Implementation of Australia Group Decisions From 2021 and 2022 Virtual Meetings: Controls on Marine Toxins, Plant Pathogens and Biological Equipment, 2507-2517 [2023-00397]

Download as PDF Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations (decreased from a 7-mile) radius of Pittsfield Penstone Municipal Airport, Pittsfield, IL; and updates the geographic coordinates of the airport to coincide with the FAA’s aeronautical database. This action is due to airspace reviews conducted as part of the decommissioning of the Quincy VOR, which provided navigation information for the instrument procedures at these airports, as part of the VOR MON Program. FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15. Regulatory Notices and Analyses The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389. 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11G, Airspace Designations and Reporting Points, dated August 19, 2022, and effective September 15, 2022, is amended as follows: ■ Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. * * * * * AGL IL E5 Mount Sterling, IL [Amended] Mount Sterling Municipal Airport, IL (Lat. 39°59′07″ N, long. 90°48′15″ W) That airspace extending upward from 700 feet above the surface within a 7.3-mile radius of Mount Sterling Municipal Airport. * * * * * AGL IL E5 Pittsfield, IL [Amended] Pittsfield Penstone Municipal Airport, IL (Lat. 39°38′20″ N, long. 90°46′43″ W) That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of the Pittsfield Penstone Airport. Issued in Fort Worth, Texas, on January 9, 2023. Martin A. Skinner, Acting Manager, Operations Support Group, ATO Central Service Center. [FR Doc. 2023–00495 Filed 1–13–23; 8:45 am] BILLING CODE 4910–13–P Environmental Review The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, ‘‘Environmental Impacts: Policies and Procedures,’’ paragraph 5–6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment. khammond on DSKJM1Z7X2PROD with RULES Lists of Subjects in 14 CFR 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment 18:47 Jan 13, 2023 Jkt 259001 Bureau of Industry and Security 15 CFR Parts 740, 742, and 774 [Docket No. 220909–0188] RIN 0694–AI21 Implementation of Australia Group Decisions From 2021 and 2022 Virtual Meetings: Controls on Marine Toxins, Plant Pathogens and Biological Equipment 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 reflect decisions SUMMARY: In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: VerDate Sep<11>2014 DEPARTMENT OF COMMERCE PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 2507 made at the November 2021 and March 2022 Australia Group (AG) Virtual Implementation Meetings and the AG Plenary Meeting held in July 2022. The amendments include revisions to certain Export Control Classification Numbers to clarify the controls on genetic elements and genetically modified organisms and the scope of the exclusion that applies to medical isolators ‘‘specially designed’’ for barrier nursing or transportation of infected patients; and makes clarifications by adding four naturally occurring, dualuse marine toxins (specifically, brevetoxins, gonyautoxins, nodularins and palytoxin) and removing cholera toxin. The addition of these four toxins is consistent with Section 1758 of the Export Control Reform Act of 2018 (ECRA) regarding emerging and foundational technologies. Finally, this rule also includes amendments to reflect the AG Plenary updates to the nomenclature of certain bacteria and fungi, and the clarification of the definition of ‘‘disinfected’’ as it applies to certain biological equipment. DATES: This rule is effective January 17, 2023. FOR FURTHER INFORMATION CONTACT: Dr. Tara Gonzalez, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: (202) 482–3343, Email: Tara.Gonzalez@bis.doc.gov. SUPPLEMENTARY INFORMATION: Background The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) (15 CFR parts 730–774) to reflect the decisions made at the November 2021 and March 2022 Australia Group (AG) Virtual Implementation Meetings and the AG Plenary Meeting held in Paris, France, from July 4 through July 8, 2022. The AG is a multilateral forum consisting of 42 participating countries and the European Union. These participants 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. At the November 2021 AG Virtual Implementation Meeting, the AG revised its ‘‘Control List of Dual-Use Biological Equipment and Related Technology and Software’’ to clarify the scope of the exclusion that applies to E:\FR\FM\17JAR1.SGM 17JAR1 2508 Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations medical isolators ‘‘specially designed’’ for barrier nursing or transportation of infected patients. Consistent with decisions made at the AG’s March 2022 Virtual Implementation Meeting, two AG common control lists (i.e., the list of ‘‘Human and Animal Pathogens and Toxins’’ and the ‘‘List of Plant Pathogens for Export Control’’) were updated to clarify that the controls on genetic elements and genetically modified organisms include, inter alia, any gene(s) or translated product(s) specific to any controlled virus. Previously, the control text for viral genetic elements referred only to the risk posed by the nucleic acid sequence itself, and not to transcribed or translated products. The AG also made changes to three of its common control lists to reflect the decisions made at its July 2022 Plenary Meeting. The AG revised its list of ‘‘Human and Animal Pathogens and Toxins’’ to add four naturally occurring, dual-use marine toxins (specifically, brevetoxins, gonyautoxins, nodularins and palytoxin) and remove cholera toxin. The AG also revised its ‘‘Control List of Dual-Use Biological Equipment and Related Technology and Software’’ by clarifying the definition of ‘‘disinfected’’ to more closely reflect the use of this term by the scientific and industrial communities. In addition, the AG revised its ‘‘List of Plant Pathogens for Export Control’’ to update the nomenclature for certain bacteria and fungi. I. EAR Changes Reflecting the November 2021 AG Virtual Implementation Meeting Decision khammond on DSKJM1Z7X2PROD with RULES Amendments to ECCN 2B352 Consistent with the decision made at the November 2021 AG Virtual Implementation Meeting, this rule amends ECCN 2B352 to reflect changes in the Notes to the AG controls on biocontainment chamber, isolators and biological safety cabinets described in the ‘‘Control List of Dual-Use Biological Equipment and Related Technology and Software.’’ Specifically, Note 2 to 2B352.g.2 is revised to clarify that this ECCN controls any isolator having all of the characteristics described in 2B352.g.2.a through g.2.d, regardless of its intended use and its designation, except for medical isolators ‘‘specially designed’’ for barrier nursing or transportation of infected patients. Additional amendments to this ECCN, which reflect decisions made at the July 2022 AG Plenary Meeting, are described later in the preamble of this rule. VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 Amendments to ECCN 1C351 This rule also makes conforming changes elsewhere in ECCN 1C351 to update references to certain toxins (i.e., in the CW Reason for Control paragraph, License Requirements Notes 1 and 2, the License Exception STA eligibility paragraph and the Related Controls paragraph). Similar conforming amendments to the Chemical Weapons Convention (CWC) and License Exception Strategic Trade Authorization (STA) provisions in the EAR are described below. As described in more detail below, BIS identified the synthesis and collection of the four marine toxins for evaluation according to the criteria in Section 1758 of the Export Control Reform Act of 2018 (ECRA), 50 U.S.C. 4801–4852, pertaining to emerging and foundational technologies. Other considerations prompted the decision to remove cholera toxin from the list of ‘‘Human and Animal Pathogens and Toxins.’’ At the time of its inclusion on this AG common control list, cholera toxin did not have any significant commercial or medical uses. However, in recent years, there has been a significant increase in biomedical research involving cholera toxins and in the use of cholera toxin in biomedical applications. Furthermore, cholera toxin, by itself (i.e., in the absence of live bacteria), is known to have limited cytotoxicity (e.g., compared to other toxins such as botulinum, saxitoxin, or ricin), and cannot be transmitted from person to person. Cholera toxin has not been the major focus of a biological weapons research program, although it may have been evaluated for such purposes. Consequently, the removal of chemical/biological (CB) controls on cholera toxins is not expected to have a significant impact on the proliferation, development, production or use of biological weapons, nor would the relative costs of such controls (e.g., in terms of their impact on public health and on biomedical and related research) be justified going forward. This final rule reflects the recent updates to the AG ‘‘Human and Animal Pathogens and Toxins’’ common control list, as described above, by amending ECCN 1C351 to add four marine toxins (brevetoxins, gonyautoxins, nodularins and palytoxin) and remove cholera toxin. Specifically, the four marine toxins are added in alphabetical order to ECCN 1C351.d, where they are controlled for chemical/biological (CB) and anti-terrorism (AT) reasons. Certain other toxins in this ECCN are renumbered, accordingly, to reflect the addition of the marine toxins and the removal of cholera toxin. Expansion of ECCN 1E001 Controls Although this rule does not amend ECCN 1E001 (which controls, inter alia, ‘‘technology’’ for the ‘‘development’’ or ‘‘production’’ of the human and animal pathogens and ‘‘toxins’’ described in ECCN 1C351), the heading of ECCN 1E001 indicates that, with limited exceptions, ECCN 1E001 controls ‘‘technology for the ‘‘development’’ or ‘‘production’’ of items listed under Category 1C of the CCL. Consequently, ECCN 1E001 now controls ‘‘technology’’ for the ‘‘development’’ or ‘‘production’’ of the four marine toxins that are being added to ECCN 1C351 by this rule. II. EAR Changes Reflecting the March 2022 AG Virtual Implementation Meeting Decision Amendments to Export Control Classification Number (ECCN) 1C353 Consistent with the decision made at the March 2022 AG Virtual Implementation Meeting, this rule amends paragraph a.1 of ECCN 1C353 on the Commerce Control List (CCL), in Supplement No. 1 to part 774 of the EAR, to clarify that the controls on genetic elements and genetically modified organisms include, inter alia, any gene(s) or translated product(s) specific to any controlled virus. Prior to the publication of this final rule, this ECCN did not explicitly state that its controls on viral genetic elements also included translated product(s) specific to any controlled virus. The control text in ECCN 1C353.a previously referred to transcribed or translated product(s) only with respect to bacterial and fungal genetic elements described in paragraph a.2.a. III. EAR Changes Reflecting the July 2022 AG Plenary Meeting Decisions Amendments to ECCN 1C350 This final rule amends ECCN 1C350, consistent with the July 2022 AG Plenary Meeting update to the ‘‘Export Control List: Chemical Weapons Precursors,’’ by adding a clarification to Technical Note 3 in this ECCN. This change is also consistent with a recommendation by the Organization for the Prohibition of Chemical Weapons (OPCW) to control all stereoisomers and isotopically-labeled forms of scheduled chemicals, even if they have different CAS 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).’’ PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations Other Conforming Amendments To Reflect the Reordering of Toxins in ECCN 1C351.d This rule amends § 740.20—License Exception Strategic Trade Authorization (STA) to make conforming changes to the ECCN 1C351.d references in paragraph (b)(2)(v) and paragraph (b)(2)(vi). Specifically, § 740.20(b)(2)(v) is amended to reference the exclusion of ECCN 1C351.d.14 and d.15 items from License Exception STA eligibility, consistent with the proposed renumbering of ricin and saxitoxin (which were previously controlled under ECCN 1C351.d.11 and d.12, respectively). Similarly, § 740.20(b)(2)(vi) is amended, consistent with the renumbering of the toxins in ECCN 1C351.d, by revising the references to the ECCN 1C351.d toxins that are authorized (with certain limitations) under License Exception STA to destinations indicated in Country Group A:5 (see Supplement No. 1 to part 740 of the EAR). This rule also makes conforming changes to § 742.18—Chemical Weapons Convention (CWC) and ECCN 1C991 (Vaccines, immunotoxins, medical products, diagnostic and food testing kits) to reflect the renumbering of the toxins in ECCN 1C351.d. Specifically, § 742.18(a)(1), (b)(1)(i), and (b)(1)(ii) and (iii) are amended to reference ECCN 1C351.d.14 and d.15, consistent with the renumbering of ricin and saxitoxin described above. In ECCN 1C991, 1C991.c.1 and .e are amended to make conforming changes to the references therein to ECCN 1C351 that are affected by the renumbering of the toxins in ECCN 1C351.d. None of the conforming amendments described above changes the scope of the controls in the affected EAR provisions. khammond on DSKJM1Z7X2PROD with RULES Amendments to ECCN 1C354 This final rule reflects the AG Plenary changes to the ‘‘List of Plant Pathogens for Export Control,’’ which updated the nomenclature for certain bacteria and fungi. Specifically, this rule amends ECCN 1C354.a by updating the nomenclature of the bacteria ‘‘Xanthomonas axonopodis pv. citri (Xanthomonas campestris pv. citri A) (Xanthomonas campestris pv. citri)’’ and ‘‘Clavibacter michiganensis subspecies sepedonicus (syn. Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum)’’ to read ‘‘Xanthomonas citri pv. citri (Xanthomonas axonopodis pv. citri, Xanthomonas campestris pv. citri)’’ and ‘‘Clavibacter michiganensis subsp. VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 sepedonicus, (Clavibacter sepedonicus, Clavibacter michiganense subsp. sepedonicus, Corynebacterium michiganensis subsp. sepedonicum, Corynebacterium sepedonicum),’’ respectively. In addition, ECCN 1C354.b is amended to update the nomenclature of the fungi ‘‘Cochliobolus miyabeanus (Helminthosporium oryzae)’’ and ‘‘Microcyclus ulei (syn. Dothidella ulei)’’ to read ‘‘Bipolaris oryzae (Cochliobolus miyabeanus, Helminthosporium oryzae)’’ and ‘‘Pseudocercospora ulei (Microcyclus ulei, Dothidella ulei),’’ respectively. To maintain the listing of these fungi in alphabetical order, ‘‘Bipolaris oryzae (Cochliobolus miyabeanus, Helminthosporium oryzae),’’ which was previously controlled under ECCN 1C354.b.2, is now controlled under ECCN 1C354.b.1 and ‘‘Colletotrichum kahawae (Colletotrichum coffeanum var. virulans),’’ which was previously controlled under ECCN 1C354.b.1, is now controlled under ECCN 1C354.b.2. Amendments to ECCN 2B352 In addition to the ECCN 2B352 amendments described above (see discussion of amendments per the November 2021 AG Virtual Implementation Meeting decision), this final rule amends ECCN 2B352 to reflect the recent updates to the AG ‘‘Control List of Dual-Use Biological Equipment and Related Technology and Software,’’ by revising the definition of ‘‘disinfected’’ to more closely reflect the use of this term by the scientific and industrial communities. Specifically, this rule amends the Technical Note following ECCN 2B352.d.2 by revising the definition of ‘‘disinfected’’ to indicate that this 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.’’ 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’’ (with ‘‘sanitization’’ referring to cleaning procedures designed to lower the microbial content of equipment without necessarily achieving elimination of all microbial infectivity or viability). Marine Toxins Identified for Evaluation Under Section 1758 of ECRA In advance of the 2022 AG Plenary meeting, BIS identified the synthesis and collection of the four marine toxins PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 2509 addressed in this final rule for evaluation according to the criteria in Section 1758 of ECRA, pertaining to emerging and foundational technologies. These marine toxins have the potential (through either accidental or deliberate release) 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, BIS determined that the absence of export controls on the toxins could be exploited for biological weapons purposes. Consistent with the emerging and foundational technologies notice and comment requirements in Section 1758(a)(2)(C) of ECRA (50 U.S.C. 4817(a)(2)(C)), BIS published a proposed rule on May 23, 2022 (87 FR 31195), to provide the public with notice and the opportunity to comment on its proposal to amend ECCN 1C351 on the CCL to add these marine toxins to ECCN 1C351. Comments Submitted in Response to BIS’s May 23 Proposed Rule BIS received comments from two respondents in response to the publication of its May 23 proposed rule. The comments from these respondents, together with BIS’s responses, are described below. Comment: One respondent indicated that clarification was needed concerning whether any of the four marine toxins proposed for control have an identified and specific biological synthesis pathway. In the respondent’s opinion, if this were the case, then certain genes or gene clusters may become subject to control as a result of imposing controls on the toxin. If not, then the respondent thought it unlikely that any genes or gene clusters would become subject to control as a consequence of controlling the toxin. BIS response: ECCN 1C353.a.3 controls any genetically modified organism that contains, or any genetic element that codes for, any toxins (or their subunits) controlled by 1C351.d. Genetically modified organisms and genetic elements are defined in Technical Notes 1 and 2, respectively, in ECCN 1C353. 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. BIS believes that the controls described in ECCN 1C353.a.3 are sufficiently clear E:\FR\FM\17JAR1.SGM 17JAR1 2510 Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES in this respect and, consequently, that no further clarification is necessary. Comment: Another respondent submitted comments that addressed COVID vaccines and treatments within the context of the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS). BIS response: These TRIPS-based comments were not responsive to the request for comments in BIS’s May 23 proposed rule, as they were focused almost exclusively on the potential relationship between intellectual property rights and the availability of COVID vaccines within various countries. Furthermore, the comments did not specifically address whether and, if so, how export controls would impact the availability of such vaccines in those countries. Consequently, these comments are not addressed in this final rule. Saving Clause Shipments of items removed from eligibility for export, reexport or transfer (in-country) under a license exception or without a license (i.e., under the designator ‘‘NLR’’) as a result of this regulatory action that were on dock for loading, on lighter, laden aboard an exporting carrier, or en route aboard a carrier to a port of export, on January 17, 2023, pursuant to actual orders for export, reexport or transfer (in-country) to a foreign destination, may proceed to that destination under the previously applicable license exception or without a license (NLR) so long as they are exported, reexported or transferred (incountry) before March 20, 2023. Any such items not actually exported, reexported or transferred (in-country) before midnight, on March 20, 2023, require a license in accordance with this regulation. ‘‘Deemed’’ exports of ‘‘technology’’ and ‘‘source code’’ removed from eligibility for export under a license exception or without a license (under the designator ‘‘NLR’’) as a result of this regulatory action may continue to be made under the previously available license exception or without a license (NLR) before March 20, 2023. Beginning at midnight on March 20, 2023, such ‘‘technology’’ and ‘‘source code’’ may no longer be released, without a license, to a foreign national subject to the ‘‘deemed’’ export controls in the EAR when a license would be required to the home country of the foreign national in accordance with this regulation. Export Control Reform Act of 2018 The Export Control Reform Act of 2018 (ECRA), as amended, codified at VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 50 U.S.C. 4801–4852, serves as the authority under which BIS issues this final rule. Rulemaking Requirements 1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including: potential economic, environmental, public health and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits and of reducing costs, harmonizing rules, and promoting flexibility. This final rule has been designated a ‘‘significant regulatory action,’’ although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this final rule has been reviewed by the Office of Management and Budget (OMB). 2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. Although this rule makes important changes to the EAR for items controlled for chemical/ biological reasons, BIS believes that the overall increases in burdens and costs associated with the following information collections due to this rule will be minimal: • OMB control number 0694–0088 (Simplified Network Application Processing System)—this collection includes license applications and carries a burden estimate of 29.4 minutes per manual or electronic submission; • OMB Control Number 0694–0096 (Five Year Records Retention Period)— this collection includes recordkeeping requirements and carries a burden estimate of less than 1 minute per response; • OMB Control Number 0607–0152 (Automated Export System (AES) Program)—this collection carries a burden hour estimate of 3 minutes per electronic submission and contains the Electronic Export Information (EEI) filing requirements under the Automated Export System (AES). Additional information regarding these collections of information, including all background materials, can be found at https://www.reginfo.gov/ PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 public/do/PRAMain and using the search function to enter either the title of the collection or the OMB Control Number. 3. This final rule does not contain policies with federalism implications as that term is defined in Executive Order 13132. 4. As stated in the preamble of this final rule, the amendments contained in this rule reflect decisions made at the Australia Group (AG) Plenary Meeting held in Paris, France, from July 4 through July 8, 2022. Therefore, pursuant to Section 1762 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. Sec. 4821), this action is exempt from the Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation and delay in effective date. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this final rule by the APA or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et seq.), are not applicable. Consistent with the emerging and foundational technologies notice and comment requirements in Section 1758(a)(2)(C) of ECRA (50 U.S.C. 4817(a)(2)(C)), BIS published a proposed rule on May 23, 2022 (87 FR 31195), to provide the public with notice and the opportunity to comment on its proposal to amend ECCN 1C351 on the Commerce Control List (CCL) to add four marine toxins (i.e., brevetoxins, gonyautoxins, nodularins and palytoxin) to ECCN 1C351, the synthesis and collection of which BIS had identified for evaluation according to the criteria in Section 1758 of the Export Control Reform Act of 2018 (ECRA) pertaining to emerging and foundational technologies. In addition, consistent with the Regulatory Flexibility Act, BIS prepared an initial regulatory flexibility analysis (IRFA) of the impact that the proposed rule, if adopted, would have on small businesses. The IRFA prepared by BIS requested comments on the analyses and conclusions contained therein, including the overall conclusion that the amendments in BIS’s May 23 proposed rule would not have a significant economic impact on a substantial number of small entities. BIS received comments from two respondents on its May 23 proposed rule—these comments and BIS’s responses are summarized in the preamble of this final rule. BIS did not E:\FR\FM\17JAR1.SGM 17JAR1 Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations receive any comments in response to the analyses and conclusions contained in the IRFA for its May 23 proposed rule. Accordingly, no regulatory flexibility analysis is required for this final rule, and none has been prepared. List of Subjects 15 CFR Part 740 Administrative practice and procedure, Exports Reporting and recordkeeping requirements, Terrorism. 15 CFR Part 742 Exports, Terrorism. 15 CFR Part 774 Exports, Reporting and recordkeeping requirements, Terrorism. For the reasons stated in the preamble, parts 740, 742, and 774 of the Export Administration Regulations (15 CFR parts 730–774) are amended as follows: PART 740—LICENSE EXCEPTIONS 1. The authority citation for part 740 continues to read as follows: Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783. 