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

MEMORANDUM Date: May 28, 2014 SUBJECT : Fluroxypyr, 1-methylheptylester: Tier I Review of Human Incidents PC Code: 128968 DP Barcode: D420478 Decision No. : 488688 Petiti on No.: NA Reg istratio n No
. : NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXRNo.: NA CAS No.: 81406-37-3 40CFR: NA MRlDNo.: NA
FROM: Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effec t Division (7509P) and Elizabeth Evans, Environmental Protection Specialist Toxicolo gy and Epidemiology Branch

THROUGH: David Miller, Act ing Branch Chief ,;}

# ;f/tij, Health Effects Division (7509P) () Toxicology and Epidemiology Branc Health Effects Division (7509P) TO: Seyed Tadayon, Risk Assessor Risk Assessment Branch V H ealth Effects Division (7509P) and K.hue Nguyen, Chemical Review Manager Risk Management & Implementation Branch 1 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Ver.Apr.08

Based on the low frequency and severity of incident cases reported for Fluroxypyr, 1- methylheptylester (F luro xypyr-MHE) , there does n ot appear to be a concern at this time that would warrant further investigatio n. 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 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 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 li ke pesticide applicators. 

### II. BACKGROUND Fluroxypyr-MHE is an herbicide intended for post-emergent selective control of broadleaf weeds. 

### It is currently registered for wheat, barley, oats, com, sorghum, fallow cropland, rangefield, pome fruit, millet, and others. Fluroxypyr-MHE is formulated as an emulsifiable concentrate that is mixed with water and applied as ground or aerial spray, although spot application by hand is also possible. For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupationa l 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 Fluroxypyr-MHE (PC codes: 128968). The purpose of the dat abase search is to identify potential patterns in the frequency and severity of the health effects attributed to Fluroxypyr

-MHE exposure. Fluroxypyr-MHE 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 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 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 oftwo modules: Main IDS and Aggregate IDS:
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 includes information about the location , date and nature of the incident. Main IDS 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 le ss 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, 2009 to January 15,2014, there was 1 incident reported for single chem ical only in the database. T his incident was classified as moderate severity. There were 7 additional incidents reported involving more than one chemical. In Aggregate IDS, from January l, 2009 to January 15,2014 , there were 50 incidents reported involving Fluroxypyr-MHE. Forty five of these incidents were classified as minor severity and fi ve were clas s ified as having no/unknown severi ty. Overall , there are few incidents involving Fluroxypyr-MHE reported to IDS

. 

### 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 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 ofHealth. A lthough both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents , and is of particular value in providing that information. The state coo rd inator at each of the 11 respective state Departments of Health conducts case followup activities such as obtaining medical record s to verify symptoms and severity. Us ing 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 sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2010 identifies a total of 11 cases , stemming from ten events , invo lving fluroxypyr , 1 -methylhelptylester (pc code 128968)

. One case involved a sing le ai and ten involved multiple ais. All cases were low in severit y . Seven cases were work-related and all seven involved the application of a product. The other f o ur cas es involved bystander exposures. Three of the 11 cases occurred in windy condition s, two cases involved an equipment malfunction (hose clamp broke). The most commonly reported symptoms were respiratory (n= 8) and nervous system (n=8) fo ll owed by ocular (n=7)

.

Page 3 of4Tab le X
. SENSOR-Pes t icides 1998

-20 I 0: Re p orte d Hea l th Effects f or Fluroxypyr , 1 -me thylhe lptyles ter N= l l

Health Effect # ofT imes Reported Dermal 2 Ocular 7 Respiratory 8 Gastrointest inal 6 Renal 0 Nervous Sy s te m 8 Cardiovascular 0 

### * Cases may report mu ltiple h eal th e ffe cts

c. Agricultural Health S tudy (A H S) The AHS is a high quality , prospective epidemiology s tudy evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spou ses. If there are AHS finding s relevant to a particular pesticide going through registration review, the Ag ency will ensure they are considered in the problem formulat ion/scoping phase of the process and, if appropria te, fully reviewed in the risk asse ssment phase ofthe process. The AHS includes information on use of 50 different pes ticide active ingredients commonly used in agricu lture. Fluroxypyr-MHE is no t included in the AHS, and therefore this study does not provide information for this report.
IV . CONCLUS ION Based on the low frequency and severity of incident cases reported for both Fluroxypyr

-MHE 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 monitor the incident information and if a concern is trigg ered, additional analysis will be included in the risk assessment.

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