Implementation of the Understandings Reached at the June 2007 Australia Group (AG) Plenary Meeting; Addition to the List of States Parties to the Chemical Weapons Convention (CWC)

AGENCY:

Bureau of Industry and Security, Commerce.

ACTION:

Final rule.

SUMMARY:

The Bureau of Industry and Security (BIS) is publishing this final rule to amend the Export Administration Regulations (EAR) to implement the understandings reached at the June 2007 plenary meeting of the Australia Group (AG). This final rule amends the EAR to reflect changes to the AG “Control List of Biological Agents” that the countries participating in the AG adopted at the plenary meeting. Specifically, this rule revises the Commerce Control List (CCL) entry that controls animal pathogens on the AG “Control List of Biological Agents” by revising the listing for mycoplasma mycoides to include only the specific subspecies and strains of mycoplasma mycoides that are of most concern as the causative agents of disease in animals, i.e., Mycoplasma mycoides subspecies mycoides SC (small colony) and Mycoplasma capricolum subspecies capripneumoniae (“strain F38”). In addition, this rule makes conforming changes to the CCL entry that controls certain select agents not included on any of the AG Common Control Lists.

This rule also amends the EAR to reflect the admission of Croatia to the Australia Group and updates the definition of “Australia Group” in the EAR by adding Croatia to the list of participating countries.

In addition to the AG plenary meeting changes described above, this rule amends the EAR by revising the CCL entry that controls certain equipment capable of being used in handling biological materials. This rule revises a Technical Note in the CCL entry by updating the edition of the World Health Organization (WHO) “Laboratory Biosafety Manual” referenced therein to to identify the current edition of the manual. This WHO manual contains safety requirements for P3 or P4 (BL3, BL4, L3, L4) complete containment facilities.

Finally, this rule amends the list of countries that currently are States Parties to the Chemical Weapons Convention (CWC) by adding “Barbados,” which recently became a State Party. As a result of this change, the CW (Chemical Weapons) license requirements and policies in the EAR that apply to Barbados now conform with those applicable to other CWC States Parties. This rule also clarifies the scope of the entry for “China” on the list of CWC States Parties by revising the footnote to this entry to indicate that, for CWC purposes only, China includes “Macau,” as well as “Hong Kong.”

DATES:

This rule is effective September 12, 2007. Although there is no formal comment period, public comments on this regulation are welcome on a continuing basis.

ADDRESSES:

You may submit comments, identified by RIN 0694-AE08, by any of the following methods:

• E-mail: publiccomments@bis.doc.gov. Include “RIN 0694-AE08” in the subject line of the message.
• Fax: (202) 482-3355. Please alert the Regulatory Policy Division, by calling (202) 482-2440, if you are faxing comments.
• Mail or Hand Delivery/Courier: Willard Fisher, U.S. Department of Commerce, Bureau of Industry and Security, Regulatory Policy Division, 14th St. & Pennsylvania Avenue, NW., Room 2705, Washington, DC 20230, ATTN: RIN 0694-AE08.

Send comments regarding this collection of information, including suggestions for reducing the burden, to David Rostker, Office of Management and Budget (OMB), by e-mail to David_Rostker@omb.eop.gov, or by fax to (202) 395-7285; and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, P.O. Box 273, Washington, DC 20044. Comments on this collection of information should be submitted separately from comments on the final rule (i.e., RIN 0694-AE08)—all comments on the latter should be submitted by one of the three methods outlined above.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Scott, Director, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343.

