United States Prevention, Pesticides EPA738-R-97-009
Environmental Protection And Toxic Substances August 1997
Agency (7508W)
4»EPA Re registration
Eligibility Decision (RED)
PROPOXUR
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case propoxur. The
enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the
data base of this chemical, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It may also include requirements for additional
data (generic) on the active ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses is due 90 days from the
receipt of this letter. The second set of required responses is due 8 months from the date
of receipt of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Bonnie Adler (703) 308-8523.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be accompanied
by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria.
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d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
PROPOXUR
LISTB
CASE 2555
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
PROPOXUR REREGISTRATION ELIGIBILITY DECISION TEAM i
ABSTRACT v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 3
D. Data Requirements 4
E. Regulatory History 4
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity 8
c. Chronic toxicity and Carcinogenicity 10
d. Developmental Toxicity 14
f. Mutagenicity 16
g. Metabolism 18
h. Dermal Absorption 19
i. Incident Information 20
j. Toxicological Endpoints of Concern Identified for Use in Risk
Assessment 21
(1) Dietary Exposure 21
(2) Occupational and Residential Exposures 21
k. Reference Dose 22
1. Carcinogenicity Classification and Risk Quantification . . 23
2. Exposure Assessment 24
a. Dietary Exposure 24
b. Occupational and Residential Exposure Assessment 24
(1) Applicator Exposure 25
(2) Post-application/Residential Exposure 29
3. Risk Assessment 32
a. Dietary 32
b. Occupational and Residential Risk Characterization .... 33
4. Food Quality Protection Act (FQPA) Considerations 35
C. Environmental Assessment 41
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1. Ecological Toxicity Data 41
a. Toxicity to Terrestrial Animals 42
b. Toxicity to Aquatic Animals 45
2. Environmental Fate 47
a. Environmental Fate Assessment 47
b. Environmental Fate and Transport 48
3. Exposure and Risk Characterization 50
a. Ecological Exposure and Risk Characterization 50
b. Environmental Risk Characterization 52
c. Exposure and Risk to Nontarget Terrestrial Animals .... 52
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 55
A. Determination of Eligibility 55
B. Determination of Eligibility Decision 55
1. Eligibility Decision 55
2. Eligible and Ineligible Uses 56
C. Regulatory Position 56
1. Food Quality Protection Act Findings 56
2. Worker Risk/Cancer 58
3. Endocrine Disrupter Effects 58
4. Tolerances 58
5. Occupational and Residential Labeling Rationale/Risk Mitigation
58
6. Ecological Effects 60
a. Avian and Mammalian Risks 60
b. Aquatic Invertebrates 60
c. Endangered Species Statement 60
V. ACTIONS REQUIRED OF REGISTRANTS 61
A. Manufacturing-Use Products 61
1. Additional Generic Data Requirements 61
2. Labeling Requirements for Manufacturing-Use Products 61
B. End-Use Products 62
1. Additional Product-Specific Data Requirements 62
2. Labeling Requirements for End-Use Products 62
C. Existing Stocks 64
VI. APPENDICES 65
APPENDIX A. Table of Use Patterns Subject to Reregistration 66
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 75
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Propoxur 81
APPENDIX D. Product Specific Data Call-in 93
Attachment 1. Chemical Status Sheets 106
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Attachment 2
Attachment 3
Attachment 4
Attachment 5
Attachment 6
APPENDIX E.
Product Specific Data Call-in Response Forms (Form A)
Plus Instructions 107
Product Specific Requirement Status and Registrant's
Response Forms (Form B) and Instructions .... Ill
EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 119
List of All Registrants Sent This Data Call-in (insert)
Notice 127
Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions ... 129
List of Available Related Documents 135
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PROPOXUR REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Dave Brassard
Ed Brandt
Wilfred Burr
Biological Analysis Branch
Economic Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Kathy Monk
Joanne Edwards
Nelson Thurman
Health Effects Risk Assessment
Tom Myers
Christine Olinger
Byron Backus
David Jacquith
Registration Support
Dennis Edwards
Meredith Johnson
Tina Levine
Risk Management
Kathy Davis
Bonnie Adler
Margaret Rice
Science Analysis and Coordination Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Reregistration Support Chemistry Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Reregistration Branch III
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
pg/g Micrograms Per Gram
Mg/L Micrograms per liter
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
N/A Not Applicable
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*j The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP Wettable Powder
WPS Worker Protection Standard
IV
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ABSTRACT
EPA has completed its reregistration eligibility decision for the pesticide propoxur and
determined that all uses, when labeled and used as specified in this document, are eligible for
reregistration. This decision includes a comprehensive reassessment of the required target data
base supporting the use patterns of currently registered products. This decision considered the
requirements of the "Food Quality Protection Act of 1996" (FQPA) which amended the Federal
Food Drug and Cosmetic Act and the Federal Insecticide Fungicide and Rodenticide Act, the two
Federal statutes that provide the framework for pesticide regulation in the United States. FQPA
became effective immediately upon signature and all reregistration eligibility decisions (REDs)
signed subsequent to August 3, 1996 are accordingly being evaluated under the new standards
imposed by FQPA.
In establishing or reassessing tolerances, FQPA requires the Agency to consider aggregate
exposures to pesticide residues, including all anticipated dietary exposures and other exposures
for which there is reliable information, as well as the potential for cumulative effects from a
pesticide and other compounds with a common mechanism of toxicity. The Act further directs
EPA to consider the potential for increased susceptibility of infants and children to the toxic
effects of pesticide residues, and to develop a screening program to determine whether pesticides
produce endocrine disrupting effects.
Propoxur is a carbamate insecticide used by homeowners and pest control operators
(PCOs) to control ants, roaches, hornets and other pests in and around residences, commercial,
industrial and institutional buildings, and in food handling establishments. Propoxur is also used
on pets as a spray and in flea and tick collars. Product formulations include aerosols, baits,
emulsifiable concentrates, wettable powders, ready-to-use solutions, impregnated shelf paper, and
insecticidal strips and tapes.
Health Effects
Propoxur has been classified as a Group B2, a probable human carcinogen. The Agency
has calculated a unit risk, Qj*, of 3.7 x 103 based on male rat bladder tumors. The RfD for
propoxur has been established at 0.005 mg/kg/day. Because studies with propoxur indicate very
low potential for dermal absorption, risk assessments for dermal exposures of any duration have
not been conducted.
The available developmental and reproductive toxicity studies do not suggest any increased
sensitivity of infants and children to propoxur from pre- and post-natal exposures. Based on
reliable data, the Agency has determined that an additional safety factor is not warranted.
Residential/Occupational Exposure and Risk
In assessing the risk of cancer to the general population, EPA has assumed that some
limited exposure to propoxur residues is possible from the diet, because propoxur is used in food
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handling establishments. Exposure is also anticipated from propoxur use to control insects in and
around the home. Drinking water exposure is not expected from current propoxur use patterns.
When the dietary and residential uses are combined the aggregate cancer risk is 7.9 x 10 7.
For non-cancer chronic dietary risk, exposures were calculated based on the proposed
tolerance of 0.2 ppm for food that may be exposed to propoxur applied in food handling
establishments and an assumption that 2% of these establishments were treated with propoxur.
Calculated risk for both the general population (< 2% of the RfD) and the sub-population with
the highest exposure, non-nursing infants, (< 8% of the RfD) are well within acceptable limits.
The only occupational endpoint of concern for propoxur is cancer. All occupational uses
of propoxur have negligible cancer risks, except PCOs applying crack and crevice treatments
which has an estimated cancer risk of 7.7 x 106.
Environmental Fate, Ecological Effects and Risk
Although supplemental data indicated that propoxur is moderately persistent and highly
mobile, current outdoor uses are limited, and exposure to the environment is expected to be
minimal. Calculated risk quotients for the granular bait use exceed the Agency's acute level of
concern (LOG) for avian species. However, the overall potential for avian exposure has been
reduced by the 1992 deletion of the broadcast use on lawns and turf. Current use is limited to
building perimeter applications. Minimal risk is expected to aquatic organisms from propoxur
use on boat mooring lines.
Risk Mitigation
EPA is requiring the following personal protective equipment for PCOs applying propoxur
to cracks and crevices: long-sleeved shirt, long pants, chemical-resistant gloves and shoes plus
socks. The Agency believes that there are no other reasonable protective clothing requirements
to further reduce risk to workers. EPA is restricting by-stander entry during application and re-
entry until sprays have dried.
Under FIFRA, the Agency has concluded that the uses of propoxur, labeled and used as
specified in this document, will not cause unreasonable risk to humans or the environment.
The Agency has assessed the pending tolerance for propoxur use in food handling
establishments under the standards of FQPA and determined, based on available information, that
there is a reasonable certainty that no harm will result to infants and children or to the general
population from aggregate exposure to propoxur residues.
The Agency has not made a determination on whether propoxur and any other compounds
have a common mechanism of toxicity for either cancer or non-cancer effects and require a
cumulative risk assessment. Therefore, for the purposes of this Reregistration Eligibility Decision
document, the Agency has considered only risks from propoxur. If required, cumulative risks
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will be assessed when methodologies for determining common mechanism of toxicity and for
performing cumulative risk assessment are finalized.
Before reregistering the products containing propoxur, the Agency is requiring that
product specific data, revised Confidential Statement of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. Those products which contain multiple active ingredients will
be eligible for reregistration only when the other active ingredients are determined to be eligible
for reregistration.
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Vlll
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data
submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately. As a
result, EPA is embarking on an intensive process, including consultation with registrants, States,
and other interested stakeholders, to make decisions on the new policies and procedures that will
be appropriate as a result of enactment of FQPA. This process will include a more in depth
analysis of the new safety standard and how it should be applied to both food and non-food use
pesticides. The FQPA does not, however, amend any of the existing reregistration deadlines set
forth in §4 of FIFRA. In addition, in light of the unaffected statutory deadlines with respect to
reregistration, the Agency will continue its ongoing reregistration program while it continues to
determine how best to implement FQPA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of propoxur including the risk to infants and children for any potential dietary,
drinking water, dermal or oral exposures, and cumulative effects as stipulated under the FQPA.
The document consists of six sections. Section I is the introduction. Section II describes
propoxur, its uses, data requirements and regulatory history. Section III discusses the human
health and environmental assessment based on the data available to the Agency. Section IV
presents the reregistration decision for propoxur. Section V discusses the reregistration
requirements for propoxur. Finally, Section VI is the Appendices which support this
Reregistration Eligibility Decision. Additional details concerning the Agency's review of
applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Propoxur
o-isopropoxyphenyl methylcarbamate
Carbamates
114-26-1
47802
B.
Empirical Formula: CUH15N03
Trade and Other Names: Baygon
Basic Manufacturer: Bayer, AG
Use Profile
Propoxur is a residual carbamate insecticide registered for indoor applications and
very limited outdoor applications. Indoor uses include residential, institutional, industrial,
and commercial buildings, with uses permitted in food handling establishments and food
processing plants as crack and crevice treatments only. Outdoor uses include structural
perimeter applications, spot treatments to wasp nests and ant hills and insecticidal tape for
boat mooring lines. Propoxur occurs in products as a single active ingredient as well as
in combination with other pesticides.
An overview of the use sites and application methods for currently registered uses
follows. Further details on these uses of propoxur are available in the table in Appendix
A.
Type of Pesticide:
Target Pests:
Use Sites:
Insecticide
Ants, cockroaches, fleas, bees, hornets, wasps, ticks, mosquitos,
yellowjackets, and spiders.
Indoor non-food applications:
within homes, apartments, dwellings, on pets (flea collars
and aerosol pet sprays); commercial, industrial, and
institutional buildings
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Indoor food areas:
limited to crack and crevice treatment in food areas of
commercial, industrial, and institutional buildings and in
food handling, storage, and processing facilities
Outdoors:
residential uses around home foundations, sidewalks, patios,
and driveways; also spot treatments to wasps nests and ant
hills. On building surfaces of commercial, industrial, and
institutional structures. Insecticidal tape is used on boat
mooring lines and in gypsy moth and medfly traps.
Formulation types and (range of percent of propoxur in formulation) :
Ready to use liquid (0.5 - 1.1%), aerosol-liquid under pressure
(0.25 - 2%), oil-soluble liquid, liquid concentrate (8 - 19.6%);
pastes (2%), wettable powders (70%), solid baits (0.25 - 2%); pet
flea collars (impregnated plastic) (0.4 - 10%), impregnated shelf
papers (1%) and insecticidal tapes (10%).
Method of Application:
aerosol can: using actuator and injection tube; concentrated liquid:
using compressed air sprayer, hand- or power-operated sprayer;
wettable powder: using sprayer liquid - ready to use; using power
operated or hand-pressurized sprayer; low-pressure sprayer oil-
soluble liquid; sprayer
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
propoxur. These estimates are derived from a variety of published and proprietary
sources available to the Agency. The data, reported on an aggregate and site basis, reflect
annual fluctuations in use patterns as well as the variability in using data from various
information sources.
The following table summarizes the pesticide's use by market sector:
Estimates of Annual Propoxur Use (in Ibs/ai)
Total use : 170, 000 to 400 , 000
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Professional Markets: 20,000 to 50,000
Consumer Markets: 150,000 to 350,000
D. Data Requirements
The ^registration Phase IV Data Call-ins (DCIs) dated 12/13/91 and 4/21/92
included requirements for product chemistry, ecological effects, environmental fate, and
residue chemistry. These data were required to support the uses listed in the Registration
Standard. Appendix B includes all data requirements identified by the Agency for
currently registered uses needed to support reregistration.
E. Regulatory History
Propoxur (Baygon) was first registered in the United States in 1963 for use as an
insecticide by Chemagro (now known as Bayer). There are currently two registered
technical products and several manufacturing-use only products. There are currently 173
products that contain propoxur registered by 67 companies.
Regarding the use of propoxur in food handling establishments, the Agency
published definitions and a policy statement (38 FR 21685) in August, 1973. This FR
Notice allowed the use of propoxur as well as other insecticides to continue in food areas
of food handling establishments, with the provision that a petition to establish a tolerance
for the use be submitted in the near future. In 1979, Bayer submitted a petition requesting
a tolerance for use of propoxur in food areas of food handling establishments. In several
reviews the Agency determined that additional data were needed to support the proposed
tolerance. While much of these data have been submitted, the Agency was, at that time,
unable to establish the tolerance (in Section 409) for food processing plants and food
handling establishments under the Delaney Clause, because propoxur had been determined
to be a carcinogen.
In December, 1987, the Agency issued a DCI to call in data needed to support the
continued registration of propoxur products. The DCI required data to support the
outdoor uses of propoxur as well as studies to examine potential risks to applicators and
persons living in treated buildings. This notice was sent only to companies with
manufacturing use products. None of the companies, including Bayer, the basic producer
of propoxur, committed to support all of the uses registered at that time. At that time
propoxur was registered for outdoor use as a premise spray, on turf, and for adult
mosquito control. These uses were not supported and were deleted from labels.
In 1988, the Agency issued a preliminary notification (Grassley-Allen) letter to
Bayer informing the company that propoxur was being considered for Special Review
because of concerns about the potential carcinogenic risks to pest control operators and the
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general public during indoor and outdoor applications of propoxur and risks to occupants
of buildings treated with propoxur products.
In 1989, a DCI was issued to end-use producers after Bayer decided not to support
the outdoor uses. These outdoor uses included ornamentals, lawns/turf, and mosquito
control. None of the end-use producers elected to support these outdoor uses and the
pertinent uses have been deleted from the labels. The remaining outdoor uses include
residential uses around home foundations, sidewalks, patios, and driveways, spot
treatments to wasp nests and ant hills, insecticidal tape on boat mooring lines and in gypsy
moth and med fly traps.
In 1990, a Notice of Intent To Suspend (NOITS) was issued for certain propoxur
registrations of indoor and outdoor aerosol spray, non-pressurized outdoor spray, granular
bait and total-release fogger end-use products. Bayer failed to provide acceptable data
after committing to provide exposure data for all uses except the fogger, which they
declined to support. These exposure data were eventually provided and the suspensions
lifted.
In January, 1995, the Agency issued a notice (60 FR 3210) proposing not to initiate
a Special Review of the insecticide propoxur. The Agency had received and evaluated
new exposure and carcinogenicity data on propoxur and determined that the uses which
posed the greatest concern (flea dips and shampoos for pets, and total-release fogger
products) had been eliminated through voluntary cancellation or label amendment.
Therefore, the Agency believed that the estimated risks did not warrant initiation of a
Special Review. The Agency issued a final decision not to initiate a Special Review in
February, 1996 (61 FR 7508).
As discussed previously, the Food Quality Protection Act was signed into law on
August 3, 1996. One of the components of the law set new standards for health-based risk
assessments, in effect, replacing the Delaney Clause. Currently all tolerances, which had
not been previously set due to the restrictions under the Delaney Clause, will need to be
established.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Propoxur is a colorless crystalline solid with a melting point of ~90°C. It is
readily soluble in methanol, acetone, dichloromethane, 2-propanol, toluene, and many
organic solvents, but is only slightly soluble in cold hydrocarbons such as n-hexane.
Propoxur is only slightly soluble in water (0.2% at 20°C) and is unstable under highly
alkaline conditions. The vapor pressure is 1.29 mPa at 20°C.
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Figure A. Propoxur [o-isopropoxyphenyl methylcarbamate]
CH
Empirical Formula:
Molecular Weight:
CAS Registry No.:
OPP Chemical Code:
CUH15N03
209.24
114-26-1
047802
The Propoxur Phase IV Review determined that Bayer product chemistry
data submissions for the 99.6% technicals met the acceptance criteria for Phase V
review for GLNs 61-1, 62-3, 63-2, 63-3, 63-4, 63-9, and 63-11. Additional data
were required for GLNs 61-2, 61-3, 62-1, 62-2, 63-5, 63-7, 63-8, and 63-13.
These data have been submitted and are acceptable. No additional product
chemistry data are required to support the technical and manufacturing-use
products of propoxur.
B. Human Health Assessment
1. Toxicology Assessment
At present, the available toxicological database for propoxur is adequate
and will support a reregistration eligibility determination.
a. Acute Toxicity
Results of the acute toxicity studies conducted with technical
propoxur are summarized below in Table 1:
Table 1. Acute Toxicity Values of Technical Propoxur
Route
Oral
Dermal
Inhalation
Eye Irritation3
Skin Irritation3
Dermal Sensitization3
Species
Rat
Rabbit
Rat
Rabbit
Rabbit
Guinea Pig
Results
LD50 (d) = 94 mg/kg
LD50 (?) = 68 mg/kg
LD50 > 2000 mg/kg
LC50 >0.5 mg/L
Mild Irritant
No Irritation
Non-sensitizer
Toxicity Category
II
III
III
III
IV
N/A
1 Not required for TGAI, however, presented here for informational purposes.
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In an oral LD50 study with rats, symptoms of muscle spasms and
salivation, accompanied by dyspnea and apathy, occurred starting 1-10
minutes after administration at doses > 50 mg/kg. These effects were not
observed at the lowest dose of 10 mg/kg. The muscle spasms and
salivation were consistent with cholinesterase inhibition. These symptoms
cleared within 1-2 days, although the animals were, in some cases,
"apathetic" for 5-6 days after dosage. Mortality occurred at the 50 mg/kg
dose where 2/10 females died and 75 mg/kg dose where 2/10 males died.
The LD50 is calculated to be 94 mg/kg for males and 68 mg/kg for females.
These results place propoxur in Toxicity Category II (MRID 00152443).
In a dermal LD50 study with rabbits there were no mortalities among
the 5 male and 5 female animals which received a 24-hour occluded dermal
exposure of 2000 mg/kg. The test material was moistened with tap water
before being applied to the rabbits. All 10 rabbits had muscular
fasciculations suggestive of cholinesterase inhibition and there was
decreased motor activity in 3 males and all females. These symptoms were
observed on Day 0 but had resolved by Day 3 (MRID 40836401).
In an inhalation LC50 study in rats there were no mortalities among
the 5 male and 5 female animals which were exposed for 4 hours to
concentrations of 28.7, 110.1, 330.4 or 497.5 mg/m3 propoxur. Test
material was delivered in a vehicle composed of 50% polyethylene glycol
400 and 50% ethanol. Rats exposed to the two highest concentrations
(330.4 or 497.5 mg/m3) showed symptoms, which included tremors,
reduced activity, piloerection and unpreened hair coat. Symptoms lasted
through the day after exposure. The LC50 > 0.498 mg/L since no mortality
occurred following exposure to this concentration. Therefore, propoxur
has an inhalation LC50 of greater than 0.5 mg/L, and is in Toxicity
Category III (MRID 40836402).
Propoxur is a Toxicity Category III primary eye irritant in rabbits.
Instillation resulted in minor eye irritation (redness and discharge) which
cleared within 48 hours (MRID 41737801).
Propoxur is a Toxicity Category IV primary dermal irritant in
rabbits (MRID 41870801) and propoxur is not a skin sensitizer in guinea
pigs (MRID 41652401).
In an acute neurotoxicity study in rats, propoxur (99.4%) was
administered by single dose oral gavage to 12 Wistar rats/sex/dose at 0, 2,
10 or 25 mg/kg with polyethylene glycol 400 (5 ml/kg) as the vehicle.
Functional Observational Batteries (FOB) and Motor and Locomotor
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Activity measurements were conducted on days -7, 0, 7 and 14.
Treatment-related effects were observed in the FOB on day 0 in all treated
groups, but effects were minimal at the low dose. For low-dose males,
there was a significantly increased incidence of sitting or lying (rather than
standing) during open field observation, a marginally decreased incidence
of rearing, and a slightly decreased tail pinch response. Two low-dose
females exhibited slight repetitive chewing and the incidence of rearing was
marginally decreased in this group. Low-dose animals also had slightly
(not significantly) lower mean body temperatures (males: 37.8°C vs.
38.0°C for controls; females 38.3°C vs. 38.6°C) which were part of dose-
related trends. On day 0 in the 10 and 25 mg/kg groups there were gait
abnormalities, involuntary clonic motor movements, labored breathing,
decreased activity, impaired righting reflex, decreased responses to
auditory and tail pinch stimuli, and decreased grip strength. Mean body
temperatures were significantly reduced in both sexes (males: controls:
38.0°C; 10 mg/kg: 37.4°C; 25 mg/kg: 35.8°C; females: controls: 38.6°C;
10 mg/kg: 37.9°C; 25 mg/kg: 36.6°C). Satellite groups of 6 rats/sex
received 0, 2, 10 or 25 mg/kg (4/6 high-dose males received 35 mg/kg)
propoxur, with sacrifice about 45 minutes after dosing. Low-dose males
and females had significant (p < 0.01) brain cholinesterase (ChE) inhibition
(-18% and -21% respectively); at 10 mg/kg both sexes had significant (p
< 0.01) RBC (males: -72%; females: -63%) and brain (males: -47%;
females: -49%) ChE inhibition.
A neurotoxic NOEL was not determined. The neurotoxic LOEL
is 2 mg/kg, based on significant (p < 0.01) brain ChE inhibition in both
sexes 45 minutes after dosage.
There were no significant differences between groups with respect
to mean body and/or brain weights at termination. There were no
indications of any dose-related gross or microscopic findings in high-dose
animals at termination.
A NOEL could not be determined for this study. This study
satisfies the guideline requirement (81-8) for an acute neurotoxicity
screening study (MRID 43445701).
b. Subchronic Toxicity
In a 13-week subchronic dermal toxicity study in rabbits, groups of
10 male and 10 female New Zealand rabbits received dermal applications
of 0, 50, 250, or 1000 mg/kg propoxur suspended in cremophor (2% v/v).
Dosing was administered for 6 hours/day, 5 days/week for a total of 65
treatments over a 90-day period. No dermal irritation was observed, and
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no treatment-related effects were observed in body weight, food
consumption, hematology, clinical chemistry parameters (including plasma,
erythrocyte and/or brain cholinesterase activities), liver enzymes, and gross
or histopathology. The NOEL is 1000 mg/kg/day which was the highest
dose tested (MRID 41066001). This study satisfies the guideline
requirement (82-3) for a subchronic dermal toxicity study for propoxur.
In a 13-week subchronic neurotoxicity study in rats groups of 12
male and 12 female SPF-bred Wistar rats were fed diets containing 0, 500,
2000 or 8000 ppm propoxur (99.5%) for 13 weeks. These exposure levels
were equivalent to 0, 33, 132 or 543 mg/kg/day of for males, and 0, 39,
163, or 703 mg/kg/day for females. Additional groups of 12 male and 12
female rats were fed diets containing 0 or 8000 ppm propoxur for 13
weeks, followed by a 4-week recovery period.
