[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Notices]
[Page 70839-70841]
[DOCID:fr13de07-51]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-1081; FRL-8155-8]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Tier 1 Screening of Certain Chemicals Under the
Endocrine Disruptor Screening Program (EDSP); EPA ICR No. 2249.01, OMB
Control No. 2070-new

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request for a new Information Collection Request (ICR) to the
Office of Management and Budget (OMB). This ICR is entitled: ``Tier 1
Screening of Certain Chemicals Under the Endocrine Disruptor Screening
Program (EDSP)'' and identified by EPA ICR No. 2249.01 and OMB Control
No. 2070-new. Before submitting the ICR to OMB for review and approval
under the PRA, EPA is soliciting comments on specific aspects of the
proposed information collection.

DATES: Comments must be received on or before February 11, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-1081, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2007-1081.

The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the DCO is<PHONE_NUMBER>.
Such deliveries are only accepted during the DCO's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-1081. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
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 information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail 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 docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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 electronically at http://www.regulations.gov
, or, if only available in hard copy, at the OPPT

Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC.
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: William Wooge, Office of Science
Coordination and Policy (OSCP) (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Should I Consider when I Prepare My Comments for EPA?

A. Considerations Under the PRA

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

B. Tips for Preparing Your Comments

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

C. Submitting CBI

    Do not submit CBI to EPA through regulations.gov or e-mail. 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 procedures set forth in 40 CFR part 2.

II. What Information Collection Activity or ICR Does this Action Apply
to?

    Affected entities: Entities potentially affected by this action are
those individuals and companies that receive an EDSP test order issued
by the Agency. Under the Federal Food, Drug, and Cosmetic Act (FFDCA)
section 408(p)(5)(A), EPA ``shall issue'' EDSP test orders ``to a
registrant of a substance for which testing is required . . . or to a
person who manufactures or imports a substance for which testing is
required.'' Using the North American Industrial Classification System
(NAICS) codes, the Agency has

determined that potential respondents to this ICR may include, but is
not limited to: Chemical manufacturers and processors (NAICS code 325);
Pesticide, fertilizer, and other agricultural chemical manufacturing
(NAICS code 3253); Producers and formulators of pesticide products
(NAICS code 32532); Producers of antifouling paints (NAICS code 32551);
Producers of antimicrobial pesticides (NAICS code 32561); Producers of
nitrogen stabilizers (NAICS code 32531); and Producers of wood
preservatives (NAICS code 32519).
    Title: Tier 1 Screening of Certain Chemicals Under the Endocrine
Disruptor Screening Program (EDSP).
    ICR numbers: EPA ICR No. 2249.01, OMB Control No. 2070-new.
    ICR status: This ICR is for a new information collection activity.
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 OMB control number. The OMB control number for this ICR will be
displayed by publication in the Federal Register and by inclusion of a
Paperwork Reduction notice on the related collection instrument, i.e.,
test order and/or form.
    Abstract: This new ICR covers the information collection activities
associated with Tier 1 screening of the first group of chemicals under
the EDSP. The EDSP is established under section 408(p) of the FFDCA,
which requires endocrine screening of all pesticide chemicals and was
established in response to growing scientific evidence that humans,
domestic animals, and fish and wildlife species have exhibited adverse
health consequences from exposure to environmental chemicals that
interact with their endocrine systems.
    The EDSP, which was established in 1998, consists of a two-tiered
approach to screen all pesticide chemicals for potential endocrine
disrupting effects. The purpose of Tier 1 screening (referred to as
``screening'') is to identify substances that have the potential to
interact with the estrogen, androgen, or thyroid hormone systems using
a battery of assays. The purpose of Tier 2 testing (referred to as
``testing''), therefore, is to identify and establish a dose-response
relationship for any adverse effects that might result from the
interactions identified through the Tier 1 assays. Additional
information about the EDSP is available through the Agency's web site
at http://www.epa.gov/scipoly/oscpendo/index.htm.

    EPA is currently implementing the EDSP in three major parts that
are being developed in parallel and with substantial work on each well
underway: 1) Assay validation; 2) Priority setting; and 3) Procedures.
This ICR is related to the third component of the EDSP, i.e., the
procedures for Tier 1 screening. This ICR is not intended to cover all
of the activities currently underway for the EDSP. Instead, the focus
of this ICR is on the information collection activities associated with
the Tier 1 screening of the 73 chemicals identified for initial
screening under the EDSP. A separate ICR will be developed to address
the information collection activities associated with Tier 2 testing.
In addition, subsequent Tier 1 screening of additional chemicals not
selected for the initial round will be addressed in a future ICR,
either when this ICR is amended in three years or in a separate ICR. In
either case, EPA will follow the notice and comment process prescribed
by the PRA to first seek public comment on the ICR before submitting it
to OMB for review and approval under the PRA.
    Burden statement: The annualized public reporting and recordkeeping
burden for this collection of information is estimated to average 2,649
hours per response, although individual respondent burden varies based
on their individual activities. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal Agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR, a copy of which is available in the docket, provides a
detailed explanation of this estimate, which is only briefly summarized
here:
    Estimated total number of potential respondents: 445.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent:
Two responses per chemical: An initial response and the final data
submission. All respondents will provide an initial response, while
only those that generate the data will complete the final data
submission.
    Estimated total annual burden hours: 93,655 hours.
    Estimated total annual costs: $6,887,418. This includes an
estimated annualized cost of $267 for non-burden hour or delivery
costs.

III. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. Although included as attachments to the ICR, EPA has
issued a separate Federal Register document to solicit public review
and comments on the related draft policy describing the procedures for
responding to the 408(p) order, and the draft template for the 408(p)
order itself. In addition to considering comments submitted on the ICR,
EPA will also consider comments received on those documents in response
to that separate solicitation. Changes to those documents may result in
changes to the ICR as well. The final ICR package will then be
submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA
will issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: November 29, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-24163 Filed 12-12-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Proposed Rules]
[Pages 40136-40142]
[FR Doc No: 2023-13148]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2023-0206; FRL-11037-01-R3]

Air Plan Disapproval; Delaware; Removal of Excess Emissions
Provisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
disapprove certain portions of a state implementation plan (SIP)
revision submitted by the State of Delaware, through the Delaware
Department of Natural Resources and Environmental Control (DNREC), on
November 22, 2016. The revision was submitted by Delaware in response
to a national finding of substantial inadequacy and SIP call published
on June 12, 2015, which included certain provisions in the Delaware SIP
related to excess emissions during startup, shutdown, and malfunction
(SSM) events. EPA is proposing disapproval of certain portions of the
SIP revision and proposing to determine that such SIP revision does not
correct the remaining deficiencies in Delaware's SIP identified in the
June 12, 2015, SIP call in accordance with the requirements for SIP
provisions under the Clean Air Act (CAA or Act). This action addresses
the remaining deficiencies identified in EPA's June 2015 SIP call that
have not yet been addressed by prior EPA actions on Delaware's November
2016 SIP submission.

