[Federal Register: February 27, 2006 (Volume 71, Number 38)]
[Notices]
[Page 9840-9841]
[DOCID:fr27fe06-77]

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SECURITIES AND EXCHANGE COMMISSION

Submissions for OMB Review; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extensions:
    Form SE--OMB Control No. 3235-0327--SEC File No. 270-289.
    Form ID--OMB Control No. 3235-0328--SEC File No. 270-291.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget
requests for extension of the previously approved collections of
information discussed below.
    Form SE is used by registrants to file paper copies of exhibits
that would be difficult or impossible to submit electronically. The
information contained in Form SE is used by the Commission to identify
paper copies of exhibits. Form SE is a public document and is filed on
occasion. Form SE is filed by individuals, companies or other for-
profit organizations that are required to file electronically.
Approximately 782 registrants file Form SE and it takes an estimated
.10 hours per response for a total annual burden of 78 hours.
    Form ID is used by companies to apply for identification numbers
and passwords used in conjunction with the EDGAR electronic filing
system. The information provided on Form ID is essential to the
security of the EDGAR system. Form ID is a not a public document
because it is used solely for the purpose of registering filers on the
EDGAR system. Form ID must be filed

every time a registrant or other person obtains or changes an
identification number. Form ID is filed by individuals, companies or
other for-profit organizations that are required to file
electronically. Approximately 196,800 registrants file Form ID and it
takes an estimated .15 hours per response for a total annual burden of
29,520 hours.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Written comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or send an e-mail to
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Office of Information Technology, Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549. Comments
must be submitted to OMB within 30 days of this notice.

    Dated: February 16, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-2687 Filed 2-24-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Page 31316]
[FR Doc No: 2021-12259]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2231]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishment
Registration and Product Listing for Manufacturers of Human Blood and
Blood Products and Licensed Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by July 12, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0052. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Establishment Registration and Product Listing for Manufacturers of
Human Blood and Blood Products and Licensed Devices--21 CFR Part 607

OMB Control Number 0910-0052--Extension

    This information collection supports Agency regulations. Under
section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360), any person owning or operating an establishment that
manufactures, prepares, propagates, compounds, or processes a drug or
device must register with the Secretary of Health and Human Services,
on or before December 31 of each year, his or her name, places of
business, and all such establishments, among other information and must
submit a listing of all drug and device products manufactured,
prepared, propagated, compounded, or processed by him or her for
commercial distribution, among other information. In part 607 (21 CFR
part 607), FDA has issued regulations implementing these requirements
for manufacturers of human blood and blood products.
    The regulations set forth procedures and requirements pertaining to
establishment registration and product listing for manufacturers of
human blood and blood products and licensed devices, including initial
registration, annual registration, product listing updates, and waiver
requests. Owners or operators of certain establishments that engage in
the manufacture of blood products shall register and submit a list of
every blood product in commercial distribution (Sec.  607.20(a)).
Initial and subsequent registrations and product listings must be
submitted electronically through FDA's Center for Biologics Evaluation
and Research (CBER) Blood Establishment Registration and Product
Listing system, or any future superseding electronic system, unless FDA
has granted a request for waiver of this requirement prior to the date
on which the information is due (Sec.  607.22(a)). Waiver requests must
be submitted in writing and must include, among other information, the
specific reasons why electronic submission is not reasonable for the
registrant (Sec.  607.22(b)). Establishment registration and product
listing information assists FDA in its inspections of facilities, among
other uses, and its collection is essential to the overall regulatory
scheme designed to ensure the safety of the Nation's blood supply.
    Description of Respondents: Respondents to this collection of
information are human blood and plasma donor centers, blood banks,
certain transfusion services, other blood product manufacturers,
independent laboratories that engage in quality control and testing for
registered blood product establishments and manufacturers of devices
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262).
    In the Federal Register of February 18, 2021 (86 FR 10085), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
          21 CFR section; activity               Number of     responses per   Total annual    Average burden  per response  (in hours)     Total hours
                                                respondents     respondent       responses
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607.20(a), 607.21, 607.22, 607.25, 607.40;               152               1             152  1.........................................             152
 Initial registration.
607.21, 607.22, 607.25, 607.26, 607.31,                2,557               1           2,557  0.5 (30 minutes)..........................           1,279
 607.40; Annual registration.
607.21, 607.25, 607.30(a), 607.31, 607.40;               256               1             256  0.25 (15 minutes).........................              64
 Product listing update.
607.22(b); Waiver request...................               1               1               1  1.........................................               1
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           1,496
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on our evaluation of Fiscal Year 2019 data from CBER's Blood
Establishment Registration and Product Listing system, we have adjusted
the currently approved burden estimate we attribute to establishment
registration and product listing to reflect a slight increase in
submissions; however, the overall burden has not changed.

    Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12259 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Proposed Rules]
[Pages 77952-77962]
[FR Doc No: 2011-32183]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2011-0352-201120; FRL-9507-4]

Approval and Promulgation of Implementation Plans; North
Carolina; 110(a)(1) and (2) Infrastructure Requirements for the 1997 8-
Hour Ozone National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve in part, and to conditionally
approve or disapprove in part, the State Implementation Plan (SIP),
submitted by the State of North Carolina, through the Department of
Environment and Natural Resources (NC DENR), Division of Air Quality
(DAQ), to demonstrate that the State meets the requirements of sections
110(a)(1) and (2) of the Clean Air Act (CAA or Act) for the 1997 8-hour
ozone national ambient air quality standards (NAAQS). Section 110(a) of
the CAA requires that each state adopt and submit a SIP for the
implementation, maintenance and enforcement of each NAAQS promulgated
by the EPA, which is commonly referred to as an ``infrastructure'' SIP.
DAQ certified that the North Carolina SIP contains provisions that
ensure the 1997 8-hour ozone NAAQS are implemented, enforced, and
maintained in North Carolina (hereafter referred to as ``infrastructure
submission''). With the exception of sub-element 110(a)(2)(E)(ii), EPA
is proposing to determine that North Carolina's infrastructure
submission, provided to EPA on December 12, 2007, and clarified in a
subsequent submission submitted on June 20, 2008, addressed the
required infrastructure elements for the 1997 8-hour ozone NAAQS.

DATES: Written comments must be received on or before January 17, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2011-0352, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2011-0352,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal holidays.

    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2011-0352. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://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 through http://www.regulations.gov or email, information that you consider to be CBI
or otherwise protected. The http://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 http://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 electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in http://www.regulations.gov or in hard copy at the Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
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 to 4:30,
excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER>. Ms. Ward can be reached via electronic mail at
<EMAIL_ADDRESS>
Table of Contents

I. Background
II. What elements are required under sections 110(a)(1) and (2)?
III. Scope of Infrastructure SIPs
IV. What is EPA's analysis of how North Carolina addressed the
elements of sections 110(a)(1) and (2) ``infrastructure''
provisions?
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. Background

