AB 70: Gene synthesis providers.
- Session Year: 2021-2022
- House: Assembly
- Latest Version Date: 2021-09-09
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 require the department to develop a process, with input from the International Gene Synthesis Consortium (IGSC) and industry stakeholders, to verify that gene synthesis providers and manufacturers of gene synthesis equipment adhere to customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. Beginning January 1, 2025, the bill would require a gene synthesis provider and manufacturer of gene synthesis equipment operating in California to be a current member of the IGSC or verified by the department as adhering to the prescribed proper screening protocols. The bill would, beginning January 1, 2022, authorize the department to charge a fee in an amount not to exceed the departments reasonable costs to establish and 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, only if they are a current member of the IGSC or verified by the department, as specified. The bill would impose specified penalties on gene synthesis providers and manufacturers of gene synthesis equipment for failure to comply with those requirements, and would require the department to develop an appeals process to address appeals on the imposition of those penalties.
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 require the department to develop a process, with input from the International Gene Synthesis Consortium (IGSC) and industry stakeholders, to verify that gene synthesis providers and manufacturers of gene synthesis equipment adhere to customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. Beginning January 1, 2025, the bill would require a gene synthesis provider and manufacturer of gene synthesis equipment operating in California to be a current member of the IGSC or verified by the department as adhering to the prescribed proper screening protocols. The bill would would, beginning January 1, 2022, authorize the department to charge a fee in an amount not to exceed the departments reasonable costs to establish and 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, only if they are a current member of the IGSC or verified by the department, as specified. The bill would impose specified penalties on gene synthesis providers and manufacturers of gene synthesis equipment for failure to comply with those requirements, and would require the department to develop an appeals process to address appeals on the imposition of those penalties.
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 require the department to develop a process, with input from the International Gene Synthesis Consortium (IGSC) and industry stakeholders, to verify that gene synthesis providers and manufacturers of gene synthesis equipment adhere to customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. Beginning January 1, 2025, the bill would require a gene synthesis provider and manufacturer of gene synthesis equipment operating in California to be verified a current member of the IGSC or verified by the department as adhering to the prescribed proper screening protocols. The bill would authorize the department to charge a fee in an amount not to exceed the departments 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 only if they are a current member of the IGSC or verified by the department, as specified. The bill would impose specified penalties on gene synthesis providers and manufacturers of gene synthesis equipment for failure to comply with those requirements, and would require the department to develop an appeals process to address appeals on the imposition of those penalties.
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 require gene synthesis providers and manufacturers of gene synthesis equipment operating in California to demonstrate to the department that they are current members, as defined, of the International Gene Synthesis Consortium (IGSC) or that they use customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. TheThis bill would require the department to develop a process, with input from the IGSC International Gene Synthesis Consortium (IGSC) and industry stakeholders, to verify that gene synthesis providers and manufacturers of gene synthesis equipment are current members of the IGSC or otherwise verified by the department and would require, beginning January 1, 2025, adhere to customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. Beginning January 1, 2025, the bill would require a gene synthesis provider and manufacturer of gene synthesis equipment operating in California to be verified. verified as adhering to the prescribed proper screening protocols. The bill would authorize the department to charge a fee in an amount not to exceed the departments 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 verified by the department, as specified. The bill would specify the penalties to be imposed impose specified penalties on gene synthesis providers and manufacturers of gene synthesis equipment for failure to comply with those requirements and requirements, and would require the department to develop an appeals process to appeal address appeals on the imposition of those penalties.
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 require gene synthesis providers and manufacturers of gene synthesis equipment operating in California to demonstrate to the department that they are current members members, as defined, of the International Gene Synthesis Consortium (IGSC). (IGSC) or that they use customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. The bill would require the department to develop a process, with input from the IGSC, IGSC and industry stakeholders, to verify that gene synthesis providers and manufacturers of gene synthesis equipment are current members of the IGSC or otherwise verified by the department and would require, beginning January 1, 2025, a gene synthesis provider and manufacturer of gene synthesis equipment operating in California to be verified as a current member of the IGSC. verified. The bill would authorize the department to charge a fee in an amount not to exceed the departments 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 a verified current member of the IGSC. verified by the department, as specified. 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.
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 departments 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.
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 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. The bill would require the department to create a process to certify that gene synthesis providers and manufacturers of gene synthesis equipment are in compliance with the guidelines and would require, beginning January 1, 2024, 2025, a gene synthesis provider 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. The bill would also require, beginning January 1, 2024, 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. 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.
