69 FR 235 pgs. 71045-71049 - Flumioxazin; Notice of Filing a Pesticide Petition to Establish aTolerance for a Certain Pesticide Chemical in or on Food
Type: NOTICEVolume: 69Number: 235Pages: 71045 - 71049
Docket number: [OPP-2004-0398; FRL-7689-1]
FR document: [FR Doc. 04-26819 Filed 12-7-04; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0398; FRL-7689-1]
Flumioxazin; Notice of Filing a Pesticide Petition to Establish aTolerance for a Certain Pesticide Chemical in or on Food
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice.
SUMMARY:
This notice announces the initial filing of apesticide petition proposing the establishment of regulations for residuesof a certain pesticide chemical in or on various foodcommodities.
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, bymail, or through hand delivery/courier. Follow the detailed instructionsas provided in Unit I. of the SUPPLEMENTARYINFORMATION .
FOR FURTHER INFORMATION CONTACT:
Joanne I. Miller,Registration Division (7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC20460-0001; 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 anagricultural 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 providesa guide for readers regarding entities likely to be affected by thisaction. Other types of entities not listed in this unit could also beaffected. The North American Industrial Classification System (NAICS) codeshave been provided to assist you and others in determining whether thisaction might apply to certain entities. If you have any questions regardingthe applicability of this action to a particular entity, consult the personlisted under FOR FURTHER INFORMATION CONTACT .
B. How Can I Get Copies of this Document and Other RelatedInformation?
1. Docket. EPA has established an official publicdocket for this action under docket ID number OPP-2004-0398.The official public docket consists of the documents specificallyreferenced in this action, any public comments received, and otherinformation related to this action. Although, a part of the officialdocket, the public docket does not include Confidential BusinessInformation (CBI) or other information whose disclosure is restricted bystatute. The official public docket is the collection of materials that isavailable for public viewing at the Public Information and RecordsIntegrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. BellSt., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,Monday through Friday, excluding legal holidays. The docket telephonenumber 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 ordelivered to the docket will be transferred to EPA's electronic publicdocket. Public comments that are mailed or delivered to the docket will bescanned and placed in EPA's electronic public docket. Where practical,physical objects will be photographed, and the photograph will be placed inEPA's electronic public docket along with a brief description written bythe docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through handdelivery/courier. To ensure proper receipt by EPA, identify theappropriate docket ID number in the subject line on the first page of yourcomment. Please ensure that your comments are submitted within thespecified comment period. Comments received after the close of the commentperiod will be marked "late." EPA is not required to considerthese late comments. If you wish to submit CBI or information that isotherwise 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 bystatute.
1. Electronically . If you submit an electroniccomment as prescribed in this unit, EPA recommends that you include yourname, mailing address, and an e-mail address or other contact informationin the body of your comment. Also, include this contact information on theoutside of any disk or CD ROM you submit, and in any cover letteraccompanying the disk or CD ROM. This ensures that you can be identifiedas the submitter of the comment and allows EPA to contact you in case EPAcannot read your comment due to technical difficulties or needs furtherinformation on the substance of your comment. EPA's policy is that EPAwill not edit your comment, and any identifying or contact informationprovided in the body of a comment will be included as part of the commentthat is placed in the official public docket, and made available in EPA'selectronic public docket. If EPA cannot read your comment due to technicaldifficulties and cannot contact you for clarification, EPA may not be ableto consider your comment.
i. EPA Dockets . Your use of EPA's electronic publicdocket to submit comments to EPA electronically is EPA's preferred methodfor receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/ , and follow the online instructionsfor submitting comments. Once in the system, select "search,"and then key in docket ID number OPP-2004-0398. The system isan "anonymous access" system, which means EPA will not knowyour identity, e-mail address, or other contact information unless youprovide 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 numberOPP-2004-0398. In contrast to EPA's electronic public docket,EPA's e-mail system is not an "anonymous access" system. Ifyou send an e-mail comment directly to the docket without going throughEPA's electronic public docket, EPA's e-mail system automatically capturesyour e-mail address. E-mail addresses that are automatically captured byEPA's e-mail system are included as part of the comment that is placed inthe official public docket, and made available in EPA's electronic publicdocket.
iii. Disk or CD ROM . You may submit comments on a diskor 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 fileformat. Avoid the use of special characters and any form ofencryption.
