Federal Register/Vol. 85, No. 117/Wednesday, June 17, 2020

Home , Bifluoride, Difluorophosphate, Sodium bifluoride, Thiodiglycol

Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Rules and Regulations 36483

other person (except an airman serving 1C350 is amended by adding twenty- program. The AG periodically reviews as an airman) not operating an aircraft four precursor chemicals, as well as items on its control list to enhance the for the transportation of passengers or mixtures in which at least one of these effectiveness of participating property for compensation. For chemicals constitutes 30 percent or governments’ national controls and to violations that occurred after November more of the weight of the mixture, to achieve greater harmonization among 2, 2015, $13,910 per violation, up to a ECCN 1C350.d. ECCN 1C351 is these controls. total of $556,419 per civil penalty amended to add Middle East respiratory Amendments to the CCL Based on the action, in the case of any other person syndrome-related coronavirus (MERS- February 2020 AG Intersessional (except an airman serving as an airman) related coronavirus). ECCN 2B352 is Recommendations not operating an aircraft for the amended by adding a Technical Note to transportation of passengers or property indicate that cultivation chamber ECCN 1C350 (Chemical Weapons for compensation. holding devices controlled in Precursors) (3) For violations that occurred on or 2B352.b.2.b include single-use This final rule amends Export Control before November 2, 2015, $25,000 per cultivation chambers with rigid walls. Classification Number (ECCN) 1C350 on violation, up to a total of $400,000 per The items addressed by this final rule the Commerce Control List (CCL) civil penalty action, in the case of a were not previously listed on the CCL (Supplement No. 1 to part 774 of the person operating an aircraft for the or controlled multilaterally. BIS, EAR) to reflect changes to the AG transportation of passengers or property consistent with the interagency process ‘‘Chemical Weapons Precursors’’ for compensation (except an individual described in the Export Control Reform common control list based on the serving as an airman). For violations Act of 2018 (ECRA), identified the February 2020 Intersessional that occurred after November 2, 2015, precursor chemicals and single-use Implementation Meeting $34,777 per violation, up to a total of cultivation chambers addressed by this recommendations that were approved $556,419 per civil penalty action, in the final rule as emerging technologies that by the AG pursuant to a silence case of a person (except an individual are essential to U.S. national security procedure which ended on February 28, serving as an airman) operating an and for which effective controls can be 2020. Specifically, this rule amends aircraft for the transportation of implemented. The inclusion of such ECCN 1C350 by adding the following passengers or property for items in this final rule is consistent with twenty-four precursor chemicals under compensation. the requirements of ECRA and the decision of the AG to add such items to ECCN 1C350.d: Chad R. Mizelle, its common control lists, thereby (C.A.S. #589–57–1) Diethyl Senior Official Performing the Duties of the making exports of such items subject to chlorophosphite; General Counsel. multilateral control (following the (C.A.S. #762–77–6) Ethyl [FR Doc. 2020–11124 Filed 6–16–20; 8:45 am] implementation of these changes by chlorofluorophosphate; BILLING CODE 9110–9–P, 9111–14–P, 9111–28–P, 9110– individual AG participating countries, (C.A.S. #1498–51–7) Ethyl 04–P, 9110–05–P including the United States). dichlorophosphate; (C.A.S. #460–52–6) Ethyl DATES: This rule is effective June 17, 2020. difluorophosphate; DEPARTMENT OF COMMERCE (C.A.S. #754–01–8) Methyl FOR FURTHER INFORMATION CONTACT: Dr. chlorofluorophosphate; Bureau of Industry and Security Wesley Johnson, Chemical and (C.A.S. #677–24–7) Methyl Biological Controls Division, Office of dichlorophosphate; 15 CFR Parts 748 and 774 Nonproliferation and Treaty (C.A.S. #22382–13–4) Methyl Compliance, Bureau of Industry and [Docket No. 200521–0143] difluorophosphate; Security, Telephone: (202) 482–0091, (C.A.S. #14277–06–6) N,N- RIN 0694–AH60 Email: [email protected]. Diethylacetamidine; SUPPLEMENTARY INFORMATION: The (C.A.S. #53510–30–8) N,N- Implementation of the February 2020 Bureau of Industry and Security (BIS) is Diethylbutanamidine; Australia Group Intersessional amending the Export Administration (C.A.S. #90324–67–7) N,N- Decisions: Addition of Certain Rigid- Regulations (EAR) to implement the Diethylformamidine; Walled, Single-Use Cultivation decisions made at the Australia Group (C.A.S. #1342789–47–2) N,N- Chambers and Precursor Chemicals to (AG) Intersessional Implementation Diethylisobutanamidine; the Commerce Control List Meeting held in Bratislava, Slovak (C.A.S. #84764–73–8) N,N- AGENCY: Bureau of Industry and Republic, on February 5 through 6, Diethylpropanamidine; Security, Commerce. 2020, and those subsequently made (C.A.S. #1315467–17–4) N,N- ACTION: Final rule. pursuant to the AG silence procedure Diisopropylbutanamidine; which ended on February 28, 2020 (the (C.A.S. #857522–08–8) N,N- SUMMARY: The Bureau of Industry and AG silence procedure provides for the Diisopropylformamidine; Security (BIS) publishes this final rule adoption of a measure, subsequent to its (C.A.S. #2909–14–0) N,N- to amend the Export Administration provisional acceptance at an AG plenary Dimethylacetamidine; Regulations (EAR) to implement the or intersessional meeting, provided that (C.A.S. #1340437–35–5) N,N- decisions made at the February 2020 no participating country submits an Dimethylbutanamidine; Australia Group (AG) Intersessional objection on or before a specified date). (C.A.S. #44205–42–7) N,N- Implementation Meeting, and those later The AG is a multilateral forum Dimethylformamidine; adopted pursuant to the AG’s silence consisting of 42 participating countries (C.A.S. #321881–25–8) N,N- procedure. Specifically, this rule and the European Union that maintain Dimethylisobutanamidine; amends Export Control Classification export controls on a list of chemicals, (C.A.S. #56776–14–8) N,N- Numbers (ECCNs) 1C350, 1C351 and biological agents, and related equipment Dimethylpropanamidine; 2B352 on the Commerce Control List and technology that could be used in a (C.A.S. #1339586–99–0) N,N- (CCL) to reflect these AG changes. ECCN chemical or biological weapons Dipropylacetamidine;

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(C.A.S. #1342422–35–8) N,N- (‘‘technology’’ for the disposal of, inter effective controls can be implemented. Dipropylbutanamidine; alia, precursor chemicals), these ECCNs This interagency process resulted in a (C.A.S. #48044–20–8) N,N- cross-reference items controlled by finding that the absence of export Dipropylformamidine; ECCN 1C350 and, consequently, controls on these precursor chemicals (C.A.S. #1342700–45–1) N,N- ‘‘software’’ or ‘‘technology’’ that is could be exploited for chemical Dipropylisobutanamidine; and related to any of the twenty-four weapons purposes. The inclusion of (C.A.S. #1341496–89–6) N,N- precursor chemicals added by this rule these precursor chemicals in this final Dipropylpropanamidine. to ECCN 1C350.d is now subject to rule is consistent with the requirements Note that mixtures in which at least control under ECCN 1D390, 1E001, of ECRA and the decision of the AG to one of the chemicals listed in ECCN 1E350 or 1E351 if such ‘‘software’’ or add these items to their common control 1C350.d (which now includes the ‘‘technology’’ falls within the lists, thereby making exports of such twenty-four precursor chemicals listed parameters of the controls described items subject to multilateral control. above) constitutes 30 percent or more of therein. the weight of the mixture are also Prior to the addition of these twenty- This rule alphabetically reorders the controlled under this ECCN. four precursor chemicals to the AG precursor chemicals listed in ECCN In addition, although this rule does chemical weapons precursors common 1C350.d to reflect the addition of the not amend ECCN 1D390 (‘‘software’’ for control list, BIS, consistent with the twenty-four precursor chemicals chemical production process control), interagency process described in the identified above. To assist in identifying ECCN 1E001 (‘‘technology’’ for the Export Control Reform Act of 2018 the precursor chemicals that are now ‘‘development’’ or ‘‘production’’ of, (ECRA) (50 U.S.C. 4801–4852) under controlled under ECCN 1C350.d, the inter alia, precursor chemicals Section 1758 (codified at 50 U.S.C. following table lists each chemical now controlled by ECCN 1C350), ECCN 4817), identified these items as found in ECCN 1C350.d, as well as the 1E350 (‘‘technology’’ for chemical emerging technologies that are essential previous ECCN 1C350.d listing (if any) production facilities) or ECCN 1E351 to U.S. national security and for which for these chemicals.

