05-10842. Furilazole; 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 (PP) by Monsanto Company proposing the establishment of regulations for residues of 3-dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine (furilazole) (safener) in or on the raw agricultural commodities sorghum grain, forage, stover, flour, and bran at 0.01 parts per million.

DATES:

Comments, identified by docket identification (ID) number OPP-2005-0135, must be received on or before July 1, 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:

Karen Angulo, 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 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-2005-0135. 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, 1801S. 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-2005-0135. 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-2005-0135. 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-2005-0135.

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-2005-0135. 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: May 23, 2005.

Lois Rossi,

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 Monsanto Company and represents the view of the petitioner. EPA is publishing the petition summary verbatim without editing it in anyway. 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.

Monsanto Company

PP 5E6919

EPA has received PP 5E6919 from Monsanto Company, 800 N. Lindbergh Blvd., St. Louis, MO 63167, proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of 3-dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine (furilazole) in or on the raw agricultural commodities sorghum grain, forage, stover, flour, and bran at 0.01 parts per million (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. The metabolism of furilazole in sorghum was examined in a field study in which uptake and metabolism of radiolabeled furilazole in sorghum and corn was determined in parallel experiments. Parent furilazole was not found in any of the sorghum samples. Furilazole is rapidly and extensively metabolized to a large number of highly polar metabolites characterized as weak organic acids or residues conjugated to natural sugars.

2. Analytical method. Monsanto has developed an analytical method using gas liquid chromatography/mass spectrometry with selected ion monitoring that has a verified limit of quantitation of 0.01 ppm for parent furilazole in sorghum grain, forage, stover, flour, and bran. This method is analogous to that validated by the Agency with the exception of the use of a mass-specific detector rather than an electron capture detector.

3. Magnitude of residues. Monsanto has conducted a residue field study with furilazole applied pre-emergence and early post-emergence to sorghum according to label use rates per acre. Analysis of sorghum forage, stover, grain, flour and bran showed no residues with an analytical method that was validated at the lower limit of 0.01 ppm.

B. Toxicological Profile

A summary of the toxicology data submitted to support this tolerance petition was published in the Federal Register on April 3, 2002 (67 FR 15727) (FRL-6828-4).

C. Aggregate Exposure

1. Dietary exposure —i. Food. Furilazole is currently registered for use only on corn. Tolerances for sorghum are proposed as part of this petition. Potential acute and chronic dietary exposures resulting from the use of furilazole on corn and sorghum were estimated using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID^TM, version 2.03, Exponent, Inc.). Food consumption was based on data from the 1994-1996 USDA Continuing Surveys of Individual Intakes (CSFII) and the 1998 Supplemental Children's Survey. For the purposes of this document, Monsanto made the very conservative assumption that the entire corn and sorghum crops were treated with furilazole (i.e., 100% crop treated), that all corn and sorghum commodities contained residues of furilazole at the existing or proposed tolerance levels, and that no losses occurred during storage, processing or cooking.

ii. Drinking water. Insufficient monitoring data are available for a comprehensive risk assessment of furilazole residues in drinking water. However, the EPA has previously used the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentrations in Ground Water (SCI-GROW) models to develop conservative estimates of potential furilazole concentrations in surface and shallow ground water, respectively as published in the Federal Register of April 3, 2002 (67 FR 15727). For surface water, the Agency calculated Estimated Environmental Concentrations (EECs) of 1.2 parts per billion (ppb), 0.8 ppb and 0.22 ppb for acute, chronic (non-cancer) and cancer risk assessments, respectively. For ground water, the Agency calculated an EEC of 0.02 ppb for all exposure scenarios. To assess potential health risks associated with possible residues of furilazole in drinking water, Monsanto compared these EECs to drinking water levels of concern (DWLOC), which were calculated by subtracting the estimated exposures to furilazole from food from the appropriate Reference Dose (RfD), and making standard assumptions regarding drinking water consumption and body weights for adults and children.

2. Non-dietary exposure. There are no residential or non-agricultural uses of furilazole. Therefore, non-dietary, non-occupational exposures to furilazole are expected to be negligible and were not included within this risk assessment.

