Flumioxazin; 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-2004-0398, must be received on or before January 7, 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:

Joanne I. Miller,Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone number: (703) 305-6224; e-mail address: miller.joanne@epamail.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 ID number OPP-2004-0398.The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,Monday through Friday, excluding legal holidays. The docket telephone number is (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 on 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-2004-0398. 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-2004-0398. 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-2004-0398.

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-2004-0398. 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'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 Valent U.S.A. Corporation 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.

Valent U.S.A. Corportion

PP 4F6829

EPA has received a pesticide petition (4F6829) from Valent U.S.A. Corporation, 1600 Riviera Ave., Suite 200, Walnut Creek, CA 94596, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180, by establishing a tolerance for residues of the herbicide chemical flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on the following raw agricultural commodities: Fruit, pome (Crop Group 11) at 0.02 parts per million (ppm) and fruit, stone (Crop Group 12) at 0.02 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 support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism of flumioxazin is adequately understood for the purpose of the proposed tolerances.

2. Analytical method. Practical analytical methods for detecting and measuring levels of flumioxazin have been developed and validated in or on all appropriate agricultural commodities and respective processing fractions. The limit of quantitation (LOQ) of flumioxazin in the methods is 0.02 ppm which will allow monitoring of food with residues at the levels proposed for the tolerances.

3. Magnitude of residues. Residue data on apples, pears, plums, peaches, and cherries (sweet and tart) have been submitted which adequately support the requested tolerances. Processing studies were conducted with apples and plums. No residues of flumioxazin were detected in any of the raw agricultural commodities or processing commodities collected from these studies even when orchards were treated at an exaggerated (2x) rate. No tolerances are proposed for apple or plum processing commodities.

B. Toxicological Profile

The toxicological profile for flumioxazin which supports this petition for tolerances was previously published in the Federal Register of April 18, 2001 (66 FR 19870) (FRL-6778-5).

C. Aggregate Exposure

1. Dietary exposure. Acute and chronic dietary analyses were conducted to estimate exposure to potential flumioxazin residues in or on the following crops: Peanuts and soybeans (existing tolerances); cotton, grapes, almond, pistachio, and sugarcane, vegetable, tuberous and corm (Subgroup 1C), onion, dry bulb and mint (tolerances pending); nut, tree (Group 14), (tolerances to be proposed in the future); and fruit, pome (Group 11) and fruit, stone (Group 12) (tolerances proposed in the current petition). The Cumulative and Aggregate Risk Evaluation System (CARES) Version 1.1 was used to conduct this assessment. Proposed tolerances and conservative estimates for percentages of the percent crop treated were used in these assessments. No adjustments were made for common washing, cooking, or preparation practices. Exposure estimates for water were made based upon modeling Generic Expected Environmental Concentration (GENEEC 1.2)

i. Food—a. Acute. The acute dietary exposure estimate of flumioxazin residues in food at the 99.9^th percentile was calculated to be, at most, 26.3% of the acute reference dose (aRfD) with a margin of exposure (MOE) of 3,797. The population subgroup with the highest exposure was children 1-2 years old. The aRfD was defined as the no observed adverse effect level (NOAEL) from an oral developmental study in rats and includes an uncertainty factor of 100 to account for intraspecies and interspecies variation and an additional 10-fold uncertainty factor for FQPA (NOAEL = 3 milligrams/kilogram body weight (mg/kg bwt/day), aRfD = 0.003 mg/kg/day).

b. Chronic. The chronic dietary exposure estimate of flumioxazin residues in food at the 100^th percentile was calculated to be, at most, 2.5% of the chronic reference dose (cRfD) with a MOE of 40,000. The population subgroup with the highest exposure was the general U.S. population. The cRfD was defined as the NOAEL from a rat 2-year chronic/oncogenicity study and includes an uncertainty factor of 100 to account for intraspecies and interspecies variation and an additional 10-fold uncertainty factor for Food Quality Protection Act (FQPA) (NOAEL = 2 mg/kg bwt/day, cRfD = 0.002 mg/kg/day).

ii. Drinking water. Since flumioxazin is applied outdoors to growing agricultural crops, the potential exists for the parent or its metabolites to reach ground water or surface water that may be used for drinking water. Because of the physical properties of flumioxazin, it is unlikely that flumioxazin or its metabolites can leach to potable ground water. To quantify potential exposure from drinking water, surface water concentrations for flumioxazin were estimated using GENEEC 1.2. Because KOC could not be measured directly in adsorption-desorption studies because of chemical stability, GENEEC values representative of a range of KOC values were modeled. The simulation that was selected for these exposure estimates used an average KOC of 385, indicating high mobility. The peak GENEEC concentration predicted in the simulated pond water was 9.8 parts per billion (ppb). Using standard assumptions about body weight and water consumption, the acute exposure from this drinking water would be 0.00028 and 0.00098 mg/kg/day for adults and children, respectively. The 56-day GENEEC concentration predicted in the simulated pond water was 0.34 ppb. Chronic exposure from this drinking water would be 0.0000097 and 0.000034 mg/kg/day for adults and children, respectively; 1.7% of the chronic population adjusted dose (cPAD) of 0.002 mg/kg/day for children. Based on this worse case analysis, the contribution of drinking water to the dietary exposure is comparable to that from food, but the risk is still negligible.

