67 FR 149 pgs. 50430-50435 - Notice of Filing a Pesticide Petition to Establish a Tolerance fora Certain Pesticide Chemical in or on Food
Type: NOTICEVolume: 67Number: 149Pages: 50430 - 50435
Docket number: [OPP-2002-0134; FRL-7185-9]
FR document: [FR Doc. 02-19443 Filed 8-1-02; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0134; FRL-7185-9]
Notice of Filing a Pesticide Petition to Establish a Tolerance fora 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 food commodities.
DATES:
Comments, identified by docket ID numberOPP-2002-0134, must be received on or before September 3, 2002.
ADDRESSES:
Comments may be submitted by mail, electronically,or in person. Please follow the detailed instructions for each method asprovided in Unit I.C. of the SUPPLEMENTARY INFORMATION . Toensure proper receipt by EPA, it is imperative that you identify docket IDnumber OPP-2002-0134 in the subject line on the first page ofyour response.
FOR FURTHER INFORMATION CONTACT:
By mail: Linda A.DeLuise, Registration Division (7505C), Office of Pesticide Programs,Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,DC 20460; telephone number: (703) 305-5428; e-mail address:deluise.linda@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural producer,food manufacturer or pesticide manufacturer. Potentially affectedcategories and entities may include, but are not limited to:
| Categories | NAICS codes | Examples of potentially affected entities |
|---|---|---|
| Industry | 111 | Crop production |
| 112 | Animal production | |
| 311 | Food manufacturing | |
| 32532 | Pesticide manufacturing |
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 the table could also be affected. TheNorth American Industrial Classification System (NAICS) codes have beenprovided to assist you and others in determining whether or not this actionmight apply to certain entities. If you have questions regarding theapplicability of this action to a particular entity, consult the personlisted under FOR FURTHER INFORMATION CONTACT .
B. How Can I Get Additional Information, Including Copies of thisDocument and Other Related Documents?
1. Electronically . You may obtain electronic copies ofthis document, and certain other related documents that might be availableelectronically, from the EPA Internet Home Page at http://www.epa.gov/. Toaccess this document, on the Home Page select "Laws andRegulations," "Regulations and Proposed Rules" and thenlook up the entry for this document under the " FederalRegister -Environmental Documents." You can also go directlyto the Federal Register listings athttp://www.epa.gov/fedrgstr/.
2. In person . The Agency has established an officialrecord for this action under docket ID number OPP-2002-0134.The official record consists of the documents specifically referenced inthis action, any public comments received during an applicable commentperiod, and other information related to this action, including anyinformation claimed as Confidential Business Information (CBI). Thisofficial record includes the documents that are physically located in thedocket, as well as the documents that are referenced in those documents.The public version of the official record does not include any informationclaimed as CBI. The public version of the official record, which includesprinted, paper versions of any electronic comments submitted during anapplicable comment period, is available for inspection in the PublicInformation and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall#2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4p.m., Monday through Friday, excluding legal holidays. The PIRIB telephonenumber is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically.To ensure proper receipt by EPA, it is imperative that you identify docketID number OPP-2002-0134 in the subject line on the first pageof your response.
1. By mail . Submit your comments to: Public Informationand Records Integrity Branch (PIRIB), Information Resources and ServicesDivision (7502C), Office of Pesticide Programs (OPP), EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier . Deliver your comments to:Public Information and Records Integrity Branch (PIRIB), InformationResources and Services Division (7502C), Office of Pesticide Programs(OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to4 p.m., Monday through Friday, excluding legal holidays. The PIRIBtelephone number is (703) 305-5805.
