[Federal Register Volume 77, Number 50 (Wednesday, March 14, 2012)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6056]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 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 petitions and request for comment.
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 April 13, 2012.
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
email. The regulations.gov Web site 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 email
comment directly to EPA without going through regulations.gov, your
email 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 email address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Antimicrobials Division (7510P), Biopesticides and Pollution Prevention
Division (7511P), or 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.
affected entities may include, but are not limited to:
[emsp14]Crop production (NAICS code 111).
[emsp14]Animal production (NAICS code 112).
[emsp14]Food manufacturing (NAICS code 311).
[emsp14]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 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,
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, requesting 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. 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
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that 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 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 1E7942. (EPA-HQ-OPP-2011-0985). Interregional Research
Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, New Jersey, 08540, 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-
trifluoromethylnicotinic acid], TFNA-AM [4-trifluoromethylnicotinamide]
TFNG [N-(4-trifluoromethylnicotinoyl) glycine], in or on berry, low
growing, subgroup 13-07G at 1.4 parts per million (ppm); cucumber at
1.3 ppm; and rapeseed, subgroup 20A at 1.5 ppm. Analytical methodology
has been developed to determine the residues of flonicamid and its
three major plant metabolites, TFNA, TFNG, and TFNA-AM in various
crops. The residue analytical method for the majority of crops includes
an initial extraction with acetonitrile (ACN)/deionized (DI) 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 a liquid chromatography
(LC) equipped with a reverse phase column and a triple quadruple mass
spectrometer (MS/MS). Contact: Sidney Jackson, Registration Division
(7505P), (703) 305-7610, email address: firstname.lastname@example.org.
2. PP 1E7950. (EPA-HQ-OPP-2011-1012). Interregional Research
Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to establish
tolerances in 40 CFR part 180 for residues of the insecticide
pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on
vegetable, bulb, group 3-07 at 0.70 ppm; vegetable, fruiting, group 8-
10 at 0.20 ppm; fruit, citrus, group 10-10 at 0.30 ppm; fruit, pome,
group 11-10 at 0.20 ppm; caneberry subgroup 13-07A at 1.0 ppm;
bushberry subgroup 13-07B at 1.0 ppm; berry, low growing, except
strawberry, subgroup 13-07H at 1.0 ppm; and herb subgroup 19A at 50
ppm. Practical analytical methods for detecting and measuring levels of
pyriproxyfen (and relevant metabolites)
have been developed and validated in/on all appropriate agricultural
commodities, respective processing fractions, milk, animal tissues, and
environmental samples. The extraction methodology has been validated
using aged radiochemical residue samples from metabolism studies. The
methods have been validated in cottonseed, apples, soil, and oranges at
independent laboratories. EPA has successfully validated the analytical
methods for analysis of cottonseed, pome fruit, nutmeats, almond hulls,
and fruiting vegetables. The limit of detection of pyriproxyfen in the
methods is 0.01 ppm which will allow monitoring of food with residues
at the levels proposed for the tolerances. Contact: Andrew Ertman,
Registration Division (7505P), (703) 308-9367, email address:
3. PP 1E7959. (EPA-HQ-OPP-2012-0009). Interregional Research
Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to establish a
tolerance in 40 CFR part 180 for residues of the fungicide fluazinam,
in or on fruiting vegetables group, pepper/eggplant subgroup 8-10B at
0.10 ppm and cucurbit vegetables, melon subgroup 9A at 0.08 ppm. This
notice includes information from a separate petition submitted by ISK
Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44057.
An analytical method using LC/MS/MS for the determination of fluazinam
and AMGT residues on cantaloupe and pepper has been developed and
validated. The method involves solvent extraction followed by liquid-
liquid partitioning and concentration prior to a final purification.
The method has been successfully validated by an independent laboratory
using peanut nutmeat as the matrix. The limit of quantitation (LOQ) of
the method is 0.01 ppm for both fluazinam and AMGT in both crops.
Contact: Andrew Ertman, Registration Division (7505P), (703) 308-9367,
email address: email@example.com.
4. PP 1F7934. (EPA-HQ-OPP-2010-0916). Gowan Company, LLC, P.O. Box
556, Yuma, AZ 85366, requests to establish tolerances in 40 CFR part
180 for residues of the insecticide hexythiazox (trans-5-(4-
in or on wheat, forage at 3.0 ppm; wheat, hay at 30 ppm; wheat, grain
at 0.02 ppm; wheat, straw at 7.0 ppm; alfalfa, forage at 7.0 ppm;
alfalfa, hay at 14 ppm; timothy, forage at 35 ppm; and timothy, hay at
17 ppm. A practical analytical method, high pressure liquid
chromatography (HPLC) with an ultraviolet (UV) detector, which detects
and measures residues of hexythiazox and its metabolites as a common
moiety, is available for enforcement purposes with a limit of detection
that allows monitoring of food with residues at or above the levels set
in this tolerance. Contact: Olga Odiott, Registration Division (7505P),
(703) 308-9369, email address: firstname.lastname@example.org.
