944 Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations

SUPPLEMENT NO. 1 TO PART 745—SCHEDULES OF CHEMICALS—Continued

CAS registry No.

16. Methyldiethanolamine ...... 105–59–9 17. Triethanolamine ...... 102–71–6

Note to Supplement 1: The numerical the export controls that apply to certain vaccines were designed for use sequence of the ‘‘Schedule 1’’ Toxic vaccines, consistent with the vaccine ‘‘against’’ such items. Chemicals and Precursors is not consecutive release (i.e., exclusion) note contained This rule also expands the scope of so as to align with the December 23, 2019, in the Australia Group (AG) ‘‘List of medical products controlled under consolidated textual changes to ‘‘Schedule 1’’ ECCN 1C991 to include those of the Annex on Chemicals to the Chemical Human and Animal Pathogens and Weapons Convention (CWC), which reflect Toxins for Export Control’’ common containing genetically modified the decisions adopted by the CWC control list, as updated by a decision organisms and genetic elements Conference of the States Parties in November made at the AG Plenary meeting held in described in ECCN 1C353.a.3. In 2019. Paris, France, in June 2019. The AG is addition, this rule clarifies the a multilateral forum consisting of 42 definition of ‘immunotoxin’ that Matthew S. Borman, participating countries and the appears in ECCN 1C351 and ECCN Deputy Assistant Secretary for Export European Union that maintain export 1C991 and removes the definition of Administration. controls on a list of chemicals, ‘subunit’ from ECCN 1C351. [FR Doc. 2020–27759 Filed 1–6–21; 8:45 am] biological agents, and related equipment Finally, this rule renumbers ECCN BILLING CODE 3510–33–P and technology that could be used in a 1C991.c and .d by listing medical chemical or biological weapons products that are subject to chemical/ program. The AG periodically reviews biological (CB) controls, as well as anti- DEPARTMENT OF COMMERCE items on its control list to enhance the terrorism (AT) controls, under ECCN effectiveness of participating 1C991.c and listing medical products Bureau of Industry and Security governments’ national controls and to that are subject only to AT controls achieve greater harmonization among under ECCN 1C991.d. A conforming 15 CFR Parts 742 and 774 these controls. amendment is made to § 742.2(a)(3) of the EAR to reflect this change in [Docket No. 201208–0330] The AG specifically excludes certain paragraph sequencing. RIN 0694–AI09 vaccines from control under its ‘‘List of Human and Animal Pathogens and ECCN 1C991 (Vaccines, Immunotoxins, Commerce Control List: Clarifications Toxins for Export Control’’ and the Medical Products, Diagnostic and Food to the Scope of Export Control associated Warning List. However, prior Testing Kits) Classification Number 1C991 To to the June 2019 Plenary changes to this This final rule amends ECCN 1C991 Reflect Decisions Adopted at the June AG common control list, it was not clear on the Commerce Control List (CCL) 2019 Australia Group Plenary Meeting if the release note therein applied not (Supplement No. 1 to part 774 of the only to vaccines containing those EAR) to make the description of the AGENCY: Bureau of Industry and human and animal pathogens and vaccines controlled by this ECCN more Security, Commerce. toxins identified on the list, but also to closely reflect the scope of the vaccine ACTION: Final rule. vaccines containing the genetic release note contained in the AG ‘‘List elements and genetically modified SUMMARY: The Bureau of Industry and of Human and Animal Pathogens and organisms identified therein. Recent Toxins for Export Control.’’ ECCN Security (BIS) publishes this final rule changes to this AG common control list, to amend the Export Administration 1C991 does not control any of the based in part on a decision made at the human and animal pathogens and Regulations (EAR) to clarify the scope of June 2019 Plenary meeting, clarify that the export controls that apply to certain toxins or genetic elements and this release note applies to vaccines genetically modified organisms vaccines and medical products, containing the genetic elements and consistent with the release (i.e., identified on this AG list; however, it genetically modified organisms does control vaccines, immunotoxins, exclusion) notes contained in the identified on this list, as well as Australia Group (AG) ‘‘Human and medical products, and diagnostic and vaccines containing the viruses, food testing kits that contain certain of Animal Pathogens and Toxins for bacteria, and toxins identified on this Export Control’’ common control list. these AG-listed items. list. The amendments contained in this DATES: This rule is effective January 7, Specifically, this rule amends Export final rule are intended to clarify the 2021. Control Classification Number (ECCN) scope of the vaccine controls described FOR FURTHER INFORMATION CONTACT: Dr. 1C991 on the Commerce Control List in ECCN 1C991. Prior to the effective Kimberly Orr, Chemical and Biological (CCL) to indicate that it includes date of this final rule, the control text Controls Division, Office of vaccines containing, or designed for use for vaccines described in ECCN 1C991.a Nonproliferation and Treaty against, any of the items identified in indicated that this ECCN controlled Compliance, Bureau of Industry and ECCN 1C351, 1C353 or 1C354. Prior to ‘‘vaccines against items controlled by Security, Telephone: (202) 482–4201, the effective date of this final rule, ECCN 1C351, 1C353 or 1C354.’’ The use Email: [email protected]. ECCN 1C991 indicated that it controlled of the term ‘‘against’’ in the control text SUPPLEMENTARY INFORMATION: The vaccines ‘‘against’’ such items, but was created some uncertainty concerning the Bureau of Industry and Security (BIS) is not specific about whether all vaccines extent to which ECCN 1C991.a applied amending the Export Administration ‘‘containing’’ such items were to vaccines that ‘‘contain’’ items Regulations (EAR) to clarify the scope of controlled, irrespective of whether the controlled by ECCN 1C351, 1C353 or

