Prioritization and Allocation of Certain Scarce and Critical Health and Medical Resources for Domestic Use
| Published date | 10 August 2020 |
| Record Number | 2020-17467 |
| Section | Rules and Regulations |
| Court | Federal Emergency Management Agency |
Federal Register, Volume 85 Issue 154 (Monday, August 10, 2020)
[Federal Register Volume 85, Number 154 (Monday, August 10, 2020)]
[Rules and Regulations]
[Pages 48113-48119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17467]
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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, 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. Through this
extension, FEMA modifies the types of PPE covered and extends the
duration of the temporary final rule.
DATES: Effective date: This rule is effective from August 10, 2020
until December 31, 2020.
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, Office of Policy and
Program Analysis, 202-709-0661, [email protected].
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
[[Page 48114]]
published a notification of exemptions to the rule.\2\ With the
continued goal of ensuring that such materials are appropriately
allocated for domestic use, FEMA is extending the temporary final rule
and modifying the list of covered materials to reflect current domestic
supply needs. The temporary final rule will remain in effect until
December 31, 2020, 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).
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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.\3\
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.\4\ 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.\5\ 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.\6\ FEMA
subsequently issued 57 major disaster declarations in response to
COVID-19 in every State, 5 territories, the Seminole Tribe of Florida,
and the District of Columbia.\7\
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\3\ Statement on the second meeting of the International Health
Regulations (2005) Emergency Committee regarding the outbreak of
novel coronavirus (2019-nCoV) (January 30, 2020), available at
https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-
emergency-committee-regarding-the-outbreak-of-novel-coronavirus-
(2019-ncov).
\4\ HHS, ``Determination that a Public Health Emergency
Exists,'' available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx (Jan. 31, 2020).
\5\ ``Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak,'' March 13, 2020,
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
\6\ COVID-19 Emergency Declaration available at https://www.fema.gov/news-release/2020/03/13/covid-19-emergency-declaration
(accessed July 28, 2020).
\7\ See https://www.fema.gov/disasters/ (accessed July 28,
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.
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) 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 (April 3,
2020).\8\
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\8\ 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/ (last visited July 28, 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 he 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 he 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)).\9\
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\9\ Executive Order 13909 also delegated to the Secretary of 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.
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[[Page 48115]]
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.\10\ The Secretary of
Homeland Security has delegated his authorities under Executive Order
13911 to FEMA. See DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020).
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\10\ 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.
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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 in DHS Delegation
09052 Rev. 00.1.\11\
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\11\ See 85 FR 20195 (Apr. 10, 2020).
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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.\12\
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\12\ 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. FEMA has
opted to extend the April allocation, with modifications, consistent
with the form of the April order.
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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 it must continue to allocate some materials contained
in the April 10, 2020 temporary final rule for domestic use, but that
it is no longer appropriate to continue the allocation of certain
covered materials listed in the Memorandum due to changes in domestic
supply and demand. In addition, FEMA has determined, consistent with
the Memorandum and FEMA's authorities under section 101 of the DPA,
that it is appropriate to designate an additional category of such
materials. In short, FEMA has determined that the original temporary
final rule must be extended, but 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 in DHS Delegation 09052 Rev. 00.1, 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 these 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.
[[Page 48116]]
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(c).
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 ten additional
exemptions to the original temporary final rule.\13\ 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 in
order 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.
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\13\ 85 FR 22021 (Apr. 21, 2020).
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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 at section
328.103(a) to update the designation of covered materials under the
rule. FEMA is reducing the list of covered materials to four types of
PPE as these modifications reflect 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 N95 Filtering
Facepiece Respirators as covered materials, with one modification. In
the original temporary final rule, FEMA designated ``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.'' This
temporary final rule modifies the existing language by adding the word,
``surgical'' to clarify the types of N95 Filtering Facepiece
Respirators subject to this order. 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 until January 2021. As of August
4, 2020, FEMA had open requests for over 6 million N95 respirators from
SLTT jurisdictions. Because this demand is specific to surgical N95
respirators and does not include industrial respirators, FEMA is
clarifying that the list only covers surgical N95 respirators.
FEMA is continuing the designation of PPE surgical masks
as covered materials due to the continued inability of domestic supply
to meet current demands. As of August 4, 2020, FEMA had open requests
for over 28 million surgical masks from SLTT jurisdictions.
FEMA is also continuing the designation of PPE gloves or
surgical gloves as covered materials, with modification. FEMA is
narrowing the scope of the materials covered to PPE nitrile gloves,
specifically those defined at 21 CFR 880.6250 (exam gloves) and
878.4460 (surgical gloves) and other such nitrile gloves intended for
the same purposes. Domestic supply for latex and vinyl examination and
surgical gloves has largely caught up with demand, but there is still a
significant shortage of nitrile gloves. As of August 4, 2020, FEMA had
open requests for over 139 million nitrile gloves from SLTT
jurisdictions.