3. Electronically . You may submit your commentselectronically by e-mail to: opp-docket@epa.gov, or you can submit acomputer disk as described above. Do not submit any informationelectronically that you consider to be CBI. Avoid the use of specialcharacters and any form of encryption. Electronic submissions will beaccepted in Wordperfect 6.1/8.0 or ASCII file format. All comments inelectronic form must be identified by docket ID numberOPP-2002-0134. Electronic comments may also be filed online atmany Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to beCBI. You may claim information that you submit to EPA in response to thisdocument as CBI by marking any part or all of that information as CBI.Information so marked will not be disclosed except in accordance withprocedures set forth in 40 CFR part 2. In addition to one complete versionof the comment that includes any information claimed as CBI, a copy of thecomment that does not contain the information claimed as CBI must besubmitted for inclusion in the public version of the official record.Information not marked confidential will be included in the public versionof the official record without prior notice. If you have any questionsabout CBI or the procedures for claiming CBI, please consult the personidentified 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 used thatsupport your views.
4. If you estimate potential burden or costs, explain how you arrived atthe 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 IDnumber assigned o this action in the subject line on the first page of yourresponse. 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 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 needed beforeEPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives, Foodadditives, Pesticides and pests, Reporting and recordkeepingrequirements.
Dated: July 23, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of PesticidePrograms.
Summary of Petition
The petitioner summary of the pesticide petition is printed below asrequired by section 408(d)(3) of the FFDCA. The summary of the petition wasprepared by the petitioner and represents the view of the petitioner. EPAis publishing the petition summary verbatim without editing it in any way.The petition 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.
FMC Corporation
2F6444
EPA has received a pesticide petition (2F6444) from FMC Corporation,1735 Market Street, Philadelphia, PA 19103 proposing, pursuant to section408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180, byestablishing a tolerance for residues ofzeta-cypermethrins-Cyano(3-phenoxyphenyl)methyl (±) cis,trans 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate andits inactive isomers) in or on the raw agricultural commodities (RACs) rootand tuber vegetables, roots at 0.10 part per million (ppm); peanuts at 0.05ppm; and cucurbit vegetables at 0.10 ppm. EPA has determined that thepetition contains data or information regarding the elements set forth insection 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 cypermethrin inplants are adequately understood. Studies have been conducted to delineatethe metabolism of radiolabelled cypermethrin in various crops all showingsimilar results. The residue of concern is the parent compound only.
2. Analytical method . There is a practical analyticalmethod for detecting and measuring levels of cypermethrin in or on foodwith a limit of detection (LOD) that allows monitoring of food withresidues at or 'above the levels set in these tolerances (gaschromatography with electron capture detection (GC/ECD)).
3. Magnitude of residues . Crop field trial residue datafrom studies conducted at the maximum label rates for root and tubervegetables, peanuts, and cucurbit vegetables show that the proposedzeta-cypermethrin tolerances on root and tuber vegetables, roots at 0.10ppm; peanuts at 0.05 ppm; and cucurbit vegetables at 0.10 ppm will not beexceeded when the zeta-cypermethrin products labeled for these uses areused as directed.
B. Toxicological Profile
1. Acute toxicity . For the purposes of assessing acutedietary risk, FMC Corporation has used the no observed adverse effectlevels (NOAEL) at 10.0 milligram/kilograms/day (mg/kg/day) from thezeta-cypermethrin acute neurotoxicity study in rats. The lowest observedadverse effect levels (LOAEL) at 50.0 mg/kg/day was based on clinicalsigns. This acute dietary endpoint is used to determine acute dietaryrisks to all population subgroups.
2. Genotoxicty . The following genotoxicity tests wereall negative:
i. In vivo chromosomal aberration in rat bone marrowcells.
ii. In vitro cytogenic chromosome aberration.
iii. Unscheduled DNA synthesis (UDS).
iv. Chinese hampster ovary/hypoxanthine guanine phophoribosyltransferase (CHO/HGPRT) mutagen assay; weakly mutagenic: Gene mutation(Ames).
