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Proposed Administrative Revisions to Plant-Incorporated Protectant Tolerance Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.


 
[Federal Register: April 25, 2007 (Volume 72, Number 79)]
[Proposed Rules]
[Page 20489-20494]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap07-20]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 174 and 180
[EPA-HQ-OPP-2005-0117; FRL-7742-3]

Proposed Administrative Revisions to Plant-Incorporated
Protectant Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.

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SUMMARY:  EPA is proposing 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 (Tolerances and Tolerance
Exemptions). EPA is also proposing some conforming changes to the text
of the individual exemptions, so that they are consistent with part
174, as well as some minor technical corrections to the wording of
certain individual exemptions. This action is administrative in nature
and no substantive changes are intended. We are proposing these
administrative revisions to plant-incorporated protectant tolerance
exemptions to take into account the promulgation of 40 CFR part 174, 66
FR 37814, July 19, 2001.

DATES:  Comments, identified by docket ID number EPA-HQ-OPP-2005-0117,
must be received on or before May 25, 2007.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0117, by one of the following methods:
    ? Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
    ? Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
    ? Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0117. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. 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. Although
listed in the index, some information is not publicly available, e.g.,
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 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: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8715; fax
number: (703) 308-8715; e-mail address: mendelsohn.mike@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 20490]]

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
    ? Crop production (NAICS code 111).
    ? Animal production (NAICS code 112).
    ? Food manufacturing (NAICS code 311).
    ? Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in [insert appropriate
cite to either another unit in the preamble or a section in a rule]. If
you have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2.  Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

    In 2001, EPA published a final rule, establishing certain basic
parameters of its regulatory program under FIFRA for a specific class
of pesticide products--plant-incorporated protectants. (66 FR 37772,
July 19, 2001). EPA defined these products as pesticidal substances,
along with the genetic material necessary to produce them, when
produced and used in living plants, As part of that rule, EPA changed
the name of this type of pesticide from ``plant-pesticide'' to ``plant-
incorporated protectant.'' EPA also established a new part in the Code
of Federal Regulations (CFR) specifically for plant-incorporated
protectants. In the same issue of the Federal Register, EPA established
a blanket tolerance exemption for all residues of nucleic acids that
are part of a plant-incorporated protectant. (66 FR 37817, July 19,
2001). See 40 CFR 174.475.
    In this notice, the Agency is proposing to make minor technical
changes to conform the wording of certain individual tolerance
exemptions with the above regulations.
    This action is being proposed under sections 408 (e)(1)(B) of the
Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a (e)(1)(B).
    Section 408(e)(1)(B)provides that the Administrator may issue a
regulation modifying an exemption of a pesticide chemical residue from
the requirement of a tolerance. 21 U.S.C. 346a (e)(1)(B). Because EPA
is making no substantive modifications to the tolerance exemptions, the
Agency has not made separate findings regarding the safety of the
individual exemptions. EPA believes that the safety standard is
applicable only where the Agency takes affirmative action to either
substantively modify the tolerance exemption, or has reviewed the
tolerance exemption and determined to leave it in effect. EPA is taking
neither action in this notice, but is merely making technical
modifications to conform the wording of the individual exemptions to
wording that is consistent with the surrounding regulations.

A. What Action is the Agency Taking?

    In 2001, EPA published a final rule, establishing certain basic
parameters of its regulatory program under FIFRA for a specific class
of pesticide products--plant-incorporated protectants. (66 FR 37772,
July 19, 2001). EPA defined these products as pesticidal substances,
along with the genetic material necessary to produce them, when
produced and used in living plants, As part of that rule, EPA changed
the name of this type of pesticide from ``plant-pesticide'' to ``plant-
incorporated protectant.'' EPA also established a new part in the Code
of Federal Regulations (CFR) specifically for plant-incorporated
protectants. In the same issue of the Federal Register, EPA established
a blanket tolerance exemption for all residues of nucleic acids that
are part of a plant-incorporated protectant. (66 FR 37817, July 19,
2001). See 40 CFR 174.475.
    In this notice, the Agency is proposing to make minor technical
changes to conform the wording of certain individual tolerance
exemptions with the above regulations.
    The Agency is proposing to move the following tolerance exemptions
listed under 40 CFR part 180 (Tolerances and Exemptions from Tolerances
for Pesticide Chemicals in Food) to 40 CFR part 174 in order to
consolidate all plant-incorporated protectant specific regulations in
the same part.

