[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Page 18546]
[FR Doc No: 2011-7859]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice Announcing Filing Priority for Preliminary Permit
Applications

------------------------------------------------------------------------
                                                                Project
                                                                  No.
------------------------------------------------------------------------
Lock+ Hydro Friends Fund XLV................................   13741-000
FFP Missouri 9, LLC.........................................   13748-000
Solia 8 Hydroelectric, LLC..................................   13771-000
------------------------------------------------------------------------

    On March 24, 2011, the Commission held a drawing to determine
priority among competing preliminary permit applications with identical
filing times. In the event that the Commission concludes that none of
the applicants' plans are better adapted than the others to develop,
conserve, and utilize in the public interest the water resources of the
region at issue, the priority established by this drawing will serve as
the tiebreaker. Based on the drawing, the order of priority is as
follows:

------------------------------------------------------------------------
                                                                Project
                                                                  No.
------------------------------------------------------------------------
1. Solia 8 Hydroelectric, LLC...............................   13771-000
2. Lock+ Hydro Friends Fund XLV.............................   13741-000
3. FFP Missouri 9, LLC......................................   13748-000
------------------------------------------------------------------------

    Dated: March 25, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-7859 Filed 4-1-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 181 (Wednesday, September 18, 2019)]
[Notices]
[Pages 49174-49175]
[FR Doc No: 2019-20163]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA 2019-0659]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Reduction of
Fuel Tank Flammability on Transport Category Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
FAA invites public comments about our intention to request Office of
Management and Budget (OMB) approval to renew an information
collection. The FAA's Fuel Tank Flammability Safety rulemaking requires
manufacturers to provide a report to the FAA every 6 months for up to 5
years after the flammability reduction system is incorporated into the
fleet. The data collection is needed to assure system performance meets
that predicted at the time of certification.

DATES: Written comments should be submitted by November 18, 2019.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Michael E. Dostert, Federal Aviation Administration,
Transport Standards Branch, 2200 South 216th Street, Des Moines, WA
98198.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael E. Dostert by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0710.
    Title: Reduction of Fuel Tank Flammability on Transport Category
Airplanes.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: Design approval holders use flammability analysis
documentation to demonstrate to their FAA Oversight Office that they
are compliant with the Fuel Tank Flammability Safety rule (73 FR
42443). Semi-annual reports submitted by design approval holders
provide listings of component failures discovered during scheduled or
unscheduled maintenance so that the reliability of the flammability
reduction means can be verified by the FAA.
    Respondents: Approximately five design approval holders.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 100 hours.
    Estimated Total Annual Burden: 4,000 hours.

    Issued in Washington, DC.
Joy Wolf,
Directives & Forms Management Officer (DMO/FMO), Aircraft Certification
Service.
[FR Doc. 2019-20163 Filed 9-17-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Proposed Rules]
[Pages 49022-49023]
[FR Doc No: 2018-21145]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2007-N-0465]

Label Requirement for Food That Has Been Refused Admission Into
the United States

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the withdrawal of a proposed rule that published in the
Federal Register. This proposed rule is not currently considered a
viable candidate for final action. FDA is taking this action because
this proposed rule does not reflect current technology and industry
practice.

DATES: The proposed rule published September 18, 2008, at 73 FR 54106
is withdrawn as of September 28, 2018.

ADDRESSES: For access to the docket, go to https://www.regulations.gov
and insert the docket number found in brackets in the heading of this
document into the ``Search'' box and follow the prompts, and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Holli Kubicki, Office of Regulatory
Affairs, Office of Strategic Planning and Operational Policy, Food and
Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-
4557, [email protected].

SUPPLEMENTARY INFORMATION: In 1990, FDA began a process of periodically
conducting comprehensive reviews of its regulation process, including
reviewing the backlog of proposed rulemakings that had not been
finalized. As FDA removed many proposed rules not finalized, the Agency
implemented a process of reviewing existing proposed rules every 5
years.
    As part of this process and the Administration's regulatory reform
initiative, we continue to conduct reviews of existing proposed rules.
The review determines if the proposals are outdated, unnecessary, or
can be revised to reduce regulatory burden while allowing FDA to
achieve our public health mission and fulfill statutory obligations.
    As part of these efforts, FDA is withdrawing the proposed rule
entitled ``Label Requirement for Food That Has Been Refused Admission
Into the

