70 FR 67 pgs. 18001-18004 - Iprovalicarb; Notice of Filing a Pesticide Petition to Establish aTolerance for a Certain Pesticide Chemical in or on Food
Type: NOTICEVolume: 70Number: 67Pages: 18001 - 18004
Docket number: [OPP-2005-0074; FRL-7703-8]
FR document: [FR Doc. 05-7042 Filed 4-7-05; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0074; FRL-7703-8]
Iprovalicarb; 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-2005-0074, must be received on or before May 9, 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:
Mary Waller,Registration Division (7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC20460-0001; telephone number: (703) 308-9354; e-mail address: waller.mary@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 provides aguide for readers regarding entities likely to be affected by this action.Other types of entities not listed in this unit could also be affected. TheNorth American Industrial Classification System (NAICS) codes have beenprovided to assist you and others in determining whether this action mightapply to certain entities. If you have any questions regarding theapplicability 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 public docketfor this action under docket ID number OPP-2005-0074. Theofficial public docket consists of the documents specifically referenced inthis action, any public comments received, and other information related tothis action. Although a part of the official docket, the public docketdoes not include Confidential Business Information (CBI) or otherinformation whose disclosure is restricted by statute. The official publicdocket is the collection of materials that is available for public viewingat the Public Information and Records Integrity Branch (PIRIB), Rm. 119,Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facilityis open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legalholidays. The docket telephone number is (703) 305-5805.
2. Electronic access . You may access this Federal Register document electronically through the EPAInternet under the " Federal Register " listings at http://www.epa.gov/fedrgstr/ .
An electronic version of the public docket is available through EPA'selectronic public docket and comment system, EPA Dockets. You may use EPADockets at http://www.epa.gov/edocket/ to submit or viewpublic comments, access the index listing of the contents of the officialpublic docket, and to access those documents in the public docket that areavailable electronically. Although not all docket materials may beavailable electronically, you may still access any of the publiclyavailable docket materials through the docket facility identified in UnitI.B.1. Once in the system, select "search," then key in theappropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.Information claimed as CBI and other information whose disclosure isrestricted 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'selectronic public docket but will be available only in printed, paper formin the official public docket. To the extent feasible, publicly availabledocket materials will be made available in EPA's electronic public docket.When a document is selected from the index list in EPA Dockets, the systemwill identify whether the document is available for viewing in EPA'selectronic public docket. Although not all docket materials may beavailable electronically, you may still access any of the publiclyavailable docket materials through the docket facility identified in UnitI.B. EPA intends to work towards providing electronic access to all of thepublicly available docket materials through EPA's electronic publicdocket.
For public commenters, it is important to note that EPA's policy is thatpublic comments, whether submitted electronically or in paper, will be madeavailable for public viewing in EPA's electronic public docket as EPAreceives them and without change, unless the comment contains copyrightedmaterial, CBI, or other information whose disclosure is restricted bystatute. When EPA identifies a comment containing copyrighted material,EPA will provide a reference to that material in the version of the commentthat is placed in EPA's electronic public docket. The entire printedcomment, including the copyrighted material, will be available in thepublic docket.
Public comments submitted on computer disks that are mailed or deliveredto the docket will be transferred to EPA's electronic public docket.Public comments that are mailed or delivered to the docket will be scannedand placed in EPA's electronic public docket. Where practical, physicalobjects will be photographed, and the photograph will be placed in EPA'selectronic public docket along with a brief description written by thedocket 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 electronic commentas prescribed in this unit, EPA recommends that you include your name,mailing address, and an e-mail address or other contact information in thebody of your comment. Also include this contact information on the outsideof any disk or CD ROM you submit, and in any cover letter accompanying thedisk or CD ROM. This ensures that you can be identified as the submitterof the comment and allows EPA to contact you in case EPA cannot read yourcomment due to technical difficulties or needs further information on thesubstance of your comment. EPA's policy is that EPA will not edit yourcomment, and any identifying or contact information provided in the body ofa comment will be included as part of the comment that is placed in theofficial public docket, and made available in EPA's electronic publicdocket. If EPA cannot read your comment due to technical difficulties andcannot contact you for clarification, EPA may not be able to consider yourcomment.
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-2005-0074. 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-2005-0074. 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: Public Informationand Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001, Attention: Docket ID NumberOPP-2005-0074.
