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

MEMORANDUM Date: May 29, 201 4 SUBJECT: Diclofop-Methyl: Tier I Review of Human Incidents PC Code: 110902 DP Barcode: 0420493 Decision No.: 490582 Petition No.: NA Risk Assessment Type: NA TXRNo.: NA MRID No.: NA Registration No.: NA Regulatory Action: NA Case N o.: NA CAS No. : 51338-27-3 40CFR:NA Ver.Apr
. 08 FROM: Shanna Recore, Industrial Hygienist , \ 

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# 0 .., ,.-., _ Toxicology and Epidemiology Branch**~'-.O.tJ\lA\..JZ_ ~**  Health Effect Division (7509P) j and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemio logy Branch Health Effects Division (7509P)



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# /1 //l dJ THROUGH: David Miller, Acting Branch Chief ( 

# J &.f/0 Toxicology and Epidemiology Branc Health Effects Division (7509P) TO: Sheila Piper, Risk Assessor Risk Assessment Branch VI Health Effects Division (7509P) and Monica Wait, Chemical Review Manager Risk Management & Implementation Branch 3 Pesticide Re-evaluation Division (7508P) Summary and Conclusions r 16) ..,. ' Ill C · ( • 

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There does not appear to be a concern at this time that would warrant further investigation, since there were no inc idents invo lving diclofop

- methyl reporte d to either IDS or SENSOR-Pesticides. The Agency w ill 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 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 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 particular 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 Diclofop-methyl controls or suppresses various grass weed species
. Diclofop-methyl 'is a restricted use herbicide used on wheat, barley, and golf courses (turt). 1 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 (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk

- Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient diclofop-methyl (pc code: 11 0902). The purpose of the database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to diclofop-methyl exposure. Diclofop-methyl are 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 reg i strants, other federal and state health and environmental agencies, and individual consumers. Since 1 992, OPP has compiled these reports in IDS. IDS contains reports from across the U.S. and most incidents have all re levant 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 oftwo modules: Main IDS and Aggregate IDS:

1 http:/ / www.epa.gov/oppsrrd 1/REDs/factsheets /2160fact.pdf Page 2 of4o 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 incl udes information about the locatio n , date and nature of the incident. Mai n ID S incidents invo lving onl y o ne active ingredient (as opposed to pesticide produ ct s 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 M a in IDS, from January 1 , 2 009 to March 5, 2014, there were 0 incidents rep orted invo lving d iclofop

- methyl in the database. In Aggregate IDS, from January 1, 2009 to March 5, 2014, there were 0 incidents reported involving diclofop-methyl in the database. b. SENSOR -Pesticides The SENSOR

- Pesticides database covers 1 1 states from 1998

- 2010, a lthough reporting varies from state to state. Cases of pesticide

-related illnesses are ascertained from a variety of so urces, including: re p orts from local Poiso n Control Centers, state D epartment of Labo r wo rkers' 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 ofparticular value in providing that information
. The state coordinator at each of the 11 respective state Departments of Health co nducts 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- Pestic ide coordinator enters the incident information into the state
-based system which i s sent to N IOS H annually to be aggregated
. A query of SENSOR

-Pesticides 1998-2010 identifies two cases involving diclofop

- methyl (pc code 110902). B oth cases involved a single active ingredient (both involved Illoxan 3EC Herbicide). Both cases were work

-related and both were low in severity. Both cases reported nervous system symptoms, one case reported respiratory symptoms and one reported gastrointestinal symptoms. Case narratives are provided: I. "Warehouse laborer loaded leaking pesticide bottle and became ill. " 2. "Case sprayed ammonium sulfate & illuxan 3ec on a ground r ig outside on a windy day. The winds blew back into face, inhaled. "
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 commercia l pesticide applicators and the ir spouses. If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the
Page 3 of4problem formulation/scoping phase ofthe process and , if appropriate , fully reviewed in the risk asse s sment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Diclofop-methyl i s not included in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION There do es not appear to be a concern at this time that would warrant further investigation, since there were no incidents involving diclofop-methyl reported to either IDS or SENSOR

- Pesticides. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

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