Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document

----- --_. 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION


### MEMORANDUM
Date: 13-MAR-2012


### SUBJECT: Chlorothalonil. Human-Health Assessment Scoping Document in Support of Registration Review.


### PC Code: 081901 

### DPBarcode: D394659 

### Decision No.: 455504 

### Registration No.: N/A 

### Petition No.: N/A 

### Regulatory Action: Registration Review Scoping Document 

### Risk Assessment Type: N/A 

### Case No.: 97 

### TXRNo.: N/A 

### CAS No.: 1897-45-6 MRID 

### No.: N/A 40 

### CFR: §180.275


### FROM: George F. Kramer, Ph.D., Senior

# Che~**~~R::C** Kelly M. Lowe, Environmental Scientist

## ~~ Chester E. Rodriguez, Ph.D., Pharmacologist**.~** 

## -"2../

. RiskAssessment Branch 1 (RAB1)

. Health Effects Division (HED,7509P) Office ofPesticide Programs (OPP)

And

# .r-'~ Timothy C. Dole, CIH, Industrial Hygienist ( RiskAssessment and Science Support Branch 1 (RASSB) Antimicrobials Division (AD)/OPP (7510P)


### THROUGH: DanaM. Vogel, Branch Chief RAB l/HED/OPP (7509P)


### TO: Jose Gayoso, Chemical Review Manager Pesticide Re-Evaluation Division (PRD)/OPP (7508P)


### Executive Summary

Introduction and Background
Chlorothalonil (2,4,5,6-tetrachloro-1,3-benzenedicarbonitrile) is abroad-spectrum, non-systemic protectantpesticide mainly used as a fungicide to control fungal foliar diseases ofvegetable, field, and ornamental crops. It is also used as a wood protectant, anti-mold and anti-mildew agent, bactericide, microbiocide, algaecide, insecticide, and acaricide. Residential uses include golfcourses, use onhome gardens, use as a wood preservative, and use inpaintformulations. Chlorothalonil-containing products are sold under the names Bravo, Echo, Daconil, Tuffguard, Busan 1192, Antiblu, and Densil. Since the Chlorothalonil ReregistrationEligibility Decision Page 1 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document (RED) was completed in 1999, the following commodities have been assessed and registered: edible-podded peas, ginseng, horseradish, lentil, lupin, okra, persimmon, rhubarb, yam, 

### Brassica head and stem subgroup (5A), cucurbit vegetable group (9), fruiting vegetable group (8). The most recenthuman-health risk assessment for chlorothalonil was completed in 2010 (Memo, G. Kramer 

### etal., 12/23/10, D370486) in conjunction with aregistrationrequest for use on lowgrowing berry subgroup 13-07G, bushberry subgroup 13-07B, bulb onion subgroup 3-07A, and green onion subgroup 3-07B. RED and AD have evaluated the status ofthe human-health assessments for chlorothalonil to determine whether sufficient data are available and whether any updates are needed to support Registration Review. RED and AD have considered the most recenthuman-health risk assessments for chlorothalonil with respectto its toxicity, exposure, and usage databases, and the most updated Agency science policy and risk assessment methodologies to determine the scope ofworknecessary to supportRegistration Review. Toxicology
The oral and inhalation routes ofexposure are ofthe most toxicological concern with chlorothalonil. Based on acute toxicity studies, chlorothalonil is highly toxic viathe inhalation route ofexposure (Category I). There was ahigh level oflethality reported in the critical acute inhalationtoxicity study (LCso

## =0.032 [M] and 0.013 [F] mgIL). RAB1, in conjunction with the HED Science Advisory Council for Toxicology (ToxSAC), believes that using any oral endpoint may underestimaterisk via the inhalation route. The decision was based on the low fraction of the administered dose that was absorbed through the oral route (estimated at 14-20%), which may underestimate toxicity at ahigher absorbed fraction (bioavailability)through the inhalation pathway. The lack ofa no-observed adverse-effect level (NOAEL) in several acute inhalation toxicity studiescarried out with technical-grade chlorothalonilorend-use productformulations is also a concern. Clinical signs consistent with respiratory-tract irritation (i.e., portal-of-entry effects) including nasal discharge, gasping, decreased activity, ptosis, and lethargy, were reported at all exposure concentrations tested across several acute inhalationtoxicity studies for chlorothalonil. The effects ofshort- and intermediate-term inhalation exposures (portal-of-entry
or systemic) have notbeen studied. In the absence ofsuch information, RED recommends that the lowest-observed adverse-effect level (LOAEL) from the critical acute inhalationtoxicity study with appropriateuncertainty factors (UFs) be used as the point ofdeparture (POD) to assess inhalation risks (acute, short-, and intermediate-term). At this LOAEL, there were no deaths (male or female) and the very slightto slight (severity) clinical signs ofrespiratory distress resolved after two days post-exposure. The use ofthis LOAELthat is based on mild portal-of-entry effects is likely to beprotective against any systemic toxicity through the inhalationroute ofexposure. Ifthe registrant submits a subchronic inhalation study, with a subset ofanimals designed to identify the NOAEL for acute inhalationtoxicity (i.e., after one day ofexposure), then the current UFs may be reduced accordingly. Therefore, RED believes that the submission ofa 90-day inhalation study (with acute toxicity measurements) is needed to refine the currentresidential risk assessments. Based on the lack ofincident data related to inhalation effects and the fact that an acute inhalationtoxicity study is being used to assess shortand intermediate-termrisk, the risk assessment canbe characterized as conservative.

Chlorothalonil exhibited low acute oral toxicity (Category IV), but in long-term (subchronic and chronic) oral dietary studies with rodents, chlorothalonil caused epithelial hyperplasia and hyperkeratosis at the limiting ridge and/or non-glandularregion ofthe stomach. There were also kidney effects that included weight increase (relative and absolute), dilation ofrenal medullary tubules, pelvic dilation, tubular cysts, and tubular degeneration. In subchronic dietary studies with dogs, the reported effects included infiltration ofinflammatory cells inthe liver ofboth Page 2 of53Chlorothalonil Registration Review Human-Health Assessment Scoring Document

------- ---_. 

### sexes and decreased body-weight gains in males. The effects in a chronic dietary study with dogs included decreased body-weight gain and food consumption, macroscopic and microscopic pathological findings in the stomach that included thickened appearance and intra-epithelial nuclearpyknosis in the mucosal epithelium ofthe antrum, and a veryslight cell hypertrophy in the zonafasciculata ofthe adrenal glands.

No specific malformations, or increase inmalformations orreproductive effects attributable to administration ofchlorothalonil were observed. Inthe 2-generationreproductive toxicity study, both parental animals and offspring exhibitedpathological effects involving the stomach consisting ofthickened and/orroughening ofthe forestomach with depressions in the epithelial aspect, and hyperplasia and hyperkeratosis ofthe non-glandular epithelium ofthe stomach. Based on overallweight-of-evidence, there is no evidence ofincreased susceptibilityto offspring following 

### in utero exposure to rats orrabbits in developmental toxicity studies orfollowing pre/post-natal exposure inthereproductive toxicity studies in rats.
Chlorothalonil exhibited low acute toxicity via the dermal route ofexposure (Category IV) and only caused moderate skin irritation (Category III). In 

### longer-term dermal toxicity studies, the reported effects were local involving skin irritation (erythema) inthe absence ofany systemic toxicity. In 

### the previous risk assessment, chlorothalonil was classified as notbeing a dermal sensitizer. However, apublished literature study in mice and guineapig ranks chlorothalonil as an extremelypotent contact allergen, inducing sensitization using onlytopical exposures on intact skin. The data from this study will be evaluated inthe registration review of chlorothalonil.

No appropriate acute endpoint was identified in the hazard database to quantitate the risk to the general population orto females 13-50 years old from single-dose oral administration of chlorothalonil. Therefore, there is no acute reference dose (aRID) or acute population-adjusted dose (aPAD).
The chronic RID (cRID) is establishedbased on the LOAEL from a chronic toxicity study inthe rat. The LOAEL of4.0 mglkg/day is based on the increased incidence and severity ofepithelial hyperplasia inthe renal proximal convoluted tubules offemale rats. The NOAEL is 2.0 mglkg/day. This NOAEL is lowerthan any NOAEL in the database based onkidney effects. Although lower NOAELslLOAELs were observed for gastrointestinal irritation in rodents, HED's Hazard Assessmentand Policy Committee (HASPOC) determined that the forestomach lesions inrodent species should notbe used for risk assessment due to the lackofahuman forestomach counterpart. Overall, there was no clearevidence that chlorothalonil was mutagenic. The Scientific Advisory Panel (SAP) concluded that the forestomach tumors chlorothalonil produced in rodents involved sustained cytotoxicity andregenerative cell proliferation as the mode ofaction and that a marginof-exposure (MOE) approach would be appropriate. Quantification ofexcess lifetime cancer riskusing a linear approach is, therefore, notrequired. Quantification ofdermal risk (all exposure scenarios) is notrequired since there is no systemic toxicity in a dermal toxicity study in rats at doses up to 600 mglkg/day and the level ofconcern (LOC) for developmental toxicity and/or neurotoxicity is low.
Short- and intermediate-term incidental oral endpoints are based onkidney toxicity observed in the 90-day oral mouse study with a NOAEL of41.3 mglkg/day. A targetMOE of 100 is Page 3 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document**------~** --- 

### considered adequate for short and intermediate-term incidental oral and inhalation exposure.
After evaluating the toxicological database, RED identified the following factors supporting reduction ofthe Food QualityProtectionAct (FQPA) Safety Factor (SF) from lOX to IX for oral exposure assessments: 1) there are no significant data gaps inthe hazard and exposure databases, 2) there are low concerns for pre- and/orpostnatal toxicity, 3) there are no residual uncertainties with regard to pre- and/orpostnatal toxicity, 4) the LOC for neurotoxicity is low, 5) there are no residual uncertainties in the exposure database, and 6) there was no evidence of immunotoxicity inthe database. However, the chlorothalonilrisk assessmentteamrecommends setting the FQPA SF at 3X for acute and 30X for repeated residential inhalation exposure scenarios based onthe lack ofan inhalation study ofappropriate durationto assess repeated exposures. There are onlyacute inhalation studies available for chlorothalonil. Its classification for acute inhalationtoxicity is Category I (combined LCso

## =0.020 mglL). The non-lethal effects reported in acute studies even at the lowest concentrationtested (i.e., no NOAEL attained) consist ofclinical signs indicative ofrespiratory-tract effects including nasal discharge, gasping/difficulty breathing, decreased activity/lethargy, respiratoryrales/gurgle, ptosis, and piloerection. The effects ofshort- and intermediate-term inhalation exposures (portal-of-entry or systemic) have notbeen studied andjustifyretaining the FQPA SF at lOX for repeated exposure scenarios. Since there is no NOAEL available for any ofthe available acute inhalation studies, butthe reported portal-of-entry effects were relatively mild at the LOAEL for the critical study,
an additional 3X factor shouldbe added to all exposure scenarios, resulting in an overall FQPA SF of3X and 30Xfor acute and repeated inhalation exposures, respectively. Since the UFs applied to residential inhalation exposure assessment arerelated to uncertainty in the hazard database, the same factors are applied to the occupational assessment ofinhalation exposure. Dietary Exposure
The mostrecent dietary-exposure assessment was performed in conjunction with the December 2010 human-health risk assessment conducted by HED in conjunction with aregistrationrequest for use on low-growing berry subgroup 13-07G; bushberry subgroup 13-07B; onion, bulb subgroup 3":07A; and onion, green subgroup 3-07B (D370486, G. Kramer, etal.; 

### 23-DEC-201O). RED was unable to make a safety finding due to inhalationrisks and the proposed uses were subsequently withdrawn. An 

### acute dietary-exposure assessment was notperformedbecause no appropriate endpoint was available to determine the aRID for the general population orany population subgroup. A partially refined chronic dietary-exposure assessment was performed using 100% crop treated (CT) for all crops; tolerance-level residues, and theDietary**E~osure** 

### Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDT ) 

### 7.81 defaultprocessing factors for all foods exceptfor tomatoes (average field-trial residues and empirical processing factors used), peppers (average field-trial residues used), orangejuice (empirical processing factor translated from tomatojuice), and snap beans (averagefield-trial residues used). Dietaryrisk estimates were determined considering exposures from food plus drinking waterusing estimated drinking water concentrations (EDWCs) for surface water sources providedbythe Environmental Fate and Effects Division (EFED).
The resulting chronic dietary risk estimates for food and drinking water combined are below RED's LOC [i.e., <100% ofthe chronic population-adjusted dose (cPAD) of0.02 mglkg bw/day] for the overall U.S. population and all population subgroups. Using DEEM-FCIDTM, dietary risk is estimated at41 % ofthe cPAD for the U.S. population and 98% ofthe cPAD for children 1-2 years old, the population subgroup with the highest estimated chronic dietary exposure to chlorothalonil. Dietary cancerrisk concerns due to long-term consumption of Page 4 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document 

### chlorothalonil residues are adequately addressed by the chronic exposure analysis using the cPAD.
Residue Chemistry and Tolerances
The residue chemistry database is sufficientto supportthe currentregistrations. The following datarequirementremains outstanding: multiresidue method recovery data for the 4-hydroxy metabolite.
The U.S., Canadian, and Codex tolerances/maximumresidue limits (MRLs) for residues of chlorothalonil are generally notharmonized. Forplantcommodities, the U.S. and Canadian residue definitions are harmonized; however, the Codex residue definition is notharmonized, as it does not include the 4-hydroxy metabolite. The U.S. and Codex residue definitions for livestockcommodities areharmonized and theU.S. and Codexhave establishedMRLs for residues in cattle, goats, hogs, horses, and sheep commodities at different levels. Canadian MRLs are not established for residues in livestock commodities.
Residential Exposure
There is sufficient information available to assess residential exposure and riskfrom the conventional uses. The residential assessments thathave beenperformedby RED are reflective ofthe currently registeredresidential uses, except for the use onhome gardens. In 

### the most recent risk assessment, inhalation risk concerns for the short-/intermediate-term exposure durations were identified for residential handlers using treated paint, post-application exposure from inhaling vapors from treated paint, and for bystander volatilization inhalation exposure. 

### As noted above, there is no inhalation study ofappropriate length available to assess short- and intermediate-termexposures, therefore, RED relied upon an acute study (in which no NOAELwas achieved) to assess short- and intermediate-term exposure. RED believes that the submission ofa 90-day inhalation study (with acute toxicity measurements) is needed to refine the currentresidential risk assessments. Based on the lack of incident datarelated to inhalation effects and the fact that an acute inhalation toxicity study is being used to assess short- and intermediate-termrisk, therisk assessment can be characterized
as conservative.
Assessments may need to be conducted ofthe registered home gardenuses. HED has revised its Residential Standard Operating Procedures (SOPs), including those used to determine exposure associated with treated paints/stains and home gardens. RED will incorporate new guidance from the updated SOPs to refine exposure estimates, as appropriate. In 

### addition, inthe most recentrisk assessment, the Agency requested additional inhalation toxicity data that may affect the inhalation POD chosen for chlorothalonil. Ifchanges are made, exposure scenarios may need to be reassessed.
With regard to the antimicrobial uses, there is potential for dermal and incidental oral exposure to pressure-treated wood that is used inresidential structures such as porches and steps. These exposures were not assessed inthe RED; therefore, they may need to be assessed during registrationreview. It 

### will also be necessary to reassess the paintuses and determine ifthe precautionary labeling strategyrequired bythe RED is still valid or ifpaints containing chlorothalonil should have labeling that can onlybe accomplished byhaving separate registrations for each paintproduct.

Page 5 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document**.~~~~-** 

### Occupational Exposures·
There is·sufficient information available to assess occupational handler and post-application exposure and risk for the conventional uses. In 

### the mostrecentrisk assessment, 

### inhalation risk
concerns for occupational handlers were identified for both acute and short-/intermediateterm exposures. As noted above, there is no inhalation study ofappropriate length available to assess short- and intermediate-termexposures, therefore, HED relied upon an acute study (in which no NOAEL was achieved) to assess short- and intermediate-term exposure. HED believes that the submission ofa 90-day inhalation study (with acute toxicity measurements) is needed to refine the current occupational risk assessments. Based onthe lack ofincident datarelatedto inhalation effects and the fact that an acute inhalation toxicity study is being used to assess shortand intermediate-termrisk, the risk assessment canbe characterized as conservative. Occupational handler scenarios mayneed to be reassessed during RegistrationReview to account for scenarios that have notbeen coveredpreviously, updated exposure data, and changes to the toxicological PODs. In 

### the mostrecentrisk assessment, the Agency requested additional inhalation toxicity data that may affect the inhalationPOD chosen for chlorothalonil. If

### changes
are made, thenexposure scenarios mayneed to be reassessed. During Registration Review, a review oftherestricted-'entry intervals (REIs) listedon the labels and theassociated label language will need to be checked for consistency across products. A review ofthe labels will also need to be done to ensure all labels withregistered turfuses include a statementprohibiting
use onhome lawns and otherresidential turfsites as required by the RED. In 

### addition, acheck ofthe omamentallabel co-formulated with propamocarb will need to be done to ensure the revisions have been made regarding maximum allowable applicationrates.
With respect to the antimicrobial uses, the occupational handler exposures that occur from the
use ofchlorothalonil for material preservation were assessed in the RED; however, these assessments may also have to be repeated during registrationreview to account for changes in the toxicological PODs. In 

### particular, the handler exposures from the openpouring ofwettable powder will have to be reassessed because the antimicrobial wettable powderproducts are not packaged in water-soluble packaging as required by the RED. In addition, exposures that occur from the use ofchlorothalonil as a wood preservative may have to be assessed because they were not assessed previously. These exposures can occur during both dip and spray treatments (i.e., sapstain treatment) and during pressure treatment.


### DataNeeds and Risk AssessmentUpdates Required: Toxicology:

• The toxicity endpoint/dose selection along with the FQPA SF may needtobe reevaluated according to currentpolicy.

• The following studies are required as specified in the revised 40 CFR Part 158:
o Guideline 870.3465 90-day inhalation study (rat)
o Guideline 870.7800 immunotoxicity, and
o Guideline 870.6200 acute neurotoxicity.


### Residue Chemistry:

• Guideline 860.1360 Multiresidue method recovery data for the 4-hydroxy metabolite.