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1C354, but that act against agents (or ECCN 1C991.c (i.e., CB controls, in included only those vaccines designed other disease causing organisms) that addition to AT controls) and to clearly to protect against biological agents are not identified in any of these ECCNs. indicate that the CB controls that apply controlled under ECCN 1C351, 1C353 or This uncertainty caused some concern to most of the medical products 1C354 on the CCL. For example, the among manufacturers and exporters controlled under this ECCN do not vaccine for protection against was about the correct classification and apply to the medical products now previously (and continues to be) licensing policies for such vaccines. controlled under ECCN 1C991.d, which classified for control under ECCN The clarifications in this rule to the are subject only to AT controls (the 1C991, because Ebola, itself, is a scope of the vaccine controls in ECCN controls that apply to items in ECCN controlled biological agent. The Ebola 1C991.a are also in response to recent 1C991 are described in more detail, vaccine also contains genetic elements scientific and medical developments. below). A conforming amendment is for recombinant vesicular stomatitis For example, viruses controlled under made to § 742.2(a)(3) of the EAR to virus (VSV), a controlled virus, and a ECCN 1C351 (e.g., vesicular stomatitis reflect this change in paragraph common vector for vaccine virus, yellow fever virus, and Newcastle sequencing. development. disease virus) are being modified to This rule also makes a technical However, ECCN 1C991 did not express surface proteins of other target correction to the definition of ‘medical previously include vaccines containing organisms or cells for stimulating products’ in the ‘‘Related Definitions’’ controlled biological agents that were immune response to the surface protein, paragraph under the List of Items not also designed to protect against a thus acting as vaccines against those Controlled for ECCN 1C991 by adding controlled agent. Other VSV-based targets. These medical products can be the parenthetical phrase ‘‘(or vaccines against EAR99 agents (i.e., designed for the following purposes: (1) veterinary)’’ to the criterion describing agents not controlled on the CCL), such Vaccination against agents controlled by pharmaceutical formulations. The as SARS-CoV–2, were controlled to all ECCN 1C351 (e.g., or criterion, as corrected, reads as follows: destinations under ECCN 1C353, Chikungunya virus); (2) to protect ‘‘(1) pharmaceutical formulations because they did not act against a against uncontrolled agents; or (3) as designed for testing and human (or controlled agent as previously required oncolytic medical products for treating veterinary) administration in the by the ECCN 1C991 vaccine control text. specific cancers (oncolytic virotherapy treatment of medical conditions.’’ In This rule amends the vaccine controls is an emerging treatment that uses addition, the definition of in paragraph (a) of ECCN 1C991 to more replication competent viruses to destroy ‘immunotoxins’ in the ‘‘Related accurately reflect the scope of the AG cancers). Definitions’’ paragraph of ECCN 1C351 release note for vaccines, which This final rule addresses industry’s and ECCN 1C991 is clarified to read as exempts vaccines from control under concerns and the recent scientific and follows: ‘‘immunotoxins are monoclonal the AG List of Human and Animal medical developments described above antibodies linked to a toxin with the Pathogens and Toxins. Specifically, the by revising ECCN 1C991.a to read as intention of destroying a specific target AG release note exempts from control follows: ‘‘Vaccines containing, or cell while leaving adjacent cells intact.’’ all vaccines containing one or more of designed for use against, items This rule also adds a Technical Note the biological agents identified on this controlled by ECCN 1C351, 1C353 or at the beginning of the ‘‘Items’’ AG common control list. 1C354.’’ As a result of this change, paragraph in the List of Items Controlled Although certain COVID vaccines are ECCN 1C991.a now clearly indicates under ECCN 1C991 to clarify that, for not affected by this rule, the that it controls all vaccines that purposes of the controls described in development of an unknown number of ‘‘contain’’ items controlled by ECCN this ECCN, ‘toxins’ means those toxins, other vaccines, COVID and otherwise, is 1C351, 1C353 or 1C354, as well as those or their subunits, controlled under expected to be greatly facilitated as a vaccines that are designed for use ECCN 1C351.d. result of these amendments to the ‘‘against’’ these items. Note that all items controlled by vaccine controls in ECCN 1C991. This rule also amends ECCN 1C991 by ECCN 1C991, including the vaccines Effective with the publication of this expanding the scope of medical described in ECCN 1C991.a, require a rule, COVID vaccines containing genetic products controlled under this ECCN, license for AT reasons to the elements of items controlled by ECCN consistent with the release (i.e., destinations indicated under AT 1C353 (such as VSV) are now controlled