Amendments to Enforceable Consent Agreement Procedural Rules, 56472-56477 [2010-23131]
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Federal Register / Vol. 75, No. 179 / Thursday, September 16, 2010 / Rules and Regulations
2. Section 501.15 is amended by
revising paragraph (i) to read as follows:
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§ 501.15 Computerized Meter Resetting
System.
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(i) Security and Revenue Protection.
To receive Postal Service approval to
continue to operate systems in the
CMRS environment, the RC must submit
to a periodic examination of its CMRS
system and any other applications and
technology infrastructure that may have
a material impact on Postal Service
revenues, as determined by the Postal
Service. The examination shall be
performed by a qualified, independent
audit firm and shall be conducted in
accordance with the Statement on
Auditing Standards (SAS) No. 70,
Service Organizations, developed by the
American Institute of Certified Public
Accountants (AICPA), as amended or
superseded. The examination shall
include testing of the operating
effectiveness of relevant RC internal
controls (Type II SAS70 Report). If the
service organization uses another
service organization (sub-service
provider), Postal Service Management
should consider the nature and
materiality of the transactions processed
by the sub-service organization and the
contribution of the sub-service
organization’s processes and controls in
the achievement of the Postal Service’s
information processing objectives. The
Postal Service should have access to the
sub-service organization’s SAS 70
report. The control objectives to be
covered by the SAS 70 report are subject
to Postal Service review and approval
and are to be provided to the Postal
Service 30 days prior to the initiation of
each examination period. As a result of
the examination, the auditor shall
provide the RC and the Postal Service
with an opinion on the design and
operating effectiveness of the RC’s
internal controls related to the CMRS
system and any other applications and
technology infrastructure considered
material to the services provided to the
Postal Service by the RC. Such
examinations are to be conducted on no
less than an annual basis, and are to be
as of and for the twelve months ended
June 30 of each year (except for the
period ending June 30, 2010, for which
the period of coverage will be no less
than six months, and except for new
contracts for which the examination
period will be no less than the period
from the contract date to the following
June 30, unless otherwise agreed to by
the Postal Service). The examination
reports are to be provided to the Postal
Service by August 15 of each year. To
the extent that internal control
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weaknesses are identified in a Type II
SAS 70 report, the Postal Service may
require the remediation of such
weaknesses and review working papers
and engage in discussions about the
work performed with the auditor. Postal
Service requires that all remediation
efforts (if applicable) are completed and
reported by the RC prior to the Postal
Service’s fiscal year end (September 30).
The RC will be responsible for all costs
to conduct these examinations.
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■ 3. Section 501.16 is amended by
revising paragraph (f) to read as follows:
§ 501.16 PC postage payment
methodology.
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(f) Security and revenue protection.
To receive Postal Service approval to
continue to operate PC Postage systems,
the provider must submit to a periodic
examination of its PC Postage system
and any other applications and
technology infrastructure that may have
a material impact on Postal Service
revenues, as determined by the Postal
Service. The examination shall be
performed by a qualified, independent
audit firm and shall be conducted in
accordance with the Statement on
Auditing Standards (SAS) No. 70,
Service Organizations, developed by the
American Institute of Certified Public
Accountants (AICPA), as amended or
superseded. The examination shall
include testing of the operating
effectiveness of relevant provider
internal controls (Type II SAS 70
Report). If the service organization uses
another service organization (subservice provider), Postal Service
Management should consider the nature
and materiality of the transactions
processed by the sub-service
organization and the contribution of the
sub-service organization’s processes and
controls in the achievement of the
Postal Service’s information processing
objectives. The Postal Service should
have access to the sub-service
organization’s SAS 70 report. The
control objectives to be covered by the
SAS 70 report are subject to Postal
Service review and approval and are to
be provided to the Postal Service 30
days prior to the initiation of each
examination period. As a result of the
examination, the auditor shall provide
the provider, and the Postal Service,
with an opinion on the design and
operating effectiveness of the internal
controls related to the PC Postage
system and any other applications and
technology infrastructure considered
material to the services provided to the
Postal Service by the provider. Such
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examinations are to be conducted on no
less than an annual basis, and are to be
as of and for the twelve months ended
June 30 of each year (except for the
period ending June 30, 2010 for which
the period of coverage will be no less
than six months, and except for new
contracts for which the examination
period will be no less than the period
from the contract date to the following
June 30, unless otherwise agreed to by
the Postal Service). The examination
reports are to be provided to the Postal
Service by August 15 of each year. To
the extent that internal control
weaknesses are identified in a Type II
SAS 70 report, the Postal Service may
require the remediation of such
weaknesses and review working papers
and engage in discussions about the
work performed with the auditor. The
provider will be responsible for all costs
to conduct these examinations.
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Neva R. Watson,
Attorney, Legislative.
[FR Doc. 2010–23031 Filed 9–15–10; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 790
[EPA–HQ–OPPT–2009–0894; FRL–8832–8]
RIN 2070–AJ59
Amendments to Enforceable Consent
Agreement Procedural Rules
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is revising the
procedures for developing Enforceable
Consent Agreements (ECAs) to generate
test data under the Toxic Substances
Control Act (TSCA). The main features
of the ECA process that EPA is changing
include when and how to initiate
negotiations and inserting a firm
deadline at which negotiations will
terminate. EPA is also deleting,
modifying, or consolidating several
sections of 40 CFR part 790 to place the
ECA provisions in one section and the
Interagency Testing Committee (ITC)
provisions in a separate section, to make
it clearer that there is one ECA
negotiation procedure applicable to all
circumstances when an ECA would be
appropriate, and to make conforming
changes in other sections that reference
the ECA procedures.
DATES: This final rule is effective
October 18, 2010.
SUMMARY:
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EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPPT–2009–0894. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number of
the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Jessica
Barkas, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 250–8880; e-mail address:
barkas.jessica@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; e-mail address: TSCAHotline@epa.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
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I. Does this Action Apply to Me?
You may be potentially affected by
this action if you manufacture (defined
by statute to include import) or process
chemical substances or mixtures
(defined as ‘‘chemical’’ in 40 CFR part
790). Potentially affected entities may
include, but are not limited to:
• Manufacturers (defined by statute to
include importers) of chemical
substances (NAIC codes 325 and
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324110), e.g., chemical manufacturing
and petroleum refineries.