• The tolerance expression for chlorothalonil residues needs to be updated to reflect current Agency policy under40 CFR §180.275(a)(l): "Tolerances are established for residues of Page 6 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document 

### --ch-I-o-rothalonil, including its metabolites and-degradates, in or on the commodities in the

. table below. Compliance with the tolerance levels specifiedbelow is to be determined by measuring only chlorothalonil(2,4,5,6-tetrachloro-l,3-benzenedicarbonitrile) and its metabolite 4-hydroxy-2,5,6-trichloro-l,3-benzenedicarbonitrile, calculated as the stoichiometric equivalent ofchlorothalonil, in or onthe commodity," and under40 CFR §180.275(a)(2): "Tolerances are established for residues ofchlorothalonil, including its metabolites and degradates, in or on the commodities inthe table below. Compliance with the tolerance levels specifiedbelow is to be determined by measuring only 4- hydroxy-2,5,6-trichloro-l,3-benzenedicarbonitrile in or on the commodity." 

### Dietary Exposure: • A new dietary exposure and risk assessment may be conducted ifthere are changes to the chlorothalonil toxicological PODs and EDWCs. 

### OccupationallResidential Exposure: • A revised occupational/residential exposure and risk assessmentis required.

• The following studies are required for occupational/residential exposure assessment: o Guideline 875.1400 Indoor Exposure, Inhalation
o Guideline 875.1600 ApplicatorExposure Monitoring DataReporting
o Guideline 875.1700 ProductUse Information·
o Guideline 875.2300 Surface Residue Dissipation



### 1.0 Introduction
Chlorothalonil (2,4,5,6-tetrachloro-l,3-benzenedicarbonitrile) is abroad-spectrum, non-systemic protectantpesticide mainly used as afungicide to control fungal foliar diseases ofvegetable, field, and ornamental crops. It is also used as a wood protectant, anti-mold and anti-mildew agent, bactericide, microbiocide, algaecide, insecticide, and acaricide. Residential uses include golfcourses, wood preservatives, and use in paint formulations. Chlorothalonil-containing products are sold under the names Bravo, Echo, Daconil, Tuffguard, Busan 1192, Antiblu, and Densil. Since the Chlorothalonil RED was completed in 1999, the following commodities have been assessed and registered: edible-poddedpeas, ginseng, horseradish, lentil, lupin, okra, persimmon, rhubarb, yarn, Brassica 

### head and stern subgroup (5A), cucurbitvegetable group (9), fruiting vegetable group (8). The most recenthuman-health risk assessmentfor chlorothalonil
was completed in 2010 (Memo, G. Kramer etal., 12123110, 

### D370486) in conjunction with a registrationrequest for use on low-growing berry subgroup 13-07G,bushberry subgroup 13-07B, bulb onion subgroup 3-07A, and green onion subgroup 3-07B. This petition was withdrawn when RED was unable to make a safetyfinding.



### 2.0 Hazard Identificationffoxicology
Chlorothalonil is abroad-spectrum, non-systemic protectantpesticide mainly used as a fungicide to control fungal foliar diseases ofvegetable fields and ornamental crops. Its postulated mechanism ofaction·as an antifungal agent involves disruption ofsulfur-dependent enzymes that mediate energyproduction in the fungal organism. Its primary mode ofaction in mammals via the oral route ofadministration is similar inthat it involves sulfur-dependentreactivity but differs inthat nephrotoxic cysteine S-conjugates are generated through abioactivationprocess in Page 7 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document

----- the kidney.

In metabolism/pharmacokinetic studies, chlorothalonil at a dose of 1.5 mg/kg was rapidly absorbed via the oral route, reaching peaklevels at 2-4 and 6 hours inthe rat and dog, respectively. Thefraction absorbed inthe rat was estimated at 23% at 1.5 mg/kg bw and about 14% at 50 mg/kg bw. The plasmahalf-life ofradiolabeled chlorothalonil inthe rat at 1.5 mg/kg
was longer in females (57.2 h) than in males (44.1 h), while being longest inthe dog (74.2 h) at the same dose. At 50 mg/kg, peaklevels ofchlorothalonil in the rat were observed at 12hours and, along with changes in maximumplasma concentration and areaunderthe plasma concentration-time curve, suggest changes in absorption (rate and extent) at this higher dose. The majority ofthe radioactivity was recovered inthe feces. Radioactivity did not appear to be retained significantly by any specific tissue, although it was detected inthe kidneys atboth doses at 120 hours post-dose. The metabolite profiles ofthe urine, bile, and tissue extracts show differences in the presence and proportions ofthe metabolites present, most notably the presence ofmercapturic acid-containing moieties in the rat that were not detected in the dog.
The oral and inhalation routes ofexposure are ofthe most toxicological concern with chlorothalonil. Based on acute toxicity studies, chlorothalonil is highly toxic via the inhalation route ofexposure (Category I). There was ahigh level oflethality reported in the critical acute inhalationtoxicity study (LCso

## =0.032 [M] and 0.013 [F] mgIL). RAB1, in conjunction with the RED ToxSAC, believes thatusing any oral endpoint may underestimate risk via the inhalation route. The decision was based on the low fraction ofthe administered dose that was absorbed through the oral route(estimated at 14-20%), which may underestimate toxicity at ahigher absorbed fraction (bioavailability) through the inhalationpathway. The lack ofa NOAEL in several acute inhalation toxicity studiescarried out with technical-grade chlorothalonil or enduse product formulations is also a concern. Clinical signs consistent with respiratory-tract irritation (i.e., portal-of-entry effects) including nasal discharge, gasping, decreased activity, ptosis, and lethargy, were reported at all exposure concentrations tested across the available acute inhalation toxicity studies for chlorothalonil. The effects ofshort- and intermediate-term inhalation exposures (portal-of.:entry or systemic) have not been studied, In the lastrisk assessment (G. Kramer, 12/23/10; D370486), a 90-day inhalation study was requested as conditionfor registration. No new inhalation studies have been submitted to the Agency and a 90-day inhalation study represents apending data requirement. However, the registrants are working with the Agency to clarify the data needed to fulfill this data gap.
In the absence ofsuch information, RED recommends that the LOAELfrom the critical acute inhalationtoxicity study with appropriate UFs be used as the POD to assess inhalationrisks (acute, short-, and intermediate-term). At this LOAEL, there were no deaths (male orfemale) and the very slightto slight (severity) clinical signs ofrespiratory distress resolved aftertwo days post-exposure. The use ofthis LOAEL that is based on mild portal-of-entry effects is likely to be protective against any systemic toxicity through the inhalationroute ofexposure. The methods and dosimetry equations described inEPA's RfC guidance (1994) were used for calculating human-equivalent concentrations (RECs) based on an inhalation toxicity LOAEL for
use in MOE calculations. The regional deposited-dose ratio (RDDR), which accounts forthe particulate diameter (mass median aerodynamicdiameter [MMAD] and geometric standard deviation [(jg] ofaerosols), can be used to estimate the different dose fractions deposited along the respiratory tract. The RDDR isalso based on interspecies differences in ventilation and respiratory-tract surface areas. Thus, the RDDR can be used to adjust an observed inhalation particulate exposure ofan animal to the predicted inhalation exposure for ahuman. Forthe aerosolized chlorothalonil used in the critical acute inhalation toxicity study (Holbert, 1993), an Page 8 of53Chlorothalonil Registration Review Human-Health AssessmentScoping Document 

### RDDR was estimated at 1.29 based onthe reported MMAD of2.35 /lm 

### and O'g 

### of5.80 and the entire respiratory-tract surface area ofthe ratrelative to the human. The details ofthese calculations are listed inthe lastrisk assessment (G. Kramer, 12/23/10; D370486).
Chlorothalonil exhibited low acute oral toxicity (Category IV), but in long-term (subchronic and chronic) oral dietary studies with rodents, chlorothalonil caused epithelialhyperplasia and hyperkeratosis at the limiting ridge and/ornon-glandularregion ofthe stomach. However, effects related to forestomach irritation (i.e., hyperplasia and hyperkeratosis ofthe non-glandular
area ofthe stomach) are not consideredrelevantfor human health risk assessment due to the lack ofahuman forestomach counterpart (HED CancerAssessmentReview Committee (CARC)- HASPOC meeting in 2008). There were also kidney effects that are relevantfor human-health risk assessment including weight increase (relative and absolute), dilation ofrenal medullary tubules, pelvic dilation, tubular cysts, and tubular degeneration. In 

### subchronic dietary studies with dogs, reported effects included infiltrationofinflammatory cells·in the liver ofboth sexes anddecreased body-weight gains in males. The effects in a chronic dietary study with dogs included decreased body-weight gain and food consumption, macroscopic and microscopic pathological findings in the stomach that included thickened appearance and intra-epithelial nuclearpyknosis in the mucosal epitheliumofthe antrum, and avery slight cell hypertrophy in the zonafasciculata ofthe adrenal glands.

In 

### one oftwo rabbit developmental toxicity studies, there was an increased incidence ofthirteen ribs and reduced sternebrae thatrepresented a small (2x) quantitative difference in susceptibility between fetal and maternal effect levels. However, the difference is often observed in the particular strain ofrabbit used and was not observed in anotherrabbit developmental study carried out inthe same strain ofrabbit and at the same doses ofchlorothalonil. In 

### one oftwo rat prenatal developmental toxicity studies, an increase intotal resorptions per dam with arelated increase inpost-implantation loss was reported at avery high dose (400 mglkg bw/day) inthe presence ofmaternal toxicity (i.e., clinical signs oftoxicity, decreases in 

### body-weightgain, and food consumption). Similarfindings were reported in arecently published mouse prenatal developmental toxicity study where very high doses ofchlorothalonil (400-600 mglkg bw/day) significantly affected the number oflive fetuses, were associated with early resorptions, and caused fetal weight deficits, all in the presence ofmaternal toxicity (Faraq, etal.; 

### 2006). In the 2-generationreproductive toxicity study, both parental animals and offspring exhibited pathological effects involving the forestomach that are not consideredrelevantfor humanhealth risk assessment. Based on the overall weight-of-evidence, there is no evidence ofincreased susceptibilityto offspring following in utero 

### exposure to rats orrabbits in developmental toxicity studies orfollowing pre/post-natal exposure in the reproductive toxicity studies in rats. The developmental effects reported in the rat and mouse prenatal developmental toxicity studies only
occur inthe presence ofsevere maternal toxicity and only athigh maternal doses.
The results ofa subchronic neurotoxicity study with chlorothalonil did notreveal any signs of neurotoxicity, onlybody weight and food consumption deficits were reported. There is no acute neurotoxicity (ACN) study available for chlorothalonil. The Agency denied awaiverrequest for the ACN studyrequirement on the basis that the highest dose evaluated inthat study was several orders ofmagnitude lowerthan the recommended limit dose without any dose-selectionrationale provided. Moreover, several clinical observations inthe LDso studies are indicative ofpotential neurotoxicity, including ataxia, ptosis, decreased muscle tone, tremors, and nervousness. Neurotoxicity in the absence oflethality is more likelyto be capturedby an acute neurotoxicity study consisting ofarobustfunctional-observational battery and motor-activity measurements. More details ofthe evaluation ofthe waiverbythe Agency are provided in the 2010 risk Page 90f53**~~---,--C~h_Iorothalonil** Registration Review Human-Health Assessment Scoping Document assessment (G. Kramer, 12/23110; D370486)
Chlorothalonil has been classified as a "likely" human carcinogen by all routes ofexposure based on an increased incidenceofrenal adenomas and carcinomas observed inboth sexes of rats and mice. The mechanistic data, including the negative findings ofall genetic toxicology testing, supported a non-neoplastic pathology as directly related to the eventual neoplasia and a non-linear mode ofaction for tumorproductionby chlorothalonil.

Chlorothalonil exhibited low acute toxicity viathe dermal route ofexposure (Category IV) and only caused moderate skin irritation (Category III). In longer-term dermal toxicity studies, the reported effects were local involving skin irritation (erythema) in the absence ofany systemic toxicity. In the previous risk assessment (G. Kramer, 12/23/10; D370486), chlorothalonil was classified as not being adermal sensitizer. However, apublished literature study in mice and guinea pig ranks chlorothalonil as an extremely potent contact allergen, inducing sensitization through topical exposures on intact skin (Boman 

### etai., 2000). The datafrom this study will be evaluated during registrationreview ofchlorothalonil.

In the lastrisk assessment (G. Kramer, 12/23110; D370486), there was no acute endpoint identified in the hazard database to quantitate the risk to the general population or to females 13- 50 years old from single-dose oral administration ofchlorothalonil. The cRill and incidental oral endpoints (short- and intermediate-term) were basedonkidney effects from rat chronic and subchronic studies, respectively. Dermal risk assessment (all exposure scenarios) was not performed based on the lack ofsystemic effects inrat dermal toxicity study inrats and the LOC for developmental toxicity and/or neurotoxicity being low. For inhalation exposure scenarios, an acute inhalation study was used with a composite FQPA SF of30x applied to short- and intermediate-termresidential inhalation exposures on the basis that there was no inhalation study ofappropriate duration (only acute studies are available) available for assessing risk from repeatedinhalation exposures. The composite FQPA SF of30x was made up of3x for the use of
a minimal LOAEL (no NOAEL achieved) from the acute inhalation study and a lOx factor for the extrapolation offindings ofan acute study to longer durations ofexposure. Similarly, a composite database UF of30x was applied to short- and intermediate-term occupational· inhalationexposure for the same reasons listed above. Based onthe lack ofincident datarelated to inhalation effects, the application ofthese UFs can be characterized as being conservative. The registrant(s) has consulted the Agency regarding the design ofan appropriate inhalation study to be submitted in the future. Once the appropriate inhalation study is submitted and evaluated by the Agency, some, ifnot all, the applied UFs canbe reduced accordingly.

In future risk assessments ofchlorothalonil, the FQPA SF may need to be updated based upon submission ofpending toxicity studies including inhalation, acute neurotoxicity, and immunotoxicity studies (see below). 

### Immunotoxicity An immunotoxicity study is required as a part ofnew data requirements in the 40 CFR Part 158 for conventional pesticide registration. Because the immuq.e system is highly complex, studies not specifically conductedto assess immunotoxic endpoints are inadequate to characterize a pesticide's potential immunotoxicity. While data from hematology, lymphoid organ weights, and histopathology in routine chronic or subchronic toxicity studies may offer useful information
on potential immunotoxic effects, these endpoints alone are insufficient to predict immunotoxicity. In the absence ofrequired studies, EPA may use a databaseUF ofup to 10X. An immunotoxicity study on chlorothalonil should be conducted. Once all datahave been Page 10 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document

--- 

### received and reviewed, the chlorothalonil RegistrationReview Teamrecommends that the PODs and safety factors used for risk assessmentpurposes be reexamined and anew risk assessment done, ifnecessary.
Endocrine Disruption As required by the Federal Insecticide, Fungicide, andRodenticide Act (FIFRA) and Federal Food, Drug, and Cosmetic Act (FFDCA), EPA reviews numerous studies to assess potential adverse outcomes from exposureto chemicals. Collectively, these studies include acute, subchronic, and chronic toxicity, including assessments ofcarcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints that maybe susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part ofits mostrecentregistration decision, EPA reviewed these data and selectedthe most sensitive endpoints for relevantrisk assessment scenarios from the existing hazard database. However, as requiredby FFDCA section 408(p), chlorothalonil is subjectto the endocrine screening part ofthe Endocrine Disruptor Screening Program (EDSP).
EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similarto an effect producedby a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." TheEDSP employs atwo-tiered approach to making the statutorily required determinations. Tier 1 consists ofabattery of 11 screening assays to identify the potential ofa chemical substance to interactwith the estrogen, androgen, orthyroid (E, A, orT) hormonal systems. Chemicals that go through Tier 1 screening and are found to havethe potential to interactwith E, A, orT hormonal systems will proceed to the next stage ofthe EDSP where EPA will determine which, ifany, ofthe Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine-related effects causedbythe substance, and establish a dose-response relationship between the dose and the E, A, orT effect.
UnderFFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the firstgroup of67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Chlorothalonil
was included on that list and has been issued an orderto conductthe Tier 1 testing; Once all required Tier 1 and Tier 2 datahave been received and reviewed, the endpoints and safety factors used for risk assessmentpurposes will be examined and anew risk assessmentperformed if necessary. Forfurther information onthe status ofthe EDSP, the policies and procedures, the list of67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit
our website: http://www.epa.gov/endo/.

Conclusions The currenttoxicity database for chlorothalonillacks the following studies according to the conditional and new 40 CFR Part 158 datarequirements: 870.3465 90-day inhalation study (rat) 870.6200 Acute neurotoxicity study 870.7800 Immunotoxicity study
Whenthe aforementioned studies are submitted, the currenttoxicity endpoint/dose selection may need to be re-evaluated along with the FQPA SFfor future risk assessments. Page 11 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document 

### 3.0 Residue Chemistry

The qualitative nature ofthe residue inplants is adequately understood based on acceptable metabolism studies with carrots, celery, lettuce, snap beans, and tomatoes. The residues of
concern are chlorothalonil and its 4-hydroxy metabolite, SDS-3701. The qualitative nature of the residue in livestock is adequately understood. The residue ofconcern in meat and milk is SDS-3701. Chlorothalonilperse has been shown to be so unstable inruminanttissues that it is impractical to establish tolerances that include the parent.
The Pesticide Analytical Manual (PAM) Vol. II lists Method I, a gas chromatography/electroncapture detection (GCIECD) method, for the enforcement oftolerances for plant commodities. The limit ofquantitation (LOQ) is 0.01 ppm for both chlorothalonil and its 4-hydroxy metabolite. Samples ofcrop commodities from recently submitted field trials were analyzed for residues ofchlorothalonil and its metabolite SDS-3701 using modified versions ofthe previously enforcementmethod entitled "ResidueAnalytical Method for the Determination of Chlorothalonil and R182281 in Crops." The lower limit ofmethod validation (LLMV) was 0.01 ppm for each analyte using gas chromatography/mass-selective detector (GC/MSD) analyses.
The FDA PESTDATA database (dated 06/05) indicates that chlorothalonil is completely recovered (>80%) using FDA multiresidue method Sections 302 (Protocol D), 303 (Protocol E), and 304 (Protocol F). The database also contains information for chlorothalonil trichloro impurity (trichloroisophthalonitrile), which is recovered (no quantitative information available) using Sections 302 and 303 but is not recovered using Section 304. The database does not contain any information for the 4-hydroxy metabolite. In the Chlorothalonil Residue Chemistry RED Chapter, the multiresidue method recovery datafor chlorothalonil trichloro impurity were incorrectly attributed to the 4-hydroxy metabolite; see DP#228522, W. Smith. Multiresidue method recovery data for the 4-hydroxy metabolite thus remain outstanding. Adequate crop field trial data are available to supportthe established tolerances on crops.
A 28-day ruminant feeding studyhas been reviewed and accepted by HED. HED recommended for the establishment oftolerances for the 4-hydroxy metabolite (SDS-3701) in meat and milk based onthe results ofthis study. The requirement for apoultry feeding study was waivedbased
onthe results ofthe poultry metabolism study. Adequate datapertaining to rotational crops are available. In response to an Agency evaluation ofconfined rotational crop data, the registrant submitted severalrotational crop studies. These data indicated that the only residue that was detected in rotated crops was the soil metabolite SDS-46851 (3-carbamyl-2,4,5-trichlorobenzoic acid). Because ofthe low toxicity ofthis metabolite, an exemptionfor the requirement ofa tolerance has been established for residues of SDS-46851 as inadvertentresidues in rotated crops (40 CFR §180.1110). In addition, the registrant's request to delete rotational crop restrictions from chlorothalonillabels was approved.