exclusion) note for such products in the Column 1 on the Commerce Country under ECCN 1C991, instead of ECCN ‘‘List of Human and Animal Pathogens Chart in Supplement No. 1 to part 738 1C353. Consequently, instead of and Toxins for Export Control,’’ to of the EAR (also see the AT license requiring a license for export or reexport include medical products containing requirements described in part 742 of to all destinations, a license is required genetically modified organisms or the EAR that apply to Iran, North Korea, only to a much more limited number of genetic elements controlled under ECCN Sudan and Syria). In addition, the destinations (i.e., countries of concern 1C353.a.3. In addition, the control text medical products now controlled by for anti-terrorism (AT) reasons). for medical products in ECCN 1C991 is ECCN 1C991.c (as renumbered by this A specific example of the impact of renumbered by listing medical products rule) require a license for CB reasons, as this rule is a VSV–SARS-CoV–2 vaccine, that are subject to chemical/biological well as AT reasons, to the destinations which is a vesicular stomatitis virus (CB) controls, as well as anti-terrorism indicated under CB Column 3 and AT modified by adding the gene for the (AT) controls, under ECCN 1C991.c and Column 1, respectively, on the coronavirus spike protein. Because this listing medical products that are subject Commerce Country Chart. A license also vaccine acts against SARS-CoV–2, only to AT controls, under ECCN is required to certain destinations in which is not controlled under ECCN 1C991.d. Prior to the effective date of accordance with the embargoes and 1C351, it was not classified as an ECCN this final rule, the former were listed other special controls described in part 1C991 vaccine, prior to the publication under ECCN 1C991.d, while the latter 746 of the EAR. of this rule. Instead, it was controlled were listed under ECCN 1C991.c. This under ECCN 1C353, in spite of having change is intended to emphasize the Anticipated Impact of This Final Rule received FDA approval and being more stringent controls that apply to the Prior to the publication of this final packaged for patient use, because it medical products now described in rule, paragraph (a) of ECCN 1C991 contains genetic elements from VSV (a

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controlled virus). Consequently, this quantifying both costs and benefits and certain items affected by this rule). vaccine previously required a license to of reducing costs, harmonizing rules, Furthermore, consistent with the stated all destinations. Effective with the and promoting flexibility. This rule has purpose of the amendments to ECCN publication of this final rule, this been designated a ‘‘significant 1C991 (i.e., to enhance the national vaccine is now controlled under ECCN regulatory action,’’ although not security of the United States), this rule 1C991 and requires a license only to economically significant, under section meets the requirements set forth in the designated countries of concern for AT 3(f) of Executive Order 12866. April 5, 2017, Office of Management reasons. Accordingly, the rule has been reviewed and Budget (OMB) guidance by the Office of Management and implementing Executive Order 13771 Saving Clause Budget. (82 FR 9339, February 3, 2017), Shipments of items removed from The cost-benefit analysis required regarding what constitutes a regulation eligibility for export, reexport or transfer pursuant to Executive Orders 13563 and issued ‘‘with respect to a national (in-country) under a license exception 12866, as described below, indicates security function of the United States,’’ or without a license (i.e., under the that this rule is intended to improve and it is, therefore, exempt from the designator ‘‘NLR’’) as a result of this national security as its primary direct requirements of E.O. 13771. regulatory action that were on dock for benefit and that this benefit significantly 2. Notwithstanding any other loading, on lighter, laden aboard an outweighs the costs of this rule. provision of law, no person is required exporting carrier, or en route aboard a Specifically, implementation, in a to respond to, nor shall any person be carrier to a port of export, on January 7, timely manner, of the Australia Group subject to a penalty for failure to comply 2021, pursuant to actual orders for (AG) agreements described herein will with, a collection of information subject export, reexport or transfer (in-country) enhance the national security of the to the requirements of the Paperwork to a foreign destination, may proceed to United States by reducing the risk that Reduction Act of 1995 (44 U.S.C. 3501 that destination under the previously international trade involving dual-use et seq.) (PRA), unless that collection of applicable license exception or without chemical and biological items would information displays a currently valid a license (NLR) so long as they are contribute to the proliferation of OMB Control Number. This rule exported, reexported or transferred (in- chemical and biological weapons of contains the following collections of country) before March 8, 2021. Any mass destruction. The principal information subject to the requirements such items not actually exported, objective of AG participating countries of the PRA. These collections have been reexported or transferred (in-country) is to use licensing measures to ensure approved by OMB under control before midnight, on March 8, 2021, that exports of certain chemicals, numbers 0694–0088 (Simplified require a license in accordance with this biological agents, and dual-use