Document ID: EPA-HQ-OPP-2013-0056-0001
Agency: epa
Document Type: Proposed Rule
Title: Pesticide Petitions Filed: Residues of Pesticide Chemicals in or on Various Commodities
Posted Date: 2013-02-27T05:00Z

[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Proposed Rules]
[Pages 13295-13298]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04594]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0023; FRL-9380-2]

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 petitions and request for comment.

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SUMMARY: This document 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 March 29, 2013.

ADDRESSES: Submit your comments, identified by the 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 online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone 
number and email 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 pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).
    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 email. 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 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), requesting the establishment or modification of 
regulations in 40 CFR part 180 for residues of pesticide chemicals in 
or on various food commodities. The Agency is taking public comment on 
the requests before responding to the petitioners. EPA is not proposing 
any particular action at this time. EPA has determined that the 
pesticide petitions described in this document 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. After 
considering the public comments, EPA intends to evaluate whether and 
what action may be warranted. 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

[[Page 13296]]

are the subject of this document, prepared by the petitioner, is 
included in a docket EPA has created for each rulemaking. The docket 
for each of the petitions is available online 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 petitions so that the public has an 
opportunity to comment on the requests for the establishment or 
modification of regulations for residues of pesticides in or on food 
commodities. Further information on the petitions may be obtained 
through the petition's summary referenced in this unit.

New Tolerance

    1. PP 2E8126. (EPA-HQ-OPP-2012-0980). Interregional Research 
Project Number 4 (IR-4), 500 College Road East, Suite 201W., Princeton, 
NJ 08540, requests to establish tolerances in 40 CFR part 180 for 
residues of the fungicide, mandipropamid, 4-chloro-N-[2-[3-methoxy-4-
(2-propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide, in 
or on basil, fresh at 30 parts per million (ppm); basil, dried at 200 
ppm; ginseng at 0.3 ppm; bean, succulent at 0.90 ppm; cowpea, forage at 
15 ppm; vegetable, fruiting, group 8-10 at 1.0 ppm; fruit, small, vine 
climbing, subgroup 13-07F, except fuzzy kiwifruit at 2.0 ppm; onion, 
bulb, subgroup 3-07A at 0.1 ppm; and onion, green, subgroup 3-07B at 
7.0 ppm. Analytical method RAM 415-01 was developed for determination 
of mandipropamid residues in crops. This method involves extraction of 
mandipropamid residues from crop samples by homogenization with 
acetonitrile: water (80:20 v/v). Extracts are centrifuged and aliquots 
diluted with water prior to being cleaned-up using polymeric solid-
phase extraction cartridges. Residues of mandipropamid are quantified 
using high performance liquid chromatography with triple quadruple mass 
spectrometric detection (HPLC-MS/MS). Contact: Laura Nollen, (703) 305-
7390, email address: nollen.laura@epa.gov.
    2. PP 2E8136. (EPA-HQ-OPP-2013-0056). Interregional Research 
Project Number 4 (IR-4), requests to establish tolerances in 40 CFR 
part 180 for residues of the herbicide, clomazone, including its 
metabolites and degradates, determined by measuring only clomazone, 2-
[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, in or on 
Brassica, head and stem, subgroup 5A at 0.10 ppm; rhubarb at 0.30 ppm; 
pea, southern, succulent, seed at 0.05 ppm; pea, southern, dry seed at 
0.05 ppm; and pea, southern, hay at 0.05 ppm. There is a practical 
analytical method for detecting and measuring levels of clomazone in or 
on raw agricultural commodities with a limit of detection that allows 
monitoring of food for residues at or above the levels proposed in this 
tolerance. Samples are analyzed using an analytical method consisting 
of an acid reflux, a C18 solid phase extraction (SPE), a 
Florisil SPE clean-up followed by gas chromatography (GC)-mass 
selective detection (MSD). Contact: Sidney Jackson, (703) 305-7610, 
email address: jackson.sidney@epa.gov.
    3. PP 3E8147. (EPA-HQ-OPP-2012-0626). Interregional Research 
Project Number 4 (IR-4), requests to establish tolerances in 40 CFR 
part 180 for residues of the insecticide, acetamiprid, (1E)-N-[(6-
chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, including 
its metabolites and degradates, in or on corn, sweet, kernel plus cob 
with husks removed at 0.01 ppm; corn, sweet, forage at 15 ppm; and 
corn, sweet, stover at 30 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 
residues of concern for enforcement purposes. As a result a method was 
developed that involves extraction of acetamiprid from crop matrices 
with a solvent followed by a decantation and filtration and finally 
analysis by a Liquid Chromotagraphy with tandem Mass Spectrometry (LC/
MS/MS) method. Contact: Andrew Ertman, (703) 308-9367, email address: 
ertman.andrew@epa.gov.
    4. PP 2F8088. (EPA-HQ-OPP-2013-0038). ISK Biosciences Corporation, 
7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish 
tolerances in 40 CFR part 180 for the combined residues of the 
insecticide, flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide, and its metabolites, TFNA (4-trifluoromethyl 
nicotinic acid), TFNA-AM (4-trifluoromethylnicotinamide), and TFNG, N-
(4-trifluoro methylnicotinoyl)glycine, calculated as the stoichiometric 
equivalent of flonicamid, in or on tree, nuts, crop group 14-12 at 0.09 
ppm; almond at 0.09 ppm; pecan at 0.04 ppm; and almond, hulls at 10.0 
ppm. The residue analytical method for the majority of crops includes 
an initial extraction with acetonitrile/deionized water, followed by a 
liquid-liquid partition with ethyl acetate. The residue method for 
wheat straw is similar, except that a C18 solid phase 
extraction (SPE) is added prior to the liquid-liquid partition. The 
final sample solution is quantitated using LC equipped with a reverse 
phase column and triple quadruple mass spectrometer (MS/MS). Contact: 
Carmen Rodia, (703) 306-0327, email address: rodia.carmen@epa.gov.
    5. PP 2F8130. (EPA-HQ-OPP-2012-0576). Arysta LifeScience North 
America, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513, requests 
to establish a tolerance in 40 CFR part 180 for residues of the 
fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-
4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on wheat, grain at 0.15 ppm. Adequate analytical 
methodology is available for enforcement purposes. The method comprises 
microwave solvent extraction followed by a solid phase extraction clean 
up and quantification by HPLC/MS/MS. The individual detector responses 
for measured E- and Z-isomers is summed to give total residue. Contact: 
Heather Garvie, (703) 308-0034, email address: garvie.heather@epa.gov.
    6. PP 2F8133. (EPA-HQ-OPP-2013-0071). BASF Corporation, 26 Davis 
Drive, Research Triangle Park, NC 27709, requests to establish a 
tolerance in 40 CFR part 180 for residues of the herbicide 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6- dinitrobenzenamine, 
and its 3,5-dinitrobenzyl alcohol metabolite (CL202347), in or on 
almond, hulls at 6.0 ppm. In plants, the practical method for detecting 
and measuring levels of pendimethalin is aqueous organic solvent 
extraction, column clean up, and quantitation by GC. Contact: Erik 
Kraft, (703) 308-9358, email address: kraft.erik@epa.gov.
    7. PP 2F8135. (EPA-HQ-OPP-2013-0051). Syngenta Crop Protection 
LLC., P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish 
a tolerance in 40 CFR part 180 for residues of the fungicide 
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] 
methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,-
dichlorobenzoic acid and expressed as parent compound, in or on 
rapeseed, subgroup 20A at 0.3 ppm. The metabolism data in plants and 
animals suggest that analytical methods to detect either the phenyl or 
the triazole ring would be appropriate for the measurement of residues. 
However, because of the natural occurrence of

