Rule2026-19207
Homeland Security Acquisition Regulation, Make Personal Protective Equipment in America Act Restrictions on Foreign Acquisition (HSAR Case 2024-003)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 18, 2026
Effective
October 19, 2026
Issuing agencies
Homeland Security Department
Abstract
DHS is issuing a final rule to amend the Homeland Security Acquisition Regulation (HSAR) codifying how DHS complies with the requirements of the Make Personal Protective Equipment (PPE) in America Act. These changes are intended to ensure the sustainment and expansion of domestic manufacturing for certain types of PPE critical to the United States' national response to a public health crisis.
Full Text
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<title>Federal Register, Volume 91 Issue 180 (Friday, September 18, 2026)</title>
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[Federal Register Volume 91, Number 180 (Friday, September 18, 2026)]
[Rules and Regulations]
[Pages 59066-59075]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19207]
[[Page 59066]]
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DEPARTMENT OF HOMELAND SECURITY
48 CFR Parts 3025 and 3052
[Docket No. DHS-2024-0020]
RIN 1601-AB15
Homeland Security Acquisition Regulation, Make Personal
Protective Equipment in America Act Restrictions on Foreign Acquisition
(HSAR Case 2024-003)
AGENCY: Office of the Chief Procurement Officer (OCPO), Department of
Homeland Security (DHS).
ACTION: Final rule.
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SUMMARY: DHS is issuing a final rule to amend the Homeland Security
Acquisition Regulation (HSAR) codifying how DHS complies with the
requirements of the Make Personal Protective Equipment (PPE) in America
Act. These changes are intended to ensure the sustainment and expansion
of domestic manufacturing for certain types of PPE critical to the
United States' national response to a public health crisis.
DATES: The final rule is effective October 19, 2026.
FOR FURTHER INFORMATION CONTACT: Shaundra Ford, Department of Homeland
Security, Office of the Chief Procurement Officer, Acquisition Policy
and Legislation, at (202) 282-8000 or email at <a href="/cdn-cgi/l/email-protection#d9918a988b99b1a8f7bdb1aaf7beb6af"><span class="__cf_email__" data-cfemail="d8908b998a98b0a9f6bcb0abf6bfb7ae">[email protected]</span></a>. Include
HSAR Case 2024-003 in the subject line.
SUPPLEMENTARY INFORMATION:
Table of Contents for Preamble
I. Background
II. Discussion of Public Comments
III. Final Rule
IV. Regulatory Analyses
A. Executive Orders 12866, 13563, and 14094
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. National Environmental Policy Act
I. Background
In a Notice of Proposed Rulemaking (NPRM), published in the Federal
Register on October 1, 2024, the Department of Homeland Security (DHS)
proposed to amend the Homeland Security Acquisition Regulation (HSAR)
to codify how DHS complies with the requirements of the Make Personal
Protective Equipment (PPE) in America Act.\1\
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\1\ See 89 FR 79851, Homeland Security Acquisition Regulation,
Make Personal Protective Equipment in America Act Restrictions on
Foreign Acquisition (HSAR Case 2024-003) (Oct. 1, 2024)
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As explained in the NPRM, the Infrastructure Investment and Jobs
Act was signed into law on November 15, 2021.\2\ Subtitle C of title IX
of Division G of the Infrastructure Investment and Jobs Act is the Make
PPE in America Act (``MPAA'' or ``the Act'').\3\ The Act requires the
DHS, Department of Veterans Affairs (VA), and the U.S. Department of
Health and Human Services (HHS) to take certain actions to ensure the
sustainment and expansion of domestic manufacturing for certain types
of PPE critical to the United States' national response to a public
health crisis.\4\
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\2\ Infrastructure Investment and Jobs Act, Public Law 117-58,
135 Stat. 429 (2021).
\3\ Make PPE in America Act, Public Law 117-58, div. G, title
IX, subtitle C, sections 70951-70953, 135 Stat. 1312-1316. The Make
PPE in America Act is codified in 41 U.S.C. 8301 note.
\4\ Public Law 117-58, 135 Stat. 1312.
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The Act defines PPE as surgical masks, respirator masks and powered
air purifying respirators and required filters, face shields and
protective eyewear, gloves, disposable and reusable surgical and
isolation gowns, head and foot coverings, and other gear or clothing
used to protect an individual from the transmission of disease.\5\ The
Act requires that any contracts for the procurement of PPE entered into
by DHS, HHS, or VA be for PPE, including the materials and components
thereof, that is domestically grown, reprocessed, reused, or
produced.\6\ The Act also requires that these contracts with DHS, HHS,
or VA for PPE last at least two years in duration plus all option
periods necessary, to incentivize investment in the domestic production
of PPE and the materials and components thereof.\7\ The Act allows for
alternatives to domestic production under certain conditions (i.e.,
where PPE assembled outside of the United States (U.S.) contains only
materials and components grown, reprocessed, reused or produced in the
U.S.).\8\ When using alternatives to domestic production, DHS, HHS, or
VA, as applicable, must certify every 120 days that alternatives to
domestic production are necessary to procure PPE due to the immediate
needs of a public health emergency.\9\ The Act further recognizes
certain exceptions to the domestic production of PPE, such as due to
nonavailability, or where the PPE cannot be procured at U.S. market
prices.\10\ Where DHS, HHS, or VA respectively grants an exception,
that Secretary would also need to certify that implementing these
exceptions are necessary to meet the immediate needs of a public health
emergency.\11\
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\5\ Public Law 117-58., 135 Stat. 1313.
\6\ Public Law 117-58, 135 Stat. 1313-14.
\7\ Public Law 117-58, 135 Stat. 1314.
\8\ Id.
\9\ Id.
\10\ Id.
\11\ Id.
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As discussed in the NPRM, the DHS Chief Procurement Officer can
issue HSAR deviations when necessary to allow Components to deviate
from the HSAR.\12\ On October 17, 2022, DHS issued a deviation
regarding how DHS would comply with the Make PPE in America Act
requirements (Deviation 23-01).\13\
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\12\ See HSAR Deviations, available at: <a href="https://www.dhs.gov/publication/current-hsar-deviations">https://www.dhs.gov/publication/current-hsar-deviations</a>.
\13\ See HSAR 3001.4 and HSAR Class Deviation 23-01
Implementation of the Make PPE in America Act at <a href="https://www.dhs.gov/sites/default/files/2022-10/HSARClassDeviation23-01ImplementationofMakePPEinAmericaAct-508Final.pdf">https://www.dhs.gov/sites/default/files/2022-10/HSARClassDeviation23-01ImplementationofMakePPEinAmericaAct-508Final.pdf</a>.
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II. Discussion of Public Comments
Interested parties were given until December 2, 2024, to comment on
the NPRM. DHS reviewed the public comments in the development of the
final rule. DHS received 23 public comments. A certain number of the
comments received were outside the scope of the rule. A discussion of
the comments within the scope of the rule is provided, as follows:
1. Definitions
Comment: Several commenters asked DHS to modify its definition of
``component,'' ``domestic personal protective equipment,'' ``foreign-
assembled domestic personal protective equipment,'' and ``foreign
personal protective equipment.'' Commenters suggested including the
availability exception in the Act for nonavailable articles listed in
FAR 25.104(a) to these definitions and, for the ``foreign-assembled
domestic personal protective equipment,'' and ``foreign personal
protective equipment'' definitions, limiting the applicability of FAR
25.104(a) to components used in American manufacturing facilities.
