Cloquintocet Mexyl; 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 ID number OPP-2004-0117, must be received on or before July 2, 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:

Bipin Gandhi, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8380; e-mail address: gandhi.bipin@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 identification (ID) number OPP-2004-0117. 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 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-2004-0117. 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 opp-docket@epa.gov, Attention: Docket ID Number OPP-2004-0117. 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-2004-0117.

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-2004-0117. 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

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 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.

Syngenta Crop Protection Inc.

PP 4E6831

EPA has received a pesticide petition (4E6831) from Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, North Carolina, 27419-8300 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 180.560 by establishing tolerances for the combined residues of cloquintocet-mexyl, (acetic acid, [(5-chloro-8-quinolinyl)oxy-, 1-methylhexyl ester) (CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinolinoxyacetic acid) when used as an inert ingredient (safener) in pesticide formulations containing either the herbicide clodinafop-propargyl or pinoxaden in a 1:4 ratio of safener to active ingredient in or on the following raw agricultural commodities: Wheat, grain at 0.10 parts per million (ppm); wheat, forage at 0.2 ppm; wheat, hay at 0.50 ppm; wheat, straw at 0.10 ppm; barley, grain at 0.01 ppm; barley, hay at 0.10 ppm; and barley, straw at 0.10 ppm. 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. Syngenta's previous Notice of Filing (NOF) indicated the metabolism of cloquintocet-mexyl in wheat is well understood, as published in the Federal Register of April 19, 2000 (65 FR 20972) (FRL-6554-3). Total residues in all crop samples are low. Metabolism involves primarily rapid hydrolysis of the parent to the resulting acid followed by conjugation.

2. Analytical method. Syngenta Crop Protection, Inc. has submitted practical analytical methodology for detecting and measuring combined levels of cloquintocet-mexyl and its acid metabolite 5-chloro-8-quinolinoxylacetic acid. The method is based upon acid hydrolysis extraction, which converts the parent and all conjugates to the acid metabolite. The acid metabolite is subject to commodity specific cleanup procedures and High Performance Liquid Chromatography (HPLC) determination with triple stage quadruple mass spectrometry (LC/MS/MS). The limit of quantitation (LOQ), as demonstrated by the lowest acceptable recovery samples, is 0.01 ppm for grain and 0.02 ppm for forage, hay and straw.

3. Magnitude of residues. In support of registration of cloquintocet-mexyl on wheat, a total of 21 field trials were conducted by the petitioner on wheat per EPA region requirements in 16 states (CO, NC, ND,NM, MT, MO, TX, CA, KS, SD, OK, IL, WA, NE, AK, MN). In support of registration of pinoxaden on barley, a total of 12 field trials were conducted on barley per EPA region requirements in 10 states (VA, SD, MN, WI, ND, CO, CA, ID, WA, MT). The magnitude of the residue program supports the setting of tolerances on all types of wheat and barley crops.

B. Toxicological Profile

1. Acute toxicity. Cloquintocet-mexyl has a low order of acute toxicity. The acute toxicity profile of cloquintocet-mexyl was published previously in the Federal Register in the petitioner's (NOF) (65 FR 20972) (FRL-6554-3) (April 19, 2000). EPA has published the acute toxicity endpoints in the Federal Register in its final rule (65 FR 38757) (FRL-6592-4) (June 22, 2000).

2. Genotoxicity. Cloquintocet-mexyl was negative in all genotoxicity tests. The genotoxicity of cloquintocet-mexyl was published previously in Federal Register in the petitioner's NOF (65 FR 20972) (FRL-6554-3) (April 19, 2000).

3. Reproductive and developmental toxicity. Cloquintocet-mexyl is not a reproductive or developmental toxicant. The toxicity of cloquintocet-mexyl was published previously in the Federal Register in the petitioner's NOF (65 FR 20972, April 19, 2000). EPA has published the reproductive and developmental toxicity endpoints in the Federal Register in its final rule (65 FR 38757, June 22, 2000).

