67 FR 149 pgs. 50354-50362 - Fludioxonil; Pesticide Tolerance
Type: RULEVolume: 67Number: 149Pages: 50354 - 50362
Docket number: [OPP-2002-0158; FRL-7188-7]
FR document: [FR Doc. 02-19442 Filed 8-1-02; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0158; FRL-7188-7]
Fludioxonil; Pesticide Tolerance
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes tolerances for residuesof fludioxonil in or on bushberry subgroup, caneberry subgroup, fruit,stone, group, juneberry, lingonberry, pistachio, salal, and watercress.Interregional Research Project Number 4 (IR-4) requested thesetolerances under the Federal Food, Drug, and Cosmetic Act, as amended bythe Food Quality Protection Act of 1996.
DATES:
This regulation is effective August 2, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0158 must be received on or before October 1, 2002.
ADDRESSES:
Written objections and hearing requests may besubmitted by mail, in person, or by courier. Please follow the detailedinstructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION . To ensure proper receipt by EPA, yourobjections and hearing requests must identify docket ID numberOPP-2002-0158 in the subject line on the first page of yourresponse.
FOR FURTHER INFORMATION CONTACT:
By mail: Shaja R. Brothers,Registration Division (7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;telephone number: (703) 308-3194; e-mail address:brothers.shaja@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 | 111 112 311 32532 | Crop production Animal production Food manufacturing 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 of thisdocument, 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 godirectly to the Federal Register listings athttp:// www.epa.gov/fedrgstr/. A frequently updated electronic version of 40CFR part 180 is available athttp://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html,a beta site currently under development. To access the OPPTS HarmonizedGuidelines referenced in this document, go directly to the guidelines athttp://www.epa.gov/opptsfrs/home/guidelin.htm.
2. In person . The Agency has established an officialrecord for this action under docket ID number OPP-2002-0158.The official record consists of the documents specifically referenced inthis action, 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 Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m.,Monday through Friday, excluding legal holidays. The PIRIB telephone numberis (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 29, 2000 (65 FR 16602)(FRL-6495-5) and May 1, 2002 (67 FR 21671)(FRL-6833-4), EPA issued notices pursuant to section 408 of theFederal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended bythe Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170),announcing the filing of pesticide petitions (PP 8E5026, 9E6049, 2E6359,2E6365, 2E6377, and 2E6393]) by IR-4, New Jersey AgriculturalExperiment Station, P. O. Box 231 Rutgers University, New Brunswick, NJ08903. These notices included summaries of the petitions prepared byNovartis Crop Protection Inc., and Syngenta Crop Protection Inc., theregistrants. There were no comments received in response to the notices offiling.
The petitions requested that 40 CFR 180.516 be amended by establishingtolerances for residues of the fungicide fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1 H -pyrrole-3-carbonitrile), in or onbushberry subgroup at 2.0 part per million (ppm), caneberry subgroup at 5.0ppm, juneberry at 2.0 ppm, lingonberry at 2.0 ppm, pistachio at 0.10 ppm,salal at 2.0 ppm, stone fruit group at 2.0 ppm, and watercress at 7.0 ppm.The petition for the stone fruit group was amended to propose a tolerancefor fludioxonil at 5.0 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance(the legal limit for a pesticide chemical residue in or on a food) only ifEPA determines that the tolerance is "safe." Section408(b)(2)(A)(ii) defines "safe" to mean that " there is areasonable certainty that no harm will result from aggregate exposure tothe pesticide chemical residue, including all anticipated dietary exposuresand all other exposures for which there is reliable information."This includes exposure through drinking water and in residential settings,but does not include occupational exposure. Section 408(b)(2)(C) requiresEPA to give special consideration to exposure of infants and children tothe pesticide chemical residue in establishing a tolerance and to"ensure that there is a reasonable certainty that no harm will resultto infants and children from aggregate exposure to the pesticide chemicalresidue...."