2. Section 740.20 is amended by revising paragraph (b)(2)(v) and paragraph (b)(2)(vi) introductory text to read as follows: ■ § 740.20 License Exception Strategic Trade Authorization (STA). khammond on DSKJM1Z7X2PROD with RULES * * * * (b) * * * (2) * * * (v) License Exception STA may not be used for any item controlled by ECCN 1C351.a, .b, .c, .d.14, .d.15 or .e, ECCNs 1C353, 1C354, 1E001 (i.e., for technology, as specified in ECCN 1E001, for items controlled by ECCN 1C351.a, .b, .c, .d.14, .d.15 or .e or ECCNs 1C353 or 1C354) or ECCN 1E351. (vi) Toxins controlled by ECCN 1C351.d.1 through 1C351.d.13 and 1C351.d.16 through 1C351.d.21 are authorized under License Exception STA to destinations indicated in Country Group A:5 (See supplement no. 1 to this part 740), subject to the following limits. For purposes of this paragraph (b)(2)(vi), all such toxins that are sent from one exporter, reexporter or transferor to a single end-user, on the same day, constitute one shipment. * * * * * VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 3. The authority citation for part 742 continues to read as follows: ■ Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108–11, 117 Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003–23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of November 10, 2021, 86 FR 62891 (November 12, 2021). 4. Section 742.18 is amended by revising paragraph (a)(1), paragraph (b)(1)(i) introductory text, and paragraphs (b)(1)(ii) and (iii) to read as follows: ■ § 742.18 Chemical Weapons Convention (CWC or Convention). * ■ * PART 742—CONTROL POLICY—CCL BASED CONTROLS * * * * (a) * * * (1) Schedule 1 chemicals and mixtures controlled under ECCN 1C351. A license is required for CW reasons to export or reexport Schedule 1 chemicals controlled under ECCN 1C351.d.14 or .d.15 to all destinations including Canada. CW applies to 1C351.d.14 for ricin in the form of Ricinus Communis AgglutininII (RCAII), which is also known as ricin D or Ricinus Communis LectinIII (RCLIII), and Ricinus Communis LectinIV (RCLIV), which is also known as ricin E. CW applies to 1C351.d.15 for saxitoxin identified by C.A.S. #35523–89–8. (Note that the advance notification procedures and annual reporting requirements described in § 745.1 of the EAR also apply to exports of Schedule 1 chemicals.) * * * * * (b) * * * (1) * * * (i) Exports to States Parties to the CWC. Applications to export Schedule 1 Chemicals controlled under ECCN 1C351.d.14 or .d.15 to States Parties to the CWC (destinations listed in supplement no. 2 to part 745 of the EAR) generally will be denied, unless all of the following conditions are met: * * * * * (ii) Exports to States not party to the CWC. Applications to export Schedule 1 chemicals controlled under ECCN 1C351.d.14 or .d.15 to States not Party to the CWC (destinations not listed in supplement no. 2 to part 745 of the EAR) generally will be denied, PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 2511 consistent with U.S. obligations under the CWC to prohibit exports of these chemicals to States not Party to the CWC. (iii) Reexports. Applications to reexport Schedule 1 chemicals controlled under ECCN 1C351.d.14 or .d.15 generally will be denied to all destinations (including both States Parties to the CWC and States not Party to the CWC). * * * * * PART 774—THE COMMERCE CONTROL LIST 5. The authority citation for part 774 continues to read as follows: ■ Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783. 6. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1, revise ECCNs 1C350, 1C351, 1C353, 1C354, 1C991, and 2B352 to read as follows: ■ Supplement No. 1 to Part 774—The Commerce Control List * * * * * 1C350 Chemicals that may be used as precursors for toxic chemical agents (see List of Items Controlled). License Requirements Reason for Control: CB, CW, AT Control(s) CB applies to entire entry. Country chart (See Supp. No. 1 to part 738) CB Column 2. CW applies to 1C350.b and .c. The Commerce Country Chart is not designed to determine licensing requirements for items controlled for CW reasons. A license is required, for CW reasons, to export or reexport Schedule 2 chemicals and mixtures identified in 1C350.b to States not Party to the CWC (destinations not listed in Supplement No. 2 to part 745 of the EAR). A license is required, for CW reasons, to export Schedule 3 chemicals and mixtures identified in 1C350.c to States not Party to the CWC, unless an End-Use Certificate issued by the government of the importing country has been obtained by the exporter prior to export. A license is required, for CW reasons, to reexport Schedule 3 chemicals and mixtures identified in 1C350.c from a State not Party to the CWC to any other State not Party to the CWC. (See § 742.18 of the EAR for license requirements and policies for toxic and precursor chemicals controlled for CW reasons. See § 745.2 of the EAR for EndUse Certificate requirements that apply to E:\FR\FM\17JAR1.SGM 17JAR1 2512 Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES exports of Schedule 3 chemicals to countries not listed in Supplement No. 2 to part 745 of the EAR.) AT applies to entire entry. The Commerce Country Chart is not designed to determine licensing requirements for items controlled for AT reasons in 1C350. A license is required, for AT reasons, to export or reexport items controlled by 1C350 to a country in Country Group E:1 of Supplement No. 1 to part 740 of the EAR. (See part 742 of the EAR for additional information on the AT controls that apply to Iran, North Korea, and Syria. See part 746 of the EAR for additional information on sanctions that apply to Iran, North Korea, and Syria.) License Requirement Notes 1. SAMPLE SHIPMENTS: Subject to the following requirements and restrictions, a license is not required for sample shipments when the cumulative total of these shipments does not exceed a 55-gallon container or 200 kg of a single chemical to any one consignee during a calendar year. A consignee that receives a sample shipment under this exclusion may not resell, transfer, or reexport the sample shipment, but may use the sample shipment for any other legal purpose unrelated to chemical weapons. a. Chemicals Not Eligible A. [Reserved] B. CWC Schedule 2 chemicals (States not Party to the CWC). No CWC Schedule 2 chemical or mixture identified in 1C350.b is eligible for sample shipment to States not Party to the CWC (destinations not listed in Supplement No. 2 to part 745 of the EAR) without a license. b. Countries Not Eligible: Countries in Country Group E:1 of Supplement No. 1 to part 740 of the EAR are not eligible to receive sample shipments of any chemicals controlled by this ECCN without a license. c. Sample shipments that require an EndUse Certificate for CW reasons: No CWC Schedule 3 chemical or mixture identified in 1C350.c is eligible for sample shipment to States not Party to the CWC (destinations not listed in Supplement No. 2 to part 745 of the EAR) without a license, unless an End-Use Certificate issued by the government of the importing country is obtained by the exporter prior to export (see § 745.2 of the EAR for End-Use Certificate requirements). d. Sample shipments that require a license for reasons set forth elsewhere in the EAR: Sample shipments, as described in this Note 1, may require a license for reasons set forth elsewhere in the EAR. See, in particular, the end-use/end-user restrictions in part 744 of the EAR, and the restrictions that apply to embargoed countries in part 746 of the EAR. e. Annual report requirement. The exporter is required to submit an annual written report for shipments of samples made under this Note 1. The report must be on company letterhead stationery (titled ‘‘Report of Sample Shipments of Chemical Precursors’’ at the top of the first page) and identify the chemical(s), Chemical Abstract Service Registry (C.A.S.) number(s), quantity(ies), the ultimate consignee’s name and address, and the date of export for all sample shipments that were made during the previous calendar year. The report must be submitted no later VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 than February 28 of the year following the calendar year in which the sample shipments were made, to: U.S. Department of Commerce, Bureau of Industry and Security, 14th Street and Pennsylvania Ave. NW, Room 2099B, Washington, DC 20230, Attn: ‘‘Report of Sample Shipments of Chemical Precursors.’’ 2. MIXTURES: a. Mixtures that contain precursor chemicals identified in ECCN 1C350, in concentrations that are below the levels indicated in 1C350.b through .d, are controlled by ECCN 1C395 or 1C995 and are subject to the licensing requirements specified in those ECCNs. b. A license is not required under this ECCN for a mixture, when the controlled chemical in the mixture is a normal ingredient in consumer goods packaged for retail sale for personal use. Such consumer goods are designated EAR99. However, a license may be required for reasons set forth elsewhere in the EAR. Note to Mixtures: Calculation of concentrations of AG-controlled chemicals: a. Exclusion. No chemical may be added to the mixture (solution) for the sole purpose of circumventing the Export Administration Regulations; b. Percent Weight Calculation. When calculating the percentage, by weight, of ingredients in a chemical mixture, include all ingredients of the mixture, including those that act as solvents. 3. COMPOUNDS. Compounds created with any chemicals identified in this ECCN 1C350 may be shipped NLR (No License Required), without obtaining an End-Use Certificate, unless those compounds are also identified in this entry or require a license for reasons set forth elsewhere in the EAR. 4. TESTING KITS: Certain medical, analytical, diagnostic, and food testing kits containing small quantities of chemicals identified in this ECCN 1C350, are excluded from the scope of this ECCN and are controlled under ECCN 1C395 or 1C995. (Note that replacement reagents for such kits are controlled by this ECCN 1C350 if the reagents contain one or more of the precursor chemicals identified in 1C350 in concentrations equal to or greater than the control levels for mixtures indicated in 1C350.) Technical Notes: 1. For purposes of this entry, a ‘‘mixture’’ is defined as a solid, liquid or gaseous product made up of two or more ingredients that do not react together under normal storage conditions. 2. The scope of this control applicable to Hydrogen Fluoride (see 1C350.d.14 in the List of Items Controlled) includes its liquid, gaseous, and aqueous phases, and hydrates. 3. Precursor chemicals in ECCN 1C350 are listed by name, Chemical Abstract Service (CAS) number and CWC Schedule (where applicable). Precursor chemicals of the same structural formula (e.g., hydrates, isotopically-labeled forms or all possible stereoisomers) are controlled by ECCN 1C350, regardless of name or CAS number. CAS numbers are shown to assist in identifying whether a particular precursor chemical or mixture is controlled under PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 ECCN 1C350, irrespective of nomenclature. However, CAS numbers cannot be used as unique identifiers in all situations because some forms of the listed precursor chemical have different CAS numbers, and mixtures containing a precursor chemical listed in ECCN 1C350 may also have different CAS numbers. List Based License Exceptions (See Part 740 for a Description of all License Exceptions) LVS: N/A GBS: N/A List of Items Controlled Related Controls: See USML Category XIV(c) for related chemicals ‘‘subject to the ITAR’’ (see 22 CFR parts 120 through 130). Related Definitions: See § 770.2(k) of the EAR for synonyms for the chemicals listed in this entry. Items: a. [Reserved] b. Australia Group-controlled precursor chemicals also identified as Schedule 2 chemicals under the CWC, as follows, and mixtures in which at least one of the following chemicals constitutes 30 percent or more of the weight of the mixture: b.1. (C.A.S. #7784–34–1) Arsenic trichloride; b.2. (C.A.S. #76–93–7) Benzilic acid; b.3. (C.A.S. #78–38–6) Diethyl ethylphosphonate; b.4. (C.A.S. #683–08–9) Diethyl methylphosphonate; b.5. (C.A.S. #15715–41–0) Diethyl methylphosphonite; b.6. (C.A.S. #2404–03–7) Diethyl-N,Ndimethylphosphoroamidate; b.7. (C.A.S. #41480–75–5) N,NDiisopropylaminoethanethiol hydrochloride; b.8. (C.A.S. #5842–07–9) N,N-Diisopropylbeta-aminoethane thiol; b.9. (C.A.S. #96–80–0) N,N-Diisopropylbeta-aminoethanol; b.10. (C.A.S. #96–79–7), N,N-Diisopropylbeta-aminoethyl chloride; b.11. (C.A.S. #4261–68–1) N,NDiisopropyl-beta-aminoethyl chloride hydrochloride; b.12. (C.A.S. #6163–75–3) Dimethyl ethylphosphonate; b.13. (C.A.S. #756–79–6) Dimethyl methylphosphonate; b.14. (C.A.S. #677–43–0) N,Ndimethylamino-phosphoryl dichloride; b.15. (C.A.S. #1498–40–4) Ethyl phosphonous dichloride [Ethyl phosphinyl dichloride]; b.16. (C.A.S. #430–78–4) Ethyl phosphonus difluoride [Ethyl phosphinyl difluoride]; b.17. (C.A.S. #1066–50–8) Ethyl phosphonyl dichloride; b.18. (C.A.S. #993–13–5) Methylphosphonic acid; b.19. (C.A.S. #676–98–2) Methylphosphonothioic dichloride. b.20. (C.A.S. #464–07–3) Pinacolyl alcohol; b.21. (C.A.S. #1619–34–7) 3-Quinuclidinol; b.22. (C.A.S. #111–48–8) Thiodiglycol. c. Australia Group-controlled precursor chemicals also identified as Schedule 3 chemicals under the CWC, as follows, and mixtures in which at least one of the following chemicals constitutes 30 percent or more of the weight of the mixture: E:\FR\FM\17JAR1.SGM 17JAR1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations c.1. (C.A.S. #762–04–9) Diethyl phosphite; c.2. (C.A.S. #868–85–9) Dimethyl phosphite (dimethyl hydrogen phosphite); c.3. (C.A.S. #139–87–7) Ethyldiethanolamine; c.4. (C.A.S. #10025–87–3) Phosphorus oxychloride; c.5. (C.A.S. #10026–13–8) Phosphorus pentachloride; c.6. (C.A.S. #7719–12–2) Phosphorus trichloride; c.7. (C.A.S. #10545–99–0) Sulfur dichloride; c.8. (C.A.S. #10025–67–9) Sulfur monochloride; c.9. (C.A.S. #7719–09–7) Thionyl chloride; c.10. (C.A.S. #102–71–6) Triethanolamine; c.11. (C.A.S. #122–52–1) Triethyl phosphite; c.12. (C.A.S. #121–45–9) Trimethyl phosphite. d. Other Australia Group-controlled precursor chemicals not also identified as Schedule 1, 2, or 3 chemicals under the CWC, as follows, and mixtures in which at least one of the following chemicals constitutes 30 percent or more of the weight of the mixture: d.1. (C.A.S. #1341–49–7) Ammonium hydrogen fluoride; d.2. (C.A.S. #107–07–3) 2-Chloroethanol; d.3. (C.A.S. #109–89–7) Diethylamine; d.4. (C.A.S. #100–37–8) N,NDiethylaminoethanol; d.5. (C.A.S. #589–57–1) Diethyl chlorophosphite; d.6. (C.A.S. #298–06–6) O,O-Diethyl phosphorodithioate; d.7. (C.A.S. #2465–65–8) O,O-Diethyl phosphorothioate; d.8. (C.A.S. #108–18–9) Di-isopropylamine; d.9. (C.A.S. #124–40–3) Dimethylamine; d.10. (C.A.S. #506–59–2) Dimethylamine hydrochloride; d.11. (C.A.S. #762–77–6) Ethyl chlorofluorophosphate; d.12. (C.A.S. #1498–51–7) Ethyl dichlorophosphate; d.13. (C.A.S. #460–52–6) Ethyl difluorophosphate; d.14. (C.A.S. #7664–39–3) Hydrogen fluoride; d.15. (C.A.S. #3554–74–3) 3-Hydroxyl-1methylpiperidine; d.16. (C.A.S. #76–89–1) Methyl benzilate; d.17. (C.A.S. #754–01–8) Methyl chlorofluorophosphate; d.18. (C.A.S. #677–24–7) Methyl dichlorophosphate; d.19. (C.A.S. #22382–13–4) Methyl difluorophosphate; d.20. (C.A.S. #14277–06–6) N,N Diethylacetamidine; d.21. (C.A.S. #53510–30–8) N,NDiethylbutanamidine; d.22. (C.A.S. #90324–67–7) N,NDiethylformamidine; d.23. (C.A.S. #1342789–47–2) N,N Diethylisobutanamidine; d.24. (C.A.S. #84764–73–8) N,NDiethylpropanamidine; d.25. (C.A.S. #1315467–17–4) N,NDiisopropylbutanamidine; d.26. (C.A.S. #857522–08–8) N,NDiisopropylformamidine; d.27. (C.A.S. #2909–14–0) N,NDimethylacetamidine; VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 d.28. (C.A.S. #1340437–35–5) N,NDimethylbutanamidine; d.29. (C.A.S. #44205–42–7) N,NDimethylformamidine; d.30. (C.A.S. #321881–25–8) N,NDimethylisobutanamidine; d.31. (C.A.S. #56776–14–8) N,NDimethylpropanamidine; d.32. (C.A.S. #1339586–99–0) N,NDipropylacetamidine; d.33. C.A.S. #1342422–35–8) N,NDipropylbutanamidine; d.34. (C.A.S. #48044–20–8) N,NDipropylformamidine; d.35. (C.A.S. #1342700–45–1) N,NDipropylisobutanamidine; d.36. (C.A.S. #1341496–89–6) N,NDipropylpropanamidine; d.37. (C.A.S. #1314–80–3) Phosphorus pentasulfide; d.38. (C.A.S. #75–97–8) Pinacolone; d.39. (C.A.S. #7789–29–9) Potassium bifluoride; d.40. (C.A.S. #151–50–8) Potassium cyanide; d.41. (C.A.S. #7789–23–3) Potassium fluoride; d.42. (C.A.S. #3731–38–2) 3-Quinuclidone; d.43. (C.A.S. #1333–83–1) Sodium bifluoride; d.44. (C.A.S. #143–33–9) Sodium cyanide; d.45. (C.A.S. #7681–49–4) Sodium fluoride; d.46. (C.A.S. #16893–85–9) Sodium hexafluorosilicate; d.47. (C.A.S. #1313–82–2) Sodium sulfide; d.48. (C.A.S. #637–39–8) Triethanolamine hydrochloride; d.49. (C.A.S. #116–17–6) Tri-isopropyl phosphite. 1C351 Human and animal pathogens and ‘‘toxins,’’ as follows (see List of Items Controlled). License Requirements Reason for Control: CB, CW, AT Control(s) CB applies to entire entry. Country chart (See Supp. No. 1 to part 738) CB Column 1. CW applies to 1C351.d.14 and .d.15 and a license is required for CW reasons for all destinations, including Canada, as follows: CW applies to 1C351.d.14 for ricin in the form of (1) Ricinus communis AgglutininII (RCAII), also known as ricin D or Ricinus Communis LectinIII (RCLIII) and (2) Ricinus communis LectinIV (RCLIV), also known as ricin E. CW applies to 1C351.d.15 for saxitoxin identified by C.A.S. #35523–89–8. See § 742.18 of the EAR for licensing information pertaining to chemicals subject to restriction pursuant to the Chemical Weapons Convention (CWC). The Commerce Country Chart is not designed to determine licensing requirements for items controlled for CW reasons. Control(s) AT applies to entire entry. PO 00000 Frm 00013 Fmt 4700 Country chart (See Supp. No. 1 to part 738) AT Column 1. Sfmt 4700 2513 License Requirement Notes: 1. All vaccines and ‘immunotoxins’ are excluded from the scope of this entry. Certain medical products and diagnostic and food testing kits that contain biological toxins controlled under 1C351.d, with the exception of toxins controlled for CW reasons under 1C351.d.14 or .d.15, are excluded from the scope of this entry. Vaccines, ‘immunotoxins,’ certain medical products, and diagnostic and food testing kits excluded from the scope of this entry are controlled under ECCN 1C991. 2. For the purposes of this entry, only saxitoxin is controlled under 1C351.d.15; other members of the paralytic shellfish poison family (e.g., neosaxitoxin) are designated EAR99. 3. Clostridium perfringens strains, other than the epsilon toxin-producing strains of Clostridium perfringens described in 1C351.c.12, are excluded from the scope of this entry, since they may be used as positive control cultures for food testing and quality control. 4. Unless specified elsewhere in this ECCN 1C351 (e.g., in License Requirement Notes 1– 3), this ECCN controls all biological agents and ‘‘toxins,’’ regardless of quantity or attenuation, that are identified in the List of Items Controlled for this ECCN, including small quantities or attenuated strains of select biological agents or ‘‘toxins’’ that are excluded from the lists of select biological agents or ‘‘toxins’’ by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture (USDA), or the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS), in accordance with their regulations in 9 CFR part 121 and 42 CFR part 73, respectively. 5. Biological agents and pathogens are controlled under this ECCN 1C351 when they are an isolated live culture of a pathogen agent, or a preparation of a toxin agent that has been isolated or extracted from any source or material, including living material that has been deliberately inoculated or contaminated with the agent. Isolated live cultures of a pathogen agent include live cultures in dormant form or in dried preparations, whether the agent is natural, enhanced or modified. List Based License Exceptions (See Part 740 for a Description of All License Exceptions) LVS: N/A GBS: N/A Special Conditions for STA STA: (1) Paragraph (c)(1) of License Exception STA (§ 740.20(c)(1)) may be used for items in 1C351.d.1 through 1C351.d.13 and 1C351.d.16 through 1C351.d.21. See § 740.20(b)(2)(vi) for restrictions on the quantity of any one toxin that may be exported in a single shipment and the number of shipments that may be made to any one end user in a single calendar year. Also see the Automated Export System (AES) requirements in § 758.1(b)(4) of the EAR. (2) Paragraph (c)(2) of License Exception STA (§ 740.20(c)(2) of the EAR) may not be used for any items in 1C351. E:\FR\FM\17JAR1.SGM 17JAR1 khammond on DSKJM1Z7X2PROD with RULES 2514 Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations List of Items Controlled Related Controls: (1) Certain forms of ricin and saxitoxin in 1C351.d.14 and .d.15 are CWC Schedule 1 chemicals (see § 742.18 of the EAR). The U.S. Government must provide advance notification and annual reports to the OPCW of all exports of Schedule 1 chemicals. See § 745.1 of the EAR for notification procedures. See 22 CFR part 121, Category XIV and § 121.7 for CWC Schedule 1 chemicals that are ‘‘subject to the ITAR.’’ (2) The Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, and the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, maintain controls on the possession, use, and transfer within the United States of certain items controlled by this ECCN (for APHIS, see 7 CFR 331.3(b), 9 CFR 121.3(b), and 9 CFR 121.4(b); for CDC, see 42 CFR 73.3(b) and 42 CFR 73.4(b)). (3) See 22 CFR part 121, Category XIV(b), for modified biological agents and biologically derived substances that are ‘‘subject to the ITAR.’’ Related Definitions: For the purposes of this entry, ‘immunotoxins’ are monoclonal antibodies linked to a toxin with the intention of destroying a specific target cell while leaving adjacent cells intact. Items: a. Viruses identified on the Australia Group (AG) ‘‘List of Human and Animal Pathogens and Toxins for Export Control,’’ as follows: a.1. African horse sickness virus; a.2. African swine fever virus; a.3. Andes virus; a.4. Avian influenza (AI) viruses identified as having high pathogenicity (HP), as follows: a.4.a. AI viruses that have an intravenous pathogenicity index (IVPI) in 6-week-old chickens greater than 1.2; or a.4.b. AI viruses that cause at least 75% mortality in 4- to 8-week-old chickens infected intravenously. Note: Avian influenza (AI) viruses of the H5 or H7 subtype that do not have either of the characteristics described in 1C351.a.4 (specifically, 1C351.a.4.a or .a.4.b) should be sequenced to determine whether multiple basic amino acids are present at the cleavage site of the haemagglutinin molecule (HA0). If the amino acid motif is similar to that observed for other HPAI isolates, then the isolate being tested should be considered as HPAI and the virus is controlled under 1C351.a.4. a.5. Bluetongue virus; a.6. Chapare virus; a.7. Chikungunya virus; a.8. Choclo virus; a.9. Classical swine fever virus (Hog cholera virus); a.10. Crimean-Congo hemorrhagic fever virus; a.11. Dobrava-Belgrade virus; a.12. Eastern equine encephalitis virus; a.13. Ebolavirus (includes all members of the Ebolavirus genus); a.14. Foot-and-mouth disease virus; a.15. Goatpox virus; a.16. Guanarito virus; a.17. Hantaan virus; a.18. Hendra virus (Equine morbillivirus); VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 a.19. Japanese encephalitis virus; a.20. Junin virus; a.21. Kyasanur Forest disease virus; a.22. Laguna Negra virus; a.23. Lassa virus; a.24. Louping ill virus; a.25. Lujo virus; a.26. Lumpy skin disease virus; a.27. Lymphocytic choriomeningitis virus; a.28. Machupo virus; a.29. Marburgvirus (includes all members of the Marburgvirus genus); a.30. Middle East respiratory syndromerelated coronavirus (MERS-related coronavirus); a.31. Monkeypox virus; a.32. Murray Valley encephalitis virus; a.33. Newcastle disease virus; a.34. Nipah virus; a.35. Omsk hemorrhagic fever virus; a.36. Oropouche virus; a.37. Peste-des-petits ruminants virus; a.38. Porcine Teschovirus; a.39. Powassan virus; a.40. Rabies virus and all other members of the Lyssavirus genus; a.41. Reconstructed 1918 influenza virus; Technical Note: 1C351.a.41 includes reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments. a.42. Rift Valley fever virus; a.43. Rinderpest virus; a.44. Rocio virus; a.45. Sabia virus; a.46. Seoul virus; a.47. Severe acute respiratory syndromerelated coronavirus (SARS-related coronavirus); a.48. Sheeppox virus; a.49. Sin Nombre virus; a.50. St. Louis encephalitis virus; a.51. Suid herpesvirus 1 (Pseudorabies virus; Aujeszky’s disease); a.52. Swine vesicular disease virus; a.53. Tick-borne encephalitis virus (Far Eastern subtype, formerly known as Russian Spring–Summer encephalitis virus—see 1C351.b.3 for Siberian subtype); a.54. Variola virus; a.55. Venezuelan equine encephalitis virus; a.56. Vesicular stomatitis virus; a.57. Western equine encephalitis virus; or a.58. Yellow fever virus. b. Viruses identified on the APHIS/CDC ‘‘select agents’’ lists (see Related Controls paragraph #2 for this ECCN), but not identified on the Australia Group (AG) ‘‘List of Human and Animal Pathogens and Toxins for Export Control,’’ as follows: b.1. [Reserved]; b.2. [Reserved]; or b.3. Tick-borne encephalitis virus (Siberian subtype, formerly West Siberian virus—see 1C351.a.53 for Far Eastern subtype). c. Bacteria identified on the Australia Group (AG) ‘‘List of Human and Animal Pathogens and Toxins for Export Control,’’ as follows: c.1. Bacillus anthracis; c.2. Brucella abortus; c.3. Brucella melitensis; c.4. Brucella suis; c.5. Burkholderia mallei (Pseudomonas mallei); PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 c.6. Burkholderia pseudomallei (Pseudomonas pseudomallei); c.7. Chlamydia psittaci (Chlamydophila psittaci); c.8. Clostriduim argentinense (formerly known as Clostridium botulinum Type G), botulinum neurotoxin producing strains; c.9. Clostridium baratii, botulinum neurotoxin producing strains; c.10. Clostridium botulinum; c.11. Clostridium butyricum, botulinum neurotoxin producing strains; c.12. Clostridium perfringens, epsilon toxin producing types; c.13. Coxiella burnetii; c.14. Francisella tularensis; c.15. Mycoplasma capricolum subspecies capripneumoniae (‘‘strain F38’’); c.16. Mycoplasma mycoides subspecies mycoides SC (small colony) (a.k.a. contagious bovine pleuropneumonia); c.17. Rickettsia prowazekii; c.18. Salmonella enterica subspecies enterica serovar Typhi (Salmonella typhi); c.19. Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups; Note: Shiga toxin producing Escherichia coli (STEC) includes, inter alia, enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) or verocytotoxin producing E. coli (VTEC). c.20. Shigella dysenteriae; c.21. Vibrio cholerae; or c.22. Yersinia pestis. d. ‘‘Toxins’’ identified on the Australia Group (AG) ‘‘List of Human and Animal Pathogens and Toxins for Export Control,’’ as follows, or their subunits: d.1. Abrin; d.2. Aflatoxins; d.3. Botulinum toxins; d.4. Brevetoxins; d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and iota toxins; d.6. Conotoxins; d.7. Diacetoxyscirpenol; d.8. Gonyautoxins; d.9. HT–2 toxin; d.10. Microcystins (Cyanginosins); d.11. Modeccin; d.12. Nodularins; d.13. Palytoxin; d.14. Ricin; d.15. Saxitoxin; d.16. Shiga toxins (shiga-like toxins, verotoxins, and verocytotoxins); d.17. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known as Staphylococcus enterotoxin F); d.18. T–2 toxin; d.19. Tetrodotoxin; d.20. Viscumin (Viscum album lectin 1); or d.21. Volkensin. e. ‘‘Fungi’’, as follows: e.1. Coccidioides immitis; or e.2. Coccidioides posadasii. * * * * * 1C353 Genetic elements and genetically modified organisms, as follows (see List of Items Controlled). License Requirements Reason for Control: CB, AT E:\FR\FM\17JAR1.SGM 17JAR1 Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations Control(s) CB applies to entire entry. AT applies to entire entry. Country chart (See Supp. No. 1 to part 738) CB Column 1. AT Column 1. License Requirements Notes: 1. Vaccines that contain genetic elements or genetically modified organisms identified in this ECCN are controlled by ECCN 1C991. 2. Unless specified elsewhere in this ECCN 1C353 (e.g., in License Requirement Note 1), this ECCN controls genetic elements or genetically modified organisms for all biological agents and ‘‘toxins,’’ regardless of quantity or attenuation, that are identified in the List of Items Controlled for this ECCN, including genetic elements or genetically modified organisms for attenuated strains of select biological agents or ‘‘toxins’’ that are excluded from the lists of select biological agents or ‘‘toxins’’ by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, or the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, in accordance with the APHIS regulations in 7 CFR part 331 and 9 CFR part 121 and the CDC regulations in 42 CFR part 73. List Based License Exceptions (See Part 740 for a Description of All License Exceptions) LVS: N/A GBS: N/A khammond on DSKJM1Z7X2PROD with RULES List of Items Controlled Related Controls: (1) The Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, and the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, maintain controls on the possession, use, and transfer within the United States of certain items controlled by this ECCN, including (but not limited to) certain genetic elements, recombinant nucleic acids, and recombinant organisms associated with the agents or toxins in ECCN 1C351 or 1C354 (for APHIS, see 7 CFR 331.3(c), 9 CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see 42 CFR 73.3(c) and 42 CFR 73.4(c)). (2) See 22 CFR part 121, Category XIV(b), for modified biological agents and biologically derived substances that are subject to the export licensing jurisdiction of the U.S. Department of State, Directorate of Defense Trade Controls. Related Definition: N/A Items: a. Any genetically modified organism that contains, or any genetic element that codes for, any of the following: a.1. Any gene, genes, translated product or translated products specific to any virus controlled by 1C351.a or .b or 1C354.c; a.2. Any gene or genes specific to any bacterium controlled by 1C351.c or 1C354.a, or any fungus controlled by 1C351.e or 1C354.b, and which; a.2.a. In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 a.2.b. Could endow or enhance pathogenicity; or a.3. Any toxins, or their subunits, controlled by 1C351.d. b. [Reserved]. Technical Notes: 1. Genetically modified organisms include organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation. 2. ‘‘Genetic elements’’ include, inter alia, chromosomes, genomes, plasmids, transposons, vectors, and inactivated organisms containing recoverable nucleic acid fragments, whether genetically modified or unmodified, or chemically synthesized in whole or in part. For the purposes of this ECCN 1C353, nucleic acids from an inactivated organism, virus, or sample are considered to be ‘recoverable’ if the inactivation and preparation of the material is intended or known to facilitate isolation, purification, amplification, detection, or identification of nucleic acids. 3. This ECCN does not control nucleic acid sequences of shiga toxin producing Escherichia coli of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups, other than those genetic elements coding for shiga toxin, or for its subunits. 4. ‘Endow or enhance pathogenicity’ is defined as when the insertion or integration of the nucleic acid sequence or sequences is/ are likely to enable or increase a recipient organism’s ability to be used to deliberately cause disease or death. This might include alterations to, inter alia: virulence, transmissibility, stability, route of infection, host range, reproducibility, ability to evade or suppress host immunity, resistance to medical countermeasures, or detectability. 1C354 Plant pathogens, as follows (see List of Items Controlled). License Requirements Reason for Control: CB, AT Control(s) CB applies to entire entry. AT applies to entire entry. Country chart (See Supp. No. 1 to part 738) CB Column 1. AT Column 1. License Requirements Notes 1. All vaccines are excluded from the scope of this ECCN. See ECCN 1C991 for vaccines. 2. Unless specified elsewhere in this ECCN 1C354 (e.g., in License Requirement Note 1), this ECCN controls all biological agents, regardless of quantity or attenuation, that are identified in the List of Items Controlled for this ECCN, including small quantities or attenuated strains of select biological agents that are excluded from the list of PPQ select agents and ‘‘toxins’’ by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, in accordance with their regulations in 7 CFR part 331. List Based License Exceptions (See Part 740 for a Description of All License Exceptions) LVS: N/A GBS: N/A PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 2515 List of Items Controlled Related Controls: (1) The Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, maintains controls on the possession, use, and transfer within the United States of certain items controlled by this ECCN (see 7 CFR 331.3(c), 9 CFR 121.3(c), and 9 CFR 121.4(c)). (2) See 22 CFR part 121, Category XIV(b), for modified biological agents and biologically derived substances that are subject to the export licensing jurisdiction of the U.S. Department of State, Directorate of Defense Trade Controls. Related Definitions: N/A Items: a. Bacteria, as follows: a.1. Xanthomonas albilineans; a.2. Xanthomonas citri pv. citri (Xanthomonas axonopodis pv. citri, Xanthomonas campestris pv. citri); a.3. Xanthomonas oryzae [this species of proteobacteria is identified on the APHIS ‘‘select agents’’ list (see Related Controls paragraph for this ECCN), but only the pathovar Xanthomonas oryzae pv. oryzae (syn. Pseudomonas campestris pv. oryzae) is identified on the Australia Group (AG) ‘‘List of Plant Pathogens for Export Control’’]; a.4. Clavibacter michiganensis subsp. sepedonicus (Clavibacter sepedonicus, Clavibacter michiganense subsp. sepedonicus, Corynebacterium michiganensis subsp. sepedonicum, Corynebacterium sepedonicum); a.5. Ralstonia solanacearum, race 3, biovar 2; a.6. Raythayibactor toxicus [this bacterium is identified on the APHIS ‘‘select agents’’ list (see the Related Controls paragraph for this ECCN), but is not identified on the Australia Group (AG) ‘‘List of Plant Pathogens for Export Control’’]. b. Fungi, as follows: b.1. Bipolaris oryzae (Cochliobolus miyabeanus, Helminthosporium oryzae); b.2. Colletotrichum kahawae (Colletotrichum coffeanum var. virulans); b.3. Pseudocercospora ulei (Microcyclus ulei, Dothidella ulei); b.4. Puccinnia graminis ssp. graminis var. graminis/Puccinia graminis ssp. graminis var. stakmanii (Puccinia graminis [syn. Puccinia graminis f. sp. tritici]); b.5. Puccinia striiformis (syn. Puccinia glumarum); b.6. Magnaporthe oryzae (Pyricularia oryzae); b.7. Peronosclerospora philippinensis (Peronosclerospora sacchari); b.8. Sclerophthora rayssiae var. zeae; b.9. Synchytrium endobioticum; b.10. Tilletia indica; b.11. Thecaphora solani; b.12. Phoma glycinicola (formerly Pyrenochaeta glycines) [this fungus is identified on the APHIS ‘‘select agents’’ list (see the Related Controls paragraph for this ECCN), but is not identified on the Australia Group (AG) ‘‘List of Plant Pathogens for Export Control’’]. c. Viruses, as follows: c.1. Andean potato latent virus (Potato Andean latent tymovirus); c.2. Potato spindle tuber viroid. * E:\FR\FM\17JAR1.SGM * * 17JAR1 * * 2516 Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations 1C991 Vaccines, immunotoxins, medical products, diagnostic and food testing kits, as follows (see List of Items Controlled). License Requirements Reason for Control: CB, AT Control(s) CB applies to 1C991.c. AT applies to entire entry. Country chart (See Supp. No. 1 to part 738) CB Column 3. AT Column 1. khammond on DSKJM1Z7X2PROD with RULES List Based License Exceptions (See Part 740 for a Description of All License Exceptions) LVS: N/A GBS: N/A List of Items Controlled Related Controls: (1) Medical products containing ricin or saxitoxin, as follows, are controlled for CW reasons under ECCN 1C351: (a) Ricinus communis AgglutininII (RCAII), also known as ricin D, or Ricinus Communis LectinIII (RCLIII); (b) Ricinus communis LectinIV (RCLIV), also known as ricin E; or (c) Saxitoxin identified by C.A.S. #35523– 89–8. (2) The export of a ‘‘medical product’’ that is an ‘‘Investigational New Drug’’ (IND), as defined in 21 CFR 312.3, is subject to certain U.S. Food and Drug Administration (FDA) requirements that are independent of the export requirements specified in this ECCN or elsewhere in the EAR. These FDA requirements are described in 21 CFR 312.110 and must be satisfied in addition to any requirements specified in the EAR. (3) Also see 21 CFR 314.410 for FDA requirements concerning exports of new drugs and new drug substances. Related Definitions: For the purpose of this entry, ‘immunotoxins’ are monoclonal antibodies linked to a toxin with the intention of destroying a specific target cell while leaving adjacent cells intact. For the purpose of this entry, ‘medical products’ are: (1) Pharmaceutical formulations designed for testing and human (or veterinary) administration in the treatment of medical conditions; (2) prepackaged for distribution as clinical or medical products; and (3) approved by the U.S. Food and Drug Administration either to be marketed as clinical or medical products or for use as an ‘‘Investigational New Drug’’ (IND) (see 21 CFR part 312). For the purpose of this entry, ‘diagnostic and food testing kits’ are specifically developed, packaged and marketed for diagnostic or public health purposes. Biological toxins in any other configuration, including bulk shipments, or for any other end-uses are controlled by ECCN 1C351. For the purpose of this entry, ‘vaccine’ is defined as a medicinal (or veterinary) product in a pharmaceutical formulation, approved by the U.S. Food and Drug Administration or the U.S. Department of Agriculture to be marketed as a medical (or veterinary) product or for use in clinical trials, that is VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or to which it is administered. Items: Technical Note: For purposes of the controls described in this ECCN, ‘toxins’ refers to those toxins, or their subunits, controlled under ECCN 1C351.d. a. Vaccines containing, or designed for use against, items controlled by ECCN 1C351, 1C353 or 1C354. b. Immunotoxins containing toxins controlled by 1C351.d; c. Medical products that contain any of the following: c.1. Toxins controlled by ECCN 1C351.d (except for botulinum toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN 1C351.d.6, or items controlled for CW reasons under ECCN 1C351.d.14 or .d.15); or c.2. Genetically modified organisms or genetic elements controlled by ECCN 1C353.a.3 (except for those that contain, or code for, botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6); d. Medical products not controlled by 1C991.c that contain any of the following: d.1. Botulinum toxins controlled by ECCN 1C351.d.3; d.2. Conotoxins controlled by ECCN 1C351.d.6; or d.3. Genetically modified organisms or genetic elements controlled by ECCN 1C353.a.3 that contain, or code for, botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6; e. Diagnostic and food testing kits containing toxins controlled by ECCN 1C351.d (except for items controlled for CW reasons under ECCN 1C351.d.14 or .d.15). * * * * * 2B352 Equipment Capable of Use in Handling Biological Materials, as Follows (See List of Items Controlled). License Requirements Reason for Control: CB, AT Control(s) CB applies to entire entry. AT applies to entire entry. Country chart (See Supp. No. 1 to part 738) CB Column 2. AT Column 1. List Based License Exceptions (See Part 740 for a Description of All License Exceptions) LVS: N/A GBS: N/A List of Items Controlled Related Controls: See ECCNs 1A004 and 1A995 for protective equipment that is not covered by this entry. Also see ECCN 9A120 for controls on certain ‘‘UAV’’ systems designed or modified to dispense an aerosol and capable of carrying elements of a payload in the form of a particulate or liquid, other than fuel ‘‘parts’’ or ‘‘components’’ of such vehicles, of a volume greater than 20 liters. PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 Related Definitions: (1) ‘‘Lighter than air vehicles’’—balloons and airships that rely on hot air or on lighter-than-air gases, such as helium or hydrogen, for their lift. (2) ‘‘UAVs’’—Unmanned Aerial Vehicles. (3) ‘‘VMD’’—Volume Median Diameter. Items: a. Containment facilities and related equipment, as follows: a.1. Complete containment facilities at P3 or P4 containment level. Technical Note to 2B352.a.1: P3 or P4 (BL3, BL4, L3, L4) containment levels are as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004). a.2. Equipment designed for fixed installation in containment facilities specified in paragraph a.1 of this ECCN, as follows: a.2.a. Double-door pass-through decontamination autoclaves; a.2.b. Breathing air suit decontamination showers; a.2.c. Mechanical-seal or inflatable-seal walkthrough doors. b. Fermenters and components as follows: b.1. Fermenters capable of cultivation of micro-organisms or of live cells for the production of viruses or toxins, without the propagation of aerosols, having a total internal volume of 20 liters or greater. b.2. Components designed for such fermenters, as follows: b.2.a. Cultivation chambers designed to be sterilized or disinfected in situ; b.2.b. Cultivation chamber holding devices; or b.2.c. Process control units capable of simultaneously monitoring and controlling two or more fermentation system parameters (e.g., temperature, pH, nutrients, agitation, dissolved oxygen, air flow, foam control). Technical Notes to 2B352.b: 1. Fermenters include bioreactors (including single-use (disposable) bioreactors), chemostats and continuous-flow systems. 2. Cultivation chamber holding devices controlled by 2B352.b.2.b include single-use cultivation chambers with rigid walls. c. Centrifugal separators capable of the continuous separation of pathogenic microorganisms, without the propagation of aerosols, and having all of the following characteristics: c.1. One or more sealing joints within the steam containment area; c.2. A flow rate greater than 100 liters per hour; c.3. ‘‘Parts’’ or ‘‘components’’ of polished stainless steel or titanium; and c.4. Capable of in-situ steam sterilization in a closed state. Technical Note to 2B352.c: Centrifugal separators include decanters. d. Cross (tangential) flow filtration equipment and ‘‘accessories’’, as follows: d.1. Cross (tangential) flow filtration equipment capable of separation of microorganisms, viruses, toxins or cell cultures having all of the following characteristics: d.1.a. A total filtration area equal to or greater than 1 square meter (1 m2); and d.1.b. Having any of the following characteristics: E:\FR\FM\17JAR1.SGM 17JAR1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 88, No. 10 / Tuesday, January 17, 2023 / Rules and Regulations d.1.b.1. Capable of being sterilized or disinfected in-situ; or d.1.b.2. Using disposable or single-use filtration ‘‘parts’’ or ‘‘components’’. N.B.: 2B352.d.1 does not control reverse osmosis and hemodialysis equipment, as specified by the manufacturer. d.2. Cross (tangential) flow filtration ‘‘parts’’ or ‘‘components’’ (e.g., modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0.2 square meters (0.2 m2) for each ‘‘part’’ or ‘‘component’’ and designed for use in cross (tangential) flow filtration equipment controlled by 2B352.d.1. Technical Note: In this ECCN, ‘‘sterilized’’ denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g., steam) or chemical agents. ‘‘Disinfected’’ 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. e. Steam, gas or vapor sterilizable freezedrying equipment with a condenser capacity of 10 kg of ice or greater in 24 hours (10 liters of water or greater in 24 hours) and less than 1000 kg of ice in 24 hours (less than 1,000 liters of water in 24 hours). f. Spray-drying equipment capable of drying toxins or pathogenic microorganisms having all of the following characteristics: f.1. A water evaporation capacity of ≥0.4 kg/h and ≤400 kg/h; f.2. The ability to generate a typical mean product particle size of ≤10 micrometers with existing fittings or by minimal modification of the spray-dryer with atomization nozzles enabling generation of the required particle size; and f.3. Capable of being sterilized or disinfected in situ. g. Protective and containment equipment, as follows: g.1. Protective full or half suits, or hoods dependent upon a tethered external air supply and operating under positive pressure. Technical Note to 2B352.g.1: 2B352.g.1 does not control suits designed to be worn with self-contained breathing apparatus. g.2. Biocontainment chambers, isolators, or biological safety cabinets having all of the following characteristics, for normal operation: g.2.a. Fully enclosed workspace where the operator is separated from the work by a physical barrier; g.2.b. Able to operate at negative pressure; g.2.c. Means to safely manipulate items in the workspace; and g.2.d. Supply and exhaust air to and from the workspace is high-efficiency particulate air (HEPA) filtered. Note 1 to 2B352.g.2: 2B352.g.2 controls class III biosafety cabinets, as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004) or constructed in accordance with national standards, regulations or guidance. Note 2 to 2B352.g.2: 2B352.g.2 controls any isolator having all of the characteristics described in 2B352.g.2.a through g.2.d, regardless of its intended use and its VerDate Sep<11>2014 15:51 Jan 13, 2023 Jkt 259001 designation, except for medical isolators ‘‘specially designed’’ for barrier nursing or transportation of infected patients. h. Aerosol inhalation equipment designed for aerosol challenge testing with microorganisms, viruses or toxins, as follows: h.1. Whole-body exposure chambers having a capacity of 1 cubic meter or greater; h.2. Nose-only exposure apparatus utilizing directed aerosol flow and having a capacity for the exposure of 12 or more rodents, or two or more animals other than rodents, and closed animal restraint tubes designed for use with such apparatus. i. Spraying or fogging systems and ‘‘parts’’ and ‘‘components’’ therefor, as follows: i.1. Complete spraying or fogging systems, ‘‘specially designed’’ or modified for fitting to aircraft, ‘‘lighter than air vehicles,’’ or ‘‘UAVs,’’ capable of delivering, from a liquid suspension, an initial droplet ‘‘VMD’’ of less than 50 microns at a flow rate of greater than 2 liters per minute; i.2. Spray booms or arrays of aerosol generating units, ‘‘specially designed’’ or modified for fitting to aircraft, ‘‘lighter than air vehicles,’’ or ‘‘UAVs,’’ capable of delivering, from a liquid suspension, an initial droplet ‘‘VMD’’ of less than 50 microns at a flow rate of greater than 2 liters per minute; i.3. Aerosol generating units ‘‘specially designed’’ for fitting to the systems as specified in paragraphs i.1 and i.2 of this ECCN. Technical Notes to 2B352.i: 1. Aerosol generating units are devices ‘‘specially designed’’ or modified for fitting to aircraft and include nozzles, rotary drum atomizers and similar devices. 2. This ECCN does not control spraying or fogging systems, ‘‘parts’’ and ‘‘components,’’ as specified in 2B352.i, that are demonstrated not to be capable of delivering biological agents in the form of infectious aerosols. 3. Droplet size for spray equipment or nozzles ‘‘specially designed’’ for use on aircraft or ‘‘UAVs’’ should be measured using either of the following methods (pending the adoption of internationally accepted standards): a. Doppler laser method, b. Forward laser diffraction method. j. Nucleic acid assemblers and synthesizers that are both: j.1 Partly or entirely automated; and j.2. Designed to generate continuous nucleic acids greater than 1.5 kilobases in length with error rates less than 5% in a single run. * * * * * Thea D. Rozman Kendler, Assistant Secretary, for Export Administration. [FR Doc. 2023–00397 Filed 1–13–23; 8:45 am] BILLING CODE 3510–33–P PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 2517 DEPARTMENT OF HOMELAND SECURITY Customs and Border Protection 19 CFR Chapter I Termination of Arrival Restrictions Applicable to Flights Carrying Persons Who Have Recently Traveled From or Were Otherwise Present Within Uganda U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Announcement of termination of arrival restrictions. AGENCY: This document announces the decision of the Secretary of Homeland Security to terminate arrival restrictions applicable to flights to the United States carrying persons who have recently traveled from, or were otherwise present within, Uganda due to an outbreak of Ebola disease in Uganda. These restrictions directed such flights to only land at one of the United States airports where the United States Government had focused public health resources to implement enhanced public health measures. DATES: The arrival restrictions applicable to flights to the United States carrying persons who have recently traveled from, or were otherwise present within, Uganda are terminated as of 11:59 p.m. Eastern Standard Time on January 11, 2023. FOR FURTHER INFORMATION CONTACT: Stephanie Watson, Office of Field Operations, U.S. Customs and Border Protection at 202–255–7018. SUPPLEMENTARY INFORMATION: SUMMARY: Background On October 12, 2022, the Secretary of Homeland Security announced arrival restrictions applicable to flights carrying persons who have recently traveled from, or were otherwise present within, Uganda, consistent with 6 U.S.C. 112(a), 19 U.S.C. 1433(c), and 19 CFR 122.32, in a Federal Register document titled ‘‘Arrival Restrictions Applicable to Flights Carrying Persons Who Have Recently Traveled From or Were Otherwise Present Within Uganda’’ (87 FR 61488). For purposes of the October 2022 arrival restrictions, a person recently traveled from Uganda if that person departed from, or was otherwise present within, Uganda within 21 days of the date of the person’s entry or attempted entry into the United States. For the reasons set forth below, the Secretary has decided to terminate the arrival restrictions applicable to flights E:\FR\FM\17JAR1.SGM 17JAR1

