[Federal Register: May 8, 2007 (Volume 72, Number 88)]
[Proposed Rules]
[Page 26069-26070]
[DOCID:fr08my07-35]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-R09-OAR-2007-0322; FRL-8309-8]

Delegation of National Emission Standards for Hazardous Air
Pollutants for Source Categories; State of Arizona, Arizona Department
of Environmental Quality; State of Nevada, Nevada Division of
Environmental Protection

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Pursuant to section 112(l) of the 1990 Clean Air Act, EPA
granted delegation of specific national emission standards for
hazardous air pollutants (NESHAP) to the Arizona Department of
Environmental Quality on March 16, 2007, and to the Nevada Division of
Environmental Protection on January 12, 2007. EPA is proposing to
revise the Code of Federal Regulations to reflect the current
delegation status of NESHAP in Arizona and Nevada.

DATES: Any comments on this proposal must arrive by June 7, 2007.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2007-0322, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow

the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov,

including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through http://www.regulations.gov or e-mail.

http://www.regulations.gov is an ``anonymous access'' system, and EPA will not

know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA Region

IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Mae Wang, EPA Region IX, (415) 947-
4124<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document concerns the delegation of
unchanged NESHAP to the Arizona Department of Environmental Quality and
the Nevada Division of Environmental Protection. In the Rules and
Regulations section of this Federal Register, EPA is amending
regulations to reflect the current delegation status of NESHAP in
Arizona and Nevada. EPA is taking direct final action without prior
proposal because the Agency believes these actions are not
controversial. If we receive adverse comments, however, we will publish
a timely withdrawal of the direct final rule and address the comments
in subsequent action based on this proposed rule. Please note that if
we receive adverse comment on an

amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, we may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Authority: This action is issued under the authority of Section
112 of the Clean Air Act, as amended, 42 U.S.C. 7412.

    Date Signed: April 19, 2007.
Deborah Jordan,
Director, Air Division, Region IX.
[FR Doc. E7-8681 Filed 5-7-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56753-56754]
[FR Doc No: 2011-23338]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0507; FRL-8888-2]

Formetanate HCl and Acephate; Cancellation Order for Amendments
To Terminate; Product Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's order for the amendments to
terminate uses, voluntarily requested by the registrants and accepted
by the Agency, of products containing formetanate HCl and acephate,
pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended. This cancellation order follows a
July 13, 2011 Federal Register Notice of Receipt of Requests from the
registrants listed in Table 2 of Unit II. to voluntarily amend their
formetanate HCl and acephate product registrations to delete uses.
These are not the last products containing these pesticides registered
for use in the United States. In the July 13, 2011 notice, EPA
indicated that it would issue an order implementing the amendments to
terminate uses, unless the Agency received substantive comments within
the 30-day comment period that would merit its further review of these
requests, or unless the registrants withdrew their requests. The Agency
did not receive any comments on the notice. Further, the registrants
did not withdraw their requests. Accordingly, EPA hereby issues in this
notice a cancellation order granting the requested amendments to
terminate uses of formetanate HCl and acephate product registrations.
Any distribution, sale, or use of the products subject to this
cancellation order is permitted only in accordance with the terms of
this order, including any existing stocks provisions.

DATES: The amendments are effective September 14, 2011.

FOR FURTHER INFORMATION CONTACT: Formetanate HCL: James Parker,
Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>.
    Acephate: Kelly Ballard, Pesticide Re-evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-8126; fax number:<PHONE_NUMBER>; e-mail 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, 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 person
listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0507. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. What action is the Agency taking?

    This notice announces the amendments to delete uses, as requested
by registrants, of products registered under section 3 of FIFRA. These
registrations are listed in sequence by registration number in Table 1
of this unit.

               Table 1--Formetanate HCL & Acephate Product Registration Amendments To Delete Uses
----------------------------------------------------------------------------------------------------------------
         EPA registration No.                   Product name                         Uses deleted
----------------------------------------------------------------------------------------------------------------
10163-264............................  Formetanate Hydrochloride      Apple, Peach & Pear.
                                        Technical.
10163-265............................  Carzol SP Miticide/            Apple, Peach & Pear.
                                        Insecticide in Water Soluble
                                        Packaging.
WA010033.............................  Carzol SP Insecticide in       Apple & Pear.
                                        Water Soluble Packaging.
5481-8975............................  Orthene Technical............  Succulent Green Beans.
70506-1..............................  Acephate 75 Insecticide......  Succulent Green Beans.
70506-2..............................  Acephate 90 Insecticide......  Succulent Green Beans.
70506-3..............................  Acephate Technical...........  Succulent Green Beans.
70506-8..............................  Acephate 97UP Insecticide....  Succulent Green Beans.
70506-71.............................  Acephate 90SP Manufacturing    Succulent Green Beans.
                                        Use Product.
70506-76.............................  Acephate 90DF Insecticide....  Succulent Green Beans.
81964-1..............................  Acephate Technical...........  Succulent Green Beans.
81964-3..............................  Acephate 90% SP..............  Succulent Green Beans.
83558-35.............................  Acephate Technical...........  Succulent Green Beans.
84229-7..............................  Tide Acephate 90 WDG.........  Succulent Green Beans.
----------------------------------------------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
all registrants of the products in Table 1 of this unit, in sequence by
EPA company number. This number corresponds to the first part of the
EPA registration numbers of the products listed in this unit.

                Table 2--Registrants of Amended Products
------------------------------------------------------------------------
          EPA company No.                 Company name and address
------------------------------------------------------------------------
5481..............................  Amvac Chemical Corporation, 4695
                                     MacArthur Ct., Suite 1250, Newport
                                     Beach, CA 92660.
10163.............................  Gowan Company, P.O. Box 5569, Yuma,
                                     AZ 85366-5569.
70506.............................  United Phosphorus, Inc., 630 Freedom
                                     Business Center, Suite 402, King of
                                     Prussia, PA 19406.
81964.............................  ChemStarr, LLC, 21 Hubble, Irvine,
                                     CA 92618.
83558.............................  Makhteshim Agan of North America,
                                     Inc., 4515 Falls of Neuse Rd, Suite
                                     300, Raleigh, NC 27609.
84229.............................  Tide International, USA, Inc., 21
                                     Hubble, Irvine, CA 92618.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received no comments
in response to the July 13, 2011 Federal Register notice (76 FR 41250)
(FRL-8879-7) announcing the Agency's receipt of the requests for
voluntary amendments to delete uses of products listed in Table 1 of
Unit II.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
amendments to terminate uses of formetanate HCl and acephate
registrations identified in Table 1 of Unit II. Accordingly, the Agency
hereby orders that the product registrations identified in Table 1 of
Unit II. are amended to terminate the affected uses. The effective date
of the cancellations that are subject of this notice is September 14,
2011. Any distribution, sale, or use of existing stocks of the products
identified in Table 1 of Unit II. in a manner inconsistent with any of
the provisions for disposition of existing stocks set forth in Unit VI.
will be a violation of FIFRA.

V. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the EPA Administrator may approve
such a request. The notice of receipt for this action was published for
comment on July 13, 2011. The comment period closed on August 15, 2011.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
action. The existing stocks provision for the products subject to this
order is as follows.
    Since the EPA has approved product labels reflecting the requested
amendments to delete uses, formetanate HCl registrants will now be
permitted to sell and distribute existing stocks of products under the
previously approved labeling until November 30, 2011. Thereafter,
registrants will be prohibited from selling or distributing the
products whose labels include the deleted uses identified in Table 1 of
Unit II., except for export consistent with FIFRA section 17 or for
proper disposal. Persons other than the registrant may sell,
distribute, or use existing stocks of products (including those of
(24c) Special Local Needs registrations) whose labels include the
deleted uses until December 31, 2013, provided that such sale,
distribution, or use is consistent with the terms of the previously
approved labeling on, or that accompanied, the deleted uses.
    Now that EPA has approved product labels reflecting the requested
amendments to delete uses, acephate registrants are permitted to sell
or distribute products listed in Table 1 of Unit II. under the
previously approved labeling until March 14, 2013, unless other
restrictions have been imposed. Thereafter, registrants will be
prohibited from selling or distributing the products whose labels
include the deleted uses identified in Table 1 of Unit II., except for
export consistent with FIFRA section 17 or for proper disposal.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 7, 2011.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2011-23338 Filed 9-13-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 251 (Thursday, December 31, 2020)]
[Rules and Regulations]
[Pages 86835-86843]
[FR Doc No: 2020-29060]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 328

[Docket ID FEMA-2020-0018]
RIN 1660-AB01

Prioritization and Allocation of Certain Scarce and Critical
Health and Medical Resources for Domestic Use

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

ACTION: Temporary final rule; extension of effective date with
modifications.

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SUMMARY: In April, the Federal Emergency Management Agency (FEMA)
issued a temporary final rule to allocate certain health and medical
resources for domestic use, so that these resources may not be exported
from the United States without explicit approval by FEMA. The rule
covered five types of personal protective equipment (PPE), outlined
below. While this rule remains in effect, and subject to certain
exemptions stated below, no shipments of such designated materials may
leave the United States without explicit approval by FEMA. In August,
FEMA modified the types of PPE covered and extended the duration of the
temporary rule. Through this action, FEMA again extends and modifies
the temporary final rule designating the list of scarce and critical
materials that cannot be exported from the United States without
explicit approval by FEMA.

DATES: Effective date: This rule is effective from December 31, 2020
until June 30, 2021.

ADDRESSES: You may review the docket by searching for Docket ID FEMA-
2020-0018, via the Federal eRulemaking Portal: http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Daniel McMasters, Program Analyst,
Office of Policy and Program Analysis,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On April 10, 2020, FEMA published a temporary final rule in the
Federal Register allocating certain health and

medical resources for domestic use, so that these resources may not be
exported from the United States without explicit approval by FEMA.\1\
The rule aids the response of the United States to the spread of
Coronavirus Disease 2019 (COVID-19) by ensuring that certain health and
medical resources are appropriately allocated for domestic use. On
April 21, 2020, FEMA published a notification of exemptions to the
rule.\2\ With the continued goal of ensuring that these resources are
appropriately allocated for domestic use, FEMA extended the date
through which the allocation in the temporary final rule would be in
effect, including the exemptions published on April 21, 2020, and
modified the list of covered materials under the rule to reflect
domestic supply needs as of August 10, 2020.\3\ FEMA is now further
extending and modifying this rule to reflect current domestic supply
needs of health and medical resources to promote the national defense.
The temporary final rule, as extended and modified, will remain in
effect until June 30, 2021, unless sooner modified or terminated by the
Administrator.
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    \1\ 85 FR 20195 (Apr. 10, 2020). See also 85 FR 22622 (Apr. 23,
2020) (correcting the date filed from ``4-8-20'' to'' 4-7-20'').
    \2\ 85 FR 22021 (Apr. 21, 2020).
    \3\ 85 FR 48113 (Aug. 10, 2020).
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A. The Current COVID-19 Pandemic

    COVID-19 is a communicable disease caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2), that was first
identified as the cause of an outbreak of respiratory illness that
began in Wuhan, Hubei Province, People's Republic of China. On January
30, 2020, the Director-General of the World Health Organization (WHO)
declared that the outbreak of COVID-19 is a Public Health Emergency of
International Concern under the International Health Regulations.\4\
The following day, the Secretary of Health and Human Services (HHS)
declared COVID-19 a public health emergency under Section 319 of the
Public Health Service (PHS) Act.\5\ On March 11, 2020, the WHO declared
COVID-19 a pandemic. On March 13, 2020, the President issued a
Proclamation on Declaring a National Emergency Concerning the Novel
Coronavirus Disease (COVID-19) Outbreak under sections 201 and 301 of
the National Emergencies Act, 50 U.S.C. 1601 et seq., and consistent
with section 1135 of the Social Security Act, 42 U.S.C. 1320b-5.\6\ On
March 13, 2020, the President declared a nationwide emergency under
section 501(b) of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, authorizing FEMA to provide assistance for emergency
protective measures to respond to the COVID-19 pandemic.\7\ FEMA
subsequently issued 57 major disaster declarations in response to
COVID-19, including for every State, 5 territories, the Seminole Tribe
of Florida, and the District of Columbia.\8\
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    \4\ Statement on the second meeting of the International Health
Regulations (2005) Emergency Committee regarding the outbreak of
novel coronavirus (2019-nCoV) (Jan. 30, 2020), available at https://www.who.int/news/item/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-
regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) (accessed
December 2, 2020).
    \5\ HHS, ``Determination that a Public Health Emergency
Exists,'' (Jan. 31, 2020) available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx (accessed
December 2, 2020).
    \6\ ``Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak,'' Mar. 13, 2020,
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/ (accessed December 15, 2020).
    \7\ COVID-19 Emergency Declaration available at https://www.fema.gov/news-release/2020/03/13/covid-19-emergency-declaration
(accessed December 15, 2020).
    \8\ See https://www.fema.gov/disasters/ (accessed December 15,
2020).
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    Within the United States, widespread transmission of COVID-19 has
occurred. Widespread transmission of COVID-19 has resulted and will
continue to result in large numbers of people needing medical care at
the same time. Public health and healthcare systems have become
overwhelmed in some areas, with elevated rates of hospitalizations and
deaths, as well as elevated demand for PPE, including the PPE covered
by this rule. Due to a surge in confirmed COVID-19 cases and
hospitalizations in October, November, and December 2020,\9\ domestic
supply of the allocated PPE has not kept pace with demand and is not
anticipated to do so. Additionally, given the high rate of influenza
vaccination administrations in 2020,\10\ along with the recent
developments in COVID-19 vaccines and vaccine trials,\11\ the projected
domestic supply of syringes and hypodermic needles is not expected to
meet demand.
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    \9\ As of December 22, 2020, the United States has over 17.79
million reported cases and over 300,000 deaths attributed to COVID-
19. See https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days (accessed December 22, 2020). As of
December 7, 2020, the number of reported weekly cases and weekly
deaths are forecast to increase. See https://covid.cdc.gov/covid-data-tracker/#forecasting_weeklycases (accessed December 22, 2020)
and https://covid.cdc.gov/covid-data-tracker/#forecasting_weeklydeaths (accessed December 22, 2020).
    \10\ See https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.htm (accessed December 15, 2020).
    \11\ See https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html (accessed December 22, 2020).
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B. Legal Authorities