    On July 18, 1997, EPA promulgated a new NAAQS for ozone based on 8-
hour average concentrations. The 8-hour averaging period replaced the
previous 1-hour averaging period, and the level of the NAAQS was
changed from 0.12 parts per million (ppm) to 0.08 ppm. See 62 FR 38856.
Pursuant to section 110(a)(1) of the CAA, states are required to submit
SIPs meeting the requirements of section 110(a)(2) within three years
after promulgation of a new or revised NAAQS. Sections 110(a)(2)
require states to address basic SIP requirements, including emissions
inventories, monitoring, and modeling to assure attainment and
maintenance of the NAAQS. States were required to submit such SIPs for
the 1997 8-hour ozone NAAQS to EPA no later than June 2000. However,
intervening litigation over the 1997 8-hour ozone NAAQS created
uncertainty about how to proceed and many states did not provide the
required ``infrastructure'' SIP submission for these newly promulgated
NAAQS.
    On March 4, 2004, Earthjustice submitted a notice of intent to sue
related to EPA's failure to issue findings of failure to submit related
to the ``infrastructure'' requirements for the 1997 8-hour ozone NAAQS.
EPA entered into a consent decree with Earthjustice which required EPA,
among other things, to complete a Federal Register notice announcing
EPA's determinations pursuant to section 110(k)(1)(B) as to whether
each state had made complete submissions to meet the requirements of
section 110(a)(2) for the 1997 8-hour ozone NAAQS by December 15, 2007.
Subsequently, EPA received an extension of the date to complete this
Federal Register notice until March 17, 2008, based upon agreement to
make the findings with respect to submissions made by January 7, 2008.
In accordance with the consent decree, EPA made completeness findings
for each state based upon what the Agency received from each state as
of January 7, 2008.
    On March 27, 2008, EPA published a final rulemaking entitled,
``Completeness Findings for Section 110(a) State Implementation Plans;
8-Hour Ozone NAAQS,'' making a finding that each state had submitted or
failed to submit a complete SIP that provided the basic program
elements of section 110(a)(2) necessary to implement the 1997 8-hour
ozone NAAQS. See 73 FR 16205. For those states that did receive
findings, such as North Carolina, the findings of failure to submit for
all or a portion of a state's implementation plan established a 24-
month deadline for EPA to promulgate a Federal Implementation Plan
(FIP) to address the outstanding SIP elements unless, prior to that
time, the affected states submitted, and EPA approved, the required
SIPs. However, the findings of failure to submit did not impose
sanctions or set deadlines for imposing sanctions as described in
section 179 of the CAA, because these findings do not pertain to the
elements contained in the Title I part D plan for nonattainment areas
as required under section 110(a)(2)(I). Additionally, the findings of
failure to submit for the infrastructure submittals are not a SIP call
pursuant to section 110(k)(5).
    The finding that all or portions of a state's submission are
complete established a 12-month deadline for EPA to take action upon
the complete SIP elements in accordance with section 110(k). North
Carolina's infrastructure submission was received by EPA on December
12, 2007, and was determined to be complete on March 27, 2008, for all
elements with the exception of 110(a)(2)(C) and (J). Specifically,
110(a)(2)(C) and (J) relate to a SIP addressing changes to its part C
prevention of significant deterioration (PSD) permit program required
by the November 29, 2005, final rule (See 70 FR 71612, 71699) that made
nitrogen oxides (NOX) a precursor for ozone in 40 CFR 51.166
and 40 CFR 52.21. North Carolina was among other states that received a
finding of failure to submit because its infrastructure submission was
not complete for elements (C) and (J) for the 1997 8-hour ozone NAAQS
by March 1, 2008. The finding of failure to submit action triggered a
24-month

clock for EPA to either issue a FIP or take final action on a SIP
revision which corrects the deficiency for which the finding of failure
to submit was received.
    On June 20, 2008, DAQ submitted a SIP revision to EPA for federal
approval which includes revisions to rules North Carolina's Air
Pollution Control Requirements (NCAC) 02D.0530 and .0531 that address
the infrastructure requirements (C) and (J). On August 10, 2011, EPA
finalized approval of North Carolina's June 20, 2008, SIP revision. See
76 FR 49313. With the exception of element 110(a)(2)(E)(ii), today's
action is proposing to approve North Carolina's infrastructure
submission for which EPA made the completeness determination and
finding of failure to submit on March 27, 2008. This action is not
approving any specific rule, but rather proposing that North Carolina's
already approved SIP meets certain CAA requirements.

II. What elements are required under Sections 110(a)(1) and (2)?

    Section 110(a) of the CAA requires states to submit SIPs to provide
for the implementation, maintenance, and enforcement of a new or
revised NAAQS within three years following the promulgation of such
NAAQS, or within such shorter period as EPA may prescribe. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and circumstances. In particular, the
data and analytical tools available at the time the state develops and
submits the SIP for a new or revised NAAQS affects the content of the
submission. The contents of such SIP submissions may also vary
depending upon what provisions the state's existing SIP already
contains. In the case of the 1997 8-hour ozone NAAQS, states typically
have met the basic program elements required in section 110(a)(2)
through earlier SIP submissions in connection with previous ozone
NAAQS.
    More specifically, section 110(a)(1) provides the procedural and
timing requirements for SIPs. Section 110(a)(2) lists specific elements
that states must meet for ``infrastructure'' SIP requirements related
to a newly established or revised NAAQS. As mentioned above, these
requirements include SIP infrastructure elements such as modeling,
monitoring, and emissions inventories that are designed to assure
attainment and maintenance of the NAAQS. The requirements that are the
subject of this proposed rulemaking are listed below \1\ and in EPA's
October 2, 2007, memorandum entitled ``Guidance on SIP Elements
Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone and
PM2.5 National Ambient Air Quality Standards.''
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    \1\ Two elements identified in section 110(a)(2) are not
governed by the three year submission deadline of section 110(a)(1)
because SIPs incorporating necessary local nonattainment area
controls are not due within three years after promulgation of a new
or revised NAAQS, but rather due at the time the nonattainment area
plan requirements are due pursuant to section 172. These
requirements are: (1) Submissions required by section 110(a)(2)(C)
to the extent that subsection refers to a permit program as required
in part D Title I of the CAA; and, (2) submissions required by
section 110(a)(2)(I) which pertain to the nonattainment planning
requirements of part D, Title I of the CAA. Today's proposed
rulemaking does not address infrastructure elements related to
section 110(a)(2)(I) or the nonattainment planning requirements of
110(a)(2)(C).
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     110(a)(2)(A): Emission limits and other control measures.
     110(a)(2)(B): Ambient air quality monitoring/data system.
     110(a)(2)(C): Program for enforcement of control
measures.\2\
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    \2\ This rulemaking only addresses requirements for this element
as they relate to attainment areas.
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     110(a)(2)(D): Interstate transport.\3\
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    \3\ Today's proposed rule does not address element
110(a)(2)(D)(i) (Interstate Transport) for the 1997 8-hour ozone
NAAQS. Interstate transport requirements were formerly addressed by
North Carolina consistent with the Clean Air Interstate Rule (CAIR).
On December 23, 2008, CAIR was remanded by the DC Circuit Court of
Appeals, without vacatur, back to EPA. See North Carolina v. EPA,
531 F.3d 896 (DC Cir. 2008). Prior to this remand, EPA took final
action to approve North Carolina's SIP revision, which was submitted
to comply with CAIR. See 72 FR 56914 (October 5, 2007). In so doing,
North Carolina's CAIR SIP revision addressed the interstate
transport provisions in section 110(a)(2)(D)(i) for the 1997 8-hour
ozone NAAQS. In response to the remand of CAIR, EPA has promulgated
a new rule to address the interstate transport. See 76 FR 48208
(August 8, 2011). EPA's action on element 110(a)(2)(D)(i) will be
addressed in a separate action.
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     110(a)(2)(E): Adequate resources.
     110(a)(2)(F): Stationary source monitoring system.
     110(a)(2)(G): Emergency power.
     110(a)(2)(H): Future SIP revisions.
     110(a)(2)(I): Areas designated nonattainment and meet the
applicable requirements of part D.\4\
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    \4\ This requirement was inadvertently omitted from EPA's
October 2, 2007, memorandum entitled ``Guidance on SIP Elements
Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone
and PM2.5 National Ambient Air Quality Standards,'' but
as mentioned above is not relevant to today's proposed rulemaking.
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     110(a)(2)(J): Consultation with government officials;
public notification; and PSD and visibility protection.
     110(a)(2)(K): Air quality modeling/data.
     110(a)(2)(L): Permitting fees.
     110(a)(2)(M): Consultation/participation by affected local
entities.

