[Federal Register Volume 61, Number 154 (Thursday, August 8, 1996)]
[Rules and Regulations]
[Pages 41326-41329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20166]


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DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Parts 774 and 799A

[Docket No. 960723206-6206-0]
RIN 0694-AB37


Biological Warfare Experts Group Meeting: Implementation of 
Changes to Export Administration Regulations; ECCNs 1C991, 1C61B, 
1B71E, and 1C91F

AGENCY: Bureau of Export Administration, Commerce.

ACTION: Final rule.

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SUMMARY: The Bureau of Export Administration (BXA) maintains the 
Commerce Control List (CCL) as part of the Export Administration 
Regulations (EAR). This rule amends the CCL by revising Export Control 
Classification Numbers (ECCNs) 1C991, 1C61B, 1B71E, and 1C91F. The 
changes made by this rule are based on discussions in the Biological 
Warfare Experts Group (a subgroup of the Australia Group (AG)).
    This rule will minimally increase the number of validated export 
licenses required for items classified under ECCN 1C61B and 1B71E.
    The EAR have been completely amended by an interim rule published 
on March 25, 1996 (61 FR 12714) that provides for a transition period 
within which exporters can take advantage of both the old rules and the 
new rules until November 1, 1996. Therefore, this rule and all other 
amendments to the EAR during the transition period will amend both the 
new EAR and the old EAR, which are now designated with the letter ``A'' 
following the part number. This rule consists primarily of changes to 
the old EAR to conform to the new EAR, except changes to ECCNs 1C991 
and 1C91F.

DATES: This rule is effective August 8, 1996.

FOR FURTHER INFORMATION CONTACT: For questions on foreign policy 
controls, call Patricia Sefcik, Bureau of Export Administration, 
Telephone: (202) 482-0707.
    For questions of a technical nature on chemical weapon precursors, 
biological agents, and equipment that can be used to produce chemical 
and biological weapons agents, call James Seevaratnam, Bureau of Export 
Administration, Telephone: (202) 482-3343.
    For questions of a general nature, call Hillary Hess, Bureau Export 
Administration, Telephone: (202) 482-2440.

SUPPLEMENTARY INFORMATION:

Background

    Consultations of the Biological Warfare Experts Group were held 
October 16-19, 1995 in conjunction with the Australia Group plenary 
meeting. The consultations resulted in changes to the list of 
controlled items, including the following revisions to the names of 
certain microorganisms: Changing Rickettsia quintana to Bartonella 
quintana (Rochalimea quintana, Rickettsia quintana), Pseudomonas mallei 
to Burkholderia mallei (Pseudomonas mallei), and Pseudomonas 
pseudomallei to Burkholderia pseudomallei (Pseudomonas pseudomallei). 
It was also agreed to place the former name in parentheses following 
the new name on the list in order to assist in appropriate 
identification for export control purposes.
    This rule revises the note in the requirement section of ECCN 1C61B 
to exclude immunotoxins. A technical note added to ECCN 1C61B provides 
the definitions of ``immunotoxin'' and ``subunit''. Immunotoxins are 
therapeutics with no biological warfare application. Immunotoxins have 
been added to ECCN 1C91F and are eligible for export under the 
provisions of General License G-DEST to all destinations but those 
listed in Country Groups S, Z, and Iran. In addition, a technical note 
that adds the definition of ``immunotoxin'' has been added to ECCN 
1C91F. This rule makes parallel changes to ECCN 1C991.
    This rule also implements changes in the area of dual-use 
biological equipment. In ECCN 1B71E, ``Equipment that can be used in 
the production of biological weapons'', the capacity parameter for 
fermenters, within paragraph (b), is decreased from ``equal to or 
greater than 300 liters'' to ``equal to or greater than 100 liters''. 
This is done to expand export controls to capture smaller fermenters 
that can be used for biological warfare purposes.
    Prior to this final rule, fermenters of the designated size were 
controlled only if they either contained ``double or multiple sealing 
joints within the steam containment area'' or were ``capable of in-situ 
sterilization in a closed state.'' These two modifiers or limiting