United States'' (September 18, 2008, 73 FR 54106).
    The proposed rule does not reflect current technology and industry
practice. For example, the proposed rule directed owners or consignees
to affix labels to physical documents such as invoices, packing lists,
bills of lading, and any other documents accompanying refused food.
Many of these documents are now electronic. Therefore, since
implementation of the proposed rule would not adequately address how to
permanently mark electronic documentation accompanying refused food, it
would not achieve the public health and efficiency benefits discussed
in the notice of proposed rulemaking. As directed by section 304 of the
FDA Food Safety Modernization Act (Pub. L. 111-353) that was enacted
after FDA issued the proposed rule, FDA now requires, as part of its
prior notice regulations, notice to FDA of the name of any country to
which imported food has been refused entry. (See 21 CFR 1.281(a)(18).)
This includes situations where the United States has refused entry, and
it therefore provides FDA with information related to what the proposed
marking rule would require.
    FDA may reassess how to effectively implement the labeling of
documentation accompanying refused food and consider whether to issue a
revised proposed rule in the future.
    The withdrawal of the proposal identified in this document does not
preclude the Agency from reinstituting rulemaking concerning the issues
addressed. Should we decide to undertake such a rulemaking in the
future, we will re-propose the action and provide a new opportunity for
comment. Furthermore, this proposed rule withdrawal is only intended to
address the specific actions identified in this document, and not any
other pending proposals that the Agency has issued or is considering.
If you need additional information about the subject matter of the
withdrawn proposed rule, you may review the Agency's website (https://www.fda.gov) for any current information on the matter.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21145 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Proposed Rules]
[Pages 73465-73466]
[FR Doc No: 2013-28670]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0683; Airspace Docket No. 13-ANE-1]

Proposed Amendment of Class E Airspace; Morrisville, VT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E Airspace at Morrisville,
VT, as the Morrisville-Stowe Non-Directional Beacon (NDB) has been
decommissioned, requiring airspace redesign at Morrisville-Stowe State
Airport. This action would enhance the safety and airspace management
of Instrument Flight Rules (IFR) operations at the airport. This action
also would update the geographic coordinates of the airport.

DATES: Comments must be received on or before January 21, 2014.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey, SE., Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2013-0683; Airspace Docket No. 13-ANE-1, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rulemaking by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2013-0683; Airspace Docket No. 13-ANE-1) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2013-0683; Airspace Docket No. 13-ANE-1.'' The postcard will be
date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, Georgia 30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class E airspace extending upward
from 700 feet above the surface at Morrisville-Stowe State Airport,
Morrisville, VT.

Airspace reconfiguration to within a 14-mile radius of the airport is
necessary due to the decommissioning of the Morrisville-Stowe NDB, and
for continued safety and management of IFR operations at the airport.
The geographic coordinates of Morrisville-Stowe State Airport would be
adjusted to coincide with the FAAs aeronautical database.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.9X, dated August 7, 2013, and effective September 15,
2013, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would amend Class E airspace at Morrisville-
Stowe State Airport, Morrisville, VT.
    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71:

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

0
1. The authority citation for Part 71 continues to read as follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, effective September 15, 2013, is amended
as follows:

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

* * * * *

ANE VT E5 Morrisville, VT [Amended]

Morrisville-Stowe State Airport, VT
    (Lat. 44[deg]32'05'' N., long. 72[deg]36'50'' W.)

    That airspace extending upward from 700 feet above the surface
within a 14-mile radius of Morrisville-Stowe State Airport.

    Issued in College Park, Georgia, on November 19, 2013.
Kip B. Johns,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2013-28670 Filed 12-5-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Notices]
[Pages 26366-26367]
[FR Doc No: 2022-09298]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0001]

Major Disaster Declarations; COVID-19 Pandemic

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice; major disaster declarations.

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

SUMMARY: This notice amends the notices of major disaster declarations
and related determinations resulting from the Coronavirus Disease 2019
(COVID-19) pandemic beginning on January 20, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472, [email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This notice applies to all major disaster
declarations and related determinations resulting from the Coronavirus
Disease 2019 (COVID-19) pandemic beginning on January 20, 2020. See
detailed declarations list below.
    Pursuant to the President's Memorandum on Maximizing Assistance to
Respond to COVID-19, dated March 1, 2022, (87 FR 12391), and under the
authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207(Stafford Act), FEMA applied the
following for all COVID-19 related declarations:

    Federal funds for emergency protective measures (Category B),
including direct Federal assistance, under the Public Assistance
program (Section 403) are authorized at 100 percent of total
eligible costs for work performed from January 20, 2020, through
July 1, 2022.

COVID-19 Declarations

     Notice; New York; Amendment No. 10 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4480-DR.
     Notice; Washington; Amendment No. 7 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4481-DR.
     Notice; California; Amendment No. 7 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4482-DR.
     Notice; Iowa; Amendment No. 7 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4483-DR.
     Notice; Louisiana; Amendment No. 5 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4484-DR.
     Notice; Texas; Amendment No. 5 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4485-DR.
     Notice; Florida; Amendment No. 5 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4486-DR.
     Notice; North Carolina; Amendment No. 6 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4487-DR.
     Notice; New Jersey; Amendment No. 10 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4488-DR.
     Notice; Illinois; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4489-DR.
     Notice; Missouri; Amendment No. 7 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4490-DR.
     Notice; Maryland; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4491-DR.
     Notice; South Carolina; Amendment No. 6 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4492-DR.
     Notice; Puerto Rico; Amendment No. 11 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4493-DR.
     Notice; Michigan; Amendment No. 7 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4494-DR.
     Notice; Guam; Amendment No. 9 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4495-DR.
     Notice; Massachusetts; Amendment No. 6 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4496-DR.
     Notice; Kentucky; Amendment No. 6 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4497-DR.
     Notice; Colorado; Amendment No. 9 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4498-DR.
     Notice; Oregon; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4499-DR.
     Notice; Connecticut; Amendment No. 7 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4500-DR.
     Notice; Georgia; Amendment No. 6 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4501-DR.
     Notice; District of Columbia; Amendment No. 8 to Notice
of a Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4502-DR.
     Notice; Alabama; Amendment No. 6 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4503-DR.
     Notice; Kansas; Amendment No. 7 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4504-DR.
     Notice; Rhode Island; Amendment No. 7 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4505-DR.
     Notice; Pennsylvania; Amendment No. 8 to Notice of a
Major Disaster Declaration;

Docket ID FEMA-2022-0001; Internal Agency Docket No. FEMA-4506-DR.
     Notice; Ohio; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4507-DR.
     Notice; Montana; Amendment No. 9 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4508-DR.
     Notice; North Dakota; Amendment No. 9 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4509-DR.
     Notice; Hawaii; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4510-DR.
     Notice; Commonwealth of the Northern Mariana Islands;
Amendment No. 9 to Notice of a Major Disaster Declaration; Docket ID
FEMA-2022-0001; Internal Agency Docket No. FEMA-4511-DR.
     Notice; Virginia; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4512-DR.
     Notice; Virgin Islands; Amendment No. 11 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4513-DR.
     Notice; Tennessee; Amendment No. 6 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4514-DR.
     Notice; Indiana; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4515-DR.
     Notice; New Hampshire; Amendment No. 7 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4516-DR.
     Notice; West Virginia; Amendment No. 8 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4517-DR.
     Notice; Arkansas; Amendment No. 6 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4518-DR.
     Notice; Wisconsin; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4520-DR.
     Notice; Nebraska; Amendment No. 7 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4521-DR.
     Notice; Maine; Amendment No. 7 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4522-DR.
     Notice; Nevada; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4523-DR.
     Notice; Arizona; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4524-DR.
     Notice; Utah; Amendment No. 9 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4525-DR.
     Notice; Delaware; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4526-DR.
     Notice; South Dakota; Amendment No. 9 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4527-DR.
     Notice; Mississippi; Amendment No. 6 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4528-DR.
     Notice; New Mexico; Amendment No. 6 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4529-DR.
     Notice; Oklahoma; Amendment No. 6 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4530-DR.
     Notice; Minnesota; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4531-DR.
     Notice; Vermont; Amendment No. 7 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4532-DR.
     Notice; Alaska; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4533-DR.
     Notice; Idaho; Amendment No. 8 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4534-DR.
     Notice; Wyoming; Amendment No. 9 to Notice of a Major
Disaster Declaration; Docket ID FEMA-2022-0001; Internal Agency
Docket No. FEMA-4535-DR.
     Notice; American Samoa; Amendment No. 7 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4537-DR.
     Notice; Seminole Tribe of Florida; Amendment No. 4 to
Notice of a Major Disaster Declaration; Docket ID FEMA-2022-0001;
Internal Agency Docket No. FEMA-4545-DR.
     Notice; Navajo Nation; Amendment No. 6 to Notice of a
Major Disaster Declaration; Docket ID FEMA-2022-0001; Internal
Agency Docket No. FEMA-4582-DR.
     Notice; Poarch Band of Creek Indians; Amendment No. 4
to Notice of a Major Disaster Declaration; Docket ID FEMA-2022-0001;
Internal Agency Docket No. FEMA-4591-DR.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-09298 Filed 5-3-22; 8:45 am]
BILLING CODE 9111-23-P


