UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: August 19,2014 

SUBJECT: Triflumizole: Tier I Review of Human Incidents for Preliminary Risk Assessment 

PC Code: 128879 DP Barcode: 0422005 

Decision No.: 493878 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.:NA 

MRIDNo.: NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 240494-70-6 

40CFR: NA 

Ver.Apr.08 

FROM: Shanna Recore, Industrial Hygienist () _ A . "' 

Toxicology and Epidemiology Branch ~ /~ 

Health Effects 

and 

Division (7509P) · ~ 

Toxicology 

Elizabeth Evans, 

and Epidemiology 

Environmental 

Branch 

Protection Specialist 

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~ 

. 

Health Effects Division (7509P) ~ 

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THROUGH: David J. Miller, Acting Branch Chief(,_}V· ' 't·l-1 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Seyed Tadayon, Risk Assessor 

Risk Assessment Branch V 

Health Effects Division (7509P) 

and 

Steven Snyderman, Chemical Review Manager 

Risk Management & Implementation Branch III 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Triflumizole was previously reviewed in 2006 (M. Hawkins and H. Allender, 08/15/2006, 

D336039). There were no incidents identified in the Main Incident Data System from 1992 to 

August 2006 and one incident identified in NIOSH SENSOR-pesticides from 1998 to 2003. 

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This updated review concurs with the previous conclusion. Overall the incident cases reported 

for Triflumizole were of low frequency and low severity in both IDS and NIOSH SENSORPesticides. 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 conducted. 

Detailed Review 

I. ACTION REQUESTED 

Triflumizole is a pesticide being considered under the FQPA-mandated Registration Review 

program established to review, on a 15 year cycle, pesticides for which a Re-registration 

Eligibility Decision has been made. One component of the Agency's Registration Review 

Program is consideration of human incident data. In conjunction with a human health risk 

assessment based on other data sources, such human incident data can assist the Agency in better 

defming and characterizing the risk of pesticides/pesticide products. 

Triflumizole was previously reviewed in 2006 (M. Hawkins and H. Allender, 08115/2006, 

0336039). It was concluded that "there was only 1 report of an ill effect from exposure to 

triflumizole in the available databases" and "no recommendations" were "made based on limited 

information available." 

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 

Triflumizole is a broad spectrum foliar fungicide for controlling plant diseases by inhibiting 

ergosterol biosynthesis in fungi. It is used to treat powdery mildew, leaf spot, scab and various 

blights, rusts, and rots. It is registered for use on almond, apple, cantaloupe, cherry, cucurbit 

vegetable, grapes, filbert/hazelnut, honeydew, pear, pumpkin, squash, strawberry, and 

watermelon. Also used on ornamentals in greenhouses, shadehouses, nurseries and 

interiorscapes. 

For this evaluation, both 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 triflumizole (PC Code: 128879). 

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

of the health effects attributed to triflurnizole exposure. 

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 (FJFRA) 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. 

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 specific. 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 

pesticide 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, 2006 to August 5, 2014, there were 3 incidents reported for 

single chemical only in the database involving triflumizole. These incidents were classified as 

moderate severity. 

In Aggregate IDS, from January 1, 2006 to August 5, 2014, there were no reported incidents 

involving triflumizole. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2010, 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 

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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 2006-2010 identifies a total of23 cases involving 

triflumizole. Of these 23 cases five were single active ingredient cases, all five of which were 

low in severity. These five cases stem from one event in California in 2007. The case notes 

explain that the five workers each entered a greenhouse after the REI had expired but there was 

improper ventilation (fans were not on) and the workers became ill. All five cases experienced 

neurological symptoms, chiefly headache and dizziness. Three cases experienced respiratory 

symptoms and three cases experienced gastrointestinal symptoms. This event was investigated 

but no violation was cited. 

IV. CONCLUSION 

Triflumizole was previously reviewed in 2006 (M. Hawkins and H. Allender, 08/ 15/2006, 

D336039). There were no incidents identified in the Main Incident Data System from 1992 to 

August 2006 and one incident identified in NIOSH SENSOR-pesticides from 1998 to 2003. 

This updated review concurs with the previous conclusion. Overall the incident cases reported 

for Triflumizole were of low frequency and low severity in both IDS and NIOSH SENSORPesticides. 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 conducted. 

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