    FEMA is extending and modifying this temporary final rule as part
of its response to the COVID-19 pandemic. The rule is issued pursuant
to the following authorities, among others:
     The Defense Production Act of 1950, as amended (``DPA'' or
``the Act''), and specifically sections 101 and 704 of the Act, 50
U.S.C. 4511, 4554;
     Executive Order 13909, 85 FR 16227 (Mar. 23, 2020);
     Executive Order 13911, 85 FR 18403 (Apr. 1, 2020);
     Department of Homeland Security (DHS) Delegations,
including DHS Delegation Number 09052 Rev. 00, ``Delegation of Defense
Production Act Authority to the Administrator of the Federal Emergency
Management Agency'' (Jan. 3, 2017) and DHS Delegation Number 09052 Rev.
00.1, ``Delegation of Defense Production Act Authority to the
Administrator of the Federal Emergency Management Agency'' (Apr. 1,
2020); and
     The Presidential Memorandum on Allocating Certain Scarce
or Threatened Health and Medical Resources to Domestic Use (Apr. 3,
2020).\12\
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    \12\ See Memorandum on Allocating Certain Scarce or Threatened
Health and Medical Resources to Domestic Use for the Secretary of
Health and Human Services, the Secretary of Homeland Security, and
the Administrator of the Federal Emergency Management Agency (Apr.
3, 2020), https://www.whitehouse.gov/presidential-actions/memorandum-allocating-certain-scarce-threatened-health-medical-resources-domestic-use/ (accessed December 15 2020).
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    Under subsection 101(a) of the Act, 50 U.S.C. 4511(a), the
President may (1) require that performance under contracts or orders
(other than contracts of employment) which the President deems
necessary or appropriate to promote the national defense shall take
priority over performance under any other contract or order, and, for
the purpose of assuring such priority, require acceptance and
performance of such contracts or orders in preference to other
contracts or orders by any person he finds to be capable of their
performance. The President may also (2) allocate materials, services,
and facilities in such manner, upon such conditions, and to such extent
as the President shall deem necessary or appropriate to promote the
national defense. FEMA refers to these authorities as relating to
``priority ratings'' and ``allocation,'' respectively.

    Under subsection 101(b) of the Act, 50 U.S.C. 4511(b), the
President may not use the aforementioned authorities to control the
general distribution of any material in the civilian market unless the
President finds (1) that such material is a scarce and critical
material essential to the national defense, and (2) that the
requirements of the national defense for such material cannot otherwise
be met without creating a significant dislocation of the normal
distribution of such material in the civilian market to such a degree
as to create appreciable hardship.
    Under subsection 101(d) of the Act, 50 U.S.C. 4511(d), the head of
each Federal agency to which the President delegates authority under
section 101 of the Act (1) shall issue, and annually review and update
whenever appropriate, final rules, in accordance with 5 U.S.C. 553,
that establish standards and procedures by which the priorities and
allocations authority under section 101 is used to promote the national
defense, under both emergency and nonemergency conditions; and (2) as
appropriate and to the extent practicable, consult with the heads of
other Federal agencies to develop a consistent and unified Federal
priorities and allocations system.
    On March 18, 2020, the President signed Executive Order 13909,
which (among other things) contained a finding that health and medical
resources needed to respond to the spread of COVID-19, including
personal protective equipment and ventilators, meet the criteria
specified in section 101(b) of the Act (50 U.S.C. 4511(b)).\13\
---------------------------------------------------------------------------

    \13\ Executive Order 13909 also delegated to the Secretary of
Health and Human Services (HHS) authority under the DPA for the
prioritization and allocation of health and medical resources to
respond to the spread of COVID-19. Further, on March 23, 2020, the
President signed Executive Order 13910, in which the President
delegated to the Secretary of HHS the authority under section 102 of
the Act to prevent hoarding and price gouging with respect to health
and medical resources necessary to respond to the spread of COVID-
19. On March 25, 2020, the Secretary of Health and Human Services
designated under section 102 of the Act 15 categories of health and
medical resources as scarce materials or materials the supply of
which would be threatened by accumulation in excess of the
reasonable demands of business, personal, or home consumption, or
for the purpose of resale at prices in excess of prevailing market
prices (``anti-hoarding designation''). See 85 FR 17592 (Mar. 30,
2020). The Secretary of HHS later modified and extended this
designation. See 85 FR 45895 (July 30, 2020). The anti-hoarding
designation relates to domestic hoarding and price-gouging activity,
and is conceptually distinct from, and serves different purposes
than, this rulemaking.
---------------------------------------------------------------------------

    On March 27, 2020, the President signed Executive Order 13911,
which (among other things) delegated to the Secretary of Homeland
Security, the President's authority under section 101 of the Act with
respect to health and medical resources needed to respond to the spread
of COVID-19 within the United States. The Executive Order provides that
the Secretary of Homeland Security may use the authority under section
101 of the Act to determine, in consultation with the heads of other
executive departments and agencies as appropriate, the proper
nationwide priorities and allocation of health and medical resources,
including by controlling the distribution of such materials (including
applicable services) in the civilian market, for responding to the
spread of COVID-19 within the United States.\14\ The Secretary of
Homeland Security has redelegated the Secretary's DPA authorities to
the FEMA Administrator. See DHS Delegation Number 09052, Rev. 00 (Jan.
3, 2017) and DHS Delegation Number 09052, Rev. 00.1 (Apr. 1, 2020).
---------------------------------------------------------------------------

    \14\ The Executive Order also delegated to the Secretary of
Homeland Security the authority under section 102 of the Act to
prevent hoarding and price gouging with respect to such resources,
and requires that before exercising the authority under section 102
of the Act, the Secretary of Homeland Security shall consult with
the Secretary of Health and Human Services.
---------------------------------------------------------------------------

    Additionally, on April 3, 2020, the President signed a Memorandum
on Allocating Certain Scarce or Threatened Health and Medical Resources
to Domestic Use (the Memorandum). The Memorandum reaffirmed the
delegations and findings contained in Executive Orders 13909 and 13911,
including that health and medical resources needed to respond to the
spread of COVID-19, including personal protective equipment (PPE), meet
the criteria specified in section 101(b) of the Act, i.e., that (1)
such material is a scarce and critical material essential to the
national defense, and (2) that the requirements of the national defense
for such material cannot otherwise be met without creating a
significant dislocation of the normal distribution of such material in
the civilian market to such a degree as to create appreciable hardship.
The Memorandum identified certain categories of PPE materials that the
Secretary of HHS had previously designated as ``scarce or threatened''
for purposes of section 102 of the DPA, and further stated that to
ensure that these materials remain in the United States for use in
responding to the spread of COVID-19, it is the policy of the United
States to prevent domestic brokers, distributors, and other
intermediaries from diverting such PPE materials overseas.
    In furtherance of such policy, the President directed the Secretary
of Homeland Security, through the FEMA Administrator, and in
consultation with the Secretary of HHS, to use any and all authority
available under section 101 of the Act to allocate to domestic use, as
appropriate, the five types of PPE identified in the Memorandum. On
April 10, 2020, FEMA executed this direction by issuing the allocation
order as a temporary final rule pursuant to the Memorandum, and with
the authority delegated to the Secretary of Homeland Security in E.O.
13911 and re-delegated to the FEMA Administrator.\15\ The temporary
final rule was modified and extended on August 10, 2020, to ensure
certain health and medical resources were appropriately allocated for
domestic use.\16\
---------------------------------------------------------------------------

    \15\ See 85 FR 20195 (Apr. 10, 2020).
    \16\ See 85 FR 48113 (Aug. 10, 2020).
---------------------------------------------------------------------------

