[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12309-12310]
[FR Doc No: 2012-4783]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0558]

Determination That PHENURONE (Phenacemide) Tablet, 500
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
PHENURONE (phenacemide) Tablet, 500 milligrams (mg), was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
phenacemide tablet, 500 mg, if all other legal and regulatory
requirements are met.

FOR FURTHER INFORMATION CONTACT: Howard P. Muller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6234, Silver Spring, MD 20993-0002, 301-
796-3602.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    PHENURONE (phenacemide) Tablet, 500 mg, is the subject of NDA
007707, held by Abbott Laboratories, and initially approved on June 28,
1951. PHENURONE is an oral anticonvulsant indicated for the treatment
of epilepsy.
    In a letter dated May 14, 2003, Abbott Laboratories requested
withdrawal of NDA 007707 for PHENURONE (phenacemide) Tablet. In the
Federal Register of May 5, 2004 (69 FR 25124), FDA announced that it
was withdrawing approval of NDA 007707, effective June 4, 2004.
    Schiff & Company submitted a citizen petition dated October 16,
2008 (Docket No. FDA-2008-P-0558), under 21 CFR 10.30, requesting that
the Agency determine whether PHENURONE (phenacemide) Tablet, 500 mg,
was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec.  314.161 that PHENURONE
(phenacemide) Tablet, 500 mg, was not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that PHENURONE (phenacemide) tablet, 500 mg, was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of

PHENURONE (phenacemide) Tablet, 500 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this product was withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list PHENURONE
(phenacemide) Tablet, 500 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to PHENURONE (phenacemide) Tablet, 500
mg, may be approved by the Agency as long as they meet all other legal
and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4783 Filed 2-28-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61506-61507]
[FR Doc No: 2010-24984]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Gastrointestinal Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 4, 2010, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballroom,
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), code<PHONE_NUMBER>. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Agenda: On November 4, 2010, the committee will discuss the
adequacy of endoscopically documented gastric ulcers as an outcome
measure to evaluate drugs intended to prevent gastrointestinal
complications of nonsteroidal anti-inflammatory drugs including
aspirin.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 21, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before October 13, 2010. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by October
14, 2010.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristine T. Khuc at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 30, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-24984 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 77 (Thursday, April 21, 2016)]
[Notices]
[Pages 23491-23493]
[FR Doc No: 2016-09289]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0774; FRL-9944-31]

2-(Decylthio) Ethanamine Hydrochloride, Aliphatic Alcohols C1-C5,
Bentazon, Propoxur, Propoxycarbazone-sodium, Sodium Acifluorfen,
Thidiazuron; Registration Review Proposed Interim Decisions; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed
interim registration review and opens a public comment period on the
proposed interim decisions. Registration review is EPA's periodic
review of pesticide registrations to ensure that each pesticide
continues to satisfy the statutory standard for registration, that is,
that the pesticide can perform its intended function without
unreasonable adverse effects on human health or the environment.
Through this program, EPA is ensuring that each pesticide's
registration is based on current scientific and other knowledge,
including its effects on human health and the environment.

DATES: Comments must be received on or before June 20, 2016.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in the Table in Unit II., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: The Chemical Review Manager for the pesticide of interest
identified in the Table in Unit II.
    For general information on the registration review program,
contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-8015; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager for the pesticide of interest
identified in the Table in Unit II.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed interim registration review decisions for the
pesticides shown in the Table in this unit and opens a 60-day public
comment period on the proposed interim decisions.

          Table--Registration Review Proposed Interim Decisions
------------------------------------------------------------------------
                                                       Chemical review
  Registration review case     Pesticide Docket ID   manager, telephone
        name and No.                   No.              number, email
                                                           address
------------------------------------------------------------------------
2-(Decylthio)ethanamine       EPA-HQ-OPP-2009-0336  Sanyvette Williams,
 hydrochloride (DTEA-HCl)                            williams.sanyvette@
 (Case 5029).                                        epa.gov, (703) 305-
                                                     7702.
Aliphatic Alcohols, C1-C5     EPA-HQ-OPP-2012-0340  Sanyvette Williams,
 (Case 4003<EMAIL_ADDRESS>(703) 305-
                                                     7702.
Bentazon (Case 0182)........  EPA-HQ-OPP-2010-0117  Moana Appleyard,
<EMAIL_ADDRESS>(703) 308-
                                                     8175.

Propoxur (Case 2555)........  EPA-HQ-OPP-2009-0806  Brittany Pruitt,
<EMAIL_ADDRESS>(703) 347-
                                                     0289.
Propoxycarbazone-sodium       EPA-HQ-OPP-2015-0095  Marianne Mannix,
 (Case 7264<EMAIL_ADDRESS>(703) 347-
                                                     0275.
Sodium Acifluorfen (Case      EPA-HQ-OPP-2010-0135  Nathan Sell,
 2605<EMAIL_ADDRESS>                                                     ,<PHONE_NUMBER>.
Thidiazuron (Case 4092).....  EPA-HQ-OPP-2015-0381  Khue Nguyen,
<EMAIL_ADDRESS>                                                     ,<PHONE_NUMBER>.
------------------------------------------------------------------------

    DTEA HCl is a biocide registered for use in cooling water systems
to control bacterial, fungal, and algal slimes. An ecological risk
assessment identified potential ecological risks to aquatic organisms.
To address these potential risks, EPA is proposing label language
changes to reduce discharge into bodies of water, limit use frequency
and location, and reduce certain use rates. A final decision will be
made after Endangered Species Act (ESA) and Endocrine Disruptor
Screening Program (EDSP) determinations have been made.
    The aliphatic alcohols, C1-C5 case contains two active ingredients,
ethanol and isopropyl alcohol, which are registered for use as
sanitizers, disinfectants and bactericides on agricultural premises and
equipment, medical premises and equipment, industrial areas,
residential and public access areas, in antifouling paints for boats,
and as a plant growth regulator. The Agency has concluded that there
are no human or ecological risk concerns associated with the pesticidal
uses of aliphatic alcohols, C1-C5 based on use patterns and chemical
characteristics. Additionally, no additional data are required in
support of this registration review case, and a ``no effect''
determination has been made for endangered species and designated
critical habitat for such species. A final decision will be made after
the EDSP determination has been made.
    Bentazon is a selective, contact, early post-emergence herbicide
registered to control broadleaf weeds and sedges in numerous
agricultural field crops, including corn, soybeans, beans, rice,
cereals, and potatoes, and for use in and around trees and vines of
various fruit and nut crops. Bentazon is also registered for use to
control weeds in residential and recreational lawns and around
ornamental plants. EPA published draft registration review human health
and ecological risk assessments in 2014. The Agency has concluded that
bentazon does not pose human health risks of concern. The ecological
risk assessment concluded that there are risks of concern for
terrestrial and semi-aquatic plants and acute risks for some birds and
mammals. The Agency is proposing that bentazon labels include drift and
herbicide resistance management language and increased spray droplet
sizes, and allow one application annually except under specific
circumstances to reduce risks to non-target plants and wildlife. This
proposed interim decision does not include a finding under the EDSP,
nor does it contain a complete ESA or pollinator component for
bentazon.
    The registration review docket for propoxur opened in December
2009. Propoxur is an N-methyl residual carbamate insecticide registered
for use to control ticks, fleas, and a variety of insects in-and-around
industrial, commercial, and residential facilities. EPA published draft
registration review human health and ecological risk assessments in
July 2015. For the human health assessment, the Agency concluded that
propoxur posed risks of concern from dietary and residential post
application exposure. A voluntary final cancellation order was issued
for the following uses, which fully mitigated the human health risks of
concerns: All indoor aerosol, spray, and liquid formulations; use in
food handling establishments; and indoor crack and crevice uses were
cancelled effective September 22, 2015. The draft ecological risk
assessment initially concluded that there were no risks of concern to
non-listed species nor to listed species, except for listed aquatic
invertebrates from outdoor spot treatment use made near aquatic water
bodies. However, additional information on the use of propoxur outdoor
spot treatments support that this use is not likely to result in
quantities of active ingredient that would result in potential effects
to listed aquatic species. Therefore, the draft propoxur ecological
risk assessment has been amended to reflect this use information and is
posted to the propoxur docket at this time. The amended ecological risk
assessment indicates that there is no reasonable expectation for any
registered use of propoxur to cause direct or indirect adverse effects
to threatened and endangered species. A ``no effect'' determination was
made for all federally listed species and designated critical habitat.
Propoxur has not been evaluated under the EDSP. Therefore, the Agency's
final registration review decision is dependent upon the result of the
evaluation of potential endocrine disruptor risk. In addition, a
pollinator risk assessment will not be required for propoxur due to
negligible exposure pathways to terrestrial invertebrates (honeybees).
Pending the EDSP determination action, EPA is planning to issue an
interim registration review decision for propoxur.
    Propoxycarbazone-sodium is an herbicide that controls post-emergent
grasses and broadleaf weeds including cheat grass, downy brome, jointed
goatgrass, pigweed, wild oat, and mustard in wheat and triticale. EPA
conducted a comprehensive human health risk assessment which indicated
that there are no risks of concern for human health. The ecological
risk assessment indicated that there are potential risks of concern for
non-target terrestrial plant species from all uses of propoxycarbazone
sodium, which is consistent with the herbicidal mode of action. To
reduce risk to non-target terrestrial plants, the Agency is proposing
several spray drift reduction measures. The Agency is also proposing
herbicide resistance management language to be included on all
propoxycarbazone-sodium labels. This proposed interim decision does not
include an endangered species determination, or any human health or
environmental safety findings associated with the EDSP. The Agency's
final registration review decision is dependent upon the assessment of
risks to threatened and endangered species, potential endocrine
disruptor risk, and an assessment of risks to bees.

