Document ID: EPA-HQ-OPP-2013-0074-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-03-27T04:00Z

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

                                                	OFFICE OF CHEMICAL SAFETY AND 
                                                           POLLUTION PREVENTION
	

MEMORANDUM

Date: 	November 27, 2012

SUBJECT:	Trifloxystrobin: Review of Human Incidents

PC Code: 129112
DP Barcode: D407067
Decision No.: 469960
Registration No.: NA
Petition No.: NA
Regulatory Action: NA
Risk Assessment Type: NA
Case No.: NA
TXR No.: NA
CAS No.: 141517-21-7
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 Effect Division (7509P)

THROUGH:	David Miller, Acting Branch Chief
		Toxicology and Epidemiology Branch
		Health Effects Division (7509P)
			
TO: 		Nancy Tsaur, Risk Assessor
		Risk Assessment Branch III
		Health Effects Division (7509P)
			and				
		Moana Appleyard, Chemical Review Manager
		Risk Management & Implementation Branch V
		Pesticide Re-evaluation Division (7508P)

Summary and Conclusions

Based on the low frequency and severity of incident cases reported for trifloxystrobin in both IDS and NIOSH SENSOR, 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		

Trifloxystrobin is a strobilurin-class fungicide that controls foliar fungal diseases and soilborne/seedling fungal diseases. It works by interrupting mitochondrial respiration in plant-pathogenic fungi, thus inhibiting spore germination and mycelial growth. It is a broad-spectrum preventative fungicide used for control of many plant diseases in various fruit, nut, vegetable, and field crops, including corn and soybean.

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 Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient trifloxystrobin (PC Code 129112).  The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to trifloxystrobin exposure.  

In addition, findings from the AHS were reviewed.  The Agricultural Health Study (AHS) is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer.  Trifloxystrobin 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 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 IDS 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 1, 2007 to September 13, 2012, there was 1 incidents reported for single chemical only in the database and 10 additional incidents reported involving more than one chemical. These incidents were classified as moderate severity.  In the single chemical incident, an adult male became ill after blowing into a hose to clear the product causing the product to blow into his face. He went to the emergency room and was admitted. No further information is available (Table 1).

In Aggregate IDS, from January 1, 2007 to September 13, 2012, there were 20 reported incidents involving trifloxystrobin.  

         b. NIOSH SENSOR

The NIOSH-led SENSOR-Pesticides database covers 11 states from 1998-2008, 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. A state SENSOR contact specialist attempts to follow-up with cases and obtains medical records to verify symptoms, circumstances surrounding the exposure, severity, and outcome.  Using standardized protocol and case definitions derived from poison center reporting, SENSOR-Pesticides coordinators at State Departments of Health enter the incident interview description provided by the case, medical report, physician into the data system. In order to be included in the database, all SENSOR-Pesticides cases, including low severity cases, must have at least two adverse health effects.

In SENSOR-Pesticides from 1998 to 2008, 11 cases, stemming from 10 exposure events, involving trifloxystrobin were identified.    Two cases were exposed to a single active ingredient whereas the other 9 involve exposure to multiple active ingredients.  Two cases are moderate in severity and 9 cases are low severity.  

Of the 11 cases, six reported respiratory symptoms, four reported dermal symptoms, four reported gastrointestinal symptoms, and three reported ocular symptoms.  It is noted that two of reported ocular symptoms despite wearing the label-required eye protection; however, both of these cases involved the application of multiple active ingredients.  One case narrative states "Patient was spraying on hop field, wearing full protection: half face respirator, rubber boots, rubber gloves, raingear and goggles.  But next day around 11:00 am he experienced ocular symptoms.  He doesn't know how he got exposed."  The second case narrative states "A 33 y/o male developed ocular symptoms after applying pesticides and fertilizers in a tank mix.  He was wearing eye protection."  Both cases were classified as low severity.

Eight of the 11 cases are coded as "work-related".  Of these, seven cases resulted from occupational pesticide exposure.  Specifically, five of these cases are pesticide applicator exposures, one involved a farmworker thinning apples, and one case was coded "work-related" but no further detail provided.

One of the two moderate severity cases involved a single active ingredient.  This case occurred in California in 2008 and involved application of Flint Fungicide (EPA reg # 00026400777).  This case was spraying Flint Fungicide from a tractor, reported wearing all required PPE, but he blew into a hose to clear it, and the product contacted him. He experienced gastrointestinal symptoms and was hospitalized for one day and reported missing at least one day of work.  The second moderate severity case occurred in Washington in 2005 and involved a 33 year old male applicator who went to a clinic complaining of neurological and gastrointestinal symptoms after applying Flint Fungicide.  This case, however, was applying Axinphosmethyl 50W in addition to Flint Fungicide.

         c. 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 50 different pesticide active ingredients commonly used in agriculture.

Trifloxystrobin 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 severity of incident cases reported for trifloxystrobin in both IDS and NIOSH SENSOR, 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.

Table 1. Main IDS Incident involving Trifloxystrobin as a single chemical
Human Incident
Chemical: Trifloxystrobin
PC Code: 129112

Incident Package Report
Incident Date
Location
Country
Reg Number
Product Name
Exposure Severity Codes
Incident Description
020180 - 00059
                                                                      5/24/2008
CA
US
000264-00777
FLINT FUNGICIDE
HC
An adult male became ill after blowing into a hose to clear the product causing the product to blow into his face. He went to ER and was admitted.
*HC-Human Moderate (if the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic nature than minor symptoms; and involved some form of treatment, even though symptoms were not life threatening and the person returned to his/her pre-exposure state of health with no additional residual disability)