• Processors of chemical substances
(NAIC codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
II. Background
A. What is the Agency’s Authority for
Taking this Action?
Section 4 of TSCA authorizes EPA to
require manufacturers and processors of
chemical substances and mixtures to
test these chemical substances to
generate data that is relevant to
determining whether the chemical
substances present an unreasonable risk.
Section 4(a) of TSCA empowers the
Agency to promulgate rules which
require such testing. Section 4 of TSCA
provides implied authority to enter into
ECAs requiring testing where such
agreements provide procedural
safeguards equivalent to those that
apply where testing is conducted by
rule.
B. What Action is the Agency Taking?
EPA is finalizing a rule revising the
procedures for initiating and negotiating
an ECA. ECAs are enforceable
agreements between EPA and one or
more chemical manufacturers or
processors to conduct specific testing on
a particular chemical substance. These
agreements are designed to provide EPA
with data identified as necessary to
evaluate a particular chemical substance
without the need for EPA to first make
the risk- or exposure-based findings for,
or promulgate, a TSCA section 4 test
rule, and without introducing delays
inherent in the rulemaking process.
ECAs were intended to permit EPA to
obtain test data more quickly than test
rules, while preserving opportunity for
input from the public and the affected
manufacturer(s).
The main features of the ECA process
that EPA is changing include when and
how to initiate negotiations and
inserting a firm deadline at which
negotiations will terminate. EPA is also
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56473
deleting, modifying, or consolidating
several parts of 40 CFR part 790 to place
the ECA provisions in one section and
the ITC provisions in a separate section,
to make it clearer that there is one ECA
negotiation procedure applicable to all
circumstances when an ECA would be
appropriate, and to make conforming
changes in other sections that reference
the ECA procedures.
The proposed rule was published in
the Federal Register of February 19,
2010 (75 FR 7428) (FRL–8802–6).
Additional detail about ECAs, the
specific changes, and the rationale for
those changes can be found in that
Federal Register document. One
comment was received on the proposed
rule. No changes have been made to the
rule since it was proposed.
C. What Was EPA’s Response to
Comment?
The comment period for the proposed
rule ended on March 22, 2010. One
comment was received, from the
American Chemistry Council (ACC).
The ACC comments indicated support
for the ECA procedural changes, and
had a few specific suggestions:
Comment 1: EPA should include in
the ECA rule what ‘‘office or program
and level of management within EPA
will have the organizational authority to
officially speak on behalf of the Agency
on such perceived [testing] needs, and
how EPA will communicate this request
to industry and through what vehicle.’’
EPA response: Under the current
delegation, the EPA Assistant
Administrator for the Office of Chemical
Safety and Pollution Prevention
(OCSPP) (formerly the Office of
Prevention, Pesticides and Toxic
Substances (OPPTS)) has the authority
to make the final decision on whether
testing is necessary under TSCA section
4. As explained in the preamble to the
proposed rule, EPA will invite testing
proposals through Federal Register
documents, EPA’s website, and other
forms of public communication.
Depending on the circumstances (e.g.,
the size and geographical distribution of
the group potentially required to
conduct testing), EPA may use more
than one of these methods, as necessary
to reach the affected companies. For
instance, one of the public forms of
communication that EPA may use is
speeches or presentations by Agency
officials at industry conferences, where
representatives from individual
companies and trade associations will
be present, and able to pass the word
along to their companies and members.
Of course, individual companies, trade
associations and other organizations,
and their representatives can always
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contact EPA, using the contact
information provided in the Federal
Register document, EPA website, or
other public communication of testing
needs, with questions about specific
testing requirements and other details
for individual chemical substances.
Comment 2: EPA should describe in
greater detail what EPA believes should
be contained in the proposed consent
agreement.
EPA response: The testing needs,
timeline, and other details will
necessarily vary for each individual
chemical substance, so it is impossible
for EPA to generalize about what will
form an adequate proposal in each
circumstance. The standard provisions
that must be included in all consent
agreements are listed in 40 CFR 790.60,
‘‘Contents of consent agreements,’’
which this action will not change.
Again, individual companies, trade
associations, and other organizations,
and their representatives can always
contact EPA, using the contact
information provided in the Federal
Register document, EPA website, or
other public communication of testing
needs, with questions about specific
testing requirements and other details
for individual chemicals. In addition, as
stated in the rule, ‘‘EPA may request
additional clarifications of or revisions
to the proposal(s).’’ This statement in the
rule makes it explicit that submitters
will have an opportunity to clarify,
correct, and otherwise revise their
proposal(s), if EPA decides that
clarification is needed, or the proposal
needs expansion or elaboration to
adequately meet testing needs.
Comment 3: The ECA procedures
should include a provision that would
permit the Agency to agree to an ECA
where some or most, but not all, data
needs might be filled.
EPA response: There is nothing in the
original or revised ECA procedural rules
that would prohibit EPA from agreeing
to an ECA that covers some, but not all,
needed testing, then pursuing a test rule
or follow-up ECA, to fill remaining data
needs—if no other interested parties
submit a timely written objection, and if
EPA concludes that such a multi-part
process is likely to be an efficient and
successful means of obtaining the
needed test data.
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III. Statutory and Executive Order
Reviews
A. Regulatory Review
Under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
the Office of Management and Budget
(OMB) has determined that this final
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rule is not a ‘‘significant regulatory
action’’ subject to review under
Executive Order 12866, because it does
not meet the criteria in section 3(f)(4) of
the Executive Order. Accordingly, EPA
did not submit this final rule to OMB for
review under Executive Order 12866.
B. Paperwork Reduction Act
This action does not impose any new
information collection burden, because
the development of the ECA regulations
does not involve information collection
activities as defined by the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq. However, the information
collection requirements contained in an
ECA are already approved by OMB
pursuant to PRA under OMB control
number 2070–0033 (EPA ICR No. 1139).
Under PRA, an agency may not conduct
or sponsor, and a person is not required
to respond to, an information collection
request unless it displays a currently
valid control number assigned by OMB.
The OMB control numbers for EPA’s
regulations in title 40 of the CFR are
listed in 40 CFR part 9, and will be
included in the individual ECAs.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), after considering the
potential economic impacts of this final
rule on small entities, the Agency
hereby certifies that this final rule
would not have a significant adverse
economic impact on a substantial
number of small entities.
