69 FR 72 pgs. 19767-19774 - Boscalid; Pesticide Tolerance
Type: RULEVolume: 69Number: 72Pages: 19767 - 19774
Docket number: [OPP-2004-0075; FRL-7353-1]
FR document: [FR Doc. 04-8316 Filed 4-13-04; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0075; FRL-7353-1]
Boscalid; Pesticide Tolerance
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes a tolerance forresidues of boscalid, 3-pyridinecarboxamide,2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) in or on certain commodies andestablishes a tolerance for the residues of boscalid in or on pome fruitcrop group, group 11 at 3.0 ppm, apple pomace, wet at 10.0 ppm, hops cones,dried at 35.0 ppm, soybean, vegetable at 2.0 ppm, soybean seed at 0.1 ppm,soybean hulls at 0.2 ppm and aspirated grain fractions at 3.0 ppm. BASFCorporation requested this tolerance under the Federal Food, Drug, andCosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996(FQPA).
DATES:
This regulation is effective April 14, 2004. Objections and requests for hearings, identified by docket ID number OPP-2004-0075, must be received on or before June 14, 2004.
ADDRESSES:
Written objections and hearing requests maybe submitted electronically, by mail, or through hand delivery/courier.Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION .
FOR FURTHER INFORMATION CONTACT:
CynthiaGiles-Parker, Registration Division (7505C), Office of Pesticide Programs,Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC20460-0001; telephone number: (703) 305-7740; e-mail address: giles-parker.cynthia@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), e.g., agricultural workers;greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS 112), e.g., cattle ranchers andfarmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311), e.g., agricultural workers;farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticideapplicators.
• Pesticide manufacturing (NAICS 32532), e.g., agriculturalworkers; commercial applicators; farmers; greenhouse, nursery, andfloriculture workers; residential users.
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.The North 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 identification (ID) numberOPP-2004-0075. The official public docket consists of thedocuments specifically referenced in this action, any public commentsreceived, and other information related to this action. Although a part ofthe official docket, the public docket does not include ConfidentialBusiness Information (CBI) or other information whose disclosure isrestricted by statute. The official public docket is the collection ofmaterials that is available for public viewing at the Public Informationand Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921Jefferson Davis Hwy., Arlington, VA. This docket facility is open from8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. Thedocket 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/ .A frequently updated electronic version of 40 CFR part 180 is available at http://www.gpoaccess.gov/ecfr/ , a beta site currently underdevelopment. To access the OPPTS Harmonized Guidelines referenced in thisdocument, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm /.
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.
II. Background and Statutory Findings
In the Federal Register of November 6, 2003 (68 FR 215)(FRL-7321-1), EPA issued a notice pursuant to section 408(d)(3)of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticidepetitions (PP 2F6434 and 3F6580) by BASF Corporation, P.O. Box 13528,Research Triangle Park, North Carolina 27708-2000. That noticeincluded a summary of the petitions prepared by BASF Corporation, theregistrant. There were no comments received in response to the notice offiling.
The petition requested that 40 CFR 180.589 be amended by establishing atolerance for residues of the fungicide boscalid in or on pome fruit cropgroup, group 11 at 3.0 ppm, apple pomace, wet at 20.0 ppm, hops cones,dried at 35.0 ppm, soybean, vegetable at 2.2 ppm, soybean seed at 0.1 ppm,soybean hulls at 0.2 ppm and soybean aspirated grain fractions at 2.5 ppm.
Section 408(b)(2)(A)(i) of 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) of FFDCA defines "safe" to mean that"there is a reasonable certainty that no harm will result from aggregateexposure to the pesticide chemical residue, including all anticipateddietary exposures and all other exposures for which there is reliableinformation." This includes exposure through drinking water and inresidential settings, but does not include occupational exposure. Section408(b)(2)(C) of FFDCA requires EPA to give special consideration toexposure of infants and children to the pesticide chemical residue inestablishing a tolerance and to "ensure that there is a reasonablecertainty that no harm will result to infants and children from aggregateexposure to the pesticide chemical residue. * * *"
EPA performs a number of analyses to determine the risks from aggregateexposure to pesticide residues. For further discussion of the regulatoryrequirements of section 408 of FFDCA 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) of FFDCA, EPA has reviewed theavailable scientific data and other relevant information in support of thisaction. EPA has sufficient data to assess the hazards of and to make adetermination on aggregate exposure, consistent with section 408(b)(2) ofFFDCA, for a tolerance for residues of boscalid. EPA's assessment ofexposures and risks associated with establishing the tolerance follows.This assessment involves adding tolerances for commodities of pome fruitcrop group, group 11 at 3.0 ppm, apple pomace, wet at 10.0 ppm, hops cones,dried at 35.0 ppm, soybean, vegetable at 2.0 ppm, soybean seed at 0.1 ppm,soybean hulls at 0.2 ppm and soybean aspirated grain fractions at 3.0 ppm.