------------------------------------------------------------------------
                                                        Redesignated as
                     Old Section                          New section
------------------------------------------------------------------------
180.1134                                                         174.521
------------------------------------------------------------------------
180.1147                                                         174.509
------------------------------------------------------------------------
180.1151                                                         174.522
------------------------------------------------------------------------
180.1155                                                         174.510
------------------------------------------------------------------------
180.1173                                                         174.511
------------------------------------------------------------------------
180.1174                                                         174.523
------------------------------------------------------------------------
180.1182                                                         174.512
------------------------------------------------------------------------
180.1183                                                         174.513
------------------------------------------------------------------------
180.1184                                                         174.514
------------------------------------------------------------------------
180.1185                                                         174.515
------------------------------------------------------------------------

[[Page 20491]]

180.1186                                                         174.516
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180.1190                                                         174.524
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180.1192                                                         174.517
------------------------------------------------------------------------
180.1214                                                         174.518
------------------------------------------------------------------------
180.1215                                                         174.519
------------------------------------------------------------------------
180.1216                                                         174.525
------------------------------------------------------------------------
180.1217                                                         174.520
------------------------------------------------------------------------
180.1249                                                         174.526
------------------------------------------------------------------------
180.1252                                                         174.527
------------------------------------------------------------------------

    The Agency is also proposing to make some conforming changes to the
wording of the exemptions, so that they are consistent with the
provisions already in part 174. These changes consist of revising the
term ``plant-pesticides'' in these exemptions to ``plant-incorporated
protectants'' and changing the term ``vegetative insecticidal protein''
to the more broad term ``plant-incorporated protectant.''
    Further, for these exemptions, as well as those found under 40 CFR
174.452, 174.453, 174.454, 174.455, 174.456, 174.457, and 174.458
(proposed to be redesignated as Sec. Sec.  174.501, 174.502, 174.503,
174.504, 174.505, 174.506, and 174.528, respectively) EPA is also
proposing to delete the references to the ``genetic material necessary
for its production'' and ``regulatory regions,'' as well as the
definitions of these terms, from individual tolerance exemptions. As
noted in Unit II.A., EPA established a blanket tolerance exemption for
nucleic acids, which includes the residues of genetic material
necessary for the production of pesticidal substances in living plants,
and residues of the genetic material necessary to produce any inert
ingredient. See 40 CFR 174.475 (proposed to be redesignated as Sec. 
174.507). Retaining the references to the genetic material necessary
for the production of the individual substances, and to regulatory
regions in the text of the individual exemptions would be wholly
duplicative of 40 CFR 174.475, and has the potential to cause confusion
as to the intended scope of that provision. Accordingly, the Agency is
removing these references. These deletions will in no way affect the
legal status of such residues, given the provisions at 40 CFR 174.475.
    Similarly, inclusion of the definitions of these terms in the
individual exemptions becomes unnecessary once the exemptions are moved
to part 174, as the terms are defined at Sec.  174.3, which is
generally applicable to all regulations contained in part 174.
Moreover, the wording of the definitions varies slightly between some
of the individual tolerance exemptions. While the Agency does not
believe that there is any substantive difference between the different