There were Functional Observation Battery (FOB) and Motor and
Locomotor observations at pretreatment and weeks 4, 8, and 13.
Epileptoid seizures were observed in 5/24 8000 ppm females during FOB-
testing. It is hypothesized that these were due to acetylcholine
accumulation in the brain and a genetic disposition of these rats. In males,
1/12 at the 2000 ppm (but 0/24 at 8000 ppm) showed epileptoid seizures
during FOB-testing; this one occurrence was not considered to be related
to treatment. Slightly decreased grip strength and foot splay in males and
females at 2000 and 8000 were considered to correlate with body weight
retardation at these dietary exposure levels. Motor and locomotor activity
were not affected in males of any dose level or in females exposed to 500
or 2000 ppm; activity was extremely low in individual females at 8000 ppm
that had epileptoid seizures during FOB testing which was immediately
prior to motor and locomotor activity measurements. There were no other
indications of neurological effects observed in testing.
Week 13 ophthalmic examination showed a reduced pupillary reflex
in 4/24 males and 2/24 females exposed to 8000 ppm, presumably due to
cholinesterase (ChE) inhibition. There were no significant differences
between groups with respect to mean brain weights. There were no
significant differences between controls and 8000 ppm rats (6/sex/group
examined) with respect to microscopic neurology findings. At week 13,
2000 ppm and 8000 ppm males had significantly lower mean body weights
(-12% and -21% respectively); as did 2000 and 8000 ppm females (-7%
and -20%) than controls.
Plasma and Red Blood Cell (RBC) cholinesterase measurements
were taken from 6/sex/group of the non-recovery rats at weeks 4 and 14,
and brain ChE was measured at week 14. For males, RBC ChE was
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significantly reduced at 2000 and 8000 ppm for week 4, and at 8000 ppm
for week 14. For females, plasma ChE was significantly reduced at 8000
ppm for week 4. Brain ChE was significantly reduced at week 14 in 2000
and 8000 ppm males and females (2000 ppm: males: -24%; females: -
18%; 8000 ppm: males: -28%; females: -19%), and "marginally" (but with
p < 0.01) in 500 ppm males (-14%). Cholinesterase inhibition associated
with exposure to carbamates is reversible, and so these measured
cholinesterase activities may not fully indicate the maximum levels of
inhibition that occurred, as presumably some time elapsed between blood
or brain collection and measurement of ChE activities.
The NOEL for FOB and motor and locomotor activity changes is
163 mg/kg/day for females, with a LOEL of 703 mg/kg/day; the NOEL
in males is 543 mg/kg/day (HDT). The NOEL for ophthalmic changes is
132 mg/kg/day for males and 164 mg/kg/day for females, with a LOEL
(reduced pupillary reflex in some rats) of 543 mg/kg/day for males and 703
mg/kg/day for females. The NOEL for reduced ChE in females was 39
mg/kg/day, and the LOEL was 163 mg/kg/day (reduced brain ChE
activity, with reduced plasma ChE at 703 mg/kg/day); for males the NOEL
was below 33 mg/kg/day (lowest dose tested); the LOEL was 33
mg/kg/day (reduced brain ChE activity at all dietary exposure levels;
reduced RBC ChE at 132 and 543 ppm). There were no indications of any
dose-related microscopic effects in skeletal muscle tissues or neural tissues;
the NOEL for microscopic lesions (and histoneurological effects) is 543
mg/kg/day for males and 703 mg/kg/day for females. This was the highest
dose tested (MRID 43445701). This study satisfies the guideline
requirement (82-7) for a subchronic neurotoxicity screening study in rats.
c. Chronic toxicity and Carcinogenicity
In a carcinogenicity study, propoxur (99.6%) was given in Altromin
diet at 0, 500, 2000 or 8000 ppm to groups of 50 male and 50 female
B6C3F1 mice, with an additional 10 animals/sex/ dietary dose level
sacrificed at 1 year. Propoxur intake values are reported as: males: 0,
114.3, 472.4 or 2080.6 mg/kg/day; females: 0, 150.4, 591.4 or 2671.1
mg/kg/day. However, these values are based on what appear to be
relatively high food consumption values (males: 7.0-7.2 gm/animal/day;
females: 8.1-8.5 gm/animal/day), and there may have been considerable
wastage. If food consumption values had been 3 gm/animal/day, then
propoxur intake would have been: males — 0, 47.6, 202.5, or 879.1
mg/kg/day; females — 0, 53.1, 219.0, or 977.2 mg/kg/day.
There was a dose-related trend of increasing incidence of
hepatocellular adenomas in male mice (10/49, 10/49, 15/49, and 21/50),
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but no other indication of any neoplastic effect. Non-neoplastic effects
included an increased incidence of bladder epithelial hyperplasia (classified
as minimal and diffuse in all instances) in both sexes at 2000 and 8000
ppm; there was also a significantly increased incidence of ovarian
hemorrhage (and thrombus formation) in 8000 ppm females. Mean liver
weights (and liver-to-body weight ratios) were increased (usually
significantly) in both sexes at 2000 and 8000 ppm. Mean body weight
gains were decreased by about 20% in 8000 ppm males, and 33-50% in
8000 ppm females. The NOEL in this study was 500 ppm (males: 114.3
mg/kg/day; females: 150.4 mg/kg/day), and the LOEL (increased mean
liver weights in both sexes, increased incidence of liver nodules in males,
increased levels of alanine aminotransferase activity, increased incidence
of ovarian nodules in females, increased incidence of urinary bladder
hyperplasia in both sexes) was 2000 ppm (males: 472.4 mg/kg/day;
females: 591.4 mg/kg/day) (MRID 42597701). This study satisfies the
guideline requirement (83-2) for a mouse carcinogenicity study.
In a combined chronic toxicity/carcinogenicity study, groups of 50
SPF strain BOR:WISW rats/sex/dietary exposure level were fed 0, 200,
1000 or 5000 ppm propoxur (0, 8.23, 42.03 or 222.3 mg/kg/day for
males; 0, 11.02, 56.16 or 292.72 mg/kg/day for females) in Altromin 1321
diet. Satellite groups of an additional 10 animals/sex/group were sacrificed
after one year. At 5000 ppm there were significantly (p < 0.01) lower
mean body weights in both sexes throughout the study (week 13: males -
16.1% from their controls; females -15.2%), and reduced food
consumption relative to controls (males: 16 gm/day vs. 17 gm/day;
females: 11 gm/day vs. 14 gm/day). At 1000 ppm males tended to have
a significantly (p < 0.05) lower mean body weight relative to their controls
through the first 66 weeks of the study, and sporadically thereafter.
Females usually had significantly (p < 0.05, often < 0.01) lower mean
body weight throughout the study.
In both sexes at 5000 ppm there were increases in incidence and
degree of what was described as slight peripheral neuropathy (mainly
characterized by myelin alterations, such as vacuolization, myelinovoid
formation, and occasional phagocytes). Additionally, there was an
increased incidence of slight muscular atrophy of the rear extremities.
At 1000 and 5000 ppm there were significant increases in
hyperplasia of the urinary bladder in both sexes (males: 1/50, 1/50, 10/50
and 44/100 for the 0, 200, 1000 and 5000 ppm groups; females: 0/50,
0/50, 5/50, 4/48).
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At 5000 ppm there were significant increases in incidences of
urinary bladder papillomas and carcinomas in both sexes (papillomas:
males: 0/50, 0/50, 1/50, 25/50 for the 0, 200, 1000 and 5000 ppm groups
respectively; females: 0/50, 0/50, 0/50, 28/50; carcinomas were present
in 8/50 males and 5/50 females at 5000 ppm, but were not observed in
controls or any of the lower-dose groups). Females at 5000 ppm showed
an increased incidence (not quite statistically significant) of carcinoma of
the uterus (3/50, 4/50, 3/50 and 8/50 for the 0, 200, 1000 and 5000 ppm
groups respectively).
The LOEL is 42.03 mg/kg/day (1000 ppm) for male rats and 56.16
mg/kg/day (1000 ppm) for female rats, based on reduced weight gains and
the occurrence of hyperplasia of the urinary bladder in both sexes. The
NOEL is 8.23 mg/kg/day (200 ppm) for male rats, and 11.02 mg/kg/day
(200 ppm) for female rats (MRID 00142725). This combined chronic
toxicity/carcinogenicity study satisfies the guideline requirements (83-1 and
83-2) for a combined rat chronic toxicity and carcinogenicity study.
In a chronic inhalation toxicity study groups of 50 Wistar
rats/sex/exposure level received whole body exposure for 6.3 hours/day,
5 days/week over a 2-year period followed by an exposure-free period of
5 months. Nominal exposure levels were 0 (vehicle: a 1:1 mixture of
propylene glycol and ethanol), 2, 10 or 50 mg propoxur/meter3.
Corresponding analytical concentrations were 0, 2.2, 10.4 or 50.5
mg/meter3. There were frequent occurrences of significant cholinesterase
inhibition (plasma, RBC and brain) at 10 and 50 mg/m3. Statistically
significant RBC cholinesterase depressions at 2 mg/m3 at weeks 25-26 and
51 were not part of dose-related trends and/or were probably within the
limits of normal variation. There were only slightly (4%) lower mean
body weights in 10 and 50 mg/m3 females at 52 weeks. There were no
dose-related effects involving mortality, clinical signs, hematology, clinical
chemistry (other than cholinesterase activities), a number of respiratory
functions, urinalyses or organ weights. The LOEL is 10.4 mg/m3 based
on significant plasma, RBC and brain cholinesterase inhibition at this
exposure level for both sexes on a number of occasions. The NOEL is 2.2
mg/m3.
There were some slight dose-related increases in tumor incidences
[the incidences of urinary bladder papillomas in males were 0/58, 0/60,
1/59 and 2/60 for the controls, 2, 10 and 50 mg/m3 groups respectively,
while for hepatocellular adenomas in males the incidences were 2/58, 0/60,
2/59 and 6/59]. The only occurrence of a papilloma of the urinary bladder
in females occurred in the highest exposure group [incidences of 0/60,
0/57, 0/60 and 1/59 for controls, 2, 10 and 50 mg/m3 groups respectively].
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For the females, there was a weak (not statistically significant) trend
involving uterine adenocarcinomas [incidences of 0/47, 2/45, 2/50 and
3/47 for the 0, 2, 10 and 50 mg/m3 groups respectively]. An apparent
dose-related increased incidence in pituitary adenomas in males was
probably due to an unusually low (3%) incidence of this tumor type in
controls (MRIDs 42648001 and 43398501).
While this chronic inhalation study does not satisfy the 83-1
Guidelines data requirement, the findings (particularly the occurrence of
urinary bladder papillomas) are consistent with what was observed in the
2-year rat chronic feeding study.
In a one-year dog feeding study groups of 6 male and 6 female
thoroughbred beagles received 0, 200, 600 or 1800 ppm propoxur (99.4%)
in their diet for a period of 12 months. The high dose dogs received 1800
ppm during weeks 1-40, 3600 ppm for weeks 41-44, and 5400 ppm for
weeks 45-52. The mean quantities of propoxur consumed per animal were
0, 62.4, 186.3, or 780.7 mg/day; or values about 0, 6.77, 22.0, or 98.2
mg/kg/day.
At the highest dose level, one male died at week 50. After week
20, highest-dose dogs of both sexes had lower mean body weights than
their corresponding controls; at week 41 and thereafter their weights were
significantly lower. At week 41 three dogs in the high-dose group showed
an increased incidence of vomiting (after the level of propoxur was raised
from 1800 to 3600 ppm). One high-dose female had poor weight gain in
the first 40 weeks, and appeared emaciated at the end of the study. This
dog was one of those vomiting more frequently after week 41, and had
gone from 6.6 kg at week 40 to 6.0 kg at week 52. After the level was
raised to 5400 ppm, almost all of the high-dose dogs had an increased
incidence of vomiting; some also showed more frequent salivation. Most
also had spasms throughout their entire bodies after feeding, while two
"exhibited an uncertain gait with slightly bent joints." One dog
"temporarily showed aggressive behavior" and another "exhibited circular
movements."
Mean thrombocyte counts were consistently (and significantly)
elevated in high-dose dogs, and there was an additional increase in this
parameter after week 40 (when the propoxur concentration was increased).
Mean cholesterol levels were significantly elevated in mid- and high-dose
dogs from week 6; mean cholesterol levels were consistently elevated,
sometimes significantly so, (relative to control values) in 200 ppm dogs
from week 6 to termination. At termination, mean N-demethylase activity
13
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was significantly elevated in mid and high-dose dogs; cytochrome P450
was elevated (but not significantly) in high-dose dogs only.
Plasma cholinesterase activities tended to be lower in high-dose
dogs relative to control values, and RBC ChE activities tended to be lower
(relative to controls) in dogs receiving 1800 ppm one hour after feeding.
Mean liver weights and mean thyroid weights were elevated at termination
in the high-dose dogs, and the organ-to-body weight ratios were
significantly elevated. However, the high mean thyroid weights were due
to findings from only two of the high-dose dogs, one of which had a
thyroid cyst; without these dogs the mean thyroid weight from high-dose
dogs was comparable to that of controls (high-dose dogs: 0.892 gm;
controls: 0.928 gm). Mean kidney and mean adrenal weights were
somewhat elevated in the high-dose dogs. Mean thymus weights in high-
dose dogs were significantly lower (4.07 gm vs. a control value of 0.869)
and the thymus-to-body weight ratio was significantly lower in high-dose
dogs (0.479 gm/kg vs. 0.872 gm/kg).
Since the low-dose dogs showed an elevated mean cholesterol level
which was part of a well-defined dose trend, a NOEL was not observed in
the original one-year study (MRID 00149040). Subsequently, in a bridging
study (MRID 42041601), groups of 4 male and 4 female beagle dogs were
fed diets containing 0 or 70 ppm propoxur for 6 months (males: 0 or 2.46
mg/kg/day; females: 0 or 2.71 mg/kg/day). In this 6-month study, there
was no indication of any effect (including an elevation of cholesterol levels)
on animals receiving the diet containing 70 ppm propoxur. This establishes
a NOEL in the dog of 2.46 mg/kg/day. The combination of the two
studies (MRIDs 00149040 and 42041601) satisfies the guideline 83-1
requirement (83-1) for a chronic feeding study in non-rodents.
d. Developmental Toxicity
In a developmental toxicity study in rats, groups of 25 mated female
Wistar/HAN rats received oral administrations of 0, 3, 9, or 27 mg/kg
propoxur (99.4%) in distilled water mixed with 0.5% cremophor daily
during days 6 through 15 of gestation; dams were sacrificed on day 21.
No maternal toxicity was observed at the low dose (3 mg/kg/day).
At the mid dose (9 mg/kg/day) maternal toxicity was evident in increased
cleaning activity, chewing motions, grinding of teeth, reduction in food
consumption, and a marginal (-7.1%) decrease in mean body weight gain
for days 6-16. At the high dose (27 mg/kg/day), signs of maternal toxicity
included mortality (3/25 dams, with one death after the first administration
on day 6, and two deaths after the second administration on day 7),
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symptoms similar to those observed in the mid-dose group and,
additionally, tremors and ventral recumbency.
In addition, there was a significant (p < 0.05) reduction in mean
food consumption (-14.6%) for days 6-16, and a decrease (-26.2%) in
mean body weight gain from day 6 through day 16. There were no
indications that propoxur was embryotoxic, fetotoxic, or teratogenic at
doses up to and including 27 mg/kg. Under the conditions of this study,
the NOEL was 3 mg/kg/day for maternal toxicity and 27 mg/kg/day
(highest dose tested) for developmental toxicity. The LOEL for maternal
toxicity was 9 mg/kg/day and > 27 mg/kg/day for developmental toxicity
(MRID 41061101). This study satisfies the guideline requirements (83-3)
for a developmental toxicity study in rats.
In a developmental toxicity study in rabbits, groups of 16 mated
female chinchilla rabbits received oral administrations of 0, 3, 10, or 30
mg/kg propoxur (99.4%) in distilled water mixed with 0.5% cremophor
daily during days 6 through 18 of gestation; dams were sacrificed on day
28. No maternal, embryo, fetal or developmental toxicity was observed at
the 3 or 10 mg/kg/day dose levels.
At the high dose (30 mg/kg/day) maternal toxicity was characterized
by mortality (3/16 dams died during the dosing period) and clinical signs
(dyspnea and restlessness), and slight decreases in mean body weight and
food consumption. Embryo/fetotoxicity was suggested by a slight (not
statistically significant) post-implantation loss (17.7% at 30 mg/kg/day, as
compared to 10.1% in vehicle control animals), and a corresponding
reduction in the mean number of pups per dam. No treatment-related
effects were observed on fetal body weights or sex ratios. Propoxur did
not induce any external, visceral or skeletal malformations at any of the
doses tested.
Under the conditions of this study, the no-observed-effect-level
(NOEL) was 10 mg/kg/day for maternal and developmental toxicity. The
LOEL was 30 mg/kg/day for both maternal and developmental toxicity
(MRID 41061102). This study satisfies the guideline requirements (83-3)
for a developmental toxicity study in rabbits.
e. Reproductive Toxicity
In a 2-generation reproduction toxicity study groups of 25 male and
25 female Wistar rats were fed propoxur (99.4%) at concentrations of 0,
100, 500 or 2500 ppm (PI females: 0, 9.7, 48.1 or 238.9 mg/kg/day; Fl
females: 0, 8.8, 43.7, or 228.3 mg/kg/day) in their diet for a 70-day pre-
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mating period, then through mating, gestation and lactation. Four groups
of 25 males and 25 females (the Fl generation) were selected and
maintained on their respective parental diets while producing F2 litters.
On day 21 post partum, all F2 pups and Fl parents were sacrificed.
The reproductive NOEL was 500 ppm (approximately 45 mg/kg/day), and
the LOEL was 2500 ppm (approximately 233 mg/kg/day) based on a
reduced mean number of implantation sites/dam and a reduced mean
number of pups/dam at 2500 ppm in the Fl females. The fetotoxicity
NOEL is also 500 ppm (45 mg/kg/day) and the LOEL 2500 ppm (233
mg/kg/day) based on reduced mean Fl and F2 pup body weights at birth
at 2500 ppm (Fl: 2500 ppm: 5.3 gm; controls: 5.8 gm; F2: 2500 ppm: 5.3
gm; controls: 5.7 gm). Other effects noted were body weight reductions
in 500 ppm P and Fl males and Fl females. Dose-related urothelial
hyperplasia was observed at 2500 ppm (P: 2/25 males and 6/25 females;
Fl: 8/25 males and 7/25 females). A NOEL for parental toxicity was not
observed as RBC ChE was significantly (p < 0.01) reduced (-21%) in 100
ppm males of the P generation; it was reduced (not significantly) in 100
ppm males of the Fl generation (-12%); brain ChE was significantly (p <
0.01) reduced in Fl females (-12%). Plasma ChE was significantly
reduced in 500 and 2500 ppm Fl females; RBC ChE was significantly
reduced in both sexes of the P and Fl at 500 and 2500 ppm, and brain ChE
was significantly reduced in P males at 500 and 2500 ppm, in P females at
2500 ppm, in Fl males at 2500 ppm, and in 100, 500 and 2500 ppm Fl
females (MRID 41817501).
In a subsequent 2-generation study (MRID 42615403), propoxur
(99.8%) was administered in Kliba 343 diet to groups of 25 male and 25
female Wistar rats at concentrations of 0, 30 or 80 ppm (males: 0, 2, or 7
mg/kg/day; females: 0, 3, or 8 mg/kg/day), with selection for an Fl
generation (25 males and 25 females per group) which were maintained on
their respective parental diets while producing F2 litters. On day 21 post
partum, all F2 pups and their Fl parent were sacrificed. No compound-
related reproductive toxicity was observed; for Fl males there was a
significant (p < 0.01) decrease (-22%) in mean RBC ChE activity. The
NOEL for ChE inhibition was approximately 2.5 mg/kg/day (30 ppm) and
the LOEL was 7 mg/kg/day. The two studies together (MRIDs 41817501
and 42615403) adequately satisfy the 83-4 data requirement for a 2-
generation study in rats with propoxur.
f. Mutagenicity
Results of the following eight mutagenicity studies indicate that
propoxur has little, if any, genotoxic activity.
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In a Salmonella typhimurium (Ames) assay, no mutagenic activity
was observed with or without metabolic activation (S9 from rat liver) in
replicate studies with doses of up to 12,500 jig/plate in Salmonella
typhimurium strains TA98, TA100, TA1535, or TA1537. At the highest
dose level used there was cytotoxicity in all strains of S^ typhimurium used
(MRID 00147479). ~~
In a second Salmonella typhimurium (Ames) assay no mutagenic
activity were observed with or without metabolic activation (S9 from rat
liver) at doses of up to 25,000 jig/plate, with cytotoxicity at highest dose
levels in all strains of S^ typhimurium used (TA98, TA100, TA1535,
TA1537 and TA1538),~~as well as R. coli strain Wp2 her (MRID
00149043). Either of these studies (MRID 00147479 or MRID 00149043)
satisfies the Guideline requirement (84-2) for a Salmonella typhimurium
reverse mutation assay.
In an in vitro CHO (hgprt) assay there was no evidence of
mutagenic activity at doses of 25, 50, 75, 100 or 125 jig/mL in the absence
of S9, or at 600, 800, 900 or 1000 jjg/mL with S9 (MRID 40836403).
This study satisfies the Guideline requirement (84-2) for a mammalian cells
in culture forward gene mutation assay.
In a chromosomal aberration study with Chinese Hamster Ovary
(CHO) cells propoxur (97.8%) was tested at 157, 313, 625 or 1250 jjg/mL
without S9 mix and at 625, 1250, 2500 or 5000 jig/mL in the presence of
S9 mix. At 2500 and 5000 jig/mL the test material precipitated out. There
was no indication of a clastogenic effect at any of the levels evaluated (at
1250 ]ag/mL without S9 mix there was an insufficient number of metaphase
spreads for analysis due to cytotoxicity), either in the absence or presence
of S9 mix. However, the 10-hour post-treatment harvest time for cells
exposed to 2500 and 5000 jig/mL +S9 was not supported by results from
the cell cycle assay (MRID 40953501).
In a second CHO chromosomal aberration assay propoxur (98.4%)
was tested at 625, 1250, 2500 or 5000 jjg/mL +S9 with 20-hour post-
treatment harvest. At 2500 and 5000 jig/mL there were significantly (p <
0.01) increased incidences of cells with chromosomal aberrations, but at
these doses there was also precipitation of the test material. The Agency's
test requirements specify that testing a substance in the absence of marked
cytotoxicity is necessary only up to solubility limits, as the presence of
particulates may result in aberrations from mechanisms other than
interactions of the test substance (and/or its metabolites) with chromosomes
(MRID 41724601). The combination of these two studies meets the
Guideline data requirement (84-2) for an in vitro test for clastogenicity.
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In an in vivo chromosomal aberration assay in Chinese hamster
bone marrow no evidence of a mutagenic response was observed in animals
which had been orally dosed with technical propoxur (several batches:
99.6-99.9%) at 75, 150 or 300 mg/kg and sacrificed at 48 hours.
Significant symptoms of toxicity (including death in 2/12 animals) at 300
mg/kg indicates this was an adequately high dose. There was no evidence
of a mutagenic response in animals sacrificed at 6 and 24 hours after
dosage, but these hamsters received only a dose level of 150 mg/kg (MRID
41008701).
In a subsequent in vivo chromosomal aberration assay in Chinese
hamsters with technical propoxur (99.4%) there was no indication of an
increased incidence of chromosomal aberrations in bone marrow cells
following oral gavage dosing of the test material at 75, 150 or 300 mg/kg
with sacrifice at 6 and 24 hours (MRID 42005101). The combination of
these two studies satisfies the 84-2 Guideline requirement for an in vivo
cytogenetics assay.
In an acceptable mouse micronucleus assay no mutagenic effect was
observed in male and female NMRI mice following doses up to and
including 20 mg/kg (administered as two 10 mg/kg doses, 24 hours apart,
with sacrifice 6 hours after the last dose). Although sacrifice was only 30
hours after the first oral dose, metabolism data (see below) show that
propoxur is rapidly and extensively metabolized within a few hours of
dosage (MRID 00149041). This study satisfies the 84-2 Guideline
requirement for an in vivo cytogenetics assay.
g. Metabolism
In general, the metabolism studies described below show that
propoxur is rapidly absorbed following ingestion, and that it is readily
metabolized.
