Who are the Organizations Behind Biosecurity Control Lists?

Control lists are compiled and maintained by governments, international forums, and international industry consortiums.

Robust and effective screening programs are essential to efforts to thwart bad actors in the synthetic biology arena. Screening programs cannot function effectively without control lists that identify organisms that are most likely to be involved in ill-intentioned activities. Just who compiles and maintains these lists and offers guidance?

United States Government

There are several government agencies that supply the lists used for screening programs:

• The U.S. Department of Health and Human Services (HHS). The stated mission of HHS is to enhance and protect the health and well-being of all Americans by providing for effective health and human services and fostering advances in medicine, public health, and social services. As part of that mission, HHS provides guidance for screening programs in the synthetic DNA industry. HHS issues Guidances in which it suggests a framework for something that is voluntary. The HHS “Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA” provides a framework for a screening program that includes customer and sequence screening along with conditions for flags and the requisite follow-up.

• The mission of the U.S. Centers for Disease Control and Prevention (CDC) is to protect America from health, safety, and security threats, both foreign and in the U.S. on a 24/7 basis. In conjunction with this mission, they provide information on diseases, medical conditions, issues of interest to public health, and more. They also maintain the Select Agent Regulations (SAR). This list, used to identify organisms of concern, is widely used in screening programs.

• The U.S. Bureau of Industry and Security (BIS) works to promote U.S. national security, foreign policy, and economic objectives. They do this by 1) ensuring effective export control and treaty compliance and 2) promoting continued U.S. strategic technology leadership. To that end, they compile and publish the Export Administration Regulations (EAR). This list covers a range of regulations for a range of industries that include “materials,” chemicals, “microorganisms,” and toxins.

International Government Forums

The U.S., along with many other governments, is involved in forums to promote screening processes in their own countries and regions.

• The Australia Group (AG) is an informal forum of countries that have decided to harmonize (synchronize) their export controls. They do this to ensure that exports are not used in the development of chemical or biological weapons. There are 43 member countries, among them are the United States, the United Kingdom, Bulgaria, Estonia, the European Union, the Scandinavian countries, and more. The Australia Group (AG) Common Control Lists cover chemical weapons, human and animal pathogens and toxins, and dual-use (can be used for positive or negative reasons) biological, and related materials.

International Industry Consortiums

The International Gene Synthesis Consortium (IGSC) is an international consortium of gene synthesis companies and organizations. The IGSC was formed to design and apply a common screening protocol for synthetic gene sequences and the customers ordering them. The IGSC has significant reach. Its members represent approximately 80% of global commercial gene synthesis capacity and are committed to following the IGSC Harmonized Screening Protocol.