[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Proposed Rules]
[Pages 12289-12290]
[FR Doc No: 2018-05585]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0082; Airspace Docket No. 16-AWP-22]

Proposed Establishment of Class E Airspace; Pago Pago, American
Samoa

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace extending
upward from 700 feet above the surface at Pago Pago International
Airport, Pago Pago, American Samoa (AS), to accommodate the development
of instrument flight rules (IFR) operations under standard instrument
approach and departure procedures at the airport, and for the safety
and management of IFR operations within the National Airspace System.

DATES: Comments must be received on or before May 7, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2018-0082 and Airspace Docket No. 16-AWP-22, at the beginning of
your comments. You may also submit comments through the internet at
http://www.regulations.gov.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Kenneth Ready, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish Class E airspace at Pago Pago International
Airport, Pago Pago, AS, to support IFR operations at the airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2018-0082 and Airspace Docket No. 16-AWP-22) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2018-0082, and Airspace Docket No. 16-AWP-22.''
The postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of Western Service Center, Operations
Support Group, Federal Aviation Administration, 2200 S 216th Street,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by establishing Class E airspace extending
upward from 700 feet above the surface within a 7-mile radius of Pago
Pago International Airport, Pago Pago, AS. This airspace is necessary
to accommodate IFR

operations in standard instrument approach and departure procedures at
the airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AWP AS E5 Pago Pago, AS [New]

Pago Pago International Airport, American Samoa
    (Lat. 14[deg]19'54'' N, long. 170[deg]42'41'' W)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Pago Pago International Airport and within
4 miles either side of the 071[deg] bearing of the Pago Pago
International Airport, extending from the 7-mile radius to 10.6
miles northeast of the airport, and within 4 miles either side of
the 240[deg] bearing of the airport extending from the 7-mile radius
to 10.4 miles southwest of the airport; and that airspace extending
upward from 1,200 feet above the surface within a 20 mile-radius of
Pago Pago International Airport, excluding that airspace extending
beyond 12 miles of the shoreline.

    Issued in Washington, DC, on March 12, 2018.
Rodger A. Dean Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2018-05585 Filed 3-20-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 90 (Friday, May 9, 2014)]
[Rules and Regulations]
[Pages 26612-26613]
[FR Doc No: 2014-09892]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0214; Airspace Docket No. 14-AGL-10]

Amendment of Class D and E Airspace; Grand Forks, ND

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Technical amendment; correction.

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SUMMARY: This action amends a typographical error in the effective date
of a final rule technical amendment correction published in the Federal
Register of February 6, 2014, that amends Class D and E airspace in the
Grand Forks, ND, area. The effective date year is corrected from
February 6, 2013, to February 6, 2014.

DATES: Effective date: 0901 UTC, May 9, 2014.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On February 6, 2014, a final rule technical amendment correction
was published in the Federal Register amending Class D and Class E
airspace in Grand Forks, ND (79 FR 7055, Docket No. FAA-2013-0950). The
document became effective upon publication. Subsequent to publication,
the FAA found the document showing the effective date as being one year
prior to publication; February 6, 2013, instead of February 6, 2014.
    Since this is an administrative change and does not affect the
boundaries, altitudes, or operating requirements of the airspace, I
find that notice and public procedure under 5 U.S.C. 553(b) is
impracticable and contrary to the public interest. Also, as immediate
corrective action is necessary to show the correct effective date to
avoid confusion in the publication of the

amendment to FAA Order 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, and effective September 15, 2013, the FAA
finds good cause, pursuant to 5 U.S.C. 553(d), for making this
amendment effective in less than 30 days.

Final Rule Correction

    Accordingly, pursuant to the authority delegated to me, in the
Federal Register of February 6, 2014 (79 FR 7055), the date, under the
DATES heading on page 7056, column 1, lines 9 and 10, is corrected to
read:

DATES: Effective Date: 0901 UTC, February 6, 2014.

    Issued in Fort Worth, Texas, on April 2, 2014.
Kent M. Wheeler
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2014-09892 Filed 5-8-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 4, 2010 (Volume 75, Number 213)]
[Notices]
[Page 67983]
[DOCID:fr04no10-49]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0190]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Infant Formula Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Infant Formula Requirements'' has
been approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of August 10, 2010
(75 FR 48350), the Agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. 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. OMB has now approved the
information collection and has assigned OMB control number 0910-0256.
The approval expires on October 31, 2013. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-27849 Filed 11-3-10; 8:45 am]
BILLING CODE 4160-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on February 12, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST 2004-17046

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  VOLGA-DNEPR J.S. CARGO AIRLINE
        Date Filed:  February 4, 2004

Relief requested:  Exemption from 49 U.S.C. section 40109(g) to permit
the applicant to operate, on behalf of Lockheed Martin, one, one-way
cargo charter flight from Denver, Colorado, to Cape Canaveral, Florida,
on or about February 17, 2004, using its AN-124-100 aircraft.
Volga-Dnepr plans to carry on this flight Lockheed Martin Space Systems
Atlas and Centaur launch vehicles.  The applicant stated that Lockheed
Martin urgently needs lift to complete aggressive integration and launch
schedules, that the cargo is too large for transportation on
U.S.-carrier aircraft; and that surface transportation is not feasible
because of the large size, delicate nature and high value of the cargo,
and conditions unsuitable to maintaining system integrity compliance.

Applicant representative:  Glenn P. Wicks,<PHONE_NUMBER>         DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  Volga-Dnepr served its application on those U.S.
carriers operating large all-cargo aircraft.  Each carrier indicated
that it did not have aircraft available to conduct the proposed
operation and that it had no comment or did not oppose grant of the
requested authority.

Statutory Standards:  Under 49 U.S.C. section 40109(g), we may authorize
a foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49 U.S.C. section 41102; that all
possible efforts have been made to place the traffic on U.S. carriers;
and that the transportation is necessary to avoid unreasonable hardship
to the traffic involved (an additional required finding, concerning
emergency transportation during labor disputes, was not relevant here).

        DISPOSITION

Action: Approved
                                             Action date:  February 12,
2004

Effective dates of authority granted:  February 12, 2004, through
February 17, 2004

Basis for approval:  We are granting Volga-Dnepr’s request to operate
its proposed one-way flight from Denver to Cape Canaveral, through
February 17, 2004.  We found that its request met all the relevant
criteria of 49 U.S.C. section 40109(g) for the grant of an exemption of
this type and that the grant was required in the public interest.
Specifically, we were persuaded that the need to move the cargo promptly
in order to meet the urgent integration and launch schedules, the fact
that the cargo could not be transported by surface transportation
because of its large size, delicate nature and high value, the potential
negative impact of delivery delay; and the unique, outsized nature of
the cargo, constituted an emergency not arising in the normal course of
business.  Moreover, based on the representations of the U.S. carriers,
we concluded that no U.S. carrier had aircraft available that could be
used to conduct the operations at issue here.  We also found that grant
of this authority would prevent unreasonable hardship to Lockheed
Martin.  Finally, we found that the applicant was qualified to perform
its proposed operation.

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions and to the condition that the applicant
must comply with an FAA-approved flight routing for the authorized
operation.

