2011-22677. Implementation of a Decision Adopted Under the Australia Group (AG) Intersessional Silent Approval Procedures in 2010 and Related Editorial Amendments

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 a decision based on a proposal that was discussed at the 2010 Australia Group (AG) Plenary and adopted under the AG intersessional silent approval procedures in November 2010. Specifically, this rule amends the Commerce Control List (CCL) entry in the EAR that controls human and zoonotic pathogens and “toxins,” consistent with the intersessional changes to the AG's “List of Biological Agents for Export Control.” First, this rule clarifies the scope of the AG-related controls in the EAR that apply to “South American haemorrhagic fever (Sabia, Flexal, Guanarito)” and “Pulmonary and renal syndrome-haemorrhagic fever viruses (Seoul, Dobrava, Puumala, Sin Nombre)” by revising the list of viruses in this CCL entry to remove these two fevers and replace them with ten viral causative agents for the fevers. These changes are intended to more clearly identify the causative agents that are of concern for purposes of the controls maintained by the AG. Second, this rule alphabetizes and renumbers the list of viruses in this CCL entry, consistent with the 2010 intersessional changes to the AG control list. Finally, this rule makes an editorial change to the CCL entry that controls human and zoonotic pathogens and “toxins.” To assist exporters to more easily identify the bacteria and “toxins” that are controlled under this CCL entry, this rule alphabetizes and renumbers the lists of bacteria and “toxins” in the entry.

DATES:

This rule is effective September 12, 2011.

ADDRESSES:

Send comments regarding this collection of information, including suggestions for reducing the burden, to Jasmeet Seehra, Office of Management and Budget (OMB), by e-mail to [e-mail], or by fax to [phone]; 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:

Elizabeth Sangine, Director, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: [phone].

SUPPLEMENTARY INFORMATION:

Background

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to implement a decision that was adopted under the Australia Group (AG) intersessional silent approval procedures in November 2010. The AG is a multilateral forum consisting of 40 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.

The November 2010 intersessional decision revised the AG “List of Biological Agents for Export Control” to clarify the scope of the AG controls that apply to certain viruses connected with the phenotypes or medical conditions known as “South American haemorrhagic fever” and “Pulmonary and renal syndrome-haemorrhagic fever viruses.” The purpose of these changes was to address a concern by the AG that the listings for “South American haemorrhagic fever (Sabia, Flexal, Guanarito)” and “Pulmonary and renal syndrome-haemorrhagic fever viruses (Seoul, Dobrova, Puumala, Sin Nombre)” could be misinterpreted (e.g., by assuming that the causative agents identified in the parentheses represented an exhaustive listing of such viruses). In addition, both of these AG listings referred to phenotypes or medical conditions known to be caused by several distinct species of viruses, some (but not all) of which were identified in parentheses for each listing.

To address this concern, the November 2010 AG intersessional decision removed “South American haemorrhagic fever” and “Pulmonary and renal syndrome-haemorrhagic fever viruses” from the List of Biological Agents and replaced them with ten viral causative agents for the fevers. Five of these causative agents (i.e., “Dobrava-Belgrade virus,” “Guanarito virus,” “Sabia virus,” “Seoul virus,” and “Sin nombre virus”) were previously identified in parentheses under the listings for the two fevers, while the other five causative agents (i.e., “Andes virus,” “Chapare virus,” “Choclo virus,” “Laguna Negra virus,” and “Lujo virus”) were not previously identified on the AG List. Two other causative agents (i.e., “Flexal virus” and “Puumala virus”) that were previously identified in parentheses under the listings for the two fevers were removed from the AG List. This rule amends Export Control Classification Number (ECCN) 1C351 on the Commerce Control List (CCL) (Supplement No. 1 to part 774 of the EAR) by revising the list of viruses contained in 1C351.a to reflect these changes to the AG List of Biological Agents.

Consistent with the changes to ECCN 1C351 described above, this rule alphabetizes and renumbers the list of viruses in ECCN 1C351.a to conform with the format in the AG List of Biological Agents. In addition, for the convenience of exporters attempting to determine the control status of certain pathogens and toxins, this rule alphabetizes and renumbers the lists of bacteria and toxins contained in ECCN 1C351.c and .d, respectively. Consistent with this reordering, this rule revises references to certain agents identified in the “CW Controls” paragraph of this ECCN, in the “License Requirements Notes” under the License Requirements section of this ECCN, and/or in the “Related Controls” paragraph under the List of Items Controlled section of this ECCN.

