UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: December I, 20 15 

SUBJECT: Aldicarb: Tier I Update of Human Incidents for Draft Risk Assessment 

PC Code: 098301 OP Barcode: 0430435 

Decision No.: 498310 

Petition No.: 1A 

Registration No.: NA 

Regulatory Action: 1 A 

Risk Assessment Type: /I. Case No.: 'A 

TXR No.: A CAS No.: 116-06-3 

MRID No.: 'A .tO C FR: NA 

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David .I. Miller, Acting Branch Chief .;; 

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Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Matthew Lloyd. Risk Assessor 

Risk Assessment Branch VII 

Health Effects Division (7509P) 

and 

Sue Bartow. Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusio ns 

Aldicarb was previously reviewed in 20 12 (S. Recore 3/ 14112. 0 398569). At the time. IDS was 

queried from January I. 2006 to December l 4. 20 I I and there were 15 reported incidents in 

Main IDS involving the single active ingredient and ten reported incidents involving aldicarb in 

Aggregate IDS. There was one incident classifi ed as mino r severity, 11 incidents classified as 

Page I of 8 
moderate severity. and two incidents classified as major severity and one fatality. Upon review 

of these incidents, it was concluded that there was not a concern warranting further investigation. 

Since the time of the 2012 scoping memo (from January 1, 2012 to Apri I 15, 2015) there have 

been three additional aldicarb incidents reported in Main IDS, including one high severity 

incident. There are two additional aldicarb cases reported in aggregate IDS. SENSORPesticides was not reviewed in 2012 and for this review. an all-year query of SENSORPesticides, from l 998-20 I I. was conducted and 63 single ai case reports involving aldicarb were 

identified. One case was high in severity. Twenty-six cases were moderate in severity and 36 

cases were low in severity. In sum. this updated review of aldicarb incidents finds that the 

frequency of aldicarb incident reports remains low. There are two high severity incidents 

involving aldicarb both of which are a result of misuse or use of illegal products. 

In the 20 12 scoping memo. a review of the Agricultural Health Study literature involving 

aldicarb identified findings of interest regarding aldicarb and its potential association with colon 

cancer and farmer's lung. These findings arc included in this memo: however the studies were 

preliminary and EPA concluded at that time that continued monitoring of follow-up 

epidemiology studies were to be evaluated as they became available. As of ovember 2015, the 

Al IS has not published subsequent papers with findings on aldicarb and cancer or non-cancer 

outcomes. Further, EPA is not aware of other recent epidemiology studies that focus on aldicarb 

exposure and health outcomes. Therefore this aldicarb update memo docs not include additional 

or updated epidemiological findings. 

Detailed Review 

I. ACTION REQUESTED 

Aldicarb is being considered under the FQPA-mandated Registration Review program 

established to review. on a 15 year cycle, pesticides for which a Re-registration Eligibility 

Decision has been made. One component of the Agency's Registration Review Program is 

consideration of human incident data. In conjunction with a human health risk assessment based 

on other data sources. such human incident data can assist the Agency in better defining and 

characterizing the risk of pesticides/pesticide products. 

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. 

Page 2of8 
I. BACKGROUND 

Aldicarb is registered for use as a systemic insecticide and nematicide on agri cultural crops. 

For this evaluation. both OPP Incident Data System (IDS) and the Centers for Disease Control 

and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel 

Event 'otification System for Occupational Risk-Pesticides (SE SOR) databases were 

consulted for pesticide incident data on the active ingredient aldicarb (PC Code: 09830 l ). The 

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

the health effects attributed to aldicarb exposure. 

In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a 

high quality, prospective epidemiology study evaluating the link between pesticide use and 

various health outcomes including cancer. Aldicarb is included in the AHS and the findings are 

summarized in this report. 

II. RES UL TS/DISCUSSION 

a. IDS (Incident Data System) 

OPP'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 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. 

