United States Prevention, Pesticides EPA 738-R-97-003
Environmental Protection And Toxic Substances March 1997
Agency (7508W)
&EPA Reregistration
EligibilityDecision(RED)
3-lodo-2-propynyl
butylcarbamate(IPBC)
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/ A \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
z
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
reregi strati on eligibility review and decisions on the pesticide chemical case 3-Iodo-2-propynyl
butylcarbamate (IPBC) which includes the active ingredient IPBC. The enclosed Reregi strati on
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
reregi strati on. The RED includes the data and labeling requirements for products for
reregi strati on. 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 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 or generic data requirements or wish to
meet with the Agency, please contact the Special Review and Reregi strati on Division
representative Richard Gebken (703) 308-8591.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, 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 REOUESTS-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 reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregi strati on. 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 (attached to the DCI).
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.
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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)
Bv 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 reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
3-iodo-2-propynl butyl carbamate (IPBC)
LISTB
CASE 2725
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
IPBC REREGISTRATION ELIGIBILITY DECISION TEAM x
ABSTRACT xiii
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History and Data Requirements 4
III. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity 5
c. Chronic toxicity/Carcinogenicity 6
d. Developmental Toxicity 7
e. Mutagenicity 8
f. Metabolism 9
g. Toxic Endpoints of Concern 10
h. Cancer Classification 10
i. Neurotoxicity 11
C. Exposure Assessment 11
a. Occupational and Residential Exposure 11
b. Summary of Use Patterns, and Formulations, and Types of
Exposures 11
1. Risk Assessment 20
a. Occupational Handler Risks 20
b. Homeowner Handler Risks 22
c. Other Considerations 22
D. Environmental Assessment 26
1. Ecological Toxicity Data 26
a. Toxicity to Terrestrial Animals 26
b. Toxicity to Aquatic Animals 28
c. Toxicity to Plants 30
2. Environmental Fate 30
a. Environmental Fate Assessment 30
b. Environmental Fate and Transport 30
c. Water Resources 32
3. Exposure and Risk Characterization 32
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a. Ecological Exposure and Risk Characterization 32
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 32
A. Determination of Eligibility 32
B. Determination of Eligibility Decision 33
1. Eligibility Decision 33
2. Eligible and Ineligible Uses 34
C. Regulatory Position 34
1. Potential Risks to Infants and Children/Aggregate
Exposure/Cumulative Effects 35
2. Occupational and Residential Labeling Rationale/Risk Mitigation
36
a. Personal Protective Equipment/Engineering Controls for
Handlers 36
b. Primary Occupational Handlers 37
3. Other Labeling Requirements 38
V. ACTIONS REQUIRED OF REGISTRANTS 38
A. Manufacturing-Use Products 38
1. Additional Generic Data Requirements 38
2. Labeling Requirements for Manufacturing-Use Products 38
B. End-Use Products 39
1. Additional Product-Specific Data Requirements 39
2. Labeling Requirements for End-Use Products 40
b. Entry Restrictions 41
c. Other Labeling Requirements 41
C. Existing Stocks 42
VI. APPENDICES 45
APPENDIX A. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 61
APPENDIX B. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 3-iodo-2-propynl butyl carbamate (IPBC) 69
APPENDIX C. Product Specific Data Call-In 77
Attachment 1. Chemical Status Sheets 91
Attachment 2. Product Specific Data Call-in Response Forms (Form
A inserts) Plus Instructions 93
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 97
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 105
Attachment 5. List of All Registrants Sent This Data Call-in (insert)
Notice 110
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions Ill
APPENDIX D. List of Available Related Documents 117
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IPBC REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Frank Hernandez Economic Analysis Branch
Doug Gurian-Sherman Benefits Analysis Branch
Environmental Fate and Effects Risk Assessment
Mary Frankenberry
Tom A. Bailey
James A. Hetrick
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Health Effects Risk Assessment
John Redden
Timothy McMahon
Laura Morris
Registration Support
Ian Blackwell
James Stone
Sami Malak
Risk Management
Richard Gebken
Bruce Sidwell
Risk Characterization and Analysis Branch
Toxicology Branch II
Occupational Risk Exposure Branch
Registration Branch
Registration Branch
Registration Support Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
x
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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
FDA Food and Drug Administration
FIFRA The Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA The Federal Food, Drug, and Cosmetic Act
FQPA The Food Quality Protection Act of 1996
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
L OD L imit 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.
Hg/g Micrograms Per Gram
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.
N/A Not Applicable
NOEC No effect concentration
XI
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GLOSSARY OF TERMS AND ABBREVIATIONS
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
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
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.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
XII
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ABSTRACT
The U. S. Environmental Protection Agency has completed its reregi strati on eligibility
decision of the pesticide case IPBC, which includes the active ingredient 3-iodo-2-propynyl
butylcarbamate. This decision includes a comprehensive reassessment of the required target data
and the use patterns of currently registered products. Additionally, the Agency has examined
information concerning the exposure and susceptibility of infants and children to IPBC, and
available information concerning aggregate exposure to IPBC as well as the potential for
cumulative effects from IPBC and other substances that have a common mode/mechanism of
toxicity.
IPBC is a fungicide/antimicrobial used as a preservative in paint, adhesives, emulsions,
metal cutting fluids, oil recovery drilling mud/packer fluids, plastics, textiles, inks, paper
coatings, and wood products. It is also used in residential settings as a wood preservative stain
to combat wood rot/decay, and as a preservative in paints. IPBC is also used in heating,
ventilation, and air conditioning (HVAC) ducts/systems to control mold and fungi. The Agency
has concluded that all uses, with the exception of industrial wood protection treatments to milled
forest products, the HVAC uses, textile uses, and non-industrial wood treatments other than
brush, roller and airless or compressed air sprayer, as prescribed in this document, will not cause
unreasonable risks to humans or the environment. Therefore, all products, except those labelled
for the above-mentioned uses, are eligible for reregi strati on. Additional exposure data are being
required to be submitted so that the Agency can assess exposure and risk from the industrial
wood treatment use, HVAC use, textile use, and certain non-industrial wood treatments. The
Agency cannot make reregi strati on eligibility decisions on these uses at this time.
The Agency has concluded that an additional uncertainty factor for estimating risk to
infants and children is not warranted, that aggregate exposures from all non-occupational sources
are not likely to be of concern, and that the contribution of IPBC exposures to the risks from
other carbamate pesticides is likely to be minimal.
Before reregistering the products containing IPBC, the Agency is requiring that product
specific data, revised Confidential Statements 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 that contain other active ingredients will be
eligible for reregi strati on only when the other active ingredients are determined to be eligible for
reregi strati on.
Xlll
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregi strati on of products with active ingredients registered before November 1,
1984. The amended Act provides a schedule for the reregi strati on process to be completed in
nine years. There are five phases to the reregi strati on process. The first four phases of the
process focus on identification of data requirements to support the reregi strati on 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 reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredients are eligible for reregi strati on" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregi strati on 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) was signed into
law. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FQPA amendments went into effect
immediately. Among other things, FQPA amended the FFDCA by setting a new safety standard
for the establishment of tolerances. Because IPBC has no food uses, and therefore no tolerances
have been established, the specific considerations outlined in FQPA are not required for this
chemical. Nevertheless, EPA believes that consideration of available data relating to the special
sensitivity of infants and children, the potential for aggregate exposures and cumulative effects is
prudent for IPBC because children and other individuals could be exposed to this compound in
non-occupational settings.
This document presents the Agency's decision regarding the reregi strati on eligibility of
the registered uses of IPBC. The document consists of six sections. Section I is the introduction.
Section II describes IPBC, 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 reregi strati on decision for IPBC. Section V discusses the
reregi strati on requirements for IPBC. Finally, Section VI is the Appendices which support this
Reregi strati on 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 Reregi strati on Eligibility
Decision:
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade and Other Names:
Basic Manufacturers:
B.
Use Patterns
Use Profile
IPBC
3-Iodo-2-propynyl butylcarbamate
carbamate
55406-53-6
107801
C8H12IN02
Troysan Polyphase Anti-Mildew
Troysan Polyphase KK-108A
Permatox IBP
ASC 67000
Carbamic acid, butyl-, 3-iodo-2-propynyl ester
Troy Corp.
72 Eagle Rock Ave.
East Hanover, NJ 07936
Olin Corp.
350KnotterDr.,
Cheshire, CT 06410
3-iodo-2-propynl butyl carbamate (IPBC) is a fungicide and antimicrobial used in both
industrial processes and residential settings. IPBC is used in the following industrial products
and processes: paint/adhesive/emulsion manufacturing, metal cutting fluids, oil recovery drilling
mud/packer fluids, plastics manufacturing, textile manufacturing, ink manufacturing, paper
coating, canvas manufacturing, and milled wood products manufacturing. IPBC is also a wood
preservative used to combat fungal wood rot/decay. For residential use, IPBC can be applied
with a paint brush, paint roller, and airless sprayer. IPBC is also applied to heating, ventilation
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and air conditioning (HVAC) ducts to control mold and fungi. IPBC is formulated as solids and
liquids (0.05 to 97% active ingredient).
Use Groups and Sites:
TERRESTRIAL NONFOOD
OUTDOOR RESIDENTIAL
INDOOR NONFOOD
INDOOR RESIDENTIAL
Pests:
Wood protection treatment of milled forest products used
for non-aquatic purposes; oil recovery, oil drilling mud and
packer fluids
Wood protection treatment of buildings/products outdoor
(e.g., decks and siding)
Industrial adhesives/coatings, metalworking cutting fluids,
latex/oil/varnish paints, plastic products, specialty
industrial products, textiles/fibers/cordage
Wood protection treatment of buildings/products indoor
black mold, brown mold, brown rot, white rot,
mold/mildew, black mold/mildew, fungal rot/decay,
industrial wood protection treatment to milled forest
products, fungal slime, blue stain, bacteria
Formulation Types:
Single Active Ingredient Products
Emulsifiable concentrate~4 to 5.97%
Soluble concentrate liquid~2.4 to 40%
Liquid ready to use~0.4 to 0.8%
Soluble concentrate solid—20 to 97%
Multiple Active Ingredient Products
Liquid ready to use—0.05 to 0.5% + one other AI
Methods and Rates of Application:
Emulsifiable concentrate
Apply treatment by brush, sprayer, or tank at 0.013 gal product/gal.
Soluble concentrate liquid
Apply by brush, tank, or sprayer at 0.12 to 0.48 Ib. or 0.01 to 0.02 gal
product/gal. During manufacture of the product, apply industrial
preservative or make up fluids treatment at 0.2 to 0.48 Ib. product/gal.
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Liquid ready to use
Apply by brush, roller, tank, sprayer, or pad at 2.5 to 20 gal.
product/1000 ft2.
Soluble concentrate solid
During manufacture, apply industrial preservative or make up fluid
treatment at 0.048 Ib. Al/gal.
C. Regulatory History and Data Requirements
IPBC was first registered in the United States in 1975 for use as a disinfectant, fungicide
and algicide. The Agency issued a Phase IV reregi strati on Data Call-in September 1993
requesting technical product chemistry, ecological effects, and environmental fate studies.
These data were required to supplement the existing database for the Agency's assessment of
IPBC under reregi strati on. This data base is included in Appendix B.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
• Chemical Structure:
I-CEC-CH2-0-C-NH-
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B.
Human Health Assessment
1. Toxicology Assessment
The toxicological data base on IPBC is adequate to support reregi strati on eligibility.
While submitted studies on chronic toxicity/carcinogenicity, developmental toxicity in a second
species, reproduction, and metabolism were not required to support the current use patterns, the
Agency included them in its assessment. The Agency's conclusions follow.
a. Acute Toxicity
Table 1 Acute Toxicity
Study
oral LD50--rat
99% Technical
Dermal LD50--rabbit
98% IPBC
Inhalation LC50--rat
98.2% IPBC
Eye Irritation— rabbit
97%IPBC
Dermal Irritation— rabbit*
Dermal Sensitization— Guinea Pig*
Results
l.lg/kg(F)
1.5g/kg(M&F)
>2,000 mg/kg
0.68 mg/L (M&F)
severely irritating
slightly irritating
non-sensitizer at 0.32%
Category
III
III
III
I
IV
N/A
* Not required for TGAI but included here for additional information
Acceptable acute toxicity studies with IPBC indicate low toxicity except eye irritation.
The Acute Oral LD50 in female rats was 1.1 g/kg with a Toxicity Category of III (guideline 81-
1; MRID 00148277). The Acute Dermal LD50 in rabbits was found to be >2,000 mg/kg with a
Toxicity Category of III (guideline 81-2; MRID 42135501). The acute inhalation LC50 in male
and female rats was 0.68 mg/L with a Toxicity Category of III (guide-line 81-3; MRID
42204301). In a primary eye irritation study in rabbits (guideline 81-4; MRID 41627109),
IPBC technical was severely irritating to the eyes of white rabbits, with corneal opacity and
corneal vascularization reported in unwashed eyes by day 21 post-treatment. The technical
grade of IPBC was slightly irritating to the skin of white rabbits (guideline 81-5; MRID
41627110). In a dermal sensitization study in Guinea pigs (guideline 81-6; MRID 43005701),
IPBC technical, at a concentration of 0.32%, produced no evidence of sensitization in male and
female Guinea pigs.
b. Subchronic Toxicity
In a subchronic oral toxicity study, male and female Sprague-Dawley rats received IPBC
technical by gavage for 13 weeks at doses of 0, 20, 50, and 125 mg/kg/day. An additional
satellite group was dosed at 125 mg/kg/day and held for a 28-day observation period following
the 13-week dosing regimen. At the 125 mg/kg/day dose level, body weight gain was decreased
by 19% in male rats for weeks 1-13 of the study, and by 12% in female rats over the same
period. Absolute liver weight was increased by 20% in male rats at the 125 mg/kg/day dose, and
by 31% in female rats at this dose level. Liver to body weight ratio was significantly increased
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by approximately 31% in both male and female rats at the 125 mg/kg/day dose level, while
kidney to body weight ratio in female rats was increased 18% at the 125 mg/kg/day dose level.
The systemic NOEL was considered to be 20 mg/kg/day, while the systemic LEL was
considered to be 50 mg/kg/day, based on increased liver to body weight ratio. This study is
classified as core supplementary data (guideline 82-1; MRTD 40947401). Although this
guideline is not satisfied, acceptable chronic toxicity data are available and therefore, additional
oral subchronic data are not required.
In a subchronic dermal toxicity study, male and female Sprague-Dawley rats
(10/sex/dose) received dermal doses of 50, 200, and 500 mg/kg/day IPBC technical grade
(97.5%) to the shaved skin for five days a week, six hours per day. At the 500 mg/kg/day dose,
decreased body weight (4-6%) and weight gain (11%) were observed in male rats, but not in
female rats. In female rats, significant increases in hemoglobin, hematocrit, and eosinophils
were observed at the 500 mg/kg/day dose level. Reticulocytes as a percentage of red cells were
decreased in the 50 and 200 mg/kg/day dose groups but not at the 500 mg/kg/day dose level.
