Document ID: EPA-HQ-OPP-2006-0913-0007
Agency: epa
Document Type: Rule
Title: Bacillus thuringiensis Vip3Aa19 Protein in Cotton; Exemption from the Requirements of a Tolerance; Technical Amendment
Posted Date: 2007-07-25T04:00Z

[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Rules and Regulations]               
[Page 40752-40754]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy07-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0913; FRL-8134-3]

 
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.

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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 (703) 305-5805.

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: (703) 605-0515, e-mail 
address: reynolds.alan@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 40753]]

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 Sec. 174.452 which was redesignated 
as Sec. 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 Sec. 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 Sec. 174.452. The May 9, 2007 version of 
Sec. 174.452 became effective on May 9, 2007. However, Sec. 174.452 was 
redesignated as Sec. 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 Sec. 174.452 as published 
in the May 9, 2007 issue of the Federal Register will be wiped out 
because Sec. 174.452 will no longer exist. With this technical 
amendment EPA is revising Sec. 174.501 to read the same as Sec. 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 Sec. 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

[[Page 40754]]

and pests, Reporting and recordkeeping requirements.

    Dated: July 17, 2007.
 Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

0
Therefore, 40 CFR part 174 is amended as follows:

PART 174--[AMENDED]

0
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.

0
2. Section 174.501 is revised to read as follows:

Sec. 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.
[FR Doc. E7-14373 Filed 7-24-07; 8:45 am]

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