4. Subchronic toxicity. The subchronic toxicity profile of cloquintocet-mexyl was published previously in the Federal Register in the petitioner's NOF (65 FR 20972, April 19, 2000). EPA has previously published the subchronic toxicity endpoints in the Federal Register in its final rule (65 FR 38757, June 22, 2000).

5. Chronic toxicity. The chronic toxicity profile of cloquintocet-mexyl was published previously in the Federal Register in the petitioner's NOF (65 FR 20972, April 19, 2000). EPA has published the chronic toxicity endpoints in the Federal Register in its final rule (65 FR 38757, June 22, 2000). The Agency classified cloquintocet-mexyl as “not likely to be a human carcinogen.”

6. Animal metabolism. The metabolism of cloquintocet-mexyl in animals is well understood, as was published previously in the Federal Register in the petitioner's NOF (65 FR 20972, April 19, 2000). In rats, approximately 50% of an oral dose of cloquintocet-mexyl was rapidly absorbed through the gastrointestinal tract and excreted via urine and bile. The administered dose was excreted independent of sex and was essentially complete within 48 hours. Ninety-five percent of the excreted dose was associated with one metabolite, the acid residue of cloquintocet-mexyl, 5-chloro-8-quinlinoxyacetic acid.

7. Metabolite toxicology. The main metabolite in both plants and animals is 5-chloro-8-quinolinoxyacetic acid. As this is the main metabolite in rats, rabbits and mice, its toxicology has been tested throughout the toxicology database for cloquintocet-mexyl. The toxicity of cloquintocet-mexyl metabolites was discussed previously in the Federal Register in the petitioner's NOF (65 FR 20972, April 19, 2000).

8. Endocrine disruption. There is no evidence that cloquintocet-mexyl has any effect on endocrine function, as was discussed previously in the Federal Register in the petitioner's NOF (65 FR 20972, April 19, 2000).

C. Aggregate Exposure

1. Dietary exposure. Tier I acute and chronic dietary exposure evaluations were made by the Agency using the Dietary Exposure Evaluation Model (DEEM^TM), version 7.87 from Exponent. DEEM^TM default processing factors were used in these assessments. All consumption data for these assessments was taken from the USDA's Continuing Survey of Food Intake by Individuals (CSFII) with the 1994-96 consumption database and the Supplemental CSFII children's survey (1998) consumption database. These exposure assessments included uses on wheat and barley. Secondary residues in animal commodities were estimated based on theoretical worst-case, yet nutritionally adequate animal diets and transfer information from metabolism studies.

i. Food. For the purposes of assessing the potential dietary exposure under the proposed tolerances, Syngenta Crop Protection has estimated aggregate exposure from all crops for which tolerances are established or proposed. These assessments utilized proposed tolerances on wheat and barley commodities and calculated residue values for secondary animal commodities. Percent of crop treated values for wheat and barley were estimated based upon economic, pest and competitive pressures. An acute reference dose of 1.0 milligram/kilogram body weight/day (mg/kg bwt/day) was based on a no observable adverse effect level (NOAEL) of 100 mg/kg bwt/day from a developmental toxicity study in the rat and an uncertainly factor of 100X. No additional FQPA safety factor was applied. The cloquintocet-mexyl Tier I acute (deterministic) dietary exposure assessment was based upon tolerance residue values. For the purpose of aggregate risk assessment, the exposure value was expressed in terms of margin of exposure (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 acute reference dose (%RfD). Acute exposure to the most sensitive subpopulation (children 1-2 years) resulted in a MOE of 606,061 (0.02% of the acute RfD of 1.0 mg/kg bwt/day). Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from dietary (food) exposure to residues arising from the current and proposed uses for cloquintocet-mexyl. The chronic reference dose (RfD) for cloquintocet-mexyl is 0.043 mg/kg bwt/day and is based on a combined chronic toxicity/carcinogenicity study in the rat with a NOAEL of 4.3 mg/kg bwt/day and an uncertainly factor of 100X. No additional FQPA safety factor was applied. The cloquintocet-mexyl Tier I chronic dietary exposure assessment was based upon tolerance residue values. For the purpose of aggregate risk assessment, the exposure values were expressed in terms of margin of exposure (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 reference dose (%RfD). Chronic exposure to the most exposed subpopulation (children 1-2 years) resulted in a MOE of 62,319 (0.20% of the chronic RfD of 0.043 mg/kg bwt/day). Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from dietary (food) exposure to residues arising from the current and proposed uses for cloquintocet-mexyl.

