70 FR 67 pgs. 17908-17916 - Triflumizole; Pesticide Tolerances for EmergencyExemptions
Type: RULEVolume: 70Number: 67Pages: 17908 - 17916
Docket number: [OPP-2005-0054; FRL-7701-6]
FR document: [FR Doc. 05-7046 Filed 4-7-05; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0054; FRL-7701-6]
Triflumizole; Pesticide Tolerances for EmergencyExemptions
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes time-limitedtolerances for combined residues of triflumizole in or on parsley, leaves;dandelion, leaves; swiss chard; collards; kale; kohlrabi; mustard greens;cabbage, chinese, napa; broccoli; and coriander, leaves (cilantro). Thisaction is in response to EPA's granting of an emergency exemption undersection 18 of the Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA) authorizing use of the pesticide on parsley; dandelion; swisschard; collards; kale; kohlrabi; mustard greens; cabbage, chinese, napa;broccoli; and coriander, leaves (cilantro). This regulation establishesmaximum permissible levels for residues of triflumizole in these foodcommodities. These tolerances will expire and are revoked on June 30,2008.
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 VII. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for thisaction under Docket identification (ID) number OPP-2005-0054.All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket . Although listed in the index, someinformation is not publicly available, i.e., CBI or other information whosedisclosure is restricted by statute. Certain other material, such ascopyrighted material, is not placed on the Internet and will be publiclyavailable only in hard copy form. Publicly available docket materials areavailable either electronically in EDOCKET or in hard copy at the PublicInformation and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall#2, 1801 S. Bell St., 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.
FOR FURTHER INFORMATION CONTACT:
Libby Pemberton,Registration Division (7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC20460-0001; telephone number: (703) 308-9364; e-mail address: Sec-18-Mailbox@epamail.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 code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides aguide for readers regarding entities likely to be affected by this action.Other types of entities not listed in this unit could also be affected.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
EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a,is establishing time-limited tolerances for combined residues of thefungicide triflumizole and its metabolites containing the4-chloro-2-trifluoromethylaniline moiety, calculated as the parentcompound, in or on parsley, leaves at 9.0 parts per million (ppm);dandelion, leaves at 7.0 (ppm); swiss chard at 7.0 (ppm); collards at 9.0ppm; kale at 9.0 ppm; kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm;cabbage, chinese, napa at 9.0 ppm; broccoli at 1.0 ppm; and coriander,leaves (cilantro) at 9.0 ppm. These tolerances will expire and are revokedon June 30, 2008. EPA will publish a document in the FederalRegister to remove the revoked tolerances from the Code of FederalRegulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-limitedtolerance or exemption from the requirement for a tolerance for pesticidechemical residues in food that will result from the use of a pesticideunder an emergency exemption granted by EPA under section 18 of FIFRA. Suchtolerances can be established without providing notice or period for publiccomment. EPA does not intend for its actions on section 18 relatedtolerances to set binding precedents for the application of section 408 ofthe FFDCA to other tolerances and exemptions. Section 408(e) of the FFDCAallows EPA to establish a tolerance or an exemption from the requirement ofa tolerance on its own initiative, i.e., without having received anypetition from an outside party.
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) of the 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 the FFDCA requires EPA to give specialconsideration to exposure of infants and children to the pesticide chemicalresidue in establishing a tolerance and to "ensure that there is areasonable certainty that no harm will result to infants and children fromaggregate exposure to the pesticide chemical residue. . .."
Section 18 of the FIFRA authorizes EPA to exempt any Federal or Stateagency from any provision of FIFRA, if EPA determines that "emergencyconditions exist which require such exemption." EPA has establishedregulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Triflumizole on Various Commodities andFFDCA Tolerances
Texas has declared a crisis exemption under FIFRA section 18 for the useof triflumizole on parsley; dandelion; swiss chard; collards; kale;kohlrabi; mustard greens; cabbage, chinese, napa; broccoli; and coriander,leaves (cilantro) for control of powdery mildew. Texas states theeffective control of powdery mildew over the 70 to 90-day growingseason requires two additional applications of a systemic pesticide beyondthose permitted on the currently registered alternative labels.
