Chlorothalonil Registration Review 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 DP Barcode: 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

TXR No.: N/A CAS No.: 1897-45-6

MRID No.: N/A 40 CFR: §180.275

FROM: George F. Kramer, Ph.D., SeniorChe~ ~~R::C

Chester

Kelly M.

E.

Lowe,

Rodriguez,

Environmental

Ph.D., Pharmacologist

Scientist ~~

.~-"2../ . Risk Assessment Branch 1 (RAB1) .

Health Effects Division (HED,7509P)

Office of Pesticide Programs (OPP)

And

Timothy C. Dole, CIH, Industrial Hygienist .r-'~ (

Risk Assessment and Science Support Branch 1 (RASSB)

Antimicrobials Division (AD)/OPP (7510P)

THROUGH: Dana M. 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 a broad-spectrum, non-systemic

protectant pesticide mainly used as a fungicide to control fungal foliar diseases of vegetable,

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

golf courses, use on home gardens, use as a wood preservative, 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 Reregistration Eligibility Decision

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Chlorothalonil 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 recent human-health risk assessment for chlorothalonil was completed in 2010 (Memo, G.

Kramer et al., 12/23/10, D370486) in conjunction with a registration request 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 of the 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

recent human-health risk assessments for chlorothalonil with respect to its toxicity, exposure, and

usage databases, and the most updated Agency science policy and risk assessment methodologies

to determine the scope of work necessary to support Registration Review.

Toxicology

The oral and inhalation routes of exposure are of the most toxicological concern with

chlorothalonil. Based on acute toxicity studies, chlorothalonil is highly toxic via the inhalation

route of exposure (Category I). There was a high level of lethality reported in the critical acute

inhalation toxicity 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 underestimate risk 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 a higher absorbed fraction (bioavailability) through the inhalation

pathway. The lack of a no-observed adverse-effect level (NOAEL) in several acute inhalation

toxicity studies carried out with technical-grade chlorothalonilor end-use 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 several acute inhalation toxicity studies for

chlorothalonil. The effects of short- and intermediate-term inhalation exposures (portal-of-entry

or systemic) have not been studied. In the absence of such information, RED recommends that

the lowest-observed adverse-effect level (LOAEL) from the critical acute inhalation toxicity

study with appropriate uncertainty factors (UFs) be used as the point of departure (POD) to

assess inhalation risks (acute, short-, and intermediate-term). At this LOAEL, there were no

deaths (male or female) and the very slight to slight (severity) clinical signs of respiratory

distress resolved after two 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

inhalation route of exposure. If the registrant submits a subchronic inhalation study, with a

subset of animals designed to identify the NOAEL for acute inhalation toxicity (i.e., after one

day of exposure), then the current UFs may be reduced accordingly. Therefore, RED believes

that the submission of a 90-day inhalation study (with acute toxicity measurements) is needed to

refine the current residential risk assessments. Based on the lack of incident data related to

inhalation effects and the fact that an acute inhalation toxicity study is being used to assess shortand intermediate-term risk, the risk assessment can be 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-glandular region of the stomach. There were also

kidney effects that included weight increase (relative and absolute), dilation of renal medullary

tubules, pelvic dilation, tubular cysts, and tubular degeneration. In subchronic dietary studies

with dogs, the reported effects included infiltration of inflammatory cells in the liver of both

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Chlorothalonil 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

nuclear pyknosis in the mucosal epithelium of the antrum, and a very slight cell hypertrophy in

the zona fasciculata of the adrenal glands.

No specific malformations, or increase in malformations or reproductive effects attributable to

administration of chlorothalonil were observed. In the 2-generation reproductive toxicity study,

both parental animals and offspring exhibited pathological effects involving the stomach

consisting of thickened and/or roughening of the forestomach with depressions in the epithelial

aspect, and hyperplasia and hyperkeratosis of the non-glandular epithelium of the stomach.

Based on overallweight-of-evidence, there is no evidence of increased susceptibility to offspring

following in utero exposure to rats or rabbits in developmental toxicity studies or following

pre/post-natal exposure in the reproductive toxicity studies in rats.

Chlorothalonil exhibited low acute toxicity via the dermal route of exposure (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 of any systemic

toxicity. In the previous risk assessment, chlorothalonil was classified as not being a dermal

sensitizer. However, a published literature study in mice and guinea pig ranks chlorothalonil as

an extremely potent contact allergen, inducing sensitization using only topical exposures on

intact skin. The data from this study will be evaluated in the registration review of

chlorothalonil.

No appropriate acute endpoint was 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 of

chlorothalonil. Therefore, there is no acute reference dose (aRID) or acute population-adjusted

dose (aPAD).

The chronic RID (cRID) is established based on the LOAEL from a chronic toxicity study in the

rat. The LOAEL of 4.0 mglkg/day is based on the increased incidence and severity of epithelial

hyperplasia in the renal proximal convoluted tubules of female rats. The NOAEL is 2.0

mglkg/day. This NOAEL is lower than any NOAEL in the database based on kidney effects.

Although lower NOAELslLOAELs were observed for gastrointestinal irritation in rodents,

HED's Hazard Assessment and Policy Committee (HASPOC) determined that the forestomach

lesions in rodent species should not be used for risk assessment due to the lack of a human

forestomach counterpart.

Overall, there was no clear evidence that chlorothalonil was mutagenic. The Scientific Advisory

Panel (SAP) concluded that the forestomach tumors chlorothalonil produced in rodents involved

sustained cytotoxicity and regenerative cell proliferation as the mode of action and that a marginof-exposure (MOE) approach would be appropriate. Quantification of excess lifetime cancer

risk using a linear approach is, therefore, not required.

Quantification of dermal risk (all exposure scenarios) is not required since there is no systemic

toxicity in a dermal toxicity study in rats at doses up to 600 mglkg/day and the level of concern

(LOC) for developmental toxicity and/or neurotoxicity is low.

Short- and intermediate-term incidental oral endpoints are based on kidney toxicity observed in

the 90-day oral mouse study with a NOAEL of 41.3 mglkg/day. A target MOE of 100 is

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Chlorothalonil 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 of the Food Quality Protection Act (FQPA) Safety Factor (SF) from lOX to IX for oral

exposure assessments: 1) there are no significant data gaps in the hazard and exposure

databases, 2) there are low concerns for pre- and/or postnatal toxicity, 3) there are no residual

uncertainties with regard to pre- and/or postnatal 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 in the database. However, the chlorothalonil risk assessment team recommends

setting the FQPA SF at 3X for acute and 30X for repeated residential inhalation exposure

scenarios based on the lack of an inhalation study of appropriate duration to assess repeated

exposures. There are only acute inhalation studies available for chlorothalonil. Its classification

for acute inhalation toxicity is Category I (combined LCso =0.020 mglL). The non-lethal effects

reported in acute studies even at the lowest concentration tested (i.e., no NOAEL attained)

consist of clinical signs indicative of respiratory-tract effects including nasal discharge,

gasping/difficulty breathing, decreased activity/lethargy, respiratory rales/gurgle, ptosis, and

piloerection. The effects of short- and intermediate-term inhalation exposures (portal-of-entry or

systemic) have not been studied and justify retaining the FQPA SF at lOX for repeated exposure

scenarios. Since there is no NOAEL available for any of the available acute inhalation studies,

but the reported portal-of-entry effects were relatively mild at the LOAEL for the critical study,

an additional 3X factor should be added to all exposure scenarios, resulting in an overall FQPA

SF of 3X and 30X for acute and repeated inhalation exposures, respectively. Since the UFs

applied to residential inhalation exposure assessment are related to uncertainty in the hazard

database, the same factors are applied to the occupational assessment of inhalation exposure.

Dietary Exposure

The most recent dietary-exposure assessment was performed in conjunction with the December

2010 human-health risk assessment conducted by HED in conjunction with a registration request

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, et al.; 23-DEC-201O).

RED was unable to make a safety finding due to inhalation risks and the proposed uses were

subsequently withdrawn. An acute dietary-exposure assessment was not performed because no

appropriate endpoint was available to determine the aRID for the general population or any

population subgroup. A partially refined chronic dietary-exposure assessment was performed

using 100% crop treated (CT) for all crops; tolerance-level residues, and the Dietary E~osure

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

) 7.81

default processing factors for all foods except for tomatoes (average field-trial residues and

empirical processing factors used), peppers (average field-trial residues used), orange juice

(empirical processing factor translated from tomato juice), and snap beans (average field-trial

residues used). Dietary risk estimates were determined considering exposures from food plus

drinking water using estimated drinking water concentrations (EDWCs) for surface water

sources provided by the 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% of the chronic population-adjusted dose (cPAD) of 0.02 mglkg

bw/day] for the overall U.S. population and all population subgroups. Using DEEM-FCIDTM,

dietary risk is estimated at 41% of the cPAD for the U.S. population and 98% of the 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 of

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Chlorothalonil 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 sufficient to support the current registrations. The following

data requirement remains outstanding: multiresidue method recovery data for the 4-hydroxy

metabolite.

The U.S., Canadian, and Codex tolerances/maximum residue limits (MRLs) for residues of

chlorothalonil are generally not harmonized. For plant commodities, the U.S. and Canadian

residue definitions are harmonized; however, the Codex residue definition is not harmonized, as

it does not include the 4-hydroxy metabolite. The U.S. and Codex residue definitions for

livestock commodities are harmonized and the U.S. and Codex have established MRLs 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 risk from the

conventional uses. The residential assessments that have been performed by RED are reflective

of the currently registered residential uses, except for the use on home 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 of appropriate length

available to assess short- and intermediate-term exposures, therefore, RED relied upon an acute

study (in which no NOAELwas achieved) to assess short- and intermediate-term exposure.