[[Page 41327]]

descriptors have been removed by this final rule.
    This rule also makes a clarification to cross-flow filtration 
equipment (ECCN 1B71E paragraph (d)). Where the control language 
formerly stated ``cross-flow filtration equipment designed for 
continuous separation * * *'', this final rule controls ``Cross-flow 
filtration equipment capable of continuous separation * * *''.
    Lastly, this rule expands controls on aerosol chambers within ECCN 
1B71E paragraph (g). Where the control language used to state 
``Chambers designed for aerosol challenge testing with pathogenic 
microorganisms * * *'', it will now state ``Chambers designed for 
aerosol challenge testing with microorganisms * * *''. The word 
``pathogenic'' is removed to expand export controls to aerosol chambers 
not specifically designed for pathogenic microorganisms.
    Although the Export Administration Act (EAA) expired on August 20, 
1994, the President invoked the International Emergency Economic Powers 
Act and continued in effect, to the extent permitted by law, the 
provisions of the EAA and the EAR in Executive Order 12924 of August 
19, 1994, as extended by the President's notice of August 15, 1995 (60 
FR 42767).

Saving Clause

    Shipments of items removed from general license authorizations as a 
result of this regulatory action that were on dock for loading, on 
lighter, laden aboard an exporting carrier, or en route aboard a 
carrier to a port of export pursuant to actual orders for export before 
August 8, 1996 may be exported under the previous general license 
provisions up to and including September 9, 1996. Any such items not 
actually exported before midnight September 9, 1996, require a 
validated export license in accordance with this regulation.

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 a 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 OMB Control Number. This rule 
involves collections of information subject to the Paperwork Reduction 
Act of 1980 (44 U.S.C. 3501 et seq.). These collections have been 
approved by the Office of Management and Budget under control numbers 
0694-0005, 0694-0010, 0694-0067, and 0694-0088.
    3. This rule does not contain policies with Federalism implications 
sufficient to warrant preparation of a Federalism assessment under 
Executive Order 12612.
    4. Because a notice of proposed rulemaking and an opportunity for 
public comment are not required to be given for this rule by section 
553 of the Administrative Procedure Act (5 U.S.C. 553) or by any other 
law, under section 3(a) of the Regulatory Flexibility Act (5 U.S.C. 
603(a) and 603(b)) no initial or final Regulatory Flexibility Analysis 
has to be or will be prepared.
    5. 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. Section 13(b) of the EAA does not 
require that this rule be published in proposed form because this rule 
does not impose a new control. Further, no other law requires that a 
notice of proposed rulemaking and an opportunity for public comment be 
given for this rule.
    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 Hillary 
Hess, Regulatory Policy Division, Office of Exporter Services, Bureau 
of Export Administration, Department of Commerce, PO Box 273, 
Washington, DC 20044.

List of Subjects

15 CFR Part 774

    Exports, Foreign trade.

15 CFR Part 799A

    Exports, Reporting and recordkeeping requirements.

    Accordingly, parts 774 and 799A of the Export Administration 
Regulations (15 CFR parts 730-799) are amended as follows:

PART 774--[AMENDED]

    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; Sec. 201, Pub. L. 104-
58, 109 Stat. 557 (30 U.S.C. 185(s)); 30 U.S.C. 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; 
Notice of August 15, 1995 (60 FR 42767, August 17, 1995).

Supplement No. 1 to Part 774

    2. In Category 1, Materials, ECCN 1C991 is revised to read as 
follows:

1C991  Vaccines containing items controlled by ECCNs 1C351, 1C352, 
1C353 and 1C354, and immunotoxins.

Licenses Requirements

    Reason for Control: AT

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                Control(s)                         Country chart        
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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 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.
    Items:
    The list of items controlled is contained in the ECCN heading.

