[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Notices]
[Page 16352-16356]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap07-61]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0936; FRL-8119-2]
Notice of Filing of Pesticide Petitions for Residues of Pesticide
Chemicals in or on Various Commodities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment or modification of regulations
for residues
[[Page 16353]]
of pesticide chemicals in or on various commodities.
DATES: Comments must be received on or before May 4, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest, 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
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to the assigned docket ID number
and the pesticide petition number of interest. 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 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
website 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. Publicly available docket materials are available
electronically 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 Bldg.), 2777 S. Crystal Dr., 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
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: The person listed at the end of the
pesticide petition summary of interest.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
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. Docket ID Numbers
When submitting comments, please use the docket ID number and the
pesticide petition number of interest, as shown in the table.
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PP number Docket ID number
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PP 3E6562 EPA-HQ-OPP-2007-0107
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PP 6E7138 EPA-HQ-OPP-2007-0107
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[[Page 16354]]
PP 6E7129 EPA-HQ-OPP-2007-0106
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PP 6E7152 EPA-HQ-OPP-2007-0116
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PP 6E7163 EPA-HQ-OPP-2007-0105
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PP 6E7165 EPA-HQ-OPP-2007-0117
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PP 5E6962 EPA-HQ-OPP-2005-0305
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PP 5E7007 EPA-HQ-OPP-2005-0305
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PP 6E7164 EPA-HQ-OPP-2007-0115
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PP 6E7168 EPA-HQ-OPP-2007-0114
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PP 5E6996 EPA-HQ-OPP-2005-0306
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III. What Action is the Agency Taking?
EPA is printing notice of the filing of pesticide petitions
received under section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petitions described in this notice contain data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the pesticide
petitions. Additional data may be needed before EPA rules on these
pesticide petitions.
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
included in this notice, prepared by the petitioner, is included in a
docket EPA has created for each rulemaking. The docket for each of the
petitions is available on-line at http://www.regulations.gov.
Amendment to Existing Tolerances
1. PPs 3E6562 and 6E7138. (Docket ID number EPA-HQ-OPP-2007-0107).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.443 by
establishing tolerances for residues of the fungicide myclobutanil in
or on the food commodities in PP 3E6562: Black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, and star apple at 3.0 parts per
million (ppm); and in PP 6E7138: Fruiting vegetables, crop group 8,
except tomato at 4.5 ppm; leafy vegetables, crop subgroup 4A, except
spinach at 11.0 ppm; globe artichoke at 0.9 ppm; cilantro at 11.0 ppm;
and okra at 4.5 ppm. The residue analytical method used was Rohm and
Haas Company method 34S-88-10, ``RH-3866 total residue analytical
method for apple, and grape'' for artichokes, lettuce, pepper, and
tropical fruits; and Rohm and Haas method TR34S-88-21, ``Analytical
method for the measure of RH-3866 in various crops, soil, meat, milk
and eggs''. The lowest level of method validation (LLMV) in this study
was 0.01 ppm for each analyte. Based on recoveries of samples fortified
at the LLMV, the limit of detection (LOD) and the limit of quantitation
(LOQ) were estimated as 0.0036 ppm and 0.011 ppm; respectively, for
myclobutanil as 0.018 ppm and 0.054 ppm; respectively, for RH-9090.
Contact: Barbara Madden, telephone number: (703) 305-6463; e-mail
address: madden.barbara@epa.gov.
2. PP 6E7129. (Docket ID number EPA-HQ-OPP-2007-0106).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.361 by
establishing tolerances for residues of the herbicide pendimethalin,
[N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its
metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol
in or on the food commodities Brassica, head and stem, subgroup 5A at
0.05 ppm; grape at 0.05 ppm; artichoke, globe at 0.05 ppm; and
asparagus at 0.1 ppm. The analytical method in plants is aqueous
organic solvent extraction, column clean-up, and quantitation by gas
chromatography (GC). The method has a LOQ of 0.05 ppm for pendimethalin
and the alcohol metabolite. Contact: Barbara Madden, telephone number:
(703) 305-6463; e-mail address: madden.barbara@epa.gov.
3. PP 6E7152. (Docket ID number EPA-HQ-OPP-2007-0116).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.361 by
establishing tolerances for residues of the herbicide dimethenamid,
(R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethyl-thien-3-
yl)-acetamide in or on the food commodities squash, winter at 0.01 ppm;
pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01
ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.01 ppm; rutabaga,
roots at 0.01 ppm; rutabaga, tops at 0.01 ppm; and hops, dried cones
0.05 ppm. The proposed analytical method uses extraction and clean-up
followed by quantification with capillary column GC using thermionic
nitrogen specific detector. A gas spectrometry/mass spectrometry (GS/
MS) method for identification is also available. This method is not
selective towards the dimethenamid isomer and is therefore valid for
residues from both racemic dimethenamid and the enriched isomer
dimethenamid-P. Tolerances are proposed based on a non-isomer specific
basis. Contact: Shaja Brothers, telephone number: (703) 308-3194; e-
mail address: brothers.shaja@epa.gov.
