80 FR 34266 - Implementation of the Australia Group (AG) November 2013 Intersessional Decisions
DEPARTMENT OF COMMERCE
Bureau of Industry and Security Federal Register Volume 80, Issue 115 (June 16, 2015)
Bureau of Industry and Security
Federal Register Volume 80, Issue 115 (June 16, 2015)
| Page Range | 34266-34274 | |
| FR Document | 2015-14471 |
[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)] [Rules and Regulations] [Pages 34266-34274] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14471] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 740, 742, 752 and 774 [Docket No. 141229999-4999-01] RIN 0694-AG45 Implementation of the Australia Group (AG) November 2013 Intersessional Decisions 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 November 2013 Australia Group (AG) intersessional implementation meeting and later adopted pursuant to the AG silent approval procedure. Specifically, this rule amends the Commerce Control List (CCL) entry in the EAR that controls [[Page 34267]] certain human and zoonotic pathogens and toxins, and removes the CCL entry that controls certain animal pathogens to reflect the merger of two AG common control lists based on recommendations presented at the AG intersessional implementation meeting. As a result of these recommendations, the AG ``List of Animal Pathogens for Export Control'' was merged with the AG ``List of Biological Agents for Export Control,'' creating a single AG common control list for these items (i.e., the AG ``List of Human and Animal Pathogens and Toxins for Export Control''). The scope of the controls on these human and animal pathogens and toxins was not affected by the merger of the two lists into a single AG common control list. This rule also makes conforming amendments to other provisions in the EAR to reflect these changes. In addition, this rule amends the CCL entry that controls chemical manufacturing facilities and equipment to reflect changes to the AG ``Control List of Dual-Use Chemical Manufacturing Facilities and Equipment and Related Technology and Software,'' based on the November 2013 AG intersessional recommendation to revise controls on certain valves, casings (valve bodies) designed for such valves, and preformed casing liners designed for such valves. This rule also amends this CCL entry to add a Technical Note clarifying how the terms ``multi-seal'' and ``seal-less'' are used with respect to the controls on pumps. In a change unrelated to any revisions to the AG common control lists or guidelines, this rule also amends this CCL entry to authorize the use of License Exception LVS for specified shipments. This rule does not contain changes based on the understandings reached at the June 2014 AG Plenary meeting, because no amendments to the EAR were required as a result of these understandings. DATES: This rule is effective June 16, 2015. ADDRESSES: Send comments regarding this collection of information, including suggestions for reducing the burden, to Jasmeet Seehra, Office of Management and Budget (OMB), by email to [email protected], 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. 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: [email protected]. 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 meeting held in Budapest, Hungary, on November 18-22, 2013, and adopted pursuant to the AG silent approval procedure in January/February 2014. The AG is a multilateral forum consisting of 41 participating countries 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. Merger of ECCN 1C352 With ECCN 1C351 (Human and Animal Pathogens and ``Toxins'') The AG intersessional recommendations adopted in January 2014 addressed the merger of the AG ``List of Animal Pathogens for Export Control'' with the AG ``List of Biological Agents for Export Control'' to create a single AG common control list for all of these pathogens and toxins (i.e., the AG ``List of Human and Animal Pathogens and Toxins for Export Control''). This final rule amends the EAR to reflect the merger of these two AG common control lists by removing ECCN 1C352 (animal pathogens) from the CCL and adding the pathogens previously controlled under ECCN 1C352 to ECCN 1C351 (human and zoonotic pathogens and ``toxins''). The latter ECCN is renamed to indicate that it now controls both human and animal pathogens and ``toxins.'' This rule also renumbers the items in ECCN 1C351.a, and certain items in ECCN 1C351.c to accommodate the addition to ECCN 1C351 of those items that were controlled under ECCN 1C352 prior to the publication of this rule. The following table lists the viruses that are controlled under ECCN 1C351.a, as a result of the removal of ECCN 1C352 and the aforementioned amendments to ECCN 1C351, and indicates the previous and current CCL designations for each item. ------------------------------------------------------------------------ Previous CCL Current CCL AG-Controlled viruses designation designation ------------------------------------------------------------------------ African horse sickness virus..... ECCN 1C352.a.17... ECCN 1C351.a.1. African swine fever virus........ ECCN 1C352.a.1.... ECCN 1C351.a.2. Andes virus...................... ECCN 1C351.a.1.... ECCN 1C351.a.3. Avian influenza virus............ ECCN 1C352.a.2.... ECCN 1C351.a.4. Bluetongue virus................. ECCN 1C352.a.3.... ECCN 1C351.a.5. Chapare virus.................... ECCN 1C351.a.2.... ECCN 1C351.a.6. Chikungunya virus................ ECCN 1C351.a.3.... ECCN 1C351.a.7. Choclo virus..................... ECCN 1C351.a.4.... ECCN 1C351.a.8. Congo-Crimean haemorrhagic fever ECCN 1C351.a.5.... ECCN 1C351.a.9. virus. Dengue fever virus............... ECCN 1C351.a.6.... ECCN 1C351.a.10. Dobrava-Belgrade virus........... ECCN 1C351.a.7.... ECCN 1C351.a.11. Eastern equine encephalitis virus ECCN 1C351.a.8.... ECCN 1C351.a.12. Ebola virus...................... ECCN 1C351.a.9.... ECCN 1C351.a.13. Foot and mouth disease virus..... ECCN 1C352.a.4.... ECCN 1C351.a.14. Goat pox virus................... ECCN 1C352.a.5.... ECCN 1C351.a.15. Guanarito virus.................. ECCN 1C351.a.10... ECCN 1C351.a.16. Hantaan virus.................... ECCN 1C351.a.11... ECCN 1C351.a.17. Hendra virus (Equine ECCN 1C351.a.12... ECCN 1C351.a.18. morbillivirus). Herpes virus (Aujeszky's disease) ECCN 1C352.a.6.... ECCN 1C351.a.19. Hog cholera virus (syn.: swine ECCN 1C352.a.7.... ECCN 1C351.a.20. fever virus). Japanese encephalitis virus...... ECCN 1C351.a.13... ECCN 1C351.a.21. Junin virus...................... ECCN 1C351.a.14... ECCN 1C351.a.22. Kyasanur Forest virus............ ECCN 1C351.a.15... ECCN 1C351.a.23. [[Page 34268]] Laguna Negra virus............... ECCN 1C351.a.16... ECCN 1C351.a.24. Lassa fever virus................ ECCN 1C351.a.17... ECCN 1C351.a.25. Louping ill virus................ ECCN 1C351.a.18... ECCN 1C351.a.26. Lujo virus....................... ECCN 1C351.a.19... ECCN 1C351.a.27. Lumpy skin disease virus......... ECCN 1C352.a.16... ECCN 1C351.a.28. Lymphocytic choriomeningitis ECCN 1C351.a.20... ECCN 1C351.a.29. virus. Machupo virus.................... ECCN 1C351.a.21... ECCN 1C351.a.30. Marburg virus.................... ECCN 1C351.a.22... ECCN 1C351.a.31. Monkey pox virus................. ECCN 1C351.a.23... ECCN 1C351.a.32. Murray Valley encephalitis virus. ECCN 1C351.a.24... ECCN 1C351.a.33. Newcastle disease virus.......... ECCN 1C352.a.9.... ECCN 1C351.a.34. Nipah virus...................... ECCN 1C351.a.25... ECCN 1C351.a.35. Omsk haemorrhagic fever virus.... ECCN 1C351.a.26... ECCN 1C351.a.36. Oropouche virus.................. ECCN 1C351.a.27... ECCN 1C351.a.37. Peste des petits ruminants virus. ECCN 1C352.a.10... ECCN 1C351.a.38. Porcine enterovirus type 9 (syn.: ECCN 1C352.a.11... ECCN 1C351.a.39. swine vesicular disease virus). Powassan virus................... ECCN 1C351.a.28... ECCN 1C351.a.40. Rabies virus and other members of ECCN 1C352.a.8.... ECCN 1C351.a.41. the Lyssavirus genus. Rift Valley fever virus.......... ECCN 1C351.a.29... ECCN 1C351.a.42. Rinderpest virus................. ECCN 1C352.a.12... ECCN 1C351.a.43. Rocio virus...................... ECCN 1C351.a.30... ECCN 1C351.a.44. Sabia virus...................... ECCN 1C351.a.31... ECCN 1C351.a.45. Seoul virus...................... ECCN 1C351.a.32... ECCN 1C351.a.46. Sheep pox virus.................. ECCN 1C352.a.13... ECCN 1C351.a.47. Sin nombre virus................. ECCN 1C351.a.33... ECCN 1C351.a.48. St. Louis encephalitis virus..... ECCN 1C351.a.34... ECCN 1C351.a.49. Teschen disease virus............ ECCN 1C352.a.14... ECCN 1C351.a.50. Tick-borne encephalitis virus ECCN 1C351.a.35... ECCN 1C351.a.51. (Russian Spring-Summer encephalitis virus). Variola virus.................... ECCN 1C351.a.36... ECCN 1C351.a.52. Venezuelan equine encephalitis ECCN 1C351.a.37... ECCN 1C351.a.53. virus. Vesicular stomatitis virus....... ECCN 1C352.a.15... ECCN 1C351.a.54. Western equine encephalitis virus ECCN 1C351.a.38... ECCN 1C351.a.55. Yellow fever virus............... ECCN 1C351.a.39... ECCN 1C351.a.56. ------------------------------------------------------------------------ The redesignations of, and additions to, the bacteria controlled under ECCN 1C351.c are indicated in the following table. The designations of the bacteria listed in ECCN 1C351.c.1 through .c.14 were not affected by the amendments to ECCN 1C351 and the removal of ECCN 1C352. ------------------------------------------------------------------------ Previous CCL Current CCL AG-Controlled bacteria designation designation ------------------------------------------------------------------------ Mycoplasma capricolum subspecies ECCN 1C352.b.1.b.. ECCN 1C351.c.15. capripneumoniae (``strain F38''). Mycoplasma mycoides subspecies ECCN 1C352.b.1.a.. ECCN 1C351.c.16. mycoides SC (small colony) (a.k.a. contagious bovine pleuropneumonia). Rickettsia prowazekii............ ECCN 1C351.c.15... ECCN 1C351.c.17. Salmonella typhi................. ECCN 1C351.c.16... ECCN 1C351.c.18. Shiga toxin producing Escherichia ECCN 1C351.c.17... ECCN 1C351.c.19. coli (STEC). Shigella dysenteriae............. ECCN 1C351.c.18... ECCN 1C351.c.20. Vibrio cholerae.................. ECCN 1C351.c.19... ECCN 1C351.c.21. Yersinia pestis.................. ECCN 1C351.c.20... ECCN 1C351.c.22. ------------------------------------------------------------------------ Conforming Amendments This rule also makes a number of conforming amendments to other EAR provisions to reflect the removal of ECCN 1C352 and the merger of the animal pathogens previously controlled under this ECCN with the human pathogens and toxins controlled under ECCN 1C351. Specifically, this rule amends Section 740.20 (License Exception Strategic Trade Authorization (STA)) by removing two references to ECCN 1C352 from paragraph (b)(2)(v), which excludes from STA eligibility certain items on the CCL that are subject to chemical/biological (CB) license requirements to destinations indicated under CB Column 1 on the Commerce Country Chart (Supplement No. 1 to part 738 of the EAR). This rule also removes the reference to ECCN 1C352 from Section 742.2(a)(1)(i), which identifies the items on the CCL that require a license for CB reasons to destinations indicated under CB Column 1 on the Commerce Country Chart. In addition, this rule amends Supplement No. 1 to part 742 (Non- proliferation of Chemical and Biological Weapons) to remove references to ECCN 1C352 from paragraph (3), paragraphs (9)(ii) and (9)(iii), and paragraph (12). This rule also amends Section 752.3 to remove the reference to ECCN 1C352 from paragraph (a)(2), which identifies items controlled for CB reasons that are excluded from eligibility for Special Comprehensive Licenses. None of these changes affect the application of the aforementioned EAR provisions to the items previously controlled under ECCN 1C352, because all of these items are now controlled under ECCN 1C351, which continues to be referenced by each of these EAR provisions. This rule also makes conforming amendments to ECCNs 1C353, 1C991, 1E001, and 1E351 to reflect the removal of ECCN 1C352 and the merger of the animal pathogens previously controlled under this ECCN with the human [[Page 34269]] pathogens and toxins controlled under ECCN 1C351. Specifically, this rule amends the List of Items controlled section in ECCN 1C353 to remove references to ECCN 1C352 from: (1) The Related Controls paragraph; (2) paragraphs .a.1 and .b.1 of the ``Items'' paragraph; and (3) the introductory text and paragraph .b of Technical Note 3 to ECCN 1C353. ECCN 1C991 is amended to remove the reference to ECCN 1C352 from paragraph .a of the ``Items'' paragraph under the List of Items Controlled section. The License Requirements section of ECCN 1E001 is amended by removing the reference to ECCN 1C352 from the ``Control(s)'' language for ``Country Chart--CB Column 1.'' In addition, this rule amends ECCN 1E351 to remove references to ECCN 1C352 from the ECCN heading and from the ``Control(s)'' language for ``Country Chart--CB Column 1'' in the License Requirements section of the ECCN. None of these changes affect the controls in ECCNs 1C353, 1C991, 1E001, and 1E351 on items related to former ECCN 1C352, because each of these ECCNs continues to control items related to ECCN 1C351, which now includes all of the items that were controlled under ECCN 1C352 prior to the publication of this rule. Amendments to ECCN 2B350 (Dual-Use Chemical Manufacturing Facilities and Equipment) The AG intersessional recommendations adopted in February 2014 made changes to the AG ``Control List of Dual-Use Chemical Manufacturing Facilities and Equipment and Related Technology and Software.'' This rule amends Export Control Classification Number (ECCN) 2B350 to reflect the AG intersessional changes to this AG common control list. Specifically, ECCN 2B350 (Chemical Manufacturing Facilities and Equipment) is amended by revising the controls in 2B350.g on valves, casings (valve bodies) designed for such valves, and preformed casing liners designed for such valves. Prior to the publication of this final rule, 2B350.g controlled valves with nominal sizes greater than 1.0 cm (\3/8\ in.), and casings (valve bodies) or preformed casing liners designed for such valves, in which all surfaces that come in direct contact with the chemical(s) being produced, processed, or contained are made from specified materials. These valves, casings, and preformed casing liners continue to be controlled under 2B350.g, but the controls have been expanded, to control valves, in addition to those described above, that have all of the following characteristics: (1) A nominal size equal to or greater than 2.54 cm (1 inch) and equal to or less than 10.16 cm (4 inches); (2) casings (valve bodies) or preformed casing liners in which all surfaces that come in direct contact with the chemical(s) being produced, processed, or contained are made from specified materials; and (3) a closure element designed to be interchangeable. These two categories of valves are now controlled under 2B350.g.1 and .g.2, respectively, while the casings (valve bodies) or preformed casing liners designed for such valves are controlled under 2B350.g.3. In addition, this rule adds a new Technical Note 1 to 2B350.g to indicate that all surfaces of the valves controlled by 2B350g.