[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2697 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
S. 2697
To authorize the National Science Foundation to conduct research for
biotechnology risk assessment, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 3, 2025
Mr. Young (for himself and Mr. Padilla) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To authorize the National Science Foundation to conduct research for
biotechnology risk assessment, 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 ``National Biotechnology Safety Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Biotechnology is routinely used to modify genetic
sequences in plants, animals, and microorganisms, resulting in
useful products across agriculture, medicine, industry, and
defense.
(2) Specific research would help inform the Federal
Government, State governments, industry, and other stakeholders
on how best to address safety of biotechnology products.
SEC. 3. BIOTECHNOLOGY RISK ASSESSMENT RESEARCH.
(a) Purposes.--The purposes of this section are to authorize and
support research--
(1) to address regulatory concerns about potential
environmental, human health, or animal health risks of
organisms produced with biotechnology; and
(2) that aids regulators in developing clear regulatory
pathways for products produced with biotechnology.
(b) Establishment.--
(1) In general.--The Director of the National Science
Foundation (referred to in this section as the ``Director'')
shall establish a program within the Directorate for
Technology, Innovation, and Partnerships to provide funding for
research concerning the introduction into the environment of
organisms that were produced with biotechnology.
(2) Mechanisms.--The Director may choose funding mechanisms
under this section as appropriate to meet the scientific need,
including research grants, cooperative agreements, and
temporary research consortia.
(c) Recipients.--Recipients of funds under this section may
include--
(1) institutions of higher education, as defined in section
102 of the Higher Education Act of 1965 (20 U.S.C. 1002);
(2) federally funded research and development centers;
(3) nonprofit research institutions;
(4) industry and other private sector entities;
(5) other entities determined appropriate by the Director
to carry out the purposes of this section; and
(6) consortia of entities described in paragraphs (1)
through (5).
(d) Award Basis.--
(1) Selection criteria.--In selecting recipients for an
award under this section, the Director shall consider, at a
minimum--
(A) the path for developing and, as appropriate,
commercializing the organism or similar organisms
produced with biotechnology and resulting products in
the United States;
(B) the current knowledge of similar organisms (as
of the date of the award), the limits of such current
knowledge, and the novelty and risks of the proposed
project;
(C) the relevance of the project to the research
priorities under paragraph (2) and the potential of the
project to advance such priorities; and
(D) the ethical, legal, and social implications of
the project.
(2) Research priorities.--In awarding funding under this
section, the Director shall give priority to research designed
to--
(A) identify unintended effects of biotechnology
methods, including unintended genetic changes;
(B) identify and develop management practices to
minimize environmental, human health, or animal health
risks associated with organisms produced with
biotechnology, in research or field trial conditions,
in commercial production, and in use as a final
product;
(C) develop methods to monitor the dispersal and
persistence of organisms produced with biotechnology,
including gene drives;
(D) identify the characteristics, rates, and
methods of gene transfer that may occur between
organisms produced with biotechnology and related wild
and agricultural organisms;
(E) compare the impacts of organisms produced with
biotechnology to impacts of comparable organisms that
were not produced with biotechnology or to other human
activities in the environment;
(F) identify potential risks of convergence of
biotechnology with artificial intelligence and other
emerging technologies; or
(G) address other topics that further the purposes
of this section.
(e) Metrics.--When appropriate, the Director may--
(1) set metrics in the terms of an award under this
section, including goals and deadlines; and
(2) use such metrics to determine whether a project carried
out under this section shall be eligible for continued or
additional funding.
(f) Regulatory Coordination.--The Director shall consult with the
Secretary of Agriculture, the Commissioner of Food and Drugs, the
Administrator of the Environmental Protection Agency, and the heads of
other Federal agencies with relevant expertise as determined by the
Director, to--
(1) determine the applicability of specific areas of
research to the regulation of products produced with
biotechnology;
(2) provide ongoing oversight and execution of projects
carried out under this section; and
(3) provide regulatory assistance to facilitate the
purposes of this section.
(g) Funding.--
(1) Authorization of appropriations.--There are authorized
to be appropriated to the Directorate for Technology,
Innovation, and Partnerships to carry out this section
$50,000,000 for each of fiscal years 2026 through 2030.
(2) Additional funding.--In addition to using amounts made
available under paragraph (1) for the program carried out under
this section, the Director may--
(A) make this program a priority of the National
Science Foundation; and
(B) elect to use other funds that are available to
the Director and not otherwise restricted in their use
to carry out the program.
SEC. 4. NATIONAL ACADEMIES BIOTECHNOLOGY 2-PHASE STUDY AND REPORTS.
(a) In General.--Not later than 90 days after the date of enactment
of this Act, the Director of the National Science Foundation (referred
to in this section as the ``Director''), in consultation with the
Secretary of Agriculture, the Commissioner of Food and Drugs, the
Administrator of the Environmental Protection Agency, and heads of
other Federal agencies with relevant expertise as determined by the
Director, shall enter into an agreement with the National Academies of
Science, Engineering, and Medicine (referred to in this section as the
``National Academies'')--
(1) to conduct a 2-phase study, in accordance with
subsections (b) and (c), on the safety and benefits of
biotechnology; and
(2) to submit reports describing the results of the studies
and including findings and recommendations, in accordance with
subsection (d).
(b) Phase One of Study.--Not later than 1 year after the date on
which the agreement described in subsection (a) is entered into, the
National Academies shall complete phase one of the study, which shall,
at a minimum--
(1) consider the characteristics and risks of biotechnology
tools used to modify genetic sequences in comparison to the
characteristics and risks of comparable conventional methods
used to modify genetic sequences;
(2) make recommendations about risk-proportionate
frameworks to assess risks of products made with biotechnology
tools; and
(3) identify research needed to further understand the
safety of biotechnology tools.
(c) Phase Two of Study.--Not later than 2 years after the date on
which the agreement described in subsection (a) is entered into, the
National Academies shall complete phase two of the study, which shall,
at a minimum--
(1) consider the safety and benefits of commercialized
biotechnology products alongside comparable conventional
products and other human activities that may impact human
health or the environment;
(2) make recommendations about evaluating the safety and
potential benefits of future biotechnology products that are
under development or not yet widely commercialized;
(3) make recommendations about processes, analysis, or
tests that could be used to rapidly reduce or remove
biotechnology-specific oversight of products that do not
present a greater risk than comparable conventional products or
other human activities; and
(4) identify research needed to further understand safety
or benefits of biotechnology products.
(d) Reports.--Within 90 days of completion of each phase of the
study under subsections (b) and (c), the National Academies shall--
(1) submit a report that includes any findings and
recommendations of the National Academies made pursuant to the
applicable phase of the study to the Director, the heads of the
agencies with which the Director consulted under subsection
(a), and the Committee on Commerce, Science, and Transportation
of the Senate and the Committee on Science, Space, and
Technology of the House of Representatives; and
(2) make each such report submitted under paragraph (1)
available on a publicly accessible website.
(e) Implementation Plan.--Not later than 180 days after the date on
which all reports from the National Academies under subsection (d) have
been submitted to the Director, the Director, in consultation with the
heads of the agencies named in subsection (a), shall submit to Congress
an implementation plan for Federal research, development, and
demonstration activities for the purpose of closing any research gaps
related to the safety of biotechnology tools and products.
(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $1,500,000 for fiscal year 2026.
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