Sec. 3. Biotechnology Oversight Coordination Committee
1,099 words·~5 min read·
/bill/118/hr/8538/ih/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 ). Not later than 90 days after the date of enactment of this Act, the Committee shall— ratify a charter for the operation of the Committee; and 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.
The Committee may expand upon or modify the initial ratified charter under subparagraph (A)(i) as needed. The Committee shall be composed of the heads, or their designees, of agencies responsible for biotechnology oversight, including— the Animal and Plant Health Inspection Service, the Agricultural Marketing Service, and the Food Safety and Inspection Service of the Department of Agriculture; the Food and Drug Administration and the National Institutes of Health of the Department of Health and Human Services; the Environmental Protection Agency; the Office of Management and Budget; the Office of Science and Technology Policy; and other Federal agencies or entities as determined appropriate by the Chair of the Committee.
The Director of the Office of Science and Technology Policy shall serve as the Chair of the Committee. The Committee shall expand or build upon efforts to coordinate biotechnology oversight, including through measurable steps— to align or clarify regulatory timelines, approaches, and data requirements; to facilitate information-sharing between regulatory agencies, notwithstanding any other provision of law; 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; 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 to conduct periodic horizon-scanning for emerging biotechnology processes and products to ensure appropriate oversight.
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: 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. 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— the type of product; the 1 or more types of review; the 1 or more agencies that reviewed that product; and an explanation of timelines where needed.
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: 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.
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. Actions taken and progress made with respect to paragraph (2). 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: Characteristics of organisms that may increase risk pathways or otherwise hinder the production of substances intended for extraction. Characteristics of organisms that may reduce risk pathways associated with the production of substances intended for extraction. 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. Examples of organisms that— fit some or all of the characteristics described in paragraph (2); and are amenable to some or all of the conditions described in paragraph (3). 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. Actions taken under paragraph
(5)and progress made with respect to those actions. The Committee shall coordinate, as appropriate, with— other working groups and committees of the Federal Government; and other relevant agencies. 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. 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. 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. The Comptroller General of the United States shall— 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; 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 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. This Act shall not apply to human medical research and products that are regulated solely by the Food and Drug Administration.
Connectionstraces to 2
Traces to 2 documents
Citation graph
cites case law
Cites 2Cited by 0 across 0 sources