04-6111. Amendments to the Export Administration Regulations (EAR) Implementing the Understandings Reached at the June 2003 Australia Group (AG) Plenary Meeting and a Subsequent AG Intersessional Decision on Certain Animal Pathogens

AGENCY:

Bureau of Industry and Security, Commerce.

ACTION:

Final rule.

SUMMARY:

The Bureau of Industry and Security (BIS) is publishing this final rule to describe the understandings reached at the June 2003 plenary meeting of the Australia Group (AG) and to amend the Export Administration Regulations (EAR), as needed, to implement these AG understandings. Specifically, this final rule amends the EAR by adding twelve new viruses and two new bacteria to the list of AG-controlled human and zoonotic pathogens and toxins described on the Commerce Control List (CCL).

This rule also amends the EAR to implement an AG intersessional decision, which was adopted after the June 2003 AG plenary meeting, by adding two viruses to the list of AG-controlled animal pathogens described on the CCL.

Finally, this rule updates the list of countries that are currently States Parties to the Chemical Weapons Convention (CWC) by adding nine countries that recently became States Parties: Afghanistan, Belize, Cape Verde, Kyrgyzstan, Libya, Sao Tome and Principe, Timor Leste, Tonga, and Tuvalu.

DATES:

This rule is effective March 18, 2004.

ADDRESSES:

Written comments should be sent to Willard Fisher, Regulatory Policy Division, Office of Exporter Services, Bureau of Industry and Security, Room 2705, 14th Street and Pennsylvania Avenue, NW., Washington, DC 20230.

FOR FURTHER INFORMATION CONTACT:

Douglas Brown, Office of Nonproliferation Controls and Treaty Compliance, Bureau of Industry and Security, Telephone: [phone].

SUPPLEMENTARY INFORMATION:

Background

A. Revisions to the EAR Based on the June 2003 Plenary Meeting of the Australia Group

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to implement the understandings reached at the annual plenary meeting of the Australia Group (AG) that was held in Paris on June 2-5, 2003. The Australia Group is a multilateral forum, consisting of 33 participating countries, that maintains export controls on a list of chemicals, biological agents, and related equipment and technology that could be used in a chemical or biological weapons program. The AG periodically reviews items on its control list to enhance the effectiveness of participating governments' national controls and to achieve greater harmonization among these controls.

The understandings reached at the June 2003 plenary meeting resulted in multiple additions to the list of biological agents controlled by the AG. This final rule implements these changes by amending the EAR to add twelve new viruses and two new bacteria to the list of AG-controlled human and zoonotic pathogens and toxins described in Export Control Classification Number (ECCN) 1C351 on the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR).

Specifically, this rule adds the following twelve viruses to the list of AG-controlled viruses described in ECCN 1C351.a on the CCL: Kyasanur Forest virus, Louping ill virus, Murray Valley encephalitis virus, Omsk haemorrhagic fever virus, Oropouche virus, Powassan virus, Rocio virus, St. Louis encephalitis virus, Hendra virus (Equine morbillivirus), South American haemorrhagic fever (Sabia, Flexal, Guanarito), Pulmonary and renal syndrome-haemorrhagic fever viruses (Seoul, Dobrava, Puumala, Sin Nombre), and Nipah virus. These AG-listed viruses, along with all other items controlled by ECCN 1C351, require a license for export or reexport to all destinations, worldwide.

In addition, this rule adds the following two bacteria to the list of AG-controlled bacteria in ECCN 1C351.c on the CCL: Clostridium perfringens, epsilon toxin producing types and Enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing serotypes. ECCN 1C351.c, as revised by this rule, does not control Clostridium perfringens strains other than epsilon toxin producing types, since the other strains can be used as positive control cultures for food testing and quality control.

In conjunction with the additions to the list of AG-controlled bacteria in ECCN 1C351.c, this rule amends the Technical Note following ECCN 1C353.a to clarify that ECCN 1C353 does not control nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing strains, except those nucleic acid sequences that contain coding for the verotoxin or its sub-units.