Small entities include small
businesses, small organizations, and
small governmental jurisdictions. For
purposes of assessing the impacts of this
final rule on small entities, small entity
is defined as:
1. A small business as defined by the
Small Business Administration’s (SBA)
regulations at 13 CFR 121.201.
2. A small governmental jurisdiction
that is a government of a city, county,
town, school district, or special district
with a population of less than 50,000.
3. A small organization that is any
not-for-profit enterprise which is
independently owned and operated and
is not dominant in its field.
This action will not have a significant
economic impact on a substantial
number of small entities. In determining
whether a final rule has a significant
economic impact on a substantial
number of small entities, the impact of
concern is any significant adverse
economic impact on small entities,
since the primary purpose of regulatory
flexibility analysis is to identify and
address regulatory alternatives ‘‘which
minimize any significant economic
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impact of the rule on small entities.’’ 5
U.S.C. 603 and 604. Thus, an agency
may certify that a final rule will not
have a significant economic impact on
a substantial number of small entities if
the final rule relieves regulatory burden,
or otherwise has a positive economic
effect on all of the small entities subject
to the final rule.
The changes discussed in this
document are expected to streamline
and improve the ECA procedures in a
way that will benefit all participants.
EPA has therefore concluded that this
final rule will not have any adverse
impacts on affected small entities. EPA
did not receive any comments on the
proposed rule regarding the impact on
small entities.
D. Unfunded Mandates Reform Act
This action does not impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), (2 U.S.C.
1531–1538). Therefore, this action is not
subject to the requirements of UMRA.
E. Federalism
Pursuant to Executive Order 13132,
entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined
that this final rule does not have
‘‘federalism implications,’’ because it
will not 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, as
specified in Executive Order 13132.
Thus, Executive Order 13132 does not
apply to this final rule.
F. Tribal Implications
Under Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000), EPA has
determined that this final rule does not
have tribal implications because it will
not have any effect on tribal
governments, on the relationship
between the Federal Government and
the Indian tribes, or on the distribution
of power and responsibilities between
the Federal Government and Indian
tribes, as specified in the Order. Thus,
Executive Order 13175 does not apply
to this action.
G. Children’s Health Protection
Executive Order 13045, entitled
Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997),
does not apply to this action because
this is not designated as an
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‘‘economically significant’’ regulatory
action as defined by Executive Order
12866 (see Unit III.A.), nor does this
action establish an environmental
standard that is intended to have a
disproportionate effect on children. To
the contrary, this action will revise
procedures which will facilitate the
development of data and information
that EPA and others can use to assess
the risks of chemical substances,
including potential risks to children.
H. Energy Effects
This action is not subject to Executive
Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use.
I. Technology Standards
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), section 12(d) (15
U.S.C. 272 note), directs EPA to use
voluntary consensus standards in its
regulatory activities unless to do so
would be inconsistent with applicable
law or otherwise impractical. Voluntary
consensus standards are technical
standards (e.g., materials specifications,
test methods, sampling procedures, and
business practices) that are developed or
adopted by voluntary consensus
standards bodies. The NTTAA directs
EPA to provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards.
This final rule does not involve
technical standards. Therefore, EPA is
not considering the use of any voluntary
consensus standards.
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J. Environmental Justice
This action does not involve special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
IV. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
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the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. This rule is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 790
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: September 8, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 790—[AMENDED]
1. The authority citation for part 790
continues to read as follows:
■
Authority: 15 U.S.C. 2603.
§ 790.1
[Amended]
2. Section 790.1 is amended by
removing the last sentence of paragraph
(c) and by removing paragraph (d).
■ 3. Section 790.20 is revised to read as
follows:
■
§790.20 Recommendation,
recommendation with an intent to
designate, and designation of testing
candidates by the ITC.
(a) ITC recommendations and
recommendations with intent to
designate. The ITC has advised EPA that
it will discharge its responsibilities
under section 4(e) of TSCA in the
following manner:
(1) When the ITC identifies a
chemical substance or mixture that it
believes should receive expedited
consideration by EPA for testing, the
ITC may add the substance or mixture
to its list of chemicals recommended for
testing and include a statement that the
ITC intends to designate the substance
or mixture for action by EPA in
accordance with section 4(e)(1)(B) of
TSCA.
(2) Chemical substances or mixtures
selected for expedited review under
paragraph (a)(1) of this section may, at
a later time, be designated for EPA
action within 12 months of such
designation. The ITC’s subsequent
decision would be based on the ITC’s
review of TSCA sections 8(a) and 8(d)
data and other relevant information.
(3) Where the ITC concludes that a
chemical substance or mixture warrants
testing consideration but that expedited
EPA review of testing needs is not
justified, the ITC will add the substance
or mixture to its list of testing
recommendations without expressing an
intent to designate the substance or
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mixture for EPA action in accordance
with section 4(e)(1)(B) of TSCA.
(4) The ITC reserves its right to
designate any chemical substance or
mixture that it determines the Agency
should, within 12 months of the date
first designated, initiate a proceeding
under section 4(a) of TSCA.
(b) Preliminary EPA evaluation of ITC
recommendations with intent to
designate. Following receipt of an ITC
report containing a recommendation
with an intent to designate, EPA will
use the following procedure for
completing a preliminary evaluation of
testing needs on those chemical
substances that the ITC has
recommended with intent to designate:
(1) EPA will publish the ITC report in
the Federal Register and announce that
interested persons have 30 days to
submit comments on the ITC’s testing
recommendations.
(2) EPA will publish a Federal
Register document adding all ITCrecommended chemicals to the
automatic reporting provisions of its
rules under sections 8(a) and 8(d) of
TSCA (40 CFR parts 712 and 716).
(3) EPA will hold a public ‘‘focus
meeting’’ to discuss the ITC’s testing
recommendations and obtain comments
and information from interested parties.
(4) EPA will evaluate submissions
received under TSCA sections 8(a) and
8(d) reporting requirements, comments
filed on the ITC’s recommendations,
and other information and data
compiled by the Agency.
(5) EPA will make a preliminary staff
determination of the need for testing
and, where testing appears warranted,
will tentatively select the studies to be
performed.
(6) EPA will hold a public meeting to
announce its preliminary testing
determinations.