RED believes that the submission of a 90-day inhalation study (with acute toxicity

measurements) is needed to refine the current residential risk assessments. Based on the lack of

incident data related to inhalation effects and the fact that an acute inhalation toxicity study is

being used to assess short- and intermediate-term risk, the risk assessment can be characterized

as conservative.

Assessments may need to be conducted of the registered home garden uses. 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, in the most

recent risk assessment, the Agency requested additional inhalation toxicity data that may affect

the inhalation POD chosen for chlorothalonil. If changes 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 in residential structures such as porches and steps. These

exposures were not assessed in the RED; therefore, they may need to be assessed during

registration review. It will also be necessary to reassess the paint uses and determine if the

precautionary labeling strategy required by the RED is still valid or if paints containing

chlorothalonil should have labeling that can only be accomplished by having separate

registrations for each paint product.

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Occupational Exposures·

There is·sufficient information available to assess occupational handler and post-application

exposure and risk for the conventional uses. In the most recent risk assessment, inhalation risk

concerns for occupational handlers were identified for both acute and short-/intermediateterm exposures. As noted above, there is no inhalation study of appropriate 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 of a 90-day inhalation study (with acute toxicity measurements) is needed to

refine the current occupational risk assessments. Based on the lack of incident data related to

inhalation effects and the fact that an acute inhalation toxicity study is being used to assess shortand intermediate-term risk, the risk assessment can be characterized as conservative.

Occupational handler scenarios may need to be reassessed during Registration Review to account

for scenarios that have not been covered previously, updated exposure data, and changes to the

toxicological PODs. In the most recent risk assessment, the Agency requested additional

inhalation toxicity data that may affect the inhalation POD chosen for chlorothalonil. If changes

are made, then exposure scenarios may need to be reassessed. During Registration Review, a

review of the restricted-'entry intervals (REIs) listed on the labels and the associated label

language will need to be checked for consistency across products. A review of the labels will

also need to be done to ensure all labels with registered turf uses include a statement prohibiting

use on home lawns and other residential turf sites as required by the RED. In addition, a check

of the omamentallabel co-formulated with propamocarb will need to be done to ensure the

revisions have been made regarding maximum allowable application rates.

With respect to the antimicrobial uses, the occupational handler exposures that occur from the

use of chlorothalonil for material preservation were assessed in the RED; however, these

assessments may also have to be repeated during registration review to account for changes in

the toxicological PODs. In particular, the handler exposures from the open pouring of wettable

powder will have to be reassessed because the antimicrobial wettable powder products are not

packaged in water-soluble packaging as required by the RED. In addition, exposures that occur

from the use of chlorothalonil 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.

Data Needs and Risk Assessment Updates Required:

Toxicology:

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

• 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 under 40 CFR §180.275(a)(l): "Tolerances are established for residues of

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Chlorothalonil Registration Review 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 specified below 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 of chlorothalonil, in or on the commodity," and under 40 CFR

§180.275(a)(2): "Tolerances are established for residues of chlorothalonil, including its

metabolites and degradates, in or on the commodities in the table below. Compliance

with the tolerance levels specified below 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 if there 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 Applicator Exposure Monitoring Data Reporting

o Guideline 875.1700 Product Use Information·

o Guideline 875.2300 Surface Residue Dissipation

1.0 Introduction

Chlorothalonil (2,4,5,6-tetrachloro-l,3-benzenedicarbonitrile) is a broad-spectrum, non-systemic

protectant pesticide mainly used as a fungicide to control fungal foliar diseases of vegetable,

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

golf courses, 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-podded peas, ginseng, horseradish, lentil, lupin, okra,

persimmon, rhubarb, yarn, Brassica head and stern subgroup (5A), cucurbit vegetable group (9),

fruiting vegetable group (8). The most recent human-health risk assessment for chlorothalonil

was completed in 2010 (Memo, G. Kramer et al., 12123110, D370486) in conjunction with a

registration request 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 safety finding.

2.0 Hazard Identificationffoxicology

Chlorothalonil is a broad-spectrum, non-systemic protectant pesticide mainly used as a fungicide

to control fungal foliar diseases of vegetable fields and ornamental crops. Its postulated

mechanism of action· as an antifungal agent involves disruption of sulfur-dependent enzymes that

mediate energy production in the fungal organism. Its primary mode of action in mammals via

the oral route of administration is similar in that it involves sulfur-dependent reactivity but

differs in that nephrotoxic cysteine S-conjugates are generated through a bioactivation process in

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Chlorothalonil 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 peak levels at 2-4 and 6 hours in the rat and dog,

respectively. The fraction absorbed in the rat was estimated at 23% at 1.5 mg/kg bw and about

14% at 50 mg/kg bw. The plasma half-life of radiolabeled chlorothalonil in the rat at 1.5 mg/kg

was longer in females (57.2 h) than in males (44.1 h), while being longest in the dog (74.2 h) at

the same dose. At 50 mg/kg, peaklevels of chlorothalonil in the rat were observed at 12 hours

and, along with changes in maximum plasma concentration and area under the plasma

concentration-time curve, suggest changes in absorption (rate and extent) at this higher dose.

The majority of the radioactivity was recovered in the feces. Radioactivity did not appear to be

retained significantly by any specific tissue, although it was detected in the kidneys at both doses

at 120 hours post-dose. The metabolite profiles ofthe urine, bile, and tissue extracts show

differences in the presence and proportions of the metabolites present, most notably the presence

of mercapturic acid-containing moieties in the rat that were not detected in the dog.

The oral and inhalation routes of exposure are of the most toxicological concern with

chlorothalonil. Based on acute toxicity studies, chlorothalonil is highly toxic via the inhalation

route of exposure (Category I). There was a high level of lethality reported in the critical acute

inhalation toxicity study (LCso =0.032 [M] and 0.013 [F] mgIL). RAB1, in conjunction with the

RED ToxSAC, believes that using any oral endpoint may underestimate risk 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 a higher

absorbed fraction (bioavailability) through the inhalation pathway. The lack of a NOAEL in

several acute inhalation toxicity studies carried 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 of short- and intermediate-term

inhalation exposures (portal-of.:entry or systemic) have not been studied, In the last risk

assessment (G. Kramer, 12/23/10; D370486), a 90-day inhalation study was requested as

condition for registration. No new inhalation studies have been submitted to the Agency and a

90-day inhalation study represents a pending data requirement. However, the registrants are

working with the Agency to clarify the data needed to fulfill this data gap.

In the absence of such information, RED recommends that the LOAEL from the critical acute

inhalation toxicity study with appropriate UFs be used as the POD to assess inhalation risks

(acute, short-, and intermediate-term). At this LOAEL, there were no deaths (male or female)

and the very slight to slight (severity) clinical signs of respiratory distress resolved after two days

post-exposure. The use of this LOAEL that is based on mild portal-of-entry effects is likely to

be protective against any systemic toxicity through the inhalation route of exposure. The

methods and dosimetry equations described in EPA'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 for the

particulate diameter (mass median aerodynamic diameter [MMAD] and geometric standard

deviation [(jg] of aerosols), 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 of an animal to the predicted inhalation exposure for a human. For the

aerosolized chlorothalonil used in the critical acute inhalation toxicity study (Holbert, 1993), an

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Chlorothalonil Registration Review Human-Health Assessment Scoping Document

RDDR was estimated at 1.29 based on the reported MMAD of 2.35 /lm and O'g of5.80 and the

entire respiratory-tract surface area of the rat relative to the human. The details ofthese

calculations are listed in the last risk 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 epithelial hyperplasia and

hyperkeratosis at the limiting ridge and/or non-glandular region of the stomach. However,

effects related to forestomach irritation (i.e., hyperplasia and hyperkeratosis of the non-glandular

area of the stomach) are not considered relevant for human health risk assessment due to the lack

of a human forestomach counterpart (HED Cancer Assessment Review Committee (CARC)-

HASPOC meeting in 2008). There were also kidney effects that are relevant for 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 infiltration of inflammatory cells· in the liver of both 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

nuclear pyknosis in the mucosal epithelium ofthe antrum, and a very slight cell hypertrophy in

the zona fasciculata of the adrenal glands.

In one of two rabbit developmental toxicity studies, there was an increased incidence of thirteen

ribs and reduced sternebrae that represented a small (2x) quantitative difference in susceptibility

between fetal and maternal effect levels. However, the difference is often observed in the

particular strain of rabbit used and was not observed in another rabbit developmental study

carried out in the same strain of rabbit and at the same doses of chlorothalonil. In one of two rat

prenatal developmental toxicity studies, an increase in total resorptions per dam with a related

increase in post-implantation loss was reported at a very high dose (400 mglkg bw/day) in the

presence of maternal toxicity (i.e., clinical signs of toxicity, decreases in body-weight gain, and

food consumption). Similar findings were reported in a recently published mouse prenatal

developmental toxicity study where very high doses of chlorothalonil (400-600 mglkg bw/day)

significantly affected the number of live fetuses, were associated with early resorptions, and

caused fetal weight deficits, all in the presence of maternal toxicity (Faraq, et al.; 2006). In the

2-generation reproductive toxicity study, both parental animals and offspring exhibited

pathological effects involving the forestomach that are not considered relevant for human health

risk assessment. Based on the overall weight-of-evidence, there is no evidence of increased

susceptibility to offspring following in utero exposure to rats or rabbits in developmental toxicity

studies or following 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 in the presence of severe maternal toxicity and only at high maternal doses.