III. Scope of Infrastructure SIPs

    EPA is currently acting upon SIPs that address the infrastructure
requirements of CAA section 110(a)(1) and (2) for ozone and
PM2.5 NAAQS for various states across the country.
Commenters on EPA's recent proposals for some states raised concerns
about EPA statements that it was not addressing certain substantive
issues in the context of acting on those infrastructure SIP
submissions.\5\ Those Commenters specifically raised concerns involving
provisions in existing SIPs and with EPA's statements in other
proposals that it would address two issues separately and not as part
of actions on the infrastructure SIP submissions: (i) Existing
provisions related to excess emissions during periods of start-up,
shutdown, or malfunction at sources, that may be contrary to the CAA
and EPA's policies addressing such excess emissions (``SSM''); and (ii)
existing provisions related to ``director's variance'' or ``director's
discretion'' that purport to permit revisions to SIP approved emissions
limits with limited public process or without requiring further
approval by EPA, that may be contrary to the CAA (``director's
discretion''). EPA notes that there are two other substantive issues
for which EPA likewise stated in other proposals that it would address
the issues separately: (i) Existing provisions for minor source new
source review programs that may be inconsistent with the requirements
of the CAA and EPA's regulations that pertain to such programs (``minor
source NSR [New Source Review]''); and (ii) existing provisions for PSD
programs that may be inconsistent with current requirements of EPA's
``Final NSR Improvement Rule,'' 67 FR 80186 (December 31, 2002), as
amended by 72 FR 32526 (June 13, 2007) (``NSR Reform''). In light of
the comments, EPA believes that its statements in various proposed
actions on infrastructure SIPs with respect to these four individual
issues should be explained in greater depth. It is important to
emphasize that EPA is taking the same position with respect to these
four substantive issues in this action on the infrastructure SIPs for
the 1997 8-hour ozone NAAQS from North Carolina.
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    \5\ See Comments of Midwest Environmental Defense Center, dated
May 31, 2011. Docket  EPA-R05-OAR-2007-1179 (adverse
comments on proposals for three states in Region 5). EPA notes that
these public comments on another proposal are not relevant to this
rulemaking and do not have to be directly addressed in this
rulemaking. EPA will respond to these comments in the appropriate
rulemaking action to which they apply.

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    EPA intended the statements in the other proposals concerning these
four issues merely to be informational, and to provide general notice
of the potential existence of provisions within the existing SIPs of
some states that might require future corrective action. EPA did not
want states, regulated entities, or members of the public to be under
the misconception that the Agency's approval of the infrastructure SIP
submission of a given state should be interpreted as a re-approval of
certain types of provisions that might exist buried in the larger
existing SIP for such state. Thus, for example, EPA explicitly noted
that the Agency believes that some states may have existing SIP
approved SSM provisions that are contrary to the CAA and EPA policy,
but that ``in this rulemaking, EPA is not proposing to approve or
disapprove any existing state provisions with regard to excess
emissions during SSM of operations at facilities.'' EPA further
explained, for informational purposes, that ``EPA plans to address such
State regulations in the future.'' EPA made similar statements, for
similar reasons, with respect to the director's discretion, minor
source NSR, and NSR Reform issues. EPA's objective was to make clear
that approval of an infrastructure SIP for these ozone and
PM2.5 NAAQS should not be construed as explicit or implicit
re-approval of any existing provisions that relate to these four
substantive issues. EPA is reiterating that position in this action on
the infrastructure SIP for North Carolina.
    Unfortunately, the Commenters and others evidently interpreted
these statements to mean that EPA considered action upon the SSM
provisions and the other three substantive issues to be integral parts
of acting on an infrastructure SIP submission, and therefore that EPA
was merely postponing taking final action on the issues in the context
of the infrastructure SIPs. This was not EPA's intention. To the
contrary, EPA only meant to convey its awareness of the potential for
certain types of deficiencies in existing SIPs, and to prevent any
misunderstanding that it was reapproving any such existing provisions.
EPA's intention was to convey its position that the statute does not
require that infrastructure SIPs address these specific substantive
issues in existing SIPs and that these issues may be dealt with
separately, outside the context of acting on the infrastructure SIP
submission of a state. To be clear, EPA did not mean to imply that it
was not taking a full final agency action on the infrastructure SIP
submission with respect to any substantive issue that EPA considers to
be a required part of acting on such submissions under section 110(k)
or under section 110(c). Given the confusion evidently resulting from
EPA's statements in those other proposals, however, we want to explain
more fully the Agency's reasons for concluding that these four
potential substantive issues in existing SIPs may be addressed
separately from actions on infrastructure SIP submissions.
    The requirement for the SIP submissions at issue arises out of CAA
section 110(a)(1). That provision requires that states must make a SIP
submission ``within 3 years (or such shorter period as the
Administrator may prescribe) after the promulgation of a national
primary ambient air quality standard (or any revision thereof)'' and
that these SIPs are to provide for the ``implementation, maintenance,
and enforcement'' of such NAAQS. Section 110(a)(2) includes a list of
specific elements that ``[e]ach such plan'' submission must meet. EPA
has historically referred to these particular submissions that states
must make after the promulgation of a new or revised NAAQS as
``infrastructure SIPs.'' This specific term does not appear in the
statute, but EPA uses the term to distinguish this particular type of
SIP submission designed to address basic structural requirements of a
SIP from other types of SIP submissions designed to address other
different requirements, such as ``nonattainment SIP'' submissions
required to address the nonattainment planning requirements of part D,
``regional haze SIP'' submissions required to address the visibility
protection requirements of CAA section 169A, new source review
permitting program submissions required to address the requirements of
part D, and a host of other specific types of SIP submissions that
address other specific matters.
    Although section 110(a)(1) addresses the timing and general
requirements for these infrastructure SIPs, and section 110(a)(2)
provides more details concerning the required contents of these
infrastructure SIPs, EPA believes that many of the specific statutory
provisions are facially ambiguous. In particular, the list of required
elements provided in section 110(a)(2) contains a wide variety of
disparate provisions, some of which pertain to required legal
authority, some of which pertain to required substantive provisions,
and some of which pertain to requirements for both authority and
substantive provisions.\6\ Some of the elements of section 110(a)(2)
are relatively straightforward, but others clearly require
interpretation by EPA through rulemaking, or recommendations through
guidance, in order to give specific meaning for a particular NAAQS.\7\
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    \6\ For example, section 110(a)(2)(E) provides that states must
provide assurances that they have adequate legal authority under
state and local law to carry out the SIP; section 110(a)(2)(C)
provides that states must have a substantive program to address
certain sources as required by part C of the CAA; section
110(a)(2)(G) provides that states must have both legal authority to
address emergencies and substantive contingency plans in the event
of such an emergency.
    \7\ For example, section 110(a)(2)(D)(i) requires EPA to be sure
that each state's SIP contains adequate provisions to prevent
significant contribution to nonattainment of the NAAQS in other
states. This provision contains numerous terms that require
substantial rulemaking by EPA in order to determine such basic
points as what constitutes significant contribution. See ``Rule To
Reduce Interstate Transport of Fine Particulate Matter and Ozone
(Clean Air Interstate Rule); Revisions to Acid Rain Program;
Revisions to the NOX SIP Call; Final Rule,'' 70 FR 25162
(May 12, 2005) (defining, among other things, the phrase
``contribute significantly to nonattainment'').
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    Notwithstanding that section 110(a)(2) provides that ``each'' SIP
submission must meet the list of requirements therein, EPA has long
noted that this literal reading of the statute is internally
inconsistent, insofar as section 110(a)(2)(I) pertains to nonattainment
SIP requirements that could not be met on the schedule provided for
these SIP submissions in section 110(a)(1).\8\ This illustrates that
EPA must determine which provisions of section 110(a)(2) may be
applicable for a given infrastructure SIP submission. Similarly, EPA
has previously decided that it could take action on different parts of
the larger, general ``infrastructure SIP'' for a given NAAQS without
concurrent action on all subsections, such as section 110(a)(2)(D)(i),
because the Agency bifurcated the action on these latter ``interstate
transport'' provisions within section 110(a)(2) and worked with states
to address each of the four prongs of section 110(a)(2)(D)(i) with
substantive administrative actions proceeding on different tracks with
different schedules.\9\ This illustrates that EPA

may conclude that subdividing the applicable requirements of section
110(a)(2) into separate SIP actions may sometimes be appropriate for a
given NAAQS where a specific substantive action is necessitated, beyond
a mere submission addressing basic structural aspects of the state's
implementation plans. Finally, EPA notes that not every element of
section 110(a)(2) would be relevant, or as relevant, or relevant in the
same way, for each new or revised NAAQS and the attendant
infrastructure SIP submission for that NAAQS. For example, the
monitoring requirements that might be necessary for purposes of section
110(a)(2)(B) for one NAAQS could be very different than what might be
necessary for a different pollutant. Thus, the content of an
infrastructure SIP submission to meet this element from a state might
be very different for an entirely new NAAQS, versus a minor revision to
an existing NAAQS.\10\
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    \8\ See Id., 70 FR 25162, at 63-65 (May 12, 2005) (explaining
relationship between timing requirement of section 110(a)(2)(D)
versus section 110(a)(2)(I)).
    \9\ EPA issued separate guidance to states with respect to SIP
submissions to meet section 110(a)(2)(D)(i) for the 1997 ozone and
1997 PM2.5 NAAQS. See ``Guidance for State Implementation
Plan (SIP) Submissions to Meet Current Outstanding Obligations Under
Section 110(a)(2)(D)(i) for the 8-Hour Ozone and PM2.5
National Ambient Air Quality Standards,'' from William T. Harnett,
Director Air Quality Policy Division OAQPS, to Regional Air Division
Director, Regions I-X, dated August 15, 2006.
    \10\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
---------------------------------------------------------------------------

