Document ID: EPA-HQ-OPP-2016-0048-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2016-11-03T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCE

September 7, 2007

MEMORANDUM

SUBJECT:	Review of Butoxypolypropylene glycol (BPG) Incident Reports 

		DP Barcode 338971, PC Code 011901, Decision # 377963

FROM:	Ruth H. Allen, PhD, MPH, Epidemiologist

 		Chemistry and Exposure Branch

		Health Effects Division (7509P)

		Monica Hawkins, M.P.H., Environmental Health Scientist

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

		Hans Allender, Ph.D., Statistician

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

THRU:	David J. Miller, Chief

		Chemistry and Exposure Branch 

		Health Effects Division (7509P)

TO:		Matthew Lloyd, Industrial Hygienist, 

		Reregistration Review Branch (RRB) 1

		Health Effects Division (HED) (7509P)

CC:		Cathryn O’Connell,  Chemical Review Manager, RRB2

		 and

		Tom Myers, Team Leader, RRB2

		Special Review and Reregistration Division (SRRD), (7509-P)

		

USE PROFILE

Butoxypolypropylene glycol PC Code 011901 (BPG) is an insecticide
typically used as a fly repellant in areas that contain animals or as a
direct pet treatment.  It is not formulated in single active ingredient
products, but is often formulated with other active ingredients into a
variety of pesticide products.  Many BPG products also contain with
Pyrethrins (botanicals)/ Pyrethroids (synthetics) and Piperonyl butoxide
(PY/PBO) or other active ingredients (e.g., synthetic pyrethroids). BPG
containing products are registered for use as direct pet treatments,
including horses and in or around large animal premises, e.g., barns. A
number of BPG registered products were voluntarily cancelled in the last
10 years. 

BACKGROUND

To generate this review, the Office of Pesticide Programs (OPP)
consulted the following databases for the poisoning incidents on the
active ingredient BPG.  Because BPG is formulated with other active
ingredients, it is not possible to isolate reported pesticide poisoning
incidents attributable to BPG exposure only.  However, upon request, HED
reviewed the respective incident data systems to qualitatively address
the frequency and severity of the health effects attributed to BPG
containing products.  This report contains several sections and case
summaries: 

1 - Cases reported in the Poison Control Center Database from 1993 to
2005. (None)

2 - Cases reported in the Incident Data System from 1999 to the present.
(3)

3 - Cases reported in NPIC 1999 to present (2)

4 - Recommendations

While each of the pesticide poisoning incident datasets were consulted
in the preparation of this report (See Attachment 1), only those
datasets which allowed provision of some qualitative or anecdotal
information are included in this incident summary report.

INCIDENT REVIEW RESULTS

A brief description of each database used for this incident review is
presented here.

1.	  SEQ CHAPTER \h \r 1 Poison Control Center Data – 1993-2005

Since BPG is not used alone, there are no individual incidents in the
American Association of Poison Control Center (AAPCC) single chemical
database. The PCC database on mixtures is not accessible at this time. 
ITRMD staff did perform a review  of the PCC’s Poisondex listing of
pesticide products (Fall 2006) for product mixtures containing BPG. 
Twelve BPG containing products are represented in both the PCC database
for mixtures and the EPA indident data system (IDS).  While HED is
unable at this time to access the PCC mixtures database and provide a
quantitative analysis of poisoning incidents for different population
sub-groups, one can conclude from this cross-comparison that some of the
products involved in pesticide exposure incidents reported to the EPA
IDS system are also reported to the AAPCC database.  Qualitatively, we
can surmise that there are pesticide incidents reported to AAPCC as a
result of BPG exposure.  

2. 	Incident Data Systems (IDS) (1992 to present)

A review of the Incident Data System (IDS) for the active ingredient BPG
revealed 7 incidents attributed to the chemical.  Most of these
incidents took place between 1996 to 2000 and involved domestic animals,
including lack of efficacy reports, deaths of dogs, and major animal
toxic poisoning requiring emergency medical treatment. 

