[Federal Register: September 4, 2009 (Volume 74, Number 171)]
[Notices]
[Page 45848-45851]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04se09-54]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0045; FRL-8434-4]
Notice of Receipt of Several Pesticide Petitions Filed 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 Agency's receipt of several initial
filings of pesticide petitions proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.
DATES: Comments must be received on or before October 5, 2009.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, 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 Facility'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 docket ID number and the
pesticide petition number of interest as shown in the body of this
document. 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 at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South 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: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at:
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
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
[[Page 45849]]
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.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have a typical or disproportionately high and adverse
human health impacts or environmental effects from exposure to the
pesticides discussed in this document, compared to the general
population.
II. What Action is the Agency Taking?
EPA is announcing its receipt of several pesticide petitions filed
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 174 or 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 the data or
information prescribed 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 can make a final determination
on these pesticide petitions.
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of 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.
As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.
New Tolerances
1. PP 8E7495. (EPA-HQ-OPP-2009-0552). Syngenta Crop Protection, P.
O. Box 18300, Greensboro, NC 27409, proposes to establish an import
tolerance in 40 CFR part 180 for residues of the fungicide fludioxonil,
4-(2, 2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or
on canola, seed at 0.01 parts per million (ppm). Syngenta has developed
and validated analytical methodology for enforcement purposes. This
method (Syngenta Crop Protection Method AG-597B) has passed an Agency
petition method validation for several commodities, and is currently
the enforcement method for fludioxonil. This method has also been
forwarded to the Food and Drug Administration (FDA) for inclusion into
the Pesticide Analytical Manual, Volume II (PAM II). An extensive
database of method validation data using this method on various crop
commodities is available. Contact: Lisa Jones, (703) 308-9424;
jones.lisa@epa.gov.
2. PP 8E7502. (EPA-HQ-OPP-2009-0551). Syngenta Crop Protection, P.
O. Box 18300, Greensboro, NC 27409, proposes to establish an import
tolerance in 40 CFR part 180 for residues of the fungicide cyprodinil,
2-Pyrimidinamine, 4-cyclopropyl-6-methyl-N-phenyl-, in or on canola,
seed at 0.03 ppm. Syngenta Crop Protection has developed and validated
analytical methodology for enforcement purposes. This method (Syngenta
Crop Protection Method AG-631B) has passed an Agency petition method
validation for several commodities and is currently the enforcement
method for cyprodinil. An extensive database of method validation data
using this method on various crop commodities is available. Contact:
Lisa Jones, (703) 308-9424; jones.lisa@epa.gov.
3. PP 9E7542. (EPA-HQ-OPP-2009-0553). Nichino America, Inc., 4550
New Linden Hill Rd., Suite 501, Wilmington, DE 19808, proposes to
establish a tolerance in 40 CFR part 180 for residues of the fungicide
flutolanil, (N-(3-(1-methylethoxy) phenyl) -2- (trifluoromethyl)
benzamide) and its metabolite, M-4, desisopropylflutolanil (N-(3-
hydroxyphenyl)-2-(trifluromethyl) benzamide), expressed as 2-
trifluoromethyl benzoic acid and calculated as flutolanil, in or on
cotton, seed and soybean, seed at 0.05 ppm. A previously submitted
analytical method designated AU-95R-04, a gas chromatography, mass
spectrometry detection method has been
[[Page 45850]]
independently validated and is adequate for enforcement purposes for
flutolanil residue detection in soybean and wheat raw agricultural
commodities. A multi-residue method for flutolanil has been previously
submitted. The method is for use only by experienced chemists who have
demonstrated knowledge of the principals of trace organic analysis and
have proven skills and abilities to run a complex residue analytical
method obtaining accurate results at the part per billion level. Users
of this method are expected to perform additional method validation
prior to using the method for either monitoring or enforcement. The
method can detect gross misuse. Contact: Lisa Jones, (703) 308-9424;
jones.lisa@epa.gov.
4. PP 9E7566. (EPA-HQ-OPP-2009-0623). Gowan Company, 370 South Main
Street, Yuma, AZ 85364, proposes to establish a tolerance in 40 CFR
part 180 for residues of the fungicide fenarimol, and its metabolites
in or on cucurbits at 0.2 ppm. Analytical methodology used for cucurbit
crops is a slight modification of the basic Pesticide Analytical Manual
(PAM II) method for fenarimol (Method R039). Residues are extracted
with methanol. Aqueous sodium chloride 5% is added and the extract is
partitioned with dichloromethane. Residues are cleaned up on a Florisil
column and detected by gas chromatography/electron capture detector
(GC/ECD). Recoveries ranged from 84 - 97% in samples fortified with
fenarimol at 0.02 ppm to 0.2 ppm. The limit of detection (LOD) is 0.01
ppm. Contact: Tamue L. Gibson, (703) 305-9095; gibson.tamue@epa.gov.
5. PP 8F7468. (EPA-HQ-OPP-2009-0622). Bayer CropScience, 2 T.W.
Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709,
proposes to establish a tolerance in 40 CFR part 180 for residues of
the fungicide pyrimethanil, (4,6-dimethyl-N-phenyl-2-pyrimidinamine) in
or on caneberries, subgroup 13-07A at 12 ppm and bushberries, subgroup
13-07B at 6 ppm. Pyrimethanil was extracted from apples by
homogenization with acetone. An aliquot of the extract was diluted with
a mixture of acetonitrile and water with subsequent residue
determination by high performance liquid chromatography-mass
spectrometry/mass spectrometry (HPLC-MS/MS). The method allows the
detection and measurement of residues in or on agricultural commodities
at or above the proposed tolerance level. Contact: Tamue L. Gibson,
(703) 305-9095; gibson.tamue@epa.gov.