Action taken by:        Karan K. Bhatia

                                  Assistant Secretary

                     for Aviation and International Affairs

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register: April 28, 2008 (Volume 73, Number 82)]
[Notices]
[Page 22956-22958]
[DOCID:fr28ap08-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cooperative Agreement to Support the World Health Organization
International Programme on Chemical Safety

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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I. Funding Opportunity Description

    The Food and Drug Administration (FDA) is announcing its intention
to receive and consider a single source application for the award of a
cooperative agreement (U01), a new Sole Source, Competitive
Continuation in fiscal year 2008 to the World Health Organization (WHO)
International Programme on Chemical Safety (IPCS). This Request for
Applications (RFA) is supported by the Center for Food Safety and
Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
This program is described in the Catalog of Federal Domestic Assistance
No. 93.103 under RFA Number: RFA-FD-08-002. A copy of the complete RFA
can also be viewed on CFSAN's Web site (http://www.cfsan.fda.gov) and
on CVM's Web site (http://www.fda.gov/cvm).
    This RFA will strengthen and allow WHO to continue their work in
important international risk assessment and standard setting activities
for food ingredients, contaminants, and veterinary drug residues in
food. WHO/IPCS is an umbrella organization that provides for timely
international collaboration on multinational cooperative activities.
Various programs under the WHO/IPCS, such as the Joint Food and
Agriculture (FAO)/WHO Expert Committee on Food Additives (JECFA),
significantly contribute to internationally-recognized, science-based
risk assessments of food additives, contaminants, and residues of
veterinary drugs in foods. The Codex Alimentarius Commission (CAC)
relies on JECFA's scientific advice when establishing international
standards for foods. The WHO/IPCS also supports

FAO/WHO Expert Consultations on risk assessments for emerging or cross-
cutting issues (e.g., non-dioxin-like polychlorinated biphenyls (PCBs),
allergenicity of foods derived from biotechnology, risk-benefit
assessment of the use of active chlorine species in food processing).
The evaluations that are produced by these Expert Consultations provide
a sound scientific basis for Codex's standard-setting activities that
contribute to improved public health and food safety worldwide.
    The following activities are to be supported by this cooperative
agreement:
    1. Schedule, plan, and conduct appropriate work groups,
consultations, and committee meetings, which have emphasis on, but are
not limited to, food additives, contaminants, and residues of
veterinary drugs in food.
    2. Identify advisers, and prepare written working papers
summarizing the data on substances under consideration.
    3. Prepare written working papers and technical documents for the
JECFA, and for the FAO/WHO Expert Consultations related to food
additives, contaminants, and residues of veterinary drugs in food.

II. Award Information

A. Mechanism of Support

    This funding opportunity will use a cooperative agreement award
mechanism. In the cooperative agreement mechanism, the Project
Director/Principal Investigator (PD/PI) retains the primary
responsibility and dominant role for planning, directing, and executing
the proposed project, with NIH staff being substantially involved as a
partner with the Principal Investigator.
    Receipt Date: Within 45 days after the publication of this
announcement in the Federal Register.

B. Funds Available

    The estimated amount of funds available for support of this
cooperative agreement is $120,000 (direct and indirect costs) for
fiscal year 2008. It is anticipated that an additional 4 years of
support will be available at $90,000 per year, depending on annual
appropriations and successful performance.
    This award will be funded based on the quality of the application
received and is subject to the availability of Federal funds to support
the project. In addition, if a cooperative agreement is awarded, the
grantee will be informed of any additional documentation that should be
submitted to the FDA.

III. Eligibility Information

Eligible Institutions

    Competition is limited to the WHO/IPCS because, as the parent
organization of the JECFA, it is solely responsible for providing
scientific advice, including risk assessments, to the CAC on matters
related to food additives, contaminants, and residues of veterinary
drugs in food. Thus, the programs under the IPCS are unique. It is
essential that the WHO/IPCS be able to provide science-based risk
assessments that are of the highest integrity, as these assessments
form the basis of international standards that both protect public
health and promote fair trade practices. Awarding this cooperative
agreement to the WHO/IPCS will ensure that JECFA's risk assessments are
science-based, will enhance the safe use of food additives, will ensure
that residues of veterinary drugs in imported foods are safe, and will
help to ensure that food sold in the United States is safe.

IV. Application and Submission Information

    The PHS 398 application instructions are available at http://
grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. Applicants must use the currently approved version of the PHS
398. For further assistance contact Grants Info at<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>    Telecommunications for the hearing impaired: TTY<PHONE_NUMBER>.

A. Content and Form of Application Submission

    Applications must be prepared using the most current PHS 398
research grant application instructions and forms. Applications must
have a Dun & Bradstreet Data Universal Numbering System (DUNS) number
as the universal identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling 866-
705-5711 or through the Web site at http://www.dnb.com/us/. The DUNS
number should be entered on line 11 of the face page of the PHS 398
form.
    The title and number of this funding opportunity must be typed on
lines 1 and 2 of the face page of the application form and the YES box
must be checked.
    Required 398 Application Components must be submitted in Non
Modular format as follows:
    Form Page 1: Face Page; Form Page 2: Description, Performance
Sites, Key Personnel, Other Significant Contributors; Form Page 3:
Table of Contents; Form Page 4: Detailed Budget for Initial Budget
Period: Form Page 5: Budget for Entire Proposed Period of Support:
Biographical Sketch Format Page; Resources Format Page; Checklist Form
Page: Personal Data Form Page; Other Support Format Page; Personnel
Report Format Page.

B. Sending an Application to FDA

    The application must be prepared using the forms found in the PHS
398 instructions for preparing a research grant application.
Applications will be accepted in hard copy or electronically at http://
www.grants.gov. A signed hard copy original application and three
signed photocopies should be sent to:
    Food and Drug Administration/OAGS/GAAT/Gladys M. Bohler, 5630
Fishers Lane, rm. 2105, HFA-500, Rockville, MD 20857 (U.S. Postal
Service Express or regular mail).
    FDA will also accept the application for this program
electronically via http://www.grants.gov. The applicant is encouraged
to apply electronically by visiting the Web site http://www.grants.gov
and following instructions under ``Apply for Grants.'' The required
application, SF 424 (R&R) can be completed and submitted online. The
package should be labeled, ``Response to RFA FD-08-002.'' If you
experience technical difficulties with your online submission you
should contact Gladys M. Bohler by telephone at<PHONE_NUMBER> or by e-
mail at<EMAIL_ADDRESS>    Information about submitting an application electronically can be
found on the http://www.grants.gov Web site.
PHS 398 Research Plan Component Sections via Grants.gov
    Items 2 through 5 of the PHS 398 Research Plan component are
limited to 25 pages. While each section of the Research Plan component
needs to be uploaded separately as a PDF attachment, applicants are
encouraged to construct the Research Plan component as a single
document, separating sections into distinct PDF attachments just before
uploading the files. This approach will enable applicants to better
monitor formatting requirements such as page limits. All attachments
must be provided to FDA in PDF format, filenames must be included with
no spaces or special characters, and a pdf extension must be used.
    In order to apply electronically the applicant must have a DUNS
number and register in the central contractor registration (CCR)
database.

C. Intergovernmental Review

    This initiative is not subject to intergovernmental review under
the terms of Executive Order 12372.

