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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3741 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
2d Session
S. 3741
To require the Secretary of Commerce to promulgate regulations to
improve nucleic acid synthesis security, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
January 29, 2026
Mr. Cotton (for himself and Ms. Klobuchar) introduced the following
bill; which was read twice and referred to the Committee on Commerce,
Science, and Transportation
_______________________________________________________________________
A BILL
To require the Secretary of Commerce to promulgate regulations to
improve nucleic acid synthesis security, 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 of 2026''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Covered provider.--The term ``covered provider'' means
a person who--
(A) synthesizes and sells synthetic nucleic acids
to persons in the United States; or
(B) produces and distributes or sells, including
resellers, equipment for synthesizing nucleic acids,
including benchtop synthesizers, to persons in the
United States.
(2) Director.--The term ``Director'' means the Director of
the Office of Science and Technology Policy.
(3) Secretary.--The term ``Secretary'' means the Secretary
of Commerce.
(4) Under secretary.--The term ``Under Secretary'' means
the Under Secretary of Commerce for Standards and Technology.
SEC. 3. SENSE OF CONGRESS.
It is the Sense of Congress that--
(1) the field of biotechnology is accelerating and the
United States is at risk of losing its biotechnology leadership
to foreign adversaries;
(2) this acceleration of the field brings the United States
into a period of both great opportunity and risk;
(3) policymaking for biosecurity, biosafety, and
responsible innovation needs to be flexible to keep pace with
advances in the biotechnology and ensure an environment that
allows biotechnology research and industry to flourish;
(4) the current landscape of biosecurity and biosafety
authorities is spread among multiple agencies, contributing to
slow policymaking, which, coupled with the rapid advancement of
biotechnology, becomes outdated quickly;
(5) previous studies conducted by the Government
Accountability Office, the National Security Commission for
Emerging Biotechnology, and several presidential
administrations have already identified gaps in the Federal
Government's oversight of biosecurity and biosafety risks;
(6) the United States Government needs to streamline
biosecurity and biosafety authorities to ensure efficiency and
clarity;
(7) gene synthesis technology is becoming increasingly
sophisticated and accessible, along with the ability to design
novel nucleic acid sequences;
(8) both of these factors described in paragraph (7) may
increase the risk of the development and deployment of new
pathogens by bad actors; and
(9) gene synthesis screening of orders and customers is
immediately needed to mitigate risk in the short-term, which
will act as a stopgap while the United States Government
develops a comprehensive biosecurity and biosafety strategy
that is appropriate for the dynamic and rapidly advancing field
of biotechnology.
SEC. 4. NUCLEIC ACID SYNTHESIS SECURITY.
(a) Regulations Required.--Not later than 1 year after the date of
the enactment of this Act, the Secretary shall, in coordination with
the Under Secretary and the heads of such other agencies as the
Secretary considers appropriate, establish and maintain by regulation
the following:
(1) A requirement for covered providers to implement
screening protocols for all sequences of concern included in
the list established and maintained under paragraph (3). Such
protocols shall--
(A) include the ability for privacy-preserving
submission of information regarding orders for
potential sequences of concern to a mechanism, which
may be maintained by the Secretary or an independent
organization designated by the Secretary, for
facilitating effective split order detection across
covered providers, utilizing the list established and
maintained under paragraph (3); and
(B) prioritize the mitigation of misuse of
sequences capable of creating pathogens with pandemic
potential.
(2) A requirement for covered providers to implement
screening protocols to verify the identity and legitimacy of
customers.
(3) A list of sequences of concern, which shall be
determined by the Secretary in consultation with such heads of
Federal departments and agencies, industry experts, academics,
and researchers as the Secretary considers appropriate.
(4) A system for reviewing and updating on a regular basis
the list of sequences of concern established and maintained
under paragraph (3) that--
(A) uses a docket to allow for privacy-preserving
submissions from the public on recommendations for the
list of sequences of concern;
(B) includes an expedited procedure to rapidly add
sequences of concern to the list on a provisional
basis, which may include, as far as technically
feasible, automatic procedures such as algorithmic
literature scanning, industry self-reporting, or inter-
agency submissions; and
(C) incorporates strong data security and
confidentiality standards.