In a metabolism study (MRID 00142731), the following metabolites
were identified in the urine of rats which had been fed 8000 ppm propoxur
for 13 weeks: Ml = 1,2-dihydoxybenzene (= catechol); M2 = 2-
isopropoxyphenol; M3 = 2-hydroxyphenyl methylcarbamate; M4 = 2-
isopropoxyphenylcarbamic acid; M5 = isopropoxyphenyl-hydroxy(-)
methylcarbamate; M6 = 2-isopropoxy-5-hydroxyphenyl-methylcarbamate;
M7 = 2-isopropoxy-5-hydroxyphenyl carbamic acid; M8 = 2-isopropoxy-
5-hydroxyphenylhydroxymethyl carbamate; M9 = l,5-dihydroxy-2-
isopropoxybenzene. In additional studies (MRID 40629703; MRID
40629702, MRID 40629704), M6 (= 2-isopropoxy-5-hydroxyphenyl-
methylcarbamate) was identified as a principle metabolite in hamsters,
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mice, and humans. The nitrosated compound M9A ( = l-hydroxy-2-
isopropoxy-4-nitrobenzene) has been identified as a metabolite in rats and
mice (MRID 40629702), the rhesus monkey (MRID 40629706), and
humans (MRID 40629704). Evidence from the human study (MRID
40629704) suggests that M9A is synthesized in the stomach.
In a second metabolism study, groups of 5 female rats received 50,
250 or 500 ppm unlabeled propoxur in their diets for 5 months, then
received (by oral gavage) a single dose of 1 mg/kg radiolabelled material.
Urine samples taken in the period from 0 to 24 hours after dosage had 87.9
to 99.8% of the total radiolabel; by thin layer chromatography it was found
that 97-98% of the activity remained at the origin, and was contained in
conjugated metabolites and/or extremely polar metabolites of unknown
structure. By enzymatic cleavage 80-86% of the activity was identified as
specific metabolites including Ml, M2, M3, M4, M5, M6, M7, M8, as
well as M6CII (= 2-isopropoxy-5-hydroxyphenyl carbamic acid), MS3 (=
2-isopropoxy-5-hydroxyphenyl-hydroxymethyl carbamate, and M7A (= 2-
isopropoxy-3-hydroxyphenyl-methyl carbamate) (MRID 00165000).
In a third metabolism study, seven male rats were used; one
received only non-labeled propoxur; the others received 1 mg/kg C14-
labeled (ring) with sacrifice at 1, 4, 8, 24, 48 and 72 hours. The rats were
sagittally sectioned and exposed (29-124 days) in direct contact with X-ray
film. At 1 hour, radioactivity was detectable in all organs (particularly
intestines) except the bone. After 24 hours, there were high concentrations
of radioactivity in the gastrointestinal tract and bladder, as well as, the
mucous membranes of the pharyngeal region. At 48 and 72 hours, some
radioactivity was still detectable in the liver, kidneys and mucous
membranes of the pharyngeal system. Propoxur (and/or its metabolites)
was shown to be distributed via the lymph system (MRID 41345801).
h. Dermal Absorption
Two studies have been reviewed which provide information on the
dermal adsorption of propoxur in humans and rats. In the human study, six
individuals received a single intravenous dose of 14C-propoxur, 1 Ci/ml.
Total urine was collected for five days post-dose and the percent of
radiolabeled-dose excreted in the urine was determined. Subsequently the
same six individuals received a single dermal dose of 14C-propoxur at 4
ug/cm2 for an exposure period of 24 hours. Total urine was collected for
five days post-dose and the percent of radiolabeled-dose excreted in the
urine was determined. The radiolabel excreted was corrected for the
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81.8% of label excreted following the i.v. dose. Corrected total excretion
was 19.6 percent of the dermally administered dose (Feldman and
Maibach).
In the rat study, four doses (0.648, 6.91, 69.5 and 692 ug/cm2)
were administered for durations of 0.5, 1, 2, 4, 8 and 24 hours. Test
material was administered in ethanol, a solvent which can increase the
absorption of a dissolved chemical. Since percent absorption decreases in
a nonlinear manner with dose, the absorption from the dose of 6.91 ug/cm2
(the nearest dose to that administered in the human study) was selected for
comparison with the human study. The results indicate (for durations 0.5,
1, 2, 4, 8, and 32 hours) a total of 7.88, 10.2 17.9, 23.2, and 32.5 percent
absorption, respectively (MRID 40953502).
The percent absorbed in the rat study exceeds the percent absorbed
in the human study for exposure durations of 8 and 24 hours. This is
expected, even without the addition of ethanol, as rat skin is more
permeable than human skin. Alternatively, the use of acetone in the human
study would show an expected increase of propoxur penetration.
Previously, the Agency had used a value of 50% dermal absorption
from the rat dermal absorption study. However, upon review of the human
data, the 19.6 percent absorption determined in the human study can be
expected to more closely approximate the rate of absorption to be expected
in the field than the rates determined in the rat study.
In a dermal absorption study with rats, a mixture of 50% ethanol
and 50% water was used as a solvent, with doses of 0.648, 6.91, 69.5, or
692 jjg/cm2 (corresponding nominal doses: 0.009875, 0.105, 1.0625 and
10.5 mg, respectively) radiolabeled propoxur. The highest values for
absorption (50 to 64.9%) were observed with the two lowest dose levels,
with the highest percentages of radioactivity (0.1-0.18%) in the blood
occurring at these dose levels at 0.5 to 1.0 hour after dosage. Because
propoxur was applied in a mixture of ethanol and water, the values
obtained for dermal absorption were probably somewhat higher than if
water alone had been the solvent (MRID 40953502).
i. Incident Information
Epidemiological Information
From OPP's Incident Data System (1992 to April 1996) there are
descriptions of 91 human exposures to propoxur. Seventy of the 91
exposures were from two incidents, both of which involved exposures post-
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application. Symptoms from these post-application exposures included
headaches, nausea, depression and respiratory irritation.
From the California Pesticide Illness Surveillance Program, 1982-
1993, 125 persons exposed to propoxur showed systemic symptoms. Sixty-
three of the exposed had respiratory symptoms including coughing,
tightness in the chest, shortness of breath, and congestion. EPA is
requiring label statements to reduce exposure during and after application.
Domestic animal incidents reported to OPP's Incident Data System
were linked in most cases to exposure from pet flea collars. Out of 49
animal exposures, fifteen dogs and nine cats were found with their flea
collar "bridled" in their mouths. One manufacturer has prepared an
instructional video (available through a toll-free number) which assists
customers in the proper placement of flea collars.
j. Toxicological Endpoints of Concern Identified for Use in Risk
Assessment
The Agency's Health Effects Division's Toxicological Endpoint
Selection Committee (document dated April 4, 1996) concluded the
following for propoxur:
(1) Dietary Exposure
An acute dietary exposure (1 day) endpoint of 0.15 mg/kg
was selected from a published study involving human volunteers
(Bull. Wld. Hlth. Org. 1971, 44, 241-249). Symptoms (blurred
vision, nausea, sweating, increased blood pressure, vomiting)
occurred in a 42-year-old 90-kg male who ingested 1.5 mg/kg;
effects were most pronounced 30-45 minutes after ingestion. There
was RBC inhibition of 73% 15 minutes after ingestion. Two hours
after ingestion, RBC ChE activity was essentially normal. A single
dose of 0.36 mg/kg caused a 43% drop in RBC ChE activity, with
transient stomach discomfort, blurred vision, moderate facial
redness and sweating. RBC ChE was normal within 3 hours. Five
doses of 0.15 or 0.2 mg/kg at half-hour intervals resulted in
transient RBC ChE depressions. The 0.15 mg/kg dose resulted in
the occurrence of 40% RBC ChE inhibition.
(2) Occupational and Residential Exposures
For short term (1-7 day), intermediate term (1 week to
several months), and chronic term (several months to lifetime)
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dermal occupational and residential exposures, a NOEL of > 1000
mg/kg/day is appropriate, based on the subchronic dermal toxicity
of propoxur to rabbit study. The lack of toxic effects observed in
this study is indicative of the low level of actual dermal absorption
and the rapid rate at which propoxur is metabolized. It is noted that
while propoxur is absorbed through the skin, it is also rapidly
metabolized (or detoxified in terms of it's cholinesterase-inhibiting
potential).
A risk assessment for dermal exposure of any duration is not
required because no adverse effects were seen at the highest dose
tested. The study indicates very low absorption potential and/or
hazard by the dermal exposure route.
For short term (1-7 day), intermediate term (1 week to
several months), and chronic term (several months to lifetime)
inhalation occupational and residential exposures, an appropriate
endpoint for risk assessment for inhalation exposure would be the
NOEL of 2.2 mg/m3 from the chronic inhalation studies (MRIDs
42648001, and 43398501). This is based on significant plasma,
RBC, and brain cholinesterase inhibition. However, a risk
assessment for inhalation exposure is not required because the vapor
pressure of propoxur is extremely low, and the registered uses of
propoxur are such that significant human exposure via the
inhalation route is not expected.
k. Reference Dose
The Agency's Reference Dose (RfD)/Peer Review Committee
(document dated September 30, 1994) recommended that an RfD be
established based on a human study with a LOEL of 0.15 mg/kg, the
lowest dose tested (Bull. Wld. Hlth. Org. 1971, 44, pp 241-249). Multiple
doses of 0.15 and/or 0.2 mg/kg were associated with transient red blood
cell cholinesterase inhibition. At 0.36 mg/kg, administered as a single
dose, red blood cell cholinesterase was inhibited (43%) and clinical signs
were also evident. An uncertainty factor (UF) of 10 was applied to account
for intra-species variability and an additional UF of 3 was applied to
compensate for the lack of a NOEL. On this basis, the RfD was calculated
to be 0.005 mg/kg/day.
It should be noted that this chemical has been reviewed by the
FAO/WHO joint committee on pesticide residue (JMPR) in 1989 and an
acceptable daily intake (ADI) of 0.02 mg/kg/day was established based on
the acute no-effect level in humans. In the JMPR evaluation of the human
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study, the NOEL was considered to be 0.2 mg/kg/day since the depression
of erythrocyte cholinesterase did not exceed 20% and the recovery was
very rapid.
It appears, then, that the ADI value generated by the JMPR was
based on the same human study used by the Agency in generating the RfD
value. However, since the criteria used by the Agency in interpreting the
significance of cholinesterase inhibition are different from those used by the
international agency, the LOEL as determined by the Agency was,
probably, considered to be a NOEL by the JMPR for the same study.
Consequently, different uncertainty factors (or safety factors as they are
called by the JMPR) were applied by the two agencies to the same dose
level.
1. Carcinogenicity Classification and Risk Quantification
The Agency's OPP Health Effects Division Carcinogenicity Peer
Review Committee (CPRC) determined that propoxur should be classified
as Group B2, probable human carcinogen (document dated June 17, 1996).
The CPRC evaluated additional data from "special studies"
submitted by the registrant, in response to requirements and
recommendations made in the previous Peer Reviews. The CPRC
concluded that these additional data were inconclusive and did not support
reclassification of propoxur. The registrant also submitted a new study in
the mouse, in which administration of propoxur was associated with
significant increases in hepatocellular adenomas and combined
adenoma/carcinoma in males. Based on these data and in consideration of
the full weight-of-the-evidence, the CPRC concluded that the classification
of propoxur should remain as Group B2, probable human carcinogen.
Since the male rats did not have statistically significant differential
mortality with incremental doses of propoxur, the estimate of unit risk,
Q!*, was obtained by the application of the Multi-Stage model. The
estimate of unit risk, Qj*, was based upon tumors in the bladder
(papillomas and/or carcinomas) observed in male rats. For the conversion
to human equivalents, weights of .40 kg for the rat, 70 kg for humans and
the 3/4's scaling factor were used.
The revised unit risk, Qx* (mg/kg/day) * of propoxur, based upon
male rat bladder (papillomas and/or carcinomas) tumors is 3.69 x 10 3 in
human equivalents (converted from animals to humans by use of the 3/4's
scaling factor-1994). The dose levels used in the SPF rat study (8/84) were
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0, 200, 1000 and 5000 ppm of propoxur. The corresponding tumor rates
in the male rats were 0/57, 0/60, 1/59 and 34/57 respectively.
Dose-Response Analysis
Since the male rats did not have statistically significant differential
mortality with incremental doses of Baygon, the estimate of unit risk, Qj*,
was obtained by the application of the Multi-Stage model. The estimate of
unit risk, Qj*, was based upon tumors in the bladder (papillomas and/or
carcinomas) observed in male rats. For the conversion to human
equivalents, weights of .40 kg for the rat, 70 kg for humans and the 3/4's
scaling factor were used. It is to be noted that Qx* (mg/kg/day) * is an
estimate of the upper bound on risk and that (as stated in the EPA Risk
Assessment Guidelines) "the true value of the risk is unknown, and may be
as low as zero."
In addition, the findings from a mouse carcinogenicity study (MRID
42597701), demonstrating that propoxur was associated with statistically
significant increases in hepatocellular adenomas in males, are considered
as additional supporting evidence for the B2 classification.
2. Exposure Assessment
a. Dietary Exposure
The only food use for propoxur is the crack and crevice treatment
in food handling and processing establishments. No tolerances have been
established for residues of propoxur in/on any commodity. The registrant
has filed a food additive petition (9H5199, 10/16/78) which included
residue data that indicated the potential for residues in food adjacent to
areas subjected to crack and crevice and spot treatment. The registrant
requested a tolerance of 0.2 ppm in/on all foods. Food metabolism/
degradation studies have shown that the residue of concern is the parent
compound.
Sufficient data are available to support a 0.2 ppm tolerance from use
of propoxur in food processing plants and food handling establishments.
b. Occupational and Residential Exposure Assessment
An occupational and/or residential exposure assessment is required
for an active ingredient if (1) certain toxicological criteria are triggered and
(2) there is potential exposure to handlers (mixers, loaders, applicators,
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etc.) during use or to persons entering treated sites after application is
complete.
The endpoints identified for short-term, intermediate-term, and
chronic dermal and inhalation exposures do not require a risk assessment
as discussed previously. Propoxur is considered to be a B2 carcinogen with
a Q* of 3.7 x 103.
The occupational and residential risk assessment for this RED
document reflects the final Special Review Decision not to Initiate a Special
Review (FR No. 40, Vol 61, February 28, 1996) and the toxicological
conclusion that a non-cancer risk assessment for dermal and inhalation
exposure for any duration is not warranted. The Agency decided not to
initiate a Special Review of propoxur because the highest risk uses have
been eliminated and the estimated excess life time cancer risks for the
remaining uses did not exceed the Agency's level of concern.
Occupational-use products and homeowner-use products
At this time products containing propoxur are intended for
occupational and homeowner uses. Propoxur is not a Restricted Use
Pesticide.
(1) Applicator Exposure
The primary routes of human exposure for handlers and
residential applicators from treating buildings with propoxur are
dermal and inhalation. Residues may be found on surfaces to which
propoxur has been applied. Inhalation exposure occurs from
breathing propoxur vapors or dust during and following application
of propoxur products. Pest Control Operators (PCOs) and
Residential Applicators (RAs) are exposed primarily during the
mixing, loading, and application of propoxur products to the
interior or around the exterior of buildings. Kennel workers are
exposed while treating animals.
EPA assessed human handler exposure to propoxur using
data obtained from several sources, including studies submitted by
Miles Inc. (now Bayer) in response to the 1987 Data Call-In, data
from the technical literature, and surrogate data. The data base for
propoxur handler studies is complete (MRIDs 42087201, 41054701,
41054702, 41054703, 41054704, 41054705, and 41858201). The
estimates of exposure for Pest Control Operators (PCOs) and
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Residential Applicators (RAs) are discussed below and displayed in
Table 2.
Crack and crevice study of PCO exposure
In this study, PCOs used a compressed air sprayer to apply
a wettable powder formulation of propoxur. The PCOs wore
chemical-resistant gloves, cotton/polyester coveralls over a long
sleeved shirt and long pants, and leather boots. Dermal exposure
was monitored using gauze patches inside and outside clothing. In
this study, coveralls were not considered to be baseline PPE,
because they were used for monitoring purposes only. Levels of
residues on PCOs' hands were measured using an ethanol
handwash. Inhalation exposure was measured by using personal
sampling devices located in the applicator's breathing zone.
Inhalation exposure was found to be negligible compared to dermal.
To estimate PCO exposure to wettable powders, EPA
supplemented the crack and crevice data with additional
assumptions as follows: the average PCO weighs 70 kg, works 8
hours per day over a 20-year working-life of a 70-year life-span,
and handles 924 oz. a.i. per year. Dermal absorption was assumed
to be 20 percent based on the human study. Dermal exposure was
estimated at 2.1 x 103 mg/kg/day.
EPA determined that Ready-to-Use (RTU) liquid products
are applied at rates similar to the wettable powder formulations, and
residues are not expected to be higher or more persistent than those
from the wettable powder formulation. Therefore, the exposure
estimate for the wettable powders can be used for the RTUs.
Granular bait study
Granular baits are scattered on paper, pasteboards, or on the
floor. Baits are used near baseboards, in closets, under sinks and
refrigerators, around structures, patios, sidewalks and other places
where insects may be. In this study, PCOs wore gloves,
long-sleeved shirts, cotton trousers, and baseball caps over normal
clothing which consisted of denim or cotton trousers, long sleeved
shirts and shoes. Dermal exposure was measured using gauze
patches worn both inside and outside the clothing. Residues on the
hands were measured using an ethanol handwash. Airborne
residues were determined by drawing air from the breathing zone.
Propoxur residues were not detected in most of the samples
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analyzed for dermal or respiratory exposure. EPA determined
under these conditions that the exposure would be negligible for
PCOs.
Aerosol spray study of Residential Applicator (RA)
In this study, the contents of an aerosol can were sprayed
into cracks, crevices, baseboards, under sinks, and in other places
where insects might be found. Applicators wore long sleeved
shirts, long pants, shoes, and baseball caps. Dermal exposure data
were gathered from gauze patches attached both outside and inside
the clothing and on the cap. Hand exposure data were gathered
from an ethanol handwash. Respiratory exposure data were
gathered from microfilters contained in a cassette attached to the
lapel of the applicator.
For RA exposure to aerosols EPA used additional
assumptions to calculate exposure as follows: the RA weighs 70 kg,
breathes 1.7 m3 of air per hour, uses up the contents of an entire
can of aerosol with each use, uses four cans per year, and during
application wears a short sleeve shirt, shorts, and shoes. Residues
below the level of detection were assumed to be present at one-half
the level of detection. The RA was assumed to apply propoxur
every year from age 18 to age 70. RAs were exposed for 1 hour
per application through dermal and inhalation exposure. Dermal
absorption was assumed to be 20 percent because a homeowner
applicator is assumed to remain in the residence following
application. Exposure was calculated at 8.4 x 10 5 mg/kg/day.
EPA also considered RA exposures for outdoor application
of propoxur aerosols, which are designed to eradicate hornet and
wasp nests around buildings and homes. These products are
generally equipped with a delivery system that will allow the
operator to apply the aerosol at a safe distance from the nest. An
applicator of these formulations of propoxur is likely to be exposed
for a shorter time than would occur with indoor use products. It is
also likely that the formulations would dissipate more quickly than
similar formulations used indoors. Thus, the exposure and
corresponding risk from outdoor aerosol uses can be expected to be
lower than is estimated for those used in indoor treatments.
For RTU liquid application by RAs EPA has used the
aerosol spray study to calculate the maximum exposure RAs incur
when applying RTU liquids with a compressed air sprayer to cracks
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and crevices. EPA assumed that the RA would wear a short
sleeved shirt, shorts, shoes, and no gloves and would apply an RTU
liquid four times per year. Only dermal exposure data were used
to calculate exposure, because inhalation exposure was considered
to be negligible. Exposure was estimated at 8.4 x 10 5 mg/kg/day.
If the RA applicator wears clothing similar to a PCO, that is, long
sleeved shirt, long pants, and gloves, dermal exposure would be
less.
For granular products applied by RAs. Some granular
products are registered for use in and around the home (including
limited outdoor application to driveways, sidewalks, patios, and
foundations). They are not applied by general broadcast treatment
indoors or in large quantities. EPA believes that potential dermal
exposure would not exceed that received from an aerosol spray can
while wearing a long sleeve shirt and long pants. Respiratory
exposure would be negligible. Exposure from the limited outdoor
applications is not expected to be greater than indoor exposure.
The limited outdoor use still permitted is expected to present
negligible exposure to RAs.
Aerosol pet spray study
In this study, exposures of five workers using an aerosol
spray containing propoxur were measured. Each worker wore a
shirt with long or short sleeves and pants, but no other protective
clothing. Urine was collected from each subject over a 24 hour
period and analyzed for the propoxur metabolite isopropoxyphenol.
This is the same as 2-isopropoxyphenol or M2 discussed in the
metabolism section. Metabolism studies show that propoxur is
rapidly absorbed following ingestion and that it is readily
metabolized.
For kennel workers an exposure estimate is not presented
here because the Agency does not believe pet aerosol products are
routinely used by kennel workers. In addition, propoxur is no
longer used in pet shampoos and dips.
In order to calculate lifetime exposure for pet owner
applicators, EPA supplemented the mean exposure data from the
aerosol exposure study with the following additional assumptions.
Pet owners were assumed to weigh 70 kg, wear long sleeved shirts
and long pants during application, and treat one dog four times per
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year over a 70-year lifetime. Exposure was estimated at 6.4 x 103
mg/kg/day per application day.
Other Applicator Exposure
Applicator exposure estimates for PCOs and RAs from
impregnated strips, shelf paper, enclosed or containerized baits, and
tick and flea collars have not been estimated but are believed to be
negligible.
(2) Post-application/Residential Exposure
Other Post-application Exposure Estimates
Residents' (including childrens') post-application exposures
from shelf paper, enclosed or containerized baits, and other pet
products, including aerosols, have not been estimated but are
believed to be negligible. In addition, EPA believes post-
application exposure to granular products will not exceed that from
aerosol and would probably be much less.
Crack and crevice study of post-application exposure.
A study of post-application residential exposure following a
crack and crevice and limited structural surface treatment by
commercial applicators was reviewed and found acceptable.
Exposures were calculated for three categories of residents based on
their ages: an infant, a 12 year old child, and an adult:
• The infant was assumed to weigh 7.5 kg, have a body
surface area of 4.8 ft2, and have a respiratory volume of 0.5
rnVhr.
• The child was assumed to weigh 40.5 kg, have a body
surface area of 14.8 ft2, and have a respiratory volume of
0.9 rnVhr.
• The adult was assumed to weigh 70 kg, have a body surface
area of 21 ft2, and have a respiratory volume of 1.0 mVhr.
In addition, they were assumed to be exposed 24, 15, and 15
hours/day, respectively. Assumptions about clothing were not
specified; rather dermal exposure was expected to occur over 20
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percent of the body surface. Individuals were assumed to contact
a 50 square foot contact area in a 4-hour interval. Exposure was
assumed to occur 365 days/year.
To calculate exposure following application of wettable
powders to cracks and crevices, EPA assumed that 64 oz. of a 1.1
percent solution by weight (total of 0.73 oz.) would be applied once
a year for cleanout treatment and 16 oz. of a 0.5 percent solution
by weight (total of 0.083 oz.) would be applied 11 times a year for
maintenance treatments. Residents were assumed to be exposed 365
days per year over a 70-year lifetime. Dissipation was assumed to
be 60 percent, and dermal absorption was assumed to be 20 percent
of the residue on skin surfaces, because dermal absorption increases
with length of time exposed.
To calculate concentrations of propoxur in the air of treated
houses, EPA pooled air concentration data for all rooms to yield an
average air concentration of 5.1 |ig/m3. Absorption by the
inhalation route was assumed to be 100 percent. The hours/day of
inhalation exposure were the same as for dermal exposure. Total
dermal and inhalation exposure was calculated at 1.4 x 104
mg/kg/day.
For RTU liquids EPA used the wettable powder exposure
assessment. EPA also estimated post-application exposure
following 12 applications per year of a 0.5 percent RTU product by
a PCO. To estimate post-application exposure to an RA, this PCO
estimate was reduced by a factor of three. Exposure was estimated
at 3.7 x 105 mg/kg/day.
To estimate a post-application exposure from the use of
aerosols, EPA used the post-application exposure data from the
crack and crevice spray study as a surrogate. EPA adjusted the
crack and crevice data to reflect the quantity of a.i. applied during
application of a 16 oz. can of 1 percent propoxur aerosol four times
per year for 70 years. Total dermal and inhalation exposure was
estimated at 2.3 x 10 5 mg/kg/day.
