[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.
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