                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460      

                                                	OFFICE OF CHEMICAL SAFETY AND 
                                                           POLLUTION PREVENTION
	


MEMORANDUM

Date: 	April 20, 2016

SUBJECT:	Florasulam: Tier I (Scoping) Review of Human Incidents and Epidemiology

PC Code: 129108
DP Barcode: D433025
Decision No.: 512706
Registration No.: NA
Petition No.: NA
Regulatory Action: NA
Risk Assessment Type: NA
Case No.: NA
TXR No.: NA
CAS No.: 145701-23-1
MRID No.: NA
40 CFR: NA
		              									Ver.Apr.08
	          	
FROM:	Shanna Recore, Industrial Hygienist
		Toxicology and Epidemiology Branch
		Health Effect Division (7509P)
			and
      Elizabeth Evans, Environmental Protection Specialist
		Toxicology and Epidemiology Branch
		Health Effects Division (7509P)		
			
THROUGH:	David Miller, Acting Branch Chief
		Toxicology and Epidemiology Branch
		Health Effects Division (7509P)
			
TO: 		Sheila Piper, Risk Assessor
		Risk Assessment Branch VI
		Health Effects Division (7509P)
			and				
		M. Appleyard, Chemical Review Manager
		Risk Management & Implementation Branch 5
		Pesticide Re-evaluation Division (7508P)

Summary and Conclusions

Based on the low frequency and severity of incident cases reported for florasulam 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.

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		

Florasulam is a selective triazolopyrimidine sulfonanilide post-emergent herbicide registered for use on various crops including beans, corn, chickpeas, lentils, and cereal grains including wheat, barley, oats, rye, and triticale.
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 florasulam (pc code: 129108).  The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to florasulam exposure.  Florasulam is not included in the AHS, and therefore this study does not provide information for this report.

 RESULTS/DISCUSSION
         
 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:
  
 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. 
            
 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, 2010 to November 17, 2015, there were no incidents reported for the single chemical florasulam only in the database.  There was one incident reported involving more than one chemical besides florasulam. This incident was classified as moderate severity.

Aggregate IDS, from January 1, 2010 to November 17, 2015, there were 15 incidents reported involving florasulam.  These incidents were classified as minor severity. Overall, there are few incidents reported to IDS involving florasulam. 

 SENSOR-Pesticides
            
The SENSOR-Pesticides database covers 12 states from 1998-2012, 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 12 respective state Departments of Health conducts case follow-up 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 review of SENSOR-Pesticides 1998-2012 identifies no incidents involving florasulam.
         
 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.  Florasulam is not included in the AHS, and therefore this study does not provide information for this report.

 CONCLUSION

Based on the low frequency and severity of incident cases reported for florasulam 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.