(c) EPA response to ITC designations
and recommendations—(1) Where a
chemical substance or mixture is
designated for EPA action under section
4(e)(1)(B) of TSCA, the Agency will take
either one of the following actions
within 12 months after receiving the ITC
designation:
(i) Initiate rulemaking proceedings
under section 4(a) of TSCA. Where the
testing recommendations of the ITC
raise unusually complex and novel
issues that require additional Agency
review and opportunity for public
comment, the Agency may initiate
rulemaking by publishing an Advance
Notice of Proposed Rulemaking
(ANPRM).
(ii) Publish a Federal Register notice
explaining the Agency’s reasons for not
initiating such rulemaking proceedings.
EPA may conclude that rulemaking
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proceedings under section 4(a) of TSCA
are unnecessary if it determines that the
findings specified in section 4(a) of
TSCA cannot be made or if the Agency
entered into a consent agreement
requiring the testing identified by the
ITC.
(2) Where a chemical substance or
mixture has been recommended for
testing by the ITC, whether with or
without an intent to designate, EPA will
use its best efforts to act on the ITC’s
recommendations as rapidly as possible
consistent with its other priorities and
responsibilities. EPA may respond to
the ITC’s recommendations with action
such as:
(i) Initiating rulemaking proceedings
under section 4(a) of TSCA,
(ii) Publishing a Federal Register
notice explaining the Agency’s reasons
for concluding that testing is
unnecessary, or
(iii) Entering into a consent agreement
in accordance with this subpart.
■ 4. Section 790.22 is revised to read as
follows:
erowe on DSK5CLS3C1PROD with RULES
§ 790.22 Procedures for developing
consent agreements.
(a) Preliminary EPA evaluation of
proposed consent agreement. Where
EPA believes that testing of a chemical
substance or mixture may be needed,
and wishes to explore whether a
consent agreement may satisfy the
identified testing needs, EPA will invite
manufacturers and/or processors of the
affected chemical substance or mixture
to submit a proposed consent agreement
to EPA. EPA will evaluate the
proposal(s) and may request additional
clarifications of or revisions to the
proposal(s).
(b) Negotiation procedures for consent
agreements. If, after evaluating the
proposed consent agreement(s), EPA
believes it is likely that proceeding with
negotiation of a consent agreement
would be an efficient means of
developing the data, EPA will use the
following procedures to conduct such
negotiations:
(1) In the Federal Register, EPA will
give notice of the availability of the
proposal(s) that is the basis for
negotiation, invite persons interested in
participating in or monitoring
negotiations to contact the Agency in
writing, set a deadline for interested
parties to contact the Agency in writing,
and set a date for the negotiation
meeting(s).
(2) The Agency will meet with
interested parties at the negotiation
meeting(s) for the purpose of attempting
to negotiate a consent agreement. Only
the submitter(s) of the proposal(s) that is
the basis for negotiation and those
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14:00 Sep 15, 2010
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persons who submit written requests to
participate in or monitor negotiations by
the deadline established under
paragraph (b)(1) of this section will be
deemed ‘‘interested parties’’ for purposes
of this section.
(3) All negotiation meetings will be
open to members of the public, but only
interested parties will be permitted to
participate in negotiations. The minutes
of each meeting will be prepared by
EPA. Meeting minutes, the proposed
consent agreement(s), background
documents, and other materials
distributed at negotiation meetings will
be placed in an Internet-accessible
public docket established by EPA.
(4) If EPA concludes at any time that
negotiations are unlikely to produce a
final agreement, EPA will terminate
negotiations and may proceed with
rulemaking. If EPA terminates
negotiations, no further opportunity for
negotiations will be provided. EPA will
notify all interested parties of the
termination.
(5) The period between the first
negotiation meeting and final
agreement, if any (‘‘the negotiation
period’’), will be no longer than 6
months, unless extended prior to its
expiration in accordance with paragraph
(b)(7) of this section. This period will
include all negotiation meetings, and
the processes discussed in paragraphs
(b)(6) and (b)(9) of this section. If the
negotiation period passes without the
production of a final agreement,
negotiations and development of the
subject ECA will terminate
automatically.
(6) EPA will circulate a draft of the
consent agreement to all interested
parties if EPA concludes that such draft
is likely to achieve final agreement. A
period of 30 days will be provided for
submitting comments or written
objections under paragraph (b)(8)(i)(B)
of this section.
(7) If, prior to the expiration of the
negotiation period, final agreement has
not been reached, EPA may at its
discretion provide one or more
extensions, each of which may be up to
60 days, if it seems likely to EPA that
a final agreement will be reached during
that time. EPA will notify all interested
parties of any extension(s).
(8) (i) EPA will enter into consent
agreements only where there is a
consensus among the Agency, one or
more manufacturers and/or processors
who agree to conduct or sponsor the
testing, and all other interested parties
who identify themselves in accordance
with paragraph (b)(2) of this section.
EPA will not enter into a consent
agreement in either of the following
circumstances:
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Fmt 4700
Sfmt 4700
(A) EPA and affected manufacturers
and/or processors cannot reach a
consensus in the timeframe described in
paragraph (b)(5) of this section.
(B) A draft consent agreement is
considered inadequate by other
interested parties who have submitted
timely written objections to the draft
consent agreement, which provide a
specific explanation of the grounds on
which the draft agreement is
objectionable.
(ii) EPA may reject objections
described in paragraph (b)(8)(i)(B) of
this section only where the Agency
concludes the objections:
(A) Are not made in good faith;
(B) Are untimely;
(C) Do not involve the adequacy of the
proposed testing program or other
features of the agreement that may affect
EPA’s ability to fulfill the goals and
purposes of TSCA; or
(D) Are not accompanied by a specific
explanation of the grounds on which the
draft agreement is considered
objectionable.
(iii) The unwillingness of some
manufacturers and/or processors to sign
the draft consent agreement does not, in
itself, establish a lack of consensus if
EPA concludes that those manufacturers
and/or processors who are prepared to
sign the agreement are capable of
accomplishing the testing to be required
and that the draft agreement will
achieve the purposes of TSCA in all
other respects.
(9) Where a consensus exists, as
described in paragraph (b)(8) of this
section, concerning the contents of a
draft consent agreement, the draft
consent agreement will be circulated to
EPA management and the parties that
are to conduct or sponsor testing under
the agreement, for final approval and
signature.