Since the year 2000, there are a few notable human incidents reported in
IDS.  These incidents reflect BPG’s use in a formulation including
other active ingredient (a mixture) but are included here because the
incident reports relay instances of serious neurotoxic outcomes.  When
reviewing IDS reported incidents, it should be noted that cases are not
necessarily medically confirmed and therefore may be anecdotal in nature
and also that case reports may be missing pertinent details concerning
the exposure circumstances. Some of the products included in this IDS
review may be cancelled or no longer in use at this time (August 2007). 

I 016329-001 (HB-Human Major Incident). In 2002, a woman in Oklahoma was
hospitalized after using Pyranha fly spray on horses (4/30/2002).
Observers reported that her face was distorted and her words were
slurred. She reported leg problems, tremors and, memory problems.
Relevant medical summary on this case was submitted to EPA and reviewed
including a medical toxicology report, medical diagnosis reports, and
lawsuit details.  The medical toxicologists conclusion was that the
patient, a professional horse trainer, developed a complex neurotoxic
movement disorder following sensitization to Pyranha that contains 0.3%
pyrethrins, 0.4% PY/PBO and 33% BPG. According to her medical
toxicologist, she can no longer work at her profession and is at risk of
developing environmental Parkinson’s disease.

I 013785-001 and -002 (HB- Human Major Incidents). In 2003, one alleged
case of wrongful death in Florida attributed to the BPG containing
product Pyranha.  The IDS includes one report of a wrongful death
lawsuit (registrant notified 12/17/02, EPA notified 2/26/03).  A female
was exposed while in a barn when an automatic sprinkler system
containing dilute product containing PY/PBO and BPG was released.  The
exposure event took place in 1983; the individual died in 2000.

b) In another instance, the IDS report includes another case of personal
injury suffered by a woman in Oklahoma (registrant notified 1/24/03, EPA
notified 2 26 03).  The report includes details of  paralysis and
apparent convulsions attributed to BPG product exposure
(unsubstantiated).  This case was reported to IDS as part of a planned
litigation.  No further details were given. This incident is distinct
from the Oklahoma reported incident above (I 016329-001).  

3. 	National Pesticide Information Center NPIC)

Two NPIC information call cases were review and both cases were ranked
“unlikely” by NPIC. 

One case involved suspected poisoning of a pet (dog).   The owner
applied “Mosquito Beater” (naphthalene and BPG), around an outdoor
firepit area.  The pet was potentially exposed over a 2-hour period in
which the pet was allowed to roam unattended in the area containing the
pesticide-treated area.  No immediate, acute effects were observed by
the owner, however at a later time point (not specified in the report)
the dog began displaying symptoms of distress (lack of eating). 
Veterinarian conditionally diagnosed dog with pancreatic cancer or
pancreatitis.  The caller inquired as to whether the exposure to
pesticide product could be a contributing factor.  The NPIC classified
this incident as unlikely related to the suspected exposure.  

In a second case, a man repored use of “Mosquito Beater”
(naphthalene and BPG) and later experienced adverse symptoms.  The
residential applicator reported wearing no gloves or other protective
equipment and did not recall inhaling pesticide dust particiles at the
time of application.  Reported symptoms were vague and included
abdominal stiffness and possible vertigo.  The NPIC classified this
incident as unlikely to be related to BPG product exposure.  

4. Recommendations

Because BPG is formulated with other active ingredients, HED cannot form
conclusions about the incidents attributable to BPG exposure singly. 
HED does not currently have the ability to evaluate pesticide
ingredients that are formulated as mixtures.  In the future, HED may
have the capacity to quantitatively address pesticide poisoning
incidents attributed to mixtures.  



Attachment 1

1) Poison Control Centers – OPP purchases American Association of
Poison Control Center (AAPCC) data covering the years 1993 through 2005
for all reported pesticides incidents.  The last acquisition of data
covering 2004 and 2005 took place in late 2006. Most of the national
Poison Control Centers (PCCs) participate in a national data collection
system called the National Poison Center System (NPCS), previously
called The Toxic Exposure Surveillance System (TESS). 