D. Other Submission Requirements and Information

    Several additional separate actions are required before an
applicant institution/organization can submit an application.
    Organizational DUNS--As of October 1, 2003, applicants are required
to have a DUNS number to apply for a grant or cooperative agreement
from the Federal Government. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number applicants should go to http://www.grants.gov/RequestaDUNS.
    Central Contractor Registration--Applicants must register with the
CCR database. This database is a government-wide warehouse of
commercial and financial information for all organizations conducting
business with the Federal Government. The preferred method for
completing a registration is at http://www.ccr.gov. This Web site
provides a CCR handbook with detailed information on data you will need
prior to beginning the online preregistration as well as steps to walk
you through the registration process. You must have a DUNS number to
begin your registration. For foreign entities the Web site is http://
www.grants.gov/RequestaDUNS.gov. In order to access Grants.gov an
applicant will be required to register with the Credential Provider.
Information about this is available at https://apply.grants.gov/
OrcRegister.
    A copy of the complete RFA can also be viewed on FDA's Center for
Food Safety and Applied Nutrition Web site at http://www.cfsan.fda.gov/
list.html.
Foreign Applications (Non-domestic (non-U.S.) Entity)
     Indicate how the proposed project has specific relevance
to the mission and objectives of FDA and has the potential for
significantly advancing sciences in the United States.
     Research grant applications from foreign or international
organizations may not be funded unless approved by the National Cancer
Institute National Advisory Board.

IV. Agency Contacts

A. Scientific/Research Contacts

    For issues regarding the programmatic aspects of this document,
contact Susan E. Carberry at<PHONE_NUMBER> or by e-mail:
<EMAIL_ADDRESS>
B. Financial or Grants Management Contacts

    For issues regarding the administrative and financial management
aspects, contact Gladys Melendez-Bohler at<PHONE_NUMBER> or by e-mail:
<EMAIL_ADDRESS>
    Dated: April 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9251 Filed 4-25-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Proposed Rules]
[Pages 2731-2735]
[FR Doc No: 2022-00467]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R05-OAR-2008-0138; EPA-R05-OAR-2011-0827; FRL-9397-01-R5]

Air Plan Approval; Indiana, Ohio; Definition of Chemical Process
Plants Under State Prevention of Significant Deterioration Regulations
and Operating Permit Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the State Implementation Plan (SIP) for Indiana
and revisions to the Operating Permit Program for Ohio. The proposed
revisions incorporate changes to the definition of ``chemical process
plants'' under Indiana's Prevention of Significant Deterioration (PSD)
regulations and under Ohio's operating permit program. EPA is also
providing an opportunity for public comment on similar changes to the
definition of ``major stationary source'' in Ohio's PSD regulations
that were approved into the SIP on October 28, 2014. This opportunity
is being provided because these revisions were not explicitly discussed
in the corresponding Federal Register action. The changes to the state
rules described below are approvable because they are consistent with
EPA regulations governing state PSD and title V

programs and will not interfere with any applicable requirement
concerning attainment and reasonable further progress (as defined in
section 171 of the Clean Air Act (CAA)), or any other applicable
requirement of the CAA.

DATES: Comments must be received on or before February 18, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2011-0827 (Indiana) or EPA-R05-OAR-2008-0138 (Ohio) at https://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 https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: For information regarding Indiana's
PSD permit program: Michael Langman, Physical Scientist, Air Permit
Section, Air Programs Branch (AR-18J), Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312)
886-6867, [email protected]. For information regarding Ohio's
title V operating permit or PSD permit programs: Mari Gonz[aacute]lez,
Environmental Engineer, Air Permit Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
[email protected]. The EPA Region 5 office is open from 8:30 a.m.
to 4:30 p.m., Monday through Friday, excluding Federal holidays and
facility closures due to COVID-19.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. What is being addressed in this document?
II. Background
    A. PSD Permitting Thresholds for Chemical Process Plants Prior
to the 2007 Ethanol Rule
    B. Title V Permitting Thresholds for Chemical Process Plants
Prior to the 2007 Ethanol Rule
    C. Ethanol Rule
    D. Petitions for Review and Reconsideration of the 2007 Ethanol
Rule
III. What revisions to the Indiana SIP is EPA proposing to approve?
IV. What revisions are being proposed by EPA in Ohio?
V. What action is EPA taking?
VI. Incorporation by Reference
VII. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    EPA is proposing to approve revisions to a SIP submission received
from Indiana on September 21, 2011. EPA is also proposing to approve
revisions to the Ohio Title V Operating Permit Program and providing an
opportunity for the public to provide comments on related revisions to
Ohio's PSD regulations that were approved on October 28, 2014 (79 FR
64119). These revisions address changes made to EPA regulations that
are reflected in EPA's final rule entitled ``Prevention of Significant
Deterioration, Nonattainment New Source Review (NA NSR), and Title V:
Treatment of Certain Ethanol Production Facilities Under the `Major
Emitting Facility' Definition'' (hereinafter referred to as the ``2007
Ethanol Rule'') as published in the Federal Register on May 1, 2007 (72
FR 24059). The 2007 Ethanol Rule amended the PSD definition of ``major
stationary source'' in the Federal PSD regulations (40 CFR 51.166
paragraphs (b)(1)(i)(a), (b)(1)(iii)(t) and (i)(1)(ii)(t)) to exclude
certain ethanol facilities from the ``chemical process plant'' source
category. In doing so, it established the PSD major source threshold
for ethanol production facilities at 250 tons per year (tpy) rather
than 100 tpy. The 2007 Ethanol Rule also removes the requirement to
include fugitive emissions when determining if an ethanol production
facility is major for PSD and title V permitting.
    On October 21, 2019, EPA responded to a petition for
reconsideration of the 2007 Ethanol Rule, denying the petition with
respect to the revisions of the PSD regulations reflected in that rule
(as described in more detail below). EPA is now proposing to approve
revisions to Indiana's SIP and Ohio's operating permit program that are
based on a part of the 2007 Ethanol Rule.

II. Background

A. PSD Permitting Thresholds for Chemical Process Plants Prior to the
2007 Ethanol Rule

    Under the CAA, there are two potential thresholds for determining
whether a source is a major emitting facility that is potentially
subject to the construction permitting requirements under the PSD
program. One threshold is 100 tpy per pollutant, and the other is 250
tpy per pollutant. Section 169(1) of the CAA lists twenty-eight source
categories that qualify as major emitting facilities if their emissions
exceed the 100 tpy threshold. If the source does not fall within one of
twenty-eight source categories listed in section 169, then the 250 tpy
threshold is applicable.
    One of the source categories in the list of twenty-eight source
categories to which the 100 tpy threshold applies is chemical process
plants. Since the Standard Industrial Classification (SIC) code for
chemical process plants includes facilities primarily engaged in
manufacturing ethanol fuel, the EPA and states had previously
considered such facilities to be subject to the 100 tpy thresholds.
    As a result of this classification, pursuant to the EPA regulations
adopted under section 302(j) of the CAA, chemical process plants were
also required to include fugitive emissions for determining the
potential emissions of such sources. Thus, prior to promulgation of the
2007 Ethanol Rule, the classification of fuel and industrial ethanol
facilities as chemical process plants had the effect of requiring these
plants to include fugitive emissions of criteria pollutants when
determining whether their emissions exceed the applicability thresholds
for the PSD and non-attainment NSR permit programs.

