[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Rules and Regulations]
[Pages 66729-66733]
[FR Doc No: 2012-26970]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2012-0738; FRL-9713-1]
RIN 2050-AG73

National Oil and Hazardous Substances Pollution Contingency Plan;
Revision To Increase Public Availability of the Administrative Record
File

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to amend the National Oil
and Hazardous Substances Pollution Contingency Plan (NCP), to
acknowledge advancements in technologies used to manage and convey
information to the public. Specifically, this revision will add
language to EPA regulations to broaden the technology, to include
computer telecommunications or other electronic means, that the lead
agency is permitted to use to make the administrative record file
available to the public. By updating the language used to describe
permitted technology, the lead agency will be able to serve the
information needs of a broader population, while maintaining the
ability to provide traditional means

of public access to the administrative record file, such as paper
copies and microform. The lead agency should assess the capacity and
resources of the public to utilize and maintain an electronic- or
computer telecommunications-based repository to make a decision on
which approach suits a specific site.

DATES: This rule is effective on February 5, 2013 without further
notice, unless EPA receives adverse comment by December 7, 2012. 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.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-2012-0738, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (EPA/DC), Superfund Docket, Mailcode: 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Ave. NW., Washington, DC 20460. Attention
Docket ID No. EPA-HQ-SFUND-2012-0738. 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-SFUND-
2012-0738. 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 email. 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 email 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 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 http://www.epa.gov/epahome/dockets.htm.
    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 Superfund Docket (Docket
ID No. EPA-HQ-SFUND-2012-0738). This Docket Facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
Superfund Docket telephone number is<PHONE_NUMBER>. EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301 Constitution Ave. NW., Washington,
DC.

FOR FURTHER INFORMATION CONTACT: For general information, contact the
Superfund, TRI, EPCRA, RMP and Oil Information Center at<PHONE_NUMBER>
or TDD<PHONE_NUMBER> (hearing impaired). In the Washington, DC
metropolitan area, call<PHONE_NUMBER> or TDD<PHONE_NUMBER>. For more
detailed information on specific aspects of this direct final rule,
contact Melissa Dreyfus at<PHONE_NUMBER> (dreyfus.melissa@epa.gov),
U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460-0002, Mail Code 5204P.

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 as this action merely adds language to 40 CFR 300.805(c) of the
NCP to broaden the technology, to include computer telecommunications
or other electronic means, that the lead agency is permitted to use to
make the administrative record file available to the public. By
updating language used to describe permitted technology, the lead
agency will be able to serve the information needs of a broader
population, while maintaining the ability to provide traditional means
of public access, such as paper copies and microform, to the
administrative record file. However, in the ``Proposed Rules'' section
of today's Federal Register, we are also publishing a separate proposed
rule to add language to broaden the technology that the lead agency is
permitted to use to make the administrative record file available to
the public under 40 CFR 300.805(c), if adverse comments are received on
this direct final rule. We will not institute a second comment period
on this action. Any parties interested in commenting must do so at this
time. For further information about commenting on this rule, see the
ADDRESSES section of this document.
    If EPA receives adverse comment, we will publish a timely
withdrawal in the Federal Register informing the public that this
direct final rule will not take effect. We would address all public
comments in any subsequent final rule based on the proposed rule.

II. What should I consider as I prepare my comments for EPA?

    A. Submitting Confidential Business Information (CBI). Do not
submit this information to EPA through www.regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with the procedures set forth in 40 CFR
part 2.
    B. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.

     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible.
     Make sure to submit your comments by the comment period
deadline identified.

III. Background

A. What is CERCLA?

    In 1980, Congress enacted the Comprehensive Environmental Response,
Compensation, and Liability Act, 42 U.S.C. 9601-9675 (``CERCLA'' or
``the Act''), in response to releases or substantial threats of
releases of hazardous substances into the environment or releases or
substantial threats of releases into the environment of any pollutant
or contaminant which may present an imminent and substantial danger to
the public health or welfare.

B. What is the National contingency plan?

    To implement CERCLA, EPA promulgated the revised National Oil and
Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300,
on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and
Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets
guidelines and procedures for responding to releases or substantial
threats of releases of hazardous substances into the environment and
releases or substantial threats of releases into the environment of any
pollutant or contaminant that may present an imminent or substantial
danger to the public health or welfare. EPA has revised the NCP on
several occasions. The most recent comprehensive revision was on March
8, 1990 (55 FR 8666).

C. What is the administrative record?

    Under CERCLA section 113(k)(1) and 40 CFR 300.800(a), the lead
agency is required to establish an administrative record that ``* * *
contains the documents that form the basis for the selection of a
response action.'' These documents are further described in 40 CFR
300.810. In addition, CERCLA section 113(k)(2)(A) requires that EPA
establish ``* * * procedures for the appropriate participation of
interested persons in the development of the administrative record * *
* '' for a removal action. For remedial actions, EPA ``* * * shall
provide for the participation of interested persons, including
potentially responsible parties, in the development of the
administrative record * * *'' CERCLA section 113(k)(2)(B). That is, EPA
should provide the public with an opportunity to participate in the
selection of a response action. In addition, CERCLA section 117
requires EPA to allow for public comment on certain aspects of a
proposed remedial action. Participation by interested persons
(including affected communities) ensures that EPA (or the lead agency,
if not EPA) has considered the concerns of the public, including
potentially responsible parties (PRPs), in the selection of a response
action.

