12 September 2011
Biological Weapons Export Controls Revised
[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]
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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.
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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
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