Technology
Gene synthesis equipment manufacturers and providers
California requires gene-synthesis equipment makers and screened-nucleic-acid providers to follow federal screening standards and publicly attest to compliance.
The law seeks to reduce biohazard risks from dangerous synthetic genetic material while preserving ordinary customer research, medical, and manufacturing activities.
What the law does
- Bars manufacturers from making, selling, or delivering benchtop nucleic acid synthesis equipment in California without complying with the September 2024 federal Framework for Nucleic Acid Synthesis Screening and posting a public compliance attestation.
- Bars providers from making, selling, or delivering synthetic nucleic acids subject to screening in California without the same compliance and public-attestation steps.
- Treats framework provisions using “should” as mandatory, while provisions using “encouraged” remain optional.
- Delays framework provisions scheduled to take effect on or after October 13, 2026, until October 13, 2027, under state law.
- Authorizes civil penalties of up to $5,000 per day for continuing violations, recoverable only through an action brought by the Attorney General.
Who it affects
- Manufacturers of benchtop nucleic acid synthesis equipment operating in or selling into California.
- Providers of synthetic nucleic acids subject to screening operating in or selling into California.
- The Attorney General, which has exclusive authority to bring civil penalty actions.
Context
The law adopts only the September 2024 version of the federal screening framework unless the Legislature later changes it.