As part of its assessment of this emergency exemption, EPA assessed thepotential risks presented by residues of triflumizole in or on parsley;dandelion; swiss chard; collards; kale; kohlrabi; mustard greens; cabbage,chinese napa; broccoli; and coriander, leaves (cilantro). In doing so, EPAconsidered the safety standard in section 408(b)(2) of the FFDCA, and EPAdecided that the necessary time-limited tolerances under section 408(l)(6)of the FFDCA would be consistent with the safety standard and with FIFRAsection 18. Consistent with the need to move quickly on the emergencyexemption in order to address an urgent non-routine situation and to ensurethat the resulting food is safe and lawful, EPA is issuing thesetime-limited tolerances without notice and opportunity for public commentas provided in section 408(l)(6) of the FFDCA. Although these toleranceswill expire and are revoked on June 30, 2008, under section 408(l)(5) ofthe FFDCA, residues of the pesticide not in excess of the amounts specifiedin the tolerances remaining in or on parsley, leaves; dandelion, leaves;swiss chard; collards; kale; kohlrabi; mustard greens; cabbage, chinesenapa; broccoli; and coriander, leaves (cilantro) after that date will notbe unlawful, provided the pesticide is applied in a manner that was lawfulunder FIFRA, and the residues do not exceed a level that was authorized bythese tolerances at the time of that application. EPA will take action torevoke these tolerances earlier if any experience with, scientific data on,or other relevant information on this pesticide indicate that the residuesare not safe.
Because these tolerances are being approved under emergency conditions,EPA has not made any decisions about whether triflumizole meets EPA'sregistration requirements for use on parsley; dandelion; swiss chard;collards; kale; kohlrabi; mustard greens; cabbage, chinese napa; broccoli;and coriander, leaves (cilantro) or whether permanent tolerances for thisuse would be appropriate. Under these circumstances, EPA does not believethat these tolerances serve as a basis for registration of triflumizole bya State for special local needs under FIFRA section 24(c). Nor do thesetolerances serve as the basis for any State other than Texas to use thispesticide on these crops under section 18 of FIFRA without following allprovisions of EPA's regulations implementing FIFRA section 18 asidentified in 40 CFR part 166. For additional information regarding theemergency exemption for triflumizole, contact the Agency's RegistrationDivision at the address provided under FOR FURTHER INFORMATIONCONTACT .
IV. Aggregate Risk Assessment and Determination of Safety
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 the FFDCA and a complete description of therisk assessment process, see the final rule on Bifenthrin PesticideTolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed theavailable scientific data and other relevant information in support of thisaction. EPA has sufficient data to assess the hazards of triflumizole andto make a determination on aggregate exposure, consistent with section408(b)(2) of the FFDCA, for time-limited tolerances for combined residuesof triflumizole in or on parsley, leaves at 9.0 parts per million (ppm);dandelion, leaves at 7.0 (ppm); swiss chard at 7.0 (ppm); collards at 9.0ppm; kale at 9.0 ppm; kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm;cabbage, chinese, napa; at 9.0 ppm; broccoli at 1.0 ppm; and coriander,leaves at 9.0 ppm. EPA's assessment of the dietary exposures and risksassociated with establishing the tolerances follows.
A. 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 endpoint. However, the lowest dose atwhich adverse effects of concern are identified (the LOAEL) is sometimesused for risk assessment if no NOAEL was achieved in the toxicology studyselected. An uncertainty factor (UF) is applied to reflect uncertaintiesinherent in the extrapolation from laboratory animal data to humans and inthe variations in sensitivity among members of the human population as wellas other unknowns. An UF of 100 is routinely used, 10X to account forinterspecies differences and 10X for intraspecies differences.