### Conclusions The qualitative nature ofthe residue inplants and livestock is adequatelyunderstood. The residues ofconcern are chlorothalonil and its 4-hydroxy metabolite (SDS-3701). The residue chemistry database is sufficientto support the currentregistrations. The following data requirementremains outstanding: multiresidue method recovery data for the 4-hydroxy metabolite.

Page 12 of53Chlorothalonil Registration Review Human-Health Assessment Scoring Document**.~~~~~- .~~~~~**  

### 4.0 Dietary Exposure
The mostrecent dietary exposure and risk assessment was performed in conjunction with the December 2010 human-health risk assessment conductedby HED (D370486, G. Kramer, etal.; 

### 23-DEC-201O). An acute dietary assessment was notperformedbecause no appropriate endpoint was available to determine the aRID for the general population or any population subgroup. A partially refined chronic dietary exposure and risk assessment was performedusing 100% CT for all crops; tolerance-level residues, and DEEM-FCIDTM 7.81 defaultprocessing factors for all foods exceptfor tomatoes (average field-trial residues and empirical processing factors used), peppers (average field-trial residues used), orangejuice (empirical processing factor translated from tomatojuice), and snap beans (average field-trialresidues used). Dietary risk estimates were determined considering exposures from food plus drinking waterusing EDWCs for surface water sources providedby EFED. Ground water sources were not included,
as the EDWCs for this drinking water source are minimal in comparisonto those for surface water.
The resulting chronic dietary risk estimates for food and drinking water combined are below HED's LOC [i.e., <100% ofthe cPAD of0.02 mglkg bw/day] for the overall

## u.s. population and all population subgroups. Using DEEM-FCIDTM, dietaryriskis estimated at41 % ofthe cPAD for the

## u.s. population and 98% ofthe cPAD for children 1-2 years old, the population subgroup with the highest estimated chronic dietary exposure to chlorothalonil. Dietary cancer risk concerns due to long-term consumption ofchlorothalonil residues are adequately addressed bythe chronic exposure analysis using the cPAD.

EFED has provided TierII EDWCs for use in drinking water assessments when chlorothalonil is used according to proposed labeling (Memo, R. Bohaty, 07-MAY-201O; DP# 370488). Because monitoring data are unavailable, estimates ofchlorothalonil and the major degradate SDS-3701 concentrations were made only with mathematical models. The models PRZMlEXAMS were used to conduct surface water exposure assessments. EDWCs were generated for the total residues ofconcern for risk assessment; parent chlorothalonil and the major degradate SDS-3701 (G. Kramer, etal., 12121/06; 

### DP# 332752). This drinking water assessment (DWA) used revised inputparameters to accurately reflect all scientifically available data, follow the most current inputparameter guidance, and correct all erroneous values used in the previous DWA (DP# D346321); resulting in significantly lower EDWCs. The highest estimated surface water concentrations were associated with the Georgia onion application scenario. Waterresidues (surface waterEDWC of0.006 ppm) were incorporated in DEEM-FCIDTM into the food categories "water, direct, all sources" and "water, indirect, all sources" for the chronic assessment.


### Conclusions The dietary-exposure database is adequate to supportthe existing registrations. However, anew dietary exposure and risk assessment may be required during RegistrationReview to incorporate potential changes to the chlorothalonil toxicological PODs and EDWCs.



### 5.0 Residential Exposure
Chlorothalonil is currently registered for use on turfgrass (including golfcourses), home gardens, and is formulated into paints (for interior and exterior applications), coatings, adhesives, caulks, sealants, grout andjoint compounds, wood stains, wood or wood structure protectiontreatments Page 13 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document (seasoned, unseasoned), and for mold control. A review was performed ofthe mostrecent Label Use Information System (LUIS) report (dated 9/14/11) prepared by the Biological and Economic Analysis Division (BEAD) to determine the currentresidential registrations, methods of application and maximum applicationrates for chlorothalonil. A summary ofthe home garden
uses is provided in Table**A4.2~** the golfcourse uses are summarized as part ofthe occupational
use summary in Table A4.1. Table A4.3 provides a summary ofthe registered paintuses. A summary ofthe antimicrobial uses is provided in Table A4.3.
Based on the registered uses, there·is the potential for residential handler andpost-application exposure, including the following: (1) post-application dermal and inhalation exposure from the
use on golf**courses~** (2) handler and post-application dermal and inhalation exposure from the
use onhome gardens; (3) handler and post-application dermal and inhalation exposure from the
use in treated paints. In the most recent risk assessment, exposures were assessed for residential handlers using treated paint, post-application exposure from inhaling vapors from treated paint, incidental ingestion oftreatedpaint chips, and bystander volatilization inhalation exposure from the agricultural uses. The potential for residential post-application dermal exposure from the use on golfcourses was**identified~** however, since no hazard had been identified viathe dermal route for chlorothalonil, no quantitative assessment was conducted. Post-application inhalation exposure was also identified as apotential exposure pathway for golfers on treated courses, but the residential bystander assessment was expected to coverthose potential exposures.


### Residential Exposure to Paints The most recent HED risk assessment (Memo, G. Kramer, 12/23/10, D370486) included an assessment ofresidential exposuresfrom the use oftreated paint, using the mostup-to-date toxicological PODs. The residential exposure assessment included inhalation risk estimates for residentialhandlers using treated paint (Table A5.I), post-application inhalationrisk estimates for residents from exposure to treatedpaint (Table A5.2), post-application incidental oral risk estimates for incidental ingestion ofpaint chips by children (Table A5.3), and aresidential bystander assessment to address potential volatilization ofchlorothalonil from treated fields (Table A5.4).

In that assessment, dermal risk was not quantified since no hazard was identified viathe dermal route for chlorothalonil. The inhalation endpoint was revised from previous assessments and
was based on effects observed in an acute inhalation study. The POD (a LOAEL of0.002 mgIL)
was converted to HECs for use in the exposure assessment for different durations. Foracute inhalation exposures, the LOC was 100 (3X for interspecies factor**extrapolation~lOX** for intraspecies**variations~** and 3X for lack ofNOAEL) and for longer-term durations, another lOx
was added to account for the use ofan acute duration study for longer-term exposures, making the LOC 1,000. The incidental oral endpoint was also revised from previous assessments and
was based on effects in a 90-day oral mouse study, with a LOC of 100.

Forresidential handlers usingtreated paint, there were no inhalation risks ofconcern for the acute exposure duration (all MOEs >LOC of 100), butthere were risks ofconcern for the shortterm exposure duration (all MOEs <LOC of 1000). Forpost-application inhalation exposure, a chemical-specific study (MRID 43600102) was available that measured air concentrations in a roomtreated with chlorothalonil and the data were used to assess indoorpost-application inhalation exposure. Usingthe available data, there were no risks ofconcern for acute**exposures~** however, there may be risks ofconcern for longer-term durations. There is no inhalation study ofappropriate length available to assess short- and intermediate-term exposures, therefore, HED relied upon an acute study (in which no NOAEL was achieved) to assess shortPage 14 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document 

### and intermediate-term exposure. HED believes that the submission ofa 90-day inhalation study (with acute toxicity measurements) is needed to refine the currentresidential risk assessments. Based on the lack ofincident data related to inhalation effects and the fact that an acute inhalationtoxicity study is being used to assess short- and intermediate-termrisk, the risk assessment canbe characterized as conservative. An assessment was also conducted for incidental ingestion ofpaint chips by children. The short-term incidental oral MOE was greater than 100 and, therefore, was not ofconcern.
AD also assesses dermal irritation for products thathave residential uses; however, this assessment was not included in the RED and will be done during registrationreview. Although not yetreviewed, there is a dermal toxicity study inrats (MRID 00158254) that indicates irritation effects occurred with a LOAEL of2.5 mglkg/day, which corresponds to a dose/concentration 2.5 mg/ml or 0.25 percent. This concentration is lowerthan the rates of0.5 and 1.0 percent allowed for interior and exteriorpaints and suggests that dermal irritationrisks may be ofconcern for antimicrobial uses ofchlorothalonil only. This study will be formally reviewed during Registration Review and the results will be used to determine whether a quantitative dermal assessment is needed.


### Residential 

### Post-application Exposure to Pressure-Treated Wood There is potential for dermal and incidental oral exposure to pressure-treated wood that is used in residential structures such as porches and steps. These exposures were not assessed in the RED; therefore, they may need to be assessed during registrationreview. There are three products (1022-584,50534-115,71581-2) that allow pressure treatment ofwood. Product71581-2 is labeled only for pressure treatment and canbe applied to wood used for a variety ofstructures, including porches and steps. Product 1022-584 canbe only applied as a co-ingredient with pressure-treatment solutions containing chromated copper arsenate (CCA) and the wood uses are not specified. Product 71581-2 canbe used in a similar manner with the exception thatthe primary ingredient is not identified.


### Residential Bystander Post-application Inhalation Exposure The Agency developed apreliminary bystander volatilization inhalation exposure assessment for chlorothalonil utilizing currently available inhalation toxicity and air monitoring data. The chlorothalonil bystander volatilization inhalation exposure assessment comparedthe maximum air concentration detected in each ofthemonitoring studies to the acute HEC for residential bystanders. This comparison was done to represent apotential resident who lives next to a treated field and may be exposed to the peakconcentration ofchlorothalonil volatilizing offthe field over a 24-hourperiod. III addition, the arithmetic mean chlorothalonil air concentration from each study was compared to the short-/intermediate-termHEC for residential bystanders. This comparison was done to represent apotential seasonal exposure. None ofthe air

. concentrations results in acute risks ofconcern; however, there were a couple ofaverage air concentrations from some sites that resulted in short-/intermediate-termrisks ofconcern. 

### Spray Drift Spray drift is always apotential source ofexposure to residents nearby to spraying operations. This is particularly the case with aerial application, but, to alesser extent, could also be a potential source ofexposure from the ground application method employed for chlorothalonil. The Agencyhas been working with the Spray DriftTaskForce, EPARegional Offices, and State Lead Agencies for pesticide**reg~lation** 

### and otherparties to develop the best spray drift managementpractices (see the Agency's SprayDrift website for more information at http://www.epa.gov/oppOOOOl/factsheets/spraydrift.htm). On a chemical-by-chemical basis, the Page 15 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document ----:-------,- Agency is now requiring interim mitigation measures for aerial applications that must be placed
on product labels/labeling. The Agency has completed its evaluation ofthe new database submittedby the Spray DriftTaskForce, a membership ofU.S. pesticide registrants,.and is developing a policy onhow to appropriately apply the data and the AgDRIFT® computer model to its risk assessments for pesticides applied by air, orchard airblast and groundhydraulic methods. Afterthe policy is inplace, the Agency may impose further refinements in spray-driftmanagementpractices to reduce off-target drift with specific products with significant risks associated with drift.

Conclusions There is sufficient information available to assess residential exposure and risk for all ofthe residential uses exceptpressure-treated wood and paint. The residential assessments thathave beenperformed by HED are reflective ofthe currentlyregisteredresidential uses, exceptfor the home garden and pressure-treated wood uses. In the most recent risk assessment, inhalation risk concerns for the short-/intermediate-term exposure durations were identified for residential handlers using treated paint, post-application exposure from inhaling vapors from treated paint, and for bystander volatilization inhalation exposure. As noted above, there is no inhalation study ofappropriate length available to assess short- and intermediate-term exposures, therefore, HED relied upon an acute study (in which no NOAEL was achieved) to assess short- and intermediate-term exposure. HED believes that the submission ofa 90-day inhalation study (with acute toxicity measurements) is needed to refine the currentresidential risk assessments. Based on the lack ofincident datarelated to inhalation effects and the fact that
an acute inhalation toxicity study is being used to assess short- and intermediate-termrisk, the risk assessment canbe characterized as conservative.

Assessments may need to be conducted for the registered home garden, treated paints/stains, and pressure-treated wood uses. HED has revised its Residential SOPs, including those used to determine exposure associated with treated paints/stains and home gardens. Registration review residential risk assessments will incorporate new guidance from the updated SOPs to refine exposure estimates as appropriate. In addition, in the most recent risk assessment, the Agency requested additional inhalation toxicity data that may affect the inhalation POD chosen for chlorothalonil. Ifchanges are made, exposure scenarios may need to be reassessed.

6.0 Aggregate-Risk Assessment
The mostrecent aggregate-risk assessment was performed in conjunction with theDecember 2010 human-healthrisk assessment conducted by HED (D370486, G. Kramer, etal.; 23-DEC2010). An acute aggregate-risk assessment was notperformed because no appropriate endpoint
was available to determine the aRID for the general population or any population subgroup. A chronic aggregate exposure assessmenttakes into consideration dietary food 

### + waterexposure only. The chronic dietary estimates represent chronic aggregate risk. In aggregating short- and intermediate-termrisk, the Agency routinely combines background chronic dietary exposure (food

### + water) with short- and intermediate-termresidential exposure. Because there is no systemic hazard via the dermal route, and since incidental oral exposure from treated paint is considered to be episodic, only inhalation exposures for homeowners applying chlorothalonil products could be included in the short- and intermediate-term aggregate risk assessment. However, as the endpoints for dietary exposure (kidney effects) andresidential short-term inhalation exposure (clinical signs) being used for the current assessmentare not the same, these exposures cannotbe combined. Page 16 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document 

### Conclusions A new aggregate risk assessment may be required during Registration Review to incorporate potential changes to the chlorothalonil toxicological PODs and EDWCs.



### 7.0 Occupational Exposure

Chlorothalonil is used as a fungicide to control fungal diseases ofagricultural crops, turf (including non-residential turf, commerciallindustriallawns, sod farms, and golfcourses), conifers (including Christmas tree plantations and nurseries), and ornamentals.(field- and greenhouse-grown). It is also used as a wood protectant, anti-mold and anti-mildew agent, bactericide, microbiocide, algaecide, insecticide, and acaricide. A review was performed ofthe most recent LUIS report (dated 9/14/11) prepared by BEAD to determine the current agricultural/commercial registrations, methods ofapplication and maximum application rates for chlorothalonil.A summary ofthe informationprovided in the LUIS report is provided in Table A4.1. The currentregistrations include several Special Local Needs registrations. 

### Occupational Handlers There is the potential for dermal and inhalation exposure to occupational handlers from the currentlyregistered use pattern ofchlorothalonil. In all pastrisk assessments, no chemicalspecific data were available with which to assess potential exposure to pesticide handlers; therefore, occupational handler assessments were based primarily on surrogate unit exposures from the Pesticide Handlers Exposure Database (PHED). Recently, both the OutdoorResidential Exposure TaskForce (ORETF) and Agricultural HandlerExposure TaskForce (AHETF) have produced pesticide handler exposure monitoring datathat the Agency is using inplace of PHED1

. As more-reliable databecome available (such as that from the AHETF and ORETF), the Agency will continue to replace existing exposure data. As a result, occupational handler scenarios may need to be revisited during Registration Review. Previous risk calculations were typically based on the maximum application rates and assuming maximum areatreated per day
or gallons handled. HaIidler's exposure and risk were calculated atbaseline (long pants, a longsleeved shirt, no chemical-resistant gloves, and no respirator) and with personal protective equipment when necessary (e.g., chemical-resistant gloves, respirators, and engineering controls).

The most recent occupational handler exposure assessment was conducted in December of2010 (Memo, K. Lowe, 23-DEC-201O; D371456). Numerous occupational handler scenarios have been assessed in the past; however, the toxicological PODs were revised for the most recent risk assessment and; therefore, only the exposure scenarios and resulting risk estimates from that assessmenthave been included in Table A6.1 ofthe attachments. As mentioned in the residential exposure section, dermal risk was not quantified in the most recent assessment since
no hazard was identified viathe dermal route for chlorothalonil and the inhalation assessment was conducted using a HEC calculated from a POD from an acute inhalation study. HED determined that inhalation risks were ofconcern for both acute exposures (i.e., MOEs were <100) and short-/intermediate-term exposure (i.e., MOEswere <1,000). Even though these risk estimates represent the latesttoxicological information, the exposure scenarios may need to be revisited during Registration Review to account for the revised handler surrogate-exposure data
now available.

1 http://www.epa.gov/pesticides/science/handler-exposure-data.html Page 17 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document

----_. 