The results of a subchronic neurotoxicity study with chlorothalonil did not reveal any signs of

neurotoxicity, only body weight and food consumption deficits were reported. There is no acute

neurotoxicity (ACN) study available for chlorothalonil. The Agency denied a waiver request for

the ACN study requirement on the basis that the highest dose evaluated in that study was several

orders of magnitude lower than the recommended limit dose without any dose-selection rationale

provided. Moreover, several clinical observations in the LDso studies are indicative of potential

neurotoxicity, including ataxia, ptosis, decreased muscle tone, tremors, and nervousness.

Neurotoxicity in the absence of lethality is more likely to be captured by an acute neurotoxicity

study consisting of a robust functional-observational battery and motor-activity measurements.

More details of the evaluation of the waiver by the Agency are provided in the 2010 risk

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assessment (G. Kramer, 12/23110; D370486)

Chlorothalonil has been classified as a "likely" human carcinogen by all routes of exposure

based on an increased incidenceof renal adenomas and carcinomas observed in both sexes of

rats and mice. The mechanistic data, including the negative findings of all genetic toxicology

testing, supported a non-neoplastic pathology as directly related to the eventual neoplasia and a

non-linear mode of action for tumor production by chlorothalonil.

Chlorothalonil exhibited low acute toxicity via the dermal route of exposure (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 of any systemic

toxicity. In the previous risk assessment (G. Kramer, 12/23/10; D370486), chlorothalonil was

classified as not being a dermal sensitizer. However, a published literature study in mice and

guinea pig ranks chlorothalonil as an extremely potent contact allergen, inducing sensitization

through topical exposures on intact skin (Boman et ai., 2000). The data from this study will be

evaluated during registration review of chlorothalonil.

In the last risk 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 of chlorothalonil. The cRill and incidental

oral endpoints (short- and intermediate-term) were based on kidney effects from rat chronic and

subchronic studies, respectively. Dermal risk assessment (all exposure scenarios) was not

performed based on the lack of systemic effects in rat dermal toxicity study in rats 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 of 30x applied to short- and

intermediate-term residential inhalation exposures on the basis that there was no inhalation study

of appropriate duration (only acute studies are available) available for assessing risk from

repeated inhalation exposures. The composite FQPA SF of 30x was made up of 3x for the use of

a minimal LOAEL (no NOAEL achieved) from the acute inhalation study and a lOx factor for

the extrapolation of findings of an acute study to longer durations of exposure. Similarly, a

composite database UF of 30x was applied to short- and intermediate-term occupational·

inhalation exposure for the same reasons listed above. Based on the lack of incident data related

to inhalation effects, the application of these UFs can be characterized as being conservative.

The registrant(s) has consulted the Agency regarding the design of an appropriate inhalation

study to be submitted in the future. Once the appropriate inhalation study is submitted and

evaluated by the Agency, some, if not all, the applied UFs can be reduced accordingly.

In future risk assessments of chlorothalonil, the FQPA SF may need to be updated based upon

submission of pending toxicity studies including inhalation, acute neurotoxicity, and

immunotoxicity studies (see below).

Immunotoxicity

An immunotoxicity study is required as a part of new data requirements in the 40 CFR Part 158

for conventional pesticide registration. Because the immuq.e system is highly complex, studies

not specifically conducted to 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 of required studies, EPA may use a database UF of up to 10X.

An immunotoxicity study on chlorothalonil should be conducted. Once all data have been

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Chlorothalonil Registration Review Human-Health Assessment Scoping Document---

received and reviewed, the chlorothalonil Registration Review Team recommends that the PODs

and safety factors used for risk assessment purposes be reexamined and a new risk assessment

done, if necessary.

Endocrine Disruption

As required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal

Food, Drug, and Cosmetic Act (FFDCA), EPA reviews numerous studies to assess potential

adverse outcomes from exposure to chemicals. Collectively, these studies include acute,

subchronic, and chronic toxicity, including assessments of carcinogenicity, neurotoxicity,

developmental, reproductive, and general or systemic toxicity. These studies include endpoints

that may be 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 of its most recent registration decision, EPA reviewed these

data and selected the most sensitive endpoints for relevant risk assessment scenarios from the

existing hazard database. However, as required by FFDCA section 408(p), chlorothalonil is

subject to the endocrine screening part of the 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 similar to an effect

produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator

may designate." The EDSP employs a two-tiered approach to making the statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal

systems. Chemicals that go through Tier 1 screening and are found to have the potential to

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2

testing is designed to identify any adverse endocrine-related effects caused by the substance, and

establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA 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 first group of 67

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Chlorothalonil

was included on that list and has been issued an order to conduct the Tier 1 testing; Once all

required Tier 1 and Tier 2 data have been received and reviewed, the endpoints and safety factors

used for risk assessment purposes will be examined and a new risk assessment performed if

necessary. For further information on the status of the EDSP, the policies and procedures, the

list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit

our website: http://www.epa.gov/endo/.

Conclusions

The current toxicity database for chlorothalonillacks the following studies according to the

conditional and new 40 CFR Part 158 data requirements:

870.3465 90-day inhalation study (rat)

870.6200 Acute neurotoxicity study

870.7800 Immunotoxicity study

When the aforementioned studies are submitted, the current toxicity endpoint/dose selection may

need to be re-evaluated along with the FQPA SF for future risk assessments.

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3.0 Residue Chemistry

The qualitative nature of the residue in plants 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 of concern in meat and milk is

SDS-3701. Chlorothalonil per se has been shown to be so unstable in ruminant tissues 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 of tolerances for plant commodities.

The limit of quantitation (LOQ) is 0.01 ppm for both chlorothalonil and its 4-hydroxy

metabolite. Samples of crop commodities from recently submitted field trials were analyzed for

residues of chlorothalonil and its metabolite SDS-3701 using modified versions of the previously

enforcement method entitled "Residue Analytical Method for the Determination of

Chlorothalonil and R182281 in Crops." The lower limit of method 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 data for 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 support the established tolerances on crops.

A 28-day ruminant feeding study has been reviewed and accepted by HED. HED recommended

for the establishment of tolerances for the 4-hydroxy metabolite (SDS-3701) in meat and milk

based on the results of this study. The requirement for a poultry feeding study was waived based

on the results of the poultry metabolism study.

Adequate data pertaining to rotational crops are available. In response to an Agency evaluation

of confined 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 of the low toxicity of this

metabolite, an exemption for the requirement of a tolerance has been established for residues of

SDS-46851 as inadvertent residues 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 of the residue in plants and livestock is adequately understood. The

residues of concern are chlorothalonil and its 4-hydroxy metabolite (SDS-3701). The residue

chemistry database is sufficient to support the current registrations. The following data

requirement remains outstanding: multiresidue method recovery data for the 4-hydroxy

metabolite.

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4.0 Dietary Exposure

The most recent dietary exposure and risk assessment was performed in conjunction with the

December 2010 human-health risk assessment conducted by HED (D370486, G. Kramer, et al.;

23-DEC-201O). An acute dietary assessment was not performed because 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 performed using

100% CT for all crops; tolerance-level residues, and DEEM-FCIDTM 7.81 default processing

factors for all foods except for tomatoes (average field-trial residues and empirical processing

factors used), peppers (average field-trial residues used), orange juice (empirical processing

factor translated from tomato juice), and snap beans (average field-trialresidues used). Dietary

risk estimates were determined considering exposures from food plus drinking water using

EDWCs for surface water sources provided by EFED. Ground water sources were not included,

as the EDWCs for this drinking water source are minimal in comparison to those for surface

water.

The resulting chronic dietary risk estimates for food and drinking water combined are below

HED's LOC [i.e., <100% of the cPAD of 0.02 mglkg bw/day] for the overall u.s. population

and all population subgroups. Using DEEM-FCIDTM, dietary risk is estimated at 41 % of the

cPAD for the u.s. population and 98% of the 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 of chlorothalonil residues are adequately addressed

by the chronic exposure analysis using the cPAD.

EFED has provided Tier II 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 of chlorothalonil 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 of concern for risk assessment; parent chlorothalonil and the major degradate SDS-3701

(G. Kramer, et al., 12121/06; DP# 332752). This drinking water assessment (DWA) used revised

input parameters to accurately reflect all scientifically available data, follow the most current

input parameter 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. Water residues

(surface water EDWC of 0.006 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 support the existing registrations. However, a new

dietary exposure and risk assessment may be required during Registration Review 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 and joint compounds, wood stains, wood or wood structure protection treatments

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Chlorothalonil Registration Review Human-Health Assessment Scoping Document

(seasoned, unseasoned), and for mold control. A review was performed of the most recent Label

Use Information System (LUIS) report (dated 9/14/11) prepared by the Biological and Economic

Analysis Division (BEAD) to determine the current residential registrations, methods of

application and maximum application rates for chlorothalonil. A summary of the home garden

uses is provided in Table A4.2~ the golf course uses are summarized as part of the occupational

use summary in Table A4.1. Table A4.3 provides a summary of the registered paint uses. A

summary ofthe antimicrobial uses is provided in Table A4.3.

Based on the registered uses, there·is the potential for residential handler and post-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 on home 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 of treated paint chips, and bystander volatilization inhalation exposure from

the agricultural uses. The potential for residential post-application dermal exposure from the use

on golf courses was identified~ however, since no hazard had been identified via the dermal route

for chlorothalonil, no quantitative assessment was conducted. Post-application inhalation

exposure was also identified as a potential exposure pathway for golfers on treated courses, but

the residential bystander assessment was expected to cover those potential exposures.

