US Environmental Protection Agency
Office of Pesticide Programs
Reregistration Eligibility
Decision for Polypropylene Glycol
September 25, 2007
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United States Prevention, Pesticides EPA738-R-07-015
Environmental Protection And Toxic Substances September 25, 2007
Agency (7508P)
x°/EPA
Reregistration
Eligibility Decision for
Polypropylene Glycol
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Reregistration Eligibility Decision (RED) Document
for Polypropylene Glycol
ListC
Case No. 3123
Approved by:
Steven Bradbury, Ph.D.
Director
Special Review and Reregistration Division
Date:
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Table of Contents
Summary 7
I. Introduction 8
II. Chemical Overview 9
A. Regulatory History 9
B. Chemical Identification 9
C. BPG Use Profile 11
III. Risk Assessment Summary 12
A. Human Health Risk Assessment 12
1. Toxicity 12
2. Dietary Risk (Drinking Water Only) 15
3. Residential Exposure and Risk 16
4. Aggregate Risk 18
5. Occupational Exposure and Risk 19
B. Ecological Risk Assessment 21
1. Environmental Fate and Transport 21
2. Environmental Effects 22
3. Risk to Aquatic Organisms 22
4. Risks to Birds 23
5. Endangered Species 23
IV. Risk Management and Reregi strati on Decision 24
A. Human Health Risks 24
B. Ecological Risks 25
V. What Registrants Need to Do 25
A. Manufacturing Use Products 26
1. Additional Generic Data Requirements 26
B. End-Use Products 26
1. Additional Product-Specific Data Requirements 26
2. Labeling for End-Use Products 27
Appendices 33
Appendix A. Non-Food/Non-Feed Uses Eligible for Reregi strati on 34
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregi strati on Decision 35
Appendix C. Technical Support Documents 37
Appendix D. Bibliography 38
Appendix E. List of Available Related Documents and Electronically Available Forms
41
Page 3 of 44
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Polypropylene Glycol Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Matthew Lloyd, Risk Assessor
Byong-Han Chin Ph.D., Toxicologist
Toiya Goodlow, Chemist
Environmental Fate and Effects Risk Assessment
Edward Odenkirchen, Ph.D.
Faruque Khan, Ph.D. Senior Physical Scientist
Thuy Nguyen, Risk Assessment Process Leader
Registration Support
Richard Gebken, Product Manager
Ann Sib old
Risk Management
Dirk Helder
Cathryn O'Connell
Page 4 of 44
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Glossary of Terms and Abbreviations
ai
CFR
CSF
DCI
EC
EEC
EPA
EUP
FDA
FIFRA
FFDCA
FQPA
G
GLN
LOC
LOD
LOAEL
mg/kg/day
mg/L
MOE
MRID
MUP
NA
NPDES
NR
NOAEL
NOAEC
OPP
OPPTS
PHED
PHI
ppb
PPE
ppm
RED
REI
RfD
RQ
SAP
SF
SLC
Active Ingredient
Code of Federal Regulations
Confidential Statement of Formula
Data Call-In
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Granular Formulation
Guideline Number
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Master Record Identification (number). EPA's system of recording
and tracking studies submitted.
Manufacturing-Use Product
Not Applicable
National Pollutant Discharge Elimination System
Not Required
No Observed Adverse Effect Level
No Observed Adverse Effect Concentration
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Reregi strati on Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Science Advisory Panel
Safety Factor
Single Layer Clothing
Page 5 of 44
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SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TGAI Technical Grade Active Ingredient
USDA United States Department of Agriculture
USGS United States Geological Survey
UF Uncertainty Factor
UV Ultraviolet
WPS Worker Protection Standard
Page 6 of 44
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Summary
The Environmental Protection Agency (hereafter referred to as "EPA" or "the
Agency") has evaluated the risks from the supported uses of polypropylene glycol and
has determined that no unreasonable adverse effects will result from exposure to
butoxypolypropylene glycol (BPG), the only active ingredient in the polypropylene
glycol case with registered products. The Agency has determined that the products
containing polypropylene glycol are eligible for reregi strati on provided the risk
mitigation measures outlined in this document are adopted and label amendments are
made.
BPG is a repellant that is used to control flying and crawling insects. BPG was
first registered for use in 1960, and can be applied to animals such as pets or horses
directly, or to areas where animals live, like animal housing, bedding, or other areas
animals may occupy. Approximately 300,000 pounds of BPG are sold annually. There
are no food uses, and no uses on animals intended for slaughter.
The Agency conducted a human health risk assessment to estimate the potential
risk from BPG in residential settings. Dietary (drinking water) exposure, residential
handler exposure, and post-application residential exposure were all assessed. In
addition, those activities that could lead to multiple exposures were aggregated. All risks
assessed for residential exposure were below the Agency's level of concern.
The Agency also conducted a risk assessment on the occupational uses of BPG,
including handlers that mix, load, and apply BPG in various ways. Two scenarios for
handlers using liquid concentrate and impregnated wipe products presented potential risk
to handlers when only baseline personal protection equipment (PPE) was assumed. The
addition of chemical-resistant gloves for both scenarios will address these risks, and
results in risk estimates below the Agency's level of concern. Therefore, to address
potential dermal risk concerns for handlers using liquid concentrate product or
impregnated wipe products, chemical resistant gloves are required to be eligible for
reregi strati on.
An ecological effects risk assessment was also conducted for BPG. Due to the
limited potential exposure pathways that BPG could enter the environment, the
assumptions used in the ecological risk assessment are considered to be conservative.
There were some quantitative risk calculation exceedances for some non-target species
based on these conservative assumptions, but there is sufficient information to conclude
that the risks are not of concern.
A summary of the risk mitigation measures that are required for BPG is included
in Table 1.
Page 7 of 44
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Table 1: Summary of Risk Mitigation Measures
Risk of Concern
Dermal risk to
handlers mixing,
loading, and applying
liquid concentrate
products
Dermal risk to
handlers applying
impregnated wipe
products
Mitigation Measure
Require chemical resistant
using liquid concentrates.
Require chemical resistant
wipes.
gloves for mixers, loaders, and applicators
gloves for applicators using impregnated
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
in 1988 to accelerate the reregi strati on of products with active ingredients registered prior
to November 1, 1984, and amended again by the Food Quality Protection Act of 1996
(FQPA) and the Pesticide Registration Improvement Act of 2003 (PRIA) to set time
frames for the issuance of Reregistration Eligibility Decisions. FIFRA calls for the
development and submission of data to support the reregi strati on of an active ingredient,
as well as a review of all data submitted to the U.S. Environmental Protection Agency.
Reregi strati on involves a thorough review of the scientific database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential
risks arising from the currently registered uses of a pesticide, to determine the need for
additional data on health and environmental effects, and to determine whether or not the
pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
This document presents the EPA's reregi strati on and risk management decision
for the registered uses of polypropylene glycol. There are two active ingredients in the
polypropylene glycol case; however, one of these active ingredients has no active
registered products. This chemical, poly(oxy(methyl-l,2-ethanediyl)), alpha-hydro-
omega-hydroxy (PC 068602), has no active registered products, is not being supported,
and is not addressed in this reregi strati on decision. Butoxypolypropylene glycol (PC
011901) is the only active ingredient in the case with active products.
The Agency made its reregi strati on eligibility determination based on the required
data, the current guidelines for conducting acceptable studies to generate such data, and
published scientific literature. The Agency has found that currently registered uses of
polypropylene glycol are eligible for reregi strati on provided the mitigation and labeling
changes outlined in this RED are implemented.
Page 8 of 44
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II. Chemical Overview
A. Regulatory History
There are 2 active ingredients in reregi strati on case 3123 for polypropylene glycol
as listed in Table 2. This RED evaluates the only active ingredient in this case with
currently registered products; therefore, only butoxypolypropylene glycol (BPG), PC
Code 011901 was assessed. The other active ingredient in this case has no product
registrations and is not being supported for reregi strati on. This active ingredient would
be evaluated only if and when new registration applications were to be submitted for new
products.
Table 2: Ingredients in the Polypropylene Glycol Chemical Case (3123)
PC Code
068602
011901
Chemical Name
Poly (oxy(methyl- 1,2-
ethanediyl)), alpha-hydro-omega-
hydroxy
Alpha-Butyl-omega-
Hydroxypoly(oxy (methyl- 1 ,2-
ethanediyl)
[BPG]
CAS
Number
25322-69-4
9003-13-8
Status
Last pesticide product cancelled October 10, 1989.
Not supported for reregistration.
57 active products as of September, 2007.
Being supported for reregistration.
