[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Rules and Regulations]
[Pages 71736-71737]
[FR Doc No: 2023-22957]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 630 and 640

[Docket No. FDA-2022-D-0588]

Compliance Policy Regarding Blood and Blood Component Donation
Suitability, Donor Eligibility and Source Plasma Quarantine Hold
Requirements; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Compliance
Policy Regarding Blood and Blood Component Donation Suitability, Donor
Eligibility and Source Plasma Quarantine Hold Requirements.'' The
guidance document addresses certain requirements that apply to blood
establishments that collect blood and blood components, including
Source Plasma. Specifically, the guidance explains the conditions under
which FDA does not intend to take regulatory action for a blood
establishment's failure to comply with certain requirements in FDA's
regulations regarding donation suitability, donor eligibility, and
quarantine hold for Source Plasma. FDA expects that the compliance
policy described in the guidance will increase the availability of
blood and blood components, including Source Plasma, while maintaining
the health of blood donors and the safety of blood and blood
components. The guidance announced in this document finalizes the draft
guidance of the same title dated May 2022, and supersedes the guidance
entitled ``Alternative Procedures for Blood and Blood Components During
the COVID-19 Public Health Emergency; Guidance for Industry,'' dated
April 2020.

DATES: The announcement of the guidance is published in the Federal
Register on October 18, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0588 for ``Compliance Policy Regarding Blood and Blood
Component Donation Suitability, Donor Eligibility and Source Plasma
Quarantine Hold Requirements; Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Phillip Kurs, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Compliance Policy Regarding Blood and Blood Component Donation
Suitability, Donor Eligibility and Source Plasma

Quarantine Hold Requirements.'' The guidance document addresses certain
requirements that apply to blood establishments that collect blood and
blood components, including Source Plasma. Specifically, the guidance
explains the conditions under which FDA does not intend to take
regulatory action for a blood establishment's failure to comply with
certain requirements in Title 21 of the Code of Federal Regulations (21
CFR 630.30) regarding donation suitability; 21 CFR 630.10(c)(2)
regarding donor eligibility; and 21 CFR 640.69(f) regarding quarantine
hold for Source Plasma.
    In the Federal Register of May 24, 2022 (87 FR 31440), FDA
announced the availability of the draft guidance of the same title
dated May 2022. FDA received several comments on the draft guidance and
those comments were considered as the guidance was finalized. A summary
of changes includes clarifying the format of the report discussed in
the guidance and clarifying the scope of the compliance policy. In
addition, editorial changes were made to improve clarity. The guidance
announced in this document finalizes the draft guidance dated May 2022,
and supersedes the guidance entitled ``Alternative Procedures for Blood
and Blood Components During the COVID-19 Public Health Emergency;
Guidance for Industry,'' dated April 2020.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Compliance Policy Regarding Blood and
Blood Component Donation Suitability, Donor Eligibility and Source
Plasma Quarantine Hold Requirements.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information have been approved under OMB control number
0910-0116. This guidance also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338 and the
collections of information in 21 CFR parts 606, 630, and 640 have been
approved under OMB control number 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22957 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P


Bill, sorry , I got your email address backwards. Of course, EPA has your email name backwards!