DATES: Written comments must be received on or before July 21, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2023-0206 at www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Mallory Moser, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, Four Penn Center, 1600
John F. Kennedy Boulevard, Philadelphia, Pennsylvania 19103. The
telephone number is<PHONE_NUMBER>. Ms. Moser can also be reached via
electronic mail at [email protected].

SUPPLEMENTARY INFORMATION: On November 22, 2016, DNREC submitted a
revision to its SIP in response to a national finding of substantial
inadequacy and SIP call published on June 12, 2015, which included
certain provisions in the Delaware SIP related to excess emissions
during SSM events.

I. Background

A. EPA's 2015 SSM SIP Action

    On February 22, 2013, EPA issued a Federal Register notice of
proposed rulemaking outlining EPA's policy at the time with respect to
SIP provisions related to periods of SSM. EPA analyzed specific SSM SIP
provisions and explained how each one either did or did not comply with
the CAA with regard to excess emission events.\1\ For each SIP
provision that EPA determined to be inconsistent with the CAA, EPA
proposed to find that the existing SIP provision was substantially
inadequate to meet CAA requirements and thus proposed to issue a SIP
call under CAA section 110(k)(5). On September 17, 2014, EPA issued a
document supplementing and revising what the Agency had previously
proposed on February 22, 2013, in light of a D.C. Circuit decision that
determined the CAA precludes authority of the EPA to create affirmative
defense provisions applicable to private civil suits. EPA outlined its
updated policy that affirmative defense SIP provisions are not
consistent with CAA requirements. EPA proposed in the supplemental
proposal document to apply its revised interpretation of the CAA to
specific affirmative defense SIP provisions and proposed SIP calls for
those provisions where appropriate.\2\
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    \1\ State Implementation Plans: Response to Petition for
Rulemaking; Findings of Substantial Inadequacy; and SIP Calls To
Amend Provisions Applying to Excess Emissions During Periods of
Startup, Shutdown, and Malfunction, 78 FR 12460 (February 22, 2013).
    \2\ 79 FR 55920 (September 17, 2014).
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    On June 12, 2015, pursuant to CAA section 110(k)(5), EPA finalized
``State Implementation Plans: Response to Petition for Rulemaking;
Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings
of Substantial Inadequacy; and SIP Calls To Amend Provisions Applying
to Excess Emissions During Periods of Startup, Shutdown and
Malfunction,'' hereafter referred to as the ``2015 SSM SIP Action.''
\3\ The 2015 SSM SIP Action clarified, restated, and updated EPA's
interpretation that SSM exemption and affirmative defense SIP
provisions are inconsistent with CAA requirements. The 2015 SSM SIP
Action found that certain SIP provisions in 36 states were
substantially inadequate to meet CAA requirements and issued a SIP call
to those states to submit SIP revisions to address the inadequacies.
EPA established an 18-month deadline by which the affected states had
to submit such SIP revisions. States were required to submit corrective
revisions to their SIPs in response to the SIP calls by November 22,
2016.
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    \3\ 80 FR 33840 (June 12, 2015).
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    EPA issued a Memorandum in October 2020 (2020 Memorandum), which
stated that certain provisions governing SSM periods in SIPs could be
viewed as consistent with CAA requirements.\4\ Importantly, the 2020

Memorandum stated that it ``did not alter in any way the determinations
made in the 2015 SSM SIP Action that identified specific state SIP
provisions that were substantially inadequate to meet the requirements
of the Act.'' Accordingly, the 2020 Memorandum had no direct impact on
the SIP call issued to Delaware in 2015. The 2020 Memorandum did,
however, indicate EPA's intent at the time to review SIP calls that
were issued in the 2015 SSM SIP Action to determine whether EPA should
maintain, modify, or withdraw particular SIP calls through future
agency actions.
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    \4\ October 9, 2020, memorandum ``Inclusion of Provisions
Governing Periods of Startup, Shutdown, and Malfunctions in State
Implementation Plans,'' from Andrew R. Wheeler, Administrator.
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    On September 30, 2021, EPA's Deputy Administrator withdrew the 2020
Memorandum and announced EPA's return to the policy articulated in the
2015 SSM SIP Action (2021 Memorandum).\5\ As articulated in the 2021
Memorandum, SIP provisions that contain exemptions or affirmative
defense provisions are not consistent with CAA requirements and,
therefore, generally are not approvable if contained in a SIP
submission. This policy approach is intended to ensure that all
communities and populations, including overburdened communities,
receive the full health and environmental protections provided by the
CAA.\6\ The 2021 Memorandum also retracted the prior statement from the
2020 Memorandum of EPA's plans to review and potentially modify or
withdraw particular SIP calls. That statement no longer reflects EPA's
intent. EPA intends to implement the principles laid out in the 2015
SSM SIP Action as the agency takes action on SIP submissions, including
this SIP submittal provided in response to the 2015 SIP call.
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    \5\ September 30, 2021, memorandum ``Withdrawal of the October
9, 2020, Memorandum Addressing Startup, Shutdown, and Malfunctions
in State Implementation Plans and Implementation of the Prior
Policy,'' from Janet McCabe, Deputy Administrator.
    \6\ 80 FR 33840 at 33985.
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B. Delaware's Provisions Related to Excess Emissions

    With regard to the Delaware SIP, EPA's 2015 SSM SIP Action
determined that the following regulations were substantially inadequate
to meet CAA requirements: Title 7 of Delaware's Administrative Code (7
DE Admin. Code) 1104 Section (Sec.  ) 1.5, 7 DE Admin. Code 1105 Sec.
1.7, 7 DE Admin. Code 1108 Sec.  1.2, 7 DE Admin. Code 1109 Sec.  1.4,
7 DE Admin. Code 1114 Sec.  1.3, 7 DE Admin. Code 1124 Sec.  1.4 and 7
DE Admin. Code 1142 Sec.  <IP_ADDRESS>.\7\ These provisions provide a state
official with the discretion, through the permitting process, to exempt
sources from otherwise applicable SIP emission limitations or to set
alternative limitations for periods of startup and shutdown. The
rationale underlying EPA's determination that these provisions were
substantially inadequate to meet CAA requirements, and therefore to
issue a SIP call to Delaware to remedy the provisions, is detailed in
the 2015 SSM SIP Action and the 2013 proposed SSM SIP Action.\8\
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    \7\ See Id. at 33973.
    \8\ See Id. and 78 FR 12460 at 12495.
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    Delaware submitted a SIP revision on November 22, 2016, in response
to the SIP call issued in the 2015 SSM SIP Action. In addition to
addressing deficiencies identified in 7 DE Admin. Code 1104, 1105, 1109
and 1114, Delaware's submission noted that the deficiency highlighted
in 7 DE Admin. Code 1108 Sec.  1.2 was corrected by a previous SIP
revision, which was submitted to EPA on July 10, 2013. A final
rulemaking which acted on this 2013 submission and remedied 7 DE Admin.
Code 1108 Sec.  1.2 published in the Federal Register on July 11,
2022.\9\ Delaware's submission also requested that EPA revise the
Delaware SIP by removing 7 DE Admin. Code 1124 Sec.  1.4 and 7 DE
Admin. Code 1142 Sec.  <IP_ADDRESS> in their entirety, thereby removing
these provisions, and their deficiencies, from the Delaware SIP. A
final rulemaking which remedied 7 DE Admin. Code 1124 Sec.  1.4 and 7
DE Admin. Code 1142 Sec.  <IP_ADDRESS> published in the Federal Register on
February 14, 2023.\10\
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    \9\ 87 FR 41074.
    \10\ 88 FR 9399.
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    Lastly, Delaware's submission requested that EPA revise the SIP to
address the deficiencies identified in the following regulations: 7 DE
Admin. Code 1104 Sec.  1.5, 7 DE Admin. Code 1105 Sec.  1.7, 7 DE
Admin. Code 1109 Sec.  1.4, and 7 DE Admin. Code 1114 Sec.  1.3.
Through this proposed rulemaking, EPA will be acting on these remaining
provisions that were identified as deficient in the 2015 SSM SIP
Action.

II. Summary of SIP Revision and EPA Analysis

    EPA has identified several significant concerns with Delaware's
revisions to 7 DE Admin. Code 1104 Sec.  1.5, 7 DE Admin. Code 1105
Sec.  1.7, 7 DE Admin. Code 1109 Sec.  1.4, and 7 DE Admin. Code 1114
Sec.  1.3, which suggest that those parts of the 2016 SIP submission
cannot be approved. Delaware's revisions to these sections in the SIP
submission and EPA's corresponding analysis are summarized below. An
underline/strikeout version of each regulation, showing the changes to
the regulations or the changes requested to the Delaware SIP, is
included in the docket for this rulemaking.\11\
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    \11\ The revisions can be found on pages 4-7 of the PDF, which
corresponds to pages 1-4 of Delaware's submitted document entitled
``Revision to Satisfy EPA's State Implementation Plan (SIP) Call
Related to Air Emissions During Equipment Start-up and Shutdown,''
which is in the docket for this action.
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A. Summary and Analysis of Revisions to 7 DE Admin. Code 1104 Sec.  1.5
and 7 DE Admin. Code 1105 Sec.  1.7

    The 2015 SSM SIP Action cited 7 DE Admin. Code 1104 (Particulate
Emissions from Fuel Burning Equipment) Sec.  1.5 because it provides a
potential exemption from the emission limit in 7 DE Admin. Code 1104
Sec.  2.1. The emission limit in 7 DE Admin. Code 1104 Sec.  2.1
currently contained in the EPA-approved SIP says, ``no person shall
cause or allow the emission of particulate matter in excess of 0.3
pound per million British Thermal Units (lb/MMBTU) heat input, maximum
two-hour average.'' Section 1.5 creates a potential exemption to this
limit during start-up or shutdown events by stating, ``The provisions
of this Regulation shall not apply to the start-up and shutdown of
equipment which operates continuously or in an extended steady state
when emissions from such equipment during start-up and shutdown are
governed by an operation permit issued pursuant to the provisions of
2.0 of 7 DE Admin. Code 1102.'' Delaware's SIP submission asked EPA to
remove Sec.  1.5 and Sec.  2.1 of 7 DE Admin. Code 1104 from the EPA-
approved Delaware SIP, but these provisions would remain in the
Delaware regulations. In addition, Delaware revised 7 DE Admin. Code
1104 by adding a new section, Sec.  2.2, which states, ``[n]o person
shall cause or allow the emission of particulate matter in excess of
0.3 pound per million BTU heat input, maximum 30-day rolling average,
from any fuel burning equipment.'' The SIP submission asked EPA to
approve this new Sec.  2.2 into the Delaware SIP. While Delaware
requested to remove Sec.  1.5, which contains the potential emission
limit exemption during start-up and shutdown, from the EPA-approved
SIP, the State also increased the two-hour averaging time found in
Sec.  2.1 to 30 days while keeping the same 0.3 lb/MMBTU limit. Thus,
the EPA-approved SIP would have a 0.3 lb/MMBTU 30-day rolling average
limit, as set forth in the