2. By mail . Send your comments to: PublicInformation and Records Integrity Branch (PIRIB) (7502C), Office ofPesticide Programs (OPP), Environmental Protection Agency, 1200Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: DocketID number OPP-2004-0398.
3. By hand delivery or courier . Deliver your commentsto: Public Information and Records Integrity Branch (PIRIB), Office ofPesticide Programs (OPP), Environmental Protection Agency, Rm. 119, CrystalMall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID numberOPP-2004-0398. Such deliveries are only accepted during thedocket'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 CBIelectronically through EPA's electronic public docket or by e-mail. Youmay claim information that you submit to EPA as CBI by marking any part orall of that information as CBI (if you submit CBI on disk or CD ROM, markthe outside of the disk or CD ROM as CBI and then identify electronicallywithin the disk or CD ROM the specific information that is CBI).Information so marked will not be disclosed except in accordance withprocedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includesany information claimed as CBI, a copy of the comment that does not containthe information claimed as CBI must be submitted for inclusion in thepublic docket and EPA's electronic public docket. If you submit the copythat does not contain CBI on disk or CD ROM, mark the outside of the diskor CD ROM clearly that it does not contain CBI. Information not marked asCBI will be included in the public docket and EPA's electronic publicdocket without prior notice. If you have any questions about CBI or theprocedures 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 yourcomments:
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 usedthat support your views.
4. If you estimate potential burden or costs, explain how you arrivedat the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in thisnotice.
7. To ensure proper receipt by EPA, be sure to identify the docket IDnumber assigned to this action in the subject line on the first page ofyour response. You may also provide the name, date, and FederalRegister citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing theestablishment and/or amendment of regulations for residues of a certainpesticide chemical in or on various food commodities under section 408 ofthe Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA hasdetermined that this petition contains data or information regarding theelements set forth in FFDCA section 408(d)(2); however, EPA has not fullyevaluated the sufficiency of the submitted data at this time or whether thedata support granting of the petition. Additional data may be neededbefore EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,Food additives, Pesticides and pests, Reporting and recordkeepingrequirements.
Dated: November 24, 2004.
Lois Rossi,
Director, Registration Division, Office of PesticidePrograms.
Summary of Petition
The petitioner's summary of the pesticide petition is printed belowas required by FFDCA section 408(d)(3). The summary of the petition wasprepared by Valent U.S.A. Corporation and represents the view of thepetitioner. The petition summary announces the availability of adescription of the analytical methods available to EPA for the detectionand measurement of the pesticide chemical residues or an explanation of whyno 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, andCosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180, byestablishing a tolerance for residues of the herbicide chemicalflumioxazin,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 (CropGroup 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 orinformation regarding the elements set forth in section 408(d)(2) of theFFDCA; however, EPA has not fully evaluated the sufficiency of thesubmitted data at this time or whether the data support granting of thepetition. Additional data may be needed before EPA rules on thepetition.
A. Residue Chemistry
1. Plant metabolism . The metabolism of flumioxazin isadequately understood for the purpose of the proposed tolerances.
2. Analytical method . Practical analytical methodsfor detecting and measuring levels of flumioxazin have been developed andvalidated in or on all appropriate agricultural commodities and respectiveprocessing fractions. The limit of quantitation (LOQ) of flumioxazin inthe methods is 0.02 ppm which will allow monitoring of food with residuesat the levels proposed for the tolerances.
3. Magnitude of residues . Residue data on apples,pears, plums, peaches, and cherries (sweet and tart) have been submittedwhich adequately support the requested tolerances. Processing studies wereconducted with apples and plums. No residues of flumioxazin were detectedin any of the raw agricultural commodities or processing commoditiescollected from these studies even when orchards were treated at anexaggerated (2x) rate. No tolerances are proposed for apple or plumprocessing commodities.
B. Toxicological Profile
The toxicological profile for flumioxazin which supports thispetition for tolerances was previously published in the FederalRegister of April 18, 2001 (66 FR 19870) (FRL-6778-5).