BPG was first registered by FMC in 1960. Bayer Environmental Science (BES)
is currently the sole technical registrant.
B. Chemical Identification
The nomenclature of BPG is in Table 3, and the physicochemical properties are
listed in Table 4.
Page 9 of 44
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Table 3: Butoxypolypropylene Glycol (BPG) Nomenclature
Chemical Structure
Chemical Name
IUPAC Name
Common name
CAS Registry Number
Molecular Formula
Chemical Class
,,
K't ;••»•
i! 'I.
^ f-
1
' M ! ' [ s > f • • s ' ^ 1 t
Lh ^.h\ •;,, ju>l/ *M^J|fh"- t-i
R = CH3 CH2 CH2 CH2
n = 1 8 (average)
m=0
alpha-butyl-omega-hydroxy-poly-oxy (methyl- 1 ,2-ethanediyl)
1 -( 1 -butoxypropan-2-yloxy)propan-2-ol
Butoxypolypropylene
Glycol (BPG)
9003-13-8
(C3H60)nC4H100
Repellent
Table 4: Physicochemical Properties of BPG
Parameter
Molecular Weight
Melting point/range
Density
Boiling point
Solvent solubility (temperature not
specified)
Vapor pressure (25°C)
Dissociation constant, pKa
Octanol/water partition coefficient,
logPow (25°C)
UV/visible absorption spectrum
Value
1119.58
None; turns to a glass at -43° C
0.989 at 20 °C
None; BPG starts to decompose at ~
250 °C
Soluble in acetone, n-butanol,
cyclohexane, butyl ether, ethylene
dichloride, heptane, isopropanol,
methanol, petroleum ether, toluene.
Insoluble in diethylene glycol,
ethylene glycol, glycerol, propylene
glycol, water.
2.81xlO"27mmHg
Not known. BPG is essentially a
high molecular weight alcohol. The
alcohol portion should have a
dissociation constant similar to
other secondary alcohols.
Not known. BPG will exist
primarily in the octanol phase.
Reference
Ecological Risk Assessment,
D338965, 8/21/07
MRID 42541403
MRID 42541403
MRID 4254 1403
MRID 4254 1403
Ecological Risk Assessment,
D338966
MRID 4254 1403
MRID 4254 1403
Not available
Page 10 of 44
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C. BPG Use Profile
Type of Pesticide:
Summary of Use:
Target Organisms:
Mode of Action:
Repellent
Insect control for companion and equine animals, applied both to
animals directly (on-animal), and to areas where animals live (off-
animal). The on-animal products are sold for equine and
companion animals. The off-animal products can be applied as a
space spray in animal housings and other areas where animals live.
There are no food uses, and no uses on animals intended for
slaughter.
BPG is included in EPA's approved Inerts List 3, "Inerts of
Unknown Toxicity." The Agency continues to evaluate substances
on List 3 and, as additional information becomes available,
determine if reclassification is appropriate.
BPG also has an FDA-regulated pharmaceutical use as a diluent in
defoamers used in the pulping of lignocellulosic materials that will
be used to make food-contact paper and paperboard. Use of BPG
may not exceed 8 grams per metric ton of dry pulp (0.0008%).
BPG is also a manufacturing ingredient marketed as UCON™
Fluid LB-250. It is sold by DOW Chemical Company to
formulators who use it as a sole lubricant or mix it with other
fluids as a base to their own lubricant. DOW's UCON™ base
stocks are polyalkylene glycols (PAGs), which are polymers of
ethylene oxide and propylene oxide.
Deer flies, face flies, gnats, horn flies, horse flies, house flies,
mosquitoes, stable flies, chiggers, lice, ticks, army worm, bot flies,
wasps, fleas, biting flies, chiggers (bed bugs), ants, and roaches.
Repel biting insects that are a nuisance to animals listed above.
The mode of action is not known.
Use Classification: General Use
Formulation Type:
Emulsifiable concentrate (EC) and a variety of ready-to-use (RTU)
formulations. BPG is never used as the sole active ingredient in a
product, but is often formulated with pyrethrins, piperonyl
butoxide, and pyrethroids.
Page 11 of 44
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Application Methods: Aerosol sprays, emulsifiable and soluble concentrate, ready-to-use
liquids (trigger spray, roll-on, gels/ointments), solids (repellent
stick), and impregnated materials (wipes).
Application Rates: Rates vary depending upon the exposure scenario and the number
of animals or the use-site treated.
Usage: Approximately 300,000 pounds of BPG are sold annually.
III. Risk Assessment Summary
The following is a summary of EPA's human health and ecological risk findings
and conclusions for BPG, as presented fully in the Health Effects Division document,
Butoxypolypropylene Glycol: Revised HED Chapter of the Reregistration Eligibility
Decision Document, ( Lloyd, September 2007), and the Environmental Fate and Effects
Division documents, EFED RED Chapter for Butoxy Polypropyleneglycol,
(Odenkirchen, September 2007) and Drinking Water Assessment for the Reregistration
Eligibility Document for butoxypolypropylene glycol, (Khan, August 2007).
A. Human Health Risk Assessment
The Agency has conducted a human health risk assessment for BPG for the
purposes of making a reregi strati on eligibility decision. The Agency evaluated the
toxicology, product and residue chemistry, and occupational/residential exposure studies
submitted and determined that the data are adequate to support a reregi strati on decision.
However, a 28-day oral toxicity study (OPPTS 870.3050) is required to more accurately
assess the potential risks resulting from repeated oral exposure and to confirm the
determination presented here. A summary of the human health risk assessment findings
and conclusions are provided below.
1. Toxicity
BPG is not acutely toxic via the oral or dermal route of exposure, and it is a minor
eye and skin irritant (Category III). Acute inhalation data on technical grade BPG are not
available but a formulation of BPG (Pyrenone®7.5-0.75 Stabilene®53% E.C.; end use
product) is not acutely toxic via the inhalation route of exposure. See Table 5 below.
Table 5: Acute Toxicity Profile - Butoxypolypropylene Glycol Technical
Guideline
No.
870.1100
870.1200
Study Type
Acute Oral -rat
Acute Dermal -
rabbit
MRID#
41884504
41884503
Results
LD50 >5000 mg/kg
LD50 > 2000 mg/kg
Toxicity
Category
IV
III
Page 12 of 44
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Table 5: Acute Toxicity Profile - Butoxypolypropylene Glycol Technical
Guideline
No.
870.1300
870.2400
870.2500
Study Type
Acute Inhalation -
Rat
Primary Eye
Irritation - Rabbit
Primary Skin
Irritation - Rabbit
MRID#
00071332
41884501
41884502
Results
LC50 > 2.62 mg/L
A minor eye irritant
A minor dermal irritant
Toxicity
Category
IV a
III
III
a Tested material was a BPG formulation (EPA Reg # 432-1060) which consisted of BPG (53%), piperonyl
butoxide (7.5%) and pyrethrins (0.75%).
The toxicity database for repeat exposures to BPG is limited to two dermal rat
studies. In the 90-day rat dermal toxicity study, the toxicity effects of decreased body-
weight gain and food efficiency and alterations in hematological parameters, were
observed at the systemic LOAEL of 4000 mg/kg/day. Clinical signs of skin irritation,
including scaling and cracking, were observed at the limit dose of 1000 mg/kg/day. In
the dermal developmental toxicity study in rats, decreased body-weight gain was
observed at a dose level greater than the limit dose of 1000 mg/kg/day. No
developmental toxicity was observed at the highest dose tested (4000 mg/kg/day).
Since there was no appropriate oral study with repeat dosing available, a material
balance study in rats was used to calculate the oral point of departure based on the dermal
endpoint selected for BPG. To convert a dermal NOAEL to an oral NOAEL, the Agency
used a material balance study that showed 12% of BPG was absorbed dermally.
Converting the dermal NOAEL of 1000 mg/kg/day to the oral equivalent produces a
NOAEL of 120 mg/kg/day [1,000 x (0.12) = 120 mg/kg/day].
Given that the BPG database also does not contain an acceptable route-specific
inhalation study, the systemic inhalation toxicity is assumed to be equivalent to the oral
NOAEL of 120 mg/kg/day.
Carcinogenicity
Mutagenicity tests, both in vivo and in vitro, were negative for BPG. There are
no carcinogens that are structurally related to BPG based on a structure-activity
relationship (SAR) analysis. Based on the current use pattern and registered non-food
uses for BPG, a carcinogenicity study is not required.
A point of departure is the data point or an estimated point that is derived from
observed dose-response data and used to mark the beginning of extrapolation to
determine risk associated with lower environmentally relevant human exposures. Table 6
contains selected points of departure for the human risk assessments.
