Official Summary Text
AB 1864, as amended, Berman.
Gene synthesis equipment manufacturers and providers.
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.
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.
This bill would provide that the provisions of this bill are severable.