Previous CCL Current CCL AG-controlled precursor chemicals designation designation

(C.A.S. #1341–49–7) Ammonium hydrogen fluoride ...... ECCN 1C350.d.1 ...... ECCN 1C350.d.1. (C.A.S. #107–07–3) 2-Chloroethanol ...... ECCN 1C350.d.2 ...... ECCN 1C350.d.2. (C.A.S. #109–89–7) Diethylamine ...... ECCN 1C350.d.3 ...... ECCN 1C350.d.3. (C.A.S. #100–37–8) N,N-Diethylaminoethanol ...... ECCN 1C350.d.4 ...... ECCN 1C350.d.4. (C.A.S. #589–57–1) Diethyl chlorophosphite ...... Not listed ...... ECCN 1C350.d.5. (C.A.S. #298–06–6) O,O-Diethyl phosphorodithioate ...... ECCN 1C350.d.5 ...... ECCN 1C350.d.6. (C.A.S. #2465–65–8) O,O-Diethyl phosphorothioate ...... ECCN 1C350.d.6 ...... ECCN 1C350.d.7. (C.A.S. #108–18–9) Di-isopropylamine ...... ECCN 1C350.d.7 ...... ECCN 1C350.d.8. (C.A.S. #124–40–3) Dimethylamine ...... ECCN 1C350.d.8 ...... ECCN 1C350.d.9. (C.A.S. #506–59–2) Dimethylamine hydrochloride ...... ECCN 1C350.d.9 ...... ECCN 1C350.d.10. (C.A.S. #762–77–6) Ethyl chlorofluorophosphate ...... Not listed ...... ECCN 1C350.d.11. (C.A.S. #1498–51–7) Ethyl dichlorophosphate ...... Not listed ...... ECCN 1C350.d.12. (C.A.S. #460–52–6) Ethyl difluorophosphate ...... Not listed ...... ECCN 1C350.d.13. (C.A.S. #7664–39–3) Hydrogen fluoride ...... ECCN 1C350.d.10 ...... ECCN 1C350.d.14. (C.A.S. #3554–74–3) 3-Hydroxyl-1-methylpiperidine ...... ECCN 1C350.d.11 ...... ECCN 1C350.d.15. (C.A.S. #76–89–1) Methyl benzilate ...... ECCN 1C350.d.12 ...... ECCN 1C350.d.16. (C.A.S. #754–01–8) Methyl chlorofluorophosphate ...... Not listed ...... ECCN 1C350.d.17. (C.A.S. #677–24–7) Methyl dichlorophosphate ...... Not listed ...... ECCN 1C350.d.18. (C.A.S. #22382–13–4) Methyl difluorophosphate ...... Not listed ...... ECCN 1C350.d.19. (C.A.S. #14277–06–6) N,N Diethylacetamidine ...... Not listed ...... ECCN 1C350.d.20. (C.A.S. #53510–30–8) N,N-Diethylbutanamidine ...... Not listed ...... ECCN 1C350.d.21. (C.A.S. #90324–67–7) N,N-Diethylformamidine ...... Not listed ...... ECCN 1C350.d.22. (C.A.S. #1342789–47–2) N,N Diethylisobutanamidine ...... Not listed ...... ECCN 1C350.d.23. (C.A.S. #84764–73–8) N,N-Diethylpropanamidine ...... Not listed ...... ECCN 1C350.d.24. (C.A.S. #1315467–17–4) N,N-Diisopropylbutanamidine ...... Not listed ...... ECCN 1C350.d.25. (C.A.S. #857522–08–8) N,N-Diisopropylformamidine ...... Not listed ...... ECCN 1C350.d.26. (C.A.S. #2909–14–0) N,N-Dimethylacetamidine ...... Not listed ...... ECCN 1C350.d.27. (C.A.S. #1340437–35–5) N,N-Dimethylbutanamidine ...... Not listed ...... ECCN 1C350.d.28. (C.A.S. #44205–42–7) N,N-Dimethylformamidine ...... Not listed ...... ECCN 1C350.d.29. (C.A.S. #321881–25–8) N,N-Dimethylisobutanamidine ...... Not listed ...... ECCN 1C350.d.30. (C.A.S. #56776–14–8) N,N-Dimethylpropanamidine ...... Not listed ...... ECCN 1C350.d.31. (C.A.S. #1339586–99–0) N,N-Dipropylacetamidine ...... Not listed ...... ECCN 1C350.d.32. C.A.S. #1342422–35–8) N,N-Dipropylbutanamidine ...... Not listed ...... ECCN 1C350.d.33. (C.A.S. #48044–20–8) N,N-Dipropylformamidine ...... Not listed ...... ECCN 1C350.d.34. (C.A.S. #1342700–45–1) N,N-Dipropylisobutanamidine ...... Not listed ...... ECCN 1C350.d.35. (C.A.S. #1341496–89–6) N,N-Dipropylpropanamidine ...... Not listed ...... ECCN 1C350.d.36. (C.A.S. #1314–80–3) Phosphorus pentasulfide ...... ECCN 1C350.d.13 ...... ECCN 1C350.d.37. (C.A.S. #75–97–8) Pinacolone ...... ECCN 1C350.d.14 ...... ECCN 1C350.d.38. (C.A.S. #7789–29–9) Potassium bifluoride ...... ECCN 1C350.d.15 ...... ECCN 1C350.d.39. (C.A.S. #151–50–8) Potassium cyanide ...... ECCN 1C350.d.16 ...... ECCN 1C350.d.40. (C.A.S. #7789–23–3) Potassium fluoride ...... ECCN 1C350.d.17 ...... ECCN 1C350.d.41. (C.A.S. #3731–38–2) 3-Quinuclidone ...... ECCN 1C350.d.18 ...... ECCN 1C350.d.42. (C.A.S. #1333–83–1) Sodium bifluoride ...... ECCN 1C350.d.19 ...... ECCN 1C350.d.43. (C.A.S. #143–33–9) Sodium cyanide ...... ECCN 1C350.d.20 ...... ECCN 1C350.d.44. (C.A.S. #7681–49–4) Sodium fluoride ...... ECCN 1C350.d.21 ...... ECCN 1C350.d.45. (C.A.S. #16893–85–9) Sodium hexafluorosilicate ...... ECCN 1C350.d.22 ...... ECCN 1C350.d.46.

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Previous CCL Current CCL AG-controlled precursor chemicals designation designation

(C.A.S. #1313–82–2) Sodium sulfide ...... ECCN 1C350.d.23 ...... ECCN 1C350.d.47. (C.A.S. #637–39–8) Triethanolamine hydrochloride ...... ECCN 1C350.d.24 ...... ECCN 1C350.d.48. (C.A.S. #116–17–6) Tri-isopropyl phosphite ...... ECCN 1C350.d.25 ...... ECCN 1C350.d.49.

