive travel authorization under ESTA are not required to
complete the paper Form I-94W when arriving on a carrier that is
capable of receiving and validating messages pertaining to the
traveler's ESTA status as part of the traveler's boarding status. By
automating the I-94W process and establishing a system to provide VWP
traveler data in advance of travel, CBP is able to determine the
eligibility of citizens and eligible nationals from VWP countries to
travel to the United States and to determine whether such travel poses
a law enforcement or security risk, before such individuals begin
travel to the United States. ESTA provides for greater efficiencies in
the screening of international travelers by allowing CBP to identify
subjects of potential interest before they depart for the United
States, thereby increasing security and reducing traveler delays upon
arrival at U.S. ports of entry.
Summary of Legal Basis: The ESTA program is based on congressional
authority provided under section 711 of the Implementing
Recommendations of the 9/11 Commission Act of 2007 and section 217 of
the Immigration and Nationality Act (INA).
Alternatives: CBP considered three alternatives to this rule:
1. The ESTA requirements in the rule, but with a $1.50 fee per each
travel authorization (more costly).
2. The ESTA requirements in the rule, but with only the name of the
passenger and the admissibility questions on the I-94W form (less
burdensome).
3. The ESTA requirements in the rule, but only for the countries
entering the VWP after 2009 (no new requirements for VWP, reduced
burden for newly entering countries).
CBP determined that the rule provides the greatest level of
enhanced security and efficiency at an acceptable cost to traveling
public and potentially affected air carriers.
Anticipated Cost and Benefits: The purpose of ESTA is to allow DHS
and CBP to establish the eligibility of certain
[[Page 7752]]
foreign travelers to travel to the United States under the VWP, and
whether the alien's proposed travel to the United States poses a law
enforcement or security risk. Upon review of such information, DHS will
determine whether the alien is eligible to travel to the United States
under the VWP.
Costs to Air & Sea Carriers
CBP estimated that eight U.S.-based air carriers and eleven sea
carriers will be affected by the rule. An additional 35 foreign-based
air carriers and five sea carriers will be affected. CBP concluded that
costs to air and sea carriers to support the requirements of the ESTA
program could cost $137 million to $1.1 billion over the next 10 years
depending on the level of effort required to integrate their systems
with ESTA, how many passengers they need to assist in applying for
travel authorizations, and the discount rate applied to annual costs.
Costs to Travelers
ESTA will present new costs and burdens to travelers in VWP
countries who were not previously required to submit any information to
the U.S. Government in advance of travel to the United States.
Travelers from Roadmap countries who become VWP countries will also
incur costs and burdens, though these are much less than obtaining a
nonimmigrant visa (category B1/B2), which is currently required for
short-term pleasure or business to travel to the United States. CBP
estimated that the total quantified costs to travelers will range from
$1.1 billion to $3.5 billion depending on the number of travelers, the
value of time, and the discount rate. Annualized costs are estimated to
range from $133 million to $366 million.
Benefits
As set forth in section 711 of the 9/11 Act, it was the intent of
Congress to modernize and strengthen the security of the Visa Waiver
Program under section 217 of the Immigration and Nationality Act (INA,
8 U.S.C. 1187) by simultaneously enhancing program security
requirements and extending visa-free travel privileges to citizens and
eligible nationals of eligible foreign countries that are partners in
the war on terrorism.
By requiring passenger data in advance of travel, CBP may be able
to determine, before the alien departs for the United States, the
eligibility of citizens and eligible nationals from VWP countries to
travel to the United States under the VWP, and whether such travel
poses a law enforcement or security risk. In addition to fulfilling a
statutory mandate, the rule serves the twin goals of promoting border
security and legitimate travel to the United States. By modernizing the
VWP, ESTA is intended to both increase national security and provide
for greater efficiencies in the screening of international travelers by
allowing for the screening of subjects of potential interest well
before boarding, thereby reducing traveler delays based on potentially
lengthy processes at U.S. ports of entry.
CBP concluded that the total benefits to travelers could total $1.1
billion to $3.3 billion over the period of analysis. Annualized
benefits could range from $134 million to $345 million.
In addition to these benefits to travelers, CBP and the carriers
should also experience the benefit of not having to administer the I-
94W except in limited situations. While CBP has not conducted an
analysis of the potential savings, it should accrue benefits from not
having to produce, ship, and store blank forms. CBP should also be able
to accrue savings related to data entry and archiving. Carriers should
realize some savings as well, though carriers will still have to
administer the I-94 for those passengers not traveling under the VWP
and the Customs Declaration forms for all passengers aboard the
aircraft and vessel.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Action................ 06/09/08 73 FR 32440
Interim Final Rule Effective........ 08/08/08 .......................
Interim Final Rule Comment Period 08/08/08 .......................
End.
Notice--Announcing Date Rule Becomes 11/13/08 73 FR 67354
Mandatory.
Final Action........................ 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Additional Information: https://www.cbp.gov/xp/cgov/travel/id_visa/esta/.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Suzanne Shepherd, Director, Electronic System for
Travel Authorization, Department of Homeland Security, U.S. Customs and
Border Protection, 1300 Pennsylvania Avenue NW., Washington, DC 20229,
Phone: 202 344-2073, Email: cbp.esta@dhs.gov.
Related RIN: Related to 1651-AA83.
RIN: 1651-AA72
DHS--USCBP
71. Establishment of Global Entry Program
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1365b(k)(1); 8 U.S.C. 1365b(k)(3); 8
U.S.C. 1225; 8 U.S.C. 1185(b)
CFR Citation: 8 CFR 235; 8 CFR 103.
Legal Deadline: None.
Abstract: CBP already operates several regulatory and non-
regulatory international registered traveler programs, also known as
trusted traveler programs. In order to comply with the Intelligence
Reform Terrorism Prevention Act of 2004 (IRPTA), CBP is proposing to
amend its regulations to establish another international registered
traveler program called Global Entry. The Global Entry program would
expedite the movement of low-risk, frequent international air travelers
by providing an expedited inspection process for pre-approved, pre-
screened travelers. These travelers would proceed directly to automated
Global Entry kiosks upon their arrival in the United States. This
Global Entry Program, along with the other programs that have already
been established, are consistent with CBP's strategic goal of
facilitating legitimate trade and travel while securing the homeland. A
pilot of Global Entry has been operating since June 6, 2008.
Statement of Need: CBP has been operating the Global Entry program
as a pilot at several airports since June 6, 2008, and the pilot has
been very successful. As a result, there is a desire on the part of the
public that CBP establish the program as a permanent program, and
expanded the program to additional airports and to citizens from other
countries if possible. By establishing this program, CBP will make
great strides toward facilitating the movement of people in a more
efficient manner, thereby accomplishing our strategic goal of balancing
legitimate travel with security. Through the use of biometric and
recordkeeping technologies, the risk of terrorists entering the United
States would be reduced. Improving security and facilitating travel at
the border, both of which are accomplished by Global Entry, are primary
concerns within CBP jurisdiction.
[[Page 7753]]
Summary of Legal Basis: The Global Entry program is based on
section 7208(k) of the Intelligence Reform and Terrorism Prevention Act
of 2004 (IRTPA), as amended by section 565 of the Consolidated
Appropriations Act, which requires the Secretary of Homeland Security
to create a program to expedite the screening and processing of pre-
approved low risk air travelers into the United States.
Anticipated Cost and Benefits: Global Entry is a voluntary program
that provides a benefit to the public by speeding the CBP processing
time for participating travelers. Travelers who are otherwise
admissible to the United States will be able to enter or exit the
country regardless of whether they participate in Global Entry. CBP
estimates that over a 5-year period, 250,000 enrollees will be
processed (an annual average of 50,000 individuals). CBP estimates that
each application will require 40 minutes (0.67 hours) of the enrollee's
time to search existing data resources, gather the data needed, and
complete and review the application form. Additionally, an enrollee
will experience an ``opportunity cost of time'' to travel to an
Enrollment Center upon acceptance of the initial application. We assume
that 1 hour will be required for this time spent at the Enrollment
Center and travel to and from the Center, though we note that during
the pilot program, many applicants coordinated their trip to an
Enrollment Center with their travel at the airport. CBP has used 1 hour
of travel time so as not to underestimate potential opportunity costs
for enrolling in the program. CBP used a value of $28.60 for the
opportunity cost for this time, which is taken from the Federal
Aviation Administration's ``Economic Values for FAA Investment and
Regulatory Decisions, A Guide.'' (Jul. 3, 2007) This value is the
weighted average for U.S. business and leisure travelers. For this
evaluation, CBP assumed that all enrollees will be U.S. citizens, U.S.
nationals, or Lawful Permanent Residents.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/19/09 74 FR 59932
NPRM Comment Period End............. 01/19/10 .......................
Final Rule.......................... 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: Includes Retrospective Review under E.O.
13563.
URL for More Information: www.globalentry.gov
Agency Contact: John P. Wagner, Executive Director, Admissibility
and Passenger Programs, Department of Homeland Security, U.S. Customs
and Border Protection, Office of Field Operations, 1300 Pennsylvania
Avenue NW., Washington, DC 20229, Phone: 202 344-2118, Email:
john.p.wagner@cbp.dhs.gov.
RIN: 1651-AA73
DHS--USCBP
72. Implementation of the Guam-CNMI Visa Waiver Program
Priority: Other Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 110-229, sec 702
CFR Citation: 8 CFR 100.4; 8 CFR 212.1; 8 CFR 233.5; 8 CFR 235.5;
19 CFR 4.7b; 19 CFR 122.49a
Legal Deadline: Final, Statutory, November 4, 2008, Pub. L. 110-
229.
Abstract: This rule amends Department of Homeland Security (DHS)
regulations to implement section 702 of the Consolidated Natural
Resources Act of 2008 (CNRA). This law extends the immigration laws of
the United States to the Commonwealth of the Northern Mariana Islands
(CNMI) and provides for a joint visa waiver program for travel to Guam
and the CNMI. This rule implements section 702 of the CNRA by amending
the regulations to replace the current Guam Visa Waiver Program with a
new Guam-CNMI Visa Waiver Program. The amended regulations set forth
the requirements for nonimmigrant visitors who seek admission for
business or pleasure and solely for entry into and stay on Guam or the
CNMI without a visa. This rule also establishes six ports of entry in
the CNMI for purposes of administering and enforcing the Guam-CNMI Visa
Waiver Program.
Statement of Need: Currently, aliens who are citizens of eligible
countries may apply for admission to Guam at a Guam port of entry as
nonimmigrant visitors for a period of fifteen (15) days or less, for
business or pleasure, without first obtaining a nonimmigrant visa,
provided that they are otherwise eligible for admission. Section 702(b)
of the Consolidated Natural Resources Act of 2008 (CNRA), supersedes
the Guam visa waiver program by providing for a visa waiver program for
Guam and the Commonwealth of the Northern Mariana Islands (Guam-CNMI
Visa Waiver Program). Section 702(b) requires DHS to promulgate
regulations within 180 days of enactment of the CNRA to allow
nonimmigrant visitors from eligible countries to apply for admission
into Guam and the CNMI, for business or pleasure, without a visa, for a
period of authorized stay of no longer than 45 days.
Summary of Legal Basis: The Guam-CNMI Visa Waiver Program is based
on congressional authority provided under 702(b) of the Consolidated
Natural Resources Act of 2008 (CNRA).
Alternatives: None.
Anticipated Cost and Benefits: The most significant change for
admission to the CNMI as a result of the rule will be for visitors from
those countries who are not included in either the existing U.S. Visa
Waiver Program or the Guam-CNMI Visa Waiver Program established by the
rule. These visitors must apply for U.S. visas, which require in-person
interviews at U.S. embassies or consulates and higher fees than the
CNMI currently assesses for its visitor entry permits. CBP anticipates
that the annual cost to the CNMI will be $6 million. These are losses
associated with the reduced visits from foreign travelers who may no
longer visit the CNMI upon implementation of this rule. In addition, we
estimate Government implementation costs of between $87 and 91 million
over the 5-year period of analysis.
The anticipated benefits of the rule are enhanced security that
will result from the federalization of the immigration functions in the
CNMI.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 01/16/09 74 FR 2824
Interim Final Rule Effective........ 01/16/09 .......................
Interim Final Rule Comment Period 03/17/09 .......................
End.
Technical Amendment; Change of 05/28/09 74 FR 25387
Implementation Date.
Final Action........................ 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Erin Martin, Program Manager, Office of Field
Operations, Department of Homeland Security, U.S. Customs and Border
Protection, 1300 Pennsylvania Avenue NW., Washington,
[[Page 7754]]
DC 20229, Phone: 202 344-2728, Email: erin.m.martin@dhs.gov.
Related RIN: Related to 1651-AA81.
RIN: 1651-AA77
DHS--TRANSPORTATION SECURITY ADMINISTRATION (TSA)
Proposed Rule Stage
73. General Aviation Security and Other Aircraft Operator Security
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 6 U.S.C. 469; 18 U.S.C. 842; 18 U.S.C. 845; 46
U.S.C. 70102 to 70106; 46 U.S.C. 70117; 49 U.S.C. 114; 49 U.S.C.
114(f)(3); 49 U.S.C. 5103; 49 U.S.C. 5103a; 49 U.S.C. 40113; 49 U.S.C.
44901 to 44907; 49 U.S.C. 44913 to 44914; 49 U.S.C. 44916 to 44918; 49
U.S.C. 44932; 49 U.S.C. 44935 to 44936; 49 U.S.C. 44942; 49 U.S.C.
46105
CFR Citation: 49 CFR 1515; 49 CFR 1520; 49 CFR 1522; 49 CFR 1540;
49 CFR 1542; 49 CFR 1544; 49 CFR 1550.
Legal Deadline: None.
Abstract: On October 30, 2008, the Transportation Security
Administration (TSA) issued a Notice of Proposed Rulemaking (NPRM),
proposing to amend current aviation transportation security regulations
to enhance the security of general aviation by expanding the scope of
current requirements, and by adding new requirements for certain large
aircraft operators and airports serving those aircraft. TSA also
proposed that all aircraft operations, including corporate and private
charter operations, with aircraft having a maximum certificated takeoff
weight (MTOW) above 12,500 pounds (large aircraft) be required to adopt
a large aircraft security program. TSA also proposed to require certain
airports that serve large aircraft to adopt security programs. TSA is
preparing a supplemental NPRM (SNPRM), which will include a comment
period for public comments.
After considering comments received on the NPRM and meeting with
stakeholders, TSA decided to revise the original proposal to tailor
security requirements to the general aviation industry. TSA is
considering alternatives to the following proposed provisions in the
SNPRM: (1) The type of aircraft subject to TSA regulation; (2)
compliance oversight; (3) watch list matching of passengers; (4)
prohibited items; (5) scope of the background check requirements and
the procedures used to implement the requirement; and (6) other issues.
Additionally, in the SNPRM, TSA plans to propose security measures for
foreign aircraft operators. U.S. and foreign operators would implement
commensurate measures under the proposed rule.
Statement of Need: This rule would enhance current security
measures and might apply security measures currently in place for
operators of certain types of aircraft to operators of other aircraft,
including general aviation operators. While the focus of TSA's existing
aviation security programs has been on air carriers and commercial
operators, TSA is aware that general aviation aircraft of sufficient
size and weight may inflict significant damage and loss of lives if
they are hijacked and used as missiles. TSA has current regulations
that apply to large aircraft operated by air carriers and commercial
operators, including the twelve-five program, the partial program, and
the private charter program. However, the current regulations in 49 CFR
part 1544 do not cover all general aviation operations, such as those
operated by corporations and individuals, and such operations do not
have the features that are necessary to enhance security. Therefore,
TSA is preparing a SNPRM which proposes to establish new security
measures for operators, including general aviation operators, that are
not covered under TSA's current regulations.