Decreased serum glucose and decreased serum creatinine were observed in male rats at 500
mg/kg/day. Minimal to mild skin irritation (acanthosis and hyperkeratosis) was observed in both
male and female rats. Increased serum gamma-glutamyl transpeptidase (24% increase) was
observed in female rats. At the 200 mg/kg/day dose, decreased serum glucose was observed in
male rats, as was minimal to mild acanthosis and hyperkeratosis in male and female rats.
Females in this study showed inhibition of plasma cholinesterase at 500 mg/k/day test article,
which may have been the result of either direct liver toxicity or inhibition of cholinesterase
itself. Based upon the results of this study, the systemic NOEL is 200 mg/kg/day, the systemic
LEL is 500 mg/kg/day for male and female rats. This study is classified as core minimum data
(guideline 82-3, MRID 42168201).
c. Chronic toxicity/Carcinogenicity
In a 2-year chronic toxicity/carcinogenicity study, technical grade IPBC (98.68% ai) was
administered to male and female Sprague Dawley rats (50/sex/group) at dose levels of 0, 20, 40,
and 80 mg/kg/day. There were no statistically significant increases in tumor incidences in male
rats. The incidence of mammary gland fibroadenoma and combined fibroadenoma/carcinoma in
female rats was significantly increased at the 20 mg/kg/day dose level vs. control by pair wise
comparison (p < 0.01), but there was no dose-related trend. Except for the 20 mg/kg/day dose
level, the incidence of this tumor type was within historical control range for Sprague-Dawley
rats. Since the mammary tumor incidence at 80 mg/kg/day was almost equal to control, the
Agency's (OPP) Health Effects Division Carcinogenicity Peer Review Committee concluded
that the mammary fibroadenomas were not related to treatment with IPBC.
At the 80 mg/kg/day dose level, body weight gain decrements of 20% and 15% were
observed in male and female rats, respectively, during the first 13 weeks of the study. At study
termination, body weight gain in male rats at the 80 mg/kg/day dose level was decreased to 71%
of control, and in female rats, to 76% of control. Significant changes in serum chemistry were
observed in male rats at the 80 mg/kg/day dose, as were significant non-neoplastic changes in
-------
the stomach (submucosal edema, submucosal inflammation, acanthosis, hyperkeratosis,
ulceration, and basal cell proliferation) in both sexes. The non-neoplastic changes in the
stomach were considered the result of chronic irritation, and were not considered indicative of a
neoplastic response. The systemic NOEL was determined to be <20 mg/kg/day (lowest dose
tested), and the systemic LEL was determined to be 20 mg/kg/day, based on decreased body
weight gain in male rats. The 80 mg/kg/day dose level was considered adequate for testing of
carcinogenic potential of IPBC, based upon decreased body weight gain in male and female rats.
This study is classified as core minimum data (guideline 83-5; MRTD 42008206).
A 78-week carcinogenicity study was conducted in male and female CD-I mice in which
50 mice/sex/dose were administered technical IPBC in the diet at dose levels of 0, 20, 50, and
150 mg/kg/day. In male mice, a statistically significant trend was observed for hepatocellular
adenoma and hepatocellular adenoma/carcinoma combined (p< 0.01). A statistically significant
pair-wise comparison was also observed for the incidence of hepatocellular adenoma and
adenoma/carcinoma combined at 150 mg/kg/day vs. control
(p< 0.05). At the 150 mg/kg/day dose, the incidence of hepatocellular adenoma (24%) and
combined adenoma/carcinoma (33%) exceeded the historical control range for CD-I mice
provided by the registrant (average benign hepatocellular tumor incidence 11%, malignant tumor
incidence 7%). There was no increase in hepatocellular tumor incidence in female mice. There
was a significant dose-related positive trend in pulmonary carcinoma for female mice, but no
significant pair-wise comparison at any dose level tested in this study. Since the formation of
pulmonary carcinomas in mice is considered part of a continuum from pulmonary adenomas, the
positive trend in carcinomas was not considered biologically significant.
At the highest dose level used (150 mg/kg/day), body weight gain in male mice was
decreased to 73% of control for weeks 0-13 of the study, and to 77% of control at study
termination. In female mice, body weight gain for weeks 0-13 at the high dose level was
decreased to 70% of control, and to 80% of control at study termination. No significant effects
on food consumption were observed in this study. In addition, no statistically significant effects
on survival were seen in this study. The systemic NOEL was determined to be < 20 mg/kg/day,
and the systemic LEL was determined to be 20 mg/kg/day, based on the increased incidence of
non-neoplastic pathology of the thyroid in both sexes (atrophic vacuolation, follicular
coalescence, and general follicular enlargement). This study is classified as core minimum data
(guideline 83-2; MRID 42008202).
d. Developmental Toxicity
The developmental toxicity of IPBC was assessed in pregnant Sprague-Dawley rats on
gestation days six through 15 by oral administration of the test chemical at doses of 0, 20, 50,
and 125 mg/kg/day. Maternal toxicity as reduced body weight gain during dosing was observed
at the 125 mg/kg/day dose level. Developmental toxicity consisted of an increased incidence of
skeletal abnormalities at the 125 mg/kg/day dose level. The maternal toxicity NOEL was
determined to be 50 mg/kg/day, and the maternal toxicity LEL was determined to be 125
mg/kg/day, based on reduced body weight gain. The developmental toxicity NOEL was
-------
determined to be 50 mg/kg/day, and the developmental toxicity LEL was determined to be 125
mg/kg/day, based on incompletely ossified frontal skull bones and pelvic girdles. This study is
classified as core minimum data (guideline 83-3; MRID 40990401).
A developmental toxicity study was conducted in female New Zealand white rabbits, in
which pregnant rabbits received oral doses of 0, 2, 20, and 50 mg/kg/day IPBC on gestation days
6 through 19 inclusive. At 50 mg/kg/day, maternal toxicity in the form of increased mortality
and abortion was observed. Although changes in cesarean section observations were reported at
the 50 mg/kg/day dose level, these changes are likely a secondary effect of maternal toxicity,
and not a primary effect of test chemical. The maternal toxicity NOEL was determined to be 20
mg/kg/day, and the maternal toxicity LEL was determined to be 50 mg/kg/day, based on
increased mortality, clinical signs, and decreased body weight gain. The developmental toxicity
NOEL was determined to be >50 mg/kg/day, and the developmental toxicity LEL was
determined to be >50 mg/kg/day. This study is classified as core minimum data (guideline 83-3;
MRID 42481604).
A 2-generation reproductive toxicity study was conducted in male and female Sprague-
Dawley rats. IPBC technical was administered over two generations at doses of 0, 120, 300, and
750 ppm (0, 6, 15, and 37.5 mg/kg/day). Reduced body weight and food consumption was
observed for Px and Fx males during the premating period at the 37.5 mg/kg/day dose. A
decreased mean live birth index was reported for Px and Fx generations without an effect on
viability and development of pups. No adverse effects on reproductive indices or mating
performance were observed at any dose level. The parental toxicity NOEL was determined to be
15 mg/kg/day, and the parental toxicity LEL was determined to be 37.5 mg/kg/day, based on
decreased body weight and food consumption during premating for Px and Fx males, and
decreased mean live birth index for the Pt and Fx generations. The reproductive toxicity NOEL
was determined to be ^37.5 mg/kg/day, and the reproductive toxicity LEL was determined to be
>37.5 mg/kg/day. This study is classified as core minimum data (guideline 83-4; MRID
40990402).
e. Mutagenicity
In a mutagenicity study, IPBC technical was tested for the ability to cause mutations in
Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100. In the five
strains used, IPBC was found to be non-mutagenic in the presence or absence of metabolic
activation at the concentrations tested, 1-1000 jig/plate (guideline 84-2; MRID 41975206). In a
micronucleus assay in mice, IPBC at doses of 200, 600, and 2000 mg/kg did not induce any
significant increase of the PCE containing micronuclei from the treated mice when compared to
that of the vehicle control mice (guideline 84-2; MRID 40990404). In two independent
unscheduled DNA synthesis (UDS) assays in primary rat hepatocytes, eight doses of IPBC
ranging from 3.0 to 13.5 ug/ml did not cause an appreciable increase in mean net nuclear grain
counts. Doses >13.5 ug/ml were cytotoxic, supporting the conclusion that IPBC induced
cytotoxicity but no genotoxicity in this assay (guideline 84-2; MRID 40990403).
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f. Metabolism
Disposition of C14 IPBC was examined in male and female Sprague-Dawley rats at single
oral doses of 20 and 125 mg/kg, at 20 mg/kg x 14 days, and as a single intravenous dose of 0.5
mg/kg. The time course of tissue distribution, conducted in 5 rats of each sex administered 7
daily doses of 20 mg/kg/day, was also performed.
Several deficiencies were noted in the original review of this study, including an
inadequate number of rats per dose group, inadequate design of the repeat dose study, no
justification for dose levels used in the study, and no identification of major metabolites (MRID
40947404).
In another rat metabolism study (MRID # 43570701), IBPC was administered orally in
0.5% carboxymethylcellulose to groups of male and female Crl:CD®BR rats in the following
manner: Groups of 5 male and 5 female rats (groups A and B) received either a single oral high
dose of radiolabelled IPBC (125mg/kg) or a repeated low oral dose of non-radiolabelled IPBC
followed by a single radiolabelled dose (20 mg/kg). Separate groups of rats (9/sex/group,
groups C and D) received single oral doses (20 and 125 mg/kg) of radiolabelled IPBC, and 3
rats/sex were sacrificed at 2, 4, and 120 hours post-dose for determination of tissue distribution
of radioactivity. Urine, feces and expired air were collected at 24 hour intervals for groups A
and B, while urine and feces were collected from groups C and D.
Absorption of test chemical at the low and high dose was between 80-90% for all dose
groups, as suggested by excretion data showing the majority of a dose eliminated through urine
or exhaled air.
Excretion of IPBC-derived radioactivity was mainly via the urine, with between 50-70%
of an administered dose excreted by this route at 168 hours post-dose. Feces was a minor route
of excretion in all dose groups (4-7% of the administered dose), while radiolabelled CO2
constituted between 18-24% of the administered dose. Repeated low oral dosing or a single high
oral dose appeared to result in a decrease in the percentage of radioactivity excreted as 14-CO2
compared to a single low dose (38.22% in MRID # 40947404).
Based on the metabolite identification data, a scheme for metabolism of IPBC was
proposed. According to this scheme, IPBC undergoes reductive dehalogenation followed by de-
alkylation to form the URM-9 and URM-10 metabolites. In addition, de-carboxylation
following reductive dehalogenation yields carbon dioxide. Various other metabolites formed
from dehalogenation are glucuronidated and constitute minor metabolites of IPBC.
This study was submitted in order to address deficiencies from review of a previous
metabolism study (MRTD # 40947404). The data provided in this study in conjunction with
MRID # 40947404, satisfy the data requirement for a metabolism study in rats under
Subdivision F guideline 85-1.
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g. Toxic Endpoints of Concern
The Agency's (OPP) Toxic Endpoint Selection Committee concluded (June 4, 1996) that
for dermal absorption a calculated value of 10% should be used. This value was derived from the
LOEL of 50 mg/kg/day in the 90 day oral study in rats (MRID 40947401) and the LOEL of 500
mg/kg/day in the 90 day dermal study in rats (MRID 42168201). The LOELs were used because
of the minimal effects seen at the LOELs.
The short term occupational or residential exposure (1 to 7 days) and the intermediate
term occupational or residential (1 week to several months) exposure endpoint was selected from
the subchronic dermal toxicity study in rats (MRID 42168201). Systemic toxicity was observed
in both male and female rats from repeated dermal administration of IPBC at 500 mg/kg/day.
In males, decreased body weight gain, clinical chemistry alterations, and dermal irritation
were observed at 500 mg/kg/day.
In female rats, significant changes in hematological and clinical chemistry parameters
were observed at 500 mg/kg/day in addition to dermal irritation. Females in this study showed
inhibition of plasma cholinesterase at 500 mg/kg/day test article, which may have been the result
of either direct liver toxicity or inhibition of cholinesterase itself.
Based upon the results of this study, the systemic NOEL is 200 mg/kg/day, and the
systemic LEL is 500mg/kg/day for male and female rats.
The endpoint for use in risk assessment is the NOEL of 200 mg/kg/day based on
decreased body weight gain, alterations in clinical chemistry parameters, and dermal irritation at
500 mg/kg/day.
The endpoint for chronic exposure, several months to lifetime was selected from the
chronic toxicity/carcinogenicity study in rats. The endpoint for use in risk assessment is the
NOEL of 20 mg/kg/day, based on the observation in male and female rats of decreased body
weight gain at the LEL of 20 mg/kg/day dose level (MRID 42008206).
h. Cancer Classification
The Agency's (OPP) Health Effects Division Carcinogenicity Peer Review Committee
(CPRC) classified (June 16, 1993), IPBC as a Group C - possible human carcinogen. The
Group C classification was based on a statistically significant increase in hepatic adenomas and
combined adenomas/carcinomas in male CD-I mice, by both pair-wise and trend analysis. The
incidence of adenomas was above the mean and the upper end of the range of historical controls.
There are also structure-activity relationships between IPBC and compounds that are classified
as liver and/or bladder carcinogens. However, there was no compound-related increase in
tumors in female mice or in Sprague-Dawley rats. Since there was only one statistically-
significant, compound-related tumor type (liver) in one sex (male) and one species (mouse), and
10
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there was no apparent genotoxicity concern, the committee recommended the RfD approach for
any future dietary risk assessment.
On September 18, 1996, at the request of the registrants and supported by an additional
review (MRID 43819001) of the slides of male and female mouse livers from the chronic mouse
study (MRID 42008202), the CPRC re-evaluated the carcinogenic potential of 3-iodo-2-propynl
butyl carbamate using the Agency's revised Guidelines for Carcinogen Risk Assessment. The
CPRC concluded that the additional evidence provided by the registrant supports re-
classification of IPBC as "not likely" to be carcinogenic. In the context of the revised
guidelines, this decision was based on: a) the lack of a carcinogenic response for combined
adenoma/carcinoma of the liver in male mice as a result of the re-evaluation of the tumor
incidence in the 18-month mouse carcinogenicity study; b) the lack of carcinogenic response in
female mice and in male or female rats; c) the absence of mutagenic activity; and d) the absence
of data suggesting formation of a reactive metabolite of IPBC which might be responsible for
initiation of the tumors observed.
i. Neurotoxicity
Since IPBC is classified as a carbamate, additional confirmatory data are being required
to satisfy the following neurotoxicity guidelines:
81-8 Acute Rat Neurotoxicity with cholinesterase
82-7 90-day Rat Neurotoxicity with cholinesterase
C. Exposure Assessment
a. Occupational and Residential Exposure
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, etc.) during use or to persons entering treated sites after
application is complete. The criteria are met for IPBC.
b. Summary of Use Patterns, and Formulations, and Types of
Exposures
IPBC is a fungicide used in both industrial and residential settings. It has many industrial
manufacturing applications as specified above as well as use in residential settings as a wood
preservative. IPBC can be applied with a paint brush, paint roller, or airless/compressed-air
sprayer, and as an on-site wood dip treatment. IPBC is formulated as a ready-to-use liquid,
liquid concentrate, and solid concentrate for occupational and residential/homeowner use.