FEMA is adding designations for Level 3 and 4 Surgical
Gowns and Surgical Isolation Gowns that meet all of the requirements in
ANSI/AAMI PB70 \14\ and ASTM F2407-06 \15\ and are classified by
Surgical Gown Barrier Performance based on AAMI PB70 to the covered
materials list at this time as domestic supply is not meeting demand.
As of August 4, 2020, FEMA had open requests for over 11 million of
these gowns from SLTT jurisdictions.
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\14\ ANSI/AAMI PB70 is the second edition of the standard for
liquid barrier performance of protective apparel.
\15\ 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.
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FEMA is eliminating two items from the covered materials
list as there are currently no indications that supply is not meeting
domestic demand to require these items to continue to be subject to
this order. FEMA is removing other filtering facepiece respirators as
this category of respirator has seen a significant drop in the number
of orders received from SLTT jurisdictions and the current supply is
sufficient to fill demand from these jurisdictions. FEMA is also
removing elastomeric, air-purifying respirators and appropriate
particulate filters/cartridges from the list of covered materials as
these items have seen low demand from SLTT jurisdictions and FEMA has
been able to fill all orders that have been placed for these items in
the past 45 days, as of July 16, 2020.
Note that this rule covers only those PPE items described above; it
does not cover other forms of PPE not described in the rule, such as
cloth-based masks.
Consistent with the DPA and the original temporary final rule, FEMA
may continue to conduct such
[[Page 48117]]
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
As explained in the original temporary final rule,\16\ 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.
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\16\ 85 FR 20195 (Apr. 10, 2020).
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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, which already have been summarized in this document,
that, with respect to this temporary final rule, urgent and compelling
circumstances make compliance with the notice and comment requirements
of section 709(b)(1) of the Act, 50 U.S.C. 4559(b)(1), impracticable.
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).
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 on August 10, 2020, the date on
which the original temporary final rule would expire. 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 ongoing spread of
COVID-19 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 affected
by this rule, continue to be allocated for domestic use as appropriate.
Given the evolving nature of this pandemic 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 in some cases, while the domestic supply of other
health and medical resources is now sufficient to meet the requests of
SLTT jurisdictions. In addition, the number of requests fluctuates
widely from day-to-day as FEMA receives the requests, evaluates them,
and satisfies them.
FEMA is continuously monitoring SLTT jurisdictions' demand for
these scarce and critical health and medical resources. This immediate
action is needed to continue to ensure that such resources are
appropriately allocated for domestic use, and to tailor the scope of
such allocation to current needs as of the prior TFR's scheduled end-
date.
In short, given the national and international emergency caused by
COVID-19 and the continuously evolving nature of the situation, 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. This temporary final
rule modification and extension is needed to appropriately allocate
scarce and critical materials for domestic use, based on current needs.
The measures described in this rule are being issued on a temporary
basis. This temporary final rule will cease to be in effect on December
31, 2020, 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 an action that is likely to result in a
regulation (1) having an annual effect on the economy of $100 million
or more in any one year, or adversely and materially affecting a sector
of the
[[Page 48118]]
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) creating a
serious inconsistency or otherwise interfering 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) raising 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, based on the need for immediate action 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 of this title 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. Currently,
that threshold is approximately $172 million. 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, of $172
million or more 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 $172 million. 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. 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
believes that 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 August 10, 2020 until December 31, 2020, 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.
[[Page 48119]]
Authority: Sections 101 et seq. of the Defense Production Act of
1950, 50 U.S.C. 4511, et seq.; Executive Order 13909, 85 FR 16227
(Mar. 23, 2020); Executive Order 13911, 85 FR 18403 (Apr. 1, 2020);
DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020); Presidential
Memorandum on Allocating Certain Scarce or Threatened Health and
Medical Resources to Domestic Use (April 3, 2020).
Sec. 328.101 Basis and purpose.
(a) Basis. These rules 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 FEMA.
(b) Purpose. The purpose of these rules is to aid the response of
the United States to the spread of COVID-19 by ensuring that scarce or
threatened 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 this exemption, such materials may be exported
without further review by FEMA, provided that the Administrator may
waive this exemption 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 this
exemption to shipments identified by CBP.
(2) The Administrator may establish, in his discretion, additional
exemptions that he 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, including masks that cover the user's nose
and mouth and provide a physical barrier to fluids and particulate
materials;
(3) PPE nitrile gloves, including those defined at 21 CFR 880.6250
(exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves
intended for the same purposes; and
(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.
(b) Upon determination that additional items are scarce and
necessary for national defense, and that consideration under this
allocation order 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 above. 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 subpart, 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 subpart, 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 subpart.
(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. 2020-17467 Filed 8-6-20; 11:15 am]
BILLING CODE 9111-19-P