3. Reproductive and developmental toxicity . No evidenceof additional sensitivity to young rats was observed following prenatal orpostnatal exposure to zeta-cypermethrin.
i. A 2-generation reproductive toxicity study withzeta-cypermethrin in rats demonstrated a NOAEL at 7.0 mg/kg/day and theLOAEL at 27.0 mg/kg/day for parental/systemic toxicity based on body weight(bwt), organ weight, and clinical signs. There were no adverse effects inreproductive performance. The NOAEL for reproductive toxicity wasconsidered to be 45.0 mg/kg/day (the highest dose tested(HDT)).
ii. A developmental study with zeta-cypermethrin in rats demonstrated amaternal NOAEL at 12.5 mg/kg/day and a LOAEL at 25 mg/kg/day based ondecreased maternal body weight gain, food consumption and clinical signs.There were no signs of developmental toxicity at 35.0 mg/kg/day, the HDT.
iii. A developmental study with cypermethrin in rabbits demonstrated amaternal NOAEL at 100 mg/kg/day and a LOAEL at 450 mg/kg/day based ondecreased body weight gain. There were no signs of developmental toxicityat 700 mg/kg/day, the HDT.
4. Subchronic toxicity . Short-term and intermediate-termtoxicity (incidental oral exposure). The NOAEL at 10.0 mg/kg/day based onclinical signs at the lowest effect level (LEL) at 50.0 mg/kg/day in thezeta-cypermethrin acute neurotoxicity study in rats would also be used forshort-term percent of the acute population adjusted dose (aPAD) and marginof exposure (MOE) calculations (as well as acute, discussed in paragraph(1) above), and the NOAEL at 5.0 mg/kg/day based on decreased motoractivity in the zeta-cypermethrin subchronic neurotoxicity study in rats,would be used for intermediate-term MOE calculations.
5. Chronic toxicity -i. The chronic referencedose (RfD) at 0.06 mg/kg/day for zeta-cypermethrin is based on a NOAEL at6.0 mg/kg/day from a cypermethrin chronic feeding study in dogs and anuncertainty factor (UF) of 100. The endpoint effect of concern was basedon clinical signs.
ii. Cypermethrin is classified as a Group C chemical (possible humancarcinogen with limited evidence of carcinogenicity in animals) based uponlimited evidence for carcinogenicity in female mice; assignment of a Q * has not been recommended.
6. Animal metabolism . The metabolism of cypermethrin inanimals is adequately understood. Cypermethrin has been shown to berapidly absorbed, distributed, and excreted in rats when administeredorally. Cypermethrin is metabolized by hydrolysis and oxidation.
7. Metabolite toxicology . The Agency has previouslydetermined that the metabolites of cypermethrin are not of toxicologicalconcern and need not be included in the tolerance expression nor in therisk exposure assessments.
8. Endocrine disruption . No special studiesinvestigating potential estrogenic or other endocrine effects ofcypermethrin have been conducted. However, no evidence of such effectswere reported in the standard battery of required toxicology studies whichhave been completed and found acceptable. Based on these studies, there isno evidence to suggest that cypermethrin has an adverse effect on theendocrine system.
C. Aggregate Exposure
1. Dietary exposure -i. Food .Permanent tolerances, in support of registrations, currently exist forresidues of zeta-cypermethrin on: alfalfa hay, alfalfa forage, alfalfaseed, aspirated grain fractions, sugar beets (roots and tops), head, stem,and leafy Brassica vegetables, cabbage, field corn grain, pop corn grain,field corn forage, field corn stover, pop corn stover, sweet corn (K+CWHR),sweet corn forage, sweet corn stover, cottonseed, dried shelled peas, andbeans, edible podded legume vegetables, fruiting vegetables (exceptCucurbits), leafy vegetables, head lettuce, bulb, and green onions, pecans,rice grain, rice hulls, rice straw, sorghum forage, sorghum grain, sorghumstover, soybean seed, succulent shelled peas and beans, sugarcane, wheatforage, wheat grain, wheat hay, wheat straw, meat, fat, and meat byproductsof cattle, goats, hogs, horses, and poultry, eggs, milk, and milk fat. Forthe purposes of assessing the potential dietary exposure for these existingand the subject proposed tolerances, FMC Corporation has utilized availableinformation on anticipated residues, monitoring data, and percent croptreated as follows:
ii. Acute exposure and risk . Acute dietary exposure riskassessments are performed for a food-use pesticide if a toxicological studyhas indicated the possibility of an effect of concern occurring as a resultof a 1 day or single exposure. For the purposes of assessing acute dietaryrisk for zeta-cypermethrin, FMC Corporation has used the NOAEL of 10.0mg/kg/day from the zeta-cypermethrin acute neurotoxicity study in rats withan UF of 100 (acute RfD = 0.10 mg/kg/day). The LEL of 50.0 mg/kg/day wasbased on clinical signs. This acute dietary endpoint is used to determineacute dietary risks to all population subgroups. Available information onanticipated residues, monitoring data, and percent crop treated wasincorporated into a Tier 3 analysis, using Monte Carlo modeling forcommodities that may be consumed in a single serving. These assessmentsshow that the percent of acute PAD all fall below EPA's level of concern(LOC) (=100%). The 95 th percentile of exposure for theoverall U.S. population was estimated to be 0.001012 mg/kg/day (percent ofthe acute RfD at 1.01); 99 th percentile 0.002913 mg/kg/day(percent of the acute RfD at 2.91); and 99.9 th percentile0.012145 mg/kg/day (percent of the acute RfD at 12.14). The 95 th percentile of exposure for all infants 1year old was estimated to be 0.000716 mg/kg/day (percent of the acute RfDat 0.72); 99 th percentile 0.005735 mg/kg/day (percent of theacute RfD at 5.74); and 99.9 th percentile 0.027673 mg/kg/day(percent of the acute RfD of 27.67). The 95 th percentile ofexposure for nursing infants 1 year old was estimated to be 0.000420mg/kg/day (percent of the acute RfD at 0.42); 99 th percentile0.001087 mg/kg/day (percent of the acute RfD at 1.09); and 99.9thpercentile 0.004944 mg/kg/day (percent of the acute RfD at 4.94). The 95 th percentile of exposure for non-nursing infants 1 year old (the most highly exposed population subgroup) wasestimated to be 0.000826 mg/kg/day (percent of the acute RfD at 0.83); 99 th percentile 0.011124 mg/kg/day (percent of the acute RfD at11.12); and 99.9 th percentile 0.031431 mg/kg/day (percent ofthe acute RfD of 31.43). The 95 th percentile of exposure for children 1 to 6 years old and children 7 to 12 years old was estimated tobe, respectively, 0.001228 mg/kg/day (percent of the acute RfD at 1.23) and0.001001 mg/kg/day (percent of the acute RfD at 1.0); 99 th, percentile 0.003716 mg/kg/day (percent of the acute RfD at 3.72) and0.002724 (percent of the acute RfD at 2.72); and 99.9 th percentile 0.015244 mg/kg/day (percent of the acute RfD at 15.24) and0.008805 (percent of the acute RfD at 8.81). The 95 th percentile of exposure for females (13+/nursing) was estimated to be0.001051mg/kg/day (percent of the acute RfD at 1.05); 99 th percentile 0.003029 mg/kg/day (percent of the acute RfD at 3.03); and99.9 th percentile 0.013146 mg/kg/day (percent of the acuteRfD at 13.15). Therefore, FMC Corporation concludes that the acute dietaryrisk of zeta-cypermethrin, as estimated by the dietary risk assessment,does not appear to be of concern.
iii. Chronic exposure risk. The chronic RfD at 0.06mg/kg/day for zeta-cypermethrin is based on a NOAEL of 6.0 mg/kg/day from acypermethrin chronic feeding study in dogs and an UF of 100. The endpointeffect of concern was based on clinical signs. A chronic dietaryexposure/risk assessment has been performed for zeta-cypermethrin using theabove chronic RfD. Available information on anticipated residues,monitoring data and percent crop treated was incorporated into the analysisto estimate the anticipated residue contribution (ARC). The ARC isgenerally considered a more realistic estimate than an estimate based ontolerance level residues. The ARC are estimated to be 0.000184 mg/kgbwt/day and utilize 0.3% of the chronic RfD for the overall U.S.population. The ARC for nursing infants ( 1 year) andnon-nursing infants ( 1 year) (subgroup most highlyexposed) are estimated to be 0.000052 mg/kg bwt/day and 0.000380 mg/kgbwt/day and utilizes 0.1% and 0.6% of the chronic RfD, respectively. TheARC for children 1 to 6 years old and children 7 to 12 years old areestimated to be 0.000337 mg/kg bwt/day and 0.000203 mg/kg bwt/day andutilizes 0.6% and 0.3% of the chronic RfD, respectively. The ARC forfemales (13+/nursing) are estimated to be 0.000177 mg/kg bwt/day andutilizes 0.3% of the RfD. Generally speaking, EPA has no cause for concernif the total dietary exposure from residues for uses for which there arepublished and proposed tolerances is less than 100% of the chronic RfD.Therefore, FMC Corporation concludes that the chronic dietary risk ofzeta-cypermethrin, as estimated by the dietary risk assessment, does notappear to be of concern.
