UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: December 17, 2013 

SUBJECT: Thiophanate-methyl and Carbendazim: Tier I Review of Human Incidents 

PC Code: 102001,128872 

Decision No.: 480779 

Petition No.: NA 

DP Barcode: D416734 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXRNo.:NA 

MRIDNo.:NA 

CAS No.: 23564-05-8, I 0605-21 -7 

40CFR:NA 

FROM: 

THROUGH: 

TO: 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

and 

Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) /2 $; 

David Miller, Acting Branch Chief elf;J), W, 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Linnea Hansen, Risk Assessor 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

and 

Russell Wasem, Chemical Review Manager 

Risk Management & Implementation Branch 1 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ver.Apr.08 

Based on the low frequency and severity of incident cases reported for thiophanate-methyl and 

carbendazim, 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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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 

TM is a systemic fungicide used on a variety of tree, vine, and root crops, as well as on canol a 

and wheat. Residential homeowners may use TM on lawns and ornamentals. MBC is registered 

as a systemic fungicide in paints in residential settings, but has no registered food uses in the US, 

nor import tolerances. 1 

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 thiophanate-methyl and 

carbendazim (PC codes: 102001, 128872). The purpose of the database search is to identify 

potential patterns in the frequency and severity of the health effects attributed to Thiophanatemethyl exposure. Thiophanate-methyl is not included in the AHS, and therefore this study does 

not provide infonnation 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 

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. 

1 Excerpt from Thiophanate-Methyl Factsheet, found online at: 

http://www.epa.gov/oppsn d 1/REDs/factsheets/trn red fs.pdf 

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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, 2008 to September 11,2013, there were 5 incidents reported 

for single chemical only in the database. There were 3 additional incidents reported involving 

more than one chemical. One incident was classified as major severity (Table 1). The other 

incidents reported were classified as moderate severity. 

In Aggregate IDS, from January 1, 2008 to September 11, 2013, there were 14 reported incidents 

involving thiophanate-methyl and carbendazim. Overall, there are few incidents involving 

thiophanate-methyl and carbendazim reported to IDS. 

T a e bl 1 M aJor . S eventy I nc1 'd en t D . r escnp110ns £ or Th' lOp h t M ana e- e th lYJ 1 

Human Incident Chemical: Thiophanate-Methyl I PC Codes: 102001, 128872 

Incident 

Package Incident Reg Exposure 

Report Date Location Number Product Name Severity Incident Description 

Caller recently discovered that her 

husband had been storing multiple 

products under the crawl space of 

their home for 3 years. The caller 

experienced symptoms during that 

same time period which she believes 

020111 000538- LAWN are related to indirect exposure to the 

- 00270 1/1/2008 NC 00088 FUNGUS Major product. Her symptoms include 

CONTROL tingling, numbness in feet, hands and 

toes, pain and progressing burning 

sensation in both arms and muscle 

twitches in legs. She also has 

headaches and nausea. No one else 

in the family experienced any 

symptoms. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides 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, 

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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-Pesticides focuses on 

occupational pesticide incidents, and is of particular value in providing that information. The 

state coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using 

standardized protocol and case definitions derived from poison center reporting, the state 

SENSOR-Pesticide coordinator enters the incident information into the state-based system which 

is sent to NIOSH annually to be aggregated. 

A query of SENSOR-Pesticides 1998-2009 finds 28 cases involving thiophanate-methyl and 

carbendazim. Of these, nine cases involved a single active ingredient. Five of the nine cases 

were work-related. All nine cases were low in severity. Case symptoms are summarized in 

Table 1. 

Table 1. SENSOR-Pesticides 1998-2009: Reported Health 

Effects for Thiophanate-methyl Cases 

Health Effect # of Times Reported 

Dermal 3 

Ocular 0 

Respiratory 2 

Gastrointestinal 4 

Renal 0 

Nervous System 5 

Cardiovascular 0 

Miscellaneous I 

* 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 formulation/scoping 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. Thiophanate-methyl and carbendazim are not 

included in the AHS, and therefore this study does not provide information for this report. 

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IV. CONCLUSION 

Based on the low frequency and severity of incident cases reported for both thiophanate-methyl 

and carbendazim in both IDS and 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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