UNITED STATES ENV I RONMENTAL PROTECTION AGENCY WASHINGTON, D.C . 20460 OFF I CE OF CHEMICAL SAFETY AND POLLUTIO N PREVENTION



### MEMORANDUM 

### Date: February 

### 6, 20 1 4 

### SUBJECT : Imazamox: Ti er I Review of Human Incidents PC Code : 129171 DPBarcode: 04 1 7802 De cision No .: 4865 14 Pe tition No.: NA Risk Assessm ent Type: NA TXRN o.: NA MRIDN o.: NA Reg istration N o.: NA Regulatory Action: NA Case No.: NA CAS No.: 1143 11-32-9 40CFR: NA 

### FROM: El izabeth Evans, E nvironmental Protection Specialist Toxicology and E pidemio lo gy B ranch Health E ffects Division (750 9P)

### VocAp~

# ~~ and Shanna Recore, Industrial Hygienist Toxico lo gy and Ep ide miol ogy Branch Health Effect Divi sion (7509P)

# t:;;~**~** THROUGH :

## Dav~d Miller,

## Acti~g**Br~nch Chie~**  

# 1&/J**f1~l'/l** Tox tcol ogy and Eptdem10logy Braneli Health Effects Division (7509P) 

### TO: Lata V enka teshwara, Risk Assessor Risk Assessment Branch I Healt h Effects Di vision (7509P) and Kell y Ballard, Chemical Review Manager Risk Management & Implementa tion Branch 1 Pesticide Re-evaluation Division (7508P) Summary and Conclusions The re does n ot appear to b e a concern at this time that would warrant further inves t igati on , si n ce there was one incident involving im azamox reported to SENSOR-Pesticides
. The Agency w ill continue to monito r t he 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 t o fulfill our requirement to docket summaries of incident data that were reported to the Agency , as we ll as to ensure hum an i ncident data and th e Agri cultural Health Study (AHS) are part of the prob lem formulation phase of registration review. Reports of adverse health effects allegedly due to a specific pesticide exp osure (i.e. , an " incident") are largely se lf-reported and there fore , generally speaking, neither exposure to a pest i c ide or reported symptom (or the connection between the two) i s valid ated or otherwise confirmed. Typically , causation cannot be determined based o n incident data
. H owever, in c ident information can be an important source of feedback to the Agency: in ci d ents of severe outcome, or a suggested pattern or trend among less severe incidents, can signal the Agency to further i nve stigate a particular c h emical or product. Observational epidemi ol ogy studi es relate the ri sk of disease, 

### e.g., cancer, and exp osure to an agent suc h as a pesticid e product in the general population or specific sub

- groups like pesticide applicators. 

### II. BA CKG RO UND Imazamox i s the common name ofthe active ingredient ammonium salt ofimaz amox (2-[4,5

- dihydro -4-methyl-4-( 1-methylethyl)- 5-oxo-1 H- imidazo 1-2- yl ]

- 5-(meth oxy m ethl)- 3- pyridinecarboxylic acid, trade name " Raptor H erbicide "
. Imazamox is applied to soy bean s via ground or aerial application and may be applied postemergence . 1 Fo r this evaluation , both the OPP Incide nt Data System (IDS) and the Centers for Disease Control and Pre ve nt ion/National Institute for Occupational Safety and Health (C D C/NI O SH) Sentine l Event Notifi cation System for Occupatio nal Ri sk-P esti cides (SENS OR) databases were consulted for pesticide incident data on the active ingredient imazamox (pc code: 129171). The purpose of th e database searc h is to identif y potential patterns in the freque n cy and severity of the health effects attributed to imazamox exposure. lmazamox i s no t in c lud e d in the AHS , and therefore thi s study does not provide information fo r thi s report. 

### III. RESULTS/DISCUSSION
a. IDS (Incident Data System) OPP 's IDS includes reports of alleged human health incidents from various source s, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6 (a)(2) rep orts from re gistrants, other federa l and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled th ese reports in IDS. ID S contains reports from across the U.S. and most incidents have all re levant product information recorded. Report s submitted to the ID S represent anecdotal reports or allegations only, unless otherwise stated in th e report .

1 EPA factsheet found on line at: http: l/ www.epa.gov/oppOOOO I / chem

_ s e arch/reg
_ actions / regi s tration/ fs

_ PC129171_22-May-97.pdf Page 2 of 4IDS records incidents in one of two modules : Main IDS and Aggregate IDS:

o 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 ingredi ent s) 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 regi s trants only as counts in what are aggregate summaries. For the Main IDS , from January 1, 2009 to January 15 ,20 14, there were 0 incidents reported involving imazamox in the database. In Aggregate IDS, from January 1, 2009 to January 15,2014, there were 0 reported incident involving imazamox in the database.



### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2010 , although reporting varies from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Contro l 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 th e database, SENSOR-Pesticides focuses on occupationa l pesticide incidents , and is of particular value in providing that information. The state coordinator at each of the 11 respective state Departments of Health conducts 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-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 identifi es one single ai case involving imazamox (pc code 129171); no multiple ai cases were identified
. This case occurred in Washington 

### in 2009, the description states , "A 36 year old.female was tending her horses in their pasture on th e morning of July II, 2009, when an air blast spray application occurred in the field beside her
. Wind was reported to be blowing in her direction at about 10 mph, and she describes seeing a cloud of mist and dust coming from the tractor onto her. She felt moisture on her skin and smelled the product. She reports experiencing immediate onset of neurological and respiratory symptoms , and GI discomfort , which resided about a day later. Onset of an additional G.J. symptom occurred 3 days after exposure. About I2 hours after exposure, Page 3 of 4she describes experiencing dermal symptoms, like a bad sunburn on exposed skin, which resolved. She sought health care 9 days after exposure, due to a continuing sensation of numbness in h er extremities. With herpermission, DOH reported this case to WSDA. " 

### It should be noted that this case was low in severity
. The product implicated was Raptor herbicide (EPA reg.# 00024100379)


### c. Agricultural Health Study (AHS) The AHS is a hi gh qua li ty, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particular pesticide going through registration review , the Agency will ensure t hey are considered in the problem formu lationl sco ping phase of the process and, if appropriate , fully reviewed in the risk assessment phase of the process. The AI-IS in c ludes information on use of 50 different pesticide active ingredients commonly used in agriculture. Imazamox is not included in the AH S, and therefore this study does not provide information for this report. IV. CONCLUSION There does not appear to be a concern at this time that would warrant further investigation, since there were was one incident involving imazamox reported to SENSOR-Pesticides. The Agency will co nti nue to monitor the i ncident information and if a concern is tri ggered, additional analysis will be included in the risk assessment.

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