iv. Drinking water . Laboratory and field data havedemonstrated that cypermethrin is immobile in soil and will not leach intoground water. Other data show that cypermethrin is virtually insoluble inwater and extremely lipophilic. As a result, FMC Corporation concludesthat residues reaching surface waters from field runoff will quickly adsorbto sediment particles and be partitioned from the water column. Drinkingwater estimated concentrations (DWEC) and the corresponding drinking waterlevel of comparison (DWLOC) values were calculated for chronic and acuteexposures. The results show that all DWLOC values exceed the DWEC values.Thus, exposure to zeta-cypermethrin and cypermethrin residues in drinkingwater is not of concern. EPA's draft SOP for Incorporating Estimates ofDrinking Water Exposure into Aggregate Risk Assessments was used to performa drinking water analysis. This SOP utilizes a variety of tools to conductdrinking water assessment. These tools include water models such as theFood Quailty Protection Act/Index Reservoir Screening Tool (FQPA)(FIRST),EPA's Pesticide Root Zone Model/Exposure Analysis Modeling System(PRZM/EXAMS), Screening Concentration in Ground Water (SCIGROW), andmonitoring data. If monitoring data is not available, then the models areused to predict potential residues in drinking water. The techniquerecommended in the drinking water SOP compares a calculated DWLOC value tothe drinking water estimated concentration (DWEC) value. The DWEC valueresults from either the monitoring data residues or modeled water residues.If the DWLOC value exceeds the DWEC value, then there is reasonablecertainty that no harm will result from the acute or chronic aggregateexposure.
In the case of cypermethrin and zeta-cypermethrin, monitoring data donot exist. Therefore, the FIRST model was used to estimate a surface waterresidue. The risk assessment for drinking water compares two values:
a. The DWLOC and the DWEC. The DWLOC is the drinking water level ofcomparsion. This is the maximum allowable drinking water concentration (inparts per billion). The DWEC is the drinking water environmentalconcentration, which is derived either from monitoring studies or frommodeling.
b. If the DWLOC is greater than the DWEC, then the overall exposurefrom water, food, and residential is considered to be acceptable. Thecalculated DWLOC values for acute and chronic exposures for all adults,adult females, and children exceed the modeled DWEC surface water residues.Therefore, there is reasonable certainty that no harm will result fromcumulative and aggregate (food and water) exposure to cypermethrin andzeta-cypermethrin residues.
2. Non-dietary exposure . Zeta-cypermethrin is registeredfor agricultural crop applications only, therefore non-dietary exposureassessments are not warranted.
D. Cumulative Effects
In consideration of potential cumulative effects of cypermethrin andother substances that may have a common mechanism of toxicity, to ourknowledge there are currently no available data or other reliableinformation indicating that any toxic effects produced by cypermethrinwould be cumulative with those of other chemical compounds; thus only thepotential risks of cypermethrin have been considered in this assessment ofits aggregate exposure. FMC Corporation intends to submit information forEPA to consider concerning potential cumulative effects of cypermethrinconsistent with the schedule established by EPA at (62 FR 42020, August 4,1997) (FRL-5734-6), and other EPA publications pursuant to theFQPA.