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 controlled by 2B350.g if they are made from any of 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). The materials specified in new Technical Note 1 to 2B350.g are identical to those identified, prior to the publication of this rule, in ECCN 2B350.g.1 through g.9. The Technical Note to 2B350.g that defined ``nominal size,'' for purposes of 2B350.g, is now designated as Technical Note 2 to 2B350.g. The overall impact of the AG intersessional changes on ECCN 2B350.g was the addition of another category of valves under 2B350.g.2, together with casings (valve bodies) and preformed casing liners designed for such valves having the characteristics described in 2B350.g.3. Although the casings (valve bodies) and preformed casing liners for valves described in 2B350.g.2 are controlled separately, under 2B350.g.3, the presence of these components in valves not controlled under 2B350.g.1 that have a nominal size equal to or greater than 2.54 cm (1 inch) and equal to or less than 10.16 cm (4 inches), and a closure element that is designed to be interchangeable, makes such valves subject to control under 2B350.g.2. This rule also amends ECCN 2B350 to reflect the adoption by the AG of the November 2013 intersessional recommendation concerning pumps described on the AG ``Control List of Dual-Use Chemical Manufacturing Facilities and Equipment and Related Technology and Software.'' Specifically, this rule adds a new Technical Note to ECCN 2B350.i to clarify how the terms ``multi-seal'' and ``seal-less'' are used with respect to the controls on pumps described in this ECCN. The new Technical Note explains that the term seals, as used in the ECCN 2B350.i controls on pumps, refers to seals that come into direct contact with the chemical(s) being processed (or that are designed to do so) and that provide a sealing function where a rotary or reciprocating drive shaft passes through the pump body. Conforming Change to ECCN 1C350 (Precursor Chemicals) In addition to the AG intersessional changes described above, this rule amends ECCN 1C350 (Precursor chemicals) by adding a Technical Note 3 at the end of the License Requirements section of this ECCN. This new Technical Note is intended to provide guidance, consistent with the AG ``List of Chemical Weapons Precursors,'' in determining whether a particular precursor chemical or mixture is controlled under ECCN 1C350. Technical Note 3 states that the CAS numbers indicated in ECCN 1C350 are intended to assist in identifying whether a particular precursor chemical or mixture is controlled under this ECCN, irrespective of nomenclature. However, this Technical Note also cautions that precursor chemicals of the same structural formula (e.g., hydrates) are controlled by ECCN 1C350, regardless of name or CAS number, and that 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. License Exception LVS Authorized for ECCN 2B350 Items In a change unrelated to any revisions to the AG common control lists or guidelines, this rule also amends ECCN 2B350 (Chemical Manufacturing Facilities and Equipment) to authorize [[Page 34270]] the use of License Exception LVS (shipments of limited value) for single shipments of $2,000 or less. This change is consistent with the requirements of Section 740.3 of the EAR, except that eligible destinations for ECCN 2B350 items under License Exception LVS are limited to those Country Group B destinations indicated in Supplement No. 1 to part 740 of the EAR that are not also included in Country Group D:3 (Chemical & Biological). Clarification of License Exception RPL Requirements BIS has received a number of inquiries concerning the requirements of the License Exception RPL (servicing and replacement of parts and equipment) ``one-for-one replacement'' provisions with respect to commodities controlled under ECCN 2B350 on the CCL. In particular, exporters have requested clarification concerning the requirement in Section 740.10(a)(2)(iii) of the EAR that ``the parts, components, accessories, or attachments to be replaced must either be destroyed abroad or returned promptly to the person who supplied the replacements, or to a foreign firm that is under the effective control of that person.'' The major concern expressed, in this regard, is whether an item (i.e., a commodity in ECCN 2B350) would be considered to be ``destroyed,'' for purposes of this requirement, if that item were not repairable. BIS considers a commodity (e.g., a commodity controlled under ECCN 2B350) to be ``destroyed,'' for purposes of the RPL requirement in Section 740.10(a)(2)(iii) of the EAR, if that commodity is: (1) No longer capable of functioning for the purpose for which it was designed (i.e., due to normal wear and tear, a defect, or damage); and (2) not capable of being repaired to function for the purpose for which it was designed. In addition, a commodity that is identified on the CCL will be considered to be ``destroyed'' only if that commodity no longer possesses the characteristics that made it subject to control by the ECCN under which it was classified prior to its being ``destroyed'' (i.e., the classification of the commodity must change and the resulting commodity may be designated as EAR99, provided that it is not enumerated or otherwise described in another ECCN on the CCL). This interpretation by BIS is consistent with, but broader in scope than, the treatment of certain ``scrap'' described in Interpretation #7 under Section 770.2 of the EAR, which applies to specified items that are no longer capable of functioning for the purpose for which they were designed, or of being repaired to function for that purpose, because the items have been damaged (e.g., by means of mangling, crushing, or cutting) to such a degree that they have been rendered useless (i.e., beyond the possibility of restoration to their original identity and condition). The difference is that Interpretation #7 addresses only a single method by which items can be ``destroyed'' (i.e., damage to the item), while BIS's interpretation of the term ``destroyed,'' as used in RPL, also refers to the inability of an item to function (i.e., for the purpose for which it was designed,) as a result of normal wear and tear to the item or because of a defect in the item, coupled with the inability to repair the item to restore its functionality. In short, turning an item into ``scrap'' is only one means of ``destroying'' its functionality, for purposes of the EAR. BIS intends to publish a separate rule that will propose amendments to License Exception RPL and Interpretation #7 (see Section 770.2 of the EAR) in order to provide additional clarification concerning what is meant in the EAR when items are referred to as having been ``destroyed.'' June 2014 AG Plenary Understandings This rule does not contain any changes based on the understandings reached at the June 2014 AG Plenary meeting, because no amendments to the EAR were required as a result of these understandings. 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 human and animal pathogens/toxins and chemical manufacturing facilities/equipment. Although the ECCN 2B350.g controls on valves, casings (valve bodies) designed for such valves, and preformed casing liners designed for such valves were expanded, the expanded controls apply only to a relatively small percentage of items not controlled under 2B350.g prior to the publication of this rule. Consequently, any increase in the number of license applications resulting from this change is not expected to be significant, when considered as a percentage of all such items. Furthermore, any increase in the number of license applications submitted to BIS, as a result of the amendments to ECCN 2B350.g, is expected to be offset by the amendment to ECCN 2B350 that authorizes the use of License Exception LVS for all items controlled by this ECCN, subject to the requirements described in Section 740.3 of the EAR and the specific limitations indicated in the LVS paragraph of this ECCN. In addition, the scope of the CCL-based CB controls on human and animal pathogens and toxins was not affected by the merger of the animal pathogens previously controlled under ECCN 1C352 with the human pathogens and toxins in ECCN 1C351 (i.e., no pathogens or toxins were either added to, or removed from, the CCL, nor were there any changes in the scope of the CB license requirements for any of these pathogens or toxins). Therefore, these changes are not expected to