### In aprevious risk assessment (D353243), HED had recommended that additional personalprotective equipment (PPE) be added to labels that allowed applications viahigh-pressure handwands due to risk concerns. Atthe time, a dust/mistrespirator (i.e., aPF5 respirator) was required to reach acceptableMOEs. During Registration Review, this scenario may need to be reassessed taking into account changes inbothhandler unit exposures and PODs to determine if
a respirator is still necessary.
There is one label registered for chlorothalonil for use on ornamentals that is co-formulated with another active ingredient, propamocarb. In 

### the mostrecent occupational exposure assessment for propamocarb (Memo, K. Lowe, 05-NOV-2009; D368432), areview ofthis label identified issues with the use directions that allowed for high application rates to be calculated, which resulted in risks ofconcernfor handlers. HED, EFED, and RD recommended revisions to the labeled use directions to clearly indicate the maximum application rates allowable that would notresult in worker and/or drinking waterrisks. Discussions with the registrants are currently on going and during Registration Review, the label will need to be checked to ensure the revised rates do not resultin risks ofconcern for chlorothalonil.
The mostrecent HED risk assessment did not cover all formulations (i.e., did not assess exposure from the use ofdry flowable and wettable powder formulations) and use sites currently registered for chlorothalonil. In 

### addition, as mentioned above, for the scenarios thatwere assessed, the unit exposures for those scenarios have subsequentlybeenrevised. Therefore, representative scenarios that coverthe currently registered chlorothalonil uses may need to be assessed during Registration Review to accountfor changes in exposure data and toxicological PODs.
With respect to the antimicrobial uses, the occupational handler exposures that occur from the
use ofchlorothalonil for material preservation were assessed in the RED; however, these assessments mayalso have to berepeated during registrationreview to account for changes in the toxicological PODs. In 

### particular, the handler exposures from the open pouring ofwettable powder will have to be reassessed because the antimicrobial wettable powderproducts are not packaged in water-soluble packaging as requiredby the RED. In 

### addition, exposures that occur from the use ofchlorothalonil as a wood preservative mayhave to be assessed because they have notbeen assessed previously. These exposures can occur during both during dip and spray treatments (i.e.,**sap~tain** 

### treatment) and during pressure treatment. 

### Occupational Post-Application In 

### the case ofchlorothalonil, there is apotential for post-application dermal exposure to workers following foliar and dip applications ofchlorothalonil to agricultural crops, turfuse sites, conifers, and ornamentals (both field and greenhouse grown). Since there is no dermal POD, an assessment ofpost-application dermal exposure and risk was not conducted and may not need to be conducted ifno change is made. Based on the Agency's currentpractices, a quantitative occupational post-application inhalation exposure assessment was notperformed for chlorothalonil atthis time. However, a quantitative assessment ofresidential bystanderrisk (for individuals in or around treated fields) was done based on available air monitoring data for chlorothalonil. The assessment ofbystanderrisk is expected to be protective ofall potential occupational post-application inhalation exposures.
Since there is no dermal endpoint and a quantitative post-application dermal exposure/risk assessment was not conducted for chlorothalonil, the REI would normallybebased onthe acute toxicity categories ofthe active ingredient. Chlorothalonil is classified in Acute Toxicity Page 18 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document Category IV for acute dermal toxicity, Toxicity Category III for primary dermal irritation, and Toxicity Category I for acute inhalationtoxicity and for primary eye irritation. For chlorothalonil, the REI would be 48 hours based on the Toxicity Category for primary eye irritation. However, the REI for chlorothalonil has been set at 12 hours previouslybecause the available incident data indicate that irritationto worker's eyes can occurbeyond the 48-hourREI [see Memo, M. Clock, 1/7/98, 

### The RevisedHED Chapterof the Reregistration Eligibility Decision (RED) Documentfor Chlorothalonil]. It was also noted that available residue dissipation data show thatresidues do not often dissipate significantly within 48 hours of application. In the absence ofa model in which to assess reentry exposure to compounds that have adverse eye effects, previous assessments have made recommendations for specific label language/product stewardship in lieu ofthe interim48-hourREI imposed bythe Worker Protection Standard (WPS). During Registration Review, a review ofthe REIs listed on the labels and the associated label language will need to be checked for consistency across products.

Conclusions There is sufficient information available to assess occupational handler andpost-application exposure and risk, except for wettable powder formulations, wood preservatives, and paints. In the mostrecentrisk assessment, inhalation risk concerns for occupational handlers were identified for both acute and short-/intermediate-term exposures. As noted above, there is
no inhalation study ofappropriate length available to assess short- and intermediate-term exposures, therefore, HED relied upon an acute study (in which no NOAEL was achieved) to
assess short- and intermediate-term exposure. HED believes that the submission ofa 90-day inhalation study (with acute toxicity measurements) is needed to refine the current occupational risk assessments. Based onthe lack ofincident datarelated to inhalation effects and the fact that
an acute inhalationtoxicity study is being used to assess short- and intermediate-termrisk, the risk assessment canbe characterized as conservative. Occupational handler scenarios may need to be reassessed during Registration Review to account for scenarios thathave not been covered previously, updated exposure data, and changes to the toxicological PODs. In addition, in the mostrecent risk assessment, the Agency requested additional inhalation toxicity datathat may affect the inhalation POD chosen for chlorothalonil. Ifchanges are made, exposure scenarios may need to be reassessed. During Registration Review, a review ofthe REIs listed onthe labels and the associated label language will need to be checked for consistency across products. A review ofthe labels will also need to be done to ensure all labels with registered turfuses include a statementprohibiting use on home lawns and otherresidential turfsites as required by the RED. In addition, a check ofthe omamentallabel co-formulated withpropamocarb will need to be done to ensure the revisions have been made regarding maximum allowable applicationrates.
A review was performed of(1) the datarequests from the RED, (2) the available submitted data for chlorothalonil, and (3) the granted data waiver requests. Table A7.1 ofthe attachments lists all ofthe submitted studies available for chlorothalonil and Agency reviews ofthe data. Data waiverrequests were submitted and granted in 2006 for the following studies:

• 132-1a

-- Foliar residue dissipation

• 133-3

-- Dermal passive dosimetry exposure

• 133-4

-- Inhalationpassive dosimetry exposure

• 231

-- Estimated Dermal exposure
- outdoors

• 232

-- Estimated Inhalation exposure
- indoors

Page 19 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document It 

### was determined that additional handler and post-application studies for the conventional uses are notnecessary at this point considering the datathathavebeen received inrecent years from various taskforces (e.g., ORETF,Agricultural Reentry TaskForce (ARTF), AHETF). In addition, since there currently are no dermal hazard concerns for the conventional uses of chlorothalonil, additional dislodgeable foliar residue and turf-transferable residue data are not required at this time. Exposure data are required to assess occupational handler inhalation exposures from certain antimicrobial use scenarios including wood preservation (dip, spray and pressuretreatment), openpouring ofliquids and wettable powders during material preservation and application of treated paints.



### 8.0 Public Health and PesticideEpidemiologyData

Forthis evaluation, the opp 

### IncidentData System (IDS) was utilized for pesticide incident data
on the active ingredient chlorothalonil. Chlorothalonil acts primarily as afungicide and mildewcide, but also has some activity as abactericide, microbiocide, algaecide, insecticide, and acaricide. It 

### is abroad-spectrum, non-systemic pesticide. Chlorothalonil is registered on awide variety ofsites including field, vegetable, and orchard crops; turf; and as a mildewcide to be added to paint and other surface treatments. The purpose ofthe database search is to identify potential patterns in the frequency and severity ofthe healtheffects attributed to chlorothalonil exposure. The IDS includes reports ofalleged humanhealth incidents from various sources, including mandatory FIFRA Section6(a)(2) reports from registrants, otherfederal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevantproduct informationrecorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated inthe report.
The Agricultural Health Study (AHS) is ahigh-quality, prospective epidemiology study evaluating the linkbetween pesticideuse and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. The AHS includes information on use of50 differentpesticide active ingredients commonlyused in agriculture.
Incidents resulting inhigher severity outcomes reported by registrants and incidents reported directly to the Agencyby non-registrants are recorded in an IDS module called the Main IDS module. This system stores incidentdata for death, major and moderate incidents (and some minor orno effects incidents that are reported as unique cases to the Agency), and it includes
more details aboutthe location, date and nature ofthe incident. Main IDS incidents involving only one pesticide are considered to provide more certain information about the potential effects ofexposure from the pesticide. When an incident involves more than one pesticide, it is difficult to determine which effects are attributed to the pesticide being considered. The less-severe human incidents (minor, unknown, orno effects outcomes) are reported by registrants as counts called aggregate summaries and are recorded in a separate module called Aggregate IDS.

In Aggregate IDS, which contains exposures classified as minor,unknown, orno effects outcomes, from January 1,2006 to November 2,2011, there were 117 reported exposures involving chlorothalonil resulting in low severity. As discussed, there are relatively few details provided onthe incidents in the Aggregate IDS module and these incidents are low severity.

Page 20 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document 

### Forthe Main IDS, from January 1, 2006 to November 2,2011, there are 22 exposures reported for single chemical only in the database (20exposure classified as resulting in amoderate outcomeand 2 classified as major), and 12 additional exposures that involved more than one chemical. During the scoping phase ofRegistrationReview, the higher severity exposures (those resulting in fatal ormajor outcomes) are considered inmore detail. Additionally, as described above, incidents involving one pesticide are typically focused onbecause they are considered to provide more certain information about the potential effects ofthe particularpesticide. The higher severity exposures (those resulting in fatal ormajor outcomes) that involve chlorothalonil
are described in Table 1 (two major outcomes). Currently available research from the AHS does notprovide strong evidence in support ofan associationbetween chlorothalonil and all cancers combined, or with lung, colorectal, and prostate cancers specifically, the only anatomical cancer sites for which authors were able to measure an association. The authors note that alinkbetweenthe pesticide andkidney tumors, which havebeen reported in some animal studies, was not investigated in this study due to limited number ofexposed cases to perform arobust statistical analysis. A 

### preliminary study linked chlorothalonil exposure (yes/no) and monoclonal gammopathy ofundetermined significance (MGUS), apre-cursorbiomarkerofpotential multiple myeloma malignancy; however, additional mechanistic and epidemiologic research is needed to clarify the nature of this relationship.
In 

### general, both the Aggregate and Main IDS modules result in relatively high frequency of chlorothalonil exposures. Although most ofthese exposures resulted in low-severity outcomes, high-severity outcomes did occur. Based on the frequency and severity ofincidentcases and AHS results, for chlorothalonil, there maybe apotential forexposure. These incidentdata may warrantfurther analysis inthe preliminary risk assessmentphase ofRegistration Review.

Major(iftheperson alleged or exhibited symptoms which mayhavebeen life-threatening, orresulted in adverse
re roductive effects orin residual disabili ) Death (ifthe erson died) 017747-

00505

022933

-

00030 5/30/06 GARDEN DISEASE CONTROL

10/1109 MULTIPURPOSE FUNGICIDE

DACONIL 2787 000239- PLAINFIELD 02522

000239-

02522 IL

CA lIB

lIB An unknown age adultfemale got the product onher arm and shoulder. About 3 weeks later she wentto the hospital feeling dizzy and like she was falling to theri ht. A senior (>65 years old) female sprayed herpeach tree infall of2009 and spring of 2010. She has experienced episodes ofhigh sed rate, low hemoglobin and pain inher hi s and legs ever since.

H-C HumanModerate Moderate (iftheperson alleged or exhibitedsymptoms morepronounced, moreprolonged orofa more systemic nature than minorsymptoms; and involved some form oftreatment, even though symptoms were not life threatenin and the erson returned to hislher re-ex osure state ofhealth withno additional residual disabili ) H-D Human Minor Minor(iftheperson alleged orexhibited some symptoms, butthey wereminimally traumatic; the symptoms resolvedra idl and usuall involve skin, e e orres irato irritation) H-E Human Unspecified Unspecified (ifsymptoms are unknown,unspecified orare alleged to be ofa delayed orchronic nature thatmay a earin the future) Page 21 of53Chlorothalonil Registration Review Human-Health AssessmentScoping Document 

### I H 

### I Human 

### I Undetennined (an undetennined severity)

from 40 CFR § 159.184



### 9.0 Tolerance Assessment

### and International Harmonization



## u.s. permanenttolerances (listed in40 CFR 180.275) and Canadian and Codex maximum residue limits (MRLs) are summarized inAttachment 8. The U.S., Canadian, and Codex tolerances/MRLs for residues ofchlorothalonil are generally not harmonized. Forplant commodities, the U.S. and Canadianresidue definitions are harmonized; however, the Codex residue definition is notharmonized, as it does not include the 4-hydroxy metabolite. Only tolerances/MRLs for residues in cherries and tomato are harmonized with Canada and Codex. Several tolerances/MRLs for residues in/on various commodities are harmonized with Canada (i.e., asparagus, carrots, celery, lentils, mushroom, parsnips, peaches, peanuts, and cucurbit vegetables), butnot with Codex. Two tolerances/MRLs are harmonized with Codex (cranberry, bulb onions), butnot with Canada. There are several U.S. tolerances for which there are not Canadian and/orCodex MRLs (e.g., almond, apricot,banana, blueberry, tropical fruits, ediblepodded peas, plums, and fruiting vegetables excepttomato). Several tolerances/MRLs for residues in/on various commodities are not harmonized between eitherthe U.S., Canada, or Codex (e.g., dry bean seeds, 

### Brassicahead and stem subgroup, and potatoes). The U.S. and Codex residue definitions for livestockcommodities are harmonized and the U.S. and Codex have establishedMRLs for residues in cattle, goats, hogs, horses, and sheep commodities at different levels. Canadian MRLs are not established for residues in livestock commodities. Codex has established MRLs for residues inbarley, currants, gooseberry, grapes, leeks, Chinese onions, welsh onions, parsley, poultry commodities, strawberries, sugarbeets, and wheat commodities; however, Canadian and U.S. tolerances/MRLs are not established for residues in these commodities. Mexico adopts U.S. tolerances and/or CodexMRLs for its exportpurposes.



### 10.0 Environmental Justice
Potential areas ofenvironmentaljustice concerns, to the extentpossible, were considered in the human-health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations," (http://www.hss.energy.gov/nuclearsafety/env/guidance/justice/eoI2898.pdf). The OPP typically considers the highestpotential exposures from the legal use ofapesticide when conducting human-health risk assessments, including, butnot limited to, people who obtain drinking water from sources near agricultural areas, the variability ofdiets withinthe U.S., and people who may beexposed whenharvesting crops. Shouldthese highest exposures indicate potential risks ofconcern, OPPfurther refines the risk assessments to ensure that the risk estimates are based on the best available information.



### 11.0 Human Studies

Past chlorothalonil risk assessments rely in part on data from studies in which adulthuman subjects were intentionally exposed to apesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many differentpesticides, comprise generic pesticide exposure databases such as PHED, the ORETF Database, and the ARTF Database. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, andhas found no clear and convincing evidence that the conduct ofany ofthem was either Page 22 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document

------- 

### fundamentally unethical or significantly deficientrelative to the ethical standards prevailing at the timethe research was conducted. All applicable requirements ofEPA's Rule for the ProtectionofHuman Subjects ofResearch (40 CFR Part 26) have been satisfied, and there is no regulatory barrierto continued reliance onthese studies.



### 12.0 Data Requirements Toxicology:

• The toxicity endpoint/dose selection along with the FQPA SF may need to be reevaluated according to currentpolicy.

• The following studies are required as specified in the revised 40 CFR Part 158:
o Guideline 870.3465 90-day inhalation study (rat)
o Guideline 870.7800 immunotoxicity, and
o Guideline 870.6200 acute neurotoxicity.


### Residue Chemistry:

• Multiresidue method recovery data for the 4-hydroxy metabolite (Guideline 860.1360).

• The tolerance expression for chlorothalonil residues needs to be updated to reflect current Agency policy under40 CFR §180.275(a)(l): "Tolerances are established for residues of chlorothalonil, including its metabolitesand degradates, in or on the commodities inthe table below. Compliancewith the tolerance levels specifiedbelow is to be determined by measuring only chlorothalonil (2,4,5,6-tetrachloro-l,3-benzenedicarbonitrile) and its metabolite 4-hydroxy-2,5,6-trichloro-l,3-benzenedicarbonitrile, calculated as the· stoichiometric equivalent ofchlorothalonil, in or on the commodity," and under40 CFR §180.275(a)(2): "Tolerances are established for residues ofchlorothalonil, including its metabolites and degradates, in or onthe commodities inthe table below. Compliance with the tolerance levels specifiedbelow is to be determined by measuring only4- hydroxy-2,5,6-trichloro-l,3-benzenedicarbonitrile in or on the commodity." 

### Dietary Exposure: • A new dietary exposure and risk assessment may need to be conducted to incorporate potential changes to the chlorothalonil toxicological PODs and EDWCs. 

### OccupationallResidentiai Exposure: • A revised occupational/residential exposure and risk assessment is required.

• There are three exposures studies that are needed to assess occupational/residential exposure scenarios. These studies are listed in Table 2.

Page 23 ofS3Chlorothalonil Registration Review Human-Health Assessment Scoping Document

InhalationExposure, Indoor Exposure Monitoring Data Reporting

Surface Residue Dissi ation ProductUse Information Open-pour liquids during material preservation. ' Open-pour wettablepowders during material preservatiouA,B Brush/roller application oftreatedpaintsB Airless sprayer application oftreated paintsB Di , s ray, and ressure treatment ofwoodB 875.2300 Residential ex osure to ressure-treated wood 875.1700 A detailed written description is needed ofall the antimicrobial
uses ofchlorothalonil to define and characterize exposure scenarios. A. Ifthe labels are amended to require closed mixing/loading; then the exposure study for this scenario can be waived. B. It may be possibleto use proprietary surrogate exposure data ifdata compensation issues canbe addressed.



### 13.0 References

G. Kramer, etat.

G.Kramer

G. Kramer

R. Bohaty

G. Kramer, etat.

G. Kramer

G. Kramer

G. Kramer

L. Shanaman

G. Kramer D370486

D371455

D371454

D370488

D371946

D370763

D373460

D351364

D346321

D346319 23-DEC-2010

23-DEC-2010

23-DEC-2010

07-MAY-2010

18-FEB-2010

18-FEB-2010

18-FEB-2010

01-MAY-2009

02-APR-2008

04-SEP-2008 Chlorothalonil. Registration Request for Use on LowGrowing Berry Subgroup 13-07G; Bushberry Subgroup 13- 07B; Onion, Bulb Subgroup 3-07A; and Onion, Green Sub rou 3-07B. Human-Health Risk Assessment. Chlorothalonil: Chronic Dietary (Food and Drinking Water) Exposure and Risk Assessment to Support a Petition For Tolerances onLow-Growing Berry Subgroup 13-07G; Bushberry Subgroup 13-07B; Onion, Bulb Subgroup 3- 07A; and Onion, Green Sub rou 3-07B. Chlorothalonil. PetitionFor Tolerances Low-Growing Berry Subgroup 13-07G; Bushberry Subgroup 13-07B; Onion, Bulb Subgroup 3-07A; and Onion, Green Subgroup 3-07B.

