H.R. 10164: Biomanufacturing Excellence, Domestic Resilience, Output, and Competitive Know-how Act

This bill would direct the Department of Commerce to take the lead on helping U.S. biomanufacturing become more competitive and more resilient. “Biomanufacturing” here means using biological systems such as cells, enzymes, or biomolecules to make commercial products like chemicals, proteins, materials, and industrial inputs.

What the Department of Commerce would have to do

Within one year, the Secretary of Commerce would have to name a senior official to coordinate the department’s biomanufacturing work. That official would be responsible for leading Commerce’s efforts, helping identify problems in the sector, and supporting U.S. competitiveness.

The bill would require the department to:

• Identify federal processes, resources, and public information that affect biomanufacturing commercialization.
• Identify barriers to private investment, product adoption, and domestic production, including unclear, duplicative, or unpredictable federal requirements.
• Identify supply-chain weaknesses, such as supplier concentration, single points of failure, and dependence on foreign adversaries or related entities.
• Look for opportunities to strengthen domestic production, diversify suppliers, and improve supply-chain resilience.
• Assess the availability in the United States of key inputs and equipment used in biomanufacturing, including amino acids, enzymes, microbial strains, cell lines, cell banks, bioreactors, and single-use bioprocessing components.

Coordination and public resources

The bill would have Commerce work with other federal agencies, including the Food and Drug Administration and the Environmental Protection Agency, on issues affecting biomanufacturing. It would also require Commerce to maintain a public website that gathers or links to federal resources relevant to commercializing biomanufactured products.

Commerce would also serve as a point of coordination for outside organizations and companies that are looking for publicly available federal information about these issues.

Assessments and reports

At least once a year for the first year, and then every two years after that, Commerce would have to conduct an assessment of the biomanufacturing landscape. That assessment would look at:

• Current and expected future availability of critical inputs and domestic production capacity.
• How much U.S. companies rely on foreign adversaries for inputs or production capacity.
• Supply-chain chokepoints, barriers, and other constraints.
• Whether substitutes for key inputs are available in the U.S.
• How hard it would be to reduce dependence on foreign adversary sources.
• Biomanufacturing capacity outside the U.S. and its effect on domestic industry.

Commerce would then include a prioritized action plan in its public reports, ranking the main risks and barriers and identifying possible federal actions, resources, and coordination opportunities to address them.

The bill would also require a separate report mapping federal processes that may apply to biomanufactured products and critical inputs. That report would identify points of contact, existing guidance, overlaps, gaps, ambiguities, and opportunities to make federal processes clearer and more predictable. It would also require FDA and EPA to each name a point of contact for outside entities seeking publicly available information about applicable rules.

Voluntary practices and public input

Commerce would be directed to publish industry-led or widely accepted voluntary practices related to commercialization, manufacturing readiness, product quality, supplier qualification, supply-chain risk management, information sharing, protecting trade secrets, participation by small and medium-sized businesses, market use of biomanufactured products, and the use of digital, automated, computational, or AI tools in biomanufacturing.

The bill would require public input and consultation with companies, suppliers, investors, commerce organizations, and experts, while giving priority to U.S. and other non-adversary stakeholders. It would also protect any nonpublic information voluntarily submitted to the department, including trade secrets and sensitive supply-chain vulnerability information.

Duration

These new requirements would end five years after enactment.

Relevant Companies

None found