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<ns0:ActionText>INTRODUCED</ns0:ActionText>
<ns0:ActionDate>2026-02-11</ns0:ActionDate>
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<ns0:AuthorText authorType="LEAD_AUTHOR">Introduced by Assembly Member Berman</ns0:AuthorText>
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<ns0:Name>Berman</ns0:Name>
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<ns0:Title> An act to add Chapter 1.5 (commencing with Section 24200) to Division 20 of the Health and Safety Code, relating to gene synthesis.</ns0:Title>
<ns0:RelatingClause>gene synthesis</ns0:RelatingClause>
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<ns0:Subject>Gene synthesis equipment manufacturers and providers.</ns0:Subject>
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<html:p>Existing law requires the State Department of Public Health to establish an advisory committee to advise the Legislature and the Governor on human cloning and other issues relating to human biotechnology. Existing law requires the California State University, and requests the University of California, to develop systemwide guidance for purchasing gene synthesis equipment or gene synthesis products from gene synthesis providers who prevent the misuse of synthetic genes and safeguard the benefits of gene synthesis technology while minimizing risk, as specified.</html:p>
<html:p>This bill would prohibit a manufacturer of benchtop nucleic acid synthesis equipment, as defined, from producing equipment in this state or selling or delivering that equipment to a customer in this state unless the manufacturer adheres to the Framework for Nucleic Acid Synthesis Screening
issued by the Fast Track Action Committee on Synthetic Nucleic Acid Procurement Screening of the National Science and Technology Council, as revised in September 2024, with respect to that equipment, and would prohibit a provider of specified synthetic nucleic acids from producing those nucleic acids in this state or selling or delivering those nucleic acids to a customer in this state unless the provider adheres to the framework described above with respect to those nucleic acids. The bill would make a violation of the prohibitions described above subject to a civil penalty in an amount dependent on the severity of the violation that does not exceed $1,000 per day that the violation continues. The bill would define “framework” to mean the framework described above, but would authorize the State Department of Public Health to adopt regulations that define “framework” to mean one or more federal law, regulation, or guidance document that provides standards for the screening of synthetic nucleic acids if the
department determines that the regulations would result in an equal or greater degree of protection for the residents of California from relevant biohazards, as specified, and would not impose, in the judgment of the department, unreasonable burdens on manufacturers or providers. The bill would define various terms to have the same meanings as in the framework described above, but would authorize the department, as part of the adoption of a different definition of “framework,” to adopt different definitions of those terms. The bill would require the department, no later than one year after the adoption of any regulation adopted as described above, to submit a report to the Legislature, as specified. The bill would make related findings and declarations.</html:p>
<html:p>This bill would provide that the provisions of this bill are severable.</html:p>
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<ns0:Preamble>The people of the State of California do enact as follows:</ns0:Preamble>
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<ns0:Num>SECTION 1.</ns0:Num>
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<html:p>The Legislature finds and declares both of the following:</html:p>
<html:p>
(a)
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The state has a strong interest in protecting the residents of California from biohazards caused by reckless or malicious individuals with access to dangerous nucleic acids synthesized by benchtop nucleic acid synthesis equipment or ordered from commercial gene synthesis providers, and providers and manufacturers must take due care in order to avoid creating unreasonable risks of serious injury.
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(b)
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In 2023, the Director of the White House Office of Science and Technology Policy initiated an interagency process for the development of a framework “to encourage providers of synthetic nucleic acid sequences to
implement comprehensive, scalable, and verifiable synthetic nucleic acid procurement screening mechanisms, including standards and recommended incentives,” resulting in the issuance by the National Science and Technology Council’s Fast Track Action Committee on Synthetic Nucleic Acid Procurement Screening of the Framework For Nucleic Acid Synthesis Screening, revised as of September 2024 (the framework). It is in the interest of all Californians that all synthesis providers and manufacturers operating in the state adhere to the framework or a future framework or standards promulgated by the federal government that the State Department of Public Health deems to be equally or more protective of the residents of California from relevant biohazards.
