05-13262. 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.

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: [phone]; e-mail address: [e-mail].

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 [phone].

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 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-2005-0058. 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 [e-mail], 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.

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-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° 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 or¹⁴ 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-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.