    Sodium acifluorfen is an herbicide that is registered for control
of broadleaf weeds in soybean, peanuts, rice, and strawberry. EPA
conducted a comprehensive human health risk assessment, which indicated
that there are no risks of concern for human health. The ecological
risk assessment indicated that there are potential risks of concern for
non-target terrestrial plant species from the aerial use of sodium
acifluorfen. To reduce risk to non-target terrestrial plants from
aerial spray drift, the Agency is proposing the deletion of aerial use
on strawberries and the implementation of uniform spray drift
management language across all labels. The Agency is also proposing the
inclusion of herbicide resistance management language on all sodium
acifluorfen labels. This proposed interim decision does not include an
endangered species determination, or any human health or environmental
safety findings associated with the EDSP. The Agency's final
registration review decision is dependent upon a finding under ESA, an
EDSP determination, and an assessment of risks to bees.
    Thidiazuron is a plant growth regulator applied as a pre-harvest
defoliant to cotton in southern states such as Mississippi, Texas, and
Georgia. Thidiazuron reduces foliage, dry leaves, and immature fruiting
structures, at the time of harvest, which contribute to the staining of
harvested cotton. Quantitative human health and ecological risk
assessments, including a screening-level endangered species risk
assessment, were conducted for thidiazuron. EPA did not identify any
human health risks. EPA identified possible risk to non-target
terrestrial plants from use of thidiazuron. In its proposed interim
decision, EPA is proposing risk mitigation to reduce spray drift to
non-target terrestrial plants. EPA is making no human health or
environmental safety findings associated with the EDSP screening of
thidiazuron, nor is it making an endangered species finding. EPA's
registration review decision for thidiazuron will depend upon the
result of an EDSP Federal Food, Drug, and Cosmetic Act section 408(p)
determination, complete pollinator determination, and an endangered
species determination.
    The registration review docket for a pesticide generally includes
earlier documents related to the registration review of the case. For
example, the review opened with a Summary Document, containing a
Preliminary Work Plan, for public comment. A Final Work Plan was placed
in the docket following public comment on the initial docket. The
documents in the docket describe EPA's rationales for conducting
additional risk assessments for the registration review of the
pesticides included in the Table in this unit, as well as the Agency's
subsequent risk findings and consideration of possible risk mitigation
measures. These proposed interim registration decisions are supported
by the rationales included in those documents. Following public
comment, the Agency will issue interim registration review decisions
for products containing the pesticides listed in the Table in this
unit.
    The registration review program is being conducted under
congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. Section 3(g) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C.
136a(g)) required EPA to establish by regulation procedures for
reviewing pesticide registrations, originally with a goal of reviewing
each pesticide's registration every 15 years to ensure that a pesticide
continues to meet the FIFRA standard for registration. The Agency's
final rule to implement this program was issued in August 2006 and
became effective in October 2006, and appears at 40 CFR part 155,
subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA)
was amended and extended in September 2007. FIFRA, as amended by PRIA
in 2007, requires EPA to complete registration review decisions by
October 1, 2022, for all pesticides registered as of October 1, 2007.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed interim
registration review decisions. This comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the proposed interim decision. All comments
should be submitted using the methods in ADDRESSES, and must be
received by EPA on or before the closing date. These comments will
become part of the docket for the pesticides included in the Table in
this unit. Comments received after the close of the comment period will
be marked ``late.'' EPA is not required to consider these late
comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a ``Response to Comments Memorandum'' in
the docket. The interim registration review decision will explain the
effect that any comments had on the interim decision and provide the
Agency's response to significant comments.
    Background on the registration review program is provided at:
http://www2.epa.gov/pesticide-reevaluation. Links to earlier documents
related to the registration review of these pesticides are provided at:
http://www.epa.gov/oppsrrd1/registration_review/reg_review_status.htm.

    Authority:  7 U.S.C. 136 et seq.

    Dated: April 13, 2016.
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2016-09289 Filed 4-20-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Page 42452]
[FR Doc No: 2022-15165]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. AD22-11-000, AD21-9-000]

Office of Public Participation Fundamentals for Participating in
FERC Matters; Notice of Virtual Workshop: Workshop on Filing Comments

    Take notice that the Federal Energy Regulatory Commission
(Commission) staff, will convene, in the above-referenced proceeding, a
virtual workshop on August 30, 2022, from 2:00 p.m. to 3:00 p.m.
Eastern time, to discuss how members of the public including consumers
and consumer advocates can file comments on the record using FERC's
eFiling and eComment online applications. The workshop will be held
remotely.
    The workshop will include video demonstrations of steps involved in
filing a comment, followed by a presentation of useful tips for using
the Commission's online applications and a question-and-answer portion
of the workshop. The workshop will provide information on the
commenting process to facilitate increased public participation in
Commission processes and decision-making.
    The workshop will be open for the public to attend, and there is no
fee for attendance. Further details on the agenda, can be found on the
FERC's Office of Public Participation website. Information on this
technical workshop will also be posted on the Calendar of Events on the
Commission's website, www.ferc.gov, prior to the event.
    The workshop will be accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to [email protected] or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY)or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information about the workshop, please contact Yewande
Bayly of the Commission's Office of Public Participation at 202-502-
6595 or send an email to [email protected].

    Dated: July 11, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-15165 Filed 7-14-22; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on November 28, 2007

NOTICE OF ACTION TAKEN - DOCKETS 	 DOT-OST-95-369     DOT-OST-96-1348

					                               DOT-OST-96-1560   DOT-OST-98-3476

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).

