[Federal Register Volume 69, Number 37 (Wednesday, February 25, 2004)]
[Notices]
[Pages 8654-8656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3938]


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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: 
[email protected].

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 [email protected], 
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 (FR 67 60902) (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)
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Apricots                                    0.2
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Cabbage, head                               0.2
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Cherries                                    0.2
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Cotton seed                                 0.02
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Cottonseed, oil                             0.02
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Oil seed (including rapeseed oil)           0.02
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Peaches                                     0.2
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Plums                                       0.1
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Pome fruit                                  0.1
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Potatoes                                    0.02
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Tree nuts (shelled and unshelled)           0.05
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    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