Note that all items controlled under under CB Column 1 and AT Column 1, is now subject to control under ECCN ECCN 1C350.d, including the newly respectively, on the Commerce Country 2E001, 2E002 or 2E301 if such added precursor chemicals described Chart in Supplement No. 1 to part 738 ‘‘technology’’ falls within the above, are controlled for chemical/ of the EAR (also see the AT license parameters of the controls described biological (CB) reasons and anti- requirements described in part 742 of therein. terrorism (AT) reasons (see CB Column the EAR that apply to Iran, North Korea, Prior to the addition of these 2 of the Commerce Country Chart in Sudan and Syria). In addition, a license cultivation chambers to the AG Supplement No. 1 to part 738 of the is required to certain destinations in biological equipment common control EAR and the AT license requirements accordance with the embargoes and list, BIS, consistent with the interagency described in part 742 of the EAR that other special controls described in part process described in Section 1758 of apply to Iran, North Korea, Sudan and 746 of the EAR. Also note that, in ECRA, identified these items as Syria). A license also is required to addition to the license requirements emerging technologies that are essential certain destinations in accordance with described above, items controlled under to U.S. national security and for which the embargoes and other special ECCN 1C351.d.11 or .d.12 require a effective controls can be implemented. controls described in part 746 of the license to certain destinations for This interagency process resulted in a EAR. chemical weapons (CW) reasons, as finding that disposable cultivation described in the License Requirements chambers that do not require the use of ECCN 1C351 (Human and Animal section of ECCN 1C351 and in Section a holding device have recently gained Pathogen and Toxins) 742.18 of the EAR. significant market share in the single- This final rule amends ECCN 1C351 use biological equipment market (both on the CCL to reflect changes to the AG ECCN 2B352 (Equipment Capable of within and outside the United States) ‘‘Control List of Human and Animal Use in Handling Biological Materials) and, furthermore, that they are capable Pathogens and Toxins’’ based on the This final rule amends ECCN 2B352 of functioning as cultivation chamber February 2020 Intersessional on the CCL to reflect changes to the AG holding devices controlled under ECCN Implementation Meeting ‘‘Control List of Dual-Use Biological 2B352.b.2.b. Consequently, the absence recommendations that were adopted by Equipment and Related Technology and of export controls on these single-use AG. Specifically, this rule adds the Software’’ based on the February 2020 cultivation chambers could be exploited Middle East respiratory syndrome- Intersessional Implementation Meeting for chemical and biological weapons related coronavirus (MERS-related recommendations that were adopted by (CBW) purposes. Among the items of coronavirus) to ECCN 1C351.a.30 due to the AG. Specifically, this rule adds a concern, in this regard, are impeller- its homology with severe acute Technical Note to ECCN 2B352.b to mixed liquid culture chambers, as well respiratory syndrome-related indicate that cultivation chamber as novel packed-bed and hollow-fiber coronavirus (SARS-related coronavirus) holding devices controlled in models. The inclusion of these and its potential use in biological 2B352.b.2.b include single-use cultivation chambers in this final rule is weapons activities. The viruses in ECCN cultivation chambers with rigid walls. consistent with the requirements of 1C351.a that were previously numbered, Consequently, such single-use ECRA and the decision of the AG to add in alphabetical order, as .a.30 through cultivation chambers require a license these items to their common control .a.57 have been renumbered as .a.31 for CB reasons and AT reasons to the lists, thereby making exports of such through .a.58, respectively, and relevant destinations indicated under CB items subject to multilateral control. cross-references adjusted as necessary. Column 2 and AT Column 1, In addition, although this rule does respectively, on the Commerce Country Conforming Changes to Supplement No. not amend ECCN 1E001 (‘‘technology’’ Chart in Supplement No. 1 to part 738 7 to Part 748 for the ‘‘development’’ or ‘‘production’’ of the EAR (also see the AT license This final rule also amends of, inter alia, pathogens or ‘‘toxins’’ requirements described in part 742 that Supplement No. 7 to part 748 to update controlled by ECCN 1C351) or ECCN apply to Iran, North Korea, Sudan and the ECCN reference to hydrogen fluoride 1E351 (‘‘technology’’ for the disposal of, Syria). A license also is required to (C.A.S. #7664–39–3) in the eligible item inter alia, microbiological materials), certain destinations in accordance with descriptions for the following validated these ECCNs cross-reference items the embargoes and other special end-users: (1) ‘‘Samsung China controlled by ECCN 1C351 and, controls described in part 746 of the Semiconductor Co. Ltd.’’ and (2) consequently, ‘‘technology’’ that is EAR. ‘‘Shanghai Huahong Grace related to the MERS-related coronavirus In addition, although this rule does Semiconductor Manufacturing added by this rule to ECCN 1C351.a.30 not amend ECCNs 2E001, 2E002 and Corporation.’’ As described above, is now subject to control under ECCN 2E301 (which control, respectively, hydrogen fluoride was previously 1E001 or 1E351 if such ‘‘technology’’ ‘‘technology’’ for the ‘‘development,’’ classified under ECCN 1C350.d.10, but falls within the parameters of the ‘‘production’’ or ‘‘use’’ of, inter alia, is now classified under ECCN controls described therein. ECCN 2B352 equipment), these ECCNs 1C350.d.14 with the publication of this Note that all items controlled under cross-reference items controlled by rule. These conforming amendments do ECCN 1C351.d, including the newly ECCN 2B352 and, consequently, not change the scope of eligible items added MERS-related coronavirus, ‘‘technology’’ that is related to rigid- for either of the two validated end-users require a license for CB reasons and AT walled, single-use cultivation chambers indicated above—they merely update reasons to the destinations indicated added by this rule to ECCN 2B352.b.2.b the ECCN references in Supplement No.

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7 to part 748 to correctly identify which Administration Act of 1979 (previously, In calculating the costs that will be ECCN 1C350.d items are eligible for 50 U.S.C. 4601 et seq.) (as in effect prior imposed by this rule, BIS estimates that each of these validated end-users. to August 13, 2018, and as continued in no more than 25 additional license Because this rule does not add or effect pursuant to the International applications will have to be submitted remove any validated end-users or Emergency Economic Powers Act (50 to BIS, annually, as a result of the revise the scope of eligible items, the U.S.C. 1701 et seq.)) or the Export implementation of the amendments citation for this rule is not indicated in Administration Regulations, and were described in this rule (see Rulemaking the ‘‘Federal Register Citation’’ column in effect as of August 13, 2018, shall Requirements #2, below). Application of of Supplement No. 7. continue in effect according to their the cost-benefit analysis required under terms until modified, superseded, set Executive Orders 13563 and 12866 to Saving Clause aside, or revoked under the authority of this rule, as described above, indicates Shipments of items removed from ECRA. that this rule is intended to improve the eligibility for export, reexport or transfer national security of the United States as Rulemaking Requirements (in-country) under a license exception its primary direct benefit. Accordingly, or without a license (i.e., under the 1. Executive Orders 13563 and 12866 consistent with the stated purpose of the designator ‘‘NLR’’) as a result of this direct agencies to assess all costs and proposed amendments to ECCNs 1C350, regulatory action that were on dock for benefits of available regulatory 1C351 and 2B352, this rule meets the loading, on lighter, laden aboard an alternatives and, if regulation is requirements set forth in the April 5, exporting carrier, or en route aboard a necessary, to select regulatory 2017, OMB guidance implementing carrier to a port of export, on June 17, approaches that maximize net benefits Executive Order 13771 (82 FR 9339, 2020, pursuant to actual orders for (including: Potential economic, February 3, 2017), regarding what export, reexport or transfer (in-country) environmental, public health and safety constitutes a regulation issued ‘‘with to a foreign destination, may proceed to effects; distributive impacts; and respect to a national security function of that destination under the previously equity). Executive Order 13563 the United States,’’ and it is, therefore, applicable license exception or without emphasizes the importance of exempt from the requirements of E.O. a license (NLR) so long as they are quantifying both costs and benefits and 13771. exported, reexported or transferred (in- of reducing costs, harmonizing rules, 2. Notwithstanding any other country) before August 17, 2020. Any and promoting flexibility. This rule has provision of law, no person is required such items not actually exported, been designated a ‘‘significant to respond to, nor shall any person be reexported or transferred (in-country) regulatory action,’’ although not subject to a penalty for failure to comply before midnight, on August 17, 2020, economically significant, under section with, a collection of information subject require a license in accordance with this 3(f) of Executive Order 12866. to the requirements of the Paperwork regulation. Accordingly, the rule has been reviewed Reduction Act of 1995 (44 U.S.C. 3501 ‘‘Deemed’’ exports of ‘‘technology’’ by the Office of Management and et seq.) (PRA), unless that collection of and ‘‘source code’’ removed from Budget. information displays a currently valid eligibility for export under a license The cost-benefit analysis required Office of Management and Budget exception or without a license (under pursuant to Executive Orders 13563 and (OMB) Control Number. This rule the designator ‘‘NLR’’) as a result of this 12866 indicates that this rule is contains the following collections of regulatory action may continue to be intended to improve national security as information subject to the requirements made under the previously available its primary direct benefit. Specifically, of the PRA. These collections have been license exception or without a license implementation, in a timely manner, of approved by OMB under control (NLR) before August 17, 2020. the Australia Group (AG) agreements numbers 0694–0088 (Simplified Beginning at midnight on August 17, described herein will enhance the Network Application Processing 2020, such ‘‘technology’’ and ‘‘source national security of the United States by System) and 0694–0096 (Five Year code’’ may no longer be released, reducing the risk that global Records Retention Period). The without a license, to a foreign national international trade involving dual-use approved information collection under subject to the ‘‘deemed’’ export controls chemical and biological items would OMB control number 0694–0088 in the EAR when a license would be contribute to the proliferation of includes license applications, among required to the home country of the chemical and biological weapons of other things, and carries a burden foreign national in accordance with this mass destruction. The principal estimate of 29.6 minutes per manual or regulation. objective of AG participating countries electronic submission for a total burden is to use licensing measures to ensure estimate of 31,833 hours. The approved Export Control Reform Act of 2018 that exports of certain chemicals, information collection under OMB On August 13, 2018, the President biological agents, and dual-use chemical control number 0694–0096 includes signed into law the John S. McCain and biological manufacturing facilities recordkeeping requirements and carries National Defense Authorization Act for and equipment, do not contribute to the a burden estimate of less than 1 minute Fiscal Year 2019, which included the proliferation of chemical and biological per response for a total burden estimate Export Control Reform Act of 2018 weapons of mass destruction, which has of 248 hours. (ECRA), 50 U.S.C. Sections 4801–4852. been identified as a threat to domestic Although this rule contains important ECRA provides the legal basis for BIS’s and international peace and security. changes to the EAR for items controlled principal authorities and serves as the The AG achieves this objective by for chemical/biological (CB) reasons, authority under which BIS issues this harmonizing participating countries’ BIS believes the overall increase in costs rule. As set forth in section 1768 of national export licensing measures. and burdens due to the implementation ECRA, all delegations, rules, These controls are essential given that of these changes will be minimal. regulations, orders, determinations, the international chemical and Specifically, BIS expects the burden licenses, or other forms of biotechnology industries are a target for hours associated with these collections administrative action that were made, proliferators as a source of materials for will increase, slightly, by 12 hours and issued, conducted, or allowed to chemical and biological weapons 45 minutes (i.e., 25 applications × 30.6 become effective under the Export programs. minutes per response) for a total