Commenters noted the MPAA includes a nonavailability exception that
permits agencies to acquire covered PPE from foreign sources when
compliant domestic products are not available in sufficient quantity or
quality to meet agency requirements or are included in the nonavailable
articles listing in FAR 25.104(a). The commenters further stated that
nitrile butadiene rubber (NBR), a key raw material used to manufacture
nitrile gloves, is a synthetic latex rubber and therefore falls within
definition of ``rubber, crude, and latex'' which is currently
identified as nonavailable in the listing. The commenters assert that
[[Page 59067]]
inclusion of an express reference to FAR 25.104(a) in the ``component''
definition will limit waivers from the Act's requirements that allow
DHS to acquire foreign-sourced nitrile gloves.
Additionally, the commenters stated that the existing definitions
of ``foreign-assembled domestic personal protective equipment,'' and
``foreign personal protective equipment'' circumvent the intent of the
Act, allowing for the offshore of manufactured items to be identified
as domestic and providing foreign manufacturers an advantage over
American manufacturers.
Response: DHS declines to adopt the commenters' suggestions to
revise the definitions to incorporate FAR 25.104(a); to otherwise
address the domestic nonavailability status of NBR; and to include
language limiting the applicability of FAR 25.104(a) to components used
in American manufacturing facilities.
First, the nonavailable articles list at FAR 25.104(a) is subject
to periodic review and amendment. Incorporating specific references to
articles identified as nonavailable under FAR 25.104(a) into the HSAR
could create inconsistencies if future revisions are made to the FAR.
DHS therefore believes it is more appropriate to rely on the existing
statutory and regulatory framework rather than codify specific
nonavailability determinations in the HSAR.
Second, DHS disagrees with the commenters' assertion that the
nonavailability exception in section 70953(d) of the MPAA applies only
to domestic manufacturing facilities. Section 70953(d)(1) expressly
provides that the requirements of sections (b) and (c) do not apply to
an item of personal protective equipment, or component or material
thereof, that is, or that includes, a material listed in FAR 25.104.
Accordingly, the statute expressly contemplates application of the
nonavailability exception to covered PPE, components, and materials,
including those acquired under the alternative domestic production
authority. Limiting the exception as suggested would be inconsistent
with the plain language of the Act.
Third, DHS does not believe that revisions to the definitions are
necessary to address NBR nonavailability under the Act. Since
implementing the MPAA in October 2022, DHS has relied on
nonavailability waivers to acquire nitrile gloves for a variety of
reasons, including limited domestic manufacturing capacity to meet DHS
specifications and quantity requirements; limited availability of
domestic nitrile gloves capable of successfully passing Transportation
Security Administration (TSA) testing requirements; and the lack of
domestic production of NBR. Prior to January 2026, DHS sourced nitrile
gloves from both domestic and foreign manufacturers. However, as
domestic manufacturing capacity expanded, DHS transitioned to sourcing
all nitrile glove requirements from domestic manufacturers.\14\
Although domestic manufacturers continue to rely on foreign-sourced NBR
due to the current absence of domestic NBR production, DHS has
demonstrated that it can achieve its domestic sourcing objectives
without modifying the definitions as suggested.
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\14\ See, e.g., DHS waiver for nitrile butadiene rubber
available at <a href="https://www.madeinamerica.gov/waivers/nonavailability/6994cfdf16e70851109b4247">https://www.madeinamerica.gov/waivers/nonavailability/6994cfdf16e70851109b4247</a> (last visited Sep. 8, 2026).
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Moreover, whether NBR may be categorized as ``rubber, crude, and
latex'' under FAR 25.104(a) is not dispositive for the purposes of this
rule. Because NBR is not currently produced domestically, agencies
acquiring covered PPE that contains NBR have historically relied on the
MPAA's nonavailability exception and associated waiver processes to
support the domestic nonavailability status of NBR. DHS therefore does
not believe revising the definitions is necessary to address the
domestic nonavailability of NBR. Accordingly, DHS declines to
incorporate specific references to FAR 25.104(a) or NBR in the
regulatory definition of ``component.''
2. Expand ``Restrictions'' Section To Include Additional Language
Comment: Multiple commenters requested that DHS revise HSAR
3025.7102-1, Restrictions, to emphasize that the MPAA prioritizes PPE
manufactured in the U.S. by American workers. These commenters also
recommended narrowing the application of waivers and exceptions to
ensure DHS gives preference to wholly domestic PPE supply chains and
manufacturing facilities. The commenters assert that DHS's proposed
implementation of the MPAA relies too heavily on broad waivers and
exceptions, which could undermine the Act's purpose of strengthening
domestic PPE manufacturing.
The commenters argued that continued reliance on foreign-
manufactured gloves and reseller-based supply chains discourages
private investment in U.S. manufacturing capacity, weakens domestic
supply chain resilience, and places American jobs at a competitive
disadvantage. The commenters requested that DHS include new paragraphs
(c) and (d) to the restrictions listed in 3025.7102-1 as follows: ``(c)
The intent of the law and priority is given to American Manufacturers
of domestic personal protective equipment to include narrow waivers
focused on United States based manufacturing facilities and exceptions
identified herein to promote national security, support American
manufacturing facilities in the United States, and American workers in
an effort to reshore and sustain critical American manufacturing
capability in the United States. (d) All contract for personal
protective equipment, per the purpose of the, as identified in Section
70951 of the Make PPE in America Act which purpose is for the United
States to ensure a robust, secure, and wholly domestic PPE supply chain
to safeguard public health and national security; to further this
effort it provides DHS with flexibility on procurement sources as it
does not incorporate any requirement to use a quasi-government
mandatory source and thus DHS will use Small Business Sources and
encourage our contracting officer to actively seek out and consider
small businesses for contracts and American based manufacturing
facilities that can manufacture in the United States as priority
options.''
Finally, some commenters contended that the Act's requirements
should apply to ``quasi-governmental'' procurement programs and
recommended DHS exhaust domestic manufacturing sources before relying
on resellers or nonmanufacturer arrangements.
Response: DHS declines to add the suggested language to the
regulatory text in section 3025.7102-1. It is unnecessary to include
the purpose and intent of the statute and intent of the law in the
regulatory text as the regulations do not change this. Such language
may also cause confusion as similar language is not typically included
in acquisition regulations.
DHS also disagrees with the commenters' characterization of DHS's
use of waivers and exceptions under the MPAA. The Act expressly
contemplates the use of exceptions and waivers in specified
circumstances, including when compliant domestic products, components,
or materials are unavailable. Accordingly, DHS's use of waivers is
consistent with the MPAA which provides for exceptions where domestic
industrial capacity is not sufficient to meet agency requirements.
DHS further notes that the MPAA establishes domestic sourcing
requirements for covered PPE but does
[[Page 59068]]
not create separate procurement preferences based on workforce
composition, ownership structure, or the nationality of a
manufacturer's employees. Therefore, DHS declines to adopt the
commenters' proposed references to ``American workers'' and ``American
manufacturers'' in the regulatory text.
Finally, DHS declines to adopt the commenters' recommendation that
contracting officers be required to exhaust domestic manufacturers
before considering authorized distributors, resellers, or other
permissible acquisition channels. The MPAA establishes sourcing
requirements for covered PPE but does not prescribe particular
distribution channels or acquisition methodologies. Accordingly, DHS
does not believe such a requirement would be appropriate for inclusion
in the HSAR. Such inclusion could inadvertently result in noncompliance
with statutes governing competition in contracts which do not allow
blanket preference of manufacturers over distributors and resellers.