From these uses of IPBC products, the Agency believes there are potential exposures to
mixers, loaders, applicators, and other people during and after application. The Agency has
identified two levels of exposures:
11
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• primary handlers — persons directly handling IPBC pesticide products; and
• secondary handlers — persons handling manufactured products, such as paints and
adhesives, to which IPBC has been added as a preservative.
(1) Occupational Handler Exposure Scenarios
Primary Handler Exposures: Based on the use patterns, several major occupational
primary handler exposure scenarios were identified for IPBC. In industrial manufacturing
settings these include mixing/loading of liquid formulations of IPBC products for:
• paint/adhesives/emulsion/paper coatings;
• metal cutting fluids;
• oil recovery drilling fluids;
• plastics;
• textiles;
• inks;
• pulp and paper mill systems;
• canvas;
• wood products (mixing/loading and application);
and mixing/loading solids for paint/adhesives/emulsion/paper coating manufacturing.
In non-industrial and residential settings, primary handler scenarios include:
• mixing/loading liquid for brush application;
• mixing/loading liquid for roller application;
• mixing/loading liquid for airless/compressed-air sprayer application;
• mixing/loading liquid for on-site wood dip application;
• applying with a brush;
• applying with a roller;
• applying with an airless/compressed-air sprayer;
• and applying as an on-site wood dip.
Secondary Handler Scenarios: Based on the use patterns and potential exposure
scenarios, several major occupational secondary handler exposure scenarios were identified for
handling and/or applying manufactured products that had been treated with IPBC:
• paints and wood stains;
• adhesives and emulsions;
• plastics, textiles, and canvas;
• paper products;
• metalworking fluids;
• wood products;
• air-conditioner and furnace filters.
(2) Homeowner Handler Exposure Scenarios
12
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Primary Homeowner Handler Scenarios: Based on the use patterns, the Agency has
identified several major exposure scenarios for primary homeowner handlers:
• mixing/loading liquid for brush application;
• mixing/loading liquid for roller application;
• mixing/loading liquid for airless/compressed-air sprayer application;
• mixing/loading liquid for on-site wood dip application;
• applying with a brush;
• applying with a roller;
• applying with an airless/compressed-air sprayer;
• and applying as an on-site wood dip.
Secondary Homeowner Handler Scenarios: Based on the use patterns, the Agency has
identified two major exposure scenarios for secondary homeowner handlers:
• exposures while handling/applying IPBC-containing paint/stain;
• exposures while handling/using IPBC-treated wood and other products;
(3) Occupational and Homeowner Handler Exposure
Estimates and Assumptions
The Agency assumes that the scenarios below represent reasonable worst-case exposures
to handlers of IPBC:
• oil-well mud-packer fluids for uses in oil-recovery drilling muds, secondary-oil
recovery injection water, and oil-well injection fluids;
• preservative uses in paint manufacturing for uses in oil/latex paint, industrial
adhesives, industrial coatings, paper coating, resin/latex/polymer emulsions;
plastic manufacturing, textile manufacturing, ink manufacturing, and canvas
manufacturing;
• pulp and paper mill systems uses;
• metalworking fluids [Note: machinists' exposure to metalworking fluids
containing IPBC is not addressed in detail in this document. However, there may
be a risk concern for machinists. Evaluation of the risk of machinists from
exposure to IPBC is deferred to OSHA (Occupational Safety and Health
Administration)];
• industrial wood product treatments for wood treatment (pressurized and non-
pressurized) of forest products;
• painting using latex paint, adhesives, emulsions, and wood stains; and
• painting and dipping wood products for wood protection treatment to
buildings/products outdoors, and wood or wood structure protection treatments
(indoors and outdoors).
For handler exposure estimates the Agency relied on available data from an exposure
study submitted by the Chemical Manufactures Association (MRID #s 41412201, 41742601,
42587501), and from a composite of exposure studies in the Pesticide Handlers Exposure
13
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Database (PHED). These studies use pesticides other than IPBC, however, the testing scenarios
are applicable to this pesticide and most of its use patterns selected for risk assessment. Based
on these data and the following formulas and assumptions, the Agency calculated estimates of
short, intermediate, and chronic exposures.
The Daily Dose is calculated using the following formula:
1. Short-Term and Intermediate-Term Daily Dose =
Unit Exposure (mg ai/lb ai) x Use Rate (Ib ai/day).
This dose is used for the short term and intermediate MOE calculation for risk assessment,
where a dermal NOEL is used. No dermal absorption adjustment is required.
2. Chronic Daily Dose = Unit Exposure (mg ai/lb ai) x Use Rate (Ib ai/day) x 10%
Dermal Absorption Adjustment.
This dose is used in the chronic MOE calculation, where an oral NOEL is used and a 10 percent
dermal absorption adjustment is required.
The actual daily exposure is calculated by dividing the Daily (Total) Dose by the average
body weight of a person. Since the toxicological endpoints for short-term, intermediate-term,
and chronic exposures are not maternal or developmental, 70 kilograms (adult male) is the body
weight used for the risk calculations.
A 4, i -r> -i -H i t\ i,\ \ Daily Dose (mg ai/day)
Actual Daily Exposurefmg/kg/day) = 3- ^-3. LL
Body Wt (70kg)
The following assumptions are made:
• Occupational and homeowner handlers may be exposed more than 7 days per year
(reasonable worst-case estimate). Therefore, the exposure/risk assessment for all
occupational and homeowner (primary and secondary) handlers must consider
both short-term (less than 7 days per year) and intermediate-term (7 or more days
per year) exposure scenarios.
• Primary and secondary occupational handlers in industrial settings may be
chronically exposed in the following settings: (1) general preservative
(represented by paint manufacturing); (2) industrial wood-products treatment; (3)
industrial/commercial wood products manufacturing, and (4) machinists using
IPBC-containing metal cutting fluids. Therefore, the exposure/risk assessment for
all such occupational (primary and secondary) handlers must consider chronic
exposure scenarios.
• Primary and secondary occupational handlers in non-industrial settings may be
chronically exposed in the following settings: (1) mixing/loading the concentrate
for wood treatment, (2) applying the dilute wood treatment, (3) handling/applying
14
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IPBC-containing paint, adhesives, and other products. Therefore, the exposure/
risk assessment for all such occupational (primary and secondary) handlers must
consider chronic exposure scenarios.
• Primary and secondary occupational handlers in industrial settings are unlikely to
be chronically exposed in the following settings: (1) oil-well mud-packer fluids,
oil-recovery drilling muds, secondary-oil recovery injection water, oil-well
injection fluids, (2) pulp and paper mills, and (3) adding IPBC to metal cutting
fluids. Therefore, the exposure/risk assessment for all such handlers need not
consider chronic exposure scenarios.
• No homeowner (primary or secondary) handlers are chronically exposed.
Therefore, the exposure/risk assessment for all homeowner handlers need not
consider chronic exposure scenarios.
Short-term, intermediate-term, and chronic exposure estimates are presented in Table 2
for occupational handlers (primary and secondary) in industrial settings. Short-term and
intermediate-term exposure assessments are presented in Table 3. for occupational and
homeowner handlers (primary and secondary) in non-industrial settings. Chronic exposure
assessments are presented in Table 3 A. for occupational and homeowner handlers (primary and
secondary) in non-industrial settings.
15
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Table 2: Short-Term, Intermediate-Term and Chronic IPBC Exposures to Handlers in Industrial Settings
Operation
Open Pour liquid
Qp$D POIJT Solid
Qpea Pour Liquid
PumpLiqijid
" .^
Pump Liqijid
Handlers
Primary
Primary
Primary
Primary
Primary
Setting
General Preservative'
General Preservative
Metal Working Fluid Treatment
Oil Recovery & Drilling Mud/
Packer Fluid
Pulp & Paper Mill Systems
UE
(mg/lb
ai)'
0.14
0.479
0.133
0.0075
0.0075
Daily Rate
Lb ai/usedb
8.34
8.0
7.5
28
1,000
Daily Dose (mg/day)c
Short- &
Intermediate-Term0
1.2
3.8
1.0
0.21
7.5
Chronic
d
0.12
0.38
N/A
N/A
N/A
Industrial Wood Protection Treatment to Milled Forest Products
Mixer /Loader
Handling Treated
Wood Products
Primary
Secondary
Industrial Wood Products
Treatment
Industrial/Commercial Wood
Products Manufacturing
No data
No data
No data
No data
No data
No data
No data
No data
Unit Exposure (UE) was derived from the CMA study (including dermal and inhalation exposure). Gloves were worn for the exposure
studies represented. However, the inhalation component is insignificant.
Ib ai/used was derived from the CMA study and the pesticide labels cited below:
Preservatives: Liquid (paint scenario; EPA Reg. No. 5383-50)
(100 gallons * 8.34 Ibs/gal * 0.01 ai) = 8.34 Ibs ai/used/day.
Preservatives: Solid (paint scenario; EPA Reg. No. 5383-51)
(100 gallons * 10.0 lbs/100 gal * 0.8 ai) = 8.0 Ibs ai/used/day.
Metal Working Fluids (EPA Reg. No. 5383-50)
(300 gallons * 8.34 Ibs/gal * 0.003 ai) = 7.5 Ibs ai/used/day.
Oil Recovery & Drilling Mud/Packer Fluid (EPA Reg. No. 1022-575)
(4200 gallons * 8.34 Ibs/gal * 0.002 * 0.4 % ai) = 28 Ib ai/used/day.
Pulp and Paper Mill (EPA Reg. No. 5383-50) (100 tons * 2,000 Ibs/ton * 0.005 ai) = 1,000 Ib ai/used/day.
Daily Dose (mg/day) = UE x Ib ai/used for short-term and intermediate, where dermal NOEL is used in MOE calculation and no dermal
absorption adjustment is required.
Daily Dose (mg/day) = UE x Ib ai/used x 0.1 (10% dermal absorption for chronic, where oral NOEL is used in MOE calculation and a
dermal absorption adjustment is required).
Preservative uses include paint, textile, plastic, ink, paper coating, and canvas manufacturing. Data for preservative uses is from paint
preservatives, which represents the worst-case scenario based on available data.
16
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Table 3: Short-Term and Intermediate-Term IPBC Exposure Assessment for Handlers in Industrial and Non-Industrial Settings
Exposure Scenario
Mixing/Loading Liquid
Concentrate for Brush
Application
Applying Dilute Solution
with Brush
Applying Paint with Brush
Mixing/Loading Liquid
Concentrate for Roller
Application
Applying Dilute Solution
with Roller
Applying Paint with Roller
Mixing/Loading Concentrate for
Sprayer Application
Applying Dilute Solution
with Airless/Compressed
Air Sprayer
Applying Paint with an Airless/
Compressed
Air Sprayer
Mixing/Loading Concentrate for
On- Site Wood Dip Treatment
Applying the Dilute Solution as
an On- Site Wood Dip Treatment
Handlers
Primary
Primary
Secondary
Primary
Primary
Secondary
Primary
Primary
Secondary
Primary
Primary
Baseline Dermal
Unit Exposure3
(mg/lb ai)
2.9
182
182
No data
No data
No data
2.9
38.4
38.4
No data
No data
Baseline Inhalation Unit
Exposure11 (//g/lb ai)
1.2
570
570
No data
No data
No data
1.2
830
830
No data
No data
Maximum Label
Application Ratec (Ib
ai/gallon)
0.63
0.04
0.1
No data
No data
No data
0.63
0.04
0.1
No data
No data
Daily Max.
Handled"
(gallons)
0.07 (H)
0.35 (O)
1(H)
5(0)
1(H)
5(0)
No data
No data
No data
0.35 (H)
3.3 (0)
5(H)
50(0)
5(H)
50(0)
No data
No data
Daily Dermal Dose"
(mg/day)
0.13(H)
1.15(0)
7.28 (H)
36.4 (O)
18.2(H)
91.0(O)
No data
No data
No data
0.64 (H)
6.03 (O)
7.68 (H)
76. 8 (O)
19.2 (H)
192.0 (O)
No data
No data
Daily Inhalation
Dosef (mg/day)
0.00005 (H)
0.0005 (O)
0.023 (H)
O.ll(O)
0.057 (H)
0.29 (O)
No data
No data
No data
0.0003 (H)
0.002 (O)
0.17(H)
1.66(O)
0.42 (H)
4.15(O)
No data
No data
Daily Total Dose8
(mg/day)
0.1 (H)
1.2(0)
7.3 (H)
36.5 (O)
18.3 (H)
91. 3 (O)
No data
No data
No data
0.6 (H)
6.0 (O)
7.7 (H)
78.5 (O)
19.6 (H)
196.2 (O)
No data
No data
a *UE = Unit Exposure for open-pour liquid mixing/loading, UE derived from PHED dermal exposure only (without gloves), based on 53 replicates for hands and 25 to 122 replicates for other dermal. For brush painting,
UE derived from PHED dermal exposure only (without gloves), based on 15 replicates, using brush as wood painting application. For airless spray painting, UE derived from PHED dermal exposure only (without
gloves) based on 15 replicates and is equipped with gasoline siphon/nozzle sprayer.
b Baseline inhalation unit exposure (derived from PHED) is based on 29 L/min as an inhalation rate and represents no respirator.
c For Primary Handlers: The concentrate is Woodtreat PT which contains 7.6% ai); the dilute is 0.5% a.i. (one gal of concentrate to 15 gal. water; For secondary handlers, the paint contains 0.1% a.i.
d Values represent the maximum likely handled per day
[(H) = homeowner, (O) = occupational] treatments for each exposure scenario of concern.
e Daily dermal dose (mg/day) = Unit Exposure (mg/lb ai) * Max. Appl. Rate (Ib ai/gal) * Max. Handled (gallons).
f Daily inhalation dose (mg/day) = Unit Exposure (ug/lb ai) * (Img/lOOOug) conversion * Max Appl Rate (Ib ai/gal) * Max Handled (gallons).
g Daily total dose (mg/day) = Daily dermal dose + Daily inhalation dose.
