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119-hr-10197119th CongressWALLET

Biosecurity Modernization and Innovation Act

Sponsored By: Representative Pfluger, August [R-TX-11]

Introduced

Summary

This bill would create a mandatory, risk-based federal biosafety and biosecurity framework focused on nucleic acid sequences and the companies that synthesize, sell, or distribute them. It centers on “covered entities” and requires screening, reporting, independent assessments, and a government list of high-risk sequences.

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Bill Overview

Analyzed Economic Effects

4 provisions identified: 0 benefits, 1 costs, 3 mixed.

Big fines for DNA sellers

If enacted, the Commerce Secretary could investigate covered entities, subpoena records or testimony, and bring civil cases in federal court for violations. The Secretary could seek monetary penalties up to $750,000 per violation, with that cap adjusted each January 1 by changes in the CPI‑U. Before suing, the Secretary would have to give written notice and at least 30 days to fix the problem; fixing it within 30 days generally satisfies the requirement for that violation.

New rules for DNA sellers

If enacted, businesses that make or sell nucleic acids or synthesizer devices would have to run a formal compliance program. The program would require verifying buyers, documenting buyer purpose, checking whether a sequence is on a government "covered sequence" list, refusing risky sales under written criteria, and keeping records for at least five years. The rules would apply to benchtop synthesizers and take effect one year after enactment. The Commerce Secretary would issue non-binding guidance within 180 days and a separate enforcement-priority guidance within one year to explain how to meet the rules and independent-assessment steps.

Government list of restricted DNA sequences

If enacted, the Commerce Secretary would create and publish a list of "covered sequences" within 180 days and update it regularly. The Secretary must explain why a sequence is listed and accept confidential public or industry submissions and requests for review. Covered entities could ask for reconsideration and may keep submitter identity private. Congress would get at least five days' notice before the Secretary establishes or changes list entries.

Federal rules override some state laws

If enacted, federal subsection (a) requirements would preempt state or local laws that conflict with those covered‑entity rules. The preemption would take effect when the bill is enacted. The bill preserves many state powers, including contract and tort law, product liability, consumer protection, data privacy and security, and general public health laws. This would make requirements more uniform for covered businesses but would limit states from adopting stricter, conflicting rules.

Sponsors & CoSponsors

Sponsor

Pfluger, August [R-TX-11]

TX • R

Cosponsors

  • Rep. Houlahan, Chrissy [D-PA-6]

    PA • D

    Sponsored 8/31/2026

Roll Call Votes

No roll call votes available for this bill.

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