Robert J. Martineau, Jr. Waller Lansden Dortch & Davis, PLLC 511 Union Street, Suite 2700 Nashville, TN 37219 Phone: ( 615) 850 8910 Cell: ( 615) 491 7901 Fax: ( 615) 244 6804 E mail: rmartineau@ wallerlaw. com Website: http:// www. wallerlaw. com >  Original Message > From: Bob Martineau > Sent: Friday, July 15, 2005 4: 45 PM > To: William Wehrum ( E mail) > Cc: ' bill. harnett@ epa. gov' > Subject: Legislative History Question  ethanol plants > > > Bill > > I have been looking to track down the information you requested re the 77 amendments and the list of 28 categories that are PSD at 100 tpy. The categories came out of the Senate bill. In looking at the history I did see statements suggesting the list was pared down from a longer list presented by EPA ( see 95 Cong. Misc Docs. 1977, CAA 77 Legis Hist. 36 at page 27. ( Senate Comm. Report , Section by Section Analysis of S. 252 and S. 253)) I have not found the actual longer EPA list in a committee report . I spoke with Gary Mc Cutchen , however, and he confirmed what I understood, that the 28 category list was largely based on source category list developed for NSPS purposes and that it was carried over to the PSD provisions. I have located an EPA document from 77 which indicates they were looking at 200 source categories for NSPS standards. There is a discussion and breakdown of the types of sources in the " chemical processing industry". It is clear from that document, that corn based ethanol fuel production was not in any way contemplated in the definition of " chemical process plant" back in 1977. Attached is an excerpt from that EPA report. See, pages iii, and 36 38. > > In further support, I spoke with an engineer involved with ethanol production since its inception. He said the first fuel ethanol production facility did not even begin to make ethanol fuel until November 1978. ( There were some beverage ones prior to that time of course ) It was an ADM facility in Decatur, Illinois. The engineer indicated ADM made ethanol after request from then President Carter in response to the energy crisis occurring at that time. Thus, as a practical matter, as there were no plants in existence at the time Congress considered the list it would be fair to conclude that Congress could not have intended that type of plant to be among the type of source intended to be covered at the lower 100tpy threshold because of their significance and impact. > > I hope this information is of assistance. If you need additional information, I can dig further to see if I can track down the actual list given to Congress. > > Again , many thanks for your assistance on this issue. > > > << Impact of NSR Standards>> > > > > Robert J. Martineau, Jr. > Waller Lansden Dortch & Davis, PLLC > 511 Union Street, Suite 2700 > Nashville, TN 37219 > Phone: ( 615) 850 8910 > Cell: ( 615) 491 7901 > Fax: ( 615) 244 6804 > E mail: rmartineau@ wallerlaw. com > Website: http:// www. wallerlaw. com >

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[Federal Register Volume 88, Number 125 (Friday, June 30, 2023)]
[Notices]
[Pages 42352-42353]
[FR Doc No: 2023-13977]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas & Oil Pipeline Rate and Refund Report filings:

Filings in Existing Proceedings

    Docket Numbers: RP19-78-010.
    Applicants: Panhandle Eastern Pipe Line Company, LP.
    Description: Compliance filing: Compliance with 05/26/23 Order-
Docket Nos. RP19-78, RP19-1523, and RP19-257 to be effective 3/1/2020.
    Filed Date: 6/26/23.
    Accession Number: 20230626-5089.
    Comment Date: 5 p.m. ET 7/10/23.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.

    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: June 26, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-13977 Filed 6-29-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 26, 2006 (Volume 71, Number 143)]
[Notices]
[Page 42379-42380]
[DOCID:fr26jy06-61]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2005-0072; FRL-8203-6]

Agency Information Collection Activities; Submission for OMB
Review and Approval; Comment Request; NESHAP for Secondary Aluminum
Production, EPA ICR Number 1894.05, OMB Control Number 2060-0433
(Renewal)

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 an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and costs.

DATES: Additional comments may be submitted on or before August 25,
2006.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2005-0072 to (1) EPA online using http://www.regulations.gov (our preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:

EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, Mail Code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
by mail to: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division (CAMPD), Office of Compliance (OC), (Mail
Code 2223A), Environmental Protection Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On September 21, 2005 (70 FR 55368), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
number EPA-HQ-OECA-2005-0072, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Enforcement and

Compliance Docket in the EPA Docket Center (EPA/DC), EPA West, Room
B102, 1301 Constitution Avenue, NW., Washington, DC. The EPA/DC Public
Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Reading Room is
(202) 566-1744, and the telephone number for the Enforcement and
Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA

receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov
.