[[Page 13297]]

compounds that interfere with the measurement of triazoles, methods 
designed to detect this moiety have been proven unreliable and 
unacceptable. Conversely, conversion of phenyl moiety to 2,4-
dichlorobenzoic acid (DCBA) has proven to be satisfactory for all 
agricultural products analyzed to date. Analytical methods AG-626 and 
AG-454A were developed for the determination of residues of 
propiconazole and its metabolites containing the DCBA moiety. 
Analytical method AG-626 has been accepted and published by EPA as the 
tolerance enforcement method for crops. Contact: Erin Malone, (703) 
347-0253, email address: malone.erin@epa.gov.
    8. PP 2F8139. (EPA-HQ-OPP-2013-0008). BASF Corporation, requests to 
establish a tolerance in 40 CFR part 180 for residues of the herbicide, 
saflufenacil, in or on crayfish at 0.01 ppm. Compliance with the 
tolerance levels is to be determined by measuring only saflufenacil, 2-
chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-
pyrimidinyl]-4-fluoro-N-[[methyl(1-
methylethyl)amino]sulfonyl]benzamide, in or on the commodities. 
Adequate enforcement methodology (LC/MS/MS) methods D0603/02 (plants) 
and L0073/01 (livestock) is available to enforce the tolerance 
expression. Contact: Bethany Benbow, (703) 347-8072, email address: 
benbow.bethany@epa.gov.

