II 

118TH CONGRESS 

2D SESSION S. 4428 

To establish an interagency committee to coordinate activities of the Federal 

Government relating to biotechnology oversight, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 23, 2024 

Mr. YOUNG (for himself and Mr. PADILLA) introduced the following bill; which 

was read twice and referred to the Committee on Commerce, Science, and 

Transportation 

A BILL 

To establish an interagency committee to coordinate activities 

of the Federal Government relating to biotechnology 

oversight, 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 ‘‘Biotechnology Over5 sight Coordination Act of 2024’’. 

6 SEC. 2. FINDINGS; PURPOSE. 

7 (a) FINDINGS.—Congress finds that— 

8 (1) biotechnology harnesses the power of biol9 ogy to create new products and provides opportuniVerDate Sep 11 2014 20:51 Jul 16, 2024 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4428.IS S4428

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1 ties to grow the United States economy, provide jobs 

2 for a skilled workforce, improve resilience of supply 

3 chains, and improve the quality of human lives and 

4 the environment; and 

5 (2) a science-based, risk-proportionate, predict6 able, efficient, and transparent system to support 

7 the safe use of products of biotechnology will enable 

8 the United States to continue to be a world leader 

9 in biotechnology research and development. 

10 (b) PURPOSE.—The purpose of this Act is to coordi11 nate and enhance the efforts of the Federal Government 

12 under the Coordinated Framework for the Regulation of 

13 Biotechnology to protect health and the environment while 

14 enabling the development, commercialization, and safe use 

15 of products derived from plants, animals, and microorga16 nisms developed with biotechnology. 

17 SEC. 3. BIOTECHNOLOGY OVERSIGHT COORDINATION COM18 MITTEE. 

19 (a) ESTABLISHMENT OF COMMITTEE.— 

20 (1) IN GENERAL.—The President, acting 

21 through the Director of the Office of Science and 

22 Technology Policy and the Director of the Office of 

23 Management and Budget, shall establish an inter24 agency committee to coordinate activities of the Fed25 eral Government relating to biotechnology-specific 


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1 regulation and oversight (referred to in this section 

2 as the ‘‘Committee’’). 

3 (2) CHARTER.— 

4 (A) IN GENERAL.—Not later than 90 days 

5 after the date of enactment of this Act, the 

6 Committee shall— 

7 (i) ratify a charter for the operation 

8 of the Committee; and 

9 (ii) make publicly available on the 

10 Unified Website for Biotechnology Regula11 tion developed pursuant to Executive 

12 Order 13874 (7 U.S.C. 3121 note; relating 

13 to modernizing the regulatory framework 

14 for agricultural biotechnology products) 

15 (referred to in this section as the ‘‘Unified 

16 Website’’) that ratified charter. 

17 (B) EXPANSION OR MODIFICATION.—The 

18 Committee may expand upon or modify the ini19 tial ratified charter under subparagraph (A)(i) 

20 as needed. 

21 (b) MEMBERSHIP.—The Committee shall be com22 posed of the heads, or their designees, of agencies respon23 sible for biotechnology oversight, including— 

24 (1) the Animal and Plant Health Inspection 

25 Service, the Agricultural Marketing Service, and the 


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1 Food Safety and Inspection Service of the Depart2 ment of Agriculture; 

3 (2) the Food and Drug Administration and the 

4 National Institutes of Health of the Department of 

5 Health and Human Services; 

6 (3) the Environmental Protection Agency; 

7 (4) the Office of Management and Budget; 

8 (5) the Office of Science and Technology Policy; 

9 and 

10 (6) other Federal agencies or entities as deter11 mined appropriate by the Chair of the Committee. 

12 (c) CHAIR.—The Director of the Office of Science 

13 and Technology Policy shall serve as the Chair of the 

14 Committee. 

15 (d) REGULATORY STREAMLINING.—The Committee 

16 shall expand or build upon efforts to coordinate bio17 technology oversight, including through measurable 

18 steps— 

19 (1) to align or clarify regulatory timelines, ap20 proaches, and data requirements; 

21 (2) to facilitate information-sharing between 

22 regulatory agencies, notwithstanding any other pro23 vision of law; 

24 (3) to identify an initial point of contact for 

25 each type of biotechnology product, including emergVerDate Sep 11 2014 20:51 Jul 16, 2024 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4428.IS S4428

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1 ing products, and clear hand-offs from one process 

2 or agency to another; 

3 (4) to identify and minimize any areas of delay 

4 relative to established timeframes, including by re5 ducing duplicative review and building upon prior re6 views to the maximum extent practicable; and 

7 (5) to conduct periodic horizon-scanning for 

8 emerging biotechnology processes and products to 

9 ensure appropriate oversight. 

10 (e) REPORT TO CONGRESS.—Not later than 1 year 

11 after the date of enactment of this Act, and annually 

12 thereafter, the Committee shall submit to Congress and 

13 make publicly available on the Unified Website a descrip14 tion of the following: 

15 (1) Actions taken and next steps under sub16 section (d), with a description of successes, specific 

17 staffing and resource needs, and recommendations 

18 for removing any identified barriers, including 

19 changes to statutes, regulations, or guidance. 