Pest Strip Study
For pest strips, EPA assumed that dermal exposure is
negligible and 100 percent of propoxur inhaled by the individual is
absorbed. Furthermore, the individual was assumed to be exposed
24 hours/day, 365 days/year for 70 years of an average lifetime,
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and the strips replaced when efficiency diminishes. EPA believes
these exposure estimates are conservative because the only
remaining registrations for pest strips are in areas where human
exposure is minimal, such as communications boxes. Inhalation
exposure was estimated at 1.1 x 104 mg/kg/day.
EPA estimated exposure to residents exposed to pet collars
using surrogate data based on propoxur pest strips and dog aerosol
spray treatment data. EPA assumed that respiratory absorption is
100 percent, and the exposure is constant over a 70-year lifetime.
Inhalation exposure was estimated at 6.3 x 106 mg/kg/day.
Other Post-application Exposure Estimates
Residents' (including childrens') post-application exposures
from shelf paper, enclosed or containerized baits, and other pet
products, including aerosols, have not been estimated but are
believed to be negligible. In addition, EPA believes post-
application exposure to granular products will not exceed that from
aerosol and would probably be much less.
Handler and Post-Application Data Requirements
At this time the handler and post-application exposure data
bases for propoxur are complete and no additional studies are
required.
Table 2. Propoxur Uses and Exposure Estimates for PCOs, RAs, Pet Owners,
and Residents of Treated Homes.
Use
Crack and Crevice
Aerosols
Granular Baits
Pet Aerosols
Pest Strips
Shelf Paper
Enclosed or
Containerized Baits
Pet Tick and Flea Collars
Applicator
PCO
RA
RA
PCO
RA
Pet Owner
RA
RA
PCO
RA
RA
Applicator Exposure
(mg/kg/day)
2.1x 10 3a
8.4 x 10 5a
8.4 x 10 5a
negligible
negligible
6.4 x 10 3
negligible
negligible
negligible
negligible
negligible
Resident Post- Application
Exposure (mg/kg/day)
l.lx 104a,b
3.7 x 10 5a,b
2.3 x 105a,b
negligible
negligible
negligible
l.lx 104
negligible
negligible
negligible
6.3x 10 6
1 Dermal absorption is assumed to be 20 percent.
b Dermal contact area is assumed to be 50 square feet
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3. Risk Assessment
a. Dietary
Acute Dietary Risk
While an acute exposure from the crack and crevice use of
propoxur in food handling establishments is possible, it is not likely
to result in any exposures of consequence. Therefore, the Agency
has not conducted an acute dietary risk assessment for propoxur.
Also, the current analysis used to estimate acute dietary exposure
and risk, the DRES system, is not capable of accurately estimating
risks from the use of a pesticide in food handling establishments.
The underlying assumption that would need to be made for such an
analysis, that all commodities that are consumed on any given day
will contain tolerance level residues of pesticides used in a food
handling establishment, is unreasonable and unrealistic. Residues
resulting from pesticide use in food handling establishments are not
likely to result in incidental contamination of all foods at tolerance
levels on a uniform and consistent basis and not all foods consumed
by an individual in a day are likely to have come from a food
handling establishment that has been treated.
The Agency asked the Scientific Advisory Panel (SAP) to
comment on this policy because: the tools/process/information
needed to perform such a risk assessment do not exist at this time;
and, while there exists the potential that an acute exposure could
occur as a result of food handling uses, the Agency believes that
this situation is unlikely. The SAP at their September 27, 1995
meeting, agreed that the exclusion of a residue value for food
handling establishments when performing acute dietary risk
assessments is reasonable. The panel agreed that inclusion of such
a value would likely be a gross over-estimate of acute dietary
exposure.
Chronic Dietary Risk
The DRES chronic analysis used the proposed tolerance
level of 0.2 ppm to calculate the Theoretical Maximum Residue
Contribution (TMRC) for the overall U.S. population and 22
population subgroups. Of these subgroups non-nursing infants (< 1
year old) is the most highly exposed subgroup. Refinements in
percent crop treated information were considered in calculating the
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Anticipated Residue Contribution (ARC) for those same population
subgroups. Non-nursing infants is again the most highly exposed
subgroup. The ARC is considered the more accurate estimate of
dietary exposure. These exposure estimates were then compared to
the RfD for propoxur to calculate estimates of dietary risk.
Using Tolerances:
The TMRC for the overall U.S. population and the two
most highly exposed subgroups from the proposed tolerance being
supported in reregistration are listed below.
Overall U.S. population: 139.4% RfD;
Non-nursing infants (< 1 year old): 352.6% RfD;
Children, 1-6 years: 322.1% RfD
Using Anticipated Residues:
The ARC for the overall U.S. population and the two most
highly exposed subgroups from the proposed tolerance being
supported in reregistration are listed below.
Overall U.S. population: 1.84% RfD;
Non-nursing infants (< 1 year old): 7.23% RfD;
Children, 1-6 years: 4.43% RfD
Cancer Dietary Risk
Using the same assumptions, the total cancer risk estimate
for propoxur used in food handling establishments for the overall
U.S. population is 3.4 x 107.
b. Occupational and Residential Risk Characterization
Using the exposure estimates discussed above and the Qx* for
propoxur, EPA estimated the excess lifetime cancer risks to applicators and
residents of treated homes. Risk estimates are displayed in Table 3 below.
The Agency issued a final decision not to initiate a Special Review
for Propoxur in February, 1996. The risk calculations for the crack and
crevice and aerosol uses in that document used a 50% dermal absorption
factor. Current data available to the Agency based on a human study
suggest that a 20% dermal absorption factor is more appropriate. The
calculations in Table 3 reflect the 20% factor for the crack and crevice and
33
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aerosol uses. Further, the risk calculations in the Special Review final
decision did not incorporate an interspecies scaling factor when estimating
the Qj*. This factor adjusts the Q * by a ratio of body surface to body
weight. Its exact value depends on the animal test species used. The Qx*
used in the Special Review document was based on the geometric mean of
tumor rates in both the male and female rats. The current Qx* is based on
the highest tumor rate, which was seen in the male rats. These adjustments
to the risk calculations have not changed the Agency's basic conclusions
regarding the occupational and residential risks from propoxur.
Estimated cancer risks to residents of buildings treated with
propoxur ranged from 2.3 x 108 to 2.6 x 10 7. Estimated cancer risk for
PCOs while applying propoxur to cracks and crevices is 7.7 x 106. Labels
will require PCOs to wear long sleeved shirts, long pants, chemical
resistant gloves, and shoes plus socks. The Agency believes there are no
other reasonable protective clothing requirements which can be required to
reduce the risk further.
Technical propoxur is considered to be Toxicity Category III or IV
for dermal, inhalation, eye and skin irritation. Propoxur is not considered
to be a skin sensitizer. The endpoints identified for short-term,
intermediate-term and chronic dermal and inhalation exposures do not
require a risk assessment because no adverse effects were seen at the
highest dose tested in the subchronic dermal study and because the vapor
pressure of propoxur is low.
Estimated cancer risks are presented below in Table 3.
Table 3. Propoxur Uses and Estimated Excess Lifetime Cancer Risks for PCOs, RAs,
Pet Owners, and Residents of Treated Homes.
Use
Crack and Crevice
Aerosols
Granular Baits
Pet Aerosols
Pest Strips
Shelf Paper
Enclosed or Containerized Baits
Pet Tick and Flea Collars
Applicator
PCO
RA
RA
PCO
RA
Pet Owner
RA
RA
PCO
RA
RA
Estimated
Applicator Risk
7.7 x 106
3.1x 10 7
3.1x 10 7
negligible
negligible
2.6x 10 7
negligible
negligible
negligible
negligible
negligible
Estimated Resident
Post-Application Risk
4.1x 10 7
1.4x 10 7
8.4 x 10 8
negligible
negligible
negligible
4.1x 10 7
negligible
negligible
negligible
2.3x 108
Estimated Total
Residential Risk3
4.1x 10 7
4.5x 10 7
3.9x 10 7
negligible
negligible
2.6x 10 7
4.1x 10 7
negligible
negligible
negligible
2.3x 108
a When application is by PCO, total residential risk includes only risk from post-application exposure as the PCO is
assumed to have left the treated house. When application is by RA, total residential risk includes both RA risk and
post-application risk, as the RA is assumed to stay in the treated house.
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4. Food Quality Protection Act (FQPA) Considerations
The Food Quality Protection Act of 1996 (FQPA) amended the FFDCA by
setting a new safety standard for the establishment of tolerances. In determining
whether a tolerance meets the new safety standard, section 408(b)(2)(C) directs
EPA to consider information concerning the susceptibility of infants and children
to pesticide residues in food, and available information concerning aggregate
exposure to infants and children of such residues, as well as the potential for
cumulative effects from pesticide residues and other substances that have a
common mechanism of toxicity.
The FQPA amendments to section 408 (b) (2) (C) require EPA to apply an
additional 10-fold uncertainty (safety) factor unless reliable data demonstrate that
the additional factor is unnecessary to protect infants and children.
Section 408 (b) (2) (D) establishes factors that the Agency must consider in
determining whether the safety standard is met in deciding to issue or reassess
tolerances. These factors include the consideration of available information on the
aggregate exposures to the pesticide from dietary sources including drinking water
as well as non-occupational exposures such as those derived from pesticides used
in and around the home. The Agency must also consider the potential cumulative
effects of the pesticide for which a tolerance is being sought as well as other
substances that have a common mechanism of toxicity.
Because propoxur has food uses, specific consideration of potential risks
to infants and children, as well as cumulative and aggregate exposures, is
warranted.
a. Potential Risks to Infants and Children
In determining whether an additional uncertainty factor is or is not
appropriate for assessing risks to infants and children, EPA uses a weight
of evidence approach taking into account the completeness and adequacy
of the toxicity data base, the nature of the effects observed in pre- and post-
natal studies, and other information such as epidemiological data.
For purposes of assessing the pre- and post-natal toxicity of
propoxur, EPA has evaluated two developmental and two reproduction
studies. Based on current toxicological data requirements, these studies
when considered along with other required toxicity studies, constitute a
complete data base for evaluating pre- and post-natal effects for food use
chemicals. However, as EPA fully implements the requirements of FQPA,
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additional data related to the special sensitivity of infants and children may
be required.
Developmental and Reproductive Effects
The effects observed in the propoxur developmental and
reproduction studies can be summarized as follows:
In a developmental toxicity study, propoxur was administered by
gavage on gestation days 6 through 15 to pregnant Wistar/HAN rats at 0,
3, 9, or 27 mg/kg/day. No maternal toxicity was observed at the low dose
(3 mg/kg/day). At the mid dose (9 mg/kg/day) maternal toxicity was
evident in increased cleaning activity, chewing motions, grinding of teeth,
reduction in food consumption, and a marginal decrease in mean body
weight gain for days 6-16. At the high dose (27 mg/kg/day), signs of
maternal toxicity included mortality (3/25 dams, with one death after the
first administration on day 6, and two deaths after the second
administration on day 7), symptoms similar to those observed in the mid-
dose group and, additionally, tremors and ventral recumbency. In
addition, there was a significant reduction in mean food consumption for
days 6-16, and a decrease in mean body weight gain from day 6 through
day 16. There were no indications that propoxur was embryotoxic,
fetotoxic, or teratogenic at doses up to and including 27 mg/kg. Under the
conditions of this study, the NOEL was 3 mg/kg/day for maternal
toxicity, and 27 mg/kg/day (highest dose tested) for developmental
toxicity. The LOEL for maternal toxicity was 9 mg/kg/day and > 27
mg/kg/day for developmental toxicity.
In a developmental toxicity study, chinchilla rabbits were given
propoxur at 0, 3, 10, or 30 mg/kg/day by gavage on gestation days 6
through 18. No maternal, embryo, fetal or developmental toxicity was
observed at the 3 or 10 mg/kg/day dose levels. At the high dose (30
mg/kg/day) maternal toxicity was characterized by mortality (3/16 dams
died during the dosing period) and clinical signs (dyspnea and restlessness),
and slight decreases in mean body weight and food consumption.
Embryo/fetotoxicity was suggested by a slight (not statistically significant)
post-implantation loss, and a corresponding reduction in the mean number
of pups per dam. No treatment-related effects were observed on fetal body
weights or sex ratios. Propoxur did not induce any external, visceral or
skeletal malformations at any of the doses tested. Under the conditions
of this study, the NOEL was 10 mg/kg/day for maternal and
developmental toxicity. The LOEL was 30 mg/kg/day for both
maternal and developmental toxicity.
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In a 2-generation reproductive toxicity study, Wistar rats were fed
propoxur (99.4%) at concentrations of 0, 9.7, 48.1, and 238.9 mg/kg/day
for the PI females and 0, 8.8, 43.7, and 228.3 mg/kg/day for Fl females
in their diet for a 70-day pre-mating period, then through mating,
gestation, and lactation. The reproductive NOEL was 45 mg/kg/day,
and the LOEL was 233 mg/kg/day based on a reduced mean number
of implantation sites/dam and a reduced mean number of pups/dam in
the Fl females. The developmental NOEL is also 45 mg/kg/day and
the LOEL 233 mg/kg/day based on reduced mean Fl and F2 pup body
weights at birth. Other effects noted were body weight reductions at 45
mg/kg/day parental in Fl males and Fl females. Dose-related urothelial
hyperplasia was observed at 233 mg/kg/day. A NOEL for parental toxicity
was not observed as RBC ChE was significantly reduced in 9.3 mg/kg/day
males of the parental generation; it was reduced in 9.3 mg/kg/day males of
the Fl generation; brain ChE was significantly reduced in Fl females.
Plasma ChE was significantly reduced in 45 and 233 mg/kg/day Fl
females; RBC ChE was significantly reduced in both sexes of the parental
and Fl at 45 and 233 mg/kg/day, and brain ChE was significantly reduced
in parental males at 45 and 233 mg/kg/day, in parental females at 233
mg/kg/day, in Fl males at 233 mg/kg/day, and in all doses of the Fl
females.
In a subsequent 2-generation study, propoxur (99.8%) was
administered in the diet to groups of 25 male and 25 female Wistar rats at
concentrations of 0, 30 or 80 ppm (males: 0, 2, or 7 mg/kg/day; females:
0, 3, or 8 mg/kg/day), with selection for an Fl generation (25 males and
25 females per group) which were maintained on their respective parental
diets while producing F2 litters. No compound-related reproductive
toxicity was observed. For Fl males there was a significant decrease in
mean RBC ChE activity. The NOEL for ChE inhibition was
approximately 2.5 mg/kg/day and the LOEL was 7 mg/kg/day.
The developmental data for propoxur indicate that there is no
evidence of an increased sensitivity to propoxur from pre- or post-natal
exposures. In the rat developmental toxicity study, no developmental
effects were noted at the highest dose tested at which significant maternal
effects were noted (e.g., mortality, tremors, ventral recumbency,
reductions in food consumption and mean body weight gains). In the rabbit
study, possible developmental toxicity was noted at the highest dose tested
(slight increase in postimplantation loss with a corresponding reduction in
mean fetuses per dam) in the presence of significant maternal toxicity
including mortality, dyspnea, restlessness and slight decreases in mean food
consumption and mean body weight. Further, no enhanced post-natal
sensitivity was observed in a two generation reproduction study in which
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reproductive effects (reductions in mean pup numbers in Fl females) were
noted at the highest dose tested whereas, parental toxicity (RBC and/or
brain cholinesterase) was observed at all doses tested (i.e., a NOEL was
not established).
Uncertainty Factor
Based on the reliable data outlined above, the Agency concludes that
an additional uncertainty factor is not warranted for the propoxur chronic
risk assessment, nor is the use of an additional uncertainty factor indicated
for estimating risk from acute or short-term exposures detailed below.
(1) Aggregate (Multipathway) Exposure
In examining aggregate exposure, FQPA directs EPA to
take into account available information concerning exposures from
pesticide residues in food and other exposures for which there is
reliable information. These other exposures may include drinking
water and non-occupational exposures, e.g., to pesticides used in
and around the home.
Propoxur has both food and non-occupational uses;
therefore, the possible considerations for aggregate exposure are
those from food, drinking water, and residential (non-occupational)
sources.
Propoxur products provide contact and residual control of
common indoor insects such as ants and cockroaches. Residential
uses include the control of fleas and ticks on pets, as a wasp and
hornet spray, and as a crack and crevice application to and around
building surfaces and foundations, patios, driveways and sidewalks.
The only food use for propoxur is as a crack and crevice treatment
to food areas of food handling establishments.
Acute Dietary Risk - Food Source: While an acute dietary
exposure from the crack and crevice use of propoxur in food
handling establishments is possible, it is not likely to result in any
exposures of consequence. Therefore, the Agency has not
conducted an acute dietary risk assessment for propoxur.
Chronic Dietary Exposure - Food Source: The only food use for
propoxur is as a crack and crevice treatment for food handling
establishments. No tolerances have been established for residues of
propoxur in/on any commodity. The registrant has filed a food
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additive petition (9H5199, 10/16/78) under Section 409 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) which included
residue data that indicated the potential for residues in food adjacent
to areas subjected to spot, crack and crevice treatment. The
registrant requested a tolerance of 0.2 ppm in/on all foods. Due to
the enactment of the Food Quality Protection Act (August 1996) all
tolerances are now required to be established under section 408 of
the FFDCA.
Chronic Dietary Exposure - Drinking Water Source: According to
the Agency's Pesticides In Ground Water Database, 21,405 samples
from wells in five states have been analyzed for residues of
propoxur. There were only five detections of propoxur from these
21,405 samples. Based on the low percentage of detections
(0.02%) the Agency has no concerns for drinking water exposure
to propoxur from groundwater.
Propoxur has been detected in 85 of 624 surface water
samples analyzed (STORET, 1988). Samples were collected at 21
surface water locations. The maximum concentration found in
surface water was 0.96 |ig/L. However, these data were collected
at a time when propoxur was registered for use on ornamentals,
lawns/turf and mosquito control. Since the time these data were
collected, all propoxur outdoor broadcast uses have been canceled.
Therefore, considering the low surface water concentrations found
when broadcast applications were registered, and the lower
likelihood of surface water residues resulting from remaining uses,
surface water contamination with propoxur is not expected to be a
drinking water risk concern.
Non-occupational Exposure: Propoxur products are available for
use by homeowners. Homeowner uses include crack and crevice
treatments, and pet sprays. Products are sold as aerosols, dusts and
powders, pest strips, shelf paper, ready-to-use solutions, granular
baits, containerized bait, and tick and flea collars.
EPA has determined that there is a potential for dermal and
inhalation exposure to homeowners during and after use of
propoxur. Homeowners are exposed primarily during application
of propoxur in and around the home and while treating pets.
Residents of treated buildings are exposed to airborne and surface
residues following application. Exposures could also occur from an
oral route from residues on food, food preparation surfaces, or
other objects such as toys.
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Chemical-specific data for some residential handler exposure
and residential post-application exposure scenarios are available for
propoxur non-occupational exposure scenarios. Where there were
no data in the Agency's files, the Agency supplemented existing
exposure data with assumptions to determine the exposure potential
of these scenarios. These assumptions included weight of the
applicator, type of clothing worn by the applicator, treatment
duration, frequency of treatment, body surface area and respiratory
volume. For a detailed description of exposure scenarios and
assumptions used, see Federal Register Vol. 60, No. 9, pages 3210-
3220.
Resident post-application exposure values ranged from
1.1 x 104 to 6.3 x 106 mg/kg/day. Residential applicator exposure
values ranged from 6.4 x 103 to 8.4 x 105 mg/kg/day. In many
cases exposure was determined to be negligible.
Chronic and Short-term Non-occupational risk: Risk assessments
for chronic (non-cancer) and short-term, dermal and inhalation
exposures to propoxur were not required because no adverse effects
were seen at the highest dose tested of 1000 mg/kg/day in a dermal
study, the vapor pressure of propoxur is extremely low, and the
registered uses of propoxur are such that significant human
exposure via the dermal or inhalation route is not expected.
Chronic Dietary Risk, food source: A chronic dietary risk
assessment was conducted for the crack and crevice treatment of
propoxur in food handling establishments. The proposed tolerance
level of 0.2 ppm was used in the DRES analysis. Refinements in
percent crop (2%) treated information were considered in
calculating the Anticipated Residue Contribution (ARC). The
proposed tolerance results in a ARC (% CT only) which represents
1.84% of the RfD for the U.S. general population, 7.23% for non-
nursing infants (< 1 year old), and 4.43% for children 1-6 years
old.
Cancer Dietary Risk, food source: Propoxur is classified as a B2
carcinogen for which the carcinogenic potential has been quantified
at 3.7 x 103. The cancer risk estimated for the general U.S.
population considering 2% crop treatment for propoxur is
3.4x 107.
Conclusions Regarding Aggregate Risk to Propoxur
The total dietary cancer risk using the proposed tolerances
for the overall U.S. population is 3.4 x 10 7. Significant levels of
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propoxur are not expected in surface or ground water so dietary
risk from drinking water will be negligible.
For the non-occupational uses of propoxur which include
crack and crevice treatments, aerosols, tick and flea collars, and
spot treatment the Agency assumes that minimal exposure may
occur. Using combined residential applicator and resident
(including children) post-application exposure estimates the Agency
calculated that the lifetime cancer risks from exposures to propoxur
ranged from 2.3 x 108 for tick and flea collars to 4.5 x 107 for
crack and crevice treatment.
When the dietary and residential uses are combined the
cancer risk to propoxur products ranges from 3.6 x 10 7 to 7.9
x 10 7.
The Agency concludes that aggregate risks to the general
U.S. population, and to the population subgroups of infants and
children, resulting from propoxur uses are not of concern.
(2) Cumulative Effects
Propoxur is structurally similar to other carbamates such as
carbaryl, methomyl, carbofuran, methiocarb, aminocarb,
bendiocarb, and IPBC. Further, other pesticides may have
common toxicity endpoints with propoxur.
The Agency has not made a determination whether propoxur
and any other pesticide have a common mechanism of toxicity for
either cancer or non-cancer effects and require cumulative risk
assessment. For the purposes of this Reregistration Eligibility
Decision document, the Agency has considered only risks from
propoxur. If required, cumulative risks will be assessed when
methodologies for determining common mechanism of toxicity and
for performing cumulative risk assessment are finalized.
C. Environmental Assessment
1. Ecological Toxicity Data
To support the currently registered uses of propoxur (indoor and residential
outdoor), six basic studies are required. Acceptable data are available for each of
these guidelines, and no further testing is required. Some additional ecotoxicity
data which either meet existing guidelines or provide useful information (e.g.
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supplemental studies) are included in this assessment. Results of studies
determined to be unacceptable by the Agency are not included in this assessment.
Toxicity Summary:
Based on the results of studies using the TGAI, propoxur is categorized as
very highly toxic to birds on an acute basis (some LD50s are < 10 mg/kg); highly
toxic to birds on a subacute dietary basis (an LC50 is in the range of 51-500 ppm);
moderately toxic to freshwater fish (some LC50s are in the range of > 1-10 ppm);
and very highly toxic to freshwater invertebrates (daphnid EC50 is < 1 ppm).
a. Toxicity to Terrestrial Animals
An acute oral toxicity study using the technical grade of the active
ingredient (TGAI) is required to establish the toxicity of propoxur to birds.
The preferred test species is either the mallard duck (a waterfowl) or the
bobwhite quail (an upland gamebird). Results of tests conducted with the
TGAI and a formulated 2% bait product are tabulated below. Formulated
product testing is not required to support residential outdoor use.
(1) Birds, Acute and Subacute
Table 4. Avian Acute Oral Toxicity
Species
Mallard duck
Bobwhite quail
Canada goose
Sharp-tailed grouse
California quail
Japanese quail
Pheasant
Chukar
Sandhill crane
Rock dove
House sparrow
Mourning dove
House finch
Dark-eyed j unco
%ai
98
2 (bait)
87
97
97
97
98
98
98
97
97
97
97
97
LD50 (mg ai/kg)
9.44
23 (mg ai/kg)
1005 (formulated product)
5.95
120
25.9
28.3
20
25.8
60.4
60.4
12.8
4.2
3.55
4.76
Toxicity Category
very highly toxic
very highly toxic
very highly toxic
moderately toxic
highly toxic
highly toxic
highly toxic
highly toxic
highly toxic
highly toxic
highly toxic
very highly toxic
very highly toxic
very highly toxic
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Technical propoxur ranges from moderately toxic to very
highly toxic on an acute oral basis. Except for the bobwhite quail
data, all data are supplemental although data are derived from
scientifically sound studies. Collectively the data fulfill the
guideline requirement. The guideline (71-1) is fulfilled (MRIDs
00160000 and 41625101).