Although this rule removes “Flexal virus” from ECCN 1C351, consistent with the AG intersessional changes to the AG List of Biological Agents as described above, this virus continues to be listed on the CCL. Specifically, this rule adds “Flexal virus” to ECCN 1C360 (Select agents not controlled under ECCN 1C351, 1C352, or 1C354), because the virus is included in the list of select agents and toxins maintained by the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, in 42 CFR 73.3(b).

This rule also amends ECCNs 1C351 and 1C352 by revising the “Related Controls” paragraph under the List of Items Controlled for each ECCN to correct the references to the regulations maintained by CDC and the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, that apply to certain select agents and toxins.

Finally, this rule amends Section 740.20 (License Exception STA), Section 742.18 (license requirements and policies related to the Chemical Weapons Convention), and the List of Items Controlled section in ECCN 1C991 (Vaccines, immunotoxins, medical products, and diagnostic and food testing kits) to update the references to certain items controlled under ECCN 1C351 that were alphabetized and renumbered, as described above. Section 740.20 also is amended to include in paragraph (b)(2)(vi) certain toxins controlled by ECCN 1C351.d that were inadvertently omitted by the License Exception STA rule that BIS published on June 16, 2011 (76 FR 35276). The toxins identified in Section 740.20(b)(2)(vi) may be exported under License Exception STA to countries listed in Section 740.20(c)(1), provided that such exports conform with the limits specified in Section 740.20(b)(2)(vi)(A) and (b)(2)(vi)(B).

None of the changes made by this rule increase the scope of the controls in ECCNs 1C351 and 1C991 (i.e., the items that are controlled under these ECCNs remain the same, although certain items are now specifically identified under separate listings in 1C351.a). As noted above, “Flexal virus,” which was previously controlled under ECCN 1C351.a, is now controlled as a “select agent” under ECCN 1C360.a; however, the license requirements for this virus remain unchanged.

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 extended by the Notice of August 12, 2010, 75 FR 50681 (August 16, 2010), has continued the EAR in effect under the International Emergency Economic Powers Act.

Saving Clause

Shipments of items removed from eligibility for export or reexport under a license exception or without a license (i.e., under the designator “NLR”) as a result of this regulatory action that were on dock for loading, on lighter, laden aboard an exporting carrier, or en route aboard a carrier to a port of export, on October 12, 2011, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previously applicable license exception or without a license (NLR) so long as they are exported or reexported before October 27, 2011. Any such items not actually exported or reexported before midnight, on October 27, 2011, require a license in accordance with this regulation.

“Deemed” exports of “technology” and “source code” removed from eligibility for export under a license exception or without a license (under the designator “NLR”) as a result of this regulatory action may continue to be made under the previously available license exception or without a license (NLR) before October 27, 2011. Beginning at midnight on October 27, 2011, such “technology” and “source code” may no longer be released, without a license, to a foreign national subject to the “deemed” export controls in the EAR when a license would be required to the home country of the foreign national in accordance with this regulation.

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 determined to be not significant for purposes of Executive Order 12866.

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 40 member countries that act on a consensus basis and the amendments set forth in this rule implement a decision adopted under the AG intersessional silent approval procedures in November 2010 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 Part 740

• Administrative practice and procedure
• Exports
• Reporting and recordkeeping requirements

15 CFR Part 742

• Exports
• Foreign trade

15 CFR Part 774

• Exports
• Foreign trade
• Reporting and recordkeeping requirements

Accordingly, parts 740, 742 and 774 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:

PART 740—[AMENDED]

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 12, 2010, 75 FR 50681 (August 16, 2010).

2. Section 740.20 is amended by revising paragraph (b)(2)(v) and paragraph (b)(2)(vi) introductory text, as follows:

§ 740.20

License Exception Strategic Trade Authorization (STA).

* * * * *

(b) * * *

(2) * * *

(v) License Exception STA may not be used for any item controlled by ECCN 1C351.a, .b, .c, d.11, .d.12 or .e, ECCNs 1C352, 1C353, 1C354, 1C360, 1E001 (i.e., for technology, as specified in ECCN 1E001, for items controlled by ECCN 1C351.a, .b, .c, .d.11, .d.12 or .e or ECCNs 1C352, 1C353, 1C354 or 1C360) or ECCN 1E351.