4. PP 6E7163. (Docket ID number EPA-HQ-OPP-2007-0105).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.578 by
establishing tolerances for residues of the insecticide acetamiprid,
N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine in or on
the food commodities strawberry, bearberry, bilberry, lowbush
blueberry, cloudberry, cranberry, ligonberry, muntries, and
partridgeberry at 0.60 ppm. Based upon the metabolism of acetamiprid in
plants and the toxicology of the parent, and metabolites quantification
of the parent acetamiprid is sufficient to determine toxic residues. As
a result, a method has been developed which involves extraction of
acetamiprid from crops with methanol and analysis by liquid
chromatography/tandem mass spectrometry (LC/MS/MS) methods. The LOQ and
the LOD for the method are calculated to be 0.002 ppm and 0.0008 ppm
for strawberries, respectively. The LLMV for strawberries was 0.01 ppm
for acetamiprid. Contact: Barbara Madden, telephone number: (703) 305-
6463; e-mail address: madden.barbara@epa.gov.
5. PP 6E7165. (Docket ID number EPA-HQ-OPP-2007-0117).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.582 by
establishing tolerances for residues of the fungicide pyraclostrobin,
(carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]
phenyl]methoxy-, methyl ester) and its metabolite (methyl-N-[[[1-(4-
chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate) (BF 500-3) expressed
as parent compound in or on the food commodities herbs, fresh at 30.0
ppm; avocado at 0.7 ppm; mango at 0.7 ppm; papaya at 0.7 ppm; sapote,
black at 0.7 ppm; sapote, mamey at 0.7 ppm; canistel at 0.7 ppm;
sapodilla at 0.7 ppm; and star apple at 0.7 ppm. In plants the method
of analysis is aqueous organic solvent extraction, column clean-up and
quantitation by LC/MS/MS. In animals the method of analysis
[[Page 16355]]
involves base hydrolysis, organic extraction, column clean up and
quantitation by LC/MS/MS or derivatization (methylation) followed by
quantitation by GC/MS. Contact: Shaja R. Brothers, telephone number:
(703) 308-3194; e-mail address: brothers.shaja@epa.gov.
6. PP 5E6962. (Docket ID number EPA-HQ-OPP-2005-0305).
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390; and Bayer
CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709,
proposes to amend the tolerances in 40 CFR 180.570 for residues of the
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline -3-carboxylate) and
its metabolite 4,5-dihydro-5,5,diphenyl-3-isoxazolecarboxylic acid when
used as an inert ingredient (safener) in or on the food commodities
corn, field, forage at 0.20 ppm (increased from existing tolerance of
0.10 ppm), and corn, field, stover at 0.40 ppm (increased from existing
tolerance of 0.20 ppm); (request removal of the specified limitation in
seasonal application rate from the existing tolerances); and
isoxadifen-ethyl and its metabolites 4,5-dihydro-5,5,diphenyl -3-
isoxazolecarboxylic acid and [beta]-hydroxy-[beta]-
benzenepropanenitrile when used as an inert ingredient (safener) in or
on the following raw agricultural commodities: Rice, grain at 0.10 ppm;
rice, hulls at 0.50 ppm; and rice, straw at 0.25 ppm (request removal
of the specified limitation in seasonal application rate from the
existing tolerances). The analytical targets selected were the parent
compound, isoxadifen-ethyl and the major metabolite isoxadifen acid (AE
F129431). In rice, AE C637375 and AE F162241 are also determined. After
extraction and cleanup, the analytes are determined by either GC/MS or
HPLC/MS. The LOQ are 0.02 ppm in corn grain, 0.05 ppm in corn forage
and stover, and 0.02 ppm in rice. Contact: Shaja R. Brothers, telephone
number: (703) 308-3194; e-mail address: brothers.shaja@epa.gov.
New Tolerances
1. PP 5E7007. (Docket ID number EPA-HQ-OPP-2005-0305).
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390; and Bayer
CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709,
proposing pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing a tolerance for residues of isoxadifen-ethyl, (ethyl 5,5-
diphenyl-2-isoxazoline-3-carboxylate) and its metabolite 4,5-dihydro-
5,5,diphenyl-3-isoxazolecarboxylic acid when used as an inert
ingredient (safener) in or on the food commodities corn, sweet, kernel
plus cob with husks removed at 0.05 ppm; corn, sweet, forage at 0.40
ppm; corn, sweet, stover at 0.40 ppm; corn, pop, grain at 0.02 ppm; and
corn, pop, stover at 0.40 ppm. The analytical targets selected were the
parent compound, isoxadifen-ethyl and the major metabolite isoxadifen
acid (AE F129431). In rice, AE C637375 and AE F162241 are also
determined. After extraction and clean-up, the analytes are determined
by either GC/MS or HPLC/MS. The LOQ are 0.02 ppm in corn grain, 0.05
ppm in corn forage and stover, and 0.02 ppm in rice. Contact: Shaja R.
