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

MEMORANDUM Date: February 11, 2014 SUBJECT: Revised: Zoxamide: T ier I Review of Human Incidents PC Code: I 01702 DP Barcode: 0417744 Decision No.: 487333 Petition No .: NA Risk Assessment Type: NA TXR No.: NA MRIDNo.: NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 156052-68-5 40CFR: NA Yer.Apr.08 FROM: Elizabeth Evans, Environmental Protection Specialist /'
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# tf;!J · Toxicology and Epidemiol ogy Branch Health Effects Division (7509P) Nancy Tsaur, Risk As sessor Risk Assessment Branch III Health Effects Division (7509P) and Jill Bloom , Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusions T his assessment was modified to reflect a revised DP Barcode. There does not appear to be a concern at this time that would warrant further investigation, s ince there were no incidents involving zoxam ide reported to either IDS or SENSOR-Pes ticides. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment. Page 1 of 4Detailed Review I. ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries of incident data that were reported to th e Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part of the problem formulation phase of registration review. Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an "incident") are largely self-reported and therefore, gener all y speaking, neither exposure to a pesticide or repo rted symptom (or the connection between th e two) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data. Howe ver, incident information can be an important source of feedback to th e Agency : incidents of severe outcome, or a suggested pattern or trend among less severe incidents, can signal the Agency to further inve stigate a particular chemical or product. Observational ep idemiology studies relate th e risk of disease, 

### e.g., cancer, and exposure to an agent such as a pesticide product in the general popula tion or specific sub- groups like pesticide applicators. II. BACKGROUND Zoxamide is an agricultural-use only fungicide targeting blight, leaf spot and mold. It is used on potatoes, cucumbers, cantaloupe, squash, pumpkins, tomato, watermelon, other cucurbits, grapes and ginseng. It is formulated as a flowable concentrate or water dispersible granu le. It is a strong dermal sens itizer and potential inhalation sensitizer. For this evaluation, both th e 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 zoxamide (pc code: 101702). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to zoxamide exposure. Zoxamide is not included in the AHS, and th erefore this study does not provide inf o rmation for this report. III. RESULTS/DISCUSSION
a. IDS (Incident Data System) OPP's IDS includes reports of alleged human health incidents from various sources, includin g mandatory Federal Insecticide , Fungicide and Rodenticide Ac t (FIFRA) Section 6(a)(2) reports from registrants, other federal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled thes e reports in IDS. IDS contains reports from across the U.S. and mo st incidents ha ve all rele vant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in th e report. IDS records incidents in one of two modules: Main IDS and Aggregate IDS:
Page 2 of 4o Main IDS contains incidents resulting in hi gher 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 ID S 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). T hese are reported by registrants only as counts in what are aggregate summaries. For the Main IDS, from January 1, 2009 to January 15,2014, there were 0 incidents reported involving zoxamide in the database
. In Aggregate ID S, from January 1, 2009 to January 1 5,2014, there were 0 reported incident involving zoxamide in the database. b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2010, although reporting varies from state to state . Cases ofpes ticide

-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

- Pestic ides focuses on occupational pest icide inc idents, and is ofparticular value in providing that information. The state coordinator at each of the 11 respective state Departments of Health conducts case fo ll ow up activities such as obtaining medical records to verify symptoms and severity. Using standardized protoco l and case definition s derived from poison center reporting, the state S ENSOR-Pesticide coordinator enters the incident information into the state -b ased system which i s sent to N IO S H annuall y to be aggregated. A query of SENSOR-Pesticides 1998-2010 finds no cases involving zoxamide (pc code 101702).


### c. Agr i cultural Health Study (AHS) T he AH S is a high quali ty, p rospective epidemiology study evaluat ing the li nk between pesticide use and various health outcomes including cancer . The AHS includes private and commercial pesticide applicators and their spouses. I f there are AHS findings re levant to a particular pesticide going through registration review, th e Agency will ensure they are cons idered in the problem formu l ation/scoping phase of the process and, if appropri ate , fu ll y 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
. Zoxamide is not in cluded in the AH S, and therefore this study does not provide information fo r this report. IV. CONCLUSION
Page 3 of4There does not appear to be a concern at this time that would warrant further investigation, since there were no incidents involving zoxamide reported to either IDS or SENSOR

- Pesticides. The Agency will continue to monitor the incident information and if a concern is t r iggered , additional analysis will be included 

### in the risk assessment.

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