chemical Network Application Processing regulation. and biological manufacturing facilities System) and 0694–0096 (Five Year ‘‘Deemed’’ exports of ‘‘technology’’ and equipment, do not contribute to the Records Retention Period). The and ‘‘source code’’ removed from proliferation of chemical and biological approved information collection under eligibility for export under a license weapons of mass destruction, which has OMB control number 0694–0088 exception or without a license (under been identified as a threat to domestic includes license applications, among the designator ‘‘NLR’’) as a result of this and international peace and security. other things, and carries a burden regulatory action may continue to be The AG achieves this objective by estimate of 29.6 minutes per manual or made under the previously available harmonizing participating countries’ electronic submission for a total burden license exception or without a license national export licensing measures. estimate of 31,833 hours. The approved (NLR) before March 8, 2021. Beginning These controls are essential, given that information collection under OMB at midnight on March 8, 2021, such the international chemical and control number 0694–0096 includes ‘‘technology’’ and ‘‘source code’’ may no biotechnology industries are a target for recordkeeping requirements and carries longer be released, without a license, to proliferators as a source of materials for a burden estimate of less than 1 minute a foreign national subject to the chemical and biological weapons per response for a total burden estimate ‘‘deemed’’ export controls in the EAR programs. of 248 hours. when a license would be required to the In calculating what costs (if any) will This rule contains minor clarifications home country of the foreign national in be imposed by this rule, BIS estimates to the EAR for certain vaccines accordance with this regulation. that 10 fewer license applications will controlled by ECCN 1C991.a for anti- need to be submitted to BIS, annually, terrorism (AT) reasons. Specifically, BIS Export Control Reform Act of 2018 as a result of the implementation of the expects the burden hours associated The Export Control Reform Act of amendments described in this rule (see with these collections will decrease by 2018 (ECRA), as amended, codified at Rulemaking Requirements #2, below). 5 hours and 6 minutes (i.e., 10 50 U.S.C. 4801–4852, serves as the By applying the cost-benefit analysis applications × 30.6 minutes per authority under which BIS issues this required under Executive Orders 13563 response) for a total estimated decrease rule. and 12866 to this rule, as described in cost of $153 (i.e., 5 hours and 6 herein, BIS has determined that the minutes × $30 per hour). The $30 per Rulemaking Requirements benefits of this rule (i.e., the hour cost estimate for OMB control 1. Executive Orders 13563 and 12866 enhancement of our national security numbers 0694–0088 and 0694–0096 is direct agencies to assess all costs and through the fulfillment our multilateral consistent with the salary data for benefits of available regulatory obligations as an AG participating export compliance specialists currently alternatives and, if regulation is country, together with the anticipated available through glassdoor.com necessary, to select regulatory reduction in the number of license (glassdoor.com estimates that an export approaches that maximize net benefits applications that would have to be compliance specialist makes $55,280 (including: Potential economic, submitted to export certain items annually, which computes to roughly environmental, public health and safety affected by this rule) significantly $26.58 per hour). Consequently, the effects; distributive impacts; and outweigh any potential costs (i.e., the burden hours associated with exports of equity). Executive Order 13563 incidental costs to exporters of adjusting the items affected by this rule will emphasizes the importance of their export control procedures for remain within the range of the existing

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estimates currently associated with ■ 2. In § 742.2, paragraph (a)(3) is License Requirement Notes: 1. All vaccines OMB control numbers 0694–0088 and revised to read as follows: and ‘immunotoxins’ are excluded from the 0694–0096. scope of this entry. Certain medical products Written comments and § 742.2 Proliferation of chemical and and diagnostic and food testing kits that biological weapons. recommendations for the information contain biological toxins controlled under (a) * * * paragraph (d) of this entry, with the collections referenced above should be exception of toxins controlled for CW reasons sent within 30 days of the publication (3) If CB Column 3 of the Country Chart (Supplement No. 1 to part 738 of under d.11 and d.12, are excluded from the of this final rule to: www.reginfo.gov/ scope of this entry. Vaccines, public/do/PRAMain. Find these the EAR) is indicated in the appropriate ECCN, a license is required to Country ‘immunotoxins,’ certain medical products, particular information collections by and diagnostic and food testing kits excluded Group D:3 (see Supplement No. 1 to part selecting ‘‘Currently under 30-day from the scope of this entry are controlled Review—Open for Public Comments’’ or 740 of the EAR) for medical products under ECCN 1C991. by using the search function. identified in ECCN 1C991.c. 2. For the purposes of this entry, only 3. This rule does not contain policies * * * * * saxitoxin is controlled under paragraph d.12; with Federalism implications as that other members of the paralytic shellfish PART 774—THE COMMERCE term is defined in Executive Order poison family (e.g., neosaxitoxin) are CONTROL LIST designated EAR99. 