SUPPLEMENTARY INFORMATION:

Background

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 4-7, 2007. The Australia Group is a multilateral forum, consisting of 40 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 2007 annual plenary meeting included a decision to revise the AG “Control List of Biological Agents” by narrowing the scope of the listing for mycoplasma mycoides to include only the specific subspecies and strains of mycoplasma mycoides that are of most concern as the causative agents of disease in animals. This rule amends the EAR to reflect that decision by revising Export Control Classification Number (ECCN) 1C352, which controls certain animal pathogens, to narrow the scope of the listing for mycoplasma mycoides in this ECCN to include only the following subspecies and strains: Mycoplasma mycoides subspecies mycoides SC (small colony) and Mycoplasma capricolum subspecies capripneumoniae (“strain F38”). Mycoplasma mycoides subspecies mycoides SC (small colony) causes severe respiratory disease primarily in cattle (i.e., contagious bovine pleuropneumonia (CBPP)), while Mycoplasma capricolum subspecies capripneumoniae (“strain F38”) causes severe respiratory disease primarily in goats (i.e., contagious caprine pleuropneumonia (CCPP)).

Prior to the publication of this rule, ECCN 1C352 controlled all subspecies and strains of mycoplasma mycoides. Mycoplasma capricolum and F38-type caprine mycoplasma (i.e., mycoplasma F38), however, were listed separately under ECCN 1C360, which contains unilaterally controlled select agents not included on any of the AG Common Control Lists. The Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, and the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, maintain controls on the possession, use, and transfer within the United States of the unilaterally controlled select agents listed in ECCN 1C360, as well as certain AG agents and toxins listed in ECCN 1C352. Since mycoplasma F38 (i.e., Mycoplasma capricolum subspecies capripneumoniae (“strain F38”)) is now specifically identified and controlled under ECCN 1C352 and the select agent mycoplasma mycoides capri is no longer controlled under this ECCN, this rule makes conforming changes to the list of unilaterally controlled select agents in ECCN 1C360 by removing mycoplasma F38 from the listing of mycoplasma controlled under this ECCN and adding mycoplasma mycoides capri. All Mycoplasma capricolum, except subspecies capripneumoniae, continues to be controlled under ECCN 1C360.

The EAR license requirements that apply to the specific items affected by the amendments to ECCN 1C352 and 1C360 (described above) remain unchanged. The affected items in these ECCNs continue to require a license for export or reexport to all countries or destinations indicated under CB Column 1 or AT Column 1 on the Commerce Country Chart (Supplement No. 1 to Part 738 of the EAR).

This rule also amends the EAR to reflect the addition of Croatia as the newest participating country in the Australia Group (which now includes a total of 40 countries). Supplement No. 1 to Part 738 (Commerce Country Chart) is revised by removing the license requirements indicated for Croatia, under CB Column 2, to conform with the country scope of the CB license requirements that apply to other AG participating countries (see Section 742.2 of the EAR). Supplement No. 1 to Part 740 (Country Groups) is revised to add Croatia to Country Group A:3 (Australia Group). The definition of “Australia Group” in Section 772.1 of the EAR is updated by adding Croatia to the list of participating countries.

In addition to the AG plenary meeting changes described above, this rule amends the EAR by revising the Technical Note to ECCN 2B352.a to update a reference therein to the World Health Organization (WHO) “Laboratory Biosafety Manual” to identify the current edition of the manual (i.e., 3rd edition, Geneva, 2004). This WHO manual contains safety requirements for P3 or P4 (BL3, BL4, L3, L4) complete containment facilities.

Finally, this rule amends 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 “Barbados,” which became a State Party to the CWC on April 6, 2007. As a result of this change, the CW (Chemical Weapons) license requirements and policies that apply to Barbados now conform with those applicable to other CWC States Parties, as described in Section 742.18 of the EAR. This rule also clarifies the scope of the entry for “China” in the list of CWC States Parties by revising the footnote to this entry to indicate that, for CWC purposes only, China includes “Macau,” as well as “Hong Kong.”

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as extended by the Notice of August 15, 2007, 72 FR 46137 (August 16, 2007), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act.

Saving Clause

Shipments of items removed from eligibility for export or reexport under a license exception or without a license (i.e., under the designator “NLR”) 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 October 12, 2007, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previously applicable license exception or without a license (NLR) so long as they are exported or reexported before October 29, 2007. Any such items not actually exported or reexported before midnight, on October 29, 2007, require a license in accordance with this regulation.