5. PP 1F7944. (EPA-HQ-OPP-2011-1002). Nichino America, Inc., 4550
New Linden Hill Road, Suite 501, Wilmington, DE 19808, requests to
establish a tolerance in 40 CFR part 180 for residues of the herbicide
pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate and its acid metabolite,
4-fluorophenoxyacetic acid, expressed in terms of the parent, in or on
hop, dried cone at 0.01 ppm; peanut at 0.01 ppm; peanut, hay at 0.07
ppm; peanut, meal at 0.01 ppm; and peanut, refined oil at 0.01 ppm.
Aqueous organic solvent extraction, column clean up, and quantitation
by gas chromatography with mass spectrometry (GC/MS) is used to measure
and evaluate the chemical residues. Contact: Tracy T. White,
Registration Division (7505P), (703) 308-0042, email address:
PP 1E7950. (EPA-HQ-OPP-2011-1012). Interregional Research Project
Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540, requests to amend the tolerances in 40 CFR 180.510
by revocation of the existing tolerances for residues of the
insecticide pyriproxyfen, 2-[1-methyl-2-(4-
phenoxyphenoxy)ethoxypyridine, in or on vegetable, bulb, group 3,
except onion, bulb; onion, bulb; vegetable, fruiting, group 8; okra;
fruit, citrus; fruit, pome; caneberry subgroup 13-A; bushberry subgroup
13-B; cranberry; loganberry; Juneberry; lingonberry; and salal, because
tolerances for the revised groupings are being requested under ``New
Tolerances''. Contact: Andrew Ertman, Registration Division (7505P),
(703) 308-9367, email address: email@example.com.
New Tolerance Exemptions
1. PP 1E7936. (EPA-HQ-OPP-2011-0951). Ecolab, Inc., EPA Company No.
1677, 370 N. Wabasha Street, St. Paul, MN 55102, requests to establish
an exemption from the requirement of tolerances for residues of the
sodium xylene sulfonate (SXS) (CAS No. 1300-72-7) under 40 CFR
180.940(a) when used as a pesticide inert ingredient in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils at 500 ppm. The petitioner believes no
analytical method is needed because it is not required for the
establishment of a tolerance exemption for inert ingredients. Contact:
John Redden, Registration Division (7505P), (703) 305-1969, email
2. PP 1F7901. (EPA-HQ-OPP-2011-1018). Wagner Regulatory Associates,
Inc., (on behalf of Bedoukan Research, Inc., 21 Finance Drive, Danbury,
CT 06810), requests to establish an exemption from the requirement of
tolerances for residues of the biochemical pesticide ethyl-2E, 4Z-
decadienoate (Pear Ester) for pre-harvest uses, in or on all
agricultural commodities. Pear Ester is the naturally occurring
compound responsible for the characteristic aroma of pears and other
fruits. Researchers have estimated that mature, ripening fruit releases
up to 3,712 grams of Pear Ester per acre per month. It is estimated
that the potential residue amounts from application of formulated
products would be virtually indistinguishable from natural background
levels. For this reason, and due to its low toxicity, it is proposed to
exempt Pear Ester from the requirement to establish a finite tolerance
for residues on food commodities. Therefore, an analytical method for
determination of residues is not needed. Contact: Gina M. Burnett,
Biopesticides and Pollution Prevention Division (7511P), (703) 605-
0513, email address: firstname.lastname@example.org.
3. PP 1F7914. (EPA-HQ-OPP-2011-1033). Albemarle Corporation, 451
Florida Street, Baton Rouge, LA 70801, requests to establish an
exemption from the requirement of tolerances for residues of the
antimicrobial 1,3-dibromo-5,5-dimethylhydantoin, in or on all raw
agricultural commodities, when such residues result from the use of
1,3-dibromo-5,5-dimethylhydantoin as an antimicrobial treatment in
solutions containing a diluted end-use concentration of all bromide-
producing chemicals in the solution not to exceed 900 ppm of total
bromine. The petitioner believes no analytical method is needed because
it is not necessary since 1,3-dibromo-5,5-dimethylhydantoin residues
are exempted from the requirements of a tolerance. Contact: Tom
Antimicrobials Division (7510P), (703) 308-8075, email address:
4. PP 1F7917. (EPA-HQ-OPP-2011-1026). Bert Volger, Ceres
International LLC., 1087 Heartsease Drive, West Chester, PA 19382 (on
behalf of Consumo Em Verde S.A., Biotecnologia De Plantas, Parque
Tecnol[oacute]gico de Cantanhede, N[uacute]cleo 04, Lote 2, 3060-197
Cantanhede, Portugal), requests to establish an exemption from the
requirement of tolerances for residues of the biofungicide BLAD, a
naturally occurring polypeptide from the catabolism of a seed storage
protein of sweet lupines (Lupinus albus), in or on various crops and
ornamentals. The petitioner believes no analytical method is needed
because the requirements of an analytical method are not applicable to
a request to establish an exemption from the requirement of a
tolerance. Contact: Menyon Adams, Biopesticides and Pollution
Prevention Division (7511P), (703) 347-8496, email address:
5. PP 9F7670. (EPA-HQ-OPP-2010-0065). Technology Sciences Group,
Inc., 1150 18th Street, NW., Suite 1000, Washington, DC 20036, (on
behalf of AMVAC Chemical Corporation, 4695 MacArthur Court, Suite 1250,
Newport Beach, CA 90660), requests to establish an exemption from the
requirement of a tolerance for residues of the biochemical potato
sprout inhibitor, 3-decen-2-one, as a post-harvest treatment, in or on
stored potatoes. An analytical method for residues is not applicable.