EPA performs a number of analyses to determine the risks from aggregateexposure to pesticide residues. For further discussion of the regulatoryrequirements of section 408 and a complete description of the riskassessment process, see the final rule on Bifenthrin Pesticide Tolerances(62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the availablescientific data and other relevant information in support of these actions.EPA has sufficient data to assess the hazards of and to make adetermination on aggregate exposure, consistent with section 408(b)(2), fortolerances for residues of fludioxonil in or on the bushberry subgroup at2.0 ppm, caneberry subgroup at 5.0 ppm, fruit, stone, group at 5.0 ppm,juneberry at 2.0 ppm, lingonberry at 2.0 ppm, pistachio at 0.10 ppm, salalat 2.0 ppm, and watercress at 7.0 ppm. EPA's assessment of exposures andrisks associated with establishing these tolerances follow.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered itsvalidity, completeness, and reliability as well as the relationship of theresults of the studies to human risk. EPA has also considered availableinformation concerning the variability of the sensitivities of majoridentifiable subgroups of consumers, including infants and children. Thenature of the toxic effects caused by fludioxonil are discussed in UnitIII.A. of the final rule on fludioxonil, which published in the Federal Register of December 29, 2000 (65 FR 82927)(FRL-6760-9). Additionally, recent toxicological studies (May2002) concluded findings in conjunction to the toxicological profile notedin Unit III.A. of the final rule on fludioxonil (65 FR 82927). Thesestudies are shown in Table 1:
| Guideline No. | Study Type | Results |
|---|---|---|
| 870.4200b | Carcino-genicity rats | NOAEL = 590 mg/kg/day (M) and 715 mg/kg/day (F). LOAEL: 851 mg/kg/day (M) and 1,008 mg/kg/day (F) based onreduced survival (F), decreased body weights (M), bile duct hyperplasia (M)and severe nephropathy (both sexes). No evidence of carcinogenicity. |
| 870.5395 | In vivo Rat hepatocyte micronucleus assay | Male rats were orally dosed at 50, 250, and 1,250 mg/kg andhepatocytes were harvested. There was no evidence of a significantincrease in micronucleated hepatocytes in treated groups in comparison tocontrols. |
| 870.5550 | Unscheduled DNA synthesis assay | There was no evidence that unscheduled DNA synthesis, asdetermined by nuclear silver grain counts, was induced in hepatocytecultures obtained from male rats dosed at 2,500 or 5,000 mg/kg. |
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from thetoxicology study identified as appropriate for use in risk assessment isused to estimate the toxicological level of concern (LOC). However, thelowest dose at which adverse effects of concern are identified (the LOAEL)is sometimes used for risk assessment if no NOAEL was achieved in thetoxicology study selected. An uncertainty factor (UF) is applied to reflectuncertainties inherent in the extrapolation from laboratory animal data tohumans and in the variations in sensitivity among members of the humanpopulation as well as other unknowns. An UF of 100 is routinely used, 10Xto account for interspecies differences and 10X for intra speciesdifferences.
For dietary risk assessment (other than cancer) the Agency uses the UFto calculate an acute or chronic reference dose (acute RfD or chronic RfD)where the RfD is equal to the NOAEL divided by the appropriate UF (RfD =NOAEL/UF). Where an additional safety factor is retained due to concernsunique to the FQPA, this additional factor is applied to the RfD bydividing the RfD by such additional factor. The acute or chronic PopulationAdjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodatethis type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used todetermine the LOC. For example, when 100 is the appropriate UF (10X toaccount for interspecies differences and 10X for intraspecies differences)the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (marginof exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currentlyused by the Agency to quantify carcinogenic risk. The Q* approach assumesthat any amount of exposure will lead to some degree of cancer risk. A Q*is calculated and used to estimate risk which represents a probability ofoccurrence of additional cancer cases (e.g., risk is expressed as1 x 10 - 6 or one in a million). Under certainspecific circumstances, MOE calculations will be used for the carcinogenicrisk assessment. In this non-linear approach, a "point ofdeparture" is identified below which carcinogenic effects are notexpected. The point of departure is typically a NOAEL based on an endpointrelated to cancer effects though it may be a different value derived fromthe dose response curve. To estimate risk, a ratio of the point ofdeparture to exposure (MOE cancer = point ofdeparture/exposures) is calculated. A summary of the toxicologicalendpoints for fludioxonil used for human risk assessment is shown in thefollowing Table 2:
| Exposure Scenario | Dose Used in Risk Assessment, UF | FQPA SF and Level of Concern for Risk Assessment | Study and Toxicological Effects |
|---|---|---|---|
| Acute Dietary females 13-50years of age | NOAEL = 100 mg/kg/day UF = 100 Acute RfD = 1.0 mg/kg/day | FQPA SF = 1X aPAD = acute RfD ÷ FQPA SF = 1.0 mg/kg/day | Developmental Toxicity Study - rat Developmental LOAEL = 1,000 mg/kg/day based on increasedincidence of fetuses and litters with dilated renal pelvis and dilatedureter |
| Chronic Dietary all populations | NOAEL= 3.3 mg/kg/day UF = 100 Chronic RfD = 0.03 mg/kg/day | FQPA SF = 1X cPAD = chronic RfD ÷ FQPA SF = 0.03 mg/kg/day | 1 year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased weight gain in femaledogs |
| Incidental Oral, Short-Term | NOAEL = 10 mg/kg/day | LOC for MOE = 100 | Rabbit developmental study LOAEL = 100 mg/kg/day based on decreased weight gain duringgestation |
| Incidental Oral,Intermediate-Term | NOAEL = 3.3 mg/kg/day | LOC for MOE = 100 | 1 year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased weight gain in femaledogs |
