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AB-70 Gene synthesis providers.(2021-2022)

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Date Published: 05/24/2021 03:39 PM
AB70:v97#DOCUMENT

Amended  IN  Assembly  May 24, 2021
Amended  IN  Assembly  April 12, 2021

CALIFORNIA LEGISLATURE— 2021–2022 REGULAR SESSION

Assembly Bill
No. 70


Introduced by Assembly Member Salas
(Coauthor: Assembly Member Lorena Gonzalez)

December 07, 2020


An act to add Chapter 1.5 (commencing with Section 24200) to Division 20 of the Health and Safety Code, relating to gene synthesis.


LEGISLATIVE COUNSEL'S DIGEST


AB 70, as amended, Salas. Gene synthesis 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.
This bill would additionally require the department, on or before January 1, 2024, to develop gene sequence and customer screening guidelines for gene synthesis providers and manufacturers of gene synthesis equipment with the purpose of increasing gene synthesis security and improving biosecurity efforts relating to the misuse of gene synthesis products. require gene synthesis providers and manufacturers of gene synthesis equipment operating in California to demonstrate to the department that they are current members of the International Gene Synthesis Consortium (IGSC). The bill would require the department to create a process develop a process, with input from the IGSC, to certify verify that gene synthesis providers and manufacturers of gene synthesis equipment are in compliance with the guidelines current members of the IGSC and would require, beginning January 1, 2025, a gene synthesis provider and manufacturer of gene synthesis equipment operating in California to be certified. The bill would require that any guidelines developed by the department not be interpreted to regulate medical or pharmaceutical research and development. verified as a current member of the IGSC. The bill would authorize the department to charge a fee in an amount not to exceed the department’s reasonable costs to administer the verification process, as specified. The bill would also require, beginning January 1, 2025, any entity that is the recipient of state resources to purchase gene synthesis products from a gene synthesis provider, and gene synthesis equipment from a manufacturer of gene synthesis equipment, that is certified. a verified current member of the IGSC. The bill would specify the penalties to be imposed for failure to comply with those requirements and require the department to develop an appeals process to appeal the imposition of those penalties.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Chapter 1.5 (commencing with Section 24200) is added to Division 20 of the Health and Safety Code, to read:
CHAPTER  1.5. Gene Synthesis Providers

24200.
 For the purposes of this chapter, the following terms have the following meanings:
(a) “Dangerous pathogen” means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, also known as COVID-19), a pathogen on the select agents and toxins list maintained by the Federal Select Agent Program, the list of human and animal pathogens and toxins for export control maintained by the Australia Group, and any other regulated pathogen identified by the department.
(b) “Department” means the State Department of Public Health.
(c)  “Gene synthesis equipment” means equipment needed to produce gene synthesis products that is not readily used for any other purpose, as specified by the department.
(d) “Gene synthesis product” is double-stranded DNA (dsDNA), double-stranded nucleic acids, RNA, or oligonucleotides, designed and created without an existing DNA template.
(e) (1) “Gene synthesis provider” means an entity that does any of the following:
(A) An entity that creates gene synthesis products for delivery to a customer.
(B) A distributor of gene synthesis products, including, but not limited to, entities who manufacture gene products for use by other parties, both inside and outside of the entity.
(C) A third-party entity that is not the end user of a gene synthesis product and does not make gene synthesis products, but otherwise fills, completes, modifies, or purifies gene synthesis products.
(2) “Gene synthesis provider” does not include a research scientist making gene synthesis products for the research scientist’s own use or for use by another research scientist.

24201.

(a)On or before January 1, 2024, the department shall, with input from industry stakeholders and universities, develop gene sequence and customer screening guidelines for gene synthesis providers and manufacturers of gene synthesis equipment. The department’s primary purpose in developing these guidelines shall be to increase gene synthesis security and improve biosecurity efforts to prevent, deter, detect, attribute, and mitigate the misuse of gene synthesis products in California.

(b)The guidelines developed pursuant to subdivision (a) shall include a requirement that gene synthesis providers identify gene synthesis product orders that include dangerous pathogen sequences and other potentially dangerous sequences and, if a dangerous pathogen or other potentially dangerous sequence is identified, a requirement that the order be reviewed by a human and subject to additional screening.

(c)The guidelines developed by the department shall not be interpreted to regulate medical or pharmaceutical research and development, including drug screening assays, reagent production, tests employed in preclinical and clinical studies, manufacturing of biologics, gene therapy, and RNA therapeutics.

24201.
 In order to improve biosecurity efforts to prevent, deter, detect, attribute, and mitigate the misuse of gene synthesis products in California, including those that may contain dangerous pathogen sequences, on or before January 1, 2024, a gene synthesis provider and manufacturer of gene synthesis equipment operating in California shall demonstrate to the department that they are a current member of the International Gene Synthesis Consortium (IGSC).

24202.
 The department shall develop a process to certify that gene synthesis providers and manufacturers of gene synthesis equipment are in compliance with the guidelines developed pursuant to Section 24201. The certification process shall include, at a minimum, a review of each entity’s compliance biennially. a verification process, with input from the IGSC, to verify that a gene synthesis provider and manufacturer of gene synthesis equipment is a current member of the IGSC. The verification process shall include, at a minimum, a review of each entity’s compliance every two years.

24203.
 (a) Beginning January 1, 2025, gene synthesis providers and manufacturers of gene synthesis equipment operating in California shall be certified verified current members of the IGSC pursuant to Section 24202.
(b) A gene synthesis provider or manufacturer of gene synthesis equipment that is not certified, a verified current member of the IGSC, or fails to maintain its certification, current membership in the IGSC, shall be subject to a civil penalty of one thousand dollars ($1,000) per day that it is not certified. a verified current member of the IGSC.
(c) The department may charge each gene synthesis provider or manufacturer of gene synthesis equipment operating in California a fee in an amount not to exceed the department’s reasonable costs to administer the verification process.

24204.
 (a) Beginning January 1, 2025, any entity that is the recipient of state resources, including, but not limited to, funds, the use of facilities, materials, and labor, whether or not the resources are received as part of a project with another entity that does not receive state resources, shall purchase gene synthesis products from a gene synthesis provider, and gene synthesis equipment from a manufacturer of gene synthesis equipment, that is certified a verified current member of the IGSC pursuant to Section 24202, whether or not the gene synthesis provider or manufacturer of gene synthesis equipment is operating in California.
(b) An entity that does not comply with subdivision (a) may have access to all state resources revoked for the duration of the noncompliance.

24205.
 The department shall develop an appeals process for gene synthesis providers and manufacturers subject to a civil penalty pursuant to Section 24203 and for entities subject to state resource revocation pursuant to Section 24204. The appeals process shall ensure that appellants are provided with due process.