Biosecurity Modernization and Innovation Act

Summary#

This bill sets rules for companies that make or sell nucleic acids or equipment that makes nucleic acids. It requires those companies (called "covered entities") to set up programs that: verify the identity of buyers; ask why a buyer wants a sequence; check whether a sequence is on a list of high-risk sequences set by the Secretary of Commerce; refuse sales based on risk rules and record refusals; notify the Secretary if they reasonably believe a buyer may misuse a high-risk sequence; conduct regular independent checks of their compliance; and keep records for at least 5 years. The Secretary of Commerce must publish guidance, make and update a list of covered sequences, accept public and company requests about that list, and provide ways to accept notifications and help identify split orders. The Secretary can inspect records, subpoena information, investigate, and bring civil actions with penalties (up to $750,000 per violation, adjusted by CPI). The bill preempts state rules on the same covered matters but preserves state laws on liability, consumer protection, data privacy/security, public health, and state procurement or use. The requirements take effect one year after enactment. Definitions include "benchtop nucleic acid synthesizer," "covered entity," and the meaning of a "covered process." Reports and regular consultations with stakeholders are required on best practices, risk identification, and U.S. competitiveness in biotechnology.

What it means for you#

• If you run a company that synthesizes or sells nucleic acids or synthesis equipment: you must implement buyer screening, document refusals, keep records for 5 years, allow independent compliance checks, and notify the Secretary about suspected misuse.
• If you buy sequences or use benchtop synthesizers: sellers may verify your identity and ask about your intended use before fulfilling orders.
• If you are a researcher or work in industry: some orders could be delayed or refused under the bill's risk-based rules.
• If you are a state official: state laws covering the same matters would be preempted, except for listed exceptions (liability, consumer protection, data privacy/security, public health, and state procurement/use).

Expenses#

No publicly available information on the total projected federal cost or the cost to companies for implementing the required programs. The bill does specify a civil penalty cap of $750,000 per violation (adjusted annually by the consumer price index).

Proponents' View#

The bill's stated purpose is "to improve the security of nucleic acid synthesis in interstate and foreign commerce." It directs the Secretary of Commerce to create guidance, lists, and enforcement tools to reduce risks from high-risk sequences and to consult with stakeholders about best practices and competitiveness in biotechnology.

Opponents' View#

No publicly available information.