Application of UNITED AIR LINES, INC. (UNITED) filed 12/8/05 for:

XX  Renewal of exemptions for two years under 49 U.S.C. §40109 to
provide the following service:

DOT-OST-95-369: Scheduled foreign air transportation of persons,
property, and mail between points in the United States and Nairobi,
Kenya, via points in third countries that United is authorized to serve,
and to integrate these services with United’s existing certificate and
exemption authority.  United operates this service pursuant to
authorized code-share arrangements with its foreign code-share partners.

DOT-OST-96-1348: Scheduled foreign air transportation of persons,
property, and mail between points in the United States and Manchester,
England via points in third countries that United is authorized to
serve, and to integrate these services with United’s existing
certificate and exemption authority.   United operates this service
pursuant to authorized code-share arrangements with its foreign
code-share partners.

DOT-OST-96-1560: Scheduled foreign air transportation of persons,
property, and mail between points in the United States and Baku,
Azerbaijan, and Ashkhabad, Turkmenistan, via points in third countries
that United is authorized to serve, and to integrate these services with
United’s existing certificate and exemption authority. United operates
this service pursuant to authorized code-share arrangements with its
foreign code-share partners.

DOT-OST-98-3476: Scheduled foreign air transportation of persons,
property, and mail between points in the United States and Sarajevo,
Bosnia, and Zagreb, Croatia, via points in third countries that United
is authorized to serve, and to integrate these services with United’s
existing certificate and exemption authority.  United operates this
service pursuant to authorized code-share arrangements with its foreign
code-share partners.

Applicant rep: Jonathan Moss<PHONE_NUMBER>    DOT Analyst: Thuy H.
Cooper<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, in part (subject to conditions, see below)

XX  Dismissed request for route integration authority

XX  Dismissed, as moot, request for renewed exemption authority to serve
between points in the United States and Sarajevo, Bosnia

The above action granting exemption authority with respect to Nairobi,
Kenya; Baku, Azerbaijan; Ashkhabad, Turkmenistan; and Zagreb, Croatia
was effective when taken: November 28, 2007, through November 28, 2009,
or until 90 days after final Department action on United’s
corresponding certificate application in Docket

DOT-OST-95-625, whichever occurs earlier.

The above action granting exemption authority with respect to
Manchester, England was effective when taken:

November 28, 2007, through March 30, 2008.

The above actions dismissing the requests for exemption authority with
respect to Bosnia and for route integration authority were effective
when taken: November 28, 2007.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX The authority granted with respect to Nairobi is consistent with the
overall state of aviation relations between the United States and Kenya.
The authority granted with respect to Baku is consistent with the
overall state of aviation relations between the United States and
Azerbaijan.  The authority granted with respect to Ashkhabad is
consistent with the overall state of aviation relations between the
United States and Turkmenistan.  The authority granted with respect to
Zagreb is consistent with the overall state of aviation relations
between the United States and Croatia.  The authority granted with
respect to Manchester is consistent with the aviation agreement between
the United States and the United Kingdom.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated: XX Holder’s
certificates of public convenience and necessity

   	    XX Standard exemption conditions (attached)

    XX Statements of authorization approving United/foreign carrier
code-share operations,

	           and conditions therein

Remarks: The authorities for which United requested renewal have
expired, but have been kept in force pursuant to the provisions of the
Administrative Procedure Act, 5 U.S.C. 558(c), as implemented by

14 CFR Part 377, pending action on its timely-filed renewal
applications.

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
 To the extent not granted or dismissed, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

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

  HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov

APPENDIX

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration, the Transportation Security Administration, and with all
applicable U.S. Government requirements concerning security, including,
but not limited to, 49 CFR Part 1544.  To assure compliance with all
applicable U.S. Government requirements concerning security, the holder
shall, before commencing any new service (including charter flights) to
or from a foreign airport, contact its International Principal Security
Inspector (IPSI) to advise the IPSI of its plans and to find out whether
the Transportation Security Administration has determined that security
is adequate to allow such airport(s) to be served;

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

			11/2006

 United also requests renewal of exemption authority in Dockets
DOT-OST-99-5097 (U.S.-Namibia), DOT-OST-99-6720 (U.S.-Ghana/Nigeria),
and DOT-OST-2000-6852 (U.S.-Portugal).  We will handle these requests
separately.

 By Order 2006-1-1, the Department awarded the carrier a blanket route
integration certificate.

 United holds broad authority to serve Bosnia, pursuant to its blanket
open-skies certificate authority.  See Order 2007-4-19.

 Effective March 30, 2008, United will be authorized to serve the United
Kingdom pursuant to its blanket open-skies certificate authority.  See
Order 2007-4-19.


[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Notices]
[Pages 730-732]
[FR Doc No: 2012-31715]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9767-1]

State Program Requirements; Approval of Application To Administer
Partial National Pollutant Discharge Elimination Program; Oklahoma

AGENCY: Environmental Protection Agency.

ACTION: Approval of Oklahoma Department of Agriculture, Food and
Forestry's (ODAFF) Agricultural Pollutant Discharge Elimination System
program under the Clean Water Act.

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SUMMARY: On December 20, 2012, the Regional Administrator for the
Environmental Protection Agency, Region 6 (EPA) approved the request of
the State of Oklahoma for authorization of the Agriculture Pollutant
Discharge Elimination System (AgPDES) program pursuant to Section
402(b) of the Clean Water Act (CWA or ``the Act''). The AgPDES program
will be administered by the Oklahoma Department of Agriculture, Food
and Forestry (ODAFF) and is a major category partial National Pollutant
Discharge Elimination System (NPDES) permit program under Section
402(n)(3) of the Act for all discharges of pollutants into waters of
the United States within ODAFF's jurisdiction.

DATES: Effective Date: Pursuant to 40 CFR 123.61(c), the AgPDES program
was approved and became effective on December 20, 2012. As of the date
of program approval, NPDES permitting authority for those discharges
subject to the AgPDES program transferred from EPA to ODAFF.
    To View or Obtain Copies of Documents: Copies of ODAFF's program
approval submission (referred to throughout this document as ODAFF's
application) and all other documents in the Administrative Record are
available for inspection from 9 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays, at EPA Region 6, 1445 Ross Ave., Dallas,
Texas 75202.
    A copy of ODAFF's application is available online at the EPA Region
6 web page: http://www.epa.gov/region6/water/npdes/ok-daff/index.html A
paper copy of part of all of the State's application or any other
documents in the Administrative Record may be obtained from EPA Region
6 in Dallas for a cost of .15 cents per page.

