UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: February 20, 2013 

SUBJECT: Captan: Review of Human Incidents 

PC Code: 081301 DP Barcode: D409190 

Decision No.: 474467 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.:NA 

MRIDNo,:NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 133-06-2 

40CFR:NA 

Ver.Apr.08 

FROM: Shanna Recore, Industrial Hygienist A A.. ~ . . . /) · /1 ~ ~ Toxicology and Epidemiology Branch .)JQl..JJ..P.-I~v - Health Effects Division (7509P) 

and ~ 

Toxicology 

Elizabeth Evans, 

and Epidemiology 

Environmental 

Branch 

Protection Specialist .::; 

-~.- !! --~ 

Health Effects Division (7509P) /J 

THROUGH: David J. Miller, Acting Branch Chief /!_fo 1 $:!~­ Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Thurston Morton, Risk Assessor 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

and 

Christina Scheltema, Chemical Review Manager 

Risk Management & Implementation Branch 3 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Based on the low frequency and severity of incident cases reported for captan in both IDS and 

NIOSH SENSOR-Pesticides, there does not appear to be a concern at this time that would 

warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be included in the risk assessment. 

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The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Captan is included in the AHS, and 

therefore this study does provide information for this report. 

Detailed Review 

I. ACTION REQUESTED 

This review is intended to fulfill our requirement to docket summaries of incident data that were 

reported to the Agency, as well as to ensure human incident data and the Agricultural Health 

Study (AHS) are part of the problem formulation phase of registration review. Reports of 

adverse health effects allegedly due to a specific pesticide exposure (i.e., an "incident") are 

largely self-reported and therefore, generally speaking, neither exposure to a pesticide or 

reported symptom (or the connection between the two) is validated or otherwise confirmed. 

Typically, causation cannot be determined based on incident data. However, incident 

information can be an important source of feedback to the Agency: incidents of severe outcome, 

or a suggested pattern or trend among less severe incidents, can signal the Agency to further 

investigate a particular chemical or product. Observational epidemiology studies relate the risk 

of disease, e.g., cancer, and exposure to an agent such as a pesticide product in the general 

population or specific sub-groups like pesticide applicators. 

II. BACKGROUND 

Captan is a fungicide used to control diseases on orchard crops, seed treatments, ornamentals, 

lawns and turf, and is also used as an in-can preservative in adhesives and paint. Formulations 

include dust, emulsifiable concentrate, flowable concentrate, water dispersible granules, wettable 

powder, and a variety of others. 

For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease 

Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) 

Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient captan (PC Code: 081301 ). The 

purpose of the database search is to identify potential patterns in the frequency and severity of 

the health effects attributed to captan exposure. 

In addition, findings from the AHS were reviewed. The Agricultural Health Study (AHS) is a 

high quality, prospective epidemiology study evaluating the link between pesticide use and 

various health outcomes including cancer. Captan is included in the AHS and provides 

information for this report. 

III. RESULTS/DISCUSSION 

a. IDS (Incident Data System) 

OPP's IDS includes reports of alleged human health incidents from various sources, including 

mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports 

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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. 

IDS records incidents in one of two modules: Main IDS and Aggregate IDS: 

o Main IDS contains incidents resulting in higher severity outcomes and provides 

more detail with regard to case specifics. This system stores incident data for 

death, major and moderate incidents, and it includes information about the 

location, date and nature of the incident. Main IDS incidents involving only one 

active ingredient (as opposed to pesticide products with multiple active 

ingredients) are considered to provide more certain information about the 

potential effects of exposure from the pesticide. 

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, 

unknown, or no effects outcomes). These are reported by registrants only as 

counts in what are aggregate summaries. 

For the Main IDS, from January 1, 2007 to December 11, 2012, there were 6 incidents reported 

for single chemical only in the database. There were 4 additional incidents reported involving 

more than one chemical. All of these incidents were classified as moderate severity. Overall, 

there are few incidents involving captan reported to IDS. 

In Aggregate IDS, from January 1, 2007 to December 11, 2012, there were 16 reported incidents 

involving captan. 

b. NIOSH SENSOR 

The NIOSH SENSOR database covers 11 states from 1998-2009, although reporting varies from 

state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, 

including: reports from local Poison Control Centers, state Department of Labor workers' 

compensation claims when reported by physicians, reports from State Departments of 

Agriculture, and physician reports to state Departments of Health. Although both occupational 

and non-occupational incidents are included in the database, SENSOR focuses on occupational 

pesticide incidents, and is of particular value in providing that information. A state SENSOR 

contact specialist attempts to follow-up with cases and obtains medical records to verify 

symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized 

protocol and case definitions derived from poison center reporting, SENSOR coordinators at 

State Departments of Health enter the incident interview description provided by the case, 

medical report, physician and patient into the SENSOR data system. The SENSOR data system 

is accessible to participating states and EPA. 