ii. Drinking water. Another potential source of exposure of the general population to residues of cloquintocet-mexyl are residues in drinking water. Estimated Environmental Concentrations (EECs) of cloquintocet-mexyl in drinking water were determined by the EPA. The EPA ground water model Screening Concentrations in Groundwater (SCI-GROW) was used to determine acute and chronic estimated environmental concentrations (EECs) in ground water and the Agency's surface water model GENEEC was used to determine acute and chronic EECs in surface water. Based on the EPA's GENEEC and SCI-GROW model outputs, the EECs for acute exposures are estimated to be 0.038 ppb for surface water and 0.0060 ppb for ground water. The EECs for chronic exposures are estimated to be 0.053 ppb for surface water and 0.0060 ppb for ground water.

Syngenta's acute Drinking Water Levels of Comparisons (DWLOC) were calculated based on an acute reference dose of 1.0 mg/kg/day. The most sensitve subpopulation (children 1-2 years) generated an acute DWLOC of approximately 9,998 ppb. Thus, the acute DWLOC is considerably higher than the acute EEC of 0.006 ppb.

Syngenta's Chronic Drinking Water Levels of Comparison (DWLOC) were calculated based on a chronic Population Adjusted Dose (cPAD) of 0.03 mg/kg/day. The children 1 and 2 years old subpopulation generated the lowest chronic DWLOC of approximately 429 ppb. Thus, the chronic DWLOC is considerably higher than the chronic EEC of 0.0060 ppb.

2. Non-dietary exposure. Products containing the safener cloquintocet-mexyl will be registered for agricultural uses only and will not be available for any residential or public uses. Therefore, the aggregate risk is the sum of the risk from food and water.

D. Cumulative Effects

Section 408(b)(2)(D)(v) 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.” A discussion of the availability of data for determination whether cloquintocet-mexyl has a common mechanism of toxicity with other substances was included in the Federal Register in EPA's final rule (65 FR 38757, June 22, 2000).

E. Safety Determination

1. U.S. population. The chronic dietary exposure analysis (food only) showed that exposure from all established and proposed cloquintocet-mexyl uses would be 0.20% of the cRfD for the most sensitive subpopulation, children 1 and 2 years old. In its final rule EPA determined that reliable data support using the standard MOE and uncertainty factor (100 for combined interspecies and intraspecies variability) for cloquintocet-mexyl and that an additional safety factor of 10 is not necessary to be protective of infants and children.

Acute DWLOCs were calculated based on an acute RfD of 1.0 mg/kg/day. For the acute assessment, children 1 and 2 years old subpopulation generated an acute DWLOC of approximately 9,998 ppb. The acute EEC of 0.006 ppb is considerably less than 9,998 ppb. For the chronic assessment, the children 1 and 2 years old subpopulation generated the lowest chronic DWLOC of 429 ppb. Thus, the chronic DWLOC of 429 ppb is considerably higher than the chronic EEC of 0.006 ppb.

2. Infants and children. Syngenta has considered the potential aggregate exposure from food, water and non-occupational exposure routes and concluded that aggregate exposure is not expected to exceed 100% of the chronic or acute RfD and that there is a reasonable certainty that no harm will result to infants and children from the aggregate exposure to cloquintocet-mexyl.

F. International Tolerances

There are no international tolerances for the inert (safener), cloquintocet-mexyl.