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

MEMORANDUM
Date: October 23, 2014 SUBJECT: Sethoxydim: Tier I Review ofHuman Incidents

PC Code: 121001 DP Barcode: D422759 Decision No.: 487076 Petition No.: NA RiskAssessment Type: NA TXRNo.: NA MRIDNo.:NA Registration No.: NA RegulatoryAction: NA Case No.: NA CAS No.: 74051-80-2 40CFR:NA Ver.Apr.08 Elizabeth Evans, Environmental Protection Specialist

# ~**~** Toxicology and Epidemiology Branch

### ~~..,.h(/JJ FROM: Health Effects Division (7509P)**~~~** - . and ShannaRecore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effect Division (7509P)
THROUGH: David Miller, ActingBranchChief

# ~JV'1 Toxicology and Epidemiology Branch Health Effects Division (7509P) TO: Ronnie Bever, RiskAssessor Risk Assessment Branch V Health Effects Division (7509P) and James Parker, Chemical Review Manager RiskManagement & Implementation Branch 1 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the low frequency and low severity ofcases involving sethoxydim reported in both IDS and SENSOR-Pesticides, there does not appearto be a concern atthis time that would warrant further investigation. The Agency will continue to monitorthe incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.

Page 1of4Detailed Review 

### I. ACTION REQUESTED
This reviewis intended to fulfill ourrequirement to docket summaries ofincident datathat were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part oftheproblem formulation phase ofregistrationreview. Reports of adverse healtheffects 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 connectionbetweenthe two) is validated or otherwise confirmed. Typically, causation cannotbe determined based on incident data. However, incident information can be an important source offeedback to the Agency: incidents ofsevere outcome, or a suggestedpattern ortrend among less severe incidents, can signal the Agency to further investigate a particular chemical orproduct. Observational epidemiology studies relate the risk ofdisease, 

### 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 Sethoxydim is a member ofthe cyclohexanedione or cyclohexenone class ofherbicides. The mode ofaction for this herbicide is lipidbiosynthesis inhibition. Sethoxydim is used postemergence for selective control ofannual andperennial grass weeds in broadleafcrops. Sethoxydim is currently registered for use in or on at least 86 different agricultural crops such as various grains, fruits, tree nuts, vegetables and herbs, as well as non-agricultural sites, including ornamentals and flowering plants, recreational areas, right-of-way, along fences, hedgerows, and public and commercial buildings/structures. The principal sethoxydim uses are on soybeans, sunflowers, alfalfa, drypeas/beans, sugarbeets, peanuts and com. Sethoxydim is formulated as a liquid. Sethoxydim application methods include high and lowpressure hand wand, backpack, gardenhose-end, handgun (lawn) sprayers, groundboom sprayers and aerial equipment.
Forthis evaluation, boththe OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel EventNotification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident dataonthe active ingredient sethoxydim (pc codes: 090201, 090202). The purpose ofthe database searchis to identify potential patterns inthe frequency and severity ofthe health effects attributedto sethoxydim exposure. Sethoxydim is not included inthe AHS, and therefore this study does notprovide information for this report. 

### III. RESULTS/DISCUSSION

a. IDS (Incident Data System) OPP's IDS includes reports ofalleged 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 compiledthese reports in IDS. IDS contains reports from

Page 2 of4across 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:

o Main IDS contains incidents resulting in higher severity outcomes and provides more detail withregard to case specifics. This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature ofthe incident. Main IDS incidents involving only one active ingredient (as opposedtopesticide products with multiple active ingredients) are consideredto provide more certain information about the potential effects ofexposure 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 inwhat are aggregate summaries.
For the Main IDS, from January 1, 2009 to August 12, 2014, there were no incidents reported involving sethoxydim.
In Aggregate IDS, from January 1, 2009 to August 12, 2014, there were 10 incidents reported involving sethoxydim. These incidents were classified as minor severity. Overall, there are few incidents involving sethoxydim reported to IDS. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2010, althoughreporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety ofsources, including: reports from local Poison Control Centers, state Department ofLabor workers' compensation claims when reported byphysicians, reports from State Departments of Agriculture, and physician reports to state Departments ofHealth. Althoughboth occupational and non-occupational incidents are included inthe database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticular value inproviding that information. The state coordinator at each ofthe 11 respective state Departments ofHealth conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standardizedprotocol 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. Sethoxydim A query ofSENSOR-Pesticides from 1998-2010 identifies seven cases involving sethoxydim (pc code 121001), five ofwhich involved a single active ingredient. These five cases were analyzed for this memo. Four cases were low in severity and one case was moderate in severity. The moderate severity case was an intentional ingestion for self-harm and will not be further considered. Ofthe remaining four low severity cases, one man was accidentally sprayed in the face withthe product. Another case was exposed whenthe product exploded. Two cases that

Page 3 of4occurred in California in 2002 do not include case descriptions. Symptoms experienced bythe four cases are summarized in Table 2.

Table2. SENSOR-Pesticides 1998-2009: Reported HealthEffects for Sethoxydim Cases (N=4)

HealthEffect #ofTimes Reported Dermal 1 Ocular 1 Respiratory 0 Gastrointestinal 2 Renal 0 Nervous System 2 Cardiovascular 0 Miscellaneous 0 

### *Cases mayreport multiple health effects



### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology study evaluating the linkbetweenpesticide 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 pesticide going through registration review, the Agency will ensure they are considered in the problem formulation/scoping phase ofthe process and, ifappropriate, fully reviewed in the risk assessmentphase ofthe process. The AHS includes information on use of80 different pesticide active ingredients commonly used in agriculture. Sethoxydim is not included inthe AHS, and therefore this study does notprovide information for this report. 

### IV. CONCLUSION Based on the low frequency and low severity ofcases involving sethoxydim reported inboth IDS and SENSOR-Pesticides, there does not appearto be a concern at this time that would warrant further investigation. The Agency will continue to monitorthe incident information and ifa concern is triggered, additional analysis will be included inthe risk assessment.

Page 4 of4