Document ID: EPA-HQ-OPP-2010-0920-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-12-22T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460      

	OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION

	

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date: August 10, 2010

SUBJECT:	Prodiamine: Review of Human Incidents

PC Code: 110201 	DP Barcode: D380376

Decision No.: 437368	Registration No.: NA

Petition No.: NA	Regulatory Action: NA

Risk Assessment Type: NA	Case No.: NA

TXR No.: NA	CAS No.: 29091-21-2 

MRID No.: NA	40 CFR: NA

		              									Ver.Apr.08

	          	

FROM:	Karlyn Middleton, Toxicologist 

		Shanna Recore, Industrial Hygienist

		Khin Oo, M.D., MPH, Environmental Health Scientist

		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)

			

TO: 		Rebecca Daiss, Risk Assessor

		Risk Assessment Branch IV 

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

			and				  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 

		Barbara Briscoe, RM 52

		Risk Management & Implementation Branch II

		Pesticide Re-evaluation Division (7508P)

CONCLUSION 

Based on the low frequency of incident cases, 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.

II.	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 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. 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. 

III.	BACKGROUND		

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) database were consulted
for pesticide incident data on the active ingredient prodiamine (PC Code
128901). Additionally, the Agency is looking to include findings from
the Agricultural Health Study (AHS), beginning with the problem
formulation phase of registration review.  The purpose of the database
searches is to identify potential patterns on the extent and severity of
the health effects attributed to prodiamine exposure.  The 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 compiles these reports in IDS.  IDS contain 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.  The NIOSH
SENSOR database covers 12 states from 1998-2006, 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.  Although both occupational
and non-occupational incidents are included in the database, SENSOR
focuses on occupational pesticide incidents, and is of particular value
in providing that information.  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.  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.  

IV. RESULTS/DISCUSSION

IDS records incidents of generally high severity in more detail, in
software which we call the main Incident Data System.  This system
stores incident data for death, major and moderate incidents, and it
includes more details about the location, date and nature of the
incident.  The less severe human incidents are reported by registrants
as counts we call aggregate summaries and recorded in separate software.
  For IDS aggregate summaries, from 2000 to May 25, 2010 there are 27
cases reported for prodiamine.  Because it falls within the categories
reported as counts (which includes minor, unknown or no effects), there
is no unique report that provides details about the incident and single
chemical incidents are not distinguished from multiple chemical
incidents. For the main IDS from 2000 to May 25, 2010, there were seven
cases reported for the single chemical prodiamine only.  Of these cases,
six were moderate incidents and one was a major incident.  The health
effects reported for the moderate incidents included: skin effects
(itchiness, swelling, rash, and tingling/numbness),
dizziness/lightheadedness, drowsiness, shaking, and muscle
spasms/ataxia.  For the major incident, the health effect reported was
shortness of breath.

For NIOSH SENSOR from 1998 to 2007, we identified two cases reported
that involve the active ingredient prodiamine.  Of these cases, one was
reviewed because, in this case, prodiamine was used as a single chemical
only and had a certainty classification of definite, probable, or
possible.  A 50 year old male was exposed to prodiamine when it soaked
through his personal protective equipment.  He experienced dermal
symptoms.  

Prodiamine is not included in the AHS, and therefore not considered in
this report. 

Based on the low frequency of incident cases, 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.



IDS Report	 	 	 	 	 	 

Chemical: Prodiamine 110201	 	Human Incidents	 	 

 	 	 	 	 	 	 	 	 

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

015709	009	01-Oct-04	BARRICADE	 	SEBASTOPOL	CA	HC	Adult (18-64 year
old) female reported that she experienced symptoms after the product was
applied around her apartment.  Detailed information was not available.

015709	010	06-Oct-04	BARRICADE MC	00010000868	SEBASTOPOL	CA	HC	Adult
(18-64 year old) female reported that the product was sprayed outside
her home a week ago.  She developed dizziness, drowsiness, tremors,
muscle spasms and ataxia. Symptoms worsened over the following 3 days. 
She was given muscle relaxant at the ER. Symptoms recurred when she
inhaled product odor in her home (lower level).  She was seeking clean
up advice.

017338	022	14-Mar-06	UNKNOWN PRODUCT	 	PITTSBURGH	PA	HC	Adult (18-64
year old) male reported that he developed dizziness and lightheadedness
after applying the product.  He received treatment from the ER.

017614	029	25-May-06	BARRICADE 4 FL HERBICIDE	00010001139	 	NC	HC	A
physician assistant reported that a 28 year old male developed tingling
and numbness on his arms and legs while applying the product, later he
had red itchy rashes.  He took a shower and oral Benadryl.  The next
morning he had same symptoms and headache.  He was given prednisone and
Benadryl in the ER.  He was using this product for the past 5 years
without the problem on the golf course.  But for the past week he had
suffered from these symptoms, taking Benadryl made him better, but the
symptoms were recurring.

018158	015	21-Oct-06	BARRICADE 4 FL HERBICIDE	00010001139	CLERMONT	FL	HB
Caller reported that his friend adult (18-64 year old), male developed
shortness of breath while playing golf, he was admitted to the hospital
and intubated.  He had a history of asthma; but playing golf for many
years on this golf course without any problem.  He stated that the
product was sprayed on the golf course last week

019218	027	08-Nov-07	PRODIAMINE (UNSPECIFIED)	 	STAMFORD	CT	HC	Adult
(18-64 year old) male developed a rash, swelling and itchiness of hands,
feet and face after applying the product. He received treatment from his
doctor.

020866	060	01-Mar-09	BARRICADE MC HERBICIDE	00010000868	 	 	HC	No
symptoms mentioned

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