PCC reports includes 61 centers at hospital and universities that
provide coverage to 100% of the United States population.  Datasets
incorporate an extensive quality assurance process including a
standardized computer-based data collection system.  Some PCCs cover
multiple States; others cover a metropolitan area, or an entire State. 
PCCs provide emergency health care information through telephone
consultation for individual consumers and health care providers
concerning suspected poisonings involving drugs, household products and,
pesticides.  Data collection to aid pesticide regulatory programs is
secondary to this service. 

An elaborate, computer assisted protocol is followed to generate
exposure reports.  Specially trained medical staff record suspected
pesticide poisoning exposures as confirmed, possible, probable, or
definite.  Approximately 50% of database reports include medical
follow-up, in those cases clinical outcomes are determined, i.e., cases
resolved by phone consultation with PCC specialist.  Specialists may
record that patients are seen in health care facility, patients
hospitalized, or patients admitted to Intensive Care Unit (ICU).  PCCs
receive calls 24 hours a day, 7-days a week throughout the entire year,
and they handle non-occupational and occupational calls.  Discussions
are underway to improve collection of OPP-specific occupational data.
Because mainly consumers initiate PCC calls, this database is not
currently a complete source of occupational poisoning incidents.

2) OPP Incident Data System (IDS) This database includes reports of
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.  The IDS has been in existence since 1992. 
Reports submitted to the Incident Data System represent anecdotal
reports or allegations only, unless otherwise stated in this report. 
Typically, OPP does not draw conclusions implicating the pesticide as a
cause of any of the reported health effects.  Nevertheless, sometimes
with enough cases and/or documentation, patterns and risk mitigation
measures may be suggested.

3) California Department of Pesticide Regulation - California has
collected uniform data on suspected pesticide poisonings since 1982. 
Physicians are required, by state statute, to report to their local
health officer all occurrences of illness suspected of being related to
exposure to pesticides.  The majority of the incidents involve workers,
i.e., pesticide applicators or farm workers.  Information on exposure
(worker activity), type of illness (systemic, eye, skin, eye/skin and
respiratory), likelihood of a causal relationship, and number of days
off work and in the hospital are provided.

4) National Institute of Occupational Safety and Health/ Sentinel Event
Notification System for Occupational Risks (NIOSH/SENSOR) performs
standardized surveillance in twelve states from 1998 through 2006. 
States included in this reporting system are Arizona, California,
Florida, Iowa, Louisiana, Michigan, North Carolina, New York, New
Mexico, Oregon, Texas, and Washington. A number of other States can and
do report, periodically and on request for special circumstances,
because they participate in the NIOSH/ SENSOR network as part of the
Council of State and Territorial Epidemiologists (CSTE).  Reporting is
variable from state-to-state because of the dissimilar cooperation from
different sources of reporting (e.g., workers compensation, Poison
Control Centers, emergency departments and hospitals, enforcement
investigations, private physicians, etc.).  Therefore, OPP does not
characterize these reports as estimating the total magnitude of
poisoning for a State.  The focus of NIOSH/SENSOR database is on
occupationally related cases. However, the information collected on each
case is standardized and categorized according to the certainty of the
information collected and the severity of the case. Detailed exposure
circumstances may be available if the State provided follow-up case
reports, as in serious cases ending in death.

National Pesticide Information Center (NPIC)  

NPIC is a hotline and pesticide health effects information service for
the public and health professionals. The service is maintained at Oregon
State University under contract to US EPA, See the NPIC web site at
<http://www.npic.orst.edu>.

6)	Agricultural Health Study (AHS) 

AHS is a long-term prospective epidemiology study of 90,000 certified
pesticide applicators and their spouses from Iowa (IA) and North
Carolina (NC). Both cancers and non-cancer endpoints are being followed
with repeated interviews on lifetime, last 5 years, and current
pesticide use and other farming characteristics. Results for various
disease patterns and for individual chemicals are published and posted
at   HYPERLINK "http://www.aghealth.org"  http://www.aghealth.org .

7)	National Health and Nutrition Examination Survey Data (NHANES) 

BPG was not included in NHANES 3 and NHANES 99+. 

8) 	Literature Study Summary 

A Pub Med search was conducted for any human clinical case reports or
health effects for this chemical. There were no recent results.

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