Summary of Legal Basis: 49 U.S.C. 114, 40113, 44903.
Alternatives: DHS considered continuing to use voluntary guidance
to secure general aviation, but determined that to ensure that each
aircraft operator maintains an appropriate level of security, these
security measures would need to be mandatory requirements.
Anticipated Cost and Benefits: TSA has not quantified benefits.
Unquantified benefits of this rule include those in the areas of
security and quality governance. The rule would enhance security by
expanding the mandatory use of security measures to certain operators
of large aircraft that are not currently required to have a security
plan. These measures would deter malicious individuals from
perpetrating acts that might compromise transportation or national
security by using large aircraft for these purposes.
As stated above, TSA is revising this proposed rule and preparing a
SNPRM. Aircraft operators, passengers, and TSA would incur costs to
comply with the requirements of the proposed rule. TSA is currently
evaluating the costs of the revised rule which will be published in the
SNPRM.
TSA uses a break-even analysis to assess the trade-off between the
beneficial effects of the SNPRM and the costs of implementing the
rulemaking. This break-even analysis uses scenarios extracted from the
TSA Transportation Sector Security Risk Assessment (TSSRA) to determine
the degree to which the SNPRM must reduce the overall risk of a
terrorist attack in order for the expected benefits of the SNPRM to
justify the estimated costs. For its analyses, TSA uses scenarios with
varying levels of risk, but only details the consequence estimates. To
maintain consistency, TSA developed the analyses with a method similar
to that used for the break-even analyses conducted in earlier DHS
rules. After estimating the total consequences of each scenario by
monetizing lives lost, injuries incurred, capital replacement, and
clean-up, TSA will use this figure and the annualized cost of the SNPRM
to calculate the frequency of attacks averted in order for the SNPRM to
break even.
Risks: This rulemaking addresses the national security risk of
general aviation aircraft being used as a weapon or as a means to
transport persons or weapons that could pose a threat to the United
States.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/30/08 73 FR 64790
NPRM Comment Period End............. 12/29/08 .......................
Notice--NPRM Comment Period Extended 11/25/08 73 FR 71590
NPRM Extended Comment Period End.... 02/27/09 .......................
Notice--Public Meetings; Requests 12/28/08 73 FR 77045
for Comments.
Supplemental NPRM................... 09/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Additional Information: Public Meetings held on: Jan. 6, 2009, at
White Plains, NY; Jan. 8, 2009, at Atlanta, GA; Jan 16, 2009, at
Chicago, IL; Jan. 23, 2009, at Burbank, CA; and Jan. 28, 2009, at
Houston, TX.
Additional Comment Sessions held in Arlington, VA, on April 16,
2009, May 6, 2009, and June 15, 2009.
[[Page 7755]]
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Erik Jensen, Assistant General Manager, General
Aviation Security, Department of Homeland Security, Transportation
Security Administration, Office of Transportation Sector Network
Management, TSA-28, HQ, E10-132S, 601 South 12th Street, Arlington, VA
20598-6028, Phone: 571 227-2154, Fax: 571 227-1923, Email:
erik.jensen@dhs.gov.
Thomas Philson, Deputy Director, Regulatory and Economic Analysis,
Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-411N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-3236, Fax: 571 227-1362, Email: thomas.philson@dhs.gov.
Denise Daniels, Attorney, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, Office of the Chief Counsel, TSA-2, HQ, E12-127S, 601
South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-3443, Fax:
571 227-1381, Email: denise.daniels@dhs.gov.
Kiersten Ols, Attorney, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, Office of the Chief Counsel, TSA-2, HQ, E12-316N, 601
South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-2403, Fax:
571 227-1378, Email: kiersten.ols@dhs.gov.
Related RIN: Related to 1652-AA03, Related to 1652-AA04.
RIN: 1652-AA53
DHS--TSA
74. Freight Railroads, Public Transportation and Passenger Railroads,
and Over-the-Road Buses--Security Training of Employees
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L. 110-53, secs 1408, 1517,
and 1534
CFR Citation: 49 CFR 1520; 49 CFR 1570; 49 CFR 1580; 49 CFR 1582
(New); 49 CFR 1584 (New).
Legal Deadline: Final, Statutory, November 1, 2007, Interim Rule
for public transportation agencies is due 90 days after date of
enactment.
Final, Statutory, February 3, 2008, Rule for railroads and over-
the-road buses are due 6 months after date of enactment.
Final, Statutory, August 3, 2008, Rule for public transportation
agencies is due 1 year after date of enactment.
According to section 1408 of Public Law 110-53, Implementing
Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121
Stat. 266), interim final regulations for public transportation
agencies are due 90 days after the date of enactment (Nov. 1, 2007),
and final regulations are due 1 year after the date of enactment of
this Act.
Abstract: The Transportation Security Administration (TSA) will
propose a new regulation to improve the security of freight railroads,
public transportation and passenger railroads, and over-the-road buses
in accordance with the Implementing Recommendations of the 9/11
Commission Act of 2007. This rulemaking will propose general
requirements for the owner/operators of a freight railroad, a public
transportation system or passenger railroad, and over-the-road bus
operation determined by TSA to be high-risk to develop and implement a
security training program to prepare security-sensitive employees,
including frontline employees identified in sections 1402 and 1501 of
the Act, for potential security threats and conditions. The rulemaking
will also propose extending the security coordinator and reporting
security incident requirements applicable to rail operators under
current 49 CFR part 1580 to the non-rail transportation components of
covered public transportation agencies. In addition, the rulemaking
will also propose requiring the affected over-the-road bus owner/
operators to identify security coordinators and report security
incidents, similar to the requirements for rail in current 49 CFR 1580.
The regulation will take into consideration any current security
training requirements or best practices.
Statement of Need: A security training program for freight
railroads, public transportation agencies and passenger railroads, and
over-the-road bus operations is proposed to prepare freight railroad
security-sensitive employees, public transportation and passenger
railroad security-sensitive employees, and over-the-road bus security
sensitive employees for potential security threats and conditions.
Summary of Legal Basis: 49 U.S.C. 114; sections 1408, 1517, and
1534 of Public Law 110-53, Implementing Recommendations of the 9/11
Commission Act of 2007 (Aug. 3, 2007; 121 Stat. 266).
Alternatives: TSA is required by statute to publish regulations
requiring security training programs for these owner/operators. As part
of its notice of proposed rulemaking, TSA will seek public comment on
the alternative ways in which the final rule could carry out the
requirements of the statute.
Anticipated Cost and Benefits: TSA will estimate the costs that the
freight railroad systems, public transportation agencies and passenger
railroads, and over-the-road bus (OTRB) entities covered by this
proposed rule would incur following its implementation. These costs
will include estimates for the following elements: (1) Creating or
modifying a security training program and submitting it to TSA; (2)
Training (initial and recurrent) all security-sensitive employees; (3)
Maintaining records of employee training; (4) Being available for
inspections; (5) As applicable, providing information on security
coordinators and alternates; and (6) As applicable, reporting security
concerns. TSA will also estimate the costs TSA itself would expect to
incur with the implementation of this rule.
TSA has not quantified benefits. However, the primary benefit of
the Security Training NPRM will be to enhance United States surface
transportation security by reducing the vulnerability of freight
railroad systems, public transportation agencies, and passenger
railroads to terrorist activity through the training of security-
sensitive employees. TSA uses a break-even analysis to assess the
trade-off between the beneficial effects of the Security Training NPRM
and the costs of implementing the rulemaking. This break-even analysis
uses scenarios extracted from the TSA Transportation Sector Security
Risk Assessment (TSSRA) to determine the degree to which the Security
Training NPRM must reduce the overall risk of a terrorist attack in
order for the expected benefits of the NPRM to justify the estimated
costs. For its analyses, TSA uses scenarios with varying levels of
risk, but only details the consequence estimates. To maintain
consistency, TSA developed the analyses with a method similar to that
used for the break-even analyses conducted in earlier DHS rules.
After estimating the total consequence of each scenario by
monetizing lives lost, injuries incurred, and capital replacement and
clean-up, TSA will use this figure and the annualized cost of the NPRM
for freight rail, public transportation and passenger rail, and
[[Page 7756]]
OTRB operators to calculate a breakeven annual likelihood of attack.
Risks: The Department of Homeland Security aims to prevent
terrorist attacks within the United States and to reduce the
vulnerability of the United States to terrorism. By providing for
security training for personnel, TSA intends in this rulemaking to
reduce the risk of a terrorist attack on this transportation sector.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Local.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Scott Gorton, Policy and Plans Branch Chief for
Freight Rail, Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-423N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-1251, Fax: 571 227-2930, Email: scott.gorton@dhs.gov.
David Kasminoff, Sr. Counsel, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, Office of the Chief Counsel, TSA-2, HQ, E12-310N, 601
South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-3583, Fax:
571 227-1378, Email: david.kasminoff@dhs.gov.
Steve Sprague, Highway Passenger, Infrastructure and Licensing
Branch Chief, Highway and Motor Carrier Programs, Department of
Homeland Security, Transportation Security Administration, Office of
Transportation Sector Network Management, TSA-28, HQ, E, 601 South 12th
Street, Arlington, VA 20598-6028, Phone: 571 227-1468, Email:
steve.sprague@dhs.gov.
Related RIN: Related to 1652-AA57, Related to 1652-AA59.
RIN: 1652-AA55
DHS--TSA
75. Freight Railroads and Passenger Railroads--Vulnerability Assessment
and Security Plan
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L. 110-53, sec 1512
CFR Citation: 49 CFR 1520; 49 CFR 1570; 49 CFR 1580; 49 CFR 1582
(New).
Legal Deadline: Final, Statutory, August 3, 2008, Rule for freight
railroads and passenger railroads is due no later than 12 months after
date of enactment.
According to section 1512 of Public Law 110-53, Implementing
Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121
Stat. 266), a final regulation for freight railroads and passenger
railroads is due no later than 12 months after the date of enactment of
the Act.
Abstract: The Transportation Security Administration (TSA) will
propose a new regulation to improve the security of freight railroads
and passenger railroads in accordance with the Implementing
Recommendations of the 9/11 Commission Act of 2007. This rulemaking
will propose thresholds for which a risk determination can be made to
determine whether a freight railroad and passenger railroad should be
considered ``high risk.'' The rulemaking will also propose requirements
for vulnerability assessments and security plans for owner/operators of
those railroads. The proposed requirements include procedures for TSA's
review and approval of these assessments and plans, and recordkeeping
requirements. The regulation will take into consideration any current
security assessment and planning requirements or best practices.
Statement of Need: The rulemaking will propose requirements for
owner/operators of high-risk freight railroads and high-risk passenger
railroads to conduct vulnerability assessments and carry-out security
plans to address the railroad carrier's preparedness and response for
potential security threats and conditions.
Summary of Legal Basis: 49 U.S.C. 114; section 1512 of Public Law
110-53, Implementing Recommendations of the 9/11 Commission Act of 2007
(Aug. 3, 2007; 121 Stat. 266).
Alternatives: TSA is required by statute to publish regulations
requiring vulnerability assessments and security plans for owner/
operators of high-risk freight railroads and high-risk passenger
railroads. As part of its notice of proposed rulemaking, TSA will seek
public comment on the alternative ways in which the final rule could
carry out the requirements of the statute.
Anticipated Cost and Benefits: TSA will estimate the costs that the
freight rail systems and passenger railroad carriers covered by this
proposed rule would incur following its implementation. These costs
will include estimates for the following elements: (1) Completing,
modifying, or updating a vulnerability assessment and submitting it to
TSA; (2) Developing, modifying, or updating a security plan and
submitting it to TSA; (3) Implementing a security plan; (4) Maintaining
records, including master copies of the vulnerability assessment and
security plan and all plans or documents referenced in the security
plan; and (5) Being available for inspection.
The expected primary benefit of the Vulnerability Assessment and
Security Plan NPRM will be to enhance U.S. surface transportation
security by reducing vulnerability to terrorist attacks in two
different ways. First, vulnerability assessments, as required in this
proposed rule, would identify assets and infrastructure that are
critical to owner/operators and provide an assessment of security risks
that need to be mitigated at these locations. Second, in an effort to
mitigate security risks, security plans would help target resources and
mitigation strategies toward security gaps in an owner/operator's
specific freight or passenger railroad operation to address the risks
identified by the vulnerability assessments.
TSA has not quantified benefits. For the purposes of this
rulemaking, TSA employs a break even analysis to compare the cost of
the risk reduction resulting from the proposed rule with the dollar
value of the type of terrorist attacks that could potentially be
averted due to the requirements in the proposed rule. This provides a
framework for evaluating the tradeoff between program costs and
benefits. For purposes of this analysis, TSA evaluates three scenarios
in the freight rail mode of surface transportation and three scenarios
in the passenger railroad mode of surface transportation covered by the
proposed rule. For each scenario, TSA calculates a total monetary
consequence from an estimated statistical value of the human casualties
and capital replacement resulting from the attack. TSA compared an
expected value of the monetary cost of an attack to the each rail mode
and TSA's annualized cost of conducting vulnerability assessments and
implementing security plans, discounted at 7 percent, to estimate how
often an attack of that nature would need to be averted for the
expected benefits to equal estimated costs. For a given level of pre-
existing or baseline risk of an attack, the calculation of the break-
even point--the reduction in baseline risk for which the estimated
costs and expected benefits are equal--
[[Page 7757]]
and a detailed description of each scenario is presented in the
regulatory evaluation for this NPRM.
Risks: The Department of Homeland Security aims to prevent
terrorist attacks within the United States and to reduce the
vulnerability of the United States to terrorism. By providing for
owner/operators of high-risk freight railroads and owner/operators of
high-risk passenger railroads to conduct vulnerability assessments and
adopt and carry out security plans, TSA intends in this rulemaking to
reduce the risk of a terrorist attack on the passenger rail
transportation sector.
Timetable:
------------------------------------------------------------------------
FR
Action Date Cite
------------------------------------------------------------------------
NPRM.................................. 09/00/12.................. ....
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Local.
Federalism: Undetermined.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Scott Gorton, Policy and Plans Branch Chief for
Freight Rail, Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-423N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-1251, Fax: 571 227-2930, Email: scott.gorton@dhs.gov.
David Kasminoff, Sr. Counsel, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, Office of the Chief Counsel, TSA-2, HQ, E12-310N, 601
South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-3583, Fax:
571 227-1378, Email: david.kasminoff@dhs.gov.
Morvarid Zolghadr, Branch Chief, Policy and Plans, Mass Transit and
Passenger Rail Security, Department of Homeland Security,
Transportation Security Administration, Office of Transportation Sector
Network Management, TSA-28, E10-113S, 601 South 12th Street, Arlington,
VA 20598-6028, Phone: 571 227-2957, Fax: 571 227-0729, Email:
morvarid.zolghadr@dhs.gov.
Related RIN: Related to 1652-AA58, Related to 1652-AA60.
RIN: 1652-AA56
DHS--TSA
76. Standardized Vetting, Adjudication, and Redress Services
Priority: Economically Significant. Major status under 5 U.S.C. 801
is undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L. 110-53, secs 1411, 1414,
1520, 1522, 1602; 6 U.S.C. 469
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Transportation Security Administration (TSA) will
propose new regulations to revise and standardize the procedures,
adjudication criteria, and fees for most of the security threat
assessments (STA) of individuals for which TSA is responsible. In
accordance with the Implementing Recommendations of the 9/11 Commission
Act of 2007 (9/11 Act), the scope of the rulemaking will include
transportation workers from all modes of transportation who are
required to undergo an STA in other regulatory programs, including
certain aviation workers and frontline employees for public
transportation agencies and railroads.
