UNITED STATES ENVIRONMENTAL PROTECTION AGE N CY WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date: May 8 , 201 4 SUBJECT: Triallate: T ier I Review of Human Incidents

PC Code: 078802 Decision No.: 489685 Petition No. : NA Risk Assessment Ty p e: NA TXRN o.: NA MRJDNo.:NA DP Barcode: D42014 1 Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 2303-17-5 40CFR: NA Ver.Apr.08 FROM: Elizabeth Evans, Environmental Protecti on Specia li st 

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_ / Toxico logy and Epidemiology Branch 

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# .,Mih**/;Vttlt~** Health Effects Division (7509P) 

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# j**~ {2_~**  Toxicology and Epidemiology Branch 

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## . (/i vfW fll**o~·fhtJ .** **w; ~**  THROUGH: David Miller, Acting Branch Chief ' 

# ,[j Toxico logy and Epidemio lo gy Branch Healt h Effec ts Di v ision (7509P) TO : Alexandra LaMay , Risk Assessor Risk Assessment Branch VII Health Effects D ivision (7509P) and Katherine St. Clair , Chemical Review Manager Ri sk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7 5 08P) Summary and Conclusions There does n ot appear to be a concern at this time that would warrant further in vestigation , since there were no incidents involving triallate reported to either ID S or SENSO R-Pe sticides

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### 4Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment. Detailed Review 

### I. ACTION REQUESTED This review i s 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 ofthe problem formulation phase ofregistration review. Reports of adverse health effects a llegedly due to a specific pesticide exposure 

### (i.e

. , an "incident") are largely self-reported and therefo re , generally speaking, neither exp osure to a pesticide or reported symptom (or the connection between the two) i s 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 rel ate 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 Triallate is a pre-emergent herbicide federally registered, but restricted to use in CO, ID, K S, MN, M T , NE, NV, ND, OR, SD, UT , WA, and WY on barley, lentils , peas (dried and succulent), triticale , wheat, and canary grass. The Agency has found that all currently registered uses of trialJate , except canary grass, are eligible for reregistration , provided specified changes are made to the labeL Canary grass is not being supported by the registrant for reregistration and the tolerance has been revoked. In addition, since completion of the RED , a tolerance has recently been established for a new use oftriallate on sugar beets. 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 (CDCINIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient triallate (pc code: 078802). The purpose of the database search is to ident ify potential patterns 

### in the frequency and severity of the health effects attributed to triallate exposure. Trial late is not included in the AHS, and therefore this study does not provide information for this report. 

### Ill. RESUL TSIDISCUSSION

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 Page 2 of4across 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 module s: 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 , 2009 to March 5 , 2014, there were 0 incidents reported involving triallate 

### in the database. In Aggregate IDS , fro m January 1, 2009 to March 5, 20 14 , there were 0 incidents reported involving trialla te in the database.



### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 1 1 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-Pesticides focuses on occupational pesticide incidents, and is of particular value in provi ding that information. The state coordinator at each of the 1 1 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptom s and severity. Using standardized protocol and case definitions derived from poison center reporting, the state SENS OR-Pes ticide 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 -201 0 identifies 0 cases involving triallate (pc code: 078802).



### c. Agricultural Health Study (AHS) The AHS is a high qu ality , prospective epidemio logy study evaluat ing the link between pe sticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS fmdings relevant to a particular Page 3 of4pesticide 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 phas e ofthe process. The AHS includes information on u se of 50 different pesticide active ingredients commonly used in agriculture. Triallate is not included in the AHS, and ther efore this study does not provide information for this report. IV. CONCLUSION There does not appear to be a concern at this time that would warrant further investigation , since there were no incidents involving triallate reported to either IDS or SENSOR-Pesticides. The Agency will continue to monitor the incident information and if a concern i s triggered, additional analysis will be included in the risk assessment.

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