How are DNA Biosecurity Screening Guidances Used?

DNA biosecurity screening guidances provide a framework for voluntary screening programs.

In the gene editing and synthetic DNA industries, biosecurity screening programs are carried out by companies on a voluntary basis. The framework for these screening programs is provided by governments and industry groups in the form of “Guidances.” A Guidance is a well-researched framework, and stakeholders are consulted for comment or actively work on the suggestions in the Guidance. This stakeholder involvement not only gives the industry a voice in the framework but also assures that the system they create takes their needs and concerns into account. The common framework provided by the guidelines also makes it possible for stakeholders to share or exchange information in the future. As a result, those in the process of establishing a screening program can confidently use Guidances as the starting point for their efforts.

What are Guidances?

Guidances are just that - a suggestion for a way to go about something in a thorough, intelligent, and effective manner. In the fields of gene editing and synthetic biology, the U.S. Department of Health and Human Services (HHS) and the International Gene Synthesis Consortium (IGSC) - an industry-led group of gene synthesis companies and organizations with approximately 80% of commercial gene synthesis capability worldwide - have issued Guidances with voluntary screening guidelines for the industry.

What Areas Does the HHS DNA Screening Guidance address?

The U.S. HHS 2010 Screening Framework Guidance is focused on what is required for the effective screening of customers and sequences. It includes specific information that should be gathered about customers. It also includes guidance on the types of screening activities to be performed on DNA sequences, along with the methods to utilize. Steps to take if a problem is identified are discussed in the guidance for flagging and follow-up.

How Do These Guidances Inform Current DNA Screening Protocols?

Currently, DNA screening protocols, whether implemented in-house or through the use of commercially available software, like Battelle’s UltraSEQ™, are based on the HHS and IGSC frameworks. Companies may require additional information from customers or perform more extensive sequence screening to aid in decision-making about specific sequences, but the core information is fairly uniform. This information is captured and retained, according to Guidance, for eight years to be certain that information about past transactions is readily available if the more recent activity causes concern.

The particular sequences that are screened are derived from the various control lists maintained by governments. The lists include, in the U.S., the Select Agent Regulations (SAR), the Export Administration Regulations (EAR), and the Commerce Control List (CCL) with the Export Control Classification Number (ECCN) used to describe items and their licensing requirements. The Australia Group (AG) maintains control lists to synchronize export controls among its participants.

The U.S. government, industry consortiums, and academic groups have played an essential role in identifying areas of vulnerability, identifying steps that can be taken to mitigate that vulnerability, and establishing consensus among the various stakeholders. The Guidances they’ve created ensure that voluntary screening programs in accordance with their frameworks are effective.