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Table 3A: Chronic IPBC Exposure Assessment for Handlers in Occupational Non-Industrial Settings
Exposure Scenario
Mixing/Loading Liquid
Concentrate for Brush
Application
Applying Dilute Solution with
Brush
Applying Paint with Brush
Mixing/Loading Liquid
Concentrate for Roller
Application
Applying Dilute Solution with
Roller
Applying Paint with Roller
Mixing/Loading Concentrate for
Sprayer Application
Applying Dilute Solution with
Airless/Compressed-Air Sprayer
Applying Paint with an Airless/
Compressed-air Sprayer
Mixing/Loading Concentrate for
On- Site Wood Dip Treatment
Applying the Dilute Solution as
an On- Site Wood Dip Treatment
Handlers
Primary
Primary
Secondary
Primary
Primary
Secondary
Primary
Primary
Secondary
Primary
Primary
Baseline Dermal Unit
Exposure* (mg/lb ai)
2.9
182
182
No data
No data
No data
2.9
38.4
38.4
No data
No Data
Baseline Inhalation Unit
Exposure11 0-tg/lb ai)
1.2
570
570
No data
No data
No data
1.2
830
830
No data
No Data
Maximum Label
Application Rate0 (Ib
ai/gallon)
0.63
0.04
0.1
No data
No data
No data
0.63
0.04
0.1
No data
No Data
Daily Max.
Treatedd
(gallons)
0.35
5
5
No data
No data
No data
3.3
50
50
No data
No Data
Daily Dermal
Dose"
(mg/day)
0.06
3.64
9.10
No data
No data
No data
0.60
7.68
19.20
No data
No Data
Daily Inhalation
Dosef (mg/day)
0.0003
0.11
0.29
No data
No data
No data
0.002
1.66
4.15
No data
No Data
Daily Total
Dose8
(mg/day)
0.064
3.8
9.4
No data
No data
No data
0.6
9.3
23.4
No data
No Data
UE = Unit Exposure; for open-pour liquid mixing/loading, UE derived from PHED (without gloves), based on 53 replicates for hands and 25 to 122 replicates for other dermal. For brush painting, dermal exposure
only (without gloves), is based on 15 replicates, using brush as painting application. For airless/compressed-air spray painting, is equipped with gasoline power siphon/nozzle sprayer.
Baseline inhalation unit exposure (derived from PHED) is based on 29 L/min as an inhalation rate and represents no respirator.
For Primary Handlers: The concentrate is Woodtreat PT which contains 7.6% ai; the dilute is 0.5%ai (one gal of concentrate to 15 gal. water. For secondary handlers, the paint contains 0.1% ai
Values represent the maximum likely handled per day
Daily dermal dose (mg/day) = Unit Exposure (mg/lb ai) * Max. Appl. Rate (Ib ai/gal) * Max. Handled (gallons) * 0.1 (10% dermal absorption).
Daily inhalation dose (mg/day) = Unit Exposure (ug/lb ai) * (Img/lOOOug) conversion * Max Appl Rate (Ib ai/gal) * Max Handled (gallons).
Daily total dose (mg/day) = Daily dermal dose + Daily inhalation dose.
18
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(a) Post-Application Exposures and Assumptions
The Agency believes there are potential post-application exposures to IPBC following
applications in commercial, industrial, and residential settings.
Such exposures could include:
• exposures following applications of IPBC to open vats of hot liquids, such as
paper-pulp, adhesives, coatings, emulsions, and paints, or where these treated
products are used;
• exposures to persons in and near areas where commercial wood-product
treatments are taking place;
• exposures in areas where metalworking fluids are being used;
• exposures in areas where IPBC-containing plastic and textile products are being
manufactured;
• exposures to persons occupying areas recently treated with IPBC wood
preservative, or paints or stains; and
• exposures where IPBC-containing air-conditioning and furnace filters are used in
commercial buildings.
The Agency does not have post-application chemical specific data to quantitatively
determine the amount of pesticide to which a person reentering a treated area would be exposed.
However, the Agency does not anticipate significant dermal or inhalation post-application
exposures for these scenarios
c. Occupational and Residential Risk Characterization
(1) Poisoning Incident Data
Four incidents from January 1994 - April 1995 were identified in the OPP Incident Data
System database. Two of the incidents involved employees at a manufacturing plant who were
not wearing protective equipment and developed skin rashes and respiratory tract problems. The
other two involved consumers who also had skin irritations. It should be noted that the condition
of one man was severe enough to require blood analysis and pulmonary studies.
19
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(2) Risk Estimates
EPA used the following equation to derive a margin of exposure (MOE) to estimate
risks.
NOEL
MOE =
Actual Daily Exposure
1. Risk Assessment
The Agency assessed the risk resulting from short-term and intermediate-term IPBC
exposures associated with occupational and homeowner handlers (primary and secondary). The
Agency also assessed the risk resulting from chronic IPBC exposures to certain occupational
handlers (primary and secondary) as specified above. The NOEL for short and intermediate-
term exposure is 200 mg/kg/day (from the subchronic dermal rat study) and the NOEL for
chronic exposures is 20 mg/kg/day (from the chronic rat study). The Actual Daily Exposure (or
Dose) are estimates from the exposure assessments above and in Tables 2-3 A.
a. Occupational Handler Risks
Primary Occupational Handler Risks: Margins of exposure (MOEs) for primary
occupational handlers were calculated for short-term (1-7 days) exposure and intermediate-term
(one week to several months) exposure and, when applicable, for chronic exposure (several
months to lifetime). The calculations indicate that MOEs of above 100 occurred for all primary
occupational scenarios for which there were data. See Table 4 for a detailed breakdown of the
MOE calculations for primary occupational handlers in industrial settings and Table 5 for a
detailed breakdown of the MOE calculations for primary occupational handlers in non-industrial
settings.
Secondary Occupational Handler Risks: Margins of exposure (MOEs) for secondary
handlers were calculated for short-term (1-7 days) exposure and intermediate-term (one week to
several months) exposure and, when applicable, for chronic exposure (several months to
lifetime). The calculations using PHED VI. 1 surrogate exposure data indicate that the MOEs
for short-term, intermediate-term, and chronic occupational exposures with baseline PPE
exceeded 100 for all scenarios for which there were data, except for painters using an airless/
compressed-air sprayer. The MOEs for the spray painting scenario are 71 for short- and
intermediate-term exposures and 61 for chronic exposures. Although data are not available for
application by roller, the Agency assumes the exposure and risk will be no greater than that from
application by brush. Refer to Tables 4 and 5 for these MOEs.
20
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Table 4. Short-Term, Intermediate-Term and Chronic IPBC Exposures to Handlers in Industrial Settings
Operation
Open Pour Liquid
Open Pour Solid
Open Pour Liquid
Pump Liquid
Pump Liquid
Pump Liquid
Handling Treated
Wood Products
Handlers
Primary
Primary
Primary
Primary
Primary
Primary
Secondary
Exposure Scenario
General Preservative*
General Preservative*
Metal Working Fluids
Oil Recovery & Drilling
Mud/Packer Fluid
Pulp and Paper Mill
Wood Products
Industrial/Commercial
Wood Products
Manufacturing
Daily Dose (mg/day)
Short &
Intermediate
Term
Exposures
1.2
3.8
1.0
0.21
7.5
No data
No data
Chronic
Exposures
0.12
0.38
N/A
N/A
N/A
No data
No data
Actual Daily Exposure
(mg/kg/day)'
Short &
Intermediate
Term Exposures
0.02
0.005
0.014
0.003
0.11
No data
No data
Chronic
Exposures
0.002
0.005
N/A
N/A
N/A
No data
No data
MOEs
Short &
Intermediate
Term
Exposures
10000
4000
14286
66667
1818
No data
No data
Chronic
Exposures
10000
4000
N/A
N/A
N/A
No data
No data
a Actual daily exposure (mg/kg/day) = Daily Dose (mg/day)/70 kg.
b MOE = NOEL/ Actual daily exposure where short-term and intermediate-term NOEL = 200 mg/kg/day and chronic NOEL = 20 mg/kg/day).
* Preservative uses include paint, textile, plastic, ink, paper coating, and canvas manufacturing. Data for general preservative uses is from paint preservatives, which
represents the worst-case scenario based on available data.
N/A = not applicable
Table 5. Short-Term, Intermediate-Term and Chronic IPBC Exposures to Handlers in Non-Industrial Settings
Exposure Scenario
Mixing/Loading Liquid
Concentrate for Brush
Application
Applying Dilute with Brush
Paint Brush
Mixing/Loading Liquid
Concentrate for Roller
Application
Applying Dilute with
Roller
Paint Roller
Mixing/Loading
Concentrate for Sprayer
Application
Applying Dilute with an
Airless/Compressed- Air
Sprayer
Airless/Compressed- Air
Sprayer
Mixing/Loading
Concentrate for On-Site
Wood Dip Treatment
Applying Dilute as an On-
Site Wood Dip Treatment
Handlers
Primary
Primary
Secondary
Primary
Primary
Secondary
Primary
Primary
Secondary
Primary
Primary
Daily Total Dose (mg/day)
Short- &
Intermediate-
Term
0.1 (H)
1.2(0)
7.3 (H)
36.5(0)
18.3 (H)
91.3 (O)
No data
No data
No data
0.6 (H)
6.0 (O)
7.7 (H)
78.5 (O)
19.6 (H)
196.2 (O)
No data
No data
Chronic
N/A (H)
0.064
(0)
N/A (H)
3.8 (0)
N/A (H)
9.4 (0)
No data
No data
No data
N/A (H)
0.6 (O)
N/A (H)
9.3 (0)
N/A (H)
23.4 (O)
No data
No data
Daily Total Exposure (mg/kg/day)
Short- &
Intermediate-
Term'
0.002 (H)
0.016 (O)
0.104(H)
0.52(0)
0.26 (H)
1.30(O)
No data
No data
No data
0.009 (H)
0.09 (O)
O.ll(H)
1.12(0)
0.28 (H)
2.8 (0)
No data
No data
Chronic"
N/A (H)
0.0009
(0)
N/A (H)
0.054(O)
N/A (H)
0.13(O)
No data
No data
No data
N/A (H)
0.009 (O)
N/A (H)
0.13(O)
N/A (H)
0.33 (O)
No data
No data
MOEs
Short- &
Intermediate-
Term
100,000 (H)
12,500(0)
1,923 (H)
384(0)
769 (H)
154(O)
No data
No data
No data
22,222 (H)
2,222 (O)
1,8 1 8 (H)
178(O)
714 (H)
71(0)
No data
No data
Chronic
N/A (H)
22,222 (0)
N/A (H)
370 (O)
N/A (H)
154(O)
No data
No data
No data
N/A (H)
2,222 (O)
N/A(H)
153 (0)
N/A (H)
61(0)
No data
No data
(H) = homeowner; (O) = occupational; N/A = not applicable.
a Short-term and Intermediate Daily Total Exposure = Short-term and Intermediate Daily Dermal Dose/70 kg. body weight
b Chronic Daily Total Exposure = Chronic Daily Dermal Dose/70 kg. body weight. Note for chronic exposure, the daily dermal dose was adjusted with a dermal
absorption factor of 10% (0.1).
Note: MOE = NOEL /daily dose, where short-term and intermediate-term NOEL = 200 mg/kg/day; chronic NOEL = 20 mg/kg.
21
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b. Homeowner Handler Risks
Margins of exposure (MOEs) for primary and secondary homeowner handlers were
calculated for short-term (1-7 days) exposure and intermediate-term (one week to several
months) exposure. Chronic exposure (several months to lifetime) and risks are not applicable
for homeowner handlers. The calculations indicate that MOEs of above 100 occurred for all
primary and secondary homeowner scenarios for which there were data. See Table 5 for a
detailed breakdown of the MOE calculations for primary and secondary homeowner handlers.
The Agency does not consider MOEs above 100 to be of concern.
Risk From Post-Application Exposures
Above, the Agency gives examples of potential post-application exposure situations to
IPBC applications and/or treated products. However, the Agency currently has no data available
to estimate such exposures.
Data Requirements
Mixer/Loader/Applicator Exposure Data Requirements:
Guideline Numbers 231, 232, 233 and 234
Data are required for wood product use (i.e., industrial handlers who operate the wood
protection treatment process for the milled forest products solution supply system, dip tanks, or
drive forklifts or carrier trucks to dip lumber). Data are also required for workers applying
IPBC products to HVAC ducts and equipment, and for occupational (non-industrial) workers
and homeowners applying wood treatments by methods other than brush, roller, and airless or
compressed air sprayer. Methods for which there are currently no exposure data available
include dipping wood (e.g., shingles), using a pad, and using any type of sprayer other than
airless or compressed air. Risk assessments will be conducted upon the receipt and evaluation of
the required data.
Guideline Numbers 133-3 and 133-4
Data are required for the wood product use [i.e., workers who handle wet wood which
has been treated (graders, lumber pullers, etc.); workers who handle dry treated wood; workers
who perform maintenance on any part of the treatment system or machinery]. Data are also
required to characterize exposure to occupants of areas where HVAC ducts/systems have been
treated, and to workers handling and consumers using textiles such as carpets, drapes, shower
curtains, and canvas to which IPBC has been applied.
c. Other Considerations
The Food Quality Protection Act of 1996 amends both the FFDCA and FIFRA by setting
a new safety standard for the establishment of tolerances. In determining whether or not a
22
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tolerance meets the new safety standard, FQPA directs EPA to consider information concerning:
the susceptibility of infants and children to pesticide residues in food; the potential for aggregate
exposure from dietary as well as non-occupational sources, such as pesticide uses in and around
the home; and the potential for cumulative effects from a pesticide and other substances that
have a common mechanism of toxicity.
Because IPBC has no food uses, and therefore no tolerances have been established, the
specific considerations outlined in FQPA are not required for this chemical. Nevertheless, EPA
believes that consideration of available data relating to the special sensitivity of infants and
children, the potential for aggregate exposures and cumulative effects is prudent for IPBC
because children and other individuals could be exposed to this compound in non-occupational
settings.
Potential Risks to Infants and Children
In determining whether or not an additional uncertainty factor is appropriate for assessing
risks to infants and children, EPA takes into account the completeness and reliability of the
toxicity data base, the nature of the effects observed in pre- and post-natal studies, and other
information such as epidemiological data.
Based on current data requirements, only one developmental study is usually required for
non-food use chemicals. However, for the purposes of assessing the pre- and post-natal toxicity
of IPBC, two developmental and one reproduction study were available and have been evaluated
by EPA. The effects observed in the IPBC developmental and reproduction studies can be
summarized as follows:
The developmental toxicity of IPBC was assessed in pregnant Sprague-Dawley rats on
gestation days six through 15 by oral administration of the test chemical at doses of 0, 20, 50,
and 125 mg/kg/day. Maternal toxicity as reduced body weight gain during dosing was observed
at the 125 mg/kg/day dose level. Developmental toxicity consisted of an increased incidence of
skeletal abnormalities at the 125 mg/kg/day dose level. The maternal toxicity NOEL was
determined to be 50 mg/kg/day, and the maternal toxicity LEL was determined to be 125
mg/kg/day, based on reduced body weight gain. The developmental toxicity NOEL was
determined to be 50 mg/kg/day, and the developmental toxicity LEL was determined to be 125
mg/kg/day, based on incompletely ossified frontal skull bones and pelvic girdles.