Agencies

[Federal Register Volume 88, Number 10 (Tuesday, January 17, 2023)]
[Rules and Regulations]
[Pages 2507-2517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00397]


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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 740, 742, and 774

[Docket No. 220909-0188]
RIN 0694-AI21


Implementation of Australia Group Decisions From 2021 and 2022 
Virtual Meetings: Controls on Marine Toxins, Plant Pathogens and 
Biological Equipment

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: The Bureau of Industry and Security (BIS) publishes this final 
rule to amend the Export Administration Regulations (EAR) to reflect 
decisions made at the November 2021 and March 2022 Australia Group (AG) 
Virtual Implementation Meetings and the AG Plenary Meeting held in July 
2022. The amendments include revisions to certain Export Control 
Classification Numbers to clarify the controls on genetic elements and 
genetically modified organisms and the scope of the exclusion that 
applies to medical isolators ``specially designed'' for barrier nursing 
or transportation of infected patients; and makes clarifications by 
adding four naturally occurring, dual-use marine toxins (specifically, 
brevetoxins, gonyautoxins, nodularins and palytoxin) and removing 
cholera toxin. The addition of these four toxins is consistent with 
Section 1758 of the Export Control Reform Act of 2018 (ECRA) regarding 
emerging and foundational technologies. Finally, this rule also 
includes amendments to reflect the AG Plenary updates to the 
nomenclature of certain bacteria and fungi, and the clarification of 
the definition of ``disinfected'' as it applies to certain biological 
equipment.

DATES: This rule is effective January 17, 2023.

