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

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]

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