EPA Response to Public Comments on

Biopesticides Registration Action Document

Proposed Decision

Coat Protein Gene of Plum Pox Virus

PC Code: 006354

May 10, 2010

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

The Biopesticides and Pollution Prevention Division (BPPD) of the Office
of Pesticide Programs, EPA, has analyzed and considered all comments
submitted on the Agency's preliminary registration decision for the C5
HoneySweet Plum, containing the new plant-incorporated protectant active
ingredient, Coat Protein Gene of the Plum Pox Virus (CPG-PPV).  These
comments were submitted to docket EPA-HQ-OPP-2008-0742.   This document
responds to significant comments received.

General Issues

Support for the registration

A number of comments were received on matters generally related to the
Agency's preliminary decision to register the C5 HoneySweet Plum.
Fifty-one comments expressed support for the registration of this PIP
pesticide.  Representative of these comments was number 0016:  "I concur
with the panel of regulators that this product does not pose any undue
risks to the environment or human health. Quite the contrary, the
‘Honeysweet’ is a promising technology that has great potential to
mitigate a devastating invasive virus."  Similarly, number 0018 noted:
"Viral coat protein genes have been known for over 20 years to provide
lasting—and very safe---resistance in plants against viruses (Fuchs &
Gonsalves, 2007 Annual Rev. Phytopathology 45:173-202.).  There is a
compelling need for this genetically modified tree with plum pox
resistance, since the only other known means to control the virus are
economically damaging quarantine and eradication measures.  Once a tree
is infected, it must be destroyed. Eradication of plum pox in
Pennsylvania in 1999 resulted in destruction of 1600 acres of trees at a
cost of $40 million (Scorza et al., 2007. Acta Hortic. 738:669-671).
Eradication of plum pox in Canada has resulted in destruction of 354,798
trees at a cost of Can.$180 million (U.S.$174 million) by the end of
March 2011." [citation omitted] [emphasis in original]  Also, number 63:
 "HoneySweet plum is highly resistant to Plum pox virus (PPV), a
devastating virus of stone fruits worldwide.  Resistance to PPV in
HoneySweet is due to the expression of a plant-incorporated protectant
that activates the anti-viral pathways of RNA silencing, a natural and
potent defense mechanism of plants against viruses.  Since no host
resistance to PPV is known in European plum, HoneySweet offers a
practical and unique solution to manage PPV.  Extensive field risk
assessment studies done in various ecosystems have shown that HoneySweet
does not pose undue risks to the environment and human health. Also, the
safe use of summer squash and papaya that express similar
plant-incorporated protectants and are grown for more than a decade on
thousands of acres further supports a safe use of HoneySweet."  In
addition to the comments providing a substantive rationale for
supporting the registration of C5 HoneySweet Plum, there were a number
of comments expressing general agreement with the decision.  Comment
0013 illustrates these comments:  "I have reviewed the data for this
plum. It poses no threat to the environment nor to people. I recommend
that it be deregulated and released as a new cultivar. It should be of
great use to consumers."

EPA Response:  EPA agrees that the C5 HoneySweet Plum should be
registered pursuant to our authority under Section 3 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The C5 HoneySweet
Plum registration application is supported by adequate data and/or
rationales for waiver of data requirements (in accordance with 40 C.F.R.
section 152.45), and we have determined that use of this product
consistent with the terms of the registration will not result in
unreasonable adverse effects on the environment.