(10) Upon final approval and
signature of a consent agreement, EPA
will publish a Federal Register
document announcing the availability of
the consent agreement and codifying (in
subpart C of 40 CFR part 799) the name
of the chemical substance(s) and/or
mixture(s) to be tested and the citation
to the Federal Register document.
§§ 790.24, 790.26, and 790.28
[Removed]
5. Remove §§ 790.24, 790.26, and
790.28.
■
§ 790.68
[Amended]
6. Remove the cross-reference ‘‘§
790.24’’ in ‘‘§ 790.68(a)(2)’’ and add in its
place ‘‘§ 790.22(b)(8).’’
■
E:\FR\FM\16SER1.SGM
16SER1
Federal Register / Vol. 75, No. 179 / Thursday, September 16, 2010 / Rules and Regulations
Appendix A to subpart E of part 790
[Removed]
[EPA–HQ–OAR–2010–0270; FRL–9202–4]
notice, unless EPA receives adverse
comment by October 18, 2010 If EPA
receives adverse comment, we will
publish a timely withdrawal in the
Federal Register informing the public
that the rule will not take effect.
Similarly, the incorporation by
reference of the published standard
listed in this regulation is approved by
the Director of the Federal Register as of
November 15, 2010 without further
notice, unless EPA receives adverse
comment.
RIN 2060–AQ18
ADDRESSES:
7. Remove Appendix A to subpart E
of part 790.
■
[FR Doc. 2010–23131 Filed 9–15–10 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 1060
Technical Amendments for Marine
Spark-Ignition Engines and Vessels
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
In the final rulemaking for
new exhaust and evaporative emissions
standards for nonroad spark-ignition
engines, vessels, and equipment (73 FR
59034, October 8, 2008), EPA
established first-ever evaporative
emissions standards for marine vessels.
These requirements included portable
marine fuel tanks commonly used in
recreational boating. During their efforts
to certify portable fuel tanks to these
new requirements, manufacturers
working together on systems integration
identified several technical issues with
the performance of the tanks/fuel
systems in use that were not fully
apparent to them before these standards
were developed. Systems integration
work conducted by the fuel tank, boat
and engine manufacturers highlighted
that under some circumstances there
was the potential for fuel spillage to
occur. Work conducted by these parties
indicated that this issue applies to
existing systems and tanks as well as
those built to comply with EPA’s
evaporative emission design standard.
We have engaged the industry to
identify a simple, safe, and emissions
neutral solution to this concern. EPA is
taking direct final action to make
technical amendments to the design
standard for portable tanks that will
allow for this solution. In addition, we
are incorporating safe recommended
practices, developed through industry
consensus, for portable marine fuel
tanks. This action is emissions neutral
with respect to the diurnal emissions
standard; however, to the extent that it
helps reduce fuel spillage, incorporating
safe recommended practices will result
in a net benefit to the environment and
lead to fuel savings.
DATES: This rule is effective on
November 15, 2010 without further
erowe on DSK5CLS3C1PROD with RULES
SUMMARY:
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14:00 Sep 15, 2010
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Submit your comments,
identified by Docket ID No. EPA–HQ–
OAR–2010–0270, by one of the
following methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• E-mail: a-and-r-docket@epa.gov.
• Fax: (202) 566–9744.
• Mail: Environmental Protection
Agency, Air Docket, Mail-Code 6102T,
1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In addition,
please mail a copy of your comments on
the information collection provisions to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget (OMB), Attn: Desk Officer for
EPA, 725 17th St., NW., Washington, DC
20503.
• Hand Delivery: EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington,
DC, Attention Docket No. EPA–HQ–
OAR–2010–0270. Such deliveries are
only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OAR–2010–
0270. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or e-mail. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an e-mail
comment directly to EPA without going
through www.regulations.gov your email address will be automatically
captured and included as part of the
comment that is placed in the public
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Fmt 4700
Sfmt 4700
56477
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://www.
epa.gov/epahome/dockets.htm. For
additional instructions on submitting
comments, go to Unit III of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: All documents in the docket
are listed in the www.regulations.gov
index. Although listed in the index,
some information is not publicly
available, e.g., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
either electronically in
www.regulations.gov or in hard copy at
the ‘‘Technical Amendments for Marine
Spark-Ignition Engines and Vessels’’
Docket, EPA/DC, EPA West, Room 3334,
1301 Constitution Ave., NW.,
Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number
for the Public Reading Room is (202)
566–1744, and the telephone number for
the ‘‘Technical Amendments for Marine
Spark-Ignition Engines and Vessels’’
Docket is (202) 566–2426.
FOR FURTHER INFORMATION CONTACT:
Michael Samulski, Environmental
Protection Agency, Office of
Transportation and Air Quality,
Assessment and Standards Division,
2000 Traverwood Drive, Ann Arbor,
Michigan 48105; telephone number:
734–214–4532; fax number: 734–214–
4050; e-mail address:
samulski.michael@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Why is EPA using a Direct Final
Rule?
EPA is publishing this rule without a
prior proposed rule because we view
this as a noncontroversial action and
anticipate no adverse comment.
However, in the ‘‘Proposed Rules’’
section of today’s Federal Register, we
are publishing a separate document that
will serve as the proposed rule to adopt
E:\FR\FM\16SER1.SGM
16SER1
Agencies
[Federal Register Volume 75, Number 179 (Thursday, September 16, 2010)]
[Rules and Regulations]
[Pages 56472-56477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23131]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 790
[EPA-HQ-OPPT-2009-0894; FRL-8832-8]
RIN 2070-AJ59
Amendments to Enforceable Consent Agreement Procedural Rules
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is revising the procedures for developing Enforceable
Consent Agreements (ECAs) to generate test data under the Toxic
Substances Control Act (TSCA). The main features of the ECA process
that EPA is changing include when and how to initiate negotiations and
inserting a firm deadline at which negotiations will terminate. EPA is
also deleting, modifying, or consolidating several sections of 40 CFR
part 790 to place the ECA provisions in one section and the Interagency
Testing Committee (ITC) provisions in a separate section, to make it
clearer that there is one ECA negotiation procedure applicable to all
circumstances when an ECA would be appropriate, and to make conforming
changes in other sections that reference the ECA procedures.
