04-19032. Chlorothalonil; 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-2004-0257, must be received on or before September 20, 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:

J. R. Tomerlin, 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 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-2004-0257. 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 South 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-2004-0257. 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-2004-0257. 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-2004-0257.

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 South Bell St., Arlington, VA, Attention: Docket ID Number OPP-2004-0257. 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 supports 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: August 12, 2004.

Lois A. 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. 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.

PP 3E6795

EPA has received a pesticide petition (PP 3E6795) from the Snowpea Commission of Guatemala, Guatemala City, Guatemala, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180.275 by establishing a tolerance for residues of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile (SDS-3701) in or on the raw agricultural commodity snow peas at 5 parts per million (ppm). GB Biosciences^TM Corporation of Greensboro, NC serves as the agent for the Snowpea Commission of Guatemala. 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 supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism of chlorothalonil as well as the nature of the residues in plants is adequately understood for purposes of the proposed tolerance. Plant metabolism has been evaluated in five diverse crops: Carrots, celery, lettuce, snap beans, and tomatoes, which should serve to define the similar metabolism of chlorothalonil in a wide range of crops. The qualitative nature of residues in plants for chlorothalonil is adequately understood. The residue of concern is chlorothalonil and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile (SDS-3701). Parent metabolite CGA-64250 is the major compound found in crops.

2. Analytical method. An adequate residue analytical method (gas chromatography) is available for enforcement purposes. The method is listed in the Pesticide Analytical Manual (PAM) Vol. II (PAM II).

3. Magnitude of residues. Field residue trials have been conducted on snap beans at various rates, timing intervals, and applications methods to represent the use patterns which would most likely result in the highest residues. Due to similarity of snap bean and the proposed snow pea use patterns, the field residue trial from snap bean will be used to support a snow pea import tolerance.

B. Toxicological Profile

An assessment of the toxic effects caused by chlorothalonil is discussed in Unit III.A. and Unit III.B. in the Federal Register of March 12, 2001 (66 FR 14330) (FRL-6759-4).

1. Animal metabolism. The metabolism of chlorothalonil in the rat is adequately understood.

2. Metabolite toxicology. The residues of concern for tolerance setting purposes in or on raw agricultural commodity are the parent compound and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile (SDS-3701). The residue of concern in meat and milk is SDS-3701.

3. Endocrine disruption. Chlorothalonil does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and a reproduction study in rats gave no indication that chlorothalonil might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long-term effect related to the endocrine system.

C. Aggregate Exposure

1. Dietary exposure. Tier II/III acute, chronic, and cancer dietary exposure evaluations were made using the Dietary Exposure Evaluation Model (DEEM^TM), version 7.87 from Exponent. These exposure assessments included all registered uses and a proposed use on imported snow peas. Empirically derived processing studies for cabbage (0.20X), carrots (0.005X), cherries (0.05X), coffee (0.10X), cucumber/cold canned (0.20X), cucumber/hot canned (0.04X), plums (0.33X), squash (0.001X), tomato juice (0.25X) and tomato paste, puree, and catsup (0.02X) were used in these assessments. All other processing factors used were the DEEM^TM defaults. All consumption data was taken from the United States Department of Agriculture's (USDA's) Continuing Survey of Food Intake by Individuals (CSFII) with the 1994-1996 consumption database and the Supplemental CSFII Children's Survey (1998) consumption database.

i. Food. For the purposes of assessing potential dietary exposure, Syngenta has estimated aggregate exposure from all crops for which tolerances are established or proposed. These assessments utilized residue data from monitoring data (Pesticide Data Program (PDP), Food and Drug Administration (FDA), and FoodContam) and field trial data where available; otherwise currently established tolerances were used. Field trial residue data for snap beans were used as a surrogate for similarly treated (i.e., application rate and pre-harvest interval) imported snow peas. Current tolerances were used as conservative estimates for secondary residues of chlorothalonil in meat and milk commodities. Percent of crop treated values were conservatively set at 100% for all commodities.

ii. Drinking water. Another potential source of exposure of the general population to residues of chlorothalonil are residues in drinking water. Estimated Drinking Water Concentrations (EDWCs) of chlorothalonil in surface and groundwater were typically less than 1 parts per billion (ppb). However, the Environmental Fate and Effects Division (EFED) used an EDWC value of 16 ppb for drinking water assessment, which was derived from metabolite concentration that was measured in groundwater at a combined concentration of 16 ppb in Suffolk County, Long Island, NY in 1981.

The Acute Drinking Water Level of Comparison (DWLOC) was calculated based on an acute reference dose (aRfD) of 0.583 mg/kg/day for the subpopulation of children (1-2 years) and a dietary exposure value of 0.134878 mg/kg-bw/day. For the acute assessment, the acute DWLOC for the children (1-2 years) subpopulation was of 4,481 ppb, which is considerably higher than the acute EDWC of 16 ppb.

