ISO/PWI 20688-3

Biotechnology — Nucleic acid synthesis — Part 3: Screening requirements for ensuring biosafety and biosecurity

Scope

This standard provides implementation guidance for the biosafety and biosecurity requirements for the safe production and quality control of synthesized nucleic acids including fragments, genes and genomes. It describes recommended approaches and implementation considerations for nucleic acid sequence screening and associated biosecurity measures intended to reduce the risk of the intentional or inadvertent misuse of nucleic acid synthesis technologies and products.
It applies to producers of synthetic DNA (single stranded and double-stranded) and RNA, including organizations using in-house (including benchtop) or third-party sequence screening systems. It covers practical considerations relating to sequence screening, customer and intended-use verification (experimental and in silico), escalation and reporting, recordkeeping and traceability, cybersecurity and information security, assurance and oversight, and the governance of implementation over time.
This document also covers implementation considerations related to the identification and handling of sequences of concern, including function-based and beyond-list approaches, translated screening, minimum screening length, treatment of fragmented or distributed orders, exempted sequences, third parties and intermediaries, user responsibilities, and benchtop DNA synthesis equipment.
It is intended for use by nucleic acid synthesis providers, screening service providers, auditors, biosafety and biosecurity practitioners, standards bodies, and competent authorities in research, commercial, industrial, and academic settings.
The aim is to provide a route to implement section 6 of ISO 20688-2 for double stranded DNA as well as other modalities of synthetic nucleic acids. It does not establish legal obligations, define binding control lists, prescribe specific technical tools or algorithms, or provide step-by-step laboratory procedures. Responsibility for compliance with applicable legal and regulatory requirements remains with the relevant organization:
·         Commercial DNA synthesis providers;
·         Academic or non-commercial synthesis facilities;
·         Providers using benchtop DNA synthesis equipment;
·         Providers relying on third-party or intermediary screening services;
·         Users of synthetic DNA, including where benchtop devices are used.
The standard requires that ordered DNA sequences be screened for biosecurity risks prior to synthesis.