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. In addition, this rule (Potato Andean latent tymovirus).’’ publication of this rule, the CDC/APHIS amends 1C351.d.14 to clarify that the In addition, this rule amends ECCN select agents listed in these ECCNs controls on ‘‘Staphylococcus aureus 2B352 (Equipment capable of use in included only those select agents that toxins’’ apply to ‘‘Staphylococcus handling biological materials) to reflect were also identified on one of the AG aureus enterotoxins, hemolysin alpha the AG intersessional changes to the common control lists. toxin, and toxic shock syndrome toxin ‘‘Control List of Dual-Use Biological As a result of the changes described (formerly known as Staphylococcus Equipment and Related Technology and above, the following select agents that enterotoxin F).’’ Software.’’ Specifically, this rule adds were controlled by ECCN 1C360 are no This rule amends ECCN 1C354 (Plant controls for certain spray-drying longer listed on the CCL: Central pathogens) to reflect the AG plenary equipment under 2B352.f. Those items European tick-borne encephalitis changes to the ‘‘List of Plant Pathogens that were controlled under 2B352.f viruses (i.e., Absettarov, Hanzalova, for Export Control.’’ Specifically, ECCN through .h, prior to the publication of Hypr, and Kumlinge); Cercopithecine 1C354 is amended by adding the this rule, are now controlled under herpesvirus 1 (Herpes B virus); Flexal following five fungi to 1C354.b: 2B352.g through .i, respectively. ECCN virus; Akabane virus; Bovine Peronosclerospora philippinensis 2B352.f, as revised by this rule, now spongiform encephalopathy agent; (Peronosclerospora sacchari); controls spray-drying equipment Camel pox virus; Malignant catarrhal Sclerophthora rayssiae var. zeae; capable of drying toxins or pathogenic fever virus; Menangle virus; Erhlichia Synchytrium endobioticum; Tilletia microorganisms and having all of the ruminantium (a.k.a. Cowdria indica; and Thecaphora solani. These following characteristics: (1) A water ruminantium); and Xylella fastidiosa pv. fungi are controlled under 1C354.b.7 evaporation capacity of ≥ 0.4 kg/h and citrus variegated chlorosis (CVC). through .b.11, respectively. ≤ 400 kg/h; (2) the ability to generate a Three select agents that were controlled under ECCN 1C360 and 2012 AG Intersessional Changes typical mean product particles size of ≤ 10 micrometers with existing fittings continue to be identified on the CDC/ This rule also implements the or by minimal modification of the spray- APHIS select agents lists are now recommendations presented at the AG dryer with atomization nozzles enabling controlled on the CCL, as follows: intersessional implementation meeting generation of the required particle size; Reconstructed replication competent held in February 2012 and adopted and (3) capable of being sterilized or forms of the 1918 pandemic influenza pursuant to the AG silent approval disinfected in situ. virus containing any portion of the procedure. These recommendations coding regions of all eight gene included changes to the AG ‘‘List of Select Agent Changes to the CCL segments (now controlled under ECCN Plant Pathogens for Export Control’’ and This rule removes ECCN 1C360 1C351.b.1); Rathayibacter toxicus (now the AG ‘‘Control List of Dual-Use (Select agents). This ECCN controlled controlled under ECCN 1C354.a.6); and Biological Equipment and Related select agents not included on any of the Phoma glycinicola, formerly Technology and Software.’’ This rule AG common controls lists that were Pyrenochaeta glycines (now controlled amends ECCN 1C354 (Plant pathogens) identified on the CCL because they are under ECCN 1C354.b.12). None of these to reflect the AG intersessional changes (or were, until recently) subject to select agents are identified on any of the to the ‘‘List of Plant Pathogens for controls maintained by the Animal and AG common control lists; however, they Export Control.’’ Specifically, ECCN Plant Health Inspection Service continue to be subject to CB controls 1C354.a (Bacteria) is amended to clarify (APHIS), U.S. Department of (for those destinations indicated under that the controls for ‘‘Xanthomonas Agriculture, and the Centers for Disease CB Column 1 on the Commerce Country campestris pv. citri’’ in 1C354.a.2 apply Control and Prevention (CDC), U.S. Chart in Supplement No. 1 to part 738 to ‘‘Xanthomonas axonopodis pv. citri Department of Health and Human of the EAR), as well as anti-terrorism

VerDate Mar<15>2010 16:07 Jun 04, 2013 Jkt 229001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\05JNR1.SGM 05JNR1 TKELLEY on DSK3SPTVN1PROD with RULES 33694 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations

(AT) controls (for those destinations 1 controls, as well as AT Column 1 identified in the List of Items Controlled indicated under AT Column 1 on the controls. Another tick-borne for each ECCN (or, in the case of ECCN Commerce Country Chart—Country encephalitis virus (Far Eastern subtype, 1C353, genetic elements or genetically Group E:1, in Supplement No. 1 to part formerly known as Russian Spring- modified organisms for such agents or 740 of the EAR, lists those countries Summer encephalitis virus) is ‘‘toxins’’), including small quantities or designated as ‘‘terrorist-supporting controlled under ECCN 1C351.a.35 and attenuated strains of select biological countries’’ for purposes of the AT is currently included in both CDC’s list agents or ‘‘toxins’’ that are excluded controls in the EAR). of ‘‘HHS select agents and toxins’’ and from the lists of select biological agents In addition, three select agents that the AG ‘‘List of Biological Agents for or ‘‘toxins’’ by APHIS or CDC, in were controlled under ECCN 1C360, and Export Control.’’ This rule amends accordance with the APHIS regulations continue to be identified on the APHIS ECCN 1C351.a.35 to reflect the current in 7 CFR part 331 or 9 CFR part 121 or select agents lists, have been added to nomenclature (i.e., Far Eastern subtype) the CDC regulations in 42 CFR part 73. the AG ‘‘List of Plant Pathogens for used by the International Committee on These changes do not affect the scope of Export Control,’’ in accordance with the Taxonomy of Viruses. ECCNs 1C351, 1C352, 1C353, and 1C354 understandings reached at the 2012 AG In addition to the select agents and conform with the controls described Plenary (see the discussion of the 2012 changes described above, this rule in the AG common control lists and in AG Plenary changes, above). These makes conforming changes to Sections the AG ‘‘Guidelines for Transfers of select agents are now controlled on the 740.20 and 742.2 of the EAR and to Sensitive Chemical or Biological Items,’’ CCL as follows: Peronosclerospora ECCNs 1C353, 1C991, 1E001 and 1E351 neither of which provide an exemption philippinensis (Peronosclerospora to reflect the removal of ECCN 1C360 from control for attenuated strains of sacchari) (now controlled under ECCN from the CCL. Specifically, Section biological agents or toxins. In 1C354.b.7); Sclerophthora rayssiae var. 740.20(b)(2)(v) is amended by removing conjunction with these changes, this zeae (now controlled under ECCN two references to ECCN 1C360 from the rule amends the Related Controls 1C354.b.8); and Synchytrium description of biological items that are paragraph in each of these four ECCNs endobioticum (now controlled under not eligible for License Exception to add a sentence referencing 22 CFR ECCN 1C354.b.9). This rule also amends Strategic Trade Authorization (STA). part 121, Category XIV(b), for modified ECCN 1C354.a.3 to include the species The items that were controlled under biological agents and biologically of proteobacteria identified as ECCN 1C360 and that remain on the derived substances that are subject to Xanthomonas oryzae, which is CCL are now controlled under ECCN the export licensing jurisdiction of the identified on the APHIS list of PPQ 1C351.a or .b, ECCN 1C352 or ECCN U.S. Department of State, Directorate of select agents and toxins; however, only 1C354, all of which are identified in Defense Trade Controls. the pathovar Xanthomonas oryzae pv. paragraph (b)(2)(v). Section oryzae (syn. Pseudomonas campestris 742.2(a)(1)(i) of the EAR is amended by Effect of This Rule on the Scope of the pv. oryzae) is identified on the AG ‘‘List removing the reference to ECCN 1C360 CB Controls in the EAR of Plant Pathogens for Export Control.’’ from the description of the license The changes made by this rule only Like all other items controlled under requirements that apply to items marginally affect the scope of the EAR ECCN 1C354, these select agents are controlled for CB reasons to destinations controls on biological agents and toxins. subject to CB Column 1 controls, as well indicated under CB Column 1 on the With the removal of ECCN 1C360 from as AT Column 1 controls. Commerce Country Chart. ECCN 1C353 the CCL, ten select agents that were Furthermore, this rule eliminates is amended by removing references to controlled under this ECCN prior to the redundant controls on two bacteria of ECCN 1C360 from the following: The publication of this rule are no longer the Mycoplasma mycoides cluster: Related Controls paragraph; paragraphs identified on the CCL and are classified Mycoplasma capricolum subspecies a.1. and b.1. in the Items paragraph as EAR99, instead. All of these select capripneumoniae and Mycoplasma under the List of Items Controlled; and agents were recently removed from the mycoides subspecies mycoides small Technical Note 3. ECCN 1C991 is CDC/APHIS select agents lists. In colony. These bacteria were identified amended by removing references to addition, six other select agents that under ECCN 1C360.b.2 and ECCN ECCN 1C360 from the fourth sentence of were controlled under ECCN 1C360 1C352.b.1, prior to the publication of the Related Definitions paragraph and have been moved to ECCN 1C351 or this rule, but are now controlled under from paragraph a. in the Items ECCN 1C354 and continue to require a ECCN 1C352.b.1, only. Both bacteria paragraph under the List of Items license for CB reasons to destinations continue to be identified on the list of Controlled. ECCN 1E001 is amended by indicated under CB Column 1 on the ‘‘VS Select Agents and Toxins’’ removing the reference to ECCN 1C360 Commerce Country Chart and for AT maintained by APHIS, as well as the AG from the control language for ‘‘Country reasons to destinations indicated under ‘‘List of Plant Pathogens for Export Chart—CB Column 1’’ in the License AT Column 1—all of these select agents Control.’’ Like all other items controlled Requirements section. ECCN 1E351 is continue to be identified on the CDC/ under ECCN 1C352, these bacteria are amended by removing references to APHIS select agents lists. Two subject to CB Column 1 controls, as well ECCN 1C360 from the ECCN heading additional select agents (Mycoplasma as AT Column 1 controls. and from the controls language for capricolum subspecies This rule also amends ECCN 1C351 by ‘‘Country Chart—CB Column 1’’ in the capripneumoniae and Mycoplasma adding SARS-associated coronavirus License Requirements section. mycoides subspecies mycoides small (SARS-CoV) under 1C351.b.2 and tick- Finally, this rule amends ECCNs colony) also were controlled under borne encephalitis virus (Siberian 1C351, 1C352, 1C353, and 1C354 by ECCN 1C360 and continue to be subtype) under 1C351.b.3. Both viruses revising the License Requirements identified on the CDC/APHIS select were recently included in CDC’s list of Note(s) in the License Requirements agents lists. As indicated above, this ‘‘HHS select agents and toxins,’’ but are section of each ECCN to add a note rule did not add these select agents to not identified on any of the AG common indicating that ECCNs 1C351, 1C352, ECCN 1C352 because they were already control lists. However, like all other 1C353, and 1C354 control all biological described in ECCN 1C352.b.1 (i.e., the items controlled under ECCN 1C351, agents or ‘‘toxins,’’ regardless of ECCN 1C360 controls on these select these viruses are subject to CB Column quantity or attenuation, that are agents duplicated the controls in ECCN

VerDate Mar<15>2010 16:07 Jun 04, 2013 Jkt 229001 PO 00000 Frm 00006 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 33695

1C352). This rule also adds two viruses approaches that maximize net benefits amendments set forth in this rule that were recently included in CDC’s list (including potential economic, implement the understandings reached of ‘‘HHS select agents and toxins’’ (i.e., environmental, public health and safety at the June 2012 AG plenary meeting, SARS-associated coronavirus and tick- effects, distributive impacts, and the 2012 AG intersessional changes, and borne encephalitis virus, Siberian equity). Executive Order 13563 other changes that are necessary to subtype) to ECCN 1C351.b. emphasizes the importance of ensure consistency with the controls Based on the understandings reached quantifying both costs and benefits, of maintained by the AG. Since the United at the June 2012 AG Plenary meeting, reducing costs, of harmonizing rules, States is a significant exporter of the this rule also adds three bacteria to and of promoting flexibility. This rule items in this rule, immediate ECCN 1C351 and two fungi to ECCN has been designated a ‘‘significant implementation of this provision is 1C354, none of which were identified regulatory action’’ although not necessary for the AG to achieve its on the CCL prior to the publication of economically significant, under section purpose. Any delay in implementation this rule. The AG Plenary also added 3(f) of Executive Order 12866. will create a disruption in the three additional fungi to the ‘‘List of Accordingly, the rule has been reviewed movement of affected items globally Plant Pathogens for Export Control,’’ but by the Office of Management and because of disharmony between export these fungi were already controlled Budget. control measures implemented by AG under ECCN 1C360, based on their 2. Notwithstanding any other members, resulting in tension between inclusion by APHIS on the list of PPQ provision of law, no person is required member countries. Export controls work select agents and toxins (7 CFR part to respond to, nor shall any person be best when all countries implement the 331), and are now controlled under subject to a penalty for failure to comply same export controls in a timely and ECCN 1C354 (i.e., these fungi are among with, a collection of information subject coordinated manner. the six select agents that have been to the requirements of the Paperwork moved by this rule from ECCN 1C360 to Reduction Act of 1995 (44 U.S.C. 3501 Further, no other law requires that a ECCN 1C351 or ECCN 1C354, as et seq.) (PRA), unless that collection of notice of proposed rulemaking and an indicated above). information displays a currently valid opportunity for public comment be To summarize the biological agent Office of Management and Budget given for this final rule. Because a and toxin changes described above, this (OMB) Control Number. This rule notice of proposed rulemaking and an rule removes ten CDC/APHIS select contains a collection of information opportunity for public comment are not agents from the CCL, while adding three subject to the requirements of the PRA. required to be given for this rule under AG-listed bacteria and two fungi, as This collection has been approved by the Administrative Procedure Act or by well as two viruses that were recently OMB under Control Number 0694–0088 any other law, the analytical identified on CDC’s list of ‘‘HHS select (Multi-Purpose Application), which requirements of the Regulatory agents and toxins.’’ These changes are carries a burden hour estimate of 58 Flexibility Act (5 U.S.C. 601 et seq.) are not expected to significantly affect the minutes to prepare and submit form not applicable. Therefore, this scope of the EAR controls on biological BIS–748. Send comments regarding this regulation is issued in final form. agents and toxins, because BIS estimates burden estimate or any other aspect of List of Subjects that there will be no increase in the this collection of information, including number of license applications for these suggestions for reducing the burden, to 15 CFR Part 740 items. Jasmeet Seehra, Office of Management Administrative practice and Finally, this rule expands the scope of and Budget (OMB), and to the procedure, Exports, Reporting and the EAR controls that apply to dual-use Regulatory Policy Division, Bureau of recordkeeping requirements. equipment capable of handling Industry and Security, Department of biological materials by amending ECCN Commerce, as indicated in the 15 CFR Part 742 2B352 to add certain spray-drying ADDRESSES section of this rule. equipment. This change is not expected 3. This rule does not contain policies Exports, Terrorism. to significantly affect the scope of the with Federalism implications as that 15 CFR Part 774 EAR controls on such equipment, term is defined in Executive Order because BIS anticipates only a small 13132. Exports, Reporting and recordkeeping increase in the number of license 4. The provisions of the requirements. Administrative Procedure Act (5 U.S.C. applications. For the reasons stated in the Although the Export Administration 553) requiring notice of proposed rulemaking, the opportunity for public preamble, parts 740, 742, and 774 of the Act expired on August 20, 2001, the Export Administration Regulations (15 President, through Executive Order participation, and a delay in effective date, are inapplicable because this CFR parts 730–774) are amended as 13222 of August 17, 2001, 3 CFR, 2001 follows: Comp., p. 783 (2002), as amended by regulation involves a military and Executive Order 13637 of March 8, foreign affairs function of the United PART 740—[AMENDED] 2013, 78 FR 16129 (March 13, 2013), States (See 5 U.S.C. 553(a)(1)). Immediate implementation of these and as extended by the Notice of August ■ 1. The authority citation for 15 CFR amendments is non-discretionary and 15, 2012, 77 FR 49699 (August 16, Part 740 continues to read as follows: 2012), has continued the EAR in effect fulfills the United States’ international under the International Emergency obligation to the Australia Group (AG). Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; Economic Powers Act. The AG contributes to international security and regional stability through E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., Rulemaking Requirements p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 the harmonization of export controls Comp., p. 783; Notice of August 15, 2012, 77 1. Executive Orders 13563 and 12866 and seeks to ensure that exports do not FR 49699 (August 16, 2012). direct agencies to assess all costs and contribute to the development of benefits of available regulatory chemical and biological weapons. The ■ 2. Section 740.20 is amended by alternatives and, if regulation is AG consists of 40 member countries that revising paragraph (b)(2)(v) to read as necessary, to select regulatory act on a consensus basis and the follows:

VerDate Mar<15>2010 16:07 Jun 04, 2013 Jkt 229001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\05JNR1.SGM 05JNR1 TKELLEY on DSK3SPTVN1PROD with RULES 33696 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations

§ 740.20 License Exception Strategic Items Controlled section, and, in the Spring-Summer encephalitis virus—see Trade Authorization (STA). ‘‘Items’’ paragraph under the List of 1C351.b.3 for Siberian subtype); * * * * * Items Controlled section, by revising the * * * * * (b) * * * heading of paragraph a., by revising b. Viruses identified on the APHIS/CDC (2) * * * paragraph a.35, by adding a new ‘‘select agents’’ lists (see Related Controls (v) License Exception STA may not be paragraph b., by revising paragraph c., paragraph #2 for this ECCN), but not used for any item controlled by ECCN by revising the heading of paragraph d., identified on the Australia Group (AG) ‘‘List of Biological Agents for Export Control,’’ as 1C351.a, .b, .c, d.11, .d.12 or .e, ECCNs and by revising paragraph d.14 to read 1C352, 1C353, 1C354, 1E001 (i.e., for follows: as follows: b.1. Reconstructed replication competent technology, as specified in ECCN 1E001, 1C351 Human and zoonotic pathogens and forms of the 1918 pandemic influenza virus for items controlled by ECCN 1C351.a, ‘‘toxins’’, as follows (see List of Items containing any portion of the coding regions .b, .c, .d.11, .d.12 or .e or ECCNs 1C352, Controlled). of all eight