    Finally, on May 13, 2020, FEMA published an interim final rule to
establish standards and procedures by which the priorities and
allocations authority under section 101 is used to promote the national
defense, under both emergency and nonemergency conditions.\17\
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    \17\ See 85 FR 28500 (May 13, 2020) (codified at 44 CFR part
333). In that interim final rule, FEMA noted that although FEMA
effectuated the April allocation order via a temporary rule that
predated the interim final rule, FEMA retains authority to
administer and enforce that allocation order according to its terms,
and to issue future allocation orders consistent with the procedures
announced in the interim final rule. See 85 FR at 28505. As noted
above, in August, FEMA opted to extend the April allocation, with
modifications, consistent with the form of the April order. FEMA
does the same here.
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    As the COVID-19 pandemic continues in the United States, the FEMA
Administrator, in consultation with other agencies as appropriate, has
determined that FEMA must continue to allocate some materials contained
in the August 10, 2020, temporary final rule for domestic use, and to
incorporate other health and medical resources due to changes in
domestic supply and demand, surges in the number of confirmed COVID-19
cases and deaths in the United States, forecasts anticipating the
increased number of COVID-19 cases and deaths, the current and
projected volume of influenza vaccination doses, and future COVID-19
vaccination predictions. FEMA has determined, consistent with the
Memorandum and FEMA's authorities under section 101 of the DPA, that it
is appropriate to designate, with modification, the PPE previously
designated and to include syringes and hypodermic needles (whether
distributed separately or attached together) to ensure domestic supply
is

able to meet the continuing demand for these materials. In short, FEMA
has determined that the original temporary final rule must be extended,
and the list of covered materials under such rule must be modified.
    Consistent with the authority delegated to the Secretary of
Homeland Security in E.O. 13911 and re-delegated to the FEMA
Administrator, FEMA now issues this temporary final rule to extend and
modify the allocation order.

II. Provisions of the Temporary Final Rule

    Following consultation with the appropriate Federal agencies;
pursuant to the President's direction; and as an exercise of the
Administrator's priority order, allocation, and regulatory authorities
under the Act, the Administrator has determined that the April 10,
2020, temporary final rule (``covered materials'') shall be extended
temporarily, and that the list of scarce and critical materials
identified in such temporary final rule shall be modified to reflect
current domestic needs. The materials identified in this rule will
continue to be allocated for domestic use and may not be exported from
the United States without explicit approval by FEMA. See 44 CFR
328.102(a).
    The rule is necessary and appropriate to promote the national
defense with respect to the covered materials because the domestic need
for them exceeds the supply. Under this temporary final rule extension,
before any shipments of such covered materials may leave the United
States, U.S. Customs and Border Protection (CBP) will continue to
detain the shipment temporarily, during which time FEMA will determine
whether to return for domestic use, issue a rated order for, or allow
the export of part or all of the shipment under section 101(a) of the
Act, 50 U.S.C. 4511(a). FEMA will continue to make such a determination
within a reasonable time of being notified of an intended shipment and
will make all decisions consistent with promoting the national defense.
See 44 CFR 328.102(b). FEMA will work to review and make determinations
quickly and will endeavor to minimize disruptions to the supply chain.
    In determining whether it is necessary or appropriate to promote
the national defense to purchase covered materials, or allocate
materials for domestic use, FEMA may continue to consult other agencies
and will consider the totality of the circumstances, including the
following factors: (1) The need to ensure that such items are
appropriately allocated for domestic use; (2) minimization of
disruption to the supply chain, both domestically and abroad; (3) the
circumstances surrounding the distribution of the materials and
potential hoarding or price-gouging concerns; (4) the quantity and
quality of the materials; (5) humanitarian considerations; and (6)
international relations and diplomatic considerations.
    This extension to the rule continues the eleven exemptions that the
Administrator has determined to be necessary or appropriate to promote
the national defense. See 44 CFR 328.102(d).
    Specifically, the Administrator has determined that FEMA will not
purchase covered materials from shipments made by or on behalf of U.S.
manufacturers with continuous export agreements with customers in other
countries since at least January 1, 2020, so long as at least 80
percent of such manufacturer's domestic production of covered
materials, on a per item basis, was distributed in the United States in
the preceding 12 months. The Administrator decided that this exemption
is necessary or appropriate to promote the national defense because it
would limit the impact of this order on pre-existing commercial
relationships, in recognition of the importance of these commercial
relationships to the international supply chain, and for humanitarian
reasons, in consideration of the global nature of the COVID-19
pandemic. If FEMA determines that a shipment of covered materials falls
within this exemption, such materials may be transferred out of the
United States without further review by FEMA, provided that the
Administrator may waive this exemption and fully review shipments of
covered materials subject to this exemption for further action by FEMA,
if the Administrator determines that doing so is necessary or
appropriate to promote the national defense. FEMA may develop
additional guidance regarding which exports are covered by this
exemption and encourages manufacturers to contact FEMA with specific
information regarding their status under this exemption.
    On April 21, 2020, FEMA published notification of 10 additional
exemptions to the original temporary final rule.\18\ These exemptions
will remain in effect for the new effective period of this rule,
subject to the Administrator's discretion to waive, modify, or
terminate such exemptions at any time in the future. The Administrator
has determined that it continues to be necessary and appropriate to
promote the national defense to exempt these categories of covered
materials from the requirements of 44 CFR 328.102(a) and (b). The
Administrator may establish, in his discretion, additional exemptions
that he determines are necessary or appropriate to promote the national
defense and will announce any such exemptions by notice in the Federal
Register.
---------------------------------------------------------------------------

    \18\ 85 FR 22021 (Apr. 21, 2020).
---------------------------------------------------------------------------

    FEMA will continue to implement this rule with the cooperation and
assistance of other U.S. Government agencies, including CBP, and will
work with manufacturers, brokers, distributors, exporters, and shippers
to ensure that the applicable requirements are carried out. Any covered
materials intended for export may be detained by CBP while FEMA
conducts its review of the shipment. FEMA will review the shipment and
provide notification as soon as possible regarding the disposition of
the covered materials under this order, provided that any goods that
have been detained by CBP and are subsequently made subject to a DPA-
rated order will be consigned to FEMA pending further distribution or
agency direction. FEMA may provide additional guidance regarding the
application of any exemptions to this temporary final rule, as
appropriate.
    FEMA is modifying the original temporary final rule's authority
citation to include both DHS Delegation Number 09052, Rev. 00 (Jan. 3,
2017) and DHS Delegation Number 09052, Rev. 00.1 (Apr. 1, 2020), and to
update the formatting of other citations previously included. FEMA is
making a number of non-substantive revisions throughout part 328 to
correct formatting errors and improve clarity and readability. FEMA is
also modifying the original temporary final rule at Sec.  328.101 to
reflect the appropriate statutory language from section 101 of the Act.
FEMA is further modifying Sec.  328.103(a) to update the designation of
covered materials under the rule. FEMA is further clarifying the types
of PPE surgical masks subject to the allocation order and is adding
specific syringes and hypodermic needles (whether distributed
separately or attached together). The continued allocation of certain
PPE materials reflects current domestic demand, as indicated by the
number of open requests for such materials from State, local, Tribal,
and territorial (SLTT) jurisdictions. Specifically--
     FEMA is continuing the designation of Surgical N95
Filtering Facepiece Respirators as covered materials. Surgical N95
respirators for medical use are still subject to high demand within the
United States, and supply is not expected to catch up with demand at
this time given the current forecasts of

increases in confirmed cases and hospitalizations.
     FEMA is continuing the designation of PPE surgical masks
as covered materials due to the continued inability of domestic supply
to meet current demands, with modification. In the original temporary
final rule, FEMA designated ``PPE surgical masks, including masks that
cover the user's nose and mouth and provide a physical barrier to
fluids and particulate materials.'' This temporary final rule clarifies
the existing language regarding the PPE surgical masks subject to this
order. As revised, 44 CFR 328.103(a)(2) now specifically designates PPE
surgical masks as described by 21 CFR 878.4040, including masks that
cover the user's nose and mouth providing a physical barrier to fluids
and particulate materials that meet fluid barrier protection standards
pursuant to ASTM F 1862 \19\ and to Class I or Class II flammability
tests under CPSC CS 191-53,\20\ NFPA Standard 702-1980,\21\ or UL 2154
standards.\22\ As of December 9, 2020, FEMA had open requests for over
13 million surgical masks from SLTT jurisdictions.
---------------------------------------------------------------------------