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). The Food Quality Protection Act of 1996 (FQPA) added to FFDCAsection 408(b)(2)(C) an additional safety factor to protect children'shealth. Where this additional FQPA safety factor is retained, thisadditional factor is applied to the RfD by dividing the RfD by suchadditional factor. The acute or chronic Population Adjusted Dose (aPAD orcPAD) is a modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used todetermine the level of concern (LOC). For example, when 100 is theappropriate UF (10X to account for interspecies differences and 10X forintraspecies differences) the LOC is 100. To estimate risk, a ratio of theNOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) iscalculated 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 as 1 x 10 -6 or one in a million). Under certain specific circumstances,MOE calculations will be used for the carcinogenic risk assessment. Inthis non-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 summaryof the toxicological endpoints for triflumizole used for human riskassessment is shown in the following Table 1:
| Exposure Scenario | Dose Used in Risk Assessment, UF | FQPA SF and Endpoint for Risk Assessment | Study and Toxicological Effects |
|---|---|---|---|
| Acute Dietary (females 13-50 yearsof age) | NOAEL = 10 mg/kg/day UF = 100 Acute RfD = 0.1 mg/kg/day | FQPA SF = 1X aPAD = acute RfD/FQPA SF= 0.1 mg/kg/day | Developmental Toxicity Study - Rat Developmental LOAEL = 35 mg/kg/daybased on decreased numbers of viable fetuses,increased dead or resorbed fetuses, increased numbers oflate resorptions, decreased fetal body weight, and increasedincidences of cervical ribs |
| Acute Dietary (general U.S.population) (including infant and children) | NOAEL = 25 mg/kg/day UF = 100 Acute RfD = 0.25mg/kg/day | FQPA SF = 1X aPAD = acute RfD/FQPA SF= 0.03 mg/kg/day | Acute Neurotoxicity Study - Rat LOAEL = 100 mg/kg/day based onfunctional observational battery findings (neuromuscular impairment) anddecreased locomotor activity |
| Chronic Dietary (allpopulations) | NOAEL= 1.5 mg/kg/day UF = 100 Chronic RfD = 0.015mg/kg/day | FQPA SF = 1X cPAD = chronic/RfD FQPA SF= 0.015 mg/kg/day | Multi-generation Reproduction Study - Rat Reproductive LOAEL = 3.5 mg/kg/day based on increased gestationlength in dams of the F 3a interval |
| Short-Term Oral (1-30 days) (Residential) | Oral NOAEL = 8.5 mg/kg/day | LOC for MOE = 100 (Residential, includes the FQPA SF) | Multi-generation Reproduction Study - Rat LOAEL = 21 mg/kg/day, based on decreased body weight gain inpupsduring lactation |
| Intermediate-Term Oral (1-6 months) (Residential) | Oral NOAEL = 8.5 mg/kg/day | LOC for MOE = 100 (Residential, includes the FQPA SF) | Multi-generation Reproduction Study - Rat LOAEL = 21 mg/kg/day, based on decreased body weight gain inpups during lactation and decreased body weight and body weight gain inparental animals |
| Short-Term Dermal (1-30 days) (Occupational/Residential) | Oral NOAEL= 8.5 mg/kg/day (dermal absorptionrate = 3.5%) | LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential, includes the FQPA SF) | Multi-generation Reproduction Study - Rat LOAEL = 21 mg/kg/day, based on decreased body weight gain inpups during lactation |
| Intermediate- and Long-Term Dermal(1-6 months and 6 month or longer) (Occupational/Residential) | Oral NOAEL = 1.5 mg/kg/day (dermal absorptionrate = 3.5%) | LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential, includes the FQPASF) | Multi-generation Reproduction Study - Rat LOAEL = 3.5 mg/kg/day based on increased gestation length in thedams of the F 3a interval |
| Short-Term Inhalation (1-30 days) (Occupational/Residential) | Oral NOAEL= 8.5 mg/kg/day (inhalation absorptionrate = 100%) | LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential, includes the FQPA SF) | Multi-generation Reproduction Study - Rat LOAEL = 21 mg/kg/day, based on decreased body weight gain inpups during lactation |
| Intermediate- and Long-TermInhalation (1-6 months and 6 month or longer) (Occupational/Residential) | Oral NOAEL = 1.5 mg/kg/day (inhalation absorption rate =100%) | LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential, includes the FQPA SF) | Multi-generation Reproduction Study - Rat LOAEL = 3.5 mg/kg/day based on increased gestation length in thedams of the F 3a interval |
| Cancer (oral, dermal, inhalation) | Evidence for non-carcinogenicity for humans | Not applicable | Combined Chronic Toxicity/Carcinogenicity Study - Rat Carcinogenicity Study - Mouse No evidence of carcinogenicity in rats and mice |
| 1 UF = uncertainty factor, FQPA SF = FQPA safety factor,NOAEL = no observed adverse effect level, LOAEL = lowest observed adverseeffect level, PAD = population adjusted dose (a = acute, c = chronic) RfD =reference dose, MOE = margin of exposure, LOC = level of concern. | |||
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Toleranceshave been established (40 CFR 180.476) for the combined residues oftriflumizole, in or on a variety of raw agricultural commodities. Riskassessments were conducted by EPA to assess dietary exposures fromtriflumizole 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 a1-day or single exposure. The Dietary Exposure Evaluation Model(DEEMTM ) analysis evaluated the individual food consumption asreported by respondents in the USDA 1994-1996 and 1998 nationwideContinuing Surveys of Food Intake by Individuals (CSFII) and accumulatedexposure to the chemical for each commodity. The following assumptionswere made for the acute exposure assessments: Tolerance level residues and100% crop treated for all registered and proposed uses.
