[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6887]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 174 and 180
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.
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.
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,
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
vi. Provide specific examples to illustrate your concerns and
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
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.
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,
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: firstname.lastname@example.org.
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: email@example.com.
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-
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
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-
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)-
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
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:
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: firstname.lastname@example.org.
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
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: email@example.com.
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: firstname.lastname@example.org.
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: email@example.com.
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
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:
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
L. Gibson, (703) 305-9096, e-mail address: firstname.lastname@example.org.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
Dated: March 15, 2011.
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-6887 Filed 3-28-11; 8:45 am]
BILLING CODE 6560-50-P