    \19\ The American Society for Testing and Materia (ASTM) F 1862
Standard Test Method for Resistance of Medical Face Masks to
Penetration by Synthetic Blood (Horizontal Projection of Fixed
Volume at a Known Velocity) is the test method used to evaluate the
resistance of medical face masks to penetration by the impact of a
small volume ((~2 mL) of a high-velocity stream of synthetic blood.
Medical face mask pass/fail determinations are based on visual
detection of synthetic blood penetration.
    \20\ The Consumer Protection Safety Commission (CPSC) CS 191-53
standard is the flammability standard for clothing textiles pursuant
to 16 CFR part 1610.
    \21\ The National Fire Protection Association (NFPA) Standard
702-1980 is the standard for classification of the flammability of
wearing apparel.
    \22\ UL (previously Underwriters Laboratories) is a global
independent safety science company with expertise in innovating
safety solutions. The UL 2154 is the standard for safety fire tests
of surgical fabrics.
---------------------------------------------------------------------------

     FEMA is also continuing the designation of PPE nitrile
gloves as covered materials with one minor edit to clarify the specific
types of gloves subject to the order. There is still a significant
shortage of nitrile gloves. As of December 9, 2020, FEMA had open
requests for over 168 million nitrile gloves from SLTT jurisdictions.
     FEMA is continuing the designation of Level 3 and 4
Surgical Gowns and Surgical Isolation Gowns that meet all of the
requirements in ANSI/AAMI PB70 \23\ and ASTM F2407-06 \24\ and are
classified by Surgical Gown Barrier Performance based on AAMI PB70. At
this time, domestic supply is not meeting demand. As of December 9,
2020, FEMA had open requests for over 1.2 million of these gowns from
SLTT jurisdictions.
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    \23\ ANSI/AAMI PB70 is the second edition of the standard for
liquid barrier performance of protective apparel.
    \24\ The American Society for Testing and Material (ASTM) F2407
is an umbrella document which describes testing for surgical gowns:
Tear resistance, seam strength, lint generation, evaporative
resistance, and water vapor transmission.
---------------------------------------------------------------------------

     FEMA is adding designations for specific syringes and
hypodermic needles (whether distributed separately or attached
together) to the covered materials list. The designated materials are
piston syringes and hypodermic needles that are either: Piston syringes
that allow for the controlled and precise flow of liquid as described
by 21 CFR 880.5860, that are compliant with ISO 7886-1:2017,\25\ and
use only Current Good Manufacturing Practice (CGMP) processes; \26\ or
hypodermic single lumen needles as described by 21 CFR 880.5570 that
have engineered sharps injury protections as described in the
Needlestick Safety and Prevention Act.\27\ Due to the current high rate
of influenza vaccine administration, in conjunction with the
development of COVID-19 vaccines, the projected domestic supply of
these materials is not anticipated to meet demand. As of the week of
December 4, 2020, more than 189.4 million influenza vaccine doses had
been distributed in the United States for this influenza season \28\
compared to the 2019-2020 influenza season, where approximately 174.5
million influenza vaccine doses were distributed for the entire
season,\29\ representing an increase of over 14.9 million vaccine doses
so far in the 2020-2021 influenza season. A record number of influenza
vaccine doses is being produced and distributed this influenza season,
and production and distribution will occur over a longer period of time
as a result,\30\ further reducing the domestic supply of syringes.
Additionally, as of December 22, 2020, the United States has authorized
for emergency use two COVID-19 vaccines, with multiple other vaccines
in large clinical trials.\31\ As of December 16, 2020, the United
Kingdom and Canada have also already approved the use of one vaccine
for COVID-19.\32\ As vaccination efforts expand, FEMA anticipates that
these materials will be in short supply.
---------------------------------------------------------------------------

    \25\ ISO 7886-1:2017 specifies requirements and test methods for
verifying the design of empty sterile single-use hypodermic
syringes, with or without needle, made of plastic or other materials
and intended for the aspiration and injection of fluids after
filling by the end-users.
    \26\ More information on CGMP processes can be found on the Food
and Drug Administration (FDA) website, Facts About the Current Good
Manufacturing Practices (CGMPs) (June 25, 2018), https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps.
    \27\ Public Law 106-430, 114 Stat. 1901 (Nov. 6, 2000).
    \28\ https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.htm (accessed December 15, 2020). As of November 27,
2020, 188 million doses of influenza vaccine had been distributed in
the United States, the highest number of influenza doses distributed
in the United States during a single influenza season. https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-distribution.html
(accessed December 15, 2020).
    \29\ https://www.cdc.gov/flu/prevent/vaccine-supply-historical.htm (accessed December 15, 2020).
    \30\ https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.htm (accessed December 15, 2020).
    \31\ See https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html (accessed December 22, 2020).
    \32\ https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine (accessed December 15,
2020) and https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines.html (accessed December 15, 2020).
---------------------------------------------------------------------------

    Consistent with the DPA and the original temporary final rule, FEMA
may continue to conduct such investigations and issue such requests for
information as may be necessary for the enforcement of the Act,
including this rule. See 44 CFR 328.104(a); see also section 705 of the
Act, 50 U.S.C. 4555; Executive Order 13911, 85 FR 18403 (Apr. 1, 2020).
FEMA may seek an injunction or other order whenever, in the
Administrator's judgment, a person has engaged or is about to engage in
any acts or practices which constitute or will constitute a violation
of the Act or any rule or order issued thereunder. See 44 CFR
328.104(b); see also section 706 of the Act, 50 U.S.C. 4556. In
addition to an injunction, failure to comply fully with this rule is a
crime punishable by a fine of not more than $10,000 or imprisonment for
not more than one year, or both. See 44 CFR 328.104(c); see also
section 103 of the Act, 50 U.S.C. 4513. In addition, pursuant to 18
U.S.C. 554, whoever fraudulently or knowingly exports or sends from the
United States, or attempts to export or send from the United States,
any merchandise, article, or object contrary to any U.S. law or
regulation, or receives, conceals, buys, sells, or in any manner
facilitates the transportation, concealment, or sale of such
merchandise, article, or object, prior to exportation, knowing the same
to be intended for exportation contrary to any U.S. law or regulation,
faces up to 10 years' imprisonment, a fine, or both, if convicted.
    At any point in time, and to the extent consistent with United
States policy, the

FEMA Administrator may determine additional materials to be subject to
this allocation order. Upon a determination under section 101(b) of the
DPA that an additional material is a scarce and critical material
essential for national defense, and that being allocated to domestic
use under this allocation order is the only way to meet national
defense requirements without significant disruption to the domestic
markets, the Administrator will include these additional materials in
this allocation order, and will provide notification of this decision
through publication in the Federal Register.

