The Biosecurity Modernization and Innovation Act mandates that "covered entities" involved in nucleic acid synthesis or equipment sales implement robust security protocols. These protocols require verifying buyer identity, establishing the purpose of purchases, and identifying high-risk "covered sequences" designated by the Secretary of Commerce. This ensures a foundational level of scrutiny for transactions involving potentially dangerous biological materials. Covered entities must also establish risk-based criteria for refusing sales of covered sequences, document all refusals, and promptly notify the Secretary if a buyer is suspected of intending misuse that poses a national security or public safety risk. Regular independent assessments of compliance, including audits and adversarial testing, are required, along with maintaining records for at least five years. These measures aim to create a transparent and accountable system for managing biosecurity risks. The Secretary of Commerce is directed to issue guidance within 180 days on best practices for implementing these requirements, assessing compliance, and defining timely notifications, with enforcement priority guidance following within one year. The Secretary will also coordinate with entities to detect split orders of covered sequences and consult stakeholders to identify improved approaches for risk mitigation and the identification of both low-risk and high-risk sequences. This collaborative approach seeks to continuously refine security measures. A central provision involves the Secretary establishing and regularly updating a publicly available list of "covered sequences," based on federal agency assessments, public submissions, or the Secretary's determination of unacceptable risk. The basis for each determination will be provided, and a process for public and entity submissions for list updates will be established, ensuring confidentiality for submitted information. This dynamic list is crucial for adapting to evolving biosecurity threats. The bill grants the Secretary broad enforcement authority, including the power to inspect records, issue subpoenas, and conduct investigations, with civil penalties up to $750,000 per violation. Entities are provided a 30-day right to cure alleged violations before civil action. This Act supersedes existing voluntary federal guidelines and preempts conflicting state laws, while preserving state authority over areas like contract law, consumer protection, and public health, with requirements taking effect one year after enactment.
Referred to the House Committee on Energy and Commerce.
Biosecurity Modernization and Innovation Act
USA119th CongressHR-10197| House
| Updated: 8/31/2026
The Biosecurity Modernization and Innovation Act mandates that "covered entities" involved in nucleic acid synthesis or equipment sales implement robust security protocols. These protocols require verifying buyer identity, establishing the purpose of purchases, and identifying high-risk "covered sequences" designated by the Secretary of Commerce. This ensures a foundational level of scrutiny for transactions involving potentially dangerous biological materials. Covered entities must also establish risk-based criteria for refusing sales of covered sequences, document all refusals, and promptly notify the Secretary if a buyer is suspected of intending misuse that poses a national security or public safety risk. Regular independent assessments of compliance, including audits and adversarial testing, are required, along with maintaining records for at least five years. These measures aim to create a transparent and accountable system for managing biosecurity risks. The Secretary of Commerce is directed to issue guidance within 180 days on best practices for implementing these requirements, assessing compliance, and defining timely notifications, with enforcement priority guidance following within one year. The Secretary will also coordinate with entities to detect split orders of covered sequences and consult stakeholders to identify improved approaches for risk mitigation and the identification of both low-risk and high-risk sequences. This collaborative approach seeks to continuously refine security measures. A central provision involves the Secretary establishing and regularly updating a publicly available list of "covered sequences," based on federal agency assessments, public submissions, or the Secretary's determination of unacceptable risk. The basis for each determination will be provided, and a process for public and entity submissions for list updates will be established, ensuring confidentiality for submitted information. This dynamic list is crucial for adapting to evolving biosecurity threats. The bill grants the Secretary broad enforcement authority, including the power to inspect records, issue subpoenas, and conduct investigations, with civil penalties up to $750,000 per violation. Entities are provided a 30-day right to cure alleged violations before civil action. This Act supersedes existing voluntary federal guidelines and preempts conflicting state laws, while preserving state authority over areas like contract law, consumer protection, and public health, with requirements taking effect one year after enactment.