D. How is the administrative record file \1\ made available to the
public?
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    \1\ Typically, EPA refers to the administrative record as the
``administrative record file'' until EPA has selected a particular
response action, to avoid creating the impression that the record is
complete at any time prior to the final selection decision. See 55
FR 8666, 8804-5 (March 6, 1990) (National Oil and Hazardous
Substances Pollution Contingency Plan Preamble).
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    CERCLA section 113(k)(1) requires that a copy of the administrative
record be available to the public ``* * * at or near the facility at
issue.'' 40 CFR 300.805(a). In addition, a docket containing the
administrative record file should be located at the Regional office or
other central location. 40 CFR 300.805(a). In the case of an emergency
removal, the administrative record need only be available for public
inspection at the central location, unless otherwise requested (e.g.,
by a member of the public). 40 CFR 300.805(a)(5), 300.805(b).
Reflective of the technology available at the time of the last revision
to the NCP (March 8, 1990 (55 FR 8666)), the ``lead agency may make the
administrative record file available to the public in microform.'' 40
CFR 300.805(c).
    The administrative record file located at or near the site should
be placed in one of the information repositories that may already exist
for community involvement purposes. An information repository contains
documents that relate to a Superfund site and the Superfund program in
general. An information repository is required at all remedial action
sites and any site where a removal action is likely to extend beyond
120 days. See 40 CFR 300.430(c)(2)(iii), 300.415(n)(3)(iii),
300.415(n)(4)(i). The information repository may contain information
beyond the scope of the administrative record, since the documents in
the administrative record file relate to a particular response action
selection decision at a site. For example, an information repository
might contain copies of site-specific press releases or public fact
sheets.

E. What does this amendment do?

    This direct final rule amends 40 CFR 300.805(c)--Location of the
Administrative Record File in Subpart I--Administrative Record for
Selection of Response Action of the National Oil and Hazardous
Substances Pollution Contingency Plan, to acknowledge advancements in
technologies used to manage and convey information to the public.
Specifically, this revision will add language to broaden the
technology, to include computer telecommunications or other electronic
means, that the lead agency is permitted to use to make the
administrative record file available to the public regarding documents
that form the basis for the selection of a response action. This
amendment does not limit the lead agency's ability to make the
administrative record file available to the public in traditional forms
such as paper and microform. The lead agency should assess the capacity
and resources of the public to utilize and maintain an electronic- or
computer telecommunications-based repository to make a decision on
which approach suits a specific site. Based on the preferences of the
community and the lead agency's assessment of the site-specific
situation, the lead agency will determine whether to provide: (1)
Traditional forms (e.g. paper copies; microform) (2) electronic
resources, or (3) both traditional forms and electronic resources.

F. What is the basis for this amendment?

    Since the passage of the CERCLA \2\, as amended, the Federal
government has made strides in encouraging electronically-available
data. For example, the Electronic Freedom of Information Act Amendments
of 1996,\3\ amending section 552(a) of title 5, United States Code,
popularly known as the Freedom of Information Act, provides for public
access to information in an electronic format. Specifically, ``For
records created on or after November 1, 1996, within one year after
such date, each agency shall make such records available, including by
computer telecommunications or, if