Amended Tolerance

    1. PP 2E8126. (EPA-HQ-OPP-2012-0980). Interregional Research 
Project Number 4 (IR-4), requests to amend the tolerances in 40 CFR 
180.637 for residues of the fungicide, mandipropamid, 4-chloro-N-[2-[3-
methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-
benzeneacetamide, by removing the previously established tolerances in 
or on grape at 1.4 ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 
ppm; okra at 1.0 ppm; and vegetable, fruiting, group 8 at 1.0 ppm, upon 
establishment of the tolerances listed under ``New Tolerance'' for PP 
2E8126, elsewhere in this document. Contact: Laura Nollen, (703) 305-
7390, email address: nollen.laura@epa.gov.
    2. PP 2E8136. (EPA-HQ-OPP-2013-0056). Interregional Research 
Project Number 4 (IR-4), requests to amend the tolerance in 40 CFR 
180.425 for residues of the herbicide, clomazone, including its 
metabolites and degradates, determined by measuring only clomazone, 2-
[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, by removing 
the previously established tolerance on cabbage at 0.10 ppm, upon 
approval of the petitioned-for tolerance on brassica, stem and head 
subgroup 5A listed under ``New Tolerance'' for PP 2E8136, elsewhere in 
this document. Contact: Sidney Jackson, (703) 305-7610, email address: 
jackson.sidney@epa.gov.
    3. PP 3E8147. (EPA-HQ-OPP-2012-0626). Interregional Research 
Project Number 4 (IR-4), requests to amend the tolerances in 40 CFR 
180.578 for residues of the insecticide acetamiprid, (1E)-N-[(6-chloro-
3-pyridinyl)methyl]- N'-cyano-N-methylethanimidamide, including its 
metabolites and degradates, by increasing the existing tolerances in 
meat, meat byproducts, and milk. Tolerances for cattle, goat, horse, 
and sheep meat are proposed at 0.30 ppm; cattle, goat, horse, and sheep 
fat at 0.20 ppm; cattle, goat, horse, and sheep meat byproducts at 0.70 
ppm; and milk at 0.30 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 residues of 
concern for enforcement purposes. As a result, a method was developed 
that involves extraction of acetamiprid from crop matrices with a 
solvent followed by a decantation and filtration and finally analysis 
by a LC/MS/MS method. Contact: Andrew Ertman, (703) 308-9367, email 
address: ertman.andrew@epa.gov.
    4. PP 2F8130. (EPA-HQ-OPP-2012-0576). Arysta LifeScience North 
America, LLC, requests to revise the tolerances in 40 CFR 180.609 for 
residues of the fungicide, fluoxastrobin, (1E)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, and its Z isomer, (1Z)-[2-[[6-
(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, and its phenoxy-
hydroxypyrimidine, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol, 
increasing the milk tolerance from 0.02 ppm to 0.03 ppm; and milk, fat 
from 0.50 ppm to 0.75 ppm. Adequate analytical methodology is available 
for enforcement purposes. The method comprises microwave solvent 
extraction followed by a solid phase extraction clean up and 
quantification by HPLC/MS/MS detection. The individual detector 
responses for measured E- and Z-isomers is summed to give total 
residue. Contact: Heather Garvie, (703) 308-0034, email address: 
garvie.heather@epa.gov.

New Tolerance Exemption

    PP 2E8049. (EPA-HQ-OPP-2012-0585). Pennzoil-Quaker State Company, 
700 Milam Street, Houston, TX 77002 c/o Wagner Regulatory Associates, 
7217 Lancaster Pike, Suite A, Hockessin, DE 19707, requests to 
establish an exemption from the requirement of a tolerance for residues 
of Distillates (Fishcher-Tropsch), heavy, C18-
C50, branched, cyclic and linear (CAS Reg. No. 848301-69-9) 
under 40 CFR 180.910 when used as a pesticide inert ingredient in 
pesticide formulations as a solvent, diluent and dust suppressant 
without limitations in pesticide formulations. The petitioner believes 
no analytical method is needed because it is not required for the 
establishment of a tolerance exemption for inert ingredients. Contact: 
Mark Dow, (703) 305-5533, email address: dow.mark@epa.gov.

Amended Tolerance Exemption

    1. PP 2E8080. (EPA-HQ-OPP-2013-0098). Toxcel, LLC, 7140 Heritage 
Village Plaza, Gainesville, VA 20156 on behalf of Penn A Kem, LLC, 3324 
Chelsea Avenue, Memphis, TN 38108, requests to amend an exemption from 
the requirement of a tolerance in 40 CFR 180.1263 for residues of 
tetrahydrofurfuryl alcohol (THFA), (CAS Reg. No. 97-99-4), when used as 
a pesticide inert ingredient in the form of a solvent/co-solvent in 
pesticide formulations, by allowing one pre-boot herbicide application 
to all small cereal grains, and by extending use on canola to early 
bolting stage, and use on soybeans up to bloom stage. The petitioner 
believes no analytical method is needed because it is not required for 
the amendment of a tolerance exemption for inert ingredients. Contact: 
Janet Whitehurst, (703) 305-6129, email address: 
whitehurst.janet@epa.gov.
    2. PP IN-10541. (EPA-HQ-OPP-2013-0093). Nichino America, Inc., 4550 
New Linden Hill Road, Suite 501, Wilmington DE 19808 c/o Wagner 
Regulatory Associates, 7217 Lancaster Pike, Suite A, Hockessin, DE 
19707, requests to amend an exemption from the requirement of a 
tolerance in 40 CFR 180.1130 for residues of N-(n-octyl)-2-pyrrolidone, 
(CAS Reg. No. 2687-94-7), when used as a pesticide inert ingredient to 
include use in pesticide formulations containing the pyraflufen ethyl 
active ingredient. The petitioner believes no analytical method is 
needed because it is not required for the amendment of a tolerance 
exemption for inert ingredients. Contact: David Lieu, (703) 305-0079, 
email address: lieu.david@epa.gov.

List of Subjects in 40 CFR Part 180

    Environmental protection, Agricultural commodities, Feed

[[Page 13298]]

additives, Food additives, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 20, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-04594 Filed 2-26-13; 8:45 am]
BILLING CODE 6560-50-P