To the extent the commenters' references to ``quasi-government''
agency program contracts are directed at the AbilityOne Program and
Procurement List requirements applicable to nitrile gloves, DHS notes
that the AbilityOne Program operates pursuant to the Javits-Wagner-
O'Day (JWOD) Act, codified at 41 U.S.C. chapter 85, which establishes a
mandatory source program for certain products and services furnished by
qualified nonprofit agencies employing people who are blind or have
significant disabilities. The Committee for Purchase From People Who
Are Blind or Severely Disabled (operating as the AbilityOne Commission)
administers the program and maintains the Procurement List, accessible
at <a href="http://www.abilityone.gov">www.abilityone.gov</a>, identifying mandatory source products and
services. Federal agencies are generally required to procure listed
items through the designated AbilityOne nonprofit agency (NPA) or its
authorized distribution channels in accordance with FAR subpart 8.7
Acquisition from Nonprofit Agencies Employing People Who Are Blind or
Severely Disabled of the Federal Acquisition Regulation. Accordingly,
DHS is required to buy Procurement List \15\ products or services from
the organization designated on the Procurement List or from an
authorized AbilityOne distributor until: (1) the government no longer
has requirements for that item, or (2) an NPA employing people who are
blind or have significant disabilities can no longer furnish that item.
This requirement remains unchanged by the MPAA.
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\15\ See 41 U.S.C. chapter 85, FAR subpart 8.7, and the
Procurement List at <a href="https://www.abilityone.gov/procurement_list/index.html">https://www.abilityone.gov/procurement_list/index.html</a>.
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It appears some commenters incorrectly believe DHS is using the
fact that nitrile gloves are a Procurement List item to circumvent the
requirements of the MPAA. Upon implementation of the Act, DHS
immediately extended the requirements of the MPAA to nitrile glove
purchases from AbilityOne. DHS's reliance on waivers to acquire nitrile
gloves had nothing to do with the fact that these items are sourced
through AbilityOne. DHS used waivers to acquire nitrile gloves for a
variety of reasons, including limited domestic manufacturing capacity
to meet DHS specifications and quantity requirements, limited
availability of domestic nitrile gloves capable of successfully passing
TSA testing requirements, and the lack of domestic production of NBR.
Prior to January 2026, DHS sourced nitrile gloves from both domestic
and foreign manufacturers. However, as domestic manufacturing capacity
expanded, DHS transitioned to sourcing all nitrile glove requirements
from domestic manufacturers. The transition to sourcing 100 percent of
DHS's nitrile gloves to domestic manufacturers is largely attributable
to the partnership between DHS and our AbilityOne NPA. Accordingly, DHS
declines to adopt the suggestion as it is not needed to achieve its
domestic sourcing objectives.
3. Exceptions Language
Comment: Several commenters asserted that section 70953(d)(1)(A) of
the MPAA expressly incorporates the nonavailability determinations
contained in FAR 25.104(a) and therefore excludes covered PPE component
and materials identified on that list from the Act's domestic sourcing
requirements. The commenters argued that DHS should revise HSAR
3025.7102-2 to clarify that materials such as NBR are automatically
exempt from the Act when used in PPE manufactured in the United States
and that no additional nonavailability determination or waiver should
be required.
Response: DHS declines the commenters' request to modify section
3025.7102-2 to include reference to FAR 25.104 or otherwise address the
domestic nonavailability status of NBR. The nonavailable articles list
at FAR 25.104 is subject to periodic review and amendment.
Incorporating specific references to articles identified as
nonavailable under FAR 25.104 into the HSAR could create
inconsistencies if future revisions are made to the FAR. DHS therefore
believes it is more appropriate to rely on the existing statutory and
regulatory framework rather than codify specific nonavailability
determinations in the HSAR. DHS also disagrees with the commenters'
assertion that the inclusion of a material, component, or supply on the
FAR 25.104 nonavailability list automatically eliminates the need for
agencies to comply with the Act's exception procedures. While section
70953(d)(1)(A) references articles, materials, and supplies identified
in FAR 25.104, DHS does not believe it is necessary or appropriate to
incorporate those determinations directly into HSAR. The existing
statutory and regulatory framework provides sufficient flexibility to
address nonavailable materials and components without creating separate
regulatory provisions for specific items in FAR 25.104. Additionally,
because NBR is not currently produced domestically, agencies acquiring
covered PPE that contains NBR have historically relied on the MPAA's
nonavailability exception and associated waiver processes to address
the lack of a domestic source. DHS therefore does not believe inclusion
of the requested language is necessary to address the current domestic
nonavailability of NBR.
4. HSAR 3052.225-7X Make PPE in America
Comment: Multiple commenters requested DHS revise 3025.7102-2(b) to
clarify treatment of components and materials identified as
nonavailable under FAR 25.104. The commenters' asserted that PPE
manufactured in the United Sates should remain compliant with the MPAA
when it contains components or materials listed in FAR 25.104,
including NBR. The commenters also proposed revising the paragraph to
expressly recognize component-specific waivers and nonavailability
determinations when evaluating compliance with the Act's domestic
sourcing requirements as follows: ``(b) The Contractor shall deliver
only domestic personal protective equipment except the domestic
manufactured products include component items except under the FAR
25.104 or the agency provides a specific component waiver for domestic
manufactured personal protective equipment or to the extent that it
specified delivery of foreign-assembled domestic personal protective
equipment in the provision of the solicitation entitled ``Make PPE in
America Certificate.''
[[Page 59069]]
Response: Although the commenter cited HSAR 3025.7102-2(b), DHS
understands the comment as requesting revisions to the clause at HSAR
3052.225-7X based on the proposed clause language provided.
Notwithstanding this, DHS declines to make this change to the clause.
The regulatory text at 3025.7102-2 makes clear the applicability of the
exception at FAR 25.104. Therefore, including a reference to the
nonavailable articles listing in FAR 25.104 in the clause text is
unnecessary and redundant.
DHS also declines to incorporate references to specific
nonavailable materials, component-specific waivers, or component-level
nonavailability determinations into the clause. The purpose of the
clause is to implement the contractor's obligation to provide covered
PPE that complies with statutory and regulatory requirements applicable
to the acquisition. The clause is not intended to restate all
exceptions, waiver authorities, and nonavailability determination that
may apply under the Act or related regulations. Those matters are
addressed elsewhere in the statutory and regulatory framework,
including HSAR 3025.7102-2. Accordingly, DHS believes the existing
clause adequately implements the Act without the proposed revisions.
5. AbilityOne and Similar Network Providers
Comment: One commenter requested creation of a specific category to
clarify the status of PPE repackaging operations under programs like
AbilityOne, ensuring transparency and alignment with domestic
manufacturing priorities. The commenter asserts this refinement would
ensure alignment with industry practices and the intent of the Act.
The commenter also recommended DHS explicitly address AbilityOne
exceptions within the order of precedence framework, stating that the
Department's current model allows for foreign-produced PPE to receive
preference through AbilityOne repackaging operations, undermining the
intent of the MPAA. The commenter further stated this is particularly
relevant for nitrile gloves, where certain providers import bulk
products from Malaysia for domestic repackaging. To prevent this from
happening, the commenter stated waiver usage should be narrowly
tailored to support U.S. manufacturers utilizing TAA-compliant
components rather than allowing broad allowances that benefit foreign
producers.