Brothers, telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
2. PP 6E7164. (Docket ID number EPA-HQ-OPP-2007-0115).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance for
residues of the fungicide boscalid, (BAS 510F), 3-pyridinecarboxamide,
2-chloro-N-(4'-chloro(1,1'-biphenyl)-2-yl) in or on food commodities
avocado at 1.5 ppm; sapote, black at 1.5 ppm; canistel at 1.5 ppm;
sopote, mamey at 1.5 ppm; mango at 1.5 ppm; papaya at 1.5 ppm;
sapodilla at 1.5 ppm; star apple at 1.5 ppm; and herbs, fresh, subgroup
19A at 60.0 ppm. In plants the parent residue is extracted using an
aqueous organic solvent mixture followed by liquid/liquid partitioning
and a column clean-up. Quantitation is by GC using MS. In livestock the
residues are extracted with methanol. The extract is treated with
enzymes in order to release the conjugated glucuronic acid metabolite.
The residues are then isolated by liquid/liquid partition followed by
column chromatography. The hydroxylated metabolite is acetylated
followed by a column clean-up. The parent and acetylated metabolite are
quantitated by GC with electron capture detection. Contact: Shaja R.
Brothers, telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
3. PP 6E7168. (Docket ID number EPA-HQ-OPP-2007-0114).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance for
residues of fluroxypyr MHE, and its metabolite fluroxypyr (expressed as
combined residues of total fluroxypyr) in or on food commodities pome,
fruit, group 11 at 0.02 ppm; millet, grain at 0.5 ppm; millet, forage
at 12.0 ppm; grass, hay at 20.0 ppm; millet, proso, grain at 0.5 ppm;
millet, proso, straw at 12.0 ppm; millet, proso, forage at 12.0 ppm;
millet, proso, hay at 20.0 ppm; millet, pearl, grain at 0.5 ppm;
millet, pearl, forage at 12.0 ppm; and millet, pearl, hay at 20.0 ppm.
Adequate enforcement method for the combined residues of total
fluroxypyr is available to enforce the tolerance expression in or on
food. The analytical method uses capillary GC and mass selective
detection (MSD) with LOQ of 0.01 ppm. Fluroxypyr has also been tested
through the Food and Drug Administration (FDA), Multi-residue
Methodology, Protocols C, D, and E. The results have been published in
the FDA Pesticide Analytical Manual, volume 1. Contact: Shaja R.
Brothers, telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
Amended Exemption from Tolerance
PP 5E6996. (Docket ID number EPA-HQ-OPP-2005-0306). BASF
Corporation, 100 Campus Drive, Florham Park, NJ 07932, proposes to
amend an exemption from the requirement of a tolerance for residues of
vitamin E (CAS no. 1406-18-4) by including the form of vitamin E
alcohol (d-alpha tocopherol, CAS no. 59-02-9 and dl-alpha tocopherol,
CAS no. 10191-41-0), and vitamin E Acetate (d-alpha tocopheryl acetate,
CAS no. 58-95-7 and dl-alpha tocopheryl acetate, CAS no. 7695-91-2), in
or on raw agricultural commodities when used as an ingredient in
pesticide formulations used in accordance with good agricultural
practices. Vitamin E is a chemical complex that includes eight
naturally occurring homologues having a chromanol ring and a twelve-
carbon aliphatic side chain containing two methyl groups in the middle
and two or more methyl groups on the end. Vitamin E is found in many
plant-derived foods and is believed to be necessary for human health.
Vitamin E alcohol in the form of d-alpha tocopherol has the highest
biological activity of the compounds in the vitamin E complex. Vitamin
E alcohol and its ester, vitamin E acetate, are commonly consumed as
dietary supplements. Vitamin E alcohol and vitamin E acetate are common
food additives. Vitamin E alcohol is used as an antioxidant for foods
or food chemicals. Vitamin E acetate is a common animal feed additive
and is used widely in topical skin care products.
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether
[[Page 16356]]
the data supports granting of the petition. Additional data may be
needed before EPA rules on the petition. Because this petition is a
request for an exemption from the requirement of a tolerance without
numerical limitations, no analytical method is required. Contact:
Kathleen Martin, telephone number: (703) 308-2857; e-mail address:
martin.kathleen@epa.gov.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: March 22, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E7-6047 Filed 4-3-07; 8:45 am]
BILLING CODE 6560-50-S