    Title: NESHAP for Secondary Aluminum Production (Renewal).
    ICR Numbers: EPA ICR Number 1894.05, OMB Control Number 2060-0433.
    ICR Status: This ICR is schedules to expire on September 30, 2006.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
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 numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for secondary aluminum production were proposed on
February 11, 1999, and promulgated on March 23, 2002, with final rule
amendments published on December 30, 2002.
    These regulations apply to component processes at secondary
aluminum production plants that are major sources and area sources
including aluminum scrap shredders, thermal chip dryers, scrap dryers/
delacquering kilns/decoating kilns, secondary aluminum processing units
(SAPUs) composed of in-line fluxers and process furnaces (including
both melting and holding furnaces of various configurations), sweat
furnaces, dross-only furnaces, and rotary dross coolers, commencing
construction, or reconstruction after the date of proposal. As a result
of a rule amendment in 2002, owners and operators of certain aluminum
die casting facilities, aluminum foundries, and aluminum extrusion
facilities were excluded from the rule coverage. Respondents do not
include the owner or operator of any facility that is not a major
source of hazardous air pollutant (HAP) emissions except for those that
are area sources of dioxin/furan emissions.
    In general all NESHAP standards require initial notifications,
performance tests, and periodic reports. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, and malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. The notifications, reports, and records are essential in
determining compliance, and are required of all sources subject to
NESHAP. Semiannual reports are also required.
    Any owner or operator subject to the provisions of this subpart
must maintain a file of these measurements, and retain the file for at
least five years following the collection of such measurements,
maintenance reports, and records. All reports are sent to the delegated
state or local authority. In the event that there is no such delegated
authority, the reports are sent directly to the EPA regional office.
    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 Numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 29
hours per response. 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.
    Respondents/Affected Entities: Secondary aluminum production
plants.
    Estimated Number of Respondents: 1,624.
    Frequency of Response: On occasion, initially, and semiannually.
    Estimated Total Annual Hour Burden: 93,725.
    Estimated Total Annual Costs: $8,164,143 which includes $84,000
annualized Capital Startup costs, $142,000 annualized O&M costs, and
$7,938,143 annualized labor costs.
    Changes in the Estimates: There is a decrease of 1,273 hours in the
total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. The decrease in burden is due to a decrease in
the number of sources. This decrease is due to a number of sweat
furnaces going out of business because of the current economic
environment. There is also four less additional sources per-year as
compared to the previous ICR.
    There is a decrease in the capital/startup and operations and
maintenance (O&M) costs from the previous ICR. This is due to the fact
that there are four less sources as compared to the previous ICR.

    Dated: July 11, 2006.
Sara Hisel McCoy,
Acting Director, Collection Strategies Division.
[FR Doc. E6-11944 Filed 7-25-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)]
[Proposed Rules]
[Pages 21235-21237]
[FR Doc No: 2018-09888]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2018-0160; FRL-9977-85--Region 9]

Air Plan Approval; California; Yolo-Solano Air Quality Management
District; Negative Declarations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Yolo-Solano Air Quality Management District
(YSAQMD or ``District'') portion of the California State Implementation
Plan (SIP). This revision concerns the District's negative declarations
for several volatile organic compound (VOC) source categories included
in its Reasonably Available Control Technology (RACT) State
Implementation Plan Analysis. We are proposing to approve these
negative declarations under the Clean Air Act (CAA or ``the Act''). We
are taking comments on this proposal and plan to follow with a final
action.

DATES: Any comments must arrive by June 8, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2018-0160 at https://www.regulations.gov/, or via email to Stanley
Tong, at [email protected]. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be removed or edited from
Regulations.gov. For either manner of submission, the 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. The 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 https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Stanley Tong, EPA Region IX, (415)
947-4122, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What document did the State submit?
    B. Are there other versions of the RACT SIP--negative
declarations?
    C. What is the purpose of the submitted negative declarations?

II. The EPA's Evaluation and Action
    A. How did the EPA evaluate the negative declarations and what
conclusions did the EPA reach?
    B. Public Comment and Proposed Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What document did the State submit?

    On September 13, 2017, YSAQMD adopted its Reasonably Available
Control Technology State Implementation Plan Analysis for the 2008
ozone National Ambient Air Quality Standards (NAAQS). Included in the
District's RACT SIP analysis were several negative declarations where
the District stated that it did not have sources subject to the Control
Techniques Guidelines (CTG) documents listed below in Table 1. The
District's RACT SIP further stated that the negative declarations were
for the 1997 and 2008 ozone NAAQS. On November 13, 2017, the California
Air Resources Board (CARB) submitted YSAQMD's RACT SIP, including the
following negative declarations, to the EPA as a SIP revision.
---------------------------------------------------------------------------

    \1\ Negative declarations are for the 1997 and 2008 8-hour ozone
standards.

