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

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[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.

• 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:

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]
BILLING CODE 6560-50-S

 
 

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