FOR FURTHER INFORMATION CONTACT: Ms. Denise Hamilton at the EPA address
listed above or by calling<PHONE_NUMBER>, FAX<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  Section 402 of the CWA created the NPDES
program under which EPA may issue permits for the point source
discharge of pollutants to waters of the United States under conditions
required by the Act. Section 402(b) requires EPA to authorize a State
to administer an equivalent state program upon the Governor's request,
provided the State has appropriate legal authority and a program
sufficient to meet the Act's requirements. Major category partial
permit program approval is provided for under section 402(n)(3) of the
CWA. Pursuant to that Section, EPA may approve a partial permit program
covering a major category of a State's discharges if the program
represents a complete permit program and covers all of the discharges
under the jurisdiction of the agency seeking approval, and if EPA
determines that the partial program represents a significant and
identifiable part of the State program required by Section 402(b) of
the Act. The Oklahoma discharges subject to regulation under the
federal NPDES program and the AgPDES program administered by ODAFF are
discharges associated with concentrated animal feeding operations
(``CAFO''), discharges from the application of biological pesticides or
chemical pesticides that leave a residue, discharges from silviculture
activities, and discharges of storm water from agricultural activities.
ODAFF does not have jurisdiction over all discharges within the State
of Oklahoma. A large portion of the State's discharges are covered by
the Oklahoma Department of Environmental Quality's (ODEQ's) approved
NPDES program. EPA retains jurisdiction over discharges to Indian
Country, as defined in 18 U.S.C. 1151, and over discharges under the
jurisdiction of the Oklahoma Corporation Commission.
    On August 16, 2012, the Governor of Oklahoma requested NPDES major
category partial permit program approval and submitted, in accordance
with 40 CFR 123.21 a program description (including funding, personnel
requirements and organization, and permit and enforcement procedures),
a Statement of Legal Authority, copies of applicable State statutes and
regulations, and a Memorandum of Agreement (MOA) to be executed by the
Regional Administrator of EPA Region 6 and the Commissioner of
Agriculture for ODAFF. ODAFF seeks permitting and enforcement authority
for all discharges within its jurisdiction. At the request of EPA,
ODAFF made revisions to several of the program submittal documents and
the last of these revisions was received by EPA on September 7, 2012.
EPA determined that ODAFF's August 16th application for partial program
approval, as amended September 7, 2012, was complete under 40 CFR
123.21 and a letter of completeness was sent to ODAFF on September 14,
2012. On September 24, 2012, notice of the State's application was
published in the Federal Register (77 FR 58830), announcing a 45 day
public comment period. Notice was also published in the Daily Oklahoman
and Tulsa World newspapers on September 25, 2012. Both an informal
public meeting and a public hearing were held in Oklahoma City,
Oklahoma on October 25, 2012. The public meeting included a
presentation on Oklahoma's request for AgPDES program approval and a
question and answer session. Oral and written comments for the official
record were accepted at the public hearing, which was held in
accordance with 40 CFR 124.12.
    EPA was required to approve ODAFF's application within 90 days of
submittal of a complete submission unless the submittal did not meet
the requirements of Section 402(b) of the Act and EPA regulations, or
EPA and ODAFF jointly agreed to extend this deadline. (See 40 CFR
123.2l (d). By email dated December 4, 2012, EPA and ODAFF extended the
statutory review period until December 20, 2012.
    To obtain program approval, ODAFF was required to show among other
things that it has authority to issue permits that comply with the Act,
authority to impose civil and criminal penalties for permit violations,
and authority to ensure that the public is given notice and opportunity
for a hearing on each proposed permit.
    Authority to approve State programs is provided to EPA pursuant to
Section 402(b) of the CWA. The regulatory requirements for state
program approval are set forth in 40 CFR part 123. EPA's decision to
approve the AgPDES program is based on the requirements of CWA Sec.
402 and 40 CFR part 123. In making its decision, EPA considered all
comments and issues raised during the public comment period, including
those

raised at the public hearing. A copy of the Region's responses to
comments and ODAFF's program submittal documents are available on the
EPA Region 6 Internet site: http://www.epa.gov/region6/water/npdes/ok-daff/index.html. The comments and public hearing record are contained
in the administrative record supporting this notice.

Scope, Transfer of NPDES Authority, and Summary of the AgPDES Program

A. Scope of the Partial Program

    The AgPDES program is a major category partial permit program in
conformance with the requirements of Section 402(n)(3) of the CWA. The
program is a complete permit program for all discharges under ODAFF's
jurisdiction and represents a significant and identifiable part of the
state program required by Sec.  402(b) of the CWA. The Oklahoma
discharges subject to regulation under the federal NPDES program and
the AgPDES program administered by ODAFF are discharges associated with
concentrated animal feeding operations (``CAFO''), discharges from the
application of biological pesticides or chemical pesticides that leave
a residue, discharges from silviculture activities, and discharges of
storm water from agricultural activities.
    ODAFF has jurisdiction over all matters affecting agriculture that
have not been expressly delegated to another state or federal agency,
as set out in the Oklahoma Agriculture Code, and is responsible for
fully implementing and enforcing the laws and rules within its
jurisdictional areas of environmental responsibility. The Oklahoma
Environmental Quality Act gives ODAFF environmental jurisdiction over
point source discharges from agricultural crop production and
agricultural services. It also gives the Agency environmental
jurisdiction specific to the application of pesticides. ODAFF does not
have jurisdiction over storm water discharges associated with
industrial activity (as defined at 40 CFR 122.26(b)(14) at facilities
whose primary industrial activity is storage of grain, feed seed,
fertilizer, and agriculture chemicals (e.g., SIC code 4121) and are
thus required by federal regulations to have a storm water permit.
However, ODAFF's jurisdiction includes all discharges at facilities
regulated by ODAFF that only incidentally store grain, feed seed,
fertilizer, and agriculture chemicals to support the primary activity
of the facility (e.g., feed storage at a CAFO). ODAFF has jurisdiction
to regulate discharges resulting from agricultural and non-agricultural
applications of pesticides; except for discharges from industrial
processes, municipal treatment works, and municipal and industrial
storm water, for which the Oklahoma Environmental Quality Act has
expressly delegated jurisdiction to the Oklahoma Department of
Environmental Quality (ODEQ). ODAFF also has jurisdiction to regulate
discharges resulting from silvicultural discharges related to tree
growing, planting management, log transport and log storage, and other
activities, except those related to wood preservation and processing
regulated pursuant to 40 CFR part 429 (Timber Products Processing) and
part 436 (Mineral Mining and Processing), which are regulated by ODEQ.
    Activities that are not within ODAFF's environmental jurisdiction
include commercial manufacturers of fertilizers, grain and feed
products, and chemicals; manufacturing of food and kindred products,
tobacco, paper, lumber, wood, textile mill and other agricultural
products; slaughterhouses, except for feedlots at those facilities; and
aquaculture and fish hatcheries. These exceptions to the Agency's
jurisdiction include, but are not limited to, discharges of pollutants
and storm water to waters of the state, surface impoundments and land
application of wastes and sludge, and other pollution originating at
these facilities.
    ODAFF did not seek authority to regulate discharges to Indian
Country, as defined in 18 U.S.C. 1151. EPA retains NPDES permitting
authority over Indian Country in the State of Oklahoma.

B. Transfer of NPDES Authority and Pending Actions

    Authority for all NPDES permitting activities within the scope of
ODAFF's jurisdiction have been transferred to the State. EPA retains on
a permanent basis its authority under section 402(d) of the CWA to
object to AgPDES permits proposed by ODAFF, and if the objections are
not resolved, to issue federal NPDES permits for those discharges. EPA
also retains on a permanent basis independent enforcement authority to
address civil and/or criminal CWA violations under Sec. Sec.  309 and
402(i) of the Act and to file federal enforcement actions in those
instances in which EPA determines the State has not taken timely or
appropriate enforcement action.
    Pursuant to the MOA between EPA and ODAFF, ODAFF has taken over
administration of EPA-issued general permits for those discharges under
its jurisdiction while EPA retains administration of general permits
for those discharges remaining under EPA jurisdiction. Dischargers
remaining under EPA jurisdiction include those discharges to waters in
Indian Country and those discharges under the jurisdiction of the
Oklahoma Corporation Commission. The transfer of EPA-issued permits is
described in Section IV.B of the MOA.
    The CAFO general permit OKG010000 (discharges from CAFOs) is being
transferred to ODAFF with no discharges authorized by that permit
remaining under EPA jurisdiction. OKR12000F (Construction General
Permit--storm water discharges associated with industrial activity),
OKR05000F (Multi-Sector General Permit--storm water associated with
construction activities), and OKG87
(Pesticides General Permit--discharges associated with application of
pesticides to waters of the United States) are being partially
transferred to ODAFF with EPA retaining the permits for discharges
remaining under EPA jurisdiction. For general permits OKR05000F and
OKR12000F, EPA will continue to administer the permit for discharges
under the jurisdiction of the OCC. For general permit
OKG87, EPA will continue to
administer the permit for discharges to Indian Country. Descriptions of
the scope of coverage in general permits
OKG87, OKR05000F and OKR12000F are
being changed to reflect the discharges still being permitted by EPA.
ODAFF is modifying the permit scope of coverage, Notice of Intent, and
reporting requirements to reflect their assumption of these permits for
those discharges under the new AgPDES program.