Response: DHS declines the commenter's recommendation to create a
specific category for repackaging operations under programs like
AbilityOne. DHS also declines to explicitly identify AbilityOne in the
order of preference framework and disagrees that the current model
allows for foreign-produced PPE to receive preference through
AbilityOne repackaging operations.
The AbilityOne Program operates pursuant to the JWOD Act, codified
at 41 U.S.C. chapter 85, which establishes a mandatory source program
for certain products and services furnished by qualified nonprofit
agencies employing people who are blind or have significant
disabilities. The Committee for Purchase From People Who Are Blind or
Severely Disabled (operating as the AbilityOne Commission) administers
the program and maintains the Procurement List, accessible at
<a href="http://www.abilityone.gov">www.abilityone.gov</a>, identifying mandatory source products and services.
Federal agencies are generally required to procure listed items through
the designated AbilityOne NPA or its authorized distribution channels
in accordance with FAR subpart 8.7 Acquisition from Nonprofit Agencies
Employing People Who Are Blind or Severely Disabled of the Federal
Acquisition Regulation.
Nitrile gloves are a Procurement List item for the Department. DHS
is required to buy Procurement List products or services from the
organization designated on the Procurement List or from an authorized
AbilityOne distributor until: (1) the government no longer has
requirements for that item, or (2) an NPA employing people who are
blind or have significant disabilities can no longer furnish that item.
This requirement remains unchanged by the MPAA.
As previously stated, it appears some commenters incorrectly
believe DHS is using the fact that nitrile gloves are a Procurement
List item to circumvent the requirements of the MPAA. Upon
implementation of the Act, DHS immediately extended the requirements of
the MPAA to nitrile glove purchases from AbilityOne. DHS's reliance on
waivers to acquire nitrile gloves was unrelated to the items being
sourced through AbilityOne. DHS used waivers to acquire nitrile gloves
for a variety of reasons, including limited domestic manufacturing
capacity to meet DHS specifications and quantity requirements, limited
availability of domestic nitrile gloves capable of successfully passing
TSA testing requirements, and the lack of domestic production of NBR.
Prior to January 2026, DHS sourced nitrile gloves from both domestic
and foreign manufacturers. However, as domestic manufacturing capacity
expanded, DHS transitioned to sourcing all nitrile glove requirements
from domestic manufacturers. The transition to sourcing 100 percent of
DHS's nitrile gloves to domestic manufacturers is largely attributable
to the partnership between DHS and our AbilityOne NPA. Accordingly, DHS
declines to adopt the suggestions as they are not needed to achieve its
domestic sourcing objectives.
6. Domestic PPE Categories
Comment: One commenter asked DHS to split ``domestic personal
protective equipment'' into two distinct categories, i.e., ``wholly
domestic PPE'' for items manufactured entirely in the United States and
``domestically manufactured PPE'' for items like nitrile gloves that
currently require some imported raw materials. The commenter requested
that the ``domestically manufactured PPE'' category explicitly
recognize FAR 25.104(a) exceptions for materials like NBR, allowing
sourcing from Trade Agreements Act (TAA)-compliant countries without
penalty while maintaining domestic manufacturing status.
Response: DHS declines to create sub-categories for domestic
personal protective equipment. For the purposes of the MPAA, PPE is
either domestic, foreign-assembled domestic, or foreign. These
definitions were established for consistency with the MPAA which
requires purchase of domestic PPE and use of alternative domestic
sources when domestic PPE is not available. An additional defined
category of PPE is not necessary to implement the availability
exception regarding FAR 25.104. Notwithstanding this, the nonavailable
articles list at FAR 25.104 is subject to periodic review and
amendment.
Incorporating specific references to articles identified as
nonavailable under FAR 25.104 into the HSAR could create
inconsistencies if future revisions are made to the FAR. DHS therefore
believes it is more appropriate to rely on the existing statutory and
regulatory framework rather than codify specific nonavailability
determinations in the HSAR.
7. Exception Criteria for Nonavailability and Unreasonable Cost
Comment: One commenter requested DHS provide additional guidance
regarding the applicability of the nonavailability and unreasonable
cost exceptions. Specifically, the commenter recommended: (1)
establishing objective quality standards and qualification benchmarks
for evaluating nonavailability determinations; (2) adopting defined
methodologies and
[[Page 59070]]
thresholds for determining when costs are unreasonable, including
consideration of total cost of ownership and reliability factors; and
(3) clarifying materials and components identified as nonavailable
under FAR 25.104, including NBR, are exempt from the Act's domestic
sourcing requirements when incorporated into PPE manufactured in the
United States.
Response: DHS declines the commenter's recommendation to identify
specific quality standards under the exception criteria for
nonavailability and unreasonable cost. First, the MPAA provides
explicit instruction on the use of the nonavailability exception.
Second, DHS does not perform subjective quality assessments and instead
relies on established PPE specifications. DHS PPE specifications are
based on standards promulgated by either the American National
Standards Institute (ANSI), American Society for Testing and Materials
(ASTM), or National Institute for Occupational Safety and Health
(NIOSH), and regarding nitrile gloves, TSA-specific testing for
interference with explosives detection equipment/machines before use.
DHS specifications for PPE have been shared with industry multiple
times via industry meetings and postings to <a href="http://SAM.gov">SAM.gov</a>. As such, it is
clear DHS does not rely on subjective quality standards.
Regarding identification of a specific methodology for determining
whether an item is being provided at an unreasonable cost, DHS declines
the commenter's recommendation. DHS intentionally refrained from
identifying a specific calculation methodology to allow more
flexibility for DHS and to minimize unfavorable impacts to industry.
This flexibility is needed due to fluctuating market conditions that
could result in the use of unreasonable cost determinations too
frequently. Additionally, given DHS acquires these items on a firm
fixed price basis, we would not review the individual cost elements
associated with the final price of the item. Notwithstanding this, to
date DHS has not used the unreasonable cost exception to acquire
personal protective equipment covered under this rulemaking.
DHS declines to further identify that the requirements of the MPAA
do not apply to PPE, or a component or material thereof, that is or
includes a material on the nonavailable articles listing in FAR
25.104(a) or limit the applicability of the exception to U.S.-based
manufacturing facilities. The nonavailability exception is already
addressed in the regulatory text. Specifically, section 3025.7102-
2(b)(1) states that the purchase restrictions of the MPAA do not apply
to PPE, or component thereof, ``that is, or that includes, a material
listed in FAR 25.104 as one for which a nonavailability determination
has been made.'' Accordingly, DHS concludes the proposed revisions are
unnecessary because the existing regulatory text already implements the
statutory nonavailability exception and appropriately addresses
materials identified in FAR 25.104.
8. Implementation Timeline
Comment: One commenter stated that the proposed implementation
timeline appears workable provided DHS maintains clear communication
with industry and allows reasonable adjustment periods for
manufacturers to scale production. The commenter recommended: (1) a
phased approach to domestic content requirements, particularly for
items requiring development of domestic raw material sources; (2)
ongoing engagement with manufacturers to address implementation
challenges and refine guidance as needed; and (3) clear instructions
regarding certification and compliance documentation to minimize
administrative burdens.
Response: DHS appreciates the commenter's support for the proposed
implementation timeline and agrees that continued communication with
industry and clear compliance guidance are important to successful
implementation of the Act. The MPAA directs agencies to implement the
contract requirements beginning 90 days after the enactment of the Act.
