[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S4927-S4928]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2586. Mr. YOUNG (for himself and Mr. Padilla) submitted an 
amendment intended to be proposed by him to the bill S. 4638, to 
authorize appropriations for fiscal year 2025 for military activities 
of the Department of Defense, for military construction, and for 
defense activities of the Department of Energy, to prescribe military 
personnel strengths for such fiscal year, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the end of subtitle H of title X, add the following:

     SEC. 1095. BIOTECHNOLOGY OVERSIGHT COORDINATION COMMITTEE.

       (a) Findings; Purpose.--
       (1) Findings.--Congress finds that--
       (A) 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
       (B) 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.
       (2) Purpose.--The purpose of this section 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.
       (b) 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.
       (c) 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.
       (d) Chair.--The Director of the Office of Science and 
     Technology Policy shall serve as the Chair of the Committee.
       (e) 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.
       (f) 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 (e), 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.
       (g) 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).
       (h) 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.
       (i) 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 (f), 
     with States, Indian Tribes, territories, local governments, 
     biotechnology developers and relevant industries, academic 
     institutions, nongovernmental organizations, and other 
     stakeholders.
       (j) 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.
       (k) 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

[[Page S4928]]

     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.
       (l) Exclusions.--This section shall not apply to human 
     medical research and products that are regulated solely by 
     the Food and Drug Administration.
                                 ______