Administrative Revisions to Plant-Incorporated Protectant
Tolerance Exemptions
[Federal Register: April 25, 2007 (Volume 72, Number 79)]
[Rules and Regulations]
[Page 20431-20436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap07-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 174 and 180
[EPA-HQ-OPP-2005-0116; FRL-7742-2]
Administrative Revisions to Plant-Incorporated Protectant
Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct Final Rule.
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SUMMARY: EPA is taking direct final 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 is also
making some conforming changes to the text of the individual exemptions
being transferred from part 180 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 made or are intended.
DATES: This Direct Final Rule is effective on July 24, 2007 without
further notice, unless EPA receives adverse comment by June 25, 2007.
If EPA receives such adverse comment, EPA will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.
If this Direct Final Rule becomes effective on July 24, 2007, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. Objections and requests for
hearings must be received on or before September 24, 2007.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0116. 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 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 Docket Facility is open 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
Polllution 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) 308-7026; e-mail address: mendelson.mike@epa.gov.
SUPPLEMENTARY INFORMATION:
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. 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. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at
http://www.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. You may also access a
frequently updated electronic version of 40 CFR parts 174 and 180
through the Government Printing Office's pilot e-CFR site at
http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0116 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before September 24, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0116, 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.
II. Background
In 2001, EPA published a final rule, establishing certain basic
parameters of its regulatory program under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) for a specific class of
[[Page 20432]]
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 title 40 of the Code
of Federal Regulations (CFR) specifically for plant-incorporated
protectants (40 CFR part 174). 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 (PIP) (66 FR 37817, July 19, 2001). See 40 CFR 174.475.
A. What Action is the Agency Taking?
In this Direct Final Rule, the Agency is making minor technical
changes to conform the wording of certain individual tolerance
exemptions with the above regulations. The specific technical changes
are discussed below.
The Agency is moving some tolerance exemptions listed under 40 CFR
part 180 to 40 CFR part 174 in order to consolidate all plant-
incorporated protectant-specific regulations in the same part.
The Agency is also making some conforming changes to the wording of
the exemptions so that they are consistent with the provisions
currently in part 174. These changes consist of revising the term
``plant-pesticides'' in these exemptions to read ``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 in newly
redesignated 40 CFR 174.501, 174.502, 174.503, 174.504, 174.505,
174.506, and 174.528 (formerly Sec. Sec. 174.452, 174.453, 174.454,
174.455, 174.456, 174.457, and 174.458, respectively), EPA is also
deleting the references to the phrase ``genetic material necessary for
its production'' and the term ``regulatory regions,'' as well as the
definitions of these terms, from individual tolerance exemptions. As
noted above, 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 (40
CFR 174.475 redesignated as Sec. 174.507). Retaining the references to
the phrase ``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 redesignated
40 CFR 174.507, 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 174.507.
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, redesignated as Sec. 174.500, EPA is changing 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 has chosen to use the one term ``food commodities.'' This
change will in no way affect the legal status of the residues exempted.
EPA is changing the term ``delta-endotoxin'' to read ``Cry
protein'' and removing 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 adding the term ``enzyme'' to descriptions of current PIP
inert ingredients to clarify the function of these proteins and to 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 updating 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/NeilCrickmore/Bt/. 
EPA is
standardizing the tolerance exemption descriptions to list the ``residues
of'' portion of the exemption first and to list field corn, sweet corn
and popcorn as corn; corn, field; corn, sweet; and corn, pop. These
changes will in no way affect the legal status of the residues exempted.
EPA is adding language to the exemption at Sec. 174.513
(redesignated from Sec. 180.1183), Potato Leaf Roll Virus Resistance
Gene (also known as orfl/orf2 gene), and the genetic material necessary
for its production 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 is adding language to the exemption at Sec. 174.523
(redesignated from Sec. 180.1174), CP4 Enolpyruvylshikimate-3-
phosphate (GP4 EPSPS), and the genetic material necessary for its
production in all plants 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
Notice of Filing (the pesticide petition) clearly stated ``synthase''
in describing the ingredient. See 60 FR 54689, October 25, 1995 (FRL-
4982-4). 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.
[[Page 20433]]
The specific tolerance exemptions that EPA is transferring from
part 180, subpart D to part 174, subpart W are identified in the
codified portion of this document. In addition to redesignating these
sections into part 174, EPA is making non-substantive changes to
terminology and for that reason the revised tolerance language that
will appear in 40 CFR part 174 appears at the end of this document as
regulatory text. While EPA believes that it has accurately transferred
each of the tolerance exemptions included in this rule, the Agency
would appreciate readers notifying EPA of discrepancies, omissions or
technical problems by submitting such comments to the address under FOR
FURTHER INFORMATION CONTACT.
EPA is publishing this rule without prior proposal because EPA
views this as a non-controversial amendment and anticipates no adverse
comments since the changes are entirely administrative in nature. As
discussed further below, these revisions are being made merely to make
the wording of certain tolerance exemptions consistent with the wording
adopted in subsequent regulations. No changes have been made that
affect in any way the legal status of the residues covered by the
existing tolerance exemptions. All of the substantive issues reflected
in the revisions to the regulatory text previously were the subject of
notice and comments rulemaking; as no substantive changes are
contemplated by this regulation, EPA anticipates no adverse comment on
this notice. However, in the ``Proposed Rules'' section of this Federal
Register, EPA is publishing a separate document that will serve as the
proposal to these administrative revisions to plant-incorporated
protectant tolerance exemptions if adverse comments are filed. This
Direct Final Rule will be effective on July 24, 2007 without further
notice unless the Agency receives adverse comment by June 25, 2007. If
EPA receives adverse comment, EPA will publish a timely withdrawal in
the Federal Register informing the public that this rule will not take
effect. The Agency will address all public comments in a subsequent
final rule based on the proposed rule. The Agency will not institute a
second comment period on this action. Any parties interested in
commenting must do so at this time.
B. What is the Agency's Authority for Taking this Action?
This action is being finalized 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)(l)(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.
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 0MB 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 a
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., 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
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.
[[Page 20434]]
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
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.
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Redesignated as
Old Section New section
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180.1134 174.521
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180.1147 174.509
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180.1151 174.522
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180.1155 174.510
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180.1173 174.511
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180.1174 174.523
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180.1182 174.512
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180.1183 174.513
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180.1184 174.514
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180.1185 174.515
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180.1186 174.516
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180.1190 174.524
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180.1192 174.517
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180.1214 174.518
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180.1215 174.519
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180.1216 174.525
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180.1217 174.520
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180.1249 174.526
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180.1252 174.527
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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.
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.
[[Page 20435]]
? 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.
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 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
[[Page 20436]]
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. E7-7768 Filed 4-24-07; 8:45 am]
BILLING CODE 6560-50-S
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