Document ID: EPA-HQ-OPP-2011-0007-0003
Agency: epa
Document Type: Proposed Rule
Title: Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
Posted Date: 2011-03-29T04:00Z

[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Proposed Rules]
[Pages 17374-17377]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6887]

[[Page 17374]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 174 and 180

[EPA-HQ-OPP-2011-0082; FRL-8867-4]

Receipt of Several Pesticide Petitions Filed for Residues of 
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of pesticide petitions.

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SUMMARY: This notice announces the Agency's receipt of several initial 
filings of pesticide petitions requesting the establishment or 
modification of regulations for residues of pesticide chemicals in or 
on various commodities.

DATES: Comments must be received on or before April 28, 2011.

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 the 
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 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.

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    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 atypical 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 0E7794. (EPA-HQ-OPP-2011-0110). BASF Corporation, 26 Davis 
Drive, Research Triangle Park, NC 27709, proposes to establish a 
tolerance in 40 CFR part 180 for residues of the herbicide imazapic, 
()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1-H-
imidazol-2-yl]-5-methyl-3-pyridinecarboxylic acid, in or on soybean at 
0.5 parts per million (ppm). The proposed analytical method for 
detecting residues of imazapic and the metabolites M715H001 (CL 
263,284) and M715H002 (CL 189,215) in soybean seed and processed 
fractions is a liquid chromatography-tandem mass spectrometry (LC/MS/
MS) method. Enforcement methods for analysis of residues of imazapic 
and metabolite M715H001 (CL 263,284) in animal commodities have been 
previously submitted. The analytical method for analysis in meat and 
meat byproducts is based on capillary electrophoreses with confirmation 
by LC/MS. The analytical method for analysis in milk and fat is based 
on determination by LC/MS with confirmation by LC/MS/MS. Contact: Mindy 
Ondish, (703) 605-0723, e-mail address: ondish.mindy@epa.gov.
    2. PP 0E7797. (EPA-HQ-OPP-2011-0146). Bayer CropScience, 2 T. W. 
Alexander Drive, Research Triangle Park, NC 27709, proposes to 
establish import tolerances in 40 CFR part 180 for residues of the 
fungicide propineb, [[[2-[(Dithiocarboxy)amino]-1-methyethyl] 
carbamodithioato(2-)-[ecirc]S,[ecirc]S']zinc], in or on apple, fruit at 
2.5 ppm; apple, wet pomace at 2.5 ppm; pear, fruit at 2.5 ppm; citrus, 
fruit at 4.5 ppm; banana, fruit (bagged) at 1.2 ppm; banana, fruit 
(unbagged) at 8.0 ppm; vegetable, cucurbit, group 9 at 8.0 ppm; 
vegetables, fruiting, group 8 at 8.0 ppm; onion, dry bulb at 1.6 ppm; 
onion, green at 13 ppm; grape at 0.8 ppm; olive at 0.35 ppm; avocado; 
and fruit crops, including: Black sapote; canistel; mamey sapote; 
mango; papaya; sapodilla; and star apple at 5.0 ppm. Propineb is 
rapidly degraded by hydrolysis and photolysis to the main metabolite 
propylenethiourea (PTU), which is the toxicologically relevant 
metabolite. Various analytical methods have been used, but samples are 
now prepared and analyzed by high performance liquid chromatography 
(HPLC)-atmosphere pressure chemical ionization/MS/MS. The limits of 
quantitation LOQ) is 0.01 ppm for PTU. Contact: Tamue L. Gibson, (703) 
305-9096, e-mail address: gibson.tamue@epa.gov.
    3. PP 0E7820. (EPA-HQ-OPP-2011-0087). Interregional Research 
Project Number 4 (IR-4), 500 College Road East, Suite 201 W., 
Princeton, NJ 08540, proposes to establish tolerances in 40 CFR part 
180 for residues of the insecticide spirodiclofen, 3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-
dimethylbutanoate, in or on sugar apple, cherimoya, atemoya, custard 
apple, ilama, soursop, biriba, guava, feijoa, jaboticaba, wax jambu, 
starfruit, passionfruit, persimmon and acerola at 0.45 ppm; and lychee, 
longan, Spanish lime, rambutan and pulasan at 3.5 ppm. Adequate 
analytical methodology using LC/MS/MS detection is available for 
enforcement purposes. Contact: Laura E. Nollen, (703) 305-7390, e-mail 
address: nollen.laura@epa.gov.
    4. PPs0F7714 and F7715. (EPA-HQ-OPP-2011-0053). Bayer CropScience, 
P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 
27709, proposes to establish tolerances in 40 CFR part 180 for residues 
of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-
chlorophenyl-2-hydroxypropyl)]-1,2-dihydro-3H-1,2,4-triazole-3-thione 
and its desthio metabolite, in or on raw or processed agricultural 
commodities rice, grain at 0.25 ppm; rice, hulls at 1.0 ppm; alfalfa, 
forage and alfalfa, hay at 0.02 ppm; and potato, tuber at 0.02 ppm. 
Bayer CropScience is also proposing use of the currently established 
tolerances for residues of prothioconazole, 2-[2-(1-chlorocyclopropyl)-
3-(2-chlorophenyl-2-hydroxypropyl)]-1,2-dihydro-3H-1,2,4-triazole-3-
thione and its desthio metabolite, in or on the raw agricultural 
commodity pea and bean, dried shelled, except soybean, subgroup 6C; 
soybean, forage; soybean, hay; and soybean, seed to support the use of 
prothioconazole as a seed treatment on these crops. Bayer CropScience 
is also proposing that the above proposed tolerances on rice, based on 
foliar data, also support the use of prothioconazole as a seed 
treatment on rice. The analytical method for determining residues of 
concern in plants extracts residues of prothioconazole and JAU6476-
desthio and converts the prothioconazole to JAU6476-desthio and 
JAU6476-sulfonic acid. Following addition of internal standards the 
sample extracts are analyzed by LC/MS/MS. Radiovalidation and 
independent laboratory validation have shown that the method adequately 
quantifies prothioconazole residues in treated commodities. The 
validated LOQ for total prothioconazole-derived residues in rice grain 
was 0.02 ppm. The validated LOQs were 0.01 ppm for 1H-1,2,4-triazole 
and 0.05 ppm for the triazole conjugates for grain. The

