[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2356 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 2356
To require the Secretary of Health and Human Services to update
guidance with respect to gene synthesis, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 18, 2023
Mr. Hickenlooper (for himself and Mr. Budd) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To require the Secretary of Health and Human Services to update
guidance with respect to gene synthesis, 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 ``Gene Synthesis Safety and Security
Act''.
SEC. 2. GENE SYNTHESIS.
(a) Guidance.--Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall update the Screening Framework
Guidance for Providers of Synthetic Double-Stranded DNA to account for
scientific and technological advancements with respect to mitigating
risk of unauthorized individuals or individuals with malicious intent
from using nucleic acid synthesis technologies to obtain biological
agents or toxins of concern. Such guidance shall include
recommendations related to--
(1) screening for sequences that the Secretary determines
may contribute to toxicity, pathogenicity, or virulence;
(2) screening and verification of the identity and
legitimacy of customers;
(3) the identification, evaluation, and use of appropriate
software or other tools to enable the screening described in
paragraphs (1) and (2);
(4) ensuring nucleic acid synthesis activities are carried
out in compliance with existing regulations under part 73 of
chapter 42, part 331 of chapter 7, part 121 of chapter 9, and
part 774 of chapter 15, Code of Federal Regulations (or
successor regulations);
(5) implementing appropriate safeguards, which may include
the use of such software or other tools, in gene synthesis
equipment to facilitate screening of nucleic acid sequences
and, as applicable, customers;
(6) maintaining records of customer orders, metadata, and
screening system or protocol performance in specified formats,
which may include standardized machine-readable and
interoperable data formats; and
(7) other recommendations as determined appropriate by the
Secretary.
(b) Sequences of Concern.--The Secretary shall maintain a public
docket to solicit recommendations on potential sequences of concern
and, in consultation with other Federal departments and agencies and
non-Federal experts, as appropriate, review and update, on a regular
basis, a list of sequences of concern to facilitate screening under
subsection (a)(1).
(c) Landscape Review.--The Secretary, in coordination with other
Federal departments and agencies, as appropriate, shall conduct a
landscape review of providers and manufacturers of gene synthesis
equipment, products, software, and other tools with the purpose of
understanding the number, types, and capabilities of products and
equipment that exist domestically and to inform the development of any
updates to the guidance under subsection (a).
(d) Technical Assistance.--The Secretary, in consultation with
other Federal departments and agencies, shall provide technical
assistance upon request of a gene synthesis provider, manufacturer of
gene synthesis equipment, or developer of software or other screening
tools to support implementation of the recommendations included in the
guidance under subsection (a).
(e) Definitions.--In this section:
(1) Gene synthesis equipment.--The term ``gene synthesis
equipment'' means equipment needed to produce gene synthesis
products.
(2) Gene synthesis product.--The term ``gene synthesis
product''--
(A) means custom single-stranded or double-stranded
DNA, or single-stranded or double-stranded RNA, which
has been chemically or enzymatically synthesized or
otherwise manufactured de novo and is of a length
exceeding the screening threshold, as determined by the
Secretary; and
(B) does not include--
(i) base chemical subunits, such as
individual nucleotides or nucleosides, or
oligonucleotides shorter than the screening
threshold typically used as polymerase chain
reaction primers, as determined by the
Secretary;
(ii) by-products generated during
sequencing that are not useful for assembly or
cloning, as determined by the Secretary; or
(iii) products generated from cloning or
assembling of existing gene or gene fragment
material, in circumstances in which the gene
synthesis provider has no access or notice to
the sequence design, as determined by the
Secretary.
(3) Gene synthesis provider.--The term ``gene synthesis
provider'' means an entity that synthesizes and distributes
gene synthesis products, including bacteria, viruses, or fungi
containing recombinant or synthetic nucleic acid molecules, for
delivery to a customer.
(4) Manufacturer of gene synthesis equipment.--The term
``manufacturer of gene synthesis equipment'' means an entity
that produces and sells equipment for synthesizing gene
synthesis products.
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