(vi) Toxins controlled by ECCN 1C351.d.1 through 1C351.d.10 and 1C351.d.13 through 1C351.d.19 are authorized under License Exception STA to destinations indicated in paragraph (c)(1) of this section, subject to the following limits. For purposes of this paragraph, all such toxins that are sent from one exporter, reexporter or transferor to a single end-user, on the same day, constitute one shipment.

* * * * *

PART 742—[AMENDED]

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 12, 2010, 75 FR 50681 (August 16, 2010); Notice of November 4, 2010, 75 FR 68673 (November 8, 2010).

4. Section 742.18 is amended by revising paragraph (a)(1), paragraph (b)(1)(i) introductory text, and paragraphs (b)(1)(ii) and (b)(1)(iii), as follows:

§ 742.18

Chemical Weapons Convention (CWC or Convention).

* * * * *

(a) * * *

(1) Schedule 1 chemicals and mixtures controlled under ECCN 1C351. A license is required for CW reasons to export or reexport Schedule 1 chemicals controlled under ECCN 1C351.d.11 or d.12 to all destinations including Canada. CW applies to 1C351.d.11 for ricin in the form of Ricinus Communis Agglutinin_II (RCA_II), which is also known as ricin D or Ricinus Communis Lectin_III (RCL_III), and Ricinus Communis Lectin_IV (RCL_IV), which is also known as ricin E. CW applies to 1C351.d.12 for saxitoxin identified by C.A.S. #35523-89-8. (Note that the advance notification procedures and annual reporting requirements described in § 745.1 of the EAR also apply to exports of Schedule 1 chemicals.)

* * * * *

(b) * * *

(1) * * *

(i) Exports to States Parties to the CWC. Applications to export Schedule 1 Chemicals controlled under ECCN 1C351.d.11 or .d.12 to States Parties to the CWC (destinations listed in Supplement No. 2 to part 745 of the EAR) generally will be denied, unless all of the following conditions are met:

* * * * *

(ii) Exports to States not party to the CWC. Applications to export Schedule 1 chemicals controlled under ECCN 1C351.d.11 or .d.12 to States not Party to the CWC (destinations not listed in Supplement No. 2 to part 745 of the EAR) generally will be denied, consistent with U.S. obligations under the CWC to prohibit exports of these chemicals to States not Party to the CWC.

(iii) Reexports. Applications to reexport Schedule 1 chemicals controlled under ECCN 1C351.d.11 or .d.12 generally will be denied to all destinations (including both States Parties to the CWC and States not Party to the CWC).

* * * * *

PART 774—[AMENDED]

5. 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 12, 2010, 75 FR 50681 (August 16, 2010).

6. 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 amended by revising the License Requirements section and the “Related Controls” and “Items” paragraphs in the List of Items Controlled section, to read as follows:

Supplement No. 1 to Part 774—The Commerce Control List

* * * * *

1C351 Human and zoonotic pathogens and “toxins”, as follows (see List of Items Controlled).

License Requirements

Reason for Control: CB, CW, AT

Control(s)	Country chart
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 Agglutinin_II (RCA_II), also known as ricin D or Ricinus Communis Lectin_III (RCL_III) and (2) Ricinus Communis Lectin_IV (RCL_IV), also known as ricin E. CW applies to 1C351.d.12 for saxitoxin identified by C.A.S. #35523-89-8. See § 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.

Control(s)	Country chart
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.9, are excluded from the scope of this entry, since they may be used as positive control cultures for food testing and quality control.

License Exceptions

* * * * *

List of Items Controlled

Unit: * * *

Related Controls: (1) Certain forms of ricin and saxitoxin in 1C351.d.11. and d.12 are CWC Schedule 1 chemicals (see § 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 § 745.1 of the EAR for notification procedures. See 22 CFR part 121, Category XIV and § 121.7 for additional CWC Schedule 1 chemicals controlled by the Department of State. (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)).