A. Toxicological Profile
EPA previously has evaluated the available toxicity data and consideredits validity, completeness, and reliability as well as the relationship ofthe results 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 boscalid as well as theno-observed-adverse-effect-level (NOAEL) and thelowest-observed-adverse-effect-level (LOAEL) from the toxicity studiesreviewed are discussed in the Federal Register of July 30,2003 (68 FR 44640) (FRL-7319-6). No new information which wouldchange the toxicological profile has been submitted or reviewed since theanalysis.
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 intraspeciesdifferences.
Three other types of safety or uncertainty factors may be used:"Traditional uncertainty factors;" the "special FQPAsafety factor;" and the "default FQPA safety factor." Bythe term "traditional uncertainty factor," EPA is referring tothose additional uncertainty factors used prior to FQPA passage to accountfor database deficiencies. These traditional uncertainty factors have beenincorporated by the FQPA into the additional safety factor for theprotection of infants and children. The term "special FQPA safetyfactor" refers to those safety factors that are deemed necessary forthe protection of infants and children primarily as a result of the FQPA.The "default FQPA safety factor" is the additional 10X safetyfactor that is mandated by the statute unless it is decided that there arereliable data to choose a different additional factor (potentially atraditional uncertainty factor or a special FQPA safety factor).
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 an UF of 100 to account forinterspecies and intraspecies differences and any traditional uncertaintyfactors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safetyfactor or the default FQPA safety factor is used, this additional factor isapplied to the RfD by dividing the RfD by such additional factor. The acuteor chronic Population Adjusted Dose (aPAD or cPAD) is a modification of theRfD to accommodate this type of 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 (10× 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 theLOC.
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). An example of how sucha probability risk is expressed would be to describe the risk as one in onehundred thousand (1 × 10 - 5 ), one in a million (1 × 10 - 6 ), or one in ten million (1 × 10 - 7 ). Under certain specific circumstances, MOEcalculations will be used for the carcinogenic risk assessment. In thisnon-linear approach, a "point of departure" is identified belowwhich carcinogenic effects are not expected. The point of departure istypically a NOAEL based on an endpoint related to cancer effects though itmay be a different value derived from the dose response curve. To estimaterisk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.
A summary of the toxicological endpoints for boscalid used for humanrisk assessment is discussed in Unit III.B. of the final rule published inthe Federal Register of July 30, 2003 (68 FR 44640)(FRL-7319-6).
C. Exposure Assessment
1. Dietary exposure from food and feed uses . Toleranceshave been established (40 CFR 180.589) for the residues of boscalid, in oron a variety of raw agricultural commodities. Risk assessments wereconducted by EPA to assess dietary exposures from boscalid in food asfollows:
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. There were no toxic effects attributable to a singledose. An endpoint of concern was not identified to quantitate acute dietaryrisk to the general population, including infants and children, or to thesubpopulation females 13-50 years old. Therefore, there is no acutereference dose (aRfD) or acute population-adjusted dose (aPAD).
ii. Chronic exposure . In conducting the chronic dietaryrisk assessment EPA used the Dietary Exposure Evaluation Model softwarewith the Food Commodity Intake Database (DEEM-FCIDTM ), whichincorporates food consumption data as reported by respondents in the USDA1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake byIndividuals (CSFII), and accumulated exposure to the chemical for eachcommodity. The following assumptions were made for the chronic exposureassessments:
The chronic dietary exposure analysis was performed using two separatemodels: DEEM- FCIDTM and LifelineTM . The analysis wasbased on tolerance-level residues (in some cases modified byDEEMTM (Version 7.81) default processing factors), and assume 100%crop treated. In both cases, the risk estimates are well below theAgency's level of concern for the general U.S. population and allpopulation subgroups. The results of the DEEM-FCIDTM andLifelineTM analyses are comparable. The most highly exposedpopulation subgroup from DEEMTM is children 1-2 years, which hasan exposure estimate of 0.057 mg/kg/day, and utilizes 26% of the cPAD. Themost highly exposed population subgroup from LifelineTM is alsochildren 1-2 years, which has an exposure estimate of 0.053 mg/kg/day, andutilizes 24% of the cPAD.