13132. 3. Clostridium perfringens strains, other 4. Pursuant to section 1762 of the ■ 3. The authority citation for 15 CFR than the epsilon toxin-producing strains of Export Control Reform Act of 2018 (50 part 774 continues to read as follows: Clostridium perfringens described in c.12, are U.S.C. Sec. 4821), this action is exempt excluded from the scope of this entry, since Authority: 50 U.S.C. 4801–4852; 50 U.S.C. from the Administrative Procedure Act they may be used as positive control cultures 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. for food testing and quality control. (APA) (5 U.S.C. 553) requirements for 8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 4. Unless specified elsewhere in this ECCN notice of proposed rulemaking, U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 1C351 (e.g., in License Requirement Notes 1– opportunity for public participation and 2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 3), this ECCN controls all biological agents delay in effective date. U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. and ‘‘toxins,’’ regardless of quantity or Because a notice of proposed 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. attenuation, that are identified in the List of rulemaking and an opportunity for 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783. Items Controlled for this ECCN, including public comment are not required to be small quantities or attenuated strains of given for this rule by the APA or any ■ 4. In Supplement No. 1 to part 774, select biological agents or ‘‘toxins’’ that are other law, the analytical requirements of Category 1, ECCN 1C351 is revised to excluded from the lists of select biological the Regulatory Flexibility Act (5 U.S.C. read as follows: agents or ‘‘toxins’’ by the Animal and Plant 601 et seq.) are not applicable. Health Inspection Service (APHIS), U.S. Accordingly, no regulatory flexibility Supplement No. 1 to Part 774—The Department of Agriculture (USDA), or the analysis is required, and none has been Commerce Control List Centers for Disease Control and Prevention prepared. * * * * * (CDC), U.S. Department of Health and 1C351 Human and animal pathogens and Human Services (HHS), in accordance with List of Subjects ‘‘toxins,’’ as follows (see List of Items their regulations in 9 CFR part 121 and 42 Controlled). CFR part 73, respectively. 15 CFR Part 742 5. Biological agents and pathogens are Exports, Terrorism. License Requirements controlled under this ECCN 1C351 when they Reason for Control: CB, CW, AT are an isolated live culture of a pathogen 15 CFR Part 774 agent, or a preparation of a toxin agent that Exports, Reporting and recordkeeping Country chart has been isolated or extracted from any requirements. Control(s) (see supp. No. 1 to source or material, including living material part 738) that has been deliberately inoculated or For the reasons stated in the contaminated with the agent. Isolated live preamble, parts 742 and 774 of the CB applies to entire CB Column 1. cultures of a pathogen agent include live Export Administration Regulations (15 entry. cultures in dormant form or in dried CFR parts 730–774) are amended as CW applies to 1C351.d.11 and d.12 and a preparations, whether the agent is natural, follows: license is required for CW reasons for all enhanced or modified. destinations, including Canada, as follows: List Based License Exceptions (See Part 740 PART 742—CONTROL POLICY—CCL CW applies to 1C351.d.11 for ricin in the for a Description of All License Exceptions) BASED CONTROLS form of (1) Ricinus communis AgglutininII (RCAII), also known as ricin D or Ricinus LVS: N/A ■ 1. The authority citation for 15 CFR Communis LectinIII (RCLIII) and (2) Ricinus GBS: N/A part 742 continues to read as follows: communis LectinIV (RCLIV), also known as Special Conditions for STA ricin E. CW applies to 1C351.d.12 for STA: (1) Paragraph (c)(1) of License Authority: 50 U.S.C. 4801–4852; 50 U.S.C. saxitoxin identified by C.A.S. #35523–89–8. Exception STA (§ 740.20(c)(1)) may be 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. See § 742.18 of the EAR for licensing 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 information pertaining to chemicals subject used for items in 1C351.d.1 through et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. to restriction pursuant to the Chemical 1C351.d.10 and 1C351.d.13 through 108–11, 117 Stat. 559; E.O. 12058, 43 FR Weapons Convention (CWC). The Commerce 1C351.d.18. See § 740.20(b)(2)(vi) for 20947, 3 CFR, 1978 Comp., p. 179; E.O. Country Chart is not designed to determine restrictions on the quantity of any one 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. licensing requirements for items controlled toxin that may be exported in a single 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 for CW reasons. shipment and the number of shipments Comp., p. 950; E.O. 13026, 61 FR 58767, 3 that may be made to any one end user in CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR Country chart a single calendar year. Also see the 44025, 3 CFR, 2001 Comp., p. 783; Control(s) (see supp. No. 1 to Automated Export System (AES) Presidential Determination 2003–23, 68 FR part 738) requirements in § 758.1(b)(4) of the EAR. 26459, 3 CFR, 2004 Comp., p. 320; Notice of (2) Paragraph (c)(2) of License Exception November 12, 2019, 84 FR 61817 (November AT applies to entire AT Column 1. STA (§ 740.20(c)(2) of the EAR) may not be 13, 2019). entry. used for any items in 1C351.

