UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: October 22, 2015 

SUBJECT: Hymexazol: Tier I Update Review of Human Incidents/Epidemiology for Draft 

Risk Assessment 

PC Code: 129 107 DP Barcode: 0429771 

Decision No.: 49934 I 

Petition No.: NA 

Risk Assessment Type: NA 

TXR No.: NA 

MRID No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: I 0004-44-1 

40 CFR: NA 

Ver.Apr.08 

FROM: Shanna Recore, Industrial Hygienist ~ I A ... , ,_ 

/1 () ,.... n 

Toxicology 

Health Effec

and 

ts Division 

Epidemiology 

(7509P

Branch 

) 

~l;V'-V'-- ~ 

THROUGH: 

TO: 

and 

Elizabeth Evans, Environmental Protection Specialist 47· 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 4 

, / ~ ;?r 'J .avf· l,J !5 

David J. Mill er, Acting Branch Chie 'IJ g/{<. 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Matthew Lloyd, Risk Assessor 

Risk Assessment Branch VII 

Health Effects Division (7509P) 

and 

Caitlin Newcamp, Chemical Review Manager 

Risk Management & Impl ementation Branch 1 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Hymexazol was previously reviewed in 2010 (S. Recore, 11124/2009, D371893). At the time, 

there were no hymexazol incidents found in IDS. It was concluded that "Because there are no 

incident cases identified, there does not appear to be a risk concern at this time that would warrant 

further investigation." 

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The cutTent IDS analysis from January 1, 20 l 0 through March 19, 20 15, shows no incidents 

reported involving hymexazol in IDS. Further, a query of SENSOR-Pesticides 1998-2011 

identifies no cases involving hymexazol. 

There are no incident cases reported for hymexazol in either IDS or NIOSH SENSOR-Pesticides, 

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. 

The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Hymexazol is not included in the AHS, 

and therefore this study does not provide information for this report. 

Detailed Review 

I. ACTION REQUESTED 

Hymexazol are 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 defining and 

characterizing the risk of pesticides/pesticide products. 

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 pa11icular 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 

Hymexazol is a fungicide, non-food use chemical used as a seed treatment for sugar beet seeds. 

There are no registered residential uses for hymexazol. 

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 hymexazol (PC Code: 129107). 

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

of the health effects attributed to hymexazol exposure. 

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In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a 

high quality, prospective epidemiology study evaluating the link between pesticide use and 

various health outcomes including cancer. Hymexazol is not included in the AHS, and therefore 

this study does not provide information for this report. 

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 (FIFRA) Section 6(a)(2) reports 

from registrants, other fede ral and state health and environmental agencies, and individual 

consumers. Since l 992, 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. 

From January I, 20 I 0 to March 19, 2015, there were no incidents reported to either Main or 

aggregate IDS involving the active ingredient, hymexazol. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from l 998-201 1, 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 

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protocol and case definitions derived from poison center reporting, SENSOR coordinators at 

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 from 1998-201 1 identifies no cases involving hymexazol. 

c. 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 applicators and their spouses. If there are AHS findings 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 50 different pesticide 

active ingredients commonly used in agriculture. 

Hymexazol is not included in the AHS, and therefore this study does not provide information for 

this report. 

IV. CONCLUSION 

There are no incident cases reported for hymexazol in either IDS or NIOSH SENSOR-Pesticides, 

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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