              Table 1--Submitted Negative Declarations \1\
------------------------------------------------------------------------
           CTG document                      CTG document title
------------------------------------------------------------------------
EPA-450/2-77-008..................  Control of Volatile Organic
                                     Emissions from Existing Stationary
                                     Sources--Volume II: Surface Coating
                                     of Cans, Coils, Paper, Fabrics,
                                     Automobiles, and Light-Duty Trucks.
EPA-450/2-77-025..................  Control of Refinery Vacuum Producing
                                     Systems, Wastewater Separators, and
                                     Process Unit Turnarounds.
EPA-450/2-77-032..................  Control of Volatile Organic
                                     Emissions from Existing Stationary
                                     Sources--Volume III: Surface
                                     Coating of Metal Furniture.
EPA-450/2-77-033..................  Control of Volatile Organic
                                     Emissions from Existing Stationary
                                     Sources--Volume IV: Surface Coating
                                     of Insulation of Magnet Wire.
EPA-450/2-77-034..................  Control of Volatile Organic
                                     Emissions from Existing Stationary
                                     Sources--Volume V: Surface Coating
                                     of Large Appliances.
EPA-450/2-77-036..................  Control of Volatile Organic
                                     Emissions from Storage of Petroleum
                                     Liquids in Fixed-Roof Tanks.
EPA-450/2-78-029..................  Control of Volatile Organic
                                     Emissions from Manufacture of
                                     Synthesized Pharmaceutical
                                     Products.
EPA-450/2-78-032..................  Control of Volatile Organic
                                     Emissions from Existing Stationary
                                     Sources--Volume VII: Factory
                                     Surface Coating of Flat Wood
                                     Paneling.
EPA-450/2-78-033..................  Control of Volatile Organic
                                     Emissions from Existing Stationary
                                     Sources--Volume VIII: Graphic Arts-
                                     Rotogravure and Flexography.
EPA-450/2-78-036..................  Control of Volatile Organic Compound
                                     Leaks from Petroleum Refinery
                                     Equipment.
EPA-450/2-78-030..................  Control of Volatile Organic
                                     Emissions from Manufacture of
                                     Pneumatic Rubber Tires.
EPA-450/3-82-009..................  Control of Volatile Organic Compound
                                     Emissions from Large Petroleum Dry
                                     Cleaners.
EPA-450/3-83-008..................  Control of Volatile Organic Compound
                                     Emissions from Manufacture of High-
                                     Density Polyethylene,
                                     Polypropylene, and Polystyrene
                                     Resins.
EPA-450/3-83-007..................  Control of Volatile Organic Compound
                                     Equipment Leaks from Natural Gas/
                                     Gasoline Processing Plants.
EPA-450/3-83-006..................  Control of Volatile Organic Compound
                                     Leaks from Synthetic Organic
                                     Chemical Polymer and Resin
                                     Manufacturing Equipment.
EPA-450/3-84-015..................  Control of Volatile Organic Compound
                                     Emissions from Air Oxidation
                                     Processes in Synthetic Organic
                                     Chemical Manufacturing Industry.
EPA-450/4-91-031..................  Control of Volatile Organic Compound
                                     Emissions from Reactor Processes
                                     and Distillation Operations in
                                     Synthetic Organic Chemical
                                     Manufacturing Industry.
EPA-453/R-96-007..................  Control of Volatile Organic Compound
                                     Emissions from Wood Furniture
                                     Manufacturing Operations.
61 FR-44050 8/27/96...............  Control Techniques Guidelines for
                                     Shipbuilding and Ship Repair
                                     Operations (Surface Coating).
EPA-453/R-97-004..................  Aerospace (CTG & MACT).
EPA-453/R-06-003..................  Control Techniques Guidelines for
                                     Flexible Package Printing.
EPA-453/R-06-004..................  Control Techniques Guidelines for
                                     Flat Wood Paneling Coatings.
EPA 453/R-07-003..................  Control Techniques Guidelines for
                                     Paper, Film, and Foil Coatings.
EPA 453/R-07-004..................  Control Techniques Guidelines for
                                     Large Appliance Coatings.
EPA 453/R-07-005..................  Control Techniques Guidelines for
                                     Metal Furniture Coatings.
EPA 453/R-08-005..................  Control Techniques Guidelines for
                                     Miscellaneous Industrial Adhesives.
EPA 453/R-08-006..................  Control Techniques Guidelines for
                                     Automobile and Light-Duty Truck
                                     Assembly Coatings.
EPA 453/R-08-003..................  Control Techniques Guidelines for
                                     Miscellaneous Metal and Plastic
                                     Parts Coatings (plastic parts
                                     portion only).
EPA 453/B-16-001..................  Control Techniques Guidelines for
                                     the Oil and Natural Gas Industry.
------------------------------------------------------------------------

    On April 11, 2018, the EPA determined that the negative
declarations submitted as part of YSAQMD's RACT SIP met the
completeness criteria in 40 CFR part 51 Appendix V, which must be met
before formal EPA review.

B. Are there other versions of the RACT SIP--negative declarations?

    On April 6, 2018 (83 FR 14754), we approved YSAQMD's RACT SIP
certification, including several negative declarations for the 1997 8-
hour ozone NAAQS.