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-2005-0074. 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 CBI electronicallythrough EPA's electronic public docket or by e-mail. You may claiminformation that you submit to EPA as CBI by marking any part or all ofthat information as CBI (if you submit CBI on disk or CD ROM, mark theoutside 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 includes anyinformation claimed as CBI, a copy of the comment that does not contain theinformation claimed as CBI must be submitted for inclusion in the publicdocket and EPA's electronic public docket. If you submit the copy thatdoes not contain CBI on disk or CD ROM, mark the outside of the disk orCD ROM clearly that it does not contain CBI. Information not marked as CBIwill be included in the public docket and EPA's electronic public docketwithout 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, Foodadditives, Pesticides and pests, Reporting and recordkeepingrequirements.
Dated: March 28, 2005.
Lois Rossi,
Director, Registration Division, Office of PesticidePrograms.
Summary of Petition
The petitioner summary of the pesticide petition is printed below asrequired by FFDCA section 408(d)(3). The summary of the petition wasprepared by the petitioner and represents the view of the petitioner. Thepetition summary announces the availability of a description of theanalytical methods available to EPA for the detection and measurement ofthe pesticide chemical residues or an explanation of why no such method isneeded.
Bayer CropScience AG
PP 3E6578
EPA has received a pesticide petition (3E6578) from Bayer CropScienceAG; 2 T.W. Alexander Drive; Research Triangle Park, NC 27709 proposing,pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR 180.581 by establishing atolerance for residues of iprovalicarb in or on the raw agriculturalcommodity tomato at 1.0 parts per million (ppm). EPA has determined thatthe petition contains data or information regarding the elements set forthin section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated thesufficiency of the submitted data at this time or whether the data supportgranting of the petition. Additional data may be needed before EPA ruleson the petition.
A. Residue Chemistry
1. Plant metabolism . The metabolism of iprovalicarb wasinvestigated in grapes, potatoes and tomatoes, and the metabolic pathway issimilar in the three crops. The rate of degradation on plants is quitelow, and the parent compound was always the major component, withquantitatively relevant metabolites formed only in potatoes. Themetabolites observed in the potato were also observed in the rat.Therefore, iprovalicarb is the only residue of concern. Plant metabolismproceeds along three pathways:
i. Hydroxylation/glycosylation of parent at the 4-methyl group on thephenyl ring, followed by further conjugations.
ii. Cleavage of the amide group between the L-valine and p -methyl-phenethylamine moieties.
iii. Hydroxylation/glycosylation of parent at the phenyl-ring 3position.
2. Analytical method . Iprovalicarb residues are quantifiedby reversed phase HPLC with Electrospray MS/MS-detection. The instrumentresponse was linear over the range of 0.0005 to 0.26 ppm. For the analysisof iprovalicarb residues in tomatoes, the limit of quantification and thelimit of detection were determined to be 0.02 ppm and 0.005 ppm,respectively. Iprovalicarb residue recoveries ranged from 81% to 98% fortomato samples fortified at 0.017 ppm and from 80% to 90% for tomatosampled fortified at 0.166 ppm.
3. Magnitude of residues . Twenty residues trials were conducted that are representative of tomatoes grown in countries that export tomato commodities to the United States. The maximum iprovalicarbresidue in/on whole, unwashed tomatoes grown for exportation to the UnitedStates was 0.41 ppm. The average iprovalicarb residue in/on whole,unwashed tomatoes grown for exportation to the United States as freshtomatoes and processed tomatoes was 0.12 ppm and 0.07 ppm, respectively.Washing of whole tomatoes reduces iprovalicarb residues by 56%.Iprovalicarb residues were reduced by 88%, 73% and 71% via processing offresh, unwashed tomatoes to peeled fruit, juice and puree, respectively.The iprovalicarb residue concentration factor for tomato paste is 1.38.The theoretical maximum iprovalicarb residue in tomato paste is 0.56 ppm,(0.41 ppm x 1.38 = 0.56 ppm). Since tomato paste is a blended commodityand the average residue in/on tomatoes grown for export to the UnitedStates as processed tomatoes is 0.07 ppm, the anticipated iprovalicarbresidue in tomato paste is only 0.10 ppm. (0.07 ppm x 1.38 = 0.10 ppm).
