UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: October 22, 20 15 

SUBJECT: Flumetralin: Tier I (Scoping) Review of Human Incidents and Epidemiology 

PC Code: 123001 OP Barcode: 0429780 

Decision No.: 505305 

Petition No.: NA 

Registration No.: A 

Regulatory Action: A 

Risk Assessment Type: NA Case No.: NA 

TXR No.: NA CAS No.: 62924-70-3 

MRIO No.: NA 40 CFR: NA 

FROM: 

THROUGH: 

TO: 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

and 

Eli zabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) IJ ~ 

David Miller, Acting Branch Chief f' .) 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Ronnie Bever, Risk Assessor 

Risk Assessment Branch VII 

Health Effects Division (7509P) 

and 

Katherine St. Clair, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Vcr.Apr.08 

Based on the low frequency and low severity of incident cases reported for flumetralin 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 infonnation 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 fulfill our requirement to docket summaries of incident 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 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, neither exposure to a pesticide or 

reported symptom (or the connection between the two) is validated 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 

Flumetralin is a plant growth regulator that was first registered in 1983 and reregistered in 2007. 

It is used on tobacco to control the growth of axillary buds (suckers). 

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/N IOSH) 

Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient flumetralin (pc code: I 2300 l ). The 

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

the health effects attributed to flumetral in exposure. Flumetralin 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 all eged 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 

submitted to the IDS represent anecdotal reports or all egations only, unless otherwise stated in 

the report. 

IDS 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 

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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 

ingredi ents) 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 I, 2010 to February 2, 20 15, there were 0 incidents reported 

involving flumetralin. 

In Aggregate IDS, from January 1, 20 l 0 to February 2, 20 15, there was 2 incidents reported 

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

incidents involving flumetralin reported to IDS. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-20 11 , although reporting 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 Departments of Health. Although both occupational 

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

occupational pestic ide incidents, and is of particular value in providing that information. The 

state coordinator at each of the 12 respective state Departments of Health conducts case followup activities such as obtaining medi cal 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 1998-20 11 identifies four cases, stemming from two events, 

involving flumetralin. All cases involved multiple active ingredients. All four cases occurred in 

North Carolina and involved pesticide application to tobacco. Three cases were low in severity 

and one case was moderate in severity. The three low severity cases occurred in one nonoccupational event with little information provided about this event. The moderate severity case 

was occupational; this case involved a Hispanic farmworker who "was topping and suckering 

tobacco and developed a rash with blisters on foreanns and throat swelling by the end of the day, 

despite PPE worn." This case was given a prevention code of "no label violation found but case 

made ill". All four cases reported respiratory symptoms: tlu·ee had burning/irritated/swelling 

throat and one had breathing problems. Three cases experienced eye pain and irritation. 

c. Agricultural Health Study (AHS) 

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

use and various health outcomes including cancer. The AHS includes private and commercial 

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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, full y reviewed in the risk 

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

active ingredients commonly used in agriculture. Flumetralin 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 tlumetralin 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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