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II. 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. 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. 

III. BACKGROUND 

For this evaluation, the OPP Incident Data System (IDS) was utilized for pesticide incident data 

on the active ingredient aldicarb (PC Code 098301). Aldicarb is registered for use as a systemic 

insecticide and nematicide on agricultural crops. The purpose of the database search is to identify 

potential patterns in the frequency and severity of the health effects attributed to aldicarb 

exposure. The 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 

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

the report. 

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 

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 50 different pesticide 

active ingredients commonly used in agriculture. 

IV. RESULTS/DISCUSSION 

Incident Data System: 

IDS records incidents resulting in higher severity outcomes in more detail, in a module called the 

Main IDS module. This system stores incident data for death, major and moderate incidents, and 

it includes more details about the location, date and nature of the incident. Main IDS incidents 

involving only one pesticide are considered to provide more certain information about the 

potential effects of exposure from the pesticide. The less severe human incidents (minor, 
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unknown, or no effects outcomes) are reported by registrants as counts called aggregate 

summaries and are recorded in a separate module called Aggregate IDS. 

In Aggregate IDS, from January 1, 2006 to December 14, 2011 there were 10 reported incidents 

involving aldicarb. 

For the main IDS, from January 1, 2006 to December 14, 2011, there were 15 reported incidents 

reported involving the single chemical aldicarb in the database and 2 incidents reported that 

involve more than one chemical (including aldicarb). For the single chemical incidents, there 

was one incident classified as minor severity, 11 incidents classified as moderate severity, and 

two incidents classified as major severity and one fatality. The incidents classified as major 

severity and the fatality are described below in Table 1. Overall, there are few incidents 

involving aldicarb reported to IDS. 

Agricultural Health Study: 

Investigators with the Agricultural Health Study (AHS) (Lee et al. (2007)) performed a nested 

case control analysis of colorectal cancer among AHS study participants and observed an 

elevated odds of colon cancer among lifetime users of a aldicarb (OR 4.1 (95% CI 1.3, 12.8), p 

for trend 0.001); however authors note the lack of an a priori hypothesis to explain this 

observation, and lack of experimental studies to support a possible mechanism of action. The 

study included 305 colon cancer cases identified through state cancer registries between the 1993 

enrollment period and 2002. Pesticide exposure was evaluated through validated self-report 

questionnaires, and authors were able to control for known colon cancer risk factors related to 

diet and exercise. There were 29 aldicarb exposed colon cancer cases which is a moderately 

small number of exposed cases, and the AHS study was not designed to capture detailed 

information concerning diet and exercise;therefore, residual confounding may be reflected in 

these estimates. Overall, authors note the significance of the finding, but suggest caution due to 

small numbers, the role of chance, and lack of biological explanation. Additional follow-up is 

on-going. 

Also within the AHS, investigators reported a link between aldicarb use and Farmer’s Lung, an 

important non-cancer, respiratory health outcome (Hoppin et al. (2007)). Using self-report 

incidence of Farmer’s Lung among private applicators and their spouses, authors observed 

elevated odds of this outcome with carbamates as a group (approximate 40% increase in risk 

among both farmers and spouses), and an odds ratio of 1.65 (95% CI 1.04, 2.61) reflective of 25 

Farmer’s lung cases who reported use of aldicarb. Authors suggest again that these preliminary 

findings could be due to chance and are unexpected given previously conducted research, but 

also note that there is some evidence of aldicarb adversely affecting immune-response. At this 

time, TEB notes these preliminary findings and suggests risk assessment teams consider this 

information when compiling hazard characterization and exposure scenarios; however the data 

are too preliminary to infer strong causal links at this time. 

Based on the low frequency and generally low severity of incident cases reported for aldicarb 

and the current status of the AHS epidemiological research, there does not appear to be a concern 

that would warrant further investigation at this time. The Agency will continue to monitor the 

incident information and AHS results and if a concern is triggered, additional analysis will be 
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included in the risk assessment and follow-up studies from the AHS will be evaluated if 

available at the time of the risk assessment. 

REFERENCE: 

 Lee WJ, Sandler DP, Blair A, Samanic C, Cross AJ, Alavanja MC. Pesticide use 

and colorectal cancer risk in the Agricultural Health Study. Int J Cancer. 2007 Jul 15;121(2):339-

46. PubMed PMID: 17390374; PubMed Central PMCID: PMC2928992. 

Hoppin, J.A., Umbach, D.M, Kullman, G.J., Henneberger, P.K., London, S.J., Alavanja, M.C., 

Sandler, D.P. Pesticides and other Agricultural Factors Associated with Self-reported Farmer’s 

Lung among Farm Residents in the Agricultural Health Study. Occupational and Environmental 

Medicine 2007, 64:334-342. 

 
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Table 1: Main IDS high severity incidents involving Aldicarb 

Human Incidents Chemical: Aldicarb PC Code: 098301 Incident Package Report

Incident Date Location

Registration Number Product Name

Exposure Severity* Incident Description

017388 ‐ 

00001 5/19/2006 LESLIE, GA NA

TEMIK

(UNSPECIFIED

PRODUCT)

HA

A 31 year old male appeare

using Temik earlier in the da

outward symptoms of Temi

autopsy has been performe

performed the autopsy said 

based on the history providexam, that the 31 year old m

Aldicarb. The medical exam

old male's post‐mortem exa

heart.

018718 ‐ 

00015 6/24/2007 IDAHO FALLS, ID NA TEMIK BRAND (NON‐SPECIFIC) HB

A 59 year old female accide

thought it was pepper. It wa

application in the garden. Sh

hypertension, hypotension, 

diaphoresis, coma, fascicula

depression. She was taken t

019734 ‐ 

00002 5/13/2008 SHAWNEE, KS 000264‐ 00322 TEMIK BRAND 10G ALDICARB PESTICIDE HB

A 47 year old male applied p

fully clothed, and wore a ma

spilled product on him while 

bradycardia, abdominal pain

diaphoresis, leg cramps, and 

hospital and treated with IV 

* Severity Categories na – not available H-A Human Fatality Death (if the person died) H-B Human Major Major (if the person alleged or exhibited symptoms which may have been life-threatening, or resulted in adverse

reproductive effects or in residual disability) 

H-C Human Moderate Moderate (if the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic 

nature than minor symptoms; and involved some form of treatment, even though symptoms were not life threatening and the person returned to his/her pre-exposure state of health with no additional residual disability) 

H-D Human Minor Minor (if the person alleged or exhibited some symptoms, but they were minimally traumatic; the symptoms 

resolved rapidly and usually involve skin, eye or respiratory irritation) 

H-E Human Unspecified Unspecified (if symptoms are unknown, unspecified or are alleged to be of a delayed or chronic nature that may 
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appear in the future) 

H Human Undetermined (an undetermined severity) from 40 CFR § 159.184