.Summary ofAnalytical Chemistry and Residue Data. Drinking Water Assessment for the IR-4 Registration of Chlorothalonil (Bravo Weather Stick®, 54%) and the DegradationProduct, 4-Hydroxy-2,5,6-trichloro-l,3- dicyanobenzene (SDS-3701) for the New Uses On: Bulb Ve etables, Bushberries, and Low Growing Berries. Chlorothalonil•.Section 18 Emergency Exemption Registration RequestForUse on Oranges in CA. HumanHealth RiskAssessment. ChIorothalonii. Request for Conditional Registration Bravo 825® (EPA Reg. No. 50534-201) to Add Uses on Fruitin Vegetables. Chlorothalonil: Chronic Dietary (Food and Drinking Water) Exposure and Risk Assessment to Support Section 18 RegistrationRe uestForUse on Oranges in CA. Chlorothalonil Technical Fungicide

- Review ofResidue Chemistry Studies Submitted by Vischim S.R.L. Drinking Water Assessment for the IR-4 Registrationof Chlorothalonil (Bravo Weather Stick®, 54%) and the DegradationProduct, 4-Hydroxy-2,5,6-trichloro-l,3- dicyanobenzene (SDS-3701) for the New Uses on: Fruiting Vegetables, Cucurbit Vegetables, Okra, Persimmon, Horseradish, Rhubarb, Ginseng, Yam, Lupin, Lentils and BrassicaHead and Stem Vegetables. Chlorothalonil. PetitionForTolerances onBrassica Head and Stem Subgrou 5A, Cucurbit Vegetable Grau 9, Page 24 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Fruiting Vegetable Group 8, Ginseng, Horseradish, Lentil, Lupin, Okra, Persimmon, Rhubarb, Yam, Lychee, and Starfruit. Summary ofAnalytical Chemistry and Residue Data.

G. Kramer, etat.

G. Kramer

G. Kramer, etat.

L. Shanaman

G. Kramer

G. Kramer, etat.

J. Tomerlin D353243

D323612

D337925

D306584

D332540

D332752

D310791 09-0CT

-2008

03-MAR-2006

16-MAR-2007

04-AUG-2006

14-SEP-2006

21-DEC-2006

09-FEB-2005 Chlorothalonil. PetitionForTolerances onBrassica Head and Stem Subgroup 5A, CucurbitVegetable Group 9, FruitingVegetable Group 8, Ginseng, Horseradish, Lentil, Lupin, Okra, Persimmon, Rhubarb, Yam, Lychee, and Starfruit. Human-Health Risk Assessment. Chlorothalonil Technical Fungicide

- Review ofResidue Chemistry Studies Submittedby Vischim S.R.L. #3E6795. Chlorothalonil: Updated Revised Risk Assessmentfor aTolerance onEdible-Podded Peas Without aU.S. Re istration. FurtherRefined Drinking Water Assessment Characterization for the Me Too Registration of Chlorothalonil and the DegradationProduct, 4-Hydroxy2,5,6-trichloro-1,3-dicyanobenzene (4-Hydroxy-2,5,6- tricloroiso hthalonitrile; SDS-3701) in Surface Water. Chlorothalonil: Preliminary Chronic DietaryExposure Assessment for a Tolerance onEdible-PoddedPeas Without a U.S. Re istration. PP#3E6795. Chlorothalonil: Revised Risk Assessment for aTolerance on Edible-Podded Peas Without a U.S. Re istration. ARIA Risk Assessment: Chlorothalonil HumanHealth Exposure and Risk Assessment for a ToleranceWithout a Registration in the United States onEdiblePoddedPeas (includin snow eas and su ar sna s).

J. Tomerlin

L. Rossi

W. Smith

M. Clock

W. Smith

W. Smith D310791 15-DEC-2004

EPA 738- April 1999 R-99-004

D257651 12-JUL-1999

07-JAN-1998

D232879 30-JUN-1997

D237223 30-JUL-1997 Chlorothalonil: Acute and Chronic Dietary Exposure Assessments for a Tolerance on EdiblePoddedPeas Without a US Re istration Chlorothalonil ReregistrationEligibility Decision (RED).

CHLOROTHALONILREREGISTRATION. Reassessment ofTolerance Exemption for the Soil Metabolite 3-carbamyl-2,4,5-trichlorobenzoic acid (40 CFR §180.1110). The Revised HED Chapter ofthe Reregistration Eligibility Decision (RED) Document for Chlorothalonil. Chlorothalonil Reregistration: List A CaseNo. 0097: Chemical No. 081901: ISK-Bioscience's Submission of Magnitude ofthe ResiduesofChlorothalonil on Sweet Corn. PP#6F4611. Chlorothalonil. PetitionMethod Validation Results for the Metabolite SDS-3701.

M. Clock

S. Knizner M. Clock

W. Smith

W. Smith D244490
D249046

D240979

D228522 1O-JUN-1998
01-SEP-1998 07-May-1997
23-DEC-1997

1O-AUG-1996 Chlorothaloni1: HED Response to ISKBiosciences February, 1998 Comments on the HED Science Chapter (dated November 25,1997). HED Review ofChlorothalonil RED. The HED Chapterofthe ReregistrationEligibility Decision Document (RED) for Chlorotha1onil. PP#6F4611. Chlorothalonil. Revised EnforcementMethod for the Metabolite SDS-3701. Chlorothalonil: Reregistration Case No. 0097: Chemical No. 08190: Comments from ISK Biosciences on the Chlorothalonil HED RED Cha ter. Page 25 of53Chlorothalonil Registration ReviewHuman-Health Assessment Scoping Document

W. Smith

C. Lewis

C. Lewis

C. Lewis

J. Evans

J. Evans

J. Evans

J. Evans

J. Evans

D. Smegal

M.Dow

S. Tadayon

M.Dow

M.Dow

J. Evans

K.Lowe D201522

D2l7313

D220337

D221Ol6

D201524

D201524

D228520

NA

NA

D295139

D3l8049

D327361

D3l7058

D346460

D343367

D371456 13-JUN-1995

l7-JUL-1995

01-NOV-1995

29-NOV-1995

22-JAN-1997

07-DEC-1995

20-AUG-1996

08-MAY-1997**20-JUL~1999**

l6-JAN-2004

l5-JUN-2005

06-MAR-2006

2l-DEC-2006

l4-JUL-2008

30-MAR-2009

23-JUL-2010 Chlorothalonil: ListA Reregistration Case No. 0097: Chemical ill No. 081901: Product and Residue Chemistry Considerations to be Included in the HED Chapter ofthe ReregistrationEligibilit DecisionDocument. Exposure Assessment for Section 18 Use ofChlorothalonil and Propamocarb onTomatoes. Exposure Assessmentfor Section 18 Use ofChlorothalonil and Propamocarb onTomatoes inFlorida. Exposure Assessment for Section 18 Use ofChlorothalonil andPropamocarb Hydrochloride onIrishPotatoes. Revised Occupational And Residential Exposure AssessmentForThe Chlorothalonil Reregistration Eli ibilit Decision (RED). Occupational And Residential Exposure AssessmentFor The Chlorothalonil ReregistrationEligibility Decision (RED). OREB Comments Regarding ISK Biosciences' Response To The HED Draft ChapterForThe Chlorothalonil RED. Revised MixerlLoader/ ApplicatorExposureEstimates (Based On 100% Inhalation Absorption) For The Chlorothalonil ReregistrationEligibilit Decision (RED). IndianaPetitionRequest

-Reduction OfREIFrom48 Hours To 0 Hours For Applications OfReduced Rate (0.78 Ai/Acre) OfChlorothalonil To Muskmelons. Chlorothalonil: Evaluation ofnew use for mold control on treated wood and wallboard in**bUildin~** to support a labeling amendment for CLORTRAM F-40 Plowable Fun icide (EPA Re

. No. 72304-1). Chlorothalonil-Re uested DataWaivers Study Review: Determination ofDermal and Inhalation Exposure to Reentry Workers During Maintenance Activities in GolfCourses" (MRID#467340-01), DP Barcode 327361. Chlorothalonil

- Consideration ofRequestfor DataWaivers b Vischim S.r.l. CHLOROTHALONIL

- ExposurelRiskAssessmentfor the Proposed Uses of Chlorothalonil onFruiting Vegetables, Cucurbits, Persimmon, Rhubarb, Horseradish, Ginseng, Yam, Okra, Lupin, Lentil, and Head and Stem Brassica. Secondary Review ofAHETFField Studies: AHE17-21. Chlorothalonil: Occupational and Residential ExposurelRiskAssessment ofProposed Section 3 Uses on Strawberry (and otherlow growing berries), Bushberry (lowbushberry subgroup, exceptcranberry) and Bulb Ve etables. (RE-ISSUED) Health Effects Division (HED) Review of Agricultural HandlerExposure TaskForce (AHETF) Monograph: Open PourMixing and Loading DryPlowable Formulations J. Dawson, etal. D373605 ll-MAR-2011 (RE-ISSUED) HealthEffects Division (HED) Reviewof Agricultural HandlerExposure TaskForce (AHETF) Monograph: OpenPourMixing and Loading Liquid Formulations Page 26 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document

(RE-ISSUED) Health Effects Division (HED) Review of Agricultural HandlerExposure TaskForce (AHETF) Monograph: Open Cab Ground BoomApplication of Li uid S rays

M. Crowley

M. Crowley D381l48

D393093 28-APR-20ll

22-SEP-20ll Review ofAgricultural HandlerExposure TaskForce (AHETF) Closed Cab AirblastApplicatorExposure Monitoring Studies: AHE55, AHE56, AHE57, AHE58, AHE59. HED Secondary Review ofChlorothalonil Handler Exposure During Applications ofDaconil 2787 Plowable Fun icide in Greenhouses.


### Literature: Faraq AT., Karkour T.A, El Okazy A, Embryotoxicity oforaladministered chlorothalonil in mice. Birth Defects Res B Dev Reprod. Toxico!. 2006 Apr:77(2):104-9.

Boman A, Montelius, J., Rissanen, R.L., and Liden, C. 

### Sensitizing potential ofchlorothalonil in the guineapig and the mouse. ContactDermatitis 2000, 273-279

Lensen 

### etai., ContactDermatitis Causedby Chlorothalonil on Imported Roses: Irritant or Allergic Reaction. Contact Dermatitis, Volume 65, Issue 1, pp 50 -U97, 2011.



### Attachments:
Attachment 1: Chemical Identity Table. Attachment 2: ChlorothalonilEndpoint Selection Tables. Attachment 3: Exposure Potentialfor Adult and Child Aggregate Risk Estimates. Attachment 4: Occupational Use PatternslExposure Scenarios for Chlorothalonil. Attachment5: Residential Handler and Post-application Scenarios Assessed and Risk Estimates. Attachment 6: Occupational HandlerScenarios Assessed and RiskEstimates. Attachment 7: Submitted OccupationallResidential Exposure Studies for Chlorothalonil Attachment 8: Chlorothalonil International Residue Limit Status Sheet.

cc: K. Lowe (RAB1), G. Kramer (RABl), C. Rodriguez (RABl) RDI: RABl (11124/11), S. Knizner (12120/11) G.P. Kramer:S 10957:PY-S:(703)305-5079:7509P:RAB 1 Page 27 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document 

### Attachment 1: Chemical Identity Table.

TABLE AI. Test Compound Nomenclature. Compound CN
Cl "":: Cl 

# I
Cl CN
Cl Common name Chlorothalonil Company experimental name N/A IUPACname tetrachloroisophthalonitrile CAS name 2,4,5,6-tetrachloro-I,3-benzenedicarbonitrile CAS registry number 1897-45-6 Compound CN
Cl "":: Cl 

# I

Cl CN
OR Common name 4-Rydroxy metabolite Company experimental name SDS-370l IUPACname 2,4,5-trichloro-6-hydroxyisophthalonitrile CAS name 4-hydroxy-2,5,6-trichloro-l,3-benzenedicarbonitrile CAS registry number Not provided

Page 28 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document 

### Attachment2: Chlorothalonil Endpoint

### Selection Tables.**Tabl~A.2.1.~llll1lllaryl)f l'o:rcicol~gicall!:nclP()illtsal)dP()DsfQr**  CI1IQrotMlonilUsed.illJbe2010·Diet3ryallcl ResidentialRiskAssessment. Exposure Dose Used in Risk Study and Relevant Scenario Assessment, UF FQPA SF OR LOC**Toxicolo~ical** Effects Acute Dietary- Anendpoint ofconcern (effect) general population, attributable to a single dose was including infants not identified inthe database. and children N/A Quantification ofacute risk to general population including infants and children is not required. Acute Dietary- An endpoint ofconcern (effect) females 13-49 attributable to asingle dose was years old N/A not identified in the database. Quantification ofacute risk to females 13-49 years old is not required. Chronic Dietary- Chlorothalonil chronic general population, toxicity/carcinogenicity

- rat. including infants NOAEL=2.0 FQPASF= IX LOAEL = 4.0 mg/kg/day, based and children mglkg/day cRfD = cPAD onkidney effects consisting of UP= 100 = 0.02 mg/kg/day epithelial hyperplasia intherenal proximal convoluted tubules of female rats. Short-Term NOAEL=41.3 LOC = MOE = 100 Chlorothalonil 90-day

- mouse: (1-30 days) mg/kg/day (residential/recreational; LOAEL = 113 mg/kg/day, based Incidental Oral includes the FQPA SF = IX) on kidney effects consisting of Intermediate-Term NOAEL=41.3 LOC = MOE = 100 minimal to slight (severity) (1-6 months) mglkg/day (residential/recreational; hyperplasia ofthe epithelium of Incidental Oral includes the FQPA SF = IX) the proximal convoluted tubules. Short-(1-30 days) Quantification ofdermal risk is and Intermediate N/A notrequired. (1-6 months)-Term Dermal Acute Inhalation Chlorothalonil- Acute inhalation100 rat: LOAEL = 0.002 mgILbased LOAEL HEC= (3X interspecies, on clinical signs consisting of

= 0.002 0.0004 lOX intraspecies, hypoactivity, gasping,

mg/L mglL lacrimation, nasal discharge, 3XFQPA) piloerection, ptosis, and respiratory gurgle. Short-Term Chlorothalonil- Acute inhalation- (1-30 days) LOC = 1000 rat: LOAEL = 0.002 mgILbased Inhalation LOAEL HEC= (3X interspecies, on clinical signs consisting of Intermediate-Term = 0.002 0.00006 lOX intraspecies, hypoactivity, gasping, (1-6 months) mg/L mg/L lacrimation, nasal discharge, Inhalation 30XFQPA) piloerection, ptosis, and respiratory gurgle. Long-Term Long-term inhalationexposures (>6 months) N/A are not expected to occurbased Inhalation on the registered/proposed uses. Cancer (oral, Classification: "Likely" to be ahuman carcinogenby all routes ofexposure(HED CPRC, 4th dermal, inhalation) Meeting, 6/1111997); however, the SAP decision (6/30/98) supports the use ofan MOE approach inrisk assessment for chlorothalonil. The HASPOCdeliberated on 3112/08 and supported the MOE approach. UP = uncertamty factor, FQPA SF = FQPA Safety Factor, NOAEL = no-observed-adverse-effect level, LOAEL = lowestobserved-adverse-effectlevel, RID = reference dose (c

### =chronic), PAD = population-adjusted dose, MOE = margin ofexposure, Page 29 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document**--=-==---=------=---=--------:~c--.** LOC

### =level ofconcern, N/A

### =not applicable, CPRC

### =Carcinogenicity Peer Review Committee, SAP

### =Scientific Advisory Panel, HASPOC

### =Hazard Assessment and Policy Committee, HEC

### =human-equivalent concentration.

Table A2.2. Summary ofToxicologicalEndpoints and PODs for Chlorothalonilin the 2010 Occupational Exposure RiskAssessments. Exposure DoseUsed inRisk Scenario Assessment Short-(1-30 days) and Intermediate (1-6 months)- TermDermal 

### HEC

N/A LOCforRisk Assessment Study and Relevant**Toxicolo~ical** Effects Quantification ofdermal risk is notrequired.
Acute Inhalation

Short-Term (1-30 days) Inhalation Intermediate-Term (1-6 months) Inhalation LOAEL

## =0.002 mglL 0.001 mgIL

0.0003 mgIL 100 (3X interspecies, lOXintraspecies, 3X for no NOAEL) 1000 (3X interspecies, lOX intraspecies, 3X forno NOAEL lOX for exposure duration) Chlorothalonil- Acute inhalation- rat: LOAEL = 0.002 mgILbased on clinical signs consisting of hypoactivity, gasping, lacrimation, nasal discharge,

piloerection, ptosis, and respiratory gurgle. Long-Term Long-terminhalation exposures (>6 months) N/ A are not expectedbased onthe Inhalation registered/proposed uses. NOAEL

### =no-observed-adverse-effect level, LOAEL

### =lowest-observed-adverse-effect level, LOC

### =level ofconcern, N/A

### =not applicable, HEC = human-equivalent concentration.

Page 30 of53__ __ Chlorothalonil Registration Review Human-I:Iealth Assessment Scoping Document 

### Attachment 3: Exposure Potential for Adult 

### and Child Aggregate 

### Risk Estimates. (FromD370486, G. Kramer, 

### etal.; 23-DEC-201O)

Table A3. Summary ofChronicDietary Exposure and Riskfor Chlorothalonil (Food + Water). Age Group cPAD (mglkg/day) Exposure (mg/kg/day) %cPAD General U.S. Population 0.02 0.008119 41 AllInfants 

### « 1 year old) 0.02 0.008653 43 Children 1-2 years old 0.02 0.019630 98 Children 3-5 years old 0.02 0.016483 82 Children 6-12 years old 0.02 0.010663 53 Youth 13-19 years old 0.02 0.006142 31 Adults 20-49 years old 0.02 0.006480 32 Adults 50+ years old 0.02 0.007754 39 Females 13-49 years old 0.02 0.006573 33 *The values for the hIghest exposed populatIOnfor each type offIsk assessment are balded.