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 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. The bill would require the department to create a process to certify that gene synthesis providers and manufacturers of gene synthesis equipment are in compliance with the guidelines and would require, beginning January 1, 2024, a gene synthesis provider operating in California to be certified. The bill would also require, beginning January 1, 2024, 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. 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.
For the purposes of this chapter, the following terms apply:
(a)Current member means a current member of the International Gene Synthesis Consortium (IGSC) who is a certified member of that organization and includes voting members, small company members, and nonprofit members. It does not include provisional associate members or any other membership tier where the entity does not implement an IGSC tested and approved screening system.
(b)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.
(c)Department means the State Department of Public Health.
(d) 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.
(e)Gene synthesis product is double-stranded DNA (dsDNA), double-stranded nucleic acids, RNA, or oligonucleotides, designed and created without an existing DNA template.
(f)(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 scientists own use or for use by another research scientist or an entity that manufactures gene synthesis products for the entitys own use.
24201.This chapter shall not be interpreted to regulate medical or pharmaceutical research and development or manufacturing, including drug screening assays, reagent production, tests employed in preclinical and clinical studies, manufacturing of biologics, gene therapy, and RNA therapeutics.
24202.In order to improve biosecurity efforts to prevent, deter, detect, attribute, and mitigate the misuse of gene synthesis products in California, including those products that may contain dangerous pathogen sequences, the department shall develop a verification process, with input from the IGSC and industry stakeholders, to verify that a gene synthesis provider and manufacturer of gene synthesis equipment adhere to customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. The verification process shall include, at a minimum, a review of each entitys compliance every two years.
24203.(a)Beginning January 1, 2025, gene synthesis providers and manufacturers of gene synthesis equipment operating in California shall either be current members of the IGSC or verified by the department as entities adhering to proper screening protocols pursuant to Section 24202.
(b)A gene synthesis provider or manufacturer of gene synthesis equipment that fails to comply with the requirements of this section shall be subject to a civil penalty of one thousand dollars ($1,000) per day that it is noncompliant.
(c)Beginning January 1, 2022, 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 departments reasonable costs to establish and 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, only if they are a current member of the IGSC or are otherwise verified by the department 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.
For the purposes of this chapter, the following terms apply:
(a)Current member means a current member of the International Gene Synthesis Consortium (IGSC) who is a certified member of that organization and includes voting members, small company members, and nonprofit members. It does not include provisional associate members or any other membership tier where the entity does not implement an IGSC tested and approved screening system.
(b)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.
(c)Department means the State Department of Public Health.
(d) 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.
(e)Gene synthesis product is double-stranded DNA (dsDNA), double-stranded nucleic acids, RNA, or oligonucleotides, designed and created without an existing DNA template.
(f)(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 scientists own use or for use by another research scientist or an entity that manufactures gene synthesis products for the entitys own use.
24201.This chapter shall not be interpreted to regulate medical or pharmaceutical research and development or manufacturing, including drug screening assays, reagent production, tests employed in preclinical and clinical studies, manufacturing of biologics, gene therapy, and RNA therapeutics.
24202.In order to improve biosecurity efforts to prevent, deter, detect, attribute, and mitigate the misuse of gene synthesis products in California, including those products that may contain dangerous pathogen sequences, the department shall develop a verification process, with input from the IGSC and industry stakeholders, to verify that a gene synthesis provider and manufacturer of gene synthesis equipment adhere to customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. The verification process shall include, at a minimum, a review of each entitys compliance every two years.
24203.(a)Beginning January 1, 2025, gene synthesis providers and manufacturers of gene synthesis equipment operating in California shall either be current members of the IGSC or verified by the department as entities adhering to proper screening protocols pursuant to Section 24202.
(b)A gene synthesis provider or manufacturer of gene synthesis equipment that fails to comply with the requirements of this section shall be subject to a civil penalty of one thousand dollars ($1,000) per day that it is noncompliant.
(c)The Beginning January 1, 2022, 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 departments reasonable costs to establish and 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, only if they are a current member of the IGSC or are otherwise verified by the department 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.
For the purposes of this chapter, the following terms have the following meanings: apply:
(a)Current member means a current member of the International Gene Synthesis Consortium (IGSC) who is a certified member of that organization and includes voting members, small company members, and nonprofit members. It does not include provisional associate members or any other membership tier where the entity does not implement an IGSC tested and approved screening system.