gene segments; 1C353, or 1C354) or ECCN 1E351. b.2. SARS-associated coronavirus (SARS- License Requirements * * * * * CoV); or * * * * * b.3. Tick-borne encephalitis virus (Siberian PART 742—[AMENDED] License Requirement Notes: * * * subtype, formerly West Siberian virus—see 4. Unless specified elsewhere in this ECCN 1C351.a.35 for Far Eastern subtype). ■ 3. The authority citation for 15 CFR 1C351 (e.g., in License Requirement Notes 1– c. Bacteria identified on the Australia Part 742 continues to read as follows: 3), this ECCN controls all biological agents Group (AG) ‘‘List of Biological Agents for and ‘‘toxins,’’ regardless of quantity or Export Control,’’ as follows: Authority: 50 U.S.C. app. 2401 et seq.; 50 attenuation, that are identified in the List of c.1. Bacillus anthracis; U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; Items Controlled for this ECCN, including c.2. Brucella abortus; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 small quantities or attenuated strains of c.3. Brucella melitensis; U.S.C. 7210; Sec 1503, Pub. L. 108–11, 117 select biological agents or ‘‘toxins’’ that are c.4. Brucella suis; Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, excluded from the lists of select biological c.5. Burkholderia mallei (Pseudomonas 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, agents or ‘‘toxins’’ by the Animal and Plant mallei); 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 Health Inspection Service (APHIS), U.S. c.6. Burkholderia pseudomallei FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. Department of Agriculture, or the Centers for (Pseudomonas pseudomallei); 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. Disease Control and Prevention (CDC), U.S. c.7. Chlamydophila psittaci (formerly 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Department of Health and Human Services, known as Chlamydia psittaci); Comp., p. 783; Presidential Determination in accordance with their regulations in 9 CFR c.8. Clostriduim argentinense (formerly 2003–23 of May 7, 2003, 68 FR 26459, May part 121 and 42 CFR part 73, respectively. known as Clostridium botulinum Type G), 16, 2003; Notice of August 15, 2012, 77 FR botulinum neurotoxin producing strains; 49699 (August 16, 2012); Notice of November * * * * * c.9. Clostridium baratii, botulinum 9, 2011, 76 FR 70319 (November 10, 2011). List of Items Controlled neurotoxin producing strains; c.10. Clostridium botulinum; § 742.2 [Amended] Unit: *** Related Controls: (1) Certain forms of ricin c.11. Clostridium butyricum, botulinum ■ 4. Section 742.2 is amended by and saxitoxin in 1C351.d.11. and d.12 are neurotoxin producing strains; removing the phrase ‘‘ECCNs 1C351, CWC Schedule 1 chemicals (see § 742.18 of c.12. Clostridium perfringens, epsilon 1C352, 1C353, 1C354, and 1C360’’ in the EAR). The U.S. Government must toxin producing types; paragraph (a)(1)(i) and adding in its provide advance notification and annual c.13. Coxiella burnetii; reports to the OPCW of all exports of c.14. Francisella tularensis; place the phrase ‘‘ECCNs 1C351, 1C352, c.15. Rickettsia prowazekii; 1C353, and 1C354’’. Schedule 1 chemicals. See § 745.1 of the EAR for notification procedures. See 22 c.16. Salmonella typhi; c.17. Shiga toxin producing Escherichia PART 774—[AMENDED] CFR part 121, Category XIV and § 121.7 for CWC Schedule 1 chemicals that are subject coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other ■ to the export licensing jurisdiction of the 5. The authority citation for 15 CFR shiga toxin producing serogroups; Part 774 continues to read as follows: U.S. Department of State, Directorate of Defense Trade Controls. (2) The Animal Note: Shiga toxin producing Escherichia Authority: 50 U.S.C. app. 2401 et seq.; 50 and Plant Health Inspection Service coli (STEC) is also known as U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. (APHIS), U.S. Department of Agriculture, enterohaemorrhagic E. coli (EHEC) or 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et and the Centers for Disease Control and verocytotoxin producing E. coli (VTEC). seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); Prevention (CDC), U.S. Department of c.18. Shigella dysenteriae; 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. Health and Human Services, maintain c.19. Vibrio cholerae; or 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22 controls on the possession, use, and c.20. Yersinia pestis. U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. transfer within the United States of certain d. ‘‘Toxins’’ identified on the Australia 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. items controlled by this ECCN (for APHIS, Group (AG) ‘‘List of Biological Agents for 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 see 7 CFR 331.3(b), 9 CFR 121.3(b), and 9 Export Control,’’ as follows, and ‘‘subunits’’ Comp., p. 783; Notice of August 15, 2012, 77 CFR 121.4(b); for CDC, see 42 CFR 73.3(b) thereof: FR 49699 (August 16, 2012). and 42 CFR 73.4(b)). (3) See 22 CFR part * * * * * 121, Category XIV(b), for modified d.14. Staphylococcus aureus enterotoxins, Supplement No. 1 to Part 774— biological