[Federal Register Volume 65, Number 192 (Tuesday, October 3, 2000)]
[Rules and Regulations]
[Pages 58911-58917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25068]


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DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Parts 742 and 774

[Docket No. 000920265-0265-01]
RIN 0694-AC13


Revisions and Clarifications to the Commerce Control List; 
Chemical and Biological Weapons Controls; Australia Group

AGENCY: Bureau of Export Administration, Commerce.

ACTION: Final rule.

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SUMMARY: This final rule amends the Commerce Control List (CCL) of the 
Export Administration Regulations to implement an October 1999 
Australia Group agreement to clarify the scope of controls on 
saxitoxin, toxic gas monitoring systems, and cross-flow filtration 
equipment, as well as clarifying the application of the rule for 
mixtures containing Australia Group (AG) chemicals that are also 
identified as Schedule 1 chemicals under the Chemical Weapons 
Convention. The final rule also amends the CCL to authorize, without a 
license, exports of certain medical products containing botulinum 
toxin, and certain diagnostic and food testing kits that contain AG-
controlled toxins. Finally, this final rule amends the CCL to add 
titanium carbide and silicon carbide to the list of construction 
materials for heat exchangers. Restrictions on chemicals and toxins 
that are also controlled for CW (Chemical Weapons Convention) purposes 
continue to apply. This rule will result in an overall decreased 
licensing burden on U.S. industry.

EFFECTIVE DATE: This rule is effective: October 3, 2000.

FOR FURTHER INFORMATION CONTACT: James Seevaratnam, Director, Chemical 
and Biological Controls Division, Bureau of Export Administration, 
(202) 501-7900.

SUPPLEMENTARY INFORMATION:

Background

    On October 7, 1999, the Bureau of Export Administration (BXA) 
published a final rule amending the Export Administration Regulations 
(EAR) to implement the October 1998 Australia Group agreement to amend 
controls on toxic gas monitoring systems and to amend the CCL to 
authorize, without a license, exports of medical products containing 
controlled biological toxins that are developed, packaged and sold for 
medical treatment.

[[Page 58912]]

    The Australia Group (AG), a multilateral forum that coordinates 
export controls to curtail the proliferation of chemical and biological 
weapons, held its annual consultations in Paris, October 4-8, 1999. The 
30 AG participating countries agreed to maintain export controls on a 
list of chemicals, biological agents, relevant equipment and technology 
that could be used in the production of chemical or biological weapons. 
The AG reviews items on its control list periodically to enhance the 
effectiveness and achieve greater harmonization of participating 
governments' national controls.
    At the October 1999 Australia Group consultations, participants 
agreed to further revise the control list entry for toxic gas 
monitoring systems to clarify the scope of controls. To implement this 
agreement, this final rule amends the Commerce Control List (CCL) of 
the Export Administration Regulations (EAR) by revising Export Control 
Classification Number (ECCN) 2B351. Specifically, this rule clarifies 
that the control of toxic gas monitoring systems under ECCN 2B351 
applies only to such systems that operate on line without any 
requirement for human intervention. The AG agreed that the intent of 
this control is to control systems capable of detecting toxic gases in 
environments such as a chemical plant rather than batch-mode operation 
equipment that is normally used in a laboratory. While not changing the 
scope of the control in any way, this rule also clarifies the 
description of cross-flow filtration equipment in ECCN 2B352 by 
describing it as cross (tangential) flow filtration equipment. In an 
expansion of controls, the Australia Group agreed to add titanium 
carbide and silicon carbide to the list of materials describing heat 
exchangers subject to control in ECCN 2B350.
    The Department of Commerce also maintains controls on exports of 
biological agents that could be used in the production of biological 
weapons. These materials require a license under ECCN 1C351 for export 
and reexport for CB (chemical and biological weapons) reasons to all 
destinations, except Canada. These controls are implemented in 
accordance with the export control provisions of the Australia Group. 
Note that two biological agents, ricin and saxitoxin, classified as 
ECCN 1C351.d.5 and .d.6, respectively, are Schedule 1 chemicals under 
the Chemical Weapons Convention and are also controlled for CW reasons 
to all destinations, including Canada.
    As agreed by the AG, medical products that contain the AG-
controlled botulinum toxin that are pharmaceutical formulations 
designed for human administration in the treatment of medical 
conditions have broad medical applications while posing no significant 
proliferation concerns. Such products are controlled under ECCN 1C991 
and may be exported and reexported without a license to all 
destinations and entities, except terrorist supporting countries (Cuba, 
Iran, Iraq, Libya, North Korea, Sudan, Syria) and Serbia, and except as 
provided in Parts 736 and 744 of the EAR. This further liberalization 
of licensing requirements for the botulinum toxin does not apply if the 
botulinum toxin is to be exported in any other configuration, including 
bulk shipments, or for any other end-uses, in which case it is still 
controlled under ECCN 1C351.
    In addition, this final rule further amends ECCN 1C991 to clarify 
the criteria for defining an item containing botulinum toxin as a 
medical product when approved by the Food and Drug Administration (FDA) 
for distribution in interstate commerce as a medical product. 
Specifically, the medical product must be: (1) Pharmaceutical 
formulations designed for human administration in the treatment of 
medical conditions; (2) prepackaged for distribution as medical 
products; and, (3) approved by the Food and Drug Administration to be 
marketed as medical products.
    Further, this rule removes controls on certain diagnostic and food 
testing kits that contain toxins controlled by the AG. Specifically, 
this final rule amends ECCN 1C991 to include diagnostic and food 
testing kits containing AG-controlled toxins controlled under ECCN 
1C351. Such testing kits may be exported and reexported without a 
license to all destinations and entities, except to terrorist 
supporting countries and Serbia, and except as provided in Parts 736 
and 744 of the EAR, when the kits are specifically developed, packaged, 
and marketed for diagnostic or public health purposes. Diagnostic and 
food testing kits containing CW-controlled toxins continue to be 
controlled under ECCN 1C351 to all destinations, including Canada.
    This rule clarifies that the scope of AG-controls on saxitoxin 
under 1C351.d.6 applies only to saxitoxin and not the entire family of 
paralytic shellfish poisons (e.g., neosaxitoxin) which, other than 
saxitoxin, are classified under EAR99. This rule also clarifies the 
forms of saxitoxin and ricin that are controlled for CW reasons under 
ECCN 1C351.
    Finally, the AG agreed to the development of a rounding rule for 
mixtures that contain trace and unintended quantities of AG-controlled 
chemicals that are also on CWC Schedule 1 listed in ECCN 1C350. The 
United States is providing a ``round to zero'' rule for Schedule 1 
chemicals similar to that agreed by the AG. This rule, currently set 
forth in section 712.1 of the Chemical Weapons Convention Regulations, 
is now added to the note under 1C350 on mixtures. The licensing 
requirements do not apply to mixtures containing less than 0.5% 
aggregate quantities of Schedule 1 chemicals as unavoidable by-products 
or impurities, and the Schedule 1 chemicals are not intentionally 
produced or added.
    Exporters are reminded that although license requirements have been 
removed for shipments of the medical products and test kits for CB 
reasons as described above, these items continue to require a license 
under 1C991 for export or reexport to terrorist supporting and 
embargoed destinations and entities. Exporters may also need to consult 
with the Department of the Treasury's Office of Foreign Assets Control, 
which administers economic sanctions against certain countries and 
entities, including the Taliban controlled areas of Afghanistan.
    Although the EAA expired on August 20, 1994, the President invoked 
the International Emergency Economic Powers Act and continued in effect 
the Export Administration Regulations and, to the extent permitted by 
law, the provisions of the EAA in Executive Order 12924 of August 19, 
1994, as extended by the President's notices of August 15, 1995 (60 FR 
42767), August 14, 1996 (61 FR 42527), August 13, 1997 (62 FR 43629), 
August 13, 1998 (63 FR 44121), August 10, 1999 (64 FR 44101) and August 
8, 2000 (65 FR 48347).

Rulemaking Requirements

    1. This final 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, unless that collection of 
information displays a currently valid Office of Management and Budget 
Control Number. This rule involves a collection of information subject 
to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This 
collection has been approved by the Office of Management and Budget 
under control numbers 0694-0088, ``Multi-Purpose Application,'' which 
carries a burden hour estimate of 45 minutes for a

[[Page 58913]]

manual submission and 40 minutes for an electronic submission.
    3. This rule does not contain policies with Federalism implications 
sufficient to warrant preparation of a Federalism assessment under 
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 (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 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. Although there is no formal 
comment period, public comments on this regulation are welcome on a 
continuing basis. Comments should be submitted to Kirsten Mortimer, 
Office of Exporter Services, Bureau of Export Administration, 
Department of Commerce, P.O. Box 273, Washington, DC 20044.

List of Subjects in 15 CFR Parts 742 and 774

    Exports, foreign trade.

    Accordingly, 15 CFR Chapter 7, Subchapter C, is amended as follows:
    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; 
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. 12924, 59 FR 43437, 3 CFR, 
1994 Comp., p. 917; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 
950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; Notice of 
November 12, 1998, 63 FR 63589, 3 CFR, 1998 Comp., p. 305; Notice of 
August 3, 2000 (65 FR 48347, August 8, 2000).

    2. 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; E.O. 12924, 59 FR 43437, 3 CFR, 1994 
Comp., p. 917; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; 
Notice of August 3, 2000 (65 FR 48347, August 8, 2000).

PART 742--[AMENDED]

    3. Section 742.18 is amended by revising paragraph (a)(1) as 
follows:


Sec. 742.18  Chemical Weapons Convention (CWC or Convention)

* * * * *
    (a) * * *
    (1) Schedule 1 chemicals identified in ECCNs 1C350 and 1C351. A 
license is required for CW reasons for exports and reexports of 
Schedule 1 chemicals identified under ECCN 1C350.a.20, a.24, and a.31 
and ECCN 1C351.d.5 and d.6 to all destinations including Canada. CW 
applies to 1C351.d.5 for ricin in the form of Ricinus Communis 
Agglutinin II (RCA II), also known as ricin D or 
Ricinus Communis Lectin III (RCL III); and 
Ricinus Communis Lectin IV (RCL IV), also known 
as ricin E. CW applies to 1C351.d.6 for saxitoxin identified by C.A.S. 
#35523-89-8. Also see the advance notification procedures and annual 
reporting requirements described in Sec. 745.1 of the EAR.
* * * * *

PART 774--[AMENDED]

    4. In Supplement No. 1 to part 774 (the Commerce Control List), 
Category 1--Materials, Chemicals, ``Microorganisms,'' and ``Toxins'', 
Export Control Classification Numbers (ECCNs) are amended:
    a. By revising the License Requirements section for ECCN 1C350;
    b. By revising ECCN 1C351; and
    c. By revising ECCN 1C991, as follows:


1C350  Chemicals, that may be used as precursors for toxic chemical 
agents.

License Requirements

    Reason for Control: CB, CW, AT

------------------------------------------------------------------------
               Control(s)                         Country chart
------------------------------------------------------------------------
CB applies to entire entry.............  CB Column 2
------------------------------------------------------------------------

    CW applies to 1C350.a.2, a.3, a.5, a.6, a.7, a.8, a.10, a.11, a.12, 
a.13, a.15, a.16, a.17, a.20, a.21, a.22, a.23, a.24, a.28, a.29, a.30, 
a.31, a.32, a.33, a.35, a.37, a.41, a.47, a.48, a.49, a.50, a.51, a.53, 
or a.54. For 1C350.a.20, a.24 and a.31, a license is required for CW 
reasons for all destinations, including Canada. For all other chemicals 
controlled for CW reasons, a license is a required for export to 
countries not listed in Supplement No. 2 to part 745, except for 
Schedule 3 chemicals which do not require a license for CW reasons if 
an End-Use Certificate has been obtained from the government of the 
importing country. See Sec. 742.18 of the EAR. Also, see Sec. 745.2 of 
the EAR for End-Use Certificate requirements. The Commerce Country 
Chart is not designed to determine licensing requirements for items 
controlled for CW reasons.

AT applies to entire entry...............  AT Column 1
 

    License Requirement Notes:
    1. SAMPLE SHIPMENTS: Certain sample shipments of chemicals 
controlled under ECCN 1C350 may be made without a license, as provided 
by the following:
    a. Chemicals Not Eligible: No CWC Schedule 1 chemical is eligible 
for sample shipment without a license. Therefore, the following 
chemicals are not eligible for sample shipments: 0-Ethyl-2-
diisopropylaminoethyl methylphosphonite (QL) (C.A.S. #57856-11-8), 
Ethylphosphonyl difluoride (C.A.S. #753-98-0), and Methylphosphonyl 
difluoride (C.A.S. #676-99-3).
    b. Countries Not Eligible: The following countries are not eligible 
to receive any sample shipments: Cuba, Iran, Iraq, Libya, North Korea, 
Sudan, Syria.
    c. Sample Shipments: A license is not required for sample shipments 
when the cumulative total of these shipments does not exceed a 55-
gallon container or 200 kg of each chemical to any one consignee per 
calendar year. Multiple sample shipments, in any quantity, not 
exceeding the totals indicated in this paragraph may be exported 
without a license, in accordance with the provisions of this Note 1. A 
consignee that receives a sample shipment under this exclusion may not 
resell, transfer, or reexport the sample shipment, but may use the 
sample shipment for any other legal purpose unrelated to chemical 
weapons. However, a sample shipment exported and received under this 
exclusion remains subject to all General Prohibitions including the 
end-use restriction described in Sec. 744.4 of the EAR. Sample 
shipments of chemicals included in CWC Schedule 2 and controlled for CW 
reasons to non-CWC States Parties (destinations not listed in 
Supplement No. 2 to part 745 of the EAR) may not be made without a 
license. Sample shipments of chemicals listed in Schedule 3 and 
controlled for CW reasons to non-States Parties may not be made without 
first obtaining an End-Use Certificate, as described in Sec. 745.2 of 
the EAR. If no End-Use Certificate is obtained pursuant to Sec. 745.2 
of the EAR, a license is required for sample shipments to non-

[[Page 58914]]

CWC States Parties of Schedule 3 chemicals controlled under ECCN 1C350 
for CW reasons.
    d. The exporter is required to submit a quarterly written report 
for shipments of samples made under this Note 1. The report must be on 
company letterhead stationery (titled ``Report of Sample Shipments of 
Chemical Precursors'' at the top of the first page) and identify the 
chemical(s), Chemical Abstract Service Registry (C.A.S.) number(s), 
quantity(ies), the ultimate consignee's name and address, and the date 
exported. The report must be sent to the U.S. Department of Commerce, 
Bureau of Export Administration, P.O. Box 273, Washington, DC 20044, 
Attn: ``Report of Sample Shipments of Chemical Precursors''.
    2. MIXTURES: Mixtures controlled by this entry that contain certain 
concentrations of precursor and intermediate chemicals are subject to 
the following licensing requirements:
    a. A license is required, regardless of the concentrations in the 
mixture, for the following chemicals: 0-Ethyl-2-diisopropylaminoethyl 
methylphosphonite (QL) (C.A.S.#57856-11-8), Ethylphosphonyl 
difluoride (C.A.S.#753-98-0) and Methylphosphonyl difluoride 
(C.A.S.#676-99-3), unless the mixture contains less than 0.5% 
aggregate quantities of Schedule 1 chemicals as unavoidable by-products 
or impurities, and the Schedule 1 chemicals are not intentionally 
produced or added.
    b. A license is required when at least one of the following 
chemicals constitutes more than 10 percent of the weight of the 
mixture: Arsenic trichloride (C.A.S.#7784-34-1), Benzilic acid 
(C.A.S.#76-93-7), Diethyl ethylphosphonate (C.A.S.#78-38-6), 
Diethyl methylphosphonite (C.A.S.#15715-41-0),Diethyl-N,N-
dimethylphosphoroamidate (C.A.S.#2404-03-7), N,N-Diisopropyl-beta-
aminoethane thiol (C.A.S.#5842-07-9), N,N-Diisopropyl-2-aminoethyl 
chloride hydrochloride (C.A.S.#4261-68-1), N,N-Diisopropyl-beta-
aminoethanol (C.A.S.#96-80-0), N,N-Diisopropyl-beta-aminoethyl 
chloride (C.A.S.#96-79-7), Dimethyl ethylphosphonate 
(C.A.S.#6163-75-3), Dimethyl methylphosphonate (C.A.S.#756-79-
6), Ethylphosphonous dichloride [Ethylphosphinyl dichloride] 
(C.A.S.#1498-40-4), Ethylphosphonus difluoride [Ethylphosphinyl 
difluoride] (C.A.S.#430-78-4), Ethylphosphonyl dichloride 
(C.A.S.#1066-50-8), Methylphosphonous dichloride [Methylphosphinyl 
dichloride] (C.A.S.#676-83-5), Methylphosphonous difluoride 
[Methylphosphinyl difluoride] (C.A.S.#753-59-3), Methylphosphonyl 
dichloride (C.A.S.#676-97-1), Pinacolyl alcohol (C.A.S.#464-07-
3), 3-Quinuclidinol (C.A.S.#1619-34-7), and Thiodiglycol 
(C.A.S.#111-48-8) (Related ECCN: 1C995);
    c. A license is required when at least one of all other chemicals 
in the List of Items Controlled under ECCN 1C350 constitutes more than 
25 percent of the weight of the mixture (related ECCN: 1C995); and
    d. A license is not required under this entry for mixtures when the 
controlled chemical is a normal ingredient in consumer goods packaged 
for retail sale for personal use. Such consumer goods are classified as 
EAR99.
    Note to Mixtures: Calculation of concentrations of AG-controlled 
chemicals:
    a. Exclusion. No chemical may be added to the mixture (solution) 
for the sole purpose of circumventing the Export Administration 
Regulations;
    b. Absolute Weight Calculation. When calculating the percentage, by 
weight, of components in a chemical mixture, include all components of 
the mixture, including those that act as solvents;
    c. Example.

11% chemical listed in paragraph b. of Note 2.
39% chemical not listed in Note 2
50% Solvent
100% Mixture
11/100=11% chemical listed in paragraph b. of Note 2.
    In this example, a license is required because a chemical listed in 
paragraph b. of Note 2 constitutes more than 10 percent of the weight 
of the mixture.
    3. COMPOUNDS. A license is not required under this entry for 
chemical compounds created with any chemicals identified in this entry, 
unless those compounds are also identified in this entry.
    Technical Notes: 1. For purposes of this entry, a ``mixture'' is 
defined as a solid, liquid or gaseous product made up of two or more 
components that do not react together under normal storage conditions.
    2. The scope of this control applicable to Hydrogen Fluoride (Item 
25 in List of Items Controlled) includes its liquid, gaseous, and 
aqueous phases, and hydrates.

LIST OF ITEMS CONTROLLED

* * * * *


1C351  Human pathogens, zoonoses, 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.5 and d.6 and a license is required for CW 
reasons for all destinations, including Canada, as follows: CW applies 
to 1C351.d.5 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 1C351d.6 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.

AT applies to entire entry................  AT Column 1
 

License Exceptions

    LVS: N/A
    GBS: N/A
    CIV: N/A

List of Items Controlled

    Unit: $ value.
    Related Controls: 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. 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. For the 
purposes of this entry, only saxitoxin is controlled under

[[Page 58915]]

paragraph d.6; other members of the paralytic shellfish poison family 
(e.g. neosaxitoxin) are classified as EAR99.
    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.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; or
    a.20. Yellow fever virus.
    b. Rickettsiae, as follows:
    b.1. Bartonella quintana (Rochalimea quintana, Rickettsia 
quintana);
    b.2. Coxiella burnetii;
    b.3. Rickettsia prowasecki; 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.
    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; or
    d.11. Aflatoxins.


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

License Requirements

    Reason for Control: CB, AT.

------------------------------------------------------------------------
               Control(s)                         Country Chart
------------------------------------------------------------------------
CB applies to 1C991.d..................  CB Column 3
AT applies to entire entry.............  AT Column 1
------------------------------------------------------------------------

License Exceptions

    LVS: N/A
    GBS: N/A
    CIV: N/A

List of Items Controlled

    Unit: $ value.
    Related Controls: Medical products containing 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; and saxitoxin identified by 
C.A.S. #35523-89-8, are controlled for CW reasons under 1C351.
    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 human administration in the 
treatment of medical conditions; (2) prepackaged for distribution as 
medical products; and, (3) approved by the Food and Drug Administration 
to be marketed as medical products. 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.
    Items:

    a. Vaccines containing items controlled by ECCNs 1C351, 1C352, 
1C353 and 1C354;
    b. Immunotoxins;
    c. Medical products containing botulinum toxins controlled by ECCN 
1C351.d.1;
    d. Medical products containing biological toxins controlled by ECCN 
1C351.d.2 through d.11, except biological toxins controlled for CW 
reasons under 1C351.d.5 and d.6; and
    e. Diagnostic and food testing kits containing biological toxins 
controlled by ECCN 1C351.d, except biological toxins controlled for CW 
reasons under ECCN 1C351.d.5 and d.6.

    5. In Supplement No. 1 to part 774 (the Commerce Control List), 
Category 2--Materials Processing, Export Control Classification Numbers 
(ECCNs) are amended:
    a. By revising the List of Items Controlled section for 2B350;
    b. By revising the entry heading and List of Items Controlled 
section for ECCN 2B351; and
    c. By revising the List of Items Controlled section for ECCN 2B352, 
as follows:


2B350  Chemical manufacturing facilities and equipment, 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: (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, Office 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 m \3\ (100 liters) 
and less than 20 m \3\ (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 enamelled 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; or
    a.7. Zirconium or zirconium alloys;
    b. Agitators for use in reaction vessels or reactors where all 
surfaces of the agitator that come in direct contact with the 
chemical(s) being processed or contained are made from any of the 
following materials:

[[Page 58916]]

    b.1. Alloys with more than 25% nickel and 20% chromium by weight;
    b.2. Fluoropolymers;
    b.3. Glass (including vitrified or enamelled 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; or
    b.7. Zirconium or zirconium alloys;
    c. Storage tanks, containers or receivers with a total internal 
(geometric) volume greater than 0.1 m\3\ (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 enamelled 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; or
    c.7. Zirconium or zirconium alloys;
    d. Heat exchangers or condensers with a heat transfer surface area 
of less than 20 m\2\, 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 enamelled coatings or glass 
lining);
    d.4. 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; or
    d.10. Zirconium or zirconium alloys
    e. Distillation or absorption columns of internal diameter greater 
than 0.1 m, 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 enamelled coatings or glass 
lining);
    e.4. 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; or
    e.8. Zirconium or zirconium 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. Multiple seal valves incorporating a leak detection port, 
bellows-seal valves, non-return (check) valves or diaphragm valves, in 
which all surfaces that come into direct contact with the chemical(s) 
being processed or contained are made from any of the following 
materials:
    g.1. Alloys with more than 25% nickel and 20% chromium by weight;
    g.2. Fluoropolymers;
    g.3. Glass (including vitrified or enamelled coatings or glass 
lining);
    g.4. Nickel or alloys with more than 40% nickel by weight;
    g.5. Tantalum or tantalum alloys;
    g.6. Titanium or titanium alloys; or
    g.7. Zirconium or zirconium 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 enamelled coatings or glass 
lining);
    h.4. 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; or
    h.8. Zirconium or zirconium alloys;
    i. Multiple-seal, canned drive, magnetic drive, bellows or 
diaphragm pumps, with manufacturer's specified maximum flow-rate 
greater than 0.6 m\3\/hour, or vacuum pumps with manufacturer's 
specified maximum flow-rate greater than 5 m\3\/hour (under standard 
temperature (273 K (0 deg. C)) and pressure (101.3 kPa) conditions), 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 enamelled coatings or glass 
lining);
    i.6. 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, or
    i.10. Zirconium or zirconium alloys;
    j. Incinerators designed to destroy chemical warfare agents, or 
chemical weapons precursors controlled by 1C350, 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.