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List of Items Controlled a.18. Hendra virus (Equine morbillivirus); c.6. Burkholderia pseudomallei Related Controls: (1) Certain forms of ricin a.19. Japanese encephalitis virus; (Pseudomonas pseudomallei); and saxitoxin in 1C351.d.11. and d.12 are a.20. Junin virus; c.7. Chlamydia psittaci (Chlamydophila CWC Schedule 1 chemicals (see § 742.18 of a.21. Kyasanur Forest disease virus; psittaci); the EAR). The U.S. Government must a.22. Laguna Negra virus; c.8. Clostriduim argentinense (formerly known as Clostridium botulinum Type G), provide advance notification and annual a.23. Lassa virus; a.24. Louping ill virus; botulinum neurotoxin producing strains; reports to the OPCW of all exports of a.25. Lujo virus; c.9. Clostridium baratii, botulinum Schedule 1 chemicals. See § 745.1 of the a.26. Lumpy skin disease virus; neurotoxin producing strains; EAR for notification procedures. See 22 a.27. Lymphocytic choriomeningitis virus; c.10. Clostridium botulinum; CFR part 121, Category XIV and § 121.7 for a.28. Machupo virus; c.11. Clostridium butyricum, botulinum CWC Schedule 1 chemicals that are a.29. (includes all members neurotoxin producing strains; ‘‘subject to the ITAR.’’ (2) The Animal and of the Marburgvirus genus); c.12. Clostridium perfringens, epsilon Plant Health Inspection Service (APHIS), a.30. respiratory syndrome- toxin producing types; U.S. Department of Agriculture, and the related coronavirus (MERS-related c.13. Coxiella burnetii; Centers for Disease Control and Prevention coronavirus); c.14. Francisella tularensis; (CDC), U.S. Department of Health and a.31. Monkeypox virus; c.15. Mycoplasma capricolum subspecies Human Services, maintain controls on the a.32. Murray Valley encephalitis virus; capripneumoniae (‘‘strain F38’’); possession, use, and transfer within the a.33. Newcastle disease virus; c.16. Mycoplasma mycoides subspecies United States of certain items controlled by a.34. Nipah virus; mycoides SC (small colony) (a.k.a. contagious this ECCN (for APHIS, see 7 CFR 331.3(b), a.35. Omsk hemorrhagic fever virus; bovine pleuropneumonia); 9 CFR 121.3(b), and 9 CFR 121.4(b); for a.36. Oropouche virus; c.17. Rickettsia prowazekii; CDC, see 42 CFR 73.3(b) and 42 CFR a.37. Peste-des-petits ruminants virus; c.18. Salmonella enterica subspecies 73.4(b)). (3) See 22 CFR part 121, Category a.38. Porcine Teschovirus; enterica serovar Typhi (Salmonella typhi); XIV(b), for modified biological agents and a.39. Powassan virus; c.19. Shiga toxin producing Escherichia biologically derived substances that are a.40. Rabies virus and all other members of coli (STEC) of serogroups O26, O45, O103, ‘‘subject to the ITAR.’’ the Lyssavirus genus; O104, O111, O121, O145, O157, and other Related Definitions: For the purposes of this a.41. Reconstructed 1918 influenza virus; shiga toxin producing serogroups; entry, ‘immunotoxins’ are monoclonal Technical Note: 1C351.a.41 includes Note: Shiga toxin producing Escherichia antibodies linked to a toxin with the reconstructed replication competent forms of coli (STEC) includes, inter alia, intention of destroying a specific target cell the 1918 pandemic influenza virus enterohaemorrhagic E. coli (EHEC), verotoxin while leaving adjacent cells intact. containing any portion of the coding regions producing E. coli (VTEC) or verocytotoxin Items: of all eight gene segments. producing E. coli (VTEC). a. Viruses identified on the Australia a.42. Rift Valley fever virus; c.20. Shigella dysenteriae; Group (AG) ‘‘List of Human and Animal a.43. Rinderpest virus; c.21. Vibrio cholerae; or Pathogens and Toxins for Export Control,’’ as a.44. Rocio virus; c.22. Yersinia pestis. follows: a.45. Sabia virus; d. ‘‘Toxins’’ identified on the Australia a.1. African horse sickness virus; a.46. Seoul virus; Group (AG) ‘‘List of Human and Animal a.2. African swine fever virus; a.47. Severe acute respiratory syndrome- Pathogens and Toxins for Export Control,’’ as a.3. Andes virus; related coronavirus (SARS-related follows, or their subunits: a.4. Avian influenza (AI) viruses identified coronavirus); d.1. Abrin; as having high pathogenicity (HP), as follows: a.48. Sheeppox virus; d.2. Aflatoxins; a.4.a. AI viruses that have an intravenous a.49. Sin Nombre virus; d.3. Botulinum toxins; pathogenicity index (IVPI) in 6-week-old a.50. St. Louis encephalitis virus; d.4. Cholera toxin; chickens greater than 1.2; or