[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 10164 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 10164
To direct the Secretary of Commerce to promote competitiveness in
biomanufacturing in the United States, identify supply-chain and
commercialization vulnerabilities relating to critical biomanufacturing
inputs and domestic production capacity, improve transparency regarding
Federal processes applicable to biomanufactured products, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 27, 2026
Mr. Latta (for himself and Mrs. Dingell) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Secretary of Commerce to promote competitiveness in
biomanufacturing in the United States, identify supply-chain and
commercialization vulnerabilities relating to critical biomanufacturing
inputs and domestic production capacity, improve transparency regarding
Federal processes applicable to biomanufactured products, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Biomanufacturing Excellence,
Domestic Resilience, Output, and Competitive Know-how Act'' or the
``BEDROCK Act''.
SEC. 2. ACTIVITIES RELATED TO PROMOTING COMPETITIVENESS IN
BIOMANUFACTURING IN THE UNITED STATES.
(a) In General.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall designate a senior official
to--
(1) lead the activities of the Department of Commerce
relating to biomanufacturing and biomanufactured products in
the United States;
(2) carry out the activities described in subsection (b);
and
(3) promote commercial competitiveness with respect to such
biomanufacturing and biomanufactured products.
(b) Activities Described.--The activities described in this
subsection are the following:
(1) Identify the following:
(A) Any Federal process, resource, or publicly
available information relevant to promoting commercial
competitiveness with respect to biomanufacturing and
biomanufactured products in domestic and foreign
commerce.
(B) Any barrier to private sector investment in
biomanufacturing, market adoption of biomanufactured
products, or domestic production of such products,
including barriers arising from unclear, duplicative,
or unpredictable Federal processes related to the
commercialization of such products.
(C) Any vulnerability, chokepoint, supplier
concentration, single point of failure, market barrier,
or other constraint affecting a supply chain related to
a critical biomanufacturing input, including any such
vulnerability, chokepoint, supplier concentration,
single point of failure, market barrier, or other
constraint related to a foreign adversary or a foreign
adversary entity.
(D) Any opportunity for a private sector entity or
policymaker to strengthen domestic production, supplier
diversification, commercialization, and supply chain
resilience related to biomanufacturing or
biomanufactured products.
(E) The availability of domestic production
capacity, inputs, equipment, and other resources
related to the commercial manufacturing of
biomanufactured products in the United States,
including with respect to the following:
(i) Amino acids.
(ii) Industrial enzymes.
(iii) Microbial strains.
(iv) Cell lines.
(v) Cell banks.
(vi) Bioreactors.
(vii) Single-use bioprocessing components.
(2) Facilitate consultations, on a voluntary basis, for
participating non-Federal entities to promote commercial
competitiveness with respect to biomanufacturing and
biomanufactured products, including consultations required
pursuant to subsection (d)(3).
(3) Consult with the heads of relevant Federal agencies,
and any relevant agency point of contact, including the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, and the Administrator of the
Environmental Protection Agency, as the Secretary determines
appropriate, with respect to matters affecting the
competitiveness of biomanufacturing, supply-chain resilience,
and the commercial manufacturing of biomanufactured products.
(4) Maintain a publicly available web resource that
consolidates or provides links to publicly available Federal
resources relevant to the commercialization of biomanufactured
products, as determined appropriate by the Secretary, including
the following information and resources:
(A) Any practice identified and made publicly
available under subsection (d).
(B) The report required under subsection (e)(1).
(C) Any point of contact designated under
subsection (e)(3) or otherwise made publicly available
by a relevant Federal agency.
(5) Serve as a point of coordination for non-Federal
entities seeking publicly available information related to a
Federal process identified under paragraph (1)(A), including by
referring such entities to the appropriate Federal agency or
point of contact.
(c) Assessment.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, and every 2 years thereafter, the
Secretary, acting through the senior official designated
pursuant to subsection (a), shall conduct an assessment with
respect to the following:
(A) The current and, to the extent practicable,
reasonably foreseeable future availability of critical
biomanufacturing inputs and domestic production
capacity related to biomanufacturing in the United
States.
(B) The extent to which private sector entities in
the United States rely on foreign adversaries or
foreign adversary entities for critical
biomanufacturing inputs or production capacity related
to biomanufacturing.