agents and biologically derived hemolysin alpha toxin, and toxic shock [Amended] substances that are subject to the export syndrome toxin (formerly known as ■ licensing jurisdiction of the U.S. Staphylococcus enterotoxin F); 6. In Supplement No. 1 to Part 774 Department of State, Directorate of Defense (the Commerce Control List), Category Trade Controls. * * * * * 1—Special Materials and Related Related Definitions: *** ■ 7. In Supplement No. 1 to Part 774 Equipment, Chemicals, Items: (the Commerce Control List), Category ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN a. Viruses identified on the Australia 1— Special Materials and Related 1C351 is amended by adding a new Group (AG) ‘‘List of Biological Agents for Equipment, Chemicals, Note 4 in the ‘‘License Requirements Export Control,’’ as follows: ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN Notes’’ under the License Requirements * * * * * 1C352 is amended by revising the section, by revising the ‘‘Related a.35. Tick-borne encephalitis virus (Far ‘‘License Requirement Note’’ under the Controls’’ paragraph under the List of Eastern subtype, formerly known as Russian License Requirements section and by

VerDate Mar<15>2010 16:07 Jun 04, 2013 Jkt 229001 PO 00000 Frm 00008 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 33697

revising the ‘‘Related Controls’’ 1. Vaccines that contain genetic elements 1C352, or 1C354, or any other organism into paragraph under the List of Items or genetically modified organisms identified which it may be inserted or otherwise Controlled section to read as follows: in this ECCN are controlled by ECCN 1C991. integrated, to cause serious harm to human, 2. Unless specified elsewhere in this ECCN animal or plant health. 1C352 Animal pathogens, as follows (see 1C353 (e.g., in License Requirement Note 1), * * * * * List of Items Controlled). this ECCN controls genetic elements or ■ 9. In Supplement No. 1 to Part 774 License Requirements genetically modified organisms for all biological agents and ‘‘toxins,’’ regardless of (the Commerce Control List), Category * * * * * quantity or attenuation, that are identified in 1—Special Materials and Related License Requirements Notes: the List of Items Controlled for this ECCN, Equipment, Chemicals, 1. All vaccines are excluded from the scope including genetic elements or genetically ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN of this ECCN. See ECCN 1C991 for vaccines. modified organisms for attenuated strains of 1C354 is amended by revising the 2. Unless specified elsewhere in this ECCN select biological agents or ‘‘toxins’’ that are ‘‘License Requirements Note’’ under the 1C352 (e.g., in License Requirement Note 1), excluded from the lists of select biological License Requirements section and by this ECCN controls all biological agents, agents or ‘‘toxins’’ by the Animal and Plant Health Inspection Service (APHIS), U.S. revising the ‘‘Related Controls’’ regardless of quantity or attenuation, that are paragraph and the ‘‘Items’’ paragraph identified in the List of Items Controlled for Department of Agriculture, or the Centers for this ECCN, including small quantities or Disease Control and Prevention (CDC), U.S. under the List of Items Controlled attenuated strains of select biological agents Department of Health and Human Services, section to read as follows: that are excluded from the lists of select in accordance with the APHIS regulations in 1C354 Plant pathogens, as follows (see List 7 CFR part 331 and 9 CFR part 121 and the biological agents or ‘‘toxins’’ by the Animal of Items Controlled). and Plant Health Inspection Service (APHIS), CDC regulations in 42 CFR part 73. U.S. Department of Agriculture, or the * * * * * License Requirements Centers for Disease Control and Prevention * * * * * List of Items Controlled (CDC), U.S. Department of Health and License Requirements Notes: Human Services, in accordance with their Unit: *** 1. All vaccines are excluded from the scope regulations in 9 CFR part 121 and 42 CFR Related Controls: (1) The Animal and Plant of this ECCN. See ECCN 1C991 for vaccines. part 73, respectively. Health Inspection Service (APHIS), U.S. 2. Unless specified elsewhere in this ECCN * * * * * Department of Agriculture, and the Centers 1C354 (e.g., in License Requirement Note 1), for Disease Control and Prevention (CDC), this ECCN controls all biological agents, List of Items Controlled U.S. Department of Health and Human regardless of quantity or attenuation, that are Services, maintain controls on the Unit: *** identified in the List of Items Controlled for possession, use, and transfer within the Related Controls: (1) The Animal and Plant this ECCN, including small quantities or United States of certain items controlled by Health Inspection Service (APHIS), U.S. attenuated strains of select biological agents this ECCN, including (but not limited to) Department of Agriculture, and the Centers that are excluded from the list of PPQ select certain genetic elements, recombinant for Disease Control and Prevention (CDC), agents and ‘‘toxins’’ by the Animal and Plant nucleic acids, and recombinant organisms