70 FR 67 pgs. 17901-17908 - Buprofezin; Pesticide Tolerance
Type: RULEVolume: 70Number: 67Pages: 17901 - 17908
Docket number: [OPP-2004-0412; FRL-7691-8]
FR document: [FR Doc. 05-7066 Filed 4-7-05; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0412; FRL-7691-8]
Buprofezin; Pesticide Tolerance
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes tolerances forresidues of buprofezin in or on avocado, papaya, star apple, black sapote,mango, sapodilla, canistel, mamey sapote, sugar apple, cherimoya, atemoya,custard apple, ilama, soursop, birida, guava, feijoa, jaboticaba, waxjambu, starfruit, passionfruit, and acerola at 0.30 parts per million(ppm); pome fruit at 0.30 ppm; peach at 9.0 ppm, meat (cattle, goat, hog,horse, and sheep) at 0.05 ppm; kidney (cattle, goat, hog, horse, and sheep)at 0.05 ppm.; lettuce, head at 5.0 ppm, Lettuce, leaf at 13.0 ppm, andVegetable, cucurbit at 0.5 ppm; fruit, citrus, group 10 at 2.5 ppm; citrus,dried, pulp at 7.5 ppm; and citrus, oil at 80 ppm. Nichino America, Inc.,Linden Park, Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19808requested these tolerances under the Federal Food, Drug, and Cosmetic Act(FFDCA), as amended by the Food Quality Protection Act of 1996(FQPA).
DATES:
This regulation is effective April 8, 2005. Objections and requests for hearings must be received on or before June 7, 2005.
ADDRESSES:
To submit a written objection or hearingrequest follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION . EPA has established a docket forthis action under Docket identification (ID) numberOPP-2004-0412. All documents in the docket are listed in theEDOCKET index at http://www.epa.gov/edocket. Although listedin the index, some information is not publicly available, i.e., CBI orother information whose disclosure is restricted by statute. Certain othermaterial, such as copyrighted material, is not placed on the Internet andwill be publicly available only in hard copy form. Publicly availabledocket materials are available either electronically in EDOCKET or in hardcopy at the Public Information and Records Integrity Branch (PIRIB), Rm.119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docketfacility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excludinglegal holidays. The docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT:
Richard J. Gebken,Registration Division (7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC20460-0001; telephone number: (703) 305-6701; e-mail address: gebken.richard@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 Access Electronic Copies of this Document and OtherRelated Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/) , you may access this Federal Register document electronically through the EPAInternet under the " Federal Register " listings at http://www.epa.gov/fedrgstr/ . A frequently updatedelectronic version of 40 CFR part 180 is available at E-CFR Beta Site Twoat http://www.gpoaccess.gov/ecfr/ .
II. Background and Statutory Findings
In the Federal Register of March 17, 2004 (69 FR 12676)(FRL-7347-1), EPA issued a notice pursuant to section 408(d)(3)of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticidepetition (PP 3E6636, 3E6741, and 3E6747) by Interregional Research ProjectNumber (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ08902 and Nichino America, Inc., Linden Park, Suite 501, 4550 New LindenHill Road, Wilmington, DE 19808. The petition requested that 40 CFR 180.511be amended by establishing a tolerance for residues of the insecticidebuprofezin(2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one),in or on the raw agricultural commodities: Fruit, pome, group 11, exceptapple and apple, pomace at 4.0 parts per million (ppm) (PP 3E6636), appleat 1.2 ppm (PP 3E6636), apple, pomace at 2.5 ppm (PP 3E6636), peach,apricot, and nectarine at 3.0 ppm (PP 3E6741), and avocado, papaya, starapple, black sapote, mango, sapodilla, canistel, mamey sapote, sugar apple,cherimoya, atemoya, custard apple, ilama, soursop, biriba, guava, feijoa,jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 0.30 ppm (PP3E6747).