A developmental toxicity study was conducted in female New Zealand white rabbits, in
which pregnant rabbits received oral doses of 0, 2, 20, and 50 mg/kg/day IPBC on gestation days
6 through 19 inclusive. At 50 mg/kg/day, maternal toxicity in the form of increased mortality
and abortion was observed. Although changes in cesarean section observations were reported at
the 50 mg/kg/day dose level, these changes are likely a secondary effect of maternal toxicity,
and not a primary effect of test chemical. The maternal toxicity NOEL was determined to be 20
mg/kg/day, and the maternal toxicity LEL was determined to be 50 mg/kg/day, based on
increased mortality, clinical signs, and decreased body weight gain. The developmental toxicity
23
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NOEL was determined to be >50 mg/kg/day, and the developmental toxicity LEL was
determined to be >50 mg/kg/day.
A 2-generation reproductive toxicity study was conducted in male and female Sprague-
Dawley rats. IPBC technical was administered over two generations at doses of 0, 120, 300, and
750 ppm (0, 6, 15, and 37.5 mg/kg/day). Reduced body weight and food consumption was
observed for PI and Fl males during the premating period at the 37.5 mg/kg/day dose. A
decreased mean live birth index was reported for PI and Fl, generations without an effect on
viability and development of pups. No adverse effects on reproductive indices or mating
performance were observed at any dose level. The parental toxicity NOEL was determined to be
15 mg/kg/day, and the parental toxicity LEL was determined to be 37.5 mg/kg/day, based on
decreased body weight and food consumption during premating for PI and Fl males, and
decreased mean live birth index for the PI and Fl generations. The reproductive toxicity NOEL
was determined to be >37.5 mg/kg/day, and the reproductive toxicity LEL was determined to be
>37.5 mg/kg/day.
The developmental data for IPBC indicate developmental effects occurred at doses that
were the same as or higher than doses which cause maternal toxicity. The Agency would
generally be concerned when developmental/reproductive effects are seen at doses lower than
those which cause maternal effects. No adverse effects on reproductive indices or mating
performance were observed in the two generation rat study. The developmental studies in
conjunction with the reproduction study do not indicate any additional sensitivity of young
organisms to IPBC. Therefore, the Agency concludes that an additional uncertainty factor need
not be applied to the NOELs selected for the IPBC risk assessments at this time.
Aggregate Exposure
In examining aggregate exposure, EPA takes into account available information
concerning exposures from the pesticide residue in food and other exposures for which there is
reliable information. These other sources of exposure can include drinking water, and non-
occupational exposures, e.g., to pesticides used in and around the home.
There are no food uses for IPBC, therefore, exposure to IPBC in the diet is not expected.
Laboratory data indicate that IPBC is mobile but non-persistent in soil and aquatic environments,
so IPBC should not be a threat to surface and ground water. Because it rapidly degrades, it is
not likely to occur in drinking water. Therefore, residential uses are the only sources of
exposure which could be aggregated for IPBC. The Agency has identified several potential
exposure scenarios for homeowners including handling and applying IPBC-containing paints and
wood stains (wood protection treatments), and handling and using IPBC-treated products, such
as wood. EPA currently does not have data to estimate exposure from all potential sources of
IPBC in and around the home, e.g., dipping wood and using treated textiles such as carpets and
drapes. However, the Agency is actively working with industry to augment the use/exposure
data base.
24
-------
The Agency assumes that the reasonable worst case exposure scenario for homeowners
would be handling and applying paint containing IPBC. Homeowner handlers could be exposed
for more than 7 days per year. Therefore, the exposure/risk assessment for homeowner handlers
considers both short-term (less than 7 days per year) and intermediate-term (7 or more days per
year) exposure scenarios. No chronic exposure to homeowners or children is anticipated.
Because of the low volatility of IPBC, inhalation exposure is expected to be minimal.
Table 6. Residential Handler/Applicator Risk from Exposure to IPBC
Exposure Scenario
Paint Brush
Paint Roller
Airless Sprayer
Daily Total Exposure
(mg/kg/day)a
0.30 (H)
No data
0.33 (H)
MOEb
667 (H)
No data
606 (H)
(H) = homeowner
a Daily total exposure = daily dermal exposure + daily inhalation dose/60 kg.
b MOE = NOEL (short-term and intermediate-term NOEL = 200 mg/kg/day) / daily total exposure.
Note: EPA assumes that exposure from roller application is no greater than exposure from brush application.
The Agency does not have chemical-specific post-application data to quantitatively
determine the amount of IBPC to which a person/child re-entering a painted room or other
treated area would be exposed. However, the Agency believes it is reasonable to assume that
such exposures would not be significant compared to exposures associated with handling and
applying IPBC-containing products.
Based on the high MOEs for homeowner applicators (see Table 6), EPA believes that
aggregate exposures to IPBC in the home are not likely to be of concern.
Cumulative Effects
Consideration has been given to cumulative effects of IPBC and other substances that
have a common mode of toxicity. IPBC is a carbamate. Carbamates can exhibit a variety of
modes/mechanisms of toxicity including the inhibition of the enzyme cholinesterase (ChE).
Some carbamates which may have a similar mode of toxicity to IPBC include carbaryl,
methomyl, carbofuran, aldicarb, oxamyl, thiodicarb, methiocarb, aminocarb, propoxur, and
bendiocarb.
The Agency has not yet made a determination regarding whether it is appropriate to
consider exposure from these other carbamates with IPBC in order to address potential
cumulative effects.
However, based on the high MOEs for homeowner applicators (see Table 6), the lack of
food uses, unlikelihood of residues in drinking water, the low concentration of IPBC in paints,
and the high NOEL for dermal exposure (200 mg/kg/day NOEL from subchronic dermal study)
25
-------
the Agency believes that the contribution of IPBC to the risks from other carbamate pesticides is
likely to be minimal considering currently registered IPBC uses.
D.
Environmental Assessment
1. Ecological Toxicity Data
The Agency has adequate data to assess the toxicity of IPBC to nontarget organisms.
Data for IPBC are outlined below.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
In order to establish the toxicity of a microbiocide to birds, the following tests are
required using technical-grade material: an avian single-dose oral (LD50) study on one species
(preferably mallard or bobwhite quail); one subacute dietary study (LC50) on one species of
waterfowl (preferably the mallard duck) or one species of upland game bird (preferably
bobwhite quail).
Table 7: Avian Acute Oral Toxicity Findings
Species
Northern Bobwhite Quail
Northern Bobwhite Quail
% A.I.
98.2 %
97.5 %
LD50 (mg/kg)
749 mg a.i./kg
970 mg a.i./kg
MRID No.
42430901
43491806
Toxicity
Category
Slightly toxic
Slightly toxic
Fulfills
Guideline
Requirement
*
Y
Y
*Y=Acceptable (Study satisfied Guideline)/Concur
P=Partial (Study partially fulfilled Guideline but additional information is net
S=Supplemental (Study provided useful information but Guideline was not satisfied)
N=Unacceptable (Study was rejected)/Nonconcur
26
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Table 8:
Avian Subacute Dietary Toxicity Findings
Species
Northern Bobwhite
Quail
Northern Bobwhite
Quail
Mallard Duck
Mallard Duck
% A.I.
97.5 %
98.2 %
98.2 %
97.5 %
LC50
(ppm)
>5620
>3881
>5620
>5620
MRID No.
43491807
42430902
42430903
43491808
Toxicity Category
practically nontoxic
practically nontoxic
practically nontoxic
practically nontoxic
Fulfills
Guideline
Requirement*
Y
Y
S
Y
*Y=Acceptable (Study satisfied Guideline )/Concur
P=Partial (Study partially fulfilled Guideline but additional information is needed
S=Supplemental (Study provided useful information but Guideline was not satisfied)
N=Unacceptable (Study was rejected)/Nonconcur
Results are adequate to indicate that IPBC is slightly toxic to practically nontoxic to
avian species on an acute oral and subacute dietary basis. The guideline requirements are
fulfilled. (MRIDs 42430901, 42430902, 42430903, 43491806, 43491807, 43491808)
(2) Birds, Chronic
Avian reproduction studies are required when birds may be exposed repeatedly or
continuously through persistence, bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. These conditions do not apply to IPBC. Avian
reproduction testing is not required.
(3) Mammals
Wild mammal testing is required on a case-by-case basis, depending on the results of the
lower tier studies such as acute and subacute testing, intended use pattern, and pertinent
environmental fate characteristics. In most cases, however, an acute oral LD50 from the Agency's
toxicology database is used to determine toxicity to mammals. For IPBC, the LD50 is reported
below.
Table 9:
Mammalian Acute Oral Toxicity Findings
Species
Rat (small mammal
surrogate)
% A.I.
LD50 (mg/kg)
1795 mg/kg (male)
1065 mg/kg (female)
1470 mg/kg (male & female)
MRID
00148277
Fulfills Guideline
Requirement*
Y
*Y=Acceptable (Study satisfied Guideline)/Concur
P=Partial (Study partially fulfilled Guideline but additional information is needed
S=Supplemental (Study provided useful information but Guideline was not satisfied)
N=Unacceptable (Study was rejected)/Nonconcur
Results show that IPBC is slightly toxic to small mammals on an acute oral basis. The
guideline requirements are fulfilled. (MRID 00148277)
(4) Insects
27
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A honey bee acute contact LD50 study is required if the proposed use will result in honey
bee exposure. Because applications of IPBC are not likely to result in exposure to honey bees,
data are not required.
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of a microbiocide to freshwater fish, the minimum data
required on the technical grade of the active ingredient is one freshwater fish acute toxicity
study. The study should be conducted with either a cold-water species (preferably the rainbow
trout) or a warm-water species (preferably the bluegill sunfish). Data for IPBC are presented in
the table below.
Table 10: Freshwater Fish Acute Toxicity Findings
Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
Rainbow trout
Bluegill sunfish
Fathead minnow
% A.I.
97.5%
97.7%
97.7%
97.5%
LC50 (ppm)
0.072
0.067
0.226
0.2
MRID
43530209
41627107
41627106
43530208
Toxicity Category
very highly toxic
very highly toxic
highly toxic
highly toxic
Fulfills
guideline
requirement*
S
Y
Y
S
*Y=Acceptable (Study satisfied Guideline)/Concur
P=Partial (Study partially fulfilled Guideline but additional information is needed
S=Supplemental (Study provided useful information but Guideline was not satisfied)
N=Unacceptable (Study was rejected)/Nonconcur
The results of the 96-hour acute toxicity studies indicate that IPBC is very highly toxic to
cold-water fish and highly toxic to warm-water fish. The guideline requirements are fulfilled.
(MRIDs 41627106, 41627107, 43530208, 43530209)
(2)
Freshwater Invertebrates
The minimum testing required to assess the hazard of a microbiocide to freshwater
invertebrates is a freshwater aquatic invertebrate toxicity test, preferably using first instar
Daphnia magna or early instar amphipods, stoneflies, mayflies, or midges. Data for IPBC are
presented in the table below.
28
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Table 11: Freshwater Invertebrate Toxicity Findings
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
Daphnia magna
% A.I.
98.7%
97.5%
EC50
(ppm)
0.956
0.16
MRID
41627108
43530210
Toxicity
Category
highly toxic
highly toxic
Fulfills
guideline
requirement*
Y
Y
*Y=Acceptable (Study satisfied Guideline)/Concur P=Partial (Study partially fulfilled Guideline but additional information is needed
S=Supplemental (Study provided useful information but Guideline was not satisfied) N=Unacceptable (Study was rejected)/Nonconcur
There is sufficient information to characterize IPBC as highly toxic to aquatic
invertebrates. The guideline requirement is fulfilled. (MRID 41627108; 43530210)
(3)
Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms is required when an end-use
product is intended for direct application to the marine/estuarine environment or is expected to
reach this environment in significant concentrations. Because of the use sites and nature of this
product, exposure of IPBC to marine/estuarine organisms is possible through industrial effluent.
Results of the data submitted are given below.
Table 12: Estuarine/marine Invertebrate Toxicity Findings
Estuarine/marine Invertebrate Toxicity Findings
Species
Eastern oyster shell deposition
Pink Shrimp
Sheepshead minnow
% A.I.
97.25%
97.25%
97.25%
ECSO (ppm)
0.028
0.103
0.18
MRID No.
(Author/Year)
42168202
42168204
42168203
Toxicity
Category
very highly toxic
highly toxic
highly toxic
Fulfills guideline
requirement*
S
Y
Y
Y=Acceptable (Study satisfied Guideline)/Concur P=Partial (Study partially fulfilled Guideline but additional information is needed
S=Supplemental (Study provided useful information but Guideline was not satisfied) N=Unacceptable (Study was rejected)/Nonconcur
There is sufficient information to characterize IPBC as highly toxic to estuarine/marine
fish and highly to very highly toxic to estuarine/marine invertebrates. (MRIDs 42168202,
42168203, 42168204)
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c. Toxicity to Plants
(1) Terrestrial
Terrestrial plant testing (seedling emergence and vegetative vigor) is required for
herbicides which have terrestrial non-food/feed or aquatic non-food (except residential) use
patterns and which have endangered or threatened plant species associated with the site of
application. These conditions do not apply for IPBC. Phytotoxicity tests are not required.
2. Environmental Fate
a. Environmental Fate Assessment
A qualitative environmental fate assessment can be made for IPBC from existing
acceptable and supplemental environmental fate and transport data.
The reported laboratory data suggest that IPBC is non-persistent and mobile in soil and
aquatic environments. IPBC should not be a threat to surface and ground water because it rapidly
degrades. The dissipation of IPBC in terrestrial and aquatic environments appears to be
dependent on alkaline catalyzed hydrolysis, microbial-mediated oxidative mineralization, and
leaching. IPBC was rapidly hydrolyzed (t1/2 = 0.947 days) in pH 9 buffer solution; however, it
was stable (t1/2 > 30 days) in pH 5 and 7 buffer solutions. IPBC was rapidly degraded (t1/2< 3
hours) in aerobic mineral soil and anaerobic aquatic environments. IPBC is expected to be very
mobile to mobile (Kad < 2.64 ml/g) in mineral soils.
The primary degradate of IPBC was isopropargyl butyl carbamate (PBC). This
degradate was detected in hydrolysis, aerobic soil, and anaerobic aquatic metabolism studies.
PBC was rapidly degraded (t1/2< 13 days) in aerobic soil and anaerobic aquatic environments.
Degradates of PBC in anaerobic aquatic environments were identified as 2-propenyl-
butylcarbamate (2-PBC) and minor unidentified degradates. No mobility data are available for
degradatesoflPBC.
b. Environmental Fate and Transport
(1) Degradation
The hydrolysis (guideline 161-1) study provides marginally acceptable data because the
study was conducted in non-sterile buffer solutions. The interpretation of the hydrolysis data is
not affected by non-sterile conditions because minimal microbial contamination was observed in
the buffer solutions.