FOR FURTHER INFORMATION CONTACT: Dr. Tara Gonzalez, Chemical and 
Biological Controls Division, Office of Nonproliferation and Treaty 
Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343, 
Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Background

    The Bureau of Industry and Security (BIS) is amending the Export 
Administration Regulations (EAR) (15 CFR parts 730-774) to reflect the 
decisions made at the November 2021 and March 2022 Australia Group (AG) 
Virtual Implementation Meetings and the AG Plenary Meeting held in 
Paris, France, from July 4 through July 8, 2022. The AG is a 
multilateral forum consisting of 42 participating countries and the 
European Union. These participants 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.
    At the November 2021 AG Virtual Implementation Meeting, the AG 
revised its ``Control List of Dual-Use Biological Equipment and Related 
Technology and Software'' to clarify the scope of the exclusion that 
applies to

[[Page 2508]]

medical isolators ``specially designed'' for barrier nursing or 
transportation of infected patients.
    Consistent with decisions made at the AG's March 2022 Virtual 
Implementation Meeting, two AG common control lists (i.e., the list of 
``Human and Animal Pathogens and Toxins'' and the ``List of Plant 
Pathogens for Export Control'') were updated to clarify that the 
controls on genetic elements and genetically modified organisms 
include, inter alia, any gene(s) or translated product(s) specific to 
any controlled virus. Previously, the control text for viral genetic 
elements referred only to the risk posed by the nucleic acid sequence 
itself, and not to transcribed or translated products.
    The AG also made changes to three of its common control lists to 
reflect the decisions made at its July 2022 Plenary Meeting. The AG 
revised its list of ``Human and Animal Pathogens and Toxins'' to add 
four naturally occurring, dual-use marine toxins (specifically, 
brevetoxins, gonyautoxins, nodularins and palytoxin) and remove cholera 
toxin. The AG also revised its ``Control List of Dual-Use Biological 
Equipment and Related Technology and Software'' by clarifying the 
definition of ``disinfected'' to more closely reflect the use of this 
term by the scientific and industrial communities. In addition, the AG 
revised its ``List of Plant Pathogens for Export Control'' to update 
the nomenclature for certain bacteria and fungi.

I. EAR Changes Reflecting the November 2021 AG Virtual Implementation 
Meeting Decision

Amendments to ECCN 2B352

    Consistent with the decision made at the November 2021 AG Virtual 
Implementation Meeting, this rule amends ECCN 2B352 to reflect changes 
in the Notes to the AG controls on biocontainment chamber, isolators 
and biological safety cabinets described in the ``Control List of Dual-
Use Biological Equipment and Related Technology and Software.'' 
Specifically, Note 2 to 2B352.g.2 is revised to clarify that this ECCN 
controls any isolator having all of the characteristics described in 
2B352.g.2.a through g.2.d, regardless of its intended use and its 
designation, except for medical isolators ``specially designed'' for 
barrier nursing or transportation of infected patients. Additional 
amendments to this ECCN, which reflect decisions made at the July 2022 
AG Plenary Meeting, are described later in the preamble of this rule.

II. EAR Changes Reflecting the March 2022 AG Virtual Implementation 
Meeting Decision

Amendments to Export Control Classification Number (ECCN) 1C353

    Consistent with the decision made at the March 2022 AG Virtual 
Implementation Meeting, this rule amends paragraph a.1 of ECCN 1C353 on 
the Commerce Control List (CCL), in Supplement No. 1 to part 774 of the 
EAR, to clarify that the controls on genetic elements and genetically 
modified organisms include, inter alia, any gene(s) or translated 
product(s) specific to any controlled virus. Prior to the publication 
of this final rule, this ECCN did not explicitly state that its 
controls on viral genetic elements also included translated product(s) 
specific to any controlled virus. The control text in ECCN 1C353.a 
previously referred to transcribed or translated product(s) only with 
respect to bacterial and fungal genetic elements described in paragraph 
a.2.a.

III. EAR Changes Reflecting the July 2022 AG Plenary Meeting Decisions

Amendments to ECCN 1C350

    This final rule amends ECCN 1C350, consistent with the July 2022 AG 
Plenary Meeting update to the ``Export Control List: Chemical Weapons 
Precursors,'' by adding a clarification to Technical Note 3 in this 
ECCN. This change is also consistent with a recommendation by the 
Organization for the Prohibition of Chemical Weapons (OPCW) to control 
all stereoisomers and isotopically-labeled forms of scheduled 
chemicals, even if they have different CAS 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).''

Amendments to ECCN 1C351

    This final rule reflects the recent updates to the AG ``Human and 
Animal Pathogens and Toxins'' common control list, as described above, 
by amending ECCN 1C351 to add four marine toxins (brevetoxins, 
gonyautoxins, nodularins and palytoxin) and remove cholera toxin. 
Specifically, the four marine toxins are added in alphabetical order to 
ECCN 1C351.d, where they are controlled for chemical/biological (CB) 
and anti-terrorism (AT) reasons. Certain other toxins in this ECCN are 
renumbered, accordingly, to reflect the addition of the marine toxins 
and the removal of cholera toxin.
    This rule also makes conforming changes elsewhere in ECCN 1C351 to 
update references to certain toxins (i.e., in the CW Reason for Control 
paragraph, License Requirements Notes 1 and 2, the License Exception 
STA eligibility paragraph and the Related Controls paragraph). Similar 
conforming amendments to the Chemical Weapons Convention (CWC) and 
License Exception Strategic Trade Authorization (STA) provisions in the 
EAR are described below.
    As described in more detail below, BIS identified the synthesis and 
collection of the four marine toxins for evaluation according to the 
criteria in Section 1758 of the Export Control Reform Act of 2018 
(ECRA), 50 U.S.C. 4801-4852, pertaining to emerging and foundational 
technologies. Other considerations prompted the decision to remove 
cholera toxin from the list of ``Human and Animal Pathogens and 
Toxins.'' At the time of its inclusion on this AG common control list, 
cholera toxin did not have any significant commercial or medical uses. 
However, in recent years, there has been a significant increase in 
biomedical research involving cholera toxins and in the use of cholera 
toxin in biomedical applications. Furthermore, cholera toxin, by itself 
(i.e., in the absence of live bacteria), is known to have limited 
cytotoxicity (e.g., compared to other toxins such as botulinum, 
saxitoxin, or ricin), and cannot be transmitted from person to person. 
Cholera toxin has not been the major focus of a biological weapons 
research program, although it may have been evaluated for such 
purposes. Consequently, the removal of chemical/biological (CB) 
controls on cholera toxins is not expected to have a significant impact 
on the proliferation, development, production or use of biological 
weapons, nor would the relative costs of such controls (e.g., in terms 
of their impact on public health and on biomedical and related 
research) be justified going forward.

Expansion of ECCN 1E001 Controls

    Although this rule does not amend ECCN 1E001 (which controls, inter 
alia, ``technology'' for the ``development'' or ``production'' of the 
human and animal pathogens and ``toxins'' described in ECCN 1C351), the 
heading of ECCN 1E001 indicates that, with limited exceptions, ECCN 
1E001 controls ``technology for the ``development'' or ``production'' 
of items listed under Category 1C of the CCL. Consequently, ECCN 1E001 
now controls ``technology'' for the ``development'' or ``production'' 
of the four marine toxins that are being added to ECCN 1C351 by this 
rule.

[[Page 2509]]

Other Conforming Amendments To Reflect the Reordering of Toxins in ECCN 
1C351.d

    This rule amends Sec.  740.20--License Exception Strategic Trade 
Authorization (STA) to make conforming changes to the ECCN 1C351.d 
references in paragraph (b)(2)(v) and paragraph (b)(2)(vi). 
Specifically, Sec.  740.20(b)(2)(v) is amended to reference the 
exclusion of ECCN 1C351.d.14 and d.15 items from License Exception STA 
eligibility, consistent with the proposed renumbering of ricin and 
saxitoxin (which were previously controlled under ECCN 1C351.d.11 and 
d.12, respectively). Similarly, Sec.  740.20(b)(2)(vi) is amended, 
consistent with the renumbering of the toxins in ECCN 1C351.d, by 
revising the references to the ECCN 1C351.d toxins that are authorized 
(with certain limitations) under License Exception STA to destinations 
indicated in Country Group A:5 (see Supplement No. 1 to part 740 of the 
EAR).
    This rule also makes conforming changes to Sec.  742.18--Chemical 
Weapons Convention (CWC) and ECCN 1C991 (Vaccines, immunotoxins, 
medical products, diagnostic and food testing kits) to reflect the 
renumbering of the toxins in ECCN 1C351.d. Specifically, Sec.  
742.18(a)(1), (b)(1)(i), and (b)(1)(ii) and (iii) are amended to 
reference ECCN 1C351.d.14 and d.15, consistent with the renumbering of 
ricin and saxitoxin described above. In ECCN 1C991, 1C991.c.1 and .e 
are amended to make conforming changes to the references therein to 
ECCN 1C351 that are affected by the renumbering of the toxins in ECCN 
1C351.d.
    None of the conforming amendments described above changes the scope 
of the controls in the affected EAR provisions.

Amendments to ECCN 1C354

    This final rule reflects the AG Plenary changes to the ``List of 
Plant Pathogens for Export Control,'' which updated the nomenclature 
for certain bacteria and fungi. Specifically, this rule amends ECCN 
1C354.a by updating the nomenclature of the bacteria ``Xanthomonas 
axonopodis pv. citri (Xanthomonas campestris pv. citri A) (Xanthomonas 
campestris pv. citri)'' and ``Clavibacter michiganensis subspecies 
sepedonicus (syn. Corynebacterium michiganensis subspecies sepedonicum 
or Corynebacterium sepedonicum)'' to read ``Xanthomonas citri pv. citri 
(Xanthomonas axonopodis pv. citri, Xanthomonas campestris pv. citri)'' 
and ``Clavibacter michiganensis subsp. sepedonicus, (Clavibacter 
sepedonicus, Clavibacter michiganense subsp. sepedonicus, 
Corynebacterium michiganensis subsp. sepedonicum, Corynebacterium 
sepedonicum),'' respectively. In addition, ECCN 1C354.b is amended to 
update the nomenclature of the fungi ``Cochliobolus miyabeanus 
(Helminthosporium oryzae)'' and ``Microcyclus ulei (syn. Dothidella 
ulei)'' to read ``Bipolaris oryzae (Cochliobolus miyabeanus, 
Helminthosporium oryzae)'' and ``Pseudocercospora ulei (Microcyclus 
ulei, Dothidella ulei),'' respectively. To maintain the listing of 
these fungi in alphabetical order, ``Bipolaris oryzae (Cochliobolus 
miyabeanus, Helminthosporium oryzae),'' which was previously controlled 
under ECCN 1C354.b.2, is now controlled under ECCN 1C354.b.1 and 
``Colletotrichum kahawae (Colletotrichum coffeanum var. virulans),'' 
which was previously controlled under ECCN 1C354.b.1, is now controlled 
under ECCN 1C354.b.2.

Amendments to ECCN 2B352

    In addition to the ECCN 2B352 amendments described above (see 
discussion of amendments per the November 2021 AG Virtual 
Implementation Meeting decision), this final rule amends ECCN 2B352 to 
reflect the recent updates to the AG ``Control List of Dual-Use 
Biological Equipment and Related Technology and Software,'' by revising 
the definition of ``disinfected'' to more closely reflect the use of 
this term by the scientific and industrial communities. Specifically, 
this rule amends the Technical Note following ECCN 2B352.d.2 by 
revising the definition of ``disinfected'' to indicate that this 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.'' 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'' (with ``sanitization'' referring to cleaning 
procedures designed to lower the microbial content of equipment without 
necessarily achieving elimination of all microbial infectivity or 
viability).

Marine Toxins Identified for Evaluation Under Section 1758 of ECRA

    In advance of the 2022 AG Plenary meeting, BIS identified the 
synthesis and collection of the four marine toxins addressed in this 
final rule for evaluation according to the criteria in Section 1758 of 
ECRA, pertaining to emerging and foundational technologies. These 
marine toxins have the potential (through either accidental or 
deliberate release) 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, BIS determined that the absence of 
export controls on the toxins could be exploited for biological weapons 
purposes.
    Consistent with the emerging and foundational technologies notice 
and comment requirements in Section 1758(a)(2)(C) of ECRA (50 U.S.C. 
4817(a)(2)(C)), BIS published a proposed rule on May 23, 2022 (87 FR 
31195), to provide the public with notice and the opportunity to 
comment on its proposal to amend ECCN 1C351 on the CCL to add these 
marine toxins to ECCN 1C351.

Comments Submitted in Response to BIS's May 23 Proposed Rule

    BIS received comments from two respondents in response to the 
publication of its May 23 proposed rule. The comments from these 
respondents, together with BIS's responses, are described below.
    Comment: One respondent indicated that clarification was needed 
concerning whether any of the four marine toxins proposed for control 
have an identified and specific biological synthesis pathway. In the 
respondent's opinion, if this were the case, then certain genes or gene 
clusters may become subject to control as a result of imposing controls 
on the toxin. If not, then the respondent thought it unlikely that any 
genes or gene clusters would become subject to control as a consequence 
of controlling the toxin.
    BIS response: ECCN 1C353.a.3 controls any genetically modified 
organism that contains, or any genetic element that codes for, any 
toxins (or their subunits) controlled by 1C351.d. Genetically modified 
organisms and genetic elements are defined in Technical Notes 1 and 2, 
respectively, in ECCN 1C353. 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. BIS 
believes that the controls described in ECCN 1C353.a.3 are sufficiently 
clear

[[Page 2510]]

in this respect and, consequently, that no further clarification is 
necessary.
    Comment: Another respondent submitted comments that addressed COVID 
vaccines and treatments within the context of the World Trade 
Organization's Trade-Related Aspects of Intellectual Property Rights 
(TRIPS).
    BIS response: These TRIPS-based comments were not responsive to the 
request for comments in BIS's May 23 proposed rule, as they were 
focused almost exclusively on the potential relationship between 
intellectual property rights and the availability of COVID vaccines 
within various countries. Furthermore, the comments did not 
specifically address whether and, if so, how export controls would 
impact the availability of such vaccines in those countries. 
Consequently, these comments are not addressed in this final rule.

Saving Clause

    Shipments of items removed from eligibility for export, reexport or 
transfer (in-country) under a license exception or without a license 
(i.e., under the designator ``NLR'') as a result of this regulatory 
action that were on dock for loading, on lighter, laden aboard an 
exporting carrier, or en route aboard a carrier to a port of export, on 
January 17, 2023, pursuant to actual orders for export, reexport or 
transfer (in-country) to a foreign destination, may proceed to that 
destination under the previously applicable license exception or 
without a license (NLR) so long as they are exported, reexported or 
transferred (in-country) before March 20, 2023. Any such items not 
actually exported, reexported or transferred (in-country) before 
midnight, on March 20, 2023, require a license in accordance with this 
regulation.
    ``Deemed'' exports of ``technology'' and ``source code'' removed 
from eligibility for export under a license exception or without a 
license (under the designator ``NLR'') as a result of this regulatory 
action may continue to be made under the previously available license 
exception or
    without a license (NLR) before March 20, 2023. Beginning at 
midnight on March 20, 2023, such ``technology'' and ``source code'' may 
no longer be released, without a license, to a foreign national subject 
to the ``deemed'' export controls in the EAR when a license would be 
required to the home country of the foreign national in accordance with 
this regulation.

Export Control Reform Act of 2018

    The Export Control Reform Act of 2018 (ECRA), as amended, codified 
at 50 U.S.C. 4801-4852, serves as the authority under which BIS issues 
this final rule.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including: potential economic, environmental, public 
health and safety effects; distributive impacts; and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits and of reducing costs, harmonizing rules, and promoting 
flexibility. This final rule has been designated a ``significant 
regulatory action,'' although not economically significant, under 
section 3(f) of Executive Order 12866. Accordingly, this final rule has 
been reviewed by the Office of Management and Budget (OMB).
    2. Notwithstanding any other provision of law, no person is 
required to respond to, nor shall any person be subject to a penalty 
for failure to comply with, a collection of information subject to the 
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.) (PRA), unless that collection of information displays a currently 
valid Office of Management and Budget (OMB) Control Number. Although 
this rule makes important changes to the EAR for items controlled for 
chemical/biological reasons, BIS believes that the overall increases in 
burdens and costs associated with the following information collections 
due to this rule will be minimal:
     OMB control number 0694-0088 (Simplified Network 
Application Processing System)--this collection includes license 
applications and carries a burden estimate of 29.4 minutes per manual 
or electronic submission;
     OMB Control Number 0694-0096 (Five Year Records Retention 
Period)--this collection includes recordkeeping requirements and 
carries a burden estimate of less than 1 minute per response;
     OMB Control Number 0607-0152 (Automated Export System 
(AES) Program)--this collection carries a burden hour estimate of 3 
minutes per electronic submission and contains the Electronic Export 
Information (EEI) filing requirements under the Automated Export System 
(AES).
    Additional information regarding these collections of information, 
including all background materials, can be found at https://www.reginfo.gov/public/do/PRAMain and using the search function to 
enter either the title of the collection or the OMB Control Number.
    3. This final rule does not contain policies with federalism 
implications as that term is defined in Executive Order 13132.
    4. As stated in the preamble of this final rule, the amendments 
contained in this rule reflect decisions made at the Australia Group 
(AG) Plenary Meeting held in Paris, France, from July 4 through July 8, 
2022. Therefore, pursuant to Section 1762 of the Export Control Reform 
Act of 2018 (ECRA) (50 U.S.C. Sec. 4821), this action is exempt from 
the Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for 
notice of proposed rulemaking, opportunity for public participation and 
delay in effective date.
    Because a notice of proposed rulemaking and an opportunity for 
public comment are not required to be given for this final rule by the 
APA or any other law, the analytical requirements of the Regulatory 
Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small 
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 
601 et seq.), are not applicable.
    Consistent with the emerging and foundational technologies notice 
and comment requirements in Section 1758(a)(2)(C) of ECRA (50 U.S.C. 
4817(a)(2)(C)), BIS published a proposed rule on May 23, 2022 (87 FR 
31195), to provide the public with notice and the opportunity to 
comment on its proposal to amend ECCN 1C351 on the Commerce Control 
List (CCL) to add four marine toxins (i.e., brevetoxins, gonyautoxins, 
nodularins and palytoxin) to ECCN 1C351, the synthesis and collection 
of which BIS had identified for evaluation according to the criteria in 
Section 1758 of the Export Control Reform Act of 2018 (ECRA) pertaining 
to emerging and foundational technologies. In addition, consistent with 
the Regulatory Flexibility Act, BIS prepared an initial regulatory 
flexibility analysis (IRFA) of the impact that the proposed rule, if 
adopted, would have on small businesses. The IRFA prepared by BIS 
requested comments on the analyses and conclusions contained therein, 
including the overall conclusion that the amendments in BIS's May 23 
proposed rule would not have a significant economic impact on a 
substantial number of small entities.
    BIS received comments from two respondents on its May 23 proposed 
rule--these comments and BIS's responses are summarized in the preamble 
of this final rule. BIS did not

[[Page 2511]]

receive any comments in response to the analyses and conclusions 
contained in the IRFA for its May 23 proposed rule. Accordingly, no 
regulatory flexibility analysis is required for this final rule, and 
none has been prepared.

