### UNITED STATES ENV IRONM ENTAL 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 39 170 9 Decision No.: 451486 Petition No.; NA Risk Assessment Type: NA TXR No.: NA MRID No.:NA Registration No.: NA Regulatory Action: NA Case N o.: NA CAS No.: 20551 0 -53-8 40 CFR: NA FROM: Shanna Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effect Division (7509P) THROUGH: Da vid 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 Rev i ew Ma nager Ri s k Man agement & Implementation Branc h 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 thi s 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 incl uded in the ri s k assessment.

Page I of3II
. 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. Typic a lly , 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., canc er , 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 in g redient clothianidin (PC Cod e 044309). The purpose of the database search is to identify potenti al 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 report s from across the U.S. and most incidents have all relevant product information recorded. Repo rts s ubmitted to the IDS represent anecdotal reports or allegation s only, unless otherwise stated in the repoft. The AHS is a high quality, prospective epidemiol ogy study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide app licators and their spous e s. If there are AHS findings rele vant 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 u s ed in agriculture. IV. RESULTS/DISCUSSION IDS record s 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 o ne pesticide are considered to provide more certain information about the potential effect s of exposure from the pesticide. The less severe human incidents (minor, unknown, or n o effects outcomes) are reported by regi strants as counts called aggregate summaries and are recorded in a separate mo dule called Aggregate IDS. In Aggregate IDS , from January 1, 2006 to June 13,2011, there are 18 incidents involving clothianidin. 

### Page 2 o f 3For the ma in ID S, from Janu ary I , 2006 t o Ju ne 13, 2011 , there are fi ve cas e s re ported f o r s ing le chemical onl y in t he datab as e (cla ss ifi ed as moderate seve rity) , and two additional incidents that in volved more than on e c hemical. O ve rall , there are few incident s inv olvin g clothianidin reported to ID S, and all are class ified as moderate se verit y. C lothianidin i s no t included in th e A H S, and th eref ore do e s not pro vide inf o rm ation for thi s report. Based on th e lo w fr equ enc y and severity o f incid e nt case s , th ere doe s not appe ar to be a c onc e rn at thi s time that wo uld w arrant f urth er in ve sti g ation
. The Ag enc y will c ontinue to mon itor the inc ident informatio n and 

### if a conc ern is tri gg ered , additi onal anal ys is w ill be incl uded in the ri s k ass e ss me nt.



# IDS Report Chemical: Clothi anidin

Incident

017571 ·000 20

018502 - 00 011

018598 -

• Severit Cate ories H Human H-A Human Fatalit H·B Human Ma ·or H- C Human Modera te H-D Human Minor H-E Human U ns ccified from40 CF R § 159
. 184 Product

PONCHO 600 

### PC code: 

## 044309

Regist r ation



### Pag e 3 o f3 Human Incidents
Exposure
SCHAGHTICOK

LANCASTER P A HC
ENNIS ,