Billing Code: 3510-33-P

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.

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: (DATE OF PUBLICATION).

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, 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

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

Control(s)	Country Chart

CB applies to 1C991.c	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: 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/m³ (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:

Iain S. Baird

Deputy Assistant Secretary

for Export Administration