HouseH.R. 10197119th Congress
Biosecurity Modernization and Innovation Act
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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 10197 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 10197
To improve the security of nucleic acid synthesis in interstate and
foreign commerce, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 31, 2026
Mr. Pfluger (for himself and Ms. Houlahan) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To improve the security of nucleic acid synthesis in interstate and
foreign commerce, 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 ``Biosecurity Modernization and
Innovation Act''.
SEC. 2. REQUIREMENTS FOR COVERED ENTITIES WITH RESPECT TO HIGH-RISK
SEQUENCES.
(a) In General.--A covered entity shall establish a program of
reasonable administrative and technical protocols to carry out, with
respect to any nucleic acid sequence made available in interstate or
foreign commerce by such covered entity, the following requirements:
(1) Verify the identity of any buyer or prospective buyer
of such a nucleic acid sequence, including with respect to any
such nucleic acid sequence generated by a benchtop nucleic acid
synthesizer.
(2) Establish the purpose for which any such buyer or
prospective buyer seeks to obtain any such nucleic acid
sequence.
(3) Identify whether such a nucleic acid sequence,
including any such nucleic acid sequence generated by a
benchtop nucleic acid synthesizer, is a covered sequence as
determined by the Secretary under paragraph (1)(A) of
subsection (e), and on the list established and made available
under paragraph (1)(C) of such subsection.
(4) Establish risk-based criteria for refusing the sale of
a covered sequence to a buyer, prospective buyer, or any
combination thereof, and document each instance of refusal by
the covered entity in accordance with such criteria.
(5) Provide timely notification to the Secretary if the
covered entity has a reasonable belief that such a buyer or
prospective buyer is likely to use a covered sequence in a
manner that poses a high risk to the national security of the
United States or to the security and safety of persons in the
United States.
(6) Ensure regular independent assessment of compliance by
the covered entity with paragraphs (1) through (5) and
paragraph (7), including through adversarial testing, third-
party certifications, independent internal or external audits,
direct examination by the Secretary, or any combination
thereof.
(7) Maintain records sufficient to demonstrate to the
Secretary compliance with the requirements described in
paragraphs (1) through (6) for a period of not less than 5
years, as practicable.
(b) Guidance.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, the Secretary, in consultation with
relevant heads of other Federal departments, agencies, or
offices, as appropriate, shall issue guidance that identifies
the following:
(A) Approaches, best practices, frameworks, and
methods that may be implemented, alone or in
combination, by a covered entity to satisfy the
requirements under subsection (a).
(B) How a covered entity may ensure regular
independent assessment of compliance as described in
paragraph (6) of such subsection.
(C) What constitutes a timely notification under
paragraph (5) of such subsection, including by when and
in what manner a covered entity is required to provide
such a notification to the Secretary.
(2) Enforcement plan.--Not later than 1 year after the date
of the enactment of this Act, the Secretary shall issue
guidance relating to the priorities of the Secretary for
enforcing the requirements under subsection (a).
(3) Process.--Any guidance issued by the Secretary under
paragraphs (1) and (2) shall be developed through a covered
process.
(4) No conferring of rights or binding effect.--Any
guidance issued by the Secretary under paragraphs (1) and (2)
may not confer any rights on any person, State, or locality or
bind the Secretary or any person recommended in such guidance.
(c) Notification, Coordination, and Direct Examination.--Not later
than 180 days after the date of the enactment of this Act, the
Secretary shall establish a means, using a covered process, for the
Secretary to carry out the following:
(1) Accept a notification provided by a covered entity
under paragraph (5) of subsection (a).
(2) Facilitate coordination with covered entities and
stakeholders to identify a buyer, prospective buyer, or any
combination thereof, that has split orders across two or more
covered entities with the purpose of obtaining or synthesizing
a covered sequence.
(3) At the request of a covered entity, provide direct
examination to carry out the requirement under paragraph (6) of
such subsection.
(d) Identification of Approaches, Best Practices, Frameworks, and
Methods.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, the Secretary shall, in consultation
with the relevant heads of other Federal departments, agencies,
or offices, as appropriate, regularly consult with
stakeholders, including persons from academia and the private
sector, to identify the approaches, best practices, frameworks,
and methods under subsection (b)(1)(A), including related to
the following:
(A) Improving the accuracy, efficiency, and
reliability of any administrative and technical
protocols required under subsection (a), including with
respect to the independent assessment requirement under
paragraph (6) of such subsection.
(B) How a covered entity may offer an expedited
review process to a previous buyer of such covered
entity with respect to which the covered entity has
carried out the requirements under paragraphs (1) and
(2) of subsection (a).
(C) How the Secretary and any covered entity may
identify nucleic acid sequences with a low potential
for misuse.
(D) How the Secretary and any covered entity may
identify nucleic acid sequences, including novel
nucleic acid sequences, that may be used in a manner
that would pose a high risk to the national security of
the United States or to the security and safety of
persons in the United States.
(E) Mitigate any risk related to misuse of benchtop
nucleic acid synthesizers.
