BIS Amends Scope of Export Controls for Certain Vaccines, Medical Products

The Bureau of Industry and Security clarified and expanded the scope of export controls for certain vaccines and medical products (see 2012090006), the agency said in a final rule effective Jan. 7. The changes align U.S. export controls with decisions agreed to at the Australia Group’s 2019 plenary group. The updated controls also have implications for vaccines related to COVID-19, BIS said.

The main intent of the change was to clarify language in the Export Administration Regulations to address “concern” from manufacturers and exporters about the correct Export Control Classification Number and licensing policies for certain vaccines, BIS said. The agency also issued the rule “in response to recent scientific and medical developments” among medical products and vaccines.

The rule amends ECCN 1C991 on the Commerce Control List to specify that it includes vaccines “containing, or designed for use against” any of the items controlled under ECCNs 1C351, 1C353 or 1C354. Previously, language in the EAR indicated that the ECCN 1C991 only controlled vaccines “‘against’ such items, but was not specific about whether all vaccines ‘containing’ such items were controlled,” BIS said, “irrespective of whether the vaccines were designed for use ‘against’ such items.”

The rule also expanded the scope of medical products controlled under ECCN 1C991, which now includes products that contain certain “genetically modified organisms and genetic elements.” The change was meant to “emphasize the more stringent controls that apply to the medical products” in ECCN 1C991 and to clarify which types of controls apply. The rule also clarified the definition of “immunotoxin,” removed a definition, renumbered certain ECCNs and made several other technical corrections and notes.

BIS stressed that all items controlled by ECCN 1C991, including vaccines, require a licensee for anti-terrorism reasons to certain country destinations, and certain medical products now controlled by the ECCN require a license for chemical and biological weapons reasons and anti-terrorism reasons for certain country destinations.

Although certain COVID-19 vaccines are not impacted by this rule, BIS said future “development of an unknown number of other vaccines, COVID and otherwise” is “expected to be greatly facilitated as a result” of the updated vaccines controls. BIS said COVID vaccines that contain genetic elements of items controlled by ECCN 1C353 are now controlled under ECCN 1C991, which imposed a more limited license requirement on those vaccines.

All exports, reexports and in-country transfers that now require a license as a result of the changes but are aboard a carrier to a port as of Jan. 7 will be able to proceed to their destinations under the previous eligibility as long as they are exported, reexported or transferred by March 8, BIS said. Items not exported, reexported or transferred before midnight on March 8 will require a license.

BIS also said any deemed exports of technology and source code that now require a license “may continue to be made” before March 8. Beginning at midnight on March 8, the technology and exports may no longer be released without a license to foreign nationals subject to deemed export controls under the EAR.