C. Aggregate Exposure
1. Dietary exposure . Acute and chronic dietaryanalyses were conducted to estimate exposure to potential flumioxazinresidues in or on the following crops: Peanuts and soybeans (existingtolerances); cotton, grapes, almond, pistachio, and sugarcane, vegetable,tuberous and corm (Subgroup 1C), onion, dry bulb and mint (tolerancespending); nut, tree (Group 14), (tolerances to be proposed in the future);and fruit, pome (Group 11) and fruit, stone (Group 12) (tolerances proposedin the current petition). The Cumulative and Aggregate Risk EvaluationSystem (CARES) Version 1.1 was used to conduct this assessment. Proposedtolerances and conservative estimates for percentages of the percent croptreated were used in these assessments. No adjustments were made forcommon washing, cooking, or preparation practices. Exposure estimates forwater were made based upon modeling Generic Expected EnvironmentalConcentration (GENEEC 1.2)
.
i. Food -a. Acute. The acute dietaryexposure estimate of flumioxazin residues in food at the 99.9 th percentile was calculated to be, at most, 26.3% of the acutereference dose (aRfD) with a margin of exposure (MOE) of 3,797. Thepopulation subgroup with the highest exposure was children 1-2 yearsold. The aRfD was defined as the no observed adverse effect level (NOAEL)from an oral developmental study in rats and includes an uncertainty factorof 100 to account for intraspecies and interspecies variation and anadditional 10-fold uncertainty factor for FQPA (NOAEL = 3milligrams/kilogram body weight (mg/kg bwt/day), aRfD = 0.003mg/kg/day).
b. Chronic. The chronic dietary exposure estimate offlumioxazin residues in food at the 100 th percentile wascalculated to be, at most, 2.5% of the chronic reference dose (cRfD) with aMOE of 40,000. The population subgroup with the highest exposure was thegeneral U.S. population. The cRfD was defined as the NOAEL from a rat2-year chronic/oncogenicity study and includes an uncertainty factorof 100 to account for intraspecies and interspecies variation and anadditional 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 appliedoutdoors to growing agricultural crops, the potential exists for the parentor its metabolites to reach ground water or surface water that may be usedfor drinking water. Because of the physical properties of flumioxazin, itis unlikely that flumioxazin or its metabolites can leach to potable groundwater. To quantify potential exposure from drinking water, surface waterconcentrations for flumioxazin were estimated using GENEEC 1.2. Because KOCcould not be measured directly in adsorption-desorption studies because ofchemical stability, GENEEC values representative of a range of KOC valueswere modeled. The simulation that was selected for these exposure estimatesused an average KOC of 385, indicating high mobility. The peak GENEECconcentration predicted in the simulated pond water was 9.8 parts perbillion (ppb). Using standard assumptions about body weight and waterconsumption, the acute exposure from this drinking water would be 0.00028and 0.00098 mg/kg/day for adults and children, respectively. The56-day GENEEC concentration predicted in the simulated pond water was0.34 ppb. Chronic exposure from this drinking water would be 0.0000097 and0.000034 mg/kg/day for adults and children, respectively; 1.7% of thechronic population adjusted dose (cPAD) of 0.002 mg/kg/day for children.Based on this worse case analysis, the contribution of drinking water tothe dietary exposure is comparable to that from food, but the risk is stillnegligible.
2. Non-dietary exposure . Flumioxazin is proposed onlyfor agricultural uses and no homeowner or turf uses. Thus, no non-dietaryrisk 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 aparticular pesticide's residues and "other substances that have acommon mechanism of toxicity." Available information in this contextinclude not only toxicity, chemistry, and exposure data, but alsoscientific policies and methodologies for understanding common mechanismsof toxicity and conducting cumulative risk assessments. Although, theAgency has some information in its files that may turn out to be helpful ineventually determining whether a pesticide shares a common mechanism oftoxicity with any other substances, EPA does not at this time have themethodologies to resolve the complex scientific issues concerning commonmechanism of toxicity in a meaningful way for most registeredpesticides.
