
[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Rules and Regulations]
[Pages 56099-56103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22677]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 740, 742 and 774

[Docket No. 110222155-1110-01]
RIN 0694-AF14


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 Jasmeet_K._Seehra@omb.eop.gov, or by fax to (202) 395-7285; and to the Regulatory 
Policy Division, Bureau of Industry and Security, Department of 
Commerce, 14th Street & Pennsylvania Avenue, NW., Room 2705, 
Washington, DC 20230.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sangine, Director, Chemical 
and Biological Controls Division, Office of Nonproliferation and Treaty 
Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343.

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

[[Page 56100]]

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

[[Page 56101]]

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]

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


0
2. Section 740.20 is amended by revising paragraph (b)(2)(v) and 
paragraph (b)(2)(vi) introductory text, as follows:


Sec.  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]

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


0
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:


Sec.  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 AgglutininII (RCAII), which is 
also known as ricin D or Ricinus Communis LectinIII 
(RCLIII), and Ricinus Communis LectinIV 
(RCLIV), 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

[[Page 56102]]

Sec.  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]

0
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).

0
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 
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.

 
               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 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 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:

[[Page 56103]]

    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.


0
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:
* * * * *

0
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];
* * * * *

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 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.
[FR Doc. 2011-22677 Filed 9-9-11; 8:45 am]
BILLING CODE 3510-33-P