(C) Any vulnerability, chokepoint, single point of
failure, supplier concentration, market barrier, or
other constraint impacting the access of a private
sector entity to critical biomanufacturing inputs or
domestic production capacity related to
biomanufacturing.
(D) The availability of substitutes for critical
biomanufacturing inputs in the United States, including
from other sources that are not foreign adversaries or
foreign adversary entities.
(E) Estimated lead times and economic or
operational barriers to reducing reliance by private
sector entities on a foreign adversary or a foreign
adversary entity for critical biomanufacturing inputs
or production capacity related to biomanufacturing.
(F) Any barrier identified under subsection
(b)(1)(B), including the following:
(i) Any Federal process for which a review
related to commercialization is divided among
multiple Federal agencies.
(ii) Any barrier arising from limited
access to shared pilot-scale and demonstration-
scale manufacturing capacity.
(G) Any opportunity for domestic producers and
suppliers to expand the capacity of, improve the
reliability of, and diversify supply chains for
critical biomanufacturing inputs.
(H) Any impact on commerce and biomanufacturing in
the United States if a vulnerability, chokepoint,
single point of failure, supplier concentration, market
barrier, or other constraint identified under
subparagraph (C) is not addressed, including any impact
on relevant domestic supply-chain resilience and access
to biomanufactured products.
(I) Biomanufacturing capacity located outside of
the United States, including capacity at contract
manufacturing facilities and company-owned facilities,
and capacity owned or controlled by foreign adversaries
or foreign adversary entities, to--
(i) compare such biomanufacturing capacity
with the biomanufacturing capacity of the
United States; and
(ii) assess the impact of such capacity on
domestic industry.
(2) Prioritization.--In conducting the assessment under
paragraph (1), the Secretary, acting through the senior
official designated pursuant to subsection (a), shall
prioritize the matters described in such paragraph based on the
following:
(A) The commercial significance of the relevant
affected critical biomanufacturing input or production
capacity.
(B) Potential consequences for commerce in the
United States.
(C) The extent of reliance on foreign adversaries
or foreign adversary entities.
(D) Estimated lead times and barriers to reducing
such reliance.
(E) The availability of substitute sources.
(3) Prioritized action plan.--Based on each assessment
under paragraph (1), the Secretary shall prepare and include in
any report submitted and made publicly available under
subsection (g) a prioritized action plan that--
(A) ranks each supply-chain risk and
commercialization barrier identified in the assessment
by commercial significance and potential consequence
for commerce in the United States;
(B) identifies actions the Secretary may take to
improve supply-chain visibility, stakeholder
coordination, and access to information related to the
commercialization of biomanufactured products;
(C) identifies existing Federal financial
assistance programs and other Federal resources that
may address any such supply-chain risk or
commercialization barrier;
(D) identifies any program or resource described in
subparagraph (C) that should be added to the web
resource maintained under subsection (b)(4); and
(E) identifies opportunities for the Secretary to
coordinate with relevant Federal agencies and non-
Federal entities to reduce such risks and barriers.
(d) Voluntary Practices.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, and as the Secretary determines
appropriate thereafter, the Secretary shall identify and make
publicly available industry-led, evidence-based, or widely
accepted practices related to the following:
(A) The commercialization of biomanufacturing
processes and biomanufactured products.
(B) The readiness of biomanufacturing processes or
biomanufactured products for commercial production.
(C) The reliability and operational consistency of
biomanufacturing processes and the quality of
biomanufactured products.
(D) Supplier qualification, supplier
diversification, and commercial supply chain risk
management for critical biomanufacturing inputs.
(E) The voluntary sharing of nonproprietary
information related to biomanufacturing process and the
supply chains for biomanufacturing processes or
biomanufactured products that is necessary to support
commercialization and commercial manufacturing,
including the secure and portable transfer of
information that a process originator elects to share
with a manufacturing partner, as appropriate.
(F) The protection of trade secrets, confidential
business information, and intellectual property
relating to biomanufacturing.
(G) The participation of small and medium-sized
businesses and manufacturers in biomanufacturing.
(H) The use of biomanufactured products in domestic
and foreign commerce.