List of Subjects

15 CFR Part 740

    Administrative practice and procedure, Exports Reporting and 
recordkeeping requirements, Terrorism.

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements, Terrorism.

    For the reasons stated in the preamble, parts 740, 742, and 774 of 
the Export Administration Regulations (15 CFR parts 730-774) are 
amended as follows:

PART 740--LICENSE EXCEPTIONS

0
1. The authority citation for part 740 continues to read as follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50 
U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 
58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 
2001 Comp., p. 783.


0
2. Section 740.20 is amended by revising paragraph (b)(2)(v) and 
paragraph (b)(2)(vi) introductory text to read as follows:


Sec.  740.20   License Exception Strategic Trade Authorization (STA).

* * * * *
    (b) * * *
    (2) * * *
    (v) License Exception STA may not be used for any item controlled 
by ECCN 1C351.a, .b, .c, .d.14, .d.15 or .e, ECCNs 1C353, 1C354, 1E001 
(i.e., for technology, as specified in ECCN 1E001, for items controlled 
by ECCN 1C351.a, .b, .c, .d.14, .d.15 or .e or ECCNs 1C353 or 1C354) or 
ECCN 1E351.
    (vi) Toxins controlled by ECCN 1C351.d.1 through 1C351.d.13 and 
1C351.d.16 through 1C351.d.21 are authorized under License Exception 
STA to destinations indicated in Country Group A:5 (See supplement no. 
1 to this part 740), subject to the following limits. For purposes of 
this paragraph (b)(2)(vi), all such toxins that are sent from one 
exporter, reexporter or transferor to a single end-user, on the same 
day, constitute one shipment.
* * * * *

PART 742--CONTROL POLICY--CCL BASED CONTROLS

0
3. The authority citation for part 742 continues to read as follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50 
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 
U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 
Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 
12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 
59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 
783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 
Comp., p. 320; Notice of November 10, 2021, 86 FR 62891 (November 
12, 2021).


0
4. Section 742.18 is amended by revising paragraph (a)(1), paragraph 
(b)(1)(i) introductory text, and paragraphs (b)(1)(ii) and (iii) to 
read as follows:


Sec.  742.18  Chemical Weapons Convention (CWC or Convention).

* * * * *
    (a) * * *
    (1) Schedule 1 chemicals and mixtures controlled under ECCN 1C351. 
A license is required for CW reasons to export or reexport Schedule 1 
chemicals controlled under ECCN 1C351.d.14 or .d.15 to all destinations 
including Canada. CW applies to 1C351.d.14 for ricin in the form of 
Ricinus Communis AgglutininII (RCAII), which is also known 
as ricin D or Ricinus Communis LectinIII (RCLIII), and 
Ricinus Communis LectinIV (RCLIV), which is also known as 
ricin E. CW applies to 1C351.d.15 for saxitoxin identified by C.A.S. 
#35523-89-8. (Note that the advance notification procedures and annual 
reporting requirements described in Sec.  745.1 of the EAR also apply 
to exports of Schedule 1 chemicals.)
* * * * *
    (b) * * *
    (1) * * *
    (i) Exports to States Parties to the CWC. Applications to export 
Schedule 1 Chemicals controlled under ECCN 1C351.d.14 or .d.15 to 
States Parties to the CWC (destinations listed in supplement no. 2 to 
part 745 of the EAR) generally will be denied, unless all of the 
following conditions are met:
* * * * *
    (ii) Exports to States not party to the CWC. Applications to export 
Schedule 1 chemicals controlled under ECCN 1C351.d.14 or .d.15 to 
States not Party to the CWC (destinations not listed in supplement no. 
2 to part 745 of the EAR) generally will be denied, consistent with 
U.S. obligations under the CWC to prohibit exports of these chemicals 
to States not Party to the CWC.
    (iii) Reexports. Applications to reexport Schedule 1 chemicals 
controlled under ECCN 1C351.d.14 or .d.15 generally will be denied to 
all destinations (including both States Parties to the CWC and States 
not Party to the CWC).
* * * * *

PART 774--THE COMMERCE CONTROL LIST

0
5. The authority citation for part 774 continues to read as follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50 
U.S.C. 1701 et seq.; 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C. 
287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 
U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; 
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 
FR 44025, 3 CFR, 2001 Comp., p. 783.


0
6. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1, revise ECCNs 1C350, 1C351, 1C353, 1C354, 1C991, and 2B352 
to read as follows:

Supplement No. 1 to Part 774--The Commerce Control List

* * * * *
1C350 Chemicals that may be used as precursors for toxic chemical 
agents (see List of Items Controlled).

License Requirements

Reason for Control: CB, CW, AT

 
                                            Country chart (See Supp. No.
                Control(s)                         1 to part 738)
 
CB applies to entire entry................  CB Column 2.
 

    CW applies to 1C350.b and .c. The Commerce Country Chart is not 
designed to determine licensing requirements for items controlled 
for CW reasons. A license is required, for CW reasons, to export or 
reexport Schedule 2 chemicals and mixtures identified in 1C350.b to 
States not Party to the CWC (destinations not listed in Supplement 
No. 2 to part 745 of the EAR). A license is required, for CW 
reasons, to export Schedule 3 chemicals and mixtures identified in 
1C350.c to States not Party to the CWC, unless an End-Use 
Certificate issued by the government of the importing country has 
been obtained by the exporter prior to export. A license is 
required, for CW reasons, to reexport Schedule 3 chemicals and 
mixtures identified in 1C350.c from a State not Party to the CWC to 
any other State not Party to the CWC. (See Sec.  742.18 of the EAR 
for license requirements and policies for toxic and precursor 
chemicals controlled for CW reasons. See Sec.  745.2 of the EAR for 
End-Use Certificate requirements that apply to

[[Page 2512]]

exports of Schedule 3 chemicals to countries not listed in 
Supplement No. 2 to part 745 of the EAR.)
    AT applies to entire entry. The Commerce Country Chart is not 
designed to determine licensing requirements for items controlled 
for AT reasons in 1C350. A license is required, for AT reasons, to 
export or reexport items controlled by 1C350 to a country in Country 
Group E:1 of Supplement No. 1 to part 740 of the EAR. (See part 742 
of the EAR for additional information on the AT controls that apply 
to Iran, North Korea, and Syria. See part 746 of the EAR for 
additional information on sanctions that apply to Iran, North Korea, 
and Syria.)
    License Requirement Notes
    1. SAMPLE SHIPMENTS: Subject to the following requirements and 
restrictions, a license is not required for sample shipments when 
the cumulative total of these shipments does not exceed a 55-gallon 
container or 200 kg of a single chemical to any one consignee during 
a calendar year. A consignee that receives a sample shipment under 
this exclusion may not resell, transfer, or reexport the sample 
shipment, but may use the sample shipment for any other legal 
purpose unrelated to chemical weapons.

a. Chemicals Not Eligible

    A. [Reserved]
    B. CWC Schedule 2 chemicals (States not Party to the CWC). No 
CWC Schedule 2 chemical or mixture identified in 1C350.b is eligible 
for sample shipment to States not Party to the CWC (destinations not 
listed in Supplement No. 2 to part 745 of the EAR) without a 
license.
    b. Countries Not Eligible: Countries in Country Group E:1 of 
Supplement No. 1 to part 740 of the EAR are not eligible to receive 
sample shipments of any chemicals controlled by this ECCN without a 
license.
    c. Sample shipments that require an End-Use Certificate for CW 
reasons: No CWC Schedule 3 chemical or mixture identified in 1C350.c 
is eligible for sample shipment to States not Party to the CWC 
(destinations not listed in Supplement No. 2 to part 745 of the EAR) 
without a license, unless an End-Use Certificate issued by the 
government of the importing country is obtained by the exporter 
prior to export (see Sec.  745.2 of the EAR for End-Use Certificate 
requirements).
    d. Sample shipments that require a license for reasons set forth 
elsewhere in the EAR: Sample shipments, as described in this Note 1, 
may require a license for reasons set forth elsewhere in the EAR. 
See, in particular, the end-use/end-user restrictions in part 744 of 
the EAR, and the restrictions that apply to embargoed countries in 
part 746 of the EAR.
    e. Annual report requirement. The exporter is required to submit 
an annual written report for shipments of samples made under this 
Note 1. The report must be on company letterhead stationery (titled 
``Report of Sample Shipments of Chemical Precursors'' at the top of 
the first page) and identify the chemical(s), Chemical Abstract 
Service Registry (C.A.S.) number(s), quantity(ies), the ultimate 
consignee's name and address, and the date of export for all sample 
shipments that were made during the previous calendar year. The 
report must be submitted no later than February 28 of the year 
following the calendar year in which the sample shipments were made, 
to: U.S. Department of Commerce, Bureau of Industry and Security, 
14th Street and Pennsylvania Ave. NW, Room 2099B, Washington, DC 
20230, Attn: ``Report of Sample Shipments of Chemical Precursors.''
    2. MIXTURES:
    a. Mixtures that contain precursor chemicals identified in ECCN 
1C350, in concentrations that are below the levels indicated in 
1C350.b through .d, are controlled by ECCN 1C395 or 1C995 and are 
subject to the licensing requirements specified in those ECCNs.
    b. A license is not required under this ECCN for a mixture, when 
the controlled chemical in the mixture is a normal ingredient in 
consumer goods packaged for retail sale for personal use. Such 
consumer goods are designated EAR99. However, a license may be 
required for reasons set forth elsewhere in the EAR.
    Note to Mixtures: Calculation of concentrations of AG-controlled 
chemicals:
    a. Exclusion. No chemical may be added to the mixture (solution) 
for the sole purpose of circumventing the Export Administration 
Regulations;
    b. Percent Weight Calculation. When calculating the percentage, 
by weight, of ingredients in a chemical mixture, include all 
ingredients of the mixture, including those that act as solvents.
    3. COMPOUNDS. Compounds created with any chemicals identified in 
this ECCN 1C350 may be shipped NLR (No License Required), without 
obtaining an End-Use Certificate, unless those compounds are also 
identified in this entry or require a license for reasons set forth 
elsewhere in the EAR.
    4. TESTING KITS: Certain medical, analytical, diagnostic, and 
food testing kits containing small quantities of chemicals 
identified in this ECCN 1C350, are excluded from the scope of this 
ECCN and are controlled under ECCN 1C395 or 1C995. (Note that 
replacement reagents for such kits are controlled by this ECCN 1C350 
if the reagents contain one or more of the precursor chemicals 
identified in 1C350 in concentrations equal to or greater than the 
control levels for mixtures indicated in 1C350.)
    Technical Notes:
    1. For purposes of this entry, a ``mixture'' is defined as a 
solid, liquid or gaseous product made up of two or more ingredients 
that do not react together under normal storage conditions.
    2. The scope of this control applicable to Hydrogen Fluoride 
(see 1C350.d.14 in the List of Items Controlled) includes its 
liquid, gaseous, and aqueous phases, and hydrates.
    3. Precursor chemicals in ECCN 1C350 are listed by name, 
Chemical Abstract Service (CAS) number and CWC Schedule (where 
applicable). Precursor chemicals of the same structural formula 
(e.g., hydrates, isotopically-labeled forms or all possible 
stereoisomers) are controlled by ECCN 1C350, regardless of name or 
CAS number. CAS numbers are shown to assist in identifying whether a 
particular precursor chemical or mixture is controlled under ECCN 
1C350, irrespective of nomenclature. However, CAS numbers cannot be 
used as unique identifiers in all situations because some forms of 
the listed precursor chemical have different CAS numbers, and 
mixtures containing a precursor chemical listed in ECCN 1C350 may 
also have different CAS numbers.

List Based License Exceptions (See Part 740 for a Description of all 
License Exceptions)

LVS: N/A
GBS: N/A

List of Items Controlled

Related Controls: See USML Category XIV(c) for related chemicals 
``subject to the ITAR'' (see 22 CFR parts 120 through 130).
Related Definitions: See Sec.  770.2(k) of the EAR for synonyms for 
the chemicals listed in this entry.
Items:

    a. [Reserved]
    b. Australia Group-controlled precursor chemicals also 
identified as Schedule 2 chemicals under the CWC, as follows, and 
mixtures in which at least one of the following chemicals 
constitutes 30 percent or more of the weight of the mixture:
    b.1. (C.A.S. #7784-34-1) Arsenic trichloride;
    b.2. (C.A.S. #76-93-7) Benzilic acid;
    b.3. (C.A.S. #78-38-6) Diethyl ethylphosphonate;
    b.4. (C.A.S. #683-08-9) Diethyl methylphosphonate;
    b.5. (C.A.S. #15715-41-0) Diethyl methylphosphonite;
    b.6. (C.A.S. #2404-03-7) Diethyl-N,N-dimethylphosphoroamidate;
    b.7. (C.A.S. #41480-75-5) N,N-Diisopropylaminoethanethiol 
hydrochloride;
    b.8. (C.A.S. #5842-07-9) N,N-Diisopropyl-beta-aminoethane thiol;
    b.9. (C.A.S. #96-80-0) N,N-Diisopropyl-beta-aminoethanol;
    b.10. (C.A.S. #96-79-7), N,N-Diisopropyl-beta-aminoethyl 
chloride;
    b.11. (C.A.S. #4261-68-1) N,N-Diisopropyl-beta-aminoethyl 
chloride hydrochloride;
    b.12. (C.A.S. #6163-75-3) Dimethyl ethylphosphonate;
    b.13. (C.A.S. #756-79-6) Dimethyl methylphosphonate;
    b.14. (C.A.S. #677-43-0) N,N-dimethylamino-phosphoryl 
dichloride;
    b.15. (C.A.S. #1498-40-4) Ethyl phosphonous dichloride [Ethyl 
phosphinyl dichloride];
    b.16. (C.A.S. #430-78-4) Ethyl phosphonus difluoride [Ethyl 
phosphinyl difluoride];
    b.17. (C.A.S. #1066-50-8) Ethyl phosphonyl dichloride;
    b.18. (C.A.S. #993-13-5) Methylphosphonic acid;
    b.19. (C.A.S. #676-98-2) Methylphosphonothioic dichloride.
    b.20. (C.A.S. #464-07-3) Pinacolyl alcohol;
    b.21. (C.A.S. #1619-34-7) 3-Quinuclidinol;
    b.22. (C.A.S. #111-48-8) Thiodiglycol.
    c. Australia Group-controlled precursor chemicals also 
identified as Schedule 3 chemicals under the CWC, as follows, and 
mixtures in which at least one of the following chemicals 
constitutes 30 percent or more of the weight of the mixture:

[[Page 2513]]

    c.1. (C.A.S. #762-04-9) Diethyl phosphite;
    c.2. (C.A.S. #868-85-9) Dimethyl phosphite (dimethyl hydrogen 
phosphite);
    c.3. (C.A.S. #139-87-7) Ethyldiethanolamine;
    c.4. (C.A.S. #10025-87-3) Phosphorus oxychloride;
    c.5. (C.A.S. #10026-13-8) Phosphorus pentachloride;
    c.6. (C.A.S. #7719-12-2) Phosphorus trichloride;
    c.7. (C.A.S. #10545-99-0) Sulfur dichloride;
    c.8. (C.A.S. #10025-67-9) Sulfur monochloride;
    c.9. (C.A.S. #7719-09-7) Thionyl chloride;
    c.10. (C.A.S. #102-71-6) Triethanolamine;
    c.11. (C.A.S. #122-52-1) Triethyl phosphite;
    c.12. (C.A.S. #121-45-9) Trimethyl phosphite.
    d. Other Australia Group-controlled precursor chemicals not also 
identified as Schedule 1, 2, or 3 chemicals under the CWC, as 
follows, and mixtures in which at least one of the following 
chemicals constitutes 30 percent or more of the weight of the 
mixture:
    d.1. (C.A.S. #1341-49-7) Ammonium hydrogen fluoride;
    d.2. (C.A.S. #107-07-3) 2-Chloroethanol;
    d.3. (C.A.S. #109-89-7) Diethylamine;
    d.4. (C.A.S. #100-37-8) N,N-Diethylaminoethanol;
    d.5. (C.A.S. #589-57-1) Diethyl chlorophosphite;
    d.6. (C.A.S. #298-06-6) O,O-Diethyl phosphorodithioate;
    d.7. (C.A.S. #2465-65-8) O,O-Diethyl phosphorothioate;
    d.8. (C.A.S. #108-18-9) Di-isopropylamine;
    d.9. (C.A.S. #124-40-3) Dimethylamine;
    d.10. (C.A.S. #506-59-2) Dimethylamine hydrochloride;
    d.11. (C.A.S. #762-77-6) Ethyl chlorofluorophosphate;
    d.12. (C.A.S. #1498-51-7) Ethyl dichlorophosphate;
    d.13. (C.A.S. #460-52-6) Ethyl difluorophosphate;
    d.14. (C.A.S. #7664-39-3) Hydrogen fluoride;
    d.15. (C.A.S. #3554-74-3) 3-Hydroxyl-1-methylpiperidine;
    d.16. (C.A.S. #76-89-1) Methyl benzilate;
    d.17. (C.A.S. #754-01-8) Methyl chlorofluorophosphate;
    d.18. (C.A.S. #677-24-7) Methyl dichlorophosphate;
    d.19. (C.A.S. #22382-13-4) Methyl difluorophosphate;
    d.20. (C.A.S. #14277-06-6) N,N Diethylacetamidine;
    d.21. (C.A.S. #53510-30-8) N,N-Diethylbutanamidine;
    d.22. (C.A.S. #90324-67-7) N,N-Diethylformamidine;
    d.23. (C.A.S. #1342789-47-2) N,N Diethylisobutanamidine;
    d.24. (C.A.S. #84764-73-8) N,N-Diethylpropanamidine;
    d.25. (C.A.S. #1315467-17-4) N,N-Diisopropylbutanamidine;
    d.26. (C.A.S. #857522-08-8) N,N-Diisopropylformamidine;
    d.27. (C.A.S. #2909-14-0) N,N-Dimethylacetamidine;
    d.28. (C.A.S. #1340437-35-5) N,N-Dimethylbutanamidine;
    d.29. (C.A.S. #44205-42-7) N,N-Dimethylformamidine;
    d.30. (C.A.S. #321881-25-8) N,N-Dimethylisobutanamidine;
    d.31. (C.A.S. #56776-14-8) N,N-Dimethylpropanamidine;
    d.32. (C.A.S. #1339586-99-0) N,N-Dipropylacetamidine;
    d.33. C.A.S. #1342422-35-8) N,N-Dipropylbutanamidine;
    d.34. (C.A.S. #48044-20-8) N,N-Dipropylformamidine;
    d.35. (C.A.S. #1342700-45-1) N,N-Dipropylisobutanamidine;
    d.36. (C.A.S. #1341496-89-6) N,N-Dipropylpropanamidine;
    d.37. (C.A.S. #1314-80-3) Phosphorus pentasulfide;
    d.38. (C.A.S. #75-97-8) Pinacolone;
    d.39. (C.A.S. #7789-29-9) Potassium bifluoride;
    d.40. (C.A.S. #151-50-8) Potassium cyanide;
    d.41. (C.A.S. #7789-23-3) Potassium fluoride;
    d.42. (C.A.S. #3731-38-2) 3-Quinuclidone;
    d.43. (C.A.S. #1333-83-1) Sodium bifluoride;
    d.44. (C.A.S. #143-33-9) Sodium cyanide;
    d.45. (C.A.S. #7681-49-4) Sodium fluoride;
    d.46. (C.A.S. #16893-85-9) Sodium hexafluorosilicate;
    d.47. (C.A.S. #1313-82-2) Sodium sulfide;
    d.48. (C.A.S. #637-39-8) Triethanolamine hydrochloride;
    d.49. (C.A.S. #116-17-6) Tri-isopropyl phosphite.
1C351 Human and animal pathogens and ``toxins,'' as follows (see 
List of Items Controlled).

License Requirements

Reason for Control: CB, CW, AT

 
                                            Country chart (See Supp. No.
                Control(s)                         1 to part 738)
 
CB applies to entire entry................  CB Column 1.
 

    CW applies to 1C351.d.14 and .d.15 and a license is required for 
CW reasons for all destinations, including Canada, as follows: CW 
applies to 1C351.d.14 for ricin in the form of (1) Ricinus communis 
AgglutininII (RCAII), also known as ricin D or Ricinus 
Communis LectinIII (RCLIII) and (2) Ricinus communis 
LectinIV (RCLIV), also known as ricin E. CW applies to 
1C351.d.15 for saxitoxin identified by C.A.S. #35523-89-8. See Sec.  
742.18 of the EAR for licensing information pertaining to chemicals 
subject to restriction pursuant to the Chemical Weapons Convention 
(CWC). The Commerce Country Chart is not designed to determine 
licensing requirements for items controlled for CW reasons.

 
                                            Country chart (See Supp. No.
                Control(s)                         1 to part 738)
 
AT applies to entire entry................  AT Column 1.
 

    License Requirement Notes: 1. All vaccines and `immunotoxins' 
are excluded from the scope of this entry. Certain medical products 
and diagnostic and food testing kits that contain biological toxins 
controlled under 1C351.d, with the exception of toxins controlled 
for CW reasons under 1C351.d.14 or .d.15, are excluded from the 
scope of this entry. Vaccines, `immunotoxins,' certain medical 
products, and diagnostic and food testing kits excluded from the 
scope of this entry are controlled under ECCN 1C991.
    2. For the purposes of this entry, only saxitoxin is controlled 
under 1C351.d.15; other members of the paralytic shellfish poison 
family (e.g., neosaxitoxin) are designated EAR99.
    3. Clostridium perfringens strains, other than the epsilon 
toxin-producing strains of Clostridium perfringens described in 
1C351.c.12, are excluded from the scope of this entry, since they 
may be used as positive control cultures for food testing and 
quality control.
    4. Unless specified elsewhere in this ECCN 1C351 (e.g., in 
License Requirement Notes 1-3), this ECCN controls all biological 
agents and ``toxins,'' regardless of quantity or attenuation, that 
are identified in the List of Items Controlled for this ECCN, 
including small quantities or attenuated strains of select 
biological agents or ``toxins'' that are excluded from the lists of 
select biological agents or ``toxins'' by the Animal and Plant 
Health Inspection Service (APHIS), U.S. Department of Agriculture 
(USDA), or the Centers for Disease Control and Prevention (CDC), 
U.S. Department of Health and Human Services (HHS), in accordance 
with their regulations in 9 CFR part 121 and 42 CFR part 73, 
respectively.
    5. Biological agents and pathogens are controlled under this 
ECCN 1C351 when they are an isolated live culture of a pathogen 
agent, or a preparation of a toxin agent that has been isolated or 
extracted from any source or material, including living material 
that has been deliberately inoculated or contaminated with the 
agent. Isolated live cultures of a pathogen agent include live 
cultures in dormant form or in dried preparations, whether the agent 
is natural, enhanced or modified.

List Based License Exceptions (See Part 740 for a Description of All 
License Exceptions)

LVS: N/A
GBS: N/A

Special Conditions for STA

STA: (1) Paragraph (c)(1) of License Exception STA (Sec.  
740.20(c)(1)) may be used for items in 1C351.d.1 through 1C351.d.13 
and 1C351.d.16 through 1C351.d.21. See Sec.  740.20(b)(2)(vi) for 
restrictions on the quantity of any one toxin that may be exported 
in a single shipment and the number of shipments that may be made to 
any one end user in a single calendar year. Also see the Automated 
Export System (AES) requirements in Sec.  758.1(b)(4) of the EAR. 
(2) Paragraph (c)(2) of License Exception STA (Sec.  740.20(c)(2) of 
the EAR) may not be used for any items in 1C351.

[[Page 2514]]

List of Items Controlled

Related Controls: (1) Certain forms of ricin and saxitoxin in 
1C351.d.14 and .d.15 are CWC Schedule 1 chemicals (see Sec.  742.18 
of the EAR). The U.S. Government must provide advance notification 
and annual reports to the OPCW of all exports of Schedule 1 
chemicals. See Sec.  745.1 of the EAR for notification procedures. 
See 22 CFR part 121, Category XIV and Sec.  121.7 for CWC Schedule 1 
chemicals that are ``subject to the ITAR.'' (2) The Animal and Plant 
Health Inspection Service (APHIS), U.S. Department of Agriculture, 
and the Centers for Disease Control and Prevention (CDC), U.S. 
Department of Health and Human Services, maintain controls on the 
possession, use, and transfer within the United States of certain 
items controlled by this ECCN (for APHIS, see 7 CFR 331.3(b), 9 CFR 
121.3(b), and 9 CFR 121.4(b); for CDC, see 42 CFR 73.3(b) and 42 CFR 
73.4(b)). (3) See 22 CFR part 121, Category XIV(b), for modified 
biological agents and biologically derived substances that are 
``subject to the ITAR.''
Related Definitions: For the purposes of this entry, `immunotoxins' 
are monoclonal antibodies linked to a toxin with the intention of 
destroying a specific target cell while leaving adjacent cells 
intact.
Items:

    a. Viruses identified on the Australia Group (AG) ``List of 
Human and Animal Pathogens and Toxins for Export Control,'' as 
follows:
    a.1. African horse sickness virus;
    a.2. African swine fever virus;
    a.3. Andes virus;
    a.4. Avian influenza (AI) viruses identified as having high 
pathogenicity (HP), as follows:
    a.4.a. AI viruses that have an intravenous pathogenicity index 
(IVPI) in 6-week-old chickens greater than 1.2; or
    a.4.b. AI viruses that cause at least 75% mortality in 4- to 8-
week-old chickens infected intravenously.
    Note: Avian influenza (AI) viruses of the H5 or H7 subtype that 
do not have either of the characteristics described in 1C351.a.4 
(specifically, 1C351.a.4.a or .a.4.b) should be sequenced to 
determine whether multiple basic amino acids are present at the 
cleavage site of the haemagglutinin molecule (HA0). If the amino 
acid motif is similar to that observed for other HPAI isolates, then 
the isolate being tested should be considered as HPAI and the virus 
is controlled under 1C351.a.4.
    a.5. Bluetongue virus;
    a.6. Chapare virus;
    a.7. Chikungunya virus;
    a.8. Choclo virus;
    a.9. Classical swine fever virus (Hog cholera virus);
    a.10. Crimean-Congo hemorrhagic fever virus;
    a.11. Dobrava-Belgrade virus;
    a.12. Eastern equine encephalitis virus;
    a.13. Ebolavirus (includes all members of the Ebolavirus genus);
    a.14. Foot-and-mouth disease virus;
    a.15. Goatpox virus;
    a.16. Guanarito virus;
    a.17. Hantaan virus;
    a.18. Hendra virus (Equine morbillivirus);
    a.19. Japanese encephalitis virus;
    a.20. Junin virus;
    a.21. Kyasanur Forest disease virus;
    a.22. Laguna Negra virus;
    a.23. Lassa virus;
    a.24. Louping ill virus;
    a.25. Lujo virus;
    a.26. Lumpy skin disease virus;
    a.27. Lymphocytic choriomeningitis virus;
    a.28. Machupo virus;
    a.29. Marburgvirus (includes all members of the Marburgvirus 
genus);
    a.30. Middle East respiratory syndrome-related coronavirus 
(MERS-related coronavirus);
    a.31. Monkeypox virus;
    a.32. Murray Valley encephalitis virus;
    a.33. Newcastle disease virus;
    a.34. Nipah virus;
    a.35. Omsk hemorrhagic fever virus;
    a.36. Oropouche virus;
    a.37. Peste-des-petits ruminants virus;
    a.38. Porcine Teschovirus;
    a.39. Powassan virus;
    a.40. Rabies virus and all other members of the Lyssavirus 
genus;
    a.41. Reconstructed 1918 influenza virus;
    Technical Note: 1C351.a.41 includes reconstructed replication 
competent forms of the 1918 pandemic influenza virus containing any 
portion of the coding regions of all eight gene segments.
    a.42. Rift Valley fever virus;
    a.43. Rinderpest virus;
    a.44. Rocio virus;
    a.45. Sabia virus;
    a.46. Seoul virus;
    a.47. Severe acute respiratory syndrome-related coronavirus 
(SARS-related coronavirus);
    a.48. Sheeppox virus;
    a.49. Sin Nombre virus;
    a.50. St. Louis encephalitis virus;
    a.51. Suid herpesvirus 1 (Pseudorabies virus; Aujeszky's 
disease);
    a.52. Swine vesicular disease virus;
    a.53. Tick-borne encephalitis virus (Far Eastern subtype, 
formerly known as Russian Spring-Summer encephalitis virus--see 
1C351.b.3 for Siberian subtype);
    a.54. Variola virus;
    a.55. Venezuelan equine encephalitis virus;
    a.56. Vesicular stomatitis virus;
    a.57. Western equine encephalitis virus; or
    a.58. Yellow fever virus.
    b. Viruses identified on the APHIS/CDC ``select agents'' lists 
(see Related Controls paragraph #2 for this ECCN), but not 
identified on the Australia Group (AG) ``List of Human and Animal 
Pathogens and Toxins for Export Control,'' as follows:
    b.1. [Reserved];
    b.2. [Reserved]; or
    b.3. Tick-borne encephalitis virus (Siberian subtype, formerly 
West Siberian virus--see 1C351.a.53 for Far Eastern subtype).
    c. Bacteria identified on the Australia Group (AG) ``List of 
Human and Animal Pathogens and Toxins for Export Control,'' as 
follows:
    c.1. Bacillus anthracis;
    c.2. Brucella abortus;
    c.3. Brucella melitensis;
    c.4. Brucella suis;
    c.5. Burkholderia mallei (Pseudomonas mallei);
    c.6. Burkholderia pseudomallei (Pseudomonas pseudomallei);
    c.7. Chlamydia psittaci (Chlamydophila psittaci);
    c.8. Clostriduim argentinense (formerly known as Clostridium 
botulinum Type G), botulinum neurotoxin producing strains;
    c.9. Clostridium baratii, botulinum neurotoxin producing 
strains;
    c.10. Clostridium botulinum;
    c.11. Clostridium butyricum, botulinum neurotoxin producing 
strains;
    c.12. Clostridium perfringens, epsilon toxin producing types;
    c.13. Coxiella burnetii;
    c.14. Francisella tularensis;
    c.15. Mycoplasma capricolum subspecies capripneumoniae (``strain 
F38'');
    c.16. Mycoplasma mycoides subspecies mycoides SC (small colony) 
(a.k.a. contagious bovine pleuropneumonia);
    c.17. Rickettsia prowazekii;
    c.18. Salmonella enterica subspecies enterica serovar Typhi 
(Salmonella typhi);
    c.19. Shiga toxin producing Escherichia coli (STEC) of 
serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other 
shiga toxin producing serogroups;
    Note: Shiga toxin producing Escherichia coli (STEC) includes, 
inter alia, enterohaemorrhagic E. coli (EHEC), verotoxin producing 
E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).
    c.20. Shigella dysenteriae;
    c.21. Vibrio cholerae; or
    c.22. Yersinia pestis.
    d. ``Toxins'' identified on the Australia Group (AG) ``List of 
Human and Animal Pathogens and Toxins for Export Control,'' as 
follows, or their subunits:
    d.1. Abrin;
    d.2. Aflatoxins;
    d.3. Botulinum toxins;
    d.4. Brevetoxins;
    d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and 
iota toxins;
    d.6. Conotoxins;
    d.7. Diacetoxyscirpenol;
    d.8. Gonyautoxins;
    d.9. HT-2 toxin;
    d.10. Microcystins (Cyanginosins);
    d.11. Modeccin;
    d.12. Nodularins;
    d.13. Palytoxin;
    d.14. Ricin;
    d.15. Saxitoxin;
    d.16. Shiga toxins (shiga-like toxins, verotoxins, and 
verocytotoxins);
    d.17. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, 
and toxic shock syndrome toxin (formerly known as Staphylococcus 
enterotoxin F);
    d.18. T-2 toxin;
    d.19. Tetrodotoxin;
    d.20. Viscumin (Viscum album lectin 1); or
    d.21. Volkensin.
    e. ``Fungi'', as follows:
    e.1. Coccidioides immitis; or
    e.2. Coccidioides posadasii.
* * * * *
1C353 Genetic elements and genetically modified organisms, as 
follows (see List of Items Controlled).

License Requirements

Reason for Control: CB, AT

[[Page 2515]]



 
                                            Country chart (See Supp. No.
                Control(s)                         1 to part 738)
 
CB applies to entire entry................  CB Column 1.
AT applies to entire entry................  AT Column 1.
 

    License Requirements Notes:
    1. Vaccines that contain genetic elements or genetically 
modified organisms identified in this ECCN are controlled by ECCN 
1C991.
    2. Unless specified elsewhere in this ECCN 1C353 (e.g., in 
License Requirement Note 1), this ECCN controls genetic elements or 
genetically modified organisms for all biological agents and 
``toxins,'' regardless of quantity or attenuation, that are 
identified in the List of Items Controlled for this ECCN, including 
genetic elements or genetically modified organisms for attenuated 
strains of select biological agents or ``toxins'' that are excluded 
from the lists of select biological agents or ``toxins'' by the 
Animal and Plant Health Inspection Service (APHIS), U.S. Department 
of Agriculture, or the Centers for Disease Control and Prevention 
(CDC), U.S. Department of Health and Human Services, in accordance 
with the APHIS regulations in 7 CFR part 331 and 9 CFR part 121 and 
the CDC regulations in 42 CFR part 73.

List Based License Exceptions (See Part 740 for a Description of All 
License Exceptions)

LVS: N/A
GBS: N/A

List of Items Controlled

Related Controls: (1) The Animal and Plant Health Inspection Service 
(APHIS), U.S. Department of Agriculture, and the Centers for Disease 
Control and Prevention (CDC), U.S. Department of Health and Human 
Services, maintain controls on the possession, use, and transfer 
within the United States of certain items controlled by this ECCN, 
including (but not limited to) certain genetic elements, recombinant 
nucleic acids, and recombinant organisms associated with the agents 
or toxins in ECCN 1C351 or 1C354 (for APHIS, see 7 CFR 331.3(c), 9 
CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see 42 CFR 73.3(c) and 42 
CFR 73.4(c)). (2) See 22 CFR part 121, Category XIV(b), for modified 
biological agents and biologically derived substances that are 
subject to the export licensing jurisdiction of the U.S. Department 
of State, Directorate of Defense Trade Controls.
Related Definition: N/A
Items:

    a. Any genetically modified organism that contains, or any 
genetic element that codes for, any of the following:
    a.1. Any gene, genes, translated product or translated products 
specific to any virus controlled by 1C351.a or .b or 1C354.c;
    a.2. Any gene or genes specific to any bacterium controlled by 
1C351.c or 1C354.a, or any fungus controlled by 1C351.e or 1C354.b, 
and which;
    a.2.a. In itself or through its transcribed or translated 
products represents a significant hazard to human, animal or plant 
health; or
    a.2.b. Could endow or enhance pathogenicity; or
    a.3. Any toxins, or their subunits, controlled by 1C351.d.
    b. [Reserved].
    Technical Notes:
    1. Genetically modified organisms include organisms in which the 
nucleic acid sequences have been created or altered by deliberate 
molecular manipulation.
    2. ``Genetic elements'' include, inter alia, chromosomes, 
genomes, plasmids, transposons, vectors, and inactivated organisms 
containing recoverable nucleic acid fragments, whether genetically 
modified or unmodified, or chemically synthesized in whole or in 
part. For the purposes of this ECCN 1C353, nucleic acids from an 
inactivated organism, virus, or sample are considered to be 
`recoverable' if the inactivation and preparation of the material is 
intended or known to facilitate isolation, purification, 
amplification, detection, or identification of nucleic acids.
    3. This ECCN does not control nucleic acid sequences of shiga 
toxin producing Escherichia coli of serogroups O26, O45, O103, O104, 
O111, O121, O145, O157, and other shiga toxin producing serogroups, 
other than those genetic elements coding for shiga toxin, or for its 
subunits.
    4. `Endow or enhance pathogenicity' is defined as when the 
insertion or integration of the nucleic acid sequence or sequences 
is/are likely to enable or increase a recipient organism's ability 
to be used to deliberately cause disease or death. This might 
include alterations to, inter alia: virulence, transmissibility, 
stability, route of infection, host range, reproducibility, ability 
to evade or suppress host immunity, resistance to medical 
countermeasures, or detectability.
1C354 Plant pathogens, as follows (see List of Items Controlled).