In the Federal Register of June 21, 2000 (65 FR 38543)(FRL-6557-3), EPA issued a notice pursuant to section 408(d)(3)of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticidepetition (PP 0F6087) by Nichino America, Inc., Linden Park, Suite 501, 4550New Linden Hill Road, Wilmington, DE 19808, (formerly Aventis CropScience,formerly AgrEvo USA Company). The petition requested that 40 CFR 180.511be amended by establishing a tolerance for residues of the insecticidebuprofezin](2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one),in or on the following meat commodities; (Cattle, goats, hogs, horse, andsheep at 0.05 ppm) and kidney commodities for (cattle, goats, hogs, horse,and sheep at 0.05 ppm) respectively.
In the Federal Register of December 22, 2004 (69 FR 76719)(FRL-7689-4), EPA issued a notice pursuant to section 408(d)(3)of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticidepetition (PP 4F6873) by Nichino America, Inc., Linden Park, Suite 501, 4550New Linden Hill Road, Wilmington, DE 19808. The petition requested that 40CFR 180.511 be amended by establishing increased tolerances for residues ofbuprofezin(2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one)in or on the following agricultural commodities: Fruit, citrus, Group 10 at2.5 ppm); citrus, dried pulp at 7.5 ppm; and citrus, oil at 80 ppm.
In the Federal Register of December 23, 2004 (69 FR 76942)(FRL-7694-1), EPA issued a notice pursuant to section 408(d)(3)of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticidepetition (PP 4F6887) by Nichino America, Inc., Linden Park, Suite 501, 4550New Linden Hill Road, Wilmington, DE 19808. The petition requested that 40CFR 180.511 be amended by establishing tolerances for residues ofbuprofezin(2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one)in or on the following raw agricultural commodities: Head lettuce at 5 ppm,leaf lettuce at 13 ppm, and Vegetables, cucurbits, group 9 at 0.5 ppm.
Each respective notice included a summary of the petition prepared bythe registrant Nichino America, Incorporated, 4550 New Linden Hill Road,Suite 501, Wilmington, DE 19808, or the previous, registrant AventisCropScience.
A private citizen responded to petitions PP 3E6636, 3E6741, 3E6747,4F6873, and 4F6887. The substantive public comments and correspondingAgency responses are addressed in a separate document available in thedocket for this action under Docket identification (ID) numberOPP-2004-0362.
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 fromaggregate exposure to the pesticide chemical residue, including allanticipated dietary exposures and all other exposures for which there isreliable information." This includes exposure through drinking waterand in residential settings, but does not include occupational exposure.Section 408(b)(2)(C) of FFDCA requires EPA to give special considerationto exposure 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 buprofezin in or on avocado, papaya,star apple, black sapote, mango, sapodilla, canistel, mamey sapote, sugarapple, cherimoya, atemoya, custard apple, ilama, soursop, birida, guava,feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 0.30parts per million (ppm); pome fruit at 4.0 ppm; peach at 9.0 ppm, meat(cattle, goat, hog, horse, and sheep) at 0.05 ppm; kidney (cattle, goat,hog, horse, and sheep) at 0.05 ppm; Lettuce, head at 5.0 ppm, Lettuce, leafat 13 ppm; Vegetable, cucurbit group 9 at 0.50 ppm; Fruit, citrus, Group 10at 2.5 parts per million (ppm); Citrus, dried pulp at 7.5 ppm, and citrus,oil at 80 ppm.
EPA's assessment of exposures and risks associated with establishing thetolerance follows:
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 buprofezin as well as the no observedadverse effect level (NOAEL) and the lowest observed adverse effect level(LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of June 25, 2003 (68 FR 37765)(FRL-7310-7).