Accordingly, DHS lacks authority to phase in domestic sourcing
requirements beyond the implementation framework established by
Congress. As such, a phased approach to domestic content requirements
is not possible. However, the Act authorizes the use of exceptions and
waivers when covered PPE is unavailable from domestic sources or
available only at an unreasonable cost, providing flexibility where
domestic industrial capacity cannot meet requirements.
DHS has established forums for ongoing engagement with industry on
a variety of procurement topics, including the MPAA. Additionally, DHS
waivers under the MPAA are publicly posted at <a href="http://MadeinAmerica.gov">MadeinAmerica.gov</a>. DHS
intends to continue engaging with industry and other stakeholders
regarding implementation of the Act and related acquisition
requirements.
The provision at 3052.225-7Y Make PPE in America Certificate
clearly articulates how contractors must certify compliance with MPAA
requirements, including requesting identification of the line item for
the covered PPE item(s) identifies and the country of assembly. DHS
believes the existing certification provision, together with publicly
available solicitation and contract documentation, provides sufficient
guidance regarding compliance with the Act and does not require further
revision as part of this rulemaking.
9. Tiered Sourcing Hierarchy
Comment: One commenter urged DHS to adopt a tiered sourcing
hierarchy that prioritizes domestic PPE manufacturing to the greatest
extent possible before allowing waivers under the MPAA. Specifically
the commenter recommends DHS: (1) give first priority to PPE
manufactured in the United States using domestically sourced
components; (2) allow U.S.-manufactured PPE using TAA-country
components when required components are not available domestically,
without requiring a waiver; (3) allow U.S.-manufactured PPE using non-
TAA foreign components when domestic or TAA-sourced components are
unavailable, without requiring a waiver; (4) permit waivers for
foreign-manufactured PPE from TAA countries only after domestic
manufacturing options have been exhausted; and (5) permit waivers for
non-TAA foreign-manufactured PPE only as a last resort when no domestic
or TAA-country sources are available. The commenter argues this
approach would better advance the MPAA's objective of strengthening
domestic PPE manufacturing by prioritizing U.S.-based production and
employment while recognizing the practical reality that certain
components, such as NBR, may not be available from domestic sources.
Response: DHS declines to adopt the commenter's proposed
restrictions on when a waiver may be used or establish the proposed
sourcing hierarchy. The circumstances under which an exception may be
used are defined in the MPAA. The Act requires agencies to prioritize
the acquisition of covered PPE manufactured in the United States and
authorizes the use of exceptions when covered PPE is unavailable or
available only at an unreasonable cost. Nothing in the Act directs
agencies to create additional tiers of preference among otherwise
permissible sources or exhaust particular categories of suppliers
before relying on a statutory exception.
DHS has nevertheless taken an additional step beyond the
requirements
[[Page 59071]]
of the MPAA by requiring procurement of either Buy American statute
compliant or TAA-compliant PPE, depending on the dollar value of the
procurement, when MPAA compliant PPE is not available. This approach
ensures domestically manufactured PPE receives first consideration and
that Buy American statute compliant or TAA-compliant PPE is acquired
when MPAA compliant PPE cannot be obtained due to nonavailability or
unreasonable cost.
DHS also declines to adopt the proposed hierarchy because it does
not account for all circumstances in which the Act authorizes use of an
exception, including situations involving either nonavailability or
unreasonable cost. Further, the proposed hierarchy does not account for
agency-specific performance requirements that may affect the
availability of compliant PPE, such as the TSA testing requirements
applicable to nitrile gloves.
Notwithstanding this, DHS has only used the nonavailability
exception when sourcing nitrile gloves and only when necessary to meet
mission requirements. To date, DHS has relied on the nonavailability
exception to cover a portion of DHS's nitrile glove demand. Prior to
January 2026, DHS sourced nitrile gloves from both domestic and foreign
manufacturers. However, as domestic manufacturing capacity expanded,
DHS transitioned to sourcing all nitrile glove requirements from
domestic manufacturers.
Accordingly, DHS declines to adopt the proposed sourcing hierarchy
and believes the final rule appropriately implements the statutory
framework established by Congress while preserving the flexibility
necessary to address nonavailability, unreasonable cost, agency mission
requirements, and changing market conditions.
10. Prioritization
Comment: One commenter asked DHS to prioritize American-made
products in government procurement decisions and carefully consider
prioritizing products fully manufactured in the United States, but that
might use certain raw materials unavailable domestically, from Trade
Act compliant nations.
Response: DHS already prioritizes wholly domestically manufactured
PPE. When these items are not available, either due to nonavailability
or unreasonable cost, DHS seeks to acquire either a Buy American
statute compliant or TAA-compliant item.
11. Out of Scope
Comment: Some commenters requested that DHS revise the regulatory
text to encourage contracting officers to seek out domestic
manufacturers, including small businesses, when acquiring covered PPE.
Response: These suggestions are beyond the scope of this rule. This
rule is about implementing the MPAA. The MPAA does not include
provisions regarding small business participation and the NPRM did not
propose requirements involving small business participation.
III. Final Rule
This final rule amends the HSAR at 48 CFR part 3025, Foreign
Acquisition, and at 48 CFR part 3052, Solicitation Provisions and
Contract Clauses. The rule adds a new HSAR subpart, an HSAR clause, and
an HSAR provision which codifies how DHS complies with the Act. These
changes also codify the requirements from Deviation 23-01. Each of
these amendments are described in detail in the following paragraphs.
This final rule adds new subpart 3025.71, Make PPE in America Act
Restrictions on Foreign Acquisition, to the HSAR, codifying the
restrictions in Deviation 23-01 applicable to the acquisition of
certain PPE consistent with the Act. These restrictions include minimum
time periods for contract duration, content requirements for certain
PPE, alternatives to domestic production when conforming PPE is not
available, and exceptions when conforming PPE is either nonavailable or
cannot be procured at U.S. market prices (or in other words, only
available at an unreasonable cost).
This rule also codifies the definitions of terms used in Deviation
23-01.\16\ These terms are ``component,'' ``domestic personal
protective equipment,'' ``foreign-assembled domestic personal
protective equipment,'' ``foreign personal protective equipment,''
``personal protective equipment,'' and ``United States.''
---------------------------------------------------------------------------
\16\ See 48 CFR 3025.7101.
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Additionally, this rule applies to all types of actions, orders,
option exercises, and contracts awarded and administered by DHS. It
requires contracting officers to purchase domestic PPE except for when
certain exceptions, specified in HSAR 3025.7102-2, apply and also
requires that any contract for PPE has a base period of performance of
at least two years, plus option periods.
HSAR 3025.7102-2 codifies the conditions under which acquisitions
of PPE, or component thereof, are excepted from the requirements of
HSAR 3025.7102-1 (i.e., alternatives to domestic production,
nonavailability, and unreasonable cost) consistent with Deviation 23-
01.
This final rule further codifies the clauses and provisions that
apply when an exception due to nonavailability or unreasonable cost is
used, as listed in Deviation 23-01.\17\ Additionally, this final rule
codifies HSAR 3025.7103, HSAR clause 3052.225-7X, Make PPE in America,
and HSAR provision HSAR 3052.225-7Y, Make PPE in America Certificate.
The final rule makes a technical edit to consistently use the term
``DHS Chief Procurement Officer'' where applicable. Otherwise, DHS
adopts the NPRM as final, amending 48 CFR part 3025, Foreign
Acquisitions, and 48 CFR part 3052, Solicitation Provisions and
Contract Clauses.
---------------------------------------------------------------------------
\17\ See 48 CFR 3025.7102-3.