B. Revisions to the EAR Based on an Intersessional Decision by the Australia Group.

BIS also is amending the EAR to implement an AG intersessional decision on animal pathogens that was adopted after the June 2003 AG plenary meeting. Specifically, this rule adds the following two viruses to the list of AG-controlled animal pathogens described in ECCN 1C352 on the CCL: Lumpy skin disease virus and African horse sickness virus.

C. Revisions to the EAR Based on the Addition of New States Parties to the Chemical Weapons Convention (CWC).

This rule revises Supplement No. 2 to Part 745 of the EAR (titled “States Parties to the Convention on the Prohibition of the Development, Production, Stockpiling, and Use of Chemical Weapons and on Their Destruction”) by adding the names of nine countries that have recently become States Parties to the CWC (i.e., Afghanistan, Belize, Cape Verde, Kyrgyzstan, Libya, Sao Tome and Principe, Timor Leste, Tonga, and Tuvalu).

Savings Clause

Shipments of items removed from license exception eligibility or eligibility for export without a license 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, on March 18, 2004, pursuant to actual orders for export to a foreign destination, may proceed to that destination under the previous license exception eligibility or without a license so long as they have been exported from the United States before April 19, 2004. Any such items not actually exported before midnight, on April 19, 2004, require a license in accordance with this regulation.

Rulemaking Requirements

1. This 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 of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule contains a collection of information subject to the requirements of the PRA. This collection has been approved by OMB under Control Number 0694-0088 (Multi-Purpose Application), which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to David Rostker, Office of Management and Budget (OMB), by e-mail to [e-mail], or by fax to [phone]; and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, PO Box 273, Washington, DC 20044.

3. This rule does not contain policies with Federalism implications as that term is defined in 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 5 U.S.C. 553 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 Willard Fisher, Regulatory Policy Division, Bureau of Industry and Security, U.S. Department of Commerce, Room 2705, 14th Street and Pennsylvania Avenue, NW., Washington, DC 20230.

List of Subjects

15 CFR Part 745

• Administrative practice and procedure
• Chemicals
• Exports
• Foreign trade
• Reporting and recordkeeping requirements

15 CFR Part 774

• Exports
• Foreign trade
• Reporting and recordkeeping requirements

Accordingly, Parts 745 and 774 of the Export Administration Regulations (15 CFR parts 730-799) are amended as follows:

PART 745—[AMENDED]

1. The authority citation for 15 CFR Part 745 continues to read as follows:

Authority: 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; Notice of November 9, 2000, 65 FR 68063, 3 CFR, 2000 Comp., p. 408.

2. Supplement No. 2 to part 745 is amended by revising the undesignated center heading “List of States Parties as of April 1, 2003” to read “List of States Parties as of March 1, 2004” and by adding, in alphabetical order, the countries “Afghanistan”, “Belize”, “Cape Verde”, “Kyrgyzstan”, “Libya”, “Sao Tome and Principe”, “Timor Leste (East Timor)”, “Tonga”, and “Tuvalu'.

PART 774—[AMENDED]

3. 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; Sec. 901-911, Pub. L. 106-387; Sec. 221, Pub. L. 107-56; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 7, 2003, 68 FR 47833, August 11, 2003.

4. In Supplement No. 1 to part 774 (the Commerce Control List), Category 1—Materials, Chemicals, “Microorganisms” & “Toxins,” ECCN 1C351 is amended by revising the List of Items Controlled to read as follows:

1C351 Human and zoonotic pathogens and “toxins”, as follows (see List of Items Controlled)

* * * * *

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 § 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 § 745.1 of the EAR for notification procedures. See 22 CFR part 121, Category XIV and § 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 paragraph d.6; other members of the paralytic shellfish poison family (e.g. neosaxitoxin) are classified as EAR99. Clostridium perfringens strains, other than the epsilon toxin-producing strains of Clostridium perfringens described in c.14, are excluded from the scope of this entry, since they may be used as positive control cultures for food testing and quality control.