Responsiveness Summary

    On September 24, 2012, notice of the State's application was
published in the Federal Register (77 FR 58830), announcing a 45 day
public comment period. EPA Region 6 has considered and prepared written
responses to all comments received. In response to comments received
and for the sake of clarification, several wording changes have been to
the Memorandum of Agreement between EPA and ODAFF. A revision to Table
3-1 of the Enforcement Management System, Chapter 3, has also been made
for the sake of clarification. A copy of the Region's responses to
comments and the program documents may be obtained from the EPA Region
6 Internet site: http://www.epa.gov/region6/water/npdes/ok-daff/index.html Changes made to the MOA and to Table 3-1 of the Enforcement
Management System as a

result of comments are marked in redline/strikeout.
    I hereby provide public notice of EPA's approval of the State of
Oklahoma's request for authorization for ODAFF to administer the AgPDES
program for discharges into navigable waters within its jurisdiction in
accordance with Section 402(b) of the CWA and 40 CFR Part 123.

    Dated: December 20, 2012.
Ron Curry,
Regional Administrator, EPA Region 6.
[FR Doc. 2012-31715 Filed 1-3-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Rules and Regulations]
[Pages 24997-25003]
[FR Doc No: 2013-10046]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2011-0111; FRL-9800-9]
RIN-2060-AQ84

Protection of Stratospheric Ozone: Listing of Substitutes for
Ozone-Depleting Substances--Fire Suppression and Explosion Protection

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: Pursuant to the U.S. Environmental Protection Agency's
Significant New Alternatives Policy program, this action lists C7
Fluoroketone as an acceptable substitute, subject to narrowed use
limits, for ozone-depleting substances used as streaming agents in the
fire suppression and explosion protection sector. The program
implements Section 612 of the Clean Air Act, as amended in 1990, which
requires the Agency to evaluate substitutes and find them acceptable
where they pose comparable or lower overall risk to human health and
the environment than other available substitutes.

DATES: This rule is effective on May 29, 2013.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2011-0111. All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and is publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the Air
and Radiation Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air and Radiation Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Bella Maranion, Stratospheric
Protection Division, Office of Atmospheric Programs (6205J),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 343-2363; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The regulations implementing the Significant
New Alternatives Policy (SNAP) program are codified at 40 CFR part 82,
subpart G. The appendices to subpart G list substitutes for ozone-
depleting substances (ODSs) for specific end uses as unacceptable or as
acceptable with certain restrictions imposed on their use. In addition,
a list of acceptable substitutes without restrictions is available at
http://www.epa.gov/ozone/snap/lists/index.html. This final rule will
add a new fire suppression agent to the SNAP list of acceptable
substitutes in the appendices to subpart G and specifically to the list
of substitutes for halon 1211 for streaming uses. This action does not
place any significant burden on the regulated community but lists as
acceptable, subject to narrowed use limits, a new halon substitute. The
restrictions will ensure that this substitute will not pose a greater
risk to human health or the environment than other available or
potentially available substitutes in the fire suppression end use.
    This final rule finds C7 Fluoroketone acceptable subject to
narrowed use limits as a substitute for halon 1211 for use as a
streaming agent in portable fire extinguishers in nonresidential
applications. Halons are chemicals that were once widely used in the
fire protection sector but have been banned from production in the U.S.
since 1994 because their emissions into the atmosphere are highly
destructive to the stratospheric ozone layer. This action will provide
users that need specialized fire protection applications with more
alternatives to the use of halons. Businesses that may be regulated,
either through manufacturing, distribution, installation and servicing,
or use of the fire suppression equipment containing the substitutes are
listed in the table below:

  Table 1--Potentially Regulated Entities, by North American Industrial
                   Classification System (NAICS) Code
------------------------------------------------------------------------
                                                      Description of
            Category               NAICS Code       regulated entities
------------------------------------------------------------------------
Construction...................          238210  Alarm system (e.g.,
                                                  fire, burglar),
                                                  electric, installation
                                                  only.
Manufacturing..................          325998  Fire extinguisher
                                                  chemical preparations
                                                  manufacturing.

Manufacturing..................          332919  Nozzles, fire fighting,
                                                  manufacturing.
Manufacturing..................          334290  Fire detection and
                                                  alarm systems
                                                  manufacturing.
Manufacturing..................          336611  Shipbuilding and
                                                  repairing.
Manufacturing..................          339999  Fire extinguishers,
                                                  portable,
                                                  manufacturing.
Manufacturing..................          336411  Aircraft manufacturing.
Manufacturing..................          336413  Other aircraft parts
                                                  and auxiliary
                                                  equipment
                                                  manufacturing.
------------------------------------------------------------------------

This table is not intended to be exhaustive, but rather a guide
regarding entities likely to be regulated by this action. If you have
any questions about whether this action applies to a particular entity,
consult the person listed in the FOR FURTHER INFORMATION CONTACT
section.

Table of Contents

I. Section 612 Program
    A. Statutory Requirements
    B. Regulatory History
II. Listing Decision: Fire Suppression and Explosion Protection
Streaming Application: C7 Fluoroketone--Acceptable Subject to
Narrowed Use Limits
III. Response to Public Comment
IV. Final Action
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132:Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act

I. Section 612 Program

A. Statutory Requirements

    Section 612 of the Clean Air Act (CAA) requires EPA to develop a
program for evaluating alternatives to ozone-depleting substances. EPA
refers to this program as the Significant New Alternatives Policy
(SNAP) program. The major provisions of Section 612 are:
     Rulemaking--Section 612(c) requires EPA to promulgate
rules making it unlawful to replace any class I (chlorofluorocarbon,
halon, carbon tetrachloride, methyl chloroform, and
hydrobromofluorocarbon) or class II (hydrochlorofluorocarbon) substance
with any substitute that the Administrator determines may present
adverse effects to human health or the environment where the
Administrator has identified an alternative that (1) reduces the
overall risk to human health and the environment, and (2) is currently
or potentially available.
     Listing of Unacceptable/Acceptable Substitutes--Section
612(c) also requires EPA to publish a list of the substitutes
unacceptable for specific uses and to publish a corresponding list of
acceptable alternatives for specific uses. The list of acceptable
substitutes is found at http://www.epa.gov/ozone/snap/lists/index.html,
and the lists of ``unacceptable,'' ``acceptable subject to use
conditions,'' and ``acceptable subject to narrowed use limits''
substitutes are found in the appendices to subpart G of 40 CFR part 82.
     Petition Process--Section 612(d) grant the right to any
person to petition EPA to add a substitute to, or delete a substitute
from, the lists published in accordance with Section 612(c). The Agency
has 90 days to grant or deny a petition. Where the Agency grants the
petition, EPA must publish the revised lists within an additional six
months.
     90-day Notification--Section 612(e) directs EPA to require
any person who produces a chemical substitute for a class I substance
to notify the Agency not less than 90 days before new or existing
chemicals are introduced into interstate commerce for significant new
uses as substitutes for a class I substance. The producer must also
provide the Agency with the producer's unpublished health and safety
studies on such substitutes.
     Outreach--Section 612(b)(1) states that the Administrator
shall seek to maximize the use of federal research facilities and
resources to assist users of class I and II substances in identifying
and developing alternatives to the use of such substances in key
commercial applications.
     Clearinghouse--Section 612(b)(4) requires the Agency to
set up a public clearinghouse of alternative chemicals, product
substitutes, and alternative manufacturing processes that are available
for products and manufacturing processes which use class I and II
substances.