C. What is the purpose of the submitted negative declarations?

    Volatile Organic Compounds (VOCs) and nitrogen oxides
(NOX) together produce ground-level ozone, smog and
particulate matter, which harm human health and the environment.
Section 110(a) of the CAA requires states to submit regulations that
control VOC and NOX emissions. Sections 182(b)(2) and (f)
require that SIPs for ozone nonattainment areas classified as Moderate
or above implement RACT for any source covered by a CTG document and
for any major source of VOCs or NOX. The YSAQMD is subject
to this requirement because it regulates part of the Sacramento
Metropolitan ozone nonattainment area that is classified as a Severe-15
ozone nonattainment area

for the 2008 8-hour ozone NAAQS.\2\ Therefore, the YSAQMD must, at a
minimum, adopt RACT-level controls for all sources covered by a CTG
document and for all major non-CTG sources of VOCs or NOX
within the nonattainment area that it regulates.
---------------------------------------------------------------------------

    \2\ 40 CFR 81.305; 80 FR 12264 (March 6, 2015). The YSAQMD
regulates the Solano County and Yolo County portions of the
Sacramento Metro ozone nonattainment area.
---------------------------------------------------------------------------

    The EPA's rule to implement the 2008 8-hour ozone NAAQS (80 FR
12264 at 12278, March 6, 2015) states in part ``. . . RACT SIPs must
contain adopted RACT regulations, certifications where appropriate that
existing provisions are RACT . . . and/or negative declarations that
there are no sources in the nonattainment area covered by a specific
CTG source category.'' YSAQMD's RACT SIP submittal includes the
negative declarations listed in Table 1 to certify that it has no
stationary sources within its jurisdiction that are covered by the
listed CTGs.

II. The EPA's Evaluation and Action

A. How did the EPA evaluate the negative declarations and what
conclusions did the EPA reach?

    SIP rules must require RACT for each category of sources covered by
a CTG document as well as each major source of VOC or NOX in
ozone nonattainment areas classified as Moderate or above (see CAA
section 182(b)(2)). States should submit for SIP approval negative
declarations for those source categories for which they are not
adopting VOC CTG-based regulations (because they have no sources
covered by the CTG) regardless of whether such negative declarations
were made for an earlier RACT SIP.
    The EPA reviewed YSAQMD's list of negative declarations and
compared the District's list against a list of stationary sources of
VOCs derived from CARB's emissions inventory database for the years
2006 and 2015. The EPA selected these years based on when the RACT SIPs
were due for the 1997 and 2008 8-hour ozone standards. Since the CTGs
only cover VOC sources and do not cover NOX sources, we took
CARB's emissions inventory list of VOC stationary sources in the YSAQMD
and identified those with a sufficient quantity of VOC emissions that
they could potentially be covered by a CTG. We then performed an
internet search on these sources to determine if they performed
operations subject to any of the CTGs for which YSAQMD was claiming a
negative declaration. Our evaluation also included a review of whether
identified stationary sources' Standard Industrial Code classification
numbers corresponded to negative declarations claimed by the District.
Finally, we queried YSAQMD staff regarding what VOC producing
operations occurred at specific stationary source facilities to
determine if any of those operations might be subject to a negative
declaration. Based on this, the EPA agrees with YSAQMD's conclusion
that it has no stationary sources of VOCs that are subject to the CTGs
for which they have adopted negative declarations for the 1997 and 2008
8-hour ozone NAAQS. We believe these negative declarations are
consistent with the relevant policy and guidance regarding RACT and SIP
relaxations.

B. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted negative declarations for the 1997 and 2008
8-hour ozone NAAQS because they fulfill all relevant requirements. We
will accept comments from the public on this proposal until June 8,
2018. If we take final action to approve the submitted negative
declarations, our final action will incorporate them into the federally
enforceable SIP.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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 approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

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

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

    Dated: April 27, 2018.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2018-09888 Filed 5-8-18; 8:45 am]
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[Federal Register: August 31, 2007 (Volume 72, Number 169)]
[Notice]
[Page 50348]
[DOCID:fr31au07-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL03-230-004]

Entergy Services, Inc; Notice of Filing

August 23, 2007.
    Take notice that on August 17, 2007, Entergy Services, Inc., acting
as agent for Entergy Gulf States, Inc. submits a compliance filing
pursuant to the Commission's July 18, 2007 Order, ExxonMobil
Corporation v. Entergy Service, Inc., 120 FERC ] 61,051.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on, September 10, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-17256 Filed 8-30-07; 8:45 am]

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