have a significant impact on the number of license applications that will have to be submitted for such items. The conforming amendments to Section 740.20(b)(2)(v), Section 742.2(a)(1)(i), Supplement No. 1 to part 742 (i.e., paragraphs (3), (9)(ii), (9)(iii), and (12) of the Supplement) and Section 752.3(a)(2), as described above, did not have any effect on the application of these provisions to the items that were controlled under ECCN 1C352 prior to the publication of this rule. Although these EAR provisions no longer contain references to ECCN 1C352, they continue to reference ECCN 1C351, which now includes the animal pathogens previously controlled under ECCN 1C352. The conforming amendments to ECCNs 1C353, 1C991, 1E001, and 1E351, as described above, also did not have any effect on the scope of the CCL-based CB controls on items related to human and animal pathogens and toxins (e.g., genetic elements, vaccines, and technology related to such pathogens and toxins). Although ECCNs 1C353, 1C991, 1E001, and 1E351 no longer contain references to ECCN 1C352, they continue to reference ECCN 1C351, which now includes the animal pathogens that were controlled under ECCN 1C352 prior to the publication of this rule. For this reason, the removal of ECCN 1C352 by this rule did not affect either the scope of the items controlled under ECCN 1C353, 1C991, 1E001, or 1E351 for CB reasons or the level of CB controls applicable to such items. Therefore, these conforming changes are not expected to have a significant impact on the number of license applications that will have to be submitted for such items. 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), [[Page 34271]] and as extended by the Notice of August 7, 2014, 79 FR 46959 (August 11, 2014), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. 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. 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 (Multi-Purpose Application), which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. 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 (OMB), and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, as indicated in the ADDRESSES section of this rule. 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 41 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 November 2013 AG intersessional meeting) and other changes that are necessary to ensure consistency with the controls maintained by the AG. Since 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. 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 and coordinated manner. 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. Therefore, this regulation is issued in final form. List of Subjects 15 CFR Parts 740 and 752 Administrative practice and procedure, Exports, Reporting and recordkeeping requirements. 15 CFR Part 742 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 740, 742, 752 and 774 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows: PART 740--[AMENDED] 0 1. The authority citation for 15 CFR part 740 continues to read as follows: Authority: 50 U.S.C. app. 2401 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 7, 2014, 79 FR 46959 (August 11, 2014). Sec. 740.20 [Amended] 0 2. In Sec. 740.20: 0 a. Remove ``1C352,'' where it appears, twice, in paragraph (b)(2)(v); and 0 b. Remove ``1C353, or'' and add in its place ``1C353 or'' in the parenthetical in paragraph (b)(2)(v). PART 742--[AMENDED] 0 3. The authority citation for 15 CFR part 742 continues to read as follows: Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003; Notice of August 7, 2014, 79 FR 46959 (August 11, 2014); Notice of November 7, 2014, 79 FR 67035 (November 12, 2014). Sec. 742.2 [Amended] 0 4. In Sec. 742.2, remove ``1C352,'' where it appears in paragraph (a)(1)(i). Supplement No. 1 to Part 742--[Amended] 0 5. In Supplement No. 1 to part 742, remove ``1C352,'' where it appears in paragraph (3), in paragraphs (9)(ii) and (9)(iii), and in paragraph (12). PART 752--[AMENDED] 0 6. The authority citation for 15 CFR part 752 continues to read as follows: Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 7, 2014, 79 FR 46959 (August 11, 2014). [[Page 34272]] Sec. 752.3 [Amended] 0 7. In Sec. 752.3, remove ``1C352,'' where it appears in paragraph (a)(2). PART 774--[AMENDED] 0 8. The authority citation for 15 CFR part 774 continues to read as follows: Authority: 50 U.S.C. app. 2401 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; 42 U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 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 7, 2014, 79 FR 46959 (August 11, 2014). 0 9. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C350 is amended by adding a new Technical Note 3 at the end of the License Requirements section 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 * * * * * Technical Notes: 1. * * * 2. * * * 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. * * * * * 0 10. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' 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. 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 1C352.a.4 (specifically, 1C352.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 [[Page 34273]] 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 1C352.a.4. a.5. Bluetongue virus; a.6. Chapare virus; a.7. Chikungunya virus; a.8. Choclo virus; a.9. Congo-Crimean haemorrhagic fever virus (a.k.a. Crimean- Congo haemorrhagic fever virus); a.10. Dengue fever virus; a.11. Dobrava-Belgrade virus; a.12. Eastern equine encephalitis virus; a.13. Ebola virus; a.14. Foot and mouth disease virus; a.15. Goat pox virus; a.16. Guanarito virus; a.17. Hantaan virus; a.18. Hendra virus (Equine morbillivirus); a.19. Herpes virus (Aujeszky's disease); a.20. Hog cholera virus (Swine fever virus); a.21. Japanese encephalitis virus; a.22. Junin virus; a.23. Kyasanur Forest virus; a.24. Laguna Negra virus; a.25. Lassa fever virus; a.26. Louping ill virus; a.27. Lujo virus; a.28. Lumpy skin disease virus; a.29. Lymphocytic choriomeningitis virus; a.30. Machupo virus; a.31. Marburg virus; a.32. Monkey pox virus; a.33. Murray Valley encephalitis virus; a.34. Newcastle disease virus; a.35. Nipah virus; a.36. Omsk haemorrhagic fever virus; a.37. Oropouche virus; a.38. Peste des petits ruminants virus; a.39. Porcine enterovirus type 9 (swine vesicular disease virus); a.40. Powassan virus; a.41. Rabies virus and all other members of the Lyssavirus genus; a.42. Rift Valley fever virus; a.43. Rinderpest virus; a.44. Rocio virus; a.45. Sabia virus; a.46. Seoul virus; a.47. Sheep pox virus; a.48. Sin nombre virus; a.49. St. Louis encephalitis virus; a.50. Teschen disease virus; a.51. Tick-borne encephalitis virus (Far Eastern subtype, formerly known as Russian Spring-Summer encephalitis virus--see 1C351.b.3 for Siberian subtype); a.52. Variola virus; a.53. Venezuelan equine encephalitis virus; a.54. Vesicular stomatitis virus; a.55. Western equine encephalitis virus; or a.56. 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. Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments; b.2. SARS-associated coronavirus (SARS-CoV); or b.3. Tick-borne encephalitis virus (Siberian subtype, formerly West Siberian virus--see 1C351.a.51 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. Chlamydophila psittaci (formerly known as Chlamydia 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 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) is also known as enterohaemorrhagic E. coli (EHEC) 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. Conotoxin; d.7. Diacetoxyscirpenol toxin; d.8. HT-2 toxin; d.9. Microcystin (Cyanginosin); d.10. Modeccin toxin; d.11. Ricin; d.12. Saxitoxin; d.13. Shiga toxin; 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. Verotoxin and other Shiga-like ribosome inactivating proteins; d.18. Viscum Album Lectin 1 (Viscumin); or d.19. Volkensin toxin. e. ``Fungi'', as follows: e.1. Coccidioides immitis; or e.2. Coccidioides posadasii. 