Page 31 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document

------- 

### Attachment4: Summary ofOccupational and Residential Registered Uses Pulled From LUIS Report (dated 9/14/11).

Table A4.1. OccupationalRegistered Uses. Application Maximum Use Site Formulation Method Application Rate Re-entry Equipment (lb ailA unless Interval otherwise noted)
Almond Liquid Aerial, Airblast 3 12hr Dry Flowable Dry Flowable Aerial, Airblast 3.1 12 hr 12 hr Apricot Liquid Chemigation 3.1 12hr Ready-to-Use

. Sprayer Apply to point of NS runoff Asparagus Liquid Aerial, 3 12 hr Dry Flowable Groundboom Banana Liquid Airblast 1.5 NS (SLN PR040006) Dry Flowable Aerial, Groundboom, 2.3 12 hr Liquid Chemigation Beans Handheld 0.01 lb ai/gal equipment OR 2.3 lb ai/A NS Ready-to-Use Sprayer Apply to point of NS runoff Dry Flowable Aerial, 3 12 hr Blueberry Groundboom Liquid Handheld 0.0033 lb ai/gal NS equipment OR 3lb ai/A Blueberry Liquid (SLN FL040007; MS0500l7) 3 NS; except for Blueberry Groundboom MS050017 label (SLN FL040008; GA040004) DF lists 12hr REI Blueberry (GA040005) 0.27 gallA Aerial, Brassica Liquid Groundboom, 1.5 12hr Chemigation Chemigation 1.16 12hr Dry Flowable Aerial, 12 hr 1.5 Groundboom 24hr Broccoli Liquid Handheld 0.0076 lb ai/gal NS equipment OR 1.65 lb ai/A Chemigation 1.43 12 hr Ready-to-Use Sprayer Apply to point of NS runoff Chemigation 1.16 12hr Dry Flowable Aerial, 1.5 12hr Groundboom

Handheld 0.0076 lb ailgal OR NS Brussels sprouts equipment 1.65lb ai/A Liquid Aerial, Groundboom, 1.5 12 hr Chemigation Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Bulb vegetables Liquid Groundboom, 1.25 12 hr Chemigation

Page 32 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document Table A4.1. Occupational Registered Uses. Application Maximum Use Site Formulation Method Application Rate Re-entry Equipment (Ib ailA unless Interval otherwise noted) Aerial, 1.5 12 hr Dry Flowable Groundboom Chemigation 1.16 12 hr Cabbage Handheld 0.0076 lb ai/gal OR NS equipment 1.65 lb ai/A Liquid Aerial, 1.5 24hr Groundboom Chemigation 1.4 12 hr Aerial, Dry Flowable Groundboom, 1.5 12 hr Chemigation Wettable Powder Aerial, in Water Soluble Groundboom, 1.44 48 hr Bags Chemigation Carrot Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Groundboom, 1.5 12 hr Liquid Chemigation Handheld 0.0076 lb ai/gal OR NS equipment 1.65 lb ai/A

Aerial, 1.5 12 hr Dry Flowable Groundboom Chemigation 1.16 12 hr

Handheld 0.0076 lb ai/gal OR NS Cauliflower equipment 1.65 lb ai/A Liquid Aerial, 1.5 24 hr Groundboom Chemigation 1.43 12 hr Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Dry Flowable Groundboom, 2.25 12 hr Chemigation Ready-to-Use Sprayer Apply to point of NS runoff Celery Aerial, Groundboom, 2.31 12 hr Liquid Chemigation Handheld 0.01 lb ai/gal OR NS equipment 2.27 lb ai/A Dry Flowable Aerial, airblast 3.135 12 hr Aerial, Airblast 3.1 lb ai/A OR 0.01 12 hr Cherry Liquid lb ai/gal Chemigation 3.1 12 hr Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Cole crops WP in WSB Groundboom, 1.08 48 hr Chemigation G Spreader 11.31 NS Groundboom, 11.44 12 hr Commercial/Industrial Lawns Liquid Handheld sprayers Chemigation 11.3 12 hr Dry Flowable Groundboom, 10.87 12 hr Handheld sprayers

Page 33 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document Table A4.1. Occupational Registered Uses. Application Maximum Use Site Formulation Method Application Rate Re-entry Equipment (lb ailA unless Interval otherwise noted) Christmas tree plantations and Forest Dry Plowable Aerial, airblast 4.125 12 hr stands Seedbeds; field grown Dry Plowable Chemigation 4.10 Ib ai/A OR 1.44 12 hr and greenhouse Ib ai/lOO gallons Conifers Christmas trees, nursery Liquid Aerial, Airblast 4.17 12 hr beds, and forest stands Liquid Handheld 0.0047 Ib ai/gal OR NS equipment 4.13 Ib ai/A Plantations, Nurseries,

ForestTrees (SLN Dry Plowable Airblast 2.1 Ib ai/lOO gal 12 hr WAOOOOI4) DryFlowable Aerial, Groundboom, 1.5 12hr Liquid Chemigation Com Liquid Handheld 0.0076 Ib ai/gal OR NS equipment 1.65 Ib ai/A Ready-to-Use Sprayer Apply to point of NS runoff Liquid Aerial, Cranberry Groundboom, 5.25 12 hr Dry Plowable Chemigation Ready-to-Use Sprayer Apply to point of NS runoff Cucumber Aerial, Liquid Groundboom 1.36 48 hr Dry Plowable Aerial, Groundboom, 2.25 12 hr Liquid Chemigation Handheld 0.01 Ib ai/gal OR Cucurbits equipment 2.271b ai/A NS Wettable Powder Aerial, in Water Soluble Groundboom, 2.16 48 hr Bags Chemigation Dry Plowable Aerial, Airblast 3 12hr Filbert (Hazelnut) Liquid Handheld 0.0033 Ib ai/gal OR NS equipment 2.891b ai/A

Aerial, Fruiting vegetables Liquid Groundboom, 1.125 12hr Chemigation Liquid Groundboom, 12 hr Garbanzos Chemigation [SLN WA020012 (L); Aerial, 1.5

OR030008 (DF)] Dry Plowable Groundboom, NS Chemigation Dry Flowable Aerial, Groundboom, 2.25 12 hr Liquid Chemigation Garlic Handheld O.Ollb ai/gal OR equipment 2.271b ai/A NS Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Ginseng Groundboom, Liquid Chemigation 1.5 12 hr Ginseng Aerial, (SLN MIl00002, WIlOOO04) Groundboom GolfCourse Turf Granular Spreader 11.31 NS
Page 34 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document Table A4.1. Occupational Registered Uses. Application Maximum Use Site Formulation Method Application Rate Re-entry Equipment (lb ailAunless Interval otherwisenoted) Groundboom, 11.44 12 hr Liquid Handheld sprayers Chemigation 8 12hr Dry Flowable Groundboom, 11.34 12 hr Handheld sprayers Dry Flowable Aerial, Grasses grown for seed Liquid Groundboom, 1.5 12 hr Chemigation Aerial, Horseradish Liquid Groundboom, 2.25 12 hr Chemigation DryFIowable Aerial, Groundboom, 2.25 12 hr Liquid Chemigation Leek Liquid Handheld 0.01 lb ai/gal OR NS equipment 2.27 lb ai/A Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Lentils and Lupine Liquid Groundboom, 1.125 12 hr Chemigation Mango Dry FIowable Aerial, airblast 2.625 12 hr Liquid Ready-to-Use Sprayer Apply to point of NS runoff Melons Aerial, Liquid Groundboom 1.36 48 hr

Mint Dry Flowable Aerial, 1.03 12hr Liquid Groundboom Aerial, 12 hr on Mint ND020009 (SLN ND020009; OR990038) Liquid Groundboom, 1.05 48 hron Chemigation OR990038 Mint Aerial, (SLN OR990037) Dry Flowable Groundboom, 1.03 12hr Chemigation
Mushrooms DryFlowable Drench; Handheld 11.3 lb ai/A OR 0.02 12 hr Liquid equipment lb ai/gal OR Dry Flowable Aerial, Airblast 3.135 12hr Liquid Aerial, Airblast, 3.1 lb ai/A OR 0.01 12 hr Nectarine Chemigation lb ai/gal Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Dry Flowable Groundboom, 2.25 12hr Chemigation

Handheld 0.01 lb ai/gal OR NS equipment 2.27 lb ai/A Liquid Aerial, Onion Groundboom, 2.31 12hr Chemigation Ready-to-Use Sprayer Apply to point of NS runoff Wettable Powder Aerial, in Water Soluble Groundboom, 1.44 48 hr Bags Chemigation
Page 35 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document Table A4.1. OccupationalRegistered Uses. Application Maximum Use Site Formulation Method Application Rate Re-entry Equipment (lb ailAunless Interval otherwise noted) Ornamentals (field-grown) Dry Flowable Airblast, Handheld 1.55 lb ailA OR 1.44 12 hr eauioment lb ai/IOO !rallons Ornamentals (in greenhouses) Fogger/ Smoke Fogger/Smoke I 3.5-oz can/ 1000 12 hr !i:enerator Generator ft2 (1.91b ai/A) Ornamentals grown in nurseries, Liquid Handheld 0.01 lb ai/gal 12 hr greenhouses equipment Dry Flowable Groundboom, 3.10 lb ai/A OR 1.44 12 hr Handheld sprayers lb ai/IOO gallons Ornamentals (groundcover) Aerial, Liquid Groundboom, 3.1 12 hr Chemigation

Sprayer 0.01 lb ai/gal OR48 48 hr lb ai/A" Ornamentals (including shade trees, Drench application 0.01 lb ai/gal OR 66 48 hr lb ai/A" herbaceous plants, non-flowering Liquid 0.01 lb ai/gal OR 85 plants, woody shrubs, and vines)" Drench application lb ai/A" 48 hr

Drench application 0.0003 lb ail4-inpot 48 hr (0.01 lb ai/!ral)a Handheld 2.1 12 hr eauioment Ornamentals (including foliage Liquid 0.021b ai/gal OR 3.1 plants) Groundboom lb ailA 12 hr Dry Flowable Aerial, 3.1 Groundboom Dry Flowable Aerial, Airblast, 1.55 12 hr Groundboom Ornamentals (including shrubs, trees, Aerial O.Qllb ailgal OR 12 hr flowering plants, and bulbs) Liquid 1.56 lb ai/A Handheld 0.0085 lb ai/gal OR eauipment 1.11 lb ai/A NS Liquid Airblast, 1.35 NS Ornamentals (including shrubs, trees, Groundboom

flowering plants and bulbs, foliage Groundboom, plants) Dry Flowable airblast, handheld 1.161b ai/lOO gal 12 hr equipment Ornamentals (including shrubs/trees, Ready-to-Use Sprayer Apply to point of NS folia!re olants) runoff Ornamental bulbs andcorms Dry Flowable Dip 0.002 lb ailgal 12 hr Ornamentals Liquid Dip 0.25 lb ai/corm 12 hr (SLN CA03001O)

Ornamentals Dry Flowable Dip O.04llb ailgal 12 hr (SLN OR000023; WAOOOO03) Dry Flowable Aerial, Airblast 2.25 12 hr Handheld 0.01 lb ai/gal OR NS Papaya equipment 2.271b ai/A Liquid Airblast 2.25 12 hr Aerial, airblast 2.15 NS Aerial, Dry Flowable Groundboom, 1.5 12 hr Chemigation Parsnip Handheld 0.0076 lb ai/gal OR NS equipment 1.65lb ai/A Liquid Aerial, Groundboom, 1.5 12 hr Chemigation Passion Fruit Dry Flowable Airblast 1.5 12 hr
Page 36 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document Table A4.1. Occupational Registered Uses. Application Maximum Use Site Formulation Method Application Rate Re-entry Equipment (lb ailA unless Interval otherwise noted) Handheld 0.0076 Ib ai/gal OR NS Liquid equipment 1.65 Ib ai/A Airblast 1.5 12 hr Dry Flowable Aerial, Airblast 3.135 12 hr Aerial, airblast 3.llb ai/A OR 0.01 12 hr Peach Liquid Ib ai/gal Chemigation 3.1 12 hr Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Dry Flowable Groundboom, 1.125 12 hr Chemigation Peanuts Aerial, Groundboom, 1.172 12 hr Liquid Chemigation Aerial 1.44 12 hr Aerial, Peas Liquid Groundboom, 1.5 12 hr Chemigation Persimmon Liquid Aerial, Airblast, 0.9375 12 hr Chemigation Dry Flowable Aerial, Airblast 4.5 12 hr Pistachio 4.51b ai/A OR 0.023 Liquid Aerial, Airblast Ib ailgal 12 hr Plantain Liquid Airblast 1.5 12 hr (SLN PR040006) Dry Flowable Aerial, airblast 3.135 12 hr Liquid Aerial, Airblast, 3.11b ai/A OR 0.01 12 hr Plum Chemigation Ib ai/gal Ready-to-Use Sprayer Apply to point of NS runoff Aerial, Dry Flowable Groundboom, 1.125 12 hr Chemigation Aerial 1.44 12 hr Handheld 0.0057 Ib ai/gal OR NS Liquid equipment 1.241b ai/A Potato Aerial, Groundboom, 1.125 12 hr Chemigation Ready-to-Use Sprayer Apply to point of NS runoff Wettable Powder in Water Soluble Chemigation 1.44 48 hr Bags Potato Aerial, (SLN WI070006) Groundboom, 12 hr Dry Flowable Chemigation 1.12 Potato Groundboom, NS (SLN MN030007) Chemigation Potato Aerial, 0.78 12 hr (SLN ND030017) Groundboom Potato Groundboom 0.84 12 hr (SLN WI040005) Liquid Potato Aerial, (SLN MN030011, WI040006, 1.1 12 hr WIlOOO02) Groundboom Page 37 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document Table A4.1. Occupational Registered Uses. Application Maximum Use Site Formulation Method Application Rate Re-entry Equipment (lb ailA unless Interval otherwise noted) Potato Groundboom, NS (SLN MN030008) Chemigation Potato Aerial, (SLN NE090002, MElOOOOl) Groundboom, 12 hr Chemigation Potato Groundboom, (SLN MI040001, MN030006, 12 hr

MN03001O, ND030007) Chemigation Potato Aerial, 12 hr (SLN ND030016) Groundboom 1.12 Potato Groundboom NS (SLN NE030004) Potato Aerial, (SLN NE090001) Groundboom, 12 hr Chemigation Potato Aerial, 1.13 12 hr (SLN WIlOOOOl) Groundboom Potato Groundboom 1.16 NS (SLN NE030005) Potato Groundboom, (SLN MI040002) Chemigation Potato Aerial, 1.17 12 hr (SLN ND030008, WI070008) Groundboom, Chemigation Liquid Groundboom, 11.44 12 hr Professional and Collegiate Athletic Handheld soravers fields Dry Plowable Groundboom, 10.87 Handheld soravers Dry Plowable Aerial, airblast 3.135 12hr Aerial, airblast 3.11b ai/A OR 0.01 12 hr Prune Liquid lb ai/gal Chemigation 3.1 12 hr Ready-to-Use Sprayer Apply to point of NS runoff Ready-to-Use Sprayer Apply to point of NS runoff Pumpkin Aerial, Liquid Groundboom 1.36 48hr Aerial, Rhubarb Liquid Groundboom, 2.25 12 hr Chemigation Aerial, Liquid Groundboom, 1.08 NS Rose (field-grown) Chemigation Dry Flowable Chemigation 1.10lb ai/A OR 1.44 12 hr lb ai/IOO gallons Aerial, Dry Plowable Groundboom, 2.25 12 hr Chemigation

Handheld 0.01 lb ai/gal OR NS eauioment 2.271b ai/A Shallot Liquid Aerial, Groundboom, 2.25 12 hr Chemigation Ready-to-Use Sprayer Apply to point of NS runoff Groundboom, 13 12 hr Sod Farms Liquid Chemigation Aerial 11.25 12 hr Page 38 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document Table A4.1. Occupational Registered Uses. Application Maximum Use Site Formulation Method Application Rate Re-entry Equipment (lb ailA unless Interval otherwise noted) Granular Spreader 11.31 24hr Dry Flowable Ground 11.34 12hr Aerial, Dry Flowable Groundboom, 1.9 12 hr Chemigation Soybeans Aerial, Liquid Groundboom, 1.69 12 hr Chemigation Aerial 1.84 12 hr Ready-to-Use Sprayer Apply to point of NS runoff Squash Aerial, Liquid Groundboom 1.36 48 hr Dry Flowable Aerial, Airblast 3.15 12 hr Stone fruits Aerial, Airblast 3.13 12hr Liquid Handheld 0.0036 lb ailA OR NS equipment 3.091b ai/A

Aerial, 1.125 12 hr Strawberry Liquid Groundboom Dip O.Olllb ai/gal 12hr Strawberry Dip 0.011 lb ai/gal 12hr (SLN CA960027) Strawberry Liquid Aerial, (SLN CA960027) Groundboom, 1.12 12 hr Chemigation Sugarbeet Dry Flowable Aerial, 1.32 48 hr (SLN OR990039) Groundboom Sugarbeet Aerial, (SLN OR990040) Liquid Groundboom, 1.27 12 hr Chemigation Ready-to-Use Sprayer Apply to point of NS runoff Wettable Powder in Water Soluble Chemigation 2.16 48 hr Bags Aerial, Tomato Dry Flowable Groundboom, 2.27 12 hr Chemigation Aerial, Groundboom, 2.25 12 hr Liquid Chemigation Handheld 0.0095 lb ai/gal OR NS equipment 2.061b ai/A Granular Spreader 11.31 NS Turf(with restriction on home lawns Dry Flowable Groundboom, 11.34 12 hr and otherresidential sites) Handheld sprayers Liquid Groundboom, 11.5 12 hr Handheld sprayers Wood treatment (freshly sawed Dip or spray 0.0211b ai/gal NS lumber ortimber) Liquid Paintbrush, Airless 0.1051b ai/gal NS sprayer Yam Liquid Aerial, 0.9375 12 hr Groundboom
a. Theseuses andrates are assocIated WIth a label that mcludes both chlorothaloml andpropamocarb as the active mgredlents. The labels were not clearwithrespect to the maximum applicationrates allowed and, therefore, the highestrates able to be calculated were used in the risk assessment. Risks ofconcern were identified and HED, EFED, and RD recommendedrevisions to the labeled use directions to clearly indicate the maximum application rates allowable that wouldnotresult in worker and/ordrinking water risks.

