[Federal Register Volume 71, Number 226 (Friday, November 24, 2006)]
[Rules and Regulations]
[Pages 67786-67792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19825]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 742, 745, and 774
[Docket No. 061027281-6281-01]
RIN 0694-AD86
Implementation of the Understandings Reached at the June 2006
Australia Group (AG) Plenary Meeting; Clarifications and Corrections;
Additions to the List of States Parties to the Chemical Weapons
Convention (CWC)
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Final rule.
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SUMMARY: The Bureau of Industry and Security (BIS) is publishing this
final rule to amend the Export Administration Regulations (EAR) to
implement the understandings reached at the June 2006 plenary meeting
of the Australia Group (AG). Specifically, this final rule amends the
EAR to reflect changes to the AG ``Control List of Biological Agents''
by revising the Commerce Control List (CCL) entry that controls certain
human and zoonotic pathogens and toxins to add certain fungi (i.e.,
Coccidioides immitis and Coccidioides posadasii) and toxins (i.e.,
Shiga-like ribosome inactivating proteins other than verotoxin).
Verotoxin continues to be listed under this CCL entry. Prior to the
publication of this rule, the fungi Coccidioides immitis and
Coccidioides posadasii and Shiga-like ribosome inactivating proteins
other than verotoxin were listed under the CCL entry containing
unilaterally controlled select agents and toxins not included on any of
the AG Common Control Lists--this rule removes these items from that
CCL entry.
As a result of the addition of Shiga-like ribosome inactivating
proteins other than verotoxin to the CCL entry that controls certain
human and zoonotic pathogens and toxins, this rule makes conforming
changes to two additional CCL entries (i.e., the CCL entry that
controls certain AG-listed genetic elements and genetically modified
organisms and the CCL entry that controls vaccines, immunotoxins,
medical products, and diagnostic and food testing kits).
This rule also amends the EAR to reflect changes to the AG
``Control List of Dual-Use Chemical Manufacturing Facilities and
Equipment and Related Technology'' by expanding the scope of the CCL
entry that controls certain chemical manufacturing facilities and
equipment to include equipment in which all surfaces that come in
direct contact with the chemical(s) being processed or contained are
made from niobium (columbium) or niobium alloys.
In addition, this final rule corrects errors in two CCL entries
that were amended by a final rule that BIS published on December 29,
2004. This rule corrects a typographical error involving a Chemical
Abstracts Service (CAS) registry number in the CCL entry that controls
AG-listed precursor chemicals. This rule also corrects an error in the
CCL entry that controls certain Chemical Weapons Convention (CWC)
Schedule 2 or Schedule 3 chemicals not included on any of the AG Common
Control Lists by removing the Schedule 3 chemical ethyldiethanolamine.
The December 29, 2004, final rule added ethyldiethanolamine to the CCL
entry that controls AG-listed precursor chemicals, but failed to remove
it from the aforementioned entry.
This rule also amends the EAR provisions describing AG-related
license requirements and licensing policies to remind applicants that,
even if an AG-related item is licensed by ``$ value'' (e.g., human and
zoonotic pathogens and toxins, plant pathogens, genetic elements and
genetically modified organisms, and select agents and toxins), the EAR
still require that the unit of quantity commonly used in the trade be
shown on the license application.
Finally, this rule updates the list of countries that currently are
States Parties to the Chemical Weapons Convention (CWC) by adding the
Central African Republic and Comoros, which recently became States
Parties. As a result of this change, the CW (Chemical Weapons) license
requirements and policies in the EAR that apply to these countries now
conform with those applicable to other CWC States Parties.
DATES: This rule is effective November 24, 2006. Although there is no
formal comment period, public comments on this regulation are welcome
on a continuing basis.
ADDRESSES: You may submit comments, identified by RIN 0694-AD86, by any
of the following methods:
E-mail: [email protected]. Include ``RIN 0694-
AD86'' in the subject line of the message.
Fax: (202) 482-3355. Please alert the Regulatory Policy
Division, by calling (202) 482-2440, if you are faxing comments.
Mail or Hand Delivery/Courier: Willard Fisher, U.S.
Department of Commerce, Bureau of Industry and Security, Regulatory
Policy Division, 14th St. & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230, Attn: RIN 0694-AD86.
Send comments regarding this collection of information, including
suggestions for reducing the burden, to David Rostker, Office of
Management and Budget (OMB), by e-mail to [email protected],
or by fax to (202) 395-7285; and to the Regulatory Policy Division,
Bureau of Industry and Security, Department of Commerce, P.O. Box 273,
Washington, DC 20044. Comments on this collection of information should
be submitted separately from comments on the final rule (i.e., RIN
0694-AD86)--all comments on the latter should be submitted by one of
the three methods outlined above.
