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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations SUPPLEMENT NO. 1 TO PART 745SCHEDULES OF CHEMICALSContinued CAS
registry No.

16. Methyldiethanolamine
17. Triethanolamine

Note to Supplement 1: The numerical sequence of the Schedule 1 Toxic Chemicals and Precursors is not consecutive so as to align with the December 23, 2019, consolidated textual changes to Schedule 1
of the Annex on Chemicals to the Chemical Weapons Convention CWC, which reflect the decisions adopted by the CWC
Conference of the States Parties in November 2019.
Matthew S. Borman, Deputy Assistant Secretary for Export Administration.
FR Doc. 202027759 Filed 1621; 8:45 am BILLING CODE 351033P

DEPARTMENT OF COMMERCE
Bureau of Industry and Security 15 CFR Parts 742 and 774
Docket No. 2012080330
RIN 0694AI09

Commerce Control List: Clarifications to the Scope of Export Control Classification Number 1C991 To Reflect Decisions Adopted at the June 2019 Australia Group Plenary Meeting Bureau of Industry and Security, Commerce.
ACTION: Final rule.
AGENCY:

The Bureau of Industry and Security BIS publishes this final rule to amend the Export Administration Regulations EAR to clarify the scope of the export controls that apply to certain vaccines and medical products, consistent with the release i.e., exclusion notes contained in the Australia Group AG Human and Animal Pathogens and Toxins for Export Control common control list.
DATES: This rule is effective January 7, 2021.
FOR FURTHER INFORMATION CONTACT: Dr.
Kimberly Orr, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: 202 4824201, Email: Kimberly.Orr@bis.doc.gov.
SUPPLEMENTARY INFORMATION: The Bureau of Industry and Security BIS is amending the Export Administration Regulations EAR to clarify the scope of
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the export controls that apply to certain vaccines, consistent with the vaccine release i.e., exclusion note contained in the Australia Group AG List of Human and Animal Pathogens and Toxins for Export Control common control list, as updated by a decision made at the AG Plenary meeting held in Paris, France, in June 2019. The AG is a multilateral forum consisting of 42
participating countries and the European Union that maintain export controls on a list of chemicals, biological agents, and related equipment and technology that could be used in a chemical or biological weapons program. The AG periodically reviews items on its control list to enhance the effectiveness of participating governments national controls and to achieve greater harmonization among these controls.
The AG specifically excludes certain vaccines from control under its List of Human and Animal Pathogens and Toxins for Export Control and the associated Warning List. However, prior to the June 2019 Plenary changes to this AG common control list, it was not clear if the release note therein applied not only to vaccines containing those human and animal pathogens and toxins identified on the list, but also to vaccines containing the genetic elements and genetically modified organisms identified therein. Recent changes to this AG common control list, based in part on a decision made at the June 2019 Plenary meeting, clarify that this release note applies to vaccines containing the genetic elements and genetically modified organisms identified on this list, as well as vaccines containing the viruses, bacteria, and toxins identified on this list.
Specifically, this rule amends Export Control Classification Number ECCN
1C991 on the Commerce Control List CCL to indicate that it includes vaccines containing, or designed for use against, any of the items identified in ECCN 1C351, 1C353 or 1C354. Prior to the effective date of this final rule, ECCN 1C991 indicated that it controlled vaccines against such items, but was not specific about whether all vaccines containing such items were controlled, irrespective of whether the
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vaccines were designed for use against such items.
This rule also expands the scope of medical products controlled under ECCN 1C991 to include those containing genetically modified organisms and genetic elements described in ECCN 1C353.a.3. In addition, this rule clarifies the definition of immunotoxin that appears in ECCN 1C351 and ECCN
1C991 and removes the definition of subunit from ECCN 1C351.
Finally, this rule renumbers ECCN
1C991.c and .d by listing medical products that are subject to chemical/
biological CB controls, as well as antiterrorism AT controls, under ECCN
1C991.c and listing medical products that are subject only to AT controls under ECCN 1C991.d. A conforming amendment is made to 742.2a3 of the EAR to reflect this change in paragraph sequencing.
ECCN 1C991 Vaccines, Immunotoxins, Medical Products, Diagnostic and Food Testing Kits This final rule amends ECCN 1C991
on the Commerce Control List CCL
Supplement No. 1 to part 774 of the EAR to make the description of the vaccines controlled by this ECCN more closely reflect the scope of the vaccine release note contained in the AG List of Human and Animal Pathogens and Toxins for Export Control. ECCN
1C991 does not control any of the human and animal pathogens and toxins or genetic elements and genetically modified organisms identified on this AG list; however, it does control vaccines, immunotoxins, medical products, and diagnostic and food testing kits that contain certain of these AG-listed items.
The amendments contained in this final rule are intended to clarify the scope of the vaccine controls described in ECCN 1C991. Prior to the effective date of this final rule, the control text for vaccines described in ECCN 1C991.a indicated that this ECCN controlled vaccines against items controlled by ECCN 1C351, 1C353 or 1C354. The use of the term against in the control text created some uncertainty concerning the extent to which ECCN 1C991.a applied to vaccines that contain items controlled by ECCN 1C351, 1C353 or
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