computer telecommunications means have not been established by the
agency, by other electronic means.'' \4\ In addition, ``* * * an agency
shall provide the record in any form or format requested by the person
if the record is readily reproducible by the agency in that form or
format. Each agency shall make reasonable efforts to maintain its
records in forms or formats that are reproducible for purposes of this
section.'' \5\
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    \2\ 42 U.S.C. 9601-9675, as amended.
    \3\ The Freedom of Information Act, 5 U.S.C. 552, As Amended By
Public Law No. 104-231, 110 Stat. 3048. Available online: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm.
    \4\ Ibid. section 552(a)(2).
    \5\ Ibid. section 552(a)(3)(B).
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    As of 2010, 99% of the over 16,800 public libraries in the U.S. had
public computers connected to the internet, with an average of 16
computer stations per library. Over 85% of these libraries had public
wireless internet access, with approximately 6% planning to add access
over the next year.\6\ However, the presence of an electronic- or
computer telecommunications-based repository does not preclude
establishing a traditional paper-based repository. The lead agency
should always assess the capacity and resources of the specific
community to utilize and maintain an electronic- or computer
telecommunications-based repository. Based on the preferences of the
community and the lead agency's assessment of the site-specific
situation, the lead agency will determine whether to provide: (1)
Traditional forms (e.g. paper copies; microform) (2) electronic
resources, or (3) both traditional forms and electronic resources.
Community preferences and access to technological resources may be
gleaned through community interviews conducted as part of the planning
for the Community Involvement Plan at a site.\7\ In addition, in
accordance with Section 508 of the Rehabilitation Act of 1973, as
amended, the lead agency is responsible for ensuring that all
electronic and information technology is accessible to persons with
disabilities. This involves procuring, creating, maintaining and using
electronic and information technology, including, Web sites, software,
hardware, video and multimedia, and telecommunications, that is Section
508 compliant,\8\ as well as incorporating other techniques to ensure
accessibility.
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    \6\ U.S. Census Bureau. 2010. Table 1154: Public Library Use of
Internet: 2009 and 2010. In: Statistical Abstract of the United
States, 2011 (30th Edition): Information & Communications: Internet
Service Providers, Data Processing & Libraries. Available online:
http://www.census.gov/compendia/statab/cats/information_communications/internet_service_providers_data_processing_libraries.html.
    \7\ U.S. Environmental Protection Agency. 2011. Superfund
Community Involvement Toolkit. Community Involvement Plans.
Available online: http://www.epa.gov/superfund/community/pdfs/toolkit/ciplans.pdf.
    \8\ Further information on Section 508 is available online:
http://www.section508.gov.
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EPA's Assessment of Superfund Information Repositories
    EPA conducted an assessment of Superfund information repositories
(IR) as part of the Office of Solid Waste and Emergency Response
Community Engagement Initiative, Action 13, Part B.\9\ While site
information repositories were traditionally paper copies of documents
maintained at locations near Superfund sites, today there are varying
degrees of usage of electronic resources to store information,
including CDs, DVDs and Web sites. For this assessment, EPA was
interested in how the repositories are organized and maintained, as
well as investigating how current technological resources could be
utilized to improve public accessibility to Superfund site information
and the general cost and time associated with maintaining a repository.
The approach adopted for this assessment consisted of two distinct
studies: (1) A survey of EPA regional practices for establishing and
maintaining information repositories, and (2) an on-site assessment of
the content, completeness, and organization of information
repositories. The on-site assessment consisted of visits to 28
information repositories in five EPA regions to assess the content,
completeness, and organization of the repositories. A complete account
of the information repository assessment and findings can be found in
the Superfund Information Repository Assessment Report (Assessment
Report).\10\
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    \9\ Access information on EPA's Community Engagement Initiative
online: http://www.epa.gov/oswer/engagementinitiative/.
    \10\ Access EPA's Superfund Information Repository Assessment
Report online: http://www.epa.gov/oswer/engagementinitiative/rr13b.pdf.
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    This assessment found that despite the careful attention and time
dedicated to appropriately locating and maintaining an information
repository, it appears to be an under-utilized and outdated source of
information for most communities. In general, community members inquire
about information repositories relatively infrequently (between 1-6
times per year). The frequency of repository use seems to be highest
for newly listed National Priorities List (NPL) sites and during the
pre-Record of Decision phase in the Superfund remedial process. New
materials and instructions are sent by the lead agency to the
repository, and the repository staff is responsible for adding and
removing documents. Due to the variation in organization and
maintenance of repositories, there can be inconsistency between
repositories. Most repositories contain useful information and are
organized in such a way that specific documents can be found. However,
some repositories lack important documents or are poorly organized due
to public usage over the years.
    In almost all repositories visited for this assessment, computers
are available. Some of these computers did not have CD drives to avoid
the introduction of viruses into the library computer system, or the CD
drives were not functional. All of the libraries that were visited had
internet access.
    Permitting the lead agency to provide the administrative record
file to the public via computer telecommunications or other electronic
means could help to alleviate situations with document access that have
been known to sometimes occur with disorganized or misplaced paper
files. Electronic access to site documents will also make this
information more widely available and accessible to a broader public
audience. The presence of an electronic- or computer
telecommunications-based repository does not preclude establishing a
traditional paper-based repository. The lead agency should always
assess the capacity and resources of the specific community to utilize
and maintain an electronic- or computer telecommunications-based
repository to make a decision on which approach suits a specific site.
Based on the preferences of the community and the lead agency's
assessment of the site-specific situation, the lead agency will
determine whether to provide: (1) Traditional forms (e.g. paper copies;
microform) (2) electronic resources, or (3) both traditional forms and
electronic resources. Community preferences and access to technological
resources may be gleaned through community interviews or community
technical needs assessments conducted as part of the planning for the
Community Involvement Plan at a site.\11\
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    \11\ U.S. Environmental Protection Agency. 2011. Superfund
Community Involvement Toolkit. Community Involvement Plans.
Available online: http://www.epa.gov/superfund/community/pdfs/toolkit/ciplans.pdf.
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IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993) and
Executive Order 13563 (76 FR 3821, January 21, 2011), this action is
not a ``significant regulatory action'' and is therefore not

subject to OMB review. This action merely adds language to 40 CFR
300.805(c) of the NCP to broaden the technology, to include computer
telecommunications or other electronic means, that the lead agency is
permitted to use to make the administrative record file available to
the public. This action will enable the lead agency to serve the
information needs of a broader population while maintaining the ability
to provide traditional means of public access, such as paper copies and
microform, to the administrative record file. This action does not
impose any requirements on any entity, including small entities.
Therefore, pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.), after considering the economic impacts of this action on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This action
does not contain any unfunded mandates or significantly or uniquely
affect small governments as described in Sections 202 and 205 of the
Unfunded Mandates Reform Act of 1999 (UMRA) (Pub. L. 104-4). This
action does not create new binding legal requirements that
substantially and directly affect Tribes under Executive Order 13175
(63 FR 67249, November 9, 2000). This action does not have significant
Federalism implications under Executive Order 13132 (64 FR 43255,
August 10, 1999). Because this action has been exempted from review
under Executive Order 12866, this final rule 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) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This action does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). This action does not
involve technical standards; thus, the requirements of Section 12(d) of
the National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
272) do not apply. The Congressional Review Act, 5 U.S.C. 801 et seq.,
generally provides that before certain actions may take effect, the
agency promulgating the action must submit a report, which includes a
copy of the action, to each House of the Congress and to the
Comptroller General of the United States. Because this action does not
contain legally binding requirements, it is not subject to the
Congressional Review Act.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: October 26, 2012
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste and Emergency Response.

    For the reasons set out above, title 40, chapter I of the Code of
Federal Regulations is amended as follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp.,p.351; E.O. 12580, 52 FR 2923,
3 CFR, 1987 Comp., p.193.

0
2. Section 300.805 is amended by revising paragraph (c) to read as
follows:

Sec.  300.805  Location of the administrative record file.

* * * * *
    (c) The lead agency may make the administrative record file
available to the public in microform, computer telecommunications, or
other electronic means.