In addition, TSA will propose fees to cover the cost of the STAs,
and credentials for some personnel. TSA plans to improve efficiencies
in processing STAs and streamline existing regulations by simplifying
language and removing redundancies.
As part of this proposed rule, TSA will propose revisions to the
Alien Flight Student Program (AFSP) regulations. TSA published an
interim final rule for ASFP on September 20, 2004. TSA regulations
require aliens seeking to train at Federal Aviation Administration-
regulated flight schools to complete an application and undergo an STA
prior to beginning flight training. There are four categories under
which students currently fall; the nature of the STA depends on the
student's category. TSA is considering changes to the AFSP that would
improve the equity among fee payers and enable the implementation of
new technologies to support vetting.
Statement of Need: Through this rulemaking, TSA proposes to carry
out statutory mandates to perform security threat assessments (STA) of
certain transportation workers pursuant to the 9/11 Act. Also, TSA
proposes to fully satisfy 6 U.S.C. 469, which requires TSA to fund
security threat assessment and credentialing activities through user
fees. The proposed rulemaking would increase transportation security by
enhancing identification and immigration verification standards,
providing for more thorough vetting, improving the reliability and
consistency of the vetting process, and increasing fairness to vetted
individuals by providing more robust redress and reducing redundant STA
requirements.
Summary of Legal Basis: 49 U.S.C. 114(f): Under the Aviation and
Transportation Security Act (ATSA) (Pub. L. 170-71, Nov. 19, 2001, 115
Stat. 597), TSA assumed responsibility to oversee the vetting of
certain aviation workers. See 49 U.S.C. 44936.
Under the Maritime Transportation Security Act (MTSA), (Pub. L.
107-295, sec. 102, Nov. 25, 2002, 116 Stat. 2064), codified at 46
U.S.C. 70105, TSA vets certain merchant mariners and individuals who
require unescorted access to secure areas of vessels and maritime
facilities.
Under the Uniting and Strengthening America by Providing
Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA
PATRIOT Act) (Pub. L. 107-56, Oct. 25, 2001, 115 Stat. 272), TSA vets
individuals seeking hazardous materials endorsements (HME) to
commercial driver's licenses (CDL) issued by the States.
In the Implementing Recommendation of the 9/11 Commission Act of
2007 (Pub. L. 110-53, Aug. 3, 2007, 121 Stat. 266), Congress directed
TSA to vet additional populations of transportation workers, including
certain public transportation and railroad workers.
In 6 U.S.C. 469, Congress directed TSA to fund vetting and
credentialing programs through user fees.
Alternatives: TSA considered a number of viable alternatives to
lessen the impact of the proposed on entities deemed ``small'' by the
Small Business Administration (SBA) standards. This included: (1)
Extending phone pre-enrollment to populations eligible to enroll via
the web; and (2) changing the current delivery and activation process
and instituting centralized activation of biometric credentials that
allow applicants to receive their credentials through the mail rather
than returning to the enrollment center to pick up the credential.
These alternatives are discussed in detail in the rule and regulatory
evaluation.
Anticipated Cost and Benefits: TSA conducted a regulatory
evaluation to estimate the costs regulated entities, individuals, and
TSA would incur to comply with the requirements of the NPRM. The NPRM
would impose new requirements for some individuals, codify existing
requirements not included in the Code of Federal Regulations (CFR), and
modify current STA requirements for many
[[Page 7758]]
transportation workers. The primary benefit of the NPRM would be that
it will improve TSA's vetting product, process, and structure by
improving STAs, increasing equity, decreasing reliance on appropriated
funds, and improving reusability of STAs and mitigating redundant STAs.
TSA has not quantified benefits. TSA uses a break-even analysis to
assess the trade-off between the beneficial effects of the NPRM and the
costs of implementing the rulemaking. This break-even analysis uses
scenarios from the TSA Transportation Sector Security Risk Assessment
(TSSRA) to determine the degree to which the NPRM must reduce the
overall risk of a terrorist attack in order for the expected benefits
of the NPRM to justify the estimated costs. For its analyses, TSA uses
scenarios with varying levels of risk, but only details the consequence
estimates. To maintain consistency, TSA developed the analyses with a
method similar to that used for the break-even analyses conducted in
earlier DHS rules. After estimating the total consequences of each
scenario by monetizing lives lost, injuries incurred, capital
replacement, and clean-up, TSA will use this figure and the annualized
cost of the NPRM to calculate the frequency of attacks averted in order
for the NPRM to break even.
TSA estimates that the total savings to the alien flight students,
over a 5-year period, will be $18,107 at a 7 percent discount rate.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Hao-y Tran Froemling, Program Manager, Maritime and
Surface Credentialing, Department of Homeland Security, Transportation
Security Administration, Office of Transportation Threat Assessment and
Credentialing, TSA-19, HQ, E3-401N, 601 South 12th Street, Arlington,
VA 20598-6019, Phone: 571 227-2782, Email: hao-y.froemling@dhs.gov.
Thomas Philson, Deputy Director, Regulatory and Economic Analysis,
Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-411N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-3236, Fax: 571 227-1362, Email: thomas.philson@dhs.gov.
John Vergelli, Attorney, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, DHS, TSA, Office of the Chief Counsel, TSA-2, HQ, E12-
309N, 601 South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-
4416, Fax: 571 227-1378, Email: john.vergelli@dhs.gov.
Related RIN: Related to 1652-AA35.
RIN: 1652-AA61
DHS--TSA
Final Rule Stage
77. Aircraft Repair Station Security
Priority: Other Significant. Major under 5 U.S.C. 801.
Legal Authority: 49 U.S.C. 114; 49 U.S.C. 44924
CFR Citation: 49 CFR 1554.
Legal Deadline: Final, Statutory, August 8, 2004, Rule within 240
days of the date of enactment of Vision 100.
Final, Statutory, August 3, 2008, Rule within 1 year after the date
of enactment of 9/11 Commission Act. Section 611(b)(1) of Vision 100--
Century of Aviation Reauthorization Act (Pub. L. 108-176; Dec. 12,
2003; 117 Stat. 2490), codified at 49 U.S.C. 44924, requires TSA issue
``final regulations to ensure the security of foreign and domestic
aircraft repair stations.'' Section 1616 of the Implementing
Recommendations of the 9/11 Commission Act of 2007 (Pub. L. 110-531;
Aug. 3, 2007; 21 Stat. 266) requires TSA issue a final rule on foreign
repair station security.
Abstract: The Transportation Security Administration (TSA) proposed
to add a new regulation to improve the security of domestic and foreign
aircraft repair stations, as required by the section 611 of Vision
100--Century of Aviation Reauthorization Act and section 1616 of the 9/
11 Commission Act of 2007. The regulation proposed general requirements
for security programs to be adopted and implemented by repair stations
certificated by the Federal Aviation Administration (FAA). A notice of
proposed rulemaking (NPRM) was published in the Federal Register on
November 18, 2009, requesting public comments to be submitted by
January 19, 2010. The comment period was extended to February 19, 2010,
on request of the stakeholders to allow the aviation industry and other
interested entities and individuals additional time to complete their
comments.
TSA has coordinated its efforts with the FAA throughout the
rulemaking process to ensure that the final rule does not interfere
with FAA's ability or authority to regulate part 145 repair station
safety matters.
Statement of Need: The Transportation Security Administration (TSA)
is proposing regulations to improve the security of domestic and
foreign aircraft repair stations. The NPRM proposed to require repair
stations that are certificated by the Federal Aviation Administration
to adopt and carry out a security program. The proposal will codify the
scope of TSA's existing inspection program. The proposal also provides
procedures for repair stations to seek review of any TSA determination
that security measures are deficient.
Summary of Legal Basis: Section 611(b)(1) of Vision 100--Century of
Aviation Reauthorization Act (Pub. L. 108-176; Dec. 12, 2003; 117 Stat.
2490), codified at 49 U.S.C. 44924, requires TSA to issue ``final
regulations to ensure the security of foreign and domestic aircraft
repair stations'' within 240 days from date of enactment of Vision 100.
Section 1616 of Public Law 110-53, Implementing Recommendations of the
9/11 Commission Act of 2007 (Aug. 3, 2007; 121 Stat. 266) requires that
the FAA may not certify any foreign repair stations if the regulations
are not issued within 1 year after the date of enactment of the 9/11
Commission Act unless the repair station was previously certificated or
is in the process of certification.
Alternatives: TSA is required by statute to publish regulations
requiring security programs for aircraft repair stations. As part of
its notice of proposed rulemaking, TSA sought public comment on the
numerous alternative ways in which the final rule could carry out the
requirements of the statute.
Anticipated Cost and Benefits: TSA anticipates costs to aircraft
repair stations mainly related to the establishment of security
programs, which may include adding such measures as access controls, a
personnel identification system, security awareness training, the
designation of a security coordinator, employee background
verification, and contingency plan.
The NPRM estimated the total 10-year undiscounted cost of the
program at $344 million. The cost of the program, annualized and
discounted at 7 percent, is $241 million. Security coordinator and
training costs represent the largest portions of the program.
TSA has not quantified benefits. However, a major line of defense
against an aviation-related terrorist act is the prevention of
explosives, weapons, and/
[[Page 7759]]
or incendiary devices from getting on board a plane. To date, efforts
have been primarily related to inspection of baggage, passengers, and
cargo, and security measures at airports that serve air carriers. With
this rule, attention is given to aircraft that are located at repair
stations, and to aircraft parts that are at repair stations themselves,
to reduce the likelihood of an attack against aviation and the country.
Since repair station personnel have direct access to all parts of an
aircraft, the potential exists for a terrorist to seek to commandeer or
compromise an aircraft when the aircraft is at one of these facilities.
Moreover, as TSA tightens security in other areas of aviation, repair
stations increasingly may become attractive targets for terrorist
organizations attempting to evade aviation security protections
currently in place.
TSA uses a break-even analysis to assess the trade-off between the
beneficial effects of the final rule and the costs of implementing the
rulemaking. This break-even analysis uses three attack scenarios to
determine the degree to which the final rule must reduce the overall
risk of a terrorist attack in order for the expected benefits of the
final rule to justify the estimated costs. For its analyses, TSA uses
scenarios with varying levels of risk, but only details the consequence
estimates. To maintain consistency, TSA developed the analyses with a
method similar to that used for the break-even analyses conducted in
earlier DHS rules. After estimating the total consequences of each
scenario by monetizing lives lost, injuries incurred, and capital
replacement, TSA will use this figure and the annualized cost of the
final rule to calculate the frequency of attacks averted in order for
the final rule to break even.
Risks: The Department of Homeland Security aims to prevent
terrorist attacks within the United States and to reduce the
vulnerability of the United States to terrorism. By requiring security
programs for aircraft repair stations, TSA will focus on preventing
unauthorized access to repair work and to aircraft to prevent sabotage
or hijacking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice--Public Meeting; Request for 02/24/04 69 FR 8357
Comments.
Report to Congress.................. 08/24/04 .......................
NPRM................................ 11/18/09 74 FR 59873
NPRM Comment Period End............. 01/19/10 .......................
NPRM Comment Period Extended........ 12/29/09 74 FR 68774
NPRM Extended Comment Period End.... 02/19/10 .......................
Final Rule.......................... 09/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Celio Young, Program Manager, Repair Stations,
Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
General Aviation Division, TSA-28, HQ, E5, 601 South 12th Street,
Arlington, VA 20598-6028, Phone: 571 227-3580, Fax: 571 227-1362,
Email: celio.young@dhs.gov.
Thomas Philson, Deputy Director, Regulatory and Economic Analysis,
Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-411N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-3236, Fax: 571 227-1362, Email: thomas.philson@dhs.gov.
Linda L. Kent, Assistant Chief Counsel, Regulations and Security
Standards Division, Department of Homeland Security, Transportation
Security Administration, Office of the Chief Counsel, TSA-2, HQ, E12-
126S, 601 South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-
2675, Fax: 571 227-1381, Email: linda.kent@dhs.gov.
RIN: 1652-AA38
DHS--U.S. IMMIGRATION AND CUSTOMS ENFORCEMENT (USICE)
Proposed Rule Stage
78. Continued Detention of Aliens Subject to Final Orders of Removal
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1223; 8 U.S.C. 1227; 8
U.S.C. 1231; 8 U.S.C. 1253
CFR Citation: 8 CFR 241.
Legal Deadline: None.
Abstract: This notice of proposed rulemaking (NPRM) is proposing to
amend the Department of Homeland Security (DHS) regulatory provisions
for custody determinations for aliens in immigration detention who are
subject to an administratively final order of removal. The proposed
amendment would add a paragraph to 8 CFR 241.4(g) providing that U.S.
Immigration and Customs Enforcement (ICE) shall have a reasonable
period of time to effectuate an alien's removal where the alien is not
in immigration custody when the order of removal becomes
administratively final. The proposed rule would also clarify the
removal period time frame afforded to the agency following an alien's
compliance with his or her obligations regarding removal subsequent to
a period of obstruction or failure to cooperate. The rule proposes to
make conforming changes to 241.13(b)(2). Lastly, the rule proposes to
add a paragraph to 8 CFR 241.13(b)(3) to make clear that aliens
certified by the Secretary under section 236A of the Immigration and
Nationality Act, 8 U.S.C. 1226a, are not subject to the provisions of 8
CFR 241.13, in accordance with the separate detention standard provided
under the Act.
Statement of Need: The companion final rule will improve the post
order custody review process in the final rule related to the Detention
of Aliens Subject to Final Orders of Removal in light of the U.S.
Supreme Court's decisions in Zadvydas v. Davis, 533 U.S. 678 (2001),
Clark v. Martinez, 543 U.S. 371 (2005) and conforming changes as
required by the enactment of the Homeland Security Act of 2002 (HSA).
This notice of proposed rulemaking (NPRM) will propose to amend 8 CFR
241.1(g) to provide for a new 90-day removal period once an alien comes
into compliance with his or her obligation to make timely application
in good faith for travel or other documents and not conspire or act to
prevent removal.
Anticipated Cost and Benefits: This proposed rule will clarify the
regulatory provisions concerning the removal of aliens that are subject
to an administratively final order of removal. DHS does not anticipate
there will be cost impacts to the public as a result of the rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Alexander Hartman, Regulatory Coordinator,
Department of Homeland Security, U.S. Immigration
[[Page 7760]]
and Customs Enforcement, 500 12th Street SW., Washington, DC 20536,
Phone: 202 732-6202, Email: alexander.hartman@dhs.gov.
Related RIN: Related to 1653-AA13.
RIN: 1653-AA60
DHS--USICE
Final Rule Stage
79. Continued Detention of Aliens Subject to Final Orders of Removal
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1223; 8 U.S.C. 1227; 8
U.S.C. 1231; 8 U.S.C. 1253; * * *
CFR Citation: 8 CFR 241.
Legal Deadline: None.
Abstract: The U.S. Department of Homeland Security is finalizing,
with amendments, the interim rule that was published on November 14,
2001, by the former Immigration and Naturalization Service (Service).
The interim rule included procedures for conducting custody
determinations in light of the U.S. Supreme Court's decision in
Zadvydas v. Davis, 533 U.S. 678 (2001), which held that the detention
period of certain aliens who are subject to a final administrative
order of removal is limited under section 241(a)(6) of the Immigration
and Nationality Act (Act) to the period reasonably necessary to effect
their removal. The interim rule amended section 241.4 of title 8, Code
of Federal Regulations (CFR), in addition to creating two new sections:
8 CFR 241.13 (establishing custody review procedures based on the
significant likelihood of the alien's removal in the reasonably
foreseeable future) and 241.14 (establishing custody review procedures
for special circumstances cases). Subsequently, in the case of Clark v.