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 (10X toaccount for interspecies differences and 10X for intraspecies differences)the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures(margin of exposure (MOE) = NOAEL/exposure) is calculated and compared tothe 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). An example of how sucha probability risk is expressed would be to describe the risk as one in onehundred thousand (1 X 10 -5 ), one in a million (1 X 10 -6 ), or one in ten million (1 X 10 -7 ). Undercertain specific circumstances, MOE calculations will be used for thecarcinogenic risk assessment. In this non-linear approach, a "pointof departure" 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 toxicological endpoints for buprofezin used for humanrisk assessment is discussed in Unit III.B. of the final rule published inthe Federal Register of June 25, 2003 (68 FR 37765)(FRL-7310-7).
C. Exposure Assessment
1. Dietary exposure from food and feed uses . Toleranceshave been established (40 CFR 180.511) for the residues of buprofezin, inor on a variety of raw agricultural commodities. Tolerances for residuesof buprofezin are currently established for ruminant fat, meat byproducts,and liver at 0.05 ppm (40 CFR 180.511). Tolerances are being establishedfor meat (cattle, goat, hog, horse, and sheep) at 0.05 ppm; and kidney(cattle, goat, hog, horse, and sheep) at 0.05 ppm; based on additionalanimal metabolism studies provided from Nichino America, Inc. Riskassessments were conducted by EPA to assess dietary exposures frombuprofezin in food as follows:
i. Acute and chronic exposure . Acute dietary riskassessments are performed for a food-use pesticide, if a toxicologicalstudy has indicated the possibility of an effect of concern occurring as aresult of a 1-day or single exposure.
In conducting the acute dietary risk assessment EPA used the DietaryExposure Evaluation Model software with the Food Commodity Intake Database(DEEM-FCIDTM ) (ver. 1.30) and LifelineTM (ver. 2.00)models, which incorporates food consumption data as reported by respondentsin the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of FoodIntake by Individuals (CSFII), and accumulated exposure to the chemical foreach commodity. The following assumptions were made for the acute exposureassessments: The acute analysis assumed tolerance level residues, 100% croptreated for all uses, and DEEMTM (ver. 7.76) default processingfactors for all registered/proposed commodities (Tier 1). The chronicanalysis assumed DEEMTM (ver.7.76) default processing factors forall registered/proposed commodities and incorporated percent crop treatedestimates and average field trial residues.
ii. Cancer . In accordance with the EPA Guidelines forCarcinogen Risk Assessment, the Carcinogen Assessment Review Commissionclassified buprofezin as having "suggestive evidence ofcarcinogenicity, but not sufficient to assess human carcinogenicpotential" based on liver tumors in female mice. The Committeefurther recommended no quantification of cancer risk.
iii. Anticipated residue and percent crop treated (PCT)information . Section 408(b)(2)(F) of FFDCA states that the Agency mayuse data on the actual percent of food treated for assessing chronicdietary risk only if the Agency can make the following findings: Condition1, that the data used are reliable and provide a valid basis to show whatpercentage of the food derived from such crop is likely to contain suchpesticide residue; Condition 2, that the exposure estimate does notunderestimate exposure for any significant subpopulation group; andCondition 3, if data are available on pesticide use and food consumption ina particular area, the exposure estimate does not understate exposure forthe population in such area. In addition, the Agency must provide forperiodic evaluation of any estimates used. To provide for the periodicevaluation of the estimate of PCT as required by section 408(b)(2)(F) ofFFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows:
• 5% crop treated (PCT) for cantaloupes;
• 2.5% crop treated for cotton, grapefruit, grapes, lemons,limes, oranges, squash, tangelos, tangerines, tomatoes, and watermelon;
• Market share % crop treated was projected not to exceed 5%for apples, and 13% for peaches;
• All other crops currently registered and/or proposedcommodities were assumed to be 100% crop treated.
