Document ID: EPA-HQ-OPP-2009-1015-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-03-31T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date: November 24, 2009

SUBJECT:	Updated Review of Amitraz Incident Reports  

 

PC Code:  106201	DP Barcode:   D368729

Decision No.: N/A	Registration No.: N/A

Petition No.: N/A	Regulatory Action: N/A

Risk Assessment Type: N/A	Case No.: N/A

TXR No.: N/A	CAS No.: 33089-61-1

MRID No.: N/A	40 CFR: N/A

		              									Ver.Apr.08

	          	

FROM:	Monica Hawkins, Ph.D., M.P.H., Environmental Health Scientist

		Shanna Recore, Industrial Hygienist

		Toxicology and Epidemiology Branch

		Health Effect Division (7509P)  SEQ CHAPTER \h \r 1 	

THROUGH:	Mary Manibusan, Branch Chief

		Toxicology and Epidemiology Branch 

		Health Effects Division (7509P)

		Sarah Winfield, Chair

		HED Incident Team

		Health Effects Division (7509P)		

TO: 		William Donovan, Risk Assessor 

		Risk Assessment Branch V

Health Effects Division (7509P)		

		

BACKGROUND		

The EPA is supplying the following incident report to fulfill our
requirement to docket summaries of incident data that were reported to
the Agency, as well as to ensure human incident data 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. Typically, causation cannot be
determined based on incident data. However, incident information can be
an important feedback loop 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.

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 (SENSOR) database were consulted for
poisoning incident data on the active ingredient amitraz. The IDS
includes reports of alleged human health incidents from various sources,
including mandatory reports from registrants, other federal and state
health and environmental agencies and individual consumers.  Since 1992,
OPP compiles these reports in an Incident Data System (IDS).  Reports
submitted to the IDS represent anecdotal reports or allegations only,
unless otherwise stated in this report.    The NIOSH SENSOR database for
acute occupational pesticide-related illness and injury covers 12 states
from 1998-2005, although reporting varies from state to state (the
database includes a total of 10,659 cases). Pesticide-related incidents
are collected from Department of Labor workers’ compensation claims
when reported by physicians, reports from State Departments of
Agriculture, from poison control centers and from State Departments of
Health based on reports by physicians suspecting pesticide exposure. A
state SENSOR contact specialist does follow-up with workers 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 coordinators
at State Departments of Health enter the incident interview description
provided by the worker, medical report, physician and patient into the
SENSOR data system, accessible to participating states and EPA.  

For IDS, we identified five incidents occurring in the United States
from 2002 to the present for the single chemical only.  The evaluation
of incident data for amitraz has determined that the symptoms appear
generic and are not confirmed to be related to exposure, there is no
clear evidence of a trend or exposure pattern. Therefore, at this time,
there are no remarkable case reports which suggest a plausible
association between a moderate or severe health outcome and exposure to
the pesticide amitraz, nor can we discern any suggestion of a trend or
pattern regarding the health effects due to the alleged exposure to the
pesticide amitraz.  

For NIOSH SENSOR, we identified ten reported cases that involve amitraz.
Of these ten cases, those that involve only amitraz and where exposure
was determined to be definite, probable or possible were reviewed in
detail, as these cases provide more certain information about the
potential effect of amitraz exposure.  These selection criteria resulted
in the exclusion of two cases.  Of the eight remaining cases, four were
professional applicator exposure (three treating dogs with dip, fourth
unknown), two were unintentional ingestion, one was non-occupational
exposure and one other was unknown exposure.  All exposures were of low
to moderate severity, except one unintentional dose case that involves a
six year old male who was given flea dip mistakenly by his grandmother
who thought it was cough medicine. This case was determined high
severity.  The health effects most often reported include: dermal (13%),
respiratory (25%), ocular (25%), cardiovascular (25%), gastrointestinal
(50%), and neurological (75%).  Symptoms are not mutually exclusive; a
patient may have many symptoms.

The applicator symptoms (three dog-dip cases) were mostly neurological
with nausea and vomiting.  Two of these cases were not wearing all the
appropriate personal protective equipment (PPE), but were wearing
gloves.  The third case was wearing the appropriate PPE.  The fourth
case exhibited dermal symptoms.  Details about this case are unknown.

Based on the low to moderate severity and low number of incident cases,
there does not appear to be a risk 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.

Cc:              James Parker, CRM, Pesticide Re-evaluation Division
(7508P)

IDS Report	 	 	 	 	 	 

Chemical: Amitraz	106201	Human Incidents	 

 	 	 	 	 	 	 	 	 

Incident Number	Incident Date	Product Name	Registration Number	City
State	Exposure Type*	Incident Description

016369	001	01-Jan-05	TAKTIC E.C.	05438200003	 	TX	HC	A 2 year old
Female ingested less than a 1/4 teaspoon of the product that was
prescribed to treat her dog. She reported blueness and her eyes turned
purple.

018212	001	31-Dec-06	TAKTIC EMULSIFIABLE CONCENTRATE, 12.5% SOLUTION
05438200003	REDLANDS	CA	HC	A 20 year old Male reported Nausea, Vomiting,
and Diarrhea after using the product. 

019496	001	26-Mar-08	TAKTIC E.C.	05438200003	BROOKLET	GA	HC	Unknown
Adult (18-64 years old) Female's friend used the product to treat a dog
on 3 consecutive Saturdays. The friend did not wear gloves and reported
Nausea, Dizziness, Tunnel Vision, Numbness, Sweating, and Chest
Tightness.

020351	001	02-Nov-08	TAKTIC EMULSIFIABLE CONCENTRATE, 12.5% SOLUTION
05438200003	 	IN	HB	A 49 year old Male reported Lethargy, Blurred
Vision, Numbness, and a Seizure two days following exposure to the
product.  He was treated by a physician.

020463	004	23-Mar-08	PREVENTIC PREVENTION PACK 2 COLLARS	00238200104	 
PA	HC	Unknown Adult (18-64 years old) Female applied the product to the
family dog.  She reported Dermal Irritation and Rash on her face.  She
was evaluated by a physician and diagnosed with a hypersensitivity
reaction. 

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