FOR FURTHER INFORMATION CONTACT: Elizabeth Scott, 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 the understandings
reached at the annual plenary meeting of the Australia Group (AG) that
was held in Paris on June 12-15, 2006. The Australia Group is a
multilateral forum, consisting of 39 participating countries, that
maintains 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 understandings reached at the June 2006 annual plenary meeting
included a decision to add certain fungi and toxins to the AG ``Control
List of Biological Agents.'' This rule amends the EAR to reflect that
decision by revising Export Control Classification Number (ECCN) 1C351,
which controls certain human and zoonotic pathogens and toxins, to add
these fungi (i.e.,
[[Page 67787]]
Coccidioides immitis and Coccidioides posadasii) and toxins (i.e.,
Shiga-like ribosome inactivating proteins other than verotoxin). All
Shiga-like ribosome inactivating proteins, including verotoxin, are now
listed in 1C351.d.10, while the fungi Coccidioides immitis and
Coccidioides posadasii are now listed in 1C351.e.1 and e.2,
respectively. Prior to the publication of this rule, the fungi
Coccidioides immitis and Coccidioides posadasii and Shiga-like ribosome
inactivating proteins other than verotoxin were listed under ECCN
1C360, which contains unilaterally controlled select agents not
included on any of the AG Common Control Lists. This rule removes these
items from ECCN 1C360.
As a result of the addition of Shiga-like ribosome inactivating
proteins other than verotoxin to ECCN 1C351 and their removal from ECCN
1C360, this rule makes conforming changes to ECCN 1C353, which controls
certain AG-listed genetic elements and genetically modified organisms,
and ECCN 1C991, which controls vaccines, immunotoxins, medical
products, and diagnostic and food testing kits. The List of Items
Controlled in each of these ECCNs is amended to remove all references
to ECCN 1C360.a.3.a, since Shiga-like ribosome inactivating proteins
other than verotoxin are now controlled under ECCN 1C351.d.10.
The scope of the EAR license requirements that apply to the
specific items affected by the amendments to ECCNs 1C351, 1C353, 1C360,
and 1C991 (described above) remains unchanged. The affected items in
ECCNs 1C351, 1C353, and 1C360 continue to require a license for export
or reexport to all countries or destinations indicated under CB Column
1 or AT Column 1 on the Commerce Country Chart (Supplement No. 1 to
Part 738 of the EAR)--none of these items are controlled under
1C351.d.5. or .d.6, which also require a license for Chemical Weapons
Convention (CW) reasons. The affected items in ECCN 1C991 continue to
require a license for export or reexport to all destinations indicated
under CB Column 3 or AT Column 1 on the Commerce Country Chart.
This rule also amends the EAR to reflect the understanding reached
at the June 2006 annual plenary meeting to expand the scope of the AG
``Control List of Dual-Use Chemical Manufacturing Facilities and
Equipment and Related Technology'' to include equipment in which all
surfaces that come in direct contact with the chemical(s) being
processed or contained are made from niobium (columbium) or niobium
alloys. Specifically, this rule amends ECCN 2B350, which controls
certain chemical manufacturing facilities and equipment, to include the
following equipment in which all surfaces that come in direct contact
with the chemical(s) being processed or contained are made from niobium
(columbium) or niobium alloys: Reaction vessels or reactors; agitators
for use in reaction vessels or reactors (including impellers, blades or
shafts designed for such agitators); certain storage tanks, containers
or receivers; certain heat exchangers or condensers (including tubes,
plates, coils or blocks designed for such heat exchangers or
condensers); certain distillation or absorption columns (including
liquid distributors, vapor distributors or liquid collectors designed
for such distillation or absorption columns); certain valves (including
casings and preformed casing liners designed for such valves); multi-
walled piping incorporating a leak detection port; and certain
multiple-seal and seal-less pumps or vacuum pumps (including casings,
preformed casing liners, impellers, rotors or jet pump nozzles designed
for such pumps).
Like all other items controlled under ECCN 2B350, the newly
controlled equipment and accessories, in which all surfaces that come
in direct contact with the chemical(s) being processed or contained are
made from niobium (columbium) or niobium alloys, require a license to
all countries or destinations indicated under CB Column 2 or AT Column
1 on the Commerce Country Chart. A license generally is not required to
export or reexport ECCN 2B350 equipment and components to AG
participating countries; however, certain transactions may be subject
to license requirements described elsewhere in the EAR (e.g., Part 744
of the EAR).
In addition, this final rule corrects errors contained in two CCL
entries that were amended by a final rule that BIS published on
December 29, 2004 (69 FR 77890). This rule corrects a typographical
error involving a Chemical Abstracts Service (C.A.S.) registry number
in ECCN 1C350, which controls AG-listed precursor chemicals.
