[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4428 Introduced in Senate (IS)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Biotechnology Oversight Coordination 
Act of 2024''.

SEC. 2. FINDINGS; PURPOSE.

    (a) Findings.--Congress finds that--
            (1) biotechnology harnesses the power of biology to create 
        new products and provides opportunities to grow the United 
        States economy, provide jobs for a skilled workforce, improve 
        resilience of supply chains, and improve the quality of human 
        lives and the environment; and
            (2) a science-based, risk-proportionate, predictable, 
        efficient, and transparent system to support the safe use of 
        products of biotechnology will enable the United States to 
        continue to be a world leader in biotechnology research and 
        development.
    (b) Purpose.--The purpose of this Act is to coordinate and enhance 
the efforts of the Federal Government under the Coordinated Framework 
for the Regulation of Biotechnology to protect health and the 
environment while enabling the development, commercialization, and safe 
use of products derived from plants, animals, and microorganisms 
developed with biotechnology.

SEC. 3. BIOTECHNOLOGY OVERSIGHT COORDINATION COMMITTEE.

    (a) Establishment of Committee.--
            (1) In general.--The President, acting through the Director 
        of the Office of Science and Technology Policy and the Director 
        of the Office of Management and Budget, shall establish an 
        interagency committee to coordinate activities of the Federal 
        Government relating to biotechnology-specific regulation and 
        oversight (referred to in this section as the ``Committee'').
            (2) Charter.--
                    (A) In general.--Not later than 90 days after the 
                date of enactment of this Act, the Committee shall--
                            (i) ratify a charter for the operation of 
                        the Committee; and
                            (ii) make publicly available on the Unified 
                        Website for Biotechnology Regulation developed 
                        pursuant to Executive Order 13874 (7 U.S.C. 
                        3121 note; relating to modernizing the 
                        regulatory framework for agricultural 
                        biotechnology products) (referred to in this 
                        section as the ``Unified Website'') that 
                        ratified charter.
                    (B) Expansion or modification.--The Committee may 
                expand upon or modify the initial ratified charter 
                under subparagraph (A)(i) as needed.
    (b) Membership.--The Committee shall be composed of the heads, or 
their designees, of agencies responsible for biotechnology oversight, 
including--
            (1) the Animal and Plant Health Inspection Service, the 
        Agricultural Marketing Service, and the Food Safety and 
        Inspection Service of the Department of Agriculture;
            (2) the Food and Drug Administration and the National 
        Institutes of Health of the Department of Health and Human 
        Services;
            (3) the Environmental Protection Agency;
            (4) the Office of Management and Budget;
            (5) the Office of Science and Technology Policy; and
            (6) other Federal agencies or entities as determined 
        appropriate by the Chair of the Committee.
    (c) Chair.--The Director of the Office of Science and Technology 
Policy shall serve as the Chair of the Committee.
    (d) Regulatory Streamlining.--The Committee shall expand or build 
upon efforts to coordinate biotechnology oversight, including through 
measurable steps--
            (1) to align or clarify regulatory timelines, approaches, 
        and data requirements;
            (2) to facilitate information-sharing between regulatory 
        agencies, notwithstanding any other provision of law;
            (3) to identify an initial point of contact for each type 
        of biotechnology product, including emerging products, and 
        clear hand-offs from one process or agency to another;
            (4) to identify and minimize any areas of delay relative to 
        established timeframes, including by reducing duplicative 
        review and building upon prior reviews to the maximum extent 
        practicable; and
            (5) to conduct periodic horizon-scanning for emerging 
        biotechnology processes and products to ensure appropriate 
        oversight.
    (e) Report to Congress.--Not later than 1 year after the date of 
enactment of this Act, and annually thereafter, the Committee shall 
submit to Congress and make publicly available on the Unified Website a 
description of the following:
            (1) Actions taken and next steps under subsection (d), with 
        a description of successes, specific staffing and resource 
        needs, and recommendations for removing any identified 
        barriers, including changes to statutes, regulations, or 
        guidance.
            (2) A summary of the duration of oversight with respect to 
        biotechnology products, from the initial contact with a 
        developer to a decision with respect to the biotechnology 
        product, during a period of not less than 5 fiscal years 
        preceding the date of the report, including--
                    (A) the type of product;
                    (B) the 1 or more types of review;
