Amendments to the Select Agents Controls in Export Control Classification Number (ECCN) 1C360 on the Commerce Control List (CCL); Correction to ECCN 1E998

Summary:

The Bureau of Industry and Security (BIS) is publishing this finalrule to amend the Export Administration Regulations (EAR) by revising the controls on certain select agents identified in Export Control Classification Number (ECCN) 1C360 on the Commerce Control List (CCL) to reflect changes that the Animal Plant and Health Inspection Service (APHIS), U.S. Department of Agriculture, recently made to the Plant Protection and Quarantine Programs (PPQ) list of select agents and toxins. The changes made by APHIS were part of a biennial review and republication of the select agents and toxins lists separately maintained by APHIS and the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS). Both agencies maintain controls on the “possession, use, and transfer within the United States” of certain select agents and toxins, including human and zoonotic pathogens, animal pathogens, and plant pathogens. BIS maintains controls on “exports” of the select agents and toxins regulated by CDC and APHIS. CDC and APHIS simultaneously published the revisions to their lists of select agents and toxins on October 16, 2008. These changes became effective on November 17, 2008. BIS determined that the only changes that required amendments to the EAR were the changes to the PPQ list of select agents and toxins maintained by APHIS.

This rule also amends ECCN 1E998 on the CCL to remove controls on technology for the “development” or “production” of materials controlled by ECCN 1C995. This technology was inadvertently included in ECCN 1E998 by a final rule published by BIS in September 2006 and was made subject to the anti-terrorism (AT) license requirements described therein. Effective with the publication of this final rule, this technology is once again classified as EAR99.

Table of Contents

Dates:

This rule is effective February 22, 2010. 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-AE67, by any of the following methods:

E-mail: publiccomments@bis.doc.gov. Include “RIN 0694-AE67” 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 Street Pennsylvania Avenue, NW., Room 2705, Washington, DC 20230, ATTN: RIN 0694-AE67.

Send comments regarding this collection of information, including suggestions for reducing the burden, to Jasmeet Seehra, Office of Management and Budget (OMB), by e-mail to Jasmeet_K._Seehra@omb.eop.gov, or by fax to (202) 395-7285; and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, 14th Street Pennsylvania Avenue, NW., Room 2705, Washington, DC 20230. Comments on this collection of information should be submitted separately from comments on the final rule (i.e., RIN 0694-AE67)—all comments on the latter should be submitted by one of the three methods outlined above.

For further information contact:

Kimberly Orr, Export Policy Analyst, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: (202) 482-4201.

Supplementary information:

Background

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to update the controls on certain select agents identified in Export Control Classification Number (ECCN) 1C360 on the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) to reflect changes that the Animal Plant and Health Inspection Service (APHIS), U.S. Department of Agriculture, recently made to the Plant Protection and Quarantine Programs (PPQ) list of select agents and toxins in 7 CFR 331.3(b). The changes published by APHIS were part of a biennial review and republication of select agents and toxins lists that are separately maintained by APHIS and the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS). Both of these U.S. Government agencies maintain controls on the “possession, use, and transfer within the United States” of certain select agents and toxins (including human and zoonotic pathogens, animal pathogens, and plant pathogens), [1] while BIS controls “exports” of these select agents and toxins.

The revisions to the lists of select agents and toxins maintained by CDC and APHIS were published, simultaneously, on October 16, 2008 (at 73 FR 61363 and 73 FR 61325, respectively), and became effective on November 17, 2008. Certain changes involving the PPQ list of select agents and toxins maintained by APHIS at 7 CFR 331.3(b) were determined by BIS to require amendments to ECCN 1C360, which controls select agents regulated by CDC and APHIS that are not controlled under ECCN 1C351, 1C352, or 1C354 on the CCL. Therefore, BIS is publishing this final rule to amend ECCN 1C360 to make the following changes consistent with the PPQ list: (1) Remove “Candidatus Liberobacter africanus” and “Candidatus Liberobacter asiaticus,” (2) add “Phoma glyciniocola (formerly Pyrenochaeta glycines)” and “Rathayibacter toxicus,” and (3) clarify that “Peronosclerospora philippinensis” is also known as “Peronosclerospora sacchari.”

This rule also makes a correction to ECCN 1E998 that is unrelated to the select agent changes described above. Specifically, this rule amends ECCN 1E998 to remove controls on technology for the “development” or “production” of materials controlled by ECCN 1C995. This technology was inadvertently included in ECCN 1E998 by a final rule published by BIS on September 7, 2006 (71 FR 52956), and was made subject to the anti-terrorism (AT) license requirements described therein. The September 2006 rule's stated purpose for adding this technology to ECCN 1E998 was to maintain AT controls on certain “development” and “production” technology previously controlled under ECCN 1E001. However, “development” and “production” technology for materials controlled by ECCN 1C995 was not controlled under ECCN 1E001 at the time the September 2006 rule was published or, in fact, at any other time. Instead, this technology was classified as EAR99 and should have remained so. Therefore, effective with the publication of this final rule, this technology is once again classified as EAR99.

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 13, 2009, 74 FR 41325 (August 14, 2009), 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 alicense 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 March 24, 2010, 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 areexported or reexported before April 8, 2010. Any such items not actually exported or reexported before midnight, on April 8, 2010, 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 April 8, 2010. Beginning at midnight on April 8, 2010, 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 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. 3501et 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 Jasmeet Seehra, 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. 601et 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 in 15 cfr part 774

Exports, Foreign trade, Reporting and recordkeeping requirements.

Accordingly, Part 774 of the Export Administration Regulations (15 CFR Parts 730-774) is 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); 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; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; 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 13, 2009, 74 FR 41325 (August 14, 2009).

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

Supplement No. 1 to Part 774—The Commerce Control List

* * * * *

1C360Select agents not controlled under ECCN 1C351, 1C352, or 1C354.

* * * * *

List of Items Controlled

Unit: * * *

Related Controls: * * *

Related Definitions: * * *

Items:

* * * * *

c. Plant pathogens, as follows:

c.1. Bacteria, as follows:

c.1.a. Rathayibacter toxicus;

c.1.b. Xylella fastidiosa pv. citrus variegated chlorosis (CVC);

c.2. Fungi, as follows:

c.2.a. Peronosclerospora philippinensis (a.k.a. Peronosclerospora sacchari);

c.2.b. Sclerophthora rayssiae var. zeae;

c.2.c. Synchytrium endobioticum;

c.2.d. Phoma glycinicola (formerly Pyrenochaeta glycines).

* * * * *
3. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1—Materials, Chemicals, “Microorganisms” “Toxins,” ECCN 1E998 is amended by revising the ECCN heading to read as follows:

1E998 “Technology” for the “development” or “production” of processing equipment controlled by 1B999, and materials controlled by 1C996, 1C997, 1C998, or 1C999.

* * * * *
Dated: February 16, 2010. Matthew S. Borman,

Deputy Assistant Secretary for Export Administration.

Footnotes

1. For select agents and toxins regulated by APHIS, see 7 CFR 331.3(b), 9 CFR 121.3(b), and 9 CFR 121.4(b). For select agents and toxins regulated by CDC, see 42 CFR 73.3(b) and 42 CFR 73.4(b).

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