Biosecurity Modernization and Innovation Act

Summary#

This bill directs the Secretary of Commerce to write rules for companies that make or sell synthetic nucleic acids or the machines that make them. The rules must require: screening of DNA/RNA orders against a maintained list of "sequences of concern," checks to verify customer identity, and tools to detect split or suspicious orders across providers. The Secretary must create and regularly update the sequences list, allow privacy-preserving submissions, and enable rapid provisional additions. A conformity assessment program (audits and random red-team testing) will check provider compliance and can revoke status after a grace period. The bill requires recipients of Federal funds to buy only from compliant providers. The Under Secretary (NIST) will develop technical standards, testing guidance, and sequence-to-function research. The bill also creates a biotechnology governance sandbox to test governance tools and measurement research, and directs the OSTP Director to assess and plan consolidation of Federal biosecurity and biosafety authorities. Customer information submitted for screening is protected from public disclosure under FOIA exemption 552(b)(4). The Attorney General can bring civil actions for violations; courts may enjoin violations and order statutory damages (up to $500,000 for individuals and $750,000 for entities, adjusted for inflation). The Secretary must report annually to Congress on administration and verified providers.

What it means for you#

• Companies that make or sell synthetic DNA/RNA or synthesizer equipment in the United States would need to follow new federal screening and customer-verification rules.
• Institutions that receive Federal research funds would have to buy synthesis products only from providers verified under the program.
• The bill creates a secure testing space (a governance sandbox) for new biosecurity tools and standards.
• The government will review how Federal biosecurity and biosafety rules are organized and may move to consolidate authorities.

Expenses#

No publicly available information on total costs to the Federal Government or to industry is included in the bill text. The bill does specify civil penalties for violations: up to $500,000 for individuals and up to $750,000 for non-individual entities, with annual inflation adjustments.

Proponents' View#

The bill states Congress believes biotechnology is advancing quickly and brings both opportunity and risk. Supporters in the bill say current oversight is spread across many agencies and can be slow, creating gaps. They argue gene synthesis is more accessible and that screening orders and customers is an immediate step to reduce the risk that dangerous sequences could be used to create pathogens. The bill frames sandbox testing, technical standards, and a streamlined governance approach as ways to keep U.S. biotechnology competitive while improving safety and security.

Opponents' View#

No publicly available information on opposition views is included in the bill text or metadata.