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estimated cost increase of $382.50 (i.e., 3. This rule does not contain policies 15 CFR Part 774 12 hours and 45 minutes × $30 per with Federalism implications as that Exports, Reporting and recordkeeping hour). The $30 per hour cost estimate term is defined in Executive Order requirements. for OMB control numbers 0694–0088 13132. and 0694–0096 is consistent with the 4. Pursuant to Section 1762 of the For the reasons stated in the salary data for export compliance Export Control Reform Act of 2018 (50 preamble, parts 748 and 774 of the specialists currently available through U.S.C. Sec. 4821), this action is exempt Export Administration Regulations (15 glassdoor.com (glassdoor.com estimates from the Administrative Procedure Act CFR parts 730–774) are amended as that an export compliance specialist (APA) (5 U.S.C. 553) requirements for follows: makes $55,280 annually, which notice of proposed rulemaking, computes to roughly $26.58 per hour). opportunity for public participation and PART 748—[AMENDED] This increase is not expected to exceed delay in effective date. ■ the existing estimates currently Because a notice of proposed 1. The authority citation for 15 CFR associated with OMB control numbers rulemaking and an opportunity for part 748 continues to read as follows: 0694–0088 and 0694–0096. Send public comment are not required to be Authority: 50 U.S.C. 4801–4582; 50 U.S.C. comments regarding this burden given for this rule by the APA or any 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. estimate or any other aspect of this other law, the analytical requirements of 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. collection of information, including the Regulatory Flexibility Act (5 U.S.C. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 suggestions for reducing the burden, to 601 et seq.) are not applicable. Comp., p. 783; Notice of August 14, 2019, 84 FR 41881 (August 15, 2019). Jasmeet Seehra, Office of Management Accordingly, no regulatory flexibility and Budget, by email to Jasmeet_K._ analysis is required, and none has been ■ 2. Supplement 7 to part 748 is [email protected] or by fax to (202) prepared. amended by revising the validated end- 395–7285; and to the Regulatory Policy List of Subjects user entries for ‘‘Samsung China Division, Bureau of Industry and Semiconductor Co. Ltd.’’ and ‘‘Shanghai Security, Department of Commerce, 15 CFR Part 748 Huahong Grace Semiconductor 14th Street & Pennsylvania Avenue NW, Administrative practice and Manufacturing Corporation,’’ listed Room 2705, Washington, DC 20230 or procedure, Exports, Reporting and under the country ‘‘China (People’s by email to [email protected]. recordkeeping requirements. Republic of)’’ to read as follows:

SUPPLEMENT NO. 7 TO PART 748—AUTHORIZATION VALIDATED END-USER (VEU): LIST OF VALIDATED END-USERS, RESPECTIVE ITEMS ELIGIBLE FOR EXPORT, REEXPORT AND TRANSFER, AND ELIGIBLE DESTINATIONS

Country Validated end-user Eligible items (by ECCN) Eligible destination Federal Register citation

Nothing in this Supplement shall be deemed to supersede other provisions in the EAR, including but not limited to § 748.15(c).

China (People’s ****** Republic of) Samsung China Semiconductor Co. Ltd 1C350.c.4, 1C350.d.14, Samsung China Semicon- 78 FR 41291, 7/10/13. 78 2B006.a, 2B006.b.1.d, ductor Co., Ltd., No. FR 69535, 11/20/13. 79 2B230, 2B350.d.2, 1999, North Xiaohe FR 30713, 5/29/14. 80 2B350.g.3, 2B350.i.3, Road, Xi’an, China FR 11863, 3/5/15. 3A233, 3B001.a.1, 710119. 3B001.b, 3B001.e, 3B001.f, 3B001.h, 3C002, 3C004, 3D002, and 3E001 (limited to ‘‘technology’’ for items classified under 3C002 and 3C004 and ‘‘technology’’ for use consistent with the Inter- national Technology Roadmap for Semi- conductors process for items classified under ECCNs 3B001 and 3B002).

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SUPPLEMENT NO. 7 TO PART 748—AUTHORIZATION VALIDATED END-USER (VEU): LIST OF VALIDATED END-USERS, RESPECTIVE ITEMS ELIGIBLE FOR EXPORT, REEXPORT AND TRANSFER, AND ELIGIBLE DESTINATIONS—Continued

Country Validated end-user Eligible items (by ECCN) Eligible destination Federal Register citation

Shanghai Huahong Grace Semicon- 1C350.c.4, 1C350.d.14, Shanghai Huahong Grace 78 FR 32981, 6/3/13. ductor Manufacturing Corporation. 2B230, 2B350.d.2, Semiconductor Manu- 2B350.g.3, 2B350.i.4, facturing Corporation— 3B001.a.1, 3B001.b, HFab 2, 668 3B001.e, 3B001.f, Guoshoujing Road, 3B001.h, 3C002, Zhangjiang Hi-Tech 3C004, 5B002, and Park, Shanghai 201203 5E002 (controlled by China. ECCNs 5A002, 5A004, Shanghai Huahong Grace or 5A992 that have Semiconductor Manu- been successfully re- facturing Corporation— viewed under the HFab 1, 1188 encryption review proc- Chuanqiao Road, ess specified in Sec- Pudong, Shanghai tions 740.17(b)(2) or 201206 China. 740.17(b)(3) of the Shanghai Huahong Grace EAR). Semiconductor Manu- facturing Corporation— GFab1, 1399 Zuchongzhi Road, Zhangjiang Hi-Tech Park, Shanghai 201203 China.

*******

PART 774—[AMENDED] CW applies to 1C350.b, and .c. The required for sample shipments when the Commerce Country Chart is not designed to cumulative total of these shipments does not determine licensing requirements for items exceed a 55-gallon container or 200 kg of a ■ 3. The authority citation for 15 CFR controlled for CW reasons. A license is single chemical to any one consignee during part 774 continues to read as follows: required, for CW reasons, to export or a calendar year. A consignee that receives a Authority: 50 U.S.C. 4801–4852; 50 U.S.C. reexport Schedule 2 chemicals and mixtures sample shipment under this exclusion may 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. identified in 1C350.b to States not Party to not resell, transfer, or reexport the sample 8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 the CWC (destinations not listed in shipment, but may use the sample shipment U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. Supplement No. 2 to part 745 of the EAR). for any other legal purpose unrelated to A license is required, for CW reasons, to 2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 chemical weapons. export Schedule 3 chemicals and mixtures a. Chemicals Not Eligible: U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. identified in 1C350.c to States not Party to A. [Reserved] 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. the CWC, unless an End-Use Certificate B. CWC Schedule 2 chemicals (States not 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 issued by the government of the importing Party to the CWC). No CWC Schedule 2 Comp., p. 783. country has been obtained by the exporter chemical or mixture identified in 1C350.b is ■ prior to export. A license is required, for CW eligible for sample shipment to States not 4. Supplement 1 to part 774 is reasons, to reexport Schedule 3 chemicals Party to the CWC (destinations not listed in amended in category 1 by revising and mixtures identified in 1C350.c from a Supplement No. 2 to part 745 of the EAR) ECCN 1C350 and ECCN 1C351 and in State not Party to the CWC to any other State without a license. category 2 by revising ECCN 2B352 to not Party to the CWC. (See § 742.18 of the b. Countries Not Eligible: Countries in read as follows: EAR for license requirements and policies for Country Group E:1 of Supplement No. 1 to toxic and precursor chemicals controlled for part 740 of the EAR are not eligible to receive Supplement No. 1 to Part 774—The CW reasons. See § 745.2 of the EAR for End- sample shipments of any chemicals Commerce Control List Use Certificate requirements that apply to controlled by this ECCN without a license. exports of Schedule 3 chemicals to countries * * * * * c. Sample shipments that require an End- not listed in Supplement No. 2 to part 745 Use Certificate for CW reasons: No CWC Category 1—Special Materials and Related of the EAR.) Schedule 3 chemical or mixture identified in Equipment, Chemicals, ‘‘Microorganisms,’’ AT applies to entire entry. The Commerce 1C350.c is eligible for sample shipment to and ‘‘Toxins’’ Country Chart is not designed to determine States not Party to the CWC (destinations not * * * * * licensing requirements for items controlled listed in Supplement No. 2 to part 745 of the 1C350 Chemicals that may be used as for AT reasons in 1C350. A license is EAR) without a license, unless an End-Use precursors for toxic chemical agents (see required, for AT reasons, to export or Certificate issued by the government of the List of Items Controlled). reexport items controlled by 1C350 to a importing country is obtained by the exporter country in Country Group E:1 of Supplement prior to export (see § 745.2 of the EAR for License Requirements No. 1 to part 740 of the EAR. (See part 742 End-Use Certificate requirements). Reason for Control: CB, CW, AT of the EAR for additional information on the d. Sample shipments that require a license AT controls that apply to Iran, North Korea, for reasons set forth elsewhere in the EAR: Sudan, and Syria. See part 746 of the EAR Country chart Sample shipments, as described in this Note Control(s) (see supp. No. 1 to for additional information on sanctions that 1, may require a license for reasons set forth part 738) apply to Iran, North Korea, and Syria.) elsewhere in the EAR. See, in particular, the License Requirement Notes: 1. Sample end-use/end-user restrictions in part 744 of CB applies to entire CB Column 2. Shipments: Subject to the following the EAR, and the restrictions that apply to entry. requirements and restrictions, a license is not embargoed countries in part 746 of the EAR.

