83 FR 13849 - Implementation of the February 2017 Australia Group (AG) Intersessional Decisions and the June 2017 AG Plenary Understandings; Addition of India to the AG
DEPARTMENT OF COMMERCE
Bureau of Industry and Security Federal Register Volume 83, Issue 63 (April 2, 2018)
Bureau of Industry and Security
Federal Register Volume 83, Issue 63 (April 2, 2018)
| Page Range | 13849-13862 | |
| FR Document | 2018-06581 |
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)] [Rules and Regulations] [Pages 13849-13862] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06581] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 738, 740, 745 and 774 [Docket No. 170306234-7234-01] RIN 0694-AH37 Implementation of the February 2017 Australia Group (AG) Intersessional Decisions and the June 2017 AG Plenary Understandings; Addition of India to the AG AGENCY: Bureau of Industry and Security, Commerce. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Bureau of Industry and Security (BIS) publishes this final rule to amend the Export Administration Regulations (EAR) to implement the recommendations presented at the February 2017 Australia Group (AG) Intersessional Implementation Meeting, and later adopted pursuant to the AG silent approval procedure, and the recommendations made at the June 2017 AG Plenary Implementation Meeting and adopted by the AG Plenary. This rule amends the following Export Control Classification Numbers (ECCNs) on the Commerce Control List (CCL) to reflect the February 2017 Intersessional Implementation Meeting recommendations that were adopted by the AG: ECCN 2B350 (by adding certain prefabricated repair assemblies, and specially designed components therefor, that are designed for attachment to glass-lined reaction vessels, reactors, storage tanks, containers or receivers controlled by this entry); ECCN 2B351 (by clarifying that toxic gas monitoring equipment includes toxic gas monitors and monitoring systems, as well as their dedicated detecting components); and ECCN 2B352 (by adding certain nucleic acid assemblers and synthesizers to this entry and clarifying how the capacity of certain fermenters should be measured for purposes of determining whether they are controlled under this entry). Consistent with the June 2017 AG Plenary Implementation Meeting recommendations that were adopted by the AG, this rule amends the following ECCNs on the CCL: ECCN 1C353 (to clarify that genetically modified organisms include organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation and that inactivated organisms containing recoverable nucleic acids are considered to be genetic elements) and ECCN 1C350 (by adding N,N-Diisopropylamino ethanethiol hydrochloride). This rule also corrects several typographical errors in a note to ECCN 1C351 and updates the advance notification requirements in the EAR that apply to certain exports of saxitoxin. Finally, this rule amends the EAR to reflect the addition of India as a participating country in the AG. DATES: This rule is effective April 2, 2018. FOR FURTHER INFORMATION CONTACT: Richard P. Duncan, Ph.D., Director, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343, Email: Richard.Duncan@bis.doc.gov. [[Page 13850]] SUPPLEMENTARY INFORMATION: The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to implement the recommendations presented at the Australia Group (AG) Intersessional Implementation Meeting held in Buenos Aires, Argentina, on February 15, 2017, and adopted pursuant to the AG silent approval procedure in April 2017, and the recommendations presented at the Implementation Meeting of the 2017 AG Plenary held in Paris, France, from June 26-30, 2017, and adopted by the AG Plenary. This rule also amends the EAR to reflect the addition of India as a participating country in the AG, as of January 19, 2018. The AG is a multilateral forum consisting of 42 participating countries and the European Union that maintain export controls on a list of chemicals, biological agents, and related equipment and technology that could be used in a chemical or biological weapons program. The AG periodically reviews items on its control list to enhance the effectiveness of participating governments' national controls and to achieve greater harmonization among these controls. Amendments to the CCL Based on the February 2017 AG Intersessional Recommendations ECCN 2B350 (Chemical Manufacturing Facilities and Equipment) This final rule amends ECCN 2B350 on the CCL to reflect changes to the AG ``Control List of Dual-Use Chemical Manufacturing Facilities and Equipment and Related Technology and Software'' based on the February 2017 Intersessional Implementation Meeting recommendations that were adopted by the AG pursuant to its silent approval procedure. Specifically, this rule amends ECCN 2B350 to control prefabricated repair assemblies, and their specially designed components, that: (1) Are designed for mechanical attachment to glass-lined reaction vessels and reactors controlled under 2B350.a or glass-lined storage tanks, containers and receivers controlled under 2B350.c; and (2) have metallic surfaces that are made from tantalum or tantalum alloys and come in direct contact with the chemical(s) being processed. These assemblies and components were added to the AG chemical manufacturing facilities and equipment common control list, because they are capable of being used to prolong the life, or even allow the recommissioning, of glass-lined reactors and storage tanks that are suitable for use in the production of chemical weapons (CW) agents or AG-listed precursor chemicals. All items controlled under ECCN 2B350 continue to require a license for chemical/biological (CB) reasons to destinations indicated in CB Column 2 on the Commerce Country Chart (see Supplement No. 1 to part 738 of the EAR) and for anti-terrorism (AT) reasons to destinations indicated in AT Column 1 on the Commerce Country Chart. ECCN 2B351 (Toxic Gas Monitors and Monitoring Systems) This final rule amends ECCN 2B351 on the CCL to reflect changes to the AG ``Control List of Dual-Use Chemical Manufacturing Facilities and Equipment and Related Technology and Software'' based on the February 2017 Intersessional Implementation Meeting recommendations that were adopted by the AG pursuant to its silent approval procedure. Specifically, this rule amends ECCN 2B351 to clarify that this entry controls toxic gas monitors and monitoring systems, and their dedicated detecting components (i.e., detectors, sensor devices, and replaceable sensor cartridges), having either of the following characteristics: (1) Designed for continuous operation and usable for the detection of chemical warfare agents or precursor chemicals controlled by ECCN 1C350 at concentrations of less than 0.3 mg/m\3\; or (2) designed for the detection of cholinesterase-inhibiting activity. The decision to specifically identify toxic gas monitors, in addition to toxic gas monitoring systems, on the AG chemical manufacturing facilities and equipment common control list is based on the fact that certain portable toxic gas monitors (e.g., small handheld detectors) are capable of satisfying the technical control criteria applicable to toxic gas monitoring systems and, as such, may also be suitable for use in a CW production or storage facility. This rule also amends related ``software'' controls in ECCN 2D351 to reflect the updates to ECCN 2B351 described above. All items controlled under ECCN 2B351 continue to require a license for CB reasons to destinations indicated in CB Column 2 on the Commerce Country Chart and for AT reasons to destinations indicated in AT Column 1 on the Commerce Country Chart. ECCN 2B352 (Equipment Capable of Use in Handling Biological Materials) This final rule amends ECCN 2B352 on the CCL to reflect changes to the AG ``Control List of Dual-Use Biological Equipment and Related Technology and Software'' based on the February 2017 Intersessional Implementation Meeting recommendations that were adopted by the AG pursuant to its silent approval procedure. Specifically, this rule amends ECCN 2B352 to indicate that the ``total internal volume'' of a fermenter must be measured to determine whether its capacity meets the control level of ``20 liters or greater'' specified in 2B352.b.1. This clarification was made to ensure that all AG participating countries apply the same criterion to measure capacity for purposes of determining whether a fermenter is subject to control. This rule also amends ECCN 2B352 by adding a new paragraph .j to control nucleic acid assemblers and synthesizers that are both: (1) Partly or entirely automated; and (2) designed to generate continuous nucleic acids greater than 1.5 kilobases in length with error rates less than 5% in a single run. These items were added to the AG dual-use biological equipment common control list because they are capable of being used to generate pathogens and toxins without the need to acquire controlled genetic elements and organisms. All items controlled under ECCN 2B352 continue to require a license for CB reasons to destinations indicated in CB Column 2 on the Commerce Country Chart and for AT reasons to destinations indicated in AT Column 1 on the Commerce Country Chart. Amendments to the CCL Based on the June 2017 AG Plenary Understandings ECCN 1C350 (Precursor Chemicals) This final rule amends ECCN 1C350 to reflect updates to the AG ``Chemical Weapons Precursors'' control list adopted at the June 2017 AG Plenary meeting. Specifically, this rule amends ECCN 1C350.b by adding the precursor chemical hydrochloride salt (C.A.S. #41480-75-5) N,N-Diisopropylamino ethanethiol hydrochloride. This rule also alphabetically reorders the precursor chemicals listed in ECCN 1C350.b, .c, and .d to facilitate the identification of these chemicals. The precursor chemicals affected by these amendments to ECCN 1C350 are indicated in the following table. [[Page 13851]] ---------------------------------------------------------------------------------------------------------------- AG-Controlled precursor chemicals Previous CCL designation Current CCL designation ---------------------------------------------------------------------------------------------------------------- (C.A.S. #683-08-9) Diethyl ECCN 1C350.b.22 ECCN 1C350.b.4 methylphosphonate. (C.A.S. #15715-41-0) Diethyl ECCN 1C350.b.4 ECCN 1C350.b.5 methylphosphonite. (C.A.S. #2404-03-7) Diethyl-N,N- ECCN 1C350.b.5 ECCN 1C350.b.6 dimethylphosphoroamidate. (C.A.S. #41480-75-5) N,N- None--EAR 99 ECCN 1C350.b.7 Diisopropylaminoethanethiol hydrochloride. (C.A.S. #5842-07-9) N,N-Diisopropyl- ECCN 1C350.b.6 ECCN 1C350.b.8 beta-aminoethane thiol. (C.A.S. #96-80-0) N,N-Diisopropyl-beta- ECCN 1C350.b.8 ECCN 1C350.b.9 aminoethanol. (C.A.S. #96-79-7), N,N-Diisopropyl-beta- ECCN 1C350.b.9 ECCN 1C350.b.10 aminoethyl chloride. (C.A.S. #4261-68-1) N,N-Diisopropyl- ECCN 1C350.b.7 ECCN 1C350.b.11 beta-aminoethyl chloride hydrochloride. (C.A.S. #6163-75-3) Dimethyl ECCN 1C350.b.10 ECCN 1C350.b.12 ethylphosphonate. (C.A.S. #756-79-6) Dimethyl ECCN 1C350.b.11 ECCN 1C350.b.13 methylphosphonate. (C.A.S. #677-43-0) N,N-Dimethylamino- ECCN 1C350.b.23 ECCN 1C350.b.14 phosphoryl dichloride. (C.A.S. #1498-40-4) Ethyl phosphonous ECCN 1C350.b.12 ECCN 1C350.b.15 dichloride [Ethyl phosphinyl dichloride]. (C.A.S. #430-78-4) Ethyl phosphonus ECCN 1C350.b.13 ECCN 1C350.b.16 difluoride [Ethyl phosphinyl difluoride]. (C.A.S. #1066-50-8) Ethyl phosphonyl ECCN 1C350.b.14 ECCN 1C350.b.17 dichloride. (C.A.S. #993-13-5) Methylphosphonic ECCN 1C350.b.21 ECCN 1C350.b.18 acid. (C.A.S. #676-98-2) Methylphos- ECCN 1C350.b.24 ECCN 1C350.b.19 phonothioic dichloride. (C.A.S. #464-07-3) Pinacolyl alcohol... ECCN 1C350.b.18 ECCN 1C350.b.20 (C.A.S. #1619-34-7) 3-Quinuclidinol.... ECCN 1C350.b.19 ECCN 1C350.b.21 (C.A.S. #111-48-8) Thiodiglycol........ ECCN 1C350.b.20 ECCN 1C350.b.22 (C.A.S. #139-87-7) Ethyldiethanolamine. ECCN 1C350.c.12 ECCN 1C350.c.3 (C.A.S. #10025-87-3) Phosphorus ECCN 1C350.c.3 ECCN 1C350.c.4 oxychloride. (C.A.S. #10026-13-8) Phosphorus ECCN 1C350.c.4 ECCN 1C350.c.5 pentachloride. (C.A.S. #7719-12-2) Phosphorus ECCN 1C350.c.5 ECCN 1C350.c.6 trichloride. (C.A.S. #10025-67-9) Sulfur ECCN 1C350.c.6 ECCN 1C350.c.8 monochloride. (C.A.S. #7719-09-7) Thionyl chloride... ECCN 1C350.c.8 ECCN 1C350.c.9 (C.A.S. #102-71-6) Triethanolamine..... ECCN 1C350.c.9 ECCN 1C350.c.10 (C.A.S. #122-52-1) Triethyl phosphite.. ECCN 1C350.c.10 ECCN 1C350.c.11 (C.A.S. #121-45-9) Trimethyl phosphite. ECCN 1C350.c.11 ECCN 1C350.c.12 (C.A.S. #109-89-7) Diethylamine........ ECCN 1C350.d.25 ECCN 1C350.d.3 (C.A.S. #100-37-8) N,N- ECCN 1C350.d.3 ECCN 1C350.d.4 Diethylaminoethanol. (C.A.S. #298-06-6) O,O-Diethyl ECCN 1C350.d.23 ECCN 1C350.d.5 phosphorodithioate. (C.A.S. #2465-65-8) O,O-Diethyl ECCN 1C350.d.22 ECCN 1C350.d.6 phosphorothioate. (C.A.S. #108-18-9) Di-isopropylamine... ECCN 1C350.d.4 ECCN 1C350.d.7 (C.A.S. #124-40-3) Dimethylamine....... ECCN 1C350.d.5 ECCN 1C350.d.8 (C.A.S. #506-59-2) Dimethylamine ECCN 1C350.d.6 ECCN 1C350.d.9 hydrochloride. (C.A.S. #7664-39-3) Hydrogen fluoride.. ECCN 1C350.d.7 ECCN 1C350.d.10 (C.A.S. #3554-74-3) 3-Hydroxyl-1- ECCN 1C350.d.8 ECCN 1C350.d.11 methylpiperidine. (C.A.S. #76-89-1) Methyl benzilate..... ECCN 1C350.d.9 ECCN 1C350.d.12 (C.A.S. #1314-80-3) Phosphorus ECCN 1C350.d.10 ECCN 1C350.d.13 pentasulfide. (C.A.S. #75-97-8) Pinacolone........... ECCN 1C350.d.11 ECCN 1C350.d.14 (C.A.S. #7789-29-9) Potassium ECCN 1C350.d.14 ECCN 1C350.d.15 bifluoride. (C.A.S. #151-50-8) Potassium cyanide... ECCN 1C350.d.12 ECCN 1C350.d.16 (C.A.S. #7789-23-3) Potassium fluoride. ECCN 1C350.d.13 ECCN 1C350.d.17 (C.A.S. #3731-38-2) 3-Quinuclidone..... ECCN 1C350.d.15 ECCN 1C350.d.18 (C.A.S. #1333-83-1) Sodium bifluoride.. ECCN 1C350.d.16 ECCN 1C350.d.19 (C.A.S. #143-33-9) Sodium cyanide...... ECCN 1C350.d.17 ECCN 1C350.d.20 (C.A.S. #7681-49-4) Sodium fluoride.... ECCN 1C350.d.18 ECCN 1C350.d.21 (C.A.S. #16893-85-9) Sodium ECCN 1C350.d.24 ECCN 1C350.d.22 hexafluorosilicate. (C.A.S. #1313-82-2) Sodium sulfide..... ECCN 1C350.d.19 ECCN 1C350.d.23 (C.A.S. #637-39-8) Triethanolamine ECCN 1C350.d.20 ECCN 1C350.d.24 hydrochloride. (C.A.S. #116-17-6) Tri-isopropyl ECCN 1C350.d.21 ECCN 1C350.d.25 phosphite. ---------------------------------------------------------------------------------------------------------------- All items controlled under ECCN 1C350 continue to require a license for CB reasons to destinations indicated in CB Column 2 on the Commerce Country Chart and for AT reasons to countries listed in Country Group E:1 (see Supplement No. 1 to part 740 of the EAR). In addition, items controlled under 1C350.b or .c require a license to certain destinations for chemical weapons (CW) reasons, as described in the License Requirements section of ECCN 1C350 and in Section 742.18 of the EAR. ECCN 1C353 (Genetic Elements and Genetically Modified Organisms) This final rule amends ECCN 1C353 on the CCL to reflect updates to the AG controls on certain genetic elements and genetically