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Table 6: Summary of Toxicological Doses and Endpoints for BPG Use in Human Risk Assessments
Exposure
Scenario
Acute Dietary
(general
population
including
infants and
children)
Chronic
Dietary
(all
populations)
Incidental
Oral Short-
and
Intermediate-
Terms
Dermal
Short- and
Intermediate-
Terms
Inhalation
Short- and
Intermediate-
Terms
Cancer
Classification
Point of
Departure
(POD)
NOAEL of 120
mg/kg/day
Oral equivalent
NOAEL= 120
mg/kg/day
(a)
NOAEL= 1000
mg/kg/day
Oral equivalent
NOAEL= 120
mg/kg/day
(a)
NOAEL= 1000
mg/kg/day
Oral equivalent
NOAEL= 120
mg/kg/day
(a)
NOAEL= 1000
mg/kg/day
Oral equivalent
NOAEL= 120
mg/kg/day
(b)
Uncertainty
Factors
LTFA=10X
LTFH=10X
LTFA=10X
LTFH=10X
UFA-10X
LTFH=10X
RfD, Level of
Concern for
Risk
Assessment
aRfD=1.2
mg/kg/day
cRfD=1.2
mg/kg/day
Residential and
Occupational LOG
forMOE=100
Study and Toxicological Effects
No appropriate endpoint attributable to a single
exposure (dose) was identified for an acute dietary
(drinking water) endpoint. Therefore, the Agency
used the short-term incidental oral endpoint
(NOAEL of 120 mg/kg/day).
90- day dermal toxicity study in rats
LOAEL= 4000 mg/kg/day based on reduced body
weight gain and changes in hematological
parameters.
90- day dermal toxicity study in rats;
Same as for chronic reference dose (cRfD)
BPG is non-mutagenic in vivo and in vitro. There are no carcinogens that are structurally related to BPG.
(a) Since a dermal study was selected, 12% dermal bioavailability was used to calculate oral equivalents. To
convert dermal NOAEL to oral NOAEL multiply dermal NOAEL by 0.12. That is, to convert from dermal
NOAEL of 1000 mg/kg/day, the oral equivalent NOAEL = (1,000) x (0.12) = 120 mg/kg/day.
(b) The systemic inhalation toxicity is assumed to be equivalent to the oral systemic toxicity for the purposes of
this assessment; no inhalation absorption data are available.
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty
factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity
among members of the human population (intraspecies). RfD = reference dose. MOE = margin of exposure.
LOG = level of concern.
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2. Dietary Risk (Drinking Water Only)
There are no registered food or feed uses for BPG; therefore, a food-related
dietary risk assessment is not necessary and has not been conducted. However, since
BPG products are used outdoors in animal quarters/stables and for outdoor animal
applications to horses and other animals, the risk assessment considered drinking water
exposures from surface water sources.
Acute and chronic drinking water risk assessments were performed using the
Dietary Exposure Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID™, Version 2.03), which uses food consumption data from the USDA's
Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.
An Estimated Drinking Water Concentration (EDWC) point estimate value was
calculated with EPISUITE (v.3.20) using the limit of solubility for BPG of 0.000193
mg/L. Since the use patterns of BPG are limited to animal applications and indoor areas,
the Agency did not use the typical agricultural modeling approach with PRZM/EXAMS.
The acute and chronic dietary assessment incorporates both exposure to and
dietary toxicity of BPG, although the Agency believes that chronic exposure is unlikely
from current use patterns. No appropriate endpoint attributable to a single exposure
(dose) was identified for an acute dietary (drinking water) endpoint. Therefore, the
Agency used a material balance study to extrapolate the dermal NOAEL of 1000
mg/kg/day from the 90-day dermal rat study (sub-chronic exposure) to the oral equivalent
producing a NOAEL of 120 mg/kg/day [1,000 x (0.12) = 120 mg/kg/day]. This is a
conservative surrogate for the acute dietary endpoint because the endpoint was selected
from the sub chronic toxicity study rather than an acute toxicity study.
The chronic dietary endpoint was based on the same NOAEL from the 90-day
dermal toxicity study in rats. This is a conservative surrogate for the chronic dietary
endpoint because the toxicity (reduced body-weight gain and food efficiency and
alterations in hematology parameters) occurred throughout the study and the body weight
effects lessened with time of exposure.
An uncertainty factor of 100 (10X for inter-species extrapolation and 10X for
intra-species variation) was applied to the NOAEL. The acute Reference Dose (aRfD) is
the dose an individual could be exposed to in one day and no adverse health effects
would be expected. The chronic Reference Dose (cRfD) is the dose at which an
individual could be exposed over the course of a lifetime and no adverse health effects
would be expected. The aRfD and cRfD were both calculated as 120 mg/kg/day -MOO =
1.2 mg/kg/day. Risk is expressed as a percentage of the aRfD or cRfD. A risk estimate
less than 100% of the aRfD or cRfD does not exceed the Agency's level of concern.
Dietary risk estimates were calculated for the general U.S. population and various
population subgroups as shown in Table 7. BPG acute and chronic dietary (drinking
water) exposure estimates for the U.S. population (<0.1% of the aRfD and cRfD) and for
Page 15 of 44
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the most highly exposed population subgroups, all infants (<0.1% of the aRfD and
cRfD), are below the Agency's level of concern.
Table 7: Summary of Drinking Water Exposure and Risk for BPG
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Acute Dietary
(95th Percentile)
Dietary Exposure
(mg/kg/day)
0.000005
0.000034
% aRfD*
0.1%
0.1%
Chronic Dietary
Dietary
Exposure
(mg/kg/day)
0.000002
0.000012
% cRfD*
0.1%
0.1%
* RfD = reference dose; a = acute, c = chronic
3. Residential Exposure and Risk
For more detail on the residential exposure and risk assessment, see the
Butoxypolypropylene Glycol: Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision., (Lloyd, August 2007).
Non-cancer risk estimates are expressed as a margin of exposure (MOE) which is
a ratio of the dose from a toxicological study selected for risk assessment, typically a
NOAEL, to the predicted exposure. Estimated MOEs are compared to a level of concern
which reflects the dose selected for risk assessment and uncertainty factors (UFs) applied
to that dose. The standard UF is 100X which includes 10X for interspecies extrapolation
(to account for differences between laboratory animals and humans) and 10X for
intraspecies variation (to account for differences between humans). For BPG, MOEs
greater than 100 for incidental oral exposure, inhalation exposure, and dermal exposure
do not exceed the Agency's level of concern.
a. Residential Handler Exposure and Risk
BPG can be used in the residential setting (on-animals and their bedding). Given
that BPG is designed to repel biting insects (flies, gnats, mosquitoes), short- and
intermediate-term (1-6 months) exposures are assessed due to the occasional nature of
applications by homeowners. The Agency assessed inhalation and dermal exposure for
the following residential handler scenarios:
Mixer/Loader/Applicators:
1) Liquid: Low Pressure Handwand Sprayers;
2) Liquid: Sponge Applications to Horses;
3) Ready-To-Use Liquids: Pour-on;
4) Ready-To-Use Wipe Applications;
5) Ready-To-Use Trigger Pump Sprayer Applications;
6) Ready-To-Use Aerosol Cans to Outdoor Surfaces and Pets;
Page 16 of 44
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7) Applying Crack and Crevice Treatment with Aerosol Cans (inhalation
exposure only was assessed for this scenario because no dermal exposure is
expected).
All residential handler risk estimates are below the Agency's level of concern; all
of the MOEs are greater than 100. MOEs for residential handlers range from about 300
to greater than 10,000.
b. Residential Post-Application Exposure and Risk
Residential post-application exposures could occur when bystanders, such as
children, come in contact with BPG in areas where end-use products have recently been
applied. Contact with treated pets and pet bedding are two common examples of post-
application exposures.
The following scenarios were evaluated for post-application exposures to BPG:
1) Hand-to-mouth activity for toddlers on carpeted indoor surfaces (used as a
surrogate for pet bedding) treated with BPG
2) Dermal exposure for toddlers and adults to carpeted indoor surfaces (surrogate
for contact with pet bedding) treated with BPG
3) Dermal exposure for toddlers after exposure with BPG-treated pets (pet "hug"
scenario)
4) Hand-to-mouth activity for toddlers after contact with BPG treated pets
No post application inhalation assessment has been conducted for aerosol product
applications; the residential handler inhalation assessment is protective of post
application inhalation risks because the exposures to handlers in those scenarios are
expected to be significantly greater. There are no residential post-application risk
estimates of concern to the Agency; all of the MOEs are greater than 100. MOEs for
residential post-application risk range from 105 to 2,400. The MOE of 105 represents
risk estimated for toddler dermal post-application exposure from treated pets. The
residue levels which were used to calculate toddler exposure were determined using a 5
minute rubbing/petting technique that leads to concentrations of residue on the hands that
would be expected to be higher than would result from a single contact with a treated pet.