Radiolabeled IPBC was stable (k=0.0064 day 1) in pH 5 buffer solution, had a half life of
139 days (k=-0.0049 day 1) in pH 7 buffer solution, and 0.947 days (k=0.732 day 1) in pH 9
30
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buffer solution. Propargyl butyl carbamate (PBC) was identified as the only hydrolysis
degradate. The guideline requirement is fulfilled. (MRID 42329301)
In an Aerobic Soil Metabolism (guideline 162-1) study, radiolabeled IPBC, at 1 |ig/g,
had a half-life of 2.13 hours (k=0.326 hours) in a non-sterile, Blackaor loam soil at 22°C. The
half-life of IPBC was 8.60 days (k=0.081 hours) in a nonsterile, Blackoar loam soil at 5°C. The
primary degradate of IPBC was identified as PBC. The aerobic soil metabolism half-life of
PBC was 4.31 days (k=0.161 days) in nonsterile Blackoar soil at 22°C. The degradate PBC
degrades to form CO2, bound soil residues, and an unidentified metabolite. The guideline
requirement is fulfilled. (MRID 42329302)
Marginally acceptable data for Anaerobic Soil Metabolism (guideline 162-2) and
Anaerobic Aquatic Metabolism (guideline 162-3) were provided. The data are deemed
marginally acceptable because low material balances were detected at later sampling intervals.
The interpretation of anaerobic aquatic data is not affected by low material balance because
supplemental information was provided to quantify and identify non-trappable volatile
degradates.
Radiolabeled IPBC, at 6 |ig/g, had a half-life of 1.5 hours (k=0.464 hours) in a non-
sterile, static, anaerobic (pe^pFK 7) sediment water test system at 22°C. The anaerobic aquatic
metabolism half-life of IPBC was 13.3 hours (k=0.052 hours) in a sterile, static, sediment-water
test system. Radiolabeled residues were predominantly detected (80% of applied IPBC) in the
water phase of sediment-water systems. The primary degradate of IPBC was PBC. The half-life
of PBC was 11.5 days (k=0.060 days) in the nonsterile, static, anaerobic aquatic system.
Secondary degradates of IPBC were 2-propenyl-butylcarbamate (2-PBC) and two unidentified
compounds. Volatile degradates were identified as PBC, 2-PBC, CO2 and possibly CH4. The
guideline requirement is fulfilled. (MRID 42481601)
(2) Mobility
Marginally acceptable data for unaged portion of the Adsorption/Desorption (guideline
163-1) data requirement were provided. The data are deemed marginally acceptable because
IPBC degradation was observed during equilibration. The interpretation of mobility is not
affected by IPBC degradation because the Freundlich adsorption coefficients for IPBC are low.
Low Freundlich coefficients indicate a worst-case mobility assessment (e.g., high mobility in
soil and aquatic environments) for IPBC. The mobility of IPBC degradates cannot be
determined at this time because no aged soil column leaching data or batch equilibrium data for
individual degradates were provided.
Radiolabeled IPBC had Freundlich adsorption coefficients of 0.67 to 2.46 ml/g in a
Hanford sandy loam, Centhan sand, Blackoar loam, Mexico silty clay, and an Evesboro sand.
Freundlich desorption coefficients ranged from 3.4 to 31 ml/g. Degradation of IPBC was
PE is a measure of the redox potential. It varies indirectly with the pH.
31
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observed in the equilibration solutions. The major degradate of IPBC was PCB. IPBC
adsorption was not correlated to organic matter content, clay content, and cation exchange
capacity of soil. The guideline requirement is partially fulfilled. (MRID 41975207)
c. Water Resources
A preliminary assessment based on laboratory data only indicates that IPBC should not
pose a threat to surface waters and ground waters because it degrades rapidly. A leaching
assessment for degradates is not possible at this time because no data on mobility of degradates
has been provided.
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
(1) Exposure and Risk to Nontarget Terrestrial Animals
The Agency requires only a limited set of ecotoxicology and environmental fate data for
microbiocides. The available data classify IPBC as slightly toxic to practically nontoxic to birds
and very highly toxic to highly toxic to freshwater fish and aquatic invertebrates.
While the hazard to aquatic organisms from IPBC has been characterized, a quantitative
risk assessment has not been conducted. The risks to aquatic environments from the
microbiocide use of this chemical are regulated under the NPDES permitting program of EPA's
Office of Water. Labels for all IPBC products must require that discharges to aquatic
environments comply with an NPDES permit.
Because the outdoor use of IPBC is limited to terrestrial wood pressure/protection
treatment of forest products, exposure of wildlife is not expected to be significant.
(2) Endangered Species
Based on the registered use patterns for IPBC, risks to endangered species are not
anticipated from direct application of products.
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 ingredient
are eligible for reregi strati on. The Agency has previously identified and required the submission
of the generic (i.e. active ingredient specific) data to support reregi strati on of products
containing IPBC as an active ingredient. The Agency has completed its review of these generic
32
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data, and has determined that the data are sufficient to support reregi strati on of all products
containing IPBC except those containing uses for industrial wood protection treatment to milled
forest products, HVAC uses, textile uses, and certain non-industrial applications to wood, under
the conditions specified in the RED. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregi strati on eligibility of IPBC, 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 IPBC and to determine that IPBC with modifications as specified in this
document, and with the exception of industrial wood protection treatment to milled forest
products, HVAC uses, textile uses, and certain non-industrial applications to wood, can be used
without resulting in unreasonable adverse effects to humans and the environment if used
according to the label as amended by this RED. The Agency therefore finds that all products
containing IPBC as the active ingredient, except those labelled for industrial wood protection
treatment to milled forest products, HVAC uses, textile uses and certain non-industrial
applications to wood, are eligible for reregi strati on under the conditions specified in this RED.
The reregi strati on of particular products is addressed in Section V of this document.
The Agency made its reregi strati on eligibility determination based upon the target data
base required for reregi strati on, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, etc. and the data identified in Appendix B.
The Agency has found that all uses of IPBC, except the industrial wood protection treatment to
milled forest products, HVAC uses, textile uses, and certain non-industrial applications to wood,
are eligible for reregi strati on under the conditions specified in this RED. However, it should be
understood that the Agency may take additional appropriate regulatory action, and/or require the
submission of additional data to support the registration of products containing IPBC, if new
information comes to the Agency's attention or if the data requirements for registration (or the
guidelines for generating such data) change.
Because IPBC currently has no food uses and no tolerances have been established, the
specific determinations outlined in FQPA are not required for this chemical. Nevertheless, EPA
has considered available data relating to the special sensitivity of infants and children, the
potential for aggregate exposures and cumulative effects in its risk management decisions for
IPBC because children and other individuals could be exposed to this compound in non-
occupational settings.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient IPBC, the Agency has
sufficient information on the health effects of IPBC, and on its potential for causing adverse
effects in fish and wildlife and the environment, for all uses except industrial wood protection
treatments to milled forest products, textile uses, HVAC uses, and certain non-industrial
33
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applications to wood. The Agency has determined that IPBC products, labeled and used as
specified in this Reregi strati on Eligibility Decision, will not pose unreasonable risks or adverse
effects to humans or the environment, and that products containing IPBC, with the exceptions
noted below, are eligible for reregi strati on.
2. Eligible and Ineligible Uses
In reaching eligibility decisions the Agency makes every effort to use available exposure
data. However, in some cases existing exposure data were not an appropriate surrogate for
currently labeled uses. EPA does not have adequate or sufficient data at this time to make
eligibility decisions for uses involving the following exposure scenarios:
• workers exposed during industrial treatments to milled forest products, including post
application exposures to workers handling or processing treated wood products;
• workers applying IPBC products to heating, ventilation and air conditioning (HVAC)
ducts or filters, and post application exposure to occupants of areas where HVAC systems have
been treated;
• post application exposure to persons handling and using textiles, such as carpets,
drapes, shower curtains, and canvas, to which IPBC has been applied;
and
• non-industrial workers and homeowners applying IPBC products to wood by dipping,
using a pad, or any method other than a brush, roller or airless or compressed air sprayer.
Eligibility decisions on products containing the industrial treatments to milled forest
products use, HVAC use, textile uses, and non-industrial wood treatments using methods other
than brush, roller and airless or compressed air sprayer, will be made after the exposure data
specified in section V.A.I are received and evaluated. Products containing these uses are not
eligible for reregistration at this time.
The Agency has determined that all other uses, except those specifically noted above, are
eligible for reregi strati on.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for IPBC. Where
labeling revisions are imposed, specific language is set forth in Section V of this document.
1. Potential Risks to Infants and Children/Aggregate
Exposure/Cumulative Effects
34
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In determining whether or not infants and children are particularly susceptible to toxic
effects from IPBC, EPA considered the completeness and reliability of the data base for
developmental and reproductive effects, the nature of the effects observed, and other
information.
Based on the current data requirements, IPBC has a complete data base for
developmental and reproductive toxicity. In the developmental studies, developmental effects
were seen at doses that were the same as or higher than doses which cause maternal toxicity. No
adverse effects on reproductive indices or mating performance were observed in the two
generation rat reproduction study. The developmental studies in conjunction with the
reproductive study do not indicate any special sensitivity of young organisms to IPBC.
Therefore, the Agency has concluded that an additional uncertainty factor need not be applied to
the short- and intermediate-term NOELs used for the IPBC risk assessments.
In examining aggregate exposure, EPA takes into account available information
concerning exposures from the pesticide residue in food and other exposures for which there is
reliable information. These other sources of exposure can include drinking water, and non-
occupational exposures, e.g., to pesticides used in and around the home.
No dietary exposure is expected since there are no food uses of IPBC. IPBC is not likely
to be found in drinking water because it degrades rapidly both in soil and aquatic environments.
Thus, residential uses are the only sources of exposure that could be aggregated for IPBC. EPA
assumes that handling and applying paint would be the reasonable worst case exposure scenario
for homeowners. Because the MOEs for this worst case exposure are high (> 600), EPA
believes that aggregate exposures to other sources of IPBC in the home are not likely to be of
concern.
The Agency has not yet made a determination regarding whether it is appropriate to
consider exposure from other carbamates with IPBC in order to address potential cumulative
effects. However, based on the high MOEs for homeowner applicators, the lack of food uses,
unlikely residues in drinking water, and the high NOEL for dermal exposure, the Agency
believes that it is reasonable to assume that the contribution of IPBC exposure to the risks from
other carbamate pesticides is likely to be minimal considering currently registered IPBC uses.
35
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2. Occupational and Residential Labeling Rationale/Risk Mitigation
a. Personal Protective Equipment/Engineering Controls for
Handlers
For each end-use product, PPE requirements for pesticide handlers are set during
reregi strati on in one of two ways:
• If the Agency determines that no regulatory action must be taken as the result of
the acute effects or other adverse effects of an active ingredient, the PPE for
pesticide handlers will be based on the acute toxicity of the end-use product. For
occupational-use products, PPE must be established using the process described
in PR Notice 93-7 or more recent the Agency guidelines.
• If the Agency determines that regulatory action on an active ingredient must be
taken as the result of very high acute toxicity or certain other adverse effects,
such as allergic effects or delayed effects (cancer, developmental toxicity,
reproductive effects, etc.):
• In the RED for that active ingredient, the Agency may establish minimum
or "baseline" handler PPE requirements that pertain to all or most end-use
products containing that active ingredient.
• These minimum PPE requirements must be compared with the PPE that
would be designated on the basis of the acute toxicity of the end-use
product.
• 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.
Personal protective equipment requirements usually are set by specifying one or more
pre-established PPE units — sets of items that are almost always required together. For example,
if chemical-resistant gloves are required, then long-sleeve shirts, long pants, socks, and shoes are
assumed and are also included in the required minimum attire. If the requirement is for two
layers of body protection (coveralls over a long- or short-sleeve shirt and long or short pants),
the minimum must also include (for all handlers) chemical-resistant footwear and chemical-
resistant headgear for overhead exposures and (for mixers, loaders, and persons cleaning
equipment) chemical-resistant aprons.
The Agency has determined that regulatory action regarding the establishment of active-
ingredient-based minimum PPE requirements for occupational handlers must be taken for IPBC.
b. Primary Occupational Handlers
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The exposure data upon which the risks were assessed were based on studies where the
handlers wore chemical-resistant gloves in addition to long-sleeve shirts, long pants, shoes, and
socks. Therefore, for the following uses chemical-resistant gloves will be required in addition to
the baseline requirements of long-sleeve shirt, long pants, shoes, and socks:
• oil-well mud-packer fluids, oil-recovery drilling muds, secondary-oil
recovery injection water, and oil-well injection fluids;
• preservative uses, including oil/latex paint manufacturing, industrial
adhesives, industrial coatings, resin/latex/polymer emulsions; plastic
manufacturing, textile manufacturing, ink manufacturing, and canvas
manufacturing;
• paper coating, and
• metalworking fluids.
NOTE: No personal protective equipment is being recommended at this time for
wood products manufacturing (no data available). This will be added if risk
mitigation measures are needed for this use.
c. Secondary Occupational Handlers
The data for occupational painters using airless or compressed air sprayers indicate the
MOEs are less than 100 (71 for subchronic and 61 for chronic exposure) unless PPE (long-
sleeve shirt, long pants, shoes, socks and chemical-resistant gloves) is used. EPA's regulatory
authority does not encompass requiring label statements for paints, and consequently, the
Agency would not be able to enforce the use of PPE by occupational painters. However, EPA
assumes that occupational painters are likely to wear appropriate PPE. Furthermore, the MOE
calculations use worst case exposure assumptions that are not likely to occur. For example, an
occupational painter is not likely to use only paints containing IPBC, nor is he/she likely to
apply paints only with an airless or compressed air sprayer.
d. Homeowner-Use Products
There are no homeowner uses of concentrated IPBC. However, for IPBC treated paints,
the MOEs for secondary homeowner handlers (i.e., painters) are not of concern. The Agency is
not establishing entry restrictions at this time for products containing IPBC, such as paints and
adhesives, that are intended primarily for homeowner use, since the anticipated frequency,
duration, and degree of dermal exposure after homeowner applications do not warrant special
risk mitigation measures.
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e. Post-Application/Entry Restrictions
The Agency is not establishing entry restrictions at this time for occupational uses of
IPBC end-use products or treated products, since the anticipated frequency, duration, and degree
of exposure following occupational applications do not warrant special risk mitigation measures.
The Agency may revisit this issue upon receipt and evaluation of the wood treatment and other
exposure data.
3. 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 IPBC. For the specific labeling statements, refer to
Section V of this document.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of IPBC has been reviewed and
determined to be substantially complete, except that information is needed to fulfill guidelines
81-8 and 82-7 to further characterize the potential for IPBC to cause neurological effects. The
Agency is issuing a DCI concurrent with this RED to IPBC (technical) registrants for these
neurotoxicity data. Additional exposure data are also required for guidelines 133-3, 133-4, 231,
232, 233, and 234 to characterize exposure to IPBC during wood protection treatment to milled
forest products and subsequent handling of treated lumber, exposure to workers during and to
occupants after application of IPBC to HVAC ducts/systems, exposure to persons handling
textiles treated with IPBC, and exposure to occupational (non-industrial) workers and
homeowners applying IPBC to wood by methods other than brush, roller and airless or
compressed air sprayer. However, because much of the exposure data needed for IPBC is
generic in nature and will also be required for other antimicrobial chemicals with similar
characteristics and the same uses, EPA is developing a generic exposure DCI. IPBC registrants
will receive the generic exposure DCI at the same time as registrants of other chemicals with
similar uses.