modified organisms adopted at the June 2017 AG Plenary meeting. Specifically, this rule amends ECCN 1C353 to control any genetically modified organism that contains, or any genetic element that codes for: (1) Any gene or genes specific to any virus controlled by ECCN 1C351.a or .b or 1C354.c; (2) any gene or genes specific to any bacterium controlled by ECCN 1C351.c or 1C354.a, or any fungus controlled by ECCN 1C351.e or 1C354.b, and which in itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health or could endow or enhance pathogenicity; or (3) any toxins, or their subunits, controlled by ECCN 1C351.d. In addition, this rule amends the Technical Notes to ECCN 1C353 to clarify that ``genetically modified organisms include organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation'' (see Technical Note 1 to ECCN 1C353, as amended by this rule) and that inactivated organisms containing recoverable nucleic acids are [[Page 13852]] considered to be genetic elements, whether genetically modified or unmodified, or chemically synthesized in whole or in part (see Technical Note 2 to ECCN 1C353, as amended by this rule). Technical Note 3 to ECCN 1C353, as amended by this rule, states that 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. This rule also defines the term ``endow or enhance pathogenicity,'' for purposes of the controls in ECCN 1C353 (see Technical Note 4 to ECCN 1C353, as amended by this rule), 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. All items controlled under ECCN 1C353 continue to require a license for CB reasons to destinations indicated in CB Column 1 on the Commerce Country Chart and for AT reasons to destinations indicated in AT Column 1 on the Commerce Country Chart. Amendments to the EAR To Reflect the Addition of India to the AG This rule makes conforming amendments to the EAR to reflect the addition of India to the AG, as of January 19, 2018. Specifically, this rule amends the entry for India in the Commerce Country Chart (Supplement No. 1 to part 738 of the EAR) by removing the ``X'' from this entry under the column CB 2. In addition, this rule amends the Country Groups chart (Supplement No. 1 to part 740 of the EAR) by adding an ``X'' to the entry for India under column A:3, Australia Group. Corrections to ECCN 1C351 (Human and Animal Pathogens and ``Toxins'') This final rule amends ECCN 1C351 on the CCL by removing several outdated references to former ECCN 1C352 in the Note that follows 1C351.a.4, which describes avian influenza (AI) viruses subject to control under this ECCN, and adding in their place references to the relevant AI controls described in 1C351.a.4. These corrections do not affect the scope of the items subject to control under this ECCN or the license requirements applicable to these items. Correction To Advance Notification Requirements for Certain Exports of Saxitoxin This final rule also corrects the Chemical Weapons Convention (CWC) Schedule 1 chemical advance notification requirements in Section 745.1 of the EAR to reflect the April 27, 2006 (71 FR 24918), amendments to the Chemical Weapons Convention Regulations (CWCR) (15 CFR parts 710- 722) that, inter alia, amended the definition of advance notification in Section 710.1 of the CWCR, as well as the advance notification requirements in Section 712.6(a) of the CWCR, to indicate that the 45- day advance notification requirement for exports or imports of Schedule 1 chemicals does not apply to the export or import of 5 milligrams or less of saxitoxin (see ECCN 1C351.d.12) for medical or diagnostic purposes only--the latter requires only a 3-day advance notification. Specifically, this final rule amends the first sentence in Section 745.1(a) of the EAR to read as follows: ``You must notify BIS at least 45 calendar days prior to exporting any quantity of a Schedule 1 chemical listed in Supplement No. 1 to this part to another State Party, except that notifications for exports of 5 milligrams or less of saxitoxin (for medical or diagnostic purposes only) must be submitted to BIS at least 3 calendar days prior to the date of export (see 15 CFR 712.6(a)).'' The advance notification requirements in Section 745.1 of the EAR refer only to exports, because imports are outside the scope of these EAR requirements. However, as indicated above, the advance notification requirements described in Section 712.6(a) of the CWCR apply to imports, as well as exports. The exemption from the 45-day advance notification requirement, for certain exports and imports of saxitoxin (as described above), was approved and entered into force for all CWC States Parties on October 31, 1999. Effect of This Rule on the Scope of the CB Controls in the EAR The changes made by this rule only marginally affect the scope of the EAR controls on chemical weapons precursors, human and animal pathogens/toxins, chemical manufacturing equipment, and equipment capable of use in handling biological materials. The scope of the CCL-based CB controls on human and animal pathogens and toxins was not affected by the correction to ECCN 1C351 in which outdated references to former ECCN 1C352 were removed from the Note that follows 1C351.a.4 and references to the relevant avian influenza (AI) controls described in 1C351.a.4 were added in their place. In addition, the updates to the controls on genetic elements and genetically modified organisms described in ECCN 1C353 clarified the scope of these controls, but did not actually expand them. In short, neither of these changes is expected to result in an increase in the number of license applications that will have to be submitted to BIS for exports, reexports, or transfers (in-country) of these items. However, the changes made by this final rule to the CCL entries controlling chemical weapons precursors, chemical manufacturing equipment, and equipment capable of use in handling biological materials are expected to result in a slight increase in the number of license applications that will have to be submitted for these items. Specifically, the addition of the precursor chemical hydrochloride salt N,N-Diisopropylaminoethanethiol hydrochloride (C.A.S. #41480-75-5) to ECCN 1C350.b is expected to result in the submission of one or two additional license applications per year. The addition of controls on certain prefabricated repair assemblies, and their specially designed components, to ECCN 2B350 is expected to result in the submission of four or five additional license applications per year. Specifically listing toxic gas monitors in ECCN 2B351 (to clarify that this entry controls, inter alia, certain portable gas monitors as well as toxic gas monitoring systems) is expected to result in the submission of two or three additional license applications per year. The addition of controls on nucleic acid assemblers and synthesizers to ECCN 2B352 is expected to result in the submission of four or five additional license applications per year. Therefore, the number of additional license applications that would have to be submitted per year, as a result of the amendments to ECCNs 1C350, 2B350, 2B351 and 2B352 described above, is not expected to exceed fifteen license applications. This total represents a relatively insignificant portion of the overall trade in such items and is well within the scope of the information collection approved by the Office of Management and Budget (OMB) under control number 0694-0088 (see Rulemaking Requirements #2, below). [[Page 13853]] Saving Clause Shipments of items removed from eligibility for export or reexport 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 May 2, 2018, pursuant to actual orders for export or reexport 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 or reexported before May 17, 2018. Any such items not actually exported or reexported before midnight, on May 17, 2018, 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 orwithout a license (NLR) before May 17, 2018. Beginning at midnight on May 17, 2018, 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 Administration Act Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 15, 2017 (82 FR 39005 (August 16, 2017)), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.). BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637. 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, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a ``significant regulatory action,'' although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget. The cost-benefit analysis required pursuant to Executive Orders 13563 and 12866 indicates that this rule is intended to improve national security as its primary direct benefit. Specifically, implementation, in a timely manner, of the AG agreements described herein would enhance the national security of the United States by reducing the risk that global international trade involving dual-use chemical/biological items would contribute to the proliferation of chemical and biological weapons of mass destruction. The first meeting of what subsequently became known as the Australia Group (AG) took place in Brussels in June 1985. At that meeting, the 15 participating countries and the European Commission agreed to explore how existing export controls might be made more effective to prevent the spread of chemical weapons. The AG has met regularly since then, and annual meetings are now held in Paris. The scope of the export controls addressed by the AG has evolved to address emerging threats and challenges. Evidence of the diversion of dual-use materials to biological weapons programs in the early 1990s led to participants' adoption of export controls on specific biological agents. The common control lists developed by the AG have also expanded to include technology and equipment that can be used in the manufacturing or disposal of chemical and biological weapons. The number of countries participating in the AG has grown from 15 in 1985 to 42, plus the European Union. The principal objective of AG participating countries is to use licensing measures to ensure that exports of certain chemicals, biological agents, and dual-use chemical and biological manufacturing facilities and equipment, do not contribute to the proliferation of chemical and biological weapons (CBW) of mass destruction, which has been identified as a threat to domestic and international peace and security. The AG achieves this objective by harmonizing participating countries' national export licensing measures. The AG's activities are especially important given that the international chemical and biotechnology industries are a target for proliferators as a source of materials for CBW programs. In calculating the costs that would be imposed by this rule, Commerce estimates that no more than 15 additional license applications would have to be submitted to BIS, annually, as a result of the implementation of the AG-related amendments described in this rule (see Rulemaking Requirements #2, below). Application of the cost-benefit analysis required under Executive Orders 13563 and 12866 to this rule, as described above, indicates that this rule is intended to improve the national security of the United States as its primary direct benefit. Furthermore, this rule qualifies for a good cause exception under 5 U.S.C. 553(b)(B) of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date--this finding, and a brief statement of the reasons therefor, are described under Rulemaking Requirements #4, below. Accordingly, this rule meets the requirements set forth in the April 5, 2017, OMB guidance implementing E.O. 13771 (82 FR 9339, February 3, 2017), regarding what constitutes a regulation issued ``with respect to a national security function of the United States'' and it is, therefore, exempt from the requirements of E.O. 13771. 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. This rule contains a collection of information subject to the requirements of the PRA. This collection has been approved by OMB under control number 0694-0088, Simplified Network Application Processing System. This collection includes license applications, among other things, and carries a burden estimate of 29.6 minutes per manual or electronic submission for a total burden estimate of 31,833 hours. Although this final rule makes important changes to the EAR for items controlled for chemical/biological (CB) reasons, Commerce believes the overall increase in costs and burdens due to this rule will be minimal. Specifically, BIS expects the burden hours associated with this collection to increase, slightly, by 7 hours and 24 minutes (i.e., 15 applications x 29.6 minutes per [[Page 13854]] response) for an estimated cost increase of $222 (i.e., 7 hours and 24 minutes x $30 per hour). This increase is not expected to exceed the existing estimates currently associated with OMB control number 0694- 0088. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Jasmeet Seehra, Office of Management and Budget, by email to Jasmeet_K._Seehra@omb.eop.gov or by fax to (202) 395-7285; and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, 14th Street & Pennsylvania Avenue NW, Room 2705, Washington, DC 20230 or by email to RPD2@bis.doc.gov. 3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132. 4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (see 5 U.S.C. 553(a)(1)). Immediate implementation of these amendments is non-discretionary and fulfills the United States' international obligation to the Australia Group (AG). The AG contributes to international security and regional stability through the harmonization of export controls and seeks to ensure that exports do not contribute to the development of chemical and biological weapons. The AG consists of 42 member countries that act on a consensus basis and the amendments set forth in this rule implement changes made to the AG common control lists (as a result of the adoption of the recommendations made at the February 2017 AG Intersessional Implementation Meeting and the understandings reached at the June 2017 AG Plenary Implementation Meeting) and other changes that are necessary to ensure consistency with the controls maintained by the AG. Because the United States is a significant exporter of the items in this rule, immediate implementation of this provision is necessary for the AG to achieve its purpose. Although the APA requirements in section 553 are not applicable to this action under the provisions of paragraph (a)(1), this action also falls within two other exceptions in the section. The subsection (b) requirement that agencies publish a notice of proposed rulemaking, which includes information on the public proceedings, does not apply when an agency for good cause finds that the notice and public procedures are impracticable, unnecessary, or contrary to the public interest, and the agency incorporates the finding (and the reasons therefor) in the rule that is issued (5 U.S.C. 553(b)(B)). In addition, the section 553(d) requirement that publication of a rule shall be made not less than 30 days before its effective date can be waived if an agency findsthere is good cause to do so. The section 553 requirements for notice and public procedures and for a delay in the date of effectiveness do not apply to this rule, as there is good cause to waive such practices. Any delay in implementation will create a disruption in the movement of affected items globally because of disharmony between export control measures implemented by AG members, resulting in tension between member countries. Export controls work best when all countries implement the same export controls in a timely manner. Delaying this rulemaking would prevent the United States from fulfilling its commitment to the AG in a timely manner, would injure the credibility of the United States in this and other multilateral regimes, and may impair the international community's ability to effectively control the export of certain potentially national- and international security-threatening items. Therefore, this regulation is issued in final form, and is effective April 2, 2018. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared. List of Subjects 15 CFR Part 738 Administrative practice and procedure, Exports, Foreign trade. 15 CFR Part 740 Administrative practice and procedure, Exports, Reporting and recordkeeping requirements. 15 CFR Part 745 Administrative practice and procedure, Chemicals, Exports, Foreign trade, Reporting and recordkeeping requirements. 15 CFR Part 774 Exports, Reporting and recordkeeping requirements. For the reasons stated in the preamble, parts 738, 740, 745 and 774 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows: PART 738--[AMENDED] 0 1. The authority citation for part 738 continues to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(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. 1824a; 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; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017). 0 2. Supplement No. 1 to Part 738 is amended by revising the entry for ``India'' to read as follows: Supplement No. 1 to Part 738--Commerce Country Chart [Reason for control] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Chemical and biological Nuclear National security Missile Regional stability Firearms Crime control Anti-terrorism weapons nonproliferation -------------------- tech convention ------------------------------------------------- Countries -------------------------------------------------- ------------------------------------------- CB 1 CB 2 CB 3 NP 1 NP 2 NS 1 NS 2 MT 1 RS 1 RS 2 FC 1 CC 1 CC 2 CC 3 AT 1 AT 2 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ * * * * * * * India 7...................... X ........ ........ X ........ X X X X ........ ........... ........ ........ ........ ........ ........ * * * * * * * ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ \7\ See Sec. 758.1(b)(9) for an AES filing requirement for exports of CC column 1 or 3, or RS column 2 items to India. Also note that a license is still required for items controlled under ECCNs 6A003.b.4.b and 9A515.e for RS column 2 reasons when destined to India. [[Page 13855]] * * * * * PART 740--[AMENDED] 0 3. The authority citation for part 740 continues to read as follows: Authority: 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; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017). 0 4. In Supplement No. 1 to Part 740, Country Groups, Country Group A is amended by revising the entry for ``India'' to read as follows: Supplement No. 1 to Part 740--Country Groups [Country Group A] -------------------------------------------------------------------------------------------------------------------------------------------------------- [A:1] Wassenaar [A:2] Missile [A:4] Nuclear Country participating technology [A:3] Australia suppliers group [A:5] [A:6] states 1 control regime group 2 -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * India............................................. ............... X X ............... ............... X * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- 1 Country Group A:1 is a list of the Wassenaar Arrangement Participating States, except for Malta, Russia and Ukraine. 2 Country Group A:4 is a list of the Nuclear Suppliers Group countries, except for the People's Republic of China (PRC). * * * * * PART 745--[AMENDED] 0 5. The authority citation for part 745 continues to read as follows: Authority: 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; Notice of November 8, 2016, 81 FR 79379 (November 10, 2016). 0 6. In Sec. 745.1, the first sentence in paragraph (a) is revised to read as follows: Sec. 745.1 Advance notification and annual report of all exports of Schedule 1 chemicals to other States Parties. * * * * * (a) Advance notification of exports. You must notify BIS at least 45 calendar days prior to exporting any quantity of a Schedule 1 chemical listed in Supplement No. 1 to this part to another State Party, except that notifications for exports of 5 milligrams or less of saxitoxin (for medical or diagnostic purposes only) must be submitted to BIS at least 3 calendar days prior to the date of export (see 15 CFR 712.6(a)). * * * * * * * * PART 774--[AMENDED] 0 7. The authority citation for part 774 continues to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 43 U.S.C. 1354; 15 U.S.C. 1824a; 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; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017). 0 8. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1, ECCN 1C350 is revised 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 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, Sudan, 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 [[Page 13856]] 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.7 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) 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 CIV: 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) Methylphos-phonothioic 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: 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. #298-06-6) O,O-Diethyl phosphorodithioate; d.6. (C.A.S. #2465-65-8) O,O-Diethyl phosphorothioate; d.7. (C.A.S. #108-18-9) Di-isopropylamine; d.8. (C.A.S. #124-40-3) Dimethylamine; d.9. (C.A.S. #506-59-2) Dimethylamine hydrochloride; d.10. (C.A.S. #7664-39-3) Hydrogen fluoride; d.11. (C.A.S. #3554-74-3) 3-Hydroxyl-1-methylpiperidine; d.12. (C.A.S. #76-89-1) Methyl benzilate; d.13. (C.A.S. #1314-80-3) Phosphorus pentasulfide; d.14. (C.A.S. #75-97-8) Pinacolone; d.15. (C.A.S. #7789-29-9) Potassium bifluoride; d.16. (C.A.S. #151-50-8) Potassium cyanide; d.17. (C.A.S. #7789-23-3) Potassium fluoride; d.18. (C.A.S. #3731-38-2) 3-Quinuclidone; d.19. (C.A.S. #1333-83-1) Sodium bifluoride; [[Page 13857]] d.20. (C.A.S. #143-33-9) Sodium cyanide; d.21. (C.A.S. #7681-49-4) Sodium fluoride; d.22. (C.A.S. #16893-85-9) Sodium hexafluorosilicate; d.23. (C.A.S. #1313-82-2) Sodium sulfide; d.24. (C.A.S. #637-39-8) Triethanolamine hydrochloride; d.25. (C.A.S. #116-17-6) Tri-isopropyl phosphite. 0 9. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1, ECCN 1C351 is revised to read as follows: 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.11 and d.12 and a license is required for CW reasons for all destinations, including Canada, as follows: CW applies to 1C351.d.11 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.12 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 paragraph (d) of this entry, with the exception of toxins controlled for CW reasons under d.11 and d.12, 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 paragraph d.12; 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 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, or the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, 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 CIV: 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.10 and 1C351.d.13 through 1C351.d.19. 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. List of Items Controlled Related Controls: (1) Certain forms of ricin and saxitoxin in 1C351.d.11. and d.12 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: (1) For the purposes of this entry ``immunotoxin'' is defined as an antibody-toxin conjugate intended to destroy specific target cells (e.g., tumor cells) that bear antigens homologous to the antibody. (2) For the purposes of this entry ``subunit'' is defined as a portion of the ``toxin''. 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. Monkeypox virus; a.31. Murray Valley encephalitis virus; a.32. Newcastle disease virus; a.33. Nipah virus; a.34. Omsk hemorrhagic fever virus; a.35. Oropouche virus; a.36. Peste-des-petits ruminants virus; a.37. Porcine Teschovirus; a.38. Powassan virus; a.39. Rabies virus and all other members of the Lyssavirus genus; [[Page 13858]] a.40. Reconstructed 1918 influenza virus; Technical Note: 1C351.a.40 includes reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments. a.41. Rift Valley fever virus; a.42. Rinderpest virus; a.43. Rocio virus; a.44. Sabia virus; a.45. Seoul virus; a.46. Severe acute respiratory syndrome-related coronavirus (SARS-related coronavirus); a.47. Sheeppox virus; a.48. Sin Nombre virus; a.49. St. Louis encephalitis virus; a.50. Suid herpesvirus 1 (Pseudorabies virus; Aujeszky's disease); a.51. Swine vesicular disease virus; a.52. Tick-borne encephalitis virus (Far Eastern subtype, formerly known as Russian Spring-Summer encephalitis virus--see 1C351.b.3 for Siberian subtype); a.53. Variola virus; a.54. Venezuelan equine encephalitis virus; a.55. Vesicular stomatitis virus; a.56. Western equine encephalitis virus; or a.57. 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.52 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, and ``subunits'' thereof: d.1. Abrin; d.2. Aflatoxins; d.3. Botulinum toxins; d.4. Cholera toxin; d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and iota toxins; d.6. Conotoxins; d.7. Diacetoxyscirpenol; d.8. HT-2 toxin; d.9. Microcystins (Cyanginosins); d.10. Modeccin; d.11. Ricin; d.12. Saxitoxin; d.13. Shiga toxins (shiga-like toxins, verotoxins, and verocytotoxins); d.14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known as Staphylococcus enterotoxin F); d.15. T-2 toxin; d.16. Tetrodotoxin; d.17. Viscumin (Viscum album lectin 1); or d.18. Volkensin. e. ``Fungi'', as follows: e.1. Coccidioides immitis; or e.2. Coccidioides posadasii. 0 10. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1, ECCN 1C353 is revised to read as follows: 1C353 Genetic elements and genetically modified organisms, as follows (see List of Items Controlled). License Requirements Reason for Control: CB, AT Country Chart Control(s) (See Supp. No. 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 CIV: 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 or genes 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 [[Page 13859]] 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. 0 11. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2, ECCN 2B350 is revised to read as follows: 2B350 Chemical manufacturing facilities and equipment, except valves controlled by 2A226, 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 License Requirement Note: This ECCN does not control equipment that is both: (1) ``Specially Designed'' for use in civil applications e.g., food processing, pulp and paper processing, or water purification) and (2) inappropriate, by the nature of its design, for use in storing, processing, producing or conducting and controlling the flow of the chemical weapons precursors controlled by 1C350. List Based License Exceptions (See Part 740 for a Description of All License Exceptions) LVS: $2,000 for all Country Group B destinations, except those also listed under Country Group D:3 (see Supplement No. 1 to part 740 of the EAR). GBS: N/A CIV: N/A List of Items Controlled Related Controls: See also ECCNs 2A226, 2A992, 2A993, 2B231, and 2B999. Related Definitions: For purposes of this entry the term `chemical warfare agents' includes those agents ``subject to the ITAR'' (see 22 CFR parts 120 through 130). Items: a. Reaction vessels, reactors and prefabricated repair assemblies therefor, as follows: a.1. Reaction vessels or reactors, with or without agitators, with total internal (geometric) volume greater than 0.1 m\3\ (100 liters) and less than 20 m\3\ (20,000 liters), where all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: a.1.a Alloys with more than 25% nickel and 20% chromium by weight; a.1.b. Nickel or alloys with more than 40% nickel by weight; a.1.c. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight); a.1.d. Glass (including vitrified or enameled coating or glass lining); a.1.e. Tantalum or tantalum alloys; a.1.f. Titanium or titanium alloys; a.1.g. Zirconium or zirconium alloys; or a.1.h. Niobium (columbium) or niobium alloys; a.2. Prefabricated repair assemblies, and their specially designed components, that: a.2.a. Are designed for mechanical attachment to glass-lined reaction vessels or reactors described in 2B350.a.1; and a.2.b. Have metallic surfaces that are made from tantalum or tantalum alloys and come in direct contact with the chemical(s) being processed. b. Agitators designed for use in reaction vessels or reactors described in 2B350.a.1, and impellers, blades or shafts designed for such agitators, where all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: b.1. Alloys with more than 25% nickel and 20% chromium by weight; b.2. Nickel or alloys with more than 40% nickel by weight; b.3. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight); b.4. Glass (including vitrified or enameled coatings or glass lining); b.5. Tantalum or tantalum alloys; b.6. Titanium or titanium alloys; b.7. Zirconium or zirconium alloys; or b.8. Niobium (columbium) or niobium alloys. c. Storage tanks, containers, receivers and prefabricated repair assemblies therefor, as follows: c.1. Storage tanks, containers or receivers with a total internal (geometric) volume greater than 0.1 m\3\ (100 liters) where all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: c.1.a. Alloys with more than 25% nickel and 20% chromium by weight; c.1.b. Nickel or alloys with more than 40% nickel by weight; c.1.c. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight); c.1.d. Glass (including vitrified or enameled coatings or glass lining); c.1.e. Tantalum or tantalum alloys; c.1.f. Titanium or titanium alloys; c.1.g. Zirconium or zirconium alloys; or c.1.h. Niobium (columbium) or niobium alloys; c.2. Prefabricated repair assemblies, and their specially designed components, that: c.2.a. Are designed for mechanical attachment to glass-lined storage tanks, containers or receivers described in 2B350.c.1; and c.2.b. Have metallic surfaces that are made from tantalum or tantalum alloys and come in direct contact with the chemical(s) being processed. d. Heat exchangers or condensers with a heat transfer surface area of less than 20 m\2\, but greater than 0.15 m\2\, and tubes, plates, coils or blocks (cores) designed for such heat exchangers or condensers, where all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials: d.1. Alloys with more than 25% nickel and 20% chromium by weight; d.2. Nickel or alloys with more than 40% nickel by weight; d.3. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight); d.4. Glass (including vitrified or enameled coatings or glass lining); d.5. Tantalum or tantalum alloys; d.6. Titanium or titanium alloys; d.7. Zirconium or zirconium alloys; d.8. Niobium (columbium) or niobium alloys; d.9. Graphite or carbon-graphite; d.10. Silicon carbide; or d.11. Titanium carbide. e. Distillation or absorption columns of internal diameter greater than 0.1 m, and liquid distributors, vapor distributors or liquid collectors designed for such distillation or absorption columns, where all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials: e.1. Alloys with more than 25% nickel and 20% chromium by weight; e.2. Nickel or alloys with more than 40% nickel by weight; e.3. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight); e.4. Glass (including vitrified or enameled coatings or glass lining); e.5. Tantalum or tantalum alloys; e.6. Titanium or titanium alloys; e.7. Zirconium or zirconium alloys; e.8. Niobium (columbium) or niobium alloys; or e.9. Graphite or carbon-graphite. f. Remotely operated filling equipment in which all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials: f.1. Alloys with more than 25% nickel and 20% chromium by weight; or f.2. Nickel or alloys with more than 40% nickel by weight. g. Valves, as follows: g.1. Valves having both of the following characteristics: g.1.a. A nominal size greater than 1.0 cm (\3/8\ in.); and g.1.b. All surfaces that come in direct contact with the chemical(s) being produced, processed, or contained are made from materials identified in Technical Note 1 to 2B350.g. g.2. Valves, except for valves controlled by 2B350.g.1, having all of the following characteristics: g.2.a. A nominal size equal to or greater than 2.54 cm (1 inch) and equal to or less than 10.16 cm (4 inches); g.2.b. Casings (valve bodies) or preformed casing liners controlled by 2B350.g.3, in which all surfaces that come in direct contact with the chemical(s) being produced, [[Page 13860]] processed, or contained are made from materials identified in Technical Note 1 to 2B350.g; and g.2.c. A closure element designed to be interchangeable. g.3. Casings (valve bodies) and preformed casing liners having both of the following characteristics: g.3.a. Designed for valves in 2B350.g.1 or .g.2; and g.3.b. All surfaces that come in direct contact with the chemical(s) being produced, processed, or contained are made from materials identified in Technical Note 1 to 2B350.g. Technical Note 1 to 2B350.g: All surfaces of the valves controlled by 2B350.g.1, and the casings (valve bodies) and preformed casing liners controlled by 2B350.g.3, that come in direct contact with the chemical(s) being produced, processed, or contained are made from the following materials: a. Alloys with more than 25% nickel and 20% chromium by weight; b. Nickel or alloys with more than 40% nickel by weight; c. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight); d. Glass (including vitrified or enameled coating or glass lining); e. Tantalum or tantalum alloys; f. Titanium or titanium alloys; g. Zirconium or zirconium alloys; h. Niobium (columbium) or niobium alloys; or i. Ceramic materials, as follows: i.1. Silicon carbide with a purity of 80% or more by weight; i.2. Aluminum oxide (alumina) with a purity of 99.9% or more by weight; or i.3. Zirconium oxide (zirconia). Technical Note 2 to 2B350.g: The `nominal size' is defined as the smaller of the inlet and outlet port diameters. h. Multi-walled piping incorporating a leak detection port, in which all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: h.1. Alloys with more than 25% nickel and 20% chromium by weight; h.2. Nickel or alloys with more than 40% nickel by weight; h.3. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight); h.4. Glass (including vitrified or enameled coatings or glass lining); h.5. Tantalum or tantalum alloys; h.6. Titanium or titanium alloys; h.7. Zirconium or zirconium alloys; h.8. Niobium (columbium) or niobium alloys; or h.9. Graphite or carbon-graphite. i. Multiple-seal and seal-less pumps with manufacturer's specified maximum flow-rate greater than 0.6 m\3\/hour (600 liters/ hour), or vacuum pumps with manufacturer's specified maximum flow- rate greater than 5 m\3\/hour (5,000 liters/hour) (under standard temperature (273 K (0 [deg]C)) and pressure (101.3 kPa) conditions), and casings (pump bodies), preformed casing liners, impellers, rotors or jet pump nozzles designed for such pumps, in which all surfaces that come into direct contact with the chemical(s) being processed are made from any of the following materials: i.1. Alloys with more than 25% nickel and 20% chromium by weight; i.2. Nickel or alloys with more than 40% nickel by weight; i.3. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight); i.4. Glass (including vitrified or enameled coatings or glass lining); i.5. Tantalum or tantalum alloys; i.6. Titanium or titanium alloys; i.7. Zirconium or zirconium alloys; i.8. Niobium (columbium) or niobium alloys. i.9. Graphite or carbon-graphite; i.10. Ceramics; or i.11. Ferrosilicon (high silicon iron alloys). Technical Note to 2B350.i: The seals referred to in 2B350.i come into direct contact with the chemical(s) being processed (or are designed to do so), and provide a sealing function where a rotary or reciprocating drive shaft passes through a pump body. j. Incinerators designed to destroy chemical warfare agents, chemical weapons precursors controlled by 1C350, or chemical munitions having ``specially designed'' waste supply systems, special handling facilities and an average combustion chamber temperature greater than 1000 [deg]C in which all surfaces in the waste supply system that come into direct contact with the waste products are made from or lined with any of the following materials: j.1. Alloys with more than 25% nickel and 20% chromium by weight; j.2. Nickel or alloys with more than 40% nickel by weight; or j.3. Ceramics. Technical Note 1: Carbon-graphite is a composition consisting primarily of graphite and amorphous carbon, in which the graphite is 8 percent or more by weight of the composition. Technical Note 2: For the items listed in 2B350, the term `alloy,' when not accompanied by a specific elemental concentration, is understood as identifying those alloys where the identified metal is present in a higher percentage by weight than any other element. Technical Note 3: The materials used for gaskets, packing, seals, screws or washers, or other materials performing a sealing function, do not determine the control status of the items in this ECCN, provided that such components are designed to be interchangeable. Note: See Categories V and XIV of the United States Munitions List for all chemicals that are ``subject to the ITAR'' (see 22 CFR parts 120 through 130). 0 12. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2, ECCN 2B351 is revised to read as follows: 2B351 Toxic gas monitors and monitoring systems, and their dedicated detecting ``parts'' and ``components'' (i.e., detectors, sensor devices, and replaceable sensor cartridges), as follows, except those systems and detectors controlled by ECCN 1A004.c (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 CIV: N/A List of Items Controlled Related Controls: See ECCN 2D351 for ``software'' for toxic gas monitors and monitoring systems, and their dedicated detecting ``parts'' and ``components,'' controlled by this ECCN. Also see ECCN 1A004, which controls chemical detection systems and ``specially designed'' ``parts'' and ``components'' therefor that are ``specially designed'' or modified for detection or identification of chemical warfare agents, but not ``specially designed'' for military use, and ECCN 1A995, which controls certain detection equipment, ``parts'' and ``components'' not controlled by ECCN 1A004 or by this ECCN. Related Definitions: (1) For the purposes of this entry, the term ``dedicated'' means committed entirely to a single purpose or device. (2) For the purposes of this entry, the term ``continuous operation'' describes the capability of the equipment to operate on line without human intervention. The intent of this entry is to control toxic gas monitors and monitoring systems capable of collection and detection of samples in environments such as chemical plants, rather than those used for batch-mode operation in laboratories. Items: a. Designed for continuous operation and usable for the detection of chemical warfare agents or precursor chemicals controlled by 1C350 at concentrations of less than 0.3 mg/m\3\; or b. Designed for the detection of cholinesterase-inhibiting activity. 0 13. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2--Materials Processing, ECCN 2B352 is revised to read as follows: 2B352 Equipment capable of use in handling biological materials, as follows (see List of Items Controlled). License Requirements Reason for Control: CB, AT [[Page 13861]] 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 CIV: 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: 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 Note: Fermenters include bioreactors (including single-use (disposable) bioreactors), chemostats and continuous-flow systems. 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: 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: 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 the destruction of potential microbial infectivity in the equipment through the use of chemical agents with a germicidal effect. ``Disinfection'' and ``sterilization'' are distinct from ``sanitization'', the latter referring to cleaning procedures designed to lower the microbial content of equipment without necessarily achieving elimination of all microbial infectivity or viability. 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 dependant upon a tethered external air supply and operating under positive pressure. Technical Note: This entry 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 does not control 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: 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 [[Page 13862]] 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. 0 14. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2, ECCN 2D351 is revised to read as follows: 2D351 Dedicated ``software'' for toxic gas monitors and monitoring systems, and their dedicated detecting ``parts'' and ``components,'' controlled by ECCN 2B351. 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) CIV: N/A TSR: N/A List of Items Controlled Related Controls: N/A Related Definitions: (1) For the purposes of this entry, the term ``dedicated'' means committed entirely to a single purpose or device. (2) See Section 772.1 of the EAR for the definitions of ``software,'' ``program,'' and ``microprogram.'' Items: The list of items controlled is contained in the ECCN heading. Dated: March 27, 2018. Matthew S. Borman, Deputy Assistant Secretary for Export Administration. [FR Doc. 2018-06581 Filed 3-30-18; 8:45 am] BILLING CODE 3510-33-P
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations 13849
(7) Consumer acknowledgment. You insurance product or annuity in any SUMMARY: The Bureau of Industry and
must obtain from the consumer, at the part of its office or on its behalf, unless Security (BIS) publishes this final rule
time a consumer receives the the person is at all times appropriately to amend the Export Administration
disclosures required under paragraph (a) qualified and licensed under applicable Regulations (EAR) to implement the
or (b) of this section, or at the time of State insurance licensing standards with recommendations presented at the
the initial purchase by the consumer of regard to the specific products being February 2017 Australia Group (AG)
an insurance product or annuity, a sold or recommended. Intersessional Implementation Meeting,
written acknowledgment by the and later adopted pursuant to the AG
consumer that the consumer received Appendix A to Part 343—Consumer silent approval procedure, and the
the disclosures. You may permit a Grievance Process recommendations made at the June 2017
consumer to acknowledge receipt of the Any consumer who believes that any AG Plenary Implementation Meeting
disclosures electronically or in paper institution or any other person selling, and adopted by the AG Plenary. This
form. If the disclosures required under soliciting, advertising, or offering rule amends the following Export
paragraph (a) or (b) of this section are insurance products or annuities to the Control Classification Numbers (ECCNs)
provided in connection with a consumer at an office of the institution on the Commerce Control List (CCL) to
transaction that is conducted by or on behalf of the institution has reflect the February 2017 Intersessional
telephone, you must: violated the requirements of this part Implementation Meeting
(i) Obtain an oral acknowledgment of should contact the Division of Depositor recommendations that were adopted by
receipt of the disclosures and maintain and Consumer Protection, Consumer the AG: ECCN 2B350 (by adding certain
sufficient documentation to show that Response Center, Federal Deposit prefabricated repair assemblies, and
the acknowledgment was given; and Insurance Corporation, at the following specially designed components therefor,
(ii) Make reasonable efforts to obtain address: 1100 Walnut Street, Box #11, that are designed for attachment to
a written acknowledgment from the Kansas City, MO 64106, or telephone 1– glass-lined reaction vessels, reactors,
consumer. 877–275–3342, or FDIC Electronic storage tanks, containers or receivers
(d) Advertisements and other Customer Assistance Form at http:// controlled by this entry); ECCN 2B351
promotional material for insurance www5.fdic.gov/starsmail/index.asp. (by clarifying that toxic gas monitoring
products or annuities. The disclosures equipment includes toxic gas monitors
described in paragraph (a) of this PART 390—REGULATIONS and monitoring systems, as well as their
section are required in advertisements TRANSFERRED FROM THE OFFICE OF dedicated detecting components); and
and promotional material for insurance THRIFT SUPERVISION ECCN 2B352 (by adding certain nucleic
products or annuities unless the acid assemblers and synthesizers to this
advertisements and promotional ■ 2. The authority citation for part 390 entry and clarifying how the capacity of
materials are of a general nature is revised to read as follows: certain fermenters should be measured
describing or listing the services or Authority: 12 U.S.C. 1831y. for purposes of determining whether
products offered by the institution. they are controlled under this entry).