[FR Doc. 2012-26970 Filed 11-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Notices]
[Pages 58319-58321]
[FR Doc No: 2011-24028]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65339]

 Order Granting Temporary Exemption of Kroll Bond Rating Agency,
Inc. From the Conflict of Interest Prohibition in Rule 17g-5(c)(1) of
the Securities Exchange Act of 1934

September 14, 2011.

I. Introduction

    Rule 17g-5(c)(1) of the Securities Exchange Act of 1934 (``Exchange
Act'') prohibits a nationally recognized statistical rating
organization (``NRSRO'') from issuing or maintaining a credit rating
solicited by a person that, in the most recently ended fiscal year,
provided the NRSRO with net revenue equaling or exceeding 10% of the
total net revenue of the NRSRO for the fiscal year. In adopting this
rule, the Commission stated that such a person would be in a position
to exercise substantial influence on the NRSRO, which in turn would
make it difficult for the NRSRO to remain impartial.\1\
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    \1\ Release No. 34-55857 (June 5, 2007), 72 FR 33564, 33598
(June 18, 2007).
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II. Application and Exemption Request of Kroll Bond Rating Agency, Inc.

    Kroll Bond Rating Agency, Inc. (``Kroll''), f/k/a LACE Financial
Corp. (``LACE''), is a credit rating agency registered with the
Commission as an NRSRO under Section 15E of the Exchange Act for the
classes of credit ratings described in clauses (i) through (v) of
Section 3(a)(62)(B) of the Exchange Act. Kroll traditionally has
operated mainly under the ``subscriber-paid'' business model, in which
the NRSRO derives its revenue from restricting access to its ratings to
paid

subscribers. Kroll has informed the Commission that it intends to
expand its existing NRSRO business by establishing a new ``issuer-
paid'' rating service under which it will issue ratings paid for by the
issuer, underwriter, or sponsor of the security being rated. In
connection with this planned expansion, Kroll has requested a temporary
and limited exemption from Rule 17g-5(c)(1) on the grounds that the
restrictions imposed by Rule 17g-5(c)(1) would pose a substantial
constraint on the firm's ability to compete effectively with large
rating agencies offering comparable ratings services. Specifically,
Kroll argues that given that the fees typically associated with issuer-
paid engagements tend to be relatively high when compared to the fees
associated with its existing subscriber-based business, it is possible
that in the early stages of its expansion the fees associated with a
single issuer-paid engagement could exceed ten percent of its total net
revenue for the fiscal year. Accordingly, Kroll has requested that the
Commission grant it an exemption from Rule 17g-5(c)(1) for any revenues
derived from non-subscription based business during the remainder of
calendar years 2011 and 2012, which are also the end of Kroll's 2011
and 2012 fiscal years, respectively.

III. Discussion

    The Commission, when adopting Rule 17g-5(c)(1), noted that it
intended to monitor how the prohibition operates in practice,
particularly with respect to asset-backed securities, and whether
exemptions may be appropriate.\2\ The Commission has previously granted
two temporary exemptions from Rule 17g-5(c)(1), including one on
February 11, 2008 to LACE, as Kroll was formerly known, in connection
with its initial registration as an NRSRO (``LACE Exemptive
Order'').\3\ The Commission noted several factors in granting that
exemption, including the fact that the revenue in question was earned
prior to the adoption of the rule, the likelihood of smaller firms such
as LACE being more likely to be affected by the rule, LACE's
expectation that the percentage of total revenue provided by the
relevant client would decrease, and the increased competition in the
asset-backed securities class that could result from LACE's
registration. In granting the LACE Exemptive Order, the Commission also
noted that an exemption would further the primary purpose of the Credit
Rating Agency Reform Act of 2006 (``Rating Agency Act'') as set forth
in the Report of the Senate Committee on Banking, Housing, and Urban
Affairs accompanying the Rating Agency Act: To ``improve ratings
quality for the protection of investors and in the public interest by
fostering accountability, transparency, and competition in the credit
rating industry.'' \4\ On June 23, 2008, the Commission, citing the
same factors set forth in the LACE Exemptive Order, issued a similar
order granting Realpoint LLC a temporary exemption from the
requirements of Rule 17g-5(c)(1) in connection with Realpoint LLC's
registration as an NRSRO.\5\
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    \2\ Release No. 34-55857 (June 5, 2007), 72 FR 33564, 33598
(June 18, 2007).
    \3\ Release No. 34-57301 (February 11, 2008), 73 FR 8720
(February 14, 2008).
    \4\ See Report of the Senate Committee on Banking, Housing, and
Urban Affairs to Accompany S. 3850, Credit Rating Agency Reform Act
of 2006, S. Report No. 109-326, 109th Cong., 2d Sess. (Sept. 6,
2006).
    \5\ Release No. 34-58001 (June 23, 2008), 73 FR 36362 (June 26,
2008).
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    On September 2, 2010, the Commission issued an Order Instituting
Administrative and Cease-and-Desist Proceedings (``LACE/Putnam Order'')
against LACE and Barron Putnam, LACE's founder as well as its majority
owner during the relevant time period. The LACE/Putnam Order found,
among other things, that the firm made misrepresentations in its
application to become registered as an NRSRO and its accompanying
request for an exemption from Rule 17g-5(c)(1). Specifically, the
Commission found that the firm materially misstated the amount of
revenue it received from its largest customer during 2007.\6\ On
November 9, 2010, the Commission issued an Order Making Findings and
Imposing A Cease-and-Desist Order (the ``Mouzon Order'') against LACE's
former president, Damyon Mouzon. The Mouzon Order found, among other
things, that as LACE's president, Mouzon was responsible for ensuring
the accuracy of the information provided to the Commission in
connection with the firm's NRSRO application and its request for an
exemption, and that he knew or should have known that the financial
information that LACE provided to the Commission in connection with its
NRSRO application and its request for an exemption from Rule 17g-
5(c)(1) was inaccurate.\7\ LACE, Putnam and Mouzon each consented to
the entry of those orders on a neither admit nor deny basis.
---------------------------------------------------------------------------

