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

MEMORANDUM Da te: March 24, 20 15 SUBJECT: Metiram: Tier 1 Review of Human Incidents

P C C ode : 014601 DP Barcode: 0 426277 Dec i sio n No.: 499278 Petitio n No.: NA Ri s k Assess ment T ype: A TXRNo.: A MRIO No.: I A Registration No.: NA Reg ul ato r y Action : NA Case No.: A CAS N o. : 9 006 -42-2 40CFR: NA Ver.Apr.08
FROM : El iz ab eth Evans, Environmental Protection Specialist <'.'.; 

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......**~** Toxicology and Ep ide miolo gy Branch ...,**J~'** l He alth Effec ts Division (7509P) and Shanna Recore , Indu stri al Hygienist 

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J**~** ,1/(., ()f"Jlf. ZOlS THROUGH : David Miller, Acting Branch C hi ef 

## V ///,J To xico logy and Epidemiology B ran c Health Effects Division (7509P) TO: Matthew Lloyd , Ri sk Assesso r Ri sk Assessment Branch 

### V II Health Effec ts Di vision (7509P) and D anette Drew, Chemical Review Manager Risk M anage ment & Implementation Branch 5 Pe s ti cide Re -evaluation Division (7508P) Summary and Conclusions Because there were no inc ident cases reported fo r met iram to either IDS or SENSO R-P esticides , there does not appear to be a concern at this time that would warrant further investigation. The

P age 1 of 4Agency will continue to monitor the incident information and if a concern i s triggered , add itional analysis wi ll be included in the risk assessment.
Detailed Review I. ACTION REQUESTED This rev iew 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 of the problem formulation phase of registration review. Reports of adverse health effects alle gedly due to a specific pesticide exposure (i.e., an "i ncident " ) are largely se lf-reporte d and therefore, generally spea king , neither exposure to a pesticide or reported symptom (or the connection between the two) is validated o r 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 s uch as a p estic id e product in the ge neral population or specific sub-groups like pesticide applicators. II. BACKGROUND Metiram is a member of the ethylene bisdithi ocarbamate (EBDC) group of fungicides, which includ es the related active ingredients mancozeb and maneb. The EBDCs share the common degradate ethylenethiourea (ETU)

. Meti ram is used on apples , potatoes, and ornamental plants (leatherleaf ferns) in nurserie s and greenhouses. Metiram was previously registered for use on tobacco seedlings and roses , but these uses have s ince been vo luntari l y cancelled. There are no residential labels , and no agricultural uses that could result in exposure to metiram in residential setting s. For this evaluation, both the OPP Incident Data System (ID S) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/N IOSH) Sentinel Event Notification System for Occupational Ri sk-Pestic ides (SENSO R) databases were consulted for pesticide incident data on the active ingredient METIRAM (pc code:). The purpose of the database search is to identify potential pattern s in the frequency and severity of the health effec ts attributed to METIRAM exposure. METIRAM is not included in the AHS, and therefore this stud y does not provide information for this report. III. RESULTS/DISCUSSION



### a. IDS (Incident Data System) OPP's IDS includes report s of alleged human health incidents from various sources, including mandatory Federal Inse cticide , Fungicide and Rodenticide Act (FI FRA) Section 6(a)(2) reports from reg istrants , other federal and state health and environmental agencies, and individual
Page 2 of4consumers. Since 199 2, OPP has compiled these reports in IDS. IDS co ntain s reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the ID S represent anecdotal reports or allegations only , unless

. otherwise stated in the report. ID S records incidents in one oftwo modules: Main IDS and Aggregate IDS:

o Main IDS co ntains 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 locatio n , date and nature of the incident. Main ID S incidents involving only one active ingred ient (as opposed to pesticid e products with multiple active ingredients) are considered to provide more certain informat ion abo ut the potenti al effects of exposure from the pesticide.

o Aggregate IDS conta in s 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 , 2010 to December 30, 2014 , there were no inc idents reported involving metiram. In Aggregate ID S , from January 1 , 2010 to December 30 , 2014, there were no incidents reported involving metiram. 

### b. SENSOR- Pesticides The SENSOR-Pesticides database covers 12 states from 1998-2011, 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, s tate Department of Labor workers' compensation claims when reported by physician s, report s from State Departments of Agriculture, and physician reports to state Departments of Health. Although both occupa ti onal and non-occupational incidents are included in the database , SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticular value in providing that information. The state coordinator at each of the 12 respectiv e state Departments of Health conducts case followup activities such as obtaining medical record s to verify symptoms and severity. Using standa rdi zed 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 sent to NIOSH annually to be aggregated. A query of SENSOR-Pest ic ides from 1998-2011 identifies no cases invo lving metiram (pc code 014601).



### c. Agricultural Health Study (AHS) The AHS is a high quality , prospective epidemiology study evalu ati ng the link between pesticide 

### use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. Ifthere are AHS findings relevant to a particular
Page 3 of 4pesticide going through registration review, the Agency will ensure they are considered in the problem formulation/scoping phase ofthe process and, if appropriate, fully reviewed in the risk assessment phase of the process. The AHS includes information on use of 80 different pesticide active ingredients commonly used in agriculture. Metiram is not included in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION Because there were no incident cases reported for metiram to either IDS or 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 i s triggered, additional analysis will be included in the risk assessment.

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