[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38918-38921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13262]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0058; FRL-7719-3]


Ethaboxam; 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-
2005-0058, must be received on or before August 5, 2005.

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: Bryant Crowe, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0025; 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 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 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-2005-0058. 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, 1801 S. Bell St., 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 the EPA 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

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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. 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 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-2005[n]dash;0058. 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-2005-0058. 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-2005-0058.
    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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0058. 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.

[[Page 38920]]

    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: June 23, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner 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. 
EPA has not fully evaluated the merits of the pesticide petition. The 
summary may have been edited by EPA if the terminology used was 
unclear, the summary contained extraneous material, or the summary 
unintentionally made the reader conclude that the findings reflected 
EPA's position and not the position 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 
pesticide chemical residues or an explanation of why no such method is 
needed.

LG Life Sciences, Ltd.

PP 4E6863

    EPA has received a pesticide petition (4E6863) from LG Life 
Sciences, Ltd., c/o Landis International, Inc., P.O. Box 5126, 
Valdosta, GA 31603-5126 proposing pursuant to section 408(d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 
amend 40 CFR part 180 to establish tolerances for residues of ethaboxam 
(LGC-30473), (RS)-N-(alpha-cyano-2-thenyl)-4-ethyl-2-(ethylamino)-1,3-
thiazole-5-carboxamide, in or on grapes, grape juice, raisins, and 
wine. The tolerances are set at the following values: Grapes at 3.5 
parts per million (ppm), grape juice at 3.3 ppm, raisins at 5.8 ppm, 
and wine at 2.5 ppm.
    A program of 19 residue trials was conducted in both Northern and 
Southern Europe over a 2-year period (2001-2002) on vines. In Northern 
Europe trials were conducted in France and Germany, while in Southern 
Europe the trials were in France, Italy, and Spain. Applications of 
ethaboxam 10% SC were made at the proposed GAP of 5 x 200 gram active 
substance/hectare (g a.s./ha) with a 21[dash]day post harvest interval 
(PHI). Of the 19 trials, 8 were conducted as decline studies, with 5 in 
Southern Europe and 3 in Northern Europe. Residue levels in grapes 
ranged from less than the limit of detection (< 0.005 ppm) to 3.4 ppm 
with a mean value of 1.07 ppm. The proposed EU maximum residue level 
(MRL) for grapes is 3.5 parts per million (ppm) and the MRLs for grape 
processed commodities based on the concentration/dilution factors 
determined in the processing study are 2.5 ppm for young wine, 1.3 ppm 
for wine, 2.3 ppm for juice, and 5.8 ppm for raisins.
    These proposed MRLs were combined with a program of seven trials 
conducted in 2004. This program was conducted in Chile (three trials), 
Australia (two trials), Argentina (one trial), and Mexico (one trial). 
Residues were analyzed resulting from five applications of ethaboxam 
10% SC at 2 or 4 Liter/hectare (L/ha), sampled at 21 days following the 
final application. No residues of ethaboxam were detected above the 
limit of detection of 0.002 ppm in any non-treated samples from any of 
the trials. Residues of ethaboxam detected in grapes ranged from 0.183 
to 1.827 ppm in samples sprayed at a rate of 2 L/ha and from 1.121 to 
7.072 ppm for grapes sprayed at a rate of 4 L/ha. Residues detected in 
juice (must) samples were between 0.64 and 3.24 ppm (2 L/ha rate); in 
raisins residues were between 0.39 and 1.68 ppm (2 L/ha rate); in wine 
residues were between 0.11 and 0.49 ppm (2 L/ha rate). Combining the 
residues from the two programs the following tolerances are proposed: 
Grapes at 3.5 ppm, grape juice at 3.3 ppm, raisins at 5.8 ppm, and wine 
at 2.5 ppm.
    Neither livestock feeding studies or livestock metabolism, 
distribution and expression of residue studies are required, as vines 
will not be utilized for feeding. The storage stability of ethaboxam 
was assessed in grape homogenates during freezer storage 
(-18[deg] C). The results of the analysis show that 
ethaboxam was stable for a minimum of 17 months.
    The primary metabolic pathways of ethaboxam in plants were 
established in grapes, tomatoes, and potatoes. Extensive metabolism 
occurred in the grape. The proposed bio-transformation pathway for 
ethaboxam in grapes is the formation of LGC-35523 from ethaboxam (by 
photolytic degradation) and incorporation of LGC-35523 into natural 
products (sugars). In the potato, most of the parent compound was 
metabolized and incorporated into starch. Following acid hydrolysis of 
the starch fraction to glucose, a substantial proportion of the 
radiolabel was converted to glucosazone. It was therefore concluded 
that the radiolabel was incorporated into the starch backbone and 
formed part of the carbohydrate pool. In the tomato, fruit taken at 
harvest showed that the major component at harvest was unchanged 
ethaboxam, accounting for 49-57% total radioactive residues. Studies of 
the absorption, distribution, metabolism and excretion of ethaboxam 
(LGC-30473) were carried out using [\14\C]-LGC-30473, \14\C-thiophene 
LGC-30473 and [\14\C-thiazole] LGC-30473 dosed separately. Studies were 
performed in rats of the same strain used for toxicity assessments at 
dose levels of 10 or 150 milligrams/kilogram (mg/kg) and oral gavage 
dosing in a 1%methylcellulose, 0.1% Tween 80 vehicle.
    Excretion of radioactivity following either a single dose of 
[\14\C-thiophene or \14\C-thiazole] LGC-30473 or 14 consecutive doses 
of [\14\C-thiazole] LGC-30473 was rapid with <90% of radioactivity 
eliminated in urine or faeces within 48 hours. Faecal excretion (66-92% 
of dose in 120 hours (h)) substantially exceeded urinary excretion (13-
30% of dose in 120 h) with the percentage excreted in the urine higher 
at the lower dose. These factors suggest capacity limited absorption. 
This was supported by the pharmacokinetic data which showed a slightly 
less than dose proportional increase in C\max\ and AUC (area under the 
plasma concentration-