(a)(b)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)(c)Department means the State Department of Public Health.
(c)(d) 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)(e)Gene synthesis product is double-stranded DNA (dsDNA), double-stranded nucleic acids, RNA, or oligonucleotides, designed and created without an existing DNA template.
(e)(f)(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 scientists own use or for use by another research scientist or an entity that manufactures gene synthesis products for the entitys own use.
24201.This chapter shall not be interpreted to regulate medical or pharmaceutical research and development or manufacturing, including drug screening assays, reagent production, tests employed in preclinical and clinical studies, manufacturing of biologics, gene therapy, and RNA therapeutics.
24202.In order to improve biosecurity efforts to prevent, deter, detect, attribute, and mitigate the misuse of gene synthesis products in California, including those products that may contain dangerous pathogen sequences, the department shall develop a verification process, with input from the International Gene Synthesis Consortium (IGSC) IGSC and industry stakeholders, to verify that a gene synthesis provider and manufacturer of gene synthesis equipment adhere to customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. The verification process shall include, at a minimum, a review of each entitys compliance every two years.
24203.(a)Beginning January 1, 2025, gene synthesis providers and manufacturers of gene synthesis equipment operating in California shall be verified as either be current members of the IGSC or verified by the department as entities adhering to proper screening protocols pursuant to Section 24202.
(b)A gene synthesis provider or manufacturer of gene synthesis equipment that fails to comply with the requirements of this section shall be subject to a civil penalty of one thousand dollars ($1,000) per day that it is noncompliant.
(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 departments 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 only if they are a current member of the IGSC or are otherwise verified by the department 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.
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 scientists own use or for use by another research scientist or an entity that manufactures gene synthesis products for the entitys own use.
(f)A current member of the International Gene Synthesis Consortium (IGSC) is a certified member of that organization and includes voting members, small company members, and nonprofit members. It does not include provisional associate members or any other membership tier where the entity does not implement an IGSC tested and approved screening system.24201.(a)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) or that they use customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol.(b)This24201.This chapter shall not be interpreted to regulate medical or pharmaceutical research and development or manufacturing, including drug screening assays, reagent production, tests employed in preclinical and clinical studies, manufacturing of biologics, gene therapy, and RNA therapeutics.
24202.The In order to improve biosecurity efforts to prevent, deter, detect, attribute, and mitigate the misuse of gene synthesis products in California, including those products that may contain dangerous pathogen sequences, the department shall develop a verification process, with input from the IGSC International Gene Synthesis Consortium (IGSC) and industry stakeholders, to verify that a gene synthesis provider and manufacturer of gene synthesis equipment is a current member of the IGSC or that they use adhere to customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. The verification process shall include, at a minimum, a review of each entitys compliance every two years.
24203.(a)Beginning January 1, 2025, gene synthesis providers and manufacturers of gene synthesis equipment operating in California shall be verified current members of the IGSC or verified entities using as adhering to proper screening protocols pursuant to Section 24202.
(b)A gene synthesis provider or manufacturer of gene synthesis equipment that is not a verified current member of the IGSC, fails to maintain its current membership in the IGSC, or is not verified by the department fails to comply with the requirements of this section shall be subject to a civil penalty of one thousand dollars ($1,000) per day that it does not meet one of those requirements. is noncompliant.
(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 departments 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 a verified current member of the IGSC or is verified by the department 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.
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 scientists own use or for use by another research scientist. scientist or an entity that manufactures gene synthesis products for the entitys own use.
(f)A current member of the International Gene Synthesis Consortium (IGSC) is a certified member of that organization and includes voting members, small company members, and nonprofit members. It does not include provisional associate members or any other membership tier where the entity does not implement an IGSC tested and approved screening system.
24201.(a)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). (IGSC) or that they use customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol.
(b)This chapter shall not be interpreted to regulate medical or pharmaceutical research and development or manufacturing, including drug screening assays, reagent production, tests employed in preclinical and clinical studies, manufacturing of biologics, gene therapy, and RNA therapeutics.
24202.The department shall develop a verification process, with input from the IGSC, IGSC and industry stakeholders, to verify that a gene synthesis provider and manufacturer of gene synthesis equipment is a current member of the IGSC. IGSC or that they use customer and sequence screening protocols that are equivalent to, or stronger than, the IGSCs Harmonized Screening Protocol. The verification process shall include, at a minimum, a review of each entitys compliance every two years.
