UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: luly21,2011 

SUBJECT: Clothianidin: Review of Human Incidents 

PC Code: 044309 DP Barcode: 0 39 1709 

Decision No.: 451486 

Petition No.; NA 

Risk Assessment Type: NA 

TXR No.: NA 

MRID No.:NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 20551 0-53-8 

40 CFR: NA 

FROM: Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

THROUGH: David Miller, Acting Branch Chief {1;),Ij;t. ""4 ;VII 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Michael Doherty, Risk Assessor 

Risk Assessment Branch II 

Health Effects Division (7509P) 

and 

Russell Wasem, Chemical Review Manager 

Risk Management & Implementation Branch I 

Pesticide Re-evaluation Division (7508P) 

I. CONCLUSION 

Vcr.Apr.08 

Based on the low frequency and severity of incident cases, there does not appear to be a concern 

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

incident informalion and if a concern is triggered, additional analysis will be included in the risk 

assessment. 

Page I of3 
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 (AI-IS) are part of the problem formulation phase ofregistration 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 (lOS) was utilized for pesticide incident data 

on the active ingredient clothianidin (PC Code 044309). The purpose of the database search is to 

identify potential patterns on the frequency and severity of the health effects attributed to 

clothianidin exposure. The IDS includes reports of alleged human health incidents from various 

sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FlFRA) 

Section 6 (a) (2) reports from registrants, other federal and state health and environmental 

agencies and individual consumers. Since 1992, OPP compiles 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 repoft. 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 

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, 

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 June 13,2011, there are 18 incidents involving 

clothianidin. 

Page 2 of 3 
For the main IDS, from January I, 2006 to June 13, 2011 , there are fi ve cases reported for single 

chemical only in the database (classified as moderate severity), and two additional incidents that 

involved more than one chemical. Overall, there are few incidents involving clothianidin 

reported to IDS, and all are classified as moderate severity. 

Clothianidin is not included in the AHS, and therefore does not provide information for this 

report. 

Based on the low frequency and severity of incident cases, 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. 

IDS Report 

Chemical: Clothianidin 

Incident 

017571 ·00020 

018502 - 00011 

018598 -

• Severit Cate ories 

H Human 

H-A Human Fatalit 

H·B Human Ma·or 

H-C Human Moderate 

H-D Human Minor 

H-E Human Uns ccified 

from40 CFR § 159.184 

Product 

PONCHO 600 

PC code: 

044309 

Registration 

Page 3 of3 

Human Incidents 

Exposure 

SCHAGHTICOK 

LANCASTER PA HC 

ENNIS,