I 

118TH CONGRESS 

2D SESSION H. R. 8065 

To require the Secretary of Health and Human Services, acting through 

the Assistant Secretary for Preparedness and Response, to carry out 

a program under which the Secretary requires each regulated seller 

of a highly infectious agent to comply with certain logbook requirements, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 18, 2024 

Mr. COSTA (for himself and Mr. KILEY) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To require the Secretary of Health and Human Services, 

acting through the Assistant Secretary for Preparedness 

and Response, to carry out a program under which the 

Secretary requires each regulated seller of a highly infectious agent to comply with certain logbook requirements, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preventing Illegal Lab5 oratories and Protecting Public Health Act of 2024’’. 


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1 SEC. 2. REQUIRING CERTAIN SELLERS OF HIGHLY INFEC2 TIOUS AGENTS TO KEEP A LOGBOOK OF 

3 SALES. 

4 (a) PROGRAM.—The Secretary of Health and Human 

5 Services, acting through the Assistant Secretary for Pre6 paredness and Response, shall carry out a program under 

7 which the Secretary requires each regulated seller of a 

8 highly infectious agent to comply with the logbook require9 ments of subsection (c). 

10 (b) LIST OF HIGHLY INFECTIOUS AGENTS.— 

11 (1) DEVELOPMENT.—The Secretary shall de12 velop and maintain a list of all agents that meet the 

13 definition of a highly infectious agent in subsection 

14 (e). 

15 (2) INITIAL LIST.—The Secretary shall develop 

16 the initial list required by paragraph (1) not later 

17 than 12 months after the date of enactment of this 

18 Act. 

19 (3) PERIODIC REVIEW.—The Secretary shall 

20 periodically review and update the list required by 

21 paragraph (1). 

22 (4) CONSULTATION; CONSIDERATION.—In de23 veloping and updating the list required by paragraph 

24 (1), the Secretary shall— 

25 (A) consult with relevant agencies, includ26 ing the Centers for Disease Control and PreVerDate Sep 11 2014 20:47 Apr 30, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8065.IH H8065

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1 vention, the National Institutes of Health, and 

2 the Department of Homeland Security; 

3 (B) take into consideration the latest edi4 tion of ‘‘Biosafety in Microbiological and Bio5 medical Laboratories’’ published by the Centers 

6 for Disease Control and Prevention and the Na7 tional Institutes of Health (or any successor to 

8 such publication); and 

9 (C) take into consideration the latest edi10 tion of ‘‘NIH Guidelines for Research Involving 

11 Recombinant or Synthetic Nucleic Acid Mol12 ecules’’ published by the National Institutes of 

13 Health (or any successor to such publication). 

14 (c) LOGBOOK REQUIREMENTS.— 

15 (1) IN GENERAL.—Each regulated seller shall 

16 maintain, in accordance with criteria issued by the 

17 Secretary, an electronic list (in this section referred 

18 to as a ‘‘logbook’’) of the sales by such seller of each 

19 highly infectious agent on the list under subsection 

20 (b) that identifies— 

21 (A) the agent by name; 

22 (B) the quantity sold; 

23 (C) the name and address of each pur24 chaser, including relevant identifying business 


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1 information as deemed necessary by the Sec2 retary; 

3 (D) a short description of the purchaser’s 

4 intended use of the agent; and 

5 (E) the date and time of the sale. 

6 (2) SALE REQUIREMENTS.—In the case of a 

7 sale to which the requirement of paragraph (1) ap8 plies, the regulated seller shall not sell the highly in9 fectious agent unless— 

10 (A) the prospective purchaser— 

11 (i) presents an identification card that 

12 provides a photograph and is issued by a 

13 State or the Federal Government, or a 

14 document that, with respect to identifica15 tion, is considered acceptable for purposes 

16 of sections 274a.2(b)(1)(v)(A) and 

17 274a.2(b)(1)(v)(B) of title 8, Code of Fed18 eral Regulations (or successor regulations); 

19 and 

20 (ii) signs the logbook and enters in 

21 the logbook— 

22 (I) the purchaser’s name and ad23 dress; 


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1 (II) a short description of the 

2 purchaser’s intended use of the agent; 

3 and 

4 (III) the date and time of the 

5 sale; and 

6 (B) the regulated seller— 

7 (i) determines that the name entered 

8 in the logbook corresponds to the name 

9 provided on such identification and that 

10 the date and time entered are correct; and 

11 (ii) enters in the logbook the name of 

12 the highly infectious agent and the quan13 tity sold. 

14 (3) CONTENTS.—The regulated seller shall in15 clude in the logbook, in accordance with criteria of 

16 the Secretary, a notice to purchasers that entering 

17 false statements or misrepresentations in the log18 book may subject the purchasers to criminal pen19 alties under section 1001 of title 18, United States 

20 Code, which notice specifies the maximum fine and 

21 term of imprisonment under such section. 

22 (4) DURATION OF MAINTENANCE OF EN23 TRIES.—The regulated seller shall maintain each 

24 entry in the logbook for not fewer than five years 

25 after the date on which the entry is made. 


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1 (5) DISCLOSURE OF LOGBOOKS.—The Sec2 retary shall establish restrictions on disclosure of in3 formation in logbooks. Such regulations shall— 

4 (A) provide for the disclosure of the infor5 mation as appropriate to the Secretary and to 

6 Federal, State, and local law enforcement agen7 cies; and 

8 (B) prohibit accessing, using, or sharing 

9 information in the logbooks for any purpose 

10 other than to ensure compliance with this sec11 tion or to protect public health and safety. 