Since common toxicity endpoints (reduced body weight gain/alterations of
hematology parameters) were used to calculate dermal and inhalation risks for each
exposure duration, the Agency calculated the combined risk from two of the BPG post-
application exposure scenarios. These two scenarios could potentially expose toddlers
through different routes of exposure to BPG simultaneously based on the nature of the
use-pattern and the behavior of toddlers. The combined risks from dermal and oral
exposure in (1) a pet "hug" scenario and (2) a pet bedding/quarters scenario do not
present potential post-application risks of concern to toddlers (MOEs are 180 and 101
respectively). This toddler scenario is protective of the general population exposed.
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4. Aggregate Risk
In an aggregate assessment, exposures from relevant sources are added together
and compared to quantitative estimates of hazard (e.g., a NOAEL), or the risks
themselves can be aggregated. When aggregating exposures and risks from various
sources, the Agency considers both the route (oral, dermal, and inhalation) and duration
(short-, intermediate-, or long-term) of exposure. Acute, intermediate, and chronic
aggregate risk assessments are not conducted based on the use patterns of BPG.
The Food and Drug Administration (FDA) has approved and regulates the use of
BPG as a defoaming agent used in the manufacture of paper and paperboard. Any
additional exposure from this use would likely be negligible. Therefore, non-pesticide
uses of BPG have not been included in the aggregate risk assessment.
Infants and Children
For residential exposure, three children subpopulation groups were examined: all
infants (<1 year) who showed the highest exposure to BPG in drinking water, and
children 1-2 and 3-5 years old who might exhibit hand-to-mouth behaviors. Residential
handler inhalation exposures were aggregated for adults (residential handlers) but infants
and children are not likely to apply BPG products, or likely be exposed to BPG through
the inhalation route for the same reason. The highest dermal and oral exposure
contribution for children and infants is from the pet-hug scenario. The pet-hug scenario
assumes a child embraces a family dog after the pet has been treated with a BPG product
once per day. Conservative water exposure values were again included in the aggregate
risk assessment. The aggregate MOEs for all infant and children populations are all 101,
which is above an MOE of 100 and below EPA's level of concern.
Adult
The short-term aggregate risk assessment for adults combines handler and post-
application scenarios. For residential aggregate risk, an application of liquids via sponge
was used to estimate the dermal and inhalation exposure contribution of the aggregate
risk because the scenario was demonstrated to have the highest exposure for both routes
among the scenarios chosen. Adults do not exhibit the hand-to-mouth behaviors that
infants and children do and no oral exposure is assumed for the adult population.
Conservative water exposure values were used in the aggregate risk assessment as well.
The aggregate MOE for adults is 315, which is above an MOE of 100 and below EPA's
level of concern. Table 8 summarizes the short-term aggregate risk calculations.
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Table 8: Summary of Short-Term Aggregate Risk Calculations
Population
General
population
[adult]
All infants <1
year old
Children 1-2
years old
Children 3 -5
years old
Short-Term Scenarios
LOC for
Aggregate
Risk
100
100
100
100
MOE
water
(exposure in mg/kg/day)
60,000,000
(0.000002)
10,000,000
(0.000012)
60,000,000
(0.000002)
60,000,000
(0.000002)
MOE
oral
(exposure in
nig/kg/day)
N/A
2,400
(0.051)
2,400
(0.051)
2,400
(0.051)
MOE
dermal
(exposure in
nig/kg/day)
340
(2.9)
105
(9.48)
105
(9.48)
105
(9.48)
MOE
inhalation
(exposure in
nig/kg/day)
4,200
(0.029)
N/A
N/A
N/A
Aggregate MOE
(water and
residential)1
315
101
101
101
N/A -Exposures through identified route are not expected for the given population or subgroup.
1 Aggregate MOE (food and residential) = l/[(l/MOEwater) + (1/MOE oral) + (1/MOE dermal) + (1/MOE
inhalation)]]
5. Occupational Exposure and Risk
For more detail on the occupational assessment, see the Butoxypolypropylene
Glycol: Occupational and Residential Exposure Assessment for the Reregistration
Eligibility Decision., (Lloyd, August 2007).
Workers can be exposed to BPG through mixing, loading, applying a pesticide, or
re-entering treated sites. Different from the residential risk assessment for handlers, the
occupational risk assessment assumes a professional handles a much greater amount of
pesticide than a residential user. Occupational handlers of BPG who are likely to be
exposed include mixers, loaders, and applicators. Occupational risk for all of these
potentially exposed populations is measured by the MOE. An MOE > 100 has been
determined to be adequately protective for both short-term (1 to 30 days) and
intermediate-term (1 to 6 months) exposures for BPG handlers based on the standard
uncertainty factors of 10X for interspecies extrapolation and 10X for intraspecies
variability. Long-term worker exposure to BPG is not expected.
BPG dermal and inhalation exposure was estimated using the Pesticide Handlers
Exposure Database (PHED), Chemical Manufactures Association (CMA) data, and
proprietary data. The quantitative exposure/risk assessment developed for occupational
handlers is based on the following scenarios:
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Mixer/Loader/Applicators:
1) Liquid: Low Pressure Handwand Sprayer;
2) Ready-To-Use Liquid: Pour On Applications;
3) Applying Wipe Applications;
4) Ready-To-Use: Trigger Pump Sprayer Applications;
5) Applying with Aerosol Cans.
All worker scenarios were assumed to be short- and intermediate-term in
exposure durations (i.e., 1-30 days and 1-6 months). Since both toxicity endpoints
selected for the short- and intermediate-term risk assessment are the same, the risk
estimates are also the same.
Table 9 summarizes the combined short-/intermediate risks at different levels of
personal protection. Baseline PPE includes long-sleeve shirt and long pants only, while
single layer protection adds chemical resistant gloves. For most scenarios, risks are
below the Agency's level of concern (i.e., the MOEs are greater than 100). Two
occupational scenarios shown below have short- and intermediate-term dermal risks that
exceed the Agency's level of concern (i.e., the MOEs are less than 100) for handlers at
baseline PPE:
• Mixing/Loading/Applying Liquids with Low Pressure Handwand for Horses
• Applying Formulations via Wipe
However, with the addition of chemical-resistant gloves risks for both scenarios are
below the Agency's level of concern.
Table 9: Short- and Intermediate-Term Combined MOEs for Handlers
Exposure Scenario
Animal or
Site
Application
Rate
(Ib ai/acre)
Use/
Day
MOEat
Baseline PPE*
MOEat
Baseline PPE
+ gloves
Mixer/Loader/Applicator (M/L/A)
Mix/Load/Apply Emulsifiable
Concentrates with Low Pressure
Hand Wand
Applying Ready to Use
Formulations via Pour-on (using
PHED mix/load liquid)
Livestock
buildings/animal
premises
animal: dogs,
cats
animal: horses,
livestock
animal: horses
0.04 Ibs
ai/gallon
0.036 Ibs
ai/animal
0.036 Ibs
ai/animal
0.036 Ibs
ai/animal
40 gallons
16
animals
400
animals
400
animals
440
1,200
Dermal: 49
Inhalation: 29,000
1,700
NA**
NA
Dermal: 11,000
Inhalation: 29,000
NA
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Table 9: Short- and Intermediate-Term Combined MOEs for Handlers
Exposure Scenario
Applying Formulations via Wipe
(CMA data)
Applying Ready to Use
Formulations via Trigger-Pump
Sprayer (using Propoxur Trigger
Pump study)
Applying with Aerosol Cans
Animal or
Site
animal: horses
indoor surfaces
animal: horses,
foals
outdoor surfaces
and/or space
spray
Application
Rate
(Ib ai/acre)
0.036 Ibs
ai/animal
0.036 Ibs
ai/gallon
0.036 Ibs
ai/animal
0.33 Ib ai/16 oz
can
Use/
Day
8 animals
2 gallons
400
animals
Four 16
oz bottles
MOEat
Baseline PPE*
Dermal: 85
Inhalation: 1,600
68,000
340
260
MOEat
Baseline PPE
+ gloves
Dermal: 850
Inhalation: 1,600
NA
NA
NA
* MOEs less than 100 are identified in bold font.