ii. Chronic exposure . In conducting this chronic dietaryrisk assessment the DEEMTM analysis evaluated the individual foodconsumption as reported by respondents in the USDA 1994-1996 and 1998nationwide CSFII and accumulated exposure to the chemical for eachcommodity. The following assumptions were made for the chronic exposureassessments: A refined, chronic dietary exposure assessment was performedfor the general U.S. population and various population subgroups usinganticipated residues (ARs) from average field trial residues for apple,grape, pear, cherry, cucurbit, strawberry, and milk commodities; registeredand proposed tolerances for all other commodities; percent crop treated(CT) information for apple, grape and pear commodities; and 100% CTinformation for all other uses.
iii. Cancer . Triflumizole has been classified as notlikely to be carcinogenic to humans. Therefore, a quantitative exposureassessment was not conducted to assess cancer risk.
iv. Anticipated residue and percent crop treated (PCT)information . Section 408(b)(2)(E) of the FFDCA authorizes EPA to useavailable data and information on the anticipated residue levels ofpesticide residues in food and the actual levels of pesticide chemicalsthat have been measured in food. If EPA relies on such information, EPAmust pursuant to section 408(f)(1) require that data be provided 5 yearsafter the tolerance is established, modified, or left in effect,demonstrating that the levels in food are not above the levels anticipated.Following the initial data submission, EPA is authorized to require similardata on a time frame it deems appropriate. For the present action, EPA willissue such Data Call-Ins for information relating to anticipated residuesas are required by FFDCA section 408(b)(2)(E) and authorized under FFDCAsection 408(f)(1). Such Data Call-Ins will be required to be submitted nolater than 5 years from the date of issuance of this tolerance.
The Agency used PCT information for the registered uses on grape, apple,and pear. EPA based these assumptions on use data for the period 1996 to1997 and 1998. For all other registered uses as well as these uses, EPAassumed that 100% of the U.S. crop would be treated with triflumizole.
The Agency believes that the three conditions previously discussed havebeen met. With respect to Condition 1, PCT estimates are derived fromFederal and private market survey data, which are reliable and have a validbasis. EPA uses a weighted average PCT for chronic dietary exposureestimates. This weighted average PCT figure is derived by averagingState-level data for a period of up to 10 years, and weighting for the morerobust and recent data. A weighted average of the PCT reasonablyrepresents a person's dietary exposure over a lifetime, and is unlikely tounderestimate exposure to an individual because of the fact that pesticideuse patterns (both regionally and nationally) tend to change continuouslyover time, such that an individual is unlikely to be exposed to more thanthe average PCT over a lifetime. For acute dietary exposure estimates, EPAuses an estimated maximum PCT. The exposure estimates resulting from thisapproach reasonably represent the highest levels to which an individualcould be exposed, and are unlikely to underestimate an individual's acutedietary exposure. The Agency is reasonably certain that the percentage ofthe food treated is not likely to be an underestimation. As to Conditions 2and 3, regional consumption information and consumption information forsignificant subpopulations is taken into account through EPA'scomputer-based model for evaluating the exposure of significantsubpopulations including several regional groups. Use of this consumptioninformation in EPA's risk assessment process ensures that EPA's exposureestimate does not understate exposure for any significant subpopulationgroup and allows the Agency to be reasonably certain that no regionalpopulation is exposed to residue levels higher than those estimated by theAgency. Other than the data available through national food consumptionsurveys, EPA does not have available information on the regionalconsumption of food to which triflumizole may be applied in a particulararea.
2. Dietary exposure from drinking water . The Agency lackssufficient monitoring exposure data to complete a comprehensive dietaryexposure analysis and risk assessment for triflumizole 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 oftriflumizole.
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. TheScreening Concentrations in Groundwater (SCI-GROW) model is used to predictpesticide concentrations in shallow ground water. For a screening-levelassessment for surface water, EPA will generally use FIRST (a Tier 1 model)before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset ofthe PRZM/EXAMS model that uses a specific high-end runoff scenario forpesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoirenvironment, 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 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 triflumizole they arefurther discussed in the aggregate risk sections below.