E. Safety Determination
1. U.S. population -i. Acute risk .The potential acute exposure from food to the U.S. population and variousnon-child/infant population subgroups will utilize at most 14.2% of theaRfD. Addition of the worse case, dietary exposure from water (0.00028mg/kg/day) increases this exposure at the 99.9 th percentileto 23.7% of the aRfD. The Agency has no cause for concern if total acuteresidue contribution is less than 100% of the aRfD, because the RfDrepresents the level at or below which daily aggregate exposure over alifetime will not pose appreciable risk to human health. Therefore, it canbe concluded that there is a reasonable certainty that no harm will resultto the overall U.S. population from aggregate, acute exposure toflumioxazin residues.
ii. Chronic risk . The potential chronic exposure fromfood to the U.S. population and various non-child/infant populationsubgroups will utilize at most 2.5% of the cRfD. Addition of the worsecase, dietary exposure from water (0.0000097 mg/kg/day) increases thisexposure at the 100 th percentile to 3.0% of the cRfD. TheAgency has no cause for concern if total chronic residue contribution isless than 100% of the cRfD, because the RfD represents the level at orbelow which daily aggregate exposure over a lifetime will not poseappreciable risk to human health. Therefore, it can be concluded thatthere is a reasonable certainty that no harm will result to the overallU.S. population from aggregate, chronic exposure to flumioxazinresidues.
2. Infants and children -i. Safetyfactor for infants and children . The FQPA safety factor (as requiredby the Food Quality Protection Act of August 3, 1996) has been retained at10x in assessing the risk posed by flumioxazin. The reasons for retainingthe 10x safety factor are as follows. First, there is evidence of increasedsusceptibility of rat fetuses to in utero exposure toflumioxazin by the oral and dermal route in the prenatal developmentaltoxicity studies in rats. In addition, there is evidence of increasedsusceptibility of young animals exposed to flumioxazin in the 2-generationreproduction toxicity study in rats. Finally, there is concern for theseverity of the effects observed in fetuses and young animals when comparedto those observed in the maternal and parental animals. Since theadditional 10x safety factor has been retained to account for the apparentincreased susceptibility from prenatal or postnatal exposures toflumioxazin, it would be appropriate to apply the extra 10x safety factorto only selected subpopulations, e.g., infants and children 6 years old and females 13 years old. Forthese assessments, however, the 10x safety factor has been applied to allpopulation subgroups for all exposure durations (acute and chronic), thusmaking these assessments additionally conservative.
ii. Acute risk. The potential acute exposure fromfood to children 1-2 years old (the most highly exposed child/infantsubgroup) will utilize at most 26.3% of the aRfD. Addition of the worsecase, dietary exposure from water (0.00098 mg/kg/day) increases thisexposure at the 99.9 th percentile to 59% of the aRfD.Therefore, it can be concluded that, there is a reasonable certainty thatno harm will result to infants and children from aggregate, acute exposureto flumioxazin residues.
iii. Chronic risk. The potential chronic exposurefrom food to children 1-2 years old (the most highly exposedchild/infant subgroup) will utilize at most 2.4% of the cRfD. Addition ofthe worse case, dietary exposure from water (0.000034 mg/kg/day) increasesthis exposure at the 100 th percentile to 4.2% of the cRfD.Therefore, it can be concluded that there is a reasonable certainty that noharm will result to infants and children from aggregate, chronic exposureto flumioxazin residues.
F. International Tolerances.
Flumioxazin has not been evaluated by the joint meeting on pesticideresidues (JMPR) and there are no codex Maximum Residue Limits (MRL) forflumioxazin. MRL values have been established to allow the following usesof flumioxazin in the following countries.
| Country | Crop | MRL (ppm) |
|---|---|---|
| Argentina | Soybean Sunflower | 0.015 0.02 |
| Brazil | Soybean | 0.05 |
| France | Grape | 0.05 |
| Paraguay | Soybean | 0.015 |
| South Africa | Soybean Groundnut | 0.02 0.02 |
| Spain | Soybean Peanut | 0.05 0.05 |
[FR Doc. 04-26819 Filed 12-7-04; 8:45 am]
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