new Sec.  2.2, while Delaware's regulations would have both a limit of
0.3 lb/MMBTU two-hour average in Sec.  2.1, which could be changed for
startup and shutdown purposes via Sec.  1.5, and a 0.3 lb/MMBTU 30-day
rolling average limit in Sec.  2.2 that could not be changed via Sec.
1.5.
    The 2015 SSM SIP Action also highlighted 7 DE Admin. Code 1105
(Particulate Emissions from Industrial Process Operations) Sec.  1.7
because it provides a potential exemption from the emission limit in 7
DE Admin. Code 1105 Sec.  2.1. The emission limit in 7 DE Admin. Code
1105 Sec.  2.1 currently contained in the EPA-approved SIP says, ``No
person shall cause or allow particulate emissions into the atmosphere
from any source not provided for in subsequent sections of this
Regulation in excess of 0.2 grains per standard cubic foot.'' Section
1.7 creates a potential exemption to this limit by stating, ``The
provisions of this Regulation shall not apply to the start-up and
shutdown of equipment which operates continuously or in an extended
steady state when emissions from such equipment during start-up and
shutdown are governed by an operation permit issued pursuant to the
provisions of 2.0 of 7 DE Admin. Code 1102.'' Delaware revised 7 DE
Admin. Code 1105 by adding a new section, Sec.  2.2, which added an
emission limit of 0.2 grains per standard cubic foot on a 30-day
rolling average basis. Delaware's SIP submission asked EPA to remove
Sec.  1.7 and Sec.  2.1 from the EPA-approved SIP, but these provisions
would remain in the Delaware regulations. Delaware's submission also
asked EPA to approve the new Sec.  2.2 into the SIP. Again, although
Delaware requested to remove Sec.  1.7, which contained the exemption
identified in the 2015 SSM SIP Action, the State also asked EPA to
approve into the SIP a newly created limit in Sec.  2.2 which adds an
averaging period of 30 days to the existing 0.2 grains per cubic foot
limit. Delaware does not explain how these differing emission limits in
Sec.  2.1 and Sec.  2.2 would be reconciled.
    Delaware explained that the increases in averaging times provide
the opportunity for any source subject to these limits to compensate
for higher emission rates during startup or shutdown events by emitting
at lower rates during normal operations, so long as continuous
compliance is demonstrated on a 30-day rolling average basis.
    However, Delaware's increases in the averaging times for the
particulate emission limits found in 7 DE Admin. Code 1104 and 1105
were not supported by a sufficient analysis explaining why these
changes meet the requirements of section 110(l) of the CAA. The 2015
SSM SIP Action did not provide an opportunity for averaging times to be
increased with no explanation or analysis of how the increased
averaging time would or would not affect the national ambient air
quality standards (NAAQS). In response to a comment regarding opacity,
EPA noted in the 2015 SSM SIP Action that the removal of impermissible
SSM exemptions should not be perceived as an opportunity to provide new
de facto exemptions for these emissions by manipulation of the
averaging time and the numerical level of existing opacity emission
limitations.\12\ This reasoning is not exclusive to opacity
limitations, and also applies to the SIP-approved particulate limit 30-
day rolling averaging times that Delaware has added to 7 De Admin. Code
1104 and 1105. During Delaware's public comment period on these
regulatory changes, EPA submitted comments raising this and other
concerns.\13\ EPA noted that Delaware did not address whether changes
to the averaging period might affect the emissions of any criteria
pollutant and recommended a more robust explanation and analysis be
provided to support Delaware's conclusion in order to meet the
requirements of section 110(l) of the CAA. The State responded to EPA's
comments during the state regulatory comment period with minimal data
to assert that the long-term average of emissions would be slightly
lower with the implementation of the revised limit. The State also
explained these limits were originally intended to protect the total
suspended particulate (TSP) NAAQS. However, the particulate matter (PM)
NAAQS replaced the TSP standard.\14\ Therefore, these limits still play
a role in protecting the existing PM NAAQS. Although Delaware is
currently attaining the PM standards,\15\ the State did not explain how
this 30-day rolling average longer-term limit is still protective of
the short-term NAAQS, such as the 24-hour PM standard. Delaware's
response to EPA's comments did not adequately explain how the increased
averaging time of the 30-day rolling average limits, without decreasing
the limit itself, would be protective of the PM NAAQS, and instead
noted, with minimal explanation, that this would not result in any
increase in emissions on a tons per year basis. Delaware explained this
using two scenarios. In the first scenario, Delaware referred to the
emissions limits and startup/shut down exemptions that are currently
SIP-approved. Delaware stated that if all steady-state hours of
operation emit exactly at, or very near, the emissions limit, and
emissions during startup/shut down events are exempt, then the long-
term average of emissions would be slightly higher than the emission
limit. In scenario two, they noted with the new 30-day rolling average
limits and no exemptions for start-up or shut down events, emissions
occurring during SSM events would have to be offset by emissions lower
than the 30-day average emission limit during non-SSM operation.
Delaware asserted, without any further explanation, that this would
result in the long-term average of emissions to be no more than the 30-
day average emission limit. Delaware explained, with respect to annual
emissions, the emissions calculation in scenario two is less than the
emissions in scenario one. Therefore, Delaware believes this change is
SIP strengthening.
---------------------------------------------------------------------------

    \12\ 80 FR 33840 at 33921 (June 12, 2015).
    \13\ See EPA Comment #1 and EPA Comment #2 of Appendix B in
State Submittal document.
    \14\ The PM2.5 24-hour standard is 35 micrograms per
cubic meter ([mu]g/m\3\). The PM2.5 annual standard is
12.0 [mu]g/m\3\. The PM10 24-hour standard is 150 [mu]g/
m\3\. See 40 CFR 50.6 and 50.7.
    \15\ See 40 CFR 81.308.
---------------------------------------------------------------------------

    EPA does not agree that the evaluation of the impacts of changing
the averaging period for an emissions limit enacted to ensure the NAAQS
is attained and protected can be limited only to consideration of
emissions on an annual basis. The potential short-term effect of a
sharp increase in particulate emissions during a startup or shutdown
event on a shorter-term NAAQS limit, such as the PM10 24-
hour standard, need to be examined and explained. Therefore, EPA does
not consider the State's explanation of why the longer 30-day averaging
period with the same emission limit are adequate to ensure continued
attainment of the NAAQS. EPA's comments and Delaware's response can be
found in the docket for this action.
    Under CAA section 110(l), EPA cannot approve a plan revision ``if
the revision would interfere with any applicable requirement concerning
attainment and reasonable further progress (as defined in section 7501
of [title 42]), or any other applicable requirement of this chapter.''
\16\ The nature of the technical demonstration needed under section
110(l) to support approval of a SIP revision depends on the facts and
circumstances of the SIP revision at issue. Based on the

information available to EPA, EPA concluded that approval of these
longer-term limits for a shorter-term NAAQS would not be consistent
with the requirements of section 110(l). For EPA's analysis to address
CAA section 110(l), EPA requested information from the State, but the
State did not respond with the appropriate information. At a minimum,
Delaware should have explained how this change would not impact
maintenance of the PM NAAQS, as well as explain how this change meets
the applicable legal requirements of the CAA, including both sections
110(l) and 193, as EPA suggested in their comments during Delaware's
public comment period. Additionally, the submittal lacks an explanation
of the maximum daily emissions that could occur with the new averaging
time. There is also no information regarding the likely frequency of
startup and shutdown events, the likely magnitude of emissions during
these events, and how many such events it would take in a 30-day period
to exceed the new 30-day average. This information is relevant because
it could be that one large startup or shutdown event with significant
PM emissions could cause an exceedance of the PM NAAQS at a monitor.
More frequent SSM events under a 30-day averaging period can cause the
short-term emissions to increase, with a deleterious effect on shorter-
term NAAQS. There is no explanation of how the NAAQS will continue to
be protected with the new, longer averaging period.
---------------------------------------------------------------------------

    \16\ A more detailed discussion of 110(l) can be found in the
SO2 air plan disapproval for Missouri at 87 FR 40759,
40760 (July 8, 2022).
---------------------------------------------------------------------------

