[Senate Report 117-269]
[From the U.S. Government Publishing Office]


                                                      Calendar No. 668

117th Congress    }                                     {    Report
                                 SENATE                          
 2d Session       }                                     {    117-269
______________________________________________________________________

                                     

                        MAKE PPE IN AMERICA ACT

                               __________

                              R E P O R T

                                 of the

                   COMMITTEE ON HOMELAND SECURITY AND

                          GOVERNMENTAL AFFAIRS

                          UNITED STATES SENATE

                              to accompany

                                S. 1306

              TO PROVIDE FOR DOMESTIC SOURCING OF PERSONAL
              PROTECTIVE EQUIPMENT, AND FOR OTHER PURPOSES



                [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]



               December 19, 2022.--Ordered to be printed




                                 ______
                                 

                 U.S. GOVERNMENT PUBLISHING OFFICE

39-010                    WASHINGTON : 2023















        COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                   GARY C. PETERS, Michigan, Chairman

THOMAS R. CARPER, Delaware           ROB PORTMAN, Ohio
MAGGIE HASSAN, New Hampshire         RON JOHNSON, Wisconsin
KYRSTEN SINEMA, Arizona              RAND PAUL, Kentucky
JACKY ROSEN, Nevada                  JAMES LANKFORD, Oklahoma
ALEX PADILLA, California             MITT ROMNEY, Utah
JON OSSOFF, Georgia                  RICK SCOTT, Florida
                                     JOSH HAWLEY, Missouri

                   David M. Weinberg, Staff Director
                    Zachary I. Schram, Chief Counsel
                  Michelle M. Benecke, Senior Counsel
                Pamela Thiessen, Minority Staff Director
            Sam J. Mulopulos, Minority Deputy Staff Director
                     Laura W. Kilbride, Chief Clerk










                                                      Calendar No. 668

117th Congress    }                                     {    Report
                                 SENATE                          
 2d Session       }                                     {    117-269

======================================================================



 
                        MAKE PPE IN AMERICA ACT

                                _______
                                

               December 19, 2022.--Ordered to be printed

                                _______
                                

 Mr. Peters, from the Committee on Homeland Security and Governmental 
                    Affairs, submitted the following

                              R E P O R T

                         [To accompany S. 1306]

    The Committee on Homeland Security and Governmental 
Affairs, to which was referred the bill (S. 1306) to provide 
for domestic sourcing of personal protective equipment, and for 
other purposes, having considered the same, reports favorably 
thereon with an amendment, in the nature of a subsitute, and 
recommends that the bill, as amended, do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and Summary..............................................1
 II. Background and Need for the Legislation..........................2
III. Legislative History..............................................3
 IV. Section-by-Section Analysis of the Bill, as Reported.............3
  V. Evaluation of Regulatory Impact..................................5
 VI. Changes in Existing Law Made by the Bill, as Reported............5

                         I. PURPOSE AND SUMMARY

    S. 1306, the ``Make PPE in America Act,'' requires certain 
departments that procure personal protective equipment (PPE) to 
ensure that any contracts those agencies issue for PPE are at 
least two years in length, and are for PPE that is grown, 
reprocessed, reused, or produced in the United States. Covered 
departments include the Departments of Homeland Security (DHS), 
Health and Human Services (HHS), Veterans Affairs, and Defense 
(DoD). The bill provides exceptions to the two-year minimum 
duration of PPE contracts and the domestic production 
requirement for non-availability and for alternatives to 
domestic production that the departmental secretary certifies 
as necessary to meet the immediate needs of a public health 
emergency. The need for use of such exceptions must be re-
certified by the departmental secretary every 120 days.
    S. 1306 requires the Director of the Office of Management 
and Budget (OMB), in consultation with the covered secretaries, 
to submit to Congress a report on the procurement of PPE not 
later than 180 days after the date of the bill's enactment. The 
report must address the United States' long-term domestic 
procurement strategy for PPE, including strategies to 
incentivize investment in and maintenance of domestic supply 
chains for PPE needed during a public health emergency. The 
report must include an estimate of long-term demand for all PPE 
items procured by the United States, recommendations for 
congressional action needed to implement the procurement 
strategy outlined in the report, and a determination as to 
whether any necessary action has been completed to bring 
existing United States international obligations into 
conformity with the requirements of the Act.
    S. 1306 authorizes a covered secretary to transfer to the 
Strategic National Stockpile any excess PPE acquired under a 
contract executed under the Act. The bill also allows DHS to 
transfer to HHS excess PPE or medically necessary equipment 
during a public health emergency, provided Congress is notified 
and a determination is made that the items are excess and that 
the transfer will not adversely impact DHS. The bill also 
requires DHS to maintain an inventory of the Department's PPE 
and make it available to HHS and Congress. The bill provides 
transfer authority for the Secretary of HHS, in coordination 
with the Secretary of Homeland Security, to sell drugs, 
vaccines, and other biological products, medical devices, and 
supplies maintained in the Stockpile, provided the items are no 
longer needed and within one year of their expiration date.