    Similarly, EPA notes that other types of SIP submissions required
under the statute also must meet the requirements of section 110(a)(2),
and this also demonstrates the need to identify the applicable elements
for other SIP submissions. For example, nonattainment SIPs required by
part D likewise have to meet the relevant subsections of section
110(a)(2) such as section 110(a)(2)(A) or (E). By contrast, it is clear
that nonattainment SIPs would not need to meet the portion of section
110(a)(2)(C) that pertains to part C, i.e., the PSD requirements
applicable in attainment areas. Nonattainment SIPs required by part D
also would not need to address the requirements of section 110(a)(2)(G)
with respect to emergency episodes, as such requirements would not be
limited to nonattainment areas. As this example illustrates, each type
of SIP submission may implicate some subsections of section 110(a)(2)
and not others.
    Given the potential for ambiguity of the statutory language of
section 110(a)(1) and (2), EPA believes that it is appropriate for EPA
to interpret that language in the context of acting on the
infrastructure SIPs for a given NAAQS. Because of the inherent
ambiguity of the list of requirements in section 110(a)(2), EPA has
adopted an approach in which it reviews infrastructure SIPs against
this list of elements ``as applicable.'' In other words, EPA assumes
that Congress could not have intended that each and every SIP
submission, regardless of the purpose of the submission or the NAAQS in
question, would meet each of the requirements, or meet each of them in
the same way. EPA elected to use guidance to make recommendations for
infrastructure SIPs for these ozone and PM2.5 NAAQS.
    On October 2, 2007, EPA issued guidance making recommendations for
the infrastructure SIP submissions for both the 1997 8-hour ozone NAAQS
and the 1997 PM2.5 NAAQS.\11\ Within this guidance document,
EPA described the duty of states to make these submissions to meet what
the Agency characterized as the ``infrastructure'' elements for SIPs,
which it further described as the ``basic SIP requirements, including
emissions inventories, monitoring, and modeling to assure attainment
and maintenance of the standards.'' \12\ As further identification of
these basic structural SIP requirements, ``attachment A'' to the
guidance document included a short description of the various elements
of section 110(a)(2) and additional information about the types of
issues that EPA considered germane in the context of such
infrastructure SIPs. EPA emphasized that the description of the basic
requirements listed on attachment A was not intended ``to constitute an
interpretation of'' the requirements, and was merely a ``brief
description of the required elements.'' \13\ EPA also stated its belief
that with one exception, these requirements were ``relatively self
explanatory, and past experience with SIPs for other NAAQS should
enable States to meet these requirements with assistance from EPA
Regions.'' \14\ However, for the one exception to that general
assumption (i.e., how states should proceed with respect to the
requirements of section 110(a)(2)(G) for the 1997 PM2.5
NAAQS), EPA gave much more specific recommendations. But for other
infrastructure SIP submittals, and for certain elements of the
submittals for the 1997 PM2.5 NAAQS, EPA assumed that each
State would work with its corresponding EPA regional office to refine
the scope of a State's submittal based on an assessment of how the
requirements of section 110(a)(2) should reasonably apply to the basic
structure of the State's implementation plans for the NAAQS in
question.
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    \11\ See ``Guidance on SIP Elements Required Under Section
110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5 National
Ambient Air Quality Standards,'' from William T. Harnett, Director
Air Quality Policy Division, to Air Division Directors, Regions I--
X, dated October 2, 2007 (the ``2007 Guidance'').
    \12\ Id., at page 2.
    \13\ Id., at attachment A, page 1.
    \14\ Id., at page 4. In retrospect, the concerns raised by
commenters with respect to EPA's approach to some substantive issues
indicates that the statute is not so ``self explanatory,'' and
indeed is sufficiently ambiguous that EPA needs to interpret it in
order to explain why these substantive issues do not need to be
addressed in the context of infrastructure SIPs and may be addressed
at other times and by other means.
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    On September 25, 2009, EPA issued guidance to make recommendations
to states with respect to the infrastructure SIPs for the 2006
PM2.5 NAAQS.\15\ In the 2009 Guidance, EPA addressed a
number of additional issues that were not germane to the infrastructure
SIPs for the 1997 8-hour ozone and 1997 PM2.5 NAAQS, but
were germane to these SIP submissions for the 2006 PM2.5
NAAQS (e.g., the requirements of section 110(a)(2)(D)(i) that EPA had
bifurcated from the other infrastructure elements for those specific
1997 ozone and PM2.5 NAAQS). Significantly, neither the 2007
Guidance nor the 2009 Guidance explicitly referred to the SSM,
director's discretion, minor source NSR, or NSR Reform issues as among
specific substantive issues EPA expected states to address in the
context of the infrastructure SIPs, nor did EPA give any more specific
recommendations with respect to how states might address such issues
even if they elected to do so. The SSM and director's discretion issues
implicate section 110(a)(2)(A), and the minor source NSR and NSR Reform
issues implicate section 110(a)(2)(C). In the 2007 Guidance and the
2009 Guidance, however, EPA did not indicate to states that it intended
to interpret these provisions as requiring a substantive submission to
address these specific issues in existing SIP provisions in the context
of the infrastructure SIPs for these NAAQS. Instead, EPA's 2007
Guidance merely indicated its belief that the states should make
submissions in which they established that they have the basic SIP
structure necessary to implement, maintain, and enforce the NAAQS. EPA
believes that states can establish that they have the basic SIP
structure, notwithstanding that there may be potential deficiencies
within the existing SIP. Thus, EPA's proposals for other states
mentioned these issues not because the Agency considers them issues
that must be addressed in the context of an infrastructure SIP as
required by section 110(a)(1) and (2), but rather because EPA wanted to
be clear that it considers these potential existing SIP problems as
separate from

the pending infrastructure SIP actions. The same holds true for this
action on the infrastructure SIPs for North Carolina.
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    \15\ See ``Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 2006 24-Hour Fine Particle
(PM2.5) National Ambient Air Quality Standards (NAAQS),''
from William T, Harnett, Director Air Quality Policy Division, to
Regional Air Division Directors, Regions I--X, dated September 25,
2009 (the ``2009 Guidance'').
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    EPA believes that this approach to the infrastructure SIP
requirement is reasonable because it would not be feasible to read
section 110(a)(1) and (2) to require a top to bottom, stem to stern,
review of each and every provision of an existing SIP merely for
purposes of assuring that the state in question has the basic
structural elements for a functioning SIP for a new or revised NAAQS.
Because SIPs have grown by accretion over the decades as statutory and
regulatory requirements under the CAA have evolved, they may include
some outmoded provisions and historical artifacts that, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA considers the overall effectiveness of the
SIP. To the contrary, EPA believes that a better approach is for EPA to
determine which specific SIP elements from section 110(a)(2) are
applicable to an infrastructure SIP for a given NAAQS, and to focus
attention on those elements that are most likely to need a specific SIP
revision in light of the new or revised NAAQS. Thus, for example, EPA's
2007 Guidance specifically directed states to focus on the requirements
of section 110(a)(2)(G) for the 1997 p.m.2.5 NAAQS because
of the absence of underlying EPA regulations for emergency episodes for
this NAAQS and an anticipated absence of relevant provisions in
existing SIPs.
    Finally, EPA believes that its approach is a reasonable reading of
section 110(a)(1) and (2) because the statute provides other avenues
and mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow the Agency to take appropriate
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a state's SIP is
substantially inadequate to attain or maintain the NAAQS, to mitigate
interstate transport, or otherwise to comply with the CAA.\16\ Section
110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submissions.\17\ Significantly, EPA's
determination that an action on the infrastructure SIP is not the
appropriate time and place to address all potential existing SIP
problems does not preclude the Agency's subsequent reliance on
provisions in section 110(a)(2) as part of the basis for action at a
later time. For example, although it may not be appropriate to require
a state to eliminate all existing inappropriate director's discretion
provisions in the course of acting on the infrastructure SIP, EPA
believes that section 110(a)(2)(A) may be among the statutory bases
that the Agency cites in the course of addressing the issue in a
subsequent action.\18\
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    \16\ EPA has recently issued a SIP call to rectify a specific
SIP deficiency related to the SSM issue. See, ``Finding of
Substantial Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revision,'' 74 FR 21639 (April 18, 2011).
    \17\ EPA has recently utilized this authority to correct errors
in past actions on SIP submissions related to PSD programs. See
``Limitation of Approval of Prevention of Significant Deterioration
Provisions Concerning Greenhouse Gas Emitting-Sources in State
Implementation Plans; Final Rule,'' 75 FR 82536 (December 30, 2010).
EPA has previously used its authority under CAA 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See 61 FR 38664 (July 25, 1996) and 62 FR 34641
(June 27, 1997) (corrections to American Samoa, Arizona, California,
Hawaii, and Nevada SIPs); 69 FR 67062 (November 16, 2004)
(corrections to California SIP); and 74 FR 57051 (November 3, 2009)
(corrections to Arizona and Nevada SIPs).
    \18\ EPA has recently disapproved a SIP submission from Colorado
on the grounds that it would have included a director's discretion
provision inconsistent with CAA requirements, including section
110(a)(2)(A). See 75 FR 42342, 42344 (July 21, 2010) (proposed
disapproval of director's discretion provisions); 76 FR 4540
(January 26, 2011) (final disapproval of such provisions).
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IV. What is EPA's analysis of how North Carolina addressed the elements
of sections 110(a)(1) and (2) ``infrastructure'' provisions?

