Biosecurity control lists name organisms that have the potential to pose a severe threat to public, animal, or plant health. These lists are compiled and used on an international basis.
An effective biosecurity screening program needs to first identify organisms with pathogenic potential, and then gain consensus about its classification at the national and international levels. Without both identification and consensus, anyone wanting something that is controlled in one country could simply make their purchase in a country where a sale is not restricted. It is for this reason that control lists include restrictions on exports along with restrictions on domestic sales.
The Major Control Lists
In the United States, the Select Agent Regulations (SAR) identify pathogens and toxins of concern. The Export Administration Regulations (EAR) include toxins and pathogens of concern among other dual-use goods and technology. The dual-use designation applies to things that can be put to both positive and negative use; biological materials clearly fall into this category. The Commerce Control List (CCL) includes the requirements for the export of EAR materials. Many other countries use these lists as the starting point for their own select agent and export controls lists.
The Australia Group (AG) also maintains a list of dual-use equipment and materials. The Australia Group is multinational. Comprised of 43 countries, the AG seeks to harmonize export controls and ensure that exports “do not contribute to the development of chemical or biological weapons.” Members include the European Commission (EC), Eastern Europe, the Americas, India, Japan, Australia, Scandinavia, and the United States. The Australia Group (AG) Common Control Lists cover chemical weapons, human and animal pathogens and toxins, and dual-use biological and related materials.
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What They Have in Common
These major lists share a common intention to limit or control the availability of materials of any type that can be used in or as weapons. With that in mind, there is an intentional overlap in the lists. Since member countries have a part in compiling the lists, they also have an interest in screening against the lists and enforcing the penalties for non-compliance. If the move to harmonize classification and identification of potential sequences and toxins of concern goes forward in the same way that countries are working to harmonize chemical classifications, the result will be comprehensive and informed by many countries.
When a List is Updated
Additions and subtractions are made to the lists on a regular basis. They are proposed by the regulating agency, open for comment for a period, and put into force. In the United States, notice often appears in the Federal Register. Businesses working in this field must stay cognizant of the current lists or face penalties.
Companies that maintain their own biosecurity screening applications must update those applications so that their screening programs will continue to flag organisms that are not in compliance with the control lists. It’s also important to identify whether or not a particular DNA sequence from that organism is pathogenic. The ThreatSEQ DNA Screening Web Service is a cloud-based solution for DNA biosecurity screening where the organisms and their associated sequences on control lists are updated without additional action required on the user’s part. ThreatSEQ assigns threat levels and flags sequences associated with pathogenic organisms to assist in decision-making.
Whether a company decides to invest in the creation and maintenance of an in-house DNA screening program or use a cloud-based solution like ThreatSEQ, control lists that are updated and maintained are essential to an effective screening program.