Page 39 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document Table A4.2. Registered Residential Home Garden Uses.
Use Site Formulation ApplicationMethod Maximum Application Equipment Rate (lb ailA) Apricot Liquid Handheld equipment 3.171b ai/A OR 0.00361b ai/gal Beans Liquid Handheld equipment 2.541b ai/A OR 0.0121b ai/gal Blueberry Liquid Handheld equipment 2.861b ai/A OR 0.0033 lb ai/gal Broccoli Liquid Handheld equipment 1.59lb ai/A OR 0.0073 lb ai/gal Brussels sprouts Liquid Handheld equipment 1.59 lb ai/A OR 0.0073 lb ai/gal Cabbage Liquid Handheld equipment 1.59 lb ai/A OR 0.0073 lb ai/gal Carrot Liquid Handheld equipment 1.59lb ai/A OR 0.0073 lb ai/gal Cauliflower Liquid Handheld equipment 1.59 lb ai/A OR 0.0073 lb ai/gal Celery Liquid Handheld equipment 2.541b ai/A OR 0.0121b ai/gal Cherry Liquid Handheld equipment 3.171b ai/A OR 0.00361b ai/gal Com Liquid Handheld equipment 1.59 lb ai/A OR 0.0073 1b ai/gal Cucumber Liquid Handheld equipment 2.541b ai/A OR 0.0121b ai/gal Filbert Liquid Handheld equipment 2.861b ai/A OR 0.0033 lb ai/gal Garlic Liquid Handheld equipment 2.54Ibai/A OR 0.0121b ai/gal Leek Liquid Handheld equipment 2.541b ai/A OR 0.012 lb ai/gal Melons Liquid Handheld equipment 2.541b ai/A OR 0.0121b ai/gal Nectarine Liquid Handheld equipment 3.171b ai/A OR 0.0036 lb ai/gal Onion Liquid Handheld equipment 2.541b ai/A OR 0.012 lb ai/gal Conifers Liquid Handheld equipment 4.45 lb ai/A OR 0.0051 lb ai/gal Ornamentals (including trees, shrubs, flowering Liquid Handheld equipment 2.541b ai/A OR 0.00291b plants and bulbs, foliage plants) ai/gal Papaya Liquid Handheld equipment 2.22 lb ai/A OR 0.0026 lb ai/gal Parsnip Liquid Handheld equipment 1.59lb ai/A OR 0.0073 lb ai/gal Passion fruit Liquid Handheld equipment 1.59 lb ai/A OR 0.0073 lb ai/gal Peach Liquid Handheld equipment 3.171b ai/A OR 0.00361b ai/gal Plum Liquid Handheld equipment 3.171b ai/A OR 0.00361b ai/gal Potato Liquid Handheld equipment 1.27 lb ai/A OR 0.0058 lb ai/gal Prune Liquid Handheld equipment 3.171b ai/A OR 0.00361b ai/gal Pumpkin Liquid Handheld equipment 2.541b ai/A OR 0.0121b ai/gal Shallot Liquid Handheld equipment 2.541b ai/A OR 0.0121b ai/gal Squash Liquid Handheld equipment 2.541b ai/A OR 0.0121b ai/gal Tomato Liquid Handheld equipment 1.9 lb ai/A OR 0.0088 lb ai/gal Page 40 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Table A4.3.**Re~istered** Antimicrobial Uses. Use Application Rate Notes Adhesives, Caulks and Sealants 4800

- 10019 ppm Note 1 Composite Wood Products 4.8 to 5.05 pcf Grouts and Joint Compounds 15350 -15680 ppm Paints, Stains and Coatings, ExteriorLatex 2200-10100 ppm Paints, Stains and Coatings, Exterior Solvent 11500 -11800 ppm Paints, Stains and Coatings, InteriorLatex 660

- 5000 ppm Paper and Paperboard (non-food) 1415 ppm Note 2 Surface treatment ofwood, wallboard concrete and masonry block in buildings 9790

- 10620ppm Note 3 (as a spray) Wood preservative applied by brush, spray or dip to lumber, timbers and particle board wood 250

- 23800 ppm Note 4 Wood preservative applied by pressure treatment 0.8 pcf Note 5 200

- 500 ppm Note 6 Wood preservative stain applied to existing structures 10,100 ppm Note 1 - Labels have food contactprohibitions for caulks and sealants. Note 2 - The paper and paperboard use is only one label 74075-1. Note 3 - Interior sides ofliving spaces must be covered with overlayment materials. Note 4 - Only label #1022-589 hasa maximum rate of23,800 ppm. The other labels have a maximumrate of 10,800ppm. Note 5 - Only two products (#71581-2 and #1022-580) specify the rate in terms ofpounds percubic feet (pet). Note 6 - Added to the pressure treatment solution as a co-ingredient.

Page 41 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document**._-----~** 

### Attachment5: Residential Handler and Post-application Scenarios Assessed and Risk Estimates (fromD371456).

Table AS.I. RiskEstimates for ResidentialHandlers Application Rate Acute Baseline Inhalation Short-termBaseline Exposure Scenario Use pattern MOE e Inhalation MOE e (lb ai/gallon)" (LaC = 100) (LaC = 1000) painting with latex interior 0.048 1,300 220 paint MixinglLoadinglApplying painting with latex exterior 0.096 670 110 Liquids with a Paint Brush paint painting with alkyd exterior 0.11 580 97 paint painting with latex interior 0.048 310 52 paint MixinglLoading/ Applying painting with Liquids with an Airless latex exterior 0.096 870 140 Sprayer paint painting with alkyd exterior 0.11 1,000 170 paint
a. The applicatIOn rate IS based on thehighest applicationrate for residential pamtIng uses for chlorothalornl. b. Science Advisory Council Policy# 12.
c. Unit Exposures based onPHED for the paintbrush scenario and from MRID 43600102 for the airless sprayer scenario. Baseline Inhalation: no respirator. d. Dose = daily unit exposure (mg/lb ai) x applicationrate (lb ailgal) x amounthandled (gal) /body weight (70 kg adult).
e. MOE =HED (0.348 mg/kg/day) / Inhalation Dose (mg/kg/day).

Table AS.2. ResidentialPost-all1plicationInhalation Exposure/Riskfrom the use ofTreated Paint. Sampling time Measured air MOEs concentrations (mg/m3) 0-6 hrs 0.00059 6-12 hrs 0.00053 Acute Short-/Intermediate-Term 12-18 hrs 0.00058 (LaC

### = 100) (LaC

### = 1,000) 18-24 hrs 0.00062 Maximum airconcentration: 0.00062 650

--

Average airconcentration: 0.00058

-- 100

Table AS.3. ResidentialPost-applicationExposure and Riskfrom Ingestion ofPaint Chips Containing Chlorothalonil Residues.
Percent ofai in Fraction ofai BW PDR b MOEc IgR (g/day) paint" available for ingestion CF1 (mg/g) (kg) (mg/kg/day) (LOC= 100) 0.04 0.48% 0.2 1,000 15 0.0026 16,000

.. . . a. % ofaI mproduct IS 40.4% howeverthe % ofal m a gallon ofpamt IS 0.48% (153.6 ozJ12,800 oz x40.4%

= 0.48%). b. PDR = potential doserate = IgR x (Percent ai inpaint) x Fraction ofai availablefor ingestion xCFl / BW.
c. MOE

### =NOAEL (41.3 mg/kg/day)/PDR.

Page 42 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document

--_.--_.

Central 40 4.29 1.27 93,000 47,000 Lompoc, CA 

# I 2000 

## rNorthwest 40 24chour 2 months 4.29 1.07 93,000 56,000 (CalDPR)C 

### L Southwest 40 4.29 1.34 93,000 h 45,000 West 40 4.29 1.61 93,000 37,000 Cantua School, CantuaCreek 18 3.5 110,000 Martin Gunderson School, Five Points 19 3.5 110,000 Fresno County, 

## I 1989 I 

### u.c. Field Station, Five Points 19 24-hour 1 month 3.5 110,000 CA(CARB)d I Police Station, Huron -- 18 3.5 110,000 Fresno (ARB air-monitoring station; 18 3.5 110,000 background site) Animal Control Shelter, Camarillo 30 I I I 5 I 4 I 80,000 I 15,000 (5 above the MDL)
Ventura 

# I TierraVista School, Oxnard 30 

# I I 2 I I 200,000 (none above MDL) 

### -- County, CA 1990 30 24-hour 1 month (CARB)e Oxnard high School, Oxnard (none above MDL) I 2 I

-- I 200,000
Ventura (AirPollution Control District 30 I I I 2 I I 200,000 Office; background site) (none above MDL) 

### -- One drift catcher site located 65 ft southwest ofcabbage field. Thirty-nine samples were collected over the 

# I 

# I 24-hour Hastings, FL 

## I 2007 

# I monitoring period (October 1 - 39 (some I 2 months I 555 I 134 I 720 I 450 (PANNA) December 6, 2007). The Drift Catcher multi-day) operator observed "spraying" or "fogging" on the mornings ofOctober 13 and 29, and November 24. Browerville Site 1 1 month in (-1/8 mi from hybrid poplar, -3 mi 8 in 2006 and 13 in 2006 and 1 

### I 29 

### I 5 I 14,000 I 12,000 2007 month in MN (PANNAi 

## I 20061 from potatoes) 2007 24-hour 1 month in 2007 Browerville Site 2 (Within a few hundred yards of 9 in 2006 and 10 in 2006 and 2 I 6 I 2 I 67,000 I 30,000 2007 weeks in potatoes) 2007

Page 43 of53Chlorothalonil Registration Review Human-Health Assessment Scoping**Documen~**

Browerville Site 3 

# I I 

# I 2 weeks in (Within a few hundred yards of 9 in 2006 and 10 in 2006 and 2 

### I 46 

### I 8 

### I 8,700 

### I 7,500 2007 weeks in potatoes) 2007 Browerville Site 4 I 11 I I 2**~eeks** in 

### I 65 

### I 26 

### I 6,200 

### I 2,300 2006 Browerville Site 5 I 4 I I 1 week in I 5 I 2 I 80,000 I 30,000 2006 Staples Site 1 

### I 4 

### I I 1 week in 

### I 0.5 

### I 0.5 

### I 800,000 

### I 120,000 2006 Staples Site 2 13 1 month in 

### I 197 

### I 65 I 2,000 I 920 2006 Frazee Site 2 months in (One sampler moved around, but 67 in 2006 and 29 in 2006 and 2 

### I 190 

### I 31 

### I 2,100 

### I 1,900 generally within 112 mi ofpotato fields, 2007 months in sometimes within a few hundred feet) 2007 Waubun Site 15 1 month in 

### I 0.5 

### I 0.5 

### I 800,000 

### I 120,000 (No potatoes in vicinity ofsampler) 2006 Application Site Data North Ranged 70 32 5,700 1,900 Northeast from I-hour 83 45 4,800 1,300 East to 24-hour 737 324 540 190 San Joaquin 

# I Southeast Each site included 9 samples; 413 262 970 230 County, CA 2002 South samples (including taken pre- 3 days 296 198 1,400 300 (CARB)g Southwest background sample) application 80 36 5,000 1,700 West up to 3 days 372 127 1,100 470 Northwest post- 29 17 14,000 3,500 application I Ranged 

### I I 74 

### I 2,500 I East Site 1 I from I-hour 

### I 158 810
to 24-hour Ventura 

# I East Site 2 Ranch site included 8 samples; 

# I I 58 

### I 28 

### I 6,900 

### I 2,100 County, CA 1992 samples (including taken pre- 3 days (CARB) background sample) application up to 3 days I I I 12,000 I West Sites 1 and 2 post- I 34 23 2,600 I I I I application a. AcuteMOE

- Acute HEC (400,000 ng/m3) I Study maximum airconcentration (ng/m3). LOC = 100. b. Short-termMOE = Short-termHEC (60,000ng/m3) IStudy arithmetic mean airconcentration (ng/m3). LOC = 1,000.

Page 44 of53Chlorothalonil Registration Review Human-Health Assessment Scoping**Docum_en_t_~.**

c. Allnon-detects and trace concentrations reported. Fornon-detects, assumed 1/2 Method Detection Limit (MDL) of 1.43 ng/m3
• Fortrace concentrations, assumed concentrationhalfwaybetween MDL and Estimated Quantitation Limit (7.15 ng/m3). d. All samples were <MDLof7.0 ng/m3
• e. All sites exceptfor Animal Control Shelter, were <MDLof4 ng/m3
• f. Samples analyzed by eitherPANNA lab (MDLranged from 0.2 to 1.0 ng/m3, depending on analyte and when sample was analyzed andthe GC parameters; estimated limit ofquantitationranged from 1.0 to 5.2 ng/m3, depending when sample was analyzed and GC parameters; and values marked "trace" indicate that a sample's concentration was between theMDL and LOQ) or Commercial lab (reporting limitfor chlorothalonil-specific analysis: lOng/tube, or 3.5 ng/m3 assuming 24 h sample and 2.0 Umin flow rate). All ofthe sampling sites were adjacent to large fields. At some sites, sampling was timed to coincide with anticipated pesticide applications, while other sampling projects captured "ambient" pesticide concentrations. g. Winds mostly out ofWest to Northwest.

Page 45 of53________**~}orothalonil** Registrat!on**Re~iew** HUlpan-Hea!th**Assessmen~** Scoping**Docu~~** _



### Attachment 6: Occupational Handler ScenariosAssessed and Risk Estimates.

MixingILoading Liquids for Aerial I 3 350 10 48 I 97 I 140 3 14 I 29 42 Applications MixinglLoading Liquids for Chemigation 3 I 350 I 10 I 48 I 97 140 3 14 29 I 42 Applications MixinglLoading Liquids for Groundboom 3 80 42 210 420 610 13 63 130 180 Aoolications 20,000 29,000 0.015 100 6,800 34,000 68,000 98,000 2,000 10,000 Mixing/Loading Liquids viaDip lb 1000 680 3,400 6,800 9,800 200 1,000 2,000 2,900 ai!l!:a1lon
3 No Data No Data 51 3 100 200 350
Flagging for Aerial§prays Applications 3 I 350 33 I 170 330 1,700 I 10 I 50 99 500
a. The applicationrate was based on thehighest applicationratefor the mostrecently proposed uses for chlorothalonil thatincluded the low-growing berry subgroup l3-07G; bushberry subgroup l3-07B; onion, bulb subgroup 3-07A; and onion, green subgroup 3-07B. b. ExpoSAC Policy# 9.1 and information from previous assessmenton applications via dip (D327566).
c. Baseline Inhalation: no respirator. d. PF5 Respirator: 80% protection factorprovidedby aNIOSH-approved quarter-face, cup-style respirator. e. PFIO Respirator: 90% protectionfactor is providedby aNIOSH-approvedhalf-face cartridgeorcanisterrespiratoror aPAPR. f. Engineering control for applying sprays via aerial equipment: enclosed cockpit. g. MOEs based on comparison ofcalculated dose to human-equivalentdoses (HED); HED =0.174 mg/kg/day for acuteexposures and HED =0.052 mg/kg/day for short-and intermediate-termexposures.

Page 46 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document 

### Attachment 7. Submitted OccupationallResidential Exposure Studies for Chlorothalonil.

Table A7.1. Exposure IResidue Studies Submitted for ChlorothaloniI.
MRID

- Study Citation
147976 Ballee, D. (1985) A Tomato HarvesterExposure Study with Chlorothalonil--1984: Document No. 655-3HE-84-0043-001. Unpublished study prepared by SDS Biotech Corp. 235 p.a 42433810 Bailee, D. (1988) A Mixer, Applicator and MowerExposure Study with Chlorothalonil forGolfCourse Maintenance"-1985: Lab Project Number: 1148-85-0051: 1148-85-0051-HE-001. Un ublished stud re ared b Ricerca, Inc. 477 .a 42433811 Ballee, D. (1990) A GolferExposure Study with Chlorothalonil Used for Golf Course Maintenance--1985: Lab Project Number: 1148-85-0059: 1148-85-0059-HE-001. Un ublished stud re ared b Ricerca, Inc. 264 .a 43600102 Formella, T. (1995) Potential Exposure ofWorkers to Chlorothalonil when Handling and Applying Paint Containing Chlorothalonil: Lab ProjectNumber: 94-0204: ISKB-1894-002-02: 5227-94-0204-CR-001. Unpublished study prepared by Ricerca, Inc. 272

. (43600101 = ilot stud )a 43623202 King, e.; Prince, P.; Formella, T. (1995) Chlorothalonil Worker Exposure During Application ofDaconil 2787 Flowable Fungicide in Greenhouses: Lab Project Number: 5968-

94-0168-CR-00l: 94-0168: SDS-2787. Unpublished study prepared by Ricerca, Inc 298 p. (43623201 = ilot stud)

45005904 Klonne, D.; Fuller, R; Honeycutt, R (1999) Determination ofDermal and Inhalation Exposure to Reentry Workers During Scouting in Sweet Com (Chlorothalonil): Lab Project Number: ARF009: 97-708HE: 017-03. Unpublished study prepared by H.E.RAe., Inc., and Centre Anal tical Laboratories, Inc. 371

. 45005905 Klonne, D.; Fuller, R; Honeycutt, R (1999) Determination ofDermal and Inhalation Exposure from Chlorothalonil to Reentry Workers During Scouting in SweetCom: Lab Project Number: ARFOlO: 017-04: 97-709HE. Unpublished study prepared by H.E.RAe., Inc., and Centre Anal tical Laboratories, Inc. 401

. 45005906 Klonne, D.; Artz, S.; Rotondaro, A. (1999) Determination ofDermal and Inhalation

Exposure to Reentry Workers During Scouting in Cauliflower (Chlorothalonil): Lab Project Number: ARF011: 97-295: 7443-98-0027-CR-001. Unpublished study prepared by Grayson Research LLC, and Ricerca, Inc. 387

. 45005907 Klonne, D.; Artz, S.; Prochaska, e. et al. (1999) Determination ofDermal and Inhalation Exposure to Reentry Workers During Scouting in Cauliflower (Chlorothalonil): Lab Project Number: 97-296: ARFOI2: 98-0005. Unpublished study prepared by Grayson Research LLC, and Ricerca, Inc.·533

. 45005908 Klonne, D.; Artz, S.; Rotondaro, A (1999) Determination ofDermal and Inhalation

