Proposed Administrative Revisions to Plant-Incorporated Protectant Tolerance Exemptions, 20489-20494 [E7-7767]
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Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Proposed Rules
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
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in hard copy during normal business
hours at the Air Protection Division,
U.S. Environmental Protection Agency,
Region III, 1650 Arch Street,
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Copies of the State submittal are
available at the Maryland Department of
the Environment, 1800 Washington
Boulevard, Suite 705, Baltimore,
Maryland 21230.
FOR FURTHER INFORMATION CONTACT: Paul
Arnold, (215) 814–2194, or by e-mail at
arnold.paul@epa.gov.
SUPPLEMENTARY INFORMATION: For
further information, please see the
information provided in the direct final
action, with the same title, that is
located in the ‘‘Rules and Regulations’’
section of this Federal Register
publication.
Dated: April 17, 2007.
Donald S. Welsh,
Regional Administrator, Region III.
[FR Doc. E7–7920 Filed 4–24–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 174 and 180
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[EPA–HQ–OPP–2005–0117; FRL–7742–3]
Proposed Administrative Revisions to
Plant-Incorporated Protectant
Tolerance Exemptions
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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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 PlantIncorporated 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: https://
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 https://
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-
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20489
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 email 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 https://
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 https://
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:
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I. General Information
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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
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
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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
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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.
Old Section
Redesignated as
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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Old Section
Redesignated as
New section
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
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180.1186
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 ‘‘plantpesticides’’ 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 §§ 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 § 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,
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as the terms are defined at § 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
§ 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
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20491
scientific committee, https://
www.biols.susx.ac.uk/home/
NeillCrickmore/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
§ 180.1183, Potato Leaf Roll Virus
Resistance Gene (also known as orf1/
orf2 gene) and the genetic material
necessary for its production, as
§ 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
§ 180.1174, CP4 Enolpyruvylshikimate3-phosphate (CP4 EPSPS) and the
genetic material necessary for its
production in all plants, as § 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
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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
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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
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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.
CFR part 174, subpart W and
redesignated as the sections in the
second column.
Old Section
Redesignated as
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
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).
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
List of Subjects
180.1249
174.526
40 CFR Part 174
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements, Plant-incorporated
protectants.
180.1252
174.527
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.
§§ 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.
§ 174.21
[Amended]
PART 180—[AMENDED]
5. Section 174.21 is amended as
follows:
i. In paragraph (b) by revising the
reference ‘‘§§ 174.475 through 174.479’’
to read ‘‘§§ 174.507 through 174.508.’’
ii. In paragraph (c) by revising the
reference ‘‘§§ 174.485 through 174.490’’
to read ‘‘§ 174.705.’’
1. The authority citation for part 180
continues to read as follows:
§§ 174.475 and 174.479 [Redesignated as
§§ 174.507 and 174.508]
Therefore, Title 40, chapter I of the
Code of Federal Regulations is proposed
to be amended 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
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6. Sections 174.475 and 174.479 are
redesignated as §§ 174.507 and 174.508,
respectively.
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§§ 174.480 and 174.485 [Redesignated as
§§ 174.700 and 174.705]
7. Sections 174.480 and 174.485 are
redesignated as § 174.700 and § 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 §§ 174.500, 174.501,
174,502, 174.503, 174.504, 174.505, and
174.506, respectively, and revised to
read as follows:
§ 174.500
Scope and purpose.
This subpart lists the tolerances and
exemptions from the requirement of a
tolerance for residues of plantincorporated protectants in or on food
commodities.
§ 174.501 Bacillus thuringiensis VIP3A
protein; temporary exemption from the
requirement of a tolerance.
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.
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.
§ 174.504 Bacillus thuringiensis Cry1F
protein in cotton; exemption from the
requirement of a tolerance.
§ 174.502 Bacillus thuringiensis Cry1A.105
protein in corn; temporary 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 plantincorporated protectant in the food and
feed commodities of corn; corn, field;
corn, sweet; and corn, pop.
cprice-sewell on PRODPC61 with PROPOSALS
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.
