[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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