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

MEMORANDUM Date: 

### November 26,2013 SUBJECT: 

### Thiabendazole and Salts: Tier I Review ofHuman Incidents
PC Code: 060101 DP Barcode: 0416313 Decision No.: 483925 Petition No.: NA RiskAssessment Type: NA TXRNo.:NA MRIDNo.:NA
FROM: Registration No.: NA

. Regulatory Action: NA

Case No.: NA CAS No.: 148-79-8 40CFR: NA Ver.Apr.08 

### Shanna Recore, Industrial Hygienist O •

### /)!QJ_,; Toxicology and Epidemiology Branch 

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### Health Effect Division (7509P)**~** 

### ' (/ Elizabeth

# Evan~~nvironmental Protection

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THROUGH:

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### Toxicology and Epidemiology Branch

## Gv~-- Health Effects Division (7509P)**~ ~**  1

# fjjl**/6· /J** **OII,~ :J**  David Miller, Acting Branch Chief 

### '1.)//jrt Toxicology and Epidemiology Branch Health Effects Division (7509P) Jessica Kidwell, Risk Assessor Risk Assessment Branch IV Health Effects Division (7509P) and R. Jones, Chemical Review Manager Risk Management & 

### Implementation Branch 1 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based onthe low frequency and severity ofincident cases reported for thiabendazole and salts, 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 ifa concern is triggered, additional analysis will be included in the risk assessment.
Page 1of4Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfill ourrequirement to docket summaries ofincident datathat were reported to the Agency, as well as to ensure humanincident data and the Agricultural Health Study (AHS) are part ofthe problem formulation phase ofregistration 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 connectionbetween the two) is validated or otherwise confirmed.

_ Typically, causation cannotbe determined based on incident data. However, incident information canbe an important source offeedback to the Agency: incidents ofsevere outcome, or a suggestedpattern ortrend among less severe incidents, can signal the Agency to further investigate a particular chemical orproduct. Observational epidemiology studies relate the risk ofdisease, 

### e.g., cancer, and exposure to an agent such as a pesticideproduct in the general population or specific sub-groups like pesticide applicators. 

### II. BACKGROUND Thiabendazole is a fungicide used on a variety offruit and vegetables to control mold, rot, blight and stain, mainly as a post-harvesttreatment. Itis also used as a seed treatment and is used to control Dutch elm disease and as a preservative in paints, carpets, textiles, paperproducts and adhesives. 1 Forthis evaluation, boththe OPP IncidentData System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel EventNotification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data onthe active ingredient thiabendazole and salts (PC code: 060101). The purpose ofthe database search is to identify potential patterns inthe frequency and severity ofthe health effects attributed to thiabendazole and salts exposure. Thiabendazole and salts is notincluded inthe AHS, and therefore this study does notprovide information for this report. 

### III. RESULTS/DISCUSSION

a. IDS (Incident Data System) OPP's IDS includes reports ofalleged humanhealth 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 relevantproduct information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.

1Excerpt from Thiabendazole Factsheet, found online at: http://www.epa.gov/oppsrrdI!REDs/thiabendazole red.pdf Page 2 of4

### IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes andprovides 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 ofthe incident. Main IDS incidents involving only one active ingredient (as opposedto pesticide products with multiple active ingredients) are consideredto provide more certain information about the potential effects ofexposure 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 no incidents reported in the database involving thiabendazole and salts. In Aggregate IDS, from January 1, 2008 to September 11, 2013, there were two minor incidents reported involving thiabendazole and salts.



### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety ofsources, including: reports from local Poison Control Centers, state Department ofLabor workers' compensation claims when reported by physicians, reports from State Departments of Agriculture, andphysicianreports to state Departments ofHealth. Althoughboth occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticularvalue inproviding that information. The state coordinator at each ofthe 11 respective state Departments ofHealth 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 sentto NIOSH annually to be aggregated. A query ofSENSOR-Pesticides from 1998-2009 identifies two cases involving thiabendazole. One case involved a single ai and one case involved multiple ais. Bothcases were low in severity.

Page 3 of4"V**l~.** ' Table 1. SENSOR-Pesticides 1998-2009: Reported Health Effects for Thiabendazole Cases

Health Effect # ofTimes Reported Dermal I Ocular I Respiratory 0 Gastrointestinal 0 Renal 0 Nervous System 0 Cardiovascular 0 Miscellaneous 0 

### *Cases may report multiple health effects



### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology study evaluating the link betweenpesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. Ifthere are AHS findings relevantto a particular pesticide going through registration review, the Agency will**ensur~** they are considered in the problem formulation/scoping phase oftheprocess and, ifappropriate, fully reviewed inthe risk assessmentphase ofthe process. The AHS includes information onuse of50 differentpesticide active ingredients commonly used in agriculture. Tliiabendazole and salts is not included in the AHS, andtherefore this study does notprovide information for this report.


### IV. CONCLUSION Based onthe low frequency and severity ofincident cases reported for thiabendazole and salts 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 monitorthe incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.

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