20 (2) A summary of the duration of oversight 

21 with respect to biotechnology products, from the ini22 tial contact with a developer to a decision with re23 spect to the biotechnology product, during a period 

24 of not less than 5 fiscal years preceding the date of 

25 the report, including— 


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1 (A) the type of product; 

2 (B) the 1 or more types of review; 

3 (C) the 1 or more agencies that reviewed 

4 that product; and 

5 (D) an explanation of timelines where 

6 needed. 

7 (f) UNIFIED PROCESS.—Not later than 180 days 

8 after the date of enactment of this Act, and annually 

9 thereafter, the Committee shall submit to Congress and 

10 make publicly available on the Unified Website the fol11 lowing: 

12 (1) A singular, unified process to identify 

13 whether a plant, animal, or microorganism produced 

14 with biotechnology could reasonably have occurred 

15 naturally or been developed by conventional means 

16 (meaning the genetic sequences of the biotechnology 

17 product are present in the gene pool of the plant, 

18 animal, or microorganism or could have arisen 

19 through natural mutation mechanisms), taking into 

20 account existing agency assessments where appro21 priate. 

22 (2) Measurable actions the Committee and any 

23 member of the Committee will take to implement or 

24 consider the unified process described in paragraph 

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1 ing into account that organisms identified via the 

2 process described in paragraph (1) would continue to 

3 be regulated with product-specific oversight. 

4 (3) Actions taken and progress made with re5 spect to paragraph (2). 

6 (g) MOLECULAR FARMING AND PRECISION FER7 MENTATION.—Not later than 180 days after the date of 

8 enactment of this Act, and annually thereafter, the Com9 mittee shall submit to Congress and make publicly avail10 able on the Unified Website a description of the following: 

11 (1) Characteristics of organisms that may in12 crease risk pathways or otherwise hinder the produc13 tion of substances intended for extraction. 

14 (2) Characteristics of organisms that may re15 duce risk pathways associated with the production of 

16 substances intended for extraction. 

17 (3) Conditions that are useful for containing or 

18 segregating organisms produced with biotechnology 

19 that may reduce risk pathways associated with the 

20 production of substances intended for extraction. 

21 (4) Examples of organisms that— 

22 (A) fit some or all of the characteristics 

23 described in paragraph (2); and 

24 (B) are amenable to some or all of the con25 ditions described in paragraph (3). 


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1 (5) Measurable actions the Committee and any 

2 member of the Committee will take to implement or 

3 consider the characteristics described in paragraph 

4 (2) and the conditions described in paragraph (3) 

5 into their oversight of biotechnology products. 

6 (6) Actions taken under paragraph (5) and 

7 progress made with respect to those actions. 

8 (h) COORDINATION AND CONSULTATION.— 

9 (1) COORDINATION.—The Committee shall co10 ordinate, as appropriate, with— 

11 (A) other working groups and committees 

12 of the Federal Government; and 

13 (B) other relevant agencies. 

14 (2) CONSULTATION.—The Committee shall reg15 ularly consult in a coordinated fashion regarding 

16 biotechnology oversight, including with respect to the 

17 reports under subsection (e), with States, Indian 

18 Tribes, territories, local governments, biotechnology 

19 developers and relevant industries, academic institu20 tions, nongovernmental organizations, and other 

21 stakeholders. 

22 (i) EXECUTIVE SECRETARIES.— 

23 (1) DEPARTMENT OF AGRICULTURE.—The Sec24 retary of Agriculture shall appoint an Executive Sec25 retary to serve the Committee, who shall be and reVerDate Sep 11 2014 20:51 Jul 16, 2024 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4428.IS S4428

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1 main a permanent employee of the Department of 

2 Agriculture. 

3 (2) DEPARTMENT OF HEALTH AND HUMAN

4 SERVICES; ENVIRONMENTAL PROTECTION AGEN5 CY.—The Secretary of Health and Human Services 

6 and the Administrator of the Environmental Protec7 tion Agency may each appoint an Executive Sec8 retary to serve the Committee, who shall be and re9 main a permanent employee of the Department of 

10 Health and Human Services and the Environmental 

11 Protection Agency, respectively. 

12 (j) COMPTROLLER GENERAL REVIEW.—The Comp13 troller General of the United States shall— 

14 (1) not later than 1 year after the date of en15 actment of this Act, begin a review to assess the ef16 ficacy of interagency coordination and other activi17 ties conducted by the Committee; 

18 (2) not later than 18 months after the date of 

19 enactment of this Act, provide to Congress a briefing 

20 of the initial findings of the Comptroller General 

21 with respect to the activities of the Committee; and 

22 (3) not later than 2 years after the date of en23 actment of this Act, provide to Congress a report de24 scribing the current statutory authorities and over25 sight processes applicable to biotechnology-specific 


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1 regulation of products derived from plants, animals, 

2 and microorganisms developed with biotechnology, 

3 including a description of opportunities to reduce 

4 gaps, duplication, overlap, and fragmentation. 

5 (k) EXCLUSIONS.—This Act shall not apply to human 

6 medical research and products that are regulated solely 

7 by the Food and Drug Administration. 

Æ 


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