Residential Exposure to Paints

The most recent HED risk assessment (Memo, G. Kramer, 12/23/10, D370486) included an

assessment of residential exposuresfrom the use of treated paint, using the most up-to-date

toxicological PODs. The residential exposure assessment included inhalation risk estimates for

residential handlers using treated paint (Table A5.I), post-application inhalation risk estimates

for residents from exposure to treated paint (Table A5.2), post-application incidental oral risk

estimates for incidental ingestion of paint chips by children (Table A5.3), and a residential

bystander assessment to address potential volatilization of chlorothalonil from treated fields

(Table A5.4).

In that assessment, dermal risk was not quantified since no hazard was identified via the 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 of 0.002 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 of NOAEL) and for longer-term durations, another lOx

was added to account for the use of an 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.

For residential handlers using treated paint, there were no inhalation risks of concern for the

acute exposure duration (all MOEs >LOC of 100), but there were risks of concern for the shortterm exposure duration (all MOEs <LOC of 1000). For post-application inhalation exposure, a

chemical-specific study (MRID 43600102) was available that measured air concentrations in a

room treated with chlorothalonil and the data were used to assess indoor post-application

inhalation exposure. Usingthe available data, there were no risks of concern for acute

exposures~ however, there may be risks of concern for longer-term durations. There is no

inhalation study of appropriate 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 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

and intermediate-term exposure. HED believes that the submission of a 90-day inhalation study

(with acute toxicity measurements) is needed to refine the current residential risk assessments.

Based on the lack of incident data related to inhalation effects and the fact that an acute

inhalation toxicity study is being used to assess short- and intermediate-term risk, the risk

assessment can be characterized as conservative. An assessment was also conducted for

incidental ingestion of paint chips by children. The short-term incidental oral MOE was greater

than 100 and, therefore, was not of concern.

AD also assesses dermal irritation for products that have residential uses; however, this

assessment was not included in the RED and will be done during registration review. Although

not yet reviewed, there is a dermal toxicity study in rats (MRID 00158254) that indicates

irritation effects occurred with a LOAEL of 2.5 mglkg/day, which corresponds to a

dose/concentration 2.5 mg/ml or 0.25 percent. This concentration is lower than the rates of 0.5

and 1.0 percent allowed for interior and exterior paints and suggests that dermal irritation risks

may be of concern for antimicrobial uses of chlorothalonil 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 registration review. There are three products

(1022-584,50534-115,71581-2) that allow pressure treatment of wood. Product 71581-2 is

labeled only for pressure treatment and can be applied to wood used for a variety of structures,

including porches and steps. Product 1022-584 can be 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 can be used in a similar manner with the exception that the

primary ingredient is not identified.

Residential Bystander Post-application Inhalation Exposure

The Agency developed a preliminary bystander volatilization inhalation exposure assessment for

chlorothalonil utilizing currently available inhalation toxicity and air monitoring data. The

chlorothalonil bystander volatilization inhalation exposure assessment compared the maximum

air concentration detected in each of the monitoring studies to the acute HEC for residential

bystanders. This comparison was done to represent a potential resident who lives next to a

treated field and may be exposed to the peak concentration of chlorothalonil volatilizing off the

field over a 24-hour period. III addition, the arithmetic mean chlorothalonil air concentration

from each study was compared to the short-/intermediate-term HEC for residential bystanders.

This comparison was done to represent a potential seasonal exposure. None of the air .

concentrations results in acute risks of concern; however, there were a couple of average air

concentrations from some sites that resulted in short-/intermediate-term risks of concern.

Spray Drift

Spray drift is always a potential source of exposure to residents nearby to spraying operations.

This is particularly the case with aerial application, but, to a lesser extent, could also be a

potential source of exposure from the ground application method employed for chlorothalonil.

The Agency has been working with the Spray Drift Task Force, EPA Regional Offices, and State

Lead Agencies for pesticide reg~lation and other parties to develop the best spray drift

management practices (see the Agency's Spray Drift website for more information at

http://www.epa.gov/oppOOOOl/factsheets/spraydrift.htm). On a chemical-by-chemical basis, the

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Agency is now requiring interim mitigation measures for aerial applications that must be placed

on product labels/labeling. The Agency has completed its evaluation of the new database

submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants,. and is

developing a policy on how to appropriately apply the data and the AgDRIFT® computer model

to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic

methods. After the policy is in place, the Agency may impose further refinements in spray-driftmanagement practices 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 of the

residential uses except pressure-treated wood and paint. The residential assessments that have

been performed by HED are reflective of the currently registered residential uses, except for 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 of appropriate 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 of a 90-day

inhalation study (with acute toxicity measurements) is needed to refine the current residential

risk assessments. Based on the lack of incident data related to inhalation effects and the fact that

an acute inhalation toxicity study is being used to assess short- and intermediate-term risk, the

risk assessment can be 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. If changes are made, exposure scenarios may need to be reassessed.

6.0 Aggregate-Risk Assessment

The most recent aggregate-risk assessment was performed in conjunction with theDecember

2010 human-health risk assessment conducted by HED (D370486, G. Kramer, et al.; 23-DEC2010). An acute aggregate-risk assessment was not performed because no appropriate endpoint

was available to determine the aRID for the general population or any population subgroup. A

chronic aggregate exposure assessment takes into consideration dietary food + water exposure

only. The chronic dietary estimates represent chronic aggregate risk. In aggregating short- and

intermediate-term risk, the Agency routinely combines background chronic dietary exposure

(food + water) with short- and intermediate-term residential 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) and residential short-term

inhalation exposure (clinical signs) being used for the current assessment are not the same, these

exposures cannot be combined.

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Chlorothalonil Registration Review 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 of agricultural crops, turf

(including non-residential turf, commerciallindustriallawns, sod farms, and golf courses),

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 of the

most recent LUIS report (dated 9/14/11) prepared by BEAD to determine the current

agricultural/commercial registrations, methods of application and maximum application rates for

chlorothalonil.A summary of the information provided in the LUIS report is provided in Table

A4.1. The current registrations include several Special Local Needs registrations.

Occupational Handlers

There is the potential for dermal and inhalation exposure to occupational handlers from the

currently registered use pattern of chlorothalonil. In all past risk 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 Outdoor Residential

Exposure Task Force (ORETF) and Agricultural Handler Exposure Task Force (AHETF) have

produced pesticide handler exposure monitoring data that the Agency is using in place of

PHED1

. As more-reliable data become 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 area treated per day

or gallons handled. HaIidler's exposure and risk were calculated at baseline (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 of 2010

(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

assessment have been included in Table A6.1 of the attachments. As mentioned in the

residential exposure section, dermal risk was not quantified in the most recent assessment since

no hazard was identified via the 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 of concern 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 latest toxicological 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

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Chlorothalonil Registration Review Human-Health Assessment Scoping Document ----_.

In a previous risk assessment (D353243), HED had recommended that additional personalprotective equipment (PPE) be added to labels that allowed applications via high-pressure

handwands due to risk concerns. At the time, a dust/mist respirator (i.e., a PF5 respirator) was

required to reach acceptable MOEs. During Registration Review, this scenario may need to be

reassessed taking into account changes in both handler 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), a review of this label identified issues

with the use directions that allowed for high application rates to be calculated, which resulted in

risks of concern for handlers. HED, EFED, and RD recommended revisions to the labeled use

directions to clearly indicate the maximum application rates allowable that would not result in

worker and/or drinking water risks. 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

result in risks of concern for chlorothalonil.

The most recent HED risk assessment did not cover all formulations (i.e., did not assess exposure

from the use of dry flowable and wettable powder formulations) and use sites currently

registered for chlorothalonil. In addition, as mentioned above, for the scenarios that were

assessed, the unit exposures for those scenarios have subsequently been revised. Therefore,

representative scenarios that cover the currently registered chlorothalonil uses may need to be

assessed during Registration Review to account for changes in exposure data and toxicological

PODs.

With respect to the antimicrobial uses, the occupational handler exposures that occur from the

use of chlorothalonil for material preservation were assessed in the RED; however, these

assessments may also have to be repeated during registration review to account for changes in

the toxicological PODs. In particular, the handler exposures from the open pouring of wettable

powder will have to be reassessed because the antimicrobial wettable powder products are not

packaged in water-soluble packaging as required by the RED. In addition, exposures that occur

from the use of chlorothalonil as a wood preservative may have to be assessed because they have

not been 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 of chlorothalonil, there is a potential for post-application dermal exposure to workers

following foliar and dip applications of chlorothalonil to agricultural crops, turf use sites,

conifers, and ornamentals (both field and greenhouse grown). Since there is no dermal POD, an

assessment of post-application dermal exposure and risk was not conducted and may not need to

be conducted if no change is made. Based on the Agency's current practices, a quantitative

occupational post-application inhalation exposure assessment was not performed for

chlorothalonil at this time. However, a quantitative assessment of residential bystander risk (for

individuals in or around treated fields) was done based on available air monitoring data for

chlorothalonil. The assessment of bystander risk 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 normally be based on the acute

toxicity categories of the active ingredient. Chlorothalonil is classified in Acute Toxicity

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Chlorothalonil 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 inhalation toxicity 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 previously because the

available incident data indicate that irritation to worker's eyes can occur beyond the 48-hour REI

[see Memo, M. Clock, 1/7/98, The Revised HED Chapter ofthe Reregistration Eligibility

Decision (RED) Documentfor Chlorothalonil]. It was also noted that available residue

dissipation data show that residues do not often dissipate significantly within 48 hours of

application. In the absence of a 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 of the interim48-hour REI imposed by the Worker

Protection Standard (WPS). During Registration Review, a review of the 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 and post-application

exposure and risk, except for wettable powder formulations, wood preservatives, and paints. In

the most recent risk 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 of appropriate 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 of a 90-day

inhalation study (with acute toxicity measurements) is needed to refine the current occupational

risk assessments. Based on the lack of incident data related to inhalation effects and the fact that

an acute inhalation toxicity study is being used to assess short- and intermediate-term risk, the

risk assessment can be characterized as conservative.