(I) The use of digital, computational, automated,
or artificial intelligence tools in commercial
biomanufacturing to improve reliability, efficiency,
product quality, and consistency.
(2) Existing practices.--In carrying out paragraph (1), the
Secretary shall--
(A) prioritize identifying existing practices,
including practices issued or maintained by industry-
led organizations, and making such practices publicly
available; and
(B) avoid unnecessary duplication of such
practices.
(3) Consultation.--In carrying out paragraph (1), the
Secretary shall consult with non-Federal entities, including
the following:
(A) The following private sector entities:
(i) Manufacturers and suppliers of critical
biomanufacturing inputs.
(ii) Small and medium-sized businesses and
manufacturers of biomanufactured products.
(iii) Companies seeking to commercialize,
produce, or use biomanufactured products.
(iv) Investors, accelerators, and other
entities involved in commercialization.
(B) State, local, Tribal, territorial, and regional
commerce or manufacturing organizations.
(C) Experts in commercial supply-chain resilience,
manufacturing, and competitiveness.
(4) Prioritization of united states and trusted
stakeholders.--In carrying out paragraph (3), the Secretary
shall prioritize, to the extent practicable, input from non-
Federal entities in the United States and other stakeholders
that are neither foreign adversaries nor foreign adversary
entities.
(5) Public input.--
(A) In general.--The Secretary shall provide at
least 1 opportunity for the public to submit input
under this subsection.
(B) Methods.--The Secretary may solicit public
input under this subsection through making requests for
information, workshops, roundtables, meetings with non-
Federal entities, or any other means the Secretary
determines appropriate.
(e) Federal Commercialization Pathway Map; Agency Points of
Contact.--
(1) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary, in consultation with the
heads of relevant Federal agencies, shall submit to the
appropriate congressional committees and make publicly
available a report that identifies and maps any Federal process
that may apply to the commercialization of biomanufactured
products and critical biomanufacturing inputs, as the Secretary
determines appropriate.
(2) Contents.--The report required under paragraph (1)
shall do the following:
(A) Organize any Federal process identified and
mapped under such paragraph by category of
biomanufactured product or critical biomanufacturing
input, as the Secretary determines appropriate.
(B) Identify the following:
(i) Any publicly available point of contact
for a Federal agency and any existing public
guidance related to any such Federal process.
(ii) Overlaps, gaps, ambiguities, and
timing or predictability concerns related to
any such Federal process.
(iii) Opportunities to improve the clarity
and predictability of, and reduce duplication
among, any such Federal process.
(3) Agency points of contact.--Not later than 180 days
after the date of the enactment of this Act--
(A) the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs,
shall--
(i) designate a point of contact to assist
non-Federal entities in identifying publicly
available information related to any process of
the Food and Drug Administration that may apply
to biomanufactured products or critical
biomanufacturing inputs; and
(ii) ensure such point of contact
coordinates, as appropriate, with relevant
components of the Food and Drug Administration
in carrying out clause (i); and
(B) the Administrator of the Environmental
Protection Agency shall designate a point of contact to
assist non-Federal entities in identifying publicly
available information related to laws administered by
the Administrator of the Environmental Protection
Agency that may apply to biomanufactured products or
critical biomanufacturing inputs.
(4) Integration with existing resources.--
(A) In general.--In carrying out paragraphs (1) and
(2), the Secretary may incorporate or rely on a
substantially similar existing Federal resource,
report, assessment, map, or other activity if the
Secretary determines that it substantially addresses
the applicable requirement.
(B) Inclusion in report.--If the Secretary
incorporates or relies on a substantially similar
existing Federal resource, report, assessment, map, or
other activity under subparagraph (A), the Secretary
shall include in the report required under paragraph
(1) the following:
(i) An identification of the resource,
report, assessment, map, or other activity.
(ii) An explanation of how the resource,
report, assessment, map, or other activity
addresses the applicable requirement.
(5) Updates.--The Secretary shall update the report
required under paragraph (1) to reflect any material change to
any Federal process described in such paragraph, as the
Secretary determines appropriate.
(f) Protection of Information.--
(1) In general.--The Secretary may not publicly disclose
any nonpublic information voluntarily submitted by a non-
Federal entity under this section that--
(A) constitutes a trade secret or confidential
business information; or
(B) is sensitive supply-chain vulnerability
information.