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e. Annual report requirement. The exporter List of Items Controlled) includes its liquid, b.18. (C.A.S. #993–13–5) is required to submit an annual written gaseous, and aqueous phases, and hydrates. Methylphosphonic acid; report for shipments of samples made under 3. Precursor chemicals in ECCN 1C350 are b.19. (C.A.S. #676–98–2) Methylphos- this Note 1. The report must be on company listed by name, Chemical Abstract Service phonothioic dichloride; letterhead stationery (titled ‘‘Report of (CAS) number and CWC Schedule (where b.20. (C.A.S. #464–07–3) Pinacolyl alcohol; Sample Shipments of Chemical Precursors’’ applicable). Precursor chemicals of the same b.21. (C.A.S. #1619–34–7) 3-Quinuclidinol; at the top of the first page) and identify the structural formula (e.g., hydrates) are b.22. (C.A.S. #111–48–8) Thiodiglycol. chemical(s), Chemical Abstract Service controlled by ECCN 1C350, regardless of c. Australia Group-controlled precursor Registry (C.A.S.) number(s), quantity(ies), the name or CAS number. CAS numbers are chemicals also identified as Schedule 3 ultimate consignee’s name and address, and shown to assist in identifying whether a chemicals under the CWC, as follows, and the date of export for all sample shipments particular precursor chemical or mixture is mixtures in which at least one of the that were made during the previous calendar controlled under ECCN 1C350, irrespective of following chemicals constitutes 30 percent or year. The report must be submitted no later nomenclature. However, CAS numbers more of the weight of the mixture: than February 28 of the year following the cannot be used as unique identifiers in all c.1. (C.A.S. #762–04–9) Diethyl phosphite; calendar year in which the sample shipments situations because some forms of the listed c.2. (C.A.S. #868–85–9) Dimethyl were made, to: U.S. Department of precursor chemical have different CAS phosphite (dimethyl hydrogen phosphite); Commerce, Bureau of Industry and Security, numbers, and mixtures containing a c.3. (C.A.S. #139–87–7) 14th Street and Pennsylvania Ave. NW, precursor chemical listed in ECCN 1C350 Ethyldiethanolamine; Room 2099B, Washington, DC 20230, Attn: may also have different CAS numbers. c.4. (C.A.S. #10025–87–3) Phosphorus ‘‘Report of Sample Shipments of Chemical oxychloride; Precursors.’’ List Based License Exceptions (See Part 740 c.5. (C.A.S. #10026–13–8) Phosphorus 2. Mixtures: for a Description of All License Exceptions) pentachloride; a. Mixtures that contain precursor LVS: N/A c.6. (C.A.S. #7719–12–2) Phosphorus chemicals identified in ECCN 1C350, in GBS: N/A trichloride; concentrations that are below the levels CIV: N/A c.7. (C.A.S. #10545–99–0) Sulfur indicated in 1C350.b through .d, are dichloride; List of Items Controlled controlled by ECCN 1C395 or 1C995 and are c.8. (C.A.S. #10025–67–9) Sulfur subject to the licensing requirements Related Controls: See USML Category XIV(c) monochloride; specified in those ECCNs. for related chemicals ‘‘subject to the ITAR’’ c.9. (C.A.S. #7719–09–7) Thionyl chloride; b. A license is not required under this (see 22 CFR parts 120 through 130). c.10. (C.A.S. #102–71–6) Triethanolamine; ECCN for a mixture, when the controlled Related Definitions: See § 770.2(k) of the EAR c.11. (C.A.S. #122–52–1) Triethyl chemical in the mixture is a normal for synonyms for the chemicals listed in phosphite; ingredient in consumer goods packaged for this entry. c.12. (C.A.S. #121–45–9) Trimethyl retail sale for personal use. Such consumer Items: phosphite. goods are designated EAR99. However, a a. [Reserved] d. Other Australia Group-controlled license may be required for reasons set forth b. Australia Group-controlled precursor precursor chemicals not also identified as elsewhere in the EAR. chemicals also identified as Schedule 2 Schedule 1, 2, or 3 chemicals under the chemicals under the CWC, as follows, and CWC, as follows, and mixtures in which at Note to mixtures: Calculation of mixtures in which at least one of the least one of the following chemicals concentrations of AG-controlled chemicals: following chemicals constitutes 30 percent or constitutes 30 percent or more of the weight a. Exclusion. No chemical may be added to more of the weight of the mixture: of the mixture: the mixture (solution) for the sole purpose of b.1. (C.A.S. #7784–34–1) Arsenic d.1. (C.A.S. #1341–49–7) Ammonium circumventing the Export Administration trichloride; hydrogen fluoride; Regulations; b.2. (C.A.S. #76–93–7) Benzilic acid; d.2. (C.A.S. #107–07–3) 2-Chloroethanol; b. Percent Weight Calculation. When b.3. (C.A.S. #78–38–6) Diethyl d.3. (C.A.S. #109–89–7) Diethylamine; calculating the percentage, by weight, of ethylphosphonate; d.4. (C.A.S. #100–37–8) N,N- ingredients in a chemical mixture, include all b.4. (C.A.S. #683–08–9) Diethyl Diethylaminoethanol; ingredients of the mixture, including those methylphosphonate; d.5. (C.A.S. #589–57–1) Diethyl that act as solvents. b.5. (C.A.S. #15715–41–0) Diethyl chlorophosphite; 3. Compounds. Compounds created with methylphosphonite; d.6. (C.A.S. #298–06–6) O,O-Diethyl any chemicals identified in this ECCN 1C350 b.6. (C.A.S. #2404–03–7) Diethyl-N,N- phosphorodithioate; may be shipped NLR (No License Required), dimethylphosphoroamidate; d.7. (C.A.S. #2465–65–8) O,O-Diethyl without obtaining an End-Use Certificate, b.7. (C.A.S. #41480–75–5) N,N- phosphorothioate; unless those compounds are also identified Diisopropylaminoethanethiol hydrochloride; d.8. (C.A.S. #108–18–9) Di-isopropylamine; in this entry or require a license for reasons b.8. (C.A.S. #5842–07–9) N,N-Diisopropyl- d.9. (C.A.S. #124–40–3) Dimethylamine; set forth elsewhere in the EAR. beta-aminoethane thiol; d.10. (C.A.S. #506–59–2) Dimethylamine 4. Testing Kits: Certain medical, analytical, b.9. (C.A.S. #96–80–0) N,N-Diisopropyl- hydrochloride; diagnostic, and food testing kits containing beta-aminoethanol; d.11. (C.A.S. #762–77–6) Ethyl small quantities of chemicals identified in b.10. (C.A.S. #96–79–7), N,N-Diisopropyl- chlorofluorophosphate; this ECCN 1C350, are excluded from the beta-aminoethyl chloride; d.12. (C.A.S. #1498–51–7) Ethyl scope of this ECCN and are controlled under b.11. (C.A.S. #4261–68–1) N,N- dichlorophosphate; ECCN 1C395 or 1C995. (Note that Diisopropyl-beta-aminoethyl chloride d.13. (C.A.S. #460–52–6) Ethyl replacement reagents for such kits are hydrochloride; difluorophosphate; controlled by this ECCN 1C350 if the reagents b.12. (C.A.S. #6163–75–3) Dimethyl d.14. (C.A.S. #7664–39–3) Hydrogen contain one or more of the precursor ethylphosphonate; fluoride; chemicals identified in 1C350 in b.13. (C.A.S. #756–79–6) Dimethyl d.15. (C.A.S. #3554–74–3) 3-Hydroxyl-1- concentrations equal to or greater than the methylphosphonate; methylpiperidine; control levels for mixtures indicated in b.14. (C.A.S. #677–43–0) N,N- d.16. (C.A.S. #76–89–1) Methyl benzilate; 1C350.) Dimethylamino-phosphoryl dichloride; d.17. (C.A.S. #754–01–8) Methyl Technical Notes: 1. For purposes of this b.15. (C.A.S. #1498–40–4) Ethyl chlorofluorophosphate; entry, a ‘‘mixture’’ is defined as a solid, phosphonous dichloride [Ethyl phosphinyl d.18. (C.A.S. #677–24–7) Methyl liquid or gaseous product made up of two or dichloride]; dichlorophosphate; more ingredients that do not react together b.16. (C.A.S. #430–78–4) Ethyl phosphonus d.19. (C.A.S. #22382–13–4) Methyl under normal storage conditions. difluoride [Ethyl phosphinyl difluoride]; difluorophosphate; 2. The scope of this control applicable to b.17. (C.A.S. #1066–50–8) Ethyl d.20. (C.A.S. #14277–06–6) N,N Hydrogen Fluoride (see 1C350.d.14 in the phosphonyl dichloride; Diethylacetamidine;