0 11. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C352 is removed. 0 12. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C353 is amended under the List of Items Controlled section: 0 a. By removing the phrase ``ECCN 1C351, 1C352, or 1C354'' and adding in its place the phrase ``ECCN 1C351 or 1C354'' in the first sentence of the ``Related Controls'' paragraph; 0 b. By removing the phrase ``1C351.a to .c, 1C352, or 1C354'' and adding in its place the phrase ``1C351.a to .c or 1C354'' in paragraph a.1 of the ``Items'' paragraph; 0 c. By removing the phrase ``1C351.a to .c, 1C352,'' and adding in its place the phrase ``1C351.a to .c or 1C354;'' in paragraph b.1 of the ``Items'' paragraph; and 0 d. By removing the phrase ``1C351.a to .c 1C352, or 1C354'' and adding in its place the phrase ``1C351.a to .c or 1C354'' in the introductory text of Technical Note 3 and in paragraph b. of Technical Note 3. 0 13. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C991 is amended, under the ``List of Items Controlled'' section, by removing the phrase ``ECCN 1C351, 1C352, 1C353 or 1C354'' and adding in its place the phrase ``ECCN 1C351, 1C353 or 1C354'' in paragraph a. of the ``Items'' paragraph. 0 14. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1E001 is amended by revising the entry for ``Country Chart--CB Column 1'' in the License Requirements section to read as follows: 1E001 ``Technology'' according to the General Technology Note for the ``development'' or ``production'' of items controlled by 1A001.b, 1A001.c, 1A002, 1A003, 1A004, 1A005, 1A006.b, 1A007, 1A008 1A101, 1B (except 1B608, 1B613 or 1B999), or 1C (except 1C355, 1C608, 1C980 to 1C984, 1C988, 1C990, 1C991, 1C995 to 1C999). License Requirements Reason for Control: NS, MT, NP, CB, RS, AT [[Page 34274]] Country chart (see Supp. No. Control(s) 1 to part 738) * * * * * CB applies to ``technology'' for items CB Column 1. controlled by 1C351, 1C353, or 1C354. * * * * * * * * * * 0 15. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1E351 is amended by revising the ECCN heading and by revising the entry for ``Country Chart--CB Column 1'' in the License Requirements section to read as follows: 1E351 ``Technology'' according to the General Technology Note for the disposal of chemicals or microbiological materials controlled by 1C350, 1C351, 1C353, or 1C354. License Requirements Reason for Control: NS, MT, NP, CB, RS, AT Country chart (see Supp. No. Control(s) 1 to part 738) CB applies to ``technology'' for items CB Column 1. controlled by 1C351, 1C353, or 1C354. * * * * * * * * * * 0 16. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2--Materials Processing, ECCN 2B350 is amended by revising the ``LVS'' paragraph in the List Based License Exceptions section and also, under the List of Items Controlled section, by revising paragraph g. in the ``Items'' paragraph, by redesignating the Technical Note to 2B350.g as Technical Note 2 to 2B350.g, by adding a Technical Note 1 to 2B350.g immediately preceding Technical Note 2, and by adding a Technical Note to 2B350.i immediately following 2B350.i.11, to read as follows: 2B350 Chemical manufacturing facilities and equipment, except valves controlled by 2A226 or 2A292, as follows (see List of Items Controlled). * * * * * 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: * * * CIV: * * * List of Items Controlled Related Controls: * * * Related Definition: * * * Items: * * * * * 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, 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). * * * * * i. * * * 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. * * * * * Dated: June 9, 2015. Kevin J. Wolf, Assistant Secretary for Export Administration. [FR Doc. 2015-14471 Filed 6-15-15; 8:45 am] BILLING CODE 3510-33-P
![34266 Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations
5302B, and R–5302C in North Carolina. Adoption of the Amendment centeredat lat. 36°02′01″ N., long.
As noted above, the locations currently In consideration of the foregoing, the 76°19′59″ W.; to lat. 36°03′56″ N., long.
listed in the restricted area descriptions Federal Aviation Administration 76°24′18″ W.; to the point of beginning.
are inaccurate. The title that reads ‘‘R– amends 14 CFR part 73, as follows: Designated altitudes. 100 feet AGL to
5301 Albemarle Sound, NC’’ is changed 14,000 feet MSL.
to read ‘‘R–5301 Harvey Point, NC.’’ The PART 73—SPECIAL USE AIRSPACE Time of designation. By NOTAM at
titles for restricted areas R–5302A, R– least 24 hours in advance.
5302B, and R–5302C, which currently ■ 1. The authority citation for part 73 Controlling agency. FAA, Washington
read ‘‘Harvey Point, NC,’’ are changed to continues to read as follows: ARTCC.
read ‘‘Albemarle Sound, NC.’’ This is an Authority: 49 U.S.C. 106(f), 106(g); 40103, Using agency. U.S. Navy, Fleet Area
editorial change to update the locations 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Control and Surveillance Facility,
in the titles of restricted areas R–5301, 1959–1963 Comp., p. 389. Virginia Capes (FACSFAC VACAPES),
R–5302A, R–5302B, and R–5302C in Virginia Beach, VA.
North Carolina. The areas are correctly § 73.53 [Amended]
R–5302C Albemarle Sound, NC [New]
depicted on aeronautical charts. This ■ 2. Section 73.53 is amended as
change does not affect the boundaries, follows: Boundaries. Beginning at lat.
designated altitudes, activities 36°00′01″ N., long. 76°12′59″ W.; to lat.
* * * * *
conducted within the restricted areas or 35°58′50″ N., long. 76°16′58″ W.; thence
the actual physical location of the R–5301 Albemarle Sound, NC clockwise via a 4 nautical mile arc
airspace; therefore, notice and public [Remove] centered at lat. 36°02′01″ N., long.
procedure under 5 U.S.C. 553(b) are R–5302A Harvey Point, NC [Remove] 76°19′59″ W.; to lat. 36°00′04″ N., long.
unnecessary. 76°24′17″ W.; to the point of beginning.
R–5302B Harvey Point, NC [Remove] Designated altitudes. 100 feet AGL to
Regulatory Notices and Analyses 3,000 feet MSL.
R–5302B Harvey Point, NC [Remove]
The FAA has determined that this Time of designation. By NOTAM at
action only involves an established R–5301 Harvey Point, NC [New] least 24 hours in advance.
body of technical regulations for which Boundaries. Beginning at lat. Controlling agency. FAA, Washington
frequent and routine amendments are 36°04′56″ N., long. 76°16′47″ W.; to lat. ARTCC.
necessary to keep them operationally 36°04′23″ N., long. 76°20′59″ W.; to lat. Using agency. U.S. Navy, Fleet Area
current. Therefore, this regulation: (1) Is 36°06′58″ N., long. 76°20′58″ W.; thence Control and Surveillance Facility,
not a ‘‘significant regulatory action’’ clockwise via a 3 nautical mile arc Virginia Capes (FACSFAC VACAPES),
under Executive Order 12866; (2) is not centered at lat. 36°04′01″ N., long. Virginia Beach, VA.
a ‘‘significant rule’’ under DOT 76°20′19″ W.; to the point of beginning. Issued in Washington, DC on June 10,
Regulatory Policies and Procedures (44 Designated altitudes. Surface to 2015.
FR 11034; February 26, 1979); and (3) 14,000 feet MSL. Gary A. Norek,
does not warrant preparation of a Time of designation. Continuous. Manager, Airspace Policy and Regulations
regulatory evaluation as the anticipated Controlling agency. FAA, Washington Group.
impact is so minimal. Since this is a ARTCC.
[FR Doc. 2015–14798 Filed 6–15–15; 8:45 am]
routine matter that only affects air traffic Using agency. U.S. Navy, Fleet Area
BILLING CODE 4910–13–P
procedures and air navigation, it is Control and Surveillance Facility,
certified that this rule, when Virginia Capes (FACSFAC VACAPES),
promulgated, does not have a significant Virginia Beach, VA.
economic impact on a substantial DEPARTMENT OF COMMERCE
R–5302A Albemarle Sound, NC [New]
number of small entities under the
Boundaries. Beginning at lat. Bureau of Industry and Security
criteria of the Regulatory Flexibility Act.
36°01′21″ N., long. 76°14′29″ W.; to lat.