| Population Subgroup | Acute Analysis | DEEM: Chronic Analysis | Dietary Exposure (mg/kg/day) | % cPAD | Lifeline: Chronic Analysis | Mean Exposure (mg/kg/day) | % cPAD |
|---|---|---|---|---|---|---|---|
| General U.S. Population | Not applicable: No acute dietary endpoint | 0.014597 | 6.7 | 0.01378 | 6.3 | ||
| All Infants ( 1 year old) | Not applicable: No acute dietary endpoint | 0.03509 | 16 | 0.03421 | 16 | ||
| Children 1-2 years old | Not applicable: No acute dietary endpoint | 0.056809 | 26 | 0.0525 | 24 | ||
| Children 3-5 years old | Not applicable: No acute dietary endpoint | 0.039112 | 18 | 0.03983 | 18 | ||
| Children 6-12 years old | Not applicable: No acute dietary endpoint | 0.019162 | 8.8 | 0.01806 | 8.3 | ||
| Youth 13-19 years old | Not applicable: No acute dietary endpoint | 0.01046 | 4.8 | 0.00975 | 4.5 | ||
| Adults 20-49 years old | Not applicable: No acute dietary endpoint | 0.010351 | 4.7 | 0.01094 | 5 | ||
| Adults 50+ years old | Not applicable: No acute dietary endpoint | 0.010935 | 5 | 0.01121 | 5.1 | ||
| Females 13-49 years old | Not applicable: No acute dietary endpoint | 0.010349 | 4.7 | 0.01191 | 5.5 |
iii. Cancer . The Agency determined that boscalid producedsuggestive evidence of carcinogenicity, but not sufficient to assess humancarcinogenic potential. This cancer classification was based on thefollowing weight of evidence considerations. First, in male Wistar rats,there was a significant trend (but not pairwise comparison) for thecombined thyroid adenomas and carcinomas. This trend was driven by theincrease in adenomas. Second, in the female rats, there was only aborderline significant trend for thyroid adenomas (there were nocarcinomas). Third, the mouse study was negative as were all of themutagenic tests. Consistent with this weak evidence of carcinogeniceffects, the Agency concluded that a dose-response assessment for cancer(either linear low-dose extrapolation or margin of exposure calculation)was not needed because boscalid was not expected to pose a carcinogenicrisk.
2. Dietary exposure from drinking water . The Agency lackssufficient monitoring exposure data to complete a comprehensive dietaryexposure analysis and risk assessment for boscalid 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 ofboscalid.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or thePesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS),to produce estimates of pesticide concentrations in an index reservoir. TheSCI-GROW model is used to predict pesticide concentrations in shallowground water. 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. Both FIRST and PRZM/EXAMSincorporate an index reservoir environment, and both models include 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 ascreen for sorting out pesticides for which it is unlikely that drinkingwater concentrations would exceed human health levels of concern.
Since the models used are considered to be screening tools in the riskassessment process, the Agency does not use estimated environmentalconcentrations (EECs), which are the model estimates of a pesticide'sconcentration in water. EECs derived from these models are used toquantify drinking water exposure and risk as a %RfD or %PAD. Insteaddrinking water levels of comparison (DWLOCs) are calculated and used as apoint of comparison against the model estimates of a pesticide'sconcentration in water. DWLOCs are theoretical upper limits on apesticide's concentration in drinking water in light of total aggregateexposure to a pesticide in food, and from residential uses. Since DWLOCsaddress total aggregate exposure to boscalid they are further discussed inthe aggregate risk sections in Unit I.
Based on the FIRST and SCI-GROW models, the EECs of boscalid for acuteand chronic exposures for surface water are estimated to be 87.53 parts perbillion (ppb) and 25.77 ppb, respectively, and the ground water EEC is0.63 ppb. Since the completion of the previous risk assessment forboscalid, the aerobic soil metabolism half lives used as input parametersfor the FIRST and SCI-GROW models have been revised.
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).