    Replacement SIP provisions should have averaging periods that are
logically related to the NAAQS at issue. The 2015 SSM SIP Action notes,
``For example, if a state chooses to modify averaging times in an
emission limitation to account for higher emissions during startup and
shutdown, the state would need to consider and demonstrate to the EPA
how the variability of emissions over that averaging period might
affect attainment and maintenance of a NAAQS with a short averaging
period (e.g., how a 30-day averaging period for emissions can ensure
attainment of an 8-hour NAAQS).'' (80 FR 33840, 33947 (June 12, 2015)).
Delaware has not explained how the 30-day average is reasonably related
to the 24-hour PM NAAQS. The 2015 SSM SIP Action also notes that in
some cases, extension of the averaging period and elevation of the
numerical limitations may in fact be appropriate. In other cases,
however, it may instead be appropriate to reduce the existing numerical
opacity limitations, given improvements in control technology since the
original imposition of the limits.\17\ In either scenario, the
appropriate analysis and justification is needed, such as specific
calculations, including emissions distributions for sources in the
state, backed up by operating data, that shows an extension of the
averaging period would not violate the NAAQS. EPA has explained, for
the sulfur dioxide (SO2) NAAQS, how an increase in the
averaging period for SO2 emission limits beyond the 8-hour
standard used for the SO2 NAAQS could be protective of the
eight-hour SO2 NAAQS. EPA's 2014 SO2
Nonattainment Guidance recommends that the emission limits be expressed
as short-term averages, but also describes the option to use emission
limits with longer averaging times of up to 30 days so long as the
state meets various suggested criteria.\18\ The guidance recommends
that--should states and sources utilize longer averaging times--the
longer-term average limit should be set at an adjusted level that
reflects a stringency comparable to the 1-hour average limit at the
critical emission value (CEV) shown to provide for attainment that the
plan otherwise would have set.\19\ To preserve comparable stringency,
it would be expected that adjusting the level would result in a
lowering of the emission rate if lengthening the averaging time. In
cases where longer-term average limits are appropriate, EPA envisions
that both the short-term and longer-term limits in practice would
require similar emission control levels and would commonly result in
similar emission patterns.\20\ Therefore, a longer averaging time can
be appropriate to protect a shorter-term NAAQS but would require an in-
depth analysis of what adjusted downward level would provide a
comparable stringency. Delaware did not lower their emissions limit
when increasing the averaging time, nor did they provide an in-depth
analysis explaining how the same emission limit with a 30-day rolling
averaging period is comparable in stringency to the same emission limit
with a shorter, 3-hour averaging period previously found in their EPA-
approved SIP.
---------------------------------------------------------------------------

    \17\ 80 FR 33840 at 33912 (June 12, 2015).
    \18\ Guidance for 1-hour Sulfur Dioxide (SO2)
Nonattainment Area State Implementation Plans (SIP) Submissions, pp.
22 to 39.
    \19\ Id. at 26.
    \20\ Id. at 29.
---------------------------------------------------------------------------

    To support their adoption of a 30-day averaging period, Delaware's
response to comments cited page 2 of EPA's 1984 guidance memo, entitled
``Averaging Times for Compliance with VOC Emission Limits--SIP Revision
Policy,'' \21\ which states ``Averaging periods must be as short as
practicable and in no case longer than 30 days.'' However, in the same
memo, EPA specifically states that a demonstration must be made to show
the use of long-term averaging will not jeopardize the NAAQS.\22\
Though this guidance is geared towards volatile organic compounds
(VOCs), the idea that retention of the same limit with a longer-term
averaging period requires some demonstration explaining how the longer-
term averaging time would not affect the NAAQS is applicable to the PM
NAAQS too.
---------------------------------------------------------------------------

    \21\ See the Averaging Times for Compliance with VOC Emission
Limits--SIP Revision Policy Memorandum.
    \22\ Id. at 2.
---------------------------------------------------------------------------

    It is also important to recognize the broadness of the source
categories for these two regulations--fuel burning equipment and
industrial process operations. Given the broadness of these categories,
significant consideration should be given to how a 30-day averaging
period would even apply to the sources falling in these categories,
especially the smaller source categories that do not operate regularly,
such as emergency generators. The State's submittal also lacks an
explanation of the type and number of Delaware sources which might be
subject to these two regulations, and how the change in averaging time
might affect their emissions and thus affect the NAAQS. Additional
explanation is required to explain how the revisions would impact the
sources subject to these regulations, and how these impacts would be
unlikely to affect the NAAQS.
    Lastly, Delaware noted that the emission limits that were
highlighted in the 2015 SSM SIP Action would remain in the Delaware
state regulations. Therefore, these short-term limits, along with the
exemptions, are still applicable as a matter of state law only.
According to Delaware, because the short-term limits are still
effective at the state level, there is no change in the status quo of
emissions, and this means air quality may remain unaffected. However,
this is still problematic for several reasons. First, EPA cannot rely
on state-only provisions when evaluating SIP submissions for compliance
with CAA requirements. Presumably, Delaware asked that these emission
limits be placed into the SIP because they were necessary to attain or
maintain the NAAQS, and as discussed above, the effect on the NAAQS of
replacing these shorter-term average SIP limits with longer-term
averaging limits on attainment or maintenance of the

NAAQS is not adequately explained. Second, removing the shorter-term
emission limits from the EPA-approved SIP but keeping them in the state
regulation, while also keeping the possibility for a state issued
startup or shutdown exemption from these limits, creates the
possibility that the current status quo of PM emissions may not be
maintained. And, because the shorter-term emission limit is no longer
in the SIP, neither EPA nor citizens can enforce the shorter-term limit
under CAA sections 113 and 304. In effect, Delaware could grant an
exemption to emission limits which might be necessary to attain or
maintain the NAAQS without going through the SIP revision process
required by the CAA.
    The concerns stated above suggest that the revisions to 7 DE Admin.
Code 1104, Particulate Emissions from Fuel Burning Equipment, and 7 DE
Admin. Code 1105, Particulate Emissions from Industrial Process
Operations, cannot be approved. Further justification and information
from the State is required to explain that these changes would not be
inconsistent with CAA section 110(l), as well as explain how this
change meets the applicable legal requirements of the CAA, including
CAA section 193.

B. Summary and Analysis of Revisions to 7 DE Admin. Code 1109 Sec.  1.4
and 7 DE Admin. Code 1114 Sec.  1.3

    The 2015 SSM SIP Action included 7 DE Admin. Code 1109 (Emissions
of Sulfur Compounds From Industrial Operations) Sec.  1.4 because it
provides a potential exemption from the emission limitations during
startup and shutdown when the emissions during startup and shutdown are
governed by an operation permit issued pursuant to Sec.  2.0 of 7 DE
Admin. Code 1102. Delaware's SIP revision requests that the EPA remove
7 DE Admin. Code 1109 in its entirety from the Delaware SIP but retains
this regulation, including the startup and shutdown exemption, at the
state level. Delaware asserts that existing Federal requirements, such
as the New Source Performance Standards (NSPS) adopted pursuant to CAA
section 111, are adequate to ensure Delaware's maintenance of the
sulfur-related NAAQS,\23\ which Delaware is currently attaining.\24\
Delaware believes that removal of this regulation from the SIP, but
retention of the regulation at the state level, will not result in any
increase in emissions on a ton per year basis, and that this revision
comports with the EPA's interpretation of the CAA and is consistent
with the EPA's approach for attainment and maintenance of all NAAQS.
---------------------------------------------------------------------------

    \23\ The SO2 1-hour standard is 75 ppb. See 40 CFR
50.17.
    \24\ See 40 CFR 81.308.
---------------------------------------------------------------------------