12 (d) FALSE STATEMENTS OR MISREPRESENTATIONS

13 BY PURCHASERS.—For purposes of section 1001 of title 

14 18, United States Code, entering information in a logbook 

15 shall be considered a matter within the jurisdiction of the 

16 executive, legislative, or judicial branch of the Government 

17 of the United States. 

18 (e) DEFINITIONS.—In this section: 

19 (1) The term ‘‘highly infectious agent’’ means 

20 an infectious agent that meets the criteria of ‘‘risk 

21 group 3’’ or ‘‘risk group 4’’ as such risk groups are 

22 defined in the latest edition of ‘‘NIH Guidelines for 

23 Research Involving Recombinant or Synthetic Nu24 cleic Acid Molecules’’ published by the National InVerDate Sep 11 2014 20:47 Apr 30, 2024 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8065.IH H8065

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1 stitutes of Health (or any successor to such publica2 tion). 

3 (2) The term ‘‘regulated seller’’ means a seller 

4 of highly infectious agents, except that such term 

5 does not include an employee or agent of such a sell6 er. 

7 (3) The term ‘‘Secretary’’ means the Secretary 

8 of Health and Human Services, acting through the 

9 Assistant Secretary for Preparedness and Response. 

10 SEC. 3. EVALUATION OF HIGH-CONTAINMENT LABORA11 TORIES. 

12 (a) IN GENERAL.—The National Security Advisor, in 

13 consultation with the Secretary of Health and Human 

14 Services, the Secretary of Agriculture, the Secretary of 

15 Defense, the Secretary of Homeland Security, the Na16 tional Intelligence Council, and such other Federal offi17 cials as the National Security Advisor determines appro18 priate, shall identify a single Federal official to oversee 

19 a periodic strategic evaluation of high-containment labora20 tories in the United States. 

21 (b) TOPICS.—Each strategic evaluation under sub22 section (a) shall include— 

23 (1) an assessment of— 

24 (A) the number, location, and mission of 

25 high-containment laboratories; 


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1 (B) the capacity of such existing labora2 tories to effectively meet national goals to 

3 counter threats to biosafety and biosecurity; 

4 (C) the aggregate risks associated with— 

5 (i) such existing laboratories; and 

6 (ii) expanding the numbers and facili7 ties of such laboratories; and 

8 (D) the type of oversight needed for high9 containment laboratories; and 

10 (2) up-to-date national standards, developed by 

11 the Federal official designated under subsection (a) 

12 in consultation with the scientific community, for the 

13 design, construction, commissioning, operation, and 

14 long-term maintenance of high-containment labora15 tories. 

16 (c) REPORTING.—Upon completion of each strategic 

17 evaluation under subsection, (a), the Federal official des18 ignated under subsection (a) shall submit to the President 

19 and the Congress a report on the results of such evalua20 tion and include in each such report recommendations 

21 on— 

22 (1) addressing gaps in Federal oversight of 

23 high-containment laboratories; and 


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1 (2) utilizing high-containment laboratories for 

2 protecting public health and ensuring biosecurity in 

3 the United States. 

4 (d) PUBLIC HEALTH AND BIOSECURITY TEAM.— 

5 (1) IN GENERAL.—The Federal official des6 ignated under subsection (a) shall maintain a team, 

7 to be known as the Public Health and Biosecurity 

8 Team, to serve as a single point of contact for State 

9 and local agencies regarding questions of public 

10 health relating to laboratory biosafety and biosecu11 rity. 

12 (2) ESTABLISHMENT.—The Federal official 

13 designated under subsection (a) shall establish the 

14 Public Health and Biosecurity Team, as required by 

15 paragraph (1), not later than one year after such of16 ficial is first designated. 

17 (3) DUTIES.—The Public Health and Biosecu18 rity Team shall be the primary point of contact in 

19 the Federal Government for State and local agencies 

20 on— 

21 (A) issues related to— 

22 (i) oversight of high-containment lab23 oratories; 

24 (ii) the impact of high-containment 

25 laboratories on public health; or 


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1 (iii) connecting State and local offi2 cials with the relevant Federal agency or 

3 agencies on matters related to high-con4 tainment laboratories; and 

5 (B) other issues as determined necessary 

6 by the Federal official designated under sub7 section (a). 

8 (e) FEASIBILITY STUDY.— 

9 (1) IN GENERAL.—The Federal official des10 ignated under subsection (a) shall conduct a feasi11 bility study on establishing and maintaining a data12 base on existing high-containment laboratories in the 

13 United States and making such database accessible 

14 to State and local officials. 

15 (2) DATABASE DESCRIBED.—The database to 

16 be studied under paragraph (1) should be designed 

17 to include, with respect to each high-containment 

18 laboratory, the following information: 

19 (A) The identity of the owners of the lab20 oratory. 

21 (B) The status of any licensing or certifi22 cation of the laboratory required under Federal, 

23 State, or local law. 

24 (C) Any legal violations by, and discipli25 nary action taken against, the laboratory. 


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1 (3) REPORT TO CONGRESS.—Upon completion 

2 of the feasibility study under this subsection, the 

3 Federal official designated under subsection (a) shall 

4 submit to the Congress a report on the results of 

5 such study. 

6 (f) DEFINITION.—In this section, the term ‘‘high7 containment laboratory’’ means laboratories that are suit8 able for ‘‘biosafety level 3’’ or ‘‘biosafety level 4’’ proce9 dures as defined in the latest edition of ‘‘Biosafety in 

10 Microbiological and Biomedical Laboratories’’ published 

11 by the Centers for Disease Control and Prevention and 

12 the National Institutes of Health (or any successor to such 

13 publication). 

Æ 


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