On May 23, 2022, the US Commerce Department’s Bureau of Industry and Security (BIS) published in the Federal Register a proposed rule and request for comments. This proposed rule seeks to amend the Export Administration Regulations (EAR) (15 CFR parts 730-774) by adding four dual-use biological toxins to Export Control Classification Number (ECCN) 1C351 on the Commerce Control List (CCL). The proposed rule also would identify the synthesis and collection of these toxins for evaluation as “emerging and foundational technologies” according to the criteria in Section 1758 of the Export Control Reform Act of 2018 (ECRA).
Proposed Export Controls on Four Marine Toxins
The proposed rule would amend ECCN 1C351 (which controls certain human and animal pathogens and toxins) to add the following four marine toxins to 1C351.d:
- Brevetoxin, which is a neurotoxin that binds to the voltage-gated sodium channels in nerve cells, disrupting normal neurological processes and causing neurotoxic shellfish poisoning.
- Gonyautoxin, a type of saxitoxin (currently controlled under ECCN 1C351.d.12) that can bind to the α-subunit of the voltage-dependent sodium channels in the postsynaptic membrane, blocking synaptic function and causing paralytic shellfish poisoning.
- Nodularin, a potent toxin that causes irreversible liver damage.
- Palytoxin, a naturally occurring toxin produced in certain corals and dinoflagellates. These toxins target the sodium-potassium pump protein, which may lead to vasoconstriction. Exposure to palytoxins can occur through inhalation, ingestion, or via direct contact with the skins or eyes. Symptoms include nausea, vomiting, diarrhea, lethargy, numbness, muscle spasms, slow heart rate, respiratory distress or kidney failure, and can result in death, which generally is caused by cardiac arrest.
BIS states that, although these toxins are naturally occurring, dual-use biological toxins, they have the potential to cause casualties in humans or animals, degrade equipment, or damage crops or the environment. BIS has determined that while these toxins are naturally occurring, novel synthesis methods and equipment have made it easier to isolate and purify these toxins. Thus, the absence of export controls on these four toxins could be exploited for biological weapons purposes.
BIS notes that these four toxins are not currently listed on the Australia Group (AG) Common Control List, which is a multilateral body that works to halt the spread of chemical and biological weapons by developing a common control list of items related to such weapons. As a result, the Chemical and Biological Weapons (CB) controls that would be implemented pursuant to the proposed rule would be unilateral, absent the adoption of comparable controls by the AG and its member states.
While the proposed rule would not amend the language of ECCN 1E001 (which controls, inter alia, technology for the development or production of toxins controlled in ECCN 1C351), the proposed rule would expand the scope of ECCN 1E001 by controlling technology for the development or production of the four marine toxins that would be added to ECCN 1C351.
Section 1758 Technologies
Under the proposed rule, BIS would identify the synthesis and collection of these four marine toxins pursuant to Section 1758 of ECRA (i.e. as “emerging and foundational technologies”). BIS explained that when identifying technologies for evaluation as emerging and foundational technologies pursuant to Section 1758 of ECRA, BIS will no longer differentiate between technologies that are “emerging” or “foundational,” because categorizing technologies as such can delay the imposition of export controls on those technologies. ECRA does not require BIS to identify a technology either as “emerging” or as “foundational,” and ECRA does impose differential treatment on one such category of technologies versus the other.
BIS highlighted the inherent difficulty in determining whether a technology is “emerging” or “foundational.” Regarding the four marine toxins, BIS states that because the four marine toxins that are the subject of this proposed rule are naturally occurring and not necessarily considered to be “emerging” technologies, they might be characterized as “foundational” technologies. However, the synthesis and collection of these toxins could be considered “emerging” technology due to novel synthesis techniques that make it easier to isolate and purify these toxins to exploit them for biological weapons purposes.
Going forward, rather than differentiating between an “emerging” technology and “foundational” technology, BIS proposes to characterize all such technologies identified pursuant to Section 1758 as “Section 1758 technologies,” which are “critical technologies” for purposes of reviews by the Committee on Foreign Investment in the United States (CFIUS).
Public Comment Period
BIS is seeking comments from the public on this proposed rule. Parties wishing to submit a comment may do so either through the Federal eRulemaking Portal at http://www.regulations.gov, or by submitting an email to PublicComments@bis.doc.gov. The docket number for this proposed rule is BIS-2022-0013 or RIN 0694-AI21. Comments are due no later than June 22, 2022.