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IV. Regulatory Analyses
A. Executive Orders 12866, 13563, and 14192
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review) 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. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. Executive Order 14192 (Unleashing
Prosperity Through Deregulation) directs agencies to significantly
reduce the private expenditures required to comply with Federal
regulations and provides that ``any new incremental costs associated
with new regulations shall, to the extent permitted by law, be offset
by the elimination of existing costs associated with at least 10 prior
regulations.''
The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, OMB has not reviewed this regulatory action.
This rule is not an Executive Order 14192 regulatory action because
this rule is not significant under Executive Order 12866. See OMB
Memorandum M-25-20, ``Guidance Implementing Section 3 of Executive
Order 14192, titled `Unleashing Prosperity Through Deregulation'''
(Mar. 26, 2025).
Need for the Rule
This final rule codifies the requirements as set forth in the Act
and Deviation 23-01. DHS is updating the Homeland Security Acquisition
[[Page 59072]]
Regulation (HSAR) to align with current DHS practice in Deviation 23-
01. This rule provides for consistency between the Act and the HSAR.
Benefits and Costs of the Final Rule
The benefits and costs of a regulation are generally measured
against a no-action baseline, which is a reasonable forecast of the way
the world would look absent the regulatory action being assessed.\18\
As the final rule aligns the regulations with DHS current practice, it
does not result in additional costs for the Federal Government. The
rule codifies the requirement for contactors to submit a Make PPE in
America Certificate, only in the situation when the contractor is
proposing foreign-assembled domestic PPE. DHS already included this
contractor requirement to certify compliance in Deviation 23-01.
Because DHS contractors already comply with Deviation 23-01, they would
not incur new costs due to this rule.
---------------------------------------------------------------------------
\18\ See OMB Circular A-4, p., 15 (September 17, 2003)
(accessible at accessible at <a href="https://www.whitehouse.gov/wp-content/uploads/2025/08/CircularA-4.pdf/">https://www.whitehouse.gov/wp-content/uploads/2025/08/CircularA-4.pdf/</a>).
---------------------------------------------------------------------------
However, Deviation 23-01, which is how DHS complies with the
requirements of the Act, may cause DHS to incur additional costs in the
form of higher prices for domestically produced PPE compared to
foreign-produced PPE. Future DHS procurement price differences between
domestic and foreign-sourced PPE are difficult to accurately estimate.
External factors (outside of the Act's requirement) may influence
prices. For example, U.S. Government investments in domestic PPE
production could factor into domestic production costs and prices.
There is uncertainty on foreign governments investment in foreign PPE
production which would impact foreign prices. An analysis of PPE would
have to be conducted by type of PPE, such as the domestic and foreign
prices of masks, protective eyewear, or gloves. Further, DHS has
specific requirements in certain procurements such as gloves (i.e.,
testing for interference with explosive equipment and protection
against Fentanyl exposure) that would need to be considered in any
price comparisons.\19\ Another factor that would be difficult to
address in direct price comparisons is product differences. There are
no internationally agreed upon guidelines or standards of what specific
products make up PPE categories, complicating product comparisons.\20\
---------------------------------------------------------------------------
\19\ DHS, White Paper: Current State of Personal Protective
Equipment Procurement by Make PPE in America Act Covered Agencies.
3-4 (March 13, 2024).
\20\ ``For example, KN95 respirator masks- China made analogues
to domestically regulated N-95 respirators- are generally not
authorized as medical PPE in the United States. KN95 are authorized
in many countries abroad and received temporary (and limited)
Emergency Use Authorization from the [U.S. Food and Drug
Administration] FDA.'' FDA, Certain Filtering Facepiece Respirators
from China May Not Provide Adequate Respiratory Protection--Letter
to Health Care Providers, October 15, 2020, at <a href="https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter">https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter</a>.
---------------------------------------------------------------------------
Consequently, due to the lack of specific data, complexity of
various factors, and uncertainty of external price influences, DHS is
not able to estimate the long-run additional DHS cost of an increased
shift to domestic PPE procurements due to the requirements of the Act.
Importantly, DHS has already complied with the requirements of the Act
through Deviation 23-01 and subsequent contract changes.
Congress recognized the need for the United States to have a
robust, secure, and wholly domestic PPE supply chain to safeguard
public health and national security.\21\ This final rule codifies the
statutory requirements that support the sustainment of the U.S. PPE
supply chain. This final rule would provide the clarification benefit
of consistency and transparency for contractors and DHS contracting
officers.
---------------------------------------------------------------------------
\21\ Public Law 117-58, 135 Stat. 1313.
---------------------------------------------------------------------------
B. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601 et seq., as
amended by the Small Business Regulatory Enforcement Fairness Act of
1996, Public Law 104-121 (Mar. 29, 1996), requires Federal agencies
engaged in rulemaking to consider the economic impacts of their rules
on small entities. A small entity may be a small business (defined as
any independently owned and operated business not dominant in its field
that qualifies as a small business per the Small Business Act); a small
not-for-profit organization; or a small governmental jurisdiction
(locality with fewer than 50,000 people). This final rule will provide
clarity and consistency between the HSAR and existing DHS practice as
set forth in Deviation 23-01. Contractors currently provide the Make
PPE in America Certificate in compliance with Deviation 23-01. The Make
PPE in America Certificate is required only if the offeror is proposing
foreign-assembled domestic PPE. DHS estimates the contractor burden
based on experience from subject matter experts familiar with Deviation
23-01. DHS estimates it will take a contractor 15 minutes to identify
any foreign-assembled domestic PPE items it is offering and complete
the Make PPE in America Certificate. DHS assumes an estimated hourly
compensation rate of $57.95 for the time burden.\22\ The time burden
cost per certificate would be $14.49 (15 minutes x $57.95).
---------------------------------------------------------------------------
\22\ The average hourly earnings are based upon the U.S.
Department of Labor, Bureau of Labor Statistics' website
(<a href="http://www.bls.gov">www.bls.gov</a>). The wage rate category selected is for Business and
Financial Operations Occupations (13-0000), May 2022. The rate is
estimated to be $57.95 ($41.39 x 1.4), which includes the wage rate
multiplier.
---------------------------------------------------------------------------
Based on the estimated cost of $14.49 per certificate, DHS assumes
this cost would not be a significant economic impact on a small entity
affected by the final rule. DHS also believes that contractors
generally pass along the cost of complying with DHS contracting
requirements to DHS. Therefore, DHS certifies under 5 U.S.C. 605(b)
that this final rule would not have a significant economic impact on a
substantial number of small entities.
C. Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.)
requires that DHS consider the impact of paperwork and other
information collection burdens imposed on the public and, under the
provisions of 44 U.S.C. 3507(d), obtain approval from the OMB for each
collection of information it conducts, sponsors, or requires through
regulations. This final rule contains information collection
requirements. Accordingly, DHS is updating OMB No. 1600-0005,
Solicitation of Proposal Information for Award of Public Contracts.
The collection requirements for this final rule are nominal and
based on the new provision, 3052.225-7Y, Make PPE in America
Certificate.
Overview of Information Collection
(1) Type of Information Collection: Modification to Existing
Collection.
(2) Title of the Form/Collection: Solicitation of Proposal
Information for Award of Public Contracts.
(3) Agency form number, if any, and the applicable component of DHS
sponsoring the collection: No form; OCPO.
(4) Affected public who will be asked or required to respond; as
well as a brief abstract: The affected public is business or other for-
profit institutions. DHS needs the information required by provision
3052.225-72 to assess contractor compliance with the Make PPE in
America Act. Responses are required for respondents to obtain or retain
benefits.
