Regulatory intelligence for US exporters

BIS Proposes New Controls, Plans to End Categorizing Emerging and Foundational Tech

The Bureau of Industry and Security is proposing new unilateral export controls on four dual-use biological toxins that can be weaponized to kill people or animals, “degrade equipment” or damage the environment, the agency said in a rule released May 20. Controls would apply to the marine toxins brevetoxin, gonyautoxin, nodularin and palytoxin, BIS said, all of which can be “exploited for biological weapons purposes.” The agency said it won’t categorize the toxins or their technologies as emerging or foundational technologies, and doesn't plan to continue to differentiate between the two categories going forward.

The toxins would fall under BIS’s emerging and foundational technology control mandate but would not be specifically categorized as either emerging or foundational technologies. The agency said it plans to abandon efforts to categorize technologies as either emerging or foundational and instead refer to them as “Section 1758 technologies,” which it said will lead to a faster and more efficient rollout of restrictions.

The proposed controls would be added to the Export Control Classification Number (ECCN) 1C351, which would control “‘technology’ for the ‘development’ or ‘production’” of the four marine toxins. The items would be controlled for chemical/biological (CB) and anti-terrorism reasons (AT) and would face certain license exception restrictions.

Although the toxins are naturally occurring, they have the “potential (through either accidental or deliberate release)” to be used as biological weapons, BIS said. The toxins aren’t controlled by the multilateral Australia Group, but BIS said they warrant unilateral controls because of their dangerous uses, especially because they can “now be more easily isolated and purified due to novel synthesis methods and equipment.”

BIS is seeking feedback on the proposed restrictions, including whether the agency should only implement the controls multilaterally “in the interest of increasing their effectiveness and minimizing their impact on U.S. industry.” The agency also is accepting comments on the effectiveness of the control language; the controls’ potential effect on the future development or production of the toxins and their related technology in the U.S.; and information on the “current capability” of U.S. companies to develop and produce the toxins. Comments are due June 22.

BIS said the effort to categorize emerging or foundational technologies “has sometimes delayed the imposition of controls,” and the agency will instead refer to the controls as Section 1758 technologies in reference to Section 1758 of the Export Control Reform Act, which mandated the export control effort.

The agency has struggled to identify emerging and foundational technologies since ECRA became law in 2018 (see 2204080033). Although it has issued nearly 40 emerging technology controls, it hasn’t yet issued a foundational technology restriction, drawing criticism from a bipartisan congressional commission last year that said BIS has “failed” to carry out its export control responsibilities (see 2106020024). Lawmakers have threatened to take away BIS’s ECRA authority, citing the slow pace of controls (see 2010010020 and 2110250035).

BIS believes that abandoning the effort to categorize technologies as either foundational or emerging will help it move faster. It also said the categorization has no effect on the actual effectiveness or scope of the restrictions, and won’t affect the activities of the Committee on Foreign Investment in the U.S., which reviews foreign investments that involve certain critical technologies defined by BIS.

Agency officials have said the control effort has proven challenging, partly because it can be difficult to place technologies in one category over the other. BIS said technologies “cannot always be readily categorized as either ‘emerging’ or ‘foundational,’” pointing to the four marine toxins as an example. Although the toxins may be considered foundational because they’re “naturally occurring,” BIS said the “synthesis and collection of these toxins could be evaluated as an ‘emerging’ technology.”

“This proposed rule demonstrates some of the difficulties in attempting to draw meaningful and functional distinctions between ‘emerging’ and ‘foundational’ technologies,” BIS said. “Similar challenges have made it difficult to characterize other technologies that have been proposed for addition to the Commerce Control List.” Rather than continuing to try to distinguish between the two categories, BIS said “the government’s resources and the mandate from Congress are better served identifying the technologies essential to U.S. national security under Section 1758.”

Referring to them only as Section 1758 technologies “will facilitate more efficient interagency review of implementing regulations, and result in more timely implementation of such controls,” BIS said. “[T]here is no impact on the scope of controls on technologies whether they are described as emerging or foundational.”