Martinez, 543 U.S. 371 (2005), the Supreme Court clarified a question
left open in Zadvydas, and held that section 241(a)(6) of the Act
applies equally to all aliens described in that section. This rule
amends the interim rule to conform to the requirements of Martinez.
Further, the procedures for custody determinations for post-removal
period aliens who are subject to an administratively final order of
removal, and who have not been released from detention or repatriated,
have been revised in response to comments received and experience
gained from administration of the interim rule published in 2001. This
final rule also makes conforming changes as required by the enactment
of the Homeland Security Act of 2002 (HSA). Additionally, certain
portions of the final rule were determined to require public comment
and, for this reason, have been developed into a separate/companion
notice of proposed rulemaking; RIN 1653-AA60.
Statement of Need: This rule will improve the post order custody
review process in the final rule related to the Detention of Aliens
Subject to Final Orders of Removal in light of the U.S. Supreme Court's
decisions in Zadvydas v. Davis, 533 U.S. 678 (2001), Clark v. Martinez,
543 U.S. 371 (2005) and conforming changes as required by the enactment
of the Homeland Security Act of 2002 (HSA). A companion notice of
proposed rulemaking (NPRM) will propose to amend 8 CFR 241.1(g) to
provide for a new 90-day removal period once an alien comes into
compliance with his or her obligation to make timely application in
good faith for travel or other documents and not conspire or act to
prevent removal.
Anticipated Cost and Benefits: The changes are administrative and
procedural in nature, and will not result in cost impacts to the
public. The benefits of making these changes to the regulations will
allow for expedited review of the post-order custody review process.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 11/14/01 66 FR 56967
Interim Final Rule Comment Period 01/14/02 .......................
End.
Final Action........................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: INS No. 2156-01. Transferred from RIN 1115-
AG29.
Agency Contact: Alexander Hartman, Regulatory Coordinator,
Department of Homeland Security, U.S. Immigration and Customs
Enforcement, 500 12th Street SW., Washington, DC 20536, Phone: 202 732-
6202, Email: alexander.hartman@dhs.gov.
RIN: 1653-AA13
DHS--USICE
80. Extending Period for Optional Practical Training by 17 Months for
F-1 Nonimmigrant Students With STEM Degrees and Expanding the Cap-Gap
Relief for All F-1 Students With Pending H-1B Petitions
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 8 U.S.C. 1101 to 1103; 8 U.S.C. 1182; 8 U.S.C.
1184 to 1187; 8 U.S.C. 1221; 8 U.S.C. 1281 and 1282; 8 U.S.C. 1301 to
1305
CFR Citation: 8 CFR 214.
Legal Deadline: None.
Abstract: Currently, foreign students in F-1 nonimmigrant status
who have been enrolled on a full-time basis for at least one full
academic year in a college, university, conservatory, or seminary
certified by U.S. Immigration and Custom Enforcement's (ICE) Student
and Exchange Visitor Program (SEVP) are eligible for 12 months of
optional practical training (OPT) to work for a U.S. employer in a job
directly related to the student's major area of study. The maximum
period of OPT is 29 months for F-1 students who have completed a
science, technology, engineering, or mathematics (STEM) degree and
accept employment with employers enrolled in U.S. Citizenship and
Immigration Services' (USCIS') E-Verify employment verification
program. Employers of F-1 students with an extension of post-completion
OPT authorization must report to the student's designated school
official (DSO) within 48 hours after the OPT student has been
terminated from, or otherwise leaves, his or her employment with that
employer prior to end of the authorized period of OPT.
The final rule will respond to public comments and may make
adjustments to the regulations.
Statement of Need: ICE will improve SEVP processes by publishing
the Final Optional Practical Training (OPT) rule, which will respond to
comments on the OPT interim final rule (IFR). The IFR increased the
maximum period of OPT from 12 months to 29 months for nonimmigrant
students who have completed a science, technology, engineering, or
mathematics (STEM) degree and who accept employment with employers who
participate in the U.S. Citizenship and Immigration Services' (USCIS')
E-Verify employment verification program.
Alternatives: DHS is considering several alternatives to the 17-
month extension of OPT and cap-gap extension, ranging from taking no
action to further extension for a larger populace. The interim final
rule addressed an immediate competitive disadvantage faced by U.S.
industries and ameliorated some of the adverse impacts on the U.S.
economy. DHS continues to evaluate both quantitative and qualitative
alternatives.
Anticipated Cost and Benefits: Based on an estimated 12,000
students per year that will receive an OPT extension and an estimated
5,300 employers that will need to enroll in E-Verify, DHS
[[Page 7761]]
projects that this rule will cost students approximately $1.49 million
per year in additional information collection burdens, $4,080,000 in
fees, and cost employers $1,240,000 to enroll in E-Verify and $168,540
per year thereafter to verify the status of new hires. However, this
rule will increase the availability of qualified workers in science,
technology, engineering, and mathematical fields; reduce delays that
place U.S. employers at a disadvantage when recruiting foreign job
candidates, thereby improving strategic and resource planning
capabilities; increase the quality of life for participating students,
and increase the integrity of the student visa program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 04/08/08 73 FR 18944
Interim Final Rule Comment Period 06/09/08 .......................
End.
Final Rule.......................... 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
URL for More Information: www.dhs.gov/sevis/.
Agency Contact: Sharon Snyder, Acting Branch Chief, SEVP Policy,
Student and Exchange Visitor Program, Department of Homeland Security,
U.S. Immigration and Customs Enforcement, Potomac Center North, 500
12th Street SW., Washington, DC 20024-6121, Phone: 703 603-3415.
RIN: 1653-AA56
DHS--FEDERAL EMERGENCY MANAGEMENT AGENCY (FEMA)
Proposed Rule Stage
81. Update of FEMA's Public Assistance Regulations
Priority: Other Significant.
Legal Authority: 42 U.S.C. 5121 to 5207
CFR Citation: 44 CFR 206.
Legal Deadline: None.
Abstract: This proposed rule would revise the Federal Emergency
Management Agency's Public Assistance program regulations. Many of
these changes reflect amendments made to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act by the Post-Katrina
Emergency Management Reform Act of 2006 and the Security and
Accountability For Every Port Act of 2006. The proposed rule also
proposes to reflect lessons learned from recent events, and propose
further substantive and non-substantive clarifications and corrections
to improve upon the Public Assistance regulations. This proposed rule
is intended to improve the efficiency and consistency of the Public
Assistance program, as well as implement new statutory authority by
expanding Federal assistance, improving the Project Worksheet process,
empowering grantees, and improving State Administrative Plans.
Statement of Need: The proposed changes implement new statutory
authorities and incorporate necessary clarifications and corrections to
streamline and improve the Public Assistance program. Portions of
FEMA's Public Assistance regulations have become out of date and do not
implement all of FEMA's available statutory authorities. The current
regulations inhibit FEMA's ability to clearly articulate its regulatory
requirements, and the Public Assistance applicants' understanding of
the program. The proposed changes are intended to improve the
efficiency and consistency of the Public Assistance program.
Summary of Legal Basis: The legal authority for the changes in this
proposed rule is contained in the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121 to 5207, as amended by the
Post-Katrina Emergency Management Reform Act of 2006, Public Law 109-
295, the Security and Accountability For Every Port Act of 2006, 6
U.S.C. 901 note, the Local Community Recovery Act of 2006, Public Law
109-218, 120 Stat. 333, and the Pets Evacuation and Transportation
Standards Act of 2006, Public Law 109-308, 120 Stat. 1725.
Alternatives: One alternative is to revise some of the current
regulatory requirements (such as application deadlines) in addition to
implementing the amendments made to the Stafford Act by (1) the Post-
Katrina Emergency Management Reform Act of 2006 (PKEMRA), Public Law
109-295, 120 Stat. 1394; (2) the Security and Accountability For Every
Port Act of 2006 (SAFE Port Act), Public Law 109-347, 120 Stat. 1884;
(3) the Local Community Recovery Act of 2006, Public Law 109-218, 120
Stat. 333; and (4) the Pets Evacuation and Transportation Standards Act
of 2006 (PETS Act), Public Law 109-308, 120 Stat. 1725. Another
alternative is to expand funding by expanding force account labor cost
eligibility to Category A Projects (debris removal).
Anticipated Cost and Benefits: The proposed rule is expected to
have economic impacts on the public, grantees, subgrantees, and FEMA.
The expected benefits are a reduction in property damages, societal
losses, and losses to local businesses, as well as improved efficiency
and consistency of the Public Assistance program. FEMA estimates the
primary economic impact of the proposed rule is the additional transfer
of funding from FEMA through the Public Assistance program to grantees
and subgrantees that is effectuated by this rulemaking.
Risks: This action does not adversely affect public health, safety,
or the environment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal, Local, State, Tribal.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Tod Wells, Recovery Directorate, Department of
Homeland Security, Federal Emergency Management Agency, 500 C Street
SW., Washington, DC 20472-3100, Phone: 202 646-3936, Fax: 202 646-3363,
Email: tod.wells@dhs.gov.
RIN: 1660-AA51
BILLING CODE 9110-9B-P
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
Statement of Regulatory Priorities
The regulatory plan for the Department of Housing and Urban
Development (HUD) for fiscal year (FY) 2012 highlights the most
significant regulations and policy initiatives that HUD seeks to
complete during the upcoming fiscal year. As the Federal agency that
serves as the Nation's housing agency, HUD's mission is to create
strong, sustainable, inclusive communities and quality affordable homes
for all. HUD strives to meet the challenges of this mission by focusing
on people and places through policies and initiatives that address the
unique conditions and needs of communities. For example, HUD recognizes
that the ``American Dream'' no longer refers to a singular vision of
success, such as owning a home, and, therefore, through programs such
as HUD's Housing Counseling program, HUD assists individuals and
families to make decisions about owning or renting that are financially
appropriate to the
[[Page 7762]]
individual or family.\1\ HUD also has been placing greater focus on
improving locational outcomes for households receiving rental
assistance. HUD's Choice Neighborhood initiative provides funding for
plans that link housing to schools, jobs, and affordable transportation
in order to transform neighborhoods of concentrated poverty into
sustainable mixed-income communities with well-functioning services,
public assets, and access to opportunity. HUD's Neighborhood
Stabilization Program helps communities acquire, rehabilitate, and
resell foreclosed and abandoned properties in order to more quickly
prevent decline in neighborhoods hard-hit by the foreclosure process.
---------------------------------------------------------------------------
\1\ This statement is based on language found on page 4,
paragraph 2, of the Introduction to HUD's FY 2010 to 2015 Strategic
Plan. (See https://portal.hud.gov/hudportal/documents/huddoc?id=DOC_4436.pdf.)
---------------------------------------------------------------------------
In addition to meeting the challenges of HUD's mission through
revitalized policies and initiatives, President Obama challenged all
agencies to identify opportunities to significantly improve near-term
performance. These opportunities were incorporated as key outcome
measures into HUD's strategic plan, representing challenging, near-
term, high-impact outcomes that reflect HUD's commitment to addressing
some of the most fundamental housing and community challenges facing
America. Building on the directions to improve performance, but on a
longer-term basis, President Obama issued Executive Order 13563
entitled ``Improving Regulation and Regulatory Review.'' Executive
Order 13563 supplements and reaffirms the rulemaking principles of
Executive Order 12866 ``Regulatory Planning and Review,'' which include
identifying regulatory approaches that reduce burden, considering the
costs and benefits of rules, and encouraging public participation, but
also directs agencies to undertake a retrospective analysis of rules
that may be outmoded, ineffective, insufficient, or excessively
burdensome, and to modify, streamline, expand, or repeal such
regulations as appropriate. The Executive order recognizes the
significant role that regulations play in protecting public health,
welfare, safety, and the environment, and in promoting economic growth,
innovation, competitiveness, and job creation, but also that
regulations cannot remain stagnant. Agencies must frequently review
regulations to ensure that they are meeting the challenges of today and
not addressing conditions, whether housing, health, business, labor, or
environmental, that are no longer reflected in today's economy. In this
regard, Executive Order 13563 directed agencies to undertake periodic
retrospective review of their regulations, and to develop, prepare, and
post their plans for retrospective review of rules. HUD's plan and that
of all agencies can be found at https://www.whitehouse.gov/21stcenturygov/actions/21st-century-regulatory-system. HUD's semiannual
agenda of regulations includes the rules highlighted in HUD's
retrospective review of rules plans.
The rules highlighted in HUD's regulatory plan for FY 2011 reflect
both HUD's continuing efforts to fulfill its mission and improve
performance, including by addressing regulations that necessitate
update and modification. HUD's FY 2011 regulatory plan reflects HUD's
retrospective review of the regulations governing one of HUD's major
mortgage insurance programs. Another rule highlighted in this
regulatory plan revises the regulations of another significant program
to address the unique conditions and needs of participants in one of
HUD's major assistance programs. The third rule related to a
significant HUD program is designed to implement flexibility provided
by a recently enacted statute.
Priority: Create Financially Sustainable Homeownership Opportunities
HUD's HECM program was established by statute to assist in
alleviating economic hardship caused by the increasing costs of health,
housing, and other needs at a time in life when one's income is
reduced. The HECM program, administered through HUD's Federal Housing
Administration (FHA), enables older homeowners to withdraw some of the
equity in their home in the form of monthly payments for life or a
fixed term, or in a lump sum, or through a line of credit. In addition,
the HECM mortgage can be used to purchase a primary home when the
borrower is 62 years of age or older and is able to use cash in hand,
money from the sale of assets, or money from an allowable FHA funding
source to pay the difference between the reverse mortgage and the sales
price plus closing costs for the property.
To be eligible for a HECM mortgage, current homeowners must be 62
years of age or older, own their home outright, or have a low mortgage
balance that can be paid off at closing with proceeds from the reverse
mortgage. Homeowners can only have one HECM at any one time and the
home must be their principal residence. In addition, the HECM can be
used to purchase a primary home if the borrower is able to pay the
difference between the HECM and the sales price and closing costs for
the property. The borrower remains the owner of the home and may sell
it and move at any time, keeping the sales proceeds that exceed the
mortgage balance. A borrower cannot be forced to sell the home to pay
off the mortgage, even if the mortgage balance grows to exceed the
value of the property, unless they fail to perform an obligation of the
mortgage.
As the Nation's population has increased in age, the attraction of
the HECM has increased as well. In 1990, there were approximately 157
HECMs. By 2008, there were more than 112,000 HECMs. The situation that
HUD has confronted recently with increasing frequency is that HECM
homeowners are not paying property taxes, insurance, and other property
charges. Payment of these items is the responsibility of the homeowner,
and failure to pay places the homeowner in default of its obligations
under the mortgage and makes the homeowner vulnerable to loss of his or
her home. FHA-approved lenders are responsible for keeping all tax and
insurance payments current, in compliance with the HECM regulations. If
homeowners stop making payments, lenders are allowed to access any
remaining home equity to pay taxes and insurance premiums. Once
homeowner funds are exhausted, lenders are legally required to advance
their own funds for such payments and seek reimbursement from
homeowners.
With the same recognition that homeownership may not be the best
choice for every individual or family, a HECM may not be the best
choice for every senior homeowner. The security that the HECM program
was designed to bring to seniors may be lost if the senior homeowner
cannot maintain payment of taxes and insurance payments.
Regulatory Action: Strengthening the Home Equity Conversion Mortgage
(HECM) Program To Promote Sustained Homeownership
To address this growing issue in the HECM program, HUD proposes to
require FHA-approved mortgagees that originate HECM mortgages to
perform a financial capacity and credit history assessment of
prospective HECM mortgagors prior to loan approval and closing.
