UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: September 2, 2015 

SUBJECT: Pinoxaden: Tier I (Scoping) Revi ew of Human Incidents 

PC Code: 147500 OP Barcode: D-128933 

Decision No.: 508570 

Petition No.: NA 

Risk Assessment Type: 1A 

TXR No.: A 

MRIO No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: A 

CAS No.: 243973-20-8. 99607-70-2 

40 CFR: NA 

Vcr.Apr.08 

FROM: Eli zabeth Evans, Environme.ntal Protection Spccia~, LL~ Toxicology and Epidemiology Branch ___;,,, ~ 

:::~:. ~~:::e~l:~:::i~~:~:::nist /}A, 

Toxicology and Epidemiology Branch/,{/ fl -, 

THROUGH: 

Health Effect Division (7509P) /JJI !!/ff ///Uk1 0 ?.Cc/-/. Z:J '-.) 

David Miller, Acting Branch Chief 

Toxicology and Epidemiology Branch 

Hea lth Effects Division (7509P) 

TO: William Wassell. Risk Assessor 

Risk Assessment Branch J 

Health Effects Division (7509P) 

and 

Linsey Walsh, Chemical Review Manager III 

Risk Management & Implementation Branch 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Based on the low frequency and severity of cases reported for pinoxaden 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 will be included in the risk assessment. 

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Detailed Review 

I. ACTION REQUESTED 

This review is intended to fulfi ll our requirement to docket summaries of inc ident 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 ofregistration review. Reports of 

adverse hea lth 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 va lidated 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 like pesticide applicators. 

II. BACKGROUND 

Pinoxaden was registered in 2005 as an herbicide for post emergence control of grass weeds in 

wheat and barley. One application per crop season can be made using either open-cab ground boom 

equipment or via aerial application. 

For this evaluation, 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 pinoxaden (pc code: 147500). The 

purpose of the database search is to identify potential patterns in the frequency and severity of 

the health effects attributed to pinoxaden exposure. Pinoxaden 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) 

OP P's IDS includes reports of alleged human health incidents from vari ous 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 individua l 

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 onl y, unless otherwise stated in 

the report. 

IDS records incidents 1n 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 

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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 less 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 l, 2010 to February 4, 20 15, there were no incidents reported 

involving pinoxaden. 

In Aggregate IDS. from January I. 20 I 0 to February 4. 2015. there were 3 incidents reported 

involving pinoxaden. These incidents were classified as minor severity. Overall, there are few 

incidents reported to IDS involving pinoxaden. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-2011. although repo11ing varies 

from state to state. Cases of pesticide-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 Depa1tments of Health. Although both occupational 

and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on 

occupational pesticide incidents, and is of particular va lue in providing that information. The 

state coordinator at each of the 12 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 review of SENSOR-Pesticides 1998-2011 identifies two cases. stemming from one event. 

involving pinoxaden (pc code 147500). Both of these cases involve a single acti ve ingredient. 

The cases were both low in severity. In 20 l 0, the cases were exposed to spray drift from an 

aerial pesticide application taking place in an adjacent field about 900 feet away. After the two 

cases developed respiratory symptoms including cough, the fami ly left their home to avoid 

further exposure. The Inspector from the Texas Department of Agriculture took clothing and 

vegetation samples, the results of the TOA inspection were not included in SENSOR. 

c. Agricultural Health Study (AHS) 

The AHS is a high quality, prospective epidemiology study eva luating the link between pesticide 

use and various health outcomes including cancer. The A.HS 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 they are considered in the 

problem formulation/scoping phase of the process and. if appropriate, fully reviewed in the risk 

assessment phase of the process. The AHS includes information on use of 80 different pesticide 

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active ingredients commonly used in agriculture. Pinoxaden is not included in the AHS, and 

therefore this study does not provide infom1ation for this report. 

IV. CONCLUSION 

Based on the low freq uency and severity of cases reported for pinoxaden 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 will be included in the risk assessment. 

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