| Short-and Intermediate TermDermal (1-30 days and 1-6 months) (Residential) | None | No systemic toxicity was seen at the limit dose (1,000mg/kg/day) in the 28-day dermal toxicity study in rats | Endpoint was not selected |
| Long-Term (severalmonths-lifetime) Dermal (Residential) | Oral study NOAEL = 3.3 mg/kg/day (dermal penetration = 40%) | LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential) | 1 year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased weight gain in femaledogs |
| Short-Term (1-30 Days)Inhalation (Residential) | Oral NOAEL = 10 mg/kg/day (inhalation absorption rate = 100%) | LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential) | Rabbit developmental study LOAEL = 100 mg/kg/day based on decreased weight gain duringgestation |
| Intermediate-term (1 month- 6 months) Inhalation (Residential) | Oral NOAEL = 3.3 mg/kg/day (inhalation absorption rate = 100%) | LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential) | 1 year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased weight gain in femaledogs |
| Long-Term (severalmonths-lifetime) Inhalation (Residential) | Oral NOAEL = 3.3 mg/kg/day (inhalation absorption rate = 100%) | LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential) | 1 year chronic toxicity study - dog LOAEL = 35.5 mg/kg/day based on decreased weight gain in femaledogs |
| Cancer (oral, dermal, inhalation) | "Group D" - not classifiable as to humancarcinogenicity via relevant routes of exposure | Not applicable | There was no evidence of carcinogenicity in mice when tested upto the limited dose 7,000 ppm. There was no evidence of carcinogenicity inmale rats, but there was a statistically significant increase, both trendand pairwise, of combined hepatocellular tumors in female rats. Thepairwise increase for combined tumors was significant at p=0.03, which isnot a strong indication of a positive effect. In addition, the increase inthese tumors was within, but at the high end, of the historical controls. |
C. Exposure Assessment
1. Dietary exposure from food and feed uses . Toleranceshave been established (40 CFR 180.516) for the residues of fludioxonil, inor on a variety of raw agricultural commodities ranging from 0.01 ppm to7.0 ppm as follows: cotton gin byproducts; flax, seed; forage, fodder, andstraw of cereal grains; fruiting vegetables except cucurbits; grain,cereal; grape; grass, forage, fodder and hay, group; herbs and spices;leafy vegetables except brassica; leaves and roots of tuber vegetables;legume vegetables; non-grass animal feed; onion, dry bulb; onion, green;peanut hay; peanuts meat (hulls removed); rape forage; rape seed;safflower, seed; strawberry; sunflower, seed; undelinted cottonseed;vegetable, brassica, leafy, group; vegetable, bulb, group; vegetable,cucurbit, group; vegetable, legume, foliage; and vegetable, root and tuber,group. Risk assessments were conducted by EPA to assess dietary exposuresfrom fludioxonil in food as follows:
i. Acute Exposure . Acute dietary risk assessments areperformed for a food-use pesticide if a toxicological study has indicatedthe possibility of an effect of concern occurring as a result of a one dayor single exposure. The Dietary Exposure Evaluation Model(DEEMTM ) analysis evaluated the individual food consumption asreported by respondents in the USDA 1989-1992 nationwide ContinuingSurveys of Food Intake by Individuals (CSFII) and accumulated exposure tothe chemical for each commodity. The following assumptions were made forthe acute exposure assessments: A conservative acute analysis was performedfor the females 13-50 years old population subgroup using publishedand proposed tolerance levels, default concentration factors, and 100% CTassumptions for all commodities.
ii. Chronic Exposure . In conducting this chronic dietaryrisk assessment the Dietary Exposure Evaluation Model (DEEMTM )analysis evaluated the individual food consumption as reported byrespondents in the USDA 1989-1992 nationwide Continuing Surveys ofFood Intake by Individuals (CSFII) and accumulated exposure to the chemicalfor each commodity. The following assumptions were made for the chronicexposure assessments: A chronic analysis was performed for the U.S.population, and other population subgroups using published and proposedtolerance levels, default concentration factors, and 100% CT assumptionsfor all commodities.
iii. Cancer . In accordance with the EPA Draft Guidelinesfor Carcinogen Risk Assessment (July, 1999), the Agency classifiedfludioxonil as a "Group D" - not classifiable as to humancarcinogenicity.
2. Dietary exposure from drinking water . The Agency lackssufficient monitoring exposure data to complete a comprehensive dietaryexposure analysis and risk assessment for fludioxonil in drinking water.Because the Agency does not have comprehensive monitoring data, drinkingwater concentration estimates are made by reliance on simulation ormodeling taking into account data on the physical characteristics offludioxonil.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or thePesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), toproduce estimates of pesticide concentrations in an index reservoir. TheSCI-GROW model is used to predict pesticide concentrations in shallowgroundwater. For a screening-level assessment for surface water EPA willuse FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). TheFIRST model is a subset of the PRZM/EXAMS model that uses a specifichigh-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMSincorporate an index reservoir environment, the PRZM/EXAMS model includes apercent crop area factor as an adjustment to account for the maximumpercent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing(mixing, dilution, or treatment) of raw water for distribution as drinkingwater would likely have on the removal of pesticides from the source water.The primary use of these models by the Agency at this stage is to provide acoarse screen for sorting out pesticides for which it is highly unlikelythat drinking water concentrations would ever exceed human health levels ofconcern.