Mortgagees will be required to evaluate whether the HECM mortgagor's
cash flow and credit history support the mortgagor's ability to comply
with the obligations of the HECM and are sufficient to meet recurring
living expenses. The proposed rule would also
[[Page 7763]]
cap the amount of insurance benefits paid in connection with a claim
involving amounts advanced by the mortgagee on behalf of a HECM
mortgagor who fails to pay such property charges when the HECM proceeds
have been exhausted, and establish a new property inspection
requirement to insure that homes secured with a HECM mortgage are
adequately maintained and meet applicable property standards.
These changes to the HECM program are necessary to ensure that
senior homeowners do not enter a program seeking security in their
later life only to find themselves without a home. Additionally,
without such changes, the HECM program will place the FHA Insurance
Fund at significant risk, with the possible result being the
unavailability of HECMs in the future.
Priority: Improve the Quality of Affordable Rental Housing
In an era when more than one-third of all American families rent
their homes, the current housing market does not create and sustain a
sufficient supply of affordable rental homes, especially for low-income
households. In many communities, affordable rental housing does not
exist without public support. Despite significant improvements in
housing quality in recent decades, much of America's rental housing
stock is not energy efficient or even accessible to people with
disabilities, and pockets of severely substandard housing remain across
the country. Even before the recent recession, the number of households
with severe housing cost burdens had increased substantially since
2000, and homelessness among families with children is a growing
problem throughout our Nation. When it comes to strong, safe, and
healthy communities, lower-cost rental housing is particularly scarce.
As the lead Federal housing agency, HUD will work with its Federal,
State, local, and private partners to meet affordable and quality
rental housing needs for all.\2\ In this regard, HUD will strengthen
the indicators by which HUD measures the performance of public housing
agencies in administering its Section 8 rental assistance program,
referred to as the Housing Choice Voucher program.
---------------------------------------------------------------------------
\2\ This statement is taken from the first column of page 19 of
section 2 of HUD's FY 2010 to 2015 Strategic Plan. (See https://portal.hud.gov/hudportal/documents/huddoc?id=DOC_4436.pdf.)
---------------------------------------------------------------------------
HUD's Housing Choice Voucher program is the Federal Government's
major program for assisting very low-income families, the elderly, and
the disabled to afford decent, safe, and sanitary housing in the
private market. Since housing assistance is provided on behalf of the
family or individual, participants are able to find their own housing,
including single-family homes, townhouses, and apartments. The
participant is free to choose any housing that meets the requirements
of the program and is not limited to units located in subsidized
housing projects. Housing choice vouchers are administered locally by
public housing agencies (PHAs). The PHAs receive Federal funds from HUD
to administer the voucher program. A family that is issued a housing
voucher is responsible for finding a suitable housing unit of the
family's choice where the owner agrees to rent under the program.
Rental units must meet minimum standards of health and safety, as
determined by the PHA.\3\
---------------------------------------------------------------------------
\3\ The information in this paragraph is taken from HUD's Web
page on Housing Choice Vouchers found at https://portal.hud.gov/hudportal/HUD?src=/program_offices/public_indian_housing/programs/hcv/about/fact_sheet.)
---------------------------------------------------------------------------
Through HUD's Section Eight Management Assessment Program (SEMAP),
HUD measures the performance of PHAs in their administration of the
Housing Choice Voucher program in key areas. The areas of review
indicate whether PHAs are helping eligible families to afford decent
rental units at a reasonable subsidy cost. SEMAP requires PHAs to
undertake an annual Housing Quality Standard (HQS) inspection of units.
Regulatory Action: Tenant-Based Rental Assistance; Improving
Performance Through a Strengthened SEMAP
HUD recognizes that SEMAP is more process-oriented than results-
oriented. To make SEMAP a more effective assessment tool, HUD is
proposing to revise the management indicators used by HUD to measure
the performance of PHAs. For example, the proposed rule would revise
the indicator that measures Section 8 voucher use to encourage PHAs to
maximize the number of Section 8 families served. Under this revised
indicator, HUD will not only consider the number of vouchers available
to a PHA, but also the funds available to the PHA, including budget
authority and a portion of reserves. HUD also proposes to assume
responsibility for conducting the inspections used to measure a PHA's
compliance with housing quality standards (HQS). Currently, HUD
measures HQS compliance through a reporting requirement for PHA self-
conducted inspections. The proposed rule would also establish a new
deconcentration indicator that will evaluate the ability of Section 8
families with children to access neighborhoods with below-average
poverty rates or neighborhoods with above-average schools.
Priority: Utilize Housing as a Platform for Improving the Quality of
Life
Stable housing, made possible with HUD support, provides an ideal
platform for delivering a wide variety of health and social services to
improve health, education, and economic outcomes. HUD housing serves at
least two broad populations: People who are in a position to markedly
increase their self-sufficiency and people who will need long-term
support (for example, the frail elderly and people with severe
disabilities). For those individuals who are able, increasing self-
sufficiency requires access to life-skills training, wealth-creation
and asset-building opportunities, job training, and career services.
For those who need long-term support, HUD housing will provide access
to income support and other benefits that can enhance an individual's
quality of life.
HUD's Supportive Housing for Persons with Disabilities Program
(Section 811) is a critical HUD program that allows persons with
disabilities to live as independently as possible in the community by
increasing the supply of rental housing with the availability of
supportive services. HUD increases the supply of rental housing for
persons with disabilities by providing interest-free capital advances
to nonprofit sponsors to help them finance the development of rental
housing such as independent living projects, condominium units, and
small group homes with the availability of supportive services for
persons with disabilities. The capital advance can finance the
construction, rehabilitation, or acquisition with or without
rehabilitation of supportive housing. The advance does not have to be
repaid as long as the housing remains available for very low-income
persons with disabilities for at least 40 years. Over the last several
years, the Section 811 program has not been as effective as desired
because the underlying statutory foundation for the program required
substantial reform and improvements to meet the challenges of current
market conditions and reflect modern practices with respect to
production of housing.
The Frank Melville Supportive Housing Investment Act of 2010 (Pub.
L. 111-374) (Melville Act), which was enacted on January 4, 2011,
amended section 811 of the Cranston-Gonzalez National Affordable
Housing Act (42 U.S.C. 8013), which authorizes the supportive housing
program for persons
[[Page 7764]]
with disabilities (Section 811 program). The Melville Act made
significant changes to the Section 811 program, with one of the most
significant changes being the establishment of new project rental
assistance authority. This new authority allows HUD to make Section 811
program operating assistance available to State housing agencies and
similar organizations for the purposes of granting funds to the
development of supportive housing for persons with disabilities, and
overseeing compliance with the requirements applicable to such housing.
Regulatory Action: Supportive Housing for Persons With Disabilities:
Implementing New Project Rental Assistance Authority
While the Melville Act makes many important changes to the Section
811 program, HUD's first priority is to implement the requirements for
the new project rental assistance authority. Project rental assistance
has long been part of eligible assistance for the Section 811 program,
and the existing Section 811 program regulations provide that project
rental assistance is available for operating costs. The new project
rental assistance provided by the Melville Act offers another method of
financing for supportive housing for persons with disabilities for
projects that do not receive capital advances. The new project rental
assistance is designed to promote and facilitate the creation of
integrated supportive housing units, which is achieved by making funds
available to State housing agencies and other appropriate entities. As
provided by the Melville Act, projects eligible for the new project
rental assistance can be either new or existing multifamily housing
projects.
HUD's proposed rule establishes the requirements and procedures
that would govern the eligibility and use of the new project rental
assistance authority in HUD's Section 811 program.
Retrospective Review of Agency Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (Jan. 18, 2011), the following
Regulatory Identifier Numbers (RINs) have been identified as associated
with retrospective review and analysis in the Department's final
retrospective review of regulations plan. Some of these entries on this
list may be completed actions, which do not appear in The Regulatory
Plan. However, more information can be found about these completed
rulemakings in past publications of the Unified Agenda on Reginfo.gov
in the Completed Actions section for that agency. These rulemakings can
also be found on Regulations.gov. HUD's retrospective review plan can
be found at: https://portal.hud.gov/hudportal/HUD?src=/program_offices/general_counsel/Review_of_Regulations.
------------------------------------------------------------------------
Regulation Identifier Anticipated Reductions
No. (RIN) Title in Regulatory Burden
------------------------------------------------------------------------
2502-AI92.............. Federal Housing Removes a
Administration (FHA): regulatory
Refinancing an restriction on FHA
Existing Cooperative refinancing of
Under Section 207 existing mortgage
Pursuant to Section debt by owners of
223(f) of the National multifamily
Housing Act; Final cooperative projects,
Rule. thus expanding the
number of individuals
eligible to
participate in FHA
programs.
2502-AJ03.............. Streamlining Inspection Removes the
and Warranty regulations for the
Requirements for FHA Inspector Roster,
Federal Housing making it easier for
Administration (FHA) lenders and borrowers
Single Family Mortgage to have inspections
Insurance: Removal of performed and
the FHA Inspector streamlining the
Roster and of the 10- mortgage insurance
Year Protection Plan application process.
Requirements for High Removes the
Loan-to-Value Ratio outdated 10-year
Mortgages; Proposed protection plan
Rule. requirement for high
Loan-to-Value newly
constructed single
family homes securing
FHA-insured
mortgages. This
eliminates an
unnecessary layer of
regulatory burden.
2502-AI91.............. Approval of Farm Credit Enables
System Lending direct lending
Institutions in FHA institutions of the
Mortgage Insurance Farm Credit System to
Programs; Proposed seek approval as FHA
Rule. mortgagees and
lenders, removing a
regulatory barrier to
participation in FHA
programs.
2502-AJ06.............. Expansion of Expands
Eligibility of roster eligibility to
Nonprofit include nonprofit
Organizations To organizations created
Participate in FHA by State and local
Single Family Mortgage governments that
Insurance Programs; qualify for tax
Proposed Rule. exemption under
section 115 of the
Internal Revenue
Code.
Removes
requirement that a
nonprofit
organization have a
voluntary board in
order to be eligible
for roster placement.
2502-AJ02.............. Federal Housing Brings
Administration (FHA) certainty to and
Single Family Mortgage streamlines the
Insurance: Removal of announced maximum
Requests for mortgage amounts for
Alternative Mortgage each calendar year by
Amounts; Proposed Rule. removing a regulation
that is no longer
relevant.
2502-AI99.............. Federal Housing Removes
Administration (FHA): permanent time
Suspension of FHA's restrictions on
Regulation Placing resale of FHA-insured
Time Restrictions on properties, thus
Resale of FHA-Insured lifting burdensome
Property; Proposed regulatory
Rule. impediments to
receiving FHA
mortgage insurance.
2502-AJ01.............. Federal Housing Removes
Administration (FHA): regulations for an
Suspension of Single underutilized
Family Mortgage program, streamlining
Insurance for Military the application
Impacted Areas; process for FHA-
Proposed Rule. insured.
2502-AJ00.............. Federal Housing Removes
Administration (FHA): overly burdensome
Approval of Lending reporting
Institutions and requirements for
Mortgagees--Alternativ small lenders wishing
e Reporting to participate in FHA
Requirements for Small programs.
Supervised Lenders. Eliminates
duplicative reporting
requirements for
lenders who already
report to other
Federal agencies,
thus reducing
paperwork and
minimizing the burden
of the process of
becoming an FHA-
approved.
2502-AI98.............. Section 8 New By reducing
Construction and regulatory barriers,
Substantial this change removes a
Rehabilitation disincentive for
Programs: Changes to nonprofit owners to
Limitation on promote affordable
Distributions of housing.
Project Funds and
Adjustment of Initial
Equity; Proposed Rule.
[[Page 7765]]
2502-AI67.............. Streamlining Removes
Requirements Governing restrictions on the
the Use of Funding for portions of
Supportive Housing for developments not
the Elderly and funded through
Persons With capital advances.
Disabilities Programs; Removes
Proposed Rule. regulatory barriers
on participations by
creating new
exemptions to the
conflict of interest
provisions.
Provides
flexibility regarding
amenities that may be
provided in projects.
Streamlines
requirements for
release of capital
advance funds upon
completion.
2577-AC68.............. Public Housing Consolidates
Assessment System assessment
(PHAS); Final Rule. regulations in 24 CFR
part 902.
Removes
outdated Public
Housing Management
Assessment Program
(PHMAP) regulations
at 24 CFR part 901.
2577-AC50.............. Public Housing Capital Streamlines
Fund Program; Final public housing
Rule. modernization
requirements.
Consolidates
the modernization
requirements for the
public housing
programs in HUD's
Capital Fund Program
regulations at 24 CFR
part 905.
Removes
outdated parts 941,
968, 969, which
currently codify the
legacy modernization
program requirements.
2577-AC88.............. Streamlined Application Reduces
Process in Public/ document submission
Private Partnerships burdens on Public
for Mixed-Finance Housing Agencies
Development of Public (PHAs).
Housing Units;
Proposed Rule.
2577-AC89.............. Revisions to the Enables PHAs
Consortia of Public to establish cross-
Housing Agencies; jurisdictional
Proposed Rule. consortia that would
be treated as a
single PHA, with a
single jurisdiction
and a single set of
reporting and audit
requirements, for
purposes of
administering the
Housing Choice
Voucher program in a
more streamlined and
less burdensome
fashion.
2577-AC87.............. Removal of the Indian Removes
HOME Investment outdated regulations
Partnerships Program for the legacy Indian
Regulations; Final HOME program.
Rule.
2577-AC86.............. Public Housing and Removes the
Section 8 Programs: administrative
Housing Choice burdens involved with
Voucher--Improving processing
Portability for portability requests.
Voucher Families
Proposed Rule.
2577-AC76.............. Revision to the Section Removes
8 Management complexity and
Assessment Program administrative burden
(SEMAP) Lease-Up caused by use of both
Indicator; Proposed the fiscal year and
Rule. calendar year
systems.
Provides a
critical
synchronization of
administration of the
voucher program,
which will reduce
program
inefficiencies.
2506-AC26, 2506-AC29, Implementation of the Provides for
2506-AC31, 2506-AC32, Homeless Emergency consolidated grant
2506-AC33. Assistance and Rapid application and
Transition to Housing administration to
Act of 2009 (HEARTH ease administrative
Act). burden and improve
coordination among
providers and,
consequently,
increase the
effectiveness of
responses to the
needs of homeless
persons.
Provides for
increased
coordination and
planning between
programs to better
meet the needs of
homeless persons.
Modernizes
the Continuum of Care
program and Emergency
Shelter Grants
program.
2501-AC94.............. HOME Investment This proposed
Partnerships--Improvin rule would update
g Performance and HUD's program
Accountability; regulations to
Updating Property reflect current legal
Standards and requirements with
Instituting Energy respect to HOME
Efficiency Standards. projects.
------------------------------------------------------------------------
Aggregate Costs and Benefits
Executive Order 12866, as amended, requires the agency to provide
its best estimate of the combined aggregate costs and benefits of all
regulations included in the agency's regulatory plan that will be made
effective in calendar year 2011. HUD expects that neither the total
economic costs nor the total efficiency gains will exceed $100 million.
None of the rules on HUD's regulatory plan is anticipated to have an
economically significant impact. The revisions proposed to be made to
HUD's HECM program are anticipated to strengthen the program, keep
seniors in their homes, and protect the FHA Insurance Fund, but the
proposed changes are prospective and are not expected to result in an
economic impact of $100 million or more annually. The changes proposed
to be made to the SEMAP program are similarly designed to strengthen
the program and are intended to have the Housing Choice Voucher program
be administered more effectively and efficiently but will also not
result in an economic impact of $100 million or more. Implementation of
the new project rental assistance authority in the Section 811 program,
as authorized by the Melville Act, will open up another source of
financing for supportive housing for persons with disabilities but not
at a level of $100 million or more.