The Chronic Drinking Water Level of Comparison (DWLOC) was calculated based on a chronic reference dose (cRfD) of 0.02 mg/kg/day and a dietary exposure value of 0.003984 mg/kg-bw/day. The children 1-2 years old subpopulation had the lowest chronic DWLOC of 160 ppb. Thus, the chronic DWLOC of 160 ppb is considerably higher than the chronic EDWC of 16 ppb.

Cancer risk from chlorothalonil drinking water exposures (upper bound 8 × 10^-9) was considered negligible since the EDWC of chlorothalonil in surface and groundwater were typically less than 1.0 ppb.

2. Non-dietary exposure. Based upon the residential use patterns, there is a potential for exposure to chlorothalonil residues for adult homeowners making applications to residential areas (ornamental and vegetable gardens) and also for both youth and adults engaged in post-application activities in these areas. The short- and intermediate-term exposure risk estimates are derived from the same daily (short-/intermediate-term) exposures, since the endpoints are the same for both scenarios. The exposure risks were all determined to be acceptable (margin of exposure (MOE) > 100) for each scenario assessed. The maximum potential non-dietary exposure was for an adult transplanting ornamentals, yielding an average daily dose (ADD) of 1.09 mg/kg-bw/day and a resulting MOE of 551, and a cancer risk of 9.79 × 10^-8. Therefore, cancer exposure risks to chlorothalonil from non-dietary exposures were determined to be negligible.

3. Acute exposure. The acute dietary risk assessment was performed for all population subgroups with an aRfD of 0.583 mg/kg-bw/day based upon an acute lowest observable adverse effect level (LOAEL) of 175 mg/kg-bw/day from a subchronic dietary rat study and an uncertainty factor of 300X (100X plus additional 3X for the absence of a no observable adverse effect level (NOAEL)). For the purpose of the aggregate risk assessment, the exposure value was expressed in terms of MOE, which was calculated by dividing the LOAEL by the exposure. In addition, exposure was expressed as a percent of the acute reference dose (%aRfD). Acute exposure for the most sensitive subpopulation (children 1-2 years old) was 23.1% of the acute RfD of 0.583 mg/kg-bw/day, with a MOE of 1,297. Since the benchmark MOE for this assessment was 300 and since EPA generally has no concern for exposures above the benchmark MOE, Syngenta believes that there is a reasonable certainty that no harm will result from the acute dietary (food) exposures arising from the current and proposed uses for chlorothalonil.

4. Chronic exposure. The cRfD for chlorothalonil is 0.02 mg/kg-bw/day and is based on a chronic rat study with a NOAEL of 2.0 mg/kg-bw/day and an uncertainty factor of 100X. No additional FQPA safety factor was applied. The chlorothalonil Tier II/III chronic dietary exposure assessment was based upon monitoring data and residue field trial results. For the purpose of the aggregate risk assessment, the exposure values were expressed in terms of MOE, which was calculated by dividing the NOAEL by the exposure for each population subgroup. In addition, exposure was expressed as a percent of the chronic reference dose (%cRfD). Chronic exposure to the most sensitive subpopulation (children 1-2 years old) was 19.9% of the cRfD of 0.02 mg/kg-bw/day, with an MOE of 502. Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures resulting in an MOE above the benchmark MOE, Syngenta believes that there is a reasonable certainty that no harm will result from the chronic dietary (food) exposures arising from the current and proposed uses for chlorothalonil.

5. Cancer exposure. A cancer dietary risk assessment was performed for all population subgroups, with a carcinogenic potency factor (Q*) of 0.0077 (mg/kg-bw/day)^-1, based upon female rat renal tumor rates. Cancer exposure to chlorothalonil results in a risk of 5.67 × 10^-7, or approximately 0.6 in one million, which is within the safe level of concern set by the EPA of 1.00 x 10^-6.

D. Cumulative Effects

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether chlorothalonil has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this tolerance action, EPA has not assumed that chlorothalonil has a common mechanism of toxicity with other substances.

E. Safety Determination

1. U.S. population. The acute and chronic aggregate exposure estimates are well below the aRfD of 0.583 mg/kg-bw/day and cRfD of 0.020 mg/kg-bw/day for all population subgroups. Aggregate cancer exposure estimates for the U.S. population were approximately 67% of the one-in-a-million exposure limit. Based on this information, Syngenta Crop Protection concludes, that there is reasonable certainty that no harm will result from acute, chronic, or cancer exposure to chlorothalonil.

2. Infants and children. Since the acute chronic aggregate exposure assessments for infants and children are well below the aRfD and cRfD of 0.583 mg/kg-bw/day and 0.02 mg/kg-bw/day respectively, there is reasonable certainty that no harm will result to infants and children from aggregate exposure to chlorothalonil residues.

F. International Tolerances

There is currently no maximum residue level (MRL) set for chlorothalonil on snow peas by the Codex Alimentarius Commission.