119-s2697

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2697 Introduced in Senate

    (IS) ]

<DOC>

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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