WASHINGTON – Today, the Commerce Department’s Bureau of Industry and Security (BIS)
issued a rule proposing unilateral controls on exports of four naturally occurring marine toxins,
the synthesis and collection of which BIS has identified for evaluation as pertaining to emerging
and foundational technologies essential to the national security of the United States under
Section 1758 of the Export Control Reform Act (ECRA) of 2018. The proposed rule released
today requests public comments from interested stakeholders to aid in its determination of the
appropriate level of controls that should apply to these items.

“Today’s rule reflects the Bureau of Industry and Security’s commitment to the Congressional
mandate to identify and implement appropriate controls on technologies essential to our national
security,” said Under Secretary of Commerce for Industry and Security Alan Estevez.
“Accordingly, this rule proposes controls on marine toxins in order to limit their proliferation for
activities contrary to our national security and foreign policy interests, while ensuring legitimate
commercial or scientific applications.”

“Today’s rule is the latest example of BIS’s ongoing, evidence-based approach to export controls
in response to national security threats posted by emerging and foundational technologies,” said
Assistant Secretary of Commerce for Export Administration Thea D. Rozman Kendler.
“We welcome public comment on our proposal to add four marine toxins to the Commerce
Control List to ensure we have appropriately defined the scope and maximized the effectiveness
of our controls on these technologies. Although we are initially proposing these controls
unilaterally, input on this proposed rule will feed into our anticipated Australia Group proposal
this July.”

BIS has preliminarily determined that these four toxins (specifically, the marine toxins
brevetoxin, gonyautoxin, nodularin, and palytoxin) 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, as these toxins are now capable of being more easily
isolated and purified due to novel synthesis methods and equipment, the absence of export
controls on such items could be exploited for biological weapons purposes. Presently, these
toxins and related “technology” are used in research and development activities in the
biotechnology field (e.g., U.S. university and military laboratories).

Today’s rule also articulates BIS’s continued commitment to meeting its statutory
responsibilities under Section 1758 of ECRA. That provision of law authorizes BIS to establish
appropriate controls on the export, reexport or transfer (in-country) of emerging and foundational
technologies that are essential to the national security of the United States by applying controls
pursuant to the authority and process outlined in Section 1758. BIS will implement that section
without characterizing a specific technology as “emerging” or “foundational,” but rather by
referring to such technologies as “Section 1758 technologies.”

The four marine toxins addressed in this proposed rule are naturally occurring and are not
necessarily considered, by themselves, to be “emerging” technologies. Consequently, they could
be evaluated as “foundational,” rather than “emerging” technologies. On the other hand, recent
advances in, the synthesis and collection of these toxins could be evaluated as an “emerging”
technology.

Regardless of whether these toxins and their synthesis and collection are identified as an
“emerging” or “foundational” technology, what is clear is that these toxins can now be more
easily isolated and purified due to novel synthesis methods and equipment and, therefore, are
capable of being more easily exploited for biological weapons purposes than in the past and,
therefore, warrant control.

As Congress did not define “emerging” and “foundational” technologies in ECRA and there are
no legal differences between the two terms, applying a “Section 1758 technology”
characterization allows BIS to more efficiently identify and control technologies that pose a
national security threat without having to distinguish between what is “emerging” and what is
“foundational,” as distinctions between those categories are often not readily apparent.
The text of the proposed rule released today is available on the Federal Register’s website here:
https://go.usa.gov/xuhkk.

For more information, visit www.bis.doc.gov.

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