H.R. 3029: Nucleic Acid Standards for Biosecurity Act

This bill, known as the Nucleic Acid Standards for Biosecurity Act, aims to enhance biosecurity measures related to nucleic acid synthesis. It seeks to amend existing legislation to provide better frameworks for managing risks associated with biological engineering and manufacturing. Here’s a breakdown of what the bill does:

Support for Nucleic Acid Screening

The bill focuses on improving nucleic acid screening by proposing the following changes:

• It updates the existing guidelines to include best practices, technical standards, and risk management strategies that consider the implications of artificial intelligence in biological contexts.
• Incorporates risk management associated with engineering biology and biomanufacturing as a part of the biosecurity measures.

Nucleic Acid Synthesis Screening Tools and Standards

The bill mandates the development of measurement research aimed at improving security and operational practices concerning nucleic acid synthesis. This includes:

• Enhancing testing methods to ensure accurate and reliable screening processes for nucleic acid synthesis.
• Establishing best practices surrounding security measures and access controls, particularly for databases of sequences that may pose safety concerns.
• Providing technical guidance to ensure the screening methods are both effective and secure.
• Setting best practices and standards for conformity assessments related to these screening methods.
• Evaluating the impact of these implemented methods and standards to measure their effectiveness.

Formation of a Consortium

To implement these objectives, the bill requires the formation of a consortium comprising various stakeholders, including:

• Industry representatives
• Institutions of higher education
• Nonprofit organizations
• Customers involved in biotech and biomanufacturing

This consortium will be responsible for:

• Developing consensus priorities and best practices for screening mechanisms used in synthetic nucleic acid procurement.
• Creating roadmaps that will guide the activities related to nucleic acid screening.

Reporting Requirements

After forming, the consortium must report its findings to the Senate and House committees focused on commerce and science within 18 months of its initial meeting. This report will outline the recommendations and updates on best practices developed by the consortium.

Funding Authorization

The bill authorizes funding of $5 million annually from 2026 to 2030 to support the scientific and technical research activities related to the National Institute of Standards and Technology. This funding will specifically be allocated toward implementing the provisions outlined in this bill.

Relevant Companies

• AMGN (Amgen Inc.) - As a biotechnology company involved in the development of therapeutics, Amgen may need to adapt its practices regarding nucleic acid synthesis and related biosecurity measures.
• ILMN (Illumina, Inc.) - Illumina, a leader in genomics, may see changes in regulatory frameworks affecting how they handle nucleic acid synthesis technologies.
• BIO (Biotechnology Innovation Organization) - As an industry organization, BIO will likely be involved in discussions about compliance with new biosecurity standards and practices.