Opposition to the Registration

One comment expressed general opposition to the registration.  Comment
0036 stated "Say no to GMOs!"  (Other comments expressed opposition to
the Agency registering this pesticide under FIFRA; but, supported the
sale and distribution of the C5 HoneySweet Plum.  These comments will be
addressed separately below.)

EPA Response:  Pursuant to Section 3 of FIFRA, EPA grants registrations
permitting the sale and distribution of pesticides that we have
determined will not result in unreasonable adverse effects to the
environment when used consistent with the terms and/or conditions of the
registration.  The Agency does not have the legal authority to
categorically deny registration to any class of pesticides for which it
is demonstrated that they can be used in a manner that does not result
in unreasonable adverse effects to the environment.

FIFRA Section 3 registration comments

A number of commenters asserted that the C5 HoneySweet Plum should not
be subject to registration under FIFRA.  Commenter 0017 noted that
HoneySweet Plum does not contain any novel product that could be
considered a toxin.  The comment further states that the fact that the
transgenic component here does not produce any toxic effect "provides
EPA ample justification to exempt" this product from registration
requirements.  Commenter 0064 stated that "the molecular components of
resistance bred into plants" should not be classified as pesticides.
Commenter 0069 stated that "there is no scientifically justifiable
reason for EPA to even consider the [CPG-PPV] to be a plant incorporated
protectant".  In particular, because no virus coat proteins are intended
to be produced, the C5 plum does not "in any meaningful sense contain a
'substance' that should be classified as a PIP."    Commenters 0070,
0072, and 0074 made similar points.

EPA Response:

Whether a substance is a toxin or has a toxic effect is not dispositive
as to whether it is a pesticide for purposes of FIFRA regulation.  FIFRA
section 2(u) defines “pesticide” as: “(1) any substance or mixture
of substances intended for preventing, destroying, repelling, or
mitigating any pest, (2) any substance or mixture of substances intended
for use as a plant regulator, defoliant, or desiccant, and (3) any
nitrogen stabilizer”.  7 U.S.C. section 136(u). Under FIFRA section
2(t), the term “pest” includes “(1) any insect, rodent, nematode,
fungus, weed, or (2) any other form of terrestrial or aquatic plant or
animal life or virus, bacteria, or other micro-organism (except viruses,
bacteria, or other micro-organisms on or in living man or other living
animals ) which [EPA] declares to be a pest under section 25(c)(1) of
[FIFRA].”  7 U.S.C. section 136(t).  Thus, any substance the intent of
which is to mitigate a pest is, by definition, a pesticide under the
statute.  There is no requirement that the substance be toxic, or, as
relevant here, that it be "present" in a particular form.  Where, as
here, the CPG-PPV has the effect of initiating a host plant defense
mechanism that functions to mitigate the harmful effects of a pest, it
is appropriately determined to be, and regulated as, a pesticide.

As to whether there was sufficient evidence presented to exempt the
CPG-PPV from the requirements of  FIFRA, that question was not before
the Agency.  The Applicant submitted a registration application, not a
petition to exempt this active ingredient.  The Agency reasonably
proceeded to make a decision on the application before it, rather than
effectuate an regulatory decision other than what was requested.

It is useful to provide some explanation as to why the CPG-PPV is a PIP.
 EPA explained the definition of a PIP at 66 Fed. Reg. 37771 (July 19,
2001).  As discussed therein, when traits from any living organism that
have pesticidal properties are introduced into novel organisms, the
substances are pesticides under the FIFRA definition of pesticide,
regardless of whether the pesticidal capability evolved in the plants or
was introduced by breeding or through the techniques of modern
biotechnology.  The genetic material necessary for the production of
such a pesticidal substance also meets the FIFRA statutory definition of
a pesticide.  Such genetic material is introduced into a plant with the
intent of ultimately producing a pesticidal effect even though the
genetic material may not, itself, directly affect pests.  The pesticidal
substance, along with the genetic material necessary to produce it,
produced and used in living plants, is designated a
“plant-incorporated protectant” by EPA.  Plant-incorporated
protectants are primarily distinguished from other types of pesticides
because they are intended to be produced and used in the living plant.