Occupational handler scenarios may need to be reassessed during Registration Review to account

for scenarios that have not been covered previously, updated exposure data, and changes to the

toxicological PODs. In addition, in the most recent risk assessment, the Agency requested

additional inhalation toxicity data that may affect the inhalation POD chosen for chlorothalonil.

If changes are made, exposure scenarios may need to be reassessed. During Registration

Review, a review of the REIs listed on the labels and the associated label language will need to

be checked for consistency across products. A review of the labels will also need to be done to

ensure all labels with registered turf uses include a statement prohibiting use on home lawns and

other residential turf sites as required by the RED. In addition, a check of the omamentallabel

co-formulated with propamocarb will need to be done to ensure the revisions have been made

regarding maximum allowable application rates.

A review was performed of (1) the data requests from the RED, (2) the available submitted data

for chlorothalonil, and (3) the granted data waiver requests. Table A7.1 of the attachments lists

all of the submitted studies available for chlorothalonil and Agency reviews of the data. Data

waiver requests were submitted and granted in 2006 for the following studies:

• 132-1a -- Foliar residue dissipation

• 133-3 -- Dermal passive dosimetry exposure

• 133-4 -- Inhalation passive dosimetry exposure

• 231 -- Estimated Dermal exposure - outdoors

• 232 -- Estimated Inhalation exposure - indoors

Page 19 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

It was determined that additional handler and post-application studies for the conventional uses

are not necessary at this point considering the data that have been received in recent years from

various task forces (e.g., ORETF,Agricultural Reentry Task Force (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),

open pouring of liquids and wettable powders during material preservation and application of

treated paints.

8.0 Public Health and Pesticide Epidemiology Data

For this evaluation, the opp Incident Data System (IDS) was utilized for pesticide incident data

on the active ingredient chlorothalonil. Chlorothalonil acts primarily as a fungicide and

mildewcide, but also has some activity as a bactericide, microbiocide, algaecide, insecticide, and

acaricide. It is a broad-spectrum, non-systemic pesticide. Chlorothalonil is registered on a wide

variety of sites including field, vegetable, and orchard crops; turf; and as a mildewcide to be

added to paint and other surface treatments. The purpose of the database search is to identify

potential patterns in the frequency and severity of the health effects attributed to chlorothalonil

exposure. The IDS includes reports of alleged human health incidents from various sources,

including mandatory FIFRA Section6(a)(2) reports from registrants, other federal 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

relevant product information recorded. Reports submitted to the IDS represent anecdotal reports

or allegations only, unless otherwise stated in the report.

The Agricultural Health Study (AHS) is a high-quality, prospective epidemiology study

evaluating the link between pesticide use and various health outcomes including cancer. The

AHS includes private and commercial pesticide applicators and their spouses. The AHS includes

information on use of 50 different pesticide active ingredients commonly used in agriculture.

Incidents resulting in higher severity outcomes reported by registrants and incidents reported

directly to the Agency by non-registrants are recorded in an IDS module called the Main IDS

module. This system stores incident data for death, major and moderate incidents (and some

minor or no effects incidents that are reported as unique cases to the Agency), and it includes

more details about the location, date and nature of the incident. Main IDS incidents involving

only one pesticide are considered to provide more certain information about the potential effects

of exposure 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, or no 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, or no 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 on the incidents in the Aggregate IDS module and these incidents are low severity.

Page 20 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

For the Main IDS, from January 1, 2006 to November 2,2011, there are 22 exposures reported

for single chemical only in the database (20 exposure classified as resulting in a moderate

outcome and 2 classified as major), and 12 additional exposures that involved more than one

chemical. During the scoping phase of Registration Review, the higher severity exposures (those

resulting in fatal or major outcomes) are considered in more detail. Additionally, as described

above, incidents involving one pesticide are typically focused on because they are considered to

provide more certain information about the potential effects of the particular pesticide. The

higher severity exposures (those resulting in fatal or major outcomes) that involve chlorothalonil

are described in Table 1 (two major outcomes).

Currently available research from the AHS does not provide strong evidence in support of an

association between 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 a link between the pesticide and kidney tumors,

which have been reported in some animal studies, was not investigated in this study due to

limited number of exposed cases to perform a robust statistical analysis. A preliminary study

linked chlorothalonil exposure (yes/no) and monoclonal gammopathy of undetermined

significance (MGUS), a pre-cursor biomarker of potential 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 of these exposures resulted in low-severity outcomes,

high-severity outcomes did occur. Based on the frequency and severity of incident cases and

AHS results, for chlorothalonil, there may be a potential for exposure. These incident data may

warrant further analysis in the preliminary risk assessment phase of Registration Review.

Major (if the person alleged or exhibited symptoms which may have been life-threatening, or resulted in adverse

re roductive effects or in residual disabili )

Death (if the 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 adult female

got the product on her arm and

shoulder. About 3 weeks later

she went to the hospital

feeling dizzy and like she was

falling to the ri ht.

A senior (>65 years old)

female sprayed her peach tree

in fall of 2009 and spring of

2010. She has experienced

episodes of high sed rate, low

hemoglobin and pain in her

hi s and legs ever since.

H-C Human Moderate Moderate (if the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic

nature than minor symptoms; and involved some form of treatment, even though symptoms were not life

threatenin and the erson returned to hislher re-ex osure state of health with no additional residual disabili )

H-D Human Minor Minor (if the person alleged or exhibited some symptoms, but they were minimally traumatic; the symptoms

resolved ra idl and usuall involve skin, e e or res irato irritation)

H-E Human Unspecified Unspecified (ifsymptoms are unknown,unspecified or are alleged to be of a delayed or chronic nature that may

a ear in the future)

Page 21 of 53
Chlorothalonil 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. permanent tolerances (listed in 40 CFR 180.275) and Canadian and Codex maximum

residue limits (MRLs) are summarized in Attachment 8. The U.S., Canadian, and Codex

tolerances/MRLs for residues of chlorothalonil are generally not harmonized. For plant

commodities, the U.S. and Canadian residue definitions are harmonized; however, the Codex

residue definition is not harmonized, 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), but not with Codex. Two tolerances/MRLs are harmonized with Codex (cranberry,

bulb onions), but not with Canada. There are several U.S. tolerances for which there are not

Canadian and/or Codex MRLs (e.g., almond, apricot,banana, blueberry, tropical fruits, ediblepodded peas, plums, and fruiting vegetables except tomato). Several tolerances/MRLs for

residues in/on various commodities are not harmonized between either the U.S., Canada, or

Codex (e.g., dry bean seeds, Brassica head and stem subgroup, and potatoes). The U.S. and

Codex residue definitions for livestock commodities are harmonized and the U.S. and Codex

have established MRLs 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 in barley, currants, gooseberry, grapes, leeks, Chinese

onions, welsh onions, parsley, poultry commodities, strawberries, sugar beets, 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 export purposes.

10.0 Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, 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 highest potential exposures from the legal use of a pesticide when

conducting human-health risk assessments, including, but not limited to, people who obtain

drinking water from sources near agricultural areas, the variability of diets within the U.S., and

people who may be exposed when harvesting crops. Should these highest exposures indicate

potential risks of concern, OPP further 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 adult human

subjects were intentionally exposed to a pesticide to determine their dermal and inhalation

exposure. Many such studies, involving exposure to many different pesticides, 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,

and has found no clear and convincing evidence that the conduct of any of them was either

Page 22 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document -------

fundamentally unethical or significantly deficient relative to the ethical standards prevailing at

the time the research was conducted. All applicable requirements of EPA's Rule for the

Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no

regulatory barrier to continued reliance on these studies.

12.0 Data Requirements

Toxicology:

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

• 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 under 40 CFR §180.275(a)(l): "Tolerances are established for residues of

chlorothalonil, including its metabolites and degradates, in or on the commodities in the

table below. Compliance with the tolerance levels specified below 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 of chlorothalonil, in or on the commodity," and under 40 CFR

§180.275(a)(2): "Tolerances are established for residues of chlorothalonil, including its

metabolites and degradates, in or on the commodities in the table below. Compliance

with the tolerance levels specified below 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 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 ofS3
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Inhalation Exposure, Indoor

Exposure Monitoring Data Reporting

Surface Residue Dissi ation

Product Use Information

Open-pour liquids during material preservation. '

Open-pour wettable powders during material preservatiouA,B

Brush/roller application of treated paintsB

Airless sprayer application of treated paintsB

Di , s ray, and ressure treatment of woodB

875.2300 Residential ex osure to ressure-treated wood

875.1700 A detailed written description is needed of all the antimicrobial

uses of chlorothalonil 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 possible to use proprietary surrogate exposure data if data compensation issues can be addressed.

