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AB 1864

Gene synthesis equipment manufacturers and providers.

2025-2026 Regular Session Introduced by Marc Berman

AB 1864 requires benchtop gene synthesis equipment and synthetic nucleic acids sold in California to meet a federal screening framework, with penalties for noncompliance.

From committee: Do pass and re-refer to Com. on APPR. with recommendation: To Consent Calendar. (Ayes 13. Noes 0.) (June 23). Re-referred to Com. on APPR.
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Bill Summary · AB 1864

Summary of AB 1864 (2025-2026) — Gene synthesis equipment manufacturers and providers

Purpose and intent

  • AB 1864 proposes adding a new Chapter 1.5 to Division 20 of the California Health and Safety Code to establish gene synthesis screening requirements for equipment manufacturers and providers operating in California.
  • The bill centers on ensuring benchtop nucleic acid synthesis equipment and synthetic nucleic acids subject to screening comply with a federal framework intended to reduce biohazard risks, and it authorizes the California Department of Public Health (CDPH) to adopt regulations that may align the state framework with federal standards or other protective regimes.
  • The overarching aim is to protect California residents from biohazards by mandating adherence to a screening framework and providing enforcement mechanisms.

Key provisions and changes

  • Framework definition and applicability
    • “Framework” is defined as the Framework for Nucleic Acid Synthesis Screening developed by the National Science and Technology Council’s Fast Track Action Committee on Synthetic Nucleic Acid Procurement Screening (as revised in September 2024), unless CDPH adopts its own regulations under §24203. If regulations are adopted, the meaning of “framework” follows those regulations.
    • The framework applies to:
    • Benchtop nucleic acid synthesis equipment produced, sold, or delivered in California.
    • Synthetic nucleic acids subject to screening produced, sold, or delivered in California.
  • Prohibitions for manufacturers and providers
    • A manufacturer may not produce benchtop nucleic acid synthesis equipment in California or sell/deliver such equipment to a California customer unless the manufacturer adheres to the framework with respect to the equipment.
    • A provider may not produce synthetic nucleic acids subject to screening in California or sell/deliver those nucleic acids to a California customer unless the provider adheres to the framework with respect to those nucleic acids.
    • If the framework uses the term “should,” it is a regulatory requirement; if it uses “encouraged,” it is a recommendation (not a hard requirement).
  • Penalties
    • Violations are subject to civil penalties up to $1,000 per day, with the exact amount depending on the severity of the violation.
    • Penalties are recoverable via civil action brought by the California Attorney General.
  • Regulatory authority and integration with federal standards
    • CDPH may adopt regulations defining “framework” to align with federal law, regulations, or guidance that provides equal or greater protection against biohazards, so long as those regulations do not impose unreasonable burdens on manufacturers or providers.
    • The department can also adopt definitions for terms in the statute as part of regulatory action.
  • Post-regulatory reporting
    • If CDPH adopts regulations under §24203, it must submit a report to the Legislature no later than one year after the regulation adoption, evaluating whether the regulations maintain or enhance protection for California residents. The report is to be submitted pursuant to Government Code §9795.
  • Scope and exclusions
    • The chapter explicitly does not regulate activities of customers that are not providers or manufacturers, including basic research, drug screening, biologics manufacturing, gene therapy, RNA therapeutics, etc.
  • Severability
    • Provisions are severable; if any part is held invalid, the remainder continues to have effect.

Who/what would be affected

  • Manufacturers of benchtop nucleic acid synthesis equipment that operate in California.
  • Providers of synthetic nucleic acids subject to screening that operate in California.
  • California-based customers of such equipment or nucleic acids (subject to the framework requirements).
  • The California Department of Public Health, which would administer, interpret, and potentially revise the framework through regulations and oversight, including reporting to the Legislature.

Procedural and timeline aspects

  • Legislative history indicates introduction in February 2026, with subsequent committee referrals, amendments, and floor actions through May 2026.
  • If CDPH adopts regulations under §24203, a formal regulatory framework would replace the default framework, with definitions and potential functional equivalents to federal terms.
  • A one-year reporting deadline from the adoption of any regulations to assess their protective impact (pursuant to Government Code §9795) is required.
  • The bill is written with severability, meaning parts could take effect independently if others are invalidated.

Practical considerations

  • The bill creates a California-specific compliance regime tied to a federal screening framework, potentially increasing costs and compliance time for manufacturers and providers.
  • It provides a target for risk mitigation in the gene synthesis supply chain within California and aligns state policy with federal biosafety screening standards.
  • Enforcement relies on civil penalties and actions by the Attorney General, offering a mechanism for penalty exposure for noncompliance.

Note: This summary focuses on the substantive provisions and their potential impact as described in the bill text.

Compiled from official sources — confirm details with the bill’s official record.

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