UNITED STATES ENVIRONMENT AL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: May 26. 2015 

SUBJECT: Nicarbazin: Tier J Review of Human Incidents 

PC Code: 0857 12 DP Barcode: D-t27460 

Decision No.: 50500-t 

Petition No.: NA 

Risk Assessment Type: A 

TXR No.: NA 

MRIO No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: 1 A 

CAS No.: I 07-02-8 

40 CFR: I A 

Vcr.Apr.08 

FROM: Elizabeth Evans, Environmental Protection Specialist nl ,,. -----J 

Toxicology and Epidemiology Branch ~~<.,ft\ "v4~ Health Effects Division (7509P) 

and 

Shanna Recore, Industrial Hygienist l J _ _. , _ () ...... _ 

Toxicology 

Health Effect 

and 

Division 

Epidemio

(7509

logy 

P) 

Branch ~ ~ 

THROUGH: David Miller, Acting Branch Chief A ~/J /1 .A 5/l::;/(5 (ov Toxicology and Epidemiology Branch '(.,,~ Y 

TO: 

Health Effects Division (7509P) 

Jaime o·Agostino, Risk Assessor 

Risk Assessment Branch II 

Health Effects Division (7509P) 

and 

Bonnie Adler, Chemical Review Manager 

Risk Management & Implementation Branch 5 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Based on the low frequency and severity of incident cases repo11ed for nicarbazin in both IDS 

and SE rsoR-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 

l. 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 Agri cultural Health 

Study (AHS) are part of the problem fonnulation 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 detennined 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 li ke pesticide applicators. 

II. BACKGROUND 

Nicarbazin is was registered in 2005. it is a granulated bate for "Egg Hatch Reduction in Canada 

Geese". Use is omitted to urban areas such as office parks, recreational parks, golf courses, 

schools, hospitals, restaurants, and commercial and industrial sites. Bait may be applied with bait 

pans. broadcast directly on the ground by hand or with mechanical feeders (up to a 20 ft radius). The 

application rate is 50 grams per goose per day. Beginning three weeks prior to first anticipated egglaying, a small amount of bait is offered (7 grams per goose). and the amount is increased each day. 

as geese become acclimated to the ba it. Baiting continues throughout the nesting period, which lasts 

8 to I 0 weeks. 

For this evaluation, both the OPP Incident Data System (fDS) 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 nicarbaz in (pc code: 085712). The 

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

the health effects attributed to nicarbazin exposure. Nicarbazin is not included in the AHS, and 

therefore this study does not provide information for this report. 

Ill. RESULTS/DISCUSSION 

a. IDS (Incident Data System) 

OP P'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 compil ed these repo11s 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. 

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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 

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 I, 2010 to February 4, 2015, there were no incidents reported 

involving nicarbazin. 

In Aggregate IDS, from January I, 20 10 to February 4, 20 15. there were 3 incidents repo11ed 

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

incidents reported to IDS involving nicarbazin. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers I 2 states from I 998-20 I I, 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 c laims when reported by physicians, reports from State Departments of 

Agriculture, and physician reports to state Depa11ments 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 value in providing that infonnation. The 

state coordinator at each of the 12 respective state Departments of Health conducts case fo llowup activities such as obtaining medical records to verify symptoms and severity. Using 

standardized protocol and case de finiti ons deri ved from poison center reporting. the state 

SENSOR-Pestic ide 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 I I identifies no cases involving nicarbazin. 

c. Agricultural Health Study (AHS) 

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

use and various hea lth 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 they are considered in the 

problem formul ation/scoping phase of the process and, if appropriate, fu lly 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. Nicarbazin 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 severity of incident cases reported for nicarbazin in both IDS 

and SENSOR-Pesticides there does not appear to be a concern at this time that would warrant 

fm1her investigation. The Agency will continue to monitor the incident infonnation and if a 

concern is triggered. additional analysis wi ll be included in the risk assessment. 

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