13.0 References

G. Kramer, et at.

G.Kramer

G. Kramer

R. Bohaty

G. Kramer, et at.

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 on Low-Growing Berry Subgroup 13-07G;

Bushberry Subgroup 13-07B; Onion, Bulb Subgroup 3-

07A; and Onion, Green Sub rou 3-07B.

Chlorothalonil. Petition For Tolerances Low-Growing

Berry Subgroup 13-07G; Bushberry Subgroup 13-07B;

Onion, Bulb Subgroup 3-07A; and Onion, Green Subgroup

3-07B. .Summary of Analytical Chemistry and Residue

Data.

Drinking Water Assessment for the IR-4 Registration of

Chlorothalonil (Bravo Weather Stick®, 54%) and the

Degradation Product, 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 Request For Use on Oranges in CA. HumanHealth Risk Assessment.

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 Registration Re uest For Use on Oranges in CA.

Chlorothalonil Technical Fungicide - Review of Residue

Chemistry Studies Submitted by Vischim S.R.L.

Drinking Water Assessment for the IR-4 Registration of

Chlorothalonil (Bravo Weather Stick®, 54%) and the

Degradation Product, 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

Brassica Head and Stem Vegetables.

Chlorothalonil. Petition For Tolerances on Brassica Head

and Stem Subgrou 5A, Cucurbit Vegetable Grau 9,

Page 24 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Fruiting Vegetable Group 8, Ginseng, Horseradish, Lentil,

Lupin, Okra, Persimmon, Rhubarb, Yam, Lychee, and

Starfruit. Summary of Analytical Chemistry and

Residue Data.

G. Kramer, et at.

G. Kramer

G. Kramer, et at.

L. Shanaman

G. Kramer

G. Kramer, et at.

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. Petition For Tolerances on Brassica Head

and Stem Subgroup 5A, Cucurbit Vegetable Group 9,

Fruiting Vegetable Group 8, Ginseng, Horseradish, Lentil,

Lupin, Okra, Persimmon, Rhubarb, Yam, Lychee, and

Starfruit. Human-Health Risk Assessment.

Chlorothalonil Technical Fungicide - Review of Residue

Chemistry Studies Submitted by Vischim S.R.L.

#3E6795. Chlorothalonil: Updated Revised Risk

Assessment for a Tolerance on Edible-Podded Peas

Without a U.S. Re istration.

Further Refined Drinking Water Assessment

Characterization for the Me Too Registration of

Chlorothalonil and the Degradation Product, 4-Hydroxy2,5,6-trichloro-1,3-dicyanobenzene (4-Hydroxy-2,5,6-

tricloroiso hthalonitrile; SDS-3701) in Surface Water.

Chlorothalonil: Preliminary Chronic Dietary Exposure

Assessment for a Tolerance on Edible-Podded Peas

Without a U.S. Re istration.

PP#3E6795. Chlorothalonil: Revised Risk Assessment

for a Tolerance on Edible-Podded Peas Without a U.S.

Re istration.

ARIA Risk Assessment: Chlorothalonil Human Health

Exposure and Risk Assessment for a Tolerance Without a

Registration in the United States on Edible Podded Peas

(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 Edible Podded Peas

Without a US Re istration

Chlorothalonil Reregistration Eligibility Decision (RED).

CHLOROTHALONIL REREGISTRATION.

Reassessment of Tolerance Exemption for the Soil

Metabolite 3-carbamyl-2,4,5-trichlorobenzoic acid (40

CFR §180.1110).

The Revised HED Chapter of the Reregistration Eligibility

Decision (RED) Document for Chlorothalonil.

Chlorothalonil Reregistration: List A Case No. 0097:

Chemical No. 081901: ISK-Bioscience's Submission of

Magnitude of the Residuesof Chlorothalonil on Sweet

Corn.

PP#6F4611. Chlorothalonil. Petition Method 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 ISK Biosciences

February, 1998 Comments on the HED Science Chapter

(dated November 25,1997).

HED Review of Chlorothalonil RED.

The HED Chapter ofthe Reregistration Eligibility Decision

Document (RED) for Chlorotha1onil.

PP#6F4611. Chlorothalonil. Revised Enforcement Method

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 of 53
Chlorothalonil Registration Review Human-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: List A Reregistration Case No. 0097:

Chemical ill No. 081901: Product and Residue Chemistry

Considerations to be Included in the HED Chapter of the

Reregistration Eligibilit Decision Document.

Exposure Assessment for Section 18 Use of Chlorothalonil

and Propamocarb on Tomatoes.

Exposure Assessment for Section 18 Use of Chlorothalonil

and Propamocarb on Tomatoes in Florida.

Exposure Assessment for Section 18 Use of Chlorothalonil

and Propamocarb Hydrochloride on Irish Potatoes.

Revised Occupational And Residential Exposure

Assessment For The Chlorothalonil Reregistration

Eli ibilit Decision (RED).

Occupational And Residential Exposure Assessment For

The Chlorothalonil Reregistration Eligibility Decision

(RED).

OREB Comments Regarding ISK Biosciences' Response

To The HED Draft Chapter For The Chlorothalonil RED.

Revised MixerlLoader/Applicator Exposure Estimates

(Based On 100% Inhalation Absorption) For The

Chlorothalonil Reregistration Eligibilit Decision (RED).

Indiana Petition Request - Reduction Of REI From 48

Hours To 0 Hours For Applications Of Reduced Rate (0.78

Ai/Acre) Of Chlorothalonil To Muskmelons.

Chlorothalonil: Evaluation of new 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 Data Waivers

Study Review: Determination of Dermal and Inhalation

Exposure to Reentry Workers During Maintenance

Activities in Golf Courses" (MRID# 467340-01), DP

Barcode 327361.

Chlorothalonil - Consideration ofRequest for Data Waivers

b Vischim S.r.l.

CHLOROTHALONIL - ExposurelRisk Assessment for

the Proposed Uses of Chlorothalonil on Fruiting

Vegetables, Cucurbits, Persimmon, Rhubarb, Horseradish,

Ginseng, Yam, Okra, Lupin, Lentil, and Head and Stem

Brassica.

Secondary Review of AHETF Field Studies:

AHE17-21.

Chlorothalonil: Occupational and Residential

ExposurelRisk Assessment of Proposed Section 3 Uses on

Strawberry (and other low growing berries), Bushberry

(low bushberry subgroup, except cranberry) and Bulb

Ve etables.

(RE-ISSUED) Health Effects Division (HED) Review of

Agricultural Handler Exposure Task Force (AHETF)

Monograph: Open Pour Mixing and Loading Dry Plowable

Formulations

J. Dawson, et al. D373605 ll-MAR-2011

(RE-ISSUED) Health Effects Division (HED) Reviewof

Agricultural Handler Exposure Task Force (AHETF)

Monograph: Open Pour Mixing and Loading Liquid

Formulations

Page 26 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

(RE-ISSUED) Health Effects Division (HED) Review of

Agricultural Handler Exposure Task Force (AHETF)

Monograph: Open Cab Ground Boom Application of

Li uid S rays

M. Crowley

M. Crowley

D381l48

D393093

28-APR-20ll

22-SEP-20ll

Review of Agricultural Handler Exposure Task Force

(AHETF) Closed Cab Airblast Applicator Exposure

Monitoring Studies: AHE55, AHE56, AHE57, AHE58,

AHE59.

HED Secondary Review of Chlorothalonil Handler

Exposure During Applications of Daconil 2787 Plowable

Fun icide in Greenhouses.

Literature:

Faraq AT., Karkour T.A, El Okazy A, Embryotoxicity of oral administered 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 of chlorothalonil in

the guinea pig and the mouse. Contact Dermatitis 2000, 273-279

Lensen et ai., Contact Dermatitis Caused by 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: Chlorothalonil Endpoint Selection Tables.

Attachment 3: Exposure Potential for Adult and Child Aggregate Risk Estimates.

Attachment 4: Occupational Use PatternslExposure Scenarios for Chlorothalonil.

Attachment 5: Residential Handler and Post-application Scenarios Assessed and Risk

Estimates.

Attachment 6: Occupational Handler Scenarios Assessed and Risk Estimates.

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:S10957:PY-S:(703)305-5079:7509P:RAB1

Page 27 of 53
Chlorothalonil 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 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Attachment 2: Chlorothalonil Endpoint Selection Tables.

Tabl~A.2.1.~llll1lllaryl)fl'o:rcicol~gicall!:nclP()illtsal)dP()DsfQrCI1IQrotMlonilUsed.illJbe2010·Diet3ryallcl

ResidentialRisk Assessment.

Exposure Dose Used in Risk Study and Relevant

Scenario Assessment, UF FQPA SF OR LOC Toxicolo~icalEffects

Acute Dietary- An endpoint of concern (effect)

general population, attributable to a single dose was

including infants not identified in the database.

and children N/A Quantification of acute risk to

general population including

infants and children is not

required.

Acute Dietary- An endpoint of concern (effect)

females 13-49 attributable to a single dose was

years old N/A not identified in the database.

Quantification of acute 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 on kidney effects consisting of

UP= 100 = 0.02 mg/kg/day epithelial hyperplasia in the renal

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 of the epithelium of

Incidental Oral includes the FQPA SF = IX) the proximal convoluted tubules.

Short-(1-30 days) Quantification of dermal risk is

and Intermediate N/A not required.

(1-6 months)-Term

Dermal

Acute Inhalation Chlorothalonil- Acute inhalation100 rat: LOAEL = 0.002 mgIL based

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 mgIL based

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 inhalation exposures

(>6 months) N/A are not expected to occur based

Inhalation on the registered/proposed uses.