E. Safety Determination
1. U.S. population . The chronic RfD at 0.06 mg/kg/dayfor zeta-cypermethrin is based on a NOAEL at 6.0 mg/kg/day from acypermethrin chronic feeding study in dogs and an UF of 100. The endpointeffect of concern was based on clinical signs. A chronic dietaryexposure/risk assessment has been performed for zeta-cypermethrin using theabove chronic RfD. Available information on anticipated residues,monitoring data and percent crop treated was incorporated into the analysisto estimate the anticipated residue contribution ARC. The ARC is generallyconsidered a more realistic estimate than an estimate based on tolerancelevel residues. The ARC is estimated to be 0.000184 mg/kg bwt/day andutilize 0.3% of the chronic RfD for the overall U.S. population. The ARCfor nursing infants ( 1 year) and non-nursing infants ( 1 year) (subgroup most highly exposed) are estimated to be0.000052 mg/kg bwt/day and 0.000380 mg/kg bwt/day and utilizes 0.1% and0.6% of the chronic RfD, respectively. The ARC for children 1 to 6 yearsold and children 7 to 12 years old are estimated to be 0.000337 mg/kgbwt/day and 0.000203 mg/kg bwt/day and utilizes 0.6% and 0.3% of thechronic RfD, respectively. The ARC for females (13+/nursing) are estimatedto be 0.000177 mg/kg bwt/day and utilizes 0.3% of the RfD. Generallyspeaking, EPA has no cause for concern if the total dietary exposure fromresidues for uses for which there are published and proposed tolerances isless than 100% of the chronic RfD. Therefore, FMC Corporation concludesthat the chronic dietary risk of zeta-cypermethrin, as estimated by thedietary risk assessment, does not appear to be of concern.
Acute dietary exposure risk assessments are performed for a food-usepesticide if a toxicological study has indicated the possibility of aneffect of concern occurring as a result of a 1 day or single exposure. Forthe purposes of assessing acute dietary risk for zeta-cypermethrin, FMCCorporation has used the NOAEL of 10.0 mg/kg/day from the zeta-cypermethrinacute neurotoxicity study in rats with an UF of 100 (acute RfD = 0.10mg/kg/day). The LEL of 50.0 mg/kg/day was based on clinical signs. Thisacute dietary endpoint is used to determine acute dietary risks to allpopulation subgroups. Available information on anticipated residues,monitoring data and percent crop treated was incorporated into a Tier 3analysis, using Monte Carlo modeling for commodities that may be consumedin a single serving. These assessments show that the percent of acute PADall fall below EPA's LOC (=100%). The 95 th percentile ofexposure for the overall U.S. popuation was estimated to be 0.001012mg/kg/day (percent of the acute RfD at 1.01); 99 th percentile0.002913 mg/kg/day (percent of the acute RfD at 2.91); and 99.9 th percentile 0.012145 mg/kg/day (percent of the acute RfD at12.14). The 95 th percentile of exposure for all infants 1 year old was estimated to be 0.000716 mg/kg/day (percentof the acute RfD at 0.72); 99 th percentile 0.005735 mg/kg/day(percent of the acute RfD at 5.74); and 99.9 th percentile0.027673 mg/kg/day (percent of the acute RfD at 27.67). The 95 th percentile of exposure for nursing infants 1 year old was estimated to be 0.000420 mg/kg/day (percentof the acute RfD at 0.42); 99 th percentile 0.001087 mg/kg/day(percent of the acute RfD at 1.09); and 99.9 th percentile0.004944 mg/kg/day (percent of the acute RfD at 4.94). The 95 th percentile of exposure for non-nursing infants 1 year old (the most highly exposed population subgroup) wasestimated to be 0.000826 mg/kg/day (percent of the acute RfD at 0.83); 99 th percentile 0.011124 mg/kg/day (percent of the acute RfD at11.12); and 99.9 th percentile 0.031431 mg/kg/day (percent ofthe acute RfD at 31.43). The 95 th percentile of exposure forchildren 1 to 6 years old and children 7 to 12 years old was estimated tobe, respectively, 0.001228 mg/kg/day (percent of the acute RfD at 1.23);and 0.001001 mg/kg/day (percent of the acute RfD at 1.0); 99 th percentile 0.003716 mg/kg/day (percent of the acute RfD at3.72); and 0.002724 (percent of the acute RfD at 2.72); and 99.9 th percentile 0.015244 mg/kg/day (percent of the acute RfD of15.24); and 0.008805 (percent of the acute RfD at 8.81). The 95 th percentile of exposure for females (13+/nursing) wasestimated to be 0.001051 mg/kg/day (percent of the acute RfD at 1.05); 99 th percentile 0.003029 mg/kg/day (percent of the acute RfD at3.03); and 99.9 th percentile 0.013146 mg/kg/day (percentacute RfD at 13.15). Therefore, FMC Corporation concludes that the acutedietary risk of zeta-cypermethrin, as estimated by the dietary riskassessment, does not appear to be of concern.
