03-19915. Benoxacor; 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-2003-0234, must be received on or before September 5, 2003.

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:

Kathryn Boyle, 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-2003-0234. 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 [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 EPA's Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed,paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper,will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket.

Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on 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-2003-0234. 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-2003-0234. 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-2003-0234.

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-2003-0234. 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: July 22, 2003.

Debra Edwards,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner.The 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

PP 7E3489

EPA has received an amendment to pesticide petition (PP 7E3489)from Syngenta Crop Protection, 410 Swing Road, Greensboro, NC 27419, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C.346a(d), to amend 40 CFR 180.460 to establish the use of benoxacor, (4-(dichloroacetyl)-3,4-dihydro-3-methyl-2H-1,4-benzoxazine)as an inert ingredient (safener) in pesticide formulations containing S-metolachlor in or on raw agricultural commodities (RACs) for which tolerances have been established for S-metolachlor or that support S-metolachlor uses. The petitioner is not requesting a change in the level or the numerical tolerance, but is requesting that benoxacor only be used with S-metolachlor, not metolachlor. EPA has determined that the request contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

The Notice of Filing was published in the Federal Register on November 21, 1997 (62 FR 62304)(FRL-5755-2). The petitioner at that time was Novartis Crop Protection, Inc. In the Federal Register of February 13, 1998 (63 FR 7299) (FRL-5771-1), EPA published a final rule establishing tolerances for residues of benoxacor at 0.01 ppm for all commodities for which tolerances have been established for metochlor. No benoxacor risk assessments have been performed by the Agency since that time.

A. Residue Chemistry

1. Plant metabolism. The metabolism of benoxacor in plants and animals is adequately understood for purposes of these tolerances. Identified metabolic pathways are similar in plants and animals (goat, hen, and rat).

2. Analytical method. Adequate enforcement methodology, gas chromatography/nitrogen phosphorous detection (GC/NPD), is available to enforce the tolerance expression. An analytical methodology for the determination of benoxacor and its metabolites in plant and animal commodities (Syngenta Analytical Method AG536(C)) is available upon request from EPA. Analytical Method AG536c involves extraction,filtering, dilution, partitioning, and cleanup. Samples are then analyzed by capillary gas chromatography using N/P detection. The limit of quantitation (LOQ) is 0.01 ppm.

3. Magnitude of residues. The magnitude of the residue in plants is adequately understood for the purposes of these tolerances. More than 30 residue trials were conducted in 19 States on a variety of agricultural crops, corn (field and sweet); soybeans, potatoes, green beans, radishes, sorghum, peanuts, head lettuce, and peas. There were no detectable residues of benoxacor at the LOQ of 0.01 ppm (many samples were analyzed at an LOQ of 0.005 ppm and no residues were detected) in any RAC or processed commodity. No transfer of residue to animals is expected through their diet.

B. Toxicological Profile

The toxicological profile of benoxacor and the end points for use in risk assessments are discussed in the final rule published in the Federal Register of February 13, 1998 (63 FR 7299) (FRL-5771-1).

C. Aggregate Exposure

1. Dietary exposure.—i. Food. Tolerances have been established (40 CFR 180.460) for the residues of benoxacor in or on a variety of RACs. Risk assessments were conducted by EPA to assess dietary exposures and risks from benoxacor. In this action, Syngenta Crop Protection is requesting to amend only the tolerance expression and therefore believes that the most recent Food Quality Protection Act (FQPA) dietary assessment completed by EPA is valid in the consideration of this amendment request.

ii. Acute exposure and risk. Since there are no acute toxicological concerns for benoxacor, EPA has previously determined that an acute dietary risk assessment was not required.

iii. Chronic exposure and risk. For the purpose of assessing chronic dietary exposure from benoxacor, EPA has previously considered the established benoxacor tolerance of 0.01 ppm and the RACs for which tolerances have been established for metolachlor. There are no other established U.S. tolerances for benoxacor, and there are no other registered uses for benoxacor on food or feed crops in the United States.Benoxacor is used currently only as a herbicide safener in end-use product formulations that contain S-metolachlor. There are no longer any registrations of other active ingredients that contain benoxacor.