[[Page 17376]]

analytical method for analysis of large animal tissues includes 
extraction of the residues of concern, followed by addition of an 
internal standard to the extract. The extract is then hydrolyzed to 
release conjugates, partitioned and analyzed by LC/MS/MS as 
prothioconazole, JAU6476-desthio and JAU6476-4-hydroxy. The method for 
analysis of milk eliminated the initial extraction step in the tissue 
method. Contact: Tawanda Maignan, (703) 308-8050, e-mail address: 
maignan.tawanda@epa.gov.
    5. PP 0F7812. (EPA-HQ-OPP-2011-0007). Nippon Soda Co., Ltd., c/o 
Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006, 
proposes to establish a tolerance in 40 CFR part 180 for residues of 
the insecticide acetamiprid, N 1-[(6-chloro-3-pyridyl)methyl]-N 2-
cyano-N 1-methylacetamidine, including its metabolites and degradates, 
in or on food/feed handling establishments at 0.05 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 was developed that 
involves extraction of acetamiprid from composite meals with a solvent 
followed by a decantation and filtration and finally analysis by a LC/
MS/MS method. The LOQ and the limit of detection (LOD) for the method 
are calculated to be 0.05 ppm and 0.01 ppm for composite meals, 
respectively. The method was reliable for composite meal analyses with 
an overall average recovery of 93  14%. Contact: Jennifer 
Urbanski, (703) 347-0156, e-mail address: urbanski.jennifer@epa.gov.
    6. PP 0F7817. (EPA-HQ-OPP-2011-0144). E.I. duPont de Nemours and 
Company, 1007 Market Street, Wilmington, DE 19898, proposes to 
establish a tolerance in 40 CFR part 180 for residues of the herbicide 
aminocyclopyrachlor, [6-amino-5-chloro-2-cyclopropyl-4-
pyrimidinecarboxylic acid] and aminocyclopyrachlor methyl ester [methyl 
6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylate], expressed as 
aminocyclopyrachlor, in or on grass forage at 65 ppm; grass hay at 125 
ppm; fat (of cattle, goat, horse and sheep) at 0.07 ppm; meat (of 
cattle, goat, horse and sheep) at 0.02 ppm; meat byproducts--excluding 
liver (of cattle, goat, horse and sheep) at 0.4 ppm; liver (of cattle, 
goat, horse and sheep) at 0.06 ppm; and milk at 0.035 ppm. Adequate 
analytical methods for enforcement purposes are available to monitor 
residues of aminocyclopyrachlor in grass commodities, milk, meat and 
meat byproducts. The analytical methods for both grass commodities and 
ruminant commodities use an LC/MS/MS system operating with an 
electrospray interface (ESI) in positive ion mode with limits of 
quantitation (LOQ) of 0.01 ppm. Both methods have been successfully 
independently validated by outside laboratories. Aminocyclopyrachlor 
had also been tested through the Food and Drug Administration (FDA), 
Multi-residue Methodology. Contact: Mindy Ondish, (703) 605-0723, e-
mail address: ondish.mindy@epa.gov.
    7. PP 1F7822. (EPA-HQ-OPP-2011-0152). E.I. du Pont de Nemours and 
Company, 1007 Market Street, Wilmington, DE 19898, proposes to 
establish tolerances in 40 CFR part 180 for residues of the herbicide 
quizalofop-p-ethyl, (ethyl-2-[4-(6-chloroquinoxalin-2-yl oxy) phenoxy] 
propanoate), including its metabolites and degradates 
(DUPONTTM ASSURE[supreg] II), in or on corn, grain at 0.01 
ppm; corn, forage at 0.01 ppm; and corn, stover at 0.03 ppm. The 
currently proposed aspirated grain fraction (AGF) tolerance of 1.0 ppm, 
based on sorghum AGF in PP 0E7802, will not be changed by corn AGF 
residues. An adequate analytical methodology (HPLC using either 
ultraviolet (UV) or fluorescence detection) is available for 
enforcement purposes in Volume II of the Food and Drug Administration 
Pesticide Analytical Method (PAM II, Method I). Contact: Mindy Ondish, 
(703) 605-0723, e-mail address: ondish.mindy@epa.gov.