2. Infants and children -i. General .In assessing the potential for additional sensitivity of infants andchildren to residues of zeta-cypermethrin, FMC Corporation considered datafrom developmental toxicity studies in the rat, rabbit, and a2-generation reproductive study in the rat. The data demonstrated noindication of increased sensitivity of rats to zeta-cypermethrin or rabbitsto cypermethrin in utero and/or postnatal exposure tozeta-cypermethrin or cypermethrin. The developmental toxicity studies aredesigned to evaluate adverse effects on the developing organism resultingfrom pesticide exposure during prenatal development to one or both parents.Reproduction studies provide information relating to effects from exposureto the pesticide on the reproductive capability of mating animals and dataon systemic toxicity. FFDCA section 408 provides that EPA may apply anadditional margin of safety (MOS) for infants and children in the case ofthreshold effects to account for prenatal and postnatal toxicity and thecompleteness of the data base.
ii. Developmental toxicity studies . In the prenataldevelopmental toxicity studies in rats and rabbits, there was no evidenceof developmental toxicity at the HDT (35.0 mg/kg/day in rats and 700mg/kg/day in rabbits). Decreased body weight gain was observed at thematernal LOAEL in each study; the maternal NOAEL was established at 12.5mg/kg/day in rats and 100 mg/kg/day in rabbits.
iii. Reproductive toxicity study . In the2-generation reproduction study in rats, offspring toxicity (bodyweight), parental toxicity (body weight, organ weight, and clinical signs),were observed at 27.0 mg/kg/day and greater. The parental systemic NOAELwas 7.0 mg/kg/day and the parental systemic LOAEL was 27.0 mg/kg/day.There were no developmental (pup) or reproductive effects up to 45.0mg/kg/day, HDT.
iv. Prenatal and postnatal sensitivity -a. Prenatal . There was no evidence of developmental toxicity inthe studies at the HDT in the rat (70.0 mg/kg/day) or in the rabbit (700mg/kg/day). Therefore, there is no evidence of a special dietary risk(either acute or chronic) for infants and children which would require anadditional safety factor.
b. Postnatal . Based on the absence of pup toxicity up todose levels which produced toxicity in the parental animals, there is noevidence of special postnatal sensitivity to infants and children in therat reproduction study.
v. Conclusion . Based on the above, FMC Corporationconcludes that reliable data support use of the standard 100-fold UF, andthat an additional UF is not needed to protect the safety of infants andchildren. As stated above, aggregate exposure assessments utilizedsignificantly less than 1% of the RfD for either the entire U.S. populationor any of the 26 population subgroups including infants and children.Therefore, it may be concluded that there is reasonable certainty that noharm will result to infants and children from aggregate exposure tocypermethrin residues.
F. International Tolerances
There are no Canadian, or Mexican residue limits for residues ofcypermethrin or zeta-cypermethrin in or on cucurbit vegetables, peanuts,root, and tuber vegetables. The Codex maximum residue levels forcypermethrin are cucumbers 0.2 ppm; peanuts 0.05 ppm; and for root andtuber vegetables 0.05 ppm.
[FR Doc. 02-19443 Filed 8-1-02; 8:45 am]
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