DATES: This final rule is effective October 18, 2010.
[[Page 56473]]
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2009-0894. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number of the EPA/DC Public Reading Room is
(202) 566-1744, and the telephone number for the OPPT Docket is (202)
566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Jessica Barkas, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 250-8880; e-mail address: barkas.jessica@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process chemical substances
or mixtures (defined as ``chemical'' in 40 CFR part 790). Potentially
affected entities may include, but are not limited to:
Manufacturers (defined by statute to include importers) of
chemical substances (NAIC codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
Processors of chemical substances (NAIC codes 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
II. Background
A. What is the Agency's Authority for Taking this Action?
Section 4 of TSCA authorizes EPA to require manufacturers and
processors of chemical substances and mixtures to test these chemical
substances to generate data that is relevant to determining whether the
chemical substances present an unreasonable risk. Section 4(a) of TSCA
empowers the Agency to promulgate rules which require such testing.
Section 4 of TSCA provides implied authority to enter into ECAs
requiring testing where such agreements provide procedural safeguards
equivalent to those that apply where testing is conducted by rule.
B. What Action is the Agency Taking?
EPA is finalizing a rule revising the procedures for initiating and
negotiating an ECA. ECAs are enforceable agreements between EPA and one
or more chemical manufacturers or processors to conduct specific
testing on a particular chemical substance. These agreements are
designed to provide EPA with data identified as necessary to evaluate a
particular chemical substance without the need for EPA to first make
the risk- or exposure-based findings for, or promulgate, a TSCA section
4 test rule, and without introducing delays inherent in the rulemaking
process. ECAs were intended to permit EPA to obtain test data more
quickly than test rules, while preserving opportunity for input from
the public and the affected manufacturer(s).
The main features of the ECA process that EPA is changing include
when and how to initiate negotiations and inserting a firm deadline at
which negotiations will terminate. EPA is also deleting, modifying, or
consolidating several parts of 40 CFR part 790 to place the ECA
provisions in one section and the ITC provisions in a separate section,
to make it clearer that there is one ECA negotiation procedure
applicable to all circumstances when an ECA would be appropriate, and
to make conforming changes in other sections that reference the ECA
procedures.
The proposed rule was published in the Federal Register of February
19, 2010 (75 FR 7428) (FRL-8802-6). Additional detail about ECAs, the
specific changes, and the rationale for those changes can be found in
that Federal Register document. One comment was received on the
proposed rule. No changes have been made to the rule since it was
proposed.
C. What Was EPA's Response to Comment?
The comment period for the proposed rule ended on March 22, 2010.
One comment was received, from the American Chemistry Council (ACC).
The ACC comments indicated support for the ECA procedural changes, and
had a few specific suggestions:
Comment 1: EPA should include in the ECA rule what ``office or
program and level of management within EPA will have the organizational
authority to officially speak on behalf of the Agency on such perceived
[testing] needs, and how EPA will communicate this request to industry
and through what vehicle.''
EPA response: Under the current delegation, the EPA Assistant
Administrator for the Office of Chemical Safety and Pollution
Prevention (OCSPP) (formerly the Office of Prevention, Pesticides and
Toxic Substances (OPPTS)) has the authority to make the final decision
on whether testing is necessary under TSCA section 4. As explained in
the preamble to the proposed rule, EPA will invite testing proposals
through Federal Register documents, EPA's website, and other forms of
public communication. Depending on the circumstances (e.g., the size
and geographical distribution of the group potentially required to
conduct testing), EPA may use more than one of these methods, as
necessary to reach the affected companies. For instance, one of the
public forms of communication that EPA may use is speeches or
presentations by Agency officials at industry conferences, where
representatives from individual companies and trade associations will
be present, and able to pass the word along to their companies and
members. Of course, individual companies, trade associations and other
organizations, and their representatives can always
[[Page 56474]]
contact EPA, using the contact information provided in the Federal
Register document, EPA website, or other public communication of
testing needs, with questions about specific testing requirements and
other details for individual chemical substances.
Comment 2: EPA should describe in greater detail what EPA believes
should be contained in the proposed consent agreement.
EPA response: The testing needs, timeline, and other details will
necessarily vary for each individual chemical substance, so it is
impossible for EPA to generalize about what will form an adequate
proposal in each circumstance. The standard provisions that must be
included in all consent agreements are listed in 40 CFR 790.60,
``Contents of consent agreements,'' which this action will not change.
Again, individual companies, trade associations, and other
organizations, and their representatives can always contact EPA, using
the contact information provided in the Federal Register document, EPA
website, or other public communication of testing needs, with questions
about specific testing requirements and other details for individual
chemicals. In addition, as stated in the rule, ``EPA may request
additional clarifications of or revisions to the proposal(s).'' This
statement in the rule makes it explicit that submitters will have an
opportunity to clarify, correct, and otherwise revise their
proposal(s), if EPA decides that clarification is needed, or the
proposal needs expansion or elaboration to adequately meet testing
needs.
Comment 3: The ECA procedures should include a provision that would
permit the Agency to agree to an ECA where some or most, but not all,
data needs might be filled.
EPA response: There is nothing in the original or revised ECA
procedural rules that would prohibit EPA from agreeing to an ECA that
covers some, but not all, needed testing, then pursuing a test rule or
follow-up ECA, to fill remaining data needs--if no other interested
parties submit a timely written objection, and if EPA concludes that
such a multi-part process is likely to be an efficient and successful
means of obtaining the needed test data.
III. Statutory and Executive Order Reviews
A. Regulatory Review
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this final rule is not a ``significant
regulatory action'' subject to review under Executive Order 12866,
because it does not meet the criteria in section 3(f)(4) of the
Executive Order. Accordingly, EPA did not submit this final rule to OMB
for review under Executive Order 12866.