    The North Carolina infrastructure submission addresses the
provisions of sections 110(a)(1) and (2) as described below.
    1. 110(a)(2)(A): Emission limits and other control measures: North
Carolina's SIP provides an overview of the provisions of the North
Carolina Air Pollution Control Regulations relevant to air quality
control regulations. The regulations described below have been
federally approved in the North Carolina SIP and include enforceable
emission limitations and other control measures. NCAC 2D.0400, Ambient
Air Quality Standards, and 2D.0500, Emissions Control Standards,
establish emission limits for ozone and address the required control
measures, means and techniques for compliance with the ozone NAAQS. EPA
has made the preliminary determination that the provisions contained in
these chapters and North Carolina's practices are adequate to protect
the 1997 8-hour ozone NAAQS in the State.
    In this action, EPA is not proposing to approve or disapprove any
existing State provisions with regard to excess emissions during SSM of
operations at a facility. EPA believes that a number of states have SSM
provisions which are contrary to the CAA and existing EPA guidance,
``State Implementation Plans: Policy Regarding Excess Emissions During
Malfunctions, Startup, and Shutdown'' (September 20, 1999), and the
Agency plans to address such state regulations in the future. In the
meantime, EPA encourages any state having a deficient SSM provision to
take steps to correct it as soon as possible.
    Additionally, in this action, EPA is not proposing to approve or
disapprove any existing State rules with regard to director's
discretion or variance provisions. EPA believes that a number of states
have such provisions which are contrary to the CAA and existing EPA
guidance (52 FR 45109, November 24, 1987), and the Agency plans to take
action in the future to address such State regulations. In the
meantime, EPA encourages any State having a director's discretion or
variance provision which is contrary to the CAA and EPA guidance to
take steps to correct the deficiency as soon as possible.
    2. 110(a)(2)(B) Ambient air quality monitoring/data system: NCAC
2D.0600, Monitoring, and 2D.0806, Ambient Monitoring and Modeling
Analysis, along with the North Carolina Network Description and Ambient
Air Monitoring Network Plan, provide for an ambient air quality
monitoring system in the State. Annually, EPA approves the ambient air
monitoring network plan for the State agencies. On July 1, 2011, North
Carolina submitted its plan to EPA, and on October 20, 2011, EPA
approved this plan. North Carolina's approved monitoring network plan
can be accessed at http://www.regulations.gov using Docket ID No. EPA-
R04-OAR-2011-0352. EPA has made the preliminary determination that
North Carolina's SIP and practices are adequate for the ambient air
quality monitoring and data system related to the 1997 8-hour ozone
NAAQS.
    3. 110(a)(2)(C) Program for enforcement of control measures
including review of proposed new sources: Regulation NCAC 2D.0530,
Prevention of Significant Deterioration, and 2D.0531, Sources in a
Nonattainment Area, pertain to the construction or modification of any
major stationary source in areas designated as attainment,
nonattainment or unclassifiable. On December 20, 2005, May 16, 2007,
and June 20, 2008,

DAQ submitted revisions to its PSD/NSR regulations for EPA approval. In
North Carolina's December 12, 2007, infrastructure submission, the
State certified that it has treated NOX as a precursor to
ozone since 1995 and that it has addressed the 110(a)(2)(J) requirement
(relating to prevention of significant deterioration of air quality and
visibility protection) with rule amendments that include reference to
definitions in 40 CFR 51.166--Prevention of significant deterioration
of air quality. These rule amendments became state-effective in March
2008. In the June 20, 2008, SIP revision, North Carolina included
revisions to NCAC 02D.0530 and .0531 that address the infrastructure
requirements of sections 110(a)(2)(C) and (J). On August 10, 2011, EPA
finalized approval of the December 20, 2005, May 16, 2007, and June 20,
2008, SIP revisions. The June 20, 2008, SIP revision addresses the
Ozone Implementation NSR Update requirements to include NOX
as an ozone precursor for permitting purposes. Specifically, the Ozone
Implementation NSR Update requirements include changes to major source
thresholds for sources in certain classes of nonattainment areas,
changes to offset ratios for marginal, moderate, serious, severe, and
extreme ozone nonattainment areas, provisions addressing offset
requirements for facilities that shut down or curtail operation, and a
requirement stating that NOX emissions are ozone precursors.
    EPA finalized approval of North Carolina's greenhouse gas (GHG)
regulations on October 18, 2011 (76 FR 64240). The proposed revisions
establish appropriate emission thresholds for determining which new
stationary sources and modification projects become subject to North
Carolina's PSD permitting requirements for their GHG emissions. The
October 18, 2011, rulemaking finalizes approval of the North Carolina
rules which address the thresholds for GHG permitting applicability in
North Carolina.
    On December 30, 2010, EPA published a final rulemaking, ``Action To
Ensure Authority To Implement Title V Permitting Programs Under the
Greenhouse Gas Tailoring Rule'' (75 FR 82254) to narrow EPA's previous
approval of State title V operating permit programs that apply (or may
apply) to GHG-emitting sources; this rule hereafter is referred to as
the ``Narrowing Rule.'' EPA narrowed its previous approval of certain
State permitting thresholds, for GHG emissions so that only sources
that equal or exceed the GHG thresholds, as established in the final
Tailoring Rule, would be covered as major sources by the Federally-
approved programs in the affected States. North Carolina was included
in this rulemaking.
    In this action, EPA is proposing to approve North Carolina's
infrastructure SIP for the 1997 8-hour ozone NAAQS with respect to the
general requirement in section 110(a)(2)(C) to include a program in the
SIP that regulates the modification and construction of any stationary
source as necessary to assure that the NAAQS are achieved. EPA is not
proposing to approve or disapprove the State's existing minor NSR
program to the extent that it is inconsistent with EPA's regulations
governing this program. EPA believes that a number of states may have
minor NSR provisions that are contrary to the existing EPA regulations
for this program. EPA intends to work with States to reconcile state
minor NSR programs with EPA's regulatory provisions for the program.
The statutory requirements of section 110(a)(2)(C) provide for
considerable flexibility in designing minor NSR programs, and EPA
believes it may be time to revisit the regulatory requirements for this
program to give the States an appropriate level of flexibility to
design a program that meets their particular air quality concerns,
while assuring reasonable consistency across the country in protecting
the NAAQS with respect to new and modified minor sources.
    EPA has made the preliminary determination that North Carolina's
SIP and practices are adequate for program enforcement of control
measures including review of proposed new sources related to the 1997
8-hour ozone NAAQS.
    4. 110(a)(2)(D)(ii) Interstate and International transport
provisions: NCAC 2D.0530, Prevention of Significant Deterioration,
2D.0531, Sources in a Nonattainment Area, and 2D.0532, Sources
Contributing to an Ambient Violation, outline how the State will notify
neighboring States of potential impacts from new or modified sources.
Additionally, North Carolina has federally-approved regulations in its
SIP that satisfy the requirements for the NOX SIP Call. See
67 FR 78987 (December 27, 2002). EPA has made the preliminary
determination that North Carolina's SIP and practices are adequate for
insuring compliance with the applicable requirements relating to
interstate and international pollution abatement for the 1997 8-hour
ozone NAAQS.
    5. 110(a)(2)(E) Adequate resources: EPA is proposing two separate
actions with respect to the sub-elements required pursuant to section
110(a)(2)(E). Section 110(a)(2)(E) requires that each implementation
plan provide (i) Necessary assurances that the State will have adequate
personnel, funding, and authority under State law to carry out its
implementation plan, (ii) that the State comply with the requirements
respecting State Boards pursuant to section 128 of the Act, and (iii)
necessary assurances that, where the State has relied on a local or
regional government, agency, or instrumentality for the implementation
of any plan provision, the State has responsibility for ensuring
adequate implementation of such plan provisions. As with the remainder
of the infrastructure elements addressed by this notice, EPA is
proposing to approve North Carolina's SIP as meeting the requirements
of sub-elements 110(a)(2)(E)(i) and (iii). With respect to
110(a)(2)(E)(ii) (regarding State Boards), EPA is proposing to either
conditionally approve, or in the alternative, proposing to disapprove
this sub-element. EPA's rationale for today's proposals respecting each
sub-element is described in turn below.
    In support of EPA's proposal to approve sub-elements
110(a)(2)(E)(i) and (iii), EPA notes that DAQ is responsible for
adopting air quality rules, revising SIPs, developing and tracking the
budget, establishing the title V fees, and other planning needs. DAQ
also coordinates agreements with local air pollution control programs.
Additionally, the SIP submittal cover letter provided by North Carolina
certifies the sufficiency of the State program with 110(a)(2)(E)(i) and
(iii) requirements. As evidence of the adequacy of DAQ's resources with
respect to sub-elements (i) and (iii), EPA submitted a letter to North
Carolina on March 17, 2011, outlining 105 grant commitments and the
current status of these commitments for fiscal year 2010. The letter
EPA submitted to North Carolina can be accessed at http://www.regulations.gov using Docket ID No. EPA-R04-OAR-2011-0352.
Annually, States update these grant commitments based on current SIP
requirements, air quality planning, and applicable requirements related
to the NAAQS. There were no outstanding issues for fiscal year 2010,
therefore, North Carolina's grants were finalized and closed out. EPA
has made a preliminary determination that, for purposes of
110(a)(2)(E)(i) and (iii), North Carolina has adequate resources for
implementation of the 1997 8-hour ozone NAAQS.