Since the models used are considered to be screening tools in the riskassessment process, the Agency does not use estimated environmentalconcentrations (EECs) from these models to quantify drinking water exposureand risk as a %RfD or %PAD. Instead drinking water levels of comparison(DWLOCs) are calculated and used as a point of comparison against the modelestimates of a pesticide's concentration in water. DWLOCs are theoreticalupper limits on a pesticide's concentration in drinking water in light oftotal aggregate exposure to a pesticide in food, and from residential uses.Since DWLOCs address total aggregate exposure to fludioxonil they arefurther discussed in the aggregate risk sections in Unit II.E. of thisdocument.
Fludioxonil is relatively immobile in soil (K oc = 991- 2440 ml/g). Laboratory adsorption-desorption studies suggest thatthe parent compound would be bound to soil and have a relatively lowpotential to leach to ground water and move in runoff to surface water.Degradates of fludioxonil are highly mobile and may enter both surface andground water. Based on their low K oc values, two of thethree photolytic degradates identified in the laboratory studies(CGA-192155 and CGA-339833) are expected to be highly mobile inthe environment. The third major photolytic degradate was found to beextremely unstable in the batch-equilibrium system; therefore, the mobilityof this degradate could not be determined.
Tier I models, FIRST and SCI-GROW, were used to derive the surface waterand ground water EECs, respectively. According to the proposed labelinformation, the maximum application rate for fludioxonil is 4 lbsai/Acre/year on turf (maximum single application rate of 0.675 lbsai/Acre). Application to turf provided the high exposure scenario;therefore, the drinking water EECs were derived from the use on turf.
Based on the [FIRST] model the estimated environmental concentrations(EECs) of fludioxonil for acute and chronic exposures are estimated to be132 parts per billion (ppb) and 49 ppb, respectively, for surface water.
Based on the SCI GROW model the estimated environmental concentration(EEC) of fludioxonil for ground water is estimated to be 0.11 ppb for boththe acute and chronic exposures.
3. From non-dietary exposure . The term "residentialexposure" is used in this document to refer to non-occupational,non-dietary exposure (e.g., for lawn and garden pest control, indoor pestcontrol, termiticides, and flea and tick control on pets).
Fludioxonil is currently registered for use on the following residentialnon-dietary sites: Based on the registered labels, fludioxonil is used as aprotectant fungicide for control of certain diseases of turfgrass andcertain foliar, stem and root diseases in ornamentals in residential andcommercial landscapes. Medallion® (EPA Reg. No. 100-769) isregistered for use on residential lawns and ornamentals. Medallion® isa wettable powder packaged in water-soluble packets, and the current labelindicates that this product is "for professional use only." Assuch, no residential handler (i.e., applicator) exposures are anticipated.
However, short- and intermediate-term dermal (adults and toddlers), andincidental ingestion (toddlers) post-application residential exposures areanticipated based on the use pattern for turfgrass applications detailed onthe Medallion® label (specifies that the product be applied at 14-dayapplication intervals, with an annual maximum rate of 2 lbs ai/A/yr, whichequates to about 3 applications at the maximum per application rate. Also,fludioxonil has half-lives ranging from 95 to 440 days in thatch sod). Aresidential post-application dermal assessment was not performed since therisks from short- and intermediate-term dermal exposure are negligible.Short- and intermediate-term dermal endpoints were not selected due to theNOAEL of 1000 mg/kg/day (highest dose tested) in the 28-day dermal toxicitystudy in rats and also since there were no developmental concerns. EPA hasconcluded that there are no significant post-application exposuresanticipated from treated landscape ornamentals. Therefore, the riskassessment was conducted using the following residential exposureassumption: post-residential lawn applications for toddler incidentalingestion.
4. Cumulative exposure to substances with a common mechanismof toxicity . Section 408(b)(2)(D)(v) requires that, when consideringwhether to establish, modify, or revoke a tolerance, the Agency consider"available information" concerning the cumulative effects of aparticular pesticide's residues and "other substances that have acommon mechanism of toxicity."