“Deemed” exports of “technology” and “source code” removed from eligibility for export under a license exception or without a license (under the designator “NLR”) as a result of this regulatory action may continue to be made under the previously available license exception or without a license (NLR) before October 29, 2007. Beginning at midnight on October 29, 2007, such “technology” and “source code” may no longer be released, without a license, to a foreign national subject to the “deemed” export controls in the EAR when a license would be required to the home country of the foreign national 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), and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, as indicated in the ADDRESSES section of this rule.

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 (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 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.

List of Subjects

15 CFR Part 738

• Administrative practice and procedure
• Exports
• Foreign trade

15 CFR Part 740

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

15 CFR Part 745

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

15 CFR Part 772

• Exports

15 CFR Part 774

• Exports
• Foreign trade
• Reporting and recordkeeping requirements

Accordingly, parts 738, 740, 745, 772, and 774 of the Export Administration Regulations (15 CFR parts 730-799) are amended as follows:

PART 738—[AMENDED]

1. The authority citation for 15 CFR part 738 is revised 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); 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 15, 2007, 72 FR 46137 (August 16, 2007).

2. Supplement No. 1 to part 738 is amended by revising the entry for “Croatia” to read as follows:

PART 740—[AMENDED]

3. The authority citation for 15 CFR part 740 is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; Sec. 901-911, Pub. L. 106-387; 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 15, 2007, 72 FR 46137 (August 16, 2007).

4. In Supplement No. 1 to part 740, Country Groups, Country Group A is amended by adding, in alphabetical order, a new entry for “Croatia” to read as follows:

Supplement No. 1 to Part 740—Country Groups

PART 745—[AMENDED]

5. The authority citation for 15 CFR part 745 is revised 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 October 27, 2006, 71 FR 64109 (October 31, 2006).

Supplement No. 2 to Part 745 [Amended]

6. Supplement No. 2 to part 745 is amended:

a. By revising the undesignated center heading “List of States Parties as of November 1, 2006” to read “List of States Parties as of August 1, 2007”;

b. By adding, in alphabetical order, the country “Barbados”; and

c. By revising the footnote for China to read “* For CWC purposes only, China includes Hong Kong and Macau.”

PART 772—[AMENDED]

7. The authority citation for 15 CFR part 772 is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007).

8. In § 772.1, the definition of “Australia Group” is revised to read as follows:

PART 774—[AMENDED]

9. The authority citation for 15 CFR part 774 is revised 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); 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 15, 2007, 72 FR 46137 (August 16, 2007).

Supplement No. 1 to Part 774—[Amended]

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

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

List of Items Controlled

Unit: * * *

Related Controls: * * *

Related Definitions: * * *

Items:

b. Bacteria, as follows:

b.1. Mycoplasma mycoides, as follows:

b.1.a. Mycoplasma mycoides subspecies mycoides SC (small colony) (a.k.a. contagious bovine pleuropneumonia);

b.1.b. Mycoplasma capricolum subspecies capripneumoniae (“strain F38”).

b.2. [RESERVED.]

Supplement No. 1 to Part 774—[Amended]

11. In Supplement No. 1 to part 774 (the Commerce Control List), Category 1—Materials, Chemicals, “Microorganisms” & “Toxins,” ECCN 1C360 is amended by revising paragraph (b)(2) under “ Items” in the List of Items Controlled to read as follows:

1C360 Select agents not controlled under ECCN 1C351, 1C352, or 1C354.

List of Items Controlled

Unit: * * *

Related Controls: * * *

Related Definitions: * * *

Items:

b. * * *

b.2. Mycoplasma, as follows:

b.2.a. Mycoplasma capricolum, except subspecies capripneumoniae (see ECCN 1C352.b.1.b);

b.2.b. Mycoplasma mycoides capri;

Supplement No. 1 to Part 774—[Amended]

12. In Supplement No. 1 to part 774 (the Commerce Control List), Category 2—Materials Processing, ECCN 2B352 is amended by revising parenthetical phrase “(Geneva, 1983)” to read “(3rd edition, Geneva, 2004)” in the Technical Note immediately following paragraph (a) in the List of Items Controlled.