Amended Tolerances

    1. PP 0E7781. (EPA-HQ-OPP-2010-0980). BASF Corporation, P.O. Box 
13528, Research Triangle Park, NC 27709, proposes to amend the 
tolerances in 40 CFR 180.560 by amending the tolerance expression to 
establish combined residues of cloquintocet-mexyl (acetic acid, [(5-
chloro-8-quinolinyl)oxy]-,1-methylhexylester) (CAS Reg. No. 99607-70-2) 
and its acid metabolite (5-chloro-8-quinlinoxyacetic acid) when used as 
an inert ingredient (safener) in pesticide formulations containing 
either the herbicide clodinafop-propargyl or pinoxaden in a 1:4 ratio 
of safener to active ingredient or in combination with the registered 
active ingredient dicamba, in or on wheat, grain at 0.10 ppm; wheat, 
forage at 0.2 ppm; wheat, hay at 0.50 ppm; and wheat, straw at 0.10 
ppm. A practical analytical method for the determination of 
cloquintocet-mexyl and its major plant metabolite CGA-153433 in wheat 
raw agricultural commodities (RACs) published in the Federal Register 
of April 19, 2000 (65 FR 20972) (FRL-6554-3). Contact: Bethany Benbow, 
(703) 347-8072, e-mail address: benbow.bethany@epa.gov.
    2. PP 0F7792. (EPA-HQ-OPP-2011-0120). Bayer CropScience, P.O. Box 
12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709, 
proposes to amend the tolerances in 40 CFR part 180.474 for residues of 
the fungicide tebuconazole, alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1 H -1,2,4-triazole-1-ethanol), in or on wheat, grain 
and oats, grain by increasing the tolerances from 0.05 ppm to 0.15 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 Pesticide Analytical Method Volume II 
(PAM II). The animal method has also been approved as an adequate 
enforcement method. Contact: Tracy Keigwin, (703) 305-6605, e-mail 
address: keigwin.tracy@epa.gov.

New Tolerance Exemptions

    1. PP 0E7815. (EPA-HQ-OPP-2011-0093). Monsanto Company, 1300 I 
Street NW., Suite 450 East, Washington, DC 20005, proposes to establish 
an exemption from the requirement of a tolerance for residues of 
amides, C5-C9, N-3-[(dimethylamino)propyl] (CAS 
No. 1044764-00-2) and amides C6-C12, N-3-
[(dimethylamino)propyl] (CAS No. 1044754-06-8) when used as a pesticide 
inert ingredient (surfactant) in pesticide formulations in 40 CFR part 
180.910 pre- and post-harvest uses. The petitioner believes no 
analytical method is needed because they are not applicable or required 
for the establishment of a tolerance exemption for inert ingredients. 
Contact: Deirdre Sunderland, (703) 603-0851, e-mail address: 
sunderland.deirdre@epa.gov.
    2. PP 0E7797. (EPA-HQ-OPP-2011-0146). Bayer CropScience, 2 T.W. 
Alexander Drive, Research Triangle Park, NC 27709, proposes to 
establish an exemption from the requirement of a tolerance for residues 
of the fungicide propineb, [[[2-[(Dithiocarboxy)amino]-1-methyethyl] 
carbamodithioato(2-)-[ecirc]S, [ecirc]S']zinc], in or on apple, juice; 
citrus, juice; citrus, oil; citrus, dried pulp; tomato, puree; tomato, 
paste. The petitioner believes no analytical method is needed because 
no concentration was recovered by the maximum residue level (MRL) for 
these raw agricultural commodities. Also, the high performance liquid 
chromatography-atmosphere pressure chemical ionization/tandem mass 
spectrometry analytical method is available to EPA for the detection 
and measurement of the pesticide residues. Contact: Tamue

[[Page 17377]]

L. Gibson, (703) 305-9096, e-mail address: gibson.tamue@epa.gov.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: March 15, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-6887 Filed 3-28-11; 8:45 am]
BILLING CODE 6560-50-P