    As discussed above, with respect to sub-element 110(a)(2)(E)(ii),
EPA is proposing to conditionally approve, and in the alternative, to
disapprove North Carolina's infrastructure SIP as to this requirement.
North Carolina's March 27, 2008, infrastructure certification letter
did not certify the adequacy of the State's implementation plan to meet
the requirements of section 110(a)(2)(E)(ii) (requiring state
compliance with section 128 of the CAA), and presently North Carolina's
SIP does not include provisions to meet section 128 requirements.
    As a result, EPA is proposing to conditionally approve North
Carolina's infrastructure SIP with respect to element 110(a)(2)(E)(ii)
based upon assurances by the State that DAQ will submit to EPA a formal
commitment to adopt specific enforceable measures into its SIP within
one year to address the applicable portions of section 128. In order
for EPA to take final action conditionally approving the State's
infrastructure SIP with respect to element 110(a)(2)(E)(ii), DAQ must
formally commit to taking the actions described in this notice prior to
EPA's final action on North Carolina's infrastructure SIP. As described
further below, in the event DAQ should fail to provide an adequate
commitment to address the applicable 110(a)(2)(E)(ii) infrastructure
requirements, EPA is hereby proposing, in the alternative, to
disapprove the State's infrastructure SIP with respect to this sub-
element.
    The section 128 State Board requirements--as applicable to the
infrastructure SIP pursuant to section 110(a)(2)(E)(ii)--provide at
subsection (a)(1) that each SIP shall contain requirements that any
board or body which approves permits or enforcement orders be subject
to the described public interest and income restrictions. It further
requires at subsection (a)(2) that any board or body, or the head of an
executive agency with similar power to approve permits or enforcement
orders under the CAA, shall also be subject to conflict of interest
disclosure requirements. EPA's proposed conditional approval of North
Carolina's 110(a)(2)(E)(ii) infrastructure SIP requires the State to
commit to adopting specific enforceable measures related to both
128(a)(1) and 128(a)(2) to address current deficiencies in the North
Carolina SIP.
    For purposes of section 128(a)(1), a recent North Carolina law,
which becomes effective no later than June 15, 2012, rescinds the
authority of the State's Environmental Management Commission to issue
final decisions on contested cases involving permits and enforcement
orders. See North Carolina Session Law 2011-398, Section 18. Instead,
Session Law 2011-398 shifts this authority to individual State
Administrative Law Judges in the North Carolina Office of
Administrative Hearings. Once corresponding revisions have been made to
the federally-approved SIP to effectuate this change, a ``board or
body'' will no longer be responsible for approving permits or
enforcement orders in North Carolina.\19\ As such, EPA is proposing to
conditionally approve element 110(a)(2)(E)(ii) with respect to
128(a)(1) based upon a commitment by the State to timely submit any SIP
revisions necessary to remove the Environmental Management Commission's
authority to approve permits or enforcement orders under the State's
Air Pollution Act.\20\
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    \19\ Initial permit approvals and enforcement orders are issued
by delegated officials within NC DENR. Pursuant to N.C.G.S. Sec.
143-215.114A, the Secretary NC DENR is authorized to assess civil
penalties for violations of the State's Air Pollution Control laws.
NC DENR is also authorized pursuant to N.C.G.S. Sec.  143-215.114C
to request the Attorney General of the State to institute a civil
action seeking injunctive relief to restrain the violation or
threatened violation of the State's Air Pollution Control laws. The
North Carolina Environmental Management Commission is authorized
pursuant to N.C.G.S. Sec.  143-215.108, to approve Air Pollution
Control permits in the State, however, the Commission has delegated
by regulation this authority to the Secretary of the Department of
Environment, Health, and Natural Resources. See 15A N.C. Admin. Code
02A.0105(a)(2).
    \20\ Pursuant to section 55.2 of N.C. Session Law 2011-398, the
North Carolina Office of Administrative Hearings is required to seek
U.S. EPA approval to become an agency responsible for administering
programs under the Clean Air Act. This ongoing separate process may
result in additional SIP revisions implicating section
110(a)(2)(E)(ii). Any such actions are distinct from today's
proposed actions and would be address in a separate rulemaking.
---------------------------------------------------------------------------