The Priority Regulations That Comprise HUD's Regulatory Plan
A more detailed description of the priority regulations that
comprise HUD's regulatory plan follows.
HUD--OFFICE OF HOUSING (OH)
Proposed Rule Stage
82. Federal Housing Administration (FHA): Strengthening the Home Equity
Conversion Mortgages (HECM) Program To Promote Sustained Homeownership
(FR-5353)
Priority: Other Significant.
Legal Authority: 12 U.S.C. 1715b, 1715z to 1720; 42 U.S.C. 3535(d)
[[Page 7766]]
CFR Citation: 24 CFR 206.19; 24 CFR 206.32; 24 CFR 206.25; 24 CFR
206.27; 24 CFR 206.29; 24 CFR 206.38.24; 24 CFR 206.51; 24 CFR 206.53;
24 CFR 206.105; 24 CFR 206.107; 24 CFR 206.124; 24 CFR 206.129; 24 CFR
206.140, 206.142; 24 CFR 206.203, 19; 24 CFR 206.58; 24 CFR 206.47.
Legal Deadline: None.
Abstract: HUD is taking another step to reform and strengthen the
mortgage insurance functions and responsibilities of the Federal
Housing Administration (FHA), and concomitantly protect the individuals
and families that use FHA-mortgage products. This proposed rule would
revise the regulations governing FHA's Home Equity Conversion Mortgage
(HECM) program, which is FHA's reverse mortgage program that enables
senior homeowners who have equity in their homes to withdraw a portion
of the accumulated equity. Most significantly, this rule proposes to
require FHA-approved mortgagees that originate HECM mortgages (HECM
mortgagees) to perform a financial capacity and credit history
assessment of prospective HECM mortgagors prior to loan approval and
closing. Mortgagees will be required to evaluate whether the HECM
mortgagor's cash flow and credit history support the mortgagor's
ability to comply with the obligations of the HECM and are sufficient
to meet recurring living expenses. A mortgagee may deny the HECM loan
application if the prospective mortgagor fails either the financial
capacity or credit history assessment. As an alternative to declining
the HECM loan application, the mortgagee may require the establishment
of a principal limit set-aside for payment of property charges. The
proposed rule would also cap the amount of insurance benefits paid in
connection with a claim involving amounts advanced by the mortgagee on
behalf of a HECM mortgagor who fails to pay such property charges when
the HECM proceeds have been exhausted and establish a new property
inspection requirement to insure that home secured with a HECM mortgage
are adequately maintained and meet applicable property standards. The
proposed rule would also make several non-substantive changes to
reflect the statutory flexibility provided to HUD in establishing the
mortgage insurance premiums for FHA-insured mortgages, conform the
regulations to existing HUD interpretations and industry practices
regarding HECM program requirements, and reduce administrative
paperwork.
Statement of Need: HUD does not currently require HECM mortgagees
to verify the mortgagor's income, assets, and debt obligations. Neither
do the HECM regulations require a mortgagee to assess the mortgagor's
credit history and capacity to pay future living expenses and meet all
other future financial obligations related to the property under the
HECM loan. Such a financial capacity and credit history assessment is a
prudent underwriting practice currently required by mortgagees for FHA
forward mortgage products. Based on data available to HUD, HECM
delinquencies are growing and occurring soon after origination. This
data also indicates that these delinquencies are largely the result of
the failure of mortgagors to pay recurring property charges. The
proposed rule would address these concerns by requiring that mortgagees
determine whether the potential mortgagor has the capacity to pay
recurring property charges and meet recurring living expenses.
Summary of Legal Basis: The HECM program is authorized under
section 255 of the National Housing Act (12 U.S.C. 1715z to 1720). This
rulemaking is undertaken pursuant to the general rulemaking authority
granted to the Secretary under section 7(d) of the Department of HUD
Act (42 U.S.C. 35335(d)), which authorizes the Secretary to make ``such
rules and regulations as may be necessary to carry out his functions,
powers, and duties.'' In addition, the National Housing Act at 12
U.S.C. 1701c(a) uses the exact wording in conferring general rulemaking
authority to the Secretary for implementing the insured mortgage
programs authorized under the National Housing Act.
Alternatives: Rulemaking is required to ensure that the financial
capacity and credit history requirements are generally applicable and
enforceable by HUD. Where appropriate, HUD will provide mortgagees with
flexibility in determining the method for conducting the required
assessments and for considering additional factors in determining and
verifying the financial capacity and credit history of prospective HECM
mortgagors.
Anticipated Cost and Benefits: The benefits of this rule would be
the reduced transaction costs and externalities associated with
foreclosure. The costs of the rule would be the additional
administrative and financial costs associated with carrying out the
required assessments.
Risks: This rule poses no risk to public health, safety, or the
environment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Kari B. Hill, Director, Office of Single Family
Program Development, Department of Housing and Urban Development,
Office of Housing, 451 7th Street SW., Washington, DC 20410, Phone: 202
708-2121.
RIN: 2502-AI79
HUD--OH
83. Supportive Housing for Persons With Disabilities
Implementing New Project Rental Assistance Authority (FR-5576)
Priority: Other Significant.
Legal Authority: 12 U.S.C. 1701q; 42 U.S.C. 1437f, 3535(d), and
8013
CFR Citation: 24 CFR 891.
Legal Deadline: None.
Abstract: This proposed rule commences the rulemaking process to
implement the project rental assistance authority as provided under the
Frank Melville Supportive Housing Investment Act of 2010 (Pub. L. 111-
374) (Melville Act), which was enacted on January 4, 2011. The Melville
Act amended section 811 of the Cranston-Gonzalez National Affordable
Housing Act (42 U.S.C. 8013), which authorizes the supportive housing
program for persons with disabilities (Section 811 program). The
Melville Act made significant changes to the Section 811 program, with
one of the most significant changes being the establishment of new
project rental assistance authority. This new authority allows HUD to
make Section 811 program operating assistance available to State
housing agencies and similar organizations for the purposes of granting
funds to the development of supportive housing for persons with
disabilities and overseeing compliance with the requirements applicable
to such housing. This proposed rule establishes the requirements and
procedures that would govern the eligibility and use of project rental
assistance in HUD's supportive housing program for persons with
disabilities.
Statement of Need: The Melville Act makes many important reforms
and improvements to the Section 811 program. One of the most
significant new features introduced by the Melville Act is the
establishment of new project
[[Page 7767]]
rental assistance authority (section 811(b)(3) of the Cranston-Gonzalez
National Affordable Housing Act, as amended by the Melville Act) that
is separate from the existing project rental assistance under the
Section 811 program that is available to cover operating costs.
Although the Melville Act establishes the prerequisite statutory
framework, the full and successful implementation of the new project
rental assistance authority requires rulemaking. This proposed rule
addresses the need for rulemaking by establishing the necessary
policies, procedures, and other requirements that will govern the
eligibility and use of project rental assistance. HUD intends to
implement other changes made by the Melville Act through separate
rulemaking.
Summary of Legal Basis: As noted, the Melville Act amended section
811 of the Cranston-Gonzalez National Affordable Housing Act to
establish new project rental assistance authority. This rulemaking is
undertaken pursuant to the general rulemaking authority granted to the
Secretary under section 7(d) of the Department of HUD Act (42 U.S.C.
35335(d)), which authorizes the Secretary to make ``such rules and
regulations as may be necessary to carry out his functions, powers, and
duties.''
Alternatives: Rulemaking is required to ensure that the new
requirements and procedures governing the eligibility and use of
project rental assistance are generally applicable to participants in
HUD's supportive housing program for persons with disabilities and
enforceable by HUD.
Anticipated Cost and Benefits: The new project rental assistance
authority offers another method of financing for supportive housing for
persons with disabilities for projects that do not receive capital
advances. The new authority is designed to promote and facilitate the
creation of integrated supportive housing units, which is achieved by
making funds available to State housing agencies and other appropriate
entities. While there may be incremental costs associated with
compliance with the new requirements, to the extent that program
participants incur such costs, it will be as a result of their
voluntary participation in the project rental assistance component of
the Section 811 program. The benefits are increased affordability of
providing housing for persons with disabilities.
Risks: This rule poses no risk to public health, safety, or the
environment
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Benjamin T. Metcalf, Senior Advisor, Office of
Multifamily Houisng Programs, Department of Housing and Urban
Development, Office of Housing, 451 7th Street SW., Washington, DC
20410, Phone: 202 708-2495.
RIN: 2502-AJ10
HUD--OFFICE OF PUBLIC AND INDIAN HOUSING (PIH)
Proposed Rule Stage
84. Tenant-Based Rental Assistance; Improving Performance Through a
Strengthened Section 8 Management Assessment Program (FR-5201)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 1437a, 1437c, 1437f; 42 U.S.C. 3535(d)
CFR Citation: 24 CFR 985.
Legal Deadline: None.
Abstract: SEMAP establishes the management indicators used by HUD
to measure the performance of public housing agencies (PHA) in key
areas of the Section 8 rental assistance programs and to assign
performance ratings. The proposed rule would revise the indicator that
measures Section 8 voucher use to encourage PHAs to maximize the number
of Section 8 families served. Specifically, under this revised
indicator, HUD will not only consider the number of vouchers available
to a PHA, but also the funds available to the PHA, including budget
authority and a portion of reserves. HUD also proposes to assume
responsibility for conducting the inspections used to measure a PHA's
compliance with housing quality standards (HQS). Currently, HUD
measures HQS compliance through a reporting requirement for PHA self-
conducted inspections. The proposed rule would also establish a new
deconcentration indicator that will evaluate the ability of Section 8
families with children to access neighborhoods with below-average
poverty rates or neighborhoods with above-average schools.
Statement of Need: While the SEMAP is currently an effective
oversight tool, HUD's experience indicates that modifications are
needed to increase its utility and to better reflect policy priorities.
The proposed regulatory amendments address these needs. For example,
the change to the voucher utilization indicator will allow HUD to
better assess whether PHAs are maximizing their use of available
voucher authority and funds to assist families. By assuming
responsibility for HQS inspections, HUD will be in a better position to
assess their quality and accuracy. The new deconcentration indicator
addresses one of HUD's highest priorities; namely, improving the
housing and educational opportunities afforded to families receiving
HUD assistance.
Summary of Legal Basis: The Section 8 rental assistance programs
are authorized under section 8 of the United States Housing Act of 1937
(42 U.S.C. 1437f). This rulemaking is undertaken pursuant to the
general rulemaking authority granted to the Secretary under section
7(d) of the Department of HUD Act (42 U.S.C. 35335(d)), which
authorizes the Secretary to make ``such rules and regulations as may be
necessary to carry out his functions, powers, and duties.''
Alternatives: Rulemaking is required to ensure that revised SEMAP
indicators are generally applicable to all PHAs administering Section 8
programs, and are enforceable by HUD. Moreover, the current SEMAP
requirements are codified in regulation and, therefore, notice and
comment rulemaking is required for their revision.
Anticipated Cost and Benefits: There may be some incremental
administrative costs borne by PHAs as a result of revised indicators.
The benefits are the cost savings of no longer having to conduct HQS
inspections, resulting in a net economic benefit. HUD will assume the
costs of conducting these inspections, but these costs will be balanced
by the management and operational benefits resulting from the proposed
SEMAP enhancements. Moreover, HUD is considering whether HQS
inspections should be conducted less frequently than on an annual
basis, in order to allow for the best use of departmental resources.
Risks: This rule poses no risk to public health, safety, or the
environment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Additional Information: Includes retrospective review under
Executive Order 13563.
[[Page 7768]]
Agency Contact: Laure Rawson, Director, Housing Voucher Management
and Operations Division, Department of Housing and Urban Development,
Office of Public and Indian Housing, 451 7th Street SW., Washington, DC
20410, Phone: 202 402-2425.
RIN: 2577-AC76
BILLING CODE 4210-67-P
DEPARTMENT OF THE INTERIOR (DOI)
Statement of Regulatory Priorities
The Department of the Interior (DOI) is the principal Federal
steward of our Nation's public lands and resources, including many of
our cultural treasures. DOI serves as trustee to Native Americans and
Alaska natives and is responsible for relations with the island
territories under United States jurisdiction. The Department manages
more than 500 million acres of Federal lands, including 397 park units,
555 wildlife refuges, and approximately 1.7 billion of submerged
offshore acres. This includes some of the highest quality renewable
energy resources available to help the United States achieve the
President's goal of energy independence, including geothermal, solar,
and wind.
The Department protects and recovers endangered species; protects
natural, historic, and cultural resources; manages water projects that
are a lifeline and economic engine for many communities in the West;
manages forests and fights wildfires; manages Federal energy resources;
regulates surface coal mining operations; reclaims abandoned coal
mines; educates children in Indian schools; and provides recreational
opportunities for over 400 million visitors annually in the Nation's
national parks, public lands, national wildlife refuges, and recreation
areas.
The DOI will continue to review and update its regulations and
policies to ensure that they are effective and efficient, and that they
promote accountability and sustainability. The DOI will emphasize
regulations and policies that:
Promote environmentally responsible, safe, and balanced
development of renewable and conventional energy on our public lands
and the Outer Continental Shelf (OCS);
Use the best available science to ensure that public
resources are protected, conserved, and used wisely;
Adopt performance approaches focused on achieving cost-
effective, timely results;
Improve the nation-to-nation relationship with American
Indian tribes;
Promote partnerships with States, tribes, local
governments, other groups, and individuals to achieve common goals;
Promote transparency, fairness, accountability, and the
highest ethical standards while maintaining performance goals.
Major Regulatory Areas
The DOI bureaus implement congressionally mandated programs through
their regulations. Some of these regulatory programs include:
Developing onshore and offshore energy, including
renewable, minerals, oil and gas, and other energy resources;
Regulating surface coal mining and reclamation operations
on public and private lands;
Managing migratory birds and preserving marine mammals and
endangered species;
Managing dedicated lands, such as national parks, wildlife
refuges, National Landscape Conservation System lands, and American
Indian trust lands;
Managing public lands open to multiple use;
Managing revenues from American Indian and Federal
minerals;
Fulfilling trust and other responsibilities pertaining to
American Indians;
Managing natural resource damage assessments; and
Managing assistance programs.
Regulatory Policy
How DOI Regulatory Priorities Support the President's Energy, Resource
Management, Environmental Sustainability, and Economic Recovery Goals
The DOI's regulatory programs seek to operate programs
transparently, efficiently, and cooperatively while maximizing
protection of our land, resources, and environment in a fiscally
responsible way by:
(1) Protecting Natural, Cultural, and Heritage Resources
The Department's mission includes protecting and providing access
to our Nation's natural and cultural heritage and honoring our trust
responsibilities to tribes. We are committed to this mission and to
applying laws and regulations fairly and effectively. Our priorities
include protecting public health and safety, restoring and maintaining
public lands, protecting threatened and endangered species,
ameliorating land- and resource-management problems on public lands,
and ensuring accountability and compliance with Federal laws and
regulations.
The Bureau of Land Management (BLM) Wildlife Program continues to
focus on maintaining and managing wildlife habitat to ensure self-
sustaining populations and a natural abundance and diversity of
wildlife resources on public lands. The BLM-managed lands are vital to
game species and hundreds of species of non-game mammals, reptiles, and
amphibians. In order to provide for long-term protection of wildlife
resources, especially given other mandated land use requirements, the
Wildlife Program supports aggressive habitat conservation and
restoration activities, many funded by partnerships with Federal,
State, and non-governmental organizations. For instance, the Wildlife
Program is restoring wildlife habitat across a multi-state region to
support species that depend upon sagebrush vegetation. Projects are
tailored to address regional issues such as fire (as in the western
portion of the sagebrush biome) or habitat degradation and loss (as in
the eastern portion of the sagebrush biome). Additionally, BLM
undertakes habitat improvement projects in partnership with a variety
of stakeholders and consistent with State fish and game wildlife action
plans and local working group plans.