              II. BACKGROUND AND NEED FOR THE LEGISLATION

    When confronted with the COVID-19 pandemic, the United 
States quickly faced a PPE supply chain crisis. For supplies 
such as gowns and gloves, domestic production was limited and 
supplies were scarce.\1\ In response to this situation, the 
Defense Logistics Agency (DLA) and the Joint Acquisition Task 
Force (JATF) made a domestic non-availability determination 
(DNAD) for PPE. The DNAD waives the normal domestic content 
requirements, such as the Berry Amendment, allowing DLA/JATF to 
procure PPE from anywhere in the world. While the DNAD was 
necessary to meet the needs of the country's pandemic response, 
it underscored a real problem: that the United States should 
have more control of its PPE supply and production.
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    \1\Congressional Research Service, COVID-19 and Domestic PPE 
Production and Distribution: Issues and Policy Options (Dec. 7, 2020) 
(https://crsreports.congress.gov/product/pdf/R/R46628); See also 
Government Accountability Office, COVID-19: Federal Efforts Could Be 
Strengthened by Timely and Concerted Actions (GAO-20-701) (Sep. 21, 
2020).
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    Long-term contracts are one option to stimulate re-shoring 
and expansion of domestic PPE production. Long-term contracts 
send a powerful demand signal to industry, providing confidence 
that there will be an assured buyer if businesses make 
investments in the United States to re-shore or expand existing 
production.\2\
---------------------------------------------------------------------------
    \2\Brookings Institution Report, Reshoring Advanced Manufacturing 
Supply Chains to Generate Good Jobs (Jul. 23, 2020) (https://
www.brookings.edu/research/reshoring-advanced-manufacturing-supply-
chains-to-generate-good-jobs/).
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                        III. LEGISLATIVE HISTORY

    Ranking Member Rob Portman (R-OH) introduced S. 1306, the 
Make PPE in America Act, on April 22, 2021, with Chairman 
Peters (D-MI) as cosponsor. The bill was referred to the Senate 
Committee on Homeland Security and Governmental Affairs.
    The Committee considered S. 1306 at a business meeting on 
May 12, 2021. During the business meeting, a substitute 
amendment was offered by Ranking Member Portman and Chairman 
Peters. The substitute amendment reduced the required contract 
length from 3 years to 2 years and provided for exceptions to 
domestic production for nonavailability, cost, and where 
necessary, as certified by the relevant Secretary, to respond 
to the immediate needs of a public health emergency. A 
modification to the substitute amendment to provide for 
transfer of PPE to the Strategic National Stockpile during a 
public health emergency was adopted by voice vote en bloc. The 
modified substitute amendment was then adopted by voice vote en 
bloc. An amendment to the modified substitute amendment to add 
the text of Senator Johnson's Securing Healthcare and Response 
Equipment Act of 2020, which allows HHS and DHS to effectuate 
the transfer and sale of excess PPE, medical equipment, and 
supplies in the event of a public health emergency, to the bill 
was then offered by Senator Johnson (R-WI) and adopted by voice 
vote en bloc.
    The Committee ordered the bill reported favorably by voice 
vote en bloc as amended with Senators Peters, Carper, Hassan, 
Sinema, Rosen, Padilla, Ossoff, Portman, Johnson, Paul, 
Lankford, Romney, Scott, and Hawley present.

        IV. SECTION-BY-SECTION ANALYSIS OF THE BILL, AS REPORTED

Section 1. Short title

    This section provides that the bill may be cited as the 
``Make PPE in America Act.''

Sec. 2. Findings

    Section 2 provides that Congress makes the following 
findings:
    (1) The COVID-19 pandemic has exposed the vulnerability of 
the United States PPE supply chain as well as a lack of 
domestic production of PPE.
    (2) The United States requires a robust, secure, and wholly 
domestic PPE supply chain to safeguard public health and 
national security.
    (3) Issuing a strategy that provides the government's 
anticipated PPE needs over the next 3 years will enable 
suppliers to assess necessary changes to their manufacturing 
capacity to meet expected demands.
    (4) Industry needs a strong and consistent demand signal 
from the Federal Government to provide the certainty needed for 
industry to expand production capacity investment in the United 
States.
    (5) Long-term contracts must be no shorter than 3 years in 
duration in order to effectively incentivize the investment in 
the United States and re-shoring of manufacturing of PPE.
    (6) The United States should seek to ensure compliance with 
international obligations such as its commitments under the 
World Trade Organization's Agreement on Government Procurement 
and its free trade agreements, including by invoking relevant 
exceptions to these agreements, especially those related to 
national security and public health.
    (7) The United States needs a long-term investment strategy 
for domestic production of PPE critical to national response to 
a public health crisis, including the COVID-19 pandemic.