The Agency believes that the three conditions listed in Unit C. 1. iii.have been met. With respect to Condition 1, PCT estimates are derived fromFederal and private market survey data, which are reliable and have a validbasis. For previously registered crops, EPA used an average of the valuesfrom these surveys over the last 5 years for estimating PCT for chronicdietary exposure assessments. For most newly registered crops, the Agencyassumed 100% PCT. In estimating PCT for the apples and peaches asnewly-registered crops, EPA assumed that the PCT for buprofezin would atleast equal or exceed the PCT for the leading comparable insect growthregulatory pesticide alternative on that crop. For peaches, PCT forbuprofezin was projected to potentially exceed the leading alternative'sPCT by a factor of five because buprofezin has a slight cost advantage overthe alternative on that crop. With regards to apples, buprofezin wasprojected to slightly exceed sales of the leading alternative's PCT becausebuprofezin is an excellent technical fit as an insect pest management (IPM)insecticide for apples. The Agency is reasonably certain that thepercentage of the food treated is not likely to be an underestimation.
As to Conditions 2 and 3, regional consumption information andconsumption information for significant subpopulations is taken intoaccount through EPA's computer-based model for evaluating the exposure ofsignificant subpopulations including several regional groups. Use of thisconsumption information in EPA's risk assessment process ensures that EPA'sexposure estimate does not understate exposure for any significantsubpopulation group and allows the Agency to be reasonably certain that noregional population is exposed to residue levels higher than thoseestimated by the Agency. Other than the data available through nationalfood consumption surveys, EPA does not have available information on theregional consumption of food to which buprofezin may be applied in aparticular area.
2. Dietary exposure from drinking water . The Agency lackssufficient monitoring exposure data to complete a comprehensive dietaryexposure analysis and risk assessment for buprofezin 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 ofbuprofezin.
The Agency uses the Generic Estimated Environmental Concentration(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling System(PRZM/EXAMS) to estimate pesticide concentrations in surface water andScreening Concentrations in Groundwater (SCI-GROW), which predictspesticide concentrations in ground water. In general, EPA will use GENEEC(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model) for ascreening-level assessment for surface water. The GENEEC model is a subsetof the PRZM/EXAMS model that uses a specific high-end runoff scenario forpesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMSincorporate an index reservoir environment in place of the previous pondscenario. The PRZM/EXAMS model includes a percent crop area factor as anadjustment to account for the maximum percent crop coverage within awatershed 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 buprofezin they are further discussedin the aggregate risk sections in Unit E.
Based on the GENEEC, PRZM/EXAMS and SCI-GROW models, the EECs ofbuprofezin for acute exposures are estimated to be 19.2 parts per billion(ppb) for surface water and 0.1 ppb for ground water. The EECs for chronicexposures are estimated to be 4.5 ppb for surface water and 0.1 ppb forground water.
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). Buprofezin isnot registered for use on any sites that would result in residentialexposure.
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 buprofezin and any other substances andbuprofezin does not appear to produce a toxic metabolite produced by othersubstances. For the purposes of this tolerance action, therefore, EPA hasnot assumed that buprofezin 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 tenfold 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 a MOEanalysis 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 . The Agencyconcluded that the available studies provided no indication of increasedsusceptibility of rats or rabbits following in utero exposureor of rats following prenatal/postnatal exposure to buprofezin.