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<ns0:Num>SEC. 2.</ns0:Num>
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Chapter 1.5 (commencing with Section 24200) is added to Division 20 of the
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, to read:
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<ns0:Num>1.5.</ns0:Num>
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<ns0:LawHeadingText>Gene Synthesis Screening</ns0:LawHeadingText>
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<ns0:Num>24200.</ns0:Num>
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(a)
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(1)
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Unless the State Department of Public Health adopts regulations pursuant to Section 24203, “framework” means the Framework for Nucleic Acid Synthesis Screening issued by the Fast Track Action Committee on Synthetic Nucleic Acid Procurement Screening of the National Science and Technology Council, as revised in September 2024.
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(2)
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If the department has adopted regulations pursuant to this chapter, “framework” has the same meaning as defined in the regulations.
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(b)
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Except as otherwise provided in regulations adopted pursuant to Section 24203, the following terms have the following meanings:
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(1)
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“Benchtop nucleic acid synthesis equipment” has the same meaning as defined in the framework.
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(2)
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“Customer” has the same meaning as defined in the framework.
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(3)
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“Manufacturer” has the same meaning as defined in the framework.
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(4)
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“Provider” has the same meaning as defined in the framework.
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(5)
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“Synthetic nucleic acids subject to screening” has the same meaning as defined in the framework.
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<ns0:Num>24201.</ns0:Num>
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(a)
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A manufacturer shall not produce benchtop nucleic acid synthesis equipment in this state or sell or deliver benchtop nucleic acid synthesis equipment to a customer in this state unless the manufacturer adheres to the framework with respect to the produced, sold, or delivered equipment.
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(b)
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A provider shall not produce synthetic nucleic acids subject to screening in this state or sell or deliver synthetic nucleic acids subject to screening to a customer in this state unless the provider adheres to the framework with respect to the produced, sold, or delivered nucleic acids.
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<html:p>
(c)
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(1)
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For the purposes of this section, if the framework uses the term “should,”
it is a requirement for a provider or manufacturer.
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(2)
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For the purposes of this section, if the framework uses the term “encouraged,” it is a recommendation, but not a requirement, for a provider or manufacturer.
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<ns0:Num>24202.</ns0:Num>
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<html:p>
(a)
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A manufacturer or provider that violates this chapter shall be subject to a civil penalty in an amount dependent on the severity of the violation that does not exceed one thousand dollars ($1,000) per day that the violation continues.
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(b)
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A civil penalty assessed pursuant to this section shall be recovered in a civil action brought only by the Attorney General.
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<ns0:Num>24203.</ns0:Num>
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<html:p>
(a)
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(1)
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The department may adopt regulations that define “framework” of Section 24200, for the purposes of this chapter, to have the same meaning as one or more, either in combination or in the alternative, federal law, regulation, or guidance document if the department determines that the regulations would result in an equal or greater degree of protection for the residents of California from relevant biohazards and would not impose, in the judgment of the department, unreasonable burdens on manufacturers or providers.
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(2)
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As part of the adoption of regulations described in paragraph (1), the department may adopt definitions of the terms in subdivision (b) of Section 24200.
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(b)
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(1)
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If the department adopts regulations pursuant to subdivision (a) and the law, regulation, or guidance document contains a definition of term that is different from, but functionally equivalent to, the definition in subdivision (b) of Section 24200, the regulations may specify which term is the functional equivalent of a term defined in Section 24200.
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(2)
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If the department adopts regulations pursuant to subdivision (a) and the law, regulation, or guidance document does not define a term defined in subdivision (b) of Section 24200, the regulations may specify that a term has the same definition as in a prior version of the framework.
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(c)
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(1)
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No later than one year after the adoption of any regulation adopted pursuant to this chapter, the department shall submit a report to
the Legislature assessing whether the regulations have maintained or enhanced the protection of the residents of California from relevant biohazards.
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(2)
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The report required by this section shall be submitted pursuant to Section 9795 of the Government Code.
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<ns0:Num>24204.</ns0:Num>
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<html:p>The provisions of this chapter are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.</html:p>
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