The National Park Service (NPS) is working with BLM and the U.S.
Fish and Wildlife Service (FWS) to finalize a rule implementing Public
Law 106-206, which directs the Secretary to establish a system of
location fees for commercial filming and still photography activities
on public lands. While commercial filming and still photography are
generally allowed on Federal lands, managing this activity through a
permitting process will minimize damage to cultural or natural
resources and interference with other visitors to the area. This
regulation would standardize location fee rates and collection for all
DOI agencies.
The NPS is proposing a new winter use rule for Yellowstone National
Park. This rule is proposed to replace an interim rule that expired at
the end of the 2010 to 2011 winter season and that was recently
reauthorized for the current (2011-2012) winter season. It would allow
a variety of winter uses for visitors while protecting park resources
by establishing maximum numbers of snowmobiles and snowcoaches
permitted in the Park on a given day. It would also require most
snowmobiles and snowcoaches operating in the Park
[[Page 7769]]
to meet air and sound emission requirements and would require a
commercial guide. The NPS intends to publish a final rule by mid-
November 2012.
The NPS is prepared to publish final rules for Off Road Vehicle use
at Cape Hatteras National Seashore and bicycle routes at Mammoth Cave
National Park. Proposed rules for bicycle routes are pending for other
park areas. These rules would manage use to protect and preserve
natural and cultural resources, and natural processes, and provide a
variety of safe visitor experiences while minimizing conflicts among
various users.
(2) Sustainably Using Energy, Water, and Natural Resources
The BLM has identified approximately 20.6 million acres of public
land with wind energy potential in the 11 western States and
approximately 29.5 million acres with solar energy potential in the six
southwestern States. There are over 140 million acres of public land in
western States and Alaska with geothermal resource potential. There is
also significant wind and wave potential in our offshore waters. The
National Renewable Energy Lab, a Department of Energy national
laboratory, has identified more than 1,000 gigawatts of wind potential
off the Atlantic coast--roughly equivalent to the Nation's existing
installed electric generating capacity--and more than 900 gigawatts of
wind potential off the Pacific Coast. Because public lands are
extensive and widely distributed, the Department has an important role,
in consultation with Federal, State, regional, and local authorities,
in approving and building new transmission lines that are crucial to
deliver renewable energy to America's homes and businesses.
Since the beginning of the Obama Administration, the Department has
focused on renewable energy issues and has established priorities for
environmentally responsible development of renewable energy on public
lands and the OCS. Industry has started to respond by investing in
development of wind farms off the Atlantic seacoast and solar, wind,
and geothermal energy facilities throughout the west. Power generation
from these new energy sources produces virtually no greenhouse gases
and, when done in an environmentally sensitive manner, harnesses with
minimum impact abundant renewable energy that nature itself provides.
The Department will continue its intra- and inter-departmental efforts
to move forward with the environmentally responsible review and
permitting of renewable energy projects on public lands.
The Secretary issued his first Secretarial Order on March 11, 2009,
making renewable energy on public lands and the OCS top priorities at
the Department. These remain top priorities. In implementing these
priorities through its regulations, the Department will continue to
create jobs and contribute to a healthy economy while protecting our
signature landscapes, natural resources, wildlife, and cultural
resources.
(3) Empowering People and Communities
The Department strongly encourages public participation in the
regulatory process. For example, every year the FWS establishes
migratory bird hunting seasons in partnership with flyway councils
composed of State fish and wildlife agencies. The FWS also holds a
series of public meetings to give other interested parties, including
hunters and other groups, opportunities to participate in establishing
the upcoming season's regulations.
Similarly, the BLM uses Resource Advisory Councils made up of
affected parties to help prepare land management plans and regulations.
The NPS has begun revising its rules on non-Federal development of
gas and oil in units of the National Park System. Of the approximately
700 gas and oil wells in 13 NPS units, 55 percent, or 385 wells, are
exempt from current regulations. The NPS is revising the regulations to
improve protection of NPS resources. The NPS actively sought public
input into designing the rule and published an Advance Notice of
Proposed Rulemaking with a comment period from November 15, 2009,
through January 25, 2010. Interested members of the public were able to
make suggestions for the content of the rule, which NPS will consider
in writing the proposed rule. After developing a proposed rule, NPS
will solicit further public comment. The NPS expects to publish a
proposed rule in 2012.
In October 2010, NPS published an interim final rule with request
for comments revising the former regulations for management of
demonstrations and the sale or distribution of printed matter in most
areas of the National Park System to allow a small-group exception to
permit requirements. In essence, under specific criteria,
demonstrations, and the sale or distribution of printed matter
involving 25 or fewer persons may be held in designated areas, without
first obtaining a permit; i.e. making it easier for individuals and
small groups to express their views. The NPS has analyzed the comments
and expects to publish a final rule in early 2012.
Retrospective Review of Regulations
President Obama's Executive Order 13563 directs agencies to make
the regulatory system work better for the American public. Regulations
should ``* * * protect public health, welfare, safety, and our
environment while promoting economic growth, innovation,
competitiveness, and job creation.'' DOI's plan for retrospective
regulatory review identifies specific efforts to relieve regulatory
burdens, add jobs to the economy, and make regulations work better for
the American public while protecting our environment and resources. The
DOI plan seeks to strengthen and maintain a culture of retrospective
review by consolidating all regulatory review requirements \1\ into
DOI's annual regulatory plan. DOI has selected the following regulatory
efforts to focus on over the next 2 years:
---------------------------------------------------------------------------
\1\ DOI conducts regulatory review under numerous statutes,
Executive orders, memoranda, and policies, including but not limited
to the Regulatory Flexibility Act of 1980 (RFA), the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), Executive
Orders 12866 and 13563, and the DOI Departmental Manual.
---------------------------------------------------------------------------
Oil and Gas Royalty Valuation Rules (Office of Natural
Resources Revenue)--DOI is exploring a simplified market-based approach
to arrive at the value of oil and gas for royalty purposes that could
dramatically reduce accounting and paperwork requirements and costs on
industry and better ensure proper royalty valuation by creating a more
transparent royalty calculation method.
Endangered Species Act Rules (Fish and Wildlife Service)--
The Fish and Wildlife Service (FWS), working in conjunction with the
National Marine Fisheries Service, will revise and update the ESA
implementing regulations and policies to improve conservation
effectiveness, reduce administrative burden, enhance clarity and
consistency for impacted stakeholders and agency staff, and encourage
partnerships, innovation, and cooperation. FWS has already proposed a
rule on May 17, 2011, that would minimize the requirements for written
descriptions of critical habitat boundaries in favor of map and
Internet-based descriptions. FWS anticipates issuing the final rule in
the spring of 2012. Additionally, FWS will develop proposed rules and/
or policies to amend existing regulations related to:
Habitat conservation plans;
[[Page 7770]]
Safe harbor agreements;
Candidate conservation agreements;
The process and procedures for designation of critical
habitat;
Section 7 consultation to revise the definition of
``destruction or adverse modification'' of critical habitat; and
Issuance of incidental take permits during section 7
consultation.
Commercial Filming on Public Land Rules--This joint effort
between the National Park Service (NPS), Fish and Wildlife Service
(FWS), Bureau of Land Management (BLM), Bureau of Reclamation (BOR),
and Bureau of Indian Affairs (BIA) will create consistent regulations
and a unified fee schedule for commercial filming and still photography
on public land. It will provide the commercial filming industry with a
predictable fee for using Federal lands, while earning the Government a
fair return for the use of that land.
Offshore Energy Safety and Environmental Rules (BSEE)--In
the wake of the Deepwater Horizon oil spill, DOI immediately instituted
regulatory reforms that strengthened the protection of workers' health
and safety and enhanced environmental safeguards. The Bureau of Safety
and Environmental Enforcement (BSEE), formerly part of the Bureau of
Ocean Energy Management, Regulation, and Enforcement (BOEMRE) is now
considering ways to apply ``safety case''-type performance standards,
such as those widely applied internationally, to the U.S. offshore
drilling regulatory regime. A hybrid combination of performance-based
and prescriptive standards will provide flexibility to adapt to
changing technologies and increasingly complex operational conditions,
while maintaining worker and environmental protections.
Leasing (BIA)--BIA is amending its leasing regulations to
eliminate the need to follow multiple cross-references in the
regulations. The amendments will also delete the requirement for BIA
review of permits, which some view as unjustified and excessively
burdensome.
Land Classification Regulations (BLM)--BLM is amending its
regulations to remove obsolete land classification regulations and
consolidate these regulations into the existing planning system
regulations. These changes will benefit the public by consolidating all
land use decisions into one systematic process.
DOI bureaus work to make our regulations easier to comply with and
understand. Our regulatory process ensures that bureaus share ideas on
how to reduce regulatory burdens while meeting the requirements of the
laws they enforce and improving their stewardship of the environment
and resources. Results include:
Effective stewardship of our Nation's resources in a way
that is responsive to the needs of small businesses;
Increased benefits per dollars spent by carefully
evaluating the economic effects of planned rules; and
Improved compliance and transparency by use of plain
language in our regulations and guidance documents.
Bureaus and Offices Within DOI
The focus of DOI's major regulatory bureaus and offices is
summarized below.
Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA) administers and manages 56
million acres of land held in trust by the United States for Indians
and Indian tribes, providing services to approximately 1.9 million
Indians and Alaska Natives, and maintaining a government-to-government
relationship with the 565 federally recognized Indian tribes. The BIA's
mission is to enhance the quality of life, to promote economic
opportunity, and to carry out the responsibility to protect and improve
the trust assets of American Indians, Indian tribes, and Alaska
Natives, as well as to provide quality education opportunities to
students in Indian schools.
In the coming year, BIA will continue its regulatory focus on
improved management of trust responsibilities and promotion of economic
development in Indian communities. In addition, BIA will focus on
updating Indian education regulations and on other regulatory changes
to increase transparency in support of the President's Open Government
Initiative.
With the input of tribal leaders, individual Indian beneficiaries,
and other subject matter experts, BIA has been examining better ways to
serve its beneficiaries. The American Indian Probate Reform Act of 2004
(AIPRA) made clear that regulatory changes were necessary. BIA has
promulgated regulations implementing the probate-related provisions of
AIPRA and will now focus on regulations to implement other AIPRA
provisions related to managing Indian land.
The focus on promoting economic development in Indian communities
is a core component of BIA's mission. Economic development initiatives
can attract businesses to Indian communities that provide jobs and fund
services that support the health and well-being of tribal members.
Economic development can enable tribes to attain self-sufficiency,
strengthen their governments, and reduce crime.
Indian education is a top priority of the Assistant Secretary for
Indian Affairs. BIA will review Indian education regulations to ensure
that they adequately support efforts to provide students of BIA-funded
schools with the best education possible.
Finally, BIA's regulatory focus on increasing transparency
implements the President's Open Government Initiative. BIA will ensure
that all regulations that it drafts or revises meet high standards of
readability and accurately and clearly describe BIA processes.
BIA's regulatory priorities are to:
Develop regulations to meet the Indian trust reform goals
for land consolidation and land use management.
BIA is amending regulations affecting land title and records,
conveyances of trust or restricted land, leasing, grazing, trespass,
rights-of-way, and energy and minerals. These regulatory changes will
help the Department better serve beneficiaries and will standardize
procedures for consistent execution of fiduciary responsibilities
across the BIA.
Identify and develop regulatory changes necessary for
improved Indian education.
BIA is reviewing regulations addressing grants to tribally
controlled community colleges and other Indian education regulations.
The review will identify provisions that need to be updated to comply
with applicable statutes and ensure that the proper regulatory
framework is in place to support students of Bureau-funded schools.
Develop regulatory changes to reform the process for
Federal acknowledgment of Indian tribes.
Over the years, BIA has received significant comments from American
Indian groups and members of Congress on the Federal acknowledgment
process. Most of these comments claim that the current process is
cumbersome and overly restrictive. The BIA is reviewing the Federal
acknowledgment regulations to determine if any regulatory changes are
appropriate.
Revise regulations governing administrative appeals and
other processes to increase transparency.
The BIA is making a concentrated effort to improve the readability
and precision of its regulations. Because trust beneficiaries often
turn to the regulations for guidance on how a given BIA process works,
BIA is ensuring that each revised regulation is written as
[[Page 7771]]
clearly as possible and accurately reflects the current organization of
the Bureau. A few of the regulations BIA will be focusing this effort
on include the regulation governing administrative appeals (25 CFR part
2), the land use management regulations mentioned above, and
regulations addressing various Indian services.
The Bureau of Land Management
The BLM manages the 245-million-acre National System of Public
Lands, located primarily in the western States, including Alaska, and
the 700-million-acre subsurface mineral estate located throughout the
Nation. BLM's complex multiple-use mission affects the lives of a great
number of Americans, including those who live near and visit the public
lands, as well as millions of Americans who benefit from commodities,
such as minerals, energy, or timber, produced from the lands' rich
resources.
The BLM's multiple-use mission conserves the lands' natural and
cultural resources and sustains the health and productivity of the
public lands for the use and enjoyment of present and future
generations. The BLM manages such varied uses as energy and mineral
development, outdoor recreation, livestock grazing, and forestry and
woodlands products.
The BLM has identified the following three areas of regulatory
priorities.
Energy Independence
Treasured Landscapes
Native American Nations
The summaries that follow explain how these three areas promote the
BLM mission and the priorities of the Department.
Energy Independence
BLM manages more Federal land than any other agency--more than 245
million surface acres and 700 million subsurface acres of mineral
estate. Thus, it plays a key role in ensuring that the Nation's energy
needs are met by managing both Federal renewable and non-renewable
sources of energy. The BLM is analyzing proposals for increasing
renewable energy development on public lands. The BLM will manage these
proposals to assure they proceed in an environmentally and fiscally
sound way that protects our natural resources and critical wildlife
habitat for such species as the sage grouse and lynx. These projects
will create environmentally friendly jobs and help sustain the quality
of life that Americans enjoy today.
Another BLM priority is siting and authorizing transmission
corridors to assist the national effort to move renewable energy from
production sites to market. The BLM has already designated more than
5,000 miles of energy transport corridors. The BLM will authorize
rights-of-way across public lands through these energy transport
corridors to allow development of transmission lines.
Treasured Landscapes
Protecting the landscapes of the National System of Public Lands
involves numerous BLM programs as the agency moves toward a holistic,
landscape-level approach to managing multiple public land uses. The BLM
also engages partners interested in working on a broader scale across
jurisdictional lines to achieve a common landscape vision. For the past
several years, BLM, which manages the largest amount and the greatest
diversity of fish and wildlife habitat of any Federal agency, has
focused on restoring healthy landscapes in a number of ways, including:
Reducing the number of wild horses and burros on public
lands, particularly in areas most affected by drought and wildfire.
Maintaining the wild horse and burro population at appropriate
management levels is critical in the effort to conserve forage
resources that also sustain native wildlife and livestock.
Restoring habitat for sensitive, rare, threatened, and
endangered species, such as sage grouse, desert tortoise, and salmon.
Supporting greater biodiversity through noxious weed and
invasive species treatments to bring back native plants.
Improving water quality by restoring riparian areas and
protecting watersheds. Enhanced water quality aids in the restoration
of habitat for fish and other aquatic and riparian species.
Conducting post-fire recovery efforts to promote healthy
landscapes and discourage the spread of invasive species.
Native American Nations
BLM consults with Indian tribes on a government-to-government basis
under multiple authorities and is continually working to assess and
improve its tribal consultation practices. The BLM held listening
sessions throughout the West on this important issue in 2009 and 2010
and received many valuable comments. BLM has continued its efforts to
improve its tribal consultation practices by participating with the
Department in multiple listening sessions with tribes throughout the
country.