Environmental Review 36°02′19″ N., long. 76°07′14″ W.; to lat. 15 CFR Parts 740, 742, 752 and 774
The FAA has determined that this 36°00′01″ N., long. 76°07′14″ W.; to lat. [Docket No. 141229999–4999–01]
action qualifies for categorical exclusion 36°00′01″ N., long. 76°14′29″ W.; to the
RIN 0694–AG45
under the National Environmental point of beginning.
Policy Act in accordance with FAA Designated altitudes. Surface to Implementation of the Australia Group
Order 1050.1E, Environmental Impacts: 14,000 feet MSL. (AG) November 2013 Intersessional
Policies and Procedures, paragraph Time of designation. By NOTAM at Decisions
311d. This action is an administrative least 24 hours in advance.
change to the titles in the descriptions Controlling agency. FAA, Washington AGENCY: Bureau of Industry and
of the affected restricted areas to reflect ARTCC. Security, Commerce.
the correct locations. It does not alter Using agency. U.S. Navy, Fleet Area ACTION: Final rule.
the dimensions, altitudes, times of Control and Surveillance Facility,
designation or actual physical locations Virginia Capes (FACSFAC VACAPES), SUMMARY: The Bureau of Industry and
of the airspace; therefore, it is not Virginia Beach, VA. Security (BIS) publishes this final rule
expected to cause any potentially to amend the Export Administration
R–5302B Albemarle Sound, NC [New]
asabaliauskas on DSK5VPTVN1PROD with RULES
significant environmental impacts, and Regulations (EAR) to implement the
no extraordinary circumstances exists Boundaries. Beginning at lat. recommendations presented at the
that warrant preparation of an 36°04′59″ N., long. 76°16′29″ W.; to lat. November 2013 Australia Group (AG)
environmental assessment. 36°04′01″ N., long. 76°05′59″ W.; to lat. intersessional implementation meeting
36°00′01″ N., long. 76°05′59″ W.; to lat. and later adopted pursuant to the AG
List of Subjects in 14 CFR Part 73 36°00′01″ N., long. 76°12′59″ W.; to lat. silent approval procedure. Specifically,
Airspace, Prohibited areas, Restricted 36°00′04″ N., long. 76°24′17″ W.; thence this rule amends the Commerce Control
areas. clockwise via a 4 nautical mile arc List (CCL) entry in the EAR that controls
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![Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations 34271
and as extended by the Notice of August rulemaking, the opportunity for public 15 CFR Part 774
7, 2014, 79 FR 46959 (August 11, 2014), participation, and a delay in effective
Exports, Reporting and recordkeeping
has continued the Export date, are inapplicable because this requirements.
Administration Regulations in effect regulation involves a military and
under the International Emergency foreign affairs function of the United For the reasons stated in the
Economic Powers Act. BIS continues to States (See 5 U.S.C. 553(a)(1)). preamble, parts 740, 742, 752 and 774
carry out the provisions of the Export Immediate implementation of these of the Export Administration
Administration Act, as appropriate and amendments is non-discretionary and Regulations (15 CFR parts 730–774) are
to the extent permitted by law, pursuant fulfills the United States’ international amended as follows:
to Executive Order 13222 as amended obligation to the Australia Group (AG).
by Executive Order 13637. PART 740—[AMENDED]
The AG contributes to international
Rulemaking Requirements security and regional stability through ■ 1. The authority citation for 15 CFR
1. Executive Orders 13563 and 12866 the harmonization of export controls part 740 continues to read as follows:
direct agencies to assess all costs and and seeks to ensure that exports do not
Authority: 50 U.S.C. app. 2401 et seq.; 50
benefits of available regulatory contribute to the development of U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.;
alternatives and, if regulation is chemical and biological weapons. The E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp.,
necessary, to select regulatory AG consists of 41 member countries that p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
approaches that maximize net benefits act on a consensus basis and the Comp., p. 783; Notice of August 7, 2014, 79
(including potential economic, amendments set forth in this rule FR 46959 (August 11, 2014).
environmental, public health and safety implement changes made to the AG § 740.20 [Amended]
effects, distributive impacts, and common control lists (as a result of the
equity). Executive Order 13563 adoption of the recommendations made ■ 2. In § 740.20:
emphasizes the importance of at the November 2013 AG intersessional ■ a. Remove ‘‘1C352,’’ where it appears,
quantifying both costs and benefits, of meeting) and other changes that are twice, in paragraph (b)(2)(v); and
reducing costs, of harmonizing rules, necessary to ensure consistency with ■ b. Remove ‘‘1C353, or’’ and add in its
and of promoting flexibility. This rule the controls maintained by the AG. place ‘‘1C353 or’’ in the parenthetical in
has been designated a ‘‘significant Since the United States is a significant paragraph (b)(2)(v).
regulatory action,’’ although not exporter of the items in this rule,
economically significant, under section immediate implementation of this PART 742—[AMENDED]
3(f) of Executive Order 12866. provision is necessary for the AG to
Accordingly, the rule has been reviewed ■ 3. The authority citation for 15 CFR
achieve its purpose. Any delay in
by the Office of Management and part 742 continues to read as follows:
implementation will create a disruption
Budget. Authority: 50 U.S.C. app. 2401 et seq.; 50
in the movement of affected items
2. Notwithstanding any other U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;
provision of law, no person is required globally because of disharmony between
42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
to respond to, nor shall any person be export control measures implemented U.S.C. 7210; Sec. 1503, Pub. L. 108–11, 117
subject to a penalty for failure to comply by AG members, resulting in tension Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR,
with, a collection of information subject between member countries. Export 1978 Comp., p. 179; E.O. 12851, 58 FR 33181,
to the requirements of the Paperwork controls work best when all countries 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
Reduction Act of 1995 (44 U.S.C. 3501 implement the same export controls in FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.
a timely and coordinated manner. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
et seq.) (PRA), unless that collection of
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
information displays a currently valid Further, no other law requires that a Comp., p. 783; Presidential Determination
Office of Management and Budget notice of proposed rulemaking and an 2003–23 of May 7, 2003, 68 FR 26459, May
(OMB) Control Number. This rule opportunity for public comment be 16, 2003; Notice of August 7, 2014, 79 FR
contains a collection of information given for this final rule. Because a 46959 (August 11, 2014); Notice of November
subject to the requirements of the PRA. notice of proposed rulemaking and an 7, 2014, 79 FR 67035 (November 12, 2014).
This collection has been approved by opportunity for public comment are not § 742.2 [Amended]
OMB under Control Number 0694–0088 required to be given for this rule under
(Multi-Purpose Application), which the Administrative Procedure Act or by ■ 4. In § 742.2, remove ‘‘1C352,’’ where
carries a burden hour estimate of 58 any other law, the analytical it appears in paragraph (a)(1)(i).
minutes to prepare and submit form requirements of the Regulatory
BIS–748. Send comments regarding this Supplement No. 1 to Part 742—
Flexibility Act (5 U.S.C. 601 et seq.) are [Amended]
burden estimate or any other aspect of
not applicable. Therefore, this
this collection of information, including ■ 5. In Supplement No. 1 to part 742,
regulation is issued in final form.
suggestions for reducing the burden, to remove ‘‘1C352,’’ where it appears in
Jasmeet Seehra, Office of Management List of Subjects paragraph (3), in paragraphs (9)(ii) and
and Budget (OMB), and to the (9)(iii), and in paragraph (12).