U.S. Department of Health and Human Health Inspection Service (APHIS), U.S. associated with the agents or toxins in Services, maintain controls on the Department of Agriculture, in accordance ECCN 1C351, 1C352, or 1C354 (for APHIS, possession, use, and transfer within the with their regulations in 7 CFR part 331. see 7 CFR 331.3(c), 9 CFR 121.3(c), and 9 United States of certain items controlled by CFR 121.4(c); for CDC, see 42 CFR 73.3(c) * * * * * this ECCN (for APHIS, see 7 CFR 331.3(b), and 42 CFR 73.4(c)). (2) See 22 CFR part List of Items Controlled 9 CFR 121.3(b), and 9 CFR 121.4(b); for 121, Category XIV(b), for modified CDC, see 42 CFR 73.3(b) and 42 CFR biological agents and biologically derived Unit: *** 73.4(b)). (2) See 22 CFR part 121, Category substances that are subject to the export Related Controls: (1) The Animal and Plant XIV(b), for modified biological agents and licensing jurisdiction of the U.S. Health Inspection Service (APHIS), U.S. biologically derived substances that are Department of State, Directorate of Defense Department of Agriculture, maintains subject to the export licensing jurisdiction Trade Controls. controls on the possession, use, and of the U.S. Department of State, Directorate Related Definition: *** transfer within the United States of certain of Defense Trade Controls. Items: items controlled by this ECCN (see 7 CFR Related Definitions: *** 331.3(c), 9 CFR 121.3(c), and 9 CFR Items: a. * * * a.1. Genetic elements that contain nucleic 121.4(c)). (2) See 22 CFR part 121, Category * * * * * acid sequences associated with the XIV(b), for modified biological agents and ■ 8. In Supplement No. 1 to Part 774 pathogenicity of microorganisms controlled biologically derived substances that are subject to the export licensing jurisdiction (the Commerce Control List), Category by 1C351.a to .c, 1C352, or 1C354; a.2. * * * of the U.S. Department of State, Directorate 1— Special Materials and Related of Defense Trade Controls. Equipment, Chemicals, b. * * * b.1. Genetically modified organisms that Related Definition: *** ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN contain nucleic acid sequences associated Items: 1C353 is amended, under the License with the pathogenicity of microorganisms a. Bacteria, as follows: Requirements section, by revising the controlled by 1C351.a to .c, 1C352, or 1C354; a.1. Xanthomonas albilineans; ‘‘License Requirements Note’’ and, b.2. * * * a.2. Xanthomonas axonopodis pv. citri under the List of Items Controlled (Xanthomonas campestris pv. citri A) Technical Notes: section, by revising the ‘‘Related (Xanthomonas campestris pv. citri); Controls’’ paragraph, by revising * * * * * a.3. Xanthomonas oryzae [this species of paragraphs a.1. and b.1. in the ‘‘Items’’ 3. ‘‘Nucleic acid sequences associated with proteobacteria is identified on the APHIS the pathogenicity of any of the ‘‘select agents’’ list (see Related Controls paragraph, and by revising Technical microorganisms controlled by 1C351.a to .c, paragraph for this ECCN), but only the Note 3, to read as follows: 1C352, or 1C354’’ means any sequence pathovar Xanthomonas oryzae pv. oryzae 1C353 Genetic elements and genetically specific to the relevant controlled (syn. Pseudomonas campestris pv. oryzae) is modified organisms, as follows (see List microorganism that: identified on the Australia Group (AG) ‘‘List of Items Controlled). a. In itself or through its transcribed or of Plant Pathogens for Export Control’’]; translated products represents a significant a.4. Clavibacter michiganensis subspecies License Requirements hazard to human, animal or plant health; or sepedonicus (syn. Corynebacterium * * * * * b. Is known to enhance the ability of a michiganensis subspecies sepedonicum or License Requirements Notes: microorganism controlled by 1C351.a to .c, Corynebacterium sepedonicum);

VerDate Mar<15>2010 16:07 Jun 04, 2013 Jkt 229001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\05JNR1.SGM 05JNR1 TKELLEY on DSK3SPTVN1PROD with RULES 33698 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations

a.5. Ralstonia solanacearum, race 3, biovar ■ 12. In Supplement No. 1 to Part 774 respectively, and adding a new 2; (the Commerce Control List), Category paragraph f. to read as follows: a.6. Raythayibactor toxicus [this bacterium 1—Special Materials and Related 2B352 Equipment capable of use in is identified on the APHIS ‘‘select agents’’ list Equipment, Chemicals, (see the Related Controls paragraph for this handling biological materials, as follows ECCN), but is not identified on the Australia ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN (see List of Items Controlled). Group (AG) ‘‘List of Plant Pathogens for 1E001 is amended by revising the ECCN * * * * * Export Control’’]. heading and by revising the ‘‘Control(s)’’ b. Fungi, as follows: language for ‘‘Country Chart—CB List of Items Controlled b.1. Colletotrichum kahawae Column 1’’ in the License Requirements Unit: *** (Colletotrichum coffeanum var. virulans); section to read as follows: Related Controls: *** b.2. Cochliobolus miyabeanus Related Definitions: *** (Helminthosporium oryzae); 1E001 ‘‘Technology’’ according to the Items: General Technology Note for the b.3. Microcyclus ulei (syn. Dothidella ulei); * * * * * b.4. Puccinnia graminis ssp. graminis var. ‘‘Development’’ or ‘‘Production’’ of items controlled by 1A001.b, 1A001.c, 1A002, f. Spray-drying equipment capable of graminis/Puccinia graminis ssp. graminis drying toxins or pathogenic microorganisms var. stakmanii (Puccinia graminis [syn. 1A003, 1A004, 1A005, 1A006.b, 1A007, 1A008, 1A101, 1B (except 1B999), or 1C having all of the flowing characteristics: Puccinia graminis f. sp. tritici]); f.1. A water evaporation capacity of b.5. Puccinia striiformis (syn. Puccinia (except 1C355, 1C980 to 1C984, 1C988, ≥ ≤ 1C990, 1C991, 1C995 to 1C999). 