** NA is "not assessed", since baseline risks do not exceed EPA's level of concern.
Post-Application Occupational Risk
The Agency does not believe there are any scenarios that are significant
contributors to occupational post application exposure. Therefore, no post application
scenarios have been assessed. Dermal and inhalation exposures for occupational handlers
are not likely to occur from the registered uses of BPG. In addition, inhalation exposures
for the post-application scenarios would account for a negligible percentage of the overall
body burden if calculated. This is particularly true for BPG, which has a negligible vapor
pressure at 25°C.
B. Ecological Risk Assessment
The Agency has conducted an environmental fate and effects risk assessment for
BPG for the purpose of making a reregi strati on decision. The Agency evaluated
environmental fate and ecological studies submitted for BPG, and along with quantitative
structure activity relationship modeling has determined that the data are adequate to
support a reregi strati on decision.
A summary of the environmental risk assessment findings and conclusions is
provided below. For more detail on the ecological exposure and risk assessment, see the
EFED RED Chapter for Butoxy Polypropyleneglycol, (Odenkirchen, September 2007).
For more information on the drinking water assessment see the Drinking Water
Assessment for the Reregistration Eligibility Document for butoxypolypropylene glycol,
(Khan, August 2007).
1. Environmental Fate and Transport
No guideline data have been submitted to the Agency that allow for an empirical
assessment of the biotic and abiotic degradation processes for BPG. To address this lack
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of data, the risk assessment used output from the EPISUITE v 3.20 model. The following
predictions from the EPISUITE v 3.20 model output can be made for BPG:
• The compound will not volatilize (estimated vapor pressure 2.81 x 10"27mm Hg at
25 °C).
• The compound will readily adsorb to organic carbon (estimated log Koc 9.643).
• There is a low probability for biodegradation.
• There is limited potential for bioconcentration (estimated BCF 86).
2. Environmental Effects
a. Ecological Risk Estimation
To estimate potential ecological risk, EPA integrated the results of exposure and
ecotoxicity studies using the risk quotient method. Risk quotients (RQs) are calculated
by dividing exposure estimates by ecotoxicity values, both acute and chronic, for various
wildlife species. RQs are then compared to the Agency's levels of concern (LOCs).
Generally, the higher the RQ, the greater the potential risk. Risk characterization
provides further information on the likelihood of adverse effects occurring by considering
the fate of the chemical in the environment, communities and species potentially at risk,
their spatial and temporal distributions, and the nature of the effects observed in studies.
The majority of BPG use sites are considered to be indoors, and it is unlikely
these use sites would significantly contribute to an outdoor exposure to the environment.
However, there are animal applications for which application may occur outdoors and for
which pathways to outdoor environments may exist. Animal applications are primarily
on horses as insect repellent for biting insects that are a nuisance, such as horse flies, deer
flies, horn fly, house fly, mosquitoes and gnats. Cats and dogs may also be treated
directly.
For the purposes of the ecological risk assessment, treatment of horses is
considered to be the most conservative application in terms of mass applied, opportunity
for wildlife interaction, and opportunity for introduction of material to surface waters
through wash-off. In the case of BPG, potential ecological organisms that could be
affected would include freshwater and estuarine/marine vertebrates and invertebrates,
aquatic plants, and birds gleaning parasites from treated livestock. Mammals, reptiles,
terrestrial amphibians and terrestrial plants are not considered as it is assumed that no
exposure pathways exist for these organisms from the registered uses of BPG.
3. Risk to Aquatic Organisms
There was little empirical information on the toxicity of BPG to aquatic
organisms. Data are available to show low acute toxicity to freshwater fish and
freshwater invertebrates. Gaps in the effects data were addressed through the application
of quantitative structure activity relationships (QSAR) usingthe ECOSAR v0.99h model
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to predict effects endpoints for chronic freshwater fish and invertebrates, as well as acute
and chronic marine/estuarine fish, acute and chronic marine/estuarine invertebrates and
aquatic plants.
The only aquatic RQ values exceeding Agency levels of concern levels are for
estuarine/marine invertebrates, with an acute RQ of 0.15 (LOG for acute risks to listed
aquatic species is 0.05) and a chronic RQ of 1.6 (LOG for chronic risks to listed aquatic
species is 1.0). Although the LOCs are exceeded in the screening level risk assessment,
these findings are considered to be extremely conservative. This is due to the very high
application rate assumed (26 applications per year), the assumption that all material is
washed from treated animals, that all material reaches a water body (despite the expected
high affinity for soils), that all the material exists in water at a concentration orders of
magnitude above estimated solubility limit, and that the concentration in water is
unaffected by potential partitioning to sediment.
Given that the RQ values are just above screening levels of concern and the
expectation that any departure from the conservative exposure assumptions would
significantly lower estimated water concentrations, EPA believes there is sufficient
information to conclude acute and chronic risks to estuarine/marine invertebrates do not
exceed EPA's level of concern.
4. Risks to Birds
Three studies of acute effects on birds were available. Using TREX v 1.3.1
terrestrial risk assessment model, the available data were scaled to calculate LD50 values
for different sizes of birds. The scaled LDSOs for birds range from >1620 mg/kg for
small 20 gram birds, to >2914 mg/kg for larger 1000 gram birds.
There are potential exceedances for listed small birds weighing 20 g (RQ is <9)
and for birds of the 100 g weight class (RQ is <1.4). The LOG for listed terrestrial
species is 0.1. It is important to note that there is considerable uncertainty in both the
exposure and effects inputs to this RQ calculation. The exposure estimate represents a
very conservative assumption that the entire mass of pesticide applied to a horse is
bioavailable to birds consuming arthropod parasites on the livestock. Because of the
large size of the BPG molecule and its low vapor pressure, gleaning birds would most
likely be exposed through ingestion of the arthropod pests on which BPG is incidentally
applied.
Comparing potential concentrations of BPG on insects, which range from 3800
mg/kg for small insects to 400 mg/kg for large insects, to the dietary acute toxicity
endpoints, that are essentially levels demonstrated to have no effects in two tested species
at the no observed adverse effects concentration (NOAEC) of 5620 mg/kg-diet, suggests
that the dietary route is of minimal significance for birds. EPA therefore concludes that
there is sufficient information to refute the hypothesis of adverse effects in birds
periodically feeding on treated livestock.
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5. Endangered Species
The Endangered Species Act required federal agencies to ensure that their actions
are not likely to jeopardize listed species or adversely modify designated critical habitats.
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on federally listed endangered and
threatened species, and to implement mitigation measures that address these impacts. To
assess the potential of registered pesticide uses that may affect any particular species,
EPA puts basic toxicity and exposure data developed for the REDs into context for
individual listed species and considers ecological parameters, pesticide use information,
the geographic relationship between specific pesticide uses and species locations and
biological requirements and behavioral aspects of the particular species. When
conducted, these analyses take into consideration any regulatory changes recommended
in the RED being implemented at that time. A determination that there is a likelihood of
potential effects to a listed species may result in limitations on the use of the pesticide,
other measures to mitigate any potential effects, and/or consultations with the Fish and
Wildlife Service or National Marine Fisheries Service, as necessary. If the Agency
determines use of BPG "may affect" listed species or their designated critical habitat,
EPA will employ the provisions in the Services regulations (50 CFR Part 402).
IV. Risk Management and Reregistration Decision
The Agency has determined that butoxypolypropylene glycol is eligible for
reregi strati on provided that the risk mitigation measures and label amendments specified
in this RED are implemented. The following Table 10 provides a summary of the
measures for managing risks associated with the use of butoxypolypropylene glycol.
Table 10: Summary of Risk Mitigation Measures
Risk of Concern
Dermal risk to
occupational handlers
mixing, loading, and
applying liquid
concentrate products
Dermal risk to
occupational handlers
applying impregnated
wipe products
Mitigation Measure
Require chemical resistant
using liquid concentrates.
Require chemical resistant
wipes.
gloves for mixers, loaders, and applicators
gloves for applicators using impregnated
A. Human Health Risks
Residential
The Agency conducted human health risk assessments for dietary (drinking water)
exposure, residential handlers and post-application residential exposure, and aggregated
those activities that could lead to multiple exposures. All potential risks were below the
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Agency's level of concern. Therefore, no risk mitigation is needed for residential uses of
BPG.
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Occupational
The Agency conducted a risk assessment on the occupational uses of BPG,
including handlers that mix, load, and apply BPG in various ways. Two scenarios
presented potential risk to handlers. The first scenario presented potential dermal risk
concerns for mixers and loaders wearing baseline personal protection equipment (PPE)
handling liquid soluble concentrations for application to horses and livestock. The
addition of chemical resistant gloves will address this risk, and results in risk estimates
below the Agency's level of concern. Therefore, to address potential dermal risk
concerns for mixers, loaders, and applicators handling liquid soluble concentrate product,
chemical resistant gloves are required.