(2) Report.--Not later than 2 years after the date of the
enactment of this Act, and annually thereafter for 6 years, the
Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Commerce,
Science, and Transportation of the Senate a report--
(A) developed through a covered process; and
(B) that includes information related to any
approaches, best practices, frameworks, or methods
identified under paragraph (1).
(e) Report and Recommendations.--
(1) In general.--Not later than 2 years after the date of
the enactment of this Act, and every 2 years thereafter for 6
years, the Secretary shall publish on a publicly available
website a report that includes the following:
(A) An assessment on the following:
(i) The economic competitiveness of the
United States with respect to biotechnology,
including the manufacturing of nucleic acids.
(ii) The ability of the Secretary, covered
entities, and any other relevant entity to
mitigate any national security risk related to
covered sequences manufactured and sold in
interstate or foreign commerce.
(B) Any legislative recommendation related to the
following:
(i) Advancing such competitiveness.
(ii) Mitigating any such national security
risk.
(2) Public consultation.--In carrying out paragraph (1),
the Secretary shall use a covered process.
(3) Congressional notification.--Prior to publishing a
report under paragraph (1), the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Commerce, Science, and
Transportation of the Senate such report.
(f) Covered Sequence List.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, and regularly thereafter, the
Secretary, in consultation with the relevant heads of other
Federal departments, agencies, or offices, as appropriate,
shall carry out the following:
(A) A determination of whether a nucleic acid
sequence is a covered sequence.
(B) If the Secretary makes a determination that a
nucleic acid sequence is a covered sequence, make
available to covered entities a statement that explains
the basis for such determination, including any basis
specified in paragraph (2), as applicable.
(C) Establish and make available to covered
entities a list that includes any such covered
sequence.
(D) Establish a procedure to make any such
statement and such list available to stakeholders in a
manner that does not pose an unacceptable risk to the
national security of the United States or the security
and safety of United States persons.
(2) Basis.--A determination under paragraph (1)(A) shall be
based on one or more of the following:
(A) An assessment by the head of any other Federal
agency, including a relevant national security agency
or public health agency.
(B) A submission by a member of the public or a
covered entity under paragraph (3)(A).
(C) A determination by the Secretary that a nucleic
acid sequence poses an imminent or high likelihood of
use in such a manner that it poses an unacceptable risk
to the national security of the United States or the
security and safety of United States persons.
(3) Updates.--
(A) In general.--The Secretary shall update, as the
Secretary determines appropriate, any list established
and made available to covered entities under
subparagraph (C) of paragraph (1), and any statement or
list made available to stakeholders pursuant to the
procedure established under subparagraph (D) of such
paragraph, including in response to a novel nucleic
acid sequence.
(B) Submission process.--Not later than 180 days
after the date of the enactment of this Act, the
Secretary shall, through a covered process, establish a
process for the following:
(i) A member of the public to submit to the
Secretary a recommendation related to adding a
nucleic acid sequence to, removing a covered
sequence from, or otherwise modifying any list
established and made available to covered
entities under subparagraph (C) of paragraph
(1), and any statement or list made available
to stakeholders pursuant to the procedure
established under subparagraph (D) of such
paragraph.
(ii) A covered entity to carry out the
following:
(I) Submit to the Secretary a
request for the Secretary to review the
inclusion of a covered sequence in any
list established and made available to
covered entities under subparagraph (C)
of paragraph (1), and any statement or
list made available to stakeholders
pursuant to the procedure established
under subparagraph (D) of such
paragraph, to remove the covered
sequence from, or otherwise modify,
such list or statement.
(II) Submit evidence to the
Secretary related to such request.
(C) Confidentiality.--Any information related to a
recommendation, request, or evidence submitted pursuant
to the process established under subparagraph (B) shall
be treated as a trade secret and commercial or
financial information, and shall be exempt from
disclosure, under section 552(b)(4) of title 5, United
States Code.
(D) Option to request nondisclosure.--In carrying
out subparagraph (B), the Secretary shall offer any
member of the public or covered entity that utilizes
the process established under such subparagraph the
ability to request that any information related to a
recommendation, request, or evidence submitted pursuant
to such process is not published or disclosed in any
identifiable form, including any publication or
disclosure of any such information that would allow the
identity of the member of the public or covered entity
to be reasonably inferred.
(4) Congressional notification.--With respect to any list
established and made available to covered entities under
subparagraph (C) of paragraph (1), and any statement or list
made available to stakeholders pursuant to the procedure
established under subparagraph (D) of such paragraph, the
Secretary shall--
(A) at least 5 days before establishing and making
available such a list under such paragraph, or adding a
nucleic acid sequence to, removing a covered sequence
from, or otherwise modifying such list, submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Commerce, Science,
and Transportation of the Senate such list; and
(B) provide to such committees a briefing related
to such list, upon request by such committees.
(g) Enforcement.--
(1) Authority.--The Secretary shall have the authority to
carry out any of the following to enforce subsection (a):
(A) Require, inspect, and compel the provision of
any physical and electronic records and any other
information from such covered entity.
(B) Administer oaths or affirmations and require
any person to appear and testify or to appear and
produce any such record or other information by
subpoena.