No new residental uses of boscalid are currently being registered thatwould increase non-dietary exposure. A non-occupational dermalpost-application exposure/risk assessment for individuals golfing andharvesting fruit at "U-pick" farms and orchards was conductedin the previous occupational and residential exposure (ORE) assessment.
4. Cumulative effects from substances with a common mechanismof toxicity . Section 408(b)(2)(D)(v) of FFDCA requires that, whenconsidering whether to establish, modify, or revoke a tolerance, the Agencyconsider "available information" concerning the cumulativeeffects of a particular pesticide's residues and "other substancesthat have a common mechanism of toxicity."
Unlike other pesticides for which EPA has followed a cumulative riskapproach based on a common mechanism of toxicity, EPA has not made a commonmechanism of toxicity finding as to boscalid and any other substances andboscalid does not appear to produce a toxic metabolite produced by othersubstances. For the purposes of this tolerance action, therefore, EPA hasnot assumed that boscalid has a common mechanism of toxicity with othersubstances. For information regarding EPA's efforts to determine whichchemicals have a common mechanism of toxicity and to evaluate thecumulative effects of such chemicals, see the policy statements released byEPA's OPP concerning common mechanism determinations and procedures forcumulating effects from substances found to have a common mechanism onEPA's web site at http://www.epa.gov/pesticides/cumulative/ .
D. Safety Factor for Infants and Children
1. In general . Section 408 of FFDCA provides that EPAshall apply an additional 10-fold margin of safety for infants and childrenin the case of threshold effects to account for prenatal and postnataltoxicity and the completeness of the data base on toxicity and exposureunless EPA determines based on reliable data that a different margin ofsafety will be safe for infants and children. Margins of safety areincorporated into EPA risk assessments either directly through use of anMOE analysis or through using uncertainty (safety) factors in calculating adose level that poses no appreciable risk to humans. In applying thisprovision, EPA either retains the default value of 10X when reliable datado not support the choice of a different factor, or, if reliable data areavailable, EPA uses a different additional safety factor value based on theuse of traditional uncertainty factors and/or special FQPA safety factors,as appropriate.
2. Prenatal and postnatal sensitivity . A completediscussion of the prenatal/postnatal sensitivity study was recentlydiscussed in our final rule dated July 30, 2003 (68 FR 44640)(FRL-7319-6). No new information has been received to changethis information. The Agency does restate the basic conclusion from thatanalysis. The Agency concluded that there are no residual uncertainties forpre- and post-natal toxicity as the degree of concern is low for thesusceptibility seen in the above studies, and the dose and endpointsselected for the overall risk assessments will address the concerns for thebody weight effects seen in the offspring. Although the dose selected foroverall risk assessments (21.8 mg/kg/day) is higher than the NOAELs in the2-generation reproduction study (10.1 mg/kg/day) and the developmentalneurotoxicity study (14 mg/kg/day), these differences are considered to bean artifact of the dose selection process in these studies. For example,there is a 10-fold difference between the LOAEL (106.8 mg/kg/ day) and theNOAEL (10.1 mg/kg/day) in the 2-generation reproduction study. A similarpattern was seen with regard to the developmental neurotoxicity study,where there is also a 10-fold difference between the LOAEL (147 mg/kg/day)and the NOAEL (14 mg/kg/day). There is only a 2-3 fold difference betweenthe LOAEL (57 mg/kg/day) and the NOAEL (21.8 mg/kg/day) in the criticalstudy used for risk assessment. Because the gap between the NOAEL and LOAELin the 2-generation reproduction and developmental neurotoxicity studieswas large and the effects at the LOAELs were minimal, the trueno-observed-adverse- effect-level was probably considerably higher.Therefore, the selection of the NOAEL of 21.8 mg/kg/day from the 1-year dogstudy is conservative and appropriate for the overall risk assessments. Inaddition, the endpoints for risk assessment are based on thyroid effectsseen in multiple species (mice, rats and dogs) and after various exposuredurations (subchronic and chronic exposures) which were not observed at theLOAELs in either the 2-generation reproduction or the developmentalneurotoxicity studies. Based on these data, the Agency concluded that thereare no residual uncertainties for pre- and post-natal toxicity.