In conducting this exposure assessment, EPA previously assumed tolerance level residues and 100% crop treated, resulting in a large overestimation of dietary exposure and protective of any chronic dietary exposure scenario. The chronic reference dose (cRfD) is 0.004 milligram/kilogram/day (mg/kg/day). Based on the chronic dietary exposure of 0.000205 mg/kg/day for the U.S. population and 0.000828 mg/kg/day for the most highly exposed population subgroup (nonnursing infants less than 1-year old), this chronic dietary risk assessment resulted in the use of 5.13% of the RfD for the U.S.population and 20.7% of the RfD for the most highly exposed population subgroup. A cancer dietary margin of exposure (MOE) was calculated to be 1,950 using 0.4 mg/kg/day as the point of departure.

iv. Drinking water. For the purposes of assessing chronic exposure in drinking water, EPA has previously considered the registered uses and the available data on persistence and mobility for benoxacor. The Agency has determined through a qualitative risk assessment that the physical and chemical characteristics of benoxacor are such that it is not expected to impact water resources. While benoxacor has the potential to be mobile, it is not persistent (half-life in soil of 49 days under aerobic conditions and 70 days anaerobically). In light of these findings, EPA has previously determined that benoxacor's use as a safener in S-metolachlor formulations will not impact ground water or surface water resources, and therefore, is not expected to lead to exposure to humans through drinking water.

2. Non-dietary exposure. All registered S-metolachlor products to which benoxacor is added as a safener are commercial agricultural products not registered for residential use. The potential for nonoccupational exposure to benoxacor by the general population is therefore unlikely except for the potential residues in food crops discussed above.

D. Cumulative Effects

EPA has previously determined that a cumulative assessment is not required for benoxacor. Benoxacor does not share a common mode of toxicity with any other moiety regulated by EPA further supporting the lack of a need for conducting a cumulative assessment in relation to this requested tolerance amendment.

E. Safety Determination

1. U.S. population—i. Acute risk. Since there are no acute toxicological concerns for benoxacor, EPA has no cause for concern for acute aggregate exposure.

ii. Chronic risk. EPA has previously concluded that aggregate chronic exposure to benoxacor from food and water will utilize 5.13%of the RfD for the U.S. population. The major identifiable subgroup with the highest aggregate exposure is non-nursing infants less than 1-year old (utilizing 20.7% of the RfD). EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. EPA does not expect the aggregate exposure to exceed 100% of the RfD. EPA has previously concluded that there is a reasonable certainty that no harm will result from aggregate exposure to benoxacor residues.

The carcinogenic risk from food uses of benoxacor for the general U.S. population was calculated previously by EPA by comparing the dietary exposure from benoxacor to the no observed adverse effect level (NOAEL) identified for use with the cancer risk assessment. Based on the NOAEL selected by EPA for cancer risk characterization of 0.4 mg/kg/day, the cancer risk was estimated to result in a MOE of 1,950 contributed through all the published uses for benoxacor. Based upon the extreme conservatism of the dietary exposure estimates and the fact that tumors were observed only at dose levels far in excess of the selected NOAEL, this MOE is at a level which the Agency does not consider raising a concern for excess lifetime cancer.

2. Infants and children. EPA has previously determined that the toxicological data base for evaluating prenatal and postnatal toxicity for benoxacor is complete with respect to current data requirements. Because both developmental and reproductive effects occurred in the presence of parental (systemic) toxicity, these data do not suggest an increased prenatal or postnatal sensitivity of children and infants to benoxacor exposure. Based on the above, EPA has previously concluded that reliable data support use of a 100-fold MOE/uncertainty factor (UF),rather than the standard 1,000-fold margin/factor to protect infants and children. EPA concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to benoxacor residues.

3. Acute risk. Since there are no acute toxicological concerns for benoxacor, EPA has no cause for concern for acute aggregate exposure.

4. Chronic risk. Using the conservative exposure assumptions described above, EPA has previously concluded that aggregate exposure to benoxacor from food will range from 3.69% of the RfD for females 13+ years, to 20.7% of the RfD for non-nursing infants less than 1-year old. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. EPA does not expect the aggregate exposure to exceed 100% of the RfD. EPA has previously concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to benoxacor residues.

F. International Tolerances

No Codex maximum residue levels have been established for residues of benoxacor.