B. Regulatory History

    On March 18, 1994, EPA published the original rulemaking (59 FR
13044) which established the process for administering the SNAP program
and issued EPA's first lists identifying acceptable and unacceptable
substitutes in the major industrial use sectors (subpart G of 40 CFR
part 82). These sectors include: Refrigeration and air-conditioning;
foam blowing; solvents cleaning; fire suppression and explosion
protection; sterilants; aerosols; adhesives, coatings and inks; and
tobacco expansion. These sectors comprise the principal industrial
sectors that historically consumed the largest volumes of ODS.
    Section 612 of the CAA requires EPA to list as acceptable those
substitutes that do not present a significantly greater risk to human
health and the environment as compared with other substitutes that are
currently or potentially available.
    Under the SNAP regulations, anyone who plans to market or produce a
substitute to replace a class I substance or class II substance in one
of the eight major industrial use sectors must provide notice to the
Agency, including health and safety information on the substitute at
least 90 days before introducing it into interstate commerce for
significant new use as an alternative. 40 CFR 82.176(a). This
requirement applies to the persons planning to introduce the substitute
into interstate commerce,\1\ which typically are

chemical manufacturers but may include importers, formulators, or end-
users when they are responsible for introducing a substitute into
commerce.\2\ The 90-day SNAP review process begins once EPA receives
the submission and determines that the submission includes complete and
adequate data (40 CFR 82.180(a)). As required by the CAA, the SNAP
regulations, 40 CFR 82.174(a), prohibit the introduction of a
substitute into interstate commerce earlier than 90 days after notice
has been provided to the Agency.
---------------------------------------------------------------------------

    \1\ As defined at 40 CFR 82.104, ``interstate commerce'' means
the distribution or transportation of any product between one state,
territory, possession or the District of Columbia, and another
state, territory, possession or the District of Columbia, or the
sale, use or manufacture of any product in more than one state,
territory, possession or District of Columbia. The entry points for
which a product is introduced into interstate commerce are the
release of a product from the facility in which the product was
manufactured, the entry into a warehouse from which the domestic
manufacturer releases the product for sale or distribution, and at
the site of United States Customs clearance.
    \2\ As defined at 40 CFR 82.172, ``end-use'' means processes or
classes of specific applications within major industrial sectors
where a substitute is used to replace an ODS.
---------------------------------------------------------------------------

    The Agency has identified four possible decision categories for
substitutes that are submitted for evaluation: acceptable; acceptable
subject to use conditions; acceptable subject to narrowed use limits;
and unacceptable \3\ (40 CFR 82.180(b)). Use conditions and narrowed
use limits are both considered ``use restrictions'' and are explained
below. Substitutes that are deemed acceptable with no use restrictions
(no use conditions or narrowed use limits) can be used for all
applications within the relevant end-uses within the sector.
Substitutes that are acceptable subject to use restrictions may be used
only in accordance with those restrictions.
---------------------------------------------------------------------------

    \3\ The SNAP regulations also include ``pending,'' referring to
submissions for which EPA has not reached a determination, under
this provision.
---------------------------------------------------------------------------

    After reviewing a substitute, the Agency may determine that a
substitute is acceptable only if certain conditions in the way that the
substitute is used are met to minimize risks to human health and the
environment. EPA describes such substitutes as ``acceptable subject to
use conditions.'' Entities that use these substitutes without meeting
the associated use conditions are in violation of EPA's SNAP
regulations. 40 CFR 82.174(c).
    For some substitutes, the Agency may permit a narrow range of use
within an end-use or sector. For example, the Agency may limit the use
of a substitute to certain end-uses or specific applications within an
industry sector. EPA describes these substitutes as ``acceptable
subject to narrowed use limits.'' A person using a substitute that is
acceptable subject to narrowed use limits in applications and end-uses
that are not consistent with the narrowed use limit is using the
substitute in an unacceptable manner and is in violation of section 612
of the CAA and EPA's SNAP regulations. 40 CFR 82.174(c).
    The Agency publishes its SNAP program decisions in the Federal
Register. EPA first publishes decisions concerning substitutes that are
deemed acceptable subject to use restrictions (use conditions and/or
narrowed use limits), or substitutes deemed unacceptable, as proposed
rulemakings to allow the public opportunity to comment, before
publishing final decisions.
    In contrast, EPA publishes decisions concerning substitutes that
are deemed acceptable with no restrictions in ``notices of
acceptability,'' rather than as proposed and final rules. As described
in the preamble to the rule initially implementing the SNAP program in
the Federal Register at 59 FR 13044 on March 18, 1994, EPA does not
believe that rulemaking procedures are necessary to list alternatives
that are acceptable without restrictions because such listings neither
impose any sanction nor prevent anyone from using a substitute.
    Many SNAP listings include ``Comments'' or ``Further Information''
to provide additional information on substitutes. Since this additional
information is not part of the regulatory decision, these statements
are not binding for use of the substitute under the SNAP program.
However, regulatory requirements so listed are binding under other
regulatory programs (e.g., worker protection regulations promulgated by
the U.S. Occupational Safety and Health Administration (OSHA)). The
``Further Information'' classification does not necessarily include all
other legal obligations pertaining to the use of the substitute. While
the items listed are not legally binding under the SNAP program, EPA
encourages users of substitutes to apply all statements in the
``Further Information'' column in their use of the substitute. In many
instances, the information simply refers to sound operating practices
that have already been identified in existing industry and/or building
codes and standards. Thus, many of the comments, if adopted, would not
require the affected user to make significant changes in existing
operating practices.
    For copies of the comprehensive SNAP lists of substitutes or
additional information on SNAP, refer to EPA's Ozone Layer Protection
Web site at www.epa.gov/ozone/snap/index.html. For more information on
the Agency's process for administering the SNAP program or criteria for
evaluation of substitutes, refer to the SNAP final rulemaking in the
Federal Register at 59 FR 13044 on March 18, 1994, codified at 40 CFR
part 82, subpart G. A complete chronology of SNAP decisions and the
appropriate citations are found at http://www.epa.gov/ozone/snap/chron.html.

II. Listing Decision: Fire Suppression and Explosion Protection
Streaming

    Application: C7 Fluoroketone--Acceptable Subject to Narrowed Use
Limits
EPA's decision: EPA finds C7 Fluoroketone acceptable subject to
narrowed use limits as a substitute for halon 1211 for use as a
streaming agent. The narrowed use limits require that C7 Fluoroketone
be used only in nonresidential applications.
    C7 Fluoroketone is also known as C7 FK or FK-6-1-14. This
substitute is a blend of two isomers, 3-pentanone,1,1,1,2,4,5,5,5-
octafluoro-2,4-bis(trifluoromethyl) (Chemical Abstracts Service
Registry Number [CAS Reg. No.] 813-44-5) and 3-
hexanone,1,1,1,2,4,4,5,5,6,6,6-undecafluoro-2-(trifluoromethyl) (CAS
Reg. No. 813-45-6). You may find the submission under docket EPA-HQ-
OAR-2011-0111 at http://www.regulations.gov.
    Environmental information: C7 Fluoroketone has zero ODP and a GWP
of approximately 1. Therefore, C7 Fluoroketone is not expected to pose
any significant adverse impact on the ozone layer or climate.
    The physicochemical properties of the majority of halon substitutes
make it unlikely that the substitutes would be released to surface
water as a result of use. In the case of C7 Fluoroketone, the proposed
substitute is insoluble in water and readily volatilizes. Thus, EPA
expects that all of the constituents would rapidly vaporize during
expulsion from the container, would not be likely to settle, and
therefore would be unlikely to lead to surface water contamination or
generation of solid waste.
    C7 Fluoroketone has not been exempted as a volatile organic
compound (VOC) under the CAA (40 CFR 51.100(s)). VOC emissions from the
production of portable extinguishers charged with C7 Fluoroketone are
controlled through standard industry practices, and as such, emissions
from manufacture of units are likely to be minimal. An assessment was
performed to compare the annual VOC emissions from use of C7
Fluoroketone in portable extinguishers in one year to other
anthropogenic sources of VOC emissions. This assessment is available in
docket EPA-HQ-OAR-2011-0111 under the name, ``Risk Screen on

