BIS Finalizes Multilateral Controls on Dual-Use Marine Toxins

The Bureau of Industry and Security finalized new export controls on four dual-use marine toxins after the restrictions were agreed to at the multilateral Australia Group (AG). BIS also announced other export control changes made by the AG, including revisions to clarify controls on certain “genetic elements and genetically modified organisms” and the “scope of the exclusion that applies” to certain medical isolators. The agency also updated the “nomenclature” of certain bacteria and fungi, and clarified the definition of “disinfected” as it applies to certain biological equipment. The changes take effect Jan. 17.

BIS first proposed new controls on the four marine toxins -- brevetoxins, gonyautoxins, nodularins and palytoxin -- in May (see 2205200017), several months before they were adopted by the AG. The toxins will be controlled under Export Control Classification Number 1C351.d for chemical/biological (CB) and anti-terrorism (AT) reasons, BIS said, adding that they can be used in biological weapons to “cause casualties in humans or animals, degrade equipment, or damage crops or the environment.”

“Because these toxins are now capable of being more easily isolated and purified due to novel synthesis methods and equipment,” the agency said, “BIS determined that the absence of export controls on the toxins could be exploited for biological weapons purposes.” The four toxins were controlled under the Export Control Reform Act as emerging and foundational technologies -- otherwise known as Section 1758 technologies.

The agency said it received just two comments on the proposed controls last year, only one of which was relevant (see 2207190014). That commenter asked for more clarity around whether any of the toxins “have an identified and specific biological synthesis pathway," because if so, then “certain genes or gene clusters may become subject to control as a result of imposing controls on the toxin.”

“To the extent that any genes and gene clusters became subject to control under ECCN 1C353, as a result of the imposition of controls on the four marine toxins and their subunits under ECCN 1C351.d, they would be among the genetically modified organisms and genetic elements described in ECCN 1C353.a.3,” the agency said. “BIS believes that the controls described in ECCN 1C353.a.3 are sufficiently clear in this respect and, consequently, that no further clarification is necessary.”

BIS also removed certain export controls from “cholera toxin” to reflect a change made by the AG. That toxin was removed because it now has “significant commercial or medical uses” that didn’t exist when it was first added to the AG’s common control list, the agency said.

“[I]n recent years, there has been a significant increase in biomedical research involving cholera toxins and in the use of cholera toxin in biomedical applications,” BIS said, also adding that the toxin hasn’t been a “major focus” of biological weapons research programs. The removal of CB controls on cholera toxins “is not expected to have a significant impact on the proliferation, development, production or use of biological weapons,” BIS said, “nor would the relative costs of such controls … be justified going forward.”

BIS made several other changes agreed to at the AG, including one that clarifies how certain export controls apply to “medical isolators ‘specially designed’ for barrier nursing or transportation of infected patients.” Another change revises ECCN 1C353 to clarify that controls on genetic elements and genetically modified organisms include, “any gene(s) or translated product(s) specific to any controlled virus.” Previously, this ECCN didn’t “explicitly state” that controls on “viral genetic elements also included translated product(s) specific to any controlled virus,” BIS said.

Another revision to ECCN 1C350 adds a clarification to the ECCN’s Technical Note 3. BIS said the change is consistent with a recommendation by the Organization for the Prohibition of Chemical Weapons to control “all stereoisomers and isotopically-labeled forms of scheduled chemicals, even if they have different” Chemical Abstract Service Registry numbers. “Specifically, this rule revises the parenthetical ‘(e.g., hydrates),’ in the second sentence of Technical Note 3, to read ‘(e.g., hydrates, isotopically-labeled forms or all possible stereoisomers),’” BIS said.

The agency also updated the nomenclature of certain bacteria and fungi to reflect decisions made by the AG and revised the definition of “disinfected” to “more closely reflect the use of this term by the scientific and industrial communities.” The definition of disinfected now specifies that the term “denotes a process to reduce the number of microorganisms, but not usually of bacterial spores, through the use of chemical agents, without necessarily killing or removing all organisms,” BIS said. “This change eliminates what appeared to be a disparity between the commonly accepted use of this term in scientific and industrial circles and the previous AG definition, wherein the latter described both ‘disinfection’ and ‘sterilization’ as being distinct from ‘sanitization.’”

All exports that now require a license as a result of the changes that were aboard a carrier to a port as of Jan. 17 may proceed to their destinations under the previous eligibility as long as they are exported by March 20, BIS said. Any items not exported before midnight March 20 will need a license.

All deemed exports of technology and source code that now require a license due to the changes may continue to be made without a license before March 20, BIS said. Beginning at midnight March 20, those deemed exports -- which are releases of technology to a foreign national whose home country would normally require an export authorization for that item -- will require a license.