EPA does not have, at this time, available data to determine whetherfludioxonil has a common mechanism of toxicity with other substances or howto include this pesticide in a cumulative risk assessment. Unlike otherpesticides for which EPA has followed a cumulative risk approach based on acommon mechanism of toxicity, fludioxonil does not appear to produce atoxic metabolite produced by other substances. For the purposes of thistolerance action, therefore, EPA has not assumed that fludioxonil has acommon mechanism of toxicity with other substances. For informationregarding EPA's efforts to determine which chemicals have a commonmechanism of toxicity and to evaluate the cumulative effects of suchchemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general . FFDCA section 408 provides that EPA shallapply an additional tenfold margin of safety for infants and children inthe case of threshold effects to account for prenatal and postnataltoxicity and the completeness of the data base on toxicity and exposureunless EPA determines that a different margin of safety will be safe forinfants and children. Margins of safety are incorporated into EPA riskassessments either directly through use of a margin of exposure (MOE)analysis or through using uncertainty (safety) factors in calculating adose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity . The developmentaland reproductive toxicity data did not indicate increased quantitative orqualitative susceptibility of rats or rabbits to in utero and/or postnatal exposure.
3. Conclusion . There is a complete toxicity data base forfludioxonil and exposure data are complete or are estimated based on datathat reasonably accounts for potential exposures. EPA determined that the10X safety factor to protect infants and children should be reduced to 1X.The FQPA factor was reduced because the toxicology data base is complete;the developmental and reproductive toxicity data did not indicate increasedquantitative or qualitative susceptibility of rats or rabbits to in utero and/or postnatal exposure; a developmentalneurotoxicity study is not required by the Agency because there was noevidence of neurotoxicity in the current toxicity data base; and theexposure assessment approach will not underestimate the potential dietary(food and water) and non-dietary exposures for infants and childrenresulting from the use of fludioxonil.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food, drinkingwater, and residential uses, the Agency calculates DWLOCs which are used asa point of comparison against the model estimates of a pesticide'sconcentration in water (EECs). DWLOC values are not regulatory standardsfor drinking water. DWLOCs are theoretical upper limits on a pesticide'sconcentration in drinking water in light of total aggregate exposure to apesticide in food and residential uses. In calculating a DWLOC, the Agencydetermines how much of the acceptable exposure (i.e., the PAD) is availablefor exposure through drinking water [e.g., allowable chronic water exposure(mg/kg/day) = cPAD - (average food + residential exposure)]. Thisallowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking waterconsumption, and body weights. Default body weights and consumption valuesas used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg(adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default bodyweights and drinking water consumption values vary on an individual basis.This variation will be taken into account in more refined screening-leveland quantitative drinking water exposure assessments. Differentpopulations will have different DWLOCs. Generally, a DWLOC is calculatedfor each type of risk assessment used: acute, short-term,intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the calculatedDWLOCs, OPP concludes with reasonable certainty that exposures to thepesticide in drinking water (when considered along with other sources ofexposure for which OPP has reliable data) would not result in unacceptablelevels of aggregate human health risk at this time. Because OPP considersthe aggregate risk resulting from multiple exposure pathways associatedwith a pesticide's uses, levels of comparison in drinking water may vary asthose uses change. If new uses are added in the future, OPP will reassessthe potential impacts of residues of the pesticide in drinking water as apart of the aggregate risk assessment process.
1. Acute risk . Using the exposure assumptions discussedin this unit for acute exposure, the acute dietary exposure from food tofludioxonil will occupy 0.7% of the aPAD for the females 13 years andolder. Risk estimated for the general U.S. population subgroups wereincluded in the representative population (females 13-50 years old).In addition, there is potential for acute dietary exposure to fludioxonilin drinking water. After calculating DWLOCs and comparing them to the EECsfor surface and ground water, EPA does not expect the aggregate exposure toexceed 100% of the aPAD, as shown in the following Table 3:
| Population Subgroup | aPAD (mg/kg) | % aPAD (Food) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Acute DWLOC (ppb) |
|---|---|---|---|---|---|
| Females 13-50 years old | 1.0 | 0.7 | 132 | 0.11 | 30,000 |
2. Chronic risk . Using the exposure assumptions describedin this unit for chronic exposure, EPA has concluded that exposure tofludioxonil from food will utilize 6.6% of the cPAD for the U.S.population; 32% of the cPAD for all infants ( 1 yearold); 16% of the cPAD for children (1-6 years old); and 4.2% of thecPAD for females (13-50 years old). Based the use pattern, chronicresidential exposure to residues of fludioxonil is not expected. Inaddition, there is potential for chronic dietary exposure to fludioxonil indrinking water. After calculating DWLOCs and comparing them to the EECsfor surface and ground water, EPA does not expect the aggregate exposure toexceed 100% of the cPAD, as shown in the following Table 4:
| Population Subgroup | cPAD mg/kg/day | % cPAD (Food) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Chronic DWLOC (ppb) |
|---|---|---|---|---|---|
| U.S. population | 0.03 | 6.6 | 49 | 0.11 | 980 |
| All infants ( 1year old) | 0.03 | 32 | 49 | 0.11 | 200 |
| Children 1-6 years old | 0.03 | 16 | 49 | 0.11 | 250 |
| Females 13-50 years old | 0.03 | 4.2 | 49 | 0.11 | 860 |
3. Short-term risk . Short-term aggregate exposure takesinto account residential exposure plus chronic exposure to food and water(considered to be a background exposure level).