2B351  Toxic gas monitoring systems that operate on-line and dedicated 
detectors therefor.

* * * * *

List of Items Controlled

    Unit: Equipment in number.
    Related Controls: N/A.
    Related Definitions: For the purposes of this entry, the term 
``continuous operation'' describes the capability of the equipment to 
operate on line without human intervention. The intent of this entry is 
to control toxic gas monitoring systems capable of collection and 
detection of samples in environments such as chemical plants, rather 
than those used for batch-mode operation in laboratories.
    Items:
    a. Designed for continuous operation and usable for the detection 
of chemical warfare agents or chemicals controlled by 1C350 at 
concentrations of less than 0.3mg/m\3\ (see technical note below); or
    b. Designed for the detection of cholinesterase-inhibiting 
activity.

    Technical Note: Toxic Gas Monitoring Systems, controlled under 
2B351.a., include those with detection capability for chemicals 
containing phosphorus, sulfur, fluorine or chlorine, other than 
those specified in 1C350.

2B352  Equipment capable of use in handling biological materials, as 
follows (see List of Items Controlled).

* * * * *

List of Items Controlled

    Unit: Equipment in number.
    Related Controls: N/A.
    Related Definitions: For purposes of this entry, isolators include 
flexible isolators, dry boxes, anaerobic chambers and glove boxes.
    Items:
    a. Complete containment facilities at P3 or P4 containment level;

    Technical Note: P3 or P4 (BL3, BL4, L3, L4) containment levels 
are as specified in the WHO Laboratory Biosafety Manual (Geneva, 
1983).

    b. Fermenters capable of cultivation of pathogenic microorganisms, 
viruses, or for toxin production, without the propagation of aerosols, 
having a capacity equal to or greater than 100 liters.


[[Page 58917]]


    Technical Note: Fermenters include bioreactors, chemostats, and 
continuous-flow systems.

    c. Centrifugal separators capable of the continuous separation of 
pathogenic microorganisms, without the propagation of aerosols, and 
having all of the following characteristics:
    c.1. A flow rate greater than 100 liters per hour;
    c.2. Components of polished stainless steel or titanium;
    c.3. Double or multiple sealing joints within the steam containment 
area; and
    c.4. Capable of in situ steam sterilization in a closed state.

    Technical Note: Centrifugal separators include decanters.

    d. Cross (tangential) flow filtration equipment capable of 
continuous separation of pathogenic microorganisms, viruses, toxins, 
and cell cultures without the propagation of aerosols, having all of 
the following characteristics:
    d.1. Equal to or greater than 5 square meters;
    d.2. Capable of in situ sterilization.
    e. Steam sterilizable freeze-drying equipment with a condenser 
capacity greater than 50 kgs of ice in 24 hours but less than 1,000 
kgs;
    f. Equipment that incorporates or is contained in P3 or P4 
containment housing, as follows:
    f.1. Independently ventilated protective full or half suits;
    f.2. Class III biological safety cabinets or isolators with similar 
performance standards;
    g. Chambers designed for aerosol challenge testing with 
microorganisms, viruses, or toxins and having a capacity of 1 m\3\ or 
greater.

    Dated: September 22, 2000.
R. Roger Majak,
Assistant Secretary for Export Administration.
[FR Doc. 00-25068 Filed 10-2-00; 8:45 am]
BILLING CODE 3510-33-P