UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
OFFI CE OF CHEMICAL SAFETY AND POLLU T ION PREV E NT ION

MEMORANDUM Date: August 19,2014 SUBJECT: Triflumizole: Tier I Review of Human Incidents for Preliminary Risk Assessment

PC Code: 128879 DP Bar code: 0422005 Decision No.: 493878 Petition No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.: NA Registration No.: NA Regu latory Action: NA Case No.: NA CAS No.: 240494

-70-6 40CFR: NA Ver.Apr.08 FROM: Shanna Recore, Industrial Hygienist ()

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. "' Toxico logy and Epidemiology Branch

### ~**/~** Health Effects Division (7509P) ·**~** and Elizabeth Evans, Environmental Protection Specialist 

# 1 a:**~** Toxicology and Epidemiology Branch '-" ().

. Health Effects Division (7509P)**~** 

# /**!Jl '** **f~.;** 

# 'w 'f 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

.
Page 1 of 4This 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 N IO SH 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 ofpesticides/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 vali dated 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 al mond, 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).
Page 2 of 4The purpose of the database search is to identify potential patterns in the frequency and sever ity 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 Rodentic ide Act (FJFRA) Section 6(a)(2) reports from registrants , other federal and state health and environmental age ncies, 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 ID S and Aggregate ID S:

o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specific. This system sto res incident data for death, major and moderate incidents , and it includes information about the location, date and nature of the incident. Main ID S 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 fo r 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 pest icide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers , state Department ofLabor workers' compensation claims when reported by physicians , reports from State Departments of Agricu lture, 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 ofparticular value in providing that information. A state SENSOR contact specialist attempts t o 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
Page 3 of4State 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

-pesticide s from 1998 to 2003. This updated review concurs with the previous conclusion

. Overall the incident cases reported for Triflumizol e were of low frequency and low severity in both IDS and NIOSH SENSORPe sticides. 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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