a.51. Suid herpesvirus 1 (Pseudorabies d.5. Clostridium perfringens alpha, beta 1, a.4.b. AI viruses that cause at least 75% virus; Aujeszky’s disease); beta 2, epsilon and iota toxins; mortality in 4- to 8-week-old chickens a.52. Swine vesicular disease virus; d.6. Conotoxins; infected intravenously. a.53. Tick-borne encephalitis virus (Far d.7. Diacetoxyscirpenol; Note: Avian influenza (AI) viruses of the Eastern subtype, formerly known as Russian d.8. HT-2 toxin; H5 or H7 subtype that do not have either of Spring-Summer encephalitis virus—see d.9. Microcystins (Cyanginosins); the characteristics described in 1C351.a.4 1C351.b.3 for Siberian subtype); d.10. Modeccin; (specifically, 1C351.a.4.a or a.4.b) should be a.54. Variola virus; d.11. Ricin; sequenced to determine whether multiple a.55. Venezuelan equine encephalitis virus; d.12. Saxitoxin; basic amino acids are present at the cleavage a.56. Vesicular stomatitis virus; d.13. Shiga toxins (shiga-like toxins, site of the haemagglutinin molecule (HA0). If a.57. Western equine encephalitis virus; or verotoxins, and verocytotoxins); the amino acid motif is similar to that a.58. Yellow fever virus. d.14. Staphylococcus aureus enterotoxins, observed for other HPAI isolates, then the b. Viruses identified on the APHIS/CDC hemolysin alpha toxin, and toxic shock isolate being tested should be considered as ‘‘select agents’’ lists (see Related Controls syndrome toxin (formerly known as HPAI and the virus is controlled under paragraph #2 for this ECCN), but not Staphylococcus enterotoxin F); 1C351.a.4. identified on the Australia Group (AG) ‘‘List d.15. T-2 toxin; of Human and Animal Pathogens and Toxins d.16. Tetrodotoxin; a.5. Bluetongue virus; for Export Control,’’ as follows: a.6. Chapare virus; d.17. Viscumin (Viscum album lectin 1); or b.1. [Reserved]; d.18. Volkensin. a.7. Chikungunya virus; b.2. [Reserved]; or e. ‘‘Fungi’’, as follows: a.8. Choclo virus; b.3. Tick-borne encephalitis virus (Siberian e.1. Coccidioides immitis; or a.9. Classical swine fever virus (Hog subtype, formerly West Siberian virus—see e.2. Coccidioides posadasii. cholera virus); 1C351.a.53 for Far Eastern subtype). a.10. Crimean-Congo hemorrhagic fever c. Bacteria identified on the Australia ■ 5. In Supplement No. 1 to part 774, virus; Group (AG) ‘‘List of Human and Animal Category 1, ECCN 1C991 is revised to a.11. Dobrava-Belgrade virus; Pathogens and Toxins for Export Control,’’ as read as follows: a.12. Eastern equine encephalitis virus; follows: 1C991 Vaccines, immunotoxins, medical a.13. Ebolavirus (includes all members of c.1. Bacillus anthracis; products, diagnostic and food testing the Ebolavirus genus); c.2. Brucella abortus; kits, as follows (see List of Items a.14. Foot-and-mouth disease virus; c.3. Brucella melitensis; Controlled). a.15. Goatpox virus; c.4. Brucella suis; a.16. Guanarito virus; c.5. Burkholderia mallei (Pseudomonas License Requirements a.17. Hantaan virus; mallei); Reason for Control: CB, AT

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Country chart (see marketed as a medical (or veterinary) ACTION: Final rule. Control(s) supp. No. 1 to part product or for use in clinical trials, that is 738) intended to stimulate a protective SUMMARY: immunological response in humans or The Commodity Futures CB applies to CB Column 3. animals in order to prevent disease in Trading Commission (Commission) is 1C991.c. those to whom or to which it is adopting policies and procedures that AT applies to entire AT Column 1. administered. the Commission will follow with entry. Items: respect to granting exemptions from List Based License Exceptions (See Part 740 Technical Note: For purposes of the registration as a derivatives clearing for a Description of All License Exceptions) controls described in this ECCN, ‘toxins’ organization (DCO). In addition, the refers to those toxins, or their subunits, LVS: N/A controlled under ECCN 1C351.d. Commission is amending certain related GBS: N/A delegation provisions in its regulations. a. Vaccines containing, or designed for use List of Items Controlled against, items controlled by ECCN 1C351, DATES: Effective February 8, 2021. Related Controls: (1) Medical products 1C353 or 1C354. FOR FURTHER INFORMATION CONTACT: containing ricin or saxitoxin, as follows, b. Immunotoxins containing toxins are controlled for CW reasons under ECCN controlled by 1C351.d; Eileen A. Donovan, Deputy Director, 