§ 343.50 Where insurance activities may
Subpart I—[Removed and Reserved] Consistent with the June 2017 AG
take place. Plenary Implementation Meeting
■ 3. Remove and reserve subpart I, recommendations that were adopted by
(a) General rule. An institution must, consisting of §§ 390.180 through
to the extent practicable, keep the area the AG, this rule amends the following
390.185, and appendix A. ECCNs on the CCL: ECCN 1C353 (to
where the institution conducts
transactions involving insurance Dated at Washington, DC, on March 20, clarify that genetically modified
2018. organisms include organisms in which
products or annuities physically
segregated from areas where retail By order of the Board of Directors. the nucleic acid sequences have been
deposits are routinely accepted from the Federal Deposit Insurance Corporation. created or altered by deliberate
general public, identify the areas where Valerie J. Best, molecular manipulation and that
insurance product or annuity sales Assistant Executive Secretary. inactivated organisms containing
activities occur, and clearly delineate [FR Doc. 2018–06163 Filed 3–30–18; 8:45 am] recoverable nucleic acids are considered
and distinguish those areas from the BILLING CODE 6714–01–P
to be genetic elements) and ECCN 1C350
areas where the institution’s retail (by adding
deposit-taking activities occur. N,N-Diisopropylaminoethanethiol
(b) Referrals. Any person who accepts hydrochloride). This rule also corrects
DEPARTMENT OF COMMERCE several typographical errors in a note to
deposits from the public in an area
where such transactions are routinely Bureau of Industry and Security ECCN 1C351 and updates the advance
conducted in the institution may refer a notification requirements in the EAR
consumer who seeks to purchase an 15 CFR Parts 738, 740, 745 and 774 that apply to certain exports of
insurance product or annuity to a saxitoxin. Finally, this rule amends the
qualified person who sells that product [Docket No. 170306234–7234–01] EAR to reflect the addition of India as
only if the person making the referral RIN 0694–AH37 a participating country in the AG.
receives no more than a one-time, DATES: This rule is effective April 2,
nominal fee of a fixed dollar amount for Implementation of the February 2017 2018.
each referral that does not depend on Australia Group (AG) Intersessional FOR FURTHER INFORMATION CONTACT:
whether the referral results in a Decisions and the June 2017 AG Richard P. Duncan, Ph.D., Director,
daltland on DSKBBV9HB2PROD with RULES
transaction. Plenary Understandings; Addition of Chemical and Biological Controls
§ 343.60 Qualification and licensing
India to the AG Division, Office of Nonproliferation and
requirements for insurance sales AGENCY: Bureau of Industry and Treaty Compliance, Bureau of Industry
personnel. Security, Commerce. and Security, Telephone: (202) 482–
An institution may not permit any 3343, Email: Richard.Duncan@
ACTION: Final rule.
person to sell or offer for sale any bis.doc.gov.
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![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations 13851
Previous CCL Current CCL
AG-Controlled precursor chemicals designation designation
(C.A.S. #683–08–9) Diethyl methylphosphonate ................................................................................... ECCN 1C350.b.22 ECCN 1C350.b.4
(C.A.S. #15715–41–0) Diethyl methylphosphonite ................................................................................. ECCN 1C350.b.4 ECCN 1C350.b.5
(C.A.S. #2404–03–7) Diethyl-N,N-dimethylphosphoroamidate .............................................................. ECCN 1C350.b.5 ECCN 1C350.b.6
(C.A.S. #41480–75–5) N,N-Diisopropylaminoethanethiol hydrochloride ................................................ None—EAR 99 ECCN 1C350.b.7
(C.A.S. #5842–07–9) N,N-Diisopropyl-beta-aminoethane thiol .............................................................. ECCN 1C350.b.6 ECCN 1C350.b.8
(C.A.S. #96–80–0) N,N-Diisopropyl-beta-aminoethanol ......................................................................... ECCN 1C350.b.8 ECCN 1C350.b.9
(C.A.S. #96–79–7), N,N-Diisopropyl-beta-aminoethyl chloride .............................................................. ECCN 1C350.b.9 ECCN 1C350.b.10
(C.A.S. #4261–68–1) N,N-Diisopropyl-beta-aminoethyl chloride hydrochloride .................................... ECCN 1C350.b.7 ECCN 1C350.b.11
(C.A.S. #6163–75–3) Dimethyl ethylphosphonate ................................................................................. ECCN 1C350.b.10 ECCN 1C350.b.12
(C.A.S. #756–79–6) Dimethyl methylphosphonate ................................................................................ ECCN 1C350.b.11 ECCN 1C350.b.13
(C.A.S. #677–43–0) N,N-Dimethylamino-phosphoryl dichloride ............................................................ ECCN 1C350.b.23 ECCN 1C350.b.14
(C.A.S. #1498–40–4) Ethyl phosphonous dichloride [Ethyl phosphinyl dichloride] ............................... ECCN 1C350.b.12 ECCN 1C350.b.15
(C.A.S. #430–78–4) Ethyl phosphonus difluoride [Ethyl phosphinyl difluoride] ..................................... ECCN 1C350.b.13 ECCN 1C350.b.16
(C.A.S. #1066–50–8) Ethyl phosphonyl dichloride ................................................................................. ECCN 1C350.b.14 ECCN 1C350.b.17
(C.A.S. #993–13–5) Methylphosphonic acid .......................................................................................... ECCN 1C350.b.21 ECCN 1C350.b.18
(C.A.S. #676–98–2) Methylphos-phonothioic dichloride ........................................................................ ECCN 1C350.b.24 ECCN 1C350.b.19
(C.A.S. #464–07–3) Pinacolyl alcohol .................................................................................................... ECCN 1C350.b.18 ECCN 1C350.b.20
(C.A.S. #1619–34–7) 3-Quinuclidinol ..................................................................................................... ECCN 1C350.b.19 ECCN 1C350.b.21
(C.A.S. #111–48–8) Thiodiglycol ............................................................................................................ ECCN 1C350.b.20 ECCN 1C350.b.22
(C.A.S. #139–87–7) Ethyldiethanolamine ............................................................................................... ECCN 1C350.c.12 ECCN 1C350.c.3
(C.A.S. #10025–87–3) Phosphorus oxychloride .................................................................................... ECCN 1C350.c.3 ECCN 1C350.c.4
(C.A.S. #10026–13–8) Phosphorus pentachloride ................................................................................. ECCN 1C350.c.4 ECCN 1C350.c.5
(C.A.S. #7719–12–2) Phosphorus trichloride ......................................................................................... ECCN 1C350.c.5 ECCN 1C350.c.6
(C.A.S. #10025–67–9) Sulfur monochloride ........................................................................................... ECCN 1C350.c.6 ECCN 1C350.c.8
(C.A.S. #7719–09–7) Thionyl chloride .................................................................................................... ECCN 1C350.c.8 ECCN 1C350.c.9
(C.A.S. #102–71–6) Triethanolamine ..................................................................................................... ECCN 1C350.c.9 ECCN 1C350.c.10
(C.A.S. #122–52–1) Triethyl phosphite .................................................................................................. ECCN 1C350.c.10 ECCN 1C350.c.11
(C.A.S. #121–45–9) Trimethyl phosphite ............................................................................................... ECCN 1C350.c.11 ECCN 1C350.c.12
(C.A.S. #109–89–7) Diethylamine .......................................................................................................... ECCN 1C350.d.25 ECCN 1C350.d.3
(C.A.S. #100–37–8) N,N-Diethylaminoethanol ....................................................................................... ECCN 1C350.d.3 ECCN 1C350.d.4
(C.A.S. #298–06–6) O,O-Diethyl phosphorodithioate ............................................................................ ECCN 1C350.d.23 ECCN 1C350.d.5
(C.A.S. #2465–65–8) O,O-Diethyl phosphorothioate ............................................................................. ECCN 1C350.d.22 ECCN 1C350.d.6
(C.A.S. #108–18–9) Di-isopropylamine .................................................................................................. ECCN 1C350.d.4 ECCN 1C350.d.7
(C.A.S. #124–40–3) Dimethylamine ....................................................................................................... ECCN 1C350.d.5 ECCN 1C350.d.8
(C.A.S. #506–59–2) Dimethylamine hydrochloride ................................................................................ ECCN 1C350.d.6 ECCN 1C350.d.9
(C.A.S. #7664–39–3) Hydrogen fluoride ................................................................................................ ECCN 1C350.d.7 ECCN 1C350.d.10
(C.A.S. #3554–74–3) 3-Hydroxyl-1-methylpiperidine ............................................................................. ECCN 1C350.d.8 ECCN 1C350.d.11
(C.A.S. #76–89–1) Methyl benzilate ....................................................................................................... ECCN 1C350.d.9 ECCN 1C350.d.12
(C.A.S. #1314–80–3) Phosphorus pentasulfide ..................................................................................... ECCN 1C350.d.10 ECCN 1C350.d.13
(C.A.S. #75–97–8) Pinacolone ............................................................................................................... ECCN 1C350.d.11 ECCN 1C350.d.14
(C.A.S. #7789–29–9) Potassium bifluoride ............................................................................................ ECCN 1C350.d.14 ECCN 1C350.d.15
(C.A.S. #151–50–8) Potassium cyanide ................................................................................................. ECCN 1C350.d.12 ECCN 1C350.d.16
(C.A.S. #7789–23–3) Potassium fluoride ............................................................................................... ECCN 1C350.d.13 ECCN 1C350.d.17
(C.A.S. #3731–38–2) 3-Quinuclidone ..................................................................................................... ECCN 1C350.d.15 ECCN 1C350.d.18
(C.A.S. #1333–83–1) Sodium bifluoride ................................................................................................. ECCN 1C350.d.16 ECCN 1C350.d.19
(C.A.S. #143–33–9) Sodium cyanide ..................................................................................................... ECCN 1C350.d.17 ECCN 1C350.d.20
(C.A.S. #7681–49–4) Sodium fluoride .................................................................................................... ECCN 1C350.d.18 ECCN 1C350.d.21
(C.A.S. #16893–85–9) Sodium hexafluorosilicate .................................................................................. ECCN 1C350.d.24 ECCN 1C350.d.22
(C.A.S. #1313–82–2) Sodium sulfide ..................................................................................................... ECCN 1C350.d.19 ECCN 1C350.d.23
(C.A.S. #637–39–8) Triethanolamine hydrochloride .............................................................................. ECCN 1C350.d.20 ECCN 1C350.d.24
(C.A.S. #116–17–6) Tri-isopropyl phosphite .......................................................................................... ECCN 1C350.d.21 ECCN 1C350.d.25
All items controlled under ECCN ECCN 1C353 (Genetic Elements and and which in itself or through its
1C350 continue to require a license for Genetically Modified Organisms) transcribed or translated products
CB reasons to destinations indicated in This final rule amends ECCN 1C353 represents a significant hazard to
CB Column 2 on the Commerce Country on the CCL to reflect updates to the AG human, animal or plant health or could
Chart and for AT reasons to countries controls on certain genetic elements and endow or enhance pathogenicity; or (3)
listed in Country Group E:1 (see genetically modified organisms adopted any toxins, or their subunits, controlled
Supplement No. 1 to part 740 of the at the June 2017 AG Plenary meeting. by ECCN 1C351.d.