The second scenario of potential concern is for handlers applying BPG using
impregnated wipes. Applicators wearing baseline PPE would have potential dermal risk
concerns. With the addition of chemical resistant gloves, the risk is below the Agency's
level of concern. Therefore, to address potential dermal risk concerns for applicators
handling impregnated wipe products, chemical resistant gloves are required.
B. Ecological Risks
Ecological Risks
From the screening level ecological risk assessment, the only RQ values above
Agency concern levels are for birds and estuarine/marine invertebrates. Therefore, for all
other evaluated taxa, risks do not exceed EPA's levels of concern and no mitigation is
required.
For smaller birds in the 20 and 100 gram weight class, further evaluation of the
most likely route of exposure (dietary) provides additional information that leads to a
conclusion of no risks of concern. Similarly for estuarine/marine invertebrates, the
conservative exposure assumptions and the slight exceedance of risk quotients above
Agency concern levels suggests that risks to these species are overestimated in the
screening-level assessment. There is sufficient information to conclude that the actual
risks are not of concern. Therefore, no risk mitigation is necessary to address ecological
risks.
V. What Registrants Need to Do
The Agency has determined that the products containing butoxypolypropylene
glycol (PC 011901) are eligible for reregi strati on provided that the mitigation measures
and label changes identified in this RED are implemented. Registrants will need to
amend their product labeling to incorporate the label statements set forth in the Label
Changes Summary Table 11. The Agency intends to issue Data Call-Ins (DCIs) requiring
generic- and product-specific data. Generally, the registrant will have 90 days from
receipt of a DCI to complete and submit response forms or request time extensions and/or
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waivers with a full written justification. For product-specific data, the registrant will
have eight months to submit data and amended labels.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of BPG for currently
registered uses has been reviewed and determined to be substantially complete.
However, the guideline requirement listed below is necessary to confirm the
reregistration eligibility decision documented in this RED.
Guideline Number: OPPTS 870.3050
The 28-day oral toxicity study is required for BPG because there are no repeat
exposure oral toxicity studies on BPG, and incidental oral exposures are possible via
exposure from its use on companion animals in residential settings. Since there are no
repeated exposure (route-specific) studies, the Agency selected the endpoint and
equivalent oral point of departure from the 90-day dermal toxicity study in rats.
The available data on BPG consists of acute oral, dermal, and inhalation data, a
90-day dermal toxicity study, and a dermal developmental toxicity study in rats. The
Agency made a reasonable assumption that the oral route is not more toxic than the
dermal route; that the dermal absorption rate is 12%, based on the material balance study
in rats, and converted the dermal NOAEL to an oral NOAEL.
Submission of the 28-day oral toxicity study will allow the Agency to more
accurately assess the potential risks resulting from repeated oral exposure. The oral
toxicity data can help in refining incidental oral risk assessments, and assist in the
effective management of health risks from drinking water and/or residential oral
exposures. The registrant has agreed to conduct this 28-day oral toxicity study for BPG.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticide after a determination of eligibility has been made.
The Registrant must review previous data submissions to ensure that they meet current
EPA acceptance criteria and if not, commit to conduct new studies. If a registrant
believes that previously submitted data meet current testing standards, then the study
MRID numbers should be cited according to the instructions in the Requirement Status
and Registrants Response Form provided for each product. The Agency intends to issue
a separate product-specific Data Call-In (PDCI), outlining specific data requirements
including the ones listed below. For any questions regarding the PDCI, please contact
Veronica Dutch at (703) 308-8585.
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Guideline: 810 Product Performance Test Guidelines
Efficacy data are required for all products that are registered for use to repel
public health pests. BPG is registered to repel a number of pests that require this type of
data, including: Deer flies, gnats, horse flies, house flies, bot flies, horn flies, mosquitoes,
stable flies, chiggers, lice, ticks, wasps, fleas, biting flies, chiggers, bed bugs, ants (only
for claims for fire ants, harvester ants, pharoah ants), and roaches.
Additional information on the efficacy data can be found in the Series 810
Product Performance Test Guidelines on the Agency's website.
(http ://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/810_Product_Performan
ce_Test_Guidelines/index.html)
Guideline: OPPTS 870.7200
Because BPG is registered for use on animals, the companion animal study
(OPPTS 870.7200) is required in both cats and dogs. The companion animal study is
required to see if there is an adequate margin of safety for use on both dogs and cats.
The most likely exposure scenario for dogs and cats is dermal exposure. In the
absence of the companion animal safety data, the Agency makes an assumption that BPG
is not toxic to pets based on the results from laboratory dermal studies in the rat, where
no systemic toxicity was observed at the limit dose (1000 mg/kg/day) and no
developmental toxicity was observed at 4000 mg/kg/day.
A companion animal study in cats and dogs will provide information on the
possible health hazards to companion animals. If the companion animal safety study
shows toxicity to pets, changes to the product labeling may be needed.
The submission of companion animal safety study would provide necessary data
to determine if an adequate margin of safety exists for the companion animal when the
products are used according to the product labeling. The general public will benefit if the
Agency can more accurately assess the potential risks to companion animals.
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement
measures outlined in Section IV. Specific language required to incorporate these changes
is provided in Table 11.
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Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.
The following table describes how language on the labels should be amended.
Table 11: Summary of Labeling Changes for Butoxypolypropylene Glycol (PC 011901)
" ^'Description'": y _',
Amended Labeling Language for. Manufacturing Use' Products-
Placement on Label
For all Manufacturing
Use Products
"Only for formulation into a repellent for the following use(s) [fill blank only
with those uses that are being supported by MP registrant]."
Directions for Use
One of these statements
may be added to a label
to allow reformulation
of the product for a
specific use or all
additional uses
supported by a
formulator or user
group
"This product may be used to formulate products for specific use(s) not listed on
the MP label if the formulator, user group, or grower has complied with U.S.
EPA submission requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not
listed on the MP label if the formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required
by the RED and
Agency Label Policies
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or other waters unless in accordance with the requirements of
a National Pollution Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
Precautionary Statements
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End Use Products Intended &r Occupational Use
PPE Requirements
Established by the
RED1
For Liquid Concentrate
Formulations
(including emulsifiable
or soluble
concentrates)
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant
inserts correct chemical-resistant material). "If you want more options, follow
the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an
EPA chemical-resistance category selection chart."
"Mixers, loaders, applicators, and other handlers must wear:
> Long-sleeved shirt and long pants,
> Shoes plus socks, and
> Chemical-resistant gloves."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
PPE Requirements
Established by the
RED1
For All Ready-To-Use
Formulations
(including pour-ons,
repellent sticks, roll-
ons, trigger sprayers,
aerosol sprayers)
except impregnated
wipes
"Personal Protective Equipment (PPE)"
"Applicators, and other handlers must wear:
> Long-sleeved shirt and long pants, and
> Shoes plus socks."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
PPE Requirements
Established by the
RED1
For Impregnated Wipe
Formulations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant
inserts correct chemical-resistant material). "If you want more options, follow
the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an
EPA chemical-resistance category selection chart."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
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"Applicators, and other handlers must wear:
> Long-sleeved shirt and long pants,
> Shoes plus socks, and
> Chemical-resistant gloves."
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. jf no sucn
instructions for washables exist, use detergent and hot water. Keep and wash
PPE separately from other laundry."
Precautionary Statements:
Hazards to Humans and
Domestic Animals immediately
following the PPE requirements
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco,
or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing.
Users should remove PPE immediately after handling this product. Wash the
outside of gloves before removing. As soon as possible, wash thoroughly and
change into clean clothing."
Precautionary Statements under:
Hazards to Humans and
Domestic Animals immediately
following Engineering Controls
(Must be placed in a box.)
Environmental Hazards
Statement
"ENVIRONMENTAL HAZARDS"
"Do not contaminate water when disposing of equipment, washwater, or rinsate.
See Directions for Use for additional precautions and requirements."
For indoor products packaged in containers equal to or greater than 5 gallons or
50 Ibs add the following statement:
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or other waters unless in accordance with the requirements of
Precautionary Statements
immediately following the User
Safety Recommendations
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a National Pollution Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
Entry Restrictions for
liquid concentration or
liquid ready-to-use
products labeled for
premises or bedding
use
"When used on animal premises or bedding, do not enter or allow others to enter
until sprays have dried."