B. Title V Permitting Thresholds for Chemical Process Plants Prior to
the 2007 Ethanol Rule

    The CAA also establishes requirements for determining applicability
for the title V operating permit program. All title V major sources
must obtain a title V permit. Section 501(2) of the CAA defines major
source for the purposes of the title V program as a major source as
defined by section 112 of the CAA or a major stationary source as
defined in section 302 or part D of title I of the CAA. Under the
general definition of ``major stationary source'' in section 302(j) of
the CAA, the major source threshold for

any air pollutant is 100 tons per year. Under the NSR requirements of
Part D of title I of the CAA, lower thresholds for major sources can
apply dependent upon the pollutant and the severity of the
nonattainment classification. Major source thresholds for hazardous air
pollutants (HAP) under section 112 of the CAA are 10 tpy of a single
HAP or 25 tpy for any combination of HAPs. A source with emissions that
exceed one of these thresholds is required to obtain a title V
operating permit.
    Section 502 of the CAA and EPA regulations provide that sources
that belong to one of 28 categories listed in 40 CFR 70.2 must include
fugitive emissions in determining applicability. The list of 28 source
categories may also be included in approved state operating permit
regulations.

C. Ethanol Rule

    On May 1, 2007, EPA published the 2007 Ethanol Rule in the Federal
Register (72 FR 24060). This final rule amended the PSD and NA NSR
regulations to exclude ethanol manufacturing facilities that produce
ethanol by natural fermentation processes from the ``chemical process
plants'' category under the regulatory definition of ``major stationary
source.''
    This change to the NSR regulations affected the threshold used to
determine PSD applicability for these ethanol production facilities,
clarifying that such facilities were subject to the 250 ton per year
major source threshold. The 2007 Ethanol Rule also changed how fugitive
emissions are considered for affected ethanol production facilities.
Because they would no longer be considered as part of the ``chemical
process plants'' category, ethanol facilities would no longer be
required to include fugitive emissions when determining major source
status under PSD, NA NSR, and Title V.

D. Petitions for Review and Reconsideration of the 2007 Ethanol Rule

    On July 2, 2007, the National Resources Defense Council (NRDC)
petitioned the U.S. Court of Appeals for the D.C. Circuit (D.C.
Circuit) to review the 2007 Ethanol Rule. On that same day, EPA
received a petition for administrative reconsideration and request for
stay of the 2007 Ethanol Rule from NRDC. On March 27, 2008, the EPA
denied NRDC's 2007 administrative petition for reconsideration.
    On March 2, 2009, EPA received a second petition for
reconsideration and a request for stay from NRDC. In 2009, NRDC also
filed a petition for judicial review challenging EPA's March 27, 2008,
denial of NRDC's 2007 administrative petition in the D.C. Circuit. This
challenge was consolidated with NRDC's challenge to the 2007 Ethanol
Rule. In August of 2009, the D.C. Circuit granted a joint motion to
hold the case in abeyance, and the case has remained in abeyance.
    On October 21, 2019, EPA partially granted and partially denied
NRDC's 2009 administrative petition for reconsideration. Specifically,
EPA granted the request for reconsideration with regard to NRDC's claim
that the 2007 Ethanol Rule did not appropriately address the CAA
section 193 antibacksliding requirements for nonattainment areas.

III. What revisions to the Indiana SIP is EPA proposing to approve?

    On September 21, 2011, EPA received a request from Indiana to
revise its SIP. More specifically, Indiana requested EPA to approve its
PSD rules at 326 Indiana Administrative Code (IAC) 2-2-1 and NA NSR
program rules at 326 IAC 2-3-2 to exclude ethanol production facilities
that produce ethanol by natural fermentation from the chemical process
plant source category.
    In this action, EPA is proposing to approve the revisions to
Indiana's PSD program at 326 IAC 2-2-1 related to the 2007 Ethanol
Rule. EPA is taking no action at this time on Indiana's request to
revise its NA NSR program at 326 IAC 2-3-2. Although Indiana also
amended its Title V program at 326 IAC 2-7, EPA is not taking action
with respect to Indiana's Title V operating permit program because
Indiana did not request such a revision.
    Pursuant to 40 CFR part 51 appendix V section 1.2, Indiana's
September 2011 SIP submission was deemed complete by operation of law
on March 21, 2012, six months after receipt of the request. The
submission includes a formal signed and dated letter requesting
approval of the revision to Indiana's PSD rules, a copy of the actual
regulation, evidence showing that the state followed all procedural
requirements, evidence that public notice was given of the proposed
change, and certification that public hearings were held. IDEM adopted
the revised PSD rules on May 4, 2011, after receiving no comments
during the public comment period. The revised PSD rules became
effective on August 20, 2011.
    The state rule submitted for approval revised the PSD definition of
``major stationary source'' at 326 IAC 2-2-1(ff) to exclude certain
ethanol production facilities that produce ethanol by natural
fermentation from the chemical process plant source category. As a
result of this revision, an ethanol production facility is subject to
the 250 tpy PSD major stationary source threshold and is no longer
required to consider fugitive emissions when determining its PSD major
stationary source applicability. The ethanol production plants excluded
from the chemical process plant source category at 326 IAC 2-2-1(ff)
are identified by NAICS codes--these codes are the same as those
identified in the 2007 Ethanol Rule and as identified at 40 CFR
51.166(b)(1)(i)(a).
    EPA is proposing to approve the 2011 changes to 326 IAC 2-2-1(ff)
into the Indiana SIP. Because sources in NAICS codes 325193 and 312140
that produce ethanol by natural fermentation are being excluded from
the chemical process plant source category, EPA has determined that the
requested changes to Indiana's PSD rules are consistent with the
current PSD requirements at 40 CFR 51.166. 40 CFR 51.166(b)(1)(i)(a)
excludes ethanol production facilities that produce ethanol by natural
fermentation included in NAICS codes 325193 or 312140 from the chemical
process plant source category.
    EPA has determined that the proposed revision will not interfere
with any applicable requirement concerning attainment and reasonable
further progress, or any other applicable requirement of the CAA as
required by section 110(l) of the CAA. Our determination is based on an
analysis of Indiana's ethanol production trends, existing ethanol
production permit requirements and locations with respect to ambient
air monitoring, Indiana's statewide emissions inventory, Indiana's air
quality design value trends, and representative photochemical modeling
results for ozone and secondary fine particulate (PM2.5)
formation. Our analysis is included in the docket for this rulemaking.
    Our analysis shows that Indiana's existing ethanol production
facilities contribute 2% or less of each criteria pollutant when
compared to statewide facility emissions. Indiana's total ethanol
production has increased since 2007 but the state's air quality has
steadily improved in general. Photochemical modeling of hypothetical
sources representative of ethanol production facilities shows that
ozone formation as a result of oxides of nitrogen (NOX) and
volatile organic compounds (VOC) emissions and secondary
PM2.5 formation as a result of NOX and sulfur
dioxide (SO2) emissions will not themselves cause or
contribute

to a violation of the ozone or PM2.5 National Ambient Air
Quality Standard (NAAQS). In addition, the applicability of Federal and
state requirements to ethanol production facilities in Indiana, such as
New Source Performance Standards at 40 CFR part 60 and National
Emission Standards for Hazardous Air Pollutants at 40 CFR parts 61 and
63, will remain unaffected by this action.

