Thursday, August 18, 2022

BIS Sends Bio-Toxins NPRM to OMB

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had receive a notice of proposed rulemaking from the DOC’s Bureau of Industry and Security (BIS) for “Implementation of Australia Group Decisions (November 2021 and March 2022 Virtual Implementation Meetings; July 2022 Plenary): Controls on Marine Toxins, Plant Pathogens and Biological Equipment”.

According to the abstract in the Spring 2022 Unified Agenda:

“The Bureau of Industry and Security (BIS) has identified four naturally occurring, dual-use, biological toxins for evaluation as a potential emerging technology, consistent with the interagency process described in Section 1758 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852), as codified under 50 U.S.C. 4817.  These toxins have the potential (through either accidental or deliberate release) to cause casualties in humans or animals, degrade equipment, or damage crops or the environment.  Furthermore, they are now capable of being more easily isolated and purified due to novel synthesis methods and equipment.  Consequently, the absence of export controls on these toxins could be exploited for biological weapons purposes.  To address this concern, BIS proposes to amend the Commerce Control List (CCL) by adding these toxins to Export Control Classification Number (ECCN) 1C351.  This rule requests public comments to ensure that the scope of these proposed controls will be effective and appropriate (with respect to their potential impact on legitimate commercial or scientific applications).”


I am not planning on expanding the scope of this blog to cover bioweapons, but there are two interesting points here. First BIS talks about “more easily isolated and purified due to novel synthesis methods and equipment”. This talking about chemical manufacturing, at least where any output of meaningful scale is concerned. Finally, BIS is concerned about using these toxins to “cause casualties in humans or animals, degrade equipment, or damage crops or the environment”. Since these are not infectious agents, this would effectively be chemical warfare if done deliberately, making these toxins potential chemical agents.

So, would this make these chemicals chemical warfare agents and thus making the facilities that produce them subject to the Chemical Facility Anti-Terrorism (CFATS) standards? Technically, not unless they are added to the Appendix A list of DHS Chemicals of Interest (COI). And that is not likely unless the chemicals are added to the lists in the Chemical Warfare Treaty. Similarly, the CFATS program participation is also triggered by the holding of inventory of key chemical precursors to chemical weapons. Somewhere down the road, someone at CISA is going to need to decide if these are significant enough to trigger a revision to Appendix A. But, mark my word, if they do, this will have been the starting point for that initiative. 

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