formulations, to avoid any confusion, EPA has chosen to delete the
definitions from the individual tolerance exemptions. The deletion of
these definitions from the individual tolerance exemptions will in no
way affect the legal status of the residues exempted.
    Further, for these exemptions and for 40 CFR 174.451 Scope and
Purpose, (proposed to be redesignated as Sec.  174.500) EPA is
proposing to change the terms ``plant raw agricultural commodities,''
``Raw agricultural commodities,'' ``raw agricultural commodities, in
food, and in animal feeds,'' ``plant RACs,'' and ``plant commodities''
to read ``food commodities.'' While the Agency does not believe that
there is any substantive difference between the different formulations,
to avoid any confusion, EPA is proposing to use the one term ``food
commodities.'' This change will in no way affect the legal status of
the residues exempted.
    EPA is proposing to change the term ``delta-endotoxin'' to ``Cry
protein'' and to remove any subspecies designations for Bacillus
thuringiensis PIPs. The terms ``delta-endotoxin'' and ``Cry protein''
are redundant. While the Agency does not believe that there is any
substantive difference between these different formulations, to avoid
any confusion, EPA has chosen to use the one term ``Cry protein''
without a subspecies designation. This change will in no way affect the
legal status of the residues exempted.
    EPA is proposing to add the term ``enzyme'' to descriptions of
current PIP inert ingredients to clarify the function of these proteins
and make classification easier for the layman. While the Agency does
not believe that there is any substantive difference between these and
the current naming formulations, to clarify the function of these
proteins and make classification easier for the layman, EPA has chosen
to add the term ``enzyme.'' This change will in no way affect the legal
status of the residues exempted.
    EPA is proposing to update Bacillus thuringiensis derived plant-
incorporated protectant exemptions to conform to updated nomenclature
as determined by the Bacillus thuringiensis Pesticidal Crystal Proteins
Nomenclature Committee, a non-governmental scientific committee, 
http://www.biols.susx.ac.uk/home/Neil_Crickmore/Bt/. The
changes will standardize the tolerance exemption descriptions by listing
the ``residues of'' portion of the exemption first and by listing field
corn, sweet corn, and popcorn as corn; corn, field; corn, sweet; and
corn, pop. Those changes will in no way affect the legal status of the
residues exempted.
    EPA is proposing to redesignate Sec.  180.1183, Potato Leaf Roll
Virus Resistance Gene (also known as orf1/orf2 gene) and the genetic
material necessary for its production, as Sec.  174.513 and to add
language to the exemption to clarify that residues in or on all food
commodities are covered under this regulation. The phrase ``in or on
all raw agricultural commodities'' was inadvertently excluded from the
regulatory text of this exemption. However, the preamble to the rule
clearly stated the Agency's intention to exempt residues of this
product in or on all raw agricultural commodities. See 62 FR 43650,
August 15, 1997. In addition, EPA's findings and supporting analyses
concerning the safety of these residues addressed residues in or on all
raw agricultural commodities. The inclusion of the phrase ``all food
commodities'' in the individual tolerance exemption will in no way
affect the legal status of the residues covered by the regulation.
    Finally, EPA proposing to redesignate Sec.  180.1174, CP4
Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) and the genetic material
necessary for its production in all plants, as Sec.  174.523 and to add
language to the exemption to clarify that this PIP inert ingredient is
a synthase. The word ``synthase'' corresponds to the last ``S'' in
``CP4 EPSPS'' and was inadvertently excluded from the exemption.
However, the proposed rule clearly stated ``synthase'' in describing
the ingredient. See 60 FR 54689, October 25, 1995. The inclusion of the
phrase ``synthase'' in the individual tolerance exemption will in no
way affect the legal status of the residues covered by the regulation.
    The specific tolerance exemptions EPA is proposing to move to part
174, as they currently appear in the CFR, follow immediately below. The
proposed revised tolerance language appears at the end of the document,
as proposed regulatory text. While EPA believes that it has accurately
transferred each of the tolerance exemptions included in this proposed
rule, the Agency would appreciate readers notifying EPA of
discrepancies, omissions or technical problems by submitting them to
the address or e-mail

[[Page 20492]]

address under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's Authority for Taking this Action?

    This action is being proposed under sections 408 (e)(1)(B) of the
Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a (e)(1)(B).
    Section 408(e)(1)(B) provides that the Administrator may issue a
regulation modifying an exemption of a pesticide chemical residue from
the requirement of a tolerance, 21 U.S.C. 346a (e)(1)(B).

III. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, 58 FR 51735, October 4, 1993, the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may: (1) Have an annual
effect on the economy of $100 million or more or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities; (2) create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; (3) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. It has been determined
that this rule is not a ``significant regulatory action'' under the
terms of Executive Order 12866 and is therefore not subject to OMB review.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) a small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
rule will not impose any requirements on small entities since this action
is administrative in nature and no substantive changes are being made.

IV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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 the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 174

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements, Plant-incorporated protectants.

40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 12, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
    Therefore, Title 40, chapter I of the Code of Federal Regulations
is proposed to be amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a, and 371.
    2. In the following table, the sections in the first column are
transferred to 40 CFR part 174, subpart W and redesignated as the
sections in the second column.

------------------------------------------------------------------------
                                                        Redesignated as
                     Old Section                          New section
------------------------------------------------------------------------
180.1134                                                         174.521
------------------------------------------------------------------------
180.1147                                                         174.509
------------------------------------------------------------------------
180.1151                                                         174.522
------------------------------------------------------------------------
180.1155                                                         174.510
------------------------------------------------------------------------
180.1173                                                         174.511
------------------------------------------------------------------------
180.1174                                                         174.523
------------------------------------------------------------------------
180.1182                                                         174.512
------------------------------------------------------------------------
180.1183                                                         174.513
------------------------------------------------------------------------
180.1184                                                         174.514
------------------------------------------------------------------------
180.1185                                                         174.515
------------------------------------------------------------------------
180.1186                                                         174.516
------------------------------------------------------------------------
180.1190                                                         174.524
------------------------------------------------------------------------
180.1192                                                         174.517
------------------------------------------------------------------------
180.1214                                                         174.518
------------------------------------------------------------------------
180.1215                                                         174.519
------------------------------------------------------------------------
180.1216                                                         174.525
------------------------------------------------------------------------
180.1217                                                         174.520
------------------------------------------------------------------------
180.1249                                                         174.526
------------------------------------------------------------------------
180.1252                                                         174.527
------------------------------------------------------------------------

Sec. Sec.  180.1227 and 180.1242  [Removed]

    3. Section 180.1227 and 180.1242 are removed.

PART 174--[AMENDED]

    4. 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.

Sec.  174.21  [Amended]

    5. Section 174.21 is amended as follows:
    i. In paragraph (b) by revising the reference ``Sec. Sec.  174.475
through 174.479'' to read ``Sec. Sec.  174.507 through 174.508.''
    ii. In paragraph (c) by revising the reference ``Sec. Sec.  174.485
through 174.490'' to read ``Sec.  174.705.''

Sec. Sec.  174.475 and 174.479  [Redesignated as Sec. Sec.  174.507 and
174.508]

    6. Sections 174.475 and 174.479 are redesignated as Sec. Sec. 
174.507 and 174.508, respectively.

[[Page 20493]]

Sec. Sec.  174.480 and 174.485  [Redesignated as Sec. Sec.  174.700 and
174.705]

    7. Sections 174.480 and 174.485 are redesignated as Sec.  174.700
and Sec.  174.705, respectively and remain in subpart X.
    8. Sections 174.451, 174.452, 174.453, 174.454, 174.455, 174.456,
and 174.457 are redesignated as Sec. Sec.  174.500, 174.501, 174,502,
174.503, 174.504, 174.505, and 174.506, respectively, and revised to
read as follows:

Sec.  174.500  Scope and purpose.

    This subpart lists the tolerances and exemptions from the
requirement of a tolerance for residues of plant-incorporated
protectants in or on food commodities.

Sec.  174.501  Bacillus thuringiensis VIP3A protein; temporary
exemption from the requirement of a tolerance.

    Residue of Bacillus thuringiensis VIP3A protein are temporarily
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant in cotton seed, cotton oil, cotton meal, cotton
hay, cotton hulls, cotton forage, and cotton gin byproducts. This temporary
exemption from the requirement of a tolerance expires May 1, 2007.