    The 2015 SSM SIP Action included 7 DE Admin. Code 1114 (Visible
Emissions), Sec.  1.3, because it provides a similar exemption from the
visible emission (VE) limits during startup and shutdown when such
emissions are governed by an operation permit issued pursuant to Sec.
2.0 of 7 DE Admin. Code 1102. Delaware's SIP revision requests that the
EPA remove 7 DE Admin. Code 1114 in its entirety from the Delaware SIP
but retains this regulation, including the exemption, in the state
regulations. The State asserts that existing Federal requirements, such
as the New Source Performance Standards (NSPS), regulate visible
emissions from certain sources, while two other Delaware SIP
regulations that regulate fine particulate matter and fine particulate
matter precursors (7 DE Admin. Code 1108 and 1146) when combined with
the NSPS, are adequate to ensure Delaware's attainment and maintenance
of any particulate-related NAAQS. In addition, Delaware argues that
there is no quantifiable relationship between visible emissions and
fine particulate matter emissions. Delaware believes that removal of
this regulation from the SIP will not result in any increase in
emissions on a ton per year basis, and that because this revision
removes from the SIP a provision allowing for excess emissions, the
change therefore comports with the EPA's interpretation of the CAA and
is consistent with the EPA's approach for attainment and maintenance of
all NAAQS. Delaware's response provides no other explanation regarding
how the revisions comply with the CAA.
    To address CAA section 110(l), EPA believes it needs more
information and analysis from the State to support EPA's approval of
the removal of these two regulations from the Delaware SIP while
keeping the regulations at the state level. Section 110(l) prohibits
approval of a SIP revision if it would interfere with attainment or any
other applicable requirement. Delaware's SIP revision merely states
that the removal of this regulation from the SIP will not result in any
increase in emissions on a ton per year basis but provides no further
explanation or any technical demonstration to support this assertion,
and EPA does not have information available that would support this
conclusion. To support an approval decision that would be consistent
with section 110(l), Delaware should have provided information
demonstrating that these changes would not impact maintenance of the
NAAQS, as well as explain how this change meets the applicable legal
requirements of the CAA, including section 193. During the state public
comment period on this SIP revision, EPA submitted comments to Delaware
raising these concerns.\25\ EPA's comments and Delaware's response can
be found in the docket for this action.
---------------------------------------------------------------------------

    \25\ See EPA Comment #3 and EPA Comment #4 of Appendix B in
State Submittal document.
---------------------------------------------------------------------------

    Despite EPA's comments, Delaware's SIP revision did not include an
analysis to address CAA section 110(l). Instead, in regard, to 7 DE
Admin. Code 1109, the State responded that the sources' reliance on the
NSPS is enough to protect the NAAQS. Specifically, Delaware noted there
are two facilities in the state currently subject to 7 DE Admin Code
1109--the Chemours Red Lion sulfuric acid plant and the Delaware City
Refinery--and that each facility is subject to a more stringent NSPS.
The Chemours Red Lion sulfuric acid plant is subject to 40 CFR part 60,
subpart H, and the Delaware City Refinery is subject to 40 CFR part 60,
subpart J. However, both subparts H and J allow for periods of excess
emissions. The provisions at 40 CFR part 60, subpart A, General
Provisions, are applicable to sources subject to 40 CFR part 60,
subparts H and J. Subpart A of 40 CFR part 60 contains exemptions in
both 40 CFR 60.8(c)and 60.11(c) . The provisions at 40 CFR 60.11(c)
note ``The opacity standards set forth in this part shall apply at all
times except during periods of startup, shutdown, malfunction, and as
otherwise provided in the applicable standard.'' While 40 CFR 60.8(c),
states ``Operations during periods of startup, shutdown, and
malfunction shall not constitute representative conditions for the
purpose of a performance test nor shall emissions in excess of the
level of the applicable emission limit during periods of startup,
shutdown, and malfunction be considered a violation of the applicable
emission limit unless otherwise specified in the applicable standard.''
Reliance on these NSPS, which include excess emission exemptions, is
problematic in some cases for multiple reasons.
    EPA acknowledges that many of the existing NSPS still contain
exemptions from emission limitations during periods of SSM. The
exemptions in these EPA regulations, however, predate the 2008 issuance
of the D.C. Circuit decision in Sierra Club v. Johnson, in which the
court held that emission limitations must be continuous and thus cannot
contain exemptions for

emissions during SSM events.\26\ Since the 2008 Sierra Club decision,
EPA has been working to remove or revise these SSM provisions as NSPS
are reviewed.\27\ Thus, some NSPS have been revised to address the 2008
Sierra Club decision, but some have not, and Delaware's sources may be
subject to not-yet-updated standards. Despite the fact that EPA has not
completed its work removing SSM provisions from every NSPS, the Agency
is not willing to approve the removal of SIP approved regulations
containing potential startup and shutdown exemptions, on the basis that
affected sources would instead be subject to NSPS that also contain SSM
exemptions.
---------------------------------------------------------------------------

    \26\ 551 F.3d 1019 (D.C. Cir. 2008).
    \27\ 80 FR 33840 at 33890-91 (June 12, 2015).
---------------------------------------------------------------------------

    Regarding 7 DE Admin Code 1114, the State responded to EPA's
comment by noting that there is no discernable relationship between
opacity and fine particulate matter emissions, and therefore this
regulation cannot be relied on to prevent a source from impacting the
NAAQS. EPA assumes Delaware meant that PM2.5 cannot be seen
as visible emissions because PM2.5 is formed after leaving
the stack or other source from the precursor emissions of nitrogen
oxides (NOX), VOCs, SO2, and ammonia. However,
PM10 can be seen as visible emissions, and the observation
of unusual levels of visible emissions could be an indication of a
malfunction in the source itself or a pollution control device which
may result in increased emissions of one or more of PM2.5
precursors. Thus, Delaware's existing opacity limits may be a warning
sign of potential increases in the precursor pollutants contributing to
PM2.5, and therefore may play a role in preventing
PM2.5 NAAQS exceedances.
    Delaware also cites to two other SIP approved regulations, 7 DE
Admin. Code 1108 Sulfur Dioxide Emissions from Fuel Burning Equipment,
and 7 DE Admin. Code 1146 EGU Multi-Pollutant Regulation, as being
adequate to protect the PM NAAQS, along with unidentified NSPS, but
does not adequately explain how these regulations or the NSPS control
emissions of PM2.5 precursors during VE events. In addition,
the State still did not provide an explanation of the number and type
of Delaware sources subject to 7 DE Admin. Code 1114, how removing this
regulation from the Delaware SIP but retaining it as a state regulation
with the potential startup and shutdown exemption would affect their
emissions and thus affect the NAAQS, and how the Delaware SIP would
remain protective of the NAAQS. Further justification is required to
explain that this change will not impact attainment and maintenance of
the NAAQS, as well as explain how this change meets the applicable
legal requirements of the CAA, including CAA section 193.
    Lastly, Delaware noted that these regulations that were highlighted
in the 2015 SSM SIP Action (1109 and 1114) would be retained at the
state level. These state regulations allow Delaware to issue case-by-
case permits via 7 DE Admin. Code 1102 to address emissions during
startup and shutdown events. Therefore, Delaware would be relying on
their own permits to regulate emissions during startup and shutdown
events to protect the NAAQS during these periods. Because these
regulations (1109 and 1114) provide a potential exemption from the
emission limitations during startup and shutdown when the emissions
during startup and shutdown are governed by a section 1102 operation
permit, but would no longer be in the SIP, neither EPA nor citizens
would be able to enforce this alternative limit for startup or shutdown
under CAA sections 113 and 304. In effect, Delaware could grant an
exemption to formerly federally enforceable emission limits which might
be necessary to attain or maintain the NAAQS without justifying these
revisions by going through the SIP revision process required by the
CAA.
    The concerns stated above suggest that the revisions to the
Delaware SIP requesting removal of 7 DE Admin. Code 1109, Emissions of
Sulfur Compounds From Industrial Operations, and 7 DE Admin. Code 1114,
Visible Emissions, from the SIP cannot be approved.