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 Agency regulations, PR Notices and applicable policies. The
MP labeling must bear the following statement under Directions for Use:
38
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"Only for formulation into an [fill blank with Insecticide, Herbicide or the applicable
term which describes the type of pesticide use(s)] for the following use(s) [fill blank
only with those uses that are being supported by MP registrant]."
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)."
(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)."
All products distributed or sold by registrants and distributors (supplemental
registrants) should bear labeling that is consistent with this notice by March 30. 1998 and all
products distributed or sold by persons other than registrants or supplemental registrants
after September 30.1998 should bear correct labeling.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The product
specific data requirements are listed in Appendix G, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet current
Agency acceptance criteria (Appendix F; Attachment E) and if not, commit to conduct new
studies. If a registrant believes that previously submitted data meet current testing standards,
then study MRTD numbers should be cited according to the instructions in the Requirement
Status and Registrants Response Form provided for each product.
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2. Labeling Requirements for End-Use Products
a. PPE/Engineering Control Requirements for Pesticide
Handlers
For sole-active-ingredient end-use products that contain IPBC, the product labeling must
be revised to adopt the handler personal protective equipment/engineering control requirements
set forth in this section. Any conflicting PPE requirements on the current labeling must be
removed.
For multiple-active-ingredient end-use products that contain IPBC, the handler personal
protective equipment/engineering control requirements set forth in this section must be
compared to the requirements on the current labeling and the more protective must be retained.
For guidance on which requirements are considered more protective, see PR Notice 93-7.
(1) Products Intended Primarily for Occupational Use
(a) Minimum (Baseline) PPE/Engineering Control
Requirements
Although the Agency is not establishing minimum (baseline) engineering controls for
occupational uses of IPBC end-use products, the Agency is establishing minimum (baseline)
personal protective equipment for occupational uses of IPBC end-use products. The minimum
(baseline) PPE for all occupational uses of IPBC end-use products is:
"Applicators and other handlers must wear:
—long-sleeve shirt and long pants,
—chemical-resistant gloves*,
—shoes plus socks.
* For the glove statement, use the statement established for IPBC through the instructions
in Supplement Three of PR Notice 93-7.
(b) Determining PPE Requirements for End-use
Product Labels
The PPE that would be established on the basis of the acute toxicity category of the end-
use product must be compared to the active-ingredient-based minimum (baseline) personal
protective equipment specified above. The more protective PPE must be placed on the product
labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
NOTE: All end-use products are required to specify a long-sleeved shirt, long pants, socks and
shoes as minimum work attire for all handlers. If the end-use product is classified as toxicity
category I or II for eye irritation potential, protective eyewear is also required.
40
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(c) Placement in Labeling
The personal protective equipment requirements must be placed on the end-use product
labeling in the location specified in PR Notice 93-7, and the format and language of the PPE
requirements must be the same as is specified in PR Notice 93-7.
(2) Products Intended Primarily for Homeowner Use
(a) Determining PPE Requirements for End-Use
Product Labels
The Agency is not establishing active-ingredient-based minimum (baseline)
handler PPE for IPBC end-use products that are intended primarily for homeowner use. Any
necessary PPE for each IPBC end-use product intended primarily for homeowner use will be
established on the basis of the end-use product's acute toxicity category.
(b) Placement in Labeling
The personal protective equipment requirements, if any, must be placed on the
end-use product labeling immediately following the precautionary statements in the
labeling section "Hazards to Humans (and domestic animals)."
b. Entry Restrictions
For sole-active-ingredient end-use products that contain IPBC the product
labeling must be revised to remove any entry restrictions on the current labeling.
For multiple-active-ingredient end-use products that contain IPBC the entry
restrictions set forth in this section must be compared to the entry restrictions on the
current labeling and the more protective must be retained. A specific time period in hours
or days is considered more protective than "sprays have dried" or "dusts have settled."
c. Other Labeling Requirements
The Agency is requiring the following labeling statements to be located on all end-use
products containing IPBC that are intended primarily for occupational use.
(1) Application Restrictions
"Do not apply this product in a way that will contact workers or other persons."
"This product is toxic to fish. Do not discharge effluent containing this product into
41
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lakes, streams, ponds, estuaries, oceans or other water unless in accord with the
requirements of a National Pollution Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not discharge this
product to sewer systems without previously notifying the local sewage treatment plant
authority. For guidance contact your State Water Board or Regional Office of the EPA."
For home use products, add:
• "Do not apply this product in a way that will contact any person or pet."
(2) User Safety Requirements for Occupational Use
Products
Add the following statement:
• "Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions exist for washables, use detergent and hot water. Keep and wash PPE
separately from other laundry."
If coveralls are required for pesticide handlers, add the following:
• "Discard clothing or other absorbent materials that have been drenched or heavily
contaminated with this product's concentrate. Do not reuse them."
(3) User Safety Recommendations for All Products
Include the following recommendations to all end-use product labels.
• "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."
• "Users should remove personnel protective equipment immediately after handling
this product. Wash the outside of gloves before removing. As soon as possible
wash thoroughly." (For occupational use products only.)
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 Reregi strati on 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
42
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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 [add chemical names
here] 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.
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44
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VI. APPENDICES
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Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
44444444444444444444444
SITE Application Type, Application
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 1
Form(s) Min. Appl.
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Disallowed Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
ADHESIVES, INDUSTRIAL
Industrial preservative treatment..
During manufacture.. Not on label.. Not
Applicable., Not applicable for this use.
SC/L
Industrial preservative treatment., Not
on label.. Not on label.. Not
Applicable., Not applicable for this use.
COATINGS, INDUSTRIAL
Industrial preservative treatment..
During manufacture.. Not on label.. Not
Applicable., Not applicable for this use.
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
EC
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
W 200
W 200
W 260
W 200
W 200
W 45
W 340
W 150
W 200
W 200
W 500
W 200
W 45
Industrial preservative treatment., Not
on label., Not on label., Not
Applicable., Not applicable for this use.
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP. (INDOOR)
Surface treatment., Not on label., RTU W 1600
Brush., Hard., Not applicable for this
use.
Use Group: INDOOR NON-FOOD
W 750 * NS NS NS
W 800 * NS NS
W 800 * NS NS
W 800 * NS NS
W 800 * NS NS
W 800 * NS NS
W 446 * NS NS
Use Group: INDOOR NON-FOOD
W 3400 * NS NS
W 7500 * NS NS
W 8000 * NS NS
W 8000 * NS NS
W 4000 * NS NS
W 8000 * NS NS
W 446 * NS NS
Use Group: INDOOR NON-FOOD
W 1600 * NS NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAD
CIS, C24
CAD
CIS, C24
A08, C04
46
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 2
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP. (INDOOR) (con't)
Surface treatment., Not on label., RTU W 1600
Brush., Porous., Not applicable for this
use.
Use Group: INDOOR NON-FOOD (con't)
W 1600 * NS NS NS NS NS
A08, C04
Surface treatment., Not on label., RTU
Sprayer., Hard., Not applicable for this
use.
W 1600 * NS NS
NS NS NS
A08, C04
Surface treatment., Not on label., RTU
Sprayer., Porous., Not applicable for
this use.
EMULSIONS, RESIN/LATEX/POLYMER
Industrial preservative treatment., Not SC/L
on label., Not on label., Not
Applicable., Not applicable for this use.
SC/S
FILTERS (AIR/AIR CONDITIONER/FURNACE)/AIR DUCTS
Surface treatment., Not on label., RTU
Brush., Hard., Not applicable for this
use.
W 1600 * NS NS
NS NS NS
A08, C04
Use Group: INDOOR NON-FOOD
W 1200 * NS NS NS NS NS
W 446 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
W 1600 * NS NS NS NS NS
A08, C04
Surface treatment., Not on label., RTU
Brush., Porous., Not applicable for this
use.
W 1600 * NS NS
NS NS NS
A08, C04
Surface treatment., Not on label., RTU
Sprayer., Hard., Not applicable for this
use.
W 1600 * NS NS
NS NS NS
A08, C04
Surface treatment., Not on label.,
Sprayer., Porous., Not applicable for
this use.
W 1600 * NS NS
NS NS NS
A08, C04
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Spray., Not on label., Sprayer. SC/L
METALWORKING CUTTING FLUIDS
Use Group: OUTDOOR RESIDENTIAL
UC * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
47
-------
Report Run Date: 09/01/95
PRD Report Date: 06/16/95
) Time 09:02
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 3
SITE Application Type, Application
Form(s) Min. Appl.
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Disallowed Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
METALWORKING CUTTING FLUIDS (con't)
Preservative treatment., Not on label.,
Not on label., Not Applicable., Not
applicable for this use.
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
W 80
W 200
W 200
W 200
W 300
W 1500
W 200
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS
Preservative treatment., Not on label., SC/L
Not on label., Not Applicable., Not
applicable for this use.
Preservative treatment., Not on label., SC/L
Not on label., Not Applicable., Not
applicable for this use.
PAINTS (IN-CAN)
Industrial preservative treatment., Not SC/L
on label., Not on label., Not
Applicable., Not applicable for this use.
SC/S
PAINTS, LATEX/OIL/VARNISH (APPLIED FILM)
Industrial preservative treatment.,
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
Use Group: INDOOR NON-FOOD (con't)
W 1700 * NS NS NS NS NS NS
W 2000 * NS NS
W 2000 * NS NS
W 2000 * NS NS
W 800 * NS NS
W 1000 * NS NS
W 1950 * NS NS
W 2000 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
Use Group: AQUATIC NON- FOOD INDUSTRIAL
W 800 * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON- FOOD CROP
W 800 * NS NS NS NS NS NS
Use Group: INDOOR NON -FOOD
V 4839 * NS NS NS NS NS NS
W 446 * NS NS NS
Use Group: INDOOR NON -FOOD
V 4626 * NS NS NS
NS NS NS
NS NS NS
CAD
CAU
CIS, C24
48
-------
SC/L V 416 V 8163
49
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
44444444444444444444444
SITE Application Type, Application
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 4
Form(s) Min. Appl.
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Disallowed Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PAINTS, LATEX/OIL/VARNISH (APPLIED FILM) (con't)
SC/L
SC/L
SC/L
SC/S
PLASTIC PRODUCTS
Industrial preservative treatment., EC
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
SC/L
SC/L
SC/L
SC/S
Industrial preservative treatment., Not SC/L
on label., Not on label., Not
Applicable., Not applicable for this use.
SPECIALITY INDUSTRIAL PRODUCTS
Industrial preservative treatment., EC
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
SC/L
SC/L
SC/L
SC/L
V 549
V 7767
W 400
No Calc
W 1950
W 2000
W 2000
W 2000
W 120
Industrial preservative treatment.
on label., Not on label., Not
SC/S
SC/L
W 150
W 200
W 200
W 500
W 200
W 200
Use Group: INDOOR NON-FOOD (con't)
V 6210 * NS NS
V 7767 * NS NS
W 5000 * NS NS
No Calc * NS NS
Use Group: INDOOR NON-FOOD
W 6800 * NS NS
W 9000 * NS NS
W 10000 * NS NS
W 10000 * NS NS
W 10000 * NS NS
W 4000 * NS NS
Use Group: INDOOR NON-FOOD
W 3400 * NS NS
W 10500 * NS NS
W 12000 * NS NS
W 12000 * NS NS
W 5000 * NS NS
W 12000 * NS NS
W 800 * NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
CIS, C24
CAD
CIS, C24
50
-------
Applicable., Not applicable for this use.
51
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
44444444444444444444444
SITE Application Type, Application
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 5
Form(s) Min. Appl.
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Disallowed Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS (con't)
TEXTILES/TEXTILE FIBERS/CORDAGE
SC/S
Industrial preservative treatment., Not SC/S W 45
on label., Not on label., Not
Applicable., Not applicable for this use.
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS
Industrial preservative treatment., Not SC/L W 200
on label., Not on label., Not
Applicable., Not applicable for this use.
WOOD PRESSURE TREATMENT TO FOREST PRODUCTS
Nonsoil contact nonfumigation., Not on RTU NA
label., Brush.
Nonsoil contact nonfumigation., Not on RTU
label., Roller.
NA
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS INDOOR
Nonsoil contact nonfumigation., Not on RTU NA
label., Brush.
Nonsoil contact nonfumigation., Not on
label., Sprayer.
Nonsoil contact nonfumigation., Not on
label., Tank.
SC/L
SC/L
RTU
SC/L
NA
NA
NA
NA
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR
Dip treatment., Not on label., Tank. SC/L NA
Dip treatment., When needed., Tank. RTU NA
RTU NA
Use Group: INDOOR NON-FOOD (con't)
W 446 * NS NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 446 * NS NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 800 * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS NS
UC * NS NS
UC * NS NS NS
Use Group: OUTDOOR RESIDENTIAL
UC * NS NS NS
.205 Ib IK sq.ft * NS NS NS
UC * NS NS NS
NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
UC
UC
UC
*
*
*
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS NS NS
NS NS NS
NS NS NS
CAU
C92
C93
52
-------
.2383 Ib IK sq.ft * NS
53
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 6
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR (con't)
SC/L
Use Group: OUTDOOR RESIDENTIAL (con't)
3.448 Ib IK board * NS
ft
Nonsoil contact nonfumigation., Not on EC
label., Brush.
Nonsoil contact nonfumigation., Not on SC/L
label., Brush., Not Applicable., Not
applicable for this use.
Nonsoil contact nonfumigation., Not on RTU
SC/L
EC
EC
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
W 5000
UC
UC
UC
UC
.2777 Ib IK sq.ft
.52416 Ib IK
sq.ft
.26901 Ib IK
sq.ft
UC
UC
.3435 Ib IK sq.ft
UC
.185 Ib IK sq.ft
UC
UC
UC
UC
UC
W 12000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
*
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92
C93
CAC
CAU
C93
CAD
CAU
CIS, C24
UC * NS
54
-------
label., Pad.
55
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 7
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR (con't)
Use Group: OUTDOOR RESIDENTIAL (con't)
Nonsoil contact nonfumigation., Not on
label., Roller.
Nonsoil contact nonfumigation., Not on
label., Sprayer.