Cancer (oral, Classification: "Likely" to be a human carcinogen by all routes of exposure(HED CPRC, 4th

dermal, inhalation) Meeting, 6/1111997); however, the SAP decision (6/30/98) supports the use of an MOE

approach in risk assessment for chlorothalonil. The HASPOC deliberated 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-effect level, RID = reference dose (c =chronic), PAD = population-adjusted dose, MOE = margin of exposure,

Page 29 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document --=-==---=------=---=--------:~c--. LOC =level of concern, 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 of Toxicological Endpoints and PODs for Chlorothalonil in the 2010 Occupational

Exposure Risk Assessments.

Exposure Dose Used in Risk

Scenario Assessment

Short-(1-30 days)

and Intermediate

(1-6 months)-

Term Dermal

HEC

N/A

LOCforRisk

Assessment

Study and Relevant

Toxicolo~ical Effects

Quantification of dermal risk is

not required.

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,

lOX intraspecies,

3X for no NOAEL)

1000

(3X interspecies,

lOX intraspecies,

3X for no NOAEL

lOX for exposure

duration)

Chlorothalonil- Acute

inhalation- rat: LOAEL =

0.002 mgIL based on clinical

signs consisting of

hypoactivity, gasping,

lacrimation, nasal discharge,

piloerection, ptosis, and

respiratory gurgle.

Long-Term Long-term inhalation exposures

(>6 months) N/A are not expected based on the

Inhalation registered/proposed uses.

NOAEL =no-observed-adverse-effect level, LOAEL =lowest-observed-adverse-effect level, LOC =level of concern, N/A =not

applicable, HEC = human-equivalent concentration.

Page 30 of 53
__ __ Chlorothalonil Registration Review Human-I:Iealth Assessment Scoping Document

Attachment 3: Exposure Potential for Adult and Child Aggregate Risk Estimates.

(From D370486, G. Kramer, et al.; 23-DEC-201O)

Table A3. Summary of Chronic Dietary Exposure and Risk for Chlorothalonil (Food + Water).

Age Group cPAD (mglkg/day) Exposure (mg/kg/day) %cPAD

General U.S. Population 0.02 0.008119 41

All Infants « 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 populatIOn for each type of fIsk assessment are balded.

Page 31 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document -------

Attachment 4: Summary of Occupational and Residential Registered Uses Pulled From

LUIS Report (dated 9/14/11).

Table A4.1. Occupational Registered Uses.

Application Maximum

Use Site Formulation Method Application Rate Re-entry

Equipment (lb ailA unless Interval

otherwise noted)

Almond Liquid Aerial, Airblast 3 12 hr Dry Flowable

Dry Flowable Aerial, Airblast 3.1 12 hr

12 hr

Apricot Liquid Chemigation 3.1 12 hr

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 12 hr REI

Blueberry (GA040005) 0.27 gallA

Aerial,

Brassica Liquid Groundboom, 1.5 12hr

Chemigation

Chemigation 1.16 12 hr

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 12 hr

Dry Flowable Aerial, 1.5 12 hr 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 of 53
Chlorothalonil 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 of 53
Chlorothalonil 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

Seed beds; 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,

Forest Trees (SLN Dry Plowable Airblast 2.1 Ib ai/lOO gal 12 hr

WAOOOOI4)

Dry Flowable Aerial,

Groundboom, 1.5 12 hr

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 12 hr

Filbert (Hazelnut) Liquid Handheld 0.0033 Ib ai/gal OR NS equipment 2.891b ai/A

Aerial,

Fruiting vegetables Liquid Groundboom, 1.125 12 hr

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

Golf Course Turf Granular Spreader 11.31 NS

Page 34 of 53
Chlorothalonil 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)

Groundboom, 11.44 12 hr

Liquid Handheld sprayers

Chemigation 8 12 hr

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

Dry FIowable 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 12 hr

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 12 hr

Chemigation

Mushrooms Dry Flowable Drench; Handheld 11.3 lb ai/A OR 0.02 12 hr

Liquid equipment lb ai/gal OR

Dry Flowable Aerial, Airblast 3.135 12 hr

Liquid Aerial, Airblast, 3.1 lb ai/A OR 0.01

Nectarine 12 hr Chemigation lb ai/gal

Ready-to-Use Sprayer Apply to point of NS runoff

Aerial,

Dry Flowable Groundboom, 2.25 12 hr

Chemigation

Handheld 0.01 lb ai/gal OR NS equipment 2.27 lb ai/A

Liquid Aerial,

Onion Groundboom, 2.31 12 hr

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 of 53
Chlorothalonil 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)

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 OR 48 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-in pot 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 and corms 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 of 53
Chlorothalonil 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 of 53
Chlorothalonil 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 of 53
Chlorothalonil 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)

Granular Spreader 11.31 24hr

Dry Flowable Ground 11.34 12 hr

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 12 hr

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 12 hr

Strawberry Dip 0.011 lb ai/gal 12 hr (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 other residential sites) Handheld sprayers

Liquid Groundboom, 11.5 12 hr Handheld sprayers

Wood treatment (freshly sawed Dip or spray 0.0211b ai/gal NS

lumber or timber) Liquid Paintbrush, Airless 0.1051b ai/gal NS

sprayer

Yam Liquid Aerial, 0.9375 12 hr Groundboom

a. These uses and rates are assocIated WIth a label that mcludes both chlorothaloml and propamocarb as the active mgredlents. The labels were

not clear with respect to the maximum application rates allowed and, therefore, the highest rates able to be calculated were used in the risk

assessment. Risks of concern were identified and HED, EFED, and RD recommended revisions to the labeled use directions to clearly indicate

the maximum application rates allowable that would not result in worker and/or drinking water risks.

Page 39 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Table A4.2. Registered Residential Home Garden Uses.

Use Site Formulation Application Method 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 of 53
Chlorothalonil 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, Exterior Latex 2200-10100 ppm

Paints, Stains and Coatings, Exterior Solvent 11500 -11800 ppm

Paints, Stains and Coatings, Interior Latex 660 - 5000 ppm

Paper and Paperboard (non-food) 1415 ppm Note 2

Surface treatment of wood, wallboard concrete and masonry block in buildings 9790 - 10620 ppm 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 contact prohibitions for caulks and sealants.

Note 2 - The paper and paperboard use is only one label 74075-1.

Note 3 - Interior sides of living spaces must be covered with overlayment materials.

Note 4 - Only label #1022-589 hasa maximum rate of 23,800 ppm. The other labels have a maximum rate of 10,800 ppm.

Note 5 - Only two products (#71581-2 and #1022-580) specify the rate in terms of pounds per cubic feet (pet).

Note 6 - Added to the pressure treatment solution as a co-ingredient.

Page 41 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document ._-----~

Attachment 5: Residential Handler and Post-application Scenarios Assessed and Risk

Estimates (from D371456).

Table AS.I. Risk Estimates for Residential Handlers

Application Rate Acute Baseline Inhalation Short-term Baseline

Exposure Scenario Use pattern MOEe Inhalation MOEe

(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 the highest application rate for residential pamtIng uses for chlorothalornl.

b. Science Advisory Council Policy # 12.

c. Unit Exposures based on PHED 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 application rate (lb ailgal) x amount handled (gal) / body weight (70 kg adult).

e. MOE = HED (0.348 mg/kg/day) / Inhalation Dose (mg/kg/day).

Table AS.2. Residential Post-all1plication Inhalation Exposure/Risk from the use of Treated 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 air concentration: 0.00062 650 --

Average air concentration: 0.00058 -- 100

Table AS.3. Residential Post-application Exposure and Risk from Ingestion of Paint Chips Containing

Chlorothalonil Residues.

Percent of ai in Fraction of ai BW PDRb 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. % of aI m product IS 40.4% however the % of al m a gallon of pamt IS 0.48% (153.6 ozJ12,800 oz x 40.4%

= 0.48%).

b. PDR = potential dose rate = IgR x (Percent ai in paint) x Fraction of ai available for ingestion x CFl / BW.

c. MOE =NOAEL (41.3 mg/kg/day)/PDR.

Page 42 of 53
Chlorothalonil 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 LSouthwest 40 4.29 1.34 93,000 h

45,000

West 40 4.29 1.61 93,000 37,000

Cantua School, Cantua Creek 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

Tierra Vista 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 (Air Pollution 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 of cabbage field. Thirty-nine

samples were collected over the

I I

24-hour Hastings, FL

I 2007 Imonitoring 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 of October

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 2007 1 month in

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 of 53
Chlorothalonil 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 of potato 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 of sampler) 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 East Site 1 I I 74 I 2,500 I 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

West Sites 1 and 2 post- I I I 12,000 I I 34 23 2,600

I I I I application

a. Acute MOE - Acute HEC (400,000 ng/m3

) I Study maximum air concentration (ng/m3

). LOC = 100.

b. Short-term MOE = Short-term HEC (60,000 ng/m3

) I Study arithmetic mean air concentration (ng/m3

). LOC = 1,000.

Page 44 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Docum_en_t_~.

c. All non-detects and trace concentrations reported. For non-detects, assumed 1/2 Method Detection Limit (MDL) of 1.43 ng/m3

• For trace concentrations, assumed concentration halfway between MDL and

Estimated Quantitation Limit (7.15 ng/m3

).

d. All samples were <MDLof7.0 ng/m3

•

e. All sites except for Animal Control Shelter, were <MDL of 4 ng/m3

•

f. Samples analyzed by either PANNA lab (MDL ranged from 0.2 to 1.0 ng/m3, depending on analyte and when sample was analyzed and the GC parameters; estimated limit of quantitation ranged 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 the MDL and LOQ) or Commercial lab (reporting limit for

chlorothalonil-specific analysis: lOng/tube, or 3.5 ng/m3 assuming 24 h sample and 2.0 Umin flow rate). All of the 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 of West to Northwest.