Two subacute dietary studies using the TGAI are required
to establish the toxicity of propoxur to birds. The preferred test
species are mallard duck and bobwhite quail. Results of these tests
are in Table 5.
Table 5. Avian Subacute Dietary Toxicity
Species
Northern bobwhite quail1
Mallard duck1
Northern bobwhite quail2
Japanese quail2
Ring-necked pheasant2
Mallard2
%ai
unknown
98.8
unknown
unknown
unknown
unknown
5-Day LC50 (ppm)
2828
>5000
206
>5000
approx. 1750
<1000
Toxicity Category
slightly toxic
practically non-toxic
highly toxic
practically non-toxic
slightly toxic
moderately toxic
1 These studies by Lamb, 1981 (MRIDs 42757101, 42301201 and 0149015) are classified supplemental.
2 These studies by Hill, et al, 1975 (MRID 0022923) although classified as supplemental are derived from scientifically
sound studies and, collectively, fulfill the guideline requirement. Although the actual % ai was not reported, it is
assumed it was greater than 95%.
As shown above, propoxur dietary studies have
demonstrated a tremendous variation in toxicity results. It would
appear that birds, within the same species, are able to metabolize
propoxur in some instances. To date, there has been no plausible
explanation for this phenomenon. The Agency has more confidence
in the Hill bobwhite and mallard toxicity values. As noted in an
Agency memo, dated, September 21, 1993, "In the oral acute
toxicity using Baygon 2% bait the LD50 was determined to be 1005
mg/Kg. This was estimated to be equivalent to an LD50 level of 23
mg ai/Kg for the active ingredient. Using the equation Estimated
LC50 = LQ0 X Avg. Bird Wt. in gms/food consumed per day
(using food consumption and bird weight presented in the Miles
dietary study) and allowing for a 10X error factor the Agency
calculated the expected LC50 would range between 150 ppm and
1500 ppm which would more closely relate to the LC50 values
calculated by Hill."
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The USDI data (Hill et. al. 1975) are considered to be
derived from scientifically sound studies and useful for risk
assessment purposes. Since one of the reported LC50 values falls in
the range of 51 - 500 ppm, technical propoxur is classified as highly
toxic to avian species on a subacute dietary basis. The guideline
(71-2) is fulfilled (MRID 0022923).
(2) Birds, Chronic
Results of avian reproduction studies using the TGAI are
tabulated below. Avian reproduction testing is not normally
required to support a residential outdoor use.
Table 6. Avian Reproduction
Species
Northern bobwhite quail1
(Colinus virginianus)
Mallard duck2
(Anas platyrhynchos)
%ai
98
98
NOEC/LOEC (ppm)
> 320 ppm, highest dose level
tested
80 ppm/320 ppm
LOEC Endpoints
-
reduced egg production
and embryo viability
1 This study is reclassified supplemental because a NOEC for reproductive effects was not established. The NOEC
for brain cholinesterase inhibition was 80 ppm.
2 This study is classified supplemental because the raw data were not provided to allow statistical verification of the
results.
The No Observable Effects Concentration (NOEC) for
bobwhite quail exposed to propoxur in the diet for an undetermined
number of weeks was >320 ppm, the highest dose level tested.
The NOEC for brain cholinesterase was 80 ppm based on a 28%
reduction in mean brain cholinesterase activity of females at the 320
ppm treatment level (MRID 149017).
The NOEC for mallard exposed to propoxur in the diet for
23 weeks was 80 ppm, based upon the following findings: (1) no
significant effects on reproduction and brain cholinesterase
inhibition were noted at the 20 ppm treatment level; and (2)
reproductive effects were manifested in reduced egg production and
embryo survival at the highest treatment level, 320 ppm (MRID
149016).
Although the outdoor use of propoxur outdoor use is not
limited to "crack and crevice" treatment, given the limited use, the
Agency will not require new avian reproduction testing, but will use
the results of these supplemental studies to assess chronic risk.
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(3)
Mammals
Wild mammal testing is not required to support the
registered residential outdoor use patterns of propoxur. Rat/mouse
toxicity values are reported below in Table 7.
Table 7. Mammalian Toxicity
Species
various rodents
laboratory rat
(Rattus norvegicus)
laboratory rat
(Rattus norvegicus)
%ai
unknown
70 (wettable
powder)
99.8
Test type
acute oral
acute oral
2 -generation
reproduction
Toxicity value
ranges 68-94 mg/kg
125 mg/kg (males)
reproductive effect
NOEC >80ppm
Endpoints
-
-
no reproductive toxicity was observed at
levels up to 80 ppm in diet
b.
Since there are some reports of LD50 values lower than 100
mg/kg, propoxur is classified as moderately toxic to mammals
(MRIDs 00152443, 00256151 and 42615403).
(4) Insects
A honey bee acute contact study is not required to support
the registered residential outdoor use pattern of propoxur, however,
an acute honey bee contact study which was reviewed indicates that
technical propoxur is highly toxic to bees (< 11 //g/bee) on an acute
contact basis (MRID 60633).
Toxicity to Aquatic Animals
(1) Freshwater Fish
Two freshwater fish acute toxicity studies using the TGAI
are required to establish the toxicity of propoxur to fish. The
preferred test species are rainbow trout (a coldwater fish) and
bluegill sunfish (a warmwater fish). Results of tests conducted with
the TGAI and certain formulated products are tabulated below.
Formulated product testing is not required to support the registered
residential outdoor use.
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Table 8. Static Freshwater Fish Acute Toxicity Tests
Species
Rainbow trout
(Oncorhynchus mykiss)
Bluegill sunfish
(Lepomis macrochirus)
Brook trout (Salvelinus fontinalis)
fathead minnow
(Pimephales promelus)
%ai
98.8
88
2
98.8
88
technical (%
unknown)
70
2
70
88
96-hour LC50 (ppm)
3.7
8.21
92 (formulated product - bait)
6.2
4.81
6.1
9.0 (formulated product - wettable powder)
> 180 (formulated product - bait)
3.55 (formulated product - wettable powder)
251
Toxicity Category
moderately toxic
moderately toxic
-
moderately toxic
moderately toxic
moderately toxic
-
-
-
moderately toxic
1 Although the J. McCann (USEPA) and USDI (MRID 40098001) data are classified supplemental, they are derived
from scientifically sound studies and are useful for risk assessment purposes.
Since some the LC50 values fall in the range of 3-10 ppm,
technical propoxur is categorized as moderately toxic to freshwater
fish on an acute basis. The guideline (72-1) is fulfilled (MRID
00149171).
(2)
Freshwater Invertebrates
A freshwater aquatic invertebrate toxicity study using the
TGAI is required to establish the toxicity of propoxur to freshwater
aquatic invertebrates. The preferred test species is the daphnid.
Results of tests conducted with the TGAI are tabulated below.
Table 9. Freshwater Aquatic Invertebrate Acute Toxicity
Species
Daphnid (Daphnia magna)
Amphipod (Gammarus lacustris)1
stonefly (Pteronarcys)1
%ai
98.8
88
88
EC/LC50 (ppm)
0.011
0.034
0.18
Toxicity Category
very highly toxic
very highly toxic
very highly toxic
1 Although scientifically sound, study is classified supplemental because species used and study duration (96-hr) not
recommended (MRID 40098001).
Since the EC50 is < 1 ppm, technical propoxur is categorized
as very highly toxic to aquatic invertebrates on an acute basis. The
guideline (72-2) is fulfilled (MRID 00149172).
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(3) Estuarine and Marine Animals
Results of an estuarine aquatic invertebrate study on pink
shrimp (Penaeus duoraum) using the TGAI indicate that the 48-
hour LC50 is 0.041 (MRID 40228401). Since the EC50 is < 1 ppm,
technical propoxur is categorized as very highly toxic to estuarine
invertebrates on an acute basis. Although scientifically sound, this
study is classified supplemental because the duration of the test was
too short (48-hr instead of 96-hr). This study is not required to
support the registered residential outdoor use pattern of propoxur.
2. Environmental Fate
a. Environmental Fate Assessment
For the currently registered uses of propoxur, the Agency typically
requires an abbreviated set of environmental fate data on hydrolysis,
metabolism, and mobility. Only supplemental data are available for
propoxur. While shortcomings in the studies preclude a comprehensive
assessment of the environmental fate of propoxur, a general assessment can
be made.
Based on supplemental data, propoxur is likely to be moderately
persistent (the metabolic half-life is on the order of several months),
mobile, and may potentially leach to groundwater. It is apparently
hydrolytically stable at acid to neutral pHs (3 to 7) but degrades rapidly at
alkaline pH values. The parent chemical appears susceptible to photolysis
in water but not on soil. However, the intensity of light in the studies did
not reflect that of natural sunlight. Aerobic and anaerobic soil metabolism
half-lives are on the order of several months. Degradate characterization
was incomplete in these studies. Laboratory mobility studies indicate that
propoxur is very mobile (Kd values less than 1). Propoxur exhibits fate and
transport characteristics similar to chemicals that are known to leach to
groundwater.
Well-designed, scientifically-valid studies could result in changes in
the overall assessment, particularly in relation to persistence. For instance,
photolysis may play a role in degradation of propoxur applied outdoors.
However, considering the nature of the listed outdoor uses, additional
studies are not required at this time. The limited data available only
support the uses discussed in this document. Any additional uses will
require data to support them.
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b. Environmental Fate and Transport
(1) Degradation
Hydrolysis (161-1)
An open literature study of several carbamates found
that propoxur was stable to hydrolysis at pH 3.0-7.0 but
degraded at alkaline pH values. The half-life for hydrolysis
was 16 days at pH 8, 1.6 days at Ph 9, and 0.17 days at pH
10 (MRID 0085762).
A new hydrolysis study may be required if other
outdoor uses are considered in the future.
Photodegradation in water (161-2)
Propoxur degraded in neutral, aqueous solutions (5
ppm propoxur) with a half-life of 10 days without a
photosensitizer and 0.7 days with an acetone sensitizer. The
degradation half-life was 41 days in the dark control.
Compensating for hydrolysis effects, the unsensitized half-
life was projected at 13 days. The major degradates were
isopropoxy phenol, unidentified polar compounds, and C02.
The artificial light source had an intensity less than that of
natural sunlight in Kansas City, MO (800 u-watts/cm2 vs.
3300-4400 u-watts/cm2 at midday in summer, MRID
0085763).
Photodegradation in soil (161-3)
Propoxur photodegraded on a pH 8.2 sandy loam
soil with a half-life of 77 days (extrapolated beyond the 28
day study). After 28 days, propoxur comprised 75% of the
applied radioactivity, unextracted residues 12%, and
volatiles 10%. The artificial light source was the same as
that used in the aqueous photolysis study (MRID 0085763).
Aerobic soil metabolism (162-1)
The degradation of Propoxur under aerobic
conditions in silt loam and sandy loam soils followed first
order kinetics for the first 112 and 180 days, respectively.
The half-life values were 80 days for the silt loam and 210
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days for the sandy loam. Propoxur was the major
extractable residue found in the studies. C02 (30% after
112 days; 35% after 336 days) and unextracted residues (up
to 40%) also comprised major portions of the applied
radioactivity. The primary mode of degradation appears to
be hydrolysis of the carbamate linkage (MRID 0085768).
Anaerobic soil metabolism (162-2)
Propoxur degraded in a silt loam soil under
anaerobic conditions with a half life of 80 days, the same as
found in the aerobic metabolism study above. The
anaerobic half-life resulting from the flooding of a sandy
loam that had been incubated aerobically for 30 days was
108 days. The half-life in sterile soils was the same as that
measured in non-sterile soils (MRID 0085768).
(2) Mobility
Leaching & adsorption/desorption (163-1)
In soil thin-layer mobility studies on six soils,
propoxur was found to be mobile, with Rf values of 0.70 to
0.89 (MRID 0029887).
In batch equilibrium studies, propoxur was very
mobile, with Freundlich Kd values of 0.05 (sandy loam),
0.30 (silt loam), and 0.27 (silty clay). Koc values,
calculated from the Kd and organic carbon (from organic
matter) data supplied in the report, were 3.4 (sandy loam),
11.2 (silt loam), and 102.6 (silty clay) (MRID 0085770).
After 28 days of aerobic incubation in a silt
loam soil, propoxur was found to be mobile in 12-
inch soil columns. The leachate contained 69 to
74% of the applied radioactivity after 100 ml of
water was applied over a 45 day period (MRID
0085769).
(3) Field Dissipation
Terrestrial field dissipation (164-1)
Rough data from 10 studies on the persistence of
propoxur in several different soil types suggest that the
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chemical moves rapidly through all the soil profiles below
the 12" sampling depth (MRID 0085772).
Environmental fate data on aqueous and soil
photolysis, aerobic and anaerobic soil metabolism, leaching
and adsorption/desorption, and terrestrial field dissipation
are not required to support the current uses for propoxur.
New studies may be required if other outdoor uses are
considered in the future.
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Risk characterization integrates the results of the exposure and
ecotoxicity data to evaluate the likelihood of adverse ecological effects.
The means of integrating the results of exposure and ecotoxicity data is
called the quotient method. For this method, risk quotients (RQs) are
calculated by dividing exposure estimates by ecotoxicity values, both acute
and chronic.
RQ = EXPOSURE/TOXICITY
RQs are then compared to OPP's levels of concern (LOCs). These
LOCs are criteria used by OPP to indicate potential risk to nontarget
organisms and the need to consider regulatory action. The criteria indicate
that a pesticide used as directed has the potential to cause adverse effects
on nontarget organisms. LOCs currently address the following risk
presumption categories: (1) acute high - potential for acute risk is high,
regulatory action may be warranted in addition to restricted use
classification (2) acute restricted use - the potential for acute risk is high,
but this may be mitigated through restricted use classification (3) acute
endangered species - the potential for acute risk to endangered species is
high, regulatory action may be warranted, and (4) chronic risk - the
potential for chronic risk is high, regulatory action may be warranted.
Currently, the Agency does not perform assessments for chronic risk to
plants, acute or chronic risks to nontarget insects, or chronic risk from
granular/bait formulations to mammalian or avian species.
The ecotoxicity test values (i.e., measurement endpoints) used in the
acute and chronic risk quotients are derived from the results of required
studies. Examples of ecotoxicity values derived from the results of short-
term laboratory studies that assess acute effects are: (1) LC50 (fish and
birds) (2) LD50 (birds and mammals) (3) EC50 (aquatic plants and aquatic
50
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invertebrates) and (4) EC25 (terrestrial plants). Examples of toxicity test
effect levels derived from the results of long-term laboratory studies that
assess chronic effects are: (1) LOEC (birds, fish, and aquatic invertebrates)
(2) NOEC (birds, fish and aquatic invertebrates) and (3) MATC (fish and
aquatic invertebrates). For birds and mammals, the NOEC value is used
as the ecotoxicity test value in assessing chronic effects. Other values may
be used when justified. Generally, the MATC (defined as the geometric
mean of the NOEC and LOEC) is used as the ecotoxicity test value in
assessing chronic effects to fish and aquatic invertebrates. However, the
NOEC is used if the measurement end point is production of offspring or
survival.
(1) Exposure and Risk to Nontarget Terrestrial Animals
Risk presumptions for terrestrial and aquatic animals, along
with the corresponding RQs and LOCs can be found in Table 10.
Table 10. Risk Presumptions for Terrestrial Animals
Species
Birds
Wild
Mammals
Risk Presumptions
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
RQ
EECVLC50 or LD50/sqft2 or LD50/day3
EEC/LC50 or LD50/sqft2 or LD50/day3 (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft2 or LD50/day3
EEC/NOEC
EEC/LC50 or LD50/sqft2 or LD50/day3
EEC/LC50 or LD50/sqft2 or LD50/day3 (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft2 or LD50/day3
EEC/NOEC
LOG
0.5
0.2
0.1
1
0.5
0.2
0.1
1
1 abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items
2 niR/ft2
LD50 * wt. of bird
mg of toxicant consumed/day
LD50 * wt. of bird
(2) Exposure and Risk to Nontarget Aquatic Animals
Table 11, below, describes the risk presumptions for
nontarget aquatic animals.
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Table 11. Risk Presumptions for Aquatic Animals
Risk Presumptions
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
RQ
EEC'/LC50 or EC50
EEC/LC50 or EC50
EEC/LC50 or EC50
EEC/MATC or NOEC
LOG
0.5
0.1
0.05
1
abbreviation for Estimated Environmental Concentration (ppm or ppb in water)
b. Environmental Risk Characterization
Propoxur is federally registered for indoor and residential outdoor
uses. Previously registered uses, including ornamental, lawns/turf, and
mosquito control, have been canceled.
c. Exposure and Risk to Nontarget Terrestrial Animals
The likelihood of wildlife exposure from certain formulations/
product types is considered slight. These include the aerosols, bait stations,
pastes, liquids and traps. The Agency is assuming that the registered liquid
products are used only for spot or crack and crevice treatment around
buildings. Risk assessments were performed for two products with
potential for wildlife exposure: (1) a 2% bait applied around patios,
driveways, sidewalks and foundations, and (2) an insecticide tape
formulation used on boat mooring lines (due to the product's close
proximity to water).
10% Insecticidal Tape Product
Minimal to no terrestrial exposure is expected from this product.
Therefore, a terrestrial risk assessment was not performed. Aquatic
animal LOCs for acute effects were not exceeded for the registered boat
guard product. Based on these risk assessment findings, the Agency
presumes minimal risk to aquatic organisms from this registered use.
Residential Outdoor Use of 2% Bait Formulation
(1) Birds
Birds may be exposed to propoxur bait by ingesting it when
foraging for food or grit. The number of lethal doses (to 50% of
the population or LD50s) that are available within one square foot
immediately after application (LD50s/ft2)is used as the risk quotient
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for these types of products. Risk quotients are normally calculated
for three separate weight class of birds: 1000 g (e.g., waterfowl),
180 g (e.g., upland gamebird) and 20 g (e.g., songbird). Since the
birds expected to be found in residential settings are small birds
(e.g., sparrows, finches, wrens, juncos, bluejays, flickers and
blackbirds), only the risk quotient for small weight-class bird was
calculated. The application rate, 4 oz per 1000 sq. ft. is equivalent
to 3.4848 oz ai/a or 0.2178 Ib ai/a. The acute risk quotient for
small birds of 20 gram weight is tabulated below.
Table 12. Avian Risk Quotient for 2% Bait Products1
Rate in Ibs ai/A
0.2178
Pesticide left on surface
1%
Body Weight (g)
20
LD 50 (mg/kg)
3.55
Acute RQ2 (LD50/ft2)
31.90
1
Based on a house finch LD50 of 3.55 mg ai/kg.
2 RQ = App. Rate (Ibs ai/A) * (453,590 mg/lbs/43,560 ft2/A)
LD50 mg/kg * Weight of Animal (g) * 1000 g/kg
The results indicate that for applications of bait products,
avian acute high risk, restricted use, and endangered species levels
of concern are exceeded at the registered application rate of 4 oz ai
per 1000 sq ft. However, because of the limited outdoor use, avian
exposure is expected to be minimal.
The Agency does not currently have procedures for
assessing chronic risk for bait products. However, if a similar
foliar application rate of 0.2 Ib ai/A were used, this would result in
a Kenaga EEC of 48 ppm on short grass, which does not exceed the
chronic LOG (EEC/NOEC; 48 ppm/80 ppm). In addition it is not
expected that birds will receive chronic exposures to propoxur, such
as occurs when feeding on large treated areas (cropland) over long
periods of time.
There are no reports of avian poisoning incidents in the
Agency's files.
(2) Mammals
Mammalian species also may be exposed to granular/bait
pesticides by ingesting granules. The number of lethal doses
(LD50s) that are available within one square foot immediately after
application can be used as a risk quotient (LD50s/ft2) for the various
types of exposure to bait pesticides. Risk quotients are calculated
for three separate weight classes of mammals: 15 g, 35 g and 1000 g.
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The acute risk quotients for applications of 2% bait products
are tabulated below. Risk quotients were calculated for all three
separate weight classes of mammals.
Table 13. Mammalian Acute Risk Quotients for 2% Bait Products1
Rate in Ibs ai/A
0.2
0.2
0.2
Pesticide left on surface
1%
1%
1%
Body Weight (g)
15
35
1000
LD 50 (mg/kg)
86
86
86
Acute RQ2 (LD50/ft2)
1.61
0.69
0.02
1 Based on a rat LD50 of 86 mg ai/kg.
2 RQ = App. Rate (Ibs ai/A) * (453,590 mg/lbs/43,560 ft2/A)
LD50 mg/kg * Weight of Animal (g) * 1000 g/kg
The results indicate that for small mammals (15 gram
weight), acute high risk, restricted use, and endangered species
levels of concern are exceeded at the registered application rate of
4 oz per 1000 sq. ft., by 3, 8, and 16 times respectively. The
results indicate that for medium-size mammals (35 gram weight),
acute high risk, restricted use, and endangered species levels of
concern are exceeded by 1, 3, and 7 times respectively. In
summary, acute risks could exist for mammalian species, especially
small rodents and/or insectivores ingesting dead/dying insects that
have ingested the bait.
(3) Aquatic Organisms
Minimal aquatic exposure from runoff or drift is expected
from the bait product. Therefore, an aquatic risk assessment was
not performed.
10% Insecticidal Tape Product
Propoxur is registered for use on boat mooring lines, water
lines and utility supply lines to control the spread of insect pests.
The product is a plastic cylindrical device containing propoxur in
combination with chlorpyrifos and formulated as an insecticide
strip. The device is snapped to the mooring lines.
A risk assessment for the registered product, Boat Guard,
EPA Reg. No. 62451-1, was performed by the Agency in the early
1990's. Propoxur is applied at a very low rate (0.5%) to the inside
of the partially enclosed trap guard units. The estimated
environmental concentration in water after considering the leaching
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rate (assumed to be 0.1%) and the number of boats using the device
in a marina (assumed to be 50) was calculated as 0.059 ppb for
propoxur. The acute risk quotient (EEC/toxicity value) derived
from using the lowest toxicity value for an aquatic animal (daphnid
= 11 ppb) does not exceed any acute level of concern. Based on
these findings, minimal to no risk is expected to aquatic organisms
from this use.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing propoxur as an active ingredient. The
Agency has completed its review of these generic data, and has determined that the data
are sufficient to support reregistration of all products containing propoxur. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of propoxur, and lists the submitted studies that
the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of propoxur and to determine that propoxur can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing propoxur as the active ingredient, when labeled and used
as specified in this document, are eligible for reregistration. The reregistration of
particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that all uses of propoxur are eligible for
reregistration under the conditions stated in this decision document, it should be
understood that the Agency may take appropriate regulatory action, and/or require the
submission of additional data to support the registration of products containing propoxur,
if new information comes to the Agency's attention or if the data requirements for
registration (or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient propoxur,
the Agency has sufficient information on the health effects of propoxur and on its
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potential for causing adverse effects in fish and wildlife and the environment. The
Agency has determined that propoxur products, labeled and used as specified in
this Reregistration Eligibility Decision, will not pose unreasonable risks of adverse
effects to humans or the environment. Therefore, the Agency concludes that
products containing propoxur for all uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of propoxur (listed in Section II)
are eligible for reregistration.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
propoxur. Where labeling revisions are imposed, specific language is set forth in Section
V of this document.
1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
EPA has determined that a tolerance needs to be established for the
crack and crevice uses of propoxur in food processing plants and food
handling establishments, and that the proposed tolerance would meet the
safety standards under the FQPA amendments to section 408 (b) (2) (D) for
the general population. Sufficient data are available to establish a
tolerance.
Significant levels of propoxur are not expected in surface or ground
water; therefore, risk from drinking water would be negligible, and has not
been included in the chronic dietary risk assessments.
In assessing chronic dietary risk, EPA estimates that the anticipated
residue contribution of propoxur (assuming 2% of all food commodities are
treated) would be 1.84% of the RfD for the U.S. general population,
7.23% for non-nursing infants (< 1 year old), and 4.43% for children 1-6
years old. Endpoints, other than cancer, for non-occupational chronic
exposure were not identified. Thus, "aggregate" non-cancer risk is limited
to dietary exposure as described above.
The propoxur cancer dietary risk estimate for the U.S. general
population (again assuming that 2% of all food commodities are treated) is
3.4 x 10 7. In addition, there are non-occupational cancer risks resulting
from propoxur exposure. For all use scenarios, the highest aggregated
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dietary and non-occupational risk estimate is 7.9 x 107. Therefore, the
Agency concludes that aggregate risks to the general U.S. population are
not of concern.
b. Determination of Safety for Infants and Children
EPA has determined that the proposed tolerance for propoxur would
meet the safety standard under the FQPA amendment to section
408(b)(2)(C) for infants and children. The safety determination for infants
and children considers the factors noted above for the general population,
but also takes into account the possibility of increased dietary exposure due
to the specific consumption patterns of infants and children, as well as the
possibility of increased susceptibility to the toxic effects of propoxur
residues in this population subgroup.