EAR). In addition, items controlled Specifically, this rule amends ECCN In addition, this rule amends the
under 1C350.b or .c require a license to 1C353 to control any genetically Technical Notes to ECCN 1C353 to
certain destinations for chemical modified organism that contains, or any clarify that ‘‘genetically modified
organisms include organisms in which
daltland on DSKBBV9HB2PROD with RULES
weapons (CW) reasons, as described in genetic element that codes for: (1) Any
the License Requirements section of gene or genes specific to any virus the nucleic acid sequences have been
ECCN 1C350 and in Section 742.18 of controlled by ECCN 1C351.a or .b or created or altered by deliberate
the EAR. 1C354.c; (2) any gene or genes specific molecular manipulation’’ (see Technical
to any bacterium controlled by ECCN Note 1 to ECCN 1C353, as amended by
1C351.c or 1C354.a, or any fungus this rule) and that inactivated organisms
controlled by ECCN 1C351.e or 1C354.b, containing recoverable nucleic acids are
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![13854 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations
response) for an estimated cost increase United States is a significant exporter of opportunity for public comment be
of $222 (i.e., 7 hours and 24 minutes × the items in this rule, immediate given for this final rule. Because a
$30 per hour). This increase is not implementation of this provision is notice of proposed rulemaking and an
expected to exceed the existing necessary for the AG to achieve its opportunity for public comment are not
estimates currently associated with purpose. required to be given for this rule under
OMB control number 0694–0088. Send Although the APA requirements in the Administrative Procedure Act or by
comments regarding this burden section 553 are not applicable to this any other law, the analytical
estimate or any other aspect of this action under the provisions of requirements of the Regulatory
collection of information, including paragraph (a)(1), this action also falls Flexibility Act (5 U.S.C. 601 et seq.) are
suggestions for reducing the burden, to within two other exceptions in the not applicable. Accordingly, no
Jasmeet Seehra, Office of Management section. The subsection (b) requirement regulatory flexibility analysis is required
and Budget, by email to Jasmeet_K._ that agencies publish a notice of and none has been prepared.
Seehra@omb.eop.gov or by fax to (202) proposed rulemaking, which includes
395–7285; and to the Regulatory Policy information on the public proceedings, List of Subjects
Division, Bureau of Industry and does not apply when an agency for good 15 CFR Part 738
Security, Department of Commerce, cause finds that the notice and public
Administrative practice and
14th Street & Pennsylvania Avenue NW, procedures are impracticable,
procedure, Exports, Foreign trade.
Room 2705, Washington, DC 20230 or unnecessary, or contrary to the public
by email to RPD2@bis.doc.gov. interest, and the agency incorporates the 15 CFR Part 740
3. This rule does not contain policies finding (and the reasons therefor) in the Administrative practice and
with Federalism implications as that rule that is issued (5 U.S.C. 553(b)(B)). procedure, Exports, Reporting and
term is defined in Executive Order In addition, the section 553(d) recordkeeping requirements.
13132. requirement that publication of a rule
4. The provisions of the shall be made not less than 30 days 15 CFR Part 745
Administrative Procedure Act (5 U.S.C. before its effective date can be waived Administrative practice and
553) requiring notice of proposed if an agency findsthere is good cause to procedure, Chemicals, Exports, Foreign
rulemaking, the opportunity for public do so. trade, Reporting and recordkeeping
participation, and a delay in effective The section 553 requirements for requirements.
date, are inapplicable because this notice and public procedures and for a
regulation involves a military and delay in the date of effectiveness do not 15 CFR Part 774
foreign affairs function of the United apply to this rule, as there is good cause Exports, Reporting and recordkeeping
States (see 5 U.S.C. 553(a)(1)). to waive such practices. Any delay in requirements.
Immediate implementation of these implementation will create a disruption
amendments is non-discretionary and For the reasons stated in the
in the movement of affected items
fulfills the United States’ international preamble, parts 738, 740, 745 and 774
globally because of disharmony between
obligation to the Australia Group (AG). of the Export Administration
export control measures implemented
The AG contributes to international Regulations (15 CFR parts 730–774) are
by AG members, resulting in tension
security and regional stability through amended as follows:
between member countries. Export
the harmonization of export controls controls work best when all countries PART 738—[AMENDED]
and seeks to ensure that exports do not implement the same export controls in
contribute to the development of a timely manner. Delaying this ■ 1. The authority citation for part 738
chemical and biological weapons. The rulemaking would prevent the United continues to read as follows:
AG consists of 42 member countries that States from fulfilling its commitment to Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C.
act on a consensus basis and the the AG in a timely manner, would 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
amendments set forth in this rule injure the credibility of the United 7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 et
implement changes made to the AG States in this and other multilateral seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15
common control lists (as a result of the regimes, and may impair the U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201
adoption of the recommendations made international community’s ability to et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR
at the February 2017 AG Intersessional effectively control the export of certain 58767, 3 CFR, 1996 Comp., p. 228; E.O.
Implementation Meeting and the potentially national- and international 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
understandings reached at the June 2017 security-threatening items. Therefore, 783; Notice of August 15, 2017, 82 FR 39005
AG Plenary Implementation Meeting) (August 16, 2017).
this regulation is issued in final form,
and other changes that are necessary to and is effective April 2, 2018. ■ 2. Supplement No. 1 to Part 738 is
ensure consistency with the controls Further, no other law requires that a amended by revising the entry for
maintained by the AG. Because the notice of proposed rulemaking and an ‘‘India’’ to read as follows:
SUPPLEMENT NO. 1 TO PART 738—COMMERCE COUNTRY CHART
[Reason for control]
Chemical and biological Nuclear Missile Firearms
weapons nonproliferation National security tech Regional stability convention Crime control Anti-terrorism
Countries
CB CB CB NP NP NS NS MT RS RS FC CC CC CC AT AT
1 2 3 1 2 1 2 1 1 2 1 1 2 3 1 2
daltland on DSKBBV9HB2PROD with RULES
* * * * * * *
India 7 ......................................... X ............ ............ X ............ X X X X ............ .................. ............ ............ ............ ............ ............
* * * * * * *
7 See
§ 758.1(b)(9) for an AES filing requirement for exports of CC column 1 or 3, or RS column 2 items to India. Also note that a license is still required for items controlled under ECCNs
6A003.b.4.b and 9A515.e for RS column 2 reasons when destined to India.
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![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations 13855
* * * * * Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. ■ 4. In Supplement No. 1 to Part 740,
1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. Country Groups, Country Group A is
PART 740—[AMENDED] 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. amended by revising the entry for
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
■ 3. The authority citation for part 740 ‘‘India’’ to read as follows:
Comp., p. 783; Notice of August 15, 2017, 82
continues to read as follows: FR 39005 (August 16, 2017).
SUPPLEMENT NO. 1 TO PART 740—COUNTRY GROUPS
[Country Group A]
[A:2]
[A:1] Missile [A:3] [A:4]
Wassenaar Nuclear
Country technology Australia [A:5] [A:6]
participating control group suppliers
states 1 regime group 2
* * * * * * *
India .......................................................... ........................ X X ........................ ........................ X
* * * * * * *
1 Country Group A:1 is a list of the Wassenaar Arrangement Participating States, except for Malta, Russia and Ukraine.
2 Country Group A:4 is a list of the Nuclear Suppliers Group countries, except for the People’s Republic of China (PRC).
* * * * * ■ 8. In Supplement No. 1 to Part 774 for AT reasons in 1C350. A license is
(the Commerce Control List), Category 1, required, for AT reasons, to export or
PART 745—[AMENDED] ECCN 1C350 is revised to read as reexport items controlled by 1C350 to a
country in Country Group E:1 of Supplement
follows: No. 1 to part 740 of the EAR. (See part 742
■ 5. The authority citation for part 745
Supplement No. 1 to Part 774—The of the EAR for additional information on the
continues to read as follows: AT controls that apply to Iran, North Korea,
Commerce Control List
Authority: 50 U.S.C. 1701 et seq.; E.O. Sudan, and Syria. See part 746 of the EAR
12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 1C350 Chemicals that may be used as for additional information on sanctions that
950; Notice of November 8, 2016, 81 FR precursors for toxic chemical agents (see apply to Iran, North Korea, and Syria.)
79379 (November 10, 2016). List of Items Controlled). License Requirement Notes: 1. Sample
Shipments: Subject to the following
■ 6. In § 745.1, the first sentence in License Requirements
requirements and restrictions, a license is not
paragraph (a) is revised to read as Reason for Control: CB, CW, AT required for sample shipments when the
follows: cumulative total of these shipments does not
Country chart (See exceed a 55-gallon container or 200 kg of a
§ 745.1 Advance notification and annual Control(s) Supp. No. 1 to part single chemical to any one consignee during
report of all exports of Schedule 1 738) a calendar year. A consignee that receives a
chemicals to other States Parties. sample shipment under this exclusion may
CB applies to entire CB Column 2 not resell, transfer, or reexport the sample
* * * * * entry. shipment, but may use the sample shipment
(a) Advance notification of exports.