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d.21. (C.A.S. #53510–30–8) N,N- saxitoxin identified by C.A.S. #35523–89–8. Special Conditions for STA Diethylbutanamidine; See § 742.18 of the EAR for licensing STA: (1) Paragraph (c)(1) of License d.22. (C.A.S. #90324–67–7) N,N- information pertaining to chemicals subject Exception STA (§ 740.20(c)(1)) may be used Diethylformamidine; to restriction pursuant to the Chemical for items in 1C351.d.1 through 1C351.d.10 d.23. (C.A.S. #1342789–47–2) N,N Weapons Convention (CWC). The Commerce and 1C351.d.13 through 1C351.d.19. See Diethylisobutanamidine; Country Chart is not designed to determine § 740.20(b)(2)(vi) for restrictions on the d.24. (C.A.S. #84764–73–8) N,N- licensing requirements for items controlled quantity of any one toxin that may be Diethylpropanamidine; for CW reasons. exported in a single shipment and the d.25. (C.A.S. #1315467–17–4) N,N- number of shipments that may be made to Diisopropylbutanamidine; Country chart any one end user in a single calendar year. d.26. (C.A.S. #857522–08–8) N,N- Control(s) (see Supp. No. 1 to Also see the Automated Export System (AES) Diisopropylformamidine; part 738) requirements in § 758.1(b)(4) of the EAR. (2) d.27. (C.A.S. #2909–14–0) N,N- Paragraph (c)(2) of License Exception STA Dimethylacetamidine; AT applies to entire AT Column 1. (§ 740.20(c)(2) of the EAR) may not be used d.28. (C.A.S. #1340437–35–5) N,N- entry. for any items in 1C351. Dimethylbutanamidine; d.29. (C.A.S. #44205–42–7) N,N- License Requirement Notes: 1. All vaccines List of Items Controlled Dimethylformamidine; and ‘‘immunotoxins’’ are excluded from the Related Controls: (1) Certain forms of ricin d.30. (C.A.S. #321881–25–8) N,N- scope of this entry. Certain medical products and saxitoxin in 1C351.d.11. and d.12 are Dimethylisobutanamidine; and diagnostic and food testing kits that CWC Schedule 1 chemicals (see § 742.18 of d.31. (C.A.S. #56776–14–8) N,N- contain biological toxins controlled under the EAR). The U.S. Government must provide Dimethylpropanamidine; paragraph (d) of this entry, with the advance notification and annual reports to d.32. (C.A.S. #1339586–99–0) N,N- exception of toxins controlled for CW reasons the OPCW of all exports of Schedule 1 Dipropylacetamidine; under d.11 and d.12, are excluded from the chemicals. See § 745.1 of the EAR for d.33. (C.A.S. #1342422–35–8) N,N- scope of this entry. Vaccines, notification procedures. See 22 CFR part 121, Dipropylbutanamidine; ‘‘immunotoxins’’, certain medical products, Category XIV and § 121.7 for CWC Schedule d.34. (C.A.S. #48044–20–8) N,N- and diagnostic and food testing kits excluded 1 chemicals that are ‘‘subject to the ITAR.’’ Dipropylformamidine; from the scope of this entry are controlled (2) The Animal and Plant Health Inspection d.35. (C.A.S. #1342700–45–1) N,N- under ECCN 1C991. Service (APHIS), U.S. Department of Dipropylisobutanamidine; 2. For the purposes of this entry, only Agriculture, and the Centers for Disease d.36. (C.A.S. #1341496–89–6) N,N- Control and Prevention (CDC), U.S. Dipropylpropanamidine; saxitoxin is controlled under paragraph d.12; other members of the paralytic shellfish Department of Health and Human Services, d.37. (C.A.S. #1314–80–3) Phosphorus maintain controls on the possession, use, and poison family (e.g., neosaxitoxin) are pentasulfide; transfer within the United States of certain designated EAR99. d.38. (C.A.S. #75–97–8) Pinacolone; items controlled by this ECCN (for APHIS, d.39. (C.A.S. #7789–29–9) Potassium 3. Clostridium perfringens strains, other see 7 CFR 331.3(b), 9 CFR 121.3(b), and 9 bifluoride; than the epsilon toxin-producing strains of CFR 121.4(b); for CDC, see 42 CFR 73.3(b) d.40. (C.A.S. #151–50–8) Potassium Clostridium perfringens described in c.12, and 42 CFR 73.4(b)). (3) See 22 CFR part 121, cyanide; are excluded from the scope of this entry, Category XIV(b), for modified biological d.41. (C.A.S. #7789–23–3) Potassium since they may be used as positive control agents and biologically derived substances fluoride; cultures for food testing and quality control. that are ‘‘subject to the ITAR.’’ d.42. (C.A.S. #3731–38–2) 3-Quinuclidone; 4. Unless specified elsewhere in this ECCN Related Definitions: (1) For the purposes of d.43. (C.A.S. #1333–83–1) Sodium 1C351 (e.g., in License Requirement Notes 1– this entry ‘‘immunotoxin’’ is defined as an bifluoride; 3), this ECCN controls all biological agents antibody-toxin conjugate intended to destroy d.44. (C.A.S. #143–33–9) Sodium cyanide; and ‘‘toxins,’’ regardless of quantity or specific target cells (e.g., tumor cells) that d.45. (C.A.S. #7681–49–4) Sodium attenuation, that are identified in the List of bear antigens homologous to the antibody. (2) fluoride; Items Controlled for this ECCN, including For the purposes of this entry ‘‘subunit’’ is d.46. (C.A.S. #16893–85–9) Sodium small quantities or attenuated strains of defined as a portion of the ‘‘toxin’’. hexafluorosilicate; select biological agents or ‘‘toxins’’ that are Items: d.47. (C.A.S. #1313–82–2) Sodium sulfide; excluded from the lists of select biological a. Viruses identified on the Australia d.48. (C.A.S. #637–39–8) Triethanolamine agents or ‘‘toxins’’ by the Animal and Plant Group (AG) ‘‘List of Human and Animal hydrochloride; Health Inspection Service (APHIS), U.S. Pathogens and Toxins for Export Control,’’ as d.49. (C.A.S. #116–17–6) Tri-isopropyl Department of Agriculture, or the Centers for follows: phosphite. Disease Control and Prevention (CDC), U.S. a.1. African horse sickness virus; a.2. African swine fever virus; 1C351 Human and Animal Pathogens and Department of Health and Human Services, a.3. Andes virus; ‘‘Toxins’’, as Follows (See List of Items in accordance with their regulations in 9 CFR a.4. Avian influenza (AI) viruses identified Controlled). part 121 and 42 CFR part 73, respectively. as having high pathogenicity (HP), as follows: License Requirements 5. Biological agents and pathogens are a.4.a. AI viruses that have an intravenous Reason for Control: CB, CW, AT. controlled under this ECCN 1C351 when they pathogenicity index (IVPI) in 6-week-old are an isolated live culture of a pathogen chickens greater than 1.2; or Country chart agent, or a preparation of a toxin agent that a.4.b. AI viruses that cause at least 75% Control(s) (see Supp. No. 1 to has been isolated or extracted from any mortality in 4- to 8-week-old chickens part 738) source or material, including living material infected intravenously. that has been deliberately inoculated or Note: Avian influenza (AI) viruses of the CB applies to entire CB Column 1. contaminated with the agent. Isolated live H5 or H7 subtype that do not have either of entry. cultures of a pathogen agent include live the characteristics described in 1C351.a.4 CW applies to 1C351.d.11 and d.12 and a cultures in dormant form or in dried (specifically, 1C351.a.4.a or a.4.b) should be license is required for CW reasons for all preparations, whether the agent is natural, sequenced to determine whether multiple destinations, including Canada, as follows: enhanced or modified. basic amino acids are present at the cleavage CW applies to 1C351.d.11 for ricin in the site of the haemagglutinin molecule (HA0). If form of (1) Ricinus Communis AgglutininII List Based License Exceptions (See Part 740 the amino acid motif is similar to that (RCAII), also known as ricin D or Ricinus for a Description of All License Exceptions) observed for other HPAI isolates, then the Communis LectinIII (RCLIII) and (2) Ricinus LVS: N/A isolate being tested should be considered as Communis LectinIV (RCLIV), also known as GBS: N/A HPAI and the virus is controlled under ricin E. CW applies to 1C351.d.12 for CIV: N/A 1C351.a.4.

