33692 Federal Register / Vol
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33692 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations interim staff guidance in the Federal SUMMARY: The Bureau of Industry and Avenue NW., Room 2705, Washington, Register (76 FR 1100) for public Security (BIS) publishes this final rule DC 20230. comment. Two comment letters were to amend the Export Administration FOR FURTHER INFORMATION CONTACT: received and considered during the Regulations (EAR) to implement the Elizabeth Sangine, Director, Chemical revision of the draft interim staff understandings reached at the June 2012 and Biological Controls Division, Office guidance. The guidance was also plenary meeting of the Australia Group of Nonproliferation and Treaty enhanced based on comments received (AG) and the 2012 AG intersessional Compliance, Bureau of Industry and on the proposed rule. decisions. Specifically, this rule amends Security, Telephone: (202) 482–3343. the Commerce Control List (CCL) entry The interim staff guidance document SUPPLEMENTARY INFORMATION: describes methods acceptable to the in the EAR that controls human and NRC staff for implementing the new zoonotic pathogens and ‘‘toxins’’ to Background requirements in the Distribution of reflect changes to the AG ‘‘List of The Bureau of Industry and Security Source Material Rule. The approaches Biological Agents for Export Control’’ (BIS) is amending the Export and methods described in the document that were made based on the Administration Regulations (EAR) to are provided for information only. understandings adopted at the June implement the understandings reached 2012 AG plenary meeting. These Methods and solutions different from at the Australia Group (AG) plenary changes included the addition of three those described in the document are meeting held in Paris, France, on June pathogens and clarifications to two acceptable if they meet the revised 12–15, 2012. This rule also implements other items. This rule also amends the requirements. The guidance is provided the recommendations presented at the CCL entry in the EAR that controls plant in the form of questions and answers on AG intersessional implementation pathogens to reflect: The 2012 AG the primary provisions of the meeting held in Ottawa, Canada, on Plenary agreement to add five pathogens Distribution of Source Material Rule. February 14–16, 2012, and adopted to the AG ‘‘List of Plant Pathogens for Guidance consistent with the revised 10 pursuant to the AG silent approval Export Control;’’ and the AG CFR part 40 will be incorporated into procedure, which closed on March 23, intersessional clarifications to six the next revision of relevant volumes of 2012. The AG is a multilateral forum pathogens identified on this AG list. In NUREG–1556, ‘‘Consolidated Guidance consisting of 40 participating countries About Materials Licenses’’ (current addition, the CCL entry in the EAR that controls equipment capable of handling that maintain export controls on a list of ADAMS Accession Nos. ML022830847 chemicals, biological agents, and related and ML003681951). biological materials is amended to reflect the 2012 AG intersessional equipment and technology that could be Congressional Review Act decision to add certain spray-drying used in a chemical or biological equipment to the AG ‘‘Control List of weapons program. The AG periodically This interim staff guidance is a rule as reviews items on its control list to designated in the Congressional Review Dual-Use Biological Equipment and Related Technology and Software.’’ This enhance the effectiveness of Act of 1996 (5 U.S.C. 801–808). participating governments’ national However, the Office of Management and rule also removes the CCL entry that controls select agents not identified on controls and to achieve greater Budget has not found it to be a major harmonization among these controls. rule as designated in the Congressional any of the AG common controls lists, Review Act. but identified on the CCL because they June 2012 AG Plenary Changes are (or were, until recently) subject to Dated at Rockville, Maryland, this 30th day controls maintained by the Centers for The June 2012 AG plenary meeting of May, 2013. Disease Control and Prevention (CDC), adopted understandings that affected For the Nuclear Regulatory Commission. U.S. Department of Health and Human the AG ‘‘List of Biological Agents for Brian J. McDermott, Services, and the Animal and Plant Export Control’’ and the AG ‘‘List of Director, Division of Materials Safety and Health Inspection Service (APHIS), U.S. Plant Pathogens for Export Control.’’ State Agreements, Office of Federal and State Department of Agriculture, on their This rule amends Export Control Materials and Environmental Management possession, use, and transfer within the Classification Number (ECCN) 1C351 to Programs. United States. Rather than continuing to reflect the AG plenary changes to the [FR Doc. 2013–13344 Filed 6–4–13; 8:45 am] control these select agents in a separate ‘‘List of Biological Agents for Export BILLING CODE 7590–01–P CCL entry, this rule adds those select Control.’’ Specifically, ECCN 1C351 agents that remain subject to the CDC/ (Human and zoonotic pathogens and APHIS controls (as well as a recent ‘‘toxins’’) is amended by adding DEPARTMENT OF COMMERCE addition to the list of select agents) to botulinum neurotoxin producing strains the AG-related CCL entries that control of the following bacteria to 1C351.c: Bureau of Industry and Security human and zoonotic pathogens and Clostridium argentinense (formerly ‘‘toxins’’ and plant pathogens, known as Clostridium botulinum Type 15 CFR Parts 740, 742, and 774 respectively. G); Clostridium baratii; and Clostridium [Docket No. 120806310–2310–01] butyricum. ECCN 1C351.c is partially DATES: This rule is effective June 5, renumbered to control these bacteria RIN 0694–AF76 2013. under 1C351.c.8., .c.9, and .c.11, ADDRESSES: Send comments regarding respectively, while the bacteria Implementation of the Understandings this collection of information, including previously controlled under these Reached at the 2012 Australia Group suggestions for reducing the burden, to subparagraphs (Clostridium botulinum; (AG) Plenary Meeting and the 2012 AG Jasmeet Seehra, Office of Management Clostridium perfringens, epsilon toxin Intersessional Decisions; Changes to and Budget (OMB), by email to producing types; and Coxiella burnetii) Select Agent Controls [email protected], or by are now controlled under 1C351.c.10, AGENCY: Bureau of Industry and fax to (202) 395–7285; and to the .c.12. and .c.13, respectively. In Security, Commerce. Regulatory Policy Division, Bureau of addition, bacteria previously controlled Industry and Security, Department of under 1C351.c.12 through .c.17 are now ACTION: Final rule. Commerce, 14th Street & Pennsylvania controlled under 1C351.c.14 through VerDate Mar<15>2010 16:07 Jun 04, 2013 Jkt 229001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\05JNR1.SGM 05JNR1 TKELLEY on DSK3SPTVN1PROD with RULES Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 33693 .c.16 (Francisella tularensis; Rickettsia (Xanthomonas campestris pv. citri A) Services, on their possession, use, and prowazekii; and Salmonella typhi) and (Xanthomonas campestris pv. citri)’’ and transfer within the United States. 1C351.c.18 through .c 20 (Shigella that the controls for ‘‘Ralstonia As a result of amendments by CDC to dysenteriae; Vibrio cholerae; and solanacearum’’ in 1C354.a.5 apply to the list of ‘‘HHS select agents’’ in 42 Yersinia pestis). Also note, with respect ‘‘Ralstonia solanacearum, race 3, biovar CFR 73.3 and the list of ‘‘Overlap select to ECCN 1C351.c.15 as amended by this 2.’’ This rule also amends ECCN agents and toxins’’ in 42 CFR 73.4 and rule, that the listing for the bacterium 1C354.b (Fungi) to reorder the wording amendments by APHIS to the list of ‘‘Rickettsia prowasecki (a.k.a. Rickettsia of the controls for ‘‘Colletotrichum ‘‘Plant Protection and Quarantine (PPQ) prowazekii)’’ is amended to read coffeanum var. virulans (Colletotrichum select agents and toxins’’ in 7 CFR 331.3 ‘‘Rickettsia prowazekii,’’ consistent with kahawae)’’ in 1C354.b.1 to read and the list of ‘‘Veterinary Services (VS) the listing of this bacterium in the AG ‘‘Colletotrichum kahawae select agents and toxins’’ in 9 CFR ‘‘List of Biological Agents for Export (Colletotrichum coffeanum var. 121.3, ten of the eighteen select agents Control’’ and the commonly accepted virulans).’’ In addition, this rule amends that were listed in ECCN 1C360 are no spelling of this bacterium within the the controls for ‘‘Puccinia graminis’’ in longer included on the CDC/APHIS scientific community. 1C354.b.4 to clarify that they apply to select agents lists. For this reason, as This rule also amends ECCN 1C351.c ‘‘Puccinnia graminis ssp. graminis var. well as to assist exporters to more easily to clarify that the controls on graminis/Puccinia graminis ssp. identify all of the select agents that are ‘‘Escherichia coli and other verotoxin graminis var. stakmanii (Puccinia subject to the chemical/biological (CB) producing serotypes’’ apply to ‘‘Shiga graminis [syn. Puccinia graminis f. sp. controls described in Section 742.2(a)(1) toxin producing Escherichia coli (STEC) tritici])’’ and the controls for of the EAR (i.e., CB Column 1), BIS is of serogroups O26, O45, O103, O104, ‘‘Magnaporthe grisea’’ in 1C354.b.6 to removing ECCN 1C360 from the CCL O111, O121, O145, O157, and other clarify that they apply to ‘‘Magnaporthe and adding the select agents that were shiga toxin producing serogroups.’’ oryzae (Pyricularia oryzae).’’ controlled by ECCN 1C360, and These bacteria are now controlled under Furthermore, this rule amends 1C354.c continue to be identified on the CDC/ 1C351.c.17. Prior to the publication of to clarify the controls for ‘‘Potato APHIS lists, to the appropriate AG- this rule and the partial renumbering of Andean latent tymovirus’’ in 1C354.c.1 related ECCNs on the CCL (i.e., ECCNs 1C351.c, these bacteria were controlled to read ‘‘Andean potato latent virus 1C351 and 1C354). Prior to the under 1C351.c.11.