	

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM

Date: November 24, 2009

				

SUBJECT:	Updated Review of Allethrin Incident Reports		

PC Code:  004004, 004005	DP Barcode:   D371343

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.: 28434-00-6, 584-79-2

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



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

		Shanna Recore, Industrial Hygienist

		Jessie Cordova, Information Technology Specialist

		Toxicology and Epidemiology Branch

		Health Effect Division (7509P)		

		

THRU:	Mary Manibusan, Branch Chief

		Toxicology and Epidemiology Branch 

		Health Effects Division (7509P)

Sarah Winfield, Chair

		HED Incident Team

		Health Effects Division (7509P)	

TO:		Toiya Goodlow, Risk Assessor

		Risk Assessment Branch VII

		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 allethrin. 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 20 incidents occurring in the United States from
2002 to the present for the single chemical only.  Since allethrin is
often mixed with other active ingredients, a query was conducted in the
IDS for incidents involving one substance (but without restricting it to
a single active ingredient) which resulted in a moderately large number
of incidents.  Since these incidents involve more than one active
ingredient there is considerable uncertainty as to whether the incidents
reported are a direct result of exposure to allethrin or the other
active ingredients.  

For NIOSH SENSOR, we identified 177 reported cases that involve the
active ingredient allethrin. Cases that involve allethrin alone 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 effects of allethrin exposure. These selection
criteria resulted in the inclusion of two cases.  For these cases, the
symptoms included neurotoxicity, dermal and ocular effects.  One case
took place in California in 1999 when a 32 year old male had contact
with a treated surface. The symptoms reported include numbness and
paresthesias.  The other case also took place in Texas in 2000.  A 15
year old female reported symptoms of erythema, skin pain; lacrimation,
eye pain/irritation/inflammation and red eyes.  Both cases were
classified as low severity. 

Of the 175 cases, where allethrin is not the only active ingredient,
three were considered suspicious and not considered in this report. 
There were 144 cases classified as low severity, 25 cases classified as
moderate severity, two cases classified as high severity and three cases
were fatal.  All of the high and fatal severity cases were cases of
misuse, four were ingestion of allethrin and the fifth was dermal
contact.

In general, both the IDS and NIOSH SENSOR queries for allethrin resulted
in moderately large numbers of case reports. However, most of these
incidents were of low severity and no patterns or trends were discerned
among the reported cases.  Subsequently, it is not clear human incident
data warrant further analysis for the risk assessment and/or risk
management of allethrin. 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:  Molly Clayton, CRM, Pesticide Re-evaluation Division (7508P) 

IDS Report	 	 	 	 	 	 

Chemical: Allethrin (Bioallethrin)	004004	Human Incidents

 	 	 	 	 	 	 	 	 

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

013098	028	15-Jun-02	OFF! MOSQUITO COIL III	00482200501	RIVER RIDGE	LA
HC	A 49 year old Male slept on the porch all night while the product
burned.  He woke up with Chest Pain. A couple of hours later he started
to pass out. He was taken to the hospital.

013226	042	16-Jul-02	OFF! MOSQUITO COIL III REFILL	00482200501	LITHONIA
GA	HC	A 29 year old Male lit the product on a table near the patient’s
work desk inside a large building that had large open doors on either
end of the building. The business is a sign making shop. The patient had
recently complained of the odor from the product and even attempted to
move it farther away from his desk. The man reported Respiratory Arrest
and had some sort of neurological effect that caused his limbs to draw
up.  He was treated at a health care facility and evaluated by a
physician.

013608	001	21-Oct-02	THERMACELL MOSQUITO REPELLENT	04391700007 071910
ORMOND BEACH	FL	HC	Unknown Adult (18-64 years old) Female, her husband
and son used the product in their hunting tree stand. She washed their
hunting clothes twice and had an allergic reaction.  When the woman's
son wore his hunting clothes again and entered the room she was in she
had another allergic reaction. She reported Itching, Hives, Chest
Tightness, and Difficulty Breathing.

014420	071	30-Aug-03	OFF! MOSQUITO COIL III	00482200501	HONOLULU	HI	HC	A
30 year old Male burned the product outdoors at a friend’s home. He
reported a Headache and Dizziness.

014507	007	03-Sep-03	OFF! MOSQUITO COIL III	00482200501	OXFORD	MI	HC	A
28 year old Male passed out after lighting the product about 12 hours
earlier. Smoke was getting in his face so he sat up and then he fainted.

020097	024	16-Aug-08	OFF! MOSQUITO COIL III	00482200501	CAMDENTON	MO	HC
A 60 year old Female's mother was visiting a neighbor's home. The
neighbors were burning the product throughout the night.  The woman
experiences congestive heart failure whenever she smells or ingests
cinnamon. The woman went to the hospital after reporting Wheezing and
Shortness of Breath that gradually worsened.





