UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM

Date: January 8

, 20 IS



### SUBJECT: Propanil: Tier 

### I Review of Human Incidents

P C Code : 028201 DP Barcode: 04 24891 D ec i sio n No. : 42444 I Petition No.: NA Risk Assessme nt Type: NA TXRNo.: NA MRIDNo.: NA R eg istrati o n No.: NA Regulat o r y Action: NA Case No.: NA CAS No.: 709

- 98-8 40 C FR: NA Ver.Apr.08

FROM: Sha nna Recore, Industrial Hygienist A l

. _ , " 

# 0

_ /'\, 1

_ Toxicology and Epidemiology Branch**c.ftV\-l/~ ~** 

# :~::e:F**i:: ,v** **:~:::::~l** P rotec tion Specialist 

# CZIJC**~**

THROUGH:

TO: Toxicolog y and Epidemiology Branch

# ~ Health Effe cts Division (7509P) /) I /1, 

# J

-1 

## r.r 

# :/IIIPL**utrJdiA ~·**  David Miller, Acting Branch Chief 1 Toxicology and Epidemiology Branch Health Effe cts Division (7509P)

Mohse n Sahafeyan

, Risk Assessor Risk Ass essment Branch II Health Effects D ivis ion (7509P) and Bonnie Adler, Chemical Review Manager Risk Manag ement & Imple mentation Branch 5 P est i cide Re -evaluation Division (7508P)

Summary and Concl usions

Based on the low freq uency and low sev e rity of incident cases reported for prop ani l in both IDS and SENSOR-Pestici d e s, there does not appear to be a concern at this t im e tha t would warr ant further investigation. The Agen cy will continue to monitor the inciden t information and if a

concern is triggered

, addi tional analysis will be included in the risk as sess m ent.

Page 1 of4

### Page 2 of 4 Detailed 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 hum an incident data and th e Agricultural Health Study (AHS) are part of the problem formulati on phase of registrati on 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 exposur e to a pesticide or reported symptom (or the connectio n between the two) is validated or otherwise confirmed. Typically, causation cannot be determined ba sed on incident data. However, incident information can be an important source of feedback to the Agency: incide nts 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. Ob servational 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

Propanil is a selective post-emergent general use herbicide registered to control broadleaf and grass weeds on rice. It is also registered (but not currently marketed) for turf use at commercial sod farms.

For this evaluation, both the O PP 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 Occupati onal Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the ac tive ingredient propanil (pc code: 119031). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to propanil exposure. Propanil 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 h ealth incidents from various sources, including mandatory Federal Insecticide, Fungicide and Ro denticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state hea lth and environmental agencies, and individual consumers. Since 1992, OPP has compiled these repor ts 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 of two modules: Main IDS and Aggregate IDS:

### Page 3 of 4 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 ingredients) are consider ed to provide more certain information about the potential effects of exposu re from the pesticide.

o Aggregate IDS contains inci dents resulting in less seve re human incidents (minor, unknown, or no effects outcomes). These ar e reported by registrants only as counts in what are aggregate summaries.

For the Main IDS, from January 1, 2010 to December 17, 2014, there was 1 incident reported involving propanil for the single chemical only in th e database. This incident was classified as minor severity. There were 2 additional incidents reported involving more than one chemical. These incidents were classified as moderate severity.

In Aggregate IDS, from January 1, 2010 to D ecember 17, 2014, there were no incidents reported involving propanil. Overall, there are few inci dents involving propanil reported to IDS.

b. SENSOR-Pesticides The SENSOR-Pesticides database covers 12 st ates from 1998-2011, although reporting varies from state to state. Cases of pesticide-related il lnesses are ascertained from a variety of sources, including: reports from local Poison Control Ce nters, state Department of Labor workers’ compensation claims when reported by physicia ns, reports from State Departments of Agriculture, and physician reports to state Departments of He alth. Although both occupational and non-occupational incidents ar e included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is of part icular value in providing that information. The state coordinator at each of the 12 respective st ate Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standardized protocol and case definitions de rived 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 review of SENSOR-Pesticides 1998-2011 identif ies 10 cases involving propanil. All cases were low in severity. One case involved a si ngle ai and nine cases involved multiple active ingredients. The single ai cas e is described as follows, “...as he was driving, a crop duster sprayed him as it was making application to adjacen t rice fields.” This case experienced severe headache and nose irritation.

All ten cases were bystanders exposed by drift (off- target movement of the chemical) via aerial applications in Louisiana or Texas. The most recent case was reported in 2004. All cases were low in severity and reported headaches and eye or respiratory irritation. Six cases also reported difficulty breathing and nausea.

c. Agricultural Health Study (AHS)

### Page 4 of 4 The AHS is a high quality, prospective epidemio logy study evaluating the link between pesticide use and various health outcomes including can cer. The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findi ngs relevant to a particular pesticide going through registration review, the Ag ency will ensure they are considered in the problem formulation/scoping phase of the process a nd, if appropriate, fully reviewed in the risk assessment phase of the process. The AHS include s information on use of 80 different pesticide active ingredients commonly used in agricultur e. Propanil is not included in the AHS, and therefore this study does not provide information for this report.

IV. CONCLUSION

Based on the low frequency and low severity of incident cases reported for propanil 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 triggered, additional analysis wi ll be included in the risk assessment.