[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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