3. Conclusion . There is a complete toxicity data basefor boscalid and exposure data are complete or are estimated based on datathat reasonably accounts for potential exposures. The submitted fieldtrials performed on hops, pome fruit, and soybeans are adequate to supportthe recommended tolerances: Hops cones, dried (35 ppm), pome fruit (3.0ppm), apple pomace, wet (10 ppm), soybean vegetable (2.0 ppm), soybean seed(0.1 ppm), soybean hulls (0.2 ppm), soybean aspirated grain fractions (3.0ppm). There is no evidence of susceptibility following inutero exposure to rats and there is low concern and no residualuncertainties in the developmental toxicity study in rabbits, in the2-generation reproduction study or in the developmental neurotoxicity studyafter establishing toxicity endpoints and traditional uncertainty factorsto be used in the risk assessment. Based on these data and conclusions, EPAreduced the FQPA safety factor to 1X.
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 EECs. DWLOC values are not regulatorystandards for drinking water. DWLOCs are theoretical upper limits on apesticide's concentration in drinking water in light of total aggregateexposure to a pesticide in food and residential uses. In calculating aDWLOC, the Agency determines how much of the acceptable exposure (i.e., thePAD) is available for exposure through drinking water [e.g., allowablechronic water exposure (mg/kg/day) = cPAD - (average food + residentialexposure)]. This allowable exposure through drinking water is used tocalculate 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 EPA's Office of Water are used to calculate DWLOCs: 2 liter(L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child).Default body weights and drinking water consumption values vary on anindividual basis. This variation will be taken into account in more refinedscreening-level and quantitative drinking water exposure assessments.Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term,intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than thecalculated DWLOCs, OPP concludes with reasonable certainty that exposuresto the pesticide in drinking water (when considered along with othersources of exposure for which OPP has reliable data) would not result inunacceptable levels of aggregate human health risk at this time. BecauseOPP considers the aggregate risk resulting from multiple exposure pathwaysassociated with a pesticide's uses, levels of comparison in drinking watermay vary as those uses change. If new uses are added in the future, OPPwill reassess the potential impacts of residues of the pesticide indrinking water as a part of the aggregate risk assessment process.
1. Acute risk . As there were no toxic effects attributableto a single dose, an endpoint of concern was not identified to quantitateacute-dietary risk to the general population or to the subpopulationfemales 13-50 years old. Therefore, there is no acute reference dose(aRfD) or acute population-adjusted dose (aPAD) for the general populationor females 13-50 years old. No acute risk is expected from exposure toboscalid.
2. Chronic risk . The chronic dietary exposure analysiswas based on tolerance-level residues (in some cases modified by DEEM(Version 7.81) default processing factors), and assume 100% crop treated.Even with these highly conservative assumptions, the risk estimates arewell below the Agency's level of concern. The most highly exposedpopulation subgroup from DEEMTM is children 1-2 years, which hasan exposure estimate of 0.057 mg/kg/day, and utilizes 26% of the cPAD. Themost highly exposed population subgroup from LifelineTM is alsochildren 1-2 years, which has an exposure estimate of 0.053 mg/kg/day, andutilizes 24% of the cPAD.
| Senario/Population Subgroup | cPAD mg/kg/day | Chronic Food Exposure, mg/kg/day | Maximum Chronic Water Exposure1 , mg/kg/day | Ground Water EDWC2 , (ppb) | Surface Water EDWC2 , (ppb) | Chronic DWLOC3 (ppb) |
|---|---|---|---|---|---|---|
| General U.S. Population | 0.218 | 0.014597 | 0.2034 | 0.63 | 26 | 7,100 |
| All infants( 1 year old) | 0.218 | 0.03509 | 0.18291 | 0.63 | 26 | 1,800 |
| Children 1-2 years old | 0.218 | 0.056809 | 0.16119 | 0.63 | 26 | 1,600 |
| Females 13-49 years old | 0.218 | 0.010349 | 0.20765 | 0.63 | 26 | 6,200 |
| 1 Maximum chronic water exposure (mg/kg/day) = cPAD(mg/kg/day) - chronic food exposure from dietary exposure analysis(mg/kg/day). | ||||||
| 2 EDWCs from EFED studies. | ||||||
| 3 Chronic DWLOCs were calculated as follows: | ||||||
| Chronic DWLOC(µg/L) = [maximum chronic water exposure (mg/kg/day)x body weight (kg)]/[water consumption (L) x 10 - 3 mg/µg] | ||||||
3. Short-term risk . The short-term aggregate riskassessment takes into account average exposure estimates from dietaryconsumption of boscalid (food and drinking water) and non-occupational uses(golf courses). Postapplication exposures from the proposed use on golfcourses is considered short- term, and applies to adults and youth.Therefore, a short-term aggregate risk assessment was conducted. Since allendpoints are from the same study, exposures from different routes can beaggregated. Table 3 summarizes the results. The MOE from food andnon-occupational uses is 1400, and the calculated short-term DWLOC is 6,100ppb. Compared to the surface and ground water EDWCs, the DWLOCs areconsiderably greater. Therefore, short-term aggregate risk does not exceedHED=s level of concern.