Sec. 3. Requirement of long-term contracts for domestically 
        manufactured personal protective equipment

    Subsection (a) defines ``appropriate congressional 
committees,'' ``covered Secretary,'' ``personal protective 
equipment,'' and ``United States.''
    Subsection (b) requires that beginning 90 days after date 
of enactment, the covered Secretaries of Homeland Security, 
Health and Human Services, Veterans Affairs, and Defense must 
issue any contract for the procurement of PPE for a duration of 
at least 2 years, plus all options necessary, and that the PPE 
and its materials and components be grown, reprocessed, reused 
or produced in the United States.
    Subsection (c) allows a covered Secretary to certify the 
need to use alternatives to domestic production after 
maximizing sources consistent with subsection (b) and 
maximizing sources for PPE assembled outside the United States 
containing materials and components that are grown, 
reprocessed, reused, or produced in the United States. This 
certification for use of alternative procedures to respond to 
the immediate needs of a public health emergency must be made 
every 120 days.
    Subsection (d) provides an exception to the domestic 
sourcing requirements for PPE that includes a material listed 
in section 25.104 of the Federal Acquisition Regulation as one 
for which a non-availability determination has been made, or 
PPE for which a covered Secretary determines that a sufficient 
quantity of a satisfactory quality cannot be procured when 
needed at United States market prices. The covered Secretary 
shall certify every 120 days that the exception is needed to 
meet the immediate needs of a public health emergency.
    Subsection (e) requires the Director of OMB, in 
consultation with the covered Secretaries, to submit a report 
to Congress within 180 days after the bill's enactment on the 
procurement of PPE. The report shall include the long-term 
domestic procurement strategy of the United States for PPE, 
including strategies to incentivize investment in and 
maintenance of domestic supply chains for PPE needed during a 
public health emergency. The report shall also include an 
estimate of long-term demand for all PPE items procured by the 
United States, recommendations for congressional action needed 
to implement the procurement strategy outlined in the report, 
and a determination as to whether any necessary action has been 
completed to bring existing United States international 
obligations into conformity with the requirements of the Act.
    Subsection (f) allows a covered Secretary to transfer to 
the Strategic National Stockpile any excess PPE acquired under 
a contract executed pursuant to subsection (b). The subsection 
amends the Homeland Security Act of 2002 to allow the Secretary 
of Homeland Security, at the request of the Secretary of Health 
and Human Services, to transfer to HHS excess PPE or medically 
necessary equipment during a public health emergency, provided 
Congress is notified and the Secretary determines the items are 
excess and certifies that the transfer will not adversely 
impact the health or safety of officers, employees, or 
contractors of DHS. The Secretary of Homeland Security, acting 
through the Chief Medical Officer, shall maintain a required 
inventory of PPE and make it available to the Secretary of 
Health and Human Services and Congress.\3\ The subsection also 
amends the Public Health Service Act to allow the Secretary of 
Health and Human Services, in coordination with the Secretary 
of Homeland Security, to sell drugs, vaccines, and other 
biological products, medical devices, and supplies maintained 
in the Strategic National Stockpile, provided the items are no 
longer needed and are within 1 year of their expiration 
date.\4\
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    \3\The change to the Homeland Security Act of 2002 set forth in 
subsection (f) of the bill was included in the Infrastructure 
Investment and Jobs Act of 2021 (Pub. L. 117-58, Sec. 70953(f)(2), 
which became law before this bill was reported out of committee. This 
change in law is now moot and is not reflected in Section VII of this 
report.
    \4\The change to the Public Health Service Act set forth in 
subsection (f) of the bill was included in the Infrastructure 
Investment and Jobs Act of 2021 (Pub. L. 117-58, Sec. 70953(f)(3), 
which became law before this bill was reported out of committee. This 
change in law is now moot and is not reflected in Section VII of this 
report.
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    Subsection (g) requires the President or President's 
designee to take all necessary steps, including invoking the 
rights of the United States under the World Trade 
Organization's Agreement on Government Procurement and relevant 
exceptions under other relevant agreements, to ensure that the 
international obligations of the United States are consistent 
with the provisions of the Act.

                   V. EVALUATION OF REGULATORY IMPACT

    Pursuant to the requirements of paragraph 11(b) of rule 
XXVI of the Standing Rules of the Senate, the Committee has 
considered the regulatory impact of this bill and determined 
that the bill will have no regulatory impact within the meaning 
of the rules. The Committee agrees with the Congressional 
Budget Office's statement that the bill contains no 
intergovernmental or private-sector mandates as defined in the 
Unfunded Mandates Reform Act (UMRA) and would impose no costs 
on state, local, or tribal governments.

       VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

    The changes in law set forth in this bill were included in 
the Infrastructure Investment and Jobs Act of 2021 (Pub. L. 
117-58, Sec. 70953(f)), which became law before this bill was 
reported out of committee. These changes in law are now moot 
and therefore are not reflected in this section. The bill as 
enacted did not include the Secretary of Defense in the 
definition of the term ``covered Secretary'' set forth in 
Section 3(a) of the substitute amendment reported out of 
Committee; the inclusion of the Secretary of Defense in the 
definition will not be enacted.

                               [all]