[[Page 59073]]
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond: The estimated
number of respondents for reporting is 0.08. This number is nominal
because a response to this provision is required only if the offeror is
proposing foreign-assembled domestic PPE. Such response should be rare,
because the offeror of such products is unlikely to receive an award,
unless no offers for domestic PPE are received. In Fiscal Year (FY)
2022, DHS awarded 8 contracts for domestic PPE. DHS estimates it will
receive ten offers per solicitation. Using the number of contracts
awarded in FY 2022, DHS estimates it received 80 offers. DHS estimates
0.2 percent of offers, or 0.16 responses, will include foreign-
assembled domestic protective equipment. The average number of
responses per respondent is two or 0.08 respondents. DHS estimates it
will take each respondent 15 minutes to complete the certificate. These
numbers are not unusual given that DHS awarded a mandatory for use,
Departmentwide contract for domestic PPE in March of 2022 and the
requirements of provision 3052.225-72 Make PPE in America Certificate
were satisfied at the contract level. Standalone contracts are awarded
only when the domestic PPE needed is not available under the
Departmentwide contract.
(6) An estimate of the total public burden (in hours) associated
with the information collection: The total estimated annual hour burden
associated with this collection is 0.033 hours or 2 minutes.
(7) An estimate of the total public burden (in cost) associated
with the information collection: The estimated total annual cost burden
associated with this collection of information is $2.32.
D. National Environmental Policy Act
DHS and its components analyze regulatory actions to determine
whether the National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et
seq., applies to them and, if so, what degree of analysis is required.
DHS Directive 023-01 Rev. 01 ``Implementing the National Environmental
Policy Act'' (Dir. 023-01 Rev. 01) and Instruction Manual 023-01-001-01
Rev. 01 (Instruction Manual) \23\ establish the policies and procedures
that DHS and its components use to comply with NEPA.
---------------------------------------------------------------------------
\23\ The Instruction Manual, which contains DHS's procedures for
implementing NEPA, was issued on November 6, 2014, and is available
at <a href="https://www.dhs.gov/ocrso/eed/epb/nepa">https://www.dhs.gov/ocrso/eed/epb/nepa</a> (last modified July 29,
2025).
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NEPA allows Federal agencies to establish, in their NEPA
implementing procedures, categories of actions (``categorical
exclusions'') that experience has shown do not, individually or
cumulatively, have a significant effect on the human environment and,
therefore, do not require an environmental assessment or environmental
impact statement. See 42 U.S.C. 4336(a)(2), 4336e(1). The Instruction
Manual, Appendix A lists the DHS Categorical Exclusions.\24\
---------------------------------------------------------------------------
\24\ See Appendix A, Table 1.
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Under DHS NEPA implementing procedures, for an action to be
categorically excluded, it must satisfy each of the following three
conditions: (1) the entire action clearly fits within one or more of
the categorical exclusions; (2) the action is not a piece of a larger
action; and (3) no extraordinary circumstances exist that create the
potential for a significant environmental effect.\25\
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\25\ Instruction Manual 023-01 at V.B(2)(a)-(c).
---------------------------------------------------------------------------
The final rule amends the HSAR to better clarify how DHS complies
with the Make PPE in America Act, and codifies Deviation 23-01 that is
currently in effect. DHS is not aware of any significant impact on the
environment, or any change in environmental effect that will result
from this final rule.
DHS has reviewed this final rule and finds that no significant
impact on the environment, or any change in environmental effect will
result from the amendments being promulgated in this final rule.
Accordingly, DHS finds that the promulgation of this final rule clearly
fits within categorical exclusion A3, established in the DHS's NEPA
implementing procedures as an administrative change with no change in
environmental effect, is not part of a larger Federal action, and does
not present extraordinary circumstances that create the potential for a
significant environmental effect. Therefore, this final rule is
categorically excluded from further NEPA review.
List of Subjects in 48 CFR Parts 3025 and 3052
Government procurement.
Accordingly, for the reasons set forth in the preamble, DHS amends
48 CFR parts 3025 and 3052 as follows:
PART 3025--FOREIGN ACQUISITION
0
1. The authority citation for part 3025 is revised to read as follows:
Authority: 5 U.S.C. 301-302, 41 U.S.C. 1303, 41 U.S.C. 1707, 41
U.S.C. 1702, 41 U.S.C. 8301 note, 48 CFR part 1, subpart 1.3, DHS
Delegation No. 00701, Revision No. 03.2, paragraphs (III)(H), and
DHS Delegation No. 00702, Revision No. 01.2, paragraphs (III)(M).
0
2. Add subpart 3025.71 to read as follows:
Subpart 3025.71--Make PPE in America Act Restrictions on Foreign
Acquisition
Sec.
3025.7100 Scope of subpart.
3025.7101 Definitions.
3025.7102 Restrictions on certain personal protective equipment.
3025.7102-1 Restrictions.
3025.7102-2 Exceptions.
3025.7102-3 Specific application of the Buy American statute and
Trade Agreements Act.
3025.7103 Solicitation provisions and contract clauses.
3025.7100 Scope of subpart.
This subpart contains restrictions on the acquisition of certain
personal protective equipment (PPE) imposed by the Make PPE in America
Act (Pub. L. 117-58), and they apply to all types of actions, orders,
option exercises, and contracts entered into on or after February 14,
2022.
3025.7101 Definitions.
As used in this subpart--
(a) Component, as applied to an item described in 3025.7102-1,
means an article, material, or supply incorporated directly into an
item of personal protective equipment.
(b) Domestic personal protective equipment, as applied to an item
described in 3025.7102-1, means personal protective equipment,
including the materials and components thereof, that is grown,
reprocessed, reused, or produced in the United States.
(c) Foreign-assembled domestic personal protective equipment, as
applied to an item described in 3025.7102-2, means personal protective
equipment that is assembled outside the United States containing only
materials and components that are grown, reprocessed, reused, or
produced in the United States.
(d) Foreign personal protective equipment means personal protective
equipment other than domestic personal protective equipment or foreign-
assembled domestic personal protective equipment.
(e) Personal protective equipment, as applied to an item described
in 3025.7102-1, means surgical masks, respirator masks and powered air
purifying respirators and required filters, face shields and protective
eyewear, gloves, disposable and reusable surgical and isolation gowns,
head and foot coverings, and other gear
[[Page 59074]]
or clothing used to protect an individual from the transmission of
disease.
(f) United States, as applied to an item described in 3025.7102-1,
means the 50 States, the District of Columbia, and the possessions of
the United States.
3025.7102 Restrictions on certain personal protective equipment.
3025.7102-1 Restrictions.
The following restrictions implement section 70953 of the Make PPE
in America Act, and they apply to all types of actions, orders, option
exercises, and contracts.
(a) Except as provided in 3025.7102-2, contracting officers shall
purchase domestic personal protective equipment.
(b) Any contract for personal protective equipment shall have a
base period of performance of at least 2 years, plus all option
periods.
3025.7102-2 Exceptions.
Acquisitions in the following categories are not subject to the
restrictions in 3025.7102-1:
(a) Acquisitions of an item of personal protective equipment, or
component thereof, otherwise covered by 3025.7102-1 when the DHS Chief
Procurement Officer:
(1) Maximizes sources for foreign-assembled domestic personal
protective equipment; and
(2) Certifies every 120 days that it is necessary to procure
personal protective equipment under alternative procedures to respond
to the immediate needs of a public health emergency.