Fludioxonil is currently registered for use that could result inshort-term residential exposure and the Agency has determined that it isappropriate to aggregate chronic food and water and short-term exposuresfor fludioxonil. The label specifies that residential application isrestricted to commercial handlers. Therefore, only post-applicationexposure is expected to result from the residential uses of fludioxonil.For adults, post-application exposures may result from dermal contact withtreated turf. For toddlers, dermal and non-dietary oral post-applicationexposures may result from dermal contact with treated turf as well ashand-to-mouth transfer of residues from turfgrass. However, the Agency didnot select short- dermal endpoints for fludioxonil. Therefore, theshort-term aggregate risk for fludioxonil considers food, water, andresidential non-dietary oral exposures (for toddlers).
Using the exposure assumptions described in this unit for short-termexposures, EPA has concluded that food and residential exposures aggregatedresult in aggregate MOEs of 5,000 for the U.S. population; 780 for allinfants ( 1 year old); 820 for children (1-6 yearsold); and 7,900 for females (13-50 years old). These aggregate MOEsdo not exceed the Agency's level of concern for aggregate exposure to foodand residential uses. In addition, short-term DWLOCs were calculated andcompared to the EECs for chronic exposure of fludioxonil in ground andsurface water. After calculating DWLOCs and comparing them to the EECs forsurface and ground water, EPA does not expect short-term aggregate exposureto exceed the Agency's level of concern, as shown in the following Table 5:
| Population Subgroup | Aggregate MOE (Food + Residential) | Aggregate Level of Concern (LOC) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Short-Term DWLOC (ppb) |
|---|---|---|---|---|---|
| U.S. population | 5,000 | 100 | 49 | 0.11 | 3,400 |
| All infants ( 1year old) | 450 | 100 | 49 | 0.11 | 780 |
| Children (1-6 years old) | 570 | 100 | 49 | 0.11 | 820 |
| Females (13-50 years old) | 7,900 | 100 | 49 | 0.11 | 3,000 |
4. Intermediate-term risk . Intermediate-term aggregateexposure takes into account residential exposure plus chronic exposure tofood and water (considered to be a background exposure level). Fludioxonilis currently registered for use(s) that could result in intermediate-termresidential exposure and the Agency has determined that it is appropriateto aggregate chronic food and water and intermediate-term exposures forfludioxonil. The label specifies that the residential application offludioxonil is restricted to commercial handlers. Therefore, onlypost-application exposure is expected to result from the residential usesof fludioxonil. For adults, post-application exposures may result fromdermal contact with treated turf. For toddlers, dermal and non-dietaryoral post-application exposures may result from dermal contact with treatedturf as well as hand-to-mouth transfer of residues from turfgrass.However, the data did not indicate any adverse effects as a result ofintermediate-term dermal exposure. Therefore, the intermediate-termaggregate risk for fludioxonil considers food, water, and residentialnon-dietary oral exposures (for toddlers).
Using the exposure assumptions described in this unit forintermediate-term exposures, EPA has concluded that food and residentialexposures aggregated result in aggregate MOEs of 1,700 for the U.S.population; 190 for all infants ( 1 year old); 270 for(children 1-6 years old); and 2,600 for females (13-50 yearsold). These aggregate MOEs do not exceed the Agency's level of concern foraggregate exposure to food and residential uses. In addition,intermediate-term DWLOCs were calculated and compared to the EECs forchronic exposure of fludioxonil in ground and surface water. Aftercalculating DWLOCs and comparing them to the EECs for surface and groundwater, EPA does not expect intermediate-term aggregate exposure to exceedthe Agency's level of concern, as shown in the following Table 6:
| Population Subgroup | Aggregate MOE (Food + Residential) | Aggregate Level of Concern (LOC) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Intermediate-Term DWLOC (ppb) |
|---|---|---|---|---|---|
| U.S. population | 1,700 | 100 | 49 | 0.11 | 980 |
| All infants ( 1year old) | 190 | 100 | 49 | 0.11 | 130 |
| Children (1-6 years old) | 270 | 100 | 49 | 0.11 | 180 |
| Females (13-50 years old) | 2,600 | 100 | 49 | 0.11 | 860 |
5. Aggregate cancer risk for U.S. population . The Agencyclassified fludioxonil as (a "Group D") not classifiable as tohuman carcinogenicity based on the lack of evidence in mice when tested upto the limited dose 7,000 ppm. Additionally, there was no evidence ofcarcinogenicity in male rats, despite the statistically significantincrease in both trend and pairwise of combined hepatocellular tumors infemale rats. The pairwise increase for combined tumors was significant atp=0.03, which is not a strong indication of a positive effect.Furthermore, the increase in these tumors was within, but at the high end,of the historical controls.