The Native American Graves Protection and Repatriation Act
(NAGPRA), enacted in 1990, addresses the rights of lineal descendants,
Indian tribes, and Native Hawaiian organizations to certain Native
American human remains, funerary objects, associated funerary objects,
sacred objects, and objects of cultural patrimony with which they are
affiliated. The statute and implementing regulations represent a
careful balance between the legitimate interests of lineal descendants,
Indian tribes, and Native Hawaiian organizations to control the remains
of their ancestors and cultural property and the legitimate public
interests in scientific and educational information associated with the
human remains and cultural items.
BLM is complying with the new NAGPRA regulations, including
inventorying and repatriating human remains and other cultural items
that are in BLM museum collections. BLM also consults with Indian
tribes on implementing appropriate actions when human remains and other
cultural items subject to NAGPRA are inadvertently discovered or
intentionally excavated on the public lands.
Additionally, BLM, in cooperation with the Bureau of Indian
Affairs, helps tribes and individual Indian allottees develop their
solid and fluid mineral resources. BLM is responsible for development,
product measurement, and inspection and enforcement of extracting
operations of the mineral estate on trust properties.
BLM's Regulatory Priorities
The BLM's regulatory focus is directed primarily by the priorities
of the President and Congress, which include:
Generating jobs and promoting a healthy economy by
facilitating domestic production of various sources of energy,
including biomass, wind, solar, and other alternative sources.
Providing for a wide variety of public uses while
maintaining the long-term health and diversity of the land.
Preserving significant natural, cultural, and historic
resource values.
Understanding the arid, semi-arid, arctic, and other
ecosystems that BLM manages.
Using the best scientific and technical information to
make resource management decisions.
Understanding the needs of the people who use and enjoy
BLM-managed public lands and providing them with quality service.
Securing the recovery of a fair return for using publicly
owned resources, and avoiding the creation of long-term liabilities for
American taxpayers.
[[Page 7772]]
Resolving problems and implementing decisions in
cooperation with other agencies, states, tribal governments, and the
public.
In developing regulations, BLM recognizes the need to ensure
communication, coordination, and consultation with the public,
including affected interests, tribes, and other stakeholders. BLM also
works to draft regulations that are easy for the public to understand
and that provide clarity to those most affected by them.
The BLM's specific regulatory priorities include:
Revising onshore oil and gas operating standards.
The BLM expects to publish rules to revise several existing onshore
oil and gas operating orders and propose one new onshore order. Onshore
orders establish requirements and minimum standards and provide
standard operating procedures. The orders are binding on operating
rights owners and operators of Federal and Indian (except the Osage
Nation) oil and gas leases and on all wells and facilities on state or
private lands committed to Federal agreements. The BLM is responsible
for ensuring that oil or gas produced and sold from Federal or Indian
leases is accurately measured for quantity and quality. The volume and
quality of oil or gas sold from leases is key to determining the proper
royalty to be paid by the lessee to the Office of Natural Resources
Revenue. Existing Onshore Orders Number 3, 4, and 5 would be revised to
use new industry standards so that they reflect current operating
procedures and to require that proper verification and accounting
practices are used consistently. New Onshore Order Number 9 would cover
waste prevention and beneficial use. The revisions would ensure that
proper royalties are paid on oil and gas removed from Federal and Trust
lands.
Revising coal-management regulations.
The BLM plans to publish a proposed rule to amend the coal-
management regulations that pertain to the administration of Federal
coal leases and logical mining units. The rule would primarily
implement provisions of the Energy Policy Act of 2005 that pertain to
administering coal leases. The rule also would clarify the royalty rate
applicable to continuous highwall mining, a new coal-mining method in
use on some Federal coal leases.
Publishing rules on paleontological resources
preservation.
The 2009 omnibus public lands law included provisions on permitting
for the collection of paleontological resources. The BLM and the
National Park Service are co-leads of a team with the U.S. Forest
Service that will be drafting a paleontological resources rule. The
rule would address the protection of paleontological resources and how
BLM would permit the collection of these resources. The rule would also
address other issues such as administering permits, casual collection
of rocks and minerals, hobby collection of common invertebrate plants
and fossils, and civil and criminal penalties for violation of these
rules.
Amending rules on royalty rate increases for new Federal
Onshore Competitive Oil and Gas Leases.
The BLM will consider amending its oil and gas regulations to set
higher royalty rates for new Federal onshore competitive oil and gas
leases issued on or after the effective date of the rule. This rule
would revise existing regulations by increasing royalty rates based on
the options set out in the proposed rule.
The Bureau of Ocean Energy Management, Regulation, and Enforcement
The Bureau of Ocean Energy Management, Regulation, and Enforcement
(BOEMRE) replaced the former Minerals Management Service (MMS). On
October 1, 2011, BOEMRE was reorganized and divided into two new
Bureaus, under the Assistant Secretary for Land and Minerals
Management:
(1) The Bureau of Ocean Energy Management (BOEM) now functions as
the resource manager for the conventional and renewable energy and
mineral resources on the OCS. It fosters environmentally responsible
and appropriate development of the OCS for both conventional and
renewable energy and mineral resources in an efficient and effective
manner that ensures fair market value for the rights conveyed.
(2) The Bureau of Safety and Environmental Enforcement (BSEE)
applies independent regulation, oversight, and enforcement powers to
promote and enforce safety in offshore energy exploration and
production operations and ensure that potentially negative
environmental impacts on marine ecosystems and coastal communities are
appropriately considered and mitigated.
Our regulatory focus for fiscal year 2012 is directed by
Presidential and legislative priorities that emphasize contributing to
America's energy supply, protecting the environment, and ensuring a
fair return for taxpayers for energy production from Federal and Indian
lands.
BOEM's regulatory priorities are to:
Finalize Regulations for Leasing of Sulphur or Oil and Gas
and Bonding Requirements in the Outer Continental Shelf
This final rule updates and streamlines the existing OCS leasing
regulations and clarifies implementation of the Federal Oil and Gas
Royalty Simplification and Fairness Act of 1996. This final rule
reorganizes leasing requirements to communicate more effectively the
leasing process, as it has evolved over the years. This final rule
makes changes to 30 CFR parts 250, 256, and 260 that relate to the oil
and gas leasing and bonding requirements.
BSEE's regulatory priorities are to:
Establish Additional Requirements for Safety Measures for
Drilling and Other Well Operations for Oil and Gas
This will be an Advance Notice of Proposed Rulemaking to address
recommendations from the ``Increased Safety Measures for Energy
Development on the Outer Continental Shelf'' report that were not
covered by an Interim Final Rule BOEMRE, BSEE's predecessor, published
on October 14, 2010. The safety measures recommendations include
additional requirements for blowout preventers, remotely operated
vehicles, secondary control systems, and cement evaluation techniques.
Detailed responses to the questions and ideas posed in this Advance
Notice of Proposed Rulemaking would allow BSEE to develop more
comprehensive regulations, if needed, and have a better understanding
of the impacts.
Revise Regulations on Safety and Environmental Management
Programs for Offshore Operations and Facilities
This rulemaking proposes to revise 30 CFR part 250 (subpart S)
regulations to require operators to develop and implement additional
provisions in their Safety and Environmental Management Systems (SEMS)
programs for oil, gas, and sulphur operations in the Outer Continental
Shelf (OCS). These revisions pertain to developing and implementing:
(1) Stop work authority, (2) ultimate work authority, (3) requiring
employee participation in the development and implementation of SEMS
programs, and (4) establishing requirements for reporting unsafe
working conditions. In addition, this proposed rule (5) requires
independent third parties to conduct audits of operators' SEMS programs
and (6) establishes further requirements relating to conducting job
safety analyses (JSA) for activities identified in an operator's SEMS
program. BSEE believes that these new requirements will further reduce
the likelihood of accidents, injuries, and spills in connection with
OCS activities,
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by requiring OCS operators to specifically address issues associated
with human behavior as it applies to their SEMS program.
Develop additional rules and regulations as a result of
ongoing reviews of BSEE's offshore regulatory regime.
Several investigations and reviews of BOEMRE, now BSEE, have been
and are being conducted by various agencies and entities--including the
Safety Oversight Board, the Office of Inspector General, the
President's Deepwater Horizon Commission, the National Academy of
Engineering, and the joint BOEMRE/United States Coast Guard (USCG)
investigation of Deepwater Horizon. Some of these investigations and
reviews focus narrowly on the Deepwater Horizon explosion; others are
broader in focus and include many aspects of the current regulatory
system. BSEE expects that recommendations for regulatory changes--both
substantive and procedural--will be generated by these investigations
and reviews, and will need to be reviewed, analyzed, and potentially
incorporated in new or modified regulations. The Secretary established
the Ocean Energy Safety Advisory Committee to provide advice on matters
related to drilling and workplace safety, and spill containment and
response. This Committee is expected to make recommendations for new or
modified regulations.
Office of Natural Resources Revenue
The revenue responsibilities of the former MMS now are located in
the Office of Natural Resources Revenue (ONRR), which will continue to
collect, account for, and disburse revenues from Federal offshore
energy and mineral leases and from onshore mineral leases on Federal
and Indian lands. The program operates nationwide and is primarily
responsible for timely and accurate collection, distribution, and
accounting for revenues associated with mineral and energy production.
The regulatory program of ONRR seeks to:
Simplify valuation regulations.
ONRR plans to simplify the regulations at 30 CFR part 1206 for
establishing the value for royalty purposes of (1) oil and natural gas
produced from Federal leases; and (2) coal and geothermal resources
produced from Federal and Indian leases. Additionally, the proposed
rules would consolidate sections of the regulations common to all
minerals, such as definitions and instructions regarding how a payor
should request a valuation determination. ONRR published Advance
Notices of Proposed Rulemaking (ANPRMs) to initiate the rulemaking
process and to obtain input from interested parties.
Finalize debt collection regulations.
ONRR is preparing regulations governing collection of delinquent
royalties, rentals, bonuses, and other amounts due under Federal and
Indian oil, gas, and other mineral leases. The regulations would
include provisions for administrative offset and would clarify and
codify the provisions of the Debt Collection Act of 1982 and the Debt
Collection Improvement Act of 1996.
Continue to meet Indian trust responsibilities.
ONRR has a trust responsibility to accurately collect and disburse
oil and gas royalties on Indian lands. ONRR will increase royalty
certainty by addressing oil valuation for Indian lands through a
negotiated rulemaking process involving key stakeholders.
Office of Surface Mining Reclamation and Enforcement
The Office of Surface Mining Reclamation and Enforcement (OSM) was
created by the Surface Mining Control and Reclamation Act of 1977
(SMCRA). Under SMCRA, OSM has two principal functions. They are:
The regulation of surface coal mining and reclamation
operations; and
The reclamation and restoration of abandoned coal mine
lands.
In enacting SMCRA, Congress directed OSM to ``strike a balance
between protection of the environment and agricultural productivity and
the Nation's need for coal as an essential source of energy.'' In
response to its statutory mandate, OSM has sought to develop and
maintain a stable regulatory program that is safe, cost-effective, and
environmentally sound. A stable regulatory program ensures that the
coal mining industry has clear guidelines for operation and
reclamation, and that citizens know how the program is being
implemented.
OSM's Federal regulatory program sets minimum requirements for
obtaining a permit for surface and underground coal mining operations,
sets performance standards for those operations, requires reclamation
of lands and waters disturbed by mining, and requires enforcement to
ensure that the standards are met.
OSM is the primary regulatory authority for SMCRA enforcement until
a State or Indian tribe develops its own regulatory program, which is
no less effective than the Federal program. When a State or Indian
tribe achieves ``primacy,'' it assumes direct responsibility for
permitting, inspection, and enforcement activities under its federally
approved regulatory program. Today, 24 of the 26 coal-producing States
have primacy. In the 2006 amendments to SMCRA, Indian tribes with coal
resources were provided the opportunity to assume primacy. No tribes
have done so to date, although three tribes have expressed an interest
in submitting a tribal program.
OSM's regulatory priorities for the coming year will focus on:
Stream Protection.
Protect streams from the adverse effects of surface coal mining
operations; and
Coal Combustion Residues
Establish Federal standards for the beneficial use of coal
combustion residues on active and abandoned coal mines.
U.S. Fish and Wildlife Service
The mission of the U.S. Fish and Wildlife Service (FWS) is to work
with others to conserve, protect, and enhance fish, wildlife, and
plants and their habitats for the continuing benefit of the American
people. FWS also helps ensure a healthy environment for people by
providing opportunities for Americans to enjoy the outdoors and our
shared natural heritage.
FWS fulfills its responsibilities through a diverse array of
programs that:
Protect and recover endangered and threatened species;
Monitor and manage migratory birds;
Restore native aquatic populations and nationally
significant fisheries;
Enforce Federal wildlife laws and regulate international
trade;
Conserve and restore wildlife habitat such as wetlands;
Help foreign governments conserve wildlife through
international conservation efforts;
Distribute Federal funds to States, territories, and
tribes for fish and wildlife conservation projects; and
Manage the almost 150-million-acre National Wildlife
Refuge System, which includes 555 National Wildlife Refuges and which
protects and conserves fish and wildlife and their habitats and allows
the public to engage in outdoor recreational activities.
Critical challenges to the work of FWS include global climate
change; shortages of clean water suitable for wildlife; invasive
species that are harmful to our fish, wildlife, and plant resources and
their habitats; and the alienation of children and adults from the
natural world. To address these challenges, FWS has identified six
priorities:
The National Wildlife Refuge System--conserving our lands
and resources;
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Landscape conservation--working with others;
Migratory birds--conservation and management;
Threatened and endangered species--achieving recovery and
preventing extinction;
Connecting people with nature--ensuring the future of
conservation; and
Aquatic species--the National Fish Habitat Action Plan (a
plan that brings public and private partners together to restore U.S.
waterways to sustainable health).
To carry out these priorities, FWS has a large regulatory agenda
that will, among other things:
List, delist, and reclassify species on the Lists of
Endangered and Threatened Wildlife and Plants and designate critical
habitat for certain listed species;
Update our regulations to carry out the Convention on
International Trade in Wild Fauna and Flora;
Manage migratory bird populations;
Administer the subsistence program for harvest of fish and
wildlife in Alaska;
Update our regulations governing the Wildlife and Sport
Fish Restoration Program; and
Set forth hunting and sport fishing regulations for the
National Wildlife Refuge System.
Additionally, FWS is working with the National Oceanic and
Atmospheric Administration and the Environmental Protection Agency, via
a contract with the National Research Council (NRC), to review
scientific issues associated with the Federal Insecticide, Fungicide,
and Rodenticide Act. Once the NRC's report is completed, the agencies
will work together to develop an approach that produces efficient,
scientifically defensible biological evaluations protective of listed
species.
Further, the FWS' Regional Directors and/or Ecological Services
State Supervisors or Project leaders will be meeting with their State
counterparts to discuss the role of State agencies in ESA initiatives
to enhance their involvement in implementing the ESA's provisions.
National Park Service
The NPS preserves unimpaired the natural and cultural resources and
values within almost 400 units of the National Park System encompassing
nearly 84 million acres of lands and waters for the enjoyment,
education, and inspiration of this and future generations. The NPS also
cooperates with partners to extend the benefits of natural and resource
conservation and outdoor recreation throughout the United States and
the world.
To achieve this mission the NPS adheres to the following guiding
principles:
Excellent Service: Providing the best possible service to
park visitors and partners.
Productive Partnerships: Collaborating with Federal,
State, tribal, and local governments, private organizations, and
businesses to work toward common goals.