IV. What revisions are being proposed by EPA in Ohio?

    On February 7, 2008, EPA received a request from Ohio EPA to revise
its SIP. This submittal included changes to the definition of ``major
stationary source'' under Ohio Administrative Code (OAC) chapters 3745-
31-01 and 3745-77-01, which incorporate into Ohio regulations the
changes EPA made to Federal PSD and title V regulations in the 2007
Ethanol Rule. The changes to the definition of ``major stationary
source'' in the PSD regulations in OAC chapter 3745-31-01 were approved
into the SIP on October 28, 2014, but these changes were not explicitly
discussed in the final rulemaking action that was published in the
Federal Register (79 FR 64119). Therefore, the technical support
document (TSD) that is available as part of this docket was developed
to demonstrate that the changes which were approved into Ohio's SIP in
2014 related to the Ethanol Rule and the corresponding title V
revisions will not interfere with any applicable requirement concerning
attainment and reasonable further progress or any other applicable CAA
requirement. In this action, EPA is proposing to approve the title V
changes in OAC 3745-77-01 relating to the 2007 Ethanol Rule and
providing an opportunity for public comment on those changes, as well
as the changes to the PSD program in OAC 3745-31-01 relating to the
2007 Ethanol Rule that were approved into Ohio's SIP in 2014.
    The changes to the PSD program that EPA approved in 2014 are
revisions under the definition of ``major stationary source'' for
stationary sources located in an attainment area that emit or have the
potential to emit 100 tpy or more of any regulated NSR pollutant.
Ethanol facilities that produce ethanol through natural fermentation
were excluded from the definition of ``chemical process plants.''
    EPA has determined that these changes are consistent with the
current PSD requirements at 40 CFR 51.166 and that the 2014 revisions
will not interfere with any applicable requirement concerning
attainment and reasonable further progress, or any other applicable
requirement of the CAA. This determination is based on EPA's 110(l)
analysis provided in the accompanying TSD for Ohio which includes
ethanol production trends in the state, an analysis of air quality
design value trends, an examination of Ohio's statewide emissions
inventory, photochemical modeling for ozone and secondary
PM2.5 formation, maps of existing ethanol facilities and
ambient air monitors, and existing ethanol facility permit
requirements. The analysis demonstrates that emissions from ethanol
production facilities account for less than 1.5% of total point source
emissions for five criteria pollutants examined in Ohio. While ethanol
production has steadily increased in Ohio since 2007, in general, air
quality has improved throughout the state as demonstrated by the
downward trend in design values for criteria pollutants. Photochemical
modeling for ozone based on NOX and VOC emissions and
secondary PM2.5 formation based on NOX and
SO2 emissions from hypothetical ethanol sources demonstrates
that that new ethanol sources and major modifications at existing
sources would not likely cause a violation of the NAAQS. The analysis
also includes a discussion of existing Federal requirements that limit
emissions to which Ohio's ethanol facilities are subject.
    The regulations that EPA approved under the PSD program and is
proposing to approve under Ohio's title V program adopt language that
is the same as or consistent with the language of EPA's 2007 Ethanol
Rule. The state regulations that EPA is proposing to approve under the
title V program similarly exclude production facilities that produce
ethanol by natural fermentation from the ``chemical process plants''
category. These revisions clarify that an ethanol facility need not
include fugitive emissions when determining major source applicability
under title V.
    EPA is proposing to approve the revision to the Ohio title V
Operating Permit Program under the definition of ``Major source'' for a
major stationary source of air pollutants that directly emits or has
the potential to emit 100 tpy or more of any pollutants. EPA has
determined that these changes are consistent with the current
requirements for title V under 40 CFR part 70.
    Based on the 110(l) analysis provided in the Ohio TSD that is
available as part of this docket, EPA concludes that the changes which
were approved into Ohio's PSD SIP in 2014 related to the Ethanol Rule
and the corresponding title V revisions will not interfere with any
applicable requirement concerning attainment and reasonable further
progress or any other applicable CAA requirement.

V. What action is EPA taking?

    EPA is proposing to approve revisions to the Indiana SIP in 40 CFR
52.770. EPA is also proposing to approve revisions to the Ohio title V
Operating Permit Program in 40 CFR 70 appendix A, and providing an
opportunity for public comment on the 2014 revisions to the Ohio PSD
SIP in 40 CFR 52.1870 related to the 2007 Ethanol Rule. The revisions
that EPA is proposing to approve change the definition of ``major
stationary source'' under Indiana's PSD regulations and Ohio's
Operating Permit Program. EPA is not taking action on changes related
to NA NSR in this action. This action would approve changes to the
state regulations that establish that the PSD applicability threshold
for certain ethanol plants is 250 tpy and remove the requirement to
include fugitive emissions when determining if an ethanol plant is
subject to major source requirements under PSD and the title V
Operating Permit Programs. EPA has determined that these revisions are
consistent with EPA's PSD and title V regulations and that approval of
these revisions is consistent with the requirements of CAA section
110(l) and will not adversely impact air quality.

VI. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference for Indiana rule 326 IAC 2-2-1(ff), effective August 20,
2011. EPA has made, and will continue to make, these documents
generally available through www.regulations.gov and at the EPA Region 5
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission and state Title V program submissions that comply with the
provisions of the CAA and applicable Federal regulations. 42 U.S.C.
7410(k); 40 CFR 52.02(a); 42 U.S.C. 7661a(d); 40 CFR 70.1(c), 70.4(i).
Thus, in reviewing SIP submissions and Title V program revision
submissions, EPA's role is to approve state choices, provided that they
meet the criteria of

the CAA. Accordingly, this action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications 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

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.

40 CFR Part 70

    Environmental protection, Air pollution control, Hazardous
substances, Incorporation by reference, Intergovernmental relations,
Reporting and recordkeeping requirements.

    Dated: January 6, 2022.
Debra Shore,
Regional Administrator, Region 5.
[FR Doc. 2022-00467 Filed 1-18-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Proposed Rules]
[Pages 16321-16322]
[FR Doc No: 2017-06581]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-1951]

Environmental Defense Fund, Earthjustice, Environmental Working
Group, Center for Environmental Health, Healthy Homes Collaborative,
Health Justice Project of Loyola University Chicago School of Law,
Breast Cancer Fund, Improving Kids' Environment, Consumers Union,
Natural Resources Defense Council, Consumer Federation of America,
Learning Disabilities Association, Maricel Maffini, and Howard Mielke;
Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by the Environmental Defense
Fund, Earthjustice, Environmental Working Group, Center for
Environmental Health, Healthy Homes Collaborative, Health Justice
Project of Loyola University Chicago School of Law, Breast Cancer Fund,
Improving Kids' Environment, Consumers Union, Natural Resources Defense
Council, Consumer Federation of America, Learning Disabilities
Association, Maricel Maffini, and Howard Mielke, proposing that FDA
repeal the color additive regulation providing for the use of lead
acetate in cosmetics intended for coloring hair on the scalp.