                    (C) the 1 or more agencies that reviewed that 
                product; and
                    (D) an explanation of timelines where needed.
    (f) Unified Process.--Not later than 180 days after the date of 
enactment of this Act, and annually thereafter, the Committee shall 
submit to Congress and make publicly available on the Unified Website 
the following:
            (1) A singular, unified process to identify whether a 
        plant, animal, or microorganism produced with biotechnology 
        could reasonably have occurred naturally or been developed by 
        conventional means (meaning the genetic sequences of the 
        biotechnology product are present in the gene pool of the 
        plant, animal, or microorganism or could have arisen through 
        natural mutation mechanisms), taking into account existing 
        agency assessments where appropriate.
            (2) Measurable actions the Committee and any member of the 
        Committee will take to implement or consider the unified 
        process described in paragraph (1) in their oversight of 
        biotechnology products, taking into account that organisms 
        identified via the process described in paragraph (1) would 
        continue to be regulated with product-specific oversight.
            (3) Actions taken and progress made with respect to 
        paragraph (2).
    (g) Molecular Farming and Precision Fermentation.--Not later than 
180 days after the date of enactment of this Act, and annually 
thereafter, the Committee shall submit to Congress and make publicly 
available on the Unified Website a description of the following:
            (1) Characteristics of organisms that may increase risk 
        pathways or otherwise hinder the production of substances 
        intended for extraction.
            (2) Characteristics of organisms that may reduce risk 
        pathways associated with the production of substances intended 
        for extraction.
            (3) Conditions that are useful for containing or 
        segregating organisms produced with biotechnology that may 
        reduce risk pathways associated with the production of 
        substances intended for extraction.
            (4) Examples of organisms that--
                    (A) fit some or all of the characteristics 
                described in paragraph (2); and
                    (B) are amenable to some or all of the conditions 
                described in paragraph (3).
            (5) Measurable actions the Committee and any member of the 
        Committee will take to implement or consider the 
        characteristics described in paragraph (2) and the conditions 
        described in paragraph (3) into their oversight of 
        biotechnology products.
            (6) Actions taken under paragraph (5) and progress made 
        with respect to those actions.
    (h) Coordination and Consultation.--
            (1) Coordination.--The Committee shall coordinate, as 
        appropriate, with--
                    (A) other working groups and committees of the 
                Federal Government; and
                    (B) other relevant agencies.
            (2) Consultation.--The Committee shall regularly consult in 
        a coordinated fashion regarding biotechnology oversight, 
        including with respect to the reports under subsection (e), 
        with States, Indian Tribes, territories, local governments, 
        biotechnology developers and relevant industries, academic 
        institutions, nongovernmental organizations, and other 
        stakeholders.
    (i) Executive Secretaries.--
            (1) Department of agriculture.--The Secretary of 
        Agriculture shall appoint an Executive Secretary to serve the 
        Committee, who shall be and remain a permanent employee of the 
        Department of Agriculture.
            (2) Department of health and human services; environmental 
        protection agency.--The Secretary of Health and Human Services 
        and the Administrator of the Environmental Protection Agency 
        may each appoint an Executive Secretary to serve the Committee, 
        who shall be and remain a permanent employee of the Department 
        of Health and Human Services and the Environmental Protection 
        Agency, respectively.
    (j) Comptroller General Review.--The Comptroller General of the 
United States shall--
            (1) not later than 1 year after the date of enactment of 
        this Act, begin a review to assess the efficacy of interagency 
        coordination and other activities conducted by the Committee;
            (2) not later than 18 months after the date of enactment of 
        this Act, provide to Congress a briefing of the initial 
        findings of the Comptroller General with respect to the 
        activities of the Committee; and
            (3) not later than 2 years after the date of enactment of 
        this Act, provide to Congress a report describing the current 
        statutory authorities and oversight processes applicable to 
        biotechnology-specific regulation of products derived from 
        plants, animals, and microorganisms developed with 
        biotechnology, including a description of opportunities to 
        reduce gaps, duplication, overlap, and fragmentation.
    (k) Exclusions.--This Act shall not apply to human medical research 
and products that are regulated solely by the Food and Drug 
Administration.
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