[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2400 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2400

 To require the Secretary of Health and Human Services to prescribe a 
regulation reducing the risks in gene synthesis products, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 19, 2023

  Mr. Markey 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 prescribe a 
regulation reducing the risks in gene synthesis 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 ``Securing Gene Synthesis Act''.

SEC. 2. REQUIREMENTS FOR THE DISSEMINATION OF SYNTHETIC GENETIC 
              MATERIAL.

    Section 351A of the Public Health Service Act (42 U.S.C. 262a) is 
amended--
            (1) in subsection (b)(2), by striking the semicolon at the 
        end and inserting the following: ``, including by--
                    ``(A) assessing uncertainties, risks, costs, and 
                benefits associated with the implementation of 
                different types of protocols or other regulations to 
                reduce the risk of potential misuse of de novo gene 
                synthesis products;
                    ``(B) determining the types of protocols or other 
                regulations that could detect the potential misuse of 
                de novo gene synthesis products while generating 
                benefits that are larger than their costs;
                    ``(C) requiring gene synthesis providers or 
                manufacturers of gene synthesis equipment to implement 
                screening protocols to detect misuse of de novo gene 
                synthesis products;
                    ``(D) verifying or provisionally verifying that 
                gene synthesis providers and manufacturers of gene 
                synthesis equipment adhere to the regulation prescribed 
                pursuant to subparagraph (C);
                    ``(E) assessing, collecting, and waiving fees for 
                enforcing the regulation prescribed pursuant to 
                subparagraph (C); and
                    ``(F) requiring any entity receiving Federal funds, 
                or any Federal agency, which purchases de novo gene 
                synthesis products from a gene synthesis provider or 
                gene synthesis equipment from a manufacturer of gene 
                synthesis equipment to purchase such products and 
                equipment only if such providers or manufacturers are 
                verified or provisionally verified pursuant to 
                subparagraph (D);'';
            (2) in subsection (e)(1), by striking the period at the end 
        and inserting ``, including through the revocation of Federal 
        research funding for any entity found to be in violation of 
        subsection (b)(2)(E), or through the withholding of such 
        funding for such an entity until the entity demonstrates 
        compliance with such subsection.'';
            (3) in subsection (k), by adding at the end the following:
            ``(4) Use of gene synthesis products and gene synthesis 
        equipment by federal agencies.--Not later than January 1, 2026, 
        the Secretary shall report to the appropriate committees of 
        Congress a description of the policies and procedures adopted 
        by all agencies that fund or conduct life sciences research 
        involving gene synthesis products or gene synthesis equipment 
        to comply with this section.'';
            (4) in subsection (l)--
                    (A) by redesignating paragraphs (2), (3), (4), (5), 
                (6), (7), and (8) as paragraphs (5), (6), (8), (9), 
                (10), (11), and (12), respectively;
                    (B) by inserting after paragraph (1) the following:
            ``(2) The term `gene synthesis equipment' means equipment 
        that can produce gene synthesis product, regardless of the 
        technical mechanism by which such equipment works.
            ``(3) 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; 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;
                            ``(ii) byproducts 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.
            ``(4) The term `gene synthesis provider'--
                    ``(A) means--
                            ``(i) an entity that creates gene synthesis 
                        product for delivery to a customer in the 
                        United States; or
                            ``(ii) a distributor of gene synthesis 
                        product in the United States, including an 
                        entity that manufactures gene synthesis product 
                        for use by another party, whether such other 
                        party is inside and outside of the entity; and
                    ``(B) does not include--
                            ``(i) an entity making gene synthesis 
                        products for the entity's own use, in 
                        circumstances in which the sequence has been 
                        previously screened in compliance with this 
                        section;
                            ``(ii) an entity that manufactures gene 
                        synthesis products in the process of developing 
                        or manufacturing another product for a 
                        customer, unless the gene synthesis product is 
                        provided to the end user thereof; or
                            ``(iii) any class of entity that the 
                        Secretary chooses to exempt, after 
                        consideration of the costs and benefits of 
                        exempting that class of entity from regulation 
                        under this section as a gene synthesis 
                        provider.'';
                    (C) by inserting after paragraph (6), as so 
                redesignated, the following:
            ``(7) The term `manufacturer of gene synthesis equipment' 
        means an entity that produces for sale gene synthesis 
        equipment.''; and
                    (D) by adding at the end the following:
            ``(13) The term `screening threshold' means the minimal 
        length of de novo gene synthesis product which ensures that the 
        results of such screening contain enough information to allow 
        an unambiguous analysis of such product's potential misuse.''; 
        and
            (5) in subsection (m), by striking ``for each of the fiscal 
        years 2023 through 2027'' and inserting ``for fiscal year 2023 
        and each subsequent fiscal year''.
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