PART 799A--[AMENDED]

    3. The authority citation for 15 CFR part 799A continues to read as 
follows:

    Authority: Pub. L. 90-351, 82 Stat. 197 (18 U.S.C. 2510 et 
seq.), as amended; Pub. L. 95-223, 91 Stat. 1626 (50 U.S.C. 1701 et 
seq.); Pub. L. 95-242, 92 Stat. 120 (22 U.S.C. 3201 et seq. and 42 
U.S.C. 2139a); Pub. L. 96-72, 93 Stat. 503 (50 U.S.C. App. 2401 et 
seq.), as amended [(extended by Pub. L. 103-10, 107 Stat. 40 and by 
Pub. L. 103-277, 108 Stat. 1407)]; Pub. L. 102-484, 106 Stat. 2575 
(22 U.S.C. 6004); E.O. 12002 of July 7, 1977 (42 FR 35623, July 7, 
1977), as amended; E.O. 12058 of May 11, 1978 (43 FR 20947, May 16, 
1978); E.O. 12214 of May 2, 1980 (45 FR 29783, May 6, 1980); E.O. 
12735 of November 16, 1990 (55 FR 48587, November 20, 1990), as 
continued by Notice of November 12, 1993 (58 FR 60361, November 15, 
1993); E.O. 12851 of June 11, 1993 (58 FR 33181, June 15, 1993); 
E.O. 12867 of September 30, 1993 (58 FR 51747, October 4, 1993); 
E.O. 12930 of September 29, 1994 (59 FR 50475, October 3, 1994); 
E.O. 12924 of August 19, 1994 (59 FR 43437 of August 23, 1994); E.O. 
12930 (59 FR 50475 of October 3, 1994); and Notice of August 15, 
1995 (60 FR 42767).

Supplement No. 1 to Sec. 799A.1

    4. In Category 1, Materials, ECCNs 1B71E, 1C61B, and 1C91F are 
revised to read as follows:

[[Page 41328]]

1B71E  Equipment that can be used in the production of biological 
weapons.

Requirements

    Validated License Required: SZ, Supplement 5 to Part 778 (see Note)
    Unit: Number
    Reason for Control: CB
    GLV: $0
    GCT: No
    GFW: No

    Note: Special chemical License Available: see Sec. 773.9 of this 
subchapter.

List of Items Controlled

    a. Biohazard containment equipment as follows:
    a.1. Complete containment facilities at P3 or P4 containment level; 
and
    a.2. Equipment that incorporates or is contained in a P3 or P4 
containment housing.
    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.

    Note: Sub-groups of 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 stream 
containment area;
    c.4. Capable of in-situ stream sterilization in a closed state.

    Note: Centrifugal separators include decanters.

    d. Cross-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 condenser 
capacity greater than 50 kgs. but less than 1,000 kgs. of ice in 24 
hours.
    f. Equipment that incorporates or is contained in P3 or P4 
containment housing, as follows:
    f.1. Independently ventilated protective full or half suits; and
    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 cubic 
meter or greater.

1C61B  Microorganisms, toxins, and aflatoxins.

Requirements

    Validated License Required: QSTVWYZ
    Unit: $ value
    Reason For Control: CB
    GLV: $0
    GCT: No
    GFW: No

    Note: Notwithstanding the provisions of this entry, all vaccines 
and immunotoxins are excluded from the scope of this entry. See ECCN 
1C91F.

    Technical Note: For the purposes of ECCN 1C61B, the following 
definitions apply:
    a. ``Immunotoxin'' is an antibody-toxin conjugate intended to 
destroy specific target cells, e.g., tumor cells, that bear antigens 
homologous to the antibody; and
    b. ``Subunit'' is a portion of the toxin.