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 specific. 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 I OS incidents involving only one 

pesticide 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. 2012 to April 28. 20 15. there were three incidents reported 

for aldicarb in the database. 1 One incident was classified as major severity. In this case, a 61 

1 There were three additional incidents reported to IDS that were not reviewed further. One moderate severity 

incident that was a self-harm atlernpt. and two deaths that were the result of suicides. 

Page 3 of 8 
year old male was in a comatose condition after experiencing a severe migraine headache that 

lasted for about 24 hours. The son of the patient had brought in a label for Temik stating that his 

father has a history of using this product off-label to control wild animals on his farm. At the 

time the incident was reported, no one kne·w how recently the patient had handled Temik. The 

other two incidents were classified as moderate severity. The incident details are found in 

Appendix/\. 

Aggregate IDS, from January I, 2012 to April 28, 20 15. there were 2 incidents reported 

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

incidents reported to IDS involving aldicarb. 

b. SENSOR-Pesticides 

A query of SENSOR-Pesticides from 1998-20 11 identifies 79 single ai cases involving aldicarb 

(pc code 098301 ). Sixteen of these 79 cases have been removed from this anal ysis because they 

were intentional exposures. therefore this memo reviews 63 single ai case reports. 

Thirty-eight cases involved various Temik products. 19 cases had unknown products and six 

cases involved the illegally distributed Chinese Chalk, aka ''Tres Pasitos". 

Svmptoms and Severity 

The most commonly reported symptoms were gastrointestinal including diarrhea. vomiting and 

abdominal pain, followed by neurological symptoms including sweating and dizziness. Also of 

note is that nine cases experienced cardiovascular symptoms including chest pain and slow 

heartbeat. 

Table 1. SENSOR-Pesticides 1998-2011 

Single Al/Unintentional Aldicarb Cases 

n=63 

Health Effects Count 

Gastrointestinal 44 

Nervous Svstcm 42 

Respiratory 18 

Ocular 15 

Cardio\'ascu lar 9 

Dermal 8 

Renal I 

Ca~es may n.:nort multiple symptoms 

One case was high in severity. Twenty-six cases were moderate in severity and 36 cases were 

low in severity. The single high severity case occurred in ew York in 2008 and involved a 

two-year-old child who was eating potato chips off a floor that had been treated with Tres 

Pasitos. The child developed several symptoms: fever, vomiting, sweating. tremor (shaking and 

falling down), limp, diarrhea. pinpoint pupi ls, and staring off to space. 

With regard to the 26 moderate severity cases. I 0 cases involved ingestion, 9 involved 

application/handling. 2 involved transport. one field exposure, and 4 cases bystander cases. 

Agricultural cases (n=34) 

Page 4of8 
Thirty-four cases occurred on a farm. Of the agricultural cases, seven cases occurred in orth 

Carolina in 2009 when he farmworkers ate watermelon from a field where fly bait (aldicarb) had 

recentl y been appli ed. Five agricultural cases involved cases where the handler did not wear 

PPE. The 21 remaining agricultural cases involved various exposure scenarios. 

Non-agricultural cases (n=29) 

• Of the 29 cases that did not occur on a farm. 16 cases occurred in or around private 

residences including: 7 home garden cases and 9 rodent bail cases. 

• Two transportation exposure cases 

• Two paramedic secondary exposure cases 

• Two residentia l drift2 cases (One of these cases was applying Temik and the wind blew 

the product into his face; the second case did not include narrative detail.) 

• Two forest workers made ill from Temik while investigating the death of a poisoned bear 

• One case received Temik from a friend lo control coyotes (and inadve11entl y ingested 

some) 

• Jn four cases the exposure scenarios were not known. 

Of the 63 cases described above, 19 cases involved the accidental ingestion o f a ldicarb: these 

cases are described in Appendix 2. 

c. Agricultural Health Study (AHS) 

The AHS is a high quality. prospective epidemiology study evaluating the link bet\veen pesticide 

use and various health outcomes including cancer. The /\HS includes private and commercial 

pesticide applicators and their spouses. If there arc Al IS findings relevant to a particular 

pesticide going through registration review, the Agency will ensure they arc 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. 

