Biosecurity Modernization and Innovation Act of 2026
Sponsored By: Senator Cotton, Tom [R-AR]
Introduced
Summary
Secure nucleic acid synthesis by creating a federal rulebook for who can make and sell synthetic DNA and the machines that do it. The bill would make the Commerce Secretary the main regulator and would require rules, standards, and a governance sandbox to guide safe biotech innovation.
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- Providers and vendors: It would define "covered providers" to include companies that synthesize or sell synthetic nucleic acids and synthesis equipment. Those providers would have to screen orders and customers, undergo conformity checks and random adversarial testing, and could lose certification if they do not comply.
- Researchers, institutions, and innovators: The bill would build in fast-track reviews for legitimate institutional users, exemptions for clearly nonhazardous sequences, technical assistance for ambiguous screening results, and a sandbox to test governance approaches without blocking innovation.
- Federal oversight, standards, and enforcement: The Commerce Secretary would lead rulemaking with help from the National Institute of Standards and Technology for technical standards. Rules would be updated regularly, customer data would get specific privacy protections, and civil penalties would be allowed up to $500,000 for individuals and $750,000 for organizations.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 1 benefits, 0 costs, 3 mixed.
Standards, tests, and enforcement
If enacted, NIST (the Under Secretary) would develop technical standards, testing tools, and guidance to support screening and conformity checks. The bill would create a conformity assessment system with audits and random adversarial "red-team" testing, and the Secretary could revoke conformity status after providing a grace period to fix problems. The Attorney General could sue violators and courts could award statutory damages up to $500,000 for individuals and $750,000 for companies, with those caps adjusted each October 1 by the annual CPI‑U change. The bill would also create a technical-assistance program for covered providers and set up a biotechnology governance sandbox within one year to test rules and tools.
90-day review of biosecurity oversight
If enacted, the Director would have 90 days to assess federal biosecurity and biosafety authorities and make an implementation plan to reduce overlaps and gaps. The assessment must list authorities and programs, include industry and academic input, identify funding or legal gaps, and evaluate whether to consolidate rules or agencies. The Director must report findings to Congress and begin implementing the plan through administrative action within 90 days after finishing the plan.
Which providers must follow rules
This bill would define who is a "covered provider." A covered provider would include companies that make and sell synthetic nucleic acids in the United States and companies that make or sell equipment that synthesizes nucleic acids, including benchtop synthesizers. If enacted, entities that receive Federal funds would only be able to buy nucleic acid synthesis products from covered providers that follow the screening and identity rules. The definition takes effect on enactment and the federal-purchase restriction would apply not later than one year after enactment.
New screening and sequence rules
If enacted, the bill would require covered providers to screen all synthetic-nucleic-acid orders against a Secretary-maintained list of "sequences of concern." Providers would also need to verify customer identity and use privacy-preserving methods to detect split orders across suppliers. The Secretary would run a public, privacy-friendly docket and an expedited provisional process to update the list, and the new regulations would replace earlier voluntary federal guidance. The Secretary would have to review and update the screening rules at least once every two years and must issue the required regulations within one year after enactment.
Sponsors & CoSponsors
Sponsor
Cotton, Tom [R-AR]
AR • R
Cosponsors
Amy Klobuchar
MN • D
Sponsored 1/29/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov