[Federal Register Volume 64, Number 194 (Thursday, October 7, 1999)]
[Rules and Regulations]
[Pages 54520-54522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26215]


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DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Part 774

[Docket No. 990920257-9257-01]
RIN 0694-AB85


Revisions to the Commerce Control List (ECCNs 1C351, 1C991, and 
2B351): Medical Products Containing Biological Toxins; and Toxic Gas 
Monitoring Systems and Dedicated Detectors

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 1998 
Australia Group agreement to amend controls on toxic gas monitoring 
systems and dedicated detectors. This final rule also amends the CCL to 
authorize, without a license, exports of medical products containing 
controlled biological toxins (except saxitoxin and ricin) that are 
developed, packaged and sold for medical treatment. This rule will 
result in a decreased licensing burden on U.S. industry.

EFFECTIVE DATE: This rule is effective October 7, 1999.:

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

SUPPLEMENTARY INFORMATION:

Background

    The Australia Group (AG), a multilateral forum for the coordination 
of export controls to curtail the proliferation of chemical and 
biological weapons, held its annual consultations in Paris, October 9-
15, 1998. The 30 AG member countries agreed to maintain export controls 
on a list of chemicals,

[[Page 54521]]

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 member governments' national controls.
    At the October 1998 Australia Group consultations, participants 
agreed to revise the control list entry for toxic gas monitoring 
systems and dedicated detectors 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, the 
phrase ``or organic compounds containing phosphorus, sulphur, fluorine 
or chlorine'' is deleted from the description of items controlled, and 
a technical note is added to clarify that systems capable of detecting 
compounds containing these chemicals are controlled. The Department of 
Commerce has routinely interpreted this entry to include systems with 
capability to detect inorganic compounds. The AG discussions confirmed 
that other AG members agreed with this interpretation.
    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 for export and reexport to 
all destinations, except Canada. These controls are implemented in 
accordance with the export control provisions of the Australia Group. 
Medical products that contain the AG-controlled biological toxins that 
are prepackaged in units applicable to the intended medical treatment 
pose no significant proliferation concerns. Therefore, this final rule 
adds to ECCN 1C991 medical products that contain biological toxins 
controlled under ECCN 1C351.d, except d.5 and d.6 (ricin and 
saxitoxin), when such products are developed, packaged and sold for 
medical treatment. Such products may be exported and reexported without 
a license to all countries except countries listed in CB Column 3 on 
the Commerce Country Chart (Supplement No. 1 to part 738 of the EAR). 
This new exemption from licensing requirements does not apply if the 
biological toxin is to be exported in any other configuration, 
including bulk shipments, or for any other end-uses.
    Although the Export Administration Act (EAA) expired on August 20, 
1994, the President invoked the International Emergency Economic Powers 
Act and continued in effect the EAR, and, to the extent permitted by 
law, the provisions of the EAA in Executive Order 12924 of August 19, 
1994, extended by Presidential notice of August 10, 1999, 64 FR 44101 
(August 13, 1999).

Rulemaking Requirements

    1. This final rule has been determined to be not significant for 
purposes of E.O. 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 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 E.O. 
12612.
    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 interim 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. or by 
any other law, the requirements of the Regulatory Flexibility Act (5 
U.S.C. 601 et seq. ) are not applicable.

List of Subjects in 15 CFR Part 774

    Exports, foreign trade.
    Accordingly, 15 CFR Chapter 7, Subchapter C, is amended to read as 
follows:
    1. 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); 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 10, 1999, 64 FR 44101 (August 13, 1999).

PART 774--[AMENDED]

    2. Category 1, Materials, of the Commerce Control List is amended 
by revising the ``List of Items Controlled'' in ECCN 1C351 and revising 
ECCN 1C991, to read as follows:

1C351  Human pathogens, zoonoses, and ``toxins'', as follows (see List 
of Items Controlled).
* * * * *
List of Items Controlled
    Unit: $ value.
    Related Controls: All vaccines and ``immunotoxins'' are excluded 
from the scope of this entry. Certain medical products that contain 
biological toxins controlled under paragraph (d) of this entry, with 
the exception of d.5 and d.6, are excluded from the scope of this 
entry. Vaccines, ``immunotoxins'', and certain medical products 
excluded from the scope of this entry are controlled under ECCN 1C991.
    Related Definition: 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

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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; or
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 and medical products, as follows (see 
List of Items controlled).
License Requirements
    Reason for Control: CB, AT.

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                Control(s)                          Country chart
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CB applies to 1C991.c.....................  CB Column 3.
AT applies to entire entry................  AT Column 1.
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License Exceptions
LVS: N/A
GBS: N/A
CIV: N/A
List of Items Controlled
    Unit: $ value.
    Related Controls: N/A.
    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 
prepackaged in units applicable to the intended medical treatment, and 
do not include biological toxins in any other configuration, including 
bulk shipments, or for any other end-uses. Such toxins are controlled 
by ECCN 1C351.
    Items: a. Vaccines containing items controlled by ECCNs 1C351, 
1C352, 1C353 and 1C354;
    b. Immunotoxins; and
    c. Medical products containing biological toxins controlled by ECCN 
1C351.d, except d.5 and d.6.
    3. Category 2, Materials Processing, of the Commerce Control List 
is amended by revising the ``List of Items Controlled'' in ECCN 2B351 
to read as follows:

    2B351  Toxic gas monitoring systems and dedicated detectors 
therefor.
* * * * *
List of Items Controlled
    Unit: Equipment in number.
    Related Controls: N/A.
    Related Definitions: N/A.
    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.

    Dated: September 30, 1999.
Iain S. Baird,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 99-26215 Filed 10-6-99; 8:45 am]
BILLING CODE 3510-33-P