Specifically, the C.A.S. number for N,N-dimethylaminophosphoryl
dichloride in 1C350.b.23 is revised to read ``C.A.S. 677-43-
0,'' instead of ``C.A.S. 667-43-0.'' This rule also corrects
an error in ECCN 1C355, which controls certain Chemical Weapons
Convention (CWC) Schedule 2 or Schedule 3 chemicals not included on any
of the AG Common Control Lists. The December 29, 2004, final rule
amended ECCN 1C350 by adding the CWC Schedule 3 chemical
ethyldiethanolamine (C.A.S. 139-87-7) and eight other
precursor chemicals to reflect an AG intersessional decision, which was
adopted after the June 2004 annual plenary meeting, to add these
precursor chemicals to the ``Chemical Weapons Precursors'' AG Common
Control List. As part of this change, the rule also should have removed
ethyldiethanolamine (C.A.S. 139-87-7) from ECCN 1C355.b.2.a,
but inadvertently failed to do so. This final rule corrects that
oversight.
This rule also amends Section 742.2 of the EAR, which describes AG-
related license requirements and licensing policies, to clarify certain
AG-related license application requirements. Specifically, this rule
adds a new paragraph (e) to indicate that, even if an AG-related item
is licensed by ``$ value'' (e.g., human and zoonotic pathogens and
toxins, plant pathogens, genetic elements and genetically modified
organisms, and select agents and toxins), the EAR still require that
the unit of quantity commonly used in the trade also be shown on the
license application. This new paragraph also contains a reference to
paragraph (a) of Supplement No. 2 to Part 748 of the EAR, which
describes unique application and submission requirements for chemicals,
medicinals, and pharmaceuticals.
Finally, this rule revises Supplement No. 2 to Part 745 of the EAR
(titled ``States Parties to the Convention on the Prohibition of the
Development, Production, Stockpiling, and Use of Chemical Weapons and
on Their Destruction'') by adding the Central African Republic and
Comoros, which recently became States Parties to the CWC. As a result
of this change, the license requirements and policies that apply to
exports and reexports of items controlled for CW reasons to each of
these countries now conform with those applicable to other CWC States
Parties, as described in Section 742.18 of the EAR.
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 3, 2006,
71 FR 44551 (August 7, 2006), has continued the Export Administration
Regulations 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
[[Page 67788]]
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 December 26, 2006, 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 January 8, 2007. Any such items not actually exported or
reexported before midnight, on January 8, 2007, 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 January 8, 2007. Beginning
at midnight on January 8, 2007, 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. 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 David Rostker, 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 (Sec. 5 U.S.C. 553(a)(1)). 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 5 U.S.C. 553 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. Although there
is no formal comment period, public comments on this regulation are
welcome on a continuing basis.
List of Subjects
15 CFR Part 742
Exports, Foreign trade.
15 CFR Part 745
Administrative practice and procedure, Chemicals, Exports, Foreign
trade, Reporting and recordkeeping requirements.
15 CFR Part 774
Exports, Foreign trade, Reporting and recordkeeping requirements.
0
Accordingly, parts 742, 745, and 774 of the Export Administration
Regulations (15 CFR parts 730-799) are amended as follows:
PART 742--[AMENDED]
0
1. The authority citation for 15 CFR part 742 is revised to read as
follows:
Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
18 U.S.C. 2510 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a;
Sec. 901-911, Pub. L. 106-387; Sec. 221, Pub. L. 107-56; 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 3, 2006, 71 FR
44551 (August 7, 2006); Notice of October 27, 2006, 71 FR 64109
(October 31, 2006).
0
2. Section 742.2 is amended by adding a new paragraph (e), at the end
of the section, to read as follows:
Sec. 742.2 Proliferation of chemical and biological weapons.
* * * * *
(e) License application requirements and instructions. (1) General
instructions for completing Form BIS-748P, Multipurpose Application,
are provided in Supplement No. 1 to Part 748 of the EAR. When preparing
applications for items controlled for chemical and biological reasons,
pay particular attention to the instructions contained in paragraphs
(e) and (f) of the Supplement that apply to entering ``Quantity'' and
``Units,'' respectively, on license applications. Paragraphs (e) and
(f) require that, if an item is licensed in terms of ``$ value'' (refer
to the ``Unit'' paragraph within the appropriate ECCN), the unit of
quantity commonly used in the trade must also be shown on the license
application. In such cases, Section 750.7 of the EAR provides that the
quantity of commodities authorized is limited by the total dollar value
as shown on the approved license and not by the quantity specified
thereon. Although the EAR do not place a specific limitation on
quantity in such cases, the total quantity that may be exported or
reexported is limited, to a significant degree, by the fact that the
EAR do not provide a shipping tolerance for items licensed by ``dollar
value'' (see Section 750.11(b)(1) of the EAR) and require that the
``unit price'' indicated on the license application reflect the fair
market value of the items listed on the application (see paragraph (g)
of Supplement No. 1 to part 748 of the EAR).
(2) Unique application and submission requirements for chemicals,
medicinals, and pharmaceuticals are described in paragraph (a) of
Supplement No. 2 to part 748 of the EAR.
PART 745--[AMENDED]
0
3. The authority citation for 15 CFR part 745 is revised to read as
follows:
Authority: 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3
CFR, 1994 Comp., p. 950; Notice of October 27, 2006, 71 FR 64109
(October 31, 2006).
Supplement No. 2 to Part 745 [Amended]
0
4. Supplement No. 2 to part 745 is amended by revising the undesignated
center heading ``List of States Parties as of March 25, 2006'' to read
``List of States Parties as of November 1, 2006'' and by adding, in
alphabetical order, the countries ``Central African Republic'' and
``Comoros''.
[[Page 67789]]
PART 774--[AMENDED]
0
5. The authority citation for 15 CFR part 774 is revised 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); 18 U.S.C. 2510 et seq.; 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; 46 U.S.C.
app. 466c; 50 U.S.C. app. 5; Sec. 901-911, Pub. L. 106-387; Sec.
221, Pub. L. 107-56; 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 3, 2006, 71 FR 44551 (August 7, 2006).
Supplement No. 1 to Part 774--[Amended]
0
6. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C350 is amended by revising the parenthetical ``(C.A.S. 667-
43-0)'' in paragraph b.23 under Items, in the List of Items Controlled,
to read ``(C.A.S. 677-43-0)''.
0
7. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C351 is amended by revising the List of Items Controlled to read as
follows:
1C351 Human and zoonotic pathogens and ``toxins'', as follows (see List
of Items Controlled).
* * * * *
List of Items Controlled
Unit: $ value.
Related Controls: (1) Certain forms of ricin and saxitoxin in
1C351.d.5. and d.6 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) 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.5 and d.6, 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. (3) For the purposes of this entry, only saxitoxin
is controlled under paragraph d.6; other members of the paralytic
shellfish poison family (e.g. neosaxitoxin) are classified as EAR99.
(4) Clostridium perfringens strains, other than the epsilon toxin-
producing strains of Clostridium perfringens described in c.14, are
excluded from the scope of this entry, since they may be used as
positive control cultures for food testing and quality control. (5)
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(c), 9 CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see
42 CFR 73.3(c) and 42 CFR 73.4(c)).
Related Definitions: (1) For the purposes of this entry
``immunotoxin'' is defined as an antibody-toxin conjugate intended
to destroy specific target cells (e.g., tumor cells) that bear
antigens homologous to the antibody. (2) For the purposes of this
entry ``subunit'' is defined as a portion of the ``toxin''.
Items:
a. Viruses, as follows:
a.1. Chikungunya virus;
a.2. Congo-Crimean haemorrhagic fever virus (a.k.a. Crimean-
Congo haemorrhagic fever virus);
a.3. Dengue fever virus;
a.4. Eastern equine encephalitis virus;
a.5. Ebola virus;
a.6. Hantaan virus;
a.7. Japanese encephalitis virus;
a.8. Junin virus;
a.9. Lassa fever virus
a.10. Lymphocytic choriomeningitis virus;
a.11. Machupo virus;
a.12. Marburg virus;
a.13. Monkey pox virus;
a.14. Rift Valley fever virus;
a.15. Tick-borne encephalitis virus (Russian Spring-Summer
encephalitis virus);
a.16. Variola virus;
a.17. Venezuelan equine encephalitis virus;
a.18. Western equine encephalitis virus;
a.19. White pox;
a.20. Yellow fever virus;
a.21. Kyasanur Forest virus;
a.22. Louping ill virus;
a.23. Murray Valley encephalitis virus;
a.24. Omsk haemorrhagic fever virus;
a.25. Oropouche virus;
a.26. Powassan virus;
a.27. Rocio virus;
a.28. St. Louis encephalitis virus;
a.29. Hendra virus (Equine morbillivirus);
a.30. South American haemorrhagic fever (Sabia, Flexal,
Guanarito);
a.31. Pulmonary and renal syndrome-haemorrhagic fever viruses
(Seoul, Dobrava, Puumala, Sin Nombre); or
a.32. Nipah 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. Chlamydia psittaci;
c.8. Clostridium botulinum;
c.9. Francisella tularensis;
c.10. Salmonella typhi;
c.11. Shigella dysenteriae;
c.12. Vibrio cholerae;
c.13. Yersinia pestis;
c.14. Clostridium perfringens, epsilon toxin producing types; or
c.15. Enterohaemorrhagic Escherichia coli, serotype O157 and
other verotoxin producing serotypes.
d. ``Toxins'', as follows, and ``subunits'' thereof:
d.1. Botulinum toxins;
d.2. Clostridium perfringens toxins;
d.3. Conotoxin;
d.4. Microcystin (Cyanginosin);
d.5. Ricin;
d.6. Saxitoxin;
d.7. Shiga toxin;
d.8. Staphylococcus aureus toxins;
d.9. Tetrodotoxin;
d.10. Verotoxin and other Shiga-like ribosome inactivating
proteins;
d.11. Aflatoxins;
d.12. Abrin;
d.13. Cholera toxin;
d.14. Diacetoxyscirpenol toxin;
d.15. T-2 toxin;
d.16. HT-2 toxin;
d.17. Modeccin toxin;
d.18. Volkensin toxin; or
d.19. Viscum Album Lectin 1 (Viscumin).
e. ``Fungi'', as follows:
e.1. Coccidioides immitis; or
e.2. Coccidioides posadasii.
0
8. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C353 is amended by revising the List of Items Controlled to read as
follows:
1C353 Genetic elements and genetically-modified organisms, as follows
(see List of Items Controlled).
* * * * *
List of Items Controlled
Unit: $ value.
Related Controls: Vaccines that contain genetic elements or
genetically modified organisms identified in this entry are
controlled by ECCN 1C991. 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, including (but not limited to) genetic elements,
recombinant nucleic acids, and recombinant organisms associated with
the agents or toxins in ECCN 1C360 (for APHIS, see 7 CFR 331.3(c), 9
CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see 42 CFR 73.3(c) and 42
CFR 73.4(c)).
Related Definition: N/A.
Items:
a. Genetic elements, as follows:
a.1. Genetic elements that contain nucleic acid sequences
associated with the pathogenicity of microorganisms controlled by
1C351.a to .c, 1C352, 1C354, or 1C360;
[[Page 67790]]
a.2. Genetic elements that contain nucleic acid sequences coding
for any of the ``toxins'' controlled by 1C351.d or ``sub-units of
toxins'' thereof.
b. Genetically modified organisms, as follows:
b.1. Genetically modified organisms that contain nucleic acid
sequences associated with the pathogenicity of microorganisms
controlled by 1C351.a to .c, 1C352, 1C354, or 1C360;
b.2. Genetically modified organisms that contain nucleic acid
sequences coding for any of the ``toxins'' controlled by 1C351.d or
``sub-units of toxins'' thereof.
Technical Note: 1. ``Genetic elements'' include, inter alia,
chromosomes, genomes, plasmids, transposons, and vectors, whether
genetically modified or unmodified.
2. This ECCN does not control nucleic acid sequences associated
with the pathogenicity of enterohaemorrhagic Escherichia coli,
serotype O157 and other verotoxin producing strains, except those
nucleic acid sequences that contain coding for the verotoxin or its
sub-units.
3. ``Nucleic acid sequences associated with the pathogenicity of
any of the microorganisms controlled by 1C351.a to .c, 1C352, 1C354,
or 1C360'' means any sequence specific to the relevant controlled
microorganism that:
a. In itself or through its transcribed or translated products
represents a significant hazard to human, animal or plant health; or
b. Is known to enhance the ability of a microorganism controlled
by 1C351.a to .c, 1C352, 1C354, or 1C360, or any other organism into
which it may be inserted or otherwise integrated, to cause serious
harm to human, animal or plant health.
0
9. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C355 is amended by revising the List of Items Controlled to read as
follows:
1C355 Chemical Weapons Convention (CWC) Schedule 2 and 3 chemicals and
families of chemicals not controlled by ECCN 1C350 or by the Department
of State under the ITAR.
* * * * *
List of Items Controlled
Unit: Liters or kilograms, as appropriate.
Related Controls: See also ECCNs 1C350 1C351, 1C395, and 1C995.
See Sec. Sec. 742.18 and 745.2 of the EAR for End-Use Certification
requirements.
Related Definitions: N/A.
Items:
a. CWC Schedule 2 chemicals and mixtures containing Schedule 2
chemicals:
a.1. Toxic chemicals, as follows, and mixtures containing toxic
chemicals:
a.1.a. PFIB: 1,1,3,3,3-Pentafluoro-2-(trifluoromethyl)-1-propene
(C.A.S. 382-21-8) and mixtures in which PFIB constitutes more than 1
percent of the weight of the mixture;
a.1.b. [RESERVED]
a.2. Precursor chemicals, as follows, and mixtures in which at
least one of the following precursor chemicals constitutes more than
10 percent of the weight of the mixture:
a.2.a. Chemicals, except for those listed in Schedule 1,
containing a phosphorus atom to which is bonded one methyl, ethyl,
or propyl (normal or iso) group but not further carbon atoms.
Note: 1C355.a.2.a does not control Fonofos: O-Ethyl S-phenyl
ethylphosphono thiolothionate (C.A.S. 944-22-9).
a.2.b. FAMILY: N,N-Dialkyl (Me, Et, n-Pr or i-Pr) phosphoramidic
dihalides;
a.2.c. FAMILY: Dialkyl (Me, Et, n-Pr or i-Pr) N,N-Dialkyl (Me,
Et, n-Pr, or i-Pr)-phosphoramidates;
a.2.d. FAMILY: N,N-Dialkyl (Me, Et, n-Pr or i-Pr) aminoethyl-2-
chlorides and corresponding protonated salts;
a.2.e. FAMILY: N,N-Dialkyl (Me, Et, n-Pr or i-Pr) aminoethane-2-
ols and corresponding protonated salts;
Note: 1C355.a.2.e. does not control N,N-Dimethylaminoethanol and
corresponding protonated salts (C.A.S. 108-01-0) or N,N-
Diethylaminoethanol and corresponding protonated salts (C.A.S. 100-
37-8).
a.2.f. FAMILY: N,N-Dialkyl (Me, Et, n-Pr or i-Pr) aminoethane-2-
thiols and corresponding protonated salts.
b. CWC Schedule 3 chemicals and mixtures containing Schedule 3
chemicals:
b.1. Toxic chemicals, as follows, and mixtures in which at least
one of the following toxic chemicals constitutes 30 percent or more
of the weight of the mixture:
b.1.a. Phosgene: Carbonyl dichloride (C.A.S. 75-44-5);
b.1.b. Cyanogen chloride (C.A.S. 506-77-4);
b.1.c. Hydrogen cyanide (C.A.S. 74-90-8);
b.1.d. Chloropicrin: Trichloronitromethane (C.A.S. 76-06-2).
b.2. Precursor chemicals, as follows, and mixtures in which at
least one of the following precursor chemicals constitutes 30
percent or more of the weight of the mixture:
b.2.a.. [Reserved];
b.2.b. Methyldiethanolamine (C.A.S. 105-59-9).
0
10. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C360 is amended by revising the ECCN heading and 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: $ value.
Related Controls: (1) All vaccines are excluded from the scope
of this entry. Vaccines excluded from the scope of this entry are
controlled under ECCN 1C991. (2) Also see ECCNs 1C351 (AG-controlled
human and zoonotic pathogens and ``toxins''), 1C352 (AG-controlled
animal pathogens), and 1C354 (AG-controlled plant pathogens). (3)
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 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
Sec. 73.3(b) and 42 CFR 73.4(b)).
Related Definitions: N/A.
Items:
Note: The control status of items listed in this ECCN is not
affected by the exemptions or exclusions contained in the domestic
possession, use, and transfer regulations maintained by APHIS (at 7
CFR part 331 and 9 CFR part 121) and/or CDC (at 42 CFR part 73).
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. 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];
b. Animal pathogens, as follows:
b.1. Viruses, as follows:
b.1.a. Akabane virus;
b.1.b. Bovine spongiform encephalopathy agent;
b.1.c. Camel pox virus;
b.1.d. Malignant catarrhal fever virus;
b.1.e. Menangle virus;
b.2. Mycoplasma, as follows:
b.2.a. Mycoplasma capricolum;
b.2.b. Mycoplasma F38;
b.3. Rickettsia, as follows:
b.3.a. Erhlichia ruminantium (a.k.a. Cowdria ruminantium);
b.3.b. [Reserved].
c. Plant pathogens, as follows:
c.1. Bacteria, as follows:
c.1.a. Candidatus Liberobacter africanus (a.k.a. Liberobacter
africanus);
c.1.b. Candidatus Liberobacter asiaticus (a.k.a. Liberobacter
asiaticus);
c.1.c. Xylella fastidiosa pv. citrus variegated chlorosis (CVC);
c.2. Fungi, as follows:
c.2.a. Peronosclerospora philippinensis;
c.2.b. Sclerophthora rayssiae var. zeae;
c.2.c. Synchytrium endobioticum.
0
11. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C991 is amended by revising 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: $ value.
[[Page 67791]]
Related Controls: (1) Medical products containing ricin or
saxitoxin, as follows, are controlled for CW reasons under ECCN
1C351:
(a) Ricinus Communis AgglutininII (RCAII),
also known as ricin D, or Ricinus Communis LectinIII
(RCLIII);
(b) Ricinus Communis LectinIV (RCLIV),
also known as ricin E; or
(c) Saxitoxin identified by C.A.S. 35523-89-8.
(2) The export of a ``medical product'' that is an
``Investigational New Drug'' (IND), as defined in 21 CFR 312.3, is
subject to certain U.S. Food and Drug Administration (FDA)
requirements that are independent of the export requirements
specified in this ECCN or elsewhere in the EAR. These FDA
requirements are described in 21 CFR 312.110 and must be satisfied
in addition to any requirements specified in the EAR.
(3) Also see 21 CFR 314.410 for FDA requirements concerning
exports of new drugs and new drug substances.
Related Definitions: For the purpose of this entry,
``immunotoxin'' is defined as an antibody-toxin conjugate intended
to destroy specific target cells (e.g., tumor cells) that bear
antigens homologous to the antibody. For the purpose of this entry,
``medical products'' are: (1) Pharmaceutical formulations designed
for testing and human administration in the treatment of medical
conditions, (2) prepackaged for distribution as clinical or medical
products, and (3) approved by the U.S. Food and Drug Administration
either to be marketed as clinical or medical products or for use as
an ``Investigational New Drug'' (IND) (see 21 CFR part 312). For the
purpose of this entry, ``diagnostic and food testing kits'' are
specifically developed, packaged and marketed for diagnostic or
public health purposes. Biological toxins in any other
configuration, including bulk shipments, or for any other end-uses
are controlled by ECCN 1C351 or ECCN 1C360. For the purpose of this
entry, ``vaccine'' is defined as a medicinal (or veterinary) product
in a pharmaceutical formulation, approved by the U.S. Food and Drug
Administration or the U.S. Department of Agriculture to be marketed
as a medical (or veterinary) product or for use in clinical trials,
that is intended to stimulate a protective immunological response in
humans or animals in order to prevent disease in those to whom or to
which it is administered.
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.1 or conotoxins controlled by ECCN 1C351.d.3;
d. Medical products containing items controlled by ECCN 1C351.d
(except botulinum toxins controlled by ECCN 1C351.d.1, conotoxins
controlled by ECCN 1C351.d.3, and items controlled for CW reasons
under 1C351.d.5 or .d.6);
e. Diagnostic and food testing kits containing items controlled
by ECCN 1C351.d (except items controlled for CW reasons under ECCN
1C351.d.5 or .d.6).
0
12. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 2--Materials Processing,'' ECCN 2B350 is amended by revising
the List of Items Controlled to read as follows:
2B350 Chemical manufacturing facilities and equipment, except valves
controlled by 2A226 or 2A292, as follows (see List of Items
Controlled).
* * * * *
List of Items Controlled
Unit: Equipment in number.
Related Controls: The controls in this entry do not apply to
equipment that is both:
(a) specially designed for use in civil applications (e.g., food
processing, pulp and paper processing, or water purification); and
(b) inappropriate, by the nature of its design, for use in storing,
processing, producing or conducting and controlling the flow of
chemical weapons precursors controlled by 1C350.
Related Definitions: For purposes of this entry the term
``chemical warfare agents'' are those agents subject to the export
licensing authority of the U.S. Department of State, Directorate of
Defense Trade Controls. (See 22 CFR part 121.)
Items:
a. Reaction vessels or reactors, with or without agitators, with
total internal (geometric) volume greater than 0.1 m3
(100 liters) and less than 20 m3 (20,000 liters), where
all surfaces that come in direct contact with the chemical(s) being
processed or contained are made from any of the following materials:
a.1. Alloys with more than 25% nickel and 20% chromium by
weight;
a.2. Fluoropolymers;
a.3. Glass (including vitrified or enameled coating or glass
lining);
a.4. Nickel or alloys with more than 40% nickel by weight;
a.5. Tantalum or tantalum alloys;
a.6. Titanium or titanium alloys;
a.7. Zirconium or zirconium alloys; or
a.8. Niobium (columbium) or niobium alloys.
b. Agitators for use in reaction vessels or reactors described
in 2B350.a, and impellers, blades or shafts designed for such
agitators, where all surfaces that come in direct contact with the
chemical(s) being processed or contained are made from any of the
following materials:
b.1. Alloys with more than 25% nickel and 20% chromium by
weight;
b.2. Fluoropolymers;
b.3. Glass (including vitrified or enameled coatings or glass
lining);
b.4. Nickel or alloys with more than 40% nickel by weight;
b.5. Tantalum or tantalum alloys;
b.6. Titanium or titanium alloys;
b.7. Zirconium or zirconium alloys; or
b.8. Niobium (columbium) or niobium alloys.
c. Storage tanks, containers or receivers with a total internal
(geometric) volume greater than 0.1 m3 (100 liters) where
all surfaces that come in direct contact with the chemical(s) being
processed or contained are made from any of the following materials:
c.1. Alloys with more than 25% nickel and 20% chromium by
weight;
c.2. Fluoropolymers;
c.3. Glass (including vitrified or enameled coatings or glass
lining);
c.4. Nickel or alloys with more than 40% nickel by weight;
c.5. Tantalum or tantalum alloys;
c.6. Titanium or titanium alloys;
c.7. Zirconium or zirconium alloys; or
c.8. Niobium (columbium) or niobium alloys.