(C) Conduct investigations within the United States
and outside the United States.
(2) Civil actions.--
(A) In general.--The Secretary may commence a civil
action against a covered entity for a violation of
subsection (a) in any district court of the United
States for appropriate relief, including--
(i) the penalty described under
subparagraph (B); or
(ii) an injunction.
(B) Penalty.--The penalty for a violation of
subsection (a) may not exceed $750,000 per violation
(as adjusted on January 1 each year by the percentage
increase, if applicable, in the consumer price index
for all urban consumers published by the Bureau of
Labor Statistics with respect to the 12-month period
preceding the date of such adjustment).
(C) Right to cure.--
(i) In general.--The Secretary may initiate
a civil action under subparagraph (A) only if--
(I) the Secretary has provided to
the relevant covered entity a written
notice that describes the alleged
violation and identifies the provision
under subsection (a) related to such
alleged violation; and
(II) at least 30 days have passed
since the date on which such written
notice was so provided.
(ii) Effect of cure.--If a covered entity
that receives a written notice under clause
(i)(I) cures the alleged violation described in
such notice not later than 30 days after the
date on which such covered entity was provided
such notice, the Secretary shall consider the
requirements under subsection (a) as satisfied
with respect to such covered entity.
(iii) Failure to cure.--After carrying out
clause (i), the Secretary may initiate an
action under subparagraph (A)--
(I) if the relevant covered entity
fails to cure the alleged violation
described in the written notice
provided pursuant to clause (i)(I); or
(II) if, after the curing the
alleged violation as specified in
clause (ii), the covered entity
violates the relevant provision under
subsection (a) again.
(3) Relation to guidance.--The Secretary may not commence a
civil action under paragraph (2) solely on the basis that a
covered entity has carried out the requirements under
subsection (a) in a manner that is inconsistent with any
guidance issued under subsection (b)(1).
(h) Relationship With Other Federal Guidelines and
Recommendations.--The requirements in subsection (a) shall supersede
any Federal guideline or recommendation related to the screening of
nucleic acid sequences made available in interstate or foreign commerce
if such guideline or recommendation is voluntary and in effect before
the date of the enactment of this Act.
(i) Preemption.--
(1) In general.--No State or political subdivision of a
State may prescribe, maintain, or enforce any law, rule,
regulation, requirement, standard, or other provision having
the force and effect of law to the extent such law, rule,
regulation, requirement, standard, or other provision is
covered by a requirement under subsection (a).
(2) Exception.--Notwithstanding paragraph (1), nothing in
this Act may be construed to preempt any law, rule,
requirement, or regulation of a State, or political subdivision
of a State, with respect to any of the following:
(A) Contract, tort, or product liability.
(B) Consumer protection, data privacy, or data
security.
(C) Any such generally applicable law, rule,
requirement, or regulation of a State, or a political
subdivision of a State, as it relates to public health.
(D) The procurement or use of nucleic acids or
nucleic acid sequences by a State or a political
subdivision of a State.
(j) Rule of Construction.--Nothing in this Act may be construed to
prohibit a covered entity from synthesizing a nucleic acid sequence or
prohibit a covered entity from producing equipment for synthesizing a
nucleic acid, including a benchtop nucleic acid synthesizer.
(k) Effective Date.--The requirement under subsection (a) shall
take effect on the date that is 1 year after the date of the enactment
of this Act.
(l) Definitions.--In this section:
(1) Benchtop nucleic acid synthesizer.--The term ``benchtop
nucleic acid synthesizer'' means a product, device, or
integrated system in interstate or foreign commerce that is--
(A) capable of generating de novo a nucleic acid
sequence--
(i) at the direction of an end user of such
product, device, or system; or
(ii) without requiring an end user of such
product, device, or system to submit to another
covered entity an order to perform the
generation of such nucleic acid sequence; and
(B) intended for distribution to, or use by, end
users other than the developer of the product, device,
or system, regardless of the physical dimensions of
such product, device, or system.
(2) Covered entity.--
(A) In general.--The term ``covered entity'' means
a person operating in interstate or foreign commerce
who--
(i) synthesizes and sells nucleic acids to
a person in the United States or in a foreign
country; or
(ii) produces, distributes, sells, or
resells equipment for synthesizing nucleic
acids, including a benchtop nucleic acid
synthesizer, to persons in the United States or
in a foreign country.
(B) Exception.--Subparagraph (A) does not apply to
the extent a person produces, distributes, sells, or
resells synthetic acids within a commercial entity
solely for the internal use of such commercial entity.
(3) Covered process.--The term ``covered process'' means,
with respect to the implementation of a requirement under this
section, a process by which the Secretary--
(A) publishes in the Federal Register a request for
public feedback on the matters described in such
provision;
(B) provides the public with an opportunity to
comment on the matters described in subparagraph (A)
for a period of not less than 60 days;
(C) ensures that public comments made under
subparagraph (B) that are not marked confidential are
available for public inspection; and
(D) demonstrates consideration of any such public
comments with respect to such implementation.
(4) Secretary.--The term ``Secretary'' means the Secretary
of Commerce, acting through the Office of the Secretary.
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