Document ID: EPA-HQ-OPP-2005-0117-0001
Agency: epa
Document Type: Proposed Rule
Title: Proposed Administrative Revisions to Plant-Incorporated Protectant Tolerance Exemptions
Posted Date: 2007-04-25T04:00Z

[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
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[[Page 20491]]

180.1186                                                         174.516
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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
------------------------------------------------------------------------

    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