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S 2697119th CongressIn Committee

National Biotechnology Safety Act

Introduced: Sep 3, 2025
Technology & Innovation
Standard Summary
Comprehensive overview in 1-2 paragraphs

This bill would give the National Science Foundation (NSF) new authority and funding to conduct and support research on the environmental, health, and safety risks of organisms produced with biotechnology. It creates a dedicated NSF program within its Directorate for Technology, Innovation, and Partnerships to fund risk-assessment research, with specific criteria, priorities, and coordination with other federal agencies (e.g., USDA, FDA, EPA). The bill also requires a two-phase study by the National Academies to evaluate the safety and benefits of biotechnology, with reports and an implementation plan to address identified research gaps. Overall, its goal is to inform regulators and stakeholders about how biotechnology products can be safely developed, tested, and overseen, including foresight on emerging technologies and potential risk-management approaches. The bill would authorize substantial NSF funding (roughly $50 million per year 2026–2030) and a separate National Academies study budget (about $1.5 million in 2026).

Key Points

  • 1Establishes an NSF risk-assessment program: Within NSF’s Directorate for Technology, Innovation, and Partnerships, to fund research on the environmental introduction of biotechnology-produced organisms and related safety concerns.
  • 2Broad range of funding recipients: Includes universities, federally funded research centers, nonprofit institutes, industry/private sector, other appropriate entities, and consortia.
  • 3Specific awarding criteria and priorities: Requires considering commercialization pathways, current knowledge and risks, relevance to research priorities, and ethical/legal/social implications; prioritizes research on unintended effects, risk mitigation, dispersal/persistence (including gene drives), gene transfer, comparisons to non-biotech counterparts or other activities, AI/biotech convergence, and other relevant topics.
  • 4Regulatory coordination: NSF Director must consult with USDA, FDA, EPA, and other relevant agencies to align research with regulation, oversee projects, and provide regulatory assistance.
  • 5Funding authorization: Authorizes $50 million per fiscal year from FY2026–FY2030 for the NSF program, with the Director prioritizing the program and leveraging other NSF funds as appropriate.
  • 6National Academies two-phase study: Requires NSF (with agency consultations) to contract a two-phase study with the National Academies to assess safety and benefits of biotechnology; Phase One (within 1 year) porpects risk frameworks and needed research; Phase Two (within 2 years) assesses safety/benefits of commercial biotech alongside conventional products and how/when to adjust oversight; both phases produce public reports.
  • 7Implementation plan and reporting: After all National Academies reports, the NSF must submit an implementation plan to Congress to address research gaps; reports from the Academies must be publicly posted and shared with key committees.
  • 8Additional study funding: Authorizes a separate $1.5 million for FY2026 to support the National Academies study activities.

Impact Areas

Primary: Researchers and institutions receiving NSF funding (universities, nonprofit labs, consortia, and industry partners) and entities involved in developing or testing biotech products; federal regulatory agencies (FDA, USDA, EPA) and other agencies with biosafety responsibilities.Secondary: The biotechnology industry and product developers; policymakers who rely on risk assessments to shape regulations; and the general public who may benefit from clearer safety standards and more transparent oversight.Additional impacts: Could influence how risk assessment is conducted for biotech tools (e.g., gene drives, gene transfer, environmental persistence), inform regulatory pathways, and encourage coordination across agencies; may affect timelines and costs associated with bringing biotech products to market; enhances attention to ethics, legal, and social implications in biotechnology research.Gene drives: Genetic elements designed to bias inheritance and spread through populations, a key topic in risk assessment and containment considerations.Risk-proportionate frameworks: Approaches that tailor regulatory scrutiny to the level of risk posed by a product or process.Consortia: Collaborative groups of multiple institutions or organizations formed to conduct research.
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