E7-14373. Bacillus thuringiensis Vip3Aa19 Protein in Cotton; Exemption from the Requirements of a Tolerance; Technical Amendment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule; technical amendment.

SUMMARY:

EPA issued a direct final rule in the Federal Register of April 25, 2007 (72 FR 20431), concerning plant-incorporated protectant tolerance exemptions. On May 9, 2007 EPA issued a final rule revising the tolerance exemption for Bacillus thuringeniensis Vip3Aa19 in cotton. This technical amendment is being issued to clarify the status and the wording of the tolerance exemption for Bacillus thuringeniensis Vip3Aa19 in cotton.

DATES:

This final rule is effective July 25, 2007.

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0913. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Alan Reynolds, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington DC 20460-0001; telephone number: [phone], e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

The Agency included in the final rule a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under the FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other Related Information?

In addition to using regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

II. What Does this Correction Do?

In a direct final rule published on April 25, 2007, (72 FR 20431)(FRL-7742-2) EPA took action to move existing active and inert ingredient plant-incorporated protectant tolerance exemptions from 40 CFR part 180, Tolerances and Exemptions from Tolerances for Pesticide Chemicals in Food to 40 CFR part 174, Procedures and Requirements for Plant-Incorporated Protectants, subpart W. EPA also made some conforming changes to the text of the individual exemptions that were transferred from part 180 so that they would be consistent with part 174, as well as some minor technical corrections to the wording of certain individual exemptions. Since this action was issued as a direct final rule the changes had a delayed effective date and did not become effective until July 24, 2007. Included in the redesignation and revision of part 174, subpart W was §174.452 which was redesignated as §174.501.

In the May 9, 2007 issue of the Federal Register (72 FR 26300), EPA issued a final rule which extended the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a plant-incorporated protectant (PIP) by revising §174.452. The extension of the temporary exemptions was requested in a petition submitted by Syngenta Seeds, Inc. to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The May 9, 2007 final rule eliminated the need to establish a maximum permissible level for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a PIP on cotton. The temporary tolerance exemption expires on May 1, 2008.

Section 174.452 as printed in the May 9, 2007 issued of the Federal Register codified the current and correct version of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a PIP on cotton in §174.452. The May 9, 2007 version of §174.452 became effective on May 9, 2007. However, §174.452 was redesignated as §174.501 in the April 25, 2007 issue of the Federal Register. The redesignation and revision becomes effective no earlier than July 24, 2007, if no adverse comment is received. Once the direct final rule becomes effective the revision of §174.452 as published in the May 9, 2007 issue of the Federal Register will be wiped out because §174.452 will no longer exist. With this technical amendment EPA is revising §174.501 to read the same as §174.452 which, as was stated above, will be eliminated once the direct final rule becomes effective.

III. Why is this Correction Issued as a Final Rule?

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical correction final without prior proposal and opportunity for comment, because the original issuance of the revised §174.452 was properly executed and the impact of the delayed effective date for the April 25, 2007 final rule removing the content of that section was inadvertent. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

IV. Do Any of the Statutory and Executive Order Reviews Apply to this Action?

No. This final rule does not impose any new requirements. It only implements a technical correction to the Code of Federal Regulations (CFR). As such, this action does not require review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not impose any enforceable duty, contain any unfunded mandate, or impose any significant or unique impact on small governments as described in the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require prior consultation with State, local, and tribal government officials as specified by Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993) and Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19,1998), or special consideration of environmental justice related issues under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law since this action is not subject to notice-and-comment requirements under the Administrative Procedure Act (APA) or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.).

EPA's compliance with these statutes and Executive Orders for the May 9, 2007 final rule, which established an extension of the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a plant-incorporated protectant (PIP), is discussed in the preamble for the final rule (72 FR 26300).

V. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides

Dated: July 17, 2007.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

Therefore, 40 CFR part 174 is amended as follows:

PART 174—[AMENDED]

1. The authority citation for part 174 continues to read as follows:

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.

2. Section 174.501 is revised to read as follows:

§174.501

Bacillus thuringiensis Vip3Aa19 protein in cotton; temporary exemption from the requirement of a tolerance.

Residues of Bacillus thuringiensis Vip3Aa19 protein in cotton are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant (PIP) in the food and feed commodities of cotton; vegetative-insecticidal protein in cotton seed, cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin byproducts. This temporary exemption from the requirement of tolerance will permit the use of the food commodities in this section when treated in accordance with the provisions of the experimental use permit (EUP) 67979-EUP-7, which is being issued in accordance with the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the requirement of a tolerance expires and is revoked May 1, 2008. However,if the EUP is revoked, or if any experience with or scientific data on this pesticide indicate that the temporary tolerance exemption is not safe, this temporary exemption from the requirement of a tolerance may be revoked at any time.