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a.5. Bluetongue virus; of Human and Animal Pathogens and Toxins d.15. T–2 toxin; a.6. Chapare virus; for Export Control,’’ as follows: d.16. Tetrodotoxin; a.7. Chikungunya virus; b.1. [Reserved]; d.17. Viscumin (Viscum album lectin 1); or a.8. Choclo virus; b.2. [Reserved]; or d.18. Volkensin. a.9. Classical swine fever virus (Hog b.3. Tick-borne encephalitis virus (Siberian e. ‘‘Fungi’’, as follows: cholera virus); subtype, formerly West Siberian virus—see e.1. Coccidioides immitis; or a.10. Crimean-Congo hemorrhagic fever 1C351.a.53 for Far Eastern subtype). e.2. Coccidioides posadasii. virus; c. Bacteria identified on the Australia * * * * * a.11. Dobrava-Belgrade virus; Group (AG) ‘‘List of Human and Animal a.12. Eastern equine encephalitis virus; Pathogens and Toxins for Export Control,’’ as Category 2—Materials Processing a.13. Ebolavirus (includes all members of follows: * * * * * the Ebolavirus genus); c.1. Bacillus anthracis; 2B352 Equipment Capable of Use in a.14. Foot-and-mouth disease virus; c.2. Brucella abortus; Handling Biological Materials, as a.15. Goatpox virus; c.3. Brucella melitensis; Follows (See List of Items Controlled). c.4. Brucella suis; a.16. Guanarito virus; License Requirements a.17. Hantaan virus; c.5. Burkholderia mallei (Pseudomonas a.18. Hendra virus (Equine morbillivirus); mallei); Reason for Control: CB, AT. a.19. Japanese encephalitis virus; c.6. Burkholderia pseudomallei a.20. Junin virus; (Pseudomonas pseudomallei); Country chart a.21. Kyasanur Forest disease virus; c.7. Chlamydia psittaci (Chlamydophila Control(s) (see Supp. No. 1 to a.22. Laguna Negra virus; psittaci); part 738) a.23. Lassa virus; c.8. Clostriduim argentinense (formerly CB applies to entire CB Column 2. a.24. Louping ill virus; known as Clostridium botulinum Type G), entry. a.25. Lujo virus; botulinum neurotoxin producing strains; AT applies to entire AT Column 1. a.26. Lumpy skin disease virus; c.9. Clostridium baratii, botulinum entry. a.27. Lymphocytic choriomeningitis virus; neurotoxin producing strains; a.28. Machupo virus; c.10. Clostridium botulinum; List Based License Exceptions (See Part 740 a.29. Marburgvirus (includes all members c.11. Clostridium butyricum, botulinum for a Description of All License Exceptions) of the Marburgvirus genus); neurotoxin producing strains; LVS: N/A a.30. Middle East respiratory syndrome- c.12. Clostridium perfringens, epsilon GBS: N/A related coronavirus (MERS-related toxin producing types; CIV: N/A coronavirus); c.13. Coxiella burnetii; a.31. Monkeypox virus; c.14. Francisella tularensis; List of Items Controlled a.32. Murray Valley encephalitis virus; c.15. Mycoplasma capricolum subspecies Related Controls: See ECCNs 1A004 and a.33. Newcastle disease virus; capripneumoniae (‘‘strain F38’’); 1A995 for protective equipment that is not a.34. Nipah virus; c.16. Mycoplasma mycoides subspecies covered by this entry. Also see ECCN a.35. Omsk hemorrhagic fever virus; mycoides SC (small colony) (a.k.a. contagious 9A120 for controls on certain ‘‘UAV’’ a.36. Oropouche virus; bovine pleuropneumonia); systems designed or modified to dispense a.37. Peste-des-petits ruminants virus; c.17. Rickettsia prowazekii; an aerosol and capable of carrying a.38. Porcine Teschovirus; c.18. Salmonella enterica subspecies elements of a payload in the form of a a.39. Powassan virus; enterica serovar Typhi (Salmonella typhi); particulate or liquid, other than fuel a.40. Rabies virus and all other members of c.19. Shiga toxin producing Escherichia ‘‘parts’’ or ‘‘components’’ of such vehicles, the Lyssavirus genus; coli (STEC) of serogroups O26, O45, O103, of a volume greater than 20 liters. a.41. Reconstructed 1918 influenza virus; O104, O111, O121, O145, O157, and other Related Definitions: (1) ‘‘Lighter than air Technical Note: 1C351.a.41 includes shiga toxin producing serogroups; vehicles’’—balloons and airships that rely reconstructed replication competent forms of Note: Shiga toxin producing Escherichia on hot air or on lighter-than-air gases, such the 1918 pandemic influenza virus coli (STEC) includes, inter alia, as helium or hydrogen, for their lift. (2) containing any portion of the coding regions enterohaemorrhagic E. coli (EHEC), verotoxin ‘‘UAVs’’—Unmanned Aerial Vehicles. (3) of all eight gene segments. producing E. coli (VTEC) or verocytotoxin ‘‘VMD’’—Volume Median Diameter. a.42. Rift Valley fever virus; producing E. coli (VTEC). Items: a.43. Rinderpest virus; c.20. Shigella dysenteriae; a. Containment facilities and related a.44. Rocio virus; c.21. Vibrio cholerae; or equipment, as follows: a.45. Sabia virus; c.22. Yersinia pestis. a.1. Complete containment facilities at P3 a.46. Seoul virus; d. ‘‘Toxins’’ identified on the Australia or P4 containment level. a.47. Severe acute respiratory syndrome- Group (AG) ‘‘List of Human and Animal Technical Note to 2B352.a.1: P3 or P4 related coronavirus (SARS-related Pathogens and Toxins for Export Control,’’ as (BL3, BL4, L3, L4) containment levels are as coronavirus); follows, and ‘‘subunits’’ thereof: specified in the WHO Laboratory Biosafety a.48. Sheeppox virus; d.1. Abrin; Manual (3rd edition, Geneva, 2004). a.49. Sin Nombre virus; d.2. Aflatoxins; a.2. Equipment designed for fixed a.50. St. Louis encephalitis virus; d.3. Botulinum toxins; installation in containment facilities a.51. Suid herpesvirus 1 (Pseudorabies d.4. Cholera toxin; specified in paragraph a.1 of this ECCN, as virus; Aujeszky’s disease); d.5. Clostridium perfringens alpha, beta 1, follows: a.52. Swine vesicular disease virus; beta 2, epsilon and iota toxins; a.2.a. Double-door pass-through a.53. Tick-borne encephalitis virus (Far d.6. Conotoxins; decontamination autoclaves; Eastern subtype, formerly known as Russian d.7. Diacetoxyscirpenol; a.2.b. Breathing air suit decontamination Spring-Summer encephalitis virus—see d.8. HT–2 toxin; showers; 1C351.b.3 for Siberian subtype); d.9. Microcystins (Cyanginosins); a.2.c. Mechanical-seal or inflatable-seal a.54. Variola virus; d.10. Modeccin; walkthrough doors. a.55. Venezuelan equine encephalitis virus; d.11. Ricin; b. Fermenters and components as follows: a.56. Vesicular stomatitis virus; d.12. Saxitoxin; b.1. Fermenters capable of cultivation of a.57. Western equine encephalitis virus; or d.13. Shiga toxins (shiga-like toxins, micro-organisms or of live cells for the a.58. Yellow fever virus. verotoxins, and verocytotoxins); production of viruses or toxins, without the b. Viruses identified on the APHIS/CDC d.14. Staphylococcus aureus enterotoxins, propagation of aerosols, having a total ‘‘select agents’’ lists (see Related Controls hemolysin alpha toxin, and toxic shock internal volume of 20 liters or greater. paragraph #2 for this ECCN), but not syndrome toxin (formerly known as b.2. Components designed for such identified on the Australia Group (AG) ‘‘List Staphylococcus enterotoxin F); fermenters, as follows:

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b.2.a. Cultivation chambers designed to be 1000 kg of ice in 24 hours (less than 1,000 i.3. Aerosol generating units ‘‘specially sterilized or disinfected in situ; liters of water in 24 hours). designed’’ for fitting to the systems as b.2.b. Cultivation chamber holding devices; f. Spray-drying equipment capable of specified in paragraphs i.1 and i.2 of this or drying toxins or pathogenic microorganisms ECCN. b.2.c. Process control units capable of having all of the following characteristics: Technical Notes to 2B352.i: 1. Aerosol ≥ simultaneously monitoring and controlling f.1. A water evaporation capacity of 0.4 generating units are devices ‘‘specially ≤ two or more fermentation system parameters kg/h and 400 kg/h; designed’’ or modified for fitting to aircraft (e.g., temperature, pH, nutrients, agitation, f.2. The ability to generate a typical mean and include nozzles, rotary drum atomizers ≤ dissolved oxygen, air flow, foam control). product particle size of 10 micrometers with and similar devices. Technical Notes to 2B352.b: 1. Fermenters existing fittings or by minimal modification 2. This ECCN does not control spraying or include bioreactors (including single-use of the spray-dryer with atomization nozzles fogging systems, ‘‘parts’’ and ‘‘components,’’ (disposable) bioreactors), chemostats and enabling generation of the required particle as specified in 2B352.i, that are demonstrated continuous-flow systems. size; and not to be capable of delivering biological 2. Cultivation chamber holding devices f.3. Capable of being sterilized or agents in the form of infectious aerosols. controlled by 2B352.b.2.b include single-use disinfected in situ. 3. Droplet size for spray equipment or cultivation chambers with rigid walls. g. Protective and containment equipment, nozzles ‘‘specially designed’’ for use on as follows: c. Centrifugal separators capable of the aircraft or ‘‘UAVs’’ should be measured using g.1. Protective full or half suits, or hoods continuous separation of pathogenic either of the following methods (pending the dependent upon a tethered external air microorganisms, without the propagation of adoption of internationally accepted supply and operating under positive aerosols, and having all of the following standards): pressure. characteristics: a. Doppler laser method, c.1. One or more sealing joints within the Technical Note to 2B352.g.1: 2B352.g.1 b. Forward laser diffraction method. does not control suits designed to be worn steam containment area; j. Nucleic acid assemblers and synthesizers with self-contained breathing apparatus. c.2. A flow rate greater than 100 liters per that are both: hour; g.2. Biocontainment chambers, isolators, or j.1 Partly or entirely automated; and c.3. ‘‘Parts’’ or ‘‘components’’ of polished biological safety cabinets having all of the j.2. Designed to generate continuous stainless steel or titanium; and following characteristics, for normal nucleic acids greater than 1.5 kilobases in c.4. Capable of in-situ steam sterilization in operation: length with error rates less than 5% in a a closed state. g.2.a. Fully enclosed workspace where the single run. operator is separated from the work by a Technical Note to 2B352.c: Centrifugal * * * * * separators include decanters. physical barrier; g.2.b. Able to operate at negative pressure; d. Cross (tangential) flow filtration Richard E. Ashooh, g.2.c. Means to safely manipulate items in equipment and ‘‘accessories’’, as follows: the workspace; and Assistant Secretary for Export d.1. Cross (tangential) flow filtration g.2.d. Supply and exhaust air to and from Administration. equipment capable of separation of the workspace is high-efficiency particulate [FR Doc. 2020–11625 Filed 6–16–20; 8:45 am] microorganisms, viruses, toxins or cell air (HEPA) filtered. BILLING CODE 3510–33–P cultures having all of the following characteristics: Note 1 to 2B352.g.2: 2B352.g.2 controls d.1.a. A total filtration area equal to or class III biosafety cabinets, as specified in the greater than 1 square meter (1 m2); and WHO Laboratory Biosafety Manual (3rd DEPARTMENT OF HOMELAND edition, Geneva, 2004) or constructed in d.1.b. Having any of the following SECURITY characteristics: accordance with national standards, regulations or guidance. d.1.b.1. Capable of being sterilized or Coast Guard disinfected in-situ; or Note 2 to 2B352.g.2: 2B352.g.2 does not d.1.b.2. Using disposable or single-use control isolators ‘‘specially designed’’ for 33 CFR Part 165 filtration ‘‘parts’’ or ‘‘components’’. barrier nursing or transportation of infected N.B.: 2B352.d.1 does not control reverse patients. [Docket Number USCG–2020–0252] osmosis and hemodialysis equipment, as h. Aerosol inhalation equipment designed specified by the manufacturer. for aerosol challenge testing with RIN 1625–AA00 d.2. Cross (tangential) flow filtration microorganisms, viruses or toxins, as follows: ‘‘parts’’ or ‘‘components’’ (e.g., modules, h.1. Whole-body exposure chambers Safety Zone; San Diego Bay, San elements, cassettes, cartridges, units or having a capacity of 1 cubic meter or greater; Diego, CA plates) with filtration area equal to or greater 2 h.2. Nose-only exposure apparatus than 0.2 square meters (0.2 m ) for each utilizing directed aerosol flow and having a AGENCY: Coast Guard, DHS. ‘‘part’’ or ‘‘component’’ and designed for use capacity for the exposure of 12 or more ACTION: Temporary final rule. in cross (tangential) flow filtration equipment rodents, or two or more animals other than controlled by 2B352.d.1. rodents, and closed animal restraint tubes SUMMARY: The Coast Guard is Technical Note: In this ECCN, ‘‘sterilized’’ designed for use with such apparatus. establishing a temporary safety zone for denotes the elimination of all viable microbes i. Spraying or fogging systems and ‘‘parts’’ the navigable waters in the vicinity of from the equipment through the use of either and ‘‘components’’ therefor, as follows: physical (e.g., steam) or chemical agents. the General Dynamics NASSCO i.1. Complete spraying or fogging systems, shipyard in San Diego Bay, San Diego, ‘‘Disinfected’’ denotes the destruction of ‘‘specially designed’’ or modified for fitting potential microbial infectivity in the to aircraft, ‘‘lighter than air vehicles,’’ or CA, during the launch of the M/V equipment through the use of chemical ‘‘UAVs,’’ capable of delivering, from a liquid Matsonia. The safety zone is needed to agents with a germicidal effect. suspension, an initial droplet ‘‘VMD’’ of less protect personnel, vessels, and the ‘‘Disinfection’’ and ‘‘sterilization’’ are than 50 microns at a flow rate of greater than marine environment from potential distinct from ‘‘sanitization’’, the latter 2 liters per minute; hazards associated with the launching referring to cleaning procedures designed to i.2. Spray booms or arrays of aerosol and subsequent berthing of the M/V lower the microbial content of equipment generating units, ‘‘specially designed’’ or Matsonia. Entry of vessels or persons without necessarily achieving elimination of modified for fitting to aircraft, ‘‘lighter than all microbial infectivity or viability. into this zone is prohibited unless air vehicles,’’ or ‘‘UAVs,’’ capable of specifically authorized by the Captain of e. Steam, gas or vapor sterilizable freeze- delivering, from a liquid suspension, an drying equipment with a condenser capacity initial droplet ‘‘VMD’’ of less than 50 the Port San Diego. of 10 kg of ice or greater in 24 hours (10 liters microns at a flow rate of greater than 2 liters DATES: This rule is effective from 6 p.m. of water or greater in 24 hours) and less than per minute; through 9 p.m. on July 2, 2020.

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