(5) A conformity assessment system to verify that covered
providers are adhering to the requirements established and
maintained under paragraphs (1) and (2), which will include--
(A) an auditing process to ensure orders and
customers have been scrutinized appropriately,
including procedures to conduct adversarial testing
(sometimes referred to as ``red-teaming'') at random
intervals to ensure compliance; and
(B) a process to revoke conformity status of
covered providers that fail to maintain compliance with
the requirements established and maintained under
paragraphs (1) and (2), including the establishment of
a grace period for covered providers who have failed
auditing or adversarial testing under subparagraph (B)
to demonstrate compliance or mitigation steps.
(6) Safeguards to ensure regulations promulgated under this
subsection avoid unnecessary burden on innovation and industry
by--
(A) allowing covered providers to offer an
expedited review process for institutional customers,
including accredited institutions of higher education,
with demonstrated records of legitimacy;
(B) providing exemptions from customer screening
requirements for sequences or products that are clearly
non-hazardous and pose no credible threat to public
health and safety based on scientific literature and
industry best practices for biosecurity screening; and
(C) conducting regular consultations with relevant
experts to determine exempted sequences and minimize
regulatory burden while maintaining security
effectiveness.
(7) A requirement that any person who receives Federal
funds can only purchase nucleic acid synthesis products from a
covered provider in compliance with the requirements in
paragraphs (1) and (2).
(8) A program to provide technical assistance upon request
of a covered provider, including assistance with orders whose
screening results are ambiguous, subject to determination by
the Secretary, in consultation with the heads of such other
Federal departments and agencies as the Secretary considers
appropriate.
(b) National Institute of Standards and Technology Requirements.--
The Under Secretary shall develop best practices, technical standards,
and other tools needed to support the administration of subsection (a),
including the following:
(1) Testing and evaluation of customer and order screening
protocols to improve accuracy, efficacy, and reliability, and
to support the conformity assessment system under of subsection
(a)(5).
(2) Evaluation of the sequences recommended for the list
established and updated under paragraphs (3) and (4) of
subsection (a), including by developing best practices and
guidelines for determining if a novel sequence is a sequence of
concern.
(3) Research and prototype sequence-to-function models to
supplement the system established and maintained under
subsection (a)(4).
(c) Updates.--As frequently as the Secretary considers appropriate
to account for technological advances, but not less frequently than
once every 2 years, the Secretary shall review and update the
regulations promulgated under subsection (a).
(d) Protection of Customer Information.--Any information about a
customer included in a submission under paragraph (1)(A) or (4)(A) of
subsection (a) shall, if applicable, be exempt from records access
under section 552(b)(4) of title 5, United States Code.
(e) Relationship With Other Federal Guidelines and
Recommendations.--The regulations established and maintained under
paragraphs (1) and (2) of subsection (a) shall supplant any Federal
guidelines or recommendations relating to nucleic acid synthesis
screening that--
(1) were in effect before the date of the enactment of this
Act; and
(2) are voluntary.
(f) Civil Enforcement.--
(1) Civil action.--The Attorney General may bring a civil
action in a court of competent jurisdiction against any person
who violates a requirement promulgated under paragraph (1) or
(2) of subsection (a), including through providing false or
misleading information or engaging in other deceptive
practices, or does not demonstrate compliance within the grace
period set forth by subsection (a)(5)(C).
(2) Powers of the court.--In an action brought under
paragraph (1), the court may--
(A) enjoin a violation described in paragraph (1);
or
(B) award damages under paragraph (3).
(3) Award of damages.--A person who violates a requirement
as described in paragraph (1) is liable for statutory damages--
(A) in the case of an individual, in the sum of not
more than $500,000, adjusted from time to time under
paragraph (4); and
(B) in the case of a person who is not an
individual, in the sum of not more than $750,000,
adjusted from time to time under paragraph (4).
(4) Adjustments for inflation.--Effective on October 1 of
each year (beginning in the first fiscal year after the date of
the enactment of this Act), the dollar amounts in effect under
paragraph (3) shall be increased by a percentage equal to the
percentage by which the Consumer Price Index for all urban
consumers (U.S. city average) increased during the 12-month
period ending with the last month for which Consumer Price
Index data is available. In the event that such Consumer Price
Index does not increase during such period, the dollar amount
in effect under such paragraph during the previous fiscal year
shall be maintained.
(g) Reports to Congress.--Not less frequently than once each year,
the Secretary shall submit to Congress a report on the administration
of this section. Each such report shall include an overview of how many
covered providers have been verified by the conformity assessment
system established and maintained under subsection (a)(5).
SEC. 5. ESTABLISHMENT OF BIOTECHNOLOGY GOVERNANCE SANDBOX.