IDS Report	 	 	 	 	 	 

Chemical: Allethrin-pynamin forte	004005	Human Incidents

 	 	 	 	 	 	 	 	 

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

013001	001	01-Jan-02	OFF! MOSQUITO LAMP	00482200469	SUWANEE	GA	HD
Unknown Adult (18-64 years old) Female reported that she had placed the
unit on her deck, lit the candle and replaced the cover. Within minutes,
the unit was on fire. There was neither damage nor injuries reported
with this incident. No Symptoms Described.

013003	001	01-Jan-02	OFF! MOSQUITO LAMP	00482200469	DEMING	NM	HD	Unknown
Adult (18-64 years old) Female used the product for about (10) minutes
and suddenly a big flame came out of the top of it. She put it in the
street and poured water on it.  The woman reported burns on her hands. 

013023	001	30-May-02	OFF! MOSQUITO LAMP	00482200469	PALMDALE	CA	HC	A 30
year old Male used the product while camping.  A plastic cooler caught
on fire nearby. The cooler then caught the tire of a mobile home and the
mobile home on fire.  The man attempted to move the cooler away from the
propane tanks of the trailer to prevent explosion and in the process
burned himself on the melted plastic of the cooler. He was taken to the
emergency room to be treated by a physician.

013226	015	03-Jul-02	OFF! HANGING MOSQUITO LANTERN	00482200469	CEDAR
RAPIDS	IA	HC	A 6 year old Female ran into the lantern and it dripped on
her skin.  She reported Bullae/Blisters, Erythema/Flushed, and
Irritation/Pain. 

013226	058	08-Jul-02	OFF! HANGING MOSQUITO LANTERN	00482200469	FISH KILL
NY	HC	A two and a half year old Male Child had 6 lanterns in his yard
for a birthday party.  He walked under one of the lanterns and the wax
dripped down his neck and burned his neck and the top of his back.

013320	014	06-Aug-02	OFF! MOSQUITO LAMP	00482200469	AMELIA	OH	HC	A 27
year old Female used the product.  The flame flickered and popped and
when she went to pick it up it the wax got on her hands.  She reported
Bullae/Blisters and Irritation/Pain.

013320	050	09-Aug-02	OFF! HANGING MOSQUITO LANTERN	00482200469	EAGLE
PASS	TX	HC	Unknown Adult (18-64 years old) Male purchased the product
with the metal poles that stick in the ground. He lit them and let them
burn for a while. Noticed one of them had large flame. Went to blow out,
but was too high to blow from the top. He tipped it a little and wax
came out the bottom and burned his hand. He reported Irritation/Pain.

013047	001	01-Jan-02	OFF! MOSQUITO LAMP	00482200469	MANSFIELD	PA	HD
Unknown Adult (18-64 years old) Male lit the product and was about to
put the top on.  The product blew up and his hands were bloody and
burned.

015690	002	24-Sep-04	OFF! MOSQUITO LAMP	00482200469	EULESS	TX	HC	Unknown
Adult (18-64 years old) Female used the product (9) days ago and sat
outside near it. The fumes were strong.  She reported a Sore Throat
after 1 hour and Laryngitis. 

016426	031	07-Jun-05	OFF! MOSQUITO LAMP	00482200469	NEWTON	MA	HC	A 57
year old Female used the product. Product was on for (20) minutes when
black smoke started to come out the top. She attempted to move the
product and reported ‘2nd degree Burns’ due to the product melting. 


016426	050	29-Jun-05	OFF! HANGING MOSQUITO LANTERN	00482200469	 	VA	HC
Unknown Adult (18-64 years old) Female used the product and later blew
it out and went inside her house where she laid down. She reported
Headache, Chest Pains, and Malaise. 

017710	036	17-Jul-06	OFF! MOSQUITO LAMP	00482200469	MIDLAND	VA	HC	A 73
year old Female used the product (4) days ago.  She reported Loss of
control of Muscles and Balance. 

018827	035	27-Jun-07	OFF! POWERPAD 3 PAD/CANDLE REFILLS	00482200469	EAU
CLAIRE	WI	HC	A 55 year old Female reported Shortness of Breath, and
Coughing/Choking.

020153	026	18-Sep-08	OFF! POWERPAD 3 PAD/CANDLE REFILLS	00482200469
TRINITY	TX	HC	A 74 year old Female reported Coughing, Difficulty
Breathing, and Passed Out.  She was transported by an ambulance to the
emergency room.



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