List of Items Controlled

    a. Viruses, as follows:
    a.1. African swine fever virus;
    a.2. Avian influenza virus;
    a.3. Bluetongue virus;
    a.4. Chikungunya virus
    a.5. Congo-Crimean haemorrhagic fever virus;
    a.6. Dengue fever virus;
    a.7. Eastern equine encephalitis virus;
    a.8. Ebola virus;
    a.9. Foot and mouth disease virus;
    a.10. Goat pox virus;
    a.11. Hantaan virus;
    a.12. Herpes virus (Aujeszky's disease);
    a.13. Hog cholera virus;
    a.14. Japanese encephalitis virus;
    a.15. Junin virus;
    a.16. Lassa fever virus;
    a.17. Lymphocytic choriomeningitis virus;
    a.18. Machupo virus;
    a.19. Marburg virus;
    a.20. Monkey pox virus;
    a.21. Newcastle disease virus;
    a.22. Peste des petits ruminants virus;
    a.23. Porcine enterovirus type 9;
    a.24. Rift Valley fever virus;
    a.25. Rinderpest virus;
    a.26. Sheep pox virus;
    a.27. Teschen disease virus;
    a.28. Tick-borne encephalitis virus (Russian Spring-Summer 
encephalitis virus);
    a.29. Variola virus;
    a.30. Venezuelan equine encephalitis virus;
    a.31. Vesicular stomatitis virus;
    a.32. Western equine encephalitis virus;
    a.33. White pox; or
    a.34. 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. Mycoplasma mycoides;
    c.11. Pseudomonas solanacerum;
    c.12. Salmonella typhi;
    c.13. Shigella dysenteriae;
    c.14. Vibrio cholerae;
    c.15. Xanthonomas albilineas;
    c.16. Xanthonomas campestris pv citri;
    c.17. Xanthomonas campestris pv oryzae; or
    c.18. Yersinia pestis.
    d. Fungi, as follows:
    d.1. Cochliobolus miyabeanus (Helminthosporium oryzae);
    d.2. Colletotrichum coffeanum var. virulans (Colletotrichum 
kahawae);
    d.3. Heliminthosporium maydis;
    d.4. Heliminthosprium oryzae;
    d.5. Microcyclus ulei (syn. Dothidella ulei);
    d.6. Puccinia glumarum;
    d.7. Puccinia graminis (syn. Puccinia graminis f. sp. tritici);
    d.8. Puccinia striiformis (syn. Puccinia glumarum);
    d.9. Pyricularia grisea/Pyricularia oryzae; or
    d.10. Ustilago maydis.
    e. Genetically modified microorganisms, as follows:
    e.1. Genetically modified micro-organisms or genetic elements that 
contain nucleic acid sequences associated with pathogenicity and are 
derived from organisms identified in this ECCN;
    e.2. Genetically modified micro-organisms or genetic elements that 
contain nucleic acid sequences associated with pathogenicity derived 
from plant pathogens identified in this ECCN; or
    e.3. Genetically modified microorganisms or genetic elements that 
contain nucleic acid sequences coding for any of the toxins, or their 
subunits listed in paragraph f of this ECCN.
    f. Toxins, as follows and subunits thereof:

[[Page 41329]]

    f.1. Botulinum toxins;
    f.2. Clostridium perfringens toxins;
    f.3. Conotoxin;
    f.4. Microcystin (cyanogenosin);
    f.5. Ricin;
    f.6. Saxitoxin;
    f.7. Shiga toxin;
    f.8. Staphylococcus aureus toxins;
    f.9. Tetrodotoxin; or
    f.10. Verotoxin.

1C91F  Vaccines containing microorganisms and/or toxins controlled by 
ECCN 1C61B, and immunotoxins.

Requirements

    Validated License Required: SZ, Iran
    Unit: $ value
    Reason for Control: FP
    GLV: No
    GCT: No
    GFW: No

    Note: Vaccines that do not contain items controlled by ECCN 
1C61B are controlled by ECCN 1C96G.

    Technical Note: For the purposes of ECCN 1C91F, the definition of 
``Immunotoxin'' is an antibody-toxin conjugate intended to destroy 
specific target cells, e.g., tumor cells, that bear antigens homologous 
to the antibody.

    Dated: July 30, 1996.
Sue E. Eckert,
Assistant Secretary for Export Administration.
[FR Doc. 96-20166 Filed 8-7-96; 8:45 am]
BILLING CODE 3510-DT-P