    \6\ In the Matter of LACE Financial Corp. and Barron Putnam,
Respondents: Order Instituting Administrative and Cease-and-Desist
Proceedings, Pursuant to Sections 15E(d) and 21C of the Securities
Exchange Act of 1934, Making Findings, and Imposing Remedial
Sanctions and Cease-and-Desist Orders, Release No. 62834 (September
2, 2010).
    \7\ In the Matter of Damyon Mouzon, Respondent: Order Making
Findings and Imposing a Cease-and-Desist Order Pursuant to Section
21C of the Securities Exchange Act of 1934, Release No. 63280
(November 9, 2010).
---------------------------------------------------------------------------

    In the request that is subject to this Order, Kroll acknowledged
the recent orders against LACE and its former owner and president and
stated that it has taken significant steps to enhance the compliance
and other functions associated with the traditional subscriber-based
business, including replacing senior management, retaining new
compliance and financial personnel, and adding new independent
directors comprising a majority of the board. Kroll has informed
Commission staff that LACE's former ownership and management personnel
no longer have any ownership or other relationship, financial or
otherwise, with Kroll. Kroll has further informed Commission staff that
LACE ceased performing any work or analysis in connection with the
issuer-paid ratings that were the subject of the LACE Exemptive Order
in December 2008.
    The Commission believes that a temporary, limited and conditional
exemption allowing Kroll to enter the market for rating structured
finance products is consistent with the Commission's goal of improving
ratings quality for the protection of investors and in the public
interest by fostering accountability, transparency, and competition in
the credit rating industry. In order to maintain this exemption, Kroll
will be required to publicly disclose in Exhibit 6 to Form NRSRO, as
applicable, that the firm received more than 10% of its net revenue in
fiscal years 2011 and 2012 from a client or clients that paid it to
rate asset-backed securities. This disclosure is designed to alert
users of credit ratings to the existence of this specific conflict and
is consistent with exemptive relief the Commission has previously
granted to LACE and Realpoint LLC. Furthermore, in addition to Kroll's
existing obligations as an NRSRO to maintain policies, procedures, and
internal controls, by the terms of this order, Kroll will also be
required to maintain policies, procedures, and internal controls
specifically designed to address the conflict created by exceeding the
10% threshold. Finally, the Commission notes that Kroll is subject to
the September 2, 2010 Order Instituting Administrative and Cease-and-
Desist Proceedings against LACE Financial Corp.
    Section 15E(p) of the Exchange Act, as added by Section 932(a)(8)
of the Dodd-

Frank Wall Street Reform and Consumer Protection Act, requires
Commission staff to conduct an examination of each NRSRO at least
annually. As part of this annual examination regimen for NRSROs,
Commission staff will closely review Kroll's activities with respect to
managing this conflict and meeting the conditions set forth below and
will consider whether to recommend that the Commission take additional
action, including administrative or other action.
    The Commission therefore finds that a temporary, limited and
conditional exemption allowing Kroll to enter the market for rating
structured finance products is consistent with the Commission's goal,
as established by the Rating Agency Act, of improving ratings quality
by fostering accountability, transparency, and competition in the
credit rating industry, subject to Kroll's making public disclosure of
the conflict created by exceeding the 10% threshold and maintaining
policies, procedures and internal controls to address that conflict, is
necessary and appropriate in the public interest and is consistent with
the protection of investors.

IV. Conclusion

    Accordingly, pursuant to Section 36 of the Exchange Act,
    It is hereby ordered that Kroll Bond Rating Agency, Inc., formerly
known as LACE Financial Corp., is exempt from the conflict of interest
prohibition in Exchange Act Rule 17g-5(c)(1) until January 1, 2013,
with respect to any revenue derived from issuer-paid ratings, provided
that: (1) Kroll Bond Rating Agency, Inc. publicly discloses in Exhibit
6 to Form NRSRO, as applicable, that the firm received more than 10% of
its total net revenue in fiscal year 2011 or 2012 from a client or
clients; and (2) in addition to fulfilling its existing obligations as
an NRSRO to maintain policies, procedures, and internal controls, Kroll
Bond Rating Agency, Inc. also maintains policies, procedures, and
internal controls specifically designed to address the conflict created
by exceeding the 10% threshold.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-24028 Filed 9-19-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 43 (Monday, March 5, 2012)]
[Notices]
[Pages 13124-13125]
[FR Doc No: 2012-5258]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9642-7]

Disclosure of Confidential Business Information Obtained Under
the Comprehensive Environmental Response, Compensation and Liability
Act to EPA Authorized Representative, South Dakota Department of
Environment and Natural Resources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for comment.

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SUMMARY: EPA hereby complies with the requirements of 40 CFR
2.310(h)(3) for notice of disclosure to its authorized representative,
the South Dakota Department of Environment and Natural Resources (SD
DENR), Superfund confidential business information (CBI) which has been
submitted to EPA Region 8, Office of Ecosystems Protection and
Remediation.

DATES: Comments may be submitted until April 4, 2012.

ADDRESSES: Comments should be sent to: Sharon Abendschan (Mail Code
8ENF-RC), Environmental Protection Agency, Region 8, 1595 Wynkoop
Street, Denver, CO 80202-1129.