III. Regulatory Procedure and Analyses

A. Temporary Final Rule With Immediate Effective Date

    Agency rulemaking is generally governed by the agency rulemaking
provisions of the Administrative Procedure Act (APA). See 5 U.S.C. 553.
Such provisions generally require that, unless the rule falls within
one of a number of enumerated exceptions, or unless another statute
exempts the rulemaking from the requirements of the APA, FEMA must
publish a notice of proposed rulemaking in the Federal Register that
provides interested persons an opportunity to submit written data,
views, or arguments, prior to finalization of regulatory requirements.
Section 553(b)(B) authorizes a department or agency to dispense with
the prior notice and opportunity for public comment requirement when
the agency, for ``good cause,'' finds that notice and public comment
thereon are impracticable, unnecessary, or contrary to the public
interest.
    This rule is exempt from the APA under section 709(a) of the Act,
50 U.S.C. 4559(a). Instead, this rule is issued subject to the
provisions of section 709(b). Pursuant to section 709(b)(2) of the Act,
the Administrator has concluded, based on the facts related to the
COVID-19 pandemic, that, with respect to this temporary final rule,
urgent and compelling circumstances continue to make compliance with
the notice and comment requirements of section 709(b)(1) of the Act, 50
U.S.C. 4559(b)(1), impracticable. The COVID-19 pandemic continues to
grow worldwide. The World Health Organization reports over 71.5 million
cases and over 1.6 million deaths in 220 countries as of December 15,
2020.\33\ The severity of the pandemic has increased significantly in
the United States in recent months, with surges of up to 244,007 new
cases in a single day.\34\ The United States now leads the world in the
total number of COVID-19 cases and deaths \35\ and the Centers for
Disease Control and Prevention (CDC) estimates the number of confirmed
cases and deaths in the United States will continue to increase.\36\ As
a result of the surge in U.S. confirmed cases and deaths, demand for
PPE used to treat patients with the disease has increased and the
domestic supply has been unable to keep pace. As explained above, FEMA
continues to have a high volume of open requests for the specific types
of PPE listed in this allocation order and anticipates this volume will
increase given the COVID-19 forecasts from the CDC. The historic
increase in the number of influenza vaccine doses manufactured and
distributed this influenza season combined with the authorization for
emergency use of vaccines for COVID-19 and the demand for the same by
those who wish to be vaccinated against the disease means the projected
domestic supply of syringes and hypodermic needles will not meet demand
in the upcoming months.\37\ If final regulations become necessary, an
opportunity for public comment will be provided for not less than 30
days before such regulations become final, pursuant to section
709(b)(2)(C) of the Act, 50 U.S.C. 4559(b)(2)(C).
---------------------------------------------------------------------------

    \33\ https://www.who.int/emergencies/diseases/novel-coronavirus-2019 (accessed December 15, 2020).
    \34\ https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases (accessed December 15, 2020).
    \35\ https://covid19.who.int/ (accessed December 15, 2020). The
United States has over 16 million confirmed cases compared to over
9.9 million confirmed cases in India as of December 15, 2020. The
United States has over 296,000 deaths from COVID-19 compared to over
181,000 deaths in Brazil from COVID-19 as of December 15, 2020.
    \36\ https://covid.cdc.gov/covid-data-tracker/#forecasting_weeklycases (accessed December 15, 2020) and https://covid.cdc.gov/covid-data-tracker/#forecasting_weeklydeaths (accessed
December 15, 2020).
    \37\ A record number of influenza vaccine doses is being
produced and distributed this influenza season, and production and
distribution will occur over a longer period as a result. https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.htm (accessed
December 15, 2020). As of December 22, 2020, the United States has
authorized for emergency use two COVID-19 vaccines, with multiple
other vaccines in large clinical trials. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html (accessed
December 22, 2020).
---------------------------------------------------------------------------

    Furthermore, the same facts that warrant waiver under section
709(b)(2) of the Act would constitute good cause for FEMA to determine,
under the APA, that notice and public comment thereon are impractical,
unnecessary, or contrary to the public interest, and that the temporary
final rule should become effective immediately upon publication in the
Federal Register. The exigent need for this rule is related to the
COVID-19 pandemic.
    Although the Federal Government, along with State and local
governments, have taken preventative and proactive measures to slow the
spread of COVID-19, and to treat those affected, the current surge of
confirmed COVID-19 cases and deaths within the Nation's communities is
straining the Nation's healthcare systems. It is imperative that health
and medical resources needed to respond to the spread of COVID-19,
including the PPE and other health and medical resources affected by
this rule, continue to be allocated for domestic use as appropriate.
Given the evolving nature of this pandemic, the current surge in
confirmed COVID-19 cases and deaths, and the frequently changing supply
of and demand for the health and medical resources needed to combat it,
full public notice and comment proceedings are impracticable. As
explained earlier in the preamble, the volume of requests for certain
health and medical resources continues to outpace domestic supply. FEMA
is continuously monitoring SLTT jurisdictions' demand for these scarce
and critical health and medical resources and is taking this immediate
action to continue to ensure that such resources are appropriately
allocated for domestic use to continue to combat the current surge of
confirmed COVID-19 cases and deaths, the forecasted increase in both,
and the projected shortages of supplies to ensure the effective
distribution of influenza vaccine doses and COVID-19 vaccine doses for
those who wish to be vaccinated against these diseases.
    In short, given the national and international emergency caused by
COVID-19 and the current surge of confirmed cases and deaths, FEMA
finds that urgent and compelling circumstances have made it
impracticable and contrary to the public health--and, by extension, the
public interest--to delay these implementing regulations until a full
public notice-and-comment process is completed. Based on current needs,
this temporary final rule modification and extension is needed to
appropriately allocate scarce and critical materials for domestic use.
Specifically, FEMA seeks to continue designation of certain PPE
materials with minor modifications based on current demand and to add
other health and medical resources based on projected domestic supply
not meeting demand.
    The measures described in this rule are being issued on a temporary
basis. This temporary final rule with

modification remains in effect until June 30, 2021, unless sooner
modified or terminated by the Administrator.

B. Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, and public
health and safety effects; distributive impacts; and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Section 3(f) of Executive Order 12866 defines a ``significant
regulatory action'' as any regulatory action that is likely to result
in a regulation that may (1) have an annual effect on the economy of
$100 million or more, or adversely affect in a material way a sector of
the economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal governments or communities
(also referred to as ``economically significant''); (2) create a
serious inconsistency or otherwise interfere with an action taken or
planned by another agency; (3) materially altering the budgetary
impacts of entitlement grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
    The Office of Management and Budget has designated this temporary
final rule as an economically significant regulatory action. Given that
the temporary final rule is a significant regulatory action, FEMA
proceeds under the emergency provision of Executive Order 12866,
section 6(a)(3)(D) based on the need for immediate action, as described
above, to ensure these health and medical resources are appropriately
allocated for domestic use.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires that when
an agency issues a proposed rule, or a final rule that the agency
issues under 5 U.S.C. 553 after being required by that section or any
other law to publish a general notice of proposed rulemaking, the
agency must prepare a regulatory flexibility analysis that meets the
requirements of the RFA and publish such analysis in the Federal
Register. 5 U.S.C. 603, 604.
    This is neither a proposed rule, nor a final rule that the agency
has issued under 5 U.S.C. 553 after being required by that section or
any other law to publish a general notice of proposed rulemaking. This
is a temporary final rule issued without a prior proposed rule, under
the separate authority of the Defense Production Act of 1950.
Accordingly, a regulatory flexibility analysis is not required.

D. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
Mandates Act), 2 U.S.C. 1532, requires that covered agencies prepare a
budgetary impact statement before promulgating a rule that includes any
Federal mandate that may result in the expenditure by State, local, and
Tribal governments, in the aggregate, or by the private sector, of $100
million in 1995 dollars, updated annually for inflation. If a budgetary
impact statement is required, section 205 of the Unfunded Mandates Act
also requires covered agencies to identify and consider a reasonable
number of regulatory alternatives before promulgating a rule. DHS has
determined that this rule is not expected to result in expenditures by
State, local, and Tribal governments, or by the private sector, in that
amount in any one year. This rule imposes no requirements on State,
local, and Tribal governments and, therefore, cannot require them to
expend any funds, let alone in excess of the threshold. To the extent
that this rule affects the private sector, it only prohibits conduct,
namely certain exports. It does not require any private sector
expenditures within the meaning of the Unfunded Mandates Act. Further,
the rule is excluded from the Unfunded Mandates Act under 2 U.S.C.
1532(a) and 1503(4) and (5).

E. National Environmental Policy Act (NEPA)

    Under the National Environmental Policy Act of 1969 (NEPA), as
amended, 42 U.S.C. 4321 et seq., an agency must prepare an
environmental assessment or environmental impact statement for any
rulemaking that significantly affects the quality of the human
environment. FEMA has determined that this rulemaking does not
significantly affect the quality of the human environment and
consequently has not prepared an environmental assessment or
environmental impact statement.
    Rulemaking is a major Federal action subject to NEPA. Categorical
exclusion A3 included in the list of exclusion categories at Department
of Homeland Security Instruction Manual 023-01-001-01, Revision 01,
Implementation of the National Environmental Policy Act, Appendix A,
issued November 6, 2014, covers the promulgation of rules, issuance of
rulings or interpretations, and the development and publication of
policies, orders, directives, notices, procedures, manuals, and
advisory circulars if they meet certain criteria provided in A3(a-f).
This temporary final rule meets Categorical Exclusion A3(a), ``Those of
a strictly administrative or procedural nature''.

F. Executive Order 13132: Federalism

    This rule has been reviewed under Executive Order 13132,
Federalism, 64 FR 43255 (August 4, 1999). That Executive order imposes
certain requirements on agencies formulating and implementing policies
or regulations that preempt State law or that have federalism
implications. DHS has determined that this temporary final rule will
not have a substantial direct effect 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.
Furthermore, there are no provisions in this rule that impose direct
compliance costs on State and local governments. Accordingly, DHS is
not providing the additional analysis as the rule does not warrant
additional analysis under Executive Order 13132.

G. Congressional Review Act

    Under the Congressional Review Act (CRA), 5 U.S.C. 801-808, before
a rule can take effect, the Federal agency promulgating the rule must:
Submit to Congress and to the Government Accountability Office (GAO) a
copy of the rule; a concise general statement relating to the rule,
including whether it is a major rule; the proposed effective date of
the rule; a copy of any cost-benefit analysis; descriptions of the
agency's actions under the Regulatory Flexibility Act and the Unfunded
Mandates Reform Act; and any other information or statements required
by relevant Executive orders.
    FEMA has sent this rule to the Congress and to GAO pursuant to the
CRA. The Office of Information and Regulatory affairs has determined
that this rule is a ``major rule'' within the meaning of the CRA. As
this rule contains FEMA's finding for good cause that notice and public
procedure are impracticable, unnecessary, or contrary to the public
interest, there is not a required delay in the effective date. See 5
U.S.C. 808.

List of Subjects in 44 CFR Part 328

    Administrative practice and procedure, Business and industry,
Government contracts, Health or medical resource, Hoarding,
Investigations, Materials, National defense, Scarce materials,
Strategic and critical materials, Threatened materials.

0
Accordingly, for the reasons set forth in the preamble, and effective
from December 31, 2020 until June 30, 2021, chapter I of title 44 of
the Code of Federal Regulations is amended by revising part 328 to read
as follows:

PART 328--COVID-19 ALLOCATION ORDERS AND PRIORITY ORDER REVIEW
UNDER THE DEFENSE PRODUCTION ACT

Sec.
328.101 Basis and purpose.
328.102 Requirements.
328.103 Designation of covered materials.
328.104 Investigations and injunctions; penalties.

    Authority:  50 U.S.C. 4511, et seq.; E.O. 13909, 85 FR 16227;
E.O. 13911, 85 FR 18403; DHS Delegation Number 09052, Rev. 00 (Jan.
3, 2017); DHS Delegation Number 09052, Rev. 00.1 (Apr. 1, 2020);
Presidential Memorandum on Allocating Certain Scarce or Threatened
Health and Medical Resources to Domestic Use (Apr. 3, 2020).

Sec.  328.101  Basis and purpose.

    (a) Basis. The rules in this part are issued pursuant to section
101 of the Defense Production Act of 1950, as amended, 50 U.S.C. 4511,
and complementary authorities, including such authorities as are
contained in subchapter III of chapter 55 of title 50, United States
Code (50 U.S.C. 4554, 4555, 4556, and 4559), which have been delegated
to the Federal Emergency Management Agency (FEMA).
    (b) Purpose. The purpose of the rules in this part are to aid the
response of the United States to the spread of COVID-19 by ensuring
that scarce and critical health and medical resources are appropriately
allocated for domestic use.

Sec.  328.102  Requirements.

    (a) Allocation order and requirement for the Administrator's
approval. All shipments of covered materials, as designated in Sec.
328.103, shall be allocated for domestic use, and may not be exported
from the United States without explicit approval by FEMA.
    (b) Procedures. U.S. Customs and Border Protection (CBP), in
coordination with such other officials as may be appropriate, will
notify FEMA of an intended export of covered materials. CBP must
temporarily detain any shipment of such covered materials, pending the
Administrator's determination whether to return for domestic use or
issue a rated order for part or all of the shipment, pursuant to the
Administrator's delegated authorities. The Administrator will make such
a determination within a reasonable timeframe after notification of an
intended export.
    (c) Administrator's determination. In making the determination
described in paragraph (b) of this section, the Administrator may
consult other agencies and will consider the totality of the
circumstances, including the following factors:
    (1) The need to ensure that scarce or threatened items are
appropriately allocated for domestic use;
    (2) Minimization of disruption to the supply chain, both
domestically and abroad;
    (3) The circumstances surrounding the distribution of the materials
and potential hoarding or price-gouging concerns;
    (4) The quantity and quality of the materials;
    (5) Humanitarian considerations; and
    (6) International relations and diplomatic considerations.
    (d) Exemption. (1) The Administrator has determined in the interest
of promoting the national defense to generally allow the export of
covered materials from shipments made by or on behalf of U.S.
manufacturers with continuous export agreements with customers in other
countries since at least January 1, 2020, so long as at least 80
percent of such manufacturer's domestic production of such covered
materials, on a per item basis, was distributed in the United States in
the preceding 12 months. If FEMA determines that a shipment of covered
materials falls within the exemption in this paragraph (d), such
materials may be exported without further review by FEMA, provided that
the Administrator may waive the exemption in this paragraph (d) and
fully review shipments of covered materials under paragraph (b) of this
section, if the Administrator determines that doing so is necessary or
appropriate to promote the national defense. FEMA will communicate to
CBP regarding the application of the exemption in this paragraph (d) to
shipments identified by CBP.
    (2) The Administrator may establish, in his or her discretion,
additional exemptions that he or she determines necessary or
appropriate to promote the national defense and will announce any such
exemptions by notice in the Federal Register.
    (e) Exportations prohibited. The exportation of covered materials
other than in accordance with this section is prohibited.