Substitute for Halon 1211 as a Streaming Agent in Portable Fire
Extinguishers Substitute: C7 Fluoroketone.'' This assessment finds that
even if the entire portion for streaming agent applications of the
allowable quantity of C7 FK produced by the submitter in one year was
all released to the atmosphere (extremely unlikely), the resulting VOC
emissions would be approximately equal to 3.0x10-2 percent
of annual VOC emissions caused by fires,\4\ or only about
1.1x10-3 percent of all annual anthropogenic VOC
emissions.\5\ The environmental impacts of these VOCs are not
considered a significant risk to local air quality.
---------------------------------------------------------------------------

    \4\ Based on 2010 projections calculated using 2008 EPA annual
VOC emissions data for residential wood burning and agricultural
field burning (EPA 2008 and EPA 2011) and ICF assumptions.
    \5\ Based on 2010 projections calculated using 2008 EPA annual
VOC emissions data (EPA 2009) and ICF assumptions.
---------------------------------------------------------------------------

    Toxicity and exposure data: Inhalation of C7 Fluoroketone could
cause respiratory tract irritation and symptoms may include cough,
sneezing, nasal discharge, headache, hoarseness, and nose and throat
pain. Contact with the eyes and/or skin during product use is not
expected to result in significant irritation. Ingestion of C7
Fluoroketone is not expected to cause health effects, and there is no
anticipated need for first aid if C7 Fluoroketone is ingested. The
potential health effects of C7 Fluoroketone can be minimized by
following the exposure guidelines and recommendations for ventilation
and personal protective equipment (PPE) outlined in the Material Safety
Data Sheet (MSDS) and discussed further below.
    EPA evaluated occupational and general population exposure at
manufacture and at end use to ensure that the use of C7 Fluoroketone
will not pose unacceptable risks to workers or the general public. This
risk screen is available in docket EPA-HQ-OAR-2011-0111 under the name,
``Risk Screen on Substitute for Halon 1211 as a Streaming Agent in
Portable Fire Extinguishers Substitute: C7 Fluoroketone.''
    EPA is providing the following additional information regarding use
of C7 Fluoroketone as a streaming agent in nonresidential applications.
Appropriate protective measures should be taken and proper training
administered for the manufacture, clean-up and disposal of this
product. For this new chemical, the manufacturer developed an
acceptable exposure limit (AEL) for the workplace set at a level
believed to protect from chronic adverse health effects those workers
who are regularly exposed, such as in the manufacturing or filling
processes. EPA reviewed the submitter's supporting data and accepts the
manufacturer's AEL for C7 Fluoroketone of 225 ppm over an 8-hour time-
weighted average.\6\ EPA recommends the following for establishments
filling canisters to be used in streaming applications:
---------------------------------------------------------------------------

    \6\ ``Determination of an AEL for C7 Fluoroketone (C7 FK),''
Appendix A to Risk Screen on Substitute for Halon 1211 as a
Streaming Agent in Portable Fire Extinguishers Substitute: C7
Fluoroketone. Available in docket EPA-HQ-OAR-2011-0111.

--adequate ventilation should be in place;
--all spills should be cleaned up immediately in accordance with good
industrial hygiene practices; and
--training for safe handling procedures should be provided to all
employees that would be likely to handle the containers of the agent or
extinguishing units filled with the agent.
EPA anticipates that C7 Fluoroketone will be used consistent with the
recommendations specified in the manufacturer's MSDS.

    EPA recommends that users of C7 Fluoroketone as a streaming agent
act in accordance with the latest edition of NFPA Standard 10 for
Portable Fire Extinguishers. We expect that users will be able to meet
the recommended workplace exposure limit and address potential health
risks by following the above recommendations, using the substitute in
accordance with the manufacturer's MSDS, and following other safety
precautions common to the fire protection industry.
    Comparison to other fire suppressants: C7 Fluoroketone is not
ozone-depleting with a GWP of approximately 1 in contrast to halon 1211
(with an ODP of 7.1 and a GWP of 1890), the ODS which it replaces.
Compared to other substitutes for halon 1211, such as HCFC Blend B
(with ODP of roughly 0.01 and GWP of roughly 80), HFC-227ea (with ODP
of 0 and GWP of 3220), and HFC-236fa (with an ODP of 0 and GWP of
9810), C7 Fluoroketone has a similar or less significant impact on the
ozone layer and climate. Risk to the general population is expected to
be negligible provided because under the narrowed use limits the
substitute is not approved for use in residential applications.
Occupational exposure should not pose a problem if use is in accordance
with the manufacturer's MSDS and other precautions normally used in the
fire protection industry.

III. Response to Public Comment

    The EPA published in the Federal Register at 77 FR 58035 on
September 19, 2012, a direct final rule and a companion proposed rule
issuing listings for three fire suppressants under EPA's SNAP program.
Because EPA received an adverse comment concerning the fire suppressant
C7 Fluoroketone, EPA withdrew that part of the direct final rule that
listed C7 Fluoroketone at 77 FR 74381 on December 19, 2012. This
section summarizes EPA's response to the comment received on the
proposed rule. The comment as well as a late comment from the
manufacturer of C7 Fluoroketone and additional supporting documents
used for EPA's response can be found in docket EPA-HQ-OAR-2011-0111.
    Comments: A commenter questioned the potential toxicity and
environmental impacts of C7 Fluoroketone based on the ability of some
other fluorinated ketones to react in water to form active
perfluorinated compounds. The commenter indicates concern that the
reactivity of perfluorinated ketones in water, particularly in tissues
in which there is a lung:blood air interface (e.g., nose, sinus,
trachea along an inhalation portal of entry), may pose significant
risks to individuals breathing the compound due to interference with
proper oxygenation of the blood and/or lung edema. The commenter also
stated that the two principal components of C7 Fluoroketone were
expected to produce derivatives of perfluorobutanoic acid in the
environment, in particular hexafluoroacetone (HFA). The commenter
provides two references documenting the extreme reactivity of HFA in
water.
    In response to the above comment, the compound's manufacturer
submitted a late comment disagreeing with these statements and
indicating that hydrate formation is significantly different for
branched fluoroketones such as C7 Fluoroketone compared to simple
unbranched fluoroketones such as HFA. The manufacturer stated that C7
Fluoroketone has low mammalian toxicity, low potential for aquatic
toxicity and low environmental impact.
    Response: After evaluating the comment, reviewing the risk screen
prepared under SNAP, and reviewing supplemental information provided by
the manufacturer, EPA disagrees with the concerns raised by the first
commenter. In the SNAP submission for C7 Fluoroketone in the streaming
end-use and in more recent information submitted by the manufacturer,
data indicate that C7 Fluoroketone has very

low solubility or reactivity in water and that it is highly volatile.
The lack of water solubility for C7 FK indicates that it will not form
gem-diol hydrates and will thus not have appreciable effects in any
organisms that might be exposed to it. In addition, the lack of
solubility and high volatility will prevent any significant formation
of perfluorobutanoic acid derivatives (e.g., HFA) in surface waters.
While the two references provided by the commenter document the extreme
reactivity of HFA in water (a fact that is supported by other sources
of chemical information), these references provide no information to
support the claim that C7 Fluoroketone should react similarly.
    Further, two inhalation studies performed for C7 Fluoroketone (a 5-
day repeat toxicity study in which study animals were exposed to high
concentrations of the compound and a 28-day repeat dose study in which
male and female rats were exposed to concentrations <=10,000 ppm for 6
hours per day) showed no inhalation portal-of-entry effects.\7\ No
other observations were reported that might indicate any other adverse
effects on blood oxygenation or similar impairments. The concern with
potential toxicity of C7 Fluoroketone is not supported by information
available about its chemistry and current toxicity testing data on the
compound.
---------------------------------------------------------------------------