Based on the FIRST and SCI-GROW models the estimated environmentalconcentrations (EECs) of triflumizole for acute exposures are estimated tobe 191 parts per billion (ppb) for surface water and 0.12 ppb for groundwater. The EECs for chronic exposures are estimated to be 40 ppb forsurface water and 0.12 ppb for ground 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).
Triflumizole is not registered for use on any sites that would result inresidential exposure.
4. Cumulative effects from substances with a common mechanismoftoxicity . Section 408(b)(2)(D)(v) of the 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 triflumizole and any other substancesand triflumizole does not appear to produce a toxic metabolite produced byother substances. For the purposes of this tolerance action, therefore,EPA has not assumed that triflumizole has a common mechanism of toxicitywith other substances. For information regarding EPA's efforts to determinewhich chemicals have a common mechanism of toxicity and to evaluate thecumulative effects of such chemicals, see the policy statements released byEPA's Office of Pesticide Programs concerning common mechanismdeterminations and procedures for cumulating effects from substances foundto have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
C. Safety Factor for Infants and Children
1. In general . Section 408(b)(2)(C) of the FFDCA providesthat EPA shall apply an additional tenfold margin of safety for infants andchildren in the case of threshold effects to account for prenatal andpostnatal toxicity and the completeness of the database on toxicity andexposure unless EPA determines that a different margin of safety will besafe for infants and children. Margins of safety are incorporated into EPArisk assessments either directly through use of a MOE analysis or throughusing uncertainty (safety) factors in calculating a dose level that posesno appreciable risk to humans.
2. Prenatal and postnatal sensitivity . There isqualitative evidence of increased susceptibility demonstrated in the oralprenatal developmental toxicity studies in rats. Developmental toxicityresulted in fetal death as compared to maternal toxicity which includeddecreases in body weight gain and food consumption and increases inplacental, spleen and liver weights at the same dosages. No quantitative orqualitative evidence of increased susceptibility was demonstrated in theprenatal developmental toxicity studies in rabbits or the multi-generationreproduction studies in rats. In the rabbit developmental studies,24-hour fetal survival was decreased at the highest dose tested. Thisendpoint is not a recommended guideline parameter and is generally believedto have limited value in the assessment of development toxicity; rather, itis more an indicator of fetal endurance in the absence of critical maternalcare, following removal from the uterus. The Hazard IdentificationAssessment Review Committee did not consider this effect to be ameasurement of treatment-related effects on fetal viability and, thus, didnot consider it to be relevant to the assessment of fetal susceptibility.There was no evidence of quantitative or qualitative susceptibility in the2-generation reproduction study in rats. In that study, increasedgestation length was observed at the study LOAEL. In rats, this alterationin normal reproductive function can result in equally adverse consequences(i.e., mortality) in both dams and offspring.
3. Conclusion . In the Agency's previous triflumizolehuman health risk assessment, the following toxicity studies weredetermined to be data gaps: A 28-day rat inhalation study GuidelineNumber (GLN) 870.3465)), acute rat neurotoxicity study (GLN 870.6200), andsubchronic rat neurotoxicity study (GLN 870.6200). The acute andsub-chronic neurotoxicity studies have been submitted, reviewed by theAgency and determined to be acceptable. As a result, the following haschanged: (1) Selection of an acute endpoint for the general U.S. population(including infants and children); and (2) the removal of the 3x databaseuncertainty factor (UFDB). All other aspects of the most recent riskassessment remain unchanged.
As acceptable acute and sub-chronic neurotoxicity studies have beensubmitted, the Agency has determined that the 3x UFDB should be removedfrom the acute and chronic RfDs. In addition, the FQPA SFC recommended aspecial FQPA SF be reduced to 1x. The Agency has re-evaluated the qualityof the exposure and hazard data; and, based on these data, concluded thatthe special FQPA SF remain at 1x. The conclusion is based on thefollowing:
• The toxicity database is complete for FQPA assessment.
• There was no quantitative or qualitative evidence ofincreased susceptibility in the rabbit fetuses following inutero exposure or the rat following prenatal and postnatal exposure inthe rat reproduction study.
• There was evidence of qualitative susceptibility in thedevelopmental rat study; however, there are no residual uncertainties, andthe use of the developmental NOAEL and the endpoint for the acute RfD forfemales 13 to 50 would be protective of the prenatal toxicity following anacute dietary exposure.
