Document ID: EPA-HQ-OPP-2009-0552-0001
Agency: epa
Document Type: Notice
Title: Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
Posted Date: 2009-09-04T04:00Z

[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