Guidance on Purchasing Gene Synthesis Equipment or Products in Compliance with AB 1963

In August 2022, the California Legislature passed AB 1963, which amended sections 6630 and 66361 of the Education Code. It required the California State University (CSU) to, and requested that the University of California (UC), develop systemwide guidance for purchasing gene synthesis equipment or gene synthesis products from providers who prevent the misuse of synthetic genes and safeguard the benefits of gene synthesis technology, while minimizing risk.
Information relevant to individuals in the research community who may be involved in purchasing gene synthesis equipment or products (e.g., researchers, lab managers, students, and procurement offices) is provided below.

Contact

Agnes Balla at Agnes.Balla@ucop.edu or (510) 987-9987

Guidance on Purchasing Gene Synthesis Equipment or Products Link

RPAC Memo 23-02

This memo informs the research community about Assembly Bill (AB) 1963 and provides guidance on purchasing gene synthesis equipment/products from gene synthesis providers.

UC Policy on Dual Use Research of Concern PDF

Effective September 24, 2015

This Policy is intended to preserve the benefits of life sciences DURC while implementing measures to mitigate the risk that the output of such research could be used for harmful purposes.

Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids Link

HHS Administration for Strategic Preparedness & Response

This guidance sets forth recommended baseline standards for gene synthesis providers and manufacturers of benchtop nucleic acid synthesis devices, and details best practices for customers of synthetic nucleic acids regarding screening orders for, and responsibly handling, sequences of concern.

OSTP Framework for Nucleic Acid Synthesis Screening PDF

April 2024

This framework encourages providers of synthetic nucleic acids to implement comprehensive, scalable, and verifiable screening mechanisms and aims to help mitigate the potential for misuse of AI-enabled biotechnologies.

International Gene Synthesis Consortium (IGSC) Link

IGSC is an industry-led group of gene synthesis companies and organizations formed to design and apply a common protocol to screen both the sequences of synthetic gene orders and the customers who place them.

Harmonized Screening Protocol for Gene Sequence & Customer Screening to Promote Biosecurity PDF

This document outlines the standards and practices that the International Gene Synthesis Consortium (IGSC) gene synthesis members apply to prevent the misuse of synthetic genes.

Video: Guidance on Purchasing Gene Synthesis Equipment or Products in Compliance with AB 1963 Link

April 26, 2023

This webinar provides an overview of AB 1963, how to comply with its requirements, and resources for compliance. The webinar applies to individuals in the research community who may be involved in purchasing gene synthesis equipment or products (e.g., researchers, lab managers, students, and procurement offices).

Smartsheet Dashboard: Gene Synthesis Suppliers Link

List of gene synthesis suppliers under AB 1963 and their status.

CSU Guidance on Purchasing Gene Synthesis Equipment or Products PDF

April 18, 2023

This memo informs the California State University research community about Assembly Bill (AB) 1963 and provides guidance on purchasing gene synthesis equipment or gene synthesis products from gene synthesis providers.

FAQs on Export Control Compliance (ECAS) Link

Frequently Asked Questions on export control compliance, including Dual Use Research of Concern, from UCOP's Ethics, Compliance and Audit Services office.