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Gamma-Cyhalothrin (Pytech Chemicals GmbH). February 25, 2004.
Pesticide tolerance petition. Federal Register.


http://www.epa.gov/fedrgstr/EPA-PEST/2004/February/Day-25/p3938.htm

[Federal Register: February 25, 2004 (Volume 69, Number 37)]
[Notices]
[Page 8654-8656]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe04-62]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0025; FRL-7345-5]

Gamma-Cyhalothrin; Notice of Filing a Pesticide Petition to
Establish a Tolerance for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2004-0025
, must be received on or before March 26, 2004

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: William G. Sproat, Jr., Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8587; e-mail address: mailto:sproat.william@epa.gov.

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 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 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 under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2004-0025. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.

2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at <http://www.epa.gov/fedrgstr/>.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at <http://www.epa.gov/edocket/> to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in EPA's Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on
[[Page 8655]]
the first page of your comment. Please ensure that your comments are
submitted within the specified comment period. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments. If you wish to submit CBI or
information that is otherwise protected by statute, please follow the
instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit
CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.

i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at <http://www.epa.gov/edocket/>,
and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0025. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to <mailto:opp-docket@epa.gov>,
Attention: Docket ID Number OPP-2004-0025. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.

2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0025.

3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2004-0025. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
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 CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any 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 and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth 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 petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: February 12, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

The petitioner's summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
The petition summary announces the availability of a description of the
analytical methods available to EPA for the detection and measurement
of the
[[Page 8656]]
pesticide chemical residues or an explanation of why no such method is
needed.

Pytech Chemicals GmbH
PP 4F6812

EPA has received a pesticide petition (4F6812) from Pytech
Chemicals GmbH, 9330 Zionsville Road, Indianapolis, IN 46268 proposing,
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40
CFR part 180 by adding gamma-cyhalothrin ((S)-[alpha]-cyano-3-
phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoripropenyl)-2,2-
dimethylcyclopropanecarboxylate) to the tolerance expression of lambda-
cyhalothrin
, ((S)-[alpha]-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-
chloro-3,3,3-trifluoroprop-1-enyl)-2,1-dimethylcyclopropanecarboxylate
and (R)-alpha-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate). Gamma-
cyhalothrin is the isolated active isomer of lambda-cyhalothrin.
EPA
has determined that the petition contains data or information regarding
the elements set forth in section 408(d)(2) of the FFDCA; however, EPA
has not fully evaluated the sufficiency of the submitted data at this
time or whether the data support granting of the petition. Additional
data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. Gamma-cyhalothrin relies on the metabolism
data conducted on lambda-cyhalothrin
, which has been thoroughly tested
and is adequately understood.
2. Analytical method. An adequate analytical method is available
for enforcement purposes.
3. Magnitude of residues. Gamma-cyhalothrin, the isolated active
isomer, will be applied at half the application rates of lambda-
cyhalothrin.
Comparison studies of gamma-cyhalothrin versus lambda-
cyhalothrin used on the representative crops of tomatoes, sweet corn,
broccoli, and cottonseed prove that the established tolerances for
lambda-cyhalothrin will be sufficient to cover the potential residues
of gamma-cyhalothrin.

B. Toxicological Profile
1. Acute toxicity. The acute oral lethal dose (LD)50 was
≤ 50 milligrams/kilogram body weight (mg/kg bwt) in male rats
and 55 mg/kg bwt in female rats, acute dermal LD50 was
≤ 1,500 mg/kg bwt in male rats and 1,643 mg/kg bwt in female
rats and the 4-hour lethal concentration (LC)50 for male
rats was 40.2 milligrams/meter (mg/m\3\) and, for female rats, 28.2 mg/
m\3\.


2. Genotoxicity. The following genotoxicity tests were all
negative: Salmonella, E.coli reverse mutation assay, mouse bone marrow
micronucleus test, in vitro chromosomal aberration in rat lymphocytes,
and mouse lymphoma forward mutation assay.

3. Reproductive and developmental toxicity. A developmental
toxicity study in rats given gavage doses of 0, 0.1, 0.5, and 2 mg/kg/
day with no developmental toxicity observed under the conditions of the
study. The developmental no observed adverse effect level (NOAEL) is
greater than 2 mg/kg/day, the highest dose tested (HDT). The maternal
NOAEL and lowest observed adverse effect level (LOAEL) are established
at 0.5 and 2 mg/kg/day, respectively, based on reduced body weight,
body weight gain, and feed consumption.


4. Subchronic toxicity. A 90-day feeding study in rats fed doses of
0, 2.5, 10, 50, and 100 parts per million (ppm) with a NOAEL of 50 ppm
and a LOAEL of 100 ppm based on mortality, decreased feed consumption,
decreased body weights, and increased relative liver and kidney weight
at 100 ppm.


5. Chronic toxicity. Gamma-cyhalothrin, and lambda-cyhalothrin are
contained within the chemical cyhalothrin. Cyhalothrin consists of four
isomers, lambda-cyhalothrin consists of two of these isomers and gamma-
cyhalothrin is the single active isomer contained in both. The chronic
studies were conducted on cyhalothrin.


6. Metabolite toxicology. The Agency has previously determined that
the metabolites of lambda-cyhalothrin are not of toxicological concern
and need not be included in the tolerance expression. Given this
determination, it is concluded that there is no need to discuss
metabolite toxicity.


7. Endocrine disruption. No studies have been conducted to
investigate the potential of gamma-cyhalothrin to induce estrogenic or
other endocrine effects. However, no evidence of such effects has been
noted in the battery of toxicity studies which have been conducted on
cyhalothrin/lambda-cyhalothrin, and there is no reason to suspect that
any such effects would be likely.

C. Aggregate Exposure
The Agency has conducted an extensive assessment of the aggregate
exposure. Results are reported in the Federal Register of September 27,
2002 (http://www.epa.gov/EPA-PEST/2002/September/Day-27/p24486.htm>(FRL-7200-1).

D. Cumulative Effects
For purposes of this request, it has been assumed that cyhalothrin
(i.e., gamma-cyhalothrin, and lambda-cyhalothrin) does not have a
common mechanism of toxicity with other substances.


E. Safety Determination
The Agency has conducted an extensive assessment of the aggregate
exposure. Results are reported in the Federal Register of September 27,
2002.

F. International Tolerances

There are Codex maximum residue levels established or pending for
residues of cyhalothrin, as the sum of all isomers, in or on the
following crops and commodities.
------------------------------------------------------------------------
Crop MRL (mg/kg)
------------------------------------------------------------------------
Apricots 0.2
------------------------------------------------------------------------
Cabbage, head 0.2
------------------------------------------------------------------------
Cherries 0.2
------------------------------------------------------------------------
Cotton seed 0.02
------------------------------------------------------------------------
Cottonseed, oil 0.02
------------------------------------------------------------------------
Oil seed (including rapeseed oil) 0.02
------------------------------------------------------------------------
Peaches 0.2
------------------------------------------------------------------------
Plums 0.1
------------------------------------------------------------------------
Pome fruit 0.1
------------------------------------------------------------------------
Potatoes 0.02
------------------------------------------------------------------------
Tree nuts (shelled and unshelled) 0.05
------------------------------------------------------------------------
Canadian maximum residue levels of 0.1 ppm for pome fruit, stone
fruit, and canola are established in Canada for lambda-cyhalothrin

based on the ``negligble'' residue clause of Canadian Food and Drug Act
Regulations (B.15.002(1)).
[FR Doc. 04-3938 Filed 2-24-04; 8:45 am]
BILLING CODE 6560-50-S