(a) In General.--Not later than 1 year after the date of the
enactment of this Act, the Under Secretary shall, in collaboration with
the heads of such Federal agencies as the Under Secretary considers
relevant and with such persons in the private sector, academia, and
civil society as the Under Secretary considers appropriate, establish a
biotechnology governance sandbox environment.
(b) Responsibilities.--Through the governance sandbox developed
under subsection (a), the Under Secretary shall--
(1) provide secure testing of innovations or tools
developed to advance the science of biosecurity, biosafety, and
responsible biotechnology innovation;
(2) foster participation of nongovernmental experts in the
development and testing of appropriate levels and methods of
governance, to achieve the goals of--
(A) ensuring the continued global competitiveness
of biotechnology innovations in the United States;
(B) bolstering the national security posture of the
United States; and
(C) strengthening the ability of the United States
to robustly analyze emerging threats, anticipate
concerns, and govern proactively in the biotechnology
space;
(3) carry out biological measurement research to support
the development and improvement of technical standards for
biosecurity, biosafety, and responsible biotechnology
innovation; and
(4) report annually to the Secretary of Commerce on the
administration of paragraph (2) and whether any promising
governance strategies have resulted from the development and
testing.
(c) Access to Environments.--The Under Secretary may contract with
the private sector or coordinate with other Federal agencies to access
environments necessary to provide testing under subsection (b)(1).
SEC. 6. STREAMLINING BIOSECURITY AND BIOSAFETY AUTHORITIES ACROSS THE
FEDERAL GOVERNMENT.
(a) Assessment and Plan Required.--Not later than 90 days after the
date of the enactment of this Act, the Director shall, in collaboration
with the heads of such Federal agencies as the Director considers
relevant--
(1) assess the current state of biosecurity and biosafety
oversight by the Federal Government; and
(2) develop, based on the findings of the Director with
respect to the assessment conducted under paragraph (1), an
implementation plan to make oversight of biosecurity and
biosafety by the Federal Government more effective and
efficient.
(b) Elements of Assessment.--The assessment required by subsection
(a)(1) shall include the following:
(1) A full accounting of Federal biosecurity and biosafety
authorities and programs, including which agencies hold these
authorities, whether these authorities are exercised
effectively, and where there are overlaps or redundancies, real
or perceived, in regulatory and enforcement authorities.
(2) Engagement with industry stakeholders and academia to
understand where there are challenges with compliance,
communication, and information sharing.
(3) Identification of gaps in funding or other Government
support for the development of research, innovation, and tools
that advance the science of applied biosecurity, biosafety, and
responsible biotechnology innovation.
(4) Identification of gaps in current Federal biosecurity
and biosafety authorities and whether these gaps are hindering
effective and efficient governance and assessment of emerging
risks and opportunities in biotechnology.
(5) An evaluation of how consolidation of biosecurity and
biosafety guidelines, authorities, and regulations across
Federal agencies, including the regulations established and
maintained under section 4(a), should be implemented to make
oversight more effective and efficient and to address the gaps
in such guidelines, authorities, and regulations, including
those identified under paragraphs (3) and (4).
(c) Report to Congress.--
(1) In general.--Not later than 90 days after the date on
which the Director completes the assessment required by
paragraph (1) of subsection (a) and the implementation plan
required by paragraph (2) of such subsection, the Director
shall submit to Congress--
(A) a report on the findings of the Director with
respect to the assessment; and
(B) a copy of the implementation plan.
(2) Contents.--The report submitted pursuant to paragraph
(1)(A) shall include the following:
(A) The findings of the Director with respect to
the assessment conducted pursuant to subsection (a)(1).
(B) Recommendations for legislative or
administrative action to support the implementation
plan developed under subsection (a)(2), according to--
(i) what, if any, new biosecurity and
biosafety authorities are needed; and
(ii) where the Federal Government can
consolidate biosecurity and biosafety
authorities, including which, if any, should be
reside under a common government entity, and
whether this necessitates establishing a new
government entity.
(d) Implementation.--
(1) In general.--Not later than 90 days after the date on
which the Director completes the implementation plan required
by subsection (a)(2), the Director shall commence implementing
the plan through administrative action in accordance with
applicable provisions of law.
(2) Governance strategies.--In carrying out the
implementation plan developed under subsection (a)(2), the
Director shall consider which, if any, of the governance
strategies reported under section 5(b)(4) should be included in
the plan.
<all>
Introduced in Senate
Read twice and referred to the Committee on Commerce, Science, and Transportation.
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