UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: June 30. 20 15 

SUBJECT: Thiram: Tier J Review of Human Incidents and Epidemiology 

PC Code: 079801 DP Barcode: 0427919 

Decision No.: 505988 

Petit ion No.: NA 

Risk Assessment Type: NA 

TXR No.: NA 

MRIO No.: NA 

Registration No.: 1 A 

Regulatory Action: 1 A 

Case No.: NA 

CAS No.: 137-26-8 

40 CFR: NA 

FROM: Ir Shanna Recore. ' Industrial Hy.gienist 1211(\ f 11 Toxicology and Epidemiology Branch\ )

1 

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Health Effect Division (7509P) 

Ver.Apr.OS 

Toxicology 

Eli zabeth 

and 

Evans. 

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pidemi

nvironm

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ental 

Branch 

Protection Specialist c; 

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Health Effects Division (7509P) a I" . _ 

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THROUGH: David Miller. Acting Branch Chief 11 ,J /I fi{/l \. . Toxicology and Epidemiology Branch 

Hea lth Effects Division (7509P) 

TO: Dennis McNealy. Risk Assessor 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

and 

Wilhelmena Livingston. Chemical Review Manager 

Risk Management & Implementation Branch 4 

Pesticide Re-evaluation Division (7508P) 

Summarv and Conclusions 

Based on the low frequency and low severity of inc ident cases reported for thiram in IDS, 

SENSOR-Pesticides, and NPJC 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 

Thiram is a non-systemic fungicide used to prevent crop damage in the field and to protect 

harvested crops (apples, peaches. and strawberries) from deterioration in storage or transport. It 

is also used as a seed protectant (e.g. small seeded vegetables. large seeded vegetables, cereal 

grains and other seeds, coniferous seeds, cotton seed, ornamental seeds, and soybeans) and to 

protect turf from fungal diseases. In addition, thiram is used as an animal repell ent to protect 

crops from damage by rabbits, rodents, and deer. 

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) 

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

consulted for pesticide inc ident data on the active ingredient thiram (pc code: 07980 I). The 

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

the health effects attributed to thiram exposure. Thiram is not included in the AHS, and 

therefore this study does not provide information for this report. 

III. RES UL TS/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. Rep011s 

submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in 

the report. 

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IDS records incidents in one of two modules: Ma in 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 l, 2010 to December 30. 2014. there were 0 incidents reported 

involving thiram. 

In Aggregate IDS, from January I, 20 l 0 to December 30, 2014, there were 28 incidents reported 

involving thiram. These incidents were classified as minor severity. Overall, there are few 

incidents involving thiram reported to IDS. 

b. SENSOR-Pesticides 

The SE SOR-Pesticides database covers 12 states from 1998-2011, although reporting varies 

from state to state. Cases of pesticide-related illnesses are asce11ained 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-Pesticides focuses on 

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

state coordinator at each of the 12 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 IOSH. annually to be aggregated. 

A review of SENSOR-Pesticides 1998-201 I identifies 14 cases involving thiram (pc code 

079801); nine cases involve a single ai. Eight of the nine cases were work-related. Eight cases 

were low in severity and one case was moderate in severity. Dermal symptoms were reported by 

five cases. four cases experienced respiratory irritation. 

c. National Pesticide Information Center (NPJC) 

The National Pesticide Information Center or NPIC is a cooperative effort between Oregon State 

University and EPA which is funded by EPA to serve as a source of objective. science-based 

pesticide infomiation and respond to inquiries from the public and to incidents. NPIC functions 

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nationally duri ng weekday business hours through a toll-free telephone number in addition to the 

internet (www.npic.orst.edu) and email. Similar to Poison Control Centers, NPIC's primary 

purpose is not to collect incident data, but rather to provide information to inquirers on a wide 

range of pesticide topics, and direct callers for pesticide incident investigation and emergency 

treatment. Nevertheless N PIC does collect information about incidents (approximately 4000 

incidents per year) from inquirers and records that information in a database. NPIC is a source 

of national incident information but generall y receives fewer reports than IDS. Regardless, if a 

high frequency is observed in IDS, NPIC provides an additional source of information to see 

whether there is evidence of consistency across national data sets or possibly duplication and 

additional information about the same incident(s). 

From 2010 to 2014, 1 incident was reported to NPIC involving thiram. NPIC estimates a 

certainty index as to whether an incident (including reported symptoms) was either definitely, 

probably, possibly, or unlikely to have been caused by the reported exposure to a pesticide, or 

whether the incident was unrelated to pesticides or if the incident was unclassifiable. This 

incident was classified with a certainty index of possible and a severity of moderate. The 

incident involves a 45 year old male who sells vegetable seeds. He was handling seeds treated 

with a fungicide containing thiram and did not wear PPE. He developed a rash on both his hands 

and feet. 

d. 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 appli cators and their spouses. If there are AHS find ings 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 80 different pesticide 

active ingredients commonly used in agriculture. Thiram is not included in the AHS, and 

therefore this study does not provide information for this report. 

IV. CONCLUSION 

Based on the low frequency and low severity of incident cases reported for thiram in IDS, 

SENSOR-Pesticides, and NPlC 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 wi ll be included in the risk assessment. 

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