1C351: c. Medical products that contain any of the 202–418–5096, [email protected]; following: (a) Ricinus communis AgglutininII (RCAII), Parisa Nouri, Associate Director, 202– c.1. Toxins controlled by ECCN 1C351.d also known as ricin D, or Ricinus Communis (except for botulinum toxins controlled by 418–6620, [email protected]; Eileen R. LectinIII (RCLIII); ECCN 1C351.d.3, conotoxins controlled by Chotiner, Senior Compliance Analyst, (b) Ricinus communis LectinIV (RCLIV), ECCN 1C351.d.6, or items controlled for CW 202–418–5467, [email protected]; also known as ricin E; or reasons under ECCN 1C351.d.11 or .d.12); or (c) Saxitoxin identified by C.A.S. #35523– Brian Baum, Special Counsel, 202–418– c.2. Genetically modified organisms or 89–8. 5654, [email protected]; August A. genetic elements controlled by ECCN (2) The export of a ‘‘medical product’’ that Imholtz III, Special Counsel, 202–418– 1C353.a.3 (except for those that contain, or is an ‘‘Investigational New Drug’’ (IND), as code for, botulinum toxins controlled by 5140, [email protected]; Abigail S. defined in 21 CFR 312.3, is subject to certain ECCN 1C351.d.3 or conotoxins controlled by Knauff, Special Counsel, 202–418–5123, U.S. Food and Drug Administration (FDA) [email protected]; Division of Clearing requirements that are independent of the ECCN 1C351.d.6); export requirements specified in this ECCN d. Medical products not controlled by and Risk, Commodity Futures Trading or elsewhere in the EAR. These FDA 1C991.c that contain any of the following: Commission, Three Lafayette Centre, requirements are described in 21 CFR d.1. Botulinum toxins controlled by ECCN 1155 21st Street NW, Washington, DC 312.110 and must be satisfied in addition to 1C351.d.3; d.2. Conotoxins controlled by ECCN 20581; Theodore Z. Polley III, Associate any requirements specified in the EAR. Director, 312–596–0551, tpolley@ (3) Also see 21 CFR 314.410 for FDA 1C351.d.6; or requirements concerning exports of new d.3. Genetically modified organisms or cftc.gov; Division of Clearing and Risk, drugs and new drug substances. genetic elements controlled by ECCN Commodity Futures Trading 1C353.a.3 that contain, or code for, Related Definitions: For the purpose of this Commission, 525 West Monroe Street, botulinum toxins controlled by ECCN Chicago, Illinois 60661. entry, ‘immunotoxins’ are monoclonal 1C351.d.3 or conotoxins controlled by ECCN antibodies linked to a toxin with the 1C351.d.6; SUPPLEMENTARY INFORMATION: intention of destroying a specific target cell e. Diagnostic and food testing kits while leaving adjacent cells intact. For the containing toxins controlled by ECCN Table of Contents purpose of this entry, ‘medical products’ 1C351.d (except for items controlled for CW are: (1) Pharmaceutical formulations reasons under ECCN 1C351.d.11 or .d.12). I. Background designed for testing and human (or A. Introduction veterinary) administration in the treatment Matthew S. Borman, B. Existing Exempt DCO Orders of medical conditions, (2) prepackaged for Deputy Assistant Secretary for Export II. Amendments to Part 39 distribution as clinical or medical Administration. A. Regulation 39.1—Scope products, and (3) approved by the U.S. B. Regulation 39.2—Definitions Food and Drug Administration either to be [FR Doc. 2020–27754 Filed 1–6–21; 8:45 am] marketed as clinical or medical products or BILLING CODE 3510–33–P C. Regulation 39.6—Exemption From DCO for use as an ‘‘Investigational New Drug’’ Registration (IND) (see 21 CFR part 312). For the D. Regulation 39.9—Scope purpose of this entry, ‘diagnostic and food COMMODITY FUTURES TRADING III. Amendments to Part 140 testing kits’ are specifically developed, COMMISSION IV. Related Matters packaged and marketed for diagnostic or A. Regulatory Flexibility Act public health purposes. Biological toxins 17 CFR Parts 39 and 140 B. Paperwork Reduction Act in any other configuration, including bulk C. Cost-Benefit Considerations shipments, or for any other end-uses are RIN 3038–AE65 D. Antitrust Considerations controlled by ECCN 1C351. For the purpose of this entry, ‘vaccine’ is defined Exemption From Derivatives Clearing as a medicinal (or veterinary) product in a Organization Registration pharmaceutical formulation, approved by the U.S. Food and Drug Administration or AGENCY: Commodity Futures Trading the U.S. Department of Agriculture to be Commission.

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