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 http://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 http://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 http://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 http://
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, http://
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 http://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 http://
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 http://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
http://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
http://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
http://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
http://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: http://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: http://
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: http://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: http://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: http://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
http://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: http://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 http://
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 http://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 http://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 http://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: http://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
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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:
http://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: http://
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
Jkt 226001
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: http://
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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7793
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
(http://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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15:08 Feb 10, 2012
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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
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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