Exposure to Reentry Workers During Scouting in Dry Peas (Chlorothalonil): Lab Project Number: ARF021: 98-326: 7608-98-0111-CR-001. Unpublished study prepared by Grayson Research LLC, and Ricerca, Inc. 361

. 45005909 Klonne, D.; Bruce, E.; Artz, S. (1999) Determination ofDermal and Inhalation Exposure to Reentry Workers During Scouting in Sunflower (Chlorothalonil): Lab Project Number: ARF022: 44500: A048.007. Unpublished study prepared by ABC Laboratories, Inc. and MaximTechnolo ies, Inc. 318

. 45005910 Klonne, D.; Artz, S.; Bruce, E. (1999) Determination ofDermal and Inhalation

Exposure to Reentry Workers During Scouting in Grapes (Chlorothalonil): Lab Project Number: ARF023: ERS98011: 44835. Unpublished study prepared by ABC Laboratories, Inc., and Excel Research Services, Inc. 333

. 45005911 Klonne, D.; Artz, S.; Prochaska, e. et al. (1999) DeterminationofDermal and InhalationExposure to Reentry Workers During Scouting in Tobacco (Chlorothalonil): Lab

Project Number: ARF024: 98-327: ML98-0739-ART. Unpublished study prepared by Gra son Research, LLC. and Morse Laboratories, Inc. 335

. 45224801 Klonne, D.; Filler, R; Howell, e. (2000) Determination ofDermal and Inhalation Exposure to Reentry Workers During Hand Line Irrigation in Potato: (Chlorothalonil): Lab Project Number: 45165: 10625-1: ARF036. Unpublished study prepared by ABC Laboratories and Ricerca, LLe. 417

. 45530101 Klonne, D.; Fuller, R; Honeycutt, R (2001) Determination ofDermal and Inhalation Exposure to Reentry Workers During Maintenance Activities on GolfCourses: Lab Pro·ect Number: ARF046. Un ublished stud re ared b H.E.RAe. Inc. 420 Page 47 of53 Agency Review Data were reviewed and incorporated as part ofrevisions to Occupational Pesticide Posta lication Ex osure Data Dataprovided are superseded by newer submitted golfcourse maintenance studies (see below underARTF); primary contractorreviews are available Data were reviewed and incorporated as part ofrevisions to Occupational Pesticide HandlerEx osure Data

0393093

Primary contractorreviews availableChlorothalonil Registration Review Human-Health**Asses~ment** Scoping**Docume~** Table A7.1. Exposure IResidue Studies Submitted for Chlorothalonil.
MRlD

- Study Citation Agency Review 45530102 Klonne, D.; Fuller, R; Honeycutt, R (2001) Determination ofDermal and Inhalation Exposure to Reentry Workers During Harvesting in Cabbage: Lab Project Number:

ERS20020: MLOO-0849-ART: ARF050. Unpublished study prepared by Excel Research Services, Inc. 345

. 45530103 Klonne, D.; Fuller, R; Merricks, D. (2001) Determination ofDermal and Inhalation Exposure to Reentry Workers During Tying in Tomatoes: Lab Project Number: 3905: HL10267: ARF051. Un ublished stud re ared b A risearchInc. 382

. 46734001 Klonne, D.; Bruce, E. (2005) Determination ofDermal and Inhalation Exposure to

Reentry Workers During Maintenance Activities in GolfCourses: (Chlorothalonil). Project

Number: ARTF/ARF057, ARF057/MG, ARF057/CC. Unpublished study prepared by A ricultural Reent TaskForce and RicercaBiosciences, LLC. 485

. 0327361

47212806 Bruce, E. (2007) Determination ofDermal and Inhalation Exposure to Workers in the Pacific Northwest During Open Pour/Mising Loading a Dry Flowable Pesticide Product

and During Application to Various Sites by a Variety ofApplication Methods. Project Number: AHE18, 050186. Unpublished study prepared by Agricultural Handlers Exposure TaskForce. 416

. 47212808 Klonne, D. (2007) Determination ofDermal and Inhalation Exposure to Workers in Southern Georgia During Open PourMixingILoading a Dry Flowable Pesticide Product and During Application to Various Sites by a Variety ofApplicationMethods. Project Number: AHE20,050188. Unpublished study prepared by Agricultural Handlers Exposure Task Force. 441

. 0343367 47212809 Klonne, D. (2007) Determination ofDermal and Inhalation Exposure to Workers in

Northern Florida During Open PourMixing/Loading a Dry Flowable Pesticide Product and during Application to Various Sites by a Variety ofApplication Methods. Project Number: AHE21. Unpublished study prepared by Agricultural Handlers Exposure Task Force, LLC. 406

. 47259801 Klonne, D.; Holden, L. (2007) Agricultural HandlerExposure Scenario Monograph: Mixing and Loading Dry Flowable Formulations. Project Number: AHE1001. Un ublished stud re ared b A ricultural Handlers Ex osure TaskForce. L.L.C. 107

. 47947801 Klonne, D.; Holden, L. (2009) Agricultural Handler Exposure Scenario Monograph: Open PourMixing and Loading Dry Flowable Formulations. Project Number: AHB1001. Un ublished stud re ared b A ricultural HandlerEx osure" TaskForce. 229 47947802 Klonne, D.; Holden, L. (2009) Agricultural HandlerExposure Scenario Monograph: Open Pour Mixing and Loading ofLiquid Formulations. Project Number: AREI003. Un ublished study re ared by Agricultural Handler Ex osure TaskForce. 209 47947803 Bruce, E.; Holden, L. (2009) Agricultural HandlerExposure Scenario Monograph: Open Cab Groundboom Application ofLiquid Sprays. Project Number: AHEI004. Un ublished study re ared by Agricultural HandlerEx osure TaskForce. 216

. 0373605

48303501 Smith, L. (2010) Determination ofDermal and Inhalation Exposure to Workers During AirblastApplications ofLiquid Sprays Using Closed Cab Equipment in Michigan Stone Fruit. Project Number: ARE57. Unpublished study prepared by Agricultural Handler Ex osure Task Force. 169

. 0381148

48164901 Klonne, D.; Holden, L. (2010) Agricultural HandlerExposureScenario Monograph: Closed Cab Airblast Application ofLiquid Sprays. Project Number: AHE1005. Data were reviewed and**1-_---=U:-:n~u.::.bl=::-is::::h~e::d7_s.:..:tu.:..:d:Ly~re~ar'="e"_:d':_b.:..y"__7A""gc:.:ri:=:cu:=:l:.::tu:::r:::al=-H=-:=an:..:d:=l.::.er:..:s.,.:E",x:L...:.o-::su:::r.::.e::::T:..:a:..:sk:..:.::.F.::.o:..:rc:=e=-.** =-2=-16::.,.<:-.:....-_---j incorporated as part ofrevisions 47714402 Klonne, D.; Holden, L. (2009) Agricultural HandlerExposure Scenario to Occupational Pesticide Monograph: Open Cab Groundboom Application ofLiquid Sprays. Project Number: HandlerExposure Data AHEI004. Un ublished re ared Handlers Ex osure Task Force. 86

No dermal hazard concerns currently (i.e., no quantitative dermal risk assessments necessary). 42875902 Formella, T. (1993) Determination ofDislodgeable Foliar Residues of Chlorothalonil and HCB from BRAVO 720 Treated Cherry Trees: Lab Project Number: 5224- 92-0069-CR-001. Un ublished stud re ared b Ricerca, Inc. 212 .a 42875903 Formella, T. (1993) Determination ofDislodgeable Foliar Residues of Chlorothalonil and HCB from BRAVO 720 Treated Broccoli Plants: Lab Project Number:**1-_~-,-=,52:=:2=:4,,-:-.::-92=--:::0:::0.::.69=--.,.:C:..:R..:..--=0.::.02=-.,-::-,:U-::n~ub::..:l:.::is=h:.:.e=d,.:;;s::.:.tu:..:d:Ly....l:..::re~ar=-e::.:d::..,b:::..y<...=.:R:.::ic:..:e=rc:..:a::...,** .:::In::,::c::..

..=2.::c52::.....<:::.:..a:......,-

__---j Data will need to be reviewed if 42875904 Formella, T. (1993) Determination ofDislodgeabk Foliar Residues of quantitative assessments Chlorothalonil and HCB from BRAVO 720 Treated Cucumber Plants: Lab Project Number: required in future. 5224-92-0069-CR-003. Un ublished study re ared by Ricerca, Inc. 230 .a 44868601 Prochaska, L. (1999) Dissipation ofDislodgeable FoliarResidues ofChlorothaloriil
on Broccoli: Final Re ort: Lab Pro·ect Number: 468C-102: SARS-97-51: 97.388. Primary contractor reviews available for 42875902 and Page 48 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document Table A7.1. Exposure IResidue Studies Submitted for Chlorothalonil.
MRID

- Study Citation Agency Review Unpublished study prepared by Stewart Agricultural Research Services, Inc. and Wildlife International, Ltd. 202

. {OPPTS 875.2100} 42875903

No dermal hazard concerns currently (i.e., no quantitative dermal risk assessments necessary). 45071501 Belcher, T. (2000) Daconol Ultrex and Daconil WeatherStikTransferable Turf Residue Study on GolfCourse Greens: Lab Project Number: RR-99-072B. Unpublished stud re ared b ZenecaA Products.436

. {OPPTS 875.2100} 44868602 Prochaska, L. (1999) Dissipation ofDislodgeable FoliarResidues ofChlorothalonil

on Sweet Com: Final Report: Lab Project Number: 468C-I04: SARS-97-53: SARS-97-CA53. Unpublished study prepared by Stewart Agricultural Research Services, Inc. and Wildlife International, Ltd. 170

.

45064901 Belcher, T. (2000) Daconil Ultrex and Daconil WeatherStik TransferableTurf Residue Study on GolfCourse Fairways: Lab Project Number: RR 99-07lB: CHLO-99-TR01: ERS-99011. Unpublished study prepared by GB Biosciences Corporation. 376 p. 1-------,-.,...,....,-----,-::-:-::-::-=---=-...,..,--:,.-:-::-:-=-_---'{L: 0 ::..: P e.,:P....:T:..::S:...:8:c: 7 .=.5.:..:.2:.:1..::0.::.°L } --,----=----,-------------,-----,----1 Data will need to be reviewed if 44901001 Hofen,1. (1999) Determination of Transferable Residues on TurfTreated With quantitative assessments Chlorothalonil: Final Report: Lab Project Number: SARS-98-80: 7616-98-0160-CR: 7616-98- required in future. 0160-CR-001. Unpublished study prepared by Stewart Agricultural Research Services, Inc., and Ricerca, Inc. 511

. {OPPTS 875.2100}
a. Studies werenoted as submitted in RED

Page 49 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document 

### Attachment 8: Chlorothalonil International Residue Limit Status Sheet. 

### International Residue Limits Chlorothalonil (081901; 10/14/11) Summary ofUS and International Tolerances and Maximum Residue Limits ResidueDefinition: US Canada Mexico CodexL 40 CFR 180.275: Chlorothalonil Plant: chlorothalonil. Plant: chlorothalonil tetrachloroisophthalonitrile, (tetrachloroisophthalonitrile) and its including the metabolite 4- Livestock: SDS-3701 metabolite 4-hydroxy-2,5,6- hydroxy-2,5,6-trichloro-l,3- (2,5,6-trichloro-4- trichloroisophthalonitrile benzenedicarbonitrile hydroxyisophthalonitrile Livestock: the metabolite 4-hydroxy- ). 2,5,6-trichloroisophthalonitrile The residue is not fatsoluble. Commodity Tolerance (ppm)/Maximum Residue Limit(mg/kg) US Canada Mexico I Codex2 Almond 0.05 Almond, hulls 1.0 Apricot 0.5 Asparagus 0.1 0.1 Banana (NMT 0.05 ppm in 0.5 0.01 (*t edible pulp) Bean, dry, seed 0.1 5 beans 0.2 beans (dry)4 7 dry chickpeas 1 pulses3 0.1 lentils Bean, snap, succulent 5 5 Common bean (pods and/or immature seeds)4 Blueberry 1.0 0.6 Brassica, head and stem, 5.0 5 broccoli, Brussels sprouts, 5 brocolli4

, subgroup 5A cauliflower, cabbages 5 Brussels sprouts 6 Brussels sprouts3 1 cabbages, head4

, cauliflower 4 5 Flowerheadbrassicas (includes broccoli, broccoli Chinese and cauliflowed Carrot, roots 1 1.0 carrots 14 0.3 root and tuber vegetables3 Celery 15 15 Celery 10; Celery 203 3 celery leaves4 Cherry, sweet 0.5 0.5 cherries 0.5 cherries4 Cherry, tart 0.5 0.5 cherries 0.5 cherries4 Cocoabean, dried bean 0.05 Coffee, bean, green 0.20 Corn, sweet, kernel plus cob I 0.02 with husks removed Cranberry 5.0 2.0 54 Ginseng 4.0 0.3 root and tuber Horseradish 4.0 vegetables3 Lentil 0.10 0.1 0.2 beans (dryt 1 pulses3 Lychee 15 Mango 1.0 Page 50 of53Chlorothalonil RegistrationReviewHuman-Health Assessment Scoping Document Summary ofUS and International Tolerances and Maximum Residue Limits Residue Definition: US Canada Mexico! CodexL Mushroom 1.0 1.0 Nectarine 0.5 Okra 6.0 Onion, bulb 0.5 5.0 onions 0.54 Onion, green 5 IOj spring onion Papaya 15 20j Parsnip, roots 1 1.0parsnips 0.3 root andtuber vegetables3 Passionfruit 3 Pea, edible podded 5 Peach 0.5 0.5 peaches/nectarines 0.24 Peanut 0.3 0.3 0.05 0.1 3 Pistachio 0.2 Plum 0.2 Plum, prune 0.2 Potato 0.1 0.08 0.24 0.3 root and tuber vegetables3 Rhubarb 4.0 Soybean 0.2 0.2 beans (dry

## t I pulses3 Starfruit 3.0 Tomato 5 5.0 54 Vegetable, cucurbit, group 9 5.0 5.0 balsam apples, balsam 5 cucumber; squash, pears, cantaloupes, chayote summer; winter squash4 fruit, Chinese cucumbers, Chinese waxgourds, citron 3 cucumber3

, gherkin3 melons, cucumbers, edible Squash, summer3 gourds (other than those listed inthis item), muskmelons (other than 2 melons, except those listed in this item) watermelon pumpkins, summer squash, 2 melons, except watermelons, west Indian watermelon3 gherkins, winter squash Vegetable, fruiting, group 8, 6.0 70 peppers Chili, dried4 excepttomato 7 peppers, Sweet (including pimento or pimiento)4 Yam, true 0.10 0.3 root and tuber vegetables3 US [40 CPR §180.275(a)(2)] Canada Mexico! CodexL Tolerances are established for the Same as above Same as above metabolite 4-hydroxy-2,5,6- trichloroisophthalonitrile in or on the following food commodities Commodity Tolerance (ppm) IMaximum Residue Limit(mg/kg) US Canada Mexico! CodexL
' Cattle, fat 0.1 0.07 mammalianfats (except milkfats)3 Cattle, kidney 0.5 0.2 Edible offal Cattle, meatbyproducts, 0.05 (mammalian)3 exceptkidney

Page 51 of53Chlorothalonil Registration Review Human-Health Assessment Scoping Document Summary ofUS and International Tolerances and Maximum Residue Limits Residue Definition: US Canada Mexico· Codex2 Cattle, meat 0.03 0.02 meatfrom mammals other than marine mammals)3 Goat, fat 0.1 0.07 mammalian fats (except milk fats)3 Goat, kidney 0.5 0.2 Edible offal Goat, meatbyproducts, 0.05 (mammalian)3 exceptkidney Goat, meat 0.03 0.02 meat from mammals other than marine mammals)3 Hog, fat 0.1 0.07 mammalian fats (except milk fats)3 Hog, kidney 0.5 0.2 Edible offal Hog, meatbyproducts, except 0.05 (mammalian)3 kidney Hog, meat 0.03 0.02 meat from mammals otherthan marine mammals)3 Horse, fat 0.1 0.07 mammalian fats (except milk fats)3 Horse, kidney 0.5 0.2 Edible offal Horse, meatbyproducts, 0.05 (mammalian)3 exceptkidney Horse, meat 0.03 0.02 meat from mammals otherthan marine mammals)3 Milk 0.1 0.07 milks5 Sheep, fat 0.1 0.07 mammalian fats (except milk fats)3 Sheep, kidney 0.5 0.2 Edible offal Sheep, meatbyproducts, 0.05 (mammalian)3 exceptkidney Sheep, meat 0.03 0.02 meat from mammals otherthan marine mammals) 3 MRLs withNO US equivalent Barley 0.1 4 Barley straw and fodder, dry 204 Currants, Black, Red, White 5 203 Gooseberry 205 Grapes 0.5 33 Leek 405 Onion, Chinese 105 Onion, Welsh 105 Parsley 3 Poultry fats 0.015 Poultry meat 0.01' Poultry skin 0.015 Poultry edible offal 0.07' Strawberry 55 Sugar beet 0.2 Wheat 0.1 4 Page 52 of53Chlorothalonil RegistrationReview Human-Health Assessment Scoping Document

MeXICo adopts US tolerances and/or Codex MRLs for Its exportpurposes. Summary ofUS and International Tolerances and Maximum Residue Limits ResidueDefinition: US Canada MexicoI Codexl Wheat straw and fodder, dry 204 Wasabi 5.0 Completed: M. Negussie; 10/1812011 I

2

### *= absent at the limit ofquantitation; Po = postharvesttreatment, such as treatment ofstored grains. PoP= processed postharvesttreated commodity, such as processing oftreated stored wheat. (fat) = to be measured onthe fat portion ofthe sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

3ProposedMRL.

4Withdrawal recommended. (c) Tolerances with regional registrations. Tolerances with regional registration, as defined in §180.1 (I), are established forthe ·d f h al·1 d· b 

### r· th £ II·

. laid·· combined resl ues 0 c loroth om an Its meta 0 Ite moron e 0 owmg raw agncu tm commo ItJes: Commodity Parts per million
Hazelnut 0.1 Peppermint, tops 2 Persimmon 1.5 Spearmint, tops 2

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