License Requirements

Reason for Control: CB, AT

 
                                            Country chart (See Supp. No.
                Control(s)                         1 to part 738)
 
CB applies to entire entry................  CB Column 1.
AT applies to entire entry................  AT Column 1.
 

    License Requirements Notes
    1. All vaccines are excluded from the scope of this ECCN. See 
ECCN 1C991 for vaccines.
    2. Unless specified elsewhere in this ECCN 1C354 (e.g., in 
License Requirement Note 1), this ECCN controls all biological 
agents, regardless of quantity or attenuation, that are identified 
in the List of Items Controlled for this ECCN, including small 
quantities or attenuated strains of select biological agents that 
are excluded from the list of PPQ select agents and ``toxins'' by 
the Animal and Plant Health Inspection Service (APHIS), U.S. 
Department of Agriculture, in accordance with their regulations in 7 
CFR part 331.

List Based License Exceptions (See Part 740 for a Description of All 
License Exceptions)

LVS: N/A
GBS: N/A

List of Items Controlled

Related Controls: (1) The Animal and Plant Health Inspection Service 
(APHIS), U.S. Department of Agriculture, maintains controls on the 
possession, use, and transfer within the United States of certain 
items controlled by this ECCN (see 7 CFR 331.3(c), 9 CFR 121.3(c), 
and 9 CFR 121.4(c)). (2) See 22 CFR part 121, Category XIV(b), for 
modified biological agents and biologically derived substances that 
are subject to the export licensing jurisdiction of the U.S. 
Department of State, Directorate of Defense Trade Controls.
Related Definitions: N/A
Items:

    a. Bacteria, as follows:
    a.1. Xanthomonas albilineans;
    a.2. Xanthomonas citri pv. citri (Xanthomonas axonopodis pv. 
citri, Xanthomonas campestris pv. citri);
    a.3. Xanthomonas oryzae [this species of proteobacteria is 
identified on the APHIS ``select agents'' list (see Related Controls 
paragraph for this ECCN), but only the pathovar Xanthomonas oryzae 
pv. oryzae (syn. Pseudomonas campestris pv. oryzae) is identified on 
the Australia Group (AG) ``List of Plant Pathogens for Export 
Control''];
    a.4. Clavibacter michiganensis subsp. sepedonicus (Clavibacter 
sepedonicus, Clavibacter michiganense subsp. sepedonicus, 
Corynebacterium michiganensis subsp. sepedonicum, Corynebacterium 
sepedonicum);
    a.5. Ralstonia solanacearum, race 3, biovar 2;
    a.6. Raythayibactor toxicus [this bacterium is identified on the 
APHIS ``select agents'' list (see the Related Controls paragraph for 
this ECCN), but is not identified on the Australia Group (AG) ``List 
of Plant Pathogens for Export Control''].
    b. Fungi, as follows:
    b.1. Bipolaris oryzae (Cochliobolus miyabeanus, Helminthosporium 
oryzae);
    b.2. Colletotrichum kahawae (Colletotrichum coffeanum var. 
virulans);
    b.3. Pseudocercospora ulei (Microcyclus ulei, Dothidella ulei);
    b.4. Puccinnia graminis ssp. graminis var. graminis/Puccinia 
graminis ssp. graminis var. stakmanii (Puccinia graminis [syn. 
Puccinia graminis f. sp. tritici]);
    b.5. Puccinia striiformis (syn. Puccinia glumarum);
    b.6. Magnaporthe oryzae (Pyricularia oryzae);
    b.7. Peronosclerospora philippinensis (Peronosclerospora 
sacchari);
    b.8. Sclerophthora rayssiae var. zeae;
    b.9. Synchytrium endobioticum;
    b.10. Tilletia indica;
    b.11. Thecaphora solani;
    b.12. Phoma glycinicola (formerly Pyrenochaeta glycines) [this 
fungus is identified on the APHIS ``select agents'' list (see the 
Related Controls paragraph for this ECCN), but is not identified on 
the Australia Group (AG) ``List of Plant Pathogens for Export 
Control''].
    c. Viruses, as follows:
    c.1. Andean potato latent virus (Potato Andean latent 
tymovirus);
    c.2. Potato spindle tuber viroid.
* * * * *

[[Page 2516]]

1C991 Vaccines, immunotoxins, medical products, diagnostic and food 
testing kits, as follows (see List of Items Controlled).

License Requirements

Reason for Control: CB, AT

 
                                            Country chart (See Supp. No.
                Control(s)                         1 to part 738)
 
CB applies to 1C991.c.....................  CB Column 3.
AT applies to entire entry................  AT Column 1.
 

List Based License Exceptions (See Part 740 for a Description of All 
License Exceptions)

LVS: N/A
GBS: N/A

List of Items Controlled

Related Controls: (1) Medical products containing ricin or 
saxitoxin, as follows, are controlled for CW reasons under ECCN 
1C351:
    (a) Ricinus communis AgglutininII (RCAII), also known 
as ricin D, or Ricinus Communis LectinIII (RCLIII);
    (b) Ricinus communis LectinIV (RCLIV), also known as 
ricin E; or
    (c) Saxitoxin identified by C.A.S. #35523-89-8.
    (2) The export of a ``medical product'' that is an 
``Investigational New Drug'' (IND), as defined in 21 CFR 312.3, is 
subject to certain U.S. Food and Drug Administration (FDA) 
requirements that are independent of the export requirements 
specified in this ECCN or elsewhere in the EAR. These FDA 
requirements are described in 21 CFR 312.110 and must be satisfied 
in addition to any requirements specified in the EAR.
    (3) Also see 21 CFR 314.410 for FDA requirements concerning 
exports of new drugs and new drug substances.
Related Definitions: For the purpose of this entry, `immunotoxins' 
are monoclonal antibodies linked to a toxin with the intention of 
destroying a specific target cell while leaving adjacent cells 
intact. For the purpose of this entry, `medical products' are: (1) 
Pharmaceutical formulations designed for testing and human (or 
veterinary) administration in the treatment of medical conditions; 
(2) prepackaged for distribution as clinical or medical products; 
and (3) approved by the U.S. Food and Drug Administration either to 
be marketed as clinical or medical products or for use as an 
``Investigational New Drug'' (IND) (see 21 CFR part 312). For the 
purpose of this entry, `diagnostic and food testing kits' are 
specifically developed, packaged and marketed for diagnostic or 
public health purposes. Biological toxins in any other 
configuration, including bulk shipments, or for any other end-uses 
are controlled by ECCN 1C351. For the purpose of this entry, 
`vaccine' is defined as a medicinal (or veterinary) product in a 
pharmaceutical formulation, approved by the U.S. Food and Drug 
Administration or the U.S. Department of Agriculture to be marketed 
as a medical (or veterinary) product or for use in clinical trials, 
that is intended to stimulate a protective immunological response in 
humans or animals in order to prevent disease in those to whom or to 
which it is administered.
Items:
    Technical Note: For purposes of the controls described in this 
ECCN, `toxins' refers to those toxins, or their subunits, controlled 
under ECCN 1C351.d.
    a. Vaccines containing, or designed for use against, items 
controlled by ECCN 1C351, 1C353 or 1C354.
    b. Immunotoxins containing toxins controlled by 1C351.d;
    c. Medical products that contain any of the following:
    c.1. Toxins controlled by ECCN 1C351.d (except for botulinum 
toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN 
1C351.d.6, or items controlled for CW reasons under ECCN 1C351.d.14 
or .d.15); or
    c.2. Genetically modified organisms or genetic elements 
controlled by ECCN 1C353.a.3 (except for those that contain, or code 
for, botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins 
controlled by ECCN 1C351.d.6);
    d. Medical products not controlled by 1C991.c that contain any 
of the following:
    d.1. Botulinum toxins controlled by ECCN 1C351.d.3;
    d.2. Conotoxins controlled by ECCN 1C351.d.6; or
    d.3. Genetically modified organisms or genetic elements 
controlled by ECCN 1C353.a.3 that contain, or code for, botulinum 
toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 
1C351.d.6;
    e. Diagnostic and food testing kits containing toxins controlled 
by ECCN 1C351.d (except for items controlled for CW reasons under 
ECCN 1C351.d.14 or .d.15).
* * * * *
2B352 Equipment Capable of Use in Handling Biological Materials, as 
Follows (See List of Items Controlled).

License Requirements

Reason for Control: CB, AT

 
                                            Country chart (See Supp. No.
                Control(s)                         1 to part 738)
 
CB applies to entire entry................  CB Column 2.
AT applies to entire entry................  AT Column 1.
 

List Based License Exceptions (See Part 740 for a Description of All 
License Exceptions)

LVS: N/A
GBS: N/A

List of Items Controlled

Related Controls: See ECCNs 1A004 and 1A995 for protective equipment 
that is not covered by this entry. Also see ECCN 9A120 for controls 
on certain ``UAV'' systems designed or modified to dispense an 
aerosol and capable of carrying elements of a payload in the form of 
a particulate or liquid, other than fuel ``parts'' or ``components'' 
of such vehicles, of a volume greater than 20 liters.
Related Definitions: (1) ``Lighter than air vehicles''--balloons and 
airships that rely on hot air or on lighter-than-air gases, such as 
helium or hydrogen, for their lift. (2) ``UAVs''--Unmanned Aerial 
Vehicles. (3) ``VMD''--Volume Median Diameter.
Items:

    a. Containment facilities and related equipment, as follows:
    a.1. Complete containment facilities at P3 or P4 containment 
level.
    Technical Note to 2B352.a.1: P3 or P4 (BL3, BL4, L3, L4) 
containment levels are as specified in the WHO Laboratory Biosafety 
Manual (3rd edition, Geneva, 2004).
    a.2. Equipment designed for fixed installation in containment 
facilities specified in paragraph a.1 of this ECCN, as follows:
    a.2.a. Double-door pass-through decontamination autoclaves;
    a.2.b. Breathing air suit decontamination showers;
    a.2.c. Mechanical-seal or inflatable-seal walkthrough doors.
    b. Fermenters and components as follows:
    b.1. Fermenters capable of cultivation of micro-organisms or of 
live cells for the production of viruses or toxins, without the 
propagation of aerosols, having a total internal volume of 20 liters 
or greater.
    b.2. Components designed for such fermenters, as follows:
    b.2.a. Cultivation chambers designed to be sterilized or 
disinfected in situ;
    b.2.b. Cultivation chamber holding devices; or
    b.2.c. Process control units capable of simultaneously 
monitoring and controlling two or more fermentation system 
parameters (e.g., temperature, pH, nutrients, agitation, dissolved 
oxygen, air flow, foam control).
    Technical Notes to 2B352.b:
    1. Fermenters include bioreactors (including single-use 
(disposable) bioreactors), chemostats and continuous-flow systems.
    2. Cultivation chamber holding devices controlled by 2B352.b.2.b 
include single-use cultivation chambers with rigid walls.
    c. Centrifugal separators capable of the continuous separation 
of pathogenic microorganisms, without the propagation of aerosols, 
and having all of the following characteristics:
    c.1. One or more sealing joints within the steam containment 
area;
    c.2. A flow rate greater than 100 liters per hour;
    c.3. ``Parts'' or ``components'' of polished stainless steel or 
titanium; and
    c.4. Capable of in-situ steam sterilization in a closed state.
    Technical Note to 2B352.c: Centrifugal separators include 
decanters.
    d. Cross (tangential) flow filtration equipment and 
``accessories'', as follows:
    d.1. Cross (tangential) flow filtration equipment capable of 
separation of microorganisms, viruses, toxins or cell cultures 
having all of the following characteristics:
    d.1.a. A total filtration area equal to or greater than 1 square 
meter (1 m\2\); and
    d.1.b. Having any of the following characteristics:

[[Page 2517]]

    d.1.b.1. Capable of being sterilized or disinfected in-situ; or
    d.1.b.2. Using disposable or single-use filtration ``parts'' or 
``components''.
    N.B.: 2B352.d.1 does not control reverse osmosis and 
hemodialysis equipment, as specified by the manufacturer.
    d.2. Cross (tangential) flow filtration ``parts'' or 
``components'' (e.g., modules, elements, cassettes, cartridges, 
units or plates) with filtration area equal to or greater than 0.2 
square meters (0.2 m\2\) for each ``part'' or ``component'' and 
designed for use in cross (tangential) flow filtration equipment 
controlled by 2B352.d.1.
    Technical Note: In this ECCN, ``sterilized'' denotes the 
elimination of all viable microbes from the equipment through the 
use of either physical (e.g., steam) or chemical agents. 
``Disinfected'' 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.
    e. Steam, gas or vapor sterilizable freeze-drying equipment with 
a condenser capacity of 10 kg of ice or greater in 24 hours (10 
liters of water or greater in 24 hours) and less than 1000 kg of ice 
in 24 hours (less than 1,000 liters of water in 24 hours).
    f. Spray-drying equipment capable of drying toxins or pathogenic 
microorganisms having all of the following characteristics:
    f.1. A water evaporation capacity of >=0.4 kg/h and <=400 kg/h;
    f.2. The ability to generate a typical mean product particle 
size of <=10 micrometers with existing fittings or by minimal 
modification of the spray-dryer with atomization nozzles enabling 
generation of the required particle size; and
    f.3. Capable of being sterilized or disinfected in situ.
    g. Protective and containment equipment, as follows:
    g.1. Protective full or half suits, or hoods dependent upon a 
tethered external air supply and operating under positive pressure.
    Technical Note to 2B352.g.1: 2B352.g.1 does not control suits 
designed to be worn with self-contained breathing apparatus.
    g.2. Biocontainment chambers, isolators, or biological safety 
cabinets having all of the following characteristics, for normal 
operation:
    g.2.a. Fully enclosed workspace where the operator is separated 
from the work by a physical barrier;
    g.2.b. Able to operate at negative pressure;
    g.2.c. Means to safely manipulate items in the workspace; and
    g.2.d. Supply and exhaust air to and from the workspace is high-
efficiency particulate air (HEPA) filtered.
    Note 1 to 2B352.g.2: 2B352.g.2 controls class III biosafety 
cabinets, as specified in the WHO Laboratory Biosafety Manual (3rd 
edition, Geneva, 2004) or constructed in accordance with national 
standards, regulations or guidance.
    Note 2 to 2B352.g.2: 2B352.g.2 controls any isolator having all 
of the characteristics described in 2B352.g.2.a through g.2.d, 
regardless of its intended use and its designation, except for 
medical isolators ``specially designed'' for barrier nursing or 
transportation of infected patients.
    h. Aerosol inhalation equipment designed for aerosol challenge 
testing with microorganisms, viruses or toxins, as follows:
    h.1. Whole-body exposure chambers having a capacity of 1 cubic 
meter or greater;
    h.2. Nose-only exposure apparatus utilizing directed aerosol 
flow and having a capacity for the exposure of 12 or more rodents, 
or two or more animals other than rodents, and closed animal 
restraint tubes designed for use with such apparatus.
    i. Spraying or fogging systems and ``parts'' and ``components'' 
therefor, as follows:
    i.1. Complete spraying or fogging systems, ``specially 
designed'' or modified for fitting to aircraft, ``lighter than air 
vehicles,'' or ``UAVs,'' capable of delivering, from a liquid 
suspension, an initial droplet ``VMD'' of less than 50 microns at a 
flow rate of greater than 2 liters per minute;
    i.2. Spray booms or arrays of aerosol generating units, 
``specially designed'' or modified for fitting to aircraft, 
``lighter than air vehicles,'' or ``UAVs,'' capable of delivering, 
from a liquid suspension, an initial droplet ``VMD'' of less than 50 
microns at a flow rate of greater than 2 liters per minute;
    i.3. Aerosol generating units ``specially designed'' for fitting 
to the systems as specified in paragraphs i.1 and i.2 of this ECCN.
    Technical Notes to 2B352.i:
    1. Aerosol generating units are devices ``specially designed'' 
or modified for fitting to aircraft and include nozzles, rotary drum 
atomizers and similar devices.
    2. This ECCN does not control spraying or fogging systems, 
``parts'' and ``components,'' as specified in 2B352.i, that are 
demonstrated not to be capable of delivering biological agents in 
the form of infectious aerosols.
    3. Droplet size for spray equipment or nozzles ``specially 
designed'' for use on aircraft or ``UAVs'' should be measured using 
either of the following methods (pending the adoption of 
internationally accepted standards):
    a. Doppler laser method,
    b. Forward laser diffraction method.
    j. Nucleic acid assemblers and synthesizers that are both:
    j.1 Partly or entirely automated; and
    j.2. Designed to generate continuous nucleic acids greater than 
1.5 kilobases in length with error rates less than 5% in a single 
run.
* * * * *

Thea D. Rozman Kendler,
Assistant Secretary, for Export Administration.
[FR Doc. 2023-00397 Filed 1-13-23; 8:45 am]
BILLING CODE 3510-33-P

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