(2) Exemption from disclosure.--Information described in
paragraph (1) shall be exempt from disclosure under section
552(b)(3) of title 5, United States Code.
(3) Identification and determination.--
(A) In general.--The Secretary shall establish a
process for a non-Federal entity that voluntarily
submits information under this section to identify
whether the entity considers such information to be
nonpublic information described in paragraph (1).
(B) Determination.--If a non-Federal entity makes
an identification under the process required by
subparagraph (A), with respect to information
voluntarily submitted under this section by such
entity, the Secretary shall determine whether such
information is nonpublic information described in
paragraph (1).
(C) Treatment pending determination.--The Secretary
may not publicly disclose any information with respect
to which a non-Federal entity makes an identification
under paragraph (3)(A) unless the Secretary has
determined such information is not nonpublic
information described in paragraph (1).
(g) Reports.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, and every 2 years thereafter, the
Secretary, acting through the senior official designated
pursuant to subsection (a), shall submit to the appropriate
congressional committees, and make publicly available on a
website of the Department of Commerce, a report that includes
the following:
(A) A summary of any action carried out by the
Secretary under this section.
(B) Any assessment conducted under subsection (c).
(C) Any prioritized action plan prepared under
paragraph (3) of such subsection.
(D) A summary of any practices identified and made
publicly available under subsection (d).
(E) Any updates related to the report required
under subsection (e)(1).
(2) Nonpublic annex.--The Secretary, acting through the
senior official designated pursuant to subsection (a), may
submit to the appropriate congressional committees a nonpublic
annex to a report required under paragraph (1) that includes
nonpublic information described in subsection (f)(1).
(h) Termination.--The requirements under subsections (a) through
(e) and subsection (g) shall terminate on the date that is 5 years
after the date of the enactment of this Act.
(i) Definitions.--In this section:
(1) Appropriate congressional committees.--The term
``appropriate congressional committees'' means--
(A) the Committee on Energy and Commerce of the
House of Representatives; and
(B) the Committee on Commerce, Science, and
Transportation of the Senate.
(2) Biomanufactured product.--The term ``biomanufactured
product'' means a commercial good, material, chemical, protein,
component, industrial input, or other product or substance in
commerce that is produced, processed, purified, or transformed
through biomanufacturing.
(3) Biomanufacturing.--The term ``biomanufacturing'' means
the use of biological systems, including cells, cell-free
systems, enzymes, or biomolecules, in manufacturing processes
to produce, process, or transform commercial goods, materials,
chemicals, proteins, components, industrial inputs, or other
products or substances in commerce.
(4) Critical biomanufacturing input.--The term ``critical
biomanufacturing input'' means an input, material, reagent,
item of equipment, or software used in biomanufacturing that is
commercially significant to biomanufacturing in the United
States and subject to supply-chain risk, such as supplier
concentration, reliance on a foreign adversary or foreign
adversary entity, limited substitutes, or long lead times.
(5) Foreign adversary.--The term ``foreign adversary''
means a foreign government or foreign non-government person
identified as a foreign adversary under section 791.4 of title
15, Code of Federal Regulations, or any successor regulation.
(6) Foreign adversary entity.--The term ``foreign adversary
entity'' has the meaning given the term ``person owned by,
controlled by, or subject to the jurisdiction or direction of a
foreign adversary'' in section 791.2 of title 15, Code of
Federal Regulations, or any successor regulation.
(7) Non-federal entity.--The term ``non-Federal entity''
means a State, local, Tribal, or territorial government,
nonprofit organization, technical organization, industry
association, commerce or manufacturing organization, private
sector entity, or other stakeholder.
(8) Secretary.--The term ``Secretary'' means the Secretary
of Commerce.
(9) Sensitive supply-chain vulnerability information.--The
term ``sensitive supply-chain vulnerability information'' means
nonpublic information with respect to which the public
disclosure of such nonpublic information could be reasonably
expected to reveal a vulnerability, dependency, chokepoint,
single point of failure, supplier concentration, or other
weakness in a supply chain relevant to biomanufacturing in the
United States.
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