In determining whether or not infants and children are particularly
susceptible to toxic effects from propoxur residues, EPA considered the
completeness of the database for developmental and reproductive effects as
well as other relevant toxicity studies, the nature of the effects observed,
and other information.
Based on the current data requirements, propoxur has a substantially
complete database for developmental and reproductive toxicity. The
available data for propoxur indicate that there is no evidence of an
increased sensitivity to propoxur from pre- or post-natal exposures. Fetal
effects were observed in only one of the developmental studies, and these
occurred at the same dose levels as maternal effects. In the reproduction
studies, no enhanced post-natal sensitivity was observed in a two generation
reproduction study in which reproductive effects were noted at the highest
dose tested. Parental toxicity was observed at all doses tested. Therefore,
based on reliable data, the Agency has concluded that an additional
uncertainty factor is not warranted for pre- and post-natal effects.
In deciding to continue to make reregistration determinations during
the early stages of FQPA implementation, EPA recognizes that it will be
necessary to make decisions relating to FQPA before the implementation
process is complete. In making these early, case-by-case decisions, EPA
does not intend to set broad precedents for the application of FQPA to its
regulatory determinations. Rather, these early decisions will be made on
a case-by-case basis and will not bind EPA as it proceeds with further
policy development and rulemaking that may be required.
If EPA determines, as a result of this later implementation process,
that any of the determinations described in this RED are no longer
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appropriate, the Agency will consider itself free to pursue whatever action
may be appropriate, including but not limited to, reconsideration of any
portion of this RED.
2. Worker Risk/Cancer
Propoxur has an estimated cancer risk for workers of 7.7 x 10 6.
The Agency's policy for applicator risk is that risk should be as close to
negligible (i.e., 1 x 106) as possible. Revisions to propoxur labels
stipulated by this RED require PCOs to wear long-sleeved shirts, long
pants, chemical resistant gloves and shoes plus socks. The Agency believes
there are no other reasonable measures or protective clothing requirements
that could be imposed to further reduce the risk. Thus, this level of risk
is in compliance with the Agency's worker risk policy. Furthermore, the
Agency believes that 7.7 x 106 may be an overestimate of the actual risk
to applicators from the crack and crevice use. Many of the replicates in the
exposure study used to derive the risk estimate showed no detectible
residues under the clothing for the chest, back and other areas. For these
replicates, the Agency made a protective assumption that some pesticide
could still be present and included half the level of detection rather than
zero in its calculations, thereby possibly overestimating the risk.
3. Endocrine Disrupter Effects
EPA is required to develop a screening program to determine
whether certain substances (including all pesticides and inerts) "may have
an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect..." The Agency is
currently working with interested stakeholders, including other government
agencies, public interest groups, industry and research scientists in
developing a screening and testing program and a priority setting scheme
to implement this program. Congress has allowed 3 years from the passage
of FQPA (August 3, 1999) to implement this program. At that time, EPA
may require further testing of this active ingredient and end use products
for endocrine disrupter effects.
4. Tolerances
A tolerance needs to be established for propoxur use in food
processing plants and food handling establishments.
5. Occupational and Residential Labeling Rationale/Risk Mitigation
At this time, some products containing propoxur are intended
primarily for occupational use and some are intended primarily for
homeowner use.
58
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Requirements for Handlers
For each end-use product, personal protective equipment (PPE) and
engineering control requirements for pesticide handlers are set during
reregistration as follows:
• Based on the risks posed to handlers by the active
ingredient, EPA may establish active ingredient-specific (ai-
specific) handler requirements for end-use products
containing that active ingredient. If the risks to handlers
posed by the active ingredient are minimal, EPA may
establish no ai-specific handler requirements.
• Based on the acute toxicity characteristics of the end-use
product, EPA usually establishes handler PPE requirements
for each end-use product.
• If ai-specific requirements have been established, they must
be compared to the end-use product-specific PPE and the
more stringent choice for each type of PPE (i.e., bodywear,
hand protection, footwear, eyewear, etc.) must be placed on
the label of the end-use product. Engineering controls are
more stringent than PPE requirements.
Occupational-Use Products
EPA is establishing ai-specific PPE for some use patterns of
propoxur. The use patterns and PPE are specified in Section V.
Homeowner-Use Products
EPA is not establishing ai-specific requirements for homeowner
handlers for propoxur.
Post-Application/Entry Restrictions
Based on a review of the incidents related to the use of propoxur,
the Agency believes that limiting entry immediately following applications
of propoxur liquid or aerosol either by a PCO or homeowners is a prudent
health and safety practice. Therefore, EPA is establishing entry
restrictions for propoxur end-use products, other than those for use on pets.
For specific language see Section V.
59
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Other Labeling Requirements
The Agency is also requiring other use and safety information to be
placed on the labeling of all end-use products containing propoxur. EPA
believes that the risks previously identified for pets will be mitigated based
on the changes implemented by the registrant for the proper adjustment of
flea collars on pets. For specific labeling statements, refer to Section V of
this document.
6. Ecological Effects
a. Avian and Mammalian Risks
Although calculated acute avian risks exceed the LOCs, the
Agency believes risks to birds from the limited outdoor bait
applications are not excessive. There are no reported bird
poisoning incidents from propoxur, even though incidents are more
apt to be observed on use patterns, such as, home lawns rather than
in agricultural settings away from human activity. It is likely that
potential exposure to birds has been drastically reduced since the
1992 deletion of broadcast uses on lawns/turf.
Outdoor applications are limited to applications to exteriors
of buildings, on and immediately around patios, sidewalks and
building foundations, and insecticidal tape on boat mooring lines,
water lines and utility supply lines. Exposure of propoxur to avian
and mammalian wildlife species with the current outdoor uses
results in slight exposures, if any. Expanding outdoor uses,
however, would increase the Agency's concerns.
b. Aquatic Invertebrates
Minimal aquatic exposure from runoff or drift is expected
from propoxur outdoor bait products. Although the toxicity is
high, the aquatic risk does not exceed the Agency's LOCs. Based
on the limited outdoor bait applications of propoxur, minimal to no
risk is expected to aquatic organisms.
c. Endangered Species Statement
Currently, the Agency is developing a program ("The
Endangered Species Protection Program") to identify all pesticides
whose use may cause adverse impacts on endangered and threatened
species and to implement mitigation measures that will eliminate the
60
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adverse impacts. The program would require use restrictions to
protect endangered and threatened species at the county level.
Consultations with the Fish and Wildlife Service may be necessary
to assess risks to newly listed species or from proposed new uses.
In the future, the Agency plans to publish a description of the
Endangered Species Program in the Federal Register and have
available voluntary county-specific bulletins. Because the Agency
is taking this approach for protecting endangered and threatened
species, it is not imposing label modifications at this time through
the RED. Rather, any requirements for product use modifications
will occur in the future under the Endangered Species Protection
Program.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of propoxur for the
above eligible uses has been reviewed and determined to be substantially complete.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing-use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into an insecticide for the following use(s) (list those
uses that are being supported by the MP registration)."
An MP registrant may, at his/her discretion, add one of the following statements
to an MP label under "Directions for Use" to permit the reformulation of the
product for a specific use or all additional uses supported by a formulator or user
group:
(a) "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)."
61
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(b) "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)."
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. Registrants 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 study MRID numbers should be cited according to the instructions
in the Requirement Status and Registrants Response Form provided for each
product.
2. Labeling Requirements for End-Use Products
PPE Requirements for Pesticide Handlers
Sole-active-ingredient end-use products that contain propoxur must be
revised to adopt the handler personal protective equipment requirements set forth
in this section. Any conflicting PPE requirements on their current labeling must
be removed.
Multiple-active-ingredient end-use products that contain propoxur must
compare the handler personal protective equipment requirements set forth in this
section to the PPE requirements on their current labeling and retain the more
protective. For guidance on which PPE is considered more protective, see PR
Notice 93-7.
Products Intended Primarily for Occupational Use
For crack and crevice treatments
PPE must include:
—long-sleeved shirt and long pants,
—chemical-resistant gloves, and
—shoes plus socks.
For PCOs applying granular and bait forms
PPE must include:
62
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—long-sleeved shirt and long pants, and
—shoes plus socks.
If an end-use product is toxicity category I or II for eye irritation,
protective eye wear will be required.
Entry Restrictions
Sole-active-ingredientend-use products that contain propoxur must
be revised to adopt the entry restrictions set forth in this section. Any
conflicting entry restrictions on their current labeling must be removed.
Multiple-active-ingredientend-use products that contain propoxur
must compare the entry restrictions set forth in this section to the entry
restrictions on their current labeling and retain the more protective. A
specific time-period in hours or days is considered more protective than
"sprays have dried" or "dusts have settled."
Products Intended for Occupational Use and Homeowner Use
Entry restrictions:
• For liquid applications to surfaces other than on pets: "Do
not allow people or pets to enter the treated area until sprays
have dried."
• For all other applications, there is no entry restriction.
Placement in labeling: Place the appropriate entry restrictions in the
Directions for Use, under the heading "Entry Restrictions."
Other Labeling Requirements
The Agency is requiring the following labeling statements to be
located on all end-use products containing propoxur that are intended for
occupational use or intended for homeowner use.
Application Restrictions
For products which have applications to surfaces other than on pets:
"Do not apply this product in a way that will contact any person or
pet, either directly or indirectly. Keep people and pets out of the
area during application."
63
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User Safety Recommendations
• "Users should wash hands before eating, drinking, chewing
gum, using tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets
inside. Then wash thoroughly and put on clean clothing."
(Select the following only if gloves and/or protective eyewear are required for
applicators:}
• "Users should remove protective clothing and equipment
immediately after handling this product. Wash the outside
of gloves before removing. Keep and wash protective
clothing and equipment separately from other laundry."
For products with residential outdoor uses
This product is toxic to wildlife and aquatic invertebrates. Birds
and small mammals feeding on treated bait may be killed. Do not apply
directly to water. Do not contaminate water by cleaning of equipment or
disposal of wastes.
• "Birds and small mammals feeding on treated bait may be killed"
• "Do not apply as a landscape treatment (to lawns, shrubs or trees,
garden plants)"
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell propoxur
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
the date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
64
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VI. APPENDICES
65
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FORMULATION
% AI
EQUIPMENT AND USE DIRECTIONS
RATE
TIMING
MAX RATE
MIN INT
PHI
REI
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES; COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT INDOOR
BAIT/SOLID
PRESSURIZED LIQUIDS
0.250
2.0
0.493
0.5
0.529
0.665
Bait traps.
Place traps in homes, cabins, apartment buildings, stores,
restaurants, trailers, campers and warehouses. Use a key to press in
semi-perforated sides. Place traps where ants are numerous (under
sinks, stoves, refrigerators and cabinets).
Apply bait lightly to floors near baseboards, in closets, under sinks
and refrigerators, around and inside garbage cans, cracks and crevies
and other places where insects are found.
Place traps in homes, cabins, apartment buildings, stores,
restaurants, trailers, campers and warehouses. Use a key to press in
semi-perforated sides. Place traps where roaches are numerous
(under sinks, stoves, refrigerators and cabinets).
Pre-filled disposable syringe or tube applicator. Use paste as a spot
or crack and crevice treatment. Apply under surface of counters,
tables, shelving, drawers, under sinks, around pipe collars, under
refrigerators, stoves, electrical boxes and computer housing.
Bait station. Place bait station near home entry points, doors, garage
doors and porches. Also place in bathrooms, pantries, and kitchens,
especially near water pipes and refrigerators.
Aerosol can. Spot treatment only. Insert extension tube into
actuator. Apply to cracks and crevices around baseboards, shelves,
cupboards, around door sills and window frames.
Aerosol can. Spray into cracks, crevices, around baseboards,
behind and beneath cabinets, furniture, refrigerators, sinks, moist
areas, bath tubs, drains, laundry tubs, stoves, around air ducts, and
in and around waste containers. Spray ant trails and places where
they enter. Applications of this product in food preparation areas
are limited to crack and crevice treatments only.
Aerosol can. Spray into cracks, crevices, around baseboards,
behind and beneath cabinets, furniture, refrigerators, sinks, moist
areas, bath tubs, drains, laundry tubs, stoves, around air ducts, and
in and around waste containers. Spray ant trails and places where
they enter. Applications of this product in food preparation areas
are limited to crack and crevice treatments only.
Aerosol can. Spray cracks, crevices, along baseboards, doors and
windowsills. Spray behind and beneath sinks, stoves, refrigerators
and around garbage cans and plumbing. Apply to ant trails.
4 oz per 1000 sq.ft.
4-6 trays per 100 sq.ft.
Use all 12 bait stations at
one time.
1-2 feet per second or until
surfaces are wet.
1 foot per second or until
surfaces are wet.
Spray until wet.
Repeat as necessary.
Replace every 4 weeks or
as needed.
Re-apply in 1-2 weeks if
no bait is visible.
Replace traps every 2-3
months for continued
control.
Repeat as necessary.
Repeat as needed.
Repeat as needed.
Repeat as necessary.
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FORMULATION
CONCENTRATED LIQUID
WETTABLE POWDER
LIQUID-RTU
% AI
0.67
1.0, 1.054,
2.0
5.0,
8.0,
10.0
10.2
13.75
13.9,
14.6,
14.8,
70.0
0.5,
0.643
EQUIPMENT AND USE DIRECTIONS
Aerosol can. Spray into cracks, crevices, around baseboards,
behind and beneath cabinets, furniture, refrigerators, sinks, moist
areas, bath tubs, drains, laundry tubs, stoves, around air ducts, and
in and around waste containers. Spray ant trails and places where
they enter. Applications of this product in food preparation areas
are limited to crack and crevice treatments only.
Aerosol can.
Apply using supplied actuator and injection tubes or other Whitmire
equipment.
Spot treatments. Spray around baseboards, into cracks and
crevices, behind and beneath sinks, stoves cabinets, refrigerators,
damp areas and in and around waste containers. Around door and
window frames, plumbing and other places where insects may enter.
Spray into voids and channels created by termites, carpenter ants and
carpenter bees.
Sprayer. Coarse spray. Spot treatment. Spray around baseboards,
into cracks and crevices, behind and beneath sinks, stoves cabinets,
refrigerators, damp areas and in and around waste containers.
Around door and window frames, plumbing and other places where
insects may enter.
Compressed air sprayer. Apply as a coarse wet spray until surfaces
are wet. Spray around baseboards, into cracks and crevices, behind
and beneath sinks, stoves cabinets, refrigerators, damp areas and in
and around waste containers. Around door and window frames,
plumbing and other places where insects may enter.
Hand or power operated sprayers. Apply as a residual spray.
Apply as a coarse spray.
Spray around baseboards, into cracks and crevices, behind and
beneath sinks, beneath shelves and drawers, stoves cabinets,
refrigerators, damp areas and in and around waste containers and
utility installations. Around door and window frames, plumbing and
other places where insects may enter.
Sprayer. Apply as a coarse spray.
Spray around baseboards, into cracks and crevices, behind and
beneath sinks, beneath shelves and drawers, stoves cabinets,
refrigerators, damp areas and in and around waste containers and
utility installations. Around door and window frames, plumbing and
other places where insects may enter.
Power operated or hand pressurized sprayers.
For areas other than those in commercial Food Handling
Establishments spray into cracks, crevices, around baseboards,
behind and beneath cabinets, to the floor, refrigerators, sinks,
stoves, and in and around waste containers. Spray ant trails and
places where they enter.
RATE
1 foot per second or until
surfaces are wet.
Spray until surfaces are
wet.
One linear foot per second.
1 second per spot with
spots 12 inches apart.
Inject 5-10 seconds of
spray into insect tunnels
and cavities.
Mix one part product with
nine parts of water or
kerosene.
Dilute one part of product
with ten parts of water.
11 fluid oz. per 1 gal
water.
8 fluid oz of product in 1
gal water.
2 oz of 70WP in 1 gallon
water.
TIMING
Repeat as needed.
Repeat as necessary.
Retreat as needed.
Repeat as needed.
Repeat as necessary.
Repeat as needed.
MAX RATE
MIN INT
PHI
REI
67
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FORMULATION
> AI
EQUIPMENT AND USE DIRECTIONS
RATE
TIMING
MAX RATE
MIN INT
PHI
REI
1.0,
1.11
Power operated or hand pressurized sprayers.
Apply with a paint brush.
Apply with a low pressure sprayer as a coarse spray.
Use as a spot treatment.
Spray into cracks, crevices, around baseboards, behind and beneath
cabinets, to the floor, refrigerators, sinks, stoves, and in and around
waste containers. Spray ant trails and places where they enter.
As a coarse spray until
surfaces are wet.
Spray until surfaces are
coated with a dew-like
mist.
Repeat as needed.
OIL SOLUBLE LIQUID
4.0
Sprayer. Spray into cracks, crevices, around baseboards, behind
and beneath cabinets, to the floor, refrigerators, sinks, stoves, and
in and around waste containers. Spray ant trails and places where
they enter.
Mix one part of product
with three parts of oil.
Reapply for cockroach
control every 1-2 weeks
until control is acheived.
IMPREGNATED PAPER
1.0
Use shelf and lining paperto line drawers and cabinets, use in storage
areas and around garbage areas, put under sinks and in broom
closets and other secluded areas where insects may congregate. Use
in basements and other damp areas.
FOOD HANDLING ESTABLISHMENTS; FOOD PROCESSING PLANT PREMISES; MEAT PROCESSING PLANT PREMISES; FOOD STORAGE AREAS; RESTAURANTS; TRANSPORTATION EQUIPMENT; ETC.: NON-
FOOD AREAS (includes garbage rooms, entries and vestibules, lavatories, floor drains, offices, locker rooms, boiler rooms, machine rooms, boiler rooms, garages, mop closets, storage after canning/bottling, warehouses where
food is not exposed, buses, boats, ships, trains, trucks, planes).
FOOD AREAS: treatments are limited to crack and crevice applications only.
LIQUID-RTU
0.5,
0.643
Power operated or hand pressurized sprayers.
Equipment capable of delivering a pin stream of insecticide.
NON-FOOD AREAS: Apply to baseboard areas, cracks and
crevices, around water pipes, behind and beneath sinks, lockers,
window and door screens, tables, pallets, etc.
FOOD AREAS: Apply a small pin stream directly into cracks,
crevices, wall voids, hollow equipment legs, etc.
Repeat as necessary
1.0,
1.11
Power operated or hand pressurized sprayers.
Compressed air sprayers.
Low pressure sprayer as a coarse spray.
NON-FOOD AREAS: Apply to baseboard areas, cracks and
crevices, around water pipes, behind and beneath sinks, lockers,
window and door screens, tables, pallets, etc.
FOOD AREAS: Apply a small pin stream directly into cracks,
crevices, wall voids, hollow equipment legs, etc.
Repeat as necessary
WETTABLE POWDER
70.0
Sprayer.
NON-FOOD AREAS: Apply to baseboard areas, cracks and
crevices, around water pipes, behind and beneath sinks, lockers,
window and door screens, tables, pallets, etc.
FOOD AREAS: Apply a small amount directly into cracks, crevices,
wall voids, hollow equipment legs, etc.
2 oz 70WP in 1 gallon
water.
Repeat as needed.
PRESSURIZED LIQUIDS
0.67
Aerosol can.
Spot treatments.
Spray untiil surfaces are
wet.
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FORMULATION
OIL SOLUBLE LIQUID
CONCENTRATED LIQUID
BAIT/SOLID
% AI
1.0, 1.054,
2.0
4.0
8.0,
10.0
10.2
13.75
13.9,
14.6,
19.6
2.0
EQUIPMENT AND USE DIRECTIONS
Supplied actuator and injection tubes or other Whitmire equipment.
Spray into cracks and crevices and void spaces.
Spot treatments.
FOOD AREAS: includes areas for receiving, storage, packing
(canning, bottling, wrapping, boxing), preparing, edible waste
storage and enclosed processing systems (mills, dairies, edible oils,
syrups). Serving areas.
Crack and Crevice treatments only in food areas.
Sprayer.
Spray into cracks, crevices, around baseboards, behind and beneath
cabinets, to the floor, refrigerators, sinks, stoves, and in and around
waste containers. Spray ant trails and places where they enter.
Sprayer.
Coarse wet spray.
Crack and crevice only.
Apply a small amount of material directly into cracks and crevices
such as expansion joints between different elements of construction
or between equipment bases and floor, wall voids, motor housing,
junction boxes, conduits, hollow equipment leg.
Compressed air sprayer.
Apply as a coarse wet spray until surfaces are wet.
Spray around baseboards, into cracks and crevices, behind and
beneath sinks, stoves cabinets, refrigerators, damp areas and in and
around waste containers. Around door and window frames,
plumbing and other places where insects may enter.
Hand or power operated sprayers.
Apply in NON-FOOD areas.
FOOD AREAS: Apply as a crack and crevice treatment. Apply a
small amount of material directly into cracks and crevices such as
expansion joints between different elements of construction or
between equipment bases and floor, wall voids, motor housing,
junction boxes, conduits, hollow equipment leg.
Apply bait on paper, pasteboard or other material that will permit
removal. Locate bait these stations on windowsills, on floors near
walls, in storage areas and other areas where insects have been
observed.
RATE
One linear foot per second
or 10 seconds per 3 cubic
feet.
1 second per spot, spots 12
inches apart.
Mix one part of product
with three parts of oil.
Mix one part of product
with nine parts of water or
kerosene.
Dilute one part of product
with ten parts of water.
1 1 fluid oz of product in 1
gal water.
8 fluid oz of product in 1
gal water.
TIMING
Repeat as necessary.
Reapply for cockroach
control every 1-2 weeks
until control is acheived.
Repeat as necessary.
Repeat as needed.
Repeat as needed.
Repeat as necessary.
MAX RATE
MIN INT
PHI
REI
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT (OUTDOOR); HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
GRANULAR
WETTABLE POWDER
0.2
70.0
Application equipment not on label.
For use on commercial and residential building exteriors, around
patios, driveways, sidewalks, and foundations.
Sprayer.
Spray thoroughly areas such as surfaces of screens, doors, window
frames, foundations, patios, around light fixtures, in garages, etc.
Perimeter treatments of structures. Ant runways. Saturate wasp and
hornet nests.
4 oz of bait per 500 sq.ft.
2 oz of 70WP in 1 gallon
water.
Repeat when necessary.
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FORMULATION
PRESSURIZED LIQUID
LIQUID-RTU
% AI
0.25
0.493
0.5
0.475,
0.5
0.529
0.665
0.67
1.0,
1.07,
1.054
0.5,
0.643
EQUIPMENT AND USE DIRECTIONS
Aerosol can.
For best results spray in early morning or early evening. Point
spray opening toward nest. Spray until nest is thoroughly saturated.
Aerosol can.
Spot treatment only.
Treat ant trails, around door sills and window frames, apply to ant
hills, apply to outside of foundations, doors, windows, screens,
porches, light fixtures, apply to wasp nests, surfaces of garages and
outbuildings.
Aerosol can.
Spray outside surfaces of screens, doors, window frames,
foundations, patios, etc. Spray ant runways. Apply to wasp and
hornet nests. Spray ant hills and runways. Install delivery tube and
spray into ant mound. Spray spider webs under porches and eaves.
Manholes, utility poles, farms, and around food processing plants.
Aerosol can.
Control of yellow jackets, wasps, hornets, and bees. Outdoor use
only, specific sites not identified.
Aerosol can.
Spray door sills, window frames, outside foundations and porches.
Spray directly on ant hills and on swarming ants outdoors. Apply to
screens, walls, door and window frames, light fixtures and other
outdoor surfaces. Apply to paper wasp and mud dauber wasp nests.
Aerosol can.
Spray door sills, window frames, outside foundations and porches.
Spray directly on ant hills and on swarming ants outdoors. Apply to
screens, walls, door and window frames, light fixtures and other
outdoor surfaces.
Aerosol can.
Spray door sills, window frames, outside foundations and porches.
Spray directly on ant hills and on swarming ants outdoors. Apply to
screens, walls, door and window frames, light fixtures and other
outdoor surfaces. Apply to paper wasp and mud dauber wasp nests.
Aerosol can.
Spray around foundations and porches, outside surfaces of screens,
doors, window frames, patios. Spray on ant hills and ant trails.
Inject into insect tunnels and cavities. Treat trails, points of entry
from voids around doors and windows.