Sec.  328.103  Designation of covered materials.

    (a) The Administrator has designated the following materials as
``covered materials'' under this part:
    (1) Surgical N95 Filtering Facepiece Respirators, including devices
that are disposable half-face-piece non-powered air-purifying
particulate respirators intended for use to cover the nose and mouth of
the wearer to help reduce wearer exposure to pathogenic biological
airborne particulates;
    (2) PPE surgical masks as described by 21 CFR 878.4040, including
masks that cover the user's nose and mouth providing a physical barrier
to fluids and particulate materials, that meet fluid barrier protection
standards pursuant to--
    (i) ASTM F 1862; and
    (ii) Class I or Class II flammability tests under CPSC CS 191-53,
NFPA Standard 702-1980, or UL 2154 standards;
    (3) PPE nitrile gloves, specifically those defined at 21 CFR
880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile
gloves intended for the same purposes;
    (4) Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that
meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and
are classified by Surgical Gown Barrier Performance based on AAMI PB70;
and
    (5) Syringes and hypodermic needles (whether distributed separately
or attached together) that are either:
    (i) Piston syringes that allow for the controlled and precise flow
of liquid as described by 21 CFR 880.5860, that are compliant with ISO
7886-1:2017 and use only Current Good Manufacturing Practices (CGMP)
processes; or
    (ii) Hypodermic single lumen needles that have engineered sharps
injury protections as described in the Needlestick Safety and
Prevention Act, Pub. L. 106-430, 114 Stat. 1901 (Nov. 6, 2000).
    (b) Upon determination that additional items are scarce and
necessary for national defense, and that consideration under the
allocation order in this part is the only way to meet national defense
requirements without significant disruption to the domestic markets,
the Administrator may designate additional materials as ``covered
materials'' in the list provided in paragraph (a) of this section. The
Administrator will publish notice of

these additional ``covered materials'' in the Federal Register.

Sec.  328.104   Investigations and injunctions; penalties.

    (a) To administer or enforce this part, the Administrator may
exercise the authorities available under section 705 of the Defense
Production Act of 1950, as amended, 50 U.S.C. 4555, including the
conduct of investigations, requests for information or testimony, and
inspections of records or premises. Before such authorities are
utilized, the Administrator will determine the scope and purpose of the
investigation, inspection, or inquiry, and be assured that no adequate
and authoritative data are available from any Federal or other
responsible agency.
    (b) Whenever, in the judgment of the Administrator, any person has
engaged or is about to engage in any acts or practices that constitute
or will constitute a violation of any provision of this part, or order
issued thereunder, the Administrator may exercise the authorities
available under section 706 of the Defense Production Act of 1950, as
amended, 50 U.S.C. 4556, including applying for a preliminary,
permanent, or temporary injunction, restraining order, or other order
to enforce compliance with this part.
    (c) Any person who willfully engages in violations of this part is
subject to penalties available under section 103 of the Defense
Production Act of 1950, as amended, 50 U.S.C. 4513, or other available
authority.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-29060 Filed 12-30-20; 8:45 am]
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[Federal Register Volume 82, Number 155 (Monday, August 14, 2017)]
[Rules and Regulations]
[Pages 37817-37819]
[FR Doc No: 2017-16485]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2017-0034; FRL-9965-26-Region 9]

Approval of California Air Plan Revisions, San Joaquin Valley
Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the San Joaquin Valley Unified Air
Pollution Control District (SJVUAPCD or ``the District'') portion of
the California State Implementation Plan (SIP). This revised rule
concerns emissions of oxides of nitrogen, carbon monoxide, oxides of
sulfur, and particulate matter of 10 microns or less from boilers,
steam generators and process heaters. We are approving a local rule
that regulates these emission sources under the Clean Air Act (CAA or
the Act).

DATES: This rule will be effective on September 13, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2017-0034. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through http://www.regulations.gov, or please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section for
additional availability information.

FOR FURTHER INFORMATION CONTACT: Nancy Levin, EPA Region IX, (415) 972-
3848<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On March 21, 2017 (82 FR 14496), the EPA proposed to approve the
following rule into the California SIP.

----------------------------------------------------------------------------------------------------------------
           Local agency                 Rule No.             Rule title             Amended         Submitted
----------------------------------------------------------------------------------------------------------------
SJVUAPCD..........................            4307   Boilers, Steam                    4/21/16          8/22/16
                                                      Generators, and Process
                                                      Heaters--2.0 MMBtu/hr to
                                                      5.0 MMBtu/hr.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this rule because we determined that it
complied with the relevant CAA requirements. Our proposed action
contains more information on the rule and our evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received one comment.
    Comment: The commenter asked how the rule revisions would affect
San Joaquin Valley residents, who would benefit from the revisions, and
whether the project's impact on human health and the environment
outweigh the costs of implementing the revisions.
    Response: This comment does not provide any new information or
basis for either supporting or opposing EPA's proposal. It merely poses
three questions that were previously addressed by EPA's proposal and
supporting docket materials. Nonetheless, out of courtesy to the
commenter, we summarize our previous analysis, as follows. Prior to the
rule revision, the rule exempted tree-nut pasteurizers fired
exclusively on natural gas. The revisions expand the exemption to tree-
nut pasteurizers fired by liquefied petroleum gas (LPG). The District
anticipates a handful of new LPG-fired tree-nut pasteurizers will
benefit from the rule revisions, but predicts that the difference in
emissions from LPG instead of natural gas will be negligible. The
District states that ``[T]he proposed amendment would not result in new
or more stringent regulatory controls and would not affect air quality
or emission limitations . . . [and that] no costs are associated with
this proposed rule amendment.'' \1\
---------------------------------------------------------------------------

    \1\ San Joaquin Valley Unified Air Pollution Control District,
Final Draft Staff Report: Rule 4307 (Boilers, Steam Generators, and
Process Heaters--2.0 MMBtu/hr to 5.0 MMBtu/hr), April 21, 2016.
---------------------------------------------------------------------------

III. EPA Action

    No comments were submitted that change our assessment of the rule
as described in our proposed action. Therefore, as authorized in
section 110(k)(3) of the Act, the EPA is fully approving this rule into
the California SIP.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.5, the EPA is finalizing the incorporation by reference of the
SJVUAPCD rule described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    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. The EPA will submit a report containing this action 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).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 13, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Carbon monoxide, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements.

    Dated: June 21, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(447)(i)(B)(2) and
(c)(488)(i)(B) to read as follows:

Sec.  52.220  Identification of plan-in part.

* * * * *
    (c) * * *
    (447) * * *
    (i) * * *
    (B) * * *
    (2) Previously approved on February 12, 2015 in paragraph
(c)(447)(i)(B)(1) of this section and now deleted with replacement in
(c)(488)(i)(C)(1), Rule 4307, ``Boilers, Steam Generators, and Process
Heaters--2.0 MMBtu/hr to 5.0 MMBtu/hr,'' amended on May 19, 2011.
* * * * *
    (488) * * *
    (i) * * *
    (B) San Joaquin Valley Unified Air Pollution Control District.
    (1) Rule 4307, ``Boilers, Steam Generators, and Process Heaters--
2.0 MMBtu/hr to 5.0 MMBtu/hr,'' amended on April 21, 2016.
* * * * *
[FR Doc. 2017-16485 Filed 8-11-17; 8:45 am]
 BILLING CODE 6560-50-P