DATES: The color additive petition was filed on February 24, 2017.
Submit either electronic or written comments by June 5, 2017. Late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 5, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of June 5, 2017. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

ADDRESSES: You may submit comments 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 comment, 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2017-C-1951 for ``Environmental Defense Fund, Earthjustice,
Environmental Working Group, Center for Environmental Health, Healthy
Homes Collaborative, Health Justice Project of Loyola University
Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment,
Consumers Union, Natural Resources Defense Council, Consumer Federation
of America, Learning Disabilities Association, Maricel Maffini, and
Howard Mielke; Filing of Color Additive Petition.'' Received comments,
those filed in a timely manner (see DATES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comment 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.'' We will review
this copy, including the claimed confidential information, in our
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 Division of Dockets Management. 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.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379e(d)(1)), we are giving notice that we
have filed a color additive petition (CAP 7C0309), submitted by the
Environmental Defense Fund, Earthjustice, Environmental Working Group,
Center for Environmental Health, Healthy Homes Collaborative, Health
Justice Project of Loyola University Chicago School of Law, Breast
Cancer Fund, Improving Kids' Environment, Consumers Union, Natural
Resources Defense Council, Consumer Federation of America, Learning
Disabilities Association, Maricel Maffini, and Howard Mielke, c/o
Thomas Neltner, 1875 Connecticut Ave. NW., Suite 600, Washington, DC
20009. The petition proposes that we repeal the color additive
regulation for lead acetate in Sec.  73.2396 (21 CFR 73.2396), which
permits the use of lead acetate in cosmetics intended for coloring hair
on the scalp only, subject to certain restrictions.

II. Repeal of Sec.  73.2396

    In accordance with the procedure in section 721(d) of the FD&C Act
for issuance, amendment, or repeal of regulations, the petition asks us
to repeal Sec.  73.2396 to no longer provide for the use of lead
acetate in cosmetics intended for coloring hair on the scalp.
Specifically, the petitioners contend that new data, available since we
issued Sec.  73.2396 in 1980 (45 FR 72112, October 31, 1980),
demonstrate that lead acetate: (1) Is readily absorbed through human
skin; (2) once absorbed, is transported to various organs, including
the brain, and into extracellular fluid compartments; (3) has been
designated as ``reasonably anticipated to be a human carcinogen'' based
on evidence of carcinogenicity in experimental animals; (4) has other
adverse health effects including neurotoxicity; and (5) there is no
safe level of exposure to lead. The petitioners cite, as evidence,
conclusions by the National Toxicology Program, the Centers for Disease
Control and Prevention, the Environmental Protection Agency, and
decisions related to lead and lead compounds by other national
regulatory agencies, including Health Canada. The petitioners claim
that there is no longer a reasonable certainty of no harm from the use
of lead acetate for coloring hair on the scalp.
    We invite comments and additional scientific data and other
information related to the issues raised by this petition. If we
determine that the available data justify repealing Sec.  73.2396 to no
longer provide for the use of lead acetate, we will publish our
decision in the Federal Register in accordance with 21 CFR 71.20.
    We also are reviewing the potential environmental impact of the
petitioners' requested action. The petitioners claim a categorical
exclusion from preparing an environmental assessment or environmental
impact statement under 21 CFR 23.32(m). In accordance with regulations
issued under the National Environmental Policy Act (40 CFR 1506.6(b)),
we are placing the environmental document submitted with the subject
petition on public display at the Division of Dockets Management (see
ADDRESSES) so that interested persons may review the document. If we
determine that the petitioners' claim of categorical exclusion is
warranted and that neither an environmental assessment nor
environmental impact statement is required, we will announce our
determination in the Federal Register if this petition results in the
repeal of Sec.  73.2396. If we determine that the claim of categorical
exclusion is not warranted, we will place the environmental assessment
on public display at the Division of Dockets Management and provide
notice in the Federal Register announcing its availability for review
and comment.

    Dated: March 29, 2017.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2017-06581 Filed 4-3-17; 8:45 am]
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[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Notices]
[Pages 26284-26287]
[FR Doc No: 2012-10659]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0867]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Review; Experimental Study on
the Public Display of Lists of Harmful and Potentially Harmful Tobacco
Constituents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by June 7,
2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Experimental Study on the Public Display of Lists of Harmful
and Potentially Harmful Tobacco Constituents.'' Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed collection of information to OMB
for review and clearance.

Experimental Study on the Public Display of Lists of Harmful and
Potentially Harmful Tobacco Constituents--(OMB Control Number 0910-NEW)

    The Tobacco Control Act (Pub. L. 111-31) amends the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health and to reduce tobacco use by
minors. Section 904(d)(1) of the FD&C Act (21 U.S.C. 387d(d)(1))
states, ``Not later than 3 years after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, and annually
thereafter, the Secretary shall publish in a format that is
understandable and not misleading to a lay person, and place on public
display (in a manner determined by the Secretary) the list [of harmful
or potentially harmful constituents] established under [section
904(e)]'' of the FD&C Act. Section 904(e) of the FD&C Act (21 U.S.C.
387d(e)) directs FDA to establish ``a list of harmful and potentially
harmful constituents, including smoke constituents, to health in each
tobacco product by brand, and by quantity in each brand and subbrand.''
On January 31, 2011, FDA announced the availability of a final guidance
representing the Agency's current thinking on the meaning of the term
``harmful and potentially harmful constituent'' (see 76 FR 5387,
January 31, 2011). On April 3, 2012, FDA published a notice in the
Federal Register establishing a list of the harmful and potentially
harmful constituents (HPHCs) in tobacco products and tobacco smoke (see
77 FR 20034) as required by section 904(e) of the FD&C Act.
    FDA intends to conduct research with consumers to help inform
decisions about how to implement section 904(d)(1) of the FD&C Act and
to provide information about how consumers understand information about
HPHCs. The primary research goal is to evaluate the impact of different
list formats on the public's ability to understand HPHC information.
The impact of different list formats will be measured by evaluating
respondents' understanding of certain communication objectives
addressed in this document. Secondary outcomes of interest include
measuring effects of different list formats upon respondents'
susceptibility to initiation of tobacco use, motivation and confidence
to quit tobacco use, and risk perceptions about tobacco use.
    FDA proposes to conduct an experimental study with current smokers
aged 13 years and older, smokeless tobacco users aged 18 years and
older, and nonsmokers aged between 13 and 17 years who may be
susceptible to initiation of smoking. Data will be collected from
members of an Internet panel. Participation in the experimental study
is voluntary. The information collected from the study is necessary to
inform the Agency's efforts to implement the requirement of the FD&C
Act to place on public display a list of HPHCs in tobacco products and
tobacco smoke in a format that is understandable and not misleading to
a lay person, and is expected to provide information that may inform
Agency communications about HPHCs. The data obtained from this study is
one factor that will be used to inform FDA's decisionmaking regarding
the public display of the list of HPHCs required under section
904(d)(1). By evaluating respondents' understanding of the concepts
listed in this document we do not intend to imply that consumer
understanding of all concepts is needed to comply with these
requirements.
    In the Federal Register of December 14, 2011 (76 FR 77837), FDA
published a 60-day notice requesting public comment on its proposed
collection of information. FDA received eight comments that were PRA
related, which required a total of 10 responses.
    (Comment 1) One comment recommended that the study examine the
effects of HPHC lists for smokeless tobacco products as well as for
cigarettes.
    (Response) FDA agrees. The proposed study will assess the impact of
different HPHC list formats for three classes of tobacco products
(cigarettes, smokeless tobacco products, and roll-your-own tobacco) on
consumer comprehension, beliefs, perceptions, and other precursors to
behavior.
    (Comment 2) One comment encouraged FDA to recruit participants from
multiple demographic groups.
    (Response) FDA agrees that it is important to include a diverse
group of individuals in the study and plans to include a
demographically diverse sample of respondents drawn from four primary
groups: Adult smoker, young adult smoker, youth smoker, and youth at
risk for tobacco initiation.
    (Comment 3) One comment recommended that FDA compare consumer
responses to the HPHC lists against those that do not view an HPHC
list. This would facilitate an evaluation of what consumers may
understand, believe, perceive, or do in the absence of the HPHC list.
    (Response) FDA agrees. Within each sample group, respondents will
be randomly assigned to one of the treatment groups that view an HPHC
list format or to a control group that does not view a list. Some of
the formats will include additional information to provide context for
the HPHC lists to the consumer. The effects of each list will be
determined during analysis through a comparison of responses between
treatment and control groups.
    (Comment 4) One comment cautioned FDA to consider the utility of
including underage nonsmokers in the experimental study.
    (Response) FDA has considered the utility of including under age
nonsmokers in the study. FDA believes it is important to consider the
risks and benefits of the HPHC lists to the population as a whole,
including users and nonusers of the tobacco product, and taking into
account the increased or decreased likelihood that existing users of
tobacco products will stop using such products, and the increased or
decreased likelihood that those who do not use tobacco products will
start using such products. Although FDA does not believe that there is
any information on the HPHC list that would encourage nonusers to
initiate tobacco use, one of the secondary outcomes it is to assess the
effects of the provision of HPHC lists on youth that do not currently
use tobacco products but who may be at risk of initiating the use of
tobacco products.
    (Comment 5) One comment recommended that the data collected from
the users of smokeless tobacco products be analyzed separately from
cigarette smokers.
    (Response) FDA agrees. FDA will collect data on the use of tobacco
products. The study now includes a sample of adult smokeless tobacco
users aged 18 years and older. The data from those who use smokeless
products will be analyzed separately.
    (Comment 6) Three comments provided recommendations on pretesting
the information provided in the lists with target audiences prior to
implementation. One of these comments suggested that FDA use open-ended
questions to allow respondents to say/type what they understand each
statement to mean.
    (Response) FDA agrees. FDA intends to conduct cognitive interviews
with individuals to assess comprehension of the test instrument and
certain aspects of the list formats prior to conducting the study.
Individuals will be asked open-ended questions during the