24203.(a)Beginning January 1, 2025, gene synthesis providers and manufacturers of gene synthesis equipment operating in California shall be verified current members of the IGSC or verified entities using proper screening protocols pursuant to Section 24202.
(b)A gene synthesis provider or manufacturer of gene synthesis equipment that is not a verified current member of the IGSC, or fails to maintain its current membership in the IGSC, or is not verified by the department shall be subject to a civil penalty of one thousand dollars ($1,000) per day that it is not a verified current member of the IGSC. does not meet one of those requirements.
(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 departments 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 a verified current member of the IGSC or is verified by the department 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.
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 scientists 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 departments 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 entitys 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 entitys 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 departments 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.
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 scientists own use or for use by another research scientist.
24201.(a)On or before January 1, 2023, 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 departments 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.
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 entitys compliance biennially.
24203.(a)Beginning January 1, 2024, 2025, gene synthesis providers and manufacturers of gene synthesis equipment operating in California shall be certified pursuant to Section 24202.
(b)A gene synthesis provider or manufacturer of gene synthesis equipment that is not certified, or fails to maintain its certification, shall be subject to a civil penalty of one thousand dollars ($1,000) per day that it is not certified.
24204.(a)Beginning January 1, 2024, 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 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.
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 scientists own use or for use by another research scientist.
24201.(a)On or before January 1, 2023, 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 departments 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.
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 entitys compliance biennially.
24203.(a)Beginning January 1, 2024, gene synthesis providers and manufacturers of gene synthesis equipment operating in California shall be certified pursuant to Section 24202.
(b)A gene synthesis provider or manufacturer of gene synthesis equipment that is not certified, or fails to maintain its certification, shall be subject to a civil penalty of one thousand dollars ($1,000) per day that it is not certified.
24204.(a)Beginning January 1, 2024, 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 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.
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Date
|
Status
|
|---|---|
| Feb 3, 2022 | Consideration of Governor's veto stricken from file. |
| Jan 3, 2022 | Consideration of Governor's veto pending. |
| Oct 5, 2021 | Vetoed by Governor. |
| Sep 13, 2021 | Enrolled and presented to the Governor at 3 p.m. |
| Sep 7, 2021 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 67. Noes 0. Page 2825.). |
| Sep 2, 2021 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after September 4 pursuant to Assembly Rule 77. |
| Sep 2, 2021 | Read third time. Passed. Ordered to the Assembly. (Ayes 35. Noes 0. Page 2339.). |
| Aug 30, 2021 | Read second time. Ordered to third reading. |
| Aug 26, 2021 | From committee: Amend, and do pass as amended. (Ayes 5. Noes 0.) (August 26). |
| Aug 16, 2021 | In committee: Referred to suspense file. |
| Jul 14, 2021 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on APPR. |
| Jul 12, 2021 | Read second time and amended. Re-referred to Com. on APPR. |
| Jul 8, 2021 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 9. Noes 0.) (July 7). |
| Jun 28, 2021 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on HEALTH. |
| Jun 9, 2021 | Referred to Com. on HEALTH. |
| Jun 2, 2021 | In Senate. Read first time. To Com. on RLS. for assignment. |
| Jun 1, 2021 | Read third time. Passed. Ordered to the Senate. (Ayes 72. Noes 2. Page 1748.) |
| May 25, 2021 | Read second time. Ordered to third reading. |
| May 24, 2021 | Read second time and amended. Ordered returned to second reading. |
| May 20, 2021 | From committee: Amend, and do pass as amended. (Ayes 13. Noes 0.) (May 20). |
| Apr 21, 2021 | In committee: Set, first hearing. Referred to APPR. suspense file. |
| Apr 13, 2021 | Re-referred to Com. on APPR. |
| Apr 12, 2021 | Read second time and amended. |
| Apr 8, 2021 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 15. Noes 0.) (April 6). |
| Jan 11, 2021 | Referred to Com. on HEALTH. |
| Dec 8, 2020 | From printer. May be heard in committee January 7. |
| Dec 7, 2020 | Read first time. To print. |
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Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 7, 2021 | AB 70 Salas Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Sep 2, 2021 | Assembly 3rd Reading AB70 Salas et al. By Pan | Senate Floor |
Passed |
|
| Jun 1, 2021 | AB 70 Salas Assembly Third Reading | Assembly Floor |
Passed |
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Positions by individuals are not included.
Bill Author
Bill Co-Author(s):