[[Page 38921]]

time curve) between the 10 and 150 mg/kg doses (dose ratio 15, AUC 
ratio 11). Substantial radioactivity was detected in bile suggesting 
first-pass metabolism was significant. T\max\ was around three times 
longer at the high dose level (3-6 hours (h) at 150 mg/kg versus 1-2 h 
at 10 mg/kg). The plasma elimination half-life of 31-41 h was similar 
for both doses. The blood cell elimination half-life was considerably 
longer at 69-162 hours for both doses. AUC 120 was higher in blood 
plasma following 14 doses at 10 mg/kg/day than following one dose (2 
fold) but more notably higher in blood cells (5 fold).
    Distribution of radioactivity after a single dose at 10 or 150 mg/
kg or 14 consecutive doses at 10 mg/kg was similar at both dose levels 
and was highest in thyroid (thiazole label only), liver and blood 
cells. Concentrations 120 hours after the 14th dose were 5-15 fold 
higher than after the single dose, but all tissue accumulation was low. 
There were no substantial differences in distribution or excretion 
pattern between sexes. Extent of absorption, assessed in biliary 
excretion experiments, was similar between the sexes at 10 mg/kg (71-
72% dose) but higher in females at 150 mg/kg (males, 48% dose; females 
61% dose). All elements of this study indicate similar results for both 
labels and there was little evidence of cleavage of the intact 
molecule. Five major metabolites were identified each accounting for 
>5% dose: LGC-32794, LGC-32800, LGC-32801, LGC-32802, and LGC-32803. In 
one pathway, ethaboxam was N-de-ethylated to LGC-32794 followed by 
oxidation of the thiazole sulphur to LGC-32800. Ethaboxam also 
underwent enolization. In a second pathway the enol form underwent 
hydrolysis to the amide LGC-32801. In a third pathway the enol 
underwent sulphate conjugation to LGC-32802 and hydroxylation/sulphate 
conjugation to LGC-32803. Ethaboxam was detected as a major component 
of faecal extracts at both dose levels. Destructive catabolism of the 
molecule appeared to be negligible.

[FR Doc. 05-13262 Filed 7-5-05; 8:45 am]
BILLING CODE 6560-50-S