CW applies to 1C350 .b, and .c. The for any other legal purpose unrelated to
You must notify BIS at least 45 calendar Commerce Country Chart is not designed to chemical weapons.
days prior to exporting any quantity of determine licensing requirements for items a. Chemicals Not Eligible:
a Schedule 1 chemical listed in controlled for CW reasons. A license is A. [Reserved]
Supplement No. 1 to this part to another required, for CW reasons, to export or B. CWC Schedule 2 chemicals (States not
State Party, except that notifications for reexport Schedule 2 chemicals and mixtures Party to the CWC). No CWC Schedule 2
exports of 5 milligrams or less of identified in 1C350.b to States not Party to chemical or mixture identified in 1C350.b is
saxitoxin (for medical or diagnostic the CWC (destinations not listed in eligible for sample shipment to States not
Supplement No. 2 to part 745 of the EAR). Party to the CWC (destinations not listed in
purposes only) must be submitted to BIS
A license is required, for CW reasons, to Supplement No. 2 to part 745 of the EAR)
at least 3 calendar days prior to the date export Schedule 3 chemicals and mixtures without a license.
of export (see 15 CFR 712.6(a)). * * * identified in 1C350.c to States not Party to b. Countries Not Eligible: Countries in
* * * * * the CWC, unless an End-Use Certificate Country Group E:1 of Supplement No. 1 to
issued by the government of the importing part 740 of the EAR are not eligible to receive
PART 774—[AMENDED] country has been obtained by the exporter sample shipments of any chemicals
prior to export. A license is required, for CW controlled by this ECCN without a license.
■ 7. The authority citation for part 774 reasons, to reexport Schedule 3 chemicals c. Sample shipments that require an End-
continues to read as follows: and mixtures identified in 1C350.c from a Use Certificate for CW reasons: No CWC
State not Party to the CWC to any other State Schedule 3 chemical or mixture identified in
Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. not Party to the CWC. (See § 742.18 of the 1C350.c is eligible for sample shipment to
1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. EAR for license requirements and policies for States not Party to the CWC (destinations not
7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et toxic and precursor chemicals controlled for listed in Supplement No. 2 to part 745 of the
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); CW reasons. See § 745.2 of the EAR for End- EAR) without a license, unless an End-Use
daltland on DSKBBV9HB2PROD with RULES
42 U.S.C. 2139a; 43 U.S.C. 1354; 15 U.S.C. Use Certificate requirements that apply to Certificate issued by the government of the
1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; exports of Schedule 3 chemicals to countries importing country is obtained by the exporter
22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 not listed in Supplement No. 2 to part 745 prior to export (see § 745.2 of the EAR for
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR of the EAR.) End-Use Certificate requirements).
44025, 3 CFR, 2001 Comp., p. 783; Notice of AT applies to entire entry. The Commerce d. Sample shipments that require a license
August 15, 2017, 82 FR 39005 (August 16, Country Chart is not designed to determine for reasons set forth elsewhere in the EAR:
2017). licensing requirements for items controlled Sample shipments, as described in this Note
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![13856 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations
1, may require a license for reasons set forth more ingredients that do not react together b.16. (C.A.S. #430–78–4) Ethyl phosphonus
elsewhere in the EAR. See, in particular, the under normal storage conditions. difluoride [Ethyl phosphinyl difluoride];
end-use/end-user restrictions in part 744 of 2. The scope of this control applicable to b.17. (C.A.S. #1066–50–8) Ethyl
the EAR, and the restrictions that apply to Hydrogen Fluoride (see 1C350.d.7 in the List phosphonyl dichloride;
embargoed countries in part 746 of the EAR. of Items Controlled) includes its liquid, b.18. (C.A.S. #993–13–5)
e. Annual report requirement. The exporter gaseous, and aqueous phases, and hydrates. Methylphosphonic acid;
is required to submit an annual written 3. Precursor chemicals in ECCN 1C350 are b.19. (C.A.S. #676–98–2) Methylphos-
report for shipments of samples made under listed by name, Chemical Abstract Service phonothioic dichloride;
this Note 1. The report must be on company (CAS) number and CWC Schedule (where b.20. (C.A.S. #464–07–3) Pinacolyl alcohol;
letterhead stationery (titled ‘‘Report of applicable). Precursor chemicals of the same b.21. (C.A.S. #1619–34–7) 3-Quinuclidinol;
Sample Shipments of Chemical Precursors’’ structural formula (e.g., hydrates) are b.22. (C.A.S. #111–48–8) Thiodiglycol.
at the top of the first page) and identify the controlled by ECCN 1C350, regardless of c. Australia Group-controlled precursor
chemical(s), Chemical Abstract Service name or CAS number. CAS numbers are chemicals also identified as Schedule 3
Registry (C.A.S.) number(s), quantity(ies), the shown to assist in identifying whether a chemicals under the CWC, as follows, and
ultimate consignee’s name and address, and particular precursor chemical or mixture is mixtures in which at least one of the
the date of export for all sample shipments controlled under ECCN 1C350, irrespective of following chemicals constitutes 30 percent or
that were made during the previous calendar nomenclature. However, CAS numbers more of the weight of the mixture:
year. The report must be submitted no later cannot be used as unique identifiers in all c.1. (C.A.S. #762–04–9) Diethyl phosphite;
than February 28 of the year following the situations because some forms of the listed c.2. (C.A.S. #868–85–9) Dimethyl
calendar year in which the sample shipments precursor chemical have different CAS phosphite (dimethyl hydrogen phosphite);
were made, to: U.S. Department of numbers, and mixtures containing a c.3. (C.A.S. #139–87–7)
Commerce, Bureau of Industry and Security, precursor chemical listed in ECCN 1C350 Ethyldiethanolamine;
14th Street and Pennsylvania Ave. NW, may also have different CAS numbers. c.4. (C.A.S. #10025–87–3) Phosphorus
Room 2099B, Washington, DC 20230, Attn: oxychloride;
‘‘Report of Sample Shipments of Chemical List Based License Exceptions (See Part 740 c.5. (C.A.S. #10026–13–8) Phosphorus
Precursors.’’ for a Description of All License Exceptions) pentachloride;
2. Mixtures: LVS: N/A c.6. (C.A.S. #7719–12–2) Phosphorus
a. Mixtures that contain precursor GBS: N/A trichloride;
chemicals identified in ECCN 1C350, in CIV: N/A c.7. (C.A.S. #10545–99–0) Sulfur
concentrations that are below the levels dichloride;
indicated in 1C350.b through .d, are List of Items Controlled c.8. (C.A.S. #10025–67–9) Sulfur
controlled by ECCN 1C395 or 1C995 and are Related Controls: See USML Category XIV(c) monochloride;
subject to the licensing requirements for related chemicals ‘‘subject to the ITAR’’ c.9. (C.A.S. #7719–09–7) Thionyl chloride;
specified in those ECCNs. (see 22 CFR parts 120 through 130). c.10. (C.A.S. #102–71–6) Triethanolamine;
b. A license is not required under this Related Definitions: See § 770.2(k) of the EAR c.11. (C.A.S. #122–52–1) Triethyl
ECCN for a mixture, when the controlled for synonyms for the chemicals listed in phosphite;
chemical in the mixture is a normal this entry. c.12. (C.A.S. #121–45–9) Trimethyl
ingredient in consumer goods packaged for Items: phosphite.
retail sale for personal use. Such consumer a. [Reserved] d. Other Australia Group-controlled
goods are designated EAR99. However, a b. Australia Group-controlled precursor precursor chemicals not also identified as
license may be required for reasons set forth chemicals also identified as Schedule 2 Schedule 1, 2, or 3 chemicals under the
elsewhere in the EAR. 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 more of the weight of the mixture: of the mixture:
to the mixture (solution) for the sole purpose b.1. (C.A.S. #7784–34–1) Arsenic d.1. (C.A.S. #1341–49–7) Ammonium
of 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. #298–06–6) O,O-Diethyl
that act as solvents. b.5. (C.A.S. #15715–41–0) Diethyl phosphorodithioate;
3. Compounds. Compounds created with methylphosphonite; d.6. (C.A.S. #2465–65–8) O,O-Diethyl
any chemicals identified in this ECCN 1C350 b.6. (C.A.S. #2404–03–7) Diethyl-N,N- phosphorothioate;
may be shipped NLR (No License Required), dimethylphosphoroamidate; d.7. (C.A.S. #108–18–9) Di-isopropylamine;
without obtaining an End-Use Certificate, b.7. (C.A.S. #41480–75–5) N,N- d.8. (C.A.S. #124–40–3) Dimethylamine;
unless those compounds are also identified Diisopropylaminoethanethiol hydrochloride; d.9. (C.A.S. #506–59–2) Dimethylamine
in this entry or require a license for reasons b.8. (C.A.S. #5842–07–9) N,N-Diisopropyl- hydrochloride;
set forth elsewhere in the EAR. beta-aminoethane thiol; d.10. (C.A.S. #7664–39–3) Hydrogen
4. Testing Kits: Certain medical, analytical, b.9. (C.A.S. #96–80–0) N,N-Diisopropyl- fluoride;
diagnostic, and food testing kits containing beta-aminoethanol; d.11. (C.A.S. #3554–74–3) 3-Hydroxyl-1-
small quantities of chemicals identified in b.10. (C.A.S. #96–79–7), N,N-Diisopropyl- methylpiperidine;
this ECCN 1C350, are excluded from the beta-aminoethyl chloride; d.12. (C.A.S. #76–89–1) Methyl benzilate;
scope of this ECCN and are controlled under b.11. (C.A.S. #4261–68–1) N,N- d.13. (C.A.S. #1314–80–3) Phosphorus
ECCN 1C395 or 1C995. (Note that Diisopropyl-beta-aminoethyl chloride pentasulfide;
replacement reagents for such kits are hydrochloride; d.14. (C.A.S. #75–97–8) Pinacolone;
controlled by this ECCN 1C350 if the reagents b.12. (C.A.S. #6163–75–3) Dimethyl d.15. (C.A.S. #7789–29–9) Potassium
contain one or more of the precursor ethylphosphonate; bifluoride;
daltland on DSKBBV9HB2PROD with RULES
chemicals identified in 1C350 in b.13. (C.A.S. #756–79–6) Dimethyl d.16. (C.A.S. #151–50–8) Potassium
concentrations equal to or greater than the methylphosphonate; cyanide;
control levels for mixtures indicated in b.14. (C.A.S. #677–43–0) N,N- d.17. (C.A.S. #7789–23–3) Potassium
1C350.) Dimethylamino-phosphoryl dichloride; fluoride;
Technical Notes: 1. For purposes of this b.15. (C.A.S. #1498–40–4) Ethyl d.18. (C.A.S. #3731–38–2) 3-Quinuclidone;
entry, a ‘‘mixture’’ is defined as a solid, phosphonous dichloride [Ethyl phosphinyl d.19. (C.A.S. #1333–83–1) Sodium
liquid or gaseous product made up of two or dichloride]; bifluoride;
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a.40. Reconstructed 1918 influenza virus; O104, O111, O121, O145, O157, and other Department of Agriculture, or the Centers for
Technical Note: 1C351.a.40 includes shiga toxin producing serogroups; Disease Control and Prevention (CDC), U.S.
reconstructed replication competent forms of Note: Shiga toxin producing Escherichia Department of Health and Human Services,
the 1918 pandemic influenza virus coli (STEC) includes, inter alia, in accordance with the APHIS regulations in
containing any portion of the coding regions enterohaemorrhagic E. coli (EHEC), verotoxin 7 CFR part 331 and 9 CFR part 121 and the
of all eight gene segments. producing E. coli (VTEC) or verocytotoxin CDC regulations in 42 CFR part 73.
a.41. Rift Valley fever virus; producing E. coli (VTEC). List Based License Exceptions (See Part 740
a.42. Rinderpest virus; c.20. Shigella dysenteriae; for a Description of All License Exceptions)
a.43. Rocio virus; c.21. Vibrio cholerae; or LVS: N/A
a.44. Sabia virus; c.22. Yersinia pestis. GBS: N/A
a.45. Seoul virus; d. ‘‘Toxins’’ identified on the Australia CIV: N/A
a.46. Severe acute respiratory syndrome- Group (AG) ‘‘List of Human and Animal
related coronavirus (SARS-related Pathogens and Toxins for Export Control,’’ as List of Items Controlled
coronavirus); follows, and ‘‘subunits’’ thereof: Related Controls: (1) The Animal and Plant
a.47. Sheeppox virus; d.1. Abrin; Health Inspection Service (APHIS), U.S.