Power operated or hand pressurized sprayers.
Spray thoroughly areas such as surfaces of screens, doors, window
frames, foundations, patios, around light fixtures, in garages, etc.
Perimeter treatments of structures. Ant runways. Saturate wasp and
hornet nests.
RATE
1 foot per second or until
surfaces are wet.
Spray for ten seconds or
until surface is moist.
Spray until area is
saturated.
1 foot per second or until
surfaces are wet.
Until surfaces are wet.
Until surfaces are wet.
Until surfaces are wet.
Coarse spray until surfaces
are wet.
TIMING
Repeat as necessary.
Repeat as necessary.
Repeat as needed.
Repeat as needed.
Repeat as needed.
Repeat as necessary
Repeat as necessary
MAX RATE
MIN INT
PHI
REI
70
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FORMULATION
CONCENTRATED LIQUID
OIL SOLUBLE LIQUID
BAIT/SOLID
% AI
1.0,
1.11
5.0,
8.0,
10.0
10.2
13.75
13.9,
14.6,
14.8,
19.6
4.0
0.250
2.0
EQUIPMENT AND USE DIRECTIONS
Power operated or hand pressurized sprayers. Low pressure sprayer
as a coarse spray.
Spray thoroughly areas such as surfaces of screens, doors, window
frames, foundations, patios, around light fixtures, in garages, etc.
Perimeter treatments of structures. Ant runways. Saturate wasp and
hornet nests.
Sprayer.
Brush.
Coarse spray.
Spot treatment.
Spray or brush areas such as surfaces of screens, doors, window
frames, foundations, patios, around light fixtures, in garages, etc.
Perimeter treatments of structures. Ant runways. Saturate wasp and
hornet nests.
Compressed air sprayer.
Apply as a coarse wet spray until surfaces are wet.
Spray or brush areas such as surfaces of screens, doors, window
frames, foundations, patios, around light fixtures, in garages, etc.
Ant runways and hills.
Hand or power operated sprayers.
Paint brush.
Spray or brush areas such as surfaces of screens, doors, window
frames, foundations, patios, around light fixtures, in garages, etc.
Perimeter treatments of structures. Ant runways. Saturate wasp and
hornet nests.
Sprayer.
Coarse spray.
Spray thoroughly areas such as surfaces of screens, doors, window
frames, foundations, patios, around light fixtures, in garages, etc.
Perimeter treatments of structures. Ant runways. Saturate wasp and
hornet nests.
Bait traps.
Place traps near ant colonies and along ant trails. Use a key to press
in the semi-perforations on side of trap.
Apply bait evenly in a band 2-3 feet wide around foundations,
patios, driveways, sidewalks, cracks and crevices, beneath concrete
drain splashpans.
RATE
Coarse spray until surfaces
are wet.
1 gallon per 500 square
feet or to runoff.
Mix one part of product
with nine parts of water or
kerosene.
Mix one part of product
with ten parts water.
1 1 fluid oz of product in 1
gal. water.
For sand flies and punkies
mix 1 1 fluid oz of product
in 1 quart of water.
8-11 fluid oz of product in
1 gal water.
For sand flies and punkies
mix 8 fl. oz. of product
with 1 quart of water
(4.5% con-centrate) .
Mix one part of product
with three parts of oil.
4 oz per 1000 sq.ft.
TIMING
Repeat as necessary
Repeat treatment when
necessary. .
Repeat as needed.
Repeat as needed.
Repeat when necessary.
MAX RATE
MIN INT
PHI
REI
DOGS/CANINES (ADULTS/PUPPIES)
71
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FORMULATION
PRESSURIZED LIQUID
IMPRG. COLLAR/TAG
% AI
0.25
4.3
9.0
9.4
10.0
EQUIPMENT AND USE DIRECTIONS
Spray bottle (non-gas aerosol) .
Thoroughly spray pet until wet. Fluff long hair so spray reaches
skin.
Collar (netwt. = .90oz)
Place collar around neck of dog.
Collar (net wt. = 0.85 oz)
Place collar around neck of dog.
Collar (net wt. not on label)
Place collar around neck of dog.
Collar (net wt. =
small dog collar = 0.42 oz
medium dog collar= 0.96 oz
large dog collar = 1.33 oz)
Place collar around dogs neck.
RATE
One collar per dog.
One collar per dog.
One collar per dog.
One collar per dog.
TIMING
Replace collar every 5
months, or when
effectiveness diminishes.
Replace collar every 5
months or sooner if
necessary to maintain
control.
Replace when effectiveness
diminishes.
Replace collar after 6
months or when
effectiveness diminishes.
MAX RATE
MIN INT
7
PHI
REI
CATS (ADULTS AND KITTENS)
PRESSURIZED LIQUID
IMPRG COLLAR/TAG
l.O
2.4
9.4
10.0
Aerosol can (foam).
Apply a line of product along the back starting at the tail and ending
at the neck.
Collar (netwt. = 0.5 oz)
Place collar on cats neck.
Collar (net wt. not on label)
Place around cats neck.
Collar (net wt. = 0.42 oz)
Place around animals neck.
2 seconds for each five
pounds of cat.
1 collar per cat.
One collar per cat.
One collar per cat.
Replace every 5 months or
when effectiveness
diminishes.
Replace when effectiveness
diminishes.
Replace collar after 6
months or when
effectiveness diminishes.
Repeat
every 7
days for
tick control
and every
14 days for
fleas.
PET LIVING/SLEEPING QUARTERS
PRESSURIZED LIQUID
0.25
0.493
Spray bottle (non-gas aerosol) .
For dogs only.
Aerosol can.
Spray cracks, crevices and areas where pet lies down.
7
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FORMULATION
CONCENTRATED LIQUID
OIL SOLUBLE LIQUID
LIQUID-RTU
% AI
0.5
0.529
0.665
0.67
1.0,
1.054
5.0,
8.0,
10.0
10.2
4.0
0.5
1.0
EQUIPMENT AND USE DIRECTIONS
Aerosol can.
Spray around baseboards, window and door frames, wall cracks, and
local areas of floors.
Aerosol can.
Spray cracks, crevices and areas where pets normally lie down. For
dog kennels apply to outside runways, window sills and ledges.
Aerosol can.
Spray around baseboards, window and door frames, wall cracks, and
local areas of floors.
Aerosol can.
Spray around baseboards, window and door frames, wall cracks, and
local areas of floors.
Aerosol can.
Spray around baseboards, window and door frames, wall cracks, and
local areas of floors.
Sprayer.
Coarse spray.
Spot treatment.
Spray around baseboards, window and door frames, wall cracks, and
local areas of floors. Apply a spot treatment to pets beds and resting
areas.
Compressed air sprayer.
Coarse wet spray until surfaces are wet.
Spray around baseboards, window and door frames, wall cracks, and
local areas of floors.
Sprayer.
Spray around baseboards, window and door frames, wall cracks, and
local areas of floors.
Power operated or hand pressurized sprayers.
Spray around baseboards, window and door frames, wall coverings.
Power operated or hand pressurized sprayers.
Spray around baseboards, window and door frames, wall cracks, and
local areas of floors.
RATE
1 foot per second or until
surfaces are wet.
Until surfaces are wet.
Until surfaces are wet.
Until surfaces are wet.
Mix one part of product
with nine parts of water or
kerosene.
Mix one part of product
with ten parts of water.
Coarse spray until surface
is wet.
Coarse spray until surfaces
are wet.
TIMING
Repeat as necessary.
Repeat as necessary.
Repeat as necessary.
Repeat as necessary.
Repeat as needed.
Repeat as needed.
Repeat when necessary.
Repeat as necessary.
Repeat as necessary.
MAX RATE
MIN INT
PHI
REI
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL); RESEARCH FACILITIES (ANIMAL QUARTERS)
PRESSURIZED LIQUIDS
0.493
0.5
Aerosol can.
Spot treatment only. Apply to outside runways, window sills, and
ledges, outdoor surfaces of screens, window frames, and other
surfaces where insects congregate.
Aerosol can.
Apply to outside runway, windowsills, and ledges.
1 foot per second or until
surface is wet.
Repeat as necessary.
73
-------
FORMULATION
LIQUID-RTU
BAIT/SOLID
% AI
0.5
1.0
2.0
EQUIPMENT AND USE DIRECTIONS
Power operated or hand pressurized sprayers.
Spray around baseboards, window and door frames, wall coverings.
Compressed air sprayers.
No specific instructions given for application.
RATE
Coarse spray until surface
is wet.
Possibly 4 oz per 1000
sq.ft.
TIMING
Repeat as necessary.
Repeat as needed.
Repeat as necessary.
MAX RATE
MIN INT
PHI
REI
BOAT MOORING LINES
INSECTICIDAL TAPE
10.0
10.0
10.0
Insect control system
Apply trap, cartridge (containing insect repellent) and Insectape to
the mooring lines of boat.
Insecticidal strip and trap.
For control of boll weevil, adult gypsy moth and Mediterranean fruit
flies in insect traps.
areas for traps to be placed not specified on label.
Specially formulated package for protection of telecommunications,
power and electronic equipment. Reppels imported fire ants and
roaches. Also use in boar guard systems.
Kills and controls insects from entering equipment.
One trap per mooring line.
Strip size will vary
depending on insects to be
controlled0.25xl.O inch up
to 6 1x4 inch strip per
trap.
Can apply entire 4x6 inch
strip. Do not apply more
than 12 1x4 inch strips per
3 cu.ft. of equipment.
Replace as needed.
Replace as effectiveness
diminishes.
Replace as effectiveness
diminishes.
SPECIAL LOCAL NEEDS (SLN's)
INSECTICIDAL TAPE
10.0
Parent label # is
8730-4-ZA.
California only.
Urban and agricultural areas under quarantine pest surveillance.
Apply to detection traps from the time they are deployed until the
end of the trapping season.
Affix one strip of product
per trap.
Replace when necessary to
maintain effectiveness.
FOR MANUFACTURING USE ONLY
LIQUID
5.0,
5.88,
5.89
10.0,
70.0,
99.6
3.35
May be used to formulate products for use in residential indoor,
food, nonfood, and industrial use areas.
INDOOR USES: Only for formulation into insecticides for
residential and commercial indoor, food, nonfood and institutional
areas.
OUTDOOR USES: Residential and commercial applications to
surfaces of buildings and around patios, driveways, sidewalks and
foundations.
This product may NOT be used to formulate products for the
following uses: 1) food producing livestock - direct application to
meat and dairy animals, treatment of occupied premises or when
animal food or feed is present, 2) growing crops - edible crops and
pre- and post-harvest sprays, 3) fumigated commodities and 4)
aquatic uses.
74
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case propoxur covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to propoxur in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are 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 if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
75
-------
76
-------
Data Supporting Guideline Requirements for the Reregistration of Propoxur
REQUIREMENT
USE PATTERN CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-11
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Octanol/Water Partition
Stability
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
42286601, 42715301
40711201, 42286601, 42286602,
42715301
42286601
40951301, 42286602, 42715300
42286602, 42715302
40951301, 42715302, 42911001
40711202
40711202
40711202
10711202, 42601201
40711202, 42601201
40711202, 42601201
40711202
40711202
40711202, 42286603, 43158001
ECOLOGICAL EFFECTS
71-1A
71-1B
71-2A
71-2B
71-3
71-4A
Acute Avian Oral -
Quail/Duck
Acute Avian Oral -
Quail/Duck TEP
Avian Dietary - Quail
Avian Dietary - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
all
all
all
all
all
k
160000, 41625101
41625101
149015, 22923, 42301201,
42757101
149015, 22923, 42301201,
42757101
152443, 256151, 42615403
149017
77
-------
Data Supporting Guideline Requirements for the Reregistration of Propoxur
REQUIREMENT
71-4B
72-1A
72-1C
72-3C
72-2A
72-4A
141-1
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Estuarine/Marine Toxicity -
Shrimp
Invertebrate Toxicity
Early Life Stage Fish
Honey Bee Acute Contact
USE PATTERN
k
all
all
all
all
WAIVED
k
CITATION(S)
149016
149171
149171
40228401
149172
60633
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-8-SS
82-1B
82-3
82-7-SS
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity -
Rat
Primary Eye Irritation -
Rabbit
Primary Dermal Irritation -
Rabbit
Dermal Sensitization - Guinea
Pig
Acute Neurotoxicity Study -
Rat
90-Day Feeding - Non-rodent
90-Day Dermal - Rodent
90-Day Neurotoxicity
all
all
all
all
all
all
all
all
all
all
149030, 152443
40836401
40836402
41737801
41870801
41652401
43445701
41066001
41066001
42041601, 43445701
Screening - Rat
83-1A Chronic Feeding Toxicity -
Rodent
all
142725
78
-------
Data Supporting Guideline Requirements for the Reregistration of Propoxur
REQUIREMENT USE PATTERN CITATION(S)
83-IB Chronic Feeding Toxicity -
Non-Rodent
83-2A Oncogenicity - Rat
83-2B Oncogenicity - Mouse
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity -
Rabbit
83-4 2-Generation Reproduction -
Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
85-2 Dermal Penetration all
OCCUPATIONAL/RESIDENTIAL EXPOSURE
all 149040, 42041601
all 142725
all 42597701
all 41061101
all 41061102
all 41817501, 42615403
all 147479, 149043, 40836403
all 149041, 40953501, 41008701,
41724601, 42005101
all 41169901
all 142731, 165000, 40629702,
40629703, 40629704, 40629706,
41345801
40953502
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive Dosimetry
Exposure
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
all 41054701, 41054702, 41054703,
41054704, 41054705, 41858201,
42087201
all 41054701, 41054702, 41054703,
41054704, 41054705, 41858201,
42087201, 42648001, 43398501
all 85762
k* 85763
k* 85763
k* 85768
79
-------
Data Supporting Guideline Requirements for the Reregistration of Propoxur
REQUIREMENT
162-2 Anaerobic Soil Metabolism
163-1 Leaching/Adsorption/De-
sorption
164-1 Terrestrial Field Dissipation
165-1 Confined Rotation! Crop
165-2 Field Rotational Crop
RESIDUE CHEMISTRY
171 -4 A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
171-4C Residue Analytical Method -
USE PATTERN
k*
k*
k*
WAIVED
WAIVED
1
WAIVED
1
CITATION(S)
85768
29887, 85769, 85770
857721
42286610
42756701
Plants
171-4D Residue Analytical Method -
Animal
171-4E Storage Stability
171-41 Magnitude of Residues - Food
Handling
42756701
42286612
42286604, 42286605, 42286606,
42286607, 42286608, 42286609,
42286610, 42286611, 42286612
These studies are not generally required for residential uses. However because data were
available for porpoxur they were reviewed and considered in the risk assessment.
80
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
81
-------
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
82
-------
BIBLIOGRAPHY
MRID
CITATION
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scientific
Report-Wildlife No. 191. (U.S. Dept. of the Interior, Fish and Wildlife
Service, Patuxent Wildlife Research Center; unpublished report)
00029887 Thornton, J.S.; Hurley, J.B.; Obrist, JJ. (1976) Soil Thin-Layer Mobility of
Twenty Four Pesticides (sic) Chemicals: Report No. 51016. (Unpublished
study received Jan. 28, 1980 under 5F1547; submitted by Mobay Chemical
Corp., Pittsburgh, Pa.; CDL: 099216-1)
00060633 Atkins, E.L., Jr.; Anderson, L.D. (1967) Toxicity of Pesticides and Other
Agricultural Chemicals to Honey Bees: Laboratory Studies. University of
California Agricultural Extension Services. (M-16; submitter report no.
22259; also "In" unpublished submission received March 27, 1974 under
4F1485; submitted by Chemagro Crop., Kansas City , Mo.; CDL:092011-M)
00085762 Aly, O.M.; El-Dib, M.A. (1971) Studies on the persistence of some carbamate
insecticides in the aquatic environment-I: Hydrolysis of Sevin, Baygon,
Pyrolan and Dimetilan in waters. (Without title) ?: 1191-1205. (Submitter
34648; also "In" unpublished submission received Oct 21, 1981 under
3125-306; submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:246088-C)
00085763 Gronberg, R.; Pither, K.M. (1981) Photodecomposition of Baygon in Aqueous
Media: Report No. 53613. (Unpublished study received Oct 21, 1981 under
3125-306; submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:246088-D)
00085768 Gronberg, R.R.; Hanna, G.R.; Atwell, S.H. (1981) The Metabolism of Baygon
in Sandy Loam and Silt Loam Soils: 69617. (Unpublished study received Oct
21, 1981 under 3125-306; submitted by Mobay Chemical Corp., Kansas City,
Mo.; CDL:246088-J)
00085769 Atwell, S.H. (1976) Leaching Characteristics of Baygon on Aged Soil: Report
No. 50718. (Unpublished study received Oct 21, 1981 under 3125-306;
submitted by Mobay Chemcial Corp., Kansas City, Mo.; CDL:246088-L)
83
-------
BIBLIOGRAPHY
MRID
CITATION
00085770 Lenz, M.F.; Gronberg, R.R. (1980) Soil Adsorption and Desorption of Baygon:
69016. (Unpublished study received Oct 21, 1981 under 3125-306; submitted
by Mobay Chemical Corp., Kansas City, Mo.; CDL:246088-N)
00085772 Mobay Chemical Corporation (1981) Residue of Baygon—Various Soils.
(Compilation; unpublished study, including report nos. 69240, 69241,
69242,..., received Oct 21, 1981 under 3125-306; CDL:246088-Q)
00142725 Suberg, H.; Loeser, E. (1984) Chronic Toxicological Study with Rats (Feeding
Study over 106 Weeks): Report No. 12870. Unpublished Mobay Study No.
88501 prepared by Bayer Institute of Toxicology. 846 p.
00142731 Klein, W. (1984) Effect of an Active Ingredient and Three Metabolites on the
DNA Metabolism: Report No. A050. Unpublished Mobay Study No. 88852
prepared by Bayer Institute of Toxicology. 36 p.
00147479 Herbold, B. (1982) Carbamate UN Technical: Salmonella/Microsome Test to
Evaluate for Point Mutation: Bayer Report No. 11301. Unpublished Mobay
report no. 82726 prepared by Bayer AG. 20 p.
00149015 Lamb, D. (1981) Acute Dietary LC50 of Technical Propoxur (Baygon) to
Bobwhite Quail: Study No. 80-175-06: Mobay Report No. 80046. Unpublished
study prepared by Mobay Chemical Corp. 9 p.
00149016 Carlisle, I; Carsel, M. (1982) Propoxur Reproduction Study with Mallard
Duck: Study No. 81-675-06: Mobay Report No. 82265. Unpublished study
prepared by Mobay Chemical Corp. 55 p.
00149017 Lamb, D.; Carsel, M. (1982) Propuxur Reproduction Study with Bobwhite
Quail: Study No. 81-675-04: Mobay Report No. 82269. Unpublished study
prepared by Mobay Chemical Corp. 58 p.
00149030 Heimann, K. (1982) Carbamate UN, Technical: Study for Acute Toxicity on
Rats: Report No. 11329. Unpublished Mobay Report No. 82740 prepared by
Bayer AG. 8 p.
00149040 Hoffmann, K.; Groning, P. (1984) BOQ 58 123 15 (BOE 58 123 15, C.N.
Propoxur): Chronic Toxicity to Dogs on Oral Administration: (12month
84
-------
BIBLIOGRAPHY
MRID
CITATION
Feeding Study): Report No. 12605. Unpublished Mobay Report No. 86665
prepared by Bayer AG. 240 p.
00149041 Herbold, B. (1980) Micronucleus Test on Mouse To Evaluate BOB 5812315
for Mutagenic Potential: BOB 5812315: Report No. 9274. Unpublished Mobay
Report No. 69317 prepared by Bayer AG. 17 p.
00149043 Ohta, T.; Moriya, M. (1983) Propoxur: Microbial Mutagenicity Study.
Unpublished study prepared by Institute of Environmental Toxicology. 7 p.
00149171 Lamb, D. (1981) Acute Toxicity of Technical Propoxur (Baygon) to Bluegill
and Rainbow Trout: Study Nos. 81-066-02 and 80-066-11. Unpublished study
prepared by Mobay Chemical Corp. 9 p.
00149172 Lamb, D. (1981) Acute Toxicity of Technical Propoxur (Baygon) to Daphnia
magna: Study No. 81-067-01. Unpublished study prepared by Mobay
Chemical Corp. 9 p.
00152443 Flucke, W. (1980) Boe 5812315 (Propoxur) Acute Toxicity Studies: Report
No: 9295. Unpublished study prepared by Bayer AG. 7 p.
00160000 Hudson, R.; Tucker, R.; Haegele, M. (1984) Handbook of toxicity of
pesticides to wildlife: Second edition. US Fish and Wildlife Service:
Resource Publication 153. 91 p.
00165000 Karl, W. (1985) Biotransformation of Propoxur Quantitative Determination of
Metabolite Spectrum in Rats Dosed Once with Carbon 14 Propoxur after Being
Fed Compound at Three Subchronic Dietary Levels. Unpublished Mobay
Report No. 90441 prepared by Bayer AG. 33 p.
40629702 Eben, C. (1987) Investigations on the Biotransformation of Propoxur in Mice:
Report Nos. 15697: 95615. Unpublished study prepared by Bayer Ag. 47 p.
40629703 Eben, C. (1986) The Biotransformation of Propoxur in Golden Hamsters:
Report No. 93152. Unpublished study prepared by Bayer Ag. 44 p.
40629704 Eben, C. (1985) Studies on Biotransformation of Propoxur in Humans: Report
No. 91951. Unpublished study prepared by Bayer Ag. 39 p.
85
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BIBLIOGRAPHY
MRID
CITATION
40629705 Eben, C. (1985) Supplementary Studies on Biotransformation of Propoxur in
the Rat: Report No. 91979. Unpublished study prepared by Bayer Ag. 33 p.
40629706 Eben, C. (1986) Propoxur (the Active Ingredient of Baygon) Biotransformation
Studies on Monkeys: Report No. 94293. Unpublished study prepared by Bayer
Ag. 41 p.
40711201 Talbott, T. (1988) Product Chemistry of Baygon Technical: BR 1599.
Unpublished study prepared by Mobay Corp. 27 p.
40711202 Talbott, T. (1988) Product Chemistry of Baygon Technical: BR 1600.
Unpublished study prepared by Mobay Corp. 104 p.
40836401 Sheets, L. (1988) Acute Dermal Toxicity of Technical Grade Baygon in
Rabbits: Study No. 88-023-AQ. Unpublished study prepared by Mobay Corp.
19 p.
40836402 Pauluhn, J. (1988) Study of the Acute Inhalation Toxicity in Accordance with
OECD Guideline No. 403: BOQ 5812315 (Propoxur): Report No. 98291.
Unpublished study prepared by Bayer AG. 83 p.
40836403 Lehn, H. (1988) Propoxur: Mutagenicity Study for the Detection of Induced
Forward Mutations in the CHO-HGPRT Assay in vitro: Report No. 98290;
17090. Unpublished study prepared by Bayer AG. 33 p.
40951301 Talbott, T. (1988) Product Chemistry of Baygon Technical: Brochure No.
1639. Unpublished compilation prepared by Mobay Corp. 202 p.
40953501 Putman, D.; Morris, M. (1988) Chromosome Aberrations in Chinese Hamster
Ovary (CHO) Cells: Final Report: Laboratory Study No.: T8297.337.
Unpublished study prepared by Microbiological Associates, Inc. 28 p.
40953502 Eigenberg, D. (1988) Dermal Absorption of Propoxur Technical in Rats Using
Carbon 14-Propoxur: Study No. 88-721-AT. Unpublished study prepared by
Mobay Corp. 84 p.
41008701 Herbold, B. (1988) Propoxur: Cytogenetic Studies of the Bone Marrow of the
Chinese Hamster in vivo to Test for Harmful Effect on Chromosomes: Rept.
86
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BIBLIOGRAPHY
MRID
CITATION
No. 17111. Unpublished Mobay report 98468 prepared by Bayer AG, Institute
of Toxicology. 53 p.
41054701 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.
41054702 Dean, V. (1988) Exposure of Mixer/Loader-Applicators to Propoxur During
Mixing/Loading and Application of Baygon 70 WP Insecticide as a
Crack/Crevice Limited Surface Treatment in Residences: Report No. 99101.
Unpublished study prepared by Mobay Corp. 222 p.
41054703 Knarr, R. (1988) Exposure to Propoxur of Residents of Homes Treated with
Baygon 70% WP: 99102. Unpublished study prepared by Mobay Corp. 599 p.