FFDCA tolerance exemption comments

A number of commenters made the point that the CPG-PPV protein should
not be regulated by EPA.  Comment 0017 stated that EPA should not assess
the safety of a "hypothetical coat protein," and that it is not “even
an inert ingredient (since it is absent).”  Comment 0061 noted that
“without a pox virus coat protein product in C5 plants, there is no
chance of an allergenic reaction from the engineered DNA construct.
Further there is also very little reason to expect any hypersensitivity
reactions from contact with C5 plants.”  Comment 0069 noted that the
C5 plum does not express any novel protein prior to initiation of the
plant’s defense mechanism and that, moreover, the C5 plum is not
intended to produce novel proteins.  Comment 0070 stated that EPA should
not “require safety assessments of the proteins per se. As noted above
humans safely ingest large amounts of coat proteins of numerous plant
viruses, and it is not the active ingredient intended to produce the PIP
effect (it is the DNA that invokes RNAi, not the protein).  Earlier work
had tried to produce resistance via coat proteins, but these have
largely been superseded by RNAi induction using the coat
protein-encoding DNA or targeting other viral sequences.”  Comment
0074 noted that “the CP coding mRNAs elicit natural plant defense
responses conferring post-transcriptional gene silencing (PTGS) to
subdue viral development. As such, CP mRNAs are merely elicitors while
innate plant compounds are the key players in the resistance reaction.
Further, translational products of the transgene are undetectable.”

EPA Response

Essentially, these comments address a key point considered in regulation
of C5 HoneySweet Plum trees – if the protein is undetectable, why is
it regulated?  EPA decided to approach this issue with caution noting
that conditions where PTGS in plants is generally known to occur include
during times of plant stress, cold weather, and upon infection with
plant viruses that express PTGS-inhibitors.  Therefore, insertion of an
open reading frame theoretically able to produce translatable mRNAs led
to analysis of the putative protein, in other words the protein that
would be produced under unknown (though probably unlikely)
circumstances.  It is the putative coat protein from genes inserted into
the C5 HoneySweet Plum, therefore, that are exempt from a food tolerance
under FFDCA as an inert ingredient.  EPA agrees with the commenters that
much of the dietary safety assessment for the coat protein of plum pox
virus is based on the safe consumption of the current food supply, which
has been demonstrated to have significant levels of plant virus present.
 The dietary safety assessment for plum pox virus resistant C5 plum and
other PIPs dependent on the RNAi gene silencing phenomenon is also
facilitated by the reduced potential for any virus coat protein
production from this trait.  The safety issue comes from the fact that,
during production of the DNA for insertion into the plant, there may be
amino acids added to the plum pox coat protein or variations in the
amino acid sequence in the plum pox coat protein.  The dietary
assessment is based on the existing plum pox coat protein exposure.  The
Agency acknowledges that there is natural variability in the population
of viruses infecting plants and possibly variant coat proteins.
However, the possible production and presence of a new protein related
to the use of a PIP requires an examination of the new protein for
dietary safety if it differs from that currently found in the food
supply.

Label comments

A number of comments were received asserting that the C5 HoneySweet Plum
should not be distributed with a FIFRA label and that any label that did
accompany the product should not include the statement “PPVR: not
intended for use in organic agriculture”.

EPA Response:

As a point of clarification, we note that the proposed label included in
the docket was not intended to be a label to accompany the product in
commerce.  Consistent with our practice with other registered PIPs, the
FIFRA label for the C5 HoneySweet Plum is not required to accompany the
product distributed in commerce.  Rather, the label is approved
concomitant with the registration and is held by the registrant.  We
placed the label in the docket because this is our normal practice for
all products for which we have made a preliminary decision to register
and which are subject to public comment.  We did not intend to
inadvertently send a signal that this is a label that would be required
as a term of the registration to accompany the product in commerce.

Consistent with practice for other registered PIPs, the C5 HoneySweet
Plum will be accompanied by labeling developed by the registrant.  This
labeling will set forth specific terms of agreement between USDA and the
distributors of the budwood.  This is consistent with the current
practice for other registered PIP products.

Similarly, with respect to the statement regarding whether the C5
HoneySweet Plum may be used in organic production, we are not requiring
as a term of the registration granted to USDA that the statement “not
intended for use in organic agriculture” be included on the C5
HoneySweet Plum label.

EPA Response to Public Comments on

BRAD Proposed Decision:  Plum Pox

May 10, 2010

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