3. Conclusion . There is a complete toxicity data base forbuprofezin and exposure data are complete or are estimated based on datathat reasonably accounts for potential exposures. EPA determined that the10X SF to protect infants and children should be reduced 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 iscalculated 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 . Using the exposure assumptions discussedin this unit for acute exposure, the acute dietary exposure from food tobuprofezin will occupy 5.0% of the aPAD for females 13 to 19 years old. Inaddition, there is potential for acute dietary exposure to buprofezin] indrinking water. After calculating DWLOCs and comparing them to the EECs forsurface water and ground water, EPA does not expect the aggregate exposureto exceed 100% of the aPAD, as shown in Table 1 of this unit:
| Population Subgroup | aPAD (mg/kg) | % aPAD (Food) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Acute DWLOC (ppb) |
|---|---|---|---|---|---|
| Females (13-49 years old) | 2.0 | 5 | 19.2 | 0.1 | 57,000 |
2. Chronic risk . Using the exposure assumptions describedin this unit for chronic exposure, the chronic aggregate risk assessmenttakes into account average exposure estimates from dietary consumption ofbuprofezin (food and drinking water). However, there are no residentialuses for buprofezin that result in chronic residential exposure tobuprofezin. Therefore, the chronic aggregate risk assessment will considerexposure from food and drinking water only. There is potential for chronicdietary exposure to buprofezin in drinking water. After calculating DWLOCsand comparing them to the EECs for surface water and ground water, EPA doesnot expect the aggregate exposure to exceed 100% of the cPAD, as shown inTable 2 of this unit:
| Population Subgroup | cPAD mg/kg/day | %cPAD (Food) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Chronic DWLOC (ppb) |
|---|---|---|---|---|---|
| U.S. population | 0.01 | 38 | 4.5 | 0.1 | 220 |
| All infants ( 1yr old) | 0.01 | 64 | 4.5 | 0.1 | 36 |
| Children (1-2 yearsold) | 0.01 | 81 | 4.5 | 0.1 | 19 |
| Youth (13-19 yearsold) | 0.01 | 32 | 4.5 | 0.1 | 200 |
| Adults (50 years + old) | 0.01 | 39 | 4.5 | 0.1 | 21 |
| Females (13-49 years old) | 0.01 | 34 | 4.5 | 0.1 | 200 |
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). Buprofezin is notregistered for use on any sites that would result in residential exposure.Therefore, the aggregate risk is the sum of the risk from food and water,which do not exceed the Agency's level of concern.
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). Buprofezinis not registered for use on any sites that would result in residentialexposure. Therefore, the aggregate risk is the sum of the risk from foodand water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population . In chronicstudies in the rat, an increased incidence of follicular cell hyperplasiaand hypertrophy in the thyroid of males was reported. Increased relativeliver weights were reported in female dogs. Buprofezin was notcarcinogenic to male and female rats. In the mouse, increased absoluteliver weights in males and females, along with an increased incidence ofhepatocellular adenomas and hepatocellular adenomas plus carcinomas infemales were reported. Buprofezin was negative in in vitro and in vivo genotoxicity assays. The findings from thepublished literature indicate that buprofezin causes cell transformationand induces micronuclei in vitro . In the absence of apositive response in an in vivo micronucleus assay, theAgency concluded that buprofezin may have aneugenic potential, which is notexpressed in vivo . In sum, buprofezin was negative in therat, negative for mutagenicity and negative for male mice; however, infemale mice, a slight or marginal increase in combined adenomas andcarcinomas was observed. Given these findings in the cancer andmutagenicity studies, EPA regards the carcinogenic potential of buprofezinas very low and concludes that it poses no greater than a negligible cancerrisk to humans.
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 buprofezin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Plants . Adequate enforcement methodology gaschromatography using nitrogen phosphorus detection is available to enforcethe tolerance expression.
Livestock . The Agency has successfully validated methodBF/11/97 for enforcement of the livestock tolerances and the method wasforwarded to FDA's Technical Editing Group for publication in a futurerevision of the Pesticide Analytical Manual I (PAM I).
The methods may be requested from: Chief, Analytical Chemistry Branch,Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .
B. International Residue Limits
There are no Canadian, Mexican, or Codex maximum residue limits (MRLs)established for buprofezin in/on any of the commodities associated with thecurrent petition. Therefore, harmonization is not relevant.
V. Conclusion
Therefore, the tolerance is established for residues of buprofezin, inor on avocado, papaya, star apple, black sapote, mango, sapodilla,canistel, mamey sapote, sugar apple, cherimoya, atemoya, custard apple,ilama, soursop, birida, guava, feijoa, jaboticaba, wax jambu, starfruit,passionfruit, and acerola] at 0.30 ppm; Fruit, Pome, Crop Group 11 at 4.0ppm; Peach at 9.0 ppm; Meat (cattle, goat, hog, horse, and sheep) at 0.05ppm; and Kidney (cattle, goat, hog, horse, and sheep) at 0.05 ppm; Lettuce,head at 5.0 ppm; Lettuce, leaf at 13 ppm; and Vegetable, cucurbit group 9at 0.50 ppm; Fruit, citrus, Group 10 at 2.5 ppm; citrus, dried pulp at 7.5ppm; and citrus, oil at 80 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 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-2004-0412 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 7, 2005.