6. Determination of safety . Based on these riskassessments, EPA concludes that there is a reasonable certainty that noharm will result to the general population, and to infants and childrenfrom aggregate exposure to fludioxonil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Based on the concurrent recovery values obtained from the crop fieldtrial analyses and the previous successful petition method validation (PMV)conducted by EPA's Analytical Chemistry Branch (ACB), EPA concludes thatHPLC method AG-597B is adequate to enforce the recommended tolerancelevels for residues of fludioxonil per se in the bushberrysubgroup, the caneberry subgroup, fruit, stone, group, juneberry,lingonberry, pistachio, salal, and watercress.
Adequate enforcement methodology (example-gas chromotography) isavailable to enforce the tolerance expression. The method may be requestedfrom: Francis Griffith, Analytical Chemistry Branch, Environmental ScienceCenter, Environmental Protection Agency, 701 Mapes Road, Fort George G.Mead, MD 20755-5350; telephone number (410) 305-2905; e-mailaddress: griffith.francis@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits (MRLs)for residues of fludioxonil in/on the bushberry subgroup, the caneberrysubgroup, fruit, stone, group, juneberry, lingonberry, pistachio, salal,and watercress. Therefore, compatibility issues are not relevant to theproposed tolerances.
V. Conclusion
Therefore, tolerances are established for residues of fludioxonil,(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1 H -pyrrole-3-carbonitrile), in or on bushberry subgroup at 2.0ppm, caneberry subgroup at 5.0 ppm, fruit, stone, group at 5.0 ppm,juneberry at 2.0 ppm, lingonberry at 2.0 ppm, pistachio at 0.10 ppm, salalat 2.0 ppm, and watercress at 7.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any personmay file an objection to any aspect of this regulation and may also requesta hearing on those objections. The EPA procedural regulations which governthe submission of objections and requests for hearings appear in 40 CFRpart 178. Although the procedures in those regulations require somemodification to reflect the amendments made to the FFDCA by the FQPA of1996, EPA will continue to use those procedures, with appropriateadjustments, until the necessary modifications can be made. The newsection 408(g) provides essentially the same process for persons to"object" to a regulation for an exemption from the requirementof a tolerance issued by EPA under new section 408(d), as was provided inthe old FFDCA sections 408 and 409. However, the period for filingobjections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation inaccordance with the instructions provided in this unit and in 40 CFR part178. To ensure proper receipt by EPA, you must identify docket ID numberOPP-2002-0158 in the subject line on the first page of yoursubmission. All requests must be in writing, and must be mailed ordelivered to the Hearing Clerk on or before October 1, 2002.
1. Filing the request . Your objection must specify thespecific provisions in the regulation that you object to, and the groundsfor the objections (40 CFR 178.25). If a hearing is requested, theobjections must include a statement of the factual issues(s) on which ahearing is requested, the requestor's contentions on such issues, and asummary of any evidence relied upon by the objector (40 CFR 178.27).Information submitted in connection with an objection or hearing requestmay be claimed confidential by marking any part or all of that informationas CBI. Information so marked will not be disclosed except in accordancewith procedures set forth in 40 CFR part 2. A copy of the information thatdoes not contain CBI must be submitted for inclusion in the public record.Information not marked confidential may be disclosed publicly by EPAwithout prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,DC 20460. You may also deliver your request to the Office of the HearingClerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460.The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Mondaythrough Friday, excluding legal holidays. The telephone number for theOffice of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment . If you file an objection orrequest a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i)or request a waiver of that fee pursuant to 40 CFR 180.33(m). You mustmail the fee to: EPA Headquarters Accounting Operations Branch, Office ofPesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Pleaseidentify the fee submission by labeling it "Tolerance PetitionFees."
EPA is authorized to waive any fee requirement "when in thejudgement of the Administrator such a waiver or refund is equitable and notcontrary to the purpose of this subsection." For additionalinformation regarding the waiver of these fees, you may contact JamesTompkins by phone at (703) 305-5697, by e-mail attompkins.jim@epa.gov, or by mailing a request for information to Mr.Tompkins at Registration Division (7505C), Office of Pesticide Programs,Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,DC 20460.
If you would like to request a waiver of the tolerance objection fees,you must mail your request for such a waiver to: James Hollins, InformationResources and Services Division (7502C), Office of Pesticide Programs,Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,DC 20460.