B. Paperwork Reduction Act
This action does not impose any new information collection burden,
because the development of the ECA regulations does not involve
information collection activities as defined by the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq. However, the information collection
requirements contained in an ECA are already approved by OMB pursuant
to PRA under OMB control number 2070-0033 (EPA ICR No. 1139). Under
PRA, an agency may not conduct or sponsor, and a person is not required
to respond to, an information collection request unless it displays a
currently valid control number assigned by OMB. The OMB control numbers
for EPA's regulations in title 40 of the CFR are listed in 40 CFR part
9, and will be included in the individual ECAs.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), after considering the potential economic
impacts of this final rule on small entities, the Agency hereby
certifies that this final rule would not have a significant adverse
economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and
small governmental jurisdictions. For purposes of assessing the impacts
of this final rule on small entities, small entity is defined as:
1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
This action will not have a significant economic impact on a
substantial number of small entities. In determining whether a final
rule has a significant economic impact on a substantial number of small
entities, the impact of concern is any significant adverse economic
impact on small entities, since the primary purpose of regulatory
flexibility analysis is to identify and address regulatory alternatives
``which minimize any significant economic impact of the rule on small
entities.'' 5 U.S.C. 603 and 604. Thus, an agency may certify that a
final rule will not have a significant economic impact on a substantial
number of small entities if the final rule relieves regulatory burden,
or otherwise has a positive economic effect on all of the small
entities subject to the final rule.
The changes discussed in this document are expected to streamline
and improve the ECA procedures in a way that will benefit all
participants. EPA has therefore concluded that this final rule will not
have any adverse impacts on affected small entities. EPA did not
receive any comments on the proposed rule regarding the impact on small
entities.
D. Unfunded Mandates Reform Act
This action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), (2 U.S.C. 1531-1538). Therefore, this action
is not subject to the requirements of UMRA.
E. Federalism
Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this final rule does
not have ``federalism implications,'' because it will not 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, as
specified in Executive Order 13132. Thus, Executive Order 13132 does
not apply to this final rule.
F. Tribal Implications
Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has
determined that this final rule does not have tribal implications
because it will not have any effect on tribal governments, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in the Order. Thus,
Executive Order 13175 does not apply to this action.
G. Children's Health Protection
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997), does not apply to this action because this is not designated as
an
[[Page 56475]]
``economically significant'' regulatory action as defined by Executive
Order 12866 (see Unit III.A.), nor does this action establish an
environmental standard that is intended to have a disproportionate
effect on children. To the contrary, this action will revise procedures
which will facilitate the development of data and information that EPA
and others can use to assess the risks of chemical substances,
including potential risks to children.
H. Energy Effects
This action is not subject to Executive Order 13211, entitled
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use.
I. Technology Standards
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), section 12(d) (15 U.S.C. 272 note), directs EPA to
use voluntary consensus standards in its regulatory activities unless
to do so would be inconsistent with applicable law or otherwise
impractical. Voluntary consensus standards are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by voluntary
consensus standards bodies. The NTTAA directs EPA to provide Congress,
through OMB, explanations when the Agency decides not to use available
and applicable voluntary consensus standards.
This final rule does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards.
J. Environmental Justice
This action does not involve special considerations of
environmental justice related issues as delineated by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
IV. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 790
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 8, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
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Therefore, 40 CFR chapter I is amended as follows:
PART 790--[AMENDED]
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1. The authority citation for part 790 continues to read as follows:
Authority: 15 U.S.C. 2603.
Sec. 790.1 [Amended]
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2. Section 790.1 is amended by removing the last sentence of paragraph
(c) and by removing paragraph (d).
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3. Section 790.20 is revised to read as follows:
Sec. 790.20 Recommendation, recommendation with an intent to
designate, and designation of testing candidates by the ITC.
(a) ITC recommendations and recommendations with intent to
designate. The ITC has advised EPA that it will discharge its
responsibilities under section 4(e) of TSCA in the following manner:
(1) When the ITC identifies a chemical substance or mixture that it
believes should receive expedited consideration by EPA for testing, the
ITC may add the substance or mixture to its list of chemicals
recommended for testing and include a statement that the ITC intends to
designate the substance or mixture for action by EPA in accordance with
section 4(e)(1)(B) of TSCA.
(2) Chemical substances or mixtures selected for expedited review
under paragraph (a)(1) of this section may, at a later time, be
designated for EPA action within 12 months of such designation. The
ITC's subsequent decision would be based on the ITC's review of TSCA
sections 8(a) and 8(d) data and other relevant information.
(3) Where the ITC concludes that a chemical substance or mixture
warrants testing consideration but that expedited EPA review of testing
needs is not justified, the ITC will add the substance or mixture to
its list of testing recommendations without expressing an intent to
designate the substance or mixture for EPA action in accordance with
section 4(e)(1)(B) of TSCA.
(4) The ITC reserves its right to designate any chemical substance
or mixture that it determines the Agency should, within 12 months of
the date first designated, initiate a proceeding under section 4(a) of
TSCA.
(b) Preliminary EPA evaluation of ITC recommendations with intent
to designate. Following receipt of an ITC report containing a
recommendation with an intent to designate, EPA will use the following
procedure for completing a preliminary evaluation of testing needs on
those chemical substances that the ITC has recommended with intent to
designate:
(1) EPA will publish the ITC report in the Federal Register and
announce that interested persons have 30 days to submit comments on the
ITC's testing recommendations.
(2) EPA will publish a Federal Register document adding all ITC-
recommended chemicals to the automatic reporting provisions of its
rules under sections 8(a) and 8(d) of TSCA (40 CFR parts 712 and 716).
(3) EPA will hold a public ``focus meeting'' to discuss the ITC's
testing recommendations and obtain comments and information from
interested parties.
(4) EPA will evaluate submissions received under TSCA sections 8(a)
and 8(d) reporting requirements, comments filed on the ITC's
recommendations, and other information and data compiled by the Agency.
(5) EPA will make a preliminary staff determination of the need for
testing and, where testing appears warranted, will tentatively select
the studies to be performed.
(6) EPA will hold a public meeting to announce its preliminary
testing determinations.
(c) EPA response to ITC designations and recommendations--(1) Where
a chemical substance or mixture is designated for EPA action under
section 4(e)(1)(B) of TSCA, the Agency will take either one of the
following actions within 12 months after receiving the ITC designation:
(i) Initiate rulemaking proceedings under section 4(a) of TSCA.
Where the testing recommendations of the ITC raise unusually complex
and novel issues that require additional Agency review and opportunity
for public comment, the Agency may initiate rulemaking by publishing an
Advance Notice of Proposed Rulemaking (ANPRM).