§ 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
VerDate Aug<31>2005
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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.
§ 174.505 Bacillus thuringiensis modified
Cry3A protein (mCry3A) in corn; exemption
from the requirement of a tolerance.
§ 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 plantincorporated protectants in the food and
feed commodities of corn; corn, field;
corn, sweet; and corn, pop.
9. Newly redesignated §§ 174.509
through 174.527 are revised to read as
follows:
§ 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.
§ 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
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Sfmt 4702
20493
when used as plant-incorporated
protectants in all food commodities.
§ 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.
§ 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.
§ 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.
§ 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 plantincorporated protectant in or on all food
commodities.
§ 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.
§ 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.
§ 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.
E:\FR\FM\25APP1.SGM
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20494
Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Proposed Rules
§ 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.
§ 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.
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.
§ 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.
§ 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 plantincorporated protectant inert
ingredients in all food commodities.
cprice-sewell on PRODPC61 with PROPOSALS
§ 174.523 CP4 Enolpyruvylshikimate-3phosphate (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 plantincorporated protectant inert
ingredients in all food commodities.
§ 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
VerDate Aug<31>2005
15:21 Apr 24, 2007
Jkt 211001
[FR Doc. E7–7767 Filed 4–24–07; 8:45 am]
§ 174.525 E. coli B-D-glucuronidase
enzyme as a plant-incorporated protectant
inert ingredient; exemption from the
requirement of a tolerance.
FEDERAL COMMUNICATIONS
COMMISSION
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.
§ 174.526 Hygromycin B
phosphotransferase (APH4) marker protein
in all plants; exemption from the
requirement of a tolerance.
§ 174.520 Bacillus thuringiensis Cry1F
protein in corn; exemption from the
requirement of a tolerance.
requirement of a tolerance may be
revoked at any time.
enzyme in all plants are exempt from
the requirement of a tolerance when
used as plant-incorporated protectant
inert ingredients in all food
commodities.
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.
§ 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 plantincorporated protectant inert
ingredients in all food commodities.
10. Section 174.458 is redesignated as
§ 174.528 and revised to read as follows:
§ 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
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BILLING CODE 6560–50–S
47 CFR Part 101
[WT Docket No. 07–54; RM–11043; FCC 07–
38]
Amendment of the Commission’s
Rules To Modify Antenna
Requirements for the 10.7–11.7 GHz
Band
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
SUMMARY: In this document, we seek
comment on modifying the
Commission’s Rules to permit the
installation of smaller antennas by
Fixed Service (FS) operators in response
to a petition for rulemaking filed by
FiberTower, Inc. (FiberTower). In
particular, we seek comment on
whether these modifications would
serve the public interest by facilitating
the efficient use of the 11 GHz band
while protecting other users in the band
from interference due to the use of
smaller antennas.
DATES: Comments must be filed on or
before May 25, 2007, and reply
comments must be filed on or before
June 11, 2007.
ADDRESSES: Federal Communications
Commission, 445 12th Street, SW.,
Washington, DC 20554. You may submit
comments, identified by WT Docket No.
07–54, by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Federal Communications
Commission’s Web Site: https://
www.fcc.gov/cgb/ecfs/. Follow the
instructions for submitting comments.
• People with Disabilities: Contact the
FCC to request reasonable
accommodations (accessible format
documents, sign language interpreters,
CART, etc.) by e-mail: FCC504@fcc.gov
or phone: 202–418–0530 or TTY: 202–
418–0432.
For detailed instructions for
submitting comments and additional
information on the rulemaking process,
see the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT:
Brian Wondrack at 202–418–2487.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Notice of
E:\FR\FM\25APP1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 79 (Wednesday, April 25, 2007)]
[Proposed Rules]
[Pages 20489-20494]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7767]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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
https://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
https://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 https://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
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
------------------------------------------------------------------------
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