a.48. Sin Nombre virus; d.2. Aflatoxins; Department of Agriculture, and the Centers
a.49. St. Louis encephalitis virus; d.3. Botulinum toxins; for Disease Control and Prevention (CDC),
a.50. Suid herpesvirus 1 (Pseudorabies d.4. Cholera toxin; U.S. Department of Health and Human
virus; Aujeszky’s disease); d.5. Clostridium perfringens alpha, beta 1, Services, maintain controls on the
a.51. Swine vesicular disease virus; beta 2, epsilon and iota toxins; possession, use, and transfer within the
a.52. Tick-borne encephalitis virus (Far d.6. Conotoxins; United States of certain items controlled by
Eastern subtype, formerly known as Russian d.7. Diacetoxyscirpenol; this ECCN, including (but not limited to)
Spring-Summer encephalitis virus—see d.8. HT–2 toxin; certain genetic elements, recombinant
1C351.b.3 for Siberian subtype); d.9. Microcystins (Cyanginosins); nucleic acids, and recombinant organisms
a.53. Variola virus; d.10. Modeccin; associated with the agents or toxins in
a.54. Venezuelan equine encephalitis virus; d.11. Ricin; ECCN 1C351 or 1C354 (for APHIS, see 7
a.55. Vesicular stomatitis virus; d.12. Saxitoxin; CFR 331.3(c), 9 CFR 121.3(c), and 9 CFR
a.56. Western equine encephalitis virus; or d.13. Shiga toxins (shiga-like toxins, 121.4(c); for CDC, see 42 CFR 73.3(c) and
a.57. Yellow fever virus. verotoxins, and verocytotoxins); 42 CFR 73.4(c)). (2) See 22 CFR part 121,
b. Viruses identified on the APHIS/CDC d.14. Staphylococcus aureus enterotoxins, Category XIV(b), for modified biological
‘‘select agents’’ lists (see Related Controls hemolysin alpha toxin, and toxic shock agents and biologically derived substances
paragraph #2 for this ECCN), but not syndrome toxin (formerly known as that are subject to the export licensing
identified on the Australia Group (AG) ‘‘List Staphylococcus enterotoxin F); jurisdiction of the U.S. Department of
of Human and Animal Pathogens and Toxins d.15. T–2 toxin; State, Directorate of Defense Trade
for Export Control,’’ as follows: d.16. Tetrodotoxin; Controls.
b.1. [Reserved]; d.17. Viscumin (Viscum album lectin 1); or
Related Definition: N/A
b.2. [Reserved]; or d.18. Volkensin.
Items:
b.3. Tick-borne encephalitis virus (Siberian e. ‘‘Fungi’’, as follows:
subtype, formerly West Siberian virus—see e.1. Coccidioides immitis; or a. Any genetically modified organism that
1C351.a.52 for Far Eastern subtype). e.2. Coccidioides posadasii. contains, or any genetic element that codes
c. Bacteria identified on the Australia for, any of the following:
■ 10. In Supplement No. 1 to Part 774 a.1. Any gene or genes specific to any virus
Group (AG) ‘‘List of Human and Animal (the Commerce Control List), Category 1,
Pathogens and Toxins for Export Control,’’ as controlled by 1C351.a or .b or 1C354.c;
follows:
ECCN 1C353 is revised to read as a.2. Any gene or genes specific to any
c.1. Bacillus anthracis; follows: bacterium controlled by 1C351.c or 1C354.a,
c.2. Brucella abortus; 1C353 Genetic elements and genetically or any fungus controlled by 1C351.e or
c.3. Brucella melitensis; modified organisms, as follows (see List 1C354.b, and which;
c.4. Brucella suis; of Items Controlled). a.2.a. In itself or through its transcribed or
c.5. Burkholderia mallei (Pseudomonas translated products represents a significant
mallei); License Requirements hazard to human, animal or plant health; or
c.6. Burkholderia pseudomallei Reason for Control: CB, AT a.2.b. Could endow or enhance
(Pseudomonas pseudomallei); pathogenicity; or
c.7. Chlamydia psittaci (Chlamydophila Country Chart a.3. Any toxins, or their subunits,
psittaci); (See Supp. controlled by 1C351.d.
Control(s) b. [Reserved].
c.8. Clostriduim argentinense (formerly No. 1 to part
known as Clostridium botulinum Type G), 738) Technical Notes: 1. Genetically modified
botulinum neurotoxin producing strains; organisms include organisms in which the
c.9. Clostridium baratii, botulinum CB applies to entire entry ..... CB Column 1 nucleic acid sequences have been created or
neurotoxin producing strains; AT applies to entire entry ..... AT Column 1 altered by deliberate molecular
c.10. Clostridium botulinum; License Requirements Notes: 1. Vaccines manipulation.
c.11. Clostridium butyricum, botulinum that contain genetic elements or genetically 2. ‘‘Genetic elements’’ include, inter alia,
neurotoxin producing strains; modified organisms identified in this ECCN chromosomes, genomes, plasmids,
c.12. Clostridium perfringens, epsilon are controlled by ECCN 1C991. transposons, vectors, and inactivated
toxin producing types; 2. Unless specified elsewhere in this ECCN organisms containing recoverable nucleic
c.13. Coxiella burnetii; 1C353 (e.g., in License Requirement Note 1), acid fragments, whether genetically modified
c.14. Francisella tularensis; this ECCN controls genetic elements or or unmodified, or chemically synthesized in
c.15. Mycoplasma capricolum subspecies genetically modified organisms for all whole or in part. For the purposes of this
capripneumoniae (‘‘strain F38’’); biological agents and ‘‘toxins,’’ regardless of ECCN 1C353, nucleic acids from an
c.16. Mycoplasma mycoides subspecies quantity or attenuation, that are identified in inactivated organism, virus, or sample are
daltland on DSKBBV9HB2PROD with RULES
mycoides SC (small colony) (a.k.a. contagious the List of Items Controlled for this ECCN, considered to be ‘recoverable’ if the
bovine pleuropneumonia); including genetic elements or genetically inactivation and preparation of the material
c.17. Rickettsia prowazekii; modified organisms for attenuated strains of is intended or known to facilitate isolation,
c.18. Salmonella enterica subspecies select biological agents or ‘‘toxins’’ that are purification, amplification, detection, or
enterica serovar Typhi (Salmonella typhi); excluded from the lists of select biological identification of nucleic acids.
c.19. Shiga toxin producing Escherichia agents or ‘‘toxins’’ by the Animal and Plant 3. This ECCN does not control nucleic acid
coli (STEC) of serogroups O26, O45, O103, Health Inspection Service (APHIS), U.S. sequences of shiga toxin producing
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either of the following methods (pending the the definitions of ‘‘software,’’ ‘‘program,’’ FOR FURTHER INFORMATION CONTACT:
adoption of internationally accepted and ‘‘microprogram.’’ Cheryl A. Williams, Director, Office of
standards): Items: The list of items controlled is Medical Policy, 6401 Security
a. Doppler laser method, contained in the ECCN heading.
Boulevard, Baltimore, MD 21235–6401,
b. Forward laser diffraction method.
Dated: March 27, 2018. (410) 965–1020. For information on
j. Nucleic acid assemblers and synthesizers
that are both: Matthew S. Borman, eligibility or filing for benefits, call our
j.1 Partly or entirely automated; and national toll-free number, 1–800–772–
Deputy Assistant Secretary for Export
j.2. Designed to generate continuous Administration. 1213, or TTY 1–800–325–0778, or visit
nucleic acids greater than 1.5 kilobases in our internet site, Social Security Online,
[FR Doc. 2018–06581 Filed 3–30–18; 8:45 am]
length with error rates less than 5% in a at http://www.socialsecurity.gov.
BILLING CODE 3510–33–P
single run. SUPPLEMENTARY INFORMATION:
■ 14. In Supplement No. 1 to Part 774 Background
(the Commerce Control List), Category 2, SOCIAL SECURITY ADMINISTRATION We use the listings in appendix 1 to
ECCN 2D351 is revised to read as subpart P of part 404 of 20 CFR at the
follows: 20 CFR Part 404
third step of the sequential evaluation
2D351 Dedicated ‘‘software’’ for toxic gas [Docket No. SSA–2018–0007] process to evaluate claims filed by
monitors and monitoring systems, and RIN 0960–AI18 adults and children for benefits based
their dedicated detecting ‘‘parts’’ and on disability under the title II and title
‘‘components,’’ controlled by ECCN Extension of Expiration Dates for Two XVI programs.1 20 CFR 404.1520(d),
2B351. 416.920(d), 416.924(d). The listings are
Body System Listings
License Requirements in two parts: Part A has listings criteria
AGENCY: Social Security Administration. for adults and Part B has listings criteria
Reason for Control: CB, AT
ACTION: Final rule. for children. If you are age 18 or over,
Country Chart (See we apply the listings criteria in Part A
Control(s) Supp. No. 1 to part SUMMARY: We are extending the when we assess your impairment or
738) expiration dates of the following body combination of impairments. If you are
systems in the Listing of Impairments under age 18, we first use the criteria in
CB applies to entire CB Column 2 (listings) in our regulations: Special
entry.
Part B of the listings when we assess
Senses and Speech and Congenital your impairment(s). If the criteria in
AT applies to entire AT Column 1 Disorders That Affect Multiple Body
entry. Part B do not apply, we may use the
Systems. We are making no other criteria in Part A when those criteria
List Based License Exceptions (See Part 740 revisions to these body systems in this consider the effects of your
for a Description of All License Exceptions) final rule. This extension ensures that impairment(s). 20 CFR 404.1525(b),
CIV: N/A we will continue to have the criteria we 416.925(b).
TSR: N/A need to evaluate impairments in the
affected body systems at step three of Explanation of Changes
List of Items Controlled
the sequential evaluation processes for In this final rule, we are extending the
Related Controls: N/A
initial claims and continuing disability dates on which the listings for the
Related Definitions: (1) For the purposes of
this entry, the term ‘‘dedicated’’ means reviews. following two body systems will no
committed entirely to a single purpose or DATES: This final rule is effective on longer be effective as set out in the
device. (2) See Section 772.1 of the EAR for April 2, 2018. following chart:
Listing Current expiration date Extended expiration date
Special Senses and Speech (2.00 and 102.00) ..................................... April 29, 2018 ................................ April 24, 2020.
Congenital Disorders That Affect Multiple Body Systems (10.00 and April 5, 2018 .................................. April 3, 2020.
110.00).
We continue to revise and update the Regulatory Procedures requirements when an agency finds
listings on a regular basis, including Justification for Final Rule there is good cause for dispensing with
those body systems not affected by this such procedures because they are
final rule.2 We intend to update the two We follow the Administrative impracticable, unnecessary, or contrary
listings affected by this final rule as Procedure Act (APA) rulemaking to the public interest.
quickly as possible, but may not be able procedures specified in 5 U.S.C. 553 in We have determined that good cause
to publish final rules revising these promulgating regulations. Section exists for dispensing with the notice and
listings by the current expiration dates. 702(a)(5) of the Social Security Act, 42 public comment procedures. 5 U.S.C.
Therefore, we are extending the U.S.C. 902(a)(5). Generally, the APA 553(b)(B). This final rule only extends
requires that an agency provide prior the date on which two body system
expiration dates listed above.
notice and opportunity for public listings will no longer be effective. It
comment before issuing a final makes no substantive changes to our
daltland on DSKBBV9HB2PROD with RULES
regulation. The APA provides rules. Our current regulations 3 provide
exceptions to the notice-and-comment that we may extend, revise, or
1 We also use the listings in the sequential 2 Since we last extended the expiration dates of (81 FR 66137 (2016)) and human immunodeficiency
evaluation processes we use to determine whether the listings affected by this rule in August 2016 (81 virus (HIV infection (81 FR 86915 (2016)).
a beneficiary’s disability continues. See 20 CFR FR 51100), we have published final rules revising 3 See the first sentence of appendix 1 to subpart
404.1594, 416.994, and 416.994a. the medical criteria for evaluating mental disorders P of part 404 of 20 CFR.
VerDate Sep<11>2014 16:23 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\02APR1.SGM 02APR1](https://thefederalregister.org/doc/83_FR_13912/page/14.svg)
Document Created: 2018-11-01 09:09:07
Document Modified: 2018-11-01 09:09:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective April 2, 2018. | |
| Contact | Richard P. Duncan, Ph.D., Director, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343, Email: [email protected] | |
| FR Citation | 83 FR 13849 | |
| RIN Number | 0694-AH37 | |
| CFR Citation | 15
CFR
738 15 CFR 740 15 CFR 745 15 CFR 774 | |
| CFR Associated | Administrative Practice and Procedure; Exports; Foreign Trade; Reporting and Recordkeeping Requirements and Chemicals |
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