Regulatory Policy Division, Bureau of 15 CFR Parts 740 and 752
Industry and Security, Department of Administrative practice and PART 752—[AMENDED]
Commerce, as indicated in the procedure, Exports, Reporting and
asabaliauskas on DSK5VPTVN1PROD with RULES
ADDRESSES section of this rule. ■ 6. The authority citation for 15 CFR
recordkeeping requirements.
3. This rule does not contain policies part 752 continues to read as follows:
with Federalism implications as that 15 CFR Part 742 Authority: 50 U.S.C. app. 2401 et seq.; 50
term is defined in Executive Order U.S.C. 1701 et seq.; E.O. 13020, 61 FR 54079,
13132. Administrative practice and 3 CFR, 1996 Comp., p. 219; E.O. 13222, 66
4. The provisions of the procedure, Chemicals, Exports, Foreign FR 44025, 3 CFR, 2001 Comp., p. 783; Notice
Administrative Procedure Act (5 U.S.C. trade, Reporting and recordkeeping of August 7, 2014, 79 FR 46959 (August 11,
553) requiring notice of proposed requirements. 2014).
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![34272 Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations
§ 752.3 [Amended] Country chart (See CIV: N/A
Control(s) Supp. No. 1 to part Special Conditions for STA
■ 7. In § 752.3, remove ‘‘1C352,’’ where 738)
it appears in paragraph (a)(2). STA: (1) Paragraph (c)(1) of License
CB applies to entire CB Column 1. Exception STA (§ 740.20(c)(1)) may be
PART 774—[AMENDED] entry. used for items in 1C351.d.1 through
1C351.d.10 and 1C351.d.13 through
CW applies to 1C351.d.11 and d.12 and a
1C351.d.19. See § 740.20(b)(2)(vi) for
■ 8. The authority citation for 15 CFR license is required for CW reasons for all
restrictions on the quantity of any one
part 774 continues to read as follows: destinations, including Canada, as follows:
toxin that may be exported in a single
CW applies to 1C351.d.11 for ricin in the
Authority: 50 U.S.C. app. 2401 et seq.; 50 shipment and the number of shipments
form of (1) Ricinus Communis AgglutininII
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. that may be made to any one end user in
(RCAII), also known as ricin D or Ricinus
7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et a single calendar year. Also see the
Communis LectinIII (RCLIII) and (2) Ricinus
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); Automated Export System (AES)
Communis LectinIV (RCLIV), also known as
42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. requirements in § 758.1(b)(4) of the EAR.
ricin E. CW applies to 1C351.d.12 for (2) Paragraph (c)(2) of License Exception
1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22 saxitoxin identified by C.A.S. #35523–89–8.
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. STA (§ 740.20(c)(2) of the EAR) may not be
See § 742.18 of the EAR for licensing used for any items in 1C351.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p. information pertaining to chemicals subject
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 to restriction pursuant to the Chemical List of Items Controlled
Comp., p. 783; Notice of August 7, 2014, 79 Weapons Convention (CWC). The Commerce Related Controls: (1) Certain forms of ricin
FR 46959 (August 11, 2014). Country Chart is not designed to determine and saxitoxin in 1C351.d.11. and d.12 are
licensing requirements for items controlled CWC Schedule 1 chemicals (see § 742.18 of
■ 9. In Supplement No. 1 to Part 774 for CW reasons. the EAR). The U.S. Government must
(the Commerce Control List), Category provide advance notification and annual
1—Special Materials and Related Country chart (See reports to the OPCW of all exports of
Equipment, Chemicals, Control(s) Supp. No. 1 to part Schedule 1 chemicals. See § 745.1 of the
‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN 738) EAR for notification procedures. See 22
1C350 is amended by adding a new AT applies to entire AT Column 1.
CFR part 121, Category XIV and § 121.7 for
Technical Note 3 at the end of the CWC Schedule 1 chemicals that are
entry.
License Requirements section to read as ‘‘subject to the ITAR.’’ (2) The Animal and
follows: License Requirement Notes: 1. All vaccines Plant Health Inspection Service (APHIS),
and ‘‘immunotoxins’’ are excluded from the U.S. Department of Agriculture, and the
Supplement No. 1 to Part 774—The scope of this entry. Certain medical products Centers for Disease Control and Prevention
Commerce Control List and diagnostic and food testing kits that (CDC), U.S. Department of Health and
contain biological toxins controlled under Human Services, maintain controls on the
* * * * * paragraph (d) of this entry, with the possession, use, and transfer within the
1C350 Chemicals that may be used as United States of certain items controlled by
exception of toxins controlled for CW reasons
precursors for toxic chemical agents (see this ECCN (for APHIS, see 7 CFR 331.3(b),
under d.11 and d.12, are excluded from the
List of Items Controlled). 9 CFR 121.3(b), and 9 CFR 121.4(b); for
scope of this entry. Vaccines,
License Requirements ‘‘immunotoxins’’, certain medical products, CDC, see 42 CFR 73.3(b) and 42 CFR
and diagnostic and food testing kits excluded 73.4(b)). (3) See 22 CFR part 121, Category
* * * * * XIV(b), for modified biological agents and
Technical Notes: 1. * * * from the scope of this entry are controlled
under ECCN 1C991. biologically derived substances that are
2. * * *
2. For the purposes of this entry, only ‘‘subject to the ITAR.’’
3. Precursor chemicals in ECCN 1C350 are
saxitoxin is controlled under paragraph d.12; Related Definitions: (1) For the purposes of
listed by name, Chemical Abstract Service
other members of the paralytic shellfish this entry ‘‘immunotoxin’’ is defined as an
(CAS) number and CWC Schedule (where
poison family (e.g., neosaxitoxin) are antibody-toxin conjugate intended to
applicable). Precursor chemicals of the same
designated EAR99. destroy specific target cells (e.g., tumor
structural formula (e.g., hydrates) are
3. Clostridium perfringens strains, other cells) that bear antigens homologous to the
controlled by ECCN 1C350, regardless of
than the epsilon toxin-producing strains of antibody. (2) For the purposes of this entry
name or CAS number. CAS numbers are
Clostridium perfringens described in c.12, ‘‘subunit’’ is defined as a portion of the
shown to assist in identifying whether a
are excluded from the scope of this entry, ‘‘toxin’’.
particular precursor chemical or mixture is
since they may be used as positive control Items:
controlled under ECCN 1C350, irrespective of
cultures for food testing and quality control. a. Viruses identified on the Australia
nomenclature. However, CAS numbers
4. Unless specified elsewhere in this ECCN Group (AG) ‘‘List of Human and Animal
cannot be used as unique identifiers in all
1C351 (e.g., in License Requirement Notes 1– Pathogens and Toxins for Export Control,’’ as
situations because some forms of the listed
3), this ECCN controls all biological agents follows:
precursor chemical have different CAS
and ‘‘toxins,’’ regardless of quantity or a.1. African horse sickness virus;
numbers, and mixtures containing a
attenuation, that are identified in the List of a.2. African swine fever virus;
precursor chemical listed in ECCN 1C350
Items Controlled for this ECCN, including a.3. Andes virus;
may also have different CAS numbers.
small quantities or attenuated strains of a.4. Avian influenza (AI) viruses identified
* * * * * select biological agents or ‘‘toxins’’ that are as having high pathogenicity (HP), as follows:
excluded from the lists of select biological a.4.a. AI viruses that have an intravenous
■ 10. In Supplement No. 1 to Part 774 pathogenicity index (IVPI) in 6-week-old
agents or ‘‘toxins’’ by the Animal and Plant
(the Commerce Control List), Category Health Inspection Service (APHIS), U.S. chickens greater than 1.2; or
1—Special Materials and Related Department of Agriculture, or the Centers for a.4.b. AI viruses that cause at least 75%
Equipment, Chemicals,
asabaliauskas on DSK5VPTVN1PROD with RULES
Disease Control and Prevention (CDC), U.S. mortality in 4- to 8-week-old chickens
‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN Department of Health and Human Services, infected intravenously.
