Document ID: EPA-HQ-OPP-2015-0053-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-03-30T04:00Z

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

                                                	OFFICE OF CHEMICAL SAFETY AND 
                                                           POLLUTION PREVENTION
	

MEMORANDUM

Date: 	October 23, 2014

SUBJECT:	Myclobutanil: Tier I Review of Human Incidents

PC Code: 128857
DP Barcode: D421958
Decision No.: 493824
Registration No.: NA
Petition No.: NA
Regulatory Action: NA
Risk Assessment Type: NA
Case No.: NA
TXR No.: NA
CAS No.: 88671-89-0
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: 		Yvonne Barnes, Risk Assessor
		Risk Assessment Branch VI
		Health Effects Division (7509P)
			and				
		Benjamin Askin, Chemical Review Manager
		Risk Management & Implementation Branch 1
		Pesticide Re-evaluation Division (7508P)

Summary and Conclusions

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

Myclobutanil is a systemic fungicide.  Myclobutanil is used to control a broad spectrum of diseases in many perennial and annual crops, turf varieties, landscape ornamental plants, fruit trees, and vines.

For this evaluation, both the OPP Incident Data System (IDS), 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), and the National Pesticide Information Center (NPIC) databases were consulted for pesticide incident data on the active ingredient myclobutanil (pc code: 128857).  The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to myclobutanil exposure.  Myclobutanil 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 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 5 incidents reported for the single chemical only in the database.  These incidents were classified as moderate severity.  The cases reported dermal, ocular, gastrointestinal, cardiovascular, neurological symptoms including tremors and muscle weakness.  More details regarding these incidents can be found in Appendix 1.  There were 6 additional incidents reported involving more than one chemical.  These incidents were also classified as moderate severity.   

In Aggregate IDS, from January 1, 2009 to August 12, 2014, there were 105 incidents reported involving myclobutanil.  These incidents were classified as minor severity.  Overall, there are few incidents involving myclobutanil 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 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 query of SENSOR-Pesticides from 1998-2010 identifies 45 cases involving myclobutanil (pc code 128857); 14 cases stemming from 12 events involve a single active ingredient and were analyzed for this memo.  Thirteen single active ingredient cases were work-related; six of which involved exposure from landscape/ornamental applications.  Three cases were moderate in severity and 11 cases were low in severity.  The three moderate severity cases occurred in California, one was a handler exposure described as follows, "Spraying vineyards at night, opened a tank of fungicide and was exposed to vapors."  The other two moderate severity cases involved agricultural field workers but no further case detail was provided.  The moderate severity cases reported dermal and respiratory symptoms including upper respiratory pain/irritation.  Table 2 presents a summary of health effects reported for the 14 single active ingredient cases.

Table 2. SENSOR-Pesticides 1998-2009: Reported Health Effects for Myclobutanil Cases (N=14)

Health Effect
# of Times Reported
Dermal
7
Ocular
4
Respiratory
7
Gastrointestinal
4
Renal
0
Nervous System
4
Cardiovascular
0
                  * Cases may report multiple health effects
            
         c. National Pesticide Information Center (NPIC)
The National Pesticide Information Center or NPIC is a cooperative effort between Oregon State University and EPA which is funded by EPA to serve as a source of objective, science-based pesticide information and respond to inquiries from the public and to incidents. NPIC functions nationally during weekday business hours through a toll-free telephone number in addition to the internet (www.npic.orst.edu) and email.  Similar to Poison Control Centers, NPIC's primary purpose is not to collect incident data, but rather to provide information to inquirers on a wide range of pesticide topics, and direct callers for pesticide incident investigation and emergency treatment.  Nevertheless NPIC does collect information about incidents (approximately 4000 incidents per year) from inquirers and records that information in a database.  NPIC is a source of national incident information but generally receives fewer reports than IDS.  Regardless, if a high frequency is observed in IDS, NPIC provides an additional source of information to see whether there is evidence of consistency across national data sets or possibly duplication and additional information about the same incident(s). 
From 2009 to June 30, 2014, 5 incidents were reported to NPIC involving myclobutanil. NPIC estimates a certainty index as to whether an incident (including reported symptoms) was either definitely, probably, possibly, or unlikely to have been caused by the reported exposure to a pesticide, or whether the incident was unrelated to pesticides or if the incident was unclassifiable.  Of the 5 reported incidents, 2 were reported as symptomatic and possibly related to the myclobutanil exposure, 1 case was classified as unlikely and 2 cases was unclassifiable. The two possible incidents were classified as moderate severity.  One case reported respiratory effect. He works on a farm with several different products on a daily basis and believes he could have inhaled any of them.  The other case applied a fungicide with myclobutanil to his yard.  He did not read the label directions or wear any protective clothing. He got the product all over himself and did not cleaned up for about 8 hours. The next day he developed a rash.
         d. 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.  Myclobutanil 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 incident cases reported for myclobutanil in IDS, SENSOR-Pesticides, and NPIC 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.

                                  Appendix 1
Human Incidents
Chemical: Myclobutanil
PC Code: 128857

Incident Package Report
Incident Date
Location
Reg Number
Product Name
Exposure Severity 
Incident Description
020658 - 00002
                                                                       3/7/2009
PITTSBURGH, PA
009688-00123-008845
SPECTRACIDE IMMUNOX MULTI-PURPOSE SPRAY CONCENTRATE
Moderate
A 59 year old male was spraying the product earlier today and the product dripped onto his arm and he inhaled some of the mist. He experienced hypertension, Diarrhea, and feeling "jittery."
020927 - 00002
                                                                       5/1/2009
HOWELL, NJ
009688-00165-008845
SPECTRACIDE IMMUNOX LAWN DISEASE CONTROL SYSTEMIC FUNGICIDE CONC
Moderate
A 45 year old female followed her husband using 2 bottles of product, moving the hose. She didn't smell anything but she experienced tightness and spasm in her chest and shortness of breath. Has been seen by several MDs, chest x-ray, prednisone, albuterol, several therapies listed. 
024332 - 00004
                                                                       6/9/2012
MARIPOSA, CA
062719-00410
RALLY 40 WSP FUNGICIDE
Moderate
A 73 year old male has a vineyard that is suffering from mildew problems. He mixed the product with Sulphur on Saturday and used it on his vineyard. He was wearing goggles but still managed to get the mixture into his eyes. He showered that day and applied eye drops. The next morning his eyes continued to water and were bloodshot. He was evaluated by Ophthalmologist, and eyes were found to be irritated but no damage. 
024441 - 00013
                                                                      7/14/2012
DELAND, FL
009688-00123-008845
SPECTRACIDE IMMUNOX MULTI-PURPOSE FUNGICIDE SPRAY CONCENTRATE FOR GARDENS
Moderate
A 54 year old female's husband sprayed the product on their lawn 1 week ago and caller walked across it with her bare feet while it was still wet. She experienced tremor pain and muscle weakness.
024582 - 00004
                                                                      9/14/2012
NORTH RIDGEVILLE, OH
009688-00123-008845
SPECTRACIDE IMMUNOX MULTI-PURPOSE FUNGICIDE SPRAY CONCENTRATE
Moderate
An adult female used the product for 1 hour and her hand was getting wet. She washed off skin with soapy water. She experienced spreading blisters/rash.