3. Copies for the Docket . In addition to filing anobjection or hearing request with the Hearing Clerk as described in UnitVI.A., you should also send a copy of your request to the PIRIB for itsinclusion in the official record that is described in Unit I.B.2. Mailyour copies, identified by docket ID number OPP-2002-0158, to:Public Information and Records Integrity Branch, Information Resources andServices Division (7502C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Inperson or by courier, bring a copy to the location of the PIRIB describedin Unit I.B.2. You may also send an electronic copy of your request viae-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoidthe use of special characters and any form of encryption. Copies ofelectronic objections and hearing requests will also be accepted on disksin WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI inyour electronic copy. You may also submit an electronic copy of yourrequest at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determinesthat the material submitted shows the following: There is a genuine andsubstantial issue of fact; there is a reasonable possibility that availableevidence identified by the requestor would, if established resolve one ormore of such issues in favor of the requestor, taking into accountuncontested claims or facts to the contrary; and resolution of the factualissues(s) in the manner sought by the requestor would be adequate tojustify the action requested (40 CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d) inresponse to a petition submitted to the Agency. The Office of Managementand Budget (OMB) has exempted these types of actions from review underExecutive Order 12866, entitled Regulatory Planning andReview (58 FR 51735, October 4, 1993). Because this rule has beenexempted from review under Executive Order 12866 due to its lack ofsignificance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect EnergySupply, Distribution, or Use (66 FR 28355, May 22, 2001). This finalrule does not contain any information collections subject to OMB approvalunder the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 etseq. , or impose any enforceable duty or contain any unfunded mandate asdescribed under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)(Public Law 104-4). Nor does it require any special considerationsunder Executive Order 12898, entitled Federal Actions to AddressEnvironmental Justice in Minority Populations and Low-IncomePopulations (59 FR 7629, February 16, 1994); or OMB review or anyAgency action under Executive Order 13045, entitled Protection ofChildren from Environmental Health Risks and Safety Risks (62 FR 19885,April 23, 1997). This action does not involve any technical standards thatwould require Agency consideration of voluntary consensus standardspursuant to section 12(d) of the National Technology Transfer andAdvancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)(15 U.S.C. 272 note). Since tolerances and exemptions that are establishedon the basis of a petition under FFDCA section 408(d), such as thetolerance in this final rule, do not require the issuance of a proposedrule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C.601 et seq. ) do not apply. In addition, the Agency hasdetermined that this action will not have a substantial direct effect onStates, on the relationship between the national government and the States,or on the distribution of power and responsibilities among the variouslevels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132requires EPA to develop an accountable process to ensure "meaningfuland timely input by State and local officials in the development ofregulatory policies that have federalism implications.""Policies that have federalism implications" is defined in theExecutive order to include regulations that have "substantial directeffects on the States, on the relationship between the national governmentand the States, or on the distribution of power and responsibilities amongthe various levels of government." This final rule directlyregulates growers, food processors, food handlers and food retailers, notStates. This action does not alter the relationships or distribution ofpower and responsibilities established by Congress in the preemptionprovisions of FFDCA section 408(n)(4). For these same reasons, the Agencyhas determined that this rule does not have any "tribalimplications" as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65FR 67249, November 6, 2000). Executive Order 13175, requires EPA todevelop an accountable process to ensure "meaningful and timely inputby tribal officials in the development of regulatory policies that havetribal implications." "Policies that have tribalimplications" is defined in the Executive order to includeregulations that have "substantial direct effects on one or moreIndian tribes, on the relationship between the Federal Government and theIndian tribes, or on the distribution of power and responsibilities betweenthe Federal Government and Indian tribes." This rule will not havesubstantial direct effects on tribal governments, on the relationshipbetween the Federal Government and Indian tribes, or on the distribution ofpower and responsibilities between the Federal Government and Indiantribes, as specified in Executive Order 13175. Thus, Executive Order 13175does not apply to this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq. , asadded by the Small Business Regulatory Enforcement Fairness Act of 1996,generally provides that before a rule may take effect, the agencypromulgating the rule must submit a rule report, which includes a copy ofthe rule, to each House of the Congress and to the Comptroller General ofthe United States. EPA will submit a report containing this rule and otherrequired information to the U.S. Senate, the U.S. House of Representatives,and the Comptroller General of the United States prior to publication ofthis final rule in the Federal Register . This final rule isnot a "major rule" as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,Agricultural commodities, Pesticides and pests, Reporting and recordkeepingrequirements.
Dated: July 18, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of PesticidePrograms.
Therefore, 40 CFR part 180 is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read asfollows:
Authority:
21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.516 is amended by alphabetically adding commoditiesto the table in paragraph (a) to read as follows:
§ 180.516 Fludioxonil; tolerances forresidues.
(a) ***
| Commodity | Parts per million |
|---|---|
| Bushberry subgroup | 2.0 |
| Caneberry subgroup | 5.0 |
| ***** | |
| Fruit, stone, group | 5.0 |
| ***** | |
| Juneberry | 2.0 |
| ***** | |
| Lingonberry | 2.0 |
| ***** | |
| Pistachio | 0.10 |
| ***** | |
| Salal | 2.0 |
| ***** | |
| Watercress | 7.0 |
[FR Doc. 02-19442 Filed 8-1-02; 8:45 am]
BILLING CODE 6560-50-S