(ii) Publish a Federal Register notice explaining the Agency's
reasons for not initiating such rulemaking proceedings. EPA may
conclude that rulemaking
[[Page 56476]]
proceedings under section 4(a) of TSCA are unnecessary if it determines
that the findings specified in section 4(a) of TSCA cannot be made or
if the Agency entered into a consent agreement requiring the testing
identified by the ITC.
(2) Where a chemical substance or mixture has been recommended for
testing by the ITC, whether with or without an intent to designate, EPA
will use its best efforts to act on the ITC's recommendations as
rapidly as possible consistent with its other priorities and
responsibilities. EPA may respond to the ITC's recommendations with
action such as:
(i) Initiating rulemaking proceedings under section 4(a) of TSCA,
(ii) Publishing a Federal Register notice explaining the Agency's
reasons for concluding that testing is unnecessary, or
(iii) Entering into a consent agreement in accordance with this
subpart.
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4. Section 790.22 is revised to read as follows:
Sec. 790.22 Procedures for developing consent agreements.
(a) Preliminary EPA evaluation of proposed consent agreement. Where
EPA believes that testing of a chemical substance or mixture may be
needed, and wishes to explore whether a consent agreement may satisfy
the identified testing needs, EPA will invite manufacturers and/or
processors of the affected chemical substance or mixture to submit a
proposed consent agreement to EPA. EPA will evaluate the proposal(s)
and may request additional clarifications of or revisions to the
proposal(s).
(b) Negotiation procedures for consent agreements. If, after
evaluating the proposed consent agreement(s), EPA believes it is likely
that proceeding with negotiation of a consent agreement would be an
efficient means of developing the data, EPA will use the following
procedures to conduct such negotiations:
(1) In the Federal Register, EPA will give notice of the
availability of the proposal(s) that is the basis for negotiation,
invite persons interested in participating in or monitoring
negotiations to contact the Agency in writing, set a deadline for
interested parties to contact the Agency in writing, and set a date for
the negotiation meeting(s).
(2) The Agency will meet with interested parties at the
negotiation meeting(s) for the purpose of attempting to negotiate a
consent agreement. Only the submitter(s) of the proposal(s) that is the
basis for negotiation and those persons who submit written requests to
participate in or monitor negotiations by the deadline established
under paragraph (b)(1) of this section will be deemed ``interested
parties'' for purposes of this section.
(3) All negotiation meetings will be open to members of the public,
but only interested parties will be permitted to participate in
negotiations. The minutes of each meeting will be prepared by EPA.
Meeting minutes, the proposed consent agreement(s), background
documents, and other materials distributed at negotiation meetings will
be placed in an Internet-accessible public docket established by EPA.
(4) If EPA concludes at any time that negotiations are unlikely to
produce a final agreement, EPA will terminate negotiations and may
proceed with rulemaking. If EPA terminates negotiations, no further
opportunity for negotiations will be provided. EPA will notify all
interested parties of the termination.
(5) The period between the first negotiation meeting and final
agreement, if any (``the negotiation period''), will be no longer than
6 months, unless extended prior to its expiration in accordance with
paragraph (b)(7) of this section. This period will include all
negotiation meetings, and the processes discussed in paragraphs (b)(6)
and (b)(9) of this section. If the negotiation period passes without
the production of a final agreement, negotiations and development of
the subject ECA will terminate automatically.
(6) EPA will circulate a draft of the consent agreement to all
interested parties if EPA concludes that such draft is likely to
achieve final agreement. A period of 30 days will be provided for
submitting comments or written objections under paragraph (b)(8)(i)(B)
of this section.
(7) If, prior to the expiration of the negotiation period, final
agreement has not been reached, EPA may at its discretion provide one
or more extensions, each of which may be up to 60 days, if it seems
likely to EPA that a final agreement will be reached during that time.
EPA will notify all interested parties of any extension(s).
(8) (i) EPA will enter into consent agreements only where there is
a consensus among the Agency, one or more manufacturers and/or
processors who agree to conduct or sponsor the testing, and all other
interested parties who identify themselves in accordance with paragraph
(b)(2) of this section. EPA will not enter into a consent agreement in
either of the following circumstances:
(A) EPA and affected manufacturers and/or processors cannot reach a
consensus in the timeframe described in paragraph (b)(5) of this
section.
(B) A draft consent agreement is considered inadequate by other
interested parties who have submitted timely written objections to the
draft consent agreement, which provide a specific explanation of the
grounds on which the draft agreement is objectionable.
(ii) EPA may reject objections described in paragraph (b)(8)(i)(B)
of this section only where the Agency concludes the objections:
(A) Are not made in good faith;
(B) Are untimely;
(C) Do not involve the adequacy of the proposed testing program or
other features of the agreement that may affect EPA's ability to
fulfill the goals and purposes of TSCA; or
(D) Are not accompanied by a specific explanation of the grounds on
which the draft agreement is considered objectionable.
(iii) The unwillingness of some manufacturers and/or processors to
sign the draft consent agreement does not, in itself, establish a lack
of consensus if EPA concludes that those manufacturers and/or
processors who are prepared to sign the agreement are capable of
accomplishing the testing to be required and that the draft agreement
will achieve the purposes of TSCA in all other respects.
(9) Where a consensus exists, as described in paragraph (b)(8) of
this section, concerning the contents of a draft consent agreement, the
draft consent agreement will be circulated to EPA management and the
parties that are to conduct or sponsor testing under the agreement, for
final approval and signature.
(10) Upon final approval and signature of a consent agreement, EPA
will publish a Federal Register document announcing the availability of
the consent agreement and codifying (in subpart C of 40 CFR part 799)
the name of the chemical substance(s) and/or mixture(s) to be tested
and the citation to the Federal Register document.
Sec. Sec. 790.24, 790.26, and 790.28 [Removed]
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5. Remove Sec. Sec. 790.24, 790.26, and 790.28.
Sec. 790.68 [Amended]
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6. Remove the cross-reference ``Sec. 790.24'' in ``Sec.
790.68(a)(2)'' and add in its place ``Sec. 790.22(b)(8).''
[[Page 56477]]
Appendix A to subpart E of part 790 [Removed]
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7. Remove Appendix A to subpart E of part 790.
[FR Doc. 2010-23131 Filed 9-15-10 8:45 am]
BILLING CODE 6560-50-S