0.4 kg/h and 400 kg/h; glumarum); f.2. The ability to generate a typical mean b.6. Magnaporthe oryzae (Pyricularia License Requirements product particle size of ≤ 10 micrometers oryzae); with existing fittings or by minimal b.7. Peronosclerospora philippinensis Reason for Control: NS, MT, NP, CB, RS, AT modification of the spray-dryer with (Peronosclerospora sacchari); atomization nozzles enabling generation of b.8. Sclerophthora rayssiae var. zeae; Country Control(s) the required particle size; and b.9. Synchytrium endobioticum; chart f.3. Capable of being sterilized or b.10. Tilletia indica; disinfected in situ. b.11. Thecaphora solani; ***** b.12. Phoma glycinicola (formerly * * * * * CB applies to ‘‘technology’’ for CB Column Pyrenochaeta glycines) [this fungus is Dated: May 29, 2013. identified on the APHIS ‘‘select agents’’ list items controlled by 1C351, 1. (see the Related Controls paragraph for this 1C352, 1C353, or 1C354. Kevin J. Wolf, ECCN), but is not identified on the Australia Assistant Secretary for Export Group (AG) ‘‘List of Plant Pathogens for ***** Administration. Export Control’’]. License Requirements Note: * * * [FR Doc. 2013–13270 Filed 6–4–13; 8:45 am] c. Viruses, as follows: * * * * * BILLING CODE 3510–33–P c.1. Andean potato latent virus (Potato Andean latent tymovirus); ■ 13. In Supplement No. 1 to Part 774 c.2. Potato spindle tuber viroid. (the Commerce Control List), Category DEPARTMENT OF HEALTH AND ■ 10. In Supplement No. 1 to Part 774 1—Special Materials and Related HUMAN SERVICES (the Commerce Control List), Category Equipment, Chemicals, 1—Special Materials and Related ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN Food and Drug Administration Equipment, Chemicals, 1E351 is amended by revising the ECCN ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN heading and by revising the ‘‘Control(s)’’ 21 CFR Part 522 1C360 is removed. language for ‘‘Country Chart—CB ■ 11. In Supplement No. 1 to Part 774 Column 1’’ in the License Requirements [Docket No. FDA–2013–N–0002] section to read as follows: (the Commerce Control List), Category New Animal Drugs; Dexmedetomidine; 1—Special Materials and Related 1E351 ‘‘Technology’’ according to the Lasalocid; Melengestrol; Monensin; Equipment, Chemicals, ‘‘General Technology Note’’ for the disposal and Tylosin; Correction ‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN of chemicals or microbiological materials 1C991 is amended under the List of controlled by 1C350, 1C351, 1C352, 1C353, AGENCY: Food and Drug Administration, Items Controlled section by revising the or 1C354. HHS. fourth sentence in the ‘‘Related License Requirements ACTION: Correcting amendments. Definitions’’ paragraph and by revising paragraph a. in the ‘‘Items’’ paragraph to Reason for Control: CB, AT SUMMARY: The Food and Drug read as follows: Administration (FDA) is correcting a Control(s) Country document amending the animal drug 1C991 Vaccines, immunotoxins, medical chart products, diagnostic and food testing regulations to reflect approval actions kits, as follows (see List of Items CB applies to ‘‘technology’’ for CB Column for new animal drug applications and Controlled). the disposal of items con- 1. abbreviated new animal drug trolled by 1C351, 1C352, * * * * * applications during March 2013 that 1C353, or 1C354. appeared in the Federal Register of List of Items Controlled April 30, 2013. FDA is correcting the Unit: *** ***** approved strengths of dexmedetomidine Related Controls: *** * * * * * hydrochloride injectable solution. This Related Definitions: * * * Biological toxins correction is being made to improve the ■ 14. In Supplement No. 1 to Part 774 in any other configuration, including bulk accuracy of the animal drug regulations. shipments, or for any other end-uses are (the Commerce Control List), Category controlled by ECCN 1C351. * * * 2—Materials Processing, ECCN 2B352 is DATES: This rule is effective June 5, Items: amended under the ‘‘Items’’ paragraph 2013. a. Vaccines against items controlled by in the List of Items Controlled section FOR FURTHER INFORMATION CONTACT: ECCN 1C351, 1C352, 1C353 or 1C354. by redesignating paragraphs f. through George K. Haibel, Center for Veterinary * * * * * h. as paragraphs g. through i., Medicine (HFV–6), Food and Drug

VerDate Mar<15>2010 16:07 Jun 04, 2013 Jkt 229001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\05JNR1.SGM 05JNR1 TKELLEY on DSK3SPTVN1PROD with RULES