B. Toxicological Profile
OPPTS Harmonized Guideline 870.1100, Acute oral toxicity, LD 50 5,000 milligram/kilogram/body weight (mg/kg/bwt) is the onlyentry that did not appear in Table 1 of the final rule of August 22,2002.
1. Acute toxicity . See Table 1 of the final rule publishedin the Federal Register of August 22, 2002 (67 FR 54351)(FRL-7194-3).
2. Genotoxicity . See Table 1 of the final rule publishedin the Federal Register of August 22, 2002 (67 FR 54351).
3. Reproductive and developmental toxicity . See Table 1 of the final rule published in the Federal Register of August 22, 2002 (67 FR 54351).
4. Subchronic toxicity. See Table 1 of the final rulepublished in the Federal Register of August 22, 2002 (67 FR54351).
5. Chronic toxicity . See Table 1 of the final rulepublished in the Federal Register of August 22, 2002 (67 FR54351).
6. Animal metabolism . See Table 1 of the final rulepublished in the Federal Register of August 22, 2002 (67 FR54351).
7. Metabolite toxicology . The toxicity of p -methyl-phenethylamine, a rat, plant and soil metabolite, wasinvestigated in two studies:
i. The acute oral LD 50 in Wistar rats was determined to bein the range of 300 to 500 mg/kg/bwt.
ii. No mutagenic activity was observed in the Salmonella/microsometest. p -Methyl-phenethylamine was found at concentrations of 0.2% and has been determined to not be toxicologicallysignificant.
8. Endocrine disruption . No endocrine disruptionpotential was observed in the 2-generation reproduction study,developmental toxicity studies, subchronic feeding studies, and chronicfeeding studies.
C. Aggregate Exposure
1. Dietary exposure . There are no registered uses ofiprovalicarb in the United States, and no registrations are pending.Dietary exposure to iprovalicarb in the United States is limited toresidues in/on imported grape commodities and the proposed imported tomatocommodities.
i. Food . Exposure to iprovalicarb residues in food islimited to imported grape and tomato commodities. U.S. consumption offresh grapes, grape juice, raisins and wine that is from imported sourcesis estimated to be 35%, 43.3%, 7%, and 15%, respectively. The percent U.S.consumption of tomato commodities potentially treated with iprovalicarbthat is from imported sources is estimated to be 13.4% for fresh tomatoesand 2.9% for processed tomatoes.
ii. Drinking water . Iprovalicarb is not registered for usein the United States. Therefore, there is no exposure to iprovalicarbthrough drinking water in the United States.
2. Non-dietary exposure . Iprovalicarb is not registeredfor use in the United States. Therefore, there is no non-dietary exposureto iprovalicarb in the United States.
D. Cumulative Effects
Iprovalicarb is a member of a new class of chemistry and does not have amode of action that is common with other registered pesticides. Therefore,there are no cumulative effects.
E. Safety Determination
1. U.S. population . Iprovalicarb has low acute toxicity,so no acute safety determination is needed. EPA has previously determinedthat the chronic Population Adjusted Dose for iprovalicarb is 0.026mg/kg/bwt/day and the uncertainty factor is 100. Based upon averageresidues in/on imported tomato commodities, and assuming that 100% of thetomato commodities that are imported from countries in which iprovalicarbis potentially used have been treated with iprovalicarb, the estimatedchronic dietary risk based upon exposure of 50% of the reference populationwas estimated using CARES verison 1.3 to be 0.1% of the cPAD. The excesslifetime cancer risk was estimated using CARES version 1.3 to be 1.64 x10 -8 .
2. Infants and children . The population subgroup with themaximum estimated dietary exposure is children age 1 to 2 years old. Forthis subgroup, and using the same assumptions as listed for the U.S.population, the estimated chronic dietary risk is 0.5% of the cPAD.
F. International Tolerances
Currently, there is no CODEX maximum residue level (MRL) foriprovalicarb residues in/on tomatoes. Italy is the only country for whichthere currently is a registration for the use of iprovalicarb on tomatoesand for which the additional active ingredient included in the formulationfor resistance management purposes also has a U.S. tolerance. Italy hasestablished an MRL of 1.0 ppm for iprovalicarb residues in/on tomatoes.
[FR Doc. 05-7042 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S