    \7\ Portal of entry effects are specifically investigated in
acute and short-term inhalation exposure studies as the relevant
tissues will receive the greatest exposure to the study compound.
---------------------------------------------------------------------------

IV. Final Action

    We are issuing a final listing for C7 Fluoroketone, finding it
acceptable subject to narrowed use limits for use as a substitute for
halon 1211 as a streaming agent in non-residential applications, as
initially proposed. We have determined that the overall environmental
and human health risk posed by C7 Fluoroketone is lower than or
comparable to the risks posed by other available substitutes in the
same end use.

V. Statutory and Executive Order Reviews

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

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and it is
therefore not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
This final rule is an Agency determination. It contains no new
requirements for reporting. However, the Office of Management and
Budget (OMB) has previously approved the information collection
requirements contained in the existing regulations in subpart G of 40
CFR part 82 under the provisions of the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. and has assigned OMB control numbers 2060-0226 (EPA
ICR No. 1596.08). The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statutes unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impact of today's rule on small
entities, small entities are defined as (1) a small business that
produces or uses fire suppressants such as total flooding and/or
streaming agents as defined by the Small Business Administration's
regulations at 13 CFR 121.201; (2) a small governmental jurisdiction
that is a government of a city, county, town, school district or
special district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
rule will not impose any requirements on small entities beyond current
industry practices. Today's action effectively supports the
introduction of a new alternative to the market for fire protection
extinguishing systems, thus providing additional options for users
making the transition away from ozone-depleting halons.
    Use of halon 1301 total flooding systems and halon 1211 streaming
agents have historically been in specialty fire protection applications
including essential electronics, civil aviation, military mobile weapon
systems, oil and gas and other process industries, and merchant
shipping with smaller segments of use including libraries, museums, and
laboratories. The majority of halon system and equipment owners
continue to maintain and refurbish existing systems since halon
supplies continue to be available in the U.S. Owners of new facilities
make up the market for the new alternative agent systems and may also
consider employing other available fire protection options including
new, improved technology for early warning and smoke detection. Thus,
EPA is providing more options to any entity, including small entities,
by finding substitutes acceptable for use. The narrowed use limit
imposed on the substitute in today's rule is consistent with the
application suggested by the submitter and with current industry
practices. Therefore, we conclude that the rule does not impose any new
cost on businesses.
    Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. By finding a
new substitute acceptable, today's rule gives additional flexibility to
small entities that are concerned with fire suppression. EPA also has
worked closely together with the NFPA, which conducts regular outreach
with small entities and involves small state, local, and tribal
governments in developing and implementing relevant fire protection
standards and codes.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandate Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. This action imposes no enforceable duty on any State, local, or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 or 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This final rule
will provide an additional option for fire protection subject to safety
guidelines in industry standards. These standards are typically already
required by state or local fire codes, so this action will not affect
small governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial

direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132. This regulation applies directly to
facilities that use the substance and not to governmental entities.
Thus, Executive Order 13132 does not apply to this action.

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

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It does not
significantly or uniquely affect the communities of Indian tribal
governments because this regulation applies directly to facilities that
use this substance and not to tribal or governmental entities. Thus,
Executive Order 13175 does not apply to this action.

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

    This action is not subject to E.O. 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in E.O.
12866, and because the Agency does not believe the environmental health
or safety risks addressed by this action present a disproportionate
risk to children. This action's health and risk assessments are
discussed in section II.

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

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This rulemaking involves technical standards. EPA defers to
existing NFPA voluntary consensus standards and Occupational Safety and
Health Administration (OSHA) regulations that relate to the safe use of
halon substitutes reviewed under SNAP. EPA has worked in consultation
with OSHA to encourage development of technical standards to be adopted
by voluntary consensus standards bodies. EPA refers users to the latest
edition of NFPA 10 Standard for Portable Fire Extinguishers. A copy of
this standard may be obtained by calling the NFPA's telephone number
for ordering publications at 1-800-344-3555.

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

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. This final rule provides a fire suppression
substitute with no ODP and low GWP. The avoided ODS and greenhouse gas
emissions would assist in restoring the stratospheric ozone layer,
avoiding adverse climate impacts, and result in human health and
environmental benefits.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A Major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective May 29, 2013.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements,
Stratospheric ozone layer.

    Dated: April 18, 2013.
Bob Perciasepe,
Acting Administrator.

    For the reasons set out in the preamble, 40 CFR part 82 is amended
as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for Part 82 continues to read as follows:

    Authority:  42 U.S.C. 7414, 7601, 7671-7671q.

Subpart G--Significant New Alternatives Policy Program

0
2. Subpart G of part 82 is amended by adding appendix T to read as
follows:

Appendix T to Subpart G of Part 82--Substitutes listed in the April 29,
2013 Final Rule, effective May 29, 2013.

           Fire Suppression and Explosion Protection Sector--Acceptable Subject to Narrowed Use Limits
----------------------------------------------------------------------------------------------------------------
            End-use                  Substitute          Decision          Conditions       Further Information
----------------------------------------------------------------------------------------------------------------
Streaming......................  C7 Fluoro-ketone   Acceptable         For use only in    Use of this agent
                                  as a substitute    subject to         non-residential    should be in
                                  for Halon 1211.    narrowed use       applications.      accordance with the
                                                     limits.                               latest edition of
                                                                                NFPA Standard 10 for
                                                                                Portable Fire
                                                                                Extinguishers.
                                                                                For operations that
                                                                                fill canisters to be
                                                                                used in streaming
                                                                                applications, EPA
                                                                                recommends the
                                                                                following:
                                                                                --Adequate ventilation
                                                                                should be in place;
                                                                                --All spills should be
                                                                                cleaned up
                                                                                immediately in
                                                                                accordance with good
                                                                                industrial hygiene
                                                                                practices; and
                                                                                --Training for safe
                                                                                handling procedures
                                                                                should be provided to
                                                                                all employees that
                                                                                would be likely to
                                                                                handle containers of
                                                                                the agent or
                                                                                extinguishing units
                                                                                filled with the
                                                                                agent.
                                                                                See additional
                                                                                comments 1, 2, 3, 4.
----------------------------------------------------------------------------------------------------------------
Additional comments:
1--Should conform to relevant OSHA requirements, including 29 CFR 1910, Subpart L, Sections 1910.160 and
  1910.162.
2--Per OSHA requirements, protective gear (SCBA) should be available in the event personnel should reenter the
  area.
3--The agent should be recovered from the fire protection system in conjunction with testing or servicing, and
  recycled for later use or destroyed.
4--EPA has no intention of duplicating or displacing OSHA coverage related to the use of personal protective
  equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other
  occupational safety and health standard with respect to halon substitutes.

[FR Doc. 2013-10046 Filed 4-26-13; 8:45 am]
BILLING CODE 6560-50-P