41054704 Dean, V. (1988) Exposure of Applicators to Propoxur During Application of
Baygon 2% Bait Insecticide Around Foundations, Patios, Driveways or
Sidewalks: 99131. Unpublished study prepared by Mobay Corp. 227 p.
41054705 Knarr, R. (1988) Exposure of Applicators to Propoxur During Residential
Application of an Aerosol Spray Containing 1% Propoxur: 99132.
Unpublished study prepared by Mobay Corp. 192 p.
41061101 Becker, H.; Mladenovic, P.; Terrier, C. (1989) Embriotoxicity Study (Including
Teratogenicity) with BOQ 5812315 (C. N. Propoxur) in the Rat: Report No.
98566. Unpublished study prepared by RCC. 337 p.
41061102 Becker, H.; Mladenovic P.; Terrier, C. (1989) Embrotoxicity Study (Including
Teratogenecity) with BOQ 5812315 (C. N. Propoxur) in the Rabbit: Report No.
98567. Unpubli shed study prepared by RCC. 269 p.
41066001 Diesing, L.; Flucke, W. (1989) Subchronic Dermal Toxicity Study in Rabbits:
BOQ 5812315 (Propoxur): Study No. T 8030050/ T 5030543. Unpublished
Mobay report 98568 prepared by Bayer AG. 269 p.
41169901 Curren, R. (1989) Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
Baygon Technical: Laboratory Study No. T8297.380: Report No. 99173.
Unpublished study prepared by Microbiological Associates, Inc. 26 p.
87
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BIBLIOGRAPHY
MRID
CITATION
41345801 Kao, L. (1989) Disposition and Metabolism of Propoxur in Rats - A Review:
Lab Project Number: 99792. Unpublished study prepared by Mobay Corp.
187 p.
41625101 Campbell, S. (1990) An Acute Oral Toxicity Study with the Northern
Bobwhite: Baygon 2% Bait (Encapsulated): Lab Project Number: 149-159:
100240. Unpublished study prepared by Wildlife International Ltd. 21 p.
41652401 Sheets, L. (1990) Dermal Sensitization Study with Technical Grade P Propoxur
(Baygon) in Guinea Pigs: Lab Project Number: 90-324-GJ: RPT. 100275.
Unpublished study prepared by Mobay Corp. 21 p.
41724601 Putman, D.; Morris, M. (1990) Chromosome Aberrations in Chinese Hamster
Ovary (CHO) Cells: Baygon Technical: Supplemental to: Lab Project Number:
T8297.337. Unpublished study prepared by Microbiological Associates, Inc.
13 p.
41737801 Sheets, L. (1990) Primary Eye Irritation Study with Technical Grade Propoxur
(Baygon) in Rabbits: Lab Project Number: 90-335-GZ. Unpublished study
prepared by Mobay Corp. 16 p.
41817501 Suter, P.; Biedermann, K.; Luetkemeier, H.; et al. (1990) BOQ 5812315 (c.n.
Propoxur): Two-Generation Reproduction Study in the Rats: Report 100650:
Lab Project Number: 207314. Unpublished prepared by Research and
Consulting Co., Ag.; Umweltchemie Ag. 679 p.
41858201 Knarr, R. (1991) Exposure of Applicators to Propoxur During Residential
Application of an Aerosol Spray Containing 1 % Propoxur: Lab Project
Number: 98896. Unpublished study prepared by Mobay Corp. 256 p.
41870801 Sheets, L.; Fuss, M. (1991) Primary Dermal Irritation Study with Technical
Grade Propoxur (Baygon) in Rabbits: Lab Project Number 90-325-HA.
Unpublished study prepared by Mobay Corp. 16 p.
42005101 Herbold, B. (1991) Propoxur: Cytogenetic Studies of the Bone Marrow of the
Chinese Hamster in vivo to Test for Harmful Effect on Chromosomes:
Supplement to MRID 41008701: Lab Proj ect Number: 98468: 17111.
Unpublished study prepared by Bayer Ag., Inst. of Toxicology. 51 p.
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BIBLIOGRAPHY
MRID
CITATION
42041601 Ruf, J.; Mager, H. (1991) Chronic Toxicity to Dogs (26-Week Feeding Study)
with Propoxur: Lab Project Number: 101280: 19964: T/9030763. Unpublished
study prepared by Bayer Ag. (Wuppertal). 245 p.
42087201 Waggoner, T. (1991) Propuxur—Dermal and Inhalation Exposure: Lab Project
Number: RPT 74253: TRPROP91DF004: ADC 1240-2. Unpublished study
prepared by Mobay Health Corp in coop, with Analytical Development Corp.
156 p.
42286601 Fountaine, L. (1992) Supplemental Product Chemistry of Baygon
Technical (Supp. to MRIDS 40711201 and 40951304): Lab Project
Number: MCL0163A; MCL0163B. Unpublished study prepared by Miles,
Inc. 7 p.
42286602 Fountaine, L. (1992) Supplemental Product Chemistry of Baygon Technical
(Supp. to MRID 40951301): Lab Project Number: 86193. Unpublished
study prepared by Miles, Inc. 7 p.
42286603 Fountaine, L. (1992) Supplemental Product Chemistry of Baygon Technical
(Supp. to MRID 40711202): Lab Project Number: BR 1796. Unpublished
study prepared by Miles, Inc. 8 p.
42286604 Gronberg, R. (1992) Residues of Baygon in Milk after Treatment of a
Dairy Processing Plant with Baygon 70 WP by Crack and Crevice Spot
Applications (Addendum I): Lab Project Number: 66123-R-l. Unpublished
study prepared by Miles Inc. 6 p.
42286605 Gronberg, R. (1992) Residues of Baygon in Raisin Bran Dry Cereal after
Treatment of Cereal Manufacturing Plant with Baygon 70 WP by Crack and
Crevice Spot Applications (Addendum I): Lab Project Number: 66246-R-l.
Unpublished study prepared by Miles Inc. 6 p.
42286606 Gronberg, R. (1992) Residues of Baygon in Pasta (Spaghetti, Macaroni
and Noodles) after Treatment of a Macaroni Manufacturing Plant with
Baygon 70 WP by Crack and Crevice Spot Applications (Addendum I): Lab
Project Number: 66247-R-l. Unpublished study prepared by Miles Inc.
6 p.
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BIBLIOGRAPHY
MRID
CITATION
42286607 Gronberg, R. (1992) Residues of Baygon in Corn Flour and Meal after
Treatment of a Grain Mill with Baygon 70 WP by Crack and Crevice Spot
Applications (Addendum I): Lab Project Number: 66198-R-l. Unpublished
study prepared by Miles Inc. 6 p.
42286608 Gronberg, R. (1992) Residues of Baygon in Foods and Beverages after
Treatment of a Delicatessen with Baygon 70 WP by Crack and Crevice Spot
Applications (Addendum I): Lab Project Number: 66200-R-l. Unpublished
study prepared by Miles Inc. 6 p.
42286609 Gronberg, R. (1992) Residues of Baygon in Food and Beverages after
Treatment of a Cafeteria with Baygon 70 WP by Crack and Crevice Spot
Applications (Addendum I): Lab Project Number: 66199-R-l. Unpublished
study prepared by Miles Inc. 6 p.
42286610 Gronberg, R. (1992) Nature of Propoxur Residues in Foods Following Various
Processing Procedures (Addendum I): Lab Project Number: 99723-1.
Unpublished study prepared by Miles Inc. 9 p.
42286611 Gronberg, R. (1992) A Gas Chromatographic Method for the Determination of
Residues of Baygon in Foods, Foodstuffs and Beverages (Addendum I): Lab
Project Number: 54213-R-l. Unpublished study prepared by Miles Inc. 6 p.
42286612 Gronberg, R. (1992) The Stability of Baygon in Liver, Kidney and Milk
(Addendum I): Lab Project Number: 31339-R-l. Unpublished study
prepared by Miles Inc. 6 p.
42301201 Stafford, T. (1992) Study Upgrade: Acute Dietary LC50 of Technical
Propuxur (Baygon) to Bobwhite Quail (Supp. to): Lab Project Number:
80-175-06: 80046-1. Unpublished study prepared by Miles Inc. 10 p.
42601201 Fontaine, L. (1992) Product Chemistry of BAYGON: Supplemental to MRID
42286603: Lab Project Number: 102591: 103874: 103880. Unpublished study
prepared by Miles Inc. 25 p.
42615403 Dotti, A.; Kinder, I; Biedermann, K.; et al. (1992) Two-generation
Reproduction Study in Rats: BOQ 5812315: Lab Project Number: 286997: T
90
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BIBLIOGRAPHY
MRID
CITATION
5039706. Unpublished study prepared by Research & Consulting Co. Ltd. and
Biological Research Labs Ltd. 734 p.
42648001 Pauluhn, J. (1992) BOQ 5812315: Study for Chronic Inhalation Toxicity in the
Rats: Lab Project Number: 21848. Unpublished study prepared by Bayer AG.
4358 p.
42715300 Miles, Inc. (1993) Supplemental submission of product chemistry data in
support of the reregi strati on of Propoxur (Baygon). Transmittal of 2
studies.
42715301 Fontaine, L. (1993) Product Chemistry of Baygon Technical: Supplement to
MRID 42286601: Lab Project Number: ANR-00093: RM 301405: BR 1822.
Unpublished study prepared by Miles Inc. 14 p.
42715302 Fontaine, L. (1993) Product Chemistry of Baygon Technical: Supplement to
MRID 42286602: Lab Project Number: 86193: TM G-19.33: ANR-00193.
Unpublished study prepared by Miles Inc. 30 p.
42756701 Stanley, C.; Thornton, J. (1990) (Reformat of MRID 121227) Gas
Chromatographic Method for Residues of BAYGON and Its Major Metabolite
in Animal Tissues and Milk: Lab Project Number: 30451-R: 30451.
Unpublished study prepared by Mobay Corp. 18 p.
42757101 Hancock, G. (1993) Acute Dietary LC50 of Technical Propoxur (Baygon) to
Bobwhite Quail: Study Upgrade: Lab Project Number: 80-175-06: 80046-2.
Unpublished study prepared by Miles Inc. 10 p.
42757102 Hancock, G. (1993) Acute Dietary LC50 of Technical Propoxur (Baygon) to
Mallard Duck: Study Upgrade: Lab Project Number: 80-175-10: 69609-2.
Unpublished study prepared by Miles Inc. 9 p.
42911001 Fontaine, L. (1993) Supplement to MRID 42715302: Product Chemistry of
BAYGON Technical: Lab Project Number: 106255: TM C-19.33: TM
G-19.33. Unpublished study prepared by Miles, Inc. 28 p.
43158001 Fontaine, L. (1994) Supplement to MRID 42286603: Product Chemistry of
Baygon Technical: Lab Project Number: 106474: BR 1867. Unpublished
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study prepared by Miles Inc. 9 p.
43398501 Pauluhn, J. (1994) Chronic Inhalation Toxicity Study on Rats: BOQ
5812315 (c.n.: Propoxur): Addendum: Lab Project Number: 103955-1:
21848: T0019172. Unpublished study prepared by Bayer Ag Department
of Toxicology. 20 p.
43445701 Dreist, M.; Popp, A. (1994) BOQ 5812315 (c.n. Propoxur): Acute Oral
Neurotoxicity Screening Study in Rats: Lab Project Numbers: 23338: T
3050251:106387. Unpublished study prepared by Bayer AG. 402 p.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
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your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-
0350).
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(s), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
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The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy of the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do
not alter the printed material. If you have questions or need assistance in preparing your
response, call or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
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III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
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request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the products
in the group. The registration number of the product for which data will be submitted must be
noted in the agreement to cost share by the registrant selecting this option. If you choose to enter
into an agreement to share in the cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant who will be submitting the data.
You must also provide EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other registrant's acceptance
of your offer, or a written statement by the parties that an agreement exists. The agreement to
produce the data need not specify all of the terms of the final arrangement between the parties or
the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve
the terms of the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment
7. In addition, you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a copy of your offer
and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your
offer must, in addition to anything else, offer to share in the burden of producing the data upon
terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
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you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
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which states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data are
usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA. You
must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
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disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry, acute
toxicity and efficacy (where appropriate) are required for all products and the Agency would grant
a waiver only under extraordinary circumstances. You should also be aware that submitting a
waiver request will not automatically extend the due date for the study in question. Waiver
requests submitted without adequate supporting rationale will be denied and the original due date
will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
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3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-in Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
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to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
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Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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PROPOXUR DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing propoxur.
This Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
propoxur. This attachment is to be used in conjunction with (1) the Product Specific Data Call-
in Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this propoxur Product
Specific Data Call-in (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for propoxur are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency
has concluded that additional data on propoxur are needed for specific products. These data
are required to be submitted to the Agency within the time frame listed. These data are needed
to fully complete the reregistration of all eligible propoxur products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Bonnie Adler at (703) 308-8523.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Bonnie Adler
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: propoxur
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-in Notice
and you will not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be in accordance
with the Existing Stocks provision of the Data Call-in Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data
exemption, you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this
form, provide the EPA registration numbers of your source(s); you would not
complete the "Requirements Status and Registrant's Response" form. Examples
of such products include repackaged products and Special Local Needs (Section
24c) products which are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding
"yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that
your product has already been transferred to another company or that you have
already voluntarily canceled this product. For these cases, please supply all
relevant details so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-in Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements,
all use patterns are covered by the data requirements. In the case of efficacy
data, the required studies only pertain to products which have the use sites
and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in
rare cases.
Item 8. The due date for submission of each study is identified. It is normally based on
8 months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-in Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined
in the Data Call-in Notice. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand
that this option is available only for acute toxicity or certain efficacy data and
only if EPA indicates in an attachment to this Notice that my product is similar
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enough to another product to qualify for this option. I certify that another party
in the agreement is committing to submit or provide the required data; if the
required study is not submitted on time, my product may be subject to
suspension. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain
efficacy data and only if EPA indicates in an attachment to this Data Call-in
Notice that my product is similar enough to another product to qualify for this
option. I am submitting evidence that I have made an offer to another registrant
(who has an obligation to submit data) to share in the cost of that data. I am
also submitting a completed "Certification of Offer to Cost Share in the
Development Data" form. I am including a copy of my offer and proof of the
other registrant's receipt of that offer. I am identifying the party which is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. I understand that
other terms under Option 3 in the Data Call-In Notice (Section III-C.l.) apply
as well. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing Study).
I certify that this study will meet all the requirements for submittal of existing
data outlined in Option 4 in the Data Call-in Notice (Section III-C.l.) and will
meet the attached acceptance criteria (for acute toxicity and product chemistry
data). I will attach the needed supporting information along with this response.
I also certify that I have determined that this study will fill the data requirement
for which I have indicated this choice. By the specified due date, I will also
submit a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) to show what data compensation
option I have chosen. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID
or Accession number of the study at the due date. I understand that the
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conditions for this option outlined Option 5 in the Data Call-In Notice (Section
III-C.l.) apply. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute
toxicity or certain efficacy data and only if the cited study was conducted on my
product, an identical product or a product which EPA has "grouped" with one
or more other products for purposes of depending on the same data. I may also
choose this option if I am citing my own data. In either case, I will provide the
MRID or Accession number(s) for the cited data on a "Product Specific Data
Report" form or in a similar format. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my request.
If the Agency approves my waiver request, I will not be required to supply the
data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30 days of my
receipt of the Agency's written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating the option chosen. I also understand
that the deadline for submission of data as specified by the original data call-in
notice will not change. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that
your product has already been transferred to another company or that you have
already voluntarily canceled this product. For these cases, please supply all
relevant details so that EPA can ensure that its records are correct.
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VEPA'S BATCHING OF PROPOXUR PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing propoxur as the
active ingredient, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products within
a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwith-standing the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need
arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see
acceptance criteria attached), the formulation tested is considered by EPA to be similar for
acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the
registrant must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-in Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the
Agency within 90 days of receipt. The first form, "Data Call-in Response," asks whether the
registrant will meet the data requirements for each product. The second form, "Requirements
Status and Registrant's Response," lists the product specific data required for each product,
including the standard six acute toxicity tests. A registrant who wishes to participate in a batch
must decide whether he/she will provide the data or depend on someone else to do so. If a
registrant supplies the data to support a batch of products, he/she must select one of the
following options: Developing Data (Option 1), Submitting an Existing Study (Option 4),
Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant
depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost
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Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know
that choosing not to participate in a batch does not preclude other registrants in the batch from
citing his/her studies and offering to cost share (Option 3) those studies.
One hundred and sixty two products were found which contain propoxur as the active
ingredient. These products have been placed into twenty-six batches and a "no batch" category
in accordance with the active and inert ingredients, type of formulation and current labeling.
Table 1 identifies the batched products. Table 2 lists the products which have been placed in
the "no batch" category. Due to the varied effects of different propellant systems on eye
irritation, propellant spray products (whether in a batch or in the "no batch" group) cannot
cite another product's eye irritation data unless the propellant systems of the two products are
identical.
TABLE 1
Batch
1
EPA Reg. No.
4822-95
4833-111
% Active Ingredient
0.5
0.665
Formulation Type
Liquid
Liquid
Batch
2
EPA Reg. No.
655-642
655-641
% Active Ingredient
0.5
1.0
Formulation Type
Liquid
Liquid
Batch
3
EPA Reg. No.
1440-7
1459-27
11694-89
% Active Ingredient
1.0
1.0
1.0
Formulation Type
Liquid
Liquid
Liquid
Batch
4
EPA Reg. No.
52-215
655-546
769-761
769-792
2155-59
6218-24
6720-160
11474-20
45385-13
58254-2
% Active Ingredient
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
120
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Batch
5
EPA Reg. No.
334-334
506-133
5887-76
6959-89
7754-42
10900-73
11715-12
35138-66
% Active Ingredient
Formulation Type
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Batch
6
EPA Reg. No.
11474-39
45385-1
% Active Ingredient
0.5
0.5
Formulation Type
Spray
Spray
Batch
7
EPA Reg. No.
1021-1005
1021-1090
1021-1121
% Active Ingredient
6.2
3.6
3.35
Formulation Type
Liquid
Liquid
Liquid
Batch
8
EPA Reg. No.
69421-33
69421-40
% Active Ingredient
0.5
0.5
Formulation Type
Spray
Spray
Batch
9
EPA Reg. No.
1021-1095
1021-1133
4972-30
% Active Ingredient
6.2
5.89
5.0
Formulation Type
Liquid
Liquid
Liquid
Batch
10
EPA Reg. No.
498-73
5887-74
11623-2
11623-10
% Active Ingredient
0.5
0.5
0.5
0.75
Formulation Type
Spray
Spray
Spray
Spray
121
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Batch
11
EPA Reg. No.
239-2360
239-2390
498-158
655-351
802-438
1203-5
1270-94
4822-127
4822-315
4822-316
9444-186
33176-23
42057-59
% Active Ingredient
1.0
0.5
0.5
1.0
0.5
1.0
0.5
0.75
1.25
1.25
1.0
0.493
1.0
Formulation Type
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Spray
Batch
12
EPA Reg. No.
498-123
4822-100
% Active Ingredient
1.0
1.0
Formulation Type
Spray
Spray
Batch
13
EPA Reg. No.
498-74
9444-92
9444-94
9444-115
% Active Ingredient
0.5
1.0
2.0
2.0
Formulation Type
Spray
Spray
Spray
Spray
Batch
14
EPA Reg. No.
10806-1
10806-19
10806-80
10806-96
% Active Ingredient
0.5
0.5
0.5
0.5
Formulation Type
Spray
Spray
Spray
Spray
122
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Batch
15
EPA Reg. No.
498-165
4822-224
4822-318
10807-165
13283-10
56276-20
% Active Ingredient
0.5
0.475
1.0
0.5
0.5
0.5
Formulation Type
Spray
Spray
Spray
Spray
Spray
Spray
Batch
16
EPA Reg. No.
1021-1007
1021-1175
1021-1196
1021-1466
% Active Ingredient
4.085
4.0
5.88
4.0
Formulation Type
Liquid
Liquid
Liquid
Liquid
Batch
17
EPA Reg. No.
769-929
769-935
% Active Ingredient
0.5
0.5
Formulation Type
Spray
Spray
Batch
18
EPA Reg. No.
861-93
3125-177
9367-50
28293-273
% Active Ingredient
1.0
1.0
1.0
1.0
Formulation Type
Liquid
Liquid
Liquid
Liquid
Batch
ISA
EPA Reg. No.
498-155
498-168
3125-176
3125-262
% Active Ingredient
0.5
0.5
0.5
1.0
Formulation Type
Spray
Spray
Spray
Spray
Batch
19
EPA Reg. No.
422-18
655-796
2553-37
% Active Ingredient
19.6
19.6
19.6
"ormulation Type
Jquid
Jquid
Jquid
123
-------
Batch
20
EPA Reg. No.
3125-313
3125-146
% Active Ingredient
70.0
70.0
Formulation Type
Solid
Solid
Batch
21
EPA Reg. No.
8730-49
8730-53
% Active Ingredient
10.0
10.0
Formulation Type
Tape
Tape
Batch
22
EPA Reg. No.
506-125
769-817
3095-25
3095-67
3125-121
3125-293
5887-65
8848-60
10370-174
62577-5
% Active Ingredient
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Batch
22A
EPA Reg. No.
506-137
% Active Ingredient
0.25
Formulation Type
Solid
Batch
23
EPA Reg. No.
2517-60
2517-61
2724-254
2724-275
8730-51
% Active Ingredient
9.0
9.0
9.4
9.4
10.0
Formulation Type
Collar
Collar
Collar
Collar
Collar
Batch
24
EPA Reg. No.
3125-445
4822-449
11715-301
% Active Ingredient
1.0
1.0
1.0
Formulation Type
Spray
Spray
Spray
124
-------
Batch
25
EPA Reg. No.
3125-174
11556-33
% Active Ingredient
99.6
99.6
Formulation Type
Solid
Solid
Batch
26
EPA Reg. No.
4822-101
4822-333
44446-26
% Active Ingredient
0.475
0.25
0.5
Formulation Type
Spray
Spray
Spray
NO BATCH
Batch
None
EPA Reg. No.
239-2426
402-95
491-194
491-214
498-121
499-289
655-328
769-807
769-823
769-917
1203-39
1270-172
1270-197
1270-199
1553-87
1685-69
1685-71
1769-164
2517-45
2517-46
2517-58
2517-65
3125-344
3125-345
% Active Ingredient
2.0
1.0
1.0
9.4
0.665
1.0
10.0
8.0
13.75
0.5
0.67
0.94
0.5
10.0
10.2
1.0
1.0
1.0
4.2
2.4
1.0
0.25
0.5
0.5
Formulation Type
Bait
Spray
Spray
Liquid
Spray
Spray
Liquid
Liquid
Liquid
Spray
Spray
Liquid
Spray
Liquid
Liquid
Liquid
Spray
Spray
Collar
Collar
Foam
Spray
Spray
Spray
125
-------
Batch
None
EPA Reg. No.
3125-450
4000-92
4816-409
4822-84
4822-331
8660-114
8730-35
9444-112
9591-124
10807-4
10807-48
10807-85
10807-125
11556-62
11694-25
11694-26
11715-106
11715-109
11715-129
44446-26
4700-18
62451-1
62451-2
62577-6
66733-3
% Active Ingredient
19.6
0.5
5.0
1.0
0.24
13.9
10.0
0.5
1.0
0.5
0.5
1.0
1.0
0.25
0.5
1.0
1.0
0.5
1.0
0.5
1.0
10.0
10.0
1.0
1.0
Formulation Type
Liquid
Spray
Liquid
Liquid
Spray
Liquid
Bait
Spray
Spray
Spray
Spray
Liquid
Spray
Spray
Spray
Spray
Liquid
Spray
Liquid
Spray
Spray
Solid
Solid
Solid
Spray
126
-------
Attachment 5. List of All Registrants Sent This Data Call-In (insert) Notice
127
-------
128
-------
Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible
party must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
129
-------
130
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131
-------
132
-------
United States Environmental Protection Agency
Washington, B.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to, Chief Information Policy
Branch, PM-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of
Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below:
Company Name
Company Number
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
an offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firms on the following
date(s):
Name of Firm (s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA form 8580 which is obselete
133
-------
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
0,^
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-99
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
134
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The following is a list of available documents for propoxur that my further assist you
in responding to this Reregistration Eligibility Decision document. These documents may
be obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregistration Information System at 703-308-7224. They also
are available on the Internet using WWW (World Wide Web) on
WWW.EPA.GOV., or contact Bonnie Adler at (703)-308-8523.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for propoxur.
The following documents are part of the Administrative Record for propoxur and
may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may
be obtained by contacting the person listed on the Chemical Status Sheet of this RED
document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
135
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136
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