2. Non-dietary exposure. Flumioxazin is proposed only for agricultural uses and no homeowner or turf uses. Thus, no non-dietary risk assessment is needed.

D. Cumulative Effects

Section 408(b)(2)(D)(v) requires that the Agency must consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Available information in this context include not only toxicity, chemistry, and exposure data, but also scientific policies and methodologies for understanding common mechanisms of toxicity and conducting cumulative risk assessments. Although, the Agency has some information in its files that may turn out to be helpful in eventually determining whether a pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this time have the methodologies to resolve the complex scientific issues concerning common mechanism of toxicity in a meaningful way for most registered pesticides.

E. Safety Determination

1. U.S. population—i. Acute risk. The potential acute exposure from food to the U.S. population and various non-child/infant population subgroups will utilize at most 14.2% of the aRfD. Addition of the worse case, dietary exposure from water (0.00028 mg/kg/day) increases this exposure at the 99.9^th percentile to 23.7% of the aRfD. The Agency has no cause for concern if total acute residue contribution is less than 100% of the aRfD, because the RfD represents the level at or below which daily aggregate exposure over a lifetime will not pose appreciable risk to human health. Therefore, it can be concluded that there is a reasonable certainty that no harm will result to the overall U.S. population from aggregate, acute exposure to flumioxazin residues.

ii. Chronic risk. The potential chronic exposure from food to the U.S. population and various non-child/infant population subgroups will utilize at most 2.5% of the cRfD. Addition of the worse case, dietary exposure from water (0.0000097 mg/kg/day) increases this exposure at the 100^th percentile to 3.0% of the cRfD. The Agency has no cause for concern if total chronic residue contribution is less than 100% of the cRfD, because the RfD represents the level at or below which daily aggregate exposure over a lifetime will not pose appreciable risk to human health. Therefore, it can be concluded that there is a reasonable certainty that no harm will result to the overall U.S. population from aggregate, chronic exposure to flumioxazin residues.

2. Infants and children—i. Safety factor for infants and children. The FQPA safety factor (as required by the Food Quality Protection Act of August 3, 1996) has been retained at 10x in assessing the risk posed by flumioxazin. The reasons for retaining the 10x safety factor are as follows. First, there is evidence of increased susceptibility of rat fetuses to in utero exposure to flumioxazin by the oral and dermal route in the prenatal developmental toxicity studies in rats. In addition, there is evidence of increased susceptibility of young animals exposed to flumioxazin in the 2-generation reproduction toxicity study in rats. Finally, there is concern for the severity of the effects observed in fetuses and young animals when compared to those observed in the maternal and parental animals. Since the additional 10x safety factor has been retained to account for the apparent increased susceptibility from prenatal or postnatal exposures to flumioxazin, it would be appropriate to apply the extra 10x safety factor to only selected subpopulations, e.g., infants and children <6 years old and females >13 years old. For these assessments, however, the 10x safety factor has been applied to all population subgroups for all exposure durations (acute and chronic), thus making these assessments additionally conservative.

ii. Acute risk. The potential acute exposure from food to children 1-2 years old (the most highly exposed child/infant subgroup) will utilize at most 26.3% of the aRfD. Addition of the worse case, dietary exposure from water (0.00098 mg/kg/day) increases this exposure at the 99.9^th percentile to 59% of the aRfD. Therefore, it can be concluded that, there is a reasonable certainty that no harm will result to infants and children from aggregate, acute exposure to flumioxazin residues.

iii. Chronic risk. The potential chronic exposure from food to children 1-2 years old (the most highly exposed child/infant subgroup) will utilize at most 2.4% of the cRfD. Addition of the worse case, dietary exposure from water (0.000034 mg/kg/day) increases this exposure at the 100^th percentile to 4.2% of the cRfD. Therefore, it can be concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate, chronic exposure to flumioxazin residues.

F. International Tolerances.

Flumioxazin has not been evaluated by the joint meeting on pesticide residues (JMPR) and there are no codex Maximum Residue Limits (MRL) for flumioxazin. MRL values have been established to allow the following uses of flumioxazin in the following countries.