d. Heat exchangers or condensers with a heat transfer surface
area of less than 20 m2, but greater than 0.15
m2, and tubes, plates, coils or blocks (cores) designed
for such heat exchangers or condensers, where all surfaces that come
in direct contact with the chemical(s) being processed are made from
any of the following materials:
d.1. Alloys with more than 25% nickel and 20% chromium by
weight;
d.2. Fluoropolymers;
d.3. Glass (including vitrified or enameled coatings or glass
lining);
d.4. Graphite or carbon-graphite;
d.5. Nickel or alloys with more than 40% nickel by weight;
d.6. Silicon carbide;
d.7. Tantalum or tantalum alloys;
d.8. Titanium or titanium alloys;
d.9. Titanium carbide;
d.10. Zirconium or zirconium alloys; or
d.11. Niobium (columbium) or niobium alloys.
e. Distillation or absorption columns of internal diameter
greater than 0.1 m, and liquid distributors, vapor distributors or
liquid collectors designed for such distillation or absorption
columns, where all surfaces that come in direct contact with the
chemical(s) being processed are made from any of the following
materials:
e.1. Alloys with more than 25% nickel and 20% chromium by
weight;
e.2. Fluoropolymers;
e.3. Glass (including vitrified or enameled coatings or glass
lining);
e.4. Graphite or carbon-graphite;
e.5. Nickel or alloys with more than 40% nickel by weight;
e.6. Tantalum or tantalum alloys;
e.7. Titanium or titanium alloys;
e.8. Zirconium or zirconium alloys; or
e.9. Niobium (columbium) or niobium alloys.
f. Remotely operated filling equipment in which all surfaces
that come in direct contact with the chemical(s) being processed are
made from any of the following materials:
f.1. Alloys with more than 25% nickel and 20% chromium by
weight; or
f.2. Nickel or alloys with more than 40% nickel by weight.
g. Valves with nominal sizes greater than 1.0 cm (.4 in.), and
casings (valve bodies) or preformed casing liners designed for such
valves, in which all surfaces that come in direct contact with the
chemical(s) being processed or contained are made from any of the
following materials:
g.1. Nickel or alloys with more than 40% nickel by weight;
g.2. Alloys with more than 25% nickel and 20% chromium by
weight;
g.3. Fluoropolymers;
[[Page 67792]]
g.4. Glass or glass lined (including vitrified or enameled
coatings);
g.5. Tantalum or tantalum alloys;
g.6. Titanium or titanium alloys;
g.7. Zirconium or zirconium alloys; or
g.8. Niobium (columbium) or niobium alloys.
h. Multi-walled piping incorporating a leak detection port, in
which all surfaces that come in direct contact with the chemical(s)
being processed or contained are made from any of the following
materials:
h.1. Alloys with more than 25% nickel and 20% chromium by
weight;
h.2. Fluoropolymers;
h.3. Glass (including vitrified or enameled coatings or glass
lining);
h.4. Graphite or carbon-graphite;
h.5. Nickel or alloys with more than 40% nickel by weight;
h.6. Tantalum or tantalum alloys;
h.7. Titanium or titanium alloys;
h.8. Zirconium or zirconium alloys; or
h.9. Niobium (columbium) or niobium alloys.
i. Multiple-seal and seal-less pumps with manufacturer's
specified maximum flow-rate greater than 0.6 m3/hour, or
vacuum pumps with manufacturer's specified maximum flow-rate greater
than 5 m3/hour (under standard temperature (273 K (0
[deg]C)) and pressure (101.3 kPa) conditions), and casings (pump
bodies), preformed casing liners, impellers, rotors or jet pump
nozzles designed for such pumps, in which all surfaces that come
into direct contact with the chemical(s) being processed are made
from any of the of the following materials:
i.1. Alloys with more than 25% nickel and 20% chromium by
weight;
i.2. Ceramics;
i.3. Ferrosilicon;
i.4. Fluoropolymers;
i.5. Glass (including vitrified or enameled coatings or glass
lining);
i.6. Graphite or carbon-graphite;
i.7. Nickel or alloys with more than 40% nickel by weight;
i.8. Tantalum or tantalum alloys;
i.9. Titanium or titanium alloys;
i.10. Zirconium or zirconium alloys; or
i.11. Niobium (columbium) or niobium alloys.
j. Incinerators designed to destroy chemical warfare agents,
chemical weapons precursors controlled by 1C350, or chemical
munitions having specially designed waste supply systems, special
handling facilities and an average combustion chamber temperature
greater than 1000 [deg]C in which all surfaces in the waste supply
system that come into direct contact with the waste products are
made from or lined with any of the following materials:
j.1. Alloys with more than 25% nickel and 20% chromium by
weight;
j.2. Ceramics; or
j.3. Nickel or alloys with more than 40% nickel by weight.
Technical Note: Carbon-graphite is a composition consisting
primarily of graphite and amorphous carbon, in which the graphite is
8 percent or more by weight of the composition.
Dated: November 16, 2006.
Christopher A. Padilla,
Assistant Secretary for Export Administration.
[FR Doc. E6-19825 Filed 11-22-06; 8:45 am]
BILLING CODE 3510-33-P