6. PP 9F7515. (EPA-HQ-OPP-2009-0611). Bayer CropScience, 2 T.W.
Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709,
proposes to establish a tolerance in 40 CFR part 180 for residues of
the fungicide tebuconazole, in or on vegetables, fruiting, group at 1.4
ppm. An enforcement method for plant commodities has been validated on
various commodities. It has undergone successful EPA validation and has
been submitted for inclusion in the PAM II. The animal method has also
been approved as an adequate enforcement method. Contact: Tracy
Keigwin, (703) 305-6605; keigwin.tracy@epa.gov.
7. PP 9F7543. (EPA-HQ-OPP-2009-0616). Elanco Animal Health via
Technology Sciences Group Inc., 4061 North 156th Drive, Goodyear, AZ
85395, proposes to establish a tolerance in 40 CFR part 180 for
residues of the insecticide spinosad, a fermentation product of
Saccharopolyspora spinosa which consists of two related active
ingredients:
Spinosyn A (Factor A: CAS No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-
methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione;
and Spinosyn D (Factor D; CAS No. 131929-63-0) or 2-[(6-deoxy-2,3,4-
tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on milk at 5 ppm;
milk, fat at 40 ppm; cattle, goat, and sheep, fat at 30 ppm; hog, meat
and poultry, meat byproducts at 0.2 ppm; hog, meat byproducts at 0.6
ppm; poultry, fat at 1.5 ppm; and hog, fat at 2.0 ppm. The supporting
assessment includes the Agency conclusion that spinosad is considered
toxicologically identical to another pesticide, spinetoram. EPA has
determined adequate analytical methods are available for enforcement
purposes for spinosad in plant and animal matrices. Methods include an
immunoassay particle-based method 97.05 and an high performance liquid
chromatography/ultraviolet (HPLC/UV) method GRM 03.15 and a suite of
specific crop methods: GRM 94.02 (cottonseed and related commodities),
GRM 95.17 (leafy vegetables), GRM 96.09 (citrus), GRM 96.14 (tree
nuts), GRM 95.04 (fruiting vegetables), GRM 94.02.S1 (cotton gin
byproducts). GRM 94.02 has a successful independent lab validation and
was submitted for inclusion in PAM II as Method I. EPA recently
concluded that for water, residues should be estimated using total
spinosad residue method (EPA, D316077, August 2, 2006). An updated Dow
AgroSciences method GRM 06.13 for the determination of residues of
spinosad and its metabolites in poultry tissues and eggs by liquid
chromatography with tandem mass spectrometry supports this petition.
Contact: Samantha Hulkower, (703) 603-0683; hulkower.samantha@epa.gov.
8. PP 9F7563. (EPA-HQ-OPP-2009-0575). Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419-8300, proposes to establish
a tolerance in 40 CFR part 180 for residues of the herbicide sodium
salt of fomesafen, 5-[2-cloro-4-(trifluoromethyl)phenoxy]-N-
(methylsulfonyl)-2-nitrobenzamide, in or on potato at 0.025 ppm; and
tomato at 0.025 ppm. The analytical method used for analysis of the
potato tubers, tomato fruit and related processed fractions was based
upon methodology previously utilized for analysis of fomesafen in
soybeans. Contact: Michael Walsh, (703) 308-2972;
walsh.michael@epa.gov.
9. PP 9F7565. (EPA-HQ-OPP-2009-0550). Devgen US, Inc., 413
McFarlan Road, Suite B, Kennett Square, PA 19348, proposes to establish
a tolerance in 40 CFR part 180 for residues of the fungicide iprodione,
in or on cucurbit crop group at 0.3 ppm; and fruiting vegetables,
except cucurbits at 2.0 ppm. An adequate analytical method, gas liquid
chromatography using an electron-capture detector, is available in the
PAM II for enforcement purposes. Contact: Lisa Jones, (703) 308-9424;
jones.lisa@epa.gov.
New Tolerance Exemptions
1. PP 9E7575. (EPA-HQ-OPP-2009-0478). BASF Corporation, 100 Campus
Drive, Florham Park, NJ 07932, proposes to establish an exemption from
the requirement of a tolerance for residues of carbonic acid, diethyl
ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-
ethanediyl)] ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol
(3:1), ester with alpha-[[[[5-(carboxyamino)-1,3,3-
trimethylcyclohexylmethyl]amino]carbonyl]-omega-methoxypoly(oxy-1,2-
ethanediyl) (CAS No. 1147260-65-8) under 40 CFR 180.960 when used as an
inert ingredient as a surfactant in pesticide formulations without
limitation. The petitioner believes no analytical method is needed
because this petition is a request for an exemption from the
requirement of a tolerance. Contact:
[[Page 45851]]
Elizabeth Fertich, (703) 347-8560; fertich.elizabeth@epa.gov.
2. PP 9E7581. (EPA-HQ-OPP-2009-0610). Dow AgroSciences, LLC, 9330
Zionsville Road, Indianapolis, IN 46268, proposes to establish an
exemption from the requirement of a tolerance for residues of the
dibenzylidene sorbitol (DBS) (CAS No. 32647-67-9); IUPAC D-Glucitol,
bis-O-(phenylmethylene) (CAS No. 32647-67-9) under 40 CFR 180.920 when
used as an inert ingredient in a pesticide formulation. A limitation to
herbicides only with a 3% formulation cap is proposed. The petitioner
believes no analytical method is needed because this petition is a
request for an exemption from the requirement of a tolerance. Contact:
Elizabeth Fertich, (703) 347-8560; fertich.elizabeth@epa.gov.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: August 24, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E9-21395 Filed 9-3-09; 8:45 am]
BILLING CODE 6560-50-S