Related Definitions: * * *

Items:

a. Viruses, as follows:

a.1. Andes virus;

a.2. Chapare virus;

a.3. Chikungunya virus;

a.4. Choclo virus;

a.5. Congo-Crimean haemorrhagic fever virus (a.k.a. Crimean-Congo haemorrhagic fever virus);

a.6. Dengue fever virus;

a.7. Dobrava-Belgrade virus;

a.8. Eastern equine encephalitis virus;

a.9. Ebola virus;

a.10. Guanarito virus;

a.11. Hantaan virus;

a.12. Hendra virus (Equine morbillivirus);

a.13. Japanese encephalitis virus;

a.14. Junin virus;

a.15. Kyasanur Forest virus;

a.16. Laguna Negra virus;

a.17. Lassa fever virus;

a.18. Louping ill virus;

a.19. Lujo virus;

a.20. Lymphocytic choriomeningitis virus;

a.21. Machupo virus;

a.22. Marburg virus;

a.23. Monkey pox virus;

a.24. Murray Valley encephalitis virus;

a.25. Nipah virus;

a.26. Omsk haemorrhagic fever virus;

a.27. Oropouche virus;

a.28. Powassan virus;

a.29. Rift Valley fever virus;

a.30. Rocio virus;

a.31. Sabia virus;

a.32. Seoul virus;

a.33. Sin nombre virus;

a.34. St. Louis encephalitis virus;

a.35. Tick-borne encephalitis virus (Russian Spring-Summer encephalitis virus);

a.36. Variola virus;

a.37. Venezuelan equine encephalitis virus;

a.38. Western equine encephalitis virus; or

a.39. Yellow fever virus.

b. Rickettsiae, as follows:

b.1. Bartonella quintana (Rochalimea quintana, Rickettsia quintana);

b.2. Coxiella burnetii;

b.3. Rickettsia prowasecki (a.k.a. Rickettsia prowazekii); or

b.4. Rickettsia rickettsii.

c. Bacteria, 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. Clostridium botulinum;

c.9. Clostridium perfringens, epsilon toxin producing types;

c.10. Enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing serotypes;

c.11. Francisella tularensis;

c.12. Salmonella typhi;

c.13. Shigella dysenteriae;

c.14. Vibrio cholerae; or

c.15. Yersinia pestis.

d. “Toxins”, as follows, and “subunits” thereof:

d.1. Abrin;

d.2. Aflatoxins;

d.3. Botulinum toxins;

d.4. Cholera toxin;

d.5. Clostridium perfringens 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 toxins;

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.

7. 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 amended by revising the “Related Controls” paragraph in the List of Items Controlled section, to read as follows:

1C352 Animal pathogens, as follows (see List of Items Controlled).

* * * * *

List of Items Controlled

Unit: * * *

Related Controls: 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)).

Related Definitions: * * *

Items:

* * * * *

8. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1—Special Materials and Related Equipment, Chemicals, “Microorganisms” and “Toxins,” ECCN 1C360 is amended by revising paragraph (a) in the “Items” paragraph in the List of Items Controlled to read as follows:

1C360 Select agents not controlled under ECCN 1C351, 1C352, or 1C354.

* * * * *

List of Items Controlled

Unit: * * *

Related Controls: * * *

Related Definitions: * * *

Items:

Note: * * *

a. Human and zoonotic pathogens, as follows:

a.1. Viruses, as follows:

a.1.a. Central European tick-borne encephalitis viruses, as follows:

a.1.a.1. Absettarov;

a.1.a.2. Hanzalova;

a.1.a.3. Hypr;

a.1.a.4. Kumlinge;

a.1.b. Cercopithecine herpesvirus 1 (Herpes B virus);

a.1.c. Flexal virus;

a.1.d. Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments;

a.2. [RESERVED];

* * * * *

9. 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 by revising the “Items” paragraph in the List of Items Controlled to read as follows:

1C991 Vaccines, immunotoxins, medical products, diagnostic and food testing kits, as follows (see List of Items controlled).

* * * * *

List of Items Controlled

Unit: * * *

Related Controls: * * *

Related Definitions: * * *

Items:

a. Vaccines against items controlled by ECCN 1C351, 1C352, 1C353, 1C354, or 1C360;

b. Immunotoxins containing items controlled by 1C351.d;

c. Medical products containing botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6;

d. Medical products containing items controlled by ECCN 1C351.d (except botulinum toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN 1C351.d.6, and items controlled for CW reasons under 1C351.d.11 or .d.12);

e. Diagnostic and food testing kits containing items controlled by ECCN 1C351.d (except items controlled for CW reasons under ECCN 1C351.d.11 or .d.12).

Dated: August 26, 2011.

Kevin J. Wolf,

Assistant Secretary for Export Administration.