Page 1 of4 1 **UNITED STATES**  **ENVIRONMENTAL PROTECTION**  **AGENCY**

**WASHINGTON, D.C.**  **20460** OFFI C E OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date: November 1 2 2013 SUBJECT: Aminopy

ra li d : Tier I Review of Human Inciden ts PC Code: 00510 0 , 005 2 1 9, { )05209 Decision No. : 482282 Petition No.: N A Risk Assessment Type: NA TXRNo.:NA MRIDNo.: NA DP Barcode: 04 1 5939 Registration No. : NA Regulat o ry Action: NA Case No.: NA CA S No.: 1 501 1 4
- 71
- 9 , 566191
- 87
- 5 40 CFR: NA Ver .A p r .08 FROM: Shanna Recore, Ind u strial Hygienist !}, " Toxicology and Epi d e m i ology Branc h Heal th E ffect Division (7509P)

and JJ. n 

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Elizabet h Evans, Environmental Protection Specialist Toxicology and Epidemi o l o gy Branch Health Effects Division (7509P) / ) THROUG H : David Miller, Acting Bran ch 

### Chie Toxicology and Epidemiol o gy Branch Health Effects Division (7509P) 11 / O/IJ

TO: Douglas Dotson, Risk Assessor

Risk Assessment Branch II Health Effects Division (7509P) and Katie Weyrauch , Chemic a l Review Manager Risk Management & Imp l e men tat ion Branch 5 Pesti c ide R

e - eva luation D ivision (7508P) Sum mary and Conclusions Based on the low frequency and severity of incident
-case s reported for aminopyralid, there does not appear to be a concern at this time that would warrant further investigation. T he Agency will con tinu e to monitor the incident information and if a concern is triggered, additional analys i s will be included in the ri sk assessment.Page 2 of 4

Detailed Review 

### I. AC TION REQUESTED This review is intended to fulfill our requirement to docket summaries of incident data that were reported to the Agency, as we ll as to ensure human inci d e nt 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, ne ither exposure to a pesticide or reporte d sy

mptom (or the connection between the two) is validated or otherwise confirmed. Typically , caus a

t ion 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. Obse rvational 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 Aminopy ralid is a new pyridine carboxylic acid herbicide intended for use in rangeland, permanent grass pastures, non - cropland areas (rights
- of
- way , roadsides and non - irrigation ditch banks), natural areas (wildlife management areas, natural re c reation areas, campgrounds, trailheads, and trails), and grazed areas in and around these s i tes, as well as wheat. Aminopyralid provides systemic postemergence broad
- spectrum control of a number of key noxious and inyasive annual, biennial and perennial weed species, as well as agronomic broadleaf weeds. Aminopy ralid can also provide residual weed control activity controlling re - infestations and reducing the need for re - treatment depending on the rate applied and the target weeds. 1 For this evaluatio n, 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 Aminopyralid (PC codes: 005100, 00519, 005209). The purpose of the database search is to i d entify potential patterns in the frequency and severity of the health effects attributed to Aminopyralid exposure. Aminopyralid is not included in the AHS, and therefore this s tudy 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

1 Excerpt from Aminopy ralid Factsheet , found online at: htt p : / /www . ep a. gov

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submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the repor t . IDS rec o rd s incidents in one of two modules: Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher seve rity outcomes and provides more deta

il 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 IDS incidents involving only on e active ingredient (as opposed to pesticide products with multiple active ingre d ients) are considered to provide more certain information about the potential effects of exposure from the pesticide.
o Aggregate IDS contains incidents resulting in l es s severe human incidents (mino r , unknown, or no effects outcomes). These are reported by regi strants only as counts in what are aggregate su mmaries. For the Main IDS, from January 1, 2008 to September 1 1 ,2013, there were 3 incidents reported for single chemical only in the database. There were 11 additional incidents reported involving more than one chemical? There was one fatality that was determined to be not due to pesticides. 3 The other incidents reported were classified as moderate severity. Overall, there are few incidents in volving aminopy ralid reported to IDS. In Aggregate IDS, from January 1, 2008 to September 1 1 , 2013, there were 35 reported incidents involvin g aminopyralid.



### b. **SENSO R** **- P**  **e**

**sticides** The SENSOR
- Pesticides database covers 11 states from 1998
- 200 9 , alth ough reporting varies from state to sta

te. Cases of pesticide - r

e l ated illnesses are ascertained from a variety of source s , including: reports from local Poison Control Centers, state Department of Labor workers' compensation claims when reported by physician s, reports from State Departments of A g ricu l tur e , and physician reports to state Departments of He alth. Altho ugh both occupational an d non o c cupational incidents are included in the database, SENSO R
- P esticides focuses on occupational pesticide incident s, and is of particular value in providing that information. The s tate coordinator at each of the 11 respective s tate Departments of Health conducts case follow- up activiti es such as obtaining medical records to verify symptoms and severity
. Using standardized protocol and case definitions derived from poison center reporting, the state SENSOR
- Pe sticide coordinator enters the incident information into the state -based system which is sent to NIOSH annual l y to be ag g reg ated.

2 There was a l so o n e in cident that occurred in Bra zil. Fo reign incidents are not reviewed in detail because of the potential differences in the exposure patterns, use practices, and produ ct formulation. 3 An adult male was alone while applying Milestone from an all terrain vehicle (A TV ). While atte

mpting a turn on a hill, the ATV rolled on top of him and pinned him
. The Sheriff
- Coroner Postmortem Examin ation stated the cause of death t o be Mechanical Asphy xia and pesticides were not involved.Page 4 of 4

A query of SENSOR
- Pesticides 1998
- 2009 finds two cases involving aminopyralid. Both cases involved multip le active ingredients. Both cases were low in severity. One case is described as follows: A 54 ye ar old male walked from his car to his home, he sm elled pesticide and saw his neighbor spraying herbicide with a tractor and boom approximately 400 feet away . As an asthmatic he was concerned for himself and family. WSDA was contacted and provided pesticide information on what was sprayed, but did not in vestigate as r

esident wanted to communicate with applicator. Resident developed upper respiratory irritation , but did not seek medical c a re . The secon

d case i s described as "Exposed while mixing and helping to a pp ly herbicides, unknown how exposed
. " This case reported dermal, respiratory, nervous system and gastrointestinal symptoms but was low in severity.

**c. Agricultural**  **Health Study**  **( AHS**  **)** The AHS is a high qualit y , prospective epi d emi o logy stud y evaluating the li nk between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their sp o uses. If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem fonnulation/scop i ng phase of the process and, if appropriate, fully reviewed in the ri sk assessment phase of the process. The AHS includes information on u se of 50 different pesticide active ingredients commonly used in agriculture. Aminopy ra lid i s not includ

e d in the AHS, and therefore this study does n ot provide inf

ormation for this report.
IV. **CONCLUSION** Based on the low frequency and severity of incident cases reported for aminopy ralid in both ID S 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 i ncident information and if a concern is triggere d , additional ana l ysis will be included in the risk assessment.