Investigators with the Agricultural Health Study (Al IS) (Lee et al. (2007)) perfom1ed an analysis 

o r colorectal cancer. looking at colon cancer. rectal cancer and colorectal (colon + rectal) cancer 

among AHS study participants. Cancer incidence was identified from state cancer registries 

from the time of study enrollment ( 1993-1997) through December 3 1. 2002. The study inc luded 

305 colorectal cancer cases (2 12 colon, 93 rectum). Pestic ide exposure was eva luated through 

validated se lf-report questionnaires, There were 40 aldicarb-exposed colorectal cancer cases and 

195 non-exposed cases generating an OR of 1.6 (95% CT: 1.0, 2.4) when cases were classified by 

ever/never use. When colo n and rectal cancer cases were considered separately, associated ORs 

were 2. 1 (95% CI: 1.3. 3.4) and 0.8 (95% Cl: 0.4. 1.8). respectively. The authors also conducted 

an exposure-response assessment by dividing exposures into 4 levels ( a non-exposed referent 

level and three tertilc exposure levels) for colorectal. colon. and rectal cancers. but the numbers 

2 SE SOR-Pesticides defines drift as "off-target movement of a pesticide"' and this includes both drift and 

vol at i I ization. 

Page 5of8 
of cases in each category were small, ranging from a low of I to a high of 8. For the highest 

exposed groups ORs for colorectal cancer were 2.6 (95% CI: 0.9, 7.6: n= 5, p-trend 0.0 14) and 

for colon cancer 4.1 (95% Cl 1.3, 12.8; n=5, 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. While authors were able to control for known colon cancer risk 

factors related to diet and exercise, the AHS study was not designed to capture detailed 

information concerning diet and exercise and thus residual confounding may be reflected in these 

escimates. Overall. authors noce the significance of the finding, but suggest caution due to small 

numbers, the role of chance, and lack of biological explanation. 

Also within the AHS, in vestigators reported a link between aldicarb use and farrner·s Lung, a 

non-cancer respiratory health outcome (Hoppin et al. (2007)). Using se lf-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 of25 farmer's lung cases 

who reported use of aldicarb. Authors suggest again that these preliminary findings could be due 

to chance. Therefore a strong causal link cannot be made based on these findings. 

As of November 2015, the AHS has not published subsequent papers with findings on aldicarb 

and cancer or non-cancer o utcomes. Further, EP /\. is not aware of other recent epidemiology 

studies that focus on aldi carb exposure and hea lth outcomes. 

III. Conclusion 

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 docs not appear to be a concern 

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

incident information and /\HS results and if a concern is triggered. additional ana lysis will be 

included in the risk assessment and follow-up studies from the Al-IS will be evaluated if 

available at the time of the risk assessment. 

Citations: 

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

and colorectal cancer risk in the Agricultural Hea lth Study. Int J Cancer. 2007 Jul 

I 5;121 (2):339-46. PubMed PMID: 17390374; PubMed Central PM CJD: PMC2928992. 

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

Sandler, D.P. Pesticides and other Agricultural factors Associated with Self-reported Farn1er's 

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

Medicine 2007. 64:334-342 

Page 6 of 8 
Appendix I. 

M ain IDS incident · lvinl! Aid' b 

Human Incidents I Chemical: Aldicarb I PC Code: 098301 

Incident 

Package Registration Exposure 

Report Incident Date Location Number Product Name Severity* Incident Description 

Two aduh female came in contact with aldicarb when their dog 

got into the neighbors garbage and ingested bones with aldicarb 

02405 1 - TEMIK BRAND on them. The dog died that night. The dog \\ US necropsied and 

00002 4/10/2012 MOLTEN. 1\I. N1\ (NON-SPECIFIC) Moderate tested positive for Temik. One female experienced nausea. 

difficuhy breathing. tingling. salivation. watering eyes. 

anorexia. and diarrhca. She went 10 the . The other fema le 

cxpcricnccd nausea. vomiting. watering cyes. salivation. runny 

nose and kidnev pain. 