cognitive testing of the list formats and the survey questions.
    (Comment 7) Two comments encouraged FDA to provide additional
information for public comment during the development of the study
including the list formats, study design, and measurement plans for the
listed unintended consequences.
    (Response) The study protocol, list formats, and the survey
questionnaire are available for review and public comment upon request.
To request this information see the FOR FURTHER INFORMATION CONTACT
section of this document.
    (Comment 8) One commenter stated that the HPHC list could not fully
inform consumers because the list is not complete, and the consumer
would not understand that the listed quantity of the chemicals were
based on machine testing and therefore are not necessarily a reflection
of human use. Other comments argued there was a high likelihood that
consumers will conclude that lower numbers or fewer constituents means
a product is less risky. They also suggested the need to have
disclaimers that provide information to counter potential
misunderstandings.
    (Response) FDA agrees that the list format may have the potential
to mislead consumers, which is why FDA plans to conduct an experiment
with consumers to assess the impact of various formats of the HPHC
lists on consumer comprehension and precursors to behavior, such as
beliefs, attitudes, and intentions. Some of the list formats to be
included in the study will contain additional text and graphics to
convey other information to consumers that may not be evident from a
list of chemicals and numerical values. The study will assess various
formats for conveying the communication goals enumerated in this
document, such as uncertainty about the information contained in the
list; that other relationships between the constituents in tobacco
products and health problems may be discovered in the future; that the
values are the results of machine testing; and that exposure to the
chemicals also depends on other factors, such as the variability of
human use.
    FDA's proposed study will also assess each list's potential for
increasing the likelihood that consumers will conclude that lower
numbers or fewer constituents imply that a tobacco product is less
risky. To evaluate whether the lists encourage consumers to compare the
relative risks of products, the study will include measures, such as
whether consumers comprehend that the amount of a chemical listed for a
specific tobacco product does not necessarily indicate the likelihood
of experiencing a health problem, and the number of chemicals listed
for a specific tobacco product does not necessarily indicate the
likelihood of experiencing a health problem.
    (Comment 9) Two comments stressed the importance of using clear
language with one suggesting that information be written at a fifth
grade reading level. They also recommended FDA consider the impact of
color, font type, and font size on consumer comprehension.
    (Response) FDA intends to use plain language, where additional
information is provided, and to select colors, font type, and font size
that are likely to improve consumer comprehension.
    (Comment 10) One commenter suggested FDA prioritize the
communication objectives to facilitate evaluation of study results.
    (Response) FDA agrees that a prioritization of the communication
objectives may facilitate the evaluation of the results. At this time,
FDA proposes a study to test the impact of various HPHC list formats on
consumer comprehension of the communication objectives, although it is
unlikely that a single format will be completely successful at meeting
all of those objectives.
    Based on comments received and preliminary qualitative research,\1\
FDA has refined the communication objectives listed in the Federal
Register of December 14, 2011 (76 FR 77837) to the following: (1) The
chemicals come from the tobacco leaf itself and different parts of a
tobacco product, such as the tobacco smoke, glues, inks, paper, and
additives; (2) for smokeless products, many of the chemicals come from
the tobacco leaf itself; for smoked products, many of the chemicals
come from burning the tobacco leaf; (3) tobacco companies are required
to test their tobacco products and smoke for the chemicals on the list
and report the amounts to FDA; (4) science has linked the chemicals on
these lists to health problems or potential health problems; (5) these
lists do not necessarily identify all of the health problems that may
be caused by the tobacco product; (6) these lists do not necessarily
include all of the chemicals in the tobacco product that may be
harmful; (7) the amount of a chemical listed for a specific tobacco
product does not necessarily indicate the likelihood of experiencing a
health problem; (8) the number of chemicals listed for a specific
tobacco product does not necessarily indicate the likelihood of
experiencing a health problem; and (9) when a chemical is listed
without a quantity it may mean that the chemical was not detected or
the information is not currently available.
---------------------------------------------------------------------------

    \1\ OMB control number 0910-0674.
---------------------------------------------------------------------------

    The remaining comments were unresponsive to the 60-day Federal
Register notice. These comments were related to the development of an
accompanying education campaign; the development of a Web site for
consumers to get additional information; the provision of HPHC
information on the packages of tobacco products; the use of claims by
tobacco manufacturers, such as ``all natural'' or ``no additives''; and
the conformance of tobacco manufacturers and retailers to section 911
of the FD&C Act (21 U.S.C. 387k) regarding modified risk claims.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           Activity                                 Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest.......................................................                60                 1                60            0.5                   30
Screener......................................................            10,000                 1            10,000            0.0167               167
Experimental Survey...........................................             3,150                 1             3,150            0.5                1,575
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................             1,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's burden estimate is based on prior experience with Internet
panel experiments similar to the study proposed here. Sixty panel
members will take part in a pretest of the study, estimated to last 30
minutes (0.5 hours), for a total of 30 hours. Approximately 10,000
respondents will complete a screener to determine eligibility for
participation in the study, estimated to take 1 minute (0.0167 hours),
for a total of 167 hours. Three thousand one hundred and fifty
respondents will complete the full study, estimated to last 30 minutes
(0.5 hours), for a total of 1,575 hours. The total estimated burden is
1,772 hours.

    Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10659 Filed 5-2-12; 8:45 am]
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[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Rules and Regulations]
[Pages 19005-19006]
[FR Doc No: 2017-07811]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 423

[EPA-HQ-OW-2009-0819; FRL-9961-67-OW]
RIN 2040-AF14

Postponement of Certain Compliance Dates for Effluent Limitations
Guidelines and Standards for the Steam Electric Power Generating Point
Source Category

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification; postponement of compliance dates.

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SUMMARY: By a letter dated April 12, 2017, the Administrator announced
the EPA decision to reconsider the final rule that amends the effluent
limitations guidelines and standards for the steam electric point
source category under the Clean Water Act (``CWA''), published in the
Federal Register on November 3, 2015. These regulations have been
challenged in the U.S. Court of Appeals for the Fifth Circuit,
Southwestern Electric Power Co., et al. v. EPA, No. 15-60821. The EPA
is postponing these compliance dates pending judicial review.

DATES: April 25, 2017.

ADDRESSES: EPA has established a docket for the Rule amending 40 CFR
part 423 under Docket ID No. EPA-HQ-OW-2009-0819. All documents in the
docket are listed on the http://www.regulations.gov Web site.

FOR FURTHER INFORMATION CONTACT: For technical information, contact
Ronald Jordan, United States Environmental Protection Agency,
Engineering and Analysis Division; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>For information related to NPDES
permitting of these facilities, contact Sean Ramach at<PHONE_NUMBER>,
email address<EMAIL_ADDRESS>    Electronic copies of this document and related materials are
available on EPA's Web site at https://www.epa.gov/eg/steam-electric-power-generating-effluent-guidelines-2015-final-rule. Copies of this
notification are also available at http://www.regulations.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 3, 2015, the EPA issued a final rule amending 40 CFR
part 423, the effluent limitations guidelines and standards for the
steam electric power generating point source category, under Sections
301, 304, 306, 307, 308, 402, and 501 of the CWA (33 U.S.C. 1311, 1314,
1316, 1317, 1318, 1342, and 1361). The amendments addressed and
contained limitations and standards on various wastestreams at steam
electric power plants: Fly ash transport water, bottom ash transport
water, flue gas mercury control wastewater, flue gas desulfurization
(``FGD'') wastewater, gasification wastewater, and combustion residual
leachate. Collectively, this rulemaking is known as the ``Effluent
Limitations Guidelines and Standards for the Steam Electric Power
Generating Point Source Category'' (``Rule''). For further information
on the Rule, see 80 FR 67838 (Nov. 3, 2015).
    EPA received seven petitions for review of the Rule. The United
States Judicial Panel on Multi-District Litigation issued an order on
December 8, 2015, consolidating all of the petitions in the U.S. Court
of Appeals for the Fifth Circuit. Petitioners have filed their briefs,
and EPA's brief is currently due by May 4, 2017.
    In a letter dated March 24, 2017, the Utility Water Act Group
(``UWAG'') \1\ submitted a petition for reconsideration of the Rule and
requested that EPA suspend the Rule's approaching deadlines. In a
letter dated April 5, 2017, the Small Business Administration Office of
Advocacy also petitioned the EPA for reconsideration of the Rule. The
petitions raise wide-ranging and sweeping objections to the Rule, some
of which overlap with the claims in the ongoing litigation challenging
the Rule in the U.S. Court of Appeals for the Fifth Circuit.\2\ The
UWAG petition also points to new data, claiming that plants burning
subbituminous and bituminous coal cannot comply with the Rule's
limitations and standards for FGD wastewater through use of EPA's model
technology. The UWAG petition says that a pilot study has been
conducted at the Pleasant Prairie plant that supports petitioner's
request, and that a final report on the pilot study ``is likely to [be]
publish[ed] . . . within the next few weeks.'' Moreover, the petitions
say that new data have been collected by American Electric Power that
``illustrate[ ] that variability in wastewater management can also
impact performance at bituminous plants such that additional
technologies beyond EPA's model technology will be needed to achieve
the limits.'' EPA wishes to review these data.
---------------------------------------------------------------------------

    \1\ UWAG is a voluntary, ad hoc, unincorporated group of 163
individual energy companies and three national trade associations of
energy companies: Edison Electric Institute, the National Rural
Electric Cooperative Association, and the American Public Power
Association.
    \2\ A copy of each petition is included in the docket for this
rule, Docket ID No. EPA-HQ-OW-2009-0819.
---------------------------------------------------------------------------

    In an April 12, 2017 letter to those who submitted the
reconsideration petitions, the Administrator announced his decision to
reconsider the Rule (a copy of this letter is included in the docket
for the Rule). As explained in that letter, after considering the
objections raised in the reconsideration petitions, the Administrator
determined that it is appropriate and in the public interest to
reconsider the Rule. Under Section 705 of the APA (``Administrative
Procedure Act''), 5 U.S.C. 705, and when justice so requires, an Agency
may postpone the effective date of action taken by it pending judicial
review. The earliest compliance dates for the new, and more stringent,
best available technology economically achievable effluent limitations
and pretreatment standards is November 1, 2018, for each of the
following wastestreams: Fly ash transport water, bottom ash transport
water, flue gas desulfurization wastewater, flue gas mercury control
wastewater, and gasification wastewater. These dates have not yet
passed, and they are within the meaning of the term ``effective date''
as that term is used in Section 705 of the APA. In light of the capital
expenditures that facilities incurring costs under the Rule will need
to undertake in order to meet the compliance deadlines for the new,
more stringent limitations and standards in the Rule--which are as
early as November 1, 2018, for direct dischargers and by November 1,
2018, for indirect dischargers--the Agency finds that justice requires
it to postpone the compliance dates of the Rule that have not yet
passed, pending judicial review. See 80 FR 67838, 67863-67868 (Nov. 3,
2015) (discussion of costs of the Rule). This will preserve the
regulatory status quo with respect to wastestreams subject to the
Rule's new, and more stringent, limitations and standards, while the
litigation is pending and the reconsideration is underway. While EPA is
not making any concession of error with respect to the rulemaking, the
far-ranging issues contained in the reconsideration petitions warrant
careful and considerate review of the Rule. EPA will also file a motion
requesting the Fifth Circuit to hold the litigation challenging the
Rule in abeyance while the Agency reconsiders the Rule, after which it
will inform the

Court of any portions of the Rule for which it seeks a remand so that
it can conduct further rulemaking. Separately, EPA intends to conduct
notice and comment rulemaking to stay the compliance deadlines for the
new, more stringent limitations and standards in the Rule.

II. Postponement of Compliance Dates

    The EPA hereby issues a postponement of the compliance dates that
have not yet passed contained in the following sections of the Effluent
Guidelines and Standards for the Steam Electric Power Generating Point
Source Category under Section 705 of the APA pending judicial review:
40 CFR 423.11(t), 423.13(g)(1)(i), (h)(1)(i), (i)(1)(i), (j)(1)(i), and
(k)(1)(i), and 423.16(e), (f), (g), (h), and (i).

List of Subjects in 40 CFR Part 423

    Environmental protection, Electric power generation, Power plants,
Waste treatment and disposal, Water pollution control.

    Dated: April 12, 2017.
E. Scott Pruitt,
Administrator.
[FR Doc. 2017-07811 Filed 4-24-17; 8:45 am]
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