• There is no evidence of increased quantitative orqualitative susceptibility in the rat developmental neurotoxicity study.
• The acute dietary food exposure assessment utilizesexisting and proposed tolerance level residues and 100% CT information forall commodities. By using these screening-level assessments, actualexposures/risks will not be underestimated.
• The chronic dietary food exposure assessment utilizes ARsand % CT data verified for several existing uses. For all proposed use,tolerance-level residue and 100% CT is assumed. The chronic assessment issomewhat refined and based on reliable data and will not underestimateexposure/risk.
• The dietary drinking water assessment utilizes waterconcentration values generated by model and associated modeling parameterswhich are designed to provide conservative, health-protective, high-endestimates of water concentrations which will not likely be exceeded.
• There are no registered or proposed uses of triflumizolethat would result in residential exposure.
D. 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 Populatedadjusted dose (PAD)) is available for exposure through drinking water(e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food+ chronic non-dietary, non-occupational exposure). This allowable exposurethrough 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: 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 morerefined screening-level and quantitative drinking water exposureassessments. 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 triflumizole in drinking water (when considered along with other sourcesof 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 triflumizole on drinking water as apart of the aggregate risk assessment process.
1. Acute risk . Using the exposure assumptions discussed inthis unit for acute exposure, the acute dietary exposure from food totriflumizole will occupy 6% of the aPAD for the U.S. population, 9% of theaPAD for females 13 to 49 years old, and 21% of the aPAD for children 1 to2 years old, the population at greatest exposure. In addition, despite thepotential for acute dietary exposure to triflumizole in drinking water,after calculating DWLOCs and comparing them to conservative model EECs oftriflumizole in surface water and ground water, EPA does not expect theaggregate exposure to exceed 100% of the aPAD, as shown in the followingTable 2:
| Population Subgroup | aPAD (mg/kg) | % aPAD (Food) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Acute DWLOC (ppb) |
|---|---|---|---|---|---|
| U.S. population (total) | 0.25 | 5 | 191 | 0.12 | 8,300 |
| Females, (13-49 years) | 0.1 | 9 | 191 | 0.12 | 2,700 |
| All Infants ( 1yearold) | 0.25 | 11 | 191 | 0.12 | 2,200 |
| Children (1-2 years old) | 0.25 | 21 | 191 | 0.12 | 2,000 |
2. Chronic risk . Using the exposure assumptions describedin this unit for chronic exposure, EPA has concluded that exposure totriflumizole from food will utilize 5% of the cPAD for the U.S. population,4% of the cPAD for all infants ( 1 year old) and 13% ofthe cPAD for children 1 to 2 years old, the subpopulation at greatestexposure. There are no residential uses for triflumizole that result inchronic residential exposure to triflumizole. In addition, despite thepotential for chronic dietary exposure to triflumizole in drinking water,after calculating DWLOCs and comparing them to conservative model EECs oftriflumizole in surface water and ground water, EPA does not expect theaggregate exposure to exceed 100% of the cPAD, as shown in the followingTable 3:
| Population Subgroup | cPAD mg/kg/day | % cPAD (Food) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Chronic DWLOC (ppb) |
|---|---|---|---|---|---|
| U.S. population | 0.015 | 5 | 40 | 0.12 | 500 |
| Children (1-2 years old) | 0.015 | 13 | 40 | 0.12 | 130 |
| Infants ( 1 year old) | 0.015 | 4 | 40 | 0.12 | 140 |
3. Short-term and intermediate-term risk . Short-term andintermediate-term aggregate exposure assessments take into accountresidential exposure plus chronic exposure to food and water (considered tobe a background exposure level). For triflumizole, the Agency did notperform short-term or intermediate-term assessments because there arecurrently no registered or proposed uses for homeowner application andresidential post- application exposures are expected to be negligible.
4. Aggregate cancer risk for U.S. population . Sincetriflumizole has been determined not to be carcinogenic, it is not expectedto pose a cancer risk.
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 triflumizole residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/mass spectrometrydetector (GC/MSD) method (Morse Method METH-115, Revision #3)) 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
There are no Codex, Canadian or Mexican maximum residue limitsestablished for triflumizole residues in/on crop commodities. Therefore, nocompatibility issues exist with regard to the proposed U.S. tolerancesdiscussed in this risk assessment.
C. Conditions
The petitioner should submit adequate limited field rotational crop dataon wheat at plant-back intervals longer than 120 days. Alternatively, thepetitioner has the option of submitting a full set of residue field trialson all intended rotational crops other than leafy and root vegetables.