FOR FURTHER INFORMATION CONTACT: Andrea Madigan (Mail Code 8ENF-L),
Environmental Protection Agency, Region 8, 1595 Wynkoop Street, Denver,
CO 80202-1129<PHONE_NUMBER>.

Notice of Required Determinations, Provisions, and Opportunity To
Comment

    The Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (CERCLA), as amended, (commonly known as
``Superfund'') requires the establishment of an

administrative record upon which the President shall base the selection
of a response action. CERCLA also requires the maintenance of many
other records including those relevant to cost recovery. EPA has
granted authorized representative status to the State of South Dakota
Department of Environment and Natural Resources. Pursuant to 40 CFR
2.310(h)(3), a state or local governmental agency which has duties or
responsibilities under CERCLA, or under regulations which implement
CERCLA, may be considered an authorized representative of the United
States for purposes of disclosure of CBI and may be furnished such CBI
upon the agency's written request, but only if:
    (i) The agency has first furnished to the EPA office, having
custody of the information, a written opinion from the agency's chief
legal officer or counsel stating that under applicable state or local
law the agency has the authority to compel a business which possesses
such information to disclose it to the agency, or
    (ii) Each affected business is informed of those disclosures under
this paragraph (h)(3) which pertain to it, and the agency has shown to
the satisfaction of an EPA legal office that the agency's use and
disclosure of such information will be governed by state or local law
and procedures which will provide adequate protection to the interests
of affected businesses.
    Pursuant to 40 CFR 2.310(h)(4), at the time any information is
released to a state or local government pursuant to paragraph 2.310(h),
EPA must notify the state or local government that the information may
be entitled to confidential treatment and that any knowing and willful
disclosure of the information may subject the state or local government
and its employees to penalties in section 104(e)(2)(B) of CERCLA. EPA
has determined that SD DENR has satisfied the requirements of
subparagraph 40 CFR 2.310(h)(3)(ii) that the agency demonstrate to the
satisfaction of EPA that the agency's use and disclosure of such
information will be governed by state or local law and procedures which
will provide adequate protection to the interests of affected
businesses. EPA hereby advises affected parties that they are informed
of potential disclosures to SD DENR under paragraph 40 CFR 2.310(h)(3),
and that they have ten working days to comment pursuant to 40 CFR
2.301(h)(2)(iii), incorporated by reference into 40 CFR 2.310(h)(2).
    Comments should be sent to: Environmental Protection Agency, Region
8, Sharon Abendschan (Mail Code 8ENF-RC), Environmental Protection
Agency, Region 8, 1595 Wynkoop Street, Denver, CO 80202-1129.

Andrew M. Gaydosh,
Assistant Regional Administrator, Office of Enforcement, Compliance and
Environmental Justice, EPA, Region 8.
[FR Doc. 2012-5258 Filed 3-2-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Pages 51576-51577]
[FR Doc No: 2014-20635]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-S-0009]

Draft Guidance for Industry: Electronic Submission of Lot
Distribution Reports; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Electronic Submission of Lot Distribution Reports'' dated August 2014.
The draft guidance document provides information and recommendations
pertaining to the electronic submission of lot distribution reports for
applicants with approved biologics license applications (BLAs). FDA
recently published in the Federal Register a final rule requiring that,
among other things, lot distribution reports be submitted to FDA in an
electronic format that the Agency can process, review, and archive. The
draft guidance, when finalized, is intended to help licensed
manufacturers of products distributed under approved BLAs (henceforth
referred to as applicants) comply with the final rule.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 28, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002 or Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The draft guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER> or CDER at<PHONE_NUMBER>.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911 or Jared Lantzy, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 1116, Silver Spring, MD 20993-0002, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Electronic Submission of Lot Distribution
Reports'' dated August 2014. The draft guidance provides information
and recommendations pertaining to the electronic submission of lot
distribution reports. The draft guidance provides information on how to
electronically submit lot distribution reports for biological products
under approved BLAs for which CBER or CDER has regulatory
responsibility. When finalized, this guidance will not apply to any
other biological product.
    FDA recently published in the Federal Register of June 10, 2014 (79
FR 33072), a final rule requiring electronic submission of certain
postmarketing submissions. Among other things, under this rule
applicants are required to submit biological lot distribution reports
to FDA in an electronic format that the Agency can process, review, and
archive. The draft guidance, when finalized, is intended to help
applicants subject to lot distribution reporting comply with the final
rule. Along with other information, the draft guidance provides updated
information about the following: (1) Structured Product Labeling
standard and vocabulary for electronic submission of lot distribution
reporting; (2) additional resources such as implementation guide,
validation procedures; and links with further information; and (3)
procedures for requesting temporary waivers from the electronic
submission requirement.
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 600.81 and

600.90 have been approved under OMB control number 0910-0308.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