    Regarding section 128(a)(2) (also made applicable to the
infrastructure SIP pursuant to section 110(a)(2)(E)(ii)), North
Carolina has indicated that it intends to commit to EPA to submit for
incorporation into the SIP relevant provisions of N.C.G.S. Sec.  138A,
Article 3: Public Disclosure of Economic Interests, sufficient to
satisfy the conflict of interest provisions applicable to the head of
NC DENR and those officials within the Department delegated his
authority.
    Both commitments described above must be received by EPA prior to
final action on this proposed conditional approval with respect to
element 110(a)(2)(E)(ii). Furthermore, these commitments must provide
that the State will adopt the specified enforceable provisions by a
date certain within one year from EPA's final action in this matter.
See section 110(k)(4) of the CAA, 42 U.S.C. 7410(k)(4). Failure to
adopt these provisions into the North Carolina SIP within one year
would result in the conditional approval becoming a disapproval.
    EPA is also proposing, in the alternative, to disapprove North
Carolina's 110(a)(2)(E)(ii) infrastructure SIP because North Carolina
has yet to submit to EPA a formal commitment to make the changes
described in this notice. In the event that North Carolina fails to
provide such commitment, or commits to addressing the section 128
requirements in a manner materially different from that which is
described herein, EPA is proposing to disapprove North Carolina's
infrastructure SIP with respect to section 110(a)(2)(E)(ii). Should
North Carolina provide the requisite timely commitment, EPA intends to
move forward with finalizing the conditional approval consistent with
section 110(k)(4) of the Act.
    6. 110(a)(2)(F) Stationary source monitoring system: North
Carolina's infrastructure submission describes how the State
establishes requirements for emissions compliance testing and utilizes
emissions sampling and analysis. It further describes how the State
ensures the quality of its data through observing emissions and
monitoring operations. North Carolina DAQ uses these data to track
progress towards maintaining the NAAQS, develop control and maintenance
strategies, identify sources and general emission levels, and determine
compliance with emission regulations and additional EPA requirements.
These requirements are provided in NCAC 2D.0605, General Recordkeeping
and Reporting Requirements, 2D.0613, Quality Assurance Program, and
2D.0614, Compliance Assurance Monitoring.
    Additionally, North Carolina is required to submit emissions data
to EPA for purposes of the National Emissions Inventory (NEI). The NEI
is EPA's central repository for air emissions data. EPA published the
Air Emissions Reporting Rule (AERR) on December 5, 2008, which modified
the requirements for collecting and reporting air emissions data (see
73 FR 76539). The AERR shortened the time states had to report
emissions data from 17 to 12 months, giving states one calendar year to
submit emissions data. All states are required to submit a
comprehensive emissions inventory every three years and report
emissions for certain larger sources annually through EPA's online
Emissions Inventory System. States report emissions data for the six
criteria pollutants and the precursors that form them--NOX,
sulfur dioxide, ammonia,

lead, carbon monoxide, particulate matter, and volatile organic
compounds (VOCs). Many states also voluntarily report emissions of
hazardous air pollutants. North Carolina made its latest update to the
NEI on March 25, 2011. EPA compiles the emissions data, supplementing
it where necessary, and releases it to the general public through the
Web site http://www.epa.gov/ttn/chief/eiinformation.html. EPA has made
the preliminary determination that North Carolina's SIP and practices
are adequate for the stationary source monitoring systems related to
the 1997 8-hour ozone NAAQS.
    7. 110(a)(2)(G) Emergency power: NCAC 2D.0300 Air Pollution
Emergencies, authorizes the North Carolina DAQ Director to determine
the existence of an air pollution emergency and it describes the
preplanned abatement strategies triggered by the occurrence of such an
emergency. These criteria have previously been approved by EPA. EPA has
made the preliminary determination that North Carolina's SIP and
practices are adequate for emergency powers related to the 1997 8-hour
ozone NAAQS.
    8. 110(a)(2)(H) Future SIP revisions: DAQ is responsible for
adopting air quality rules and revising SIPs as needed to attain or
maintain the NAAQS in North Carolina. DAQ has the ability and authority
to respond to calls for SIP revisions, and has provided a number of SIP
revisions over the years for implementation of the NAAQS. Specific to
the 1997 8-hour ozone NAAQS, North Carolina has provided a number of
submissions, including the following:
     June 19, 2006, SIP Revision--(EPA approval, 71 FR 64891,
November 6, 2006) Redesignation of the Rocky Mount, North Carolina
Area;
     June 15, 2007, SIP Revision, Charlotte, North Carolina
(North Carolina portion)--8-hr Ozone Reasonably Available Control
Technology and Reasonable Further Progress;
     February 4, 2008, SIP Revision (EPA approval, 73 FR 18963,
April 8, 2008) Raleigh/Durham and Greensboro 1-hour Maintenance Plan
Update;
     July 24, 2009, SIP Revision (EPA approval, 74 FR 63995,
December 7, 2009) Great Smoky Mountains National Park Redesignation;
     November 30, 2009, SIP Revision--Charlotte, North Carolina
(North Carolina portion)--8-hr Ozone Reasonable Further Progress
Update;
     April 5, 2010, SIP Revision--Supplement and Resubmission
of the 1997 8-hour Ozone Charlotte Attainment Demonstration (North
Carolina portion); and
     November 2, 2011, SIP Revision--Charlotte, North Carolina
(North Carolina portion) 1997 8-hour Ozone Redesignation/Maintenance
Plan.

    EPA has made the preliminary determination that North Carolina's
SIP and practices adequately demonstrate a commitment to provide future
SIP revisions related to the 1997 8-hour ozone NAAQS when necessary.
EPA notes, however, that North Carolina's one remaining 1997 8-hour
ozone NAAQS nonattainment area--the Charlotte-Gastonia-Rock Hill, NC-SC
Area (hereafter referred to as the ``Charlotte Area'')--is currently
attaining 1997 8-hour ozone NAAQS. In a November 15, 2011, final
rulemaking, EPA determined that the Charlotte Area has attained the
1997 8-hour ozone NAAQS. See 76 FR 70656. That final action, in
accordance with 40 CFR 51.918, suspended the requirements for the
Charlotte Area to submit attainment demonstrations, associated RACM,
RFP plans, contingency measures, and other planning SIPs related to
attainment of the 1997 8-hour ozone NAAQS so long as the Charlotte Area
continues to meet the 1997 8-hour ozone NAAQS.
    9. 110(a)(2)(J) (121 consultation) Consultation with government
officials: NCAC 2D.0530, Prevention of Significant Deterioration, and
2D.0531, Sources in a Nonattainment Area, as well as North Carolina's
Regional Haze Implementation Plan (which allows for consultation
between appropriate state, local, and tribal air pollution control
agencies as well as the corresponding Federal Land Managers), provide
for consultation with government officials whose jurisdictions might be
affected by SIP development activities. North Carolina adopted state-
wide consultation procedures for the implementation of transportation
conformity. These consultation procedures include considerations
associated with the development of mobile inventories for SIPs.
Implementation of transportation conformity as outlined in the
consultation procedures requires DAQ to consult with federal, state and
local transportation and air quality agency officials on the
development of motor vehicle emissions budgets. EPA approved North
Carolina's consultation procedures on December 27, 2002 (See 67 FR
78983). EPA has made the preliminary determination that North
Carolina's SIP and practices adequately demonstrate consultation with
government officials related to the 1997 8-hour ozone NAAQS when
necessary.
    10. 110(a)(2)(J) (127 public notification) Public notification: DAQ
has public notice mechanisms in place to notify the public of ozone and
other pollutant forecasting, including an air quality monitoring Web
site providing ground level ozone alerts, http://xapps.enr.state.nc.us/aq/ForecastCenter. North Carolina also has an outreach program to
educate the public and promote voluntary emissions reduction measures
including the ``Turn Off Your Engine'' idling reduction program. NCAC
2D.0300, Air Pollution Emergencies, requires that DAQ notify the public
of any air pollution episode or NAAQS violation. EPA has made the
preliminary determination that North Carolina's SIP and practices
adequately demonstrate the State's ability to provide public
notification related to the 1997 8-hour ozone NAAQS when necessary.
    11. 110(a)(2)(J) (PSD) PSD and visibility protection: North
Carolina demonstrates its authority to regulate new and modified
sources of ozone precursors, VOCs and NOx to assist in the protection
of air quality in NCAC 2D.0530, Prevention of Significant
Deterioration, and 2D.0531, Sources in a Nonattainment Area. On
December 20, 2005, May 16, 2007, and June 20, 2008, DAQ submitted
revisions to its PSD/NSR regulations for EPA approval. In North
Carolina's December 12, 2007, infrastructure submission, the State
certified that it has treated NOX as a precursor to ozone
since 1995 and has addressed the requirement for 110(a)(2)(J) with rule
amendments that include reference to definitions in 40 CFR 51.166--
Prevention of significant deterioration of air quality. These revisions
addressing section 110(a)(2)(J) requirements became state-effective in
March 2008.
    As described above, the June 20, 2008, SIP revision, includes
revisions to rules NCAC 02D.0530 and .0531 that address the
infrastructure requirements of sections 110(a)(2)(C) and (J). SIP
revision addressed the Ozone Implementation NSR Update requirements to
include NOx as an ozone precursor for permitting purposes. This
involved changes to major source thresholds for sources in certain
classes of nonattainment areas, changes to offset ratios for marginal,
moderate, serious, severe, and extreme ozone nonattainment areas,
provisions addressing offset requirements for facilities that shut down
or curtail operation, and a requirement stating that NOx emissions are
ozone precursors. In a August 10, 2011, final rulemaking action, EPA
approved the December 20, 2005, May 16, 2007, and