III. Proposed Action

    EPA's review of this material indicates Delaware did not provide
adequate justification to support the revisions to Delaware's SIP
pertaining to 7 DE Admin. Code 1104, 1105, 1109 and 1114 requested in
their 2016 SIP submission. Further justification is required to explain
that these changes will not impact maintenance of the PM and
SO2 NAAQS. EPA is proposing to disapprove the portion of
Delaware's November 22, 2016, SIP submission addressing 7 DE Admin.
Code 1104 Sec.  1.5, 7 DE Admin. Code 1105 Sec.  1.7, 7 DE Admin. Code
1109 Sec.  1.4, and 7 DE Admin. Code 1114 Sec.  1.3. EPA is not
reopening the 2015 SSM SIP Action and is only taking comment on the
issues discussed in this document. These comments will be considered
before taking final action.

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' as defined
by Executive Order 12866 and was therefore not submitted to the Office
of Management and Budget for review.

B. Paperwork Reduction Act (PRA)

    This proposed action does not impose an information collection
burden under the PRA because it does not contain any information
collection activities.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action merely proposes to disapprove a SIP submission as not meeting
the CAA.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This action does not apply on any Indian
reservation land, any other area where the EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction, or non-reservation areas of
Indian country. Thus, Executive Order 13175 does not apply to this
action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those

regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it merely proposes to disapprove a SIP
submission as not meeting the CAA.

H. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to review state choices,
and approve those choices if they meet the minimum criteria of the Act.
Accordingly, this proposed action disapproves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law.
    The air agency did not evaluate environmental justice
considerations as part of its SIP submittal; the CAA and applicable
implementing regulations neither prohibit nor require such an
evaluation. EPA did not perform an EJ analysis and did not consider EJ
in this action. Due to the nature of the action being taken here, this
action is expected to have a neutral to positive impact on the air
quality of the affected area. Consideration of EJ is not required as
part of this action, and there is no information in the record
inconsistent with the stated goal of E.O. 12898 of achieving
environmental justice for people of color, low-income populations, and
Indigenous peoples. This action merely proposes to disapprove a SIP
submission as not meeting the CAA.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

Adam Ortiz,
Regional Administrator, Region III.
[FR Doc. 2023-13148 Filed 6-20-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Page 53337]
[FR Doc No: 2018-22943]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-10568; 34-84441; File No. 265-28]

Investor Advisory Committee Meeting

AGENCY: Securities and Exchange Commission.

ACTION: Notice of telephonic meeting of Securities and Exchange
Commission Dodd-Frank Investor Advisory Committee.

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

SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a telephonic public meeting. The public is invited to
submit written statements to the Committee.

DATES: The meeting will be held on Wednesday, November 7, 2018 from
2:00 p.m. until 3:30 p.m. (ET) and will be open to the public via
telephone at 1-800-260-0702, participant code 455778. Written
statements should be received on or before November 7, 2018.

ADDRESSES: Written statements may be submitted by any of the following
methods:

Electronic Statements

    [ssquf] Use the Commission's internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to [email protected]. Please
include File No. 265-28 on the subject line; or

Paper Statements

    [ssquf] Send paper statements to Brent J. Fields, Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for website viewing and printing
in the Commission's Public Reference Room, 100 F Street NE, Room 1503,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change. Persons submitting comments are cautioned that we do not redact
or edit personal identifying information from comment submissions. You
should submit only information that you wish to make available
publicly.

FOR FURTHER INFORMATION CONTACT: Marc Oorloff Sharma, Chief Counsel,
Office of the Investor Advocate, at<PHONE_NUMBER>, Securities and
Exchange Commission, 100 F Street NE, Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public via
telephone. Persons needing special accommodations to take part because
of a disability should notify the contact person listed in the section
above entitled FOR FURTHER INFORMATION CONTACT.
    The agenda for the meeting includes: Welcome remarks; a discussion
of the Commission's Proposed Regulation Best Interest and Proposed Form
CRS Relationship Summary (which may include a recommendation of the
Investor as Purchaser subcommittee).

    Dated: October 17, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-22943 Filed 10-19-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Notices]
[Page 27889-27890]
[DOCID:fr14my08-133]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2008-0088; Notice 1]

Ford Motor Company, Receipt of Petition for Decision of
Inconsequential Noncompliance

    Ford Motor Company (Ford), on behalf of Jaguar and Land Rover, has
determined that certain motor vehicles seat belt assemblies sold during
the period 1981 through 2008 for certain model year 1981 through 2008
Jaguar and Land Rover make vehicles, did not fully comply with
paragraphs S4.1(k) and S4.1(l) of 49 CFR 571.209 Federal Motor Vehicle
Safety Standards (FMVSS) No. 209 Seat Belt Assemblies. Ford has filed
an appropriate report pursuant to 49 CFR Part 573, Defect and
Noncompliance Responsibility and Reports.
    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), Ford has petitioned for an exemption from the
notification and remedy requirements of 49 U.S.C. Chapter 301 on the
basis that this noncompliance is inconsequential to motor vehicle
safety.
    This notice of receipt of Ford's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Affected are an undetermined number of model year 1981 through 2008
Jaguar and Land Rover make passenger cars and multi-purpose vehicles.
Ford stated that because these seat belt assemblies are supplied as
replacement parts they can be used for non-warranty purposes, and
therefore it is unable to ascertain into which individual vehicles
these parts may have been installed. The model years that are affected
are:

2001-2008 Model Year Jaguar X-Type
1999-2008 Model Year Jaguar S-Type
1982-2008 Model Year Jaguar XJ
1997-2008 Model year Jaguar XK
1981-1996 Model Year Jaguar XJS

