[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4702 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 4702
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 HOUSE OF REPRESENTATIVES
July 18, 2023
Ms. Eshoo introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
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); and
``(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''.
<all>