1C351 is revised to read as follows: in accordance with their regulations in 9 CFR Note: Avian influenza (AI) viruses of the
1C351 Human and animal pathogens and part 121 and 42 CFR part 73, respectively. H5 or H7 subtype that do not have either of
‘‘toxins’’, as follows (see List of Items the characteristics described in 1C352.a.4
Controlled). List Based License Exceptions (See Part 740 (specifically, 1C352.a.4.a or a.4.b) should be
for a Description of All License Exceptions) sequenced to determine whether multiple
License Requirements LVS: N/A basic amino acids are present at the cleavage
Reason for Control: CB, CW, AT GBS: N/A site of the haemagglutinin molecule (HA0). If
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![34274 Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations
Country chart (see Country Group D:3 (see Supplement No. 1 contact with the chemical(s) being processed
Control(s) Supp. No. 1 to part to part 740 of the EAR). (or are designed to do so), and provide a
738) GBS: * * * sealing function where a rotary or
CIV: * * * reciprocating drive shaft passes through a
pump body.
List of Items Controlled
* * * * *
CB applies to ‘‘tech- CB Column 1. Related Controls: * * * * * * * *
nology’’ for items Related Definition: * * * Dated: June 9, 2015.
controlled by Items: Kevin J. Wolf,
1C351, 1C353, or * * * * * Assistant Secretary for Export
1C354. g. Valves, as follows: Administration.
g.1. Valves having both of the following
[FR Doc. 2015–14471 Filed 6–15–15; 8:45 am]
* * * * * characteristics:
g.1.a. A nominal size greater than 1.0 cm BILLING CODE 3510–33–P
* * * * * (3⁄8 in.); and
■ 15. In Supplement No. 1 to Part 774 g.1.b. All surfaces that come in direct
(the Commerce Control List), Category contact with the chemical(s) being produced, DEPARTMENT OF HEALTH AND
1—Special Materials and Related processed, or contained are made from HUMAN SERVICES
materials identified in Technical Note 1 to
Equipment, Chemicals, 2B350.g.
‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN Food and Drug Administration
g.2. Valves, except for valves controlled by
1E351 is amended by revising the ECCN 2B350.g.1, having all of the following
heading and by revising the entry for characteristics: 21 CFR Part 172
‘‘Country Chart—CB Column 1’’ in the g.2.a. A nominal size equal to or greater [Docket No. FDA–2014–F–0364]
License Requirements section to read as than 2.54 cm (1 inch) and equal to or less
follows: than 10.16 cm (4 inches); Food Additives Permitted for Direct
1E351 ‘‘Technology’’ according to the g.2.b. Casings (valve bodies) or preformed Addition to Food for Human
General Technology Note for the casing liners controlled by 2B350.g.3, in
which all surfaces that come in direct contact
Consumption; TBHQ
disposal of chemicals or microbiological
materials controlled by 1C350, 1C351, with the chemical(s) being produced, AGENCY: Food and Drug Administration,
1C353, or 1C354. processed, or contained are made from HHS.
materials identified in Technical Note 1 to
License Requirements 2B350.g; and ACTION: Final rule.
Reason for Control: NS, MT, NP, CB, RS, AT g.2.c. A closure element designed to be
SUMMARY: The Food and Drug
interchangeable.
g.3. Casings (valve bodies) and preformed Administration (FDA or we) is
Country chart (see amending the food additive regulations
Control(s) Supp. No. 1 to part casing liners having both of the following
738) characteristics: by removing the upper bound of the
g.3.a. Designed for valves in 2B350.g.1 or melting point range in the regulation for
CB applies to ‘‘tech- CB Column 1. .g.2; and the antioxidant tertiary
nology’’ for items g.3.b. All surfaces that come in direct butylhydroquinone (TBHQ) and adding
controlled by contact with the chemical(s) being produced, a purity acceptance criterion. This
1C351, 1C353, or processed, or contained are made from
action is in response to a petition
1C354. materials identified in Technical Note 1 to
2B350.g. submitted by Eastman Chemical
Technical Note 1 to 2B350.g: All surfaces
Company.
* * * * *
of the valves controlled by 2B350.g.1, and the DATES: This rule is effective June 16,
* * * * * casings (valve bodies) and preformed casing 2015. See section VIII for further
■ 16. In Supplement No. 1 to Part 774 liners controlled by 2B350.g.3, that come in information on the filing of objections.
(the Commerce Control List), Category direct contact with the chemical(s) being Submit either electronic or written
produced, processed, or contained are made
2—Materials Processing, ECCN 2B350 is from the following materials:
objections and requests for a hearing by
amended by revising the ‘‘LVS’’ a. Alloys with more than 25% nickel and July 16, 2015. The Director of the
paragraph in the List Based License 20% chromium by weight; Federal Register approves the
Exceptions section and also, under the b. Nickel or alloys with more than 40% incorporation by reference of certain
List of Items Controlled section, by nickel by weight; publications listed in the rule as of June
revising paragraph g. in the ‘‘Items’’ c. Fluoropolymers (polymeric or 16, 2015.
paragraph, by redesignating the elastomeric materials with more than 35% ADDRESSES: You may submit either
fluorine by weight);
Technical Note to 2B350.g as Technical electronic or written objections and
d. Glass (including vitrified or enameled
Note 2 to 2B350.g, by adding a coating or glass lining); requests for a hearing identified by
Technical Note 1 to 2B350.g e. Tantalum or tantalum alloys; Docket No. FDA–2014–F–0364, by any
immediately preceding Technical Note f. Titanium or titanium alloys; of the following methods:
2, and by adding a Technical Note to g. Zirconium or zirconium alloys;
h. Niobium (columbium) or niobium
Electronic Submissions
2B350.i immediately following
2B350.i.11, to read as follows: alloys; or Submit electronic objections in the
i. Ceramic materials, as follows: following way:
2B350 Chemical manufacturing facilities
i.1. Silicon carbide with a purity of 80% • Federal eRulemaking Portal: http://
asabaliauskas on DSK5VPTVN1PROD with RULES
and equipment, except valves controlled
or more by weight; www.regulations.gov. Follow the
by 2A226 or 2A292, as follows (see List
i.2. Aluminum oxide (alumina) with a instructions for submitting comments.
of Items Controlled).
purity of 99.9% or more by weight; or
* * * * * i.3. Zirconium oxide (zirconia). Written Submissions
List Based License Exceptions (See Part 740 * * * * * Submit written objections in the
for a Description of All License Exceptions) i. * * * following ways:
LVS: $2,000 for all Country Group B Technical Note to 2B350.i: The seals • Mail/Hand delivery/Courier (for
destinations, except those also listed under referred to in 2B350.i come into direct paper submissions): Division of Dockets
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Document Created: 2018-02-22 10:22:55
Document Modified: 2018-02-22 10:22:55
| 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 June 16, 2015. | |
| 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 | 80 FR 34266 | |
| RIN Number | 0694-AG45 | |
| CFR Citation | 15
CFR
740 15 CFR 742 15 CFR 752 15 CFR 774 | |
| CFR Associated | Administrative Practice and Procedure; Exports; Reporting and Recordkeeping Requirements; Chemicals and Foreign Trade |
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