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;

a.20. Yellow fever virus;

a.21. Kyasanur Forest virus;

a.22. Louping ill virus;

a.23. Murray Valley encephalitis virus;

a.24. Omsk haemorrhagic fever virus;

a.25. Oropouche virus;

a.26. Powassan virus;

a.27. Rocio virus;

a.28. St. Louis encephalitis virus;

a.29. Hendra virus (Equine morbillivirus);

a.30. South American haemorrhagic fever (Sabia, Flexal, Guanarito);

a.31. Pulmonary and renal syndrome-haemorrhagic fever viruses (Seoul, Dobrava, Puumala, Sin Nombre); or

a.32. Nipah 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;

c.14. Clostridium perfringens, epsilon toxin producing types; or

c.15. Enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing serotypes.

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;

d.11. Aflatoxins;

d.12. Abrin;

d.13. Cholera toxin;

d.14. Diacetoxyscirpenol toxin;

d.15. T-2 toxin;

d.16. HT-2 toxin;

d.17. Modeccin toxin;

d.18. Volkensin toxin; or

d.19. Viscum Album Lectin 1 (Viscumin).

5. In Supplement No. 1 to part 774 (the Commerce Control List), Category 1—Materials, Chemicals, “Microorganisms” & “Toxins,” ECCN 1C352 is amended by revising the List of Items Controlled to read as follows:

1C352 Animal pathogens, as follows (see List of Items Controlled).

* * * * *

List of Items Controlled

Unit: $ value.

Related Controls: All vaccines are excluded from the scope of this entry. See ECCN 1C991.

Related Definitions: N/A.

Items:

a. Viruses, as follows:

a.1. African swine fever virus;

a.2. Avian influenza viruses that are:

a.2.a. Defined in EC Directive 92/40/EC (O.J. L.16 23.1.92 p. 19) as having high pathogenicity, as follows:

a.2.a.1. Type A viruses with an IVPI (intravenous pathogenicity index) in 6 week old chickens of greater than 1.2; or

a.2.a.2. Type A viruses H5 or H7 subtype for which nucleotide sequencing has demonstrated multiple basic amino acids at the cleavage site of haemagglutinin;

a.3. Bluetongue virus;

a.4. Foot and mouth disease virus;

a.5. Goat pox virus;

a.6. Porcine herpes virus (Aujeszky's disease);

a.7. Swine fever virus (Hog cholera virus);

a.8. Lyssa virus;

a.9. Newcastle disease virus;

a.10. Peste des petits ruminants virus;

a.11. Porcine enterovirus type 9 (swine vesicular disease virus);

a.12. Rinderpest virus;

a.13. Sheep pox virus;

a.14. Teschen disease virus;

a.15. Vesicular stomatitis virus;

a.16. Lumpy skin disease virus;

a.17. African horse sickness virus.

b. Bacteria, as follows:

b.1. Mycoplasma mycoides;

b.2. Reserved.

6. In Supplement No. 1 to part 774 (the Commerce Control List), Category 1—Materials, Chemicals, “Microorganisms” & “Toxins,” ECCN 1C353 is amended by revising the List of Items Controlled to read as follows:

1C353 Genetic elements and genetically modified organisms, as follows (see List of Items Controlled).

* * * * *

List of Items Controlled

Unit: $ value.

Related Controls: Vaccines that contain genetic elements or genetically modified organisms identified in this entry are controlled by ECCN 1C991.

Related Definitions: N/A.

Items:

a. Genetic elements, as follows:

a.1. Genetic elements that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a. to .c, 1C352, or 1C354;

a.2. Genetic elements that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “subunits of toxins” thereof.

Technical Note: 1. Genetic elements include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified.

2. This ECCN does not control nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing strains, except those nucleic acid sequences that contain coding for the verotoxin or its sub-units.

b. Genetically modified organisms, as follows:

b.1. Genetically modified organisms that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a. to .c, 1C352, or 1C354;

b.2. Genetically modified organisms that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “subunits of toxins” thereof.

Dated: March 5, 2004.

Peter Lichtenbaum,

Assistant Secretary for Export Administration.