A query of SENSOR-Pesticides 1998-2009 identifies 36 cases stemming from 33 events. Ofthe 

36 cases, 9 involved the single active ingredient Captan and 27 involved multiple active 

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ingredients. One case was high in severity, 8 cases were moderate in severity, and 27 were low _ 

in severity. The high severity case occurred in New York in 1998; the case was spraying a tree 

in his yard (with Dragon Fruit Tree Spray and Al-Joe's Bonide A Complete Tree Fruit Spray) 

and was exposed. The case was admitted to ICU for nervous system (and other) symptoms and 

was treated with pralidoxime and atropine. Each of the 8 moderate severity cases reported 

symptoms involving the nervous system. A breakdown of symptoms reported for all cases is 

provided. 

SENSOR-Pesticides 1998-2009: Reported 

Health Effects for Captan Cases* 

Dermal 10 

Ocular 9 

Respiratory 14 

Gastrointestinal 18 

Renal 1 

Nervous System 22 

Cardiovascular 6 

Misc. 9 

* Cases may report multiple health effects 

c. Agricultural Health Study (AHS) 

The 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. If there are AHS findings relevant to a particular 

pesticide going through registration review, the Agency will ensure they are considered in the 

problem formulationlscoping phase of the process and, if appropriate, fully reviewed in the risk 

assessment phase of the process. The AHS includes information on use of 50 different pesticide 

active ingredients commonly used in agriculture. 

Greenburg et al. (2008) evaluated captan exposure in relation to cancer outcomes within the 

Agricultural Health Study (AHS) and did not observe an association with any cancer site tested 

(only anatomical cancer sites for which at least 15 exposed cases were included in this study). In 

this analysis, authors evaluated prostate, lung, colon, colorectal and all blood cancers combined 

among 4383 participants who reported using captan in their lifetime, and among 2912 new cases 

of cancer determined in the cohort. Among this total group of 48, 986 AHS participants, authors 

did not identify any statistically significant, elevated risks of any cancer in relation to captan use. 

Similarly, in separate AHS studies of specific anatomical cancer sites (prostate, lung, breast, 

colorectal, pancreatic and cutaneous melanoma) in association with use of pesticides, including 

captan, authors did not report elevated risks of these cancers with captan use. Engel et al. (2005) 

reported slightly elevated risks of breast cancer among female spouses of AHS pesticide 

applicators who reported use of captan, but these analyses were based upon small number of 

captan exposed cases, and should be interpreted with caution. In others areas of AHS research, 

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industrial hygienists performed several studies evaluating the validity of the AHS method of 

exposure assessment as applied to fungicide applicators. As a result, several changes to the AHS 

exposure metric for fungicide users were made (Hines et al, 2007, 2008, and 2011). The new 

AHS exposure algorithm is reflective of these modifications for fungicide uses, but was not 

utilized in these earlier studies of captan and cancer (Greenburg et al. 2008 and Engel et al. 

2005). This may, in part, explain the lack of an association with captan, if an association truly 

exists. AHS researchers plan to update these initial captan analyses using additional pesticide 

(including captan) exposure information collected since the time of enrollment, as well as the 

updated AHS exposure metric. As these newer analyses are completed, EPA will continue to 

review the literature regarding evidence of the carcinogenic potential of captan in the AHS 

cohort. 

IV. CONCLUSION 

Based on the low frequency and severity of incident cases reported for captan in both IDS and 

NIOSH SENSOR-Pesticides, there does not appear to be a concern at this time that would 

warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be included in the risk assessment. In addition, 

EPA will continue to review the literature regarding evidence of the carcinogenic potential of 

captan in the AHS cohort. 

Articles Reviewed: 

1: Hines CJ, Deddens JA, Coble J, Kamel F, Alavanja MC. Determinants of captan 

air and dermal exposures among orchard pesticide applicators in the Agricultural 

Health Study. Ann Occup Hyg. 2011 Jul;55(6):620-33. doi: 10.1093/annhyg/mer008. 

Epub 2011 Mar 22. PubMed PMID: 21427168; PubMed Central PMCID: PMC3131503. 

2: Greenburg DL, Rusiecki J, Koutros S, Dosemeci M, Patel R, Hines CJ, Hoppin JA, 

Alavanja MC. Cancer incidence among pesticide applicators exposed to captan in 

the Agricultural Health Study. Cancer Causes Control. 2008 Dec;19(10):1401-7. 

doi: 10.1007/s10552-008-9187-9. Epub 2008 Jun 28. PubMed PMID: 18587656. 

3: Hines CJ, Deddens JA, Jaycox LB, Andrews RN, Striley CA, Alavanja MC. Captan 

exposure and evaluation of a pesticide exposure algorithm among orchard pesticide 

applicators in the Agricultural Health Study. Ann Occup Hyg. 2008 

Apr;52(3):153-66. doi: 10.1093/annhyg/menOOl. Epub 2008 Mar 6. PubMed PMID: 

18326518. 

4: Hines CJ, Deddens JA, Coble J, Alavanja MC. Fungicide application practices 

and personal protective equipment use among orchard farmers in the agricultural 

health study. J Agric SafHealth. 2007 Apr;13(2):205-23. PubMed PMID: 17555208. 

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5: Engel LS, Hill DA, Hoppin JA, Lubin JH, Lynch CF, Pierce J, Samanic C, Sandler 

DP, Blair A, Alavanja MC. Pesticide use and breast cancer risk among farmers' 

wives in the agricultural health study. Am J Epidemiol. 2005 Jan 

15;161(2):121-35. PubMed PMID: 15632262. 

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