The MOE and DWLOC are considered to be representative for youth becauseyouth and adults possess similar body surface area to weight ratios, andbecause the dietary exposure for youth (13-19 years old) is less than thatof the general U.S. population.
| Population | Short-Term Scenario | NOAEL mg/kg/day | Target MOE1 | Max Exposure2 mg/kg/day | Average Food Exposure mg/kg/day | Residential Exposure3 mg/kg/day | Aggregate MOE4 (food and residential) | Max Water Exposure5 mg/kg/day | Ground Water EDWC6 (units) | Surface Water EDWC6 (units) | Short-Term DWLOC7,8 (µg/L) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S. | 21.8 | 100 | 0.218 | 0.014597 | 0.0008 | 1400 | 0.2026 | 0.63 | 25.77 | 6,100 | |
| 1 The target MOE for dermal is 100. | |||||||||||
| 2 Maximum Exposure (mg/kg/day) = NOAEL/Target MOE | |||||||||||
| 3 Residential Exposure = Dermal exposure from golf courseonly | |||||||||||
| 4 Aggregate MOE = [NOAEL ) (Avg Food Exposure +Residential Exposure)] | |||||||||||
| 5 Maximum Water Exposure (mg/kg/day) = Target MaximumExposure - (Food Exposure + Residential Exposure) | |||||||||||
| 6 The crop producing the highest level was used. | |||||||||||
| 7 DWLOC(Fg/L) = [maximum water exposure (mg/kg/day) x bodyweight (kg)]/ [water consumption (L) x 10 - 3 mg/µg] | |||||||||||
| 8 Adult female body weight was used, which covers adult malerisk. The dietary exposure for the U. S. population is higher than that ofgroups having residential (golf) exposure (i.e., adults, youth 13-19). | |||||||||||
4. Aggregate cancer risk for U.S. population . For thereason stated above, EPA does not expect boscalid to pose a cancerrisk.
5. 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 boscalid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example-gas chromotography) isavailable to enforce the tolerance expression. The method may be requestedfrom: Chief, Analytical Chemistry Branch, Environmental Science Center, 701Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410)305-2905; e-mail address: residuemethods@epa.gov .
B. International Residue Limits
Boscalid is a relatively new fungicide. There are currently no pendingor established Codex maximum residue limits (MRLs) for boscalid. There arealso no Mexican MRLs. The previous risk assessment was performed as ajoint review with PMRA/Canada. The tolerances were harmonized with respectto the residue of concern and tolerance level.
V. Conclusion
Therefore, the tolerances are established for residues of boscalid inor on apple pomace, aspirated grain fractions at 3.0 ppm, wet at 10.0 ppm,hops cones, dried at 35.0 ppm, pome fruit crop group, group 11 at 3.0 ppm,soybean hulls at 0.2 ppm, soybean seed at 0.1 ppm, and soybean, vegetableat 2.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may filean objection to any aspect of this regulation and may also request ahearing 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 FFDCA by FQPA, EPA willcontinue to use those procedures, with appropriate adjustments, until thenecessary modifications can be made. The new section 408(g) of FFDCAprovides essentially the same process for persons to "object"to a regulation for an exemption from the requirement of a tolerance issuedby EPA under new section 408(d) of FFDCA, as was provided in the oldsections 408 and 409 of FFDCA. However, the period for filing objectionsis now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request aHearing?
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-2004-0075 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 June 14, 2004.
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 (1900C),Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,DC 20460-0001. You may also deliver your request to the Office ofthe Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson DavisHwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m.to 4 p.m., Monday through Friday, excluding legal holidays. The telephonenumber for the Office of the Hearing Clerk is (703) 603-0061.
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 at tompkins.jim@epa.gov , or by mailing a request for information toMr. Tompkins at Registration Division (7505C), Office of PesticidePrograms, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001.