D. Cumulative Effects

Monsanto has no reliable data or information to suggest that furilazole shares a common mechanism of toxicity with any other chemical. Therefore, only the potential effects of furilazole are addressed in this document.

E. Safety Determination

1. U.S. population. The toxicology endpoints used to assess potential acute, chronic and carcinogenic risks from furilazole were those previously identified by the EPA and published in the Federal Register on April 3, 2002 (67 FR 15727). Acute dietary risks were assessed using an acute reference dose (RfD) of 0.1 milligrams/kilograms (mg/kg)/day. This was based on a no observed adverse effect level (NOAEL) of 10 mg/kg/day for increased resorptions in a developmental toxicity study in rats and a 100-fold uncertainty factor (UF). The only population subgroup of potential concern for this effect was females aged 13 and older because this is an in-utero effect applicable only to females of childbearing age. Acute risk assessments for other population subgroups were not conducted since no other acute toxicology endpoint was identified.

Potential risks for chronic toxicity to all population subgroups were assessed using a chronic reference dose (cRfD) of 0.0009 mg/kg/day. This was based on a NOAEL of 0.26 mg/kg/day for increased liver and kidney weights in a chronic rat study and an UF of 300. This UF included an extra 3X to account for the lack of a one-year dog study. Since furilazole is classified by the EPA as “likely to be carcinogenic to humans”, potential carcinogenic risks have been quantified using the cancer slope factor (Q*) of 0.0274 (mg/kg/day)^-1 previously used by EPA.

With the exception of a lack of a one-year dog study, the toxicology and exposure information available for furilazole was considered to be valid, reliable and complete according to current regulatory standards. No evidence of increased susceptibility of offspring was noted in rats or rabbits following in utero and/or postnatal exposure to furilazole. Therefore, the Agency has determined that no additional Food Quality Protection Act (FQPA) safety factor was needed to protect infants or children.

2. Acute risk. Based on the above assumptions, the 99th percentile for acute dietary (food) exposure to furilazole for females aged 13 to 50 was estimated to be 0.000095 mg/kg/day. This exposure represents 0.09% of the RfD. In general, exposures utilizing less than 100% of the RfD are not of concern. The DWLOC calculated for this scenario was 3000 ppb, which is far above the acute EECs of 1.2 ppb for surface water and 0.02 ppb for ground water calculated by the EPA. Therefore, Monsanto concludes that there is a reasonable certainty that acute dietary exposure to furilazole will not pose a significant risk to human health.

3. Chronic risk. Based on the above assumptions, chronic dietary exposure to furilazole from food for the overall U.S. population was estimated to be 0.000014 mg/kg/day. This represents about 1.5% of the cRfD. Chronic dietary exposure from food for children 3-5, the most highly exposed population subgroup, was estimated to be 0.000032 mg/kg/day, which represents 3.6% of the cRfD. Both of these values are well below 100% of the RfD. In addition, the chronic DWLOCs for the overall U.S. population and children were calculated to be 31 and 8.7 ppb, which are greater than the chronic EECs of 0.8 ppb for surface water and 0.02 ppb for ground water calculated by the Agency. Therefore, Monsanto concludes that there is a reasonable certainty that chronic dietary exposure to furilazole will not pose a significant risk to human health.

4. Cancer risk. Based on the above assumptions, the average daily lifetime exposure to furilazole from food for the overall U.S. population was estimated to be 0.000014 mg/kg/day. Using linear low-dose extrapolation, the 95% upper confidence limit of the lifetime cancer risk associated with this level of exposure was estimated to be 3.7 x 10^-7. Cancer risks of less than 1 x 10^-6 are generally considered to be negligible. The DWLOC for carcinogenic risks to the overall U.S. population was calculated to be 0.8 ppb, which is greater than the EECs of 0.22 ppb for surface water and 0.02 ppb for ground water calculated by EPA for use in cancer risk assessment. Therefore, Monsanto concludes that there is a reasonable certainty that lifetime aggregate exposure to furilazole will not pose a significant risk of cancer.

5. Overall conclusion of safety. Based on the data summarized herein, Monsanto concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from the current and proposed uses of furilazole.

F. International Tolerances

The Codex Alimentarius Commission has not established a maximum residue level for furilazole.