Directions for Use Under General
Precautions and Restrictions
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area
during application."
Direction for Use
Other Application
Restrictions
All products:
"Not for use on meat or dairy animals, poultry, horses or foals intended for
slaughter."
"Not for use in farm structures or buildings housing food producing animals or
poultry, or in milk rooms."
All products applied as a spray:
"Only spray in a well ventilated area."
"Do not spray product when food is present."
For products applied to pets or animals:
"Do not allow product to contact animal's eyes, nose, mouth, or sores during
application."
"Do not use on foals, puppies or kittens under 12 weeks old."
For products applied to pet or other animal premises:
"Remove pets or animals when spraying animal premises."
Directions for Use
Page 32 of 44
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Other Application
Restrictions
All application rates must be stated on product labels that are consistent with the
rates supported in Appendix A.
All rates must be expressed in terms the applicator can use in order to arrive at
the maximum application rate. For example, for sprays to animals the duration
of the spray must be included (e.g., 3 seconds per side; 6 sides).
Directions for Use
-. -, -. -, -. -, -. -, -. -, -. -, -. -, -. -, -.End Use Products Intended ftsr Residential Use -. -, -. -, -. -,
Application
Restrictions
"Do not apply this product in a way that will contact any person, pet*, either
directly or through drift. Keep people and pets* out of the area during
application."
* Note: For products with direct pet uses, delete the reference to pets on these
statements.
Directions for Use under General
Precautions and Restrictions
Entry Restrictions for
end-use products with
directions for use on
animal premises
"When used on animal premises or bedding, do not allow people or pets* to
enter the treated area until sprays have dried."
* Note: For products with direct pet uses, delete the reference to pets on these
statements.
Directions for use under General
Precautions and Restrictions
Other Application
Restrictions
The application restrictions listed above for occupational use products also apply
to residential use products.
Directions for Use
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document.
The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
Page 3 3 of 44
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Appendices
Page 34 of 44
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Appendix A. Non-Food/Non-Feed Uses Eligible
for Reregistration
Butoxypolypropylene glycol (011901)
Case No. 3123
Use Site
AGRICULTURAL/
FARM PREMISES
ANIMAL
KENNELS/SLEEPIN
G QUARTERS
(COMMERCIAL)
DOGS/CANINES
(ADULTS/PUPPIES)
CATS
(ADULTS/KITTENS)
HORSES
(SHOW/RACE/SPECI
AL/PONIES)
PET
LIVING/SLEEPING
QUARTERS
Form
Code
EC
RTU
EC, PRL
RTU
PRL,
RTU,
Wipes
PRL,
RTU
EC, PRL,
RTU,
Wipes
PRL,
RTU
Max.App
Rate/App
0.04
0.33
0.04
0.036
0.036
0.036
0.036
0.036
Unit
Ib ai/gal
Ib ai/ 16
oz. can
Ib ai/gal
Ib ai/gal
Ib
ai/animal
Ib
ai/animal
Ib
ai/animal
Ib
ai/gallon
Minimum
Re-
treatment
Interval
(days)
NS
NS
o
5
o
3
i
NS
Limitations
Do not apply to plant foliage.
Not for use in farm structures or buildings
housing food producing animals or poultry,
or in milk rooms.
Remove or carefully protect food products
and food packaging. Remove animals prior
to treatment. Do not apply to plant foliage.
Not for use in farm structures or buildings
housing food producing animals or poultry,
or in milk rooms.
Do not treat animals under 12 weeks of
age. Do not apply to humans.
Do not allow product to contact animal's
eyes, nose, mouth, or sores during
application.
Do not treat animals under 12 weeks of
age. Do not apply to humans. Do not allow
product to contact animal's eyes, nose,
mouth, or sores during application.
Remove animals prior to treatment. Do not
apply to plant foliage. Do not treat animals
under 6 weeks of age. Remove feed and
water prior to treatment.
Not for use on meat or dairy animals,
poultry, horses or foals intended for
slaughter. Do not allow product to contact
animal's eyes, nose, mouth, or sores during
application.
Remove food and animals from premises
prior to treatment.
Not for use in farm structures or buildings
housing food producing animals or poultry,
or in milk rooms.
NS: Not Specified
EC: Emulsifiable Concentrate
PRL: Pressurized Liquid
RTU: Ready to Use
Page 35 of 44
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Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision
GUIDE TO APPENDIX B
Appendix B contains a listing of data requirements which support the
reregi strati on for active ingredients within the dodine case covered by this RED. It
contains generic data requirements that apply dodine in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR 158. The reference numbers accompanying each
test refer to the test protocols set in the Pesticide Assessment Guidance, which is
available from the National Technical Information Service, 5285 Port Royal
Road, Springfield, VA 22161. (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given
use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number is no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
Page 36 of 44
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Data Requirement
. Itot
Guideline
Number
Old
Guideline
Number
Description
Use
Pattern
Citations
PRODUCT CHEMISTRY
830.7200
830.7220
830.7300
830.7370
830.7550
830.7840
63-5
63-6
63-7
63-10
63-11
63-8
Melting Point
Boiling Point/boiling range
Density
Dissociation Constants in Water
Partition coefficient, shake flask
method
Solubility
All
All
All
All
All
All
42541403
42541403
42541403
42541403
42541403
42541403
ECOLOGICAL EFFECTS
850.2200
850.1075
850.1010
71-2
72-1
72-2
Avian Dietary Toxicity
Acute Toxicity to Freshwater Fish
Acute Toxicity to Freshwater
Invertebrates
C,K
C,K
C,K
43117501,43117502
42753302
42753301
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.3050
870.3250
870.3700A
870.4100B
870.5265
870.5395
870.5900
Special Study
81-1
81-2
81-3
81-4
81-5
None
82-3
83-3A
83-1B
None
84-2
84-2
None
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Skin Irritation
Repeated Dose 28-day Oral
Toxicity Study in Rodents
90-Day Dermal Toxicity - Rat
Developmental Toxicity - Rat
Chronic Feeding Toxicity Study -
Non-rodent
Microbial Gene Mutation (Ames
assay)
In Vitro Mammalian Cytogenetics
Tests
Sister Chromatid Exchange (SCE)
Material Balance Study in Rats
All
All
All
All
All
K
All
All
All
All
All
All
All
41884504
41884503
00071332
41884501
41884502
DATA GAP
42269901
42815501
00081467
41886202
41886201
41886203
43349901
OTHER
Special Study
Special Study
Special Study
None
None
None
Trigger Spray Study - Inhalation
and Dermal Exposure
Wipe and Sponge Application Data
- Inhalation and Dermal Exposure
Handler Application Data -
Inhalation and Dermal Exposure
All
All
All
41054701 (Propoxur)
Chemical Manufacturers
Association (CMA) Data
ORETF Chemical Handlers
Exposure Studies
Page 37 of 44
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP
docket, EPA-HQ-OPP-2007-1090.
It is open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site: www.epa.gov/pes1icides/reregistra1ion
These documents include:
HEP Document:
Butoxypolypropylene Glycol: Revised HED Chapter of the Reregi strati on Eligibility
Decision Document (RED). Lloyd, M., et al. D338969, September 2007.
Butoxypolypropylene Glycol: Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision. Lloyd, M. D338970, August 27, 2007.
EFED Document:
EFED RED Chapter for Butoxy Polypropyleneglycol. Odenkirchen, E. D338964,
September 2007.
Drinking Water Assessment for the Reregistration Eligibility Document for
butoxypolypropylene glycol. Khan, F. D338965. August 21, 2007.
Page 3 8 of 44
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Appendix D. Bibliography
MRID
71332
81467
41054701
41884501
41884502
41884503
41884504
41886201
41886202
41886203
42269901
42541403
42753301
42753302
42815501
Citation Reference
Freeman, J.J.; Robbins, G.R. (1980) Acute Inhalation Toxicity Study in Rats: C.S.E.
Study #0454C. (Unpublished study received Jan 9, 1981 under 4816-538; prepared
by Cosmopolitan Safety Evalua- tion, Inc., submitted by Fairfield American Corp.,
Medina, N.Y.; CDL244170-A)
Weil, C.S.; Palm, P.E. (1958) Special Report on One Year of Oral Doses of Crag Fly
Repellent to Dogs: Report 21-24. (Unpublished study received Jan 6, 1968 under
8F0694; prepared by Univ. of Pittsburgh, Mellon Institute of Industrial Research,
Industrial Fellowship, submitted by Union Carbide Corp., New York, N.Y.;
CDL091203-D)
Knarr, R. (1988) Exposure of Applicators to Propoxur During Trigger Pum Spray
Application of a Liquid Product: 99100. Unpublished study prepared by Mobay Corp.