2002-2005 Model Year Land Rover Freelander
2008 Model Year Land Rover LR2
1993-1997 Model Year Land Rover Defender
1994-1999 Model Year Land Rover Discovery Series I
1999-2004 Model Year Land Rover Discovery Series II
2005-2008 Model Year Land Rover LR3
1987-2008 Model Year Land Rover Range Rover
2006-2008 Model Year Land Rover Range Rover Sport

    Paragraphs S4.1(k) and S4.1(l) of FMVSS No. 209 require:

    (k) Installation instructions. A seat belt assembly, other than
a seat belt assembly installed in a motor vehicle by an automobile
manufacturer, shall be accompanied by an instruction sheet providing
sufficient information for installing the assembly in a motor
vehicle. The installation instructions shall state whether the
assembly is for universal installation or for installation only in
specifically stated motor vehicles, and shall include at least those
items specified in SAE Recommended Practice J800c, ``Motor Vehicle
Seat Belt Installations,'' November 1973. If the assembly is for use
only in specifically stated motor vehicles, the assembly shall
either be permanently and legibly marked or labeled with the
following statement, or the instruction sheet shall include the
following statement:
    This seat belt assembly is for use only in [insert specific
seating position(s), e.g., ``front right''] in [insert specific
vehicle make(s) and model(s)].
    (l) Usage and maintenance instructions. A seat belt assembly or
retractor shall be accompanied by written instructions for the
proper use of the assembly, stressing particularly the importance of
wearing the assembly snugly and properly located on the body, and on
the maintenance of the assembly and periodic inspection of all
components. The instructions shall show the proper manner of
threading webbing in the hardware of seat belt assemblies in which
the webbing is not permanently fastened. Instructions for a
nonlocking retractor shall include a caution that the webbing must
be fully extended from the retractor during use of the seat belt
assembly unless the retractor is attached to the free end of webbing
which is not subjected to any tension during restraint of an
occupant by the assembly. Instructions for Type 2a shoulder belt
shall include a warning that the shoulder belt is not to be used
without a lap belt.

    Ford explains that the subject seat belt assemblies were sold in
the United States and federalized territories without the installation,
usage, and maintenance instructions required by paragraphs in S4.1(k)
and S4.1(1) of FMVSS 209.
    Ford makes the argument that the service seat belt assemblies in
question are only made available to Jaguar and Land Rover authorized
dealerships for their use or subsequent resale and that the Jaguar and
Land Rover parts ordering process used by its dealers clearly
identifies the correct service part required by model year, model, and
seating position. By way of example, Ford further explains that an
order for a driver's-side front buckle assembly for a 2002 model year
Range Rover would be filled by the components specifically designed to
be installed in that particular position in that specific vehicle.
Furthermore, Ford states that Jaguar's and Land Rover's service seat
belt assemblies are designed to be installed properly only in their
intended application.
    Ford additionally states that technicians at Jaguar and Land Rover
dealerships that replace seat belts have access to the installation
instruction information available in workshop manuals. Installers other
than Jaguar and Land Rover dealership technicians also have seat belt
installation information available because most workshop manual
information, including seat belt replacement information, is made
available to the general public on the Jaguar and Land Rover Global
Technical Reference (GTR) Web sites.

    Ford additionally argues that a significant portion of paragraph
S4.1(k) appears to address a concern with proper installation of
aftermarket seat belts into vehicles that were not originally equipped
with these restraints. Ford also notes that SAE J800c which is cited in
the regulation involves installation of ``universal type seat belt
assemblies,'' particularly where no seat belt had previously been
installed, and that these concerns do not apply to the service seat
belts. The vehicles involved in this petition have uniquely designed
seat belt components and replacement seat belt assemblies are installed
into the identical location from which the original parts were removed.
    Ford also states that proper seat belt usage instructions are
clearly explained in the Owner Handbook that is included with each new
vehicle. Information concerning maintenance, periodic inspection for
wear and function of the seat belts, as well as for their proper usage
is included in the vehicle Owner Handbook and this information equally
applies to replacement seat belt assemblies. Many Jaguar and Land Rover
Owner Handbooks are also available to the public, free of charge on the
Jaguar and Land Rover (GTR) Web sites.
    Ford is not aware of any customer or field reports of service seat
belt assemblies being incorrectly installed in the subject applications
as a result of installation instructions not accompanying the service
part. Ford also is not aware of any reports requesting installation
instructions.
    Ford also informed NHTSA that it has corrected the problem that
caused these errors so that they will not be repeated in future
production.
    In summation, Ford states that it believes that because the
noncompliances are inconsequential to motor vehicle safety that no
corrective action is warranted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance.
    Interested persons are invited to submit written data, views, and
arguments on this petition. Comments must refer to the docket and
notice number cited at the beginning of this notice and be submitted by
any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
    b. By hand delivery to U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 am to 5 pm except Federal Holidays.
    c. Electronically: By logging onto the Federal Docket Management
System (FDMS) Web site at http://www.regulations.gov/. Follow the
online instructions for submitting comments. Comments may also be faxed
to 1-202-493-2251.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://
www.regulations.gov, including any personal information provided.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).
    You may view documents submitted to a docket at the address and
times given above. You may also view the documents on the Internet at
http://www.regulations.gov by following the online instructions for
accessing the dockets available at that Web site.
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.
    Comment closing date: June 13, 2008.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.50 and 501.8.

    Issued on: May 8, 2008.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
 [FR Doc. E8-10730 Filed 5-13-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]
[Page 24718]
[DOCID:fr05my10-103]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0052]

Guidance for Industry on Documenting Statistical Analysis
Programs and Data Files; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry 197 entitled
``Documenting Statistical Analysis Programs and Data Files.'' This
guidance is provided to inform study statisticians of recommendations
for documenting statistical analyses and data files submitted to the
Center for Veterinary Medicine (CVM) for the evaluation of safety and
effectiveness in new animal drug applications. These recommendations
are intended to encompass the most complex data submissions to CVM, to
reduce the number of revisions that may be required for CVM to
effectively review statistical analyses and to simplify submission
preparation by providing a uniform documentation system.

DATES:  Submit written or electronic comments on agency guidances at
any time.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Communications Staff (HFV-12), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests.
    Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Anna Nevius, Center for Veterinary
Medicine (HFV-163), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 16, 2009 (74 FR 11118), FDA
published the notice of availability for a draft guidance entitled
``Draft Guidance for Industry on Documenting Statistical Analysis
Programs and Data Files; Availability'' giving interested persons until
June 1, 2009, to comment on the draft guidance. FDA received no
comments on the draft guidance. Minor editorial changes were made to
improve clarity. The guidance announced in this notice finalizes the
draft guidance dated April 27, 2009.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the agency's current thinking on the 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.

III. Paperwork Reduction Act of 1995

    This 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 part 514 have been approved under
OMB control no. 0910-0032.

IV. Comments

    Submit written requests for single copies of the guidance to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/default.htm or http://
www.regulations.gov.

    Dated: April 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10582 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S