June 20, 2008, SIP revisions. See 76 FR 49313.
    With regard to the applicable requirements for visibility
protection, EPA recognizes that states are subject to visibility and
regional haze program requirements under part C of the Act (which
includes sections 169A and 169B). In the event of the establishment of
a new NAAQS, however, the visibility and regional haze program
requirements under part C do not change. Thus, EPA finds that there is
no new visibility obligation ``triggered'' under section 110(a)(2)(J)
when a new NAAQS becomes effective. This would be the case even in the
event a secondary PM2.5 NAAQS for visibility is established,
because this NAAQS would not affect visibility requirements under part
C. North Carolina has submitted SIP revisions for approval to satisfy
the requirements of the CAA Section 169A and 169B, and the regional
haze and best available retrofit technology rules contained in 40 CFR
51.308. These revisions are currently under review and will be acted on
in a separate action. EPA has made the preliminary determination that
North Carolina's SIP and practices adequately demonstrate the State's
ability to implement PSD programs and to provide for visibility
protection related to the 1997 8-hour ozone NAAQS when necessary.\21\
---------------------------------------------------------------------------

    \21\ Notably, EPA is currently engaged in discussions with North
Carolina and Federal Land Managers regarding an aspect of visibility
analysis for Class I areas under the State's PSD Program.
---------------------------------------------------------------------------

    12. 110(a)(2)(K) Air quality and modeling/data: NCAC 2D.0300, Air
Pollution Emergencies, and NCAC 2D.0806, Ambient Monitoring and
Modeling Analysis, require that air modeling be conducted to determine
permit applicability. These regulations demonstrate that North Carolina
has the authority to provide relevant data for the purpose of
predicting the effect on ambient air quality of the 8-hour ozone NAAQS.
Additionally, North Carolina supports a regional effort to coordinate
the development of emissions inventories and conduct regional modeling
for several NAAQS, including the 1997 8-hour ozone NAAQS, for the
Southeastern states. Taken as a whole, North Carolina's air quality
regulations demonstrate that DAQ has the authority to provide relevant
data for the purpose of predicting the effect on ambient air quality of
the 8-hour ozone NAAQS. EPA has made the preliminary determination that
North Carolina's SIP and practices adequately demonstrate the State's
ability to provide for air quality and modeling, along with analysis of
the associated data, related to the 1997 8-hour ozone NAAQS when
necessary.
    13. 110(a)(2)(L) Permitting fees: North Carolina addresses the
review of construction permits as previously discussed in 110(a)(2)(C).
Permitting fees in North Carolina are collected through the State's
federally-approved title V fees program, according to State's
federally-approved title V fees program according to State Regulation
NCAC 2Q.0200, Permit Fees. EPA has made the preliminary determination
that North Carolina's SIP and practices adequately provide for
permitting fees related to the 1997 8-hour ozone NAAQS when necessary.
    14. 110(a)(2)(M) Consultation/participation by affected local
entities: NCAC 2Q.0307, Public Participation Procedures requires that
DAQ notify the public of an application, preliminary determination, the
activity or activities involved in a permit action, any emissions
associated with a permit modification, and the opportunity for comment
prior to making a final permitting decision. Furthermore, DAQ has
demonstrated consultation with, and participation by, affected local
entities through its work with local political subdivisions during the
developing of its Transportation Conformity SIP, Regional Haze
Implementation Plan, Early Action Compacts, and the 8-Hour Ozone
Attainment Demonstration for the North Carolina portion of the
Charlotte-Gastonia-Rock Hill NC-SC nonattainment area. EPA has made the
preliminary determination that North Carolina's SIP and practices
adequately demonstrate consultation with affected local entities
related to the 1997 8-hour ozone NAAQS when necessary.

V. Proposed Action

    As described above, with the exception of sub-element
110(a)(2)(E)(ii), EPA is proposing to determine that North Carolina's
infrastructure submission, provided to EPA on December 12, 2007, and
clarified in a subsequent submission submitted on June 20, 2008,
addressed the required infrastructure elements for the 1997 8-hour
ozone NAAQS. EPA is proposing to approve in part, and to conditionally
approve or disapprove in part consistent with section 110 of the CAA.
    With respect to 110(a)(2)(E)(ii) (referencing section 128 of the
CAA), EPA is proposing to conditionally approve North Carolina's
infrastructure SIP with respect to element 110(a)(2)(E)(ii) based upon
assurances by the State that DAQ will submit to EPA a formal commitment
to adopt specific enforceable measures into its SIP within one year to
address the applicable portions of section 128. In order for EPA to
take final action conditionally approving the State's infrastructure
SIP with respect to element 110(a)(2)(E)(ii), DAQ must formally commit
to taking the actions described in this notice prior to EPA's final
action on North Carolina's infrastructure SIP. In the event DAQ fails
to provide an adequate commitment to address the applicable
110(a)(2)(E)(ii) infrastructure requirements, EPA is hereby proposing,
in the alternative, to disapprove the State's infrastructure SIP with
respect to this sub-element. EPA is also proposing to approve North
Carolina's infrastructure submission for the 1997 8-hour ozone NAAQS,
with the exception of sub-element 110(a)(2)(E)(ii) because its December
12, 2007, and June 20, 2008, submissions are consistent with section
110 of the CAA.

VI. 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. Accordingly, this
proposed 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 proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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).

In addition, this proposed rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: December 7, 2011.
Gwendolyn Keyes Fleming,
Regional Administrator, Region 4.
[FR Doc. 2011-32183 Filed 12-14-11; 8:45 am]
BILLING CODE 6560-50-P


Reader’s Guide Aldicarb

CRM:  Tracy Perry

EPA/OPPTS/OPP/SRRD

Reader’s Guide to the Aldicarb Docket # OPP-2005-0163

EPA has created this document to provide an organizational structure to
the Aldicarb docket.  The docket index lists the caption entries
sequentially, while this document lists them by subject matter.  The
Agency is providing the “Readers Guide” to allow the reader to more
easily access and navigate the various entries contained in the Aldicarb
docket.

Phase 5 of 6  Federal Register and Docket Organizational Documents:

Docket Entry 1.	Federal Register Notice:  Aldicarb Revised Risk
Assessments, Notice of Availability, and Solicitation of Risk Reduction
Options (Phase 5 of 6-Phase Process)

Docket Entry 2.	Reader’s Guide for Aldicarb Docket #
EPA-HQ-OPP-2005-0163

Docket Entry 3.	Response to Comments on Preliminary Impact Analysis for
Aldicarb on Major Citrus Crops, Potatoes, and Pecans.

Docket Entry 4.	Aldicarb - Ecological risk results for alternative
application rate and incorporation efficiencies

Docket Entry 5.		Environmental Fate and Effects Division

			Aldicarb Revised RED

Docket Enrty 6.		Aldicarb (List A Case 0140, Chemical ID No. 098301).
HED Response to Comments Received During the Public Comment Period.

Docket Entry 7.	Aldicarb: Acute Dietary Exposure Assessment to Support
the Reregistration Eligibility Decision

Docket Entry 8.	Aldicarb (List A Case 0140, Chemical ID No. 098301).
HED Revised Human Health Risk Assessment for the Reregistration
Eligibility Decision Document (RED).

Docket Entry 9.	Aldicarb.  List A Reregistration Case No. 0140/Chemical
ID No. 098301.  Revised Dietary Exposure Analyses for the HED Human
Health Risk Assessment.

Docket Entry 10.	Alternative Analysis for Aldicarb on Sugar Beets

Docket Entry 11.	Analysis for Aldicarb on Peanuts

Docket Entry 12.	Alternatives Assessment for Aldicarb

Docket Entry 13. 	Agency's response to a letter from the American Bird
Conservancy

Docket Entry 14.	American Bird Conservancy comments and response to
comments by the Agency.

Docket Entry 15.	Revised Note to Reader for Aldicarb

Docket Entry 16.	Drinking Water Exposure Assessment for Total Aldicarb
Residues (Parent, Aldicarb Sulfoxide, and Aldicarb Sulfone) Based on the
N-Methyl Carbamate Cumulative Risk Assessment

Docket Entry 17.	EFED Response to Public Comments for Aldicarb RED