VI. Conclusion
Therefore, tolerances are established for combined residues oftriflumizole and its metabolites containing the4-chloro-2-trifluoromethylaniline moiety, calculated as the parentcompound, in or on parsley, leaves at 9.0 ppm; dandelion, leaves at 7.0ppm; swiss chard at 7.0 ppm; collards at 9.0 ppm; kale at 9.0 ppm; kohlrabiat 9.0 ppm; mustard greens at 9.0 ppm; cabbage, chinese, napa at 9.0 ppm;broccoli at 1.0 ppm; and coriander, leaves at 9.0 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, any person may file an objection toany aspect of this regulation and may also request a hearing on thoseobjections. The EPA procedural regulations which govern the submission ofobjections and requests for hearings appear in 40 CFR part 178. Althoughthe procedures in those regulations require some modification to reflectthe amendments made to the FFDCA by the FQPA, EPA will continue to usethose procedures, with appropriate adjustments, until the necessarymodifications can be made. The new section 408(g) of the FFDCA providesthat the period for filing objections is now 60 days, rather than 30days.
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-2005-0054 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 UnitVII.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 the docket ID numberOPP-2005-0054, 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 thatavailable evidence identified by the requestor would, if establishedresolve one or more of such issues in favor of the requestor, taking intoaccount uncontested claims or facts to the contrary; and resolution of thefactual issues(s) in the manner sought by the requestor would be adequateto justify the action requested (40 CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes time-limited tolerances under section 408 ofthe FFDCA. The Office of Management and Budget (OMB) has exempted thesetypes of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).Because this rule has been exempted from review under Executive Order 12866due to its lack of significance, this rule is not subject to ExecutiveOrder 13211, Actions Concerning Regulations That SignificantlyAffect Energy Supply, Distribution, or Use (66 FR 28355, May 22,2001). This final rule does not contain any information collectionssubject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C.3501 et seq. , or impose any enforceable duty or contain anyunfunded mandate as described under Title II of the Unfunded MandatesReform Act of 1995 (UMRA) (Public Law 104-4). Nor does it requireany special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in MinorityPopulations and Low-Income Populations (59 FR 7629, February 16, 1994);or OMB review or 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 FIFRA section 18 exemption under section408 of the FFDCA, such as the tolerances in this final rule, do not requirethe issuance of a proposed rule, the requirements of the RegulatoryFlexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.In addition, the Agency has determined that this action will not have asubstantial direct effect on States, on the relationship between thenational government and the States, or on the distribution of power andresponsibilities among the various levels of government, as specified inExecutive Order 13132, entitled Federalism (64 FR 43255,August 10, 1999). Executive Order 13132 requires EPA to develop anaccountable process to ensure "meaningful and timely input by Stateand local officials in the development of regulatory policies that havefederalism implications." "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 actiondoes not alter the relationships or distribution of power andresponsibilities established by Congress in the preemption provisions ofsection 408(n)(4) of the FFDCA. For these same reasons, the Agency hasdetermined 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.
IX. 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 28, 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 and371.
2. Section 180.476 is amended by adding text to paragraph (b) toread as follows:
§ 180.476 Triflumizole;tolerances for residues.
*****
(b) Section 18 emergency exemptions . Time limitedtolerances are established for the residues triflumizole(1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2- propoxyethyl)-1H-imidazole)and its metabolites containing the 4-chloro-2-trifluoromethylanilinemoiety, calculated as the parent in connection with use of the pesticideunder section 18 emergency exemptions granted by EPA. The tolerances arespecified in the following table, and will expire and are revoked on thedates specified.
| Commodity | Parts per million | Expiration/revocation date |
|---|---|---|
| Broccoli | 1.0 | 6/30/08 |
| Cabbage, chinese, napa | 9.0 | 6/30/08 |
| Collards | 9.0 | 6/30/08 |
| Coriander, leaves | 9.0 | 6/30/08 |
| Dandelion, leaves | 7.0 | 6/30/08 |
| Kale | 9.0 | 6/30/08 |
| Kohlrabi | 9.0 | 6/30/08 |
| Mustard greens | 9.0 | 6/30/08 |
| Parsley, leaves | 9.0 | 6/30/08 |
| Swiss chard | 7.0 | 6/30/08 |
[FR Doc. 05-7046 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S