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 20460-0001.
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.1. Mailyour copies, identified by docket ID number OPP-2004-0075, to:Public Information and Records Integrity Branch, Information Resources andServices Division (7502C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC20460-0001. In person or by courier, bring a copy to the location ofthe PIRIB described in Unit I.B.1. You may also send an electronic copy ofyour request via e-mail to: opp-docket@epa.gov . Please usean ASCII file format and avoid the use of special characters and any formof encryption. Copies of electronic objections and hearing requests willalso be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Donot include any CBI in your electronic copy. You may also submit anelectronic copy of your request 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. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of FFDCA 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). Thisfinal rule does not contain any information collections subject to OMBapproval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfundedmandate as described under Title II of the Unfunded Mandates Reform Act of1995 (UMRA) (Public Law 104-4). Nor does it require any specialconsiderations under Executive Order 12898, entitled FederalActions to Address Environmental Justice in Minority Populations andLow-Income Populations (59 FR 7629, February 16, 1994); or OMB reviewor any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and SafetyRisks (62 FR 19885, April 23, 1997). This action does not involve anytechnical standards that would require Agency consideration of voluntaryconsensus standards pursuant to section 12(d) of the National TechnologyTransfer and Advancement Act of 1995 (NTTAA), Public Law 104-113,section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions thatare established on the basis of a petition under section 408(d) of FFDCA,such as the tolerance in this final rule, do not require the issuance of aproposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5U.S.C. 601 et seq. ) do not apply. In addition, the Agencyhas determined that this action will not have a substantial direct effecton States, on the relationship between the national government and theStates, or on the distribution of power and responsibilities among thevarious levels of government, as specified in Executive Order 13132,entitled Federalism (64 FR 43255, August 10, 1999).Executive Order 13132 requires EPA to develop an accountable process toensure "meaningful and timely input by State and local officials inthe development of regulatory policies that have federalismimplications." "Policies that have federalismimplications" is defined in the Executive order to includeregulations that have "substantial direct effects on the States, onthe relationship between the national government and the States, or on thedistribution of power and responsibilities among the various levels ofgovernment." This final rule directly regulates growers, foodprocessors, food handlers and food retailers, not States. This action doesnot alter the relationships or distribution of power and responsibilitiesestablished by Congress in the preemption provisions of section 408(n)(4)of FFDCA. For these same reasons, the Agency has determined that this ruledoes not have any "tribal implications" as described inExecutive Order 13175, entitled Consultation and Coordinationwith Indian Tribal Governments (65 FR 67249, November 6, 2000).Executive Order 13175, requires EPA to develop an accountable process toensure "meaningful and timely input by tribal officials in thedevelopment of regulatory policies that have tribal implications.""Policies that have tribal implications" is defined in theExecutive order to include regulations that have "substantial directeffects on one or more Indian tribes, on the relationship between theFederal Government and the Indian tribes, or on the distribution of powerand responsibilities between the Federal Government and Indiantribes." This rule will not have substantial direct effects ontribal governments, on the relationship between the Federal Government andIndian tribes, or on the distribution of power and responsibilities betweenthe Federal Government and Indian tribes, as specified in Executive Order13175. Thus, Executive Order 13175 does not apply to this rule.
VIII. Congressional Review Act
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: March 31, 2004.
Lois Rossi,
Director, Registration Division, Office of PesticidePrograms.
Therefore, 40 CFR chapter I 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), 346a and371.
2. Section 180.589 is amended by alphabetically adding commoditiesto the table in paragraph (a)(1) to read as follows:
§ 180.589 Boscalid; tolerances for residues.
(a) General . (1) * **
| Commodity | Parts per million |
|---|---|
| ***** | |
| Apple, wet, pomace | 10 |
| Aspirated grain fractions | 3.0 |
| ***** | |
| Fruit, pome, crop group, group 11 | 3.0 |
| ***** | |
| Hops, cones, dried | 35 |
| ***** | |
| Soybean, hulls | 0.2 |
| Soybean, seed | 0.1 |
| Soybean, vegetable | 2.0 |
| ***** |
3. Section 180.589 paragraph (d) is amended by removing tolerancesfor "Soybean, hulls," and "Soybean, seed" from thetable.
[FR Doc. 04-8316 Filed 4-13-04; 8:45 am]
BILLING CODE 6560-50-S