TEMIK BRAND 15G A 39 year old male used the product outdoors. About 30 

025612 - 6115/20 13 RUPERT. ID 000264-00330 J\LDICARB minutes after \\Orking \\ ith it. he began to fi:cl "poorly." He 

00009 PESTICIDE Moderate experienced vomiting and lethargy. Three ''eeks later. he was 

hospitalized for three day with evidence of pulmonary cmboli 

on film. as well as pneumon ia. 

t\ 61 year old mah: was in a comatose condition <1ftc r 

experiencing a severe migraine headache that lasted fo r nboul 

02578 1 - 000264-00330 TEMIK BRAND I 5 2,1 hours. The son of the paticlll had brought inn label for 

00006 8119/2013 JONESBORO. AZ G Major Temik staling that his father has a history of using this product 

otl~labcl to control\\ ild animals on his form. At the time the 

incident was reported. no one knew hO\\ recently the patient 

had handled Tcmik. 

Page 7of8 
Appendix 2. 

' Table 2. SENSOR-Pesticides 

Accidental Ingestion Cases for Aldicarb . N=l9 

Case ID Age Year Case Description Severity Reg # 

NYOl703 2.3 2008 Child played on the floor of a bodega \\hen he consumed potato chips off the floor or a High L3odega that had heen treated with 'Trcs Pasitos." 

NY00897 29.8 2004 Subject aceidently ingested Tres Pasi tos on bread left on the kitchen counter as ra t bait. Moderate 

NY00890 0.8 2004 A 9 month old chi ld ingested "tres pasitos" {aldiearb) that she found in a dish on the floor. Moderate Child \\as hospitalized. 

NY00215 12 1998 Child ingested cake mixed with illegal rat poison in his home. ivloderate 

NC02237 27 2009 7 Mexican form workers at..: watermelon in field where lly bait/carbamate had been scattered. Moderate 00026400330 

He was exposed while placing the pesticide into a spreader. I le got hit on the face with the 

\VA.00309 33.2 20 11 pesticide. The poison center indicated he had a mouthful of the product. DOI I was not able to Modaatc 00026400330 

locate the \\Orkcr for inten ie\\ . Good MD information. 

FL0 1602 51.7 2006 Patient ate Tcmic mixed \\ ith peanut buner that \\as used to bait rat traps. Moderate 00026400322 

NCO l98 1 45.3 2009 Man. wife & stepdaughter ate squash from home garden that had been grown in soil treated Moderate 00026400330 with Temik and all became very ill. 

NC02232 38.1 2009 7 Mexican farm workers ate watermelon in field where fly bait/carbamatc had been scattered. Moderate 00026400330 

NCOJ983 38 2009 Man. \\Oman & stepdaughter ate squash from home garden soil that had been treated \\ ith Moderate 00026400330 Temik and all became very ill. 

NCO l982 15 2009 Man. win: & stepdaughter ate squash that hnd been grown in home garden soil treated with Moderate 00026400330 Tcmik and all became very ill. 

NC02235 22.5 2009 7 Mexican farm workers ate watcnnelon in !ield \I here lly bait/carbarnate had been seauered. LO\\ 00026400330 

FL01023 2002 No description provided Low 00026-10033 1 

FL01255 32.2 2003 No description provided Low 0002640033 1 

FL0 1022 2002 Workers exposed lo temik and dorex in\'estignting cause of death of a bi:ar. Low 00026400331 

NC0223.t 53..J 2009 7 Mexican farm workers ate 1\atermclon in lield where lly bait/carbamatc had been scaucrcd. Low 00026-1 00330 

NC02236 28.1 2009 7 l'vlcxican farm workers ate 11-.11crmelon in lield where lly bait/carbarnate had been scaucrccl. Low 00026400330 

NC02238 23.2 2009 7 Mexican farm workers ate watenm:lon in fie ld where lly bait/carbamale had been scattered. Low 00026400330 

NC02233 34.3 2009 7 Mexican farm workers ate 1\ atermelon in field where lly bait/carbarnatc had been scaucred. Low 00026400330 

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