(b) Acquisitions of an item of personal protective equipment, or
component thereof, including those described in paragraph (a) of this
section--
(1) That is, or that includes, a material listed in FAR 25.104 as
one for which a nonavailability determination has been made; or
(2) As to which the DHS Chief Procurement Officer determines that a
sufficient quantity of a satisfactory quality that is grown,
reprocessed, reused, or produced in the United States cannot be
procured as, and when, needed at United States market prices; and
(3) The DHS Chief Procurement Officer certifies every 120 days that
it is necessary to procure personal protective equipment to respond to
the immediate needs of a public health emergency.
(c) When either of the exceptions in paragraph (a) or (b) of this
section are used:
(1) Only the DHS Chief Procurement Officer is authorized to make
the certification in paragraphs (a)(2) and (b)(3) of this section or
the nonavailability or unreasonable cost determination in paragraph (b)
of this section.
(2) The supporting documentation for the DHS Chief Procurement
Officer shall be prepared by the DHS Component(s) and:
(i) For the certification in paragraphs (a)(2) and (b)(3) of this
section:
(A) Include a written justification documenting the immediate
public health emergency requiring use of alternative procedures; and
(B) Be concurred on by the Head of the Contracting Activity before
submission to the DHS Chief Procurement Officer.
(ii) For the nonavailability or unreasonable cost determination in
paragraph (b) of this section:
(A) Include a written justification documenting why a
nonavailability or unreasonable cost exception is required; and
(B) Be concurred on by the Head of the Contracting Activity before
submission to the DHS Chief Procurement Officer.
3025.7102-3 Specific application of the Buy American statute and Trade
Agreements Act.
In the event the DHS Chief Procurement Officer determines neither
domestic personal protective equipment nor foreign-assembled domestic
personal protective equipment is available due to nonavailability or
unreasonable cost, contracting officers shall apply one of the
following:
(a) The clause at FAR 52.225-1, Buy American--Supplies, and the
provision at FAR 52.225-2, Buy American Certificate;
(b) The clause at FAR 52.225-3, Buy American--Free Trade
Agreements--Israeli Trade Act, and the provision at FAR 52.225-4, Buy
American--Free Trade Agreements--Israeli Trade Act Certificate; or
(c) The clause at FAR 52.225-5, Trade Agreements, and the provision
at FAR 52.225-6, Trade Agreements Certificate, as applicable.
3025.7103 Solicitation provisions and contract clauses.
(a) Insert the clause at 3052.225-71, Make PPE in America, in
solicitations and contracts, regardless of dollar value, when procuring
any item covered under 3025.7102-1(a).
(b) Insert the provision at 3052.225-72, Make PPE in America
Certificate, in solicitations containing the clause at 3052.225-71.
PART 3052--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
0
3. The authority citation for part 3052 is revised to read as follows:
Authority: 5 U.S.C. 301-302, 41 U.S.C. 1303, 41 U.S.C. 1707, 41
U.S.C. 1702, 41 U.S.C. 8301 note, 48 CFR part 1, subpart 1.3, DHS
Delegation No. 00701, Revision No. 03.2, paragraphs (III)(H), and
DHS Delegation No. 00702, Revision No. 01.2, paragraphs (III)(M).
0
4. Add section 3052.225-71 to read as follows:
3052.225-71 Make PPE in America.
As prescribed in 3025.7103(a), insert the following clause:
Make PPE in America (Oct. 2026)
(a) Definitions. As used in this clause--
Component, as applied to an item described in paragraph (b) of
this clause, means an article, material, or supply incorporated
directly into personal protective equipment.
Domestic personal protective equipment, as applied to an item
described in paragraph (b) of this clause, means personal protective
equipment, including the materials and components thereof, that is
grown, reprocessed, reused, or produced in the United States.
Foreign-assembled domestic personal protective equipment, as
applied to an item described in paragraph (b) of this clause, means
personal protective equipment that is assembled outside the United
States containing only materials and components that are grown,
reprocessed, reused, or produced in the United States.
Foreign personal protective equipment means personal protective
equipment other than domestic personal protective equipment or
foreign-assembled domestic personal protective equipment.
Personal protective equipment, as applied to an item described
in paragraph (b) of this clause, means surgical masks, respirator
masks and powered air purifying respirators and required filters,
face shields and protective eyewear, gloves, disposable and reusable
surgical and isolation gowns, head and foot coverings, and other
gear or clothing used to protect an individual from the transmission
of disease.
United States, as applied to an item described in paragraph (b)
of this clause, means the 50 States, the District of Columbia, and
the possessions of the United States.
(b) The Contractor shall deliver only domestic personal
protective equipment except to the extent that it specified delivery
of foreign-assembled domestic personal protective equipment in the
provision of the solicitation entitled ``Make PPE in America
Certificate.''
(c) Order of Precedence. In the event the Department of Homeland
Security determines neither domestic personal protective equipment
nor foreign-assembled domestic personal protective equipment are
available due to nonavailability or
[[Page 59075]]
unreasonable cost, the Contractor shall comply with the clauses at
Federal Acquisition Regulation (FAR) 52.225-1 Buy American--Supplies
or 52.225-3 Buy American--Free Trade Agreements--Israeli Trade Act
and the provisions at FAR 52.225-2 Buy American Certificate or
52.225-4 Buy American--Free Trade Agreements--Israeli Trade Act
Certificate or the clause at FAR 52.225-5 Trade Agreements and the
provision at FAR 52.225-6 Trade Agreements Certificate, as
applicable.
(End of clause)
0
5. Add section 3052.225-72 to read as follows:
3052.225-72 Make PPE in America Certificate.
As prescribed in 3025.7103(b), insert the following provision:
Make PPE in America Certificate (Oct. 2026)
(a)(1) The Offeror certifies that each item of personal
protective equipment, except those listed in paragraph (b) of this
provision, is domestic personal protective equipment.
(2) The Offeror shall list foreign-assembled domestic personal
protective equipment items.
(3) The terms ``domestic personal protective equipment,''
``foreign-assembled domestic personal protective equipment,''
``foreign personal protective equipment,'' and ``personal protective
equipment,'' are defined in the clause of this solicitation entitled
``Make PPE in America.''
(b) Foreign-assembled Domestic Personal Protective Equipment:
------------------------------------------------------------------------
Line item No. Country of assembly
------------------------------------------------------------------------
...............................
...............................
...............................
------------------------------------------------------------------------
[List as Necessary]
(c) In the event the Department of Homeland Security determines
both domestic personal protective equipment and foreign-assembled
domestic personal protective equipment are not available due to
nonavailability or unreasonable cost, the Contractor shall comply
with the clauses at Federal Acquisition Regulation (FAR) 52.225-1
Buy American--Supplies or 52.225-3 Buy American--Free Trade
Agreements--Israeli Trade Act and the provisions at FAR 52.225-2 Buy
American Certificate or 52.225-4 Buy American--Free Trade
Agreements--Israeli Trade Act Certificate or the clause at FAR
52.225-5 Trade Agreements and the provision at FAR 52.225-6 Trade
Agreements Certificate, as applicable. The contracting officer will
notify offerors if a nonavailability or unreasonable cost
determination is made.
(End of Provision)
Paul Courtney,
Chief Procurement Officer, U.S. Department of Homeland Security.
[FR Doc. 2026-19207 Filed 9-17-26; 8:45 am]
BILLING CODE 9112-FE-P
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</html>Indexed from Federal Register on September 18, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.