Sec.  174.502  Bacillus thuringiensis Cry1A.105 protein in corn;
temporary exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1A.105 protein in corn are
exempt from the requirement of a tolerance when used as plant-
incorporated protectant in the food and feed commodities of corn; corn,
field; corn, sweet; and corn, pop. This temporary exemption from the
requirement of a tolerance will permit the use of the food commodities
in this paragraph when treated in accordance with the provisions of the
experimental use permit 524-EUP-97 which is being issued under 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 June 30, 2009; however, if the
experimental use permit is revoked, or if any experience with or
scientific data on this pesticide indicate that the tolerance is not
safe, this temporary exemption from the requirement of a tolerance may
be revoked at any time.

Sec.  174.503  Bacillus thuringiensis Cry2Ab2 protein in corn;
temporary exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ab2 protein in corn are
exempt from the requirement of a tolerance when used as plant-
incorporated protectant in the food and feed commodities of corn; corn,
field; corn, sweet; and corn, pop. This temporary exemption from the
requirement of a tolerance will permit the use of the food commodities
in this paragraph when treated in accordance with the provisions of the
experimental use permit 524-EUP-97 which is being issued under 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 June 30, 2009; however, if the
experimental use permit is revoked, or if any experience with or
scientific data on this pesticide indicate that the tolerance is not
safe, this temporary exemption from the requirement of a tolerance may
be revoked at any time.

Sec.  174.504  Bacillus thuringiensis Cry1F protein in cotton;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1F protein in cotton are
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant in food and feed commodities of cotton.

Sec.  174.505  Bacillus thuringiensis modified Cry3A protein (mCry3A)
in corn; exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis modified Cry3A protein (mCry3A)
in corn are exempt from the requirement of a tolerance when used as
plant-incorporated protectant in the food and feed commodities of corn;
corn, field; corn, sweet; and corn, pop.

Sec.  174.506  Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins in
corn; exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins
in corn are exempted from the requirement of a tolerance when used as
plant-incorporated protectants in the food and feed commodities of
corn; corn, field; corn, sweet; and corn, pop.
    9. Newly redesignated Sec. Sec.  174.509 through 174.527 are
revised to read as follows:

Sec.  174.509  Bacillus thuringiensis Cry3A protein; exemption from the
requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry3A protein are exempted from
the requirement of a tolerance when used as a plant-incorporated
protectant in potatoes.

Sec.  174.510  Bacillus thuringiensis Cry1Ac protein in all plants;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1Ac protein in all plants are
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in all food commodities.

Sec.  174.511  Bacillus thuringiensis Cry1Ab protein in all plants;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1Ab protein in all plants are
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in all food commodities.

Sec.  174.512  Coat Protein of Potato Virus Y; exemption from the
requirement of a tolerance.

    Residues of Coat Protein of Potato Virus Y are exempt from the
requirement of a tolerance when used as a plant-incorporated protectant
in or on all food commodities.

Sec.  174.513  Potato Leaf Roll Virus Resistance Gene (also known as
orf1/orf2 gene); exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the plant-incorporated protectant Potato Leaf Roll Virus
Resistance Gene (also known as orf1/orf2 gene) in or on all food
commodities.

Sec.  174.514  Coat Protein of Watermelon Mosaic Virus-2 and Zucchini
Yellow Mosaic Virus; exemption from the requirement for a tolerance.

    Residues of Coat Protein of Watermelon Mosaic Virus-2 and Zucchini
Yellow Mosaic Virus are exempt from the requirement of a tolerance when
used as a plant-incorporated protectant in or on all food commodities.

Sec.  174.515  Coat Protein of Papaya Ringspot Virus; exemption from
the requirement of a tolerance.

    Residues of Coat Protein of Papaya Ringspot Virus are exempt from
the requirement of a tolerance when used as a plant-incorporated
protectant in or on all food commodities.

Sec.  174.516  Coat protein of cucumber mosaic virus; exemption from
the requirement of a tolerance.

    Residues of Coat Protein of Cucumber Mosaic Virus are exempt from
the requirement of a tolerance when used as a plant-incorporated
protectant in or on all food commodities.