195 p.
Myers, R.; Christopher, S. (1991) Stabilene Fly Repellent: Primary Eye Irritancy
Study in the Rabbit: Lab Project Number: 53-160. Unpublished study prepared by
Bushy Run Research Center. 22 p.
Myers, R.; Christopher, S. (1991) Stabilene Fly Repellent: Primary Skin Irritancy
Study in the Rabbit: Lab Project Number: 53-159. Unpublished study prepared by
Bushy Run Research Center. 21 p.
Myers, R.; Christopher, S. (1991) Stabilene Fly Repellent: Acute Percutaneous
Toxicity Study in the Rabbit: Lab Project Number: 53-158. Unpublished study
prepared by Bushy Run Research Center. 21 p.
Myers, R.; Christopher, S. (1991) Stabilene Fly Repellent: Acute Peroral Toxicity
Study in the Rat: Lab Project Number: 53-157. Unpublished study prepared by
Bushy Run Research Center. 21 p.
Vergnes, J.; Morabit, E. (1991) Stabilene Fly Repellent: Determination of in vivo
Clastogenic Potential Using the Micronucleus Test wth Swiss-Webster Mice: Lab
Project Number: 54-4. Unpublished study prepared by Bushy Run Research Center
(Union Carbide). 45 p.
Vergens, J.; Morabit, E. (1991) Stabilene Fly Repellent: Determina- tion of
Mutagenic Potential in the Salmonella/Microsome (Ames) Assay: Lab Project
Number: 53-153. Unpublished study prepared by Bushy Run Research Center
(Union Carbide). 42 p.
Vergnes, J.; Morabit, E. (1991) Stabilene Fly Repellent: Determina- tion of Chemical
Effects Upon Sister Chromatid Exchanges in Cultured Chinese Hamster Ovary
Cells: Lab Project No: 53-163. Unpublished study prepared by Bushy Run Research
Center (Union Carbide). 41 p.
Wagner, C.; Loughran, K.; Gill, M. (1992) Stabilene Fly Repellent: Ninety-Day
Repeated Cutaneous Dose Toxicity Study in Fischer 344 Rats: Lab Project Number:
54-96. Unpublished study prepared by Bushy Run research Center. 468 p.
Matlock, P. (1989) Stabilene Fly Repellant: Product Chemistry Data (1987): ?Series
63|. Unpublished study prepared by Union Carbide Corp. 5 p.
Waggy, G. (1993) Acute Toxicity of Stabilene Fly Repellent to Daphnia magna: Lab
Project Number: 93010802: 302. Unpublished study prepared by Union Carbide
Technical Center. 25 p.
Waggy, G. (1993) Acute Toxicity of Stabilene Fly Repellent to Pimephales promelas
(fathead minnows): Lab Project Number: 93010801: 301. Unpublished study
prepared by Union Carbide Technical Center. 26 p.
Neeper-Bradley, T.; Kubena, M. (1993) STABILENE Fly Repellent: Developmental
Toxicity Study of Cutaneous Administration in CD (Sprague-Dawley) Rats: Lab
Project Number: 91U0029. Unpublished study prepared by Bushy Run Research
Center, Union Carbide Chemicals and Plastics Co. Inc. 446 p.
Page 3 9 of 44
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43117501 Campbell, S.; Beavers, J. (1994) Stabilene: A Dietary LC50 Study with the Mallard:
Lab Project Number: 142-145. Unpublished study prepared by Wildlife International
Ltd. 17 p.
43117502 Campbell, S.; Beavers, J. (1994) Stabilene: A Dietary LC50 Study with the Northern
Bobwhite: Lab Project Number: 142-144. Unpublished study prepared by Wildlife
International Ltd. 18 p.
43349901 Morris, E.; Beskitt, J. (1994) STABILENE Fly Repellent: Material Balance Study
Following Oral and Cutaneous Administration to Female Sprague Dawley Rats:
Revised Report: Lab Project Number: 92U1076 REVISED. Unpublished study
prepared by Bushy Run Research Center. 105 p.
References
Chemical Manufacturers Association (CMA) Antimicrobial Exposure Assessment Study.
W. Popendorf, et al. December 1992.
Exposure of Applicators to Propoxur During Trigger Pump Spray Application of a Liquid
Product: 99100. MRID 410547-01. R. Knarr. (1988).
Fletcher, J.S., I.E. Nellesson and T. G. Pfleeger. 1994. Literature review and evaluation
of the EPA food-chain(Kenaga) nomogram, an instrument for estimating pesticide
residues on plants. Environ. Tox. And Chem. 13(9): 1383-1391.
Hazard Characterization Section for the Reregi strati on Eligibility Decision. Byong-Han
Chin, Ph.D. D338972. August 27, 2007.
Measurement of Air Concentration, Dermal Exposure, and Deposition of Pyrethrin and
Piperonyl Butoxide Following the Use of an Aerosol Spray. MRID 461886-18.
S. Selim. (2002).
Permethrin: Third Revision of the Occupational and Residential Exposure Assessment for
the Reregi strati on Eligibility Decision Document, D325428. April 4, 2006.
USEPA.
Rutgers University, New Jersey Agricultural Experiment Station, Cooperative research
and Extension. Horse pasture management, Best management Practices.
http ://njaes.rutgers.edu/horsepastures/past_mgt.htm May 21, 2007.
Spencer, E.Y. Guide to the Chemicals Used in Crop Protection. 6th ed. Publication 1093,
Research Institute, Agriculture Canada, Ottawa, Canada: Information Canada,
1973., p. 58
Standard Operating Procedures (SOPs) for Residential Exposure Assessments. Contract
No. 68-W6-0030. Work Assignment No. 3385.102. Prepared by The Residential
Exposure Assessment Work Group. Office of Pesticide Programs, Health Effects
Division and Versar, Inc. December 1997. [Revised Feb.22, 2001;]
Page 40 of 44
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The Samuel Roberts Noble Foundation. Horse Forage and Forage Management.
http://www.noble.org/ag/forage/horseforage/page2.html May 22, 2007.
U.S. EPA Guidelines For Exposure Assessment, U.S. EPA; Federal Register Volume 57,
Number 104; May 29, 1992).
U. S. EPA. Pesticide Handler Exposure Database (PHED) Version 1.1. Office of
Pesticide Programs. August 1998.
Use Closure Memorandum for Butoxypolypropylene Glycol, Case 3123, (Polypropylene
Glycol). May 24, 2007. USEPA.
USEPA. 1993. Wildlife Exposure Factors Handbook. Volume I of II. EPA/600/R-
93/187a. Office of Research and Development, Washington, D. C. 20460.
Virginia Polytechnical Institute and State University, Virginia Cooperative Extension.
Maintaining Healthy Horse Pastures, http://www.ext.vt.edu/pubs/horse/418-
105/418-105.pdf May 22, 2007.
Page 41 of 44
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Appendix E. List of Available Related Documents and Electronically Available
Forms
Pesticide Registration Forms are available via the Agency's website at
http://www.epa. gov/opprdOOl/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed).
2. The completed form(s) should be submitted in hard copy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at Williams.nicole(a),epa.gov.
The following Agency Pesticide Registration Forms are currently available via the Internet at the
following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution
of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (PR
Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical Properties (PR
Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www. epa.sov/opprdOOl /forms/8 5 70-4. pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www. epa.sov/opprdOOl/forms/85 70-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www. epa.sov/opprdOOl/forms/85 70-32. pdf
http://www. epa.sov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-l.pdf
Page 42 of 44
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Pesticide Registration Kit http://www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which
contains the following pertinent forms and information needed to register a pesticide
product with the U.S. Environmental Protection Agency's Office of Pesticide Programs
(OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection
Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PRNotices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader).
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR §156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR § 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
Page 43 of 44
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1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States," PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161-0002
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does
charge a fee for subscriptions and custom searches. You can contact NPIRS by
telephone at (765) 494-6614 or through their website.
4. The National Pesticide Information Center (NPIC) can provide information on active
ingredients, uses, toxicology and chemistry of pesticides. You can contact NPIC by
telephone at (800) 858-7378 or through their website at http://www.nets.orst.edu.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
• Date of receipt;
• EPA identifying number; and
• Product Manager assignment.
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying file symbol or petition number for the
new submission. The identifying number should be used whenever you contact the
Agency concerning an application for registration, experimental use permit, or tolerance
petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and
trade names, company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a chemical abstract system (CAS) number if one has
been assigned.
Page 44 of 44
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