No CRS summary available for this bill.
This section defines key terms for the Act, including "(1) covered provider," as a person who synthesizes and sells synthetic nucleic acids to persons in the United States or produces, distributes, or sells (including resellers) equipment for synthesizing nucleic acids—including benchtop synthesizers—to persons in the United States; "(2) Director," as the Director of the Office of Science and Technology Policy; "(3) Secretary," as the Secretary of Commerce; and "(4) Under Secretary," as the Under Secretary of Commerce for Standards and Technology.
This section expresses the sense of Congress that the United States risks losing its biotechnology leadership to foreign adversaries amid accelerating advances in the field; policymaking for biosecurity, biosafety, and responsible innovation must be flexible and streamlined across fragmented federal agencies; previous studies have identified oversight gaps; and gene synthesis screening of orders and customers is immediately needed as a short-term risk mitigation measure while developing a comprehensive biosecurity and biosafety strategy.
This section directs the Secretary, in coordination with the Under Secretary of Commerce for Standards and Technology (NIST) and other agencies, to establish and maintain regulations not later than one year after enactment to secure nucleic acid synthesis (i.e., commercial DNA/RNA synthesis services that could be misused to create pathogens). The regulations require covered providers to (1) screen all orders for sequences of concern (from a list in (3)) using privacy-preserving mechanisms for split-order detection across providers and prioritizing pandemic-potential pathogens; (2) verify customer identity and legitimacy; (3) use a regularly updated list of sequences of concern developed via consultations, public docket, expedited provisional additions (e.g., algorithmic scanning), and data security standards; (4) undergo conformity assessments via audits, random adversarial testing ("red-teaming"), and potential revocation with a compliance grace period; (5) provide safeguards against undue burden, such as expedited reviews for legitimate institutions, exemptions for non-hazardous sequences, and expert consultations; (6) restrict federally funded persons to compliant providers; and (7) access technical assistance for ambiguous orders. NIST must develop supporting best practices, standards, and tools, including for screening protocols, sequence evaluations, and sequence-to-function models. The Secretary must review and update the regulations at least every two years; customer information submitted is exempt from FOIA disclosure; the regulations supplant prior voluntary federal guidelines; and the Attorney General may pursue civil enforcement against violators.
This section directs the Under Secretary to establish, not later than one year after enactment of this Act and in collaboration with relevant federal agencies, private sector, academia, and civil society entities, a biotechnology governance sandbox environment. Through the sandbox, the Under Secretary must (1) provide secure testing of innovations and tools to advance biosecurity, biosafety, and responsible biotechnology innovation; (2) foster nongovernmental expert participation in developing and testing governance methods to ensure U.S. global competitiveness in biotechnology, bolster national security, and enable proactive threat analysis and governance; (3) conduct biological measurement research to develop and improve technical standards for those areas; and (4) report annually to the Secretary of Commerce on the administration of governance testing and any promising strategies. The Under Secretary may contract with the private sector or coordinate with other federal agencies for necessary testing environments.
This section directs the Director, in collaboration with relevant federal agency heads, to assess—not later than 90 days after enactment—the current state of federal biosecurity and biosafety oversight (i.e., authorities, programs, effectiveness, overlaps, redundancies, compliance challenges, funding gaps, and regulatory gaps hindering governance of biotechnology risks and opportunities) and to develop an implementation plan for more effective and efficient oversight, including evaluation of consolidating guidelines, authorities, and regulations across agencies. Not later than 90 days after completing the assessment and plan, the Director must submit to Congress (1) a report detailing the assessment findings and (2) the plan, along with recommendations for legislative or administrative actions such as new authorities, consolidations, or establishing a common government entity. Not later than 90 days after completing the plan, the Director must commence implementation through administrative action, considering relevant governance strategies identified elsewhere in the bill.