Gene synthesis equipment manufacturers and providers.

Plain English Breakdown

The official source material does not provide specific details on the enforcement mechanisms and penalties beyond stating that they are dependent on severity.

Rules for Gene Synthesis Equipment

AB-1864 requires manufacturers and providers of gene synthesis equipment in California to follow specific guidelines to prevent misuse and ensure safety.

What This Bill Does

• Prohibits a manufacturer of benchtop nucleic acid synthesis equipment from producing, selling, or delivering such equipment in California 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.
• Prohibits providers of specified synthetic nucleic acids from producing, selling, or delivering these products in California unless they adhere to the same framework.
• Imposes a civil penalty not exceeding $1,000 per day for each day that a violation continues.
• Allows the State Department of Public Health to redefine 'framework' based on federal laws if it provides equal or greater protection against biohazards without imposing unreasonable burdens on businesses.
• Requires the department to report back to the Legislature about how well these rules are working after one year.

Who It Names or Affects

• Manufacturers of benchtop nucleic acid synthesis equipment
• Providers of specified synthetic nucleic acids

Terms To Know

Framework for Nucleic Acid Synthesis Screening

A set of rules and guidelines issued by the Fast Track Action Committee on Synthetic Nucleic Acid Procurement Screening to prevent misuse of gene synthesis technology.

Benchtop nucleic acid synthesis equipment

Equipment used in laboratories for synthesizing small amounts of DNA or RNA.

Limits and Unknowns

• The bill does not specify what happens if the State Department of Public Health decides that new federal laws do not provide enough protection.
• It is unclear how strictly these rules will be enforced and how many violations might occur.
• The effectiveness of the penalties in stopping misuse of gene synthesis technology remains to be seen.

Official Summary Text

AB 1864, as introduced, 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.

Current Bill Text

Download Bill PDF