Page 45 of 53
________~}orothalonilRegistrat!on Re~iew HUlpan-Hea!th Assessmen~ Scoping Docu~~ _

Attachment 6: Occupational Handler Scenarios Assessed 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

0.015 100 6,800 34,000 68,000 98,000 2,000 10,000 20,000 29,000

Mixing/Loading Liquids via Dip 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 application rate was based on the highest application rate for the most recently proposed uses for chlorothalonil that included 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 assessment on applications via dip (D327566).

c. Baseline Inhalation: no respirator.

d. PF5 Respirator: 80% protection factor provided by a NIOSH-approved quarter-face, cup-style respirator.

e. PFIO Respirator: 90% protection factor is provided by a NIOSH-approved half-face cartridge or canister respirator or a PAPR.

f. Engineering control for applying sprays via aerial equipment: enclosed cockpit.

g. MOEs based on comparison of calculated dose to human-equivalent doses (HED); HED = 0.174 mg/kg/day for acute exposures and HED = 0.052 mg/kg/day for short-and intermediate-term exposures.

Page 46 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Attachment 7. Submitted OccupationallResidential Exposure Studies for Chlorothalonil.

Table A7.1. Exposure I Residue Studies Submitted for ChlorothaloniI.

MRID - Study Citation

147976 Ballee, D. (1985) A Tomato Harvester Exposure 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 Mower Exposure Study with

Chlorothalonil for Golf Course 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 Golfer Exposure 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 Project Number: 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 of Daconil 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 of Dermal 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 of Dermal and

Inhalation Exposure from Chlorothalonil to Reentry Workers During Scouting in Sweet Com:

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 of Dermal 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 of Dermal 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 of Dermal 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 Maxim Technolo ies, Inc. 318 .

45005910 Klonne, D.; Artz, S.; Bruce, E. (1999) Determination of Dermal 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) Determination of Dermal and

Inhalation Exposure 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 of Dermal 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 of Dermal and

Inhalation Exposure to Reentry Workers During Maintenance Activities on Golf Courses: Lab

Pro·ect Number: ARF046. Un ublished stud re ared b H.E.RAe. Inc. 420

Page 47 of 53

Agency Review

Data were reviewed and

incorporated as part ofrevisions

to Occupational Pesticide Posta lication Ex osure Data

Data provided are superseded

by newer submitted golf course

maintenance studies (see below

under ARTF); primary

contractor reviews are available

Data were reviewed and

incorporated as part of revisions

to Occupational Pesticide

Handler Ex osure Data

0393093

Primary contractor reviews

available
Chlorothalonil Registration Review Human-Health Asses~mentScoping Docume~

Table A7.1. Exposure I Residue Studies Submitted for Chlorothalonil.

MRlD - Study Citation Agency Review

45530102 Klonne, D.; Fuller, R; Honeycutt, R (2001) Determination of Dermal 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 of Dermal 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 of Dermal and Inhalation Exposure to

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

Number: ARTF/ARF057, ARF057/MG, ARF057/CC. Unpublished study prepared by

A ricultural Reent Task Force and Ricerca Biosciences, LLC. 485 .

0327361

47212806 Bruce, E. (2007) Determination of Dermal 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 of Application Methods. Project

Number: AHE18, 050186. Unpublished study prepared by Agricultural Handlers Exposure

Task Force. 416 .

47212808 Klonne, D. (2007) Determination of Dermal and Inhalation Exposure to Workers in

Southern Georgia During Open Pour MixingILoading a Dry Flowable Pesticide Product and

During Application to Various Sites by a Variety of Application Methods. Project Number:

AHE20,050188. Unpublished study prepared by Agricultural Handlers Exposure Task Force.

441 . 0343367

47212809 Klonne, D. (2007) Determination of Dermal and Inhalation Exposure to Workers in

Northern Florida During Open Pour Mixing/Loading a Dry Flowable Pesticide Product and

during Application to Various Sites by a Variety of Application Methods. Project Number:

AHE21. Unpublished study prepared by Agricultural Handlers Exposure Task Force, LLC.

406 .

47259801 Klonne, D.; Holden, L. (2007) Agricultural Handler Exposure Scenario

Monograph: Mixing and Loading Dry Flowable Formulations. Project Number: AHE1001.

Un ublished stud re ared b A ricultural Handlers Ex osure Task Force. L.L.C. 107 .

47947801 Klonne, D.; Holden, L. (2009) Agricultural Handler Exposure Scenario

Monograph: Open Pour Mixing and Loading Dry Flowable Formulations. Project Number:

AHB1001. Un ublished stud re ared b A ricultural Handler Ex osure" Task Force. 229

47947802 Klonne, D.; Holden, L. (2009) Agricultural Handler Exposure Scenario

Monograph: Open Pour Mixing and Loading ofLiquid Formulations. Project Number:

AREI003. Un ublished study re ared by Agricultural Handler Ex osure Task Force. 209

47947803 Bruce, E.; Holden, L. (2009) Agricultural Handler Exposure Scenario Monograph:

Open Cab Groundboom Application of Liquid Sprays. Project Number: AHEI004.

Un ublished study re ared by Agricultural Handler Ex osure Task Force. 216 .

0373605

48303501 Smith, L. (2010) Determination of Dermal and Inhalation Exposure to Workers

During Airblast Applications of Liquid 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 Handler ExposureScenario

Monograph: Closed Cab Airblast Application of Liquid 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 of revisions

47714402 Klonne, D.; Holden, L. (2009) Agricultural Handler Exposure Scenario to Occupational Pesticide

Monograph: Open Cab Groundboom Application of Liquid Sprays. Project Number: Handler Exposure 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 of Dislodgeable 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 of Dislodgeable 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 of Dislodgeabk 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 of Dislodgeable Foliar Residues of Chlorothaloriil

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 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Table A7.1. Exposure I Residue 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 WeatherStik Transferable Turf

Residue Study on Golf Course Greens: Lab Project Number: RR-99-072B. Unpublished

stud re ared b ZenecaA Products.436 . {OPPTS 875.2100}

44868602 Prochaska, L. (1999) Dissipation of Dislodgeable Foliar Residues of Chlorothalonil

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 Transferable Turf

Residue Study on Golf Course Fairways: Lab Project Number: RR 99-07lB: CHLO-99-TR01: ERS-99011. Unpublished study prepared by GB Biosciences Corporation. 376 p.

1-------,-.,...,....,-----,-::-:-::-::-=---=-...,..,--:,.-:-::-:-=-_---'{L:0::..:Pe.,:P....:T:..::S:...:8:c:7.=.5.:..:.2:.:1..::0.::.°L} --,----=----,-------------,-----,----1 Data will need to be reviewed if

44901001 Hofen,1. (1999) Determination ofTransferable Residues on Turf Treated 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 were noted as submitted in RED

Page 49 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Attachment 8: Chlorothalonil International Residue Limit Status Sheet.

International Residue Limits

Chlorothalonil (081901; 10/14/11)

Summary of US and International Tolerances and Maximum Residue Limits

Residue Definition:

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 MexicoI 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,

cauliflower4

5 Flowerhead brassicas

(includes broccoli,

broccoli Chinese and

cauliflowed

Carrot, roots 1 1.0 carrots 1

4

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

Cocoa bean, 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 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Summary of US 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 1.0 parsnips 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 (dryt

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 in this 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

except tomato 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 mammalian fats

(except milk fats)3

Cattle, kidney 0.5 0.2 Edible offal

Cattle, meat byproducts, 0.05 (mammalian)3

except kidney

Page 51 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

Summary of US and International Tolerances and Maximum Residue Limits

Residue Definition:

US Canada Mexico· Codex2

Cattle, meat 0.03 0.02 meat from

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, meat byproducts, 0.05 (mammalian)3

except kidney

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, meat byproducts, except 0.05 (mammalian)3

kidney

Hog, meat 0.03 0.02 meat from

mammals other than

marine mammals)3

Horse, fat 0.1 0.07 mammalian fats

(except milk fats)3

Horse, kidney 0.5 0.2 Edible offal

Horse, meat byproducts, 0.05 (mammalian)3

except kidney

Horse, meat 0.03 0.02 meat from

mammals other than

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, meat byproducts, 0.05 (mammalian)3

except kidney

Sheep, meat 0.03 0.02 meat from

mammals other than

marine mammals) 3

MRLs with NO 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 of 53
Chlorothalonil Registration Review Human-Health Assessment Scoping Document

MeXICo adopts US tolerances and/or Codex MRLs for Its export purposes.

Summary of US and International Tolerances and Maximum Residue Limits

Residue Definition:

US Canada MexicoI Codexl

Wheat straw and fodder, dry 204

Wasabi 5.0

Completed: M. Negussie; 10/1812011

I

2 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP=

processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the

fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

3 ProposedMRL.

4 Withdrawal recommended.

(c) Tolerances with regional registrations. Tolerances with regional registration, as defined in §180.1(I), are established for the

combined resl·dues 0 f hc lorothal·1om and·Its metab0 r·Ite mor on the £0 II· owmg raw agncu. laid·· tm commo ItJes:

Commodity Parts per million

Hazelnut 0.1

Peppermint, tops 2

Persimmon 1.5

Spearmint, tops 2

Page 53 of 53