    Dated: August 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20635 Filed 8-28-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Pages 3967-3969]
[FR Doc No: 2015-01267]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pharmacy Compounding Advisory Committee.
    General Function of the Committee: To provide advice on scientific,
technical, and medical issues concerning drug compounding under
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), and, as required, any other product for which FDA has
regulatory responsibility, and make appropriate recommendations to the
Commissioner of Food and Drugs.
    Date and Time: The meeting will be held on February 23, 2015, from
8:30 a.m. to 5 p.m., and February 24, 2015, from 8:15 a.m. to 3 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Jayne E. Peterson, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Background: On November 27, 2013, the Drug Quality and Security Act
(DQSA) amended section 503A of the FD&C Act to remove certain
provisions regarding the advertising and promotion of compounded drugs
and the solicitation of prescriptions for compounded drugs that were
found to be unconstitutional by the U.S. Supreme Court in 2002. By
removing the unconstitutional provisions, the law removed uncertainty
regarding the validity of section 503A of the FD&C Act, which is
applicable to compounders nationwide.
    Section 503A of the FD&C Act (21 U.S.C. 353a) describes the
conditions under which a human drug product compounded for an
identified individual patient based on the receipt of a prescription
can qualify for exemptions from three sections of the FD&C Act: (1)
Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice (CGMP) requirements for drugs); (2) section
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with
adequate directions for use); and (3) section 505 (21 U.S.C. 355)
(concerning the approval of human drug products under new drug
applications or abbreviated new drug applications).
    The DQSA also created a new section 503B of the FD&C Act, under
which a compounder can register as an ``outsourcing facility.'' Drug
products compounded at outsourcing facilities may be able to qualify
for exemptions from the FDA approval requirements (section 505 of the
FD&C Act) and the requirement to label products with adequate
directions for use (section 502(f)(1) of the FD&C Act) but will still
be subject to CGMP requirements under section 501(a)(2)(B) of the FD&C
Act.
    One of the conditions that must be satisfied to qualify for the
exemptions under both sections 503A and 503B of the FD&C Act is that
the drug that is compounded does not appear on a list of drugs
published by the Secretary that have been withdrawn or removed from the
market because such drug products or components of such drug products
have been found to be unsafe or not effective (see sections
503A(b)(1)(C) and 503B(a)(4) of the FD&C Act).
    Another condition in section 503A of the FD&C Act that must be
satisfied to qualify for the section 503A exemptions is that bulk drug
substances used in a compounded drug must meet one of the following
criteria: (I) Comply with the standards of an applicable United States
Pharmacopoeia (USP) or National Formulary monograph, if a monograph
exists, and the USP chapter on pharmacy compounding; (II) if such a
monograph does not exist, are drug substances that are components of
drugs approved by the Secretary of Health and Human Services (the
Secretary); or (III) if such a monograph does not exist and the drug
substance is not a component of a drug approved by the Secretary, that
appear on a list developed by the Secretary through regulations issued
by the Secretary (section 503A(b)(1)(A)(i) of the FD&C Act). FDA will
discuss drugs proposed for inclusion on these two lists with the
Pharmacy Compounding Advisory Committee (committee).
    Agenda: On February 23, 2015, during the morning session, the
committee will discuss proposed revisions to the list of drug products
that may not be compounded under the exemptions provided by the FD&C
Act because the drug products have been withdrawn or removed from the
market because such drug products or components of such drug products
have been found to be unsafe or not effective. The list of products is
currently codified at 216.24 (21 CFR 216.24), and FDA is proposing to
revise and update the list at Sec.  216.24 for purposes of both
sections 503A and 503B of the FD&C Act. On July 2, 2014, FDA published
a proposed rule that would add 25 drug products to this list and modify
the description of one drug product on this list to add an exception
(79 FR 37687, July 2, 2014). FDA received two drug-specific comments on
the proposed rule. One comment requested that FDA clarify whether the
entry for adenosine phosphate that is currently included on the list
(all drug products containing adenosine phosphate) is intended to
include all three forms of adenosine phosphate (mono-, di-, and
triphosphate). The second comment requested that chloramphenicol
tablets, 250 milligrams, be excluded from the list. FDA will discuss
both of these comments with the committee.
    On February 23, 2015, during the afternoon session, and on February
24, 2015, the committee will discuss proposed criteria for developing
the list of bulk drug substances that may be used to compound drug
products in accordance with section 503A of the FD&C Act and will
discuss six substances nominated for inclusion on the list. On December
4, 2013, and July 2, 2014, FDA published notices in the Federal
Register (78 FR 72841 and 79 FR 37747) soliciting nominations for this
list. At this first meeting of the committee, FDA intends to discuss
the following nominated bulk drug substances: Cantharidin,
diphenylcyclopropenone, piracetam, silver protein mild, squaric acid
dibutyl ester, and thymol iodide. The nominators of these substances
will be invited to make a short presentation supporting the nomination.
Other nominated substances will be discussed at future committee
meetings.

    FDA intends to make background material available to the public at
no later than 2 business days before the meeting. If FDA is unable to
post the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 9, 2015. Oral presentations from the public will be scheduled
between approximately 10:15 a.m. to 10:45 a.m. and 3:35 p.m. to 3:50
p.m. on February 23, 2015, and between approximately 9:30 a.m. to 9:45
a.m. and 11:45 a.m. to noon on February 24, 2015. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before February 12, 2015.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by February 13, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Jayne E. Peterson at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 21, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-01267 Filed 1-23-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Rules and Regulations]
[Pages 59436-59438]
[FR Doc No: 2020-19287]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0072; FRL-10013-73-Region 4]

Air Plan Approval; Georgia: Emission Reduction Credits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) revision submitted
by the State of Georgia in a letter dated October 18, 2019. The SIP
revision updates Georgia's rule entitled Emission Reduction Credits
which establishes a program for sources in specified counties to apply
for credits for voluntary emissions reductions. EPA has evaluated
Georgia's submittal and determined that it meets the applicable
requirements of the Clean Air Act (CAA or Act) and EPA regulations.