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 (1900L),Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,DC 20460-0001. You may also deliver your request to the Office ofthe Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m.,Monday through Friday, excluding legal holidays. The telephone number forthe Office of the Hearing Clerk is (202) 564-6255.
2. 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 ADDRESSES . Mail your copies, identified by docket ID numberOPP-2004-0412, to: Public Information and Records IntegrityBranch, Information Resources and Services Division (7502C), Office ofPesticide Programs, Environmental Protection Agency, 1200 PennsylvaniaAve., NW., Washington, DC 20460-0001. In person or by courier, bringa copy to the location of the PIRIB described in ADDRESSES .You may also send an electronic copy of your request via e-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. 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). 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 section 408(d) of FFDCA, 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. The Agency hereby certifies thatthis rule will not have significant negative economic impact on asubstantial number of small entities. 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 Order13132 requires EPA to develop an accountable process to ensure"meaningful and timely input by State and local officials in thedevelopment 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 29, 2005.
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 and 371.
2. Section 180.511 is amended by revising the entries for"Fruit, citrus"; "Lettuce, head"; "Lettuce,leaf"; and "Vegetable, cucurbit" and by alphabeticallyadding commodities in the table in paragraph (a) to read asfollows:
§ 180.511 Buprofezin;tolerances for residues.
(a) * * *
| Commodity | Parts per million | Expiration/Revocation Date |
|---|---|---|
| Acerola | 0.30 | None |
| ***** | ||
| Atemoya | 0.30 | None |
| Avocado | 0.30 | None |
| ***** | ||
| Birida | 0.30 | None |
| Black sapote | 0.30 | None |
| Canistel | 0.30 | None |
| ***** | ||
| Cattle, kidney | 0.05 | None |
| ***** | ||
| Cattle, meat | 0.05 | None |
| ***** | ||
| Cherimoya | 0.30 | None |
| ***** | ||
| Citrus, dried pulp | 7.5 | None |
| Citrus, oil | 80 | None |
| ***** | ||
| Custard, apple | 0.30 | None |
| Feijoa | 0.30 | None |
| Fruit, Citrus, Group 10 | 2.5 | None |
| Fruit, Pome, Crop Group 11 | 4.0 | None |
| ***** | ||
| Goat, kidney | 0.05 | None |
| Goat, meat | 0.05 | None |
| ***** | ||
| Guava | 0.30 | None |
| ***** | ||
| Hog, kidney | 0.05 | None |
| Hog, meat | 0.05 | None |
| ***** | ||
| Horse, kidney | 0.05 | None |
| Horse, meat | 0.05 | None |
| ***** | ||
| Ilama | 0.30 | None |
| Jaboticaba | 0.30 | None |
| ***** | ||
| Lettuce, head | 5.0 | None |
| Lettuce, leaf | 13.0 | None |
| Mamey sapote | 0.30 | None |
| Mango | 0.30 | None |
| ***** | ||
| Papaya | 0.30 | None |
| Passion fruit | 0.30 | None |
| Peach | 9.0 | None |
| ***** | ||
| Sapodilla | 0.30 | None |
| ***** | ||
| Sheep, kidney | 0.05 | None |
| Sheep, meat | 0.05 | None |
| ***** | ||
| Soursop | 0.30 | None |
| ***** | ||
| Star apple | 0.30 | None |
| Starfruit | 0.30 | None |
| Sugar apple | 0.30 | None |
| ***** | ||
| Vegetable, Cucurbit, Group 9 | 0.50 | None |
| Wax jambu | 0.30 | None |
[FR Doc. 05-7066 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S