It is expected that, when used as proposed, 3-decen-2-one would not
result in residues that are of toxicological concern. The Agency is re-
issuing this notice of filing (NOF) of a pesticide petition for 3-
decen-2-one (PP 9F7670) because the petitioner revised the pending
petition. Instead of proposing an exemption from the requirement of a
tolerance for residues of the potato sprout inhibitor, 3-decen-2-one,
in or on all food commodities, the petitioner is now requesting the
tolerance exemption for use of 3-decen-2-one as a post-harvest
treatment on stored potatoes only. The original NOF published in the
Federal Register for comment on March 10, 2010 (75 FR 11171)(FRL-8810-
8), with a 30 day comment period. One comment was received in response
to this NOF. The Agency will respond to this comment in the final rule
but notes that the comment was not germane to the active ingredient
described herein, and focused on concerns that were not specific to
dietary exposure. Contact: Colin G. Walsh, Biopesticides and Pollution
Prevention Division (7511P), (703) 308-0298, email address:
Amended Tolerance Exemptions
1. PP 1E7931. (EPA-HQ-OPP-2011-0949). BASF Corporation, 100 Campus
Drive, Florham Park, NJ 07932, requests to amend an exemption from the
requirement of a tolerance for residues of N,N-Bis-[alpha]-ethyl-
saturated and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl)
content is 2-60 moles; herein referred to as Alkyl Amines
Polyalkoxylates under 40 CFR 180.920 and 180.930 to include CAS No.
1266162-49-5 when used as a pesticide inert ingredient in pesticide
formulations. An analytical method is not required for enforcement
purposes since the Agency has established an exemption from the
requirement of a tolerance without any numerical limitation. Contact:
Elizabeth Fertich, Registration Division (7505P), (703) 347-8560, email
2. PP 1F7914. (EPA-HQ-OPP-2011-1033). Albemarle Corporation, 451
Florida Street, Baton Rouge, LA 70801, requests to amend 40 CFR
180.940(a) by establishing an exemption from the requirement of a
tolerance for the residues of the antimicrobial 1,2-dibromo-5,5-
dimethylhyadantoin (CAS Reg. No. 77-48-5) in antimicrobial
formulations, in or on food contact surface sanitizing solutions. May
be applied to: Food contact surfaces in public eating places, dairy
processing equipment, and food-processing equipment and utensils. When
ready for use, end-use concentration of all bromine-producing chemicals
in solution is not to exceed 500 ppm of total bromine. Analytical
method is not necessary since 1,3-dibromo-5,5-dimethylhydantoin
residues are exempted from the requirements of a tolerance. Contact:
Tom Luminello, Antimicrobials Division (7510P), (703) 308-8075, email
3. PP 1F7920. (EPA-HQ-OPP-2011-1029). D-I-1-4, Inc., a Division of
1,4 Group, Inc., P.O. Box 680, Meridian, ID 83680, requests to amend an
exemption from the requirement of a tolerance in 40 CFR 180.1142 for
residues of the plant growth regulator 1,4-Dimethylnaphthalene (1,4-
DMN) when applied post-harvest to potatoes and other sprouting root,
tuber and bulb crops in accordance with good agricultural practices. An
analytical method for residues is not applicable. It is expected that,
when used as proposed, 1,4-Dimethylnaphthalene would not result in
residues that are of toxicological concern. Contact: Colin G. Walsh,
Biopesticides and Pollution Prevention Division (7511P), (703) 308-
0298, email address: email@example.com.
4. PP 1F7940. (EPA-HQ-OPP-2011-1028). Kaken Pharmaceutical Co.,
Ltd., c/o Conn & Smith, Inc., Agent, 6713 Catskill Road, Lorton, VA
22079, requests to amend an existing exemption from the requirement of
tolerances in 40 CFR 180.1285 for residues of the biochemical pesticide
polyoxin D zinc salt when used as a fungicide for pre-harvest and post-
harvest uses in accordance with good agricultural practices, in or on
all agricultural commodities. A tolerance exemption is proposed.
Therefore, no tolerance enforcement method is proposed. Contact: Colin
G. Walsh, Biopesticides and Pollution Prevention Division (7511P),
(703) 308-0298, email address: firstname.lastname@example.org.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
Dated: February 28, 2012.
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-6056 Filed 3-13-12; 8:45 am]
BILLING CODE 6560-50-P