DATES: This rule is effective October 22, 2020.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2020-0072. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information 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 can either
be retrieved electronically via www.regulations.gov or in hard copy at
the Air Regulatory Management Section, Air Planning and Implementation
Branch, Air and Radiation Division, U.S. Environmental Protection
Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960.
EPA requests that if at all possible, you contact the person listed in
the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The Regional Office's official hours of business are Monday
through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Pearlene Williams, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Williams can be
reached via telephone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Georgia Environmental Protection Division (GA EPD) submitted a
revision to its SIP in a letter dated October 18, 2019,\1\ modifying
Rule 391-3-1-.03(13), Emission Reduction Credits,\2\ in the State's air
permitting rules. This submittal revises the counties in which sources
may create emission reduction credits (ERCs). This change aligns
Georgia's ERC program with the current status of counties designated
nonattainment or contributing to a nonattainment area.
---------------------------------------------------------------------------

    \1\ EPA notes the Agency received the submittal on October 24,
2019.
    \2\ EPA notes that the Agency received several submittals
revising the Georgia SIP transmitted with the same October 18, 2019,
cover letter. EPA is considering action for these other SIP
revisions in separate rulemakings.
---------------------------------------------------------------------------

    Georgia's October 18, 2019, SIP submittal revises the counties
listed in Rule 391-3-1-.03(13)(a) to ensure that only sources in
counties currently designated nonattainment--and counties \3\
contributing to the ambient air quality in the nonattainment area--may
participate in the ERC program. The details of the submittal and EPA's
rationale for approving the changes are discussed in a notice of
proposed rulemaking (NPRM) dated May 22, 2020. See 85 FR 31112.
Comments were due on the May 22, 2020, NPRM by June 22, 2020. No
comments were received on the proposed action.
---------------------------------------------------------------------------

    \3\ The NPRM dated May 22, 2020 (85 FR 31112) incorrectly
included Rockdale county in the list of five counties being moved
from 391-3-1-.03(13)(a)2 to (a)3. The correct list of counties being
moved in this action includes Barrow, Carroll, Hall, Spalding, and
Walton. Rockdale county remains in the list of counties under (a)2.
---------------------------------------------------------------------------

    These changes clarify eligibility for sources in certain counties
to bank and create ERCs. These changes also make paragraph 391-3-
1-.03(13)(a) consistent with current provisions under the State's
Nonattainment New Source Review permitting program.\4\ EPA also notes
that the ERC program is a flexibility tool used by States and affected
sources to comply with otherwise applicable requirements and is not
expected to impact emissions in the State. Therefore, EPA concludes
that these changes are consistent with the CAA and applicable EPA
regulations.\5\
---------------------------------------------------------------------------

    \4\ See 85 FR 2646 (January 16, 2020).
    \5\ EPA has also concluded that these changes are consistent
with applicable guidance on emissions trading, including EPA's
``Emissions Trading Policy Statement; General Principles for
Creation, Banking and Use of Emission Reduction Credits.'' See 51 FR
43814 (December 4, 1986).
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II. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Georgia Rule
391-3-1-.03(13), entitled ``Emission Reduction Credits,'' effective
September 26, 2019,\6\ to clarify which sources in which areas of the
State are eligible to create and bank emission reduction credits. EPA
has made, and will continue to make, these materials generally
available through www.regulations.gov and at the EPA Region 4 Office
(please contact the person identified in the For Further Information
Contact section of this preamble for more information). Therefore,
these materials have been approved by EPA for inclusion in the SIP,
have been incorporated by reference by EPA into that plan, are fully
federally enforceable under sections 110 and 113 of the CAA as of the
effective date of the final rulemaking of EPA's approval, and will be
incorporated by reference by the Director of the Federal Register in
the next update to the SIP compilation.\7\
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    \6\ Specifically, in this action, EPA is incorporating by
reference subsections (a), (d), and (h) of Rule 391-3-1-.03(13) with
a state-effective date of September 26, 2019. EPA previously
approved and incorporated by reference subsection (f) with a state-
effective date of July 18, 2001, and subsections (b), (c), (e), (g),
and (i) with a state-effective date of February 6, 2000; those prior
approvals are not impacted by this action. EPA has included a
clarifying explanation to this effect in the entry for Rule 391-3-
1-.03(13) at 40 CFR 52.570(c).
    \7\ See 62 FR 27968 (May 22, 1997).

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III. Final Action

    EPA is approving the Georgia SIP revision with changes to
Regulation 391-3-1-.03(13), Emission Reduction Credits, submitted
October 18, 2019, to clarify which sources in which areas are eligible
to create, bank, transfer, or use ERCs for Nitrogen Oxides and Volatile
Organic Compounds, corresponding to the counties that are either
currently in nonattainment or contributing to the current nonattainment
area. EPA has concluded that the SIP revision is consistent with the
CAA and EPA's federal regulations.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, 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 action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 23, 2020. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Volatile organic compounds.

    Dated: August 26, 2020.
Mary Walker,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart L--Georgia

0
2. In Sec.  52.570, the table in paragraph (c) is amended by revising
the entry for ``391-3-1-.03(13)'' to read as follows:

Sec.  52.570   Identification of plan.

* * * * *
    (c) * * *

                                        EPA Approved Georgia Regulations
----------------------------------------------------------------------------------------------------------------
                                                          State
         State citation             Title/subject    effective date   EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
391-3-1-.03(13)................  Emission Reduction       9/26/2019  9/22/2020, Insert   Except subparagraph 391-
                                  Credits.                            citation of         3-1-.03(13)(f), which
                                                                      publication].       was approved into the
                                                                                SIP with a state-
                                                                                effective date of 7/18/
                                                                                2001, and
                                                                                subparagraphs (b),
                                                                                (c), (e), (g), and
                                                                                (i), which were
                                                                                approved into the SIP
                                                                                with a state-effective
                                                                                date of 2/16/2000.

                                                  * * * * * * *
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* * * * *
[FR Doc. 2020-19287 Filed 9-21-20; 8:45 am]
BILLING CODE 6560-50-P