UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: October 23, 2014 

SUBJECT: Spiromesifen: Tier I Review of Human Incidents 

PC Code: 024875 DP Barcode: D422439 

Decision No.: 494564 

Petition No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXRNo.:NA 

MRIDNo.:NA 

CAS No.: 283594-90-1 

40CFR:NA 

FROM: Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

and 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

THROUGH: David Miller, Acting Branch Chief t{);J!.,ifv•l/ Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Sarah Levy, Risk Assessor 

Risk Assessment Branch V 

Health Effects Division (7509P) 

and 

Julia Stokes, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ver.Apr.08 

Based on the low frequency and low severity of cases involving spiromesifen reported in both 

IDS and SENSOR-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. 

Page 1 of5 
Detailed Review 

I. 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 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. 

II. BACKGROUND 

Spiromesifen belongs to the keto-enols class of pesticides. The keto-enols are derivatives of 

tetronic acid (spirocyclic tetronic acids) and are reported to act through inhibition of lipid 

biosynthesis. This active ingredient works on all developmental stages of mites. However, mite 

juvenile stages are more susceptible than adults. The active ingredient is also effective against 

whitefly nymphs and pupal stages. 

For this evaluation, both the OPP Incident Data System (IDS) 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 carboxin (pc code: 024875). The 

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

the health effects attributed to carboxin exposure. Spiromesifen is not included in the AHS, and 

therefore this study does not provide information for this report. 

III. RESULTS/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 rec<?rded. Reports 

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

the report. 

Page 2 of5 
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 1, 2009 to August 12, 2014, there were 3 incidents reported for 

the single chemical only in the database. These incidents were classified as moderate severity. 

These cases reported gastrointestinal, dermal, respiratory, ocular, and neurological (headache) 

symptoms. More details regarding these incidents can be found in Appendix 1. There was 1 

additional incident reported involving more than one chemical. 

In Aggregate IDS, from January 1, 2009 to August 12, 2014, there were 2 incidents reported 

involving spiromesifen in the database. These incidents were classified as minor severity. 

Overall, there are few incidents involving spiromesifen reported to IDS. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2010, 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 claims when reported by physicians, reports from State Departments of 

Agriculture, and physician reports to state Departments 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 information. The 

state coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using 

standardized protocol and case definitions derived from poison center reporting, the state 

SENSOR-Pesticide coordinator enters the incident information into the state-based system which 

is sent to NIOSH annually to be aggregated. 

A query of SENSOR-Pesticides from 1998-2010 identifies two cases involving spiromesifen (pc 

code 024875); both cases involved a single active ingredient and will analyzed for this memo. 

Both cases were low in severity. Both cases were work-related and involved agricultural spray 

drift. One case involved a civil engineer who inhaled the pesticide that was being sprayed while 

he was surveying. This case experienced gastrointestinal symptoms. The second case involved a 

mechanic who was drifted upon by an aerial application while fixing/welding a water pump in a 

potato circle. The following day he sought medical care. This case experienced respiratory 

symptoms as well as a headache. 

Page 3 of5 
c. Agricultural Health Study (AHS) 

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 80 different pesticide 

active ingredients commonly used in agriculture. Spiromesifen 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 low severity of cases involving spiromesifen reported in both 

IDS and SENSOR-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. 

Page 4 of5 
Appendix 1 

Human Incidents I Chemical: Spiromesifen I PC Code: 024875 ' - - .. 

.... .. ,. Uoao 

Incident 

Package Incident 

Report Date Location Reg Number Product Name Severity Incident Description 

A 28 year old male was spraying the 

diluted product yesterday, when some of it 

splashed back into his eye. He developed 

redness in the eye, and removed and 

discarded his contacts. The next day, he 

was evaluated by MD, who diagnosed him 

020611- GAINESVILLE, OBERON4SC with a chemical bum and prescribed 

00002 2/4/2009 FL 000264-00850 INSECTICIDE/MITICIDE Moderate ointment. 

A 40 year old male used the product at 

work. He did not wear PPE when using the 

product. He came home from work and 

took a shower. Then he had dinner and two 

cocktails. About 6 hours later, he got out of 

bed and urinated around the bedroom and 

then collapsed on the floor. He also 

experienced vomiting and a rash on the 

021485- OBERON2SC back of his neck. On follow-up two day 

00001 1/1/2009 SALEM, OR 000264-00719 INSECTICIDE/MITICIDE Moderate later, he had not seen a MD and was fine. 

A 44 year old male was sprayed by a crop 

duster. After his exposure, he was able to 

briefly wash up at an outdoor irrigation 

well but full skin and clothing 

decontamination took place some hours 

later. That evening he began to develop a 

rash/dermal eruption and felt nauseated. 

Two days later he also experienced blurred 

vision, vomiting, diarrhea, respiratory 

023302- PANHANDLE, OBERON4SC irritation, coughing, headache, and 

00001 7/31/2011 TX 000264-00850 INSECTICIDE/MI'I]<:IDg_ , Moderate elevated blood pressure. 

Page 5 of5