Sec.  174.517  Bacillus thuringiensis Cry9C protein in corn; exemption
from the requirement of a tolerance.

    The plant-incorporated protectant Bacillus thuringiensis Cry9C
protein in corn is exempted from the requirement of a tolerance for
residues, only in corn used for feed; as well as in meat, poultry,
milk, or eggs resulting from animals fed such feed.

[[Page 20494]]

Sec.  174.518  Bacillus thuringiensis Cry3Bb1 protein in corn;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry3Bb1 protein in corn are
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in the food and feed commodities of corn;
corn, field; corn, sweet; and corn, pop.

Sec.  174.519  Bacillus thuringiensis Cry2Ab2 protein in cotton;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ab2 protein in cotton is
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant in the food and feed commodities, cotton seed,
cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and
cotton gin byproducts.

Sec.  174.520  Bacillus thuringiensis Cry1F protein in corn; exemption
from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1F protein in corn are exempt
from the requirement of a tolerance when used as plant-incorporated
protectants in the food and feed commodities of corn; corn, field;
corn, sweet; and corn, pop.

Sec.  174.521  Neomycin phosphotransferase II; exemption from the
requirement of a tolerance.

    Residues of the neomycin phosphotransferase II (NPTII) enzyme are
exempted from the requirement of a tolerance in all food commodities
when used as a plant-incorporated protectant inert ingredient.

Sec.  174.522  Phosphinothricin Acetyltransferase (PAT); exemption from
the requirement of a tolerance.

    Residues of the Phosphinothricin Acetyltransferase (PAT) enzyme are
exempt from the requirement of a tolerance when used as plant-
incorporated protectant inert ingredients in all food commodities.

Sec.  174.523  CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS)
synthase in all plants; exemption from the requirement of a tolerance.

    Residues of the CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS)
synthase enzyme in all plants are exempt from the requirement of a
tolerance when used as plant-incorporated protectant inert ingredients
in all food commodities.

Sec.  174.524  Glyphosate Oxidoreductase GOX or GOXv247 in all plants;
exemption from the requirement of a tolerance.

    Residues of the Glyphosate Oxidoreductase GOX or GOXv247 enzyme in
all plants are exempt from the requirement of a tolerance when used as
plant-incorporated protectant inert ingredients in all food commodities.

Sec.  174.525  E. coli B-D-glucuronidase enzyme as a plant-incorporated
protectant inert ingredient; exemption from the requirement of a tolerance.

    Residues of E. coli B-D-glucuronidase enzyme are exempt from the
requirement of a tolerance when used as a plant-incorporated protectant
inert ingredient in all food commodities.

Sec.  174.526  Hygromycin B phosphotransferase (APH4) marker protein in
all plants; exemption from the requirement of a tolerance.

    Residues of the Hygromycin B phosphotransferase (APH4) enzyme in
all plants are exempt from the requirement of a tolerance when used as
a plant-incorporated protectant inert ingredient in cotton.

Sec.  174.527  Phosphomannose isomerase in all plants; exemption from
the requirement of a tolerance.

    Residues of the phosphomannose isomerase (PMI) enzyme in plants are
exempt from the requirement of a tolerance when used as plant-
incorporated protectant inert ingredients in all food commodities.
    10. Section 174.458 is redesignated as Sec.  174.528 and revised to
read as follows:

Sec.  174.528  Bacillus thuringiensis Vip3Aa20 protein; temporary
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Vip3Aa20 protein in corn are
temporarily exempt from the requirement of a tolerance when used as a
plant-incorporated protectant in the food and feed commodities of corn;
corn, field; corn, sweet; corn, pop. This temporary exemption from the
requirement of tolerance will permit the use of the food commodities in
this paragraph when treated in accordance with the provisions of the
experimental use permit 67979-EUP-6, 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
March 31, 2008; however, if the experimental use permit 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. E7-7767 Filed 4-24-07; 8:45 am]
BILLING CODE 6560-50-S 

 
 


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