RTU
RTU
EC
RTU
RTU
RTU
RTU
RTU
RTU
RTU
SC/L
SC/L
EC
EC
RTU
RTU
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC
.0351 Ib IK sq.ft
UC
UC
.52416 Ib IK
sq.ft
.26901 Ib IK
sq.ft
UC
UC
.3435 Ib IK sq.ft
UC
.185 Ib IK sq.ft
UC
UC
UC
UC
UC
.2777 Ib IK sq.ft
.52416 Ib IK
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
*
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C93
C93
C93
CAD
C93
CAC
CAU
C93
C93
CAD
C92
C93
sq.ft
.26901 Ib IK * NS
sq.ft
UC * NS
56
-------
57
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR (con't)
RTU NA
Use Group: OUTDOOR RESIDENTIAL (con't)
Nonsoil contact nonfumigation., Not on SC/L
label., Sprayer., Not Applicable., Not
applicable for this use.
Nonsoil contact nonfumigation., Not on EC
label., Tank.
UC * NS
.3435 Ib IK sq.ft *
RTU
RTU
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
EC
EC
RTU
RTU
RTU
RTU
RTU
SC/L
SC/L
SC/L
SC/S
NA
NA
NA
NA
NA
NA
NA
W 5000
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC
.185 Ib IK sq.ft
UC
UC
UC
UC
UC
W 12000
UC
UC
UC
.2777 Ib IK sq.ft
.52416 Ib IK
sq.ft
UC
.185 Ib IK sq.ft
UC
UC
UC
UC
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAC
CAU
C93
CAD
CAU
CIS, C24
C92
C93
C93
CAD
58
-------
59
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 9
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR (con't)
Nonsoil contact nonfumigation., Not on SC/L W 5000
label.. Tank., Not Applicable., Not
applicable for this use.
Nonsoil contact nonfumigation., When
needed., Brush.
Use Group: OUTDOOR RESIDENTIAL (con't)
W 12000 * NS NS NS NS
.205 Ib IK sq.ft * NS NS
CIS, C24
Nonsoil contact nonfumigation., When
needed.. Not on label.
Nonsoil contact nonfumigation., When
needed., Roller.
Nonsoil contact nonfumigation., When
needed., Sprayer.
Nonsoil contact nonfumigation., When
needed.. Vacuum pressure system.
Soak., Not on label.. Tank.
Soil contact nonfumigation., Not on
label., Brush.
Soil contact nonfumigation., Not on
label.. Roller.
Soil contact nonfumigation., Not on
RTU
SC/L
SC/L
RTU
SC/L
RTU
RTU
SC/L
RTU
EC
RTU
RTU
RTU
RTU
RTU
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.2383 Ib IK sq.ft
1.533 Ib IK sq.ft
UC
.205 Ib IK sq.ft
1.533 Ib IK sq.ft
.205 Ib IK sq.ft
.2383 Ib IK sq.ft
1.533 Ib IK sq.ft
UC
UC
.3435 Ib IK sq.ft
UC
UC
UC
UC
UC
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAU
C93
CAU
C92
C93
C92
CAU
C93
C93
C93
C93
CAC
CAC
60
-------
label., Sprayer.
61
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 10
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR (con't)
RTU NA
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED)
Nonsoil contact nonfumigation., Not on RTU NA
label., Brush.
Use Group: OUTDOOR RESIDENTIAL (con't)
UC * NS NS NS NS
Use Group: OUTDOOR RESIDENTIAL
1387 Ib IK sq.ft * NS NS NS NS
Nonsoil contact nonfumigation., Not on RTU NA
label., Sprayer.
Nonsoil contact nonfumigation., Not on RTU NA
label.. Tank.
.1387 Ib IK sq.ft * NS NS
.1387 Ib IK sq.ft * NS NS
NS NS AN
NS NS AN
C93
Use Group: TERRESTRIAL NON-FOOD CROP
Dip treatment., When needed., Tank.
Nonsoil contact nonfumigation., Not on
label., Brush.
Nonsoil contact nonfumigation., Not on
label., Roller.
RTU
RTU
SC/L
SC/L
RTU
RTU
SC/L
EC
NA
NA
NA
NA
NA
NA
NA
NA
.2777 Ib IK sq.ft
UC
UC
UC
UC
.3435 Ib IK sq.ft
.2383 Ib IK sq.ft
UC
UC
* NS
* NS
* NS
* NS
* NS
*
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92
C93
C93
CAU
C93
CAU
CAU
C93
Nonsoil contact nonfumigation., Not on
label., Sprayer.
Nonsoil contact nonfumigation., Not on
label., Tank.
NA
NA
UC * NS NS
.3435 Ib IK sq.ft *
UC * NS NS
.3435 Ib IK sq.ft * NS NS
UC * NS NS
NS
NS
NS
NS
NS
NS
NS
NS
C93
C93
62
-------
.2383 Ib IK sq.ft * NS
63
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Report Run Date: 09/01/95
PRD Report Date: 06/16/95
) Time 09:02
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 11
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED) (con't)
SC/L NA
Nonsoil contact nonfumigation., When RTU NA .2777
needed., Brush.
Nonsoil contact nonfumigation., When
needed., Dip tank.
Nonsoil contact nonfumigation., When
needed., Not on label.
Nonsoil contact nonfumigation., When
needed., Roller.
Nonsoil contact nonfumigation.
needed., Sprayer.
Nonsoil contact nonfumigation., When
needed., Vacuum pressure system.
Preservative treatment., Not on label.
Not on label., Not Applicable., Not
applicable for this use.
Soak., Not on label., Tank.
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
UC * NS NS NS NS AN NS
Ib IK sq.ft * NS NS NS NS NS NS
RTU NA .26901 Ib IK * NS NS
sq.ft
SC/L NA 1.533 Ib IK sq.ft * NS NS
SC/L NA UC * NS NS
SC/L NA UC * NS NS
RTU NA .205 Ib IK sq.ft * NS NS
RTU NA .26901 Ib IK * NS NS
sq.ft
SC/L NA 1.533 Ib IK sq.ft * NS NS
RTU NA .2777 Ib IK sq.ft * NS NS
RTU NA .26901 Ib IK * NS NS
sq.ft
RTU NA .2383 Ib IK sq.ft * NS NS
SC/L NA UC * NS NS
SC/L NA 1.533 Ib IK sq.ft * NS NS
RTU NA UC * NS NS
SC/L W 200 W 8000 * NS NS
EC NA UC * NS NS
NS NS NS
NS NS NS
NS NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAU
C92
C93
C92
C93
C93
NS NS NS
C93
64
-------
.3435 Ib IK sq.ft
65
-------
Report Run Date: 09/01/95 ) Time 09:02
PRD Report Date: 06/16/95
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 12
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED) (con't)
SC/L NA
SC/L NA
Soil contact nonfumigation., Not on
label., Brush.
Soil contact nonfumigation., Not on
label., Sprayer.
SC/L
NA
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (UNSEASONED)
Dip treatment., Not on label., Tank. SC/L NA
Dip treatment., When needed., Tank. EC NA
Nonsoil contact nonfumigation., Not on
label., Brush.
Nonsoil contact nonfumigation., Not on
label., Roller.
Nonsoil contact nonfumigation., Not on
label., Sprayer.
Nonsoil contact nonfumigation., Not on
label., Tank.
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
UC * NS NS NS NS AN
UC * NS NS NS NS NS
UC * NS
NS
NS
Nonsoil contact nonfumigation., Not on
label., Tank., Not Applicable., Not
applicable for this use.
Nonsoil contact nonfumigation., When
needed., Brush.
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS
UC * NS NS NS NS
Ib IK sq.ft * NS NS NS NS
UC * NS NS NS NS
UC * NS NS NS NS
UC * NS NS NS NS
NS
NS
.205 Ib IK sq.ft * NS NS
CAU
CAU
CAU
C93
C92
CAU
C93
SC/L
EC
SC/L
SC/L
SC/L
SC/S
SC/L
NA
NA
NA
NA
NA
NA
W 5000
UC
UC
UC
UC
UC
UC
W 12000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS CAU
NS CAD
NS
NS CAD
NS CAU
NS
NS CIS,
66
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67
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Report Run Date: 09/01/95
PRD Report Date: 06/16/95
) Time 09:02
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 13
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (UNSEASONED) (con't)
SC/L NA
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
Nonsoil contact nonfumigation., When
needed., Hand move irrigation.
Nonsoil contact nonfumigation., When
needed., Roller.
Nonsoil contact nonfumigation., When
needed., Sprayer.
Preservative treatment., Not on label.,
Not on label., Not Applicable., Not
applicable for this use.
Soak., Not on label., Tank.
Soil contact nonfumigation., Not on
label., Brush.
Soil contact nonfumigation., Not on
label., Sprayer.
Soil contact nonfumigation., Not on
label., Tank.
RTU
RTU
SC/L
EC
SC/L
SC/L
SC/L
NA
NA
W 200
NA
NA
.205 Ib IK sq.ft * NS
.205 Ib IK sq.ft
W 8000
UC
UC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92
C92
CAU
C93
CAU
68
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Report Run Date: 09/01/95
PRD Report Date: 06/16/95
) Time 09:02
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 14
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
PRD Report Date : LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
EC : EMULSIFIABLE CONCENTRATE
RTU : LIQUID-READY TO USE
SC/L : SOLUBLE CONCENTRATE/LIQUID
SC/S : SOLUBLE CONCENTRATE/SOLID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC
No Calc
W
V
U
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04" is equivalent to
USE LIMITATIONS CODES
A08 : Preclean claim.
C04 : Proper ventilation required.
CIS : Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority (POTW).
C24 : Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water. (NPDES license restriction)
C92 : For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
69
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Report Run Date: 09/01/95
PRD Report Date: 06/16/95
) Time 09:02
APPENDIX A ) CASE 2725, [3-iodo-2-propynl butyl carbamate] Chemical 107801
LUIS 2.1 ) Page 15
USE LIMITATIONS CODES (Cent.)
C93 : Do not apply directly to water.
CAC : Keep out of lakes, streams, and ponds.
CAD : Do not apply directly to water or wetlands.
CAU : Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
70
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case 3-iodo-2-propynl butyl carbamate (IPBC) covered by this
Reregi strati on Eligibility Decision Document. It contains generic data requirements that apply to
3-iodo-2-propynl butyl carbamate (IPBC) 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 31 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.
71
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72
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of IPBC
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
63-6
63-7
63-8
63-9
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
All
All
All
All
All
All
All
All
All
All
All
All
All
All
41722901
41722901
41722901
41722901
41722901
41722901
41722901
41722901
41722901
41802601
N/A
41802501
Data Gap
42389802
* Indicates that this study has been classified as supplemental by the Agency. Additional confirmatory data may be required from
the registrant to satisfy this guideline requirement. 73
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Data Supporting Guideline Requirements for the Reregistration of IPBC
REQUIREMENT USE CITATION(S)
PATTERN
63-10 Dissociation Constant All N/A
63-11 Octanol/Water Partition All N/A
63-12 pH All 41802601,42257901
63-13 Stability All Data Gap
* Indicates that this study has been classified as supplemental by the Agency. Additional confirmatory data may be required from
the registrant to satisfy this guideline requirement. 74
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Data Supporting Guideline Requirements for the Reregistration of IPBC
REQUIREMENT
USE
PATTERN
CITATION(S)
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-3 Wild Mammal Toxicity
72-1A Fish Toxicity Bluegill
72-1C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
72-3A Estuarine/Marine Toxicity - Fish
72-3B Estuarine/Marine Toxicity - Mollusk
72-3C Estuarine/Marine Toxicity - Shrimp
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity - Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
C,K,M,O
42430901, 43491806
43491807, 42430902
42430903*, 43491808
00148277
41627106, 43530208*
43530209*, 41627107
41627108, 43530210
42168203
42168202*
42168204
00148277
42135501
42204301
41627109
41627110
* Indicates that this study has been classified as supplemental by the Agency. Additional confirmatory data may be required from
the registrant to satisfy this guideline requirement. 75
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Data Supporting Guideline Requirements for the Reregistration of IPBC
REQUIREMENT
USE
PATTERN
CITATION(S)
81-6 Dermal Sensitization - Guinea Pig C,K,M,O
81-8 Acute Rat Neurotoxicity with cholinesterase C,K,M,O
82-1A 90-Day Feeding - Rodent C,K,M,O
82-3 90-Day Dermal - Rodent C,K,M,O
82-7 90-day Rat Neurotoxicity with cholinesterase C,K,M,O
83-1A Chronic Feeding Toxicity - Rodent C,K,M,O
83-2A Oncogenicity - Rat C,K,M,O
83-2B Oncogenicity - Mouse C,K,M,O
83-3A Developmental Toxicity - Rat C,K,M,O
83-3B Developmental Toxicity - Rabbit C,K,M,O
83-4 2-Generation Reproduction - Rat C,K,M,O
84-2A Gene Mutation (Ames Test) C,K,M,O
84-2B Structural Chromosomal Aberration C,K,M,O
84-4 Other Genotoxic Effects C,K,M,O
85-1 General Metabolism C,K,M,O
43005701
Data gap
40947401*
42168201
Data gap
42008206
42008206, 42008202
43819001
40990401
42481604
40990402
41975206
40990404
40990403
40947404, 43570701
* Indicates that this study has been classified as supplemental by the Agency. Additional confirmatory data may be required from
the registrant to satisfy this guideline requirement. 76
-------
Data Supporting Guideline Requirements for the Reregistration of IPBC
REQUIREMENT
USE
PATTERN
CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
133-3 Dermal Passive Dosimetry Exposure C,K,M,O
ENVIRONMENTAL FATE
161-1 Hydrolysis C,K,M,O
162-1 Aerobic Soil Metabolism C,K,M,O
162-2 Anaerobic Soil Metabolism C,K,M,O
162-3 Anaerobic Aquatic Metabolism C,K,M,O
163-1 Leaching/Adsorption/Desorption C,K,M,O
41412201, 41742601, 42587501
42329301
42329302
42481601
42481601
41975207
* Indicates that this study has been classified as supplemental by the Agency. Additional confirmatory data may be required from
the registrant to satisfy this guideline requirement. 77
-------
78
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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 Reregi strati on 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 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.
79
-------
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.
80
-------
BIBLIOGRAPHY
MRID
CITATION
00148277 Gargus, J. (1984) Acute Oral Toxicity Study in Rats: 3-Iodo-2-Propynyl Butyl
Carbamate: Final Report: Project No. 2277-100. Unpublished study prepared by
Hazleton Laboratories America, Inc. 28 p.
40947401 Gordon, E. (1984) Troysan Polyphase (IPBC): 90-Day Subchronic Oral Toxicity
Test in Rats: Project ID: BSC/No. 11787. Unpublished study prepared by
Bioassay Systems Corp. 151 p.
40947404 Cameron, B. (1986) Troysan Polyphase (IPBC): The Residue Kinetics of
3-Iodo-2-propynyl-N-l-carbon14-butyl carbon14-carbamate: Project ID: 131952.
Unpublished study prepared by Inveresk Research International. 89 p.
40990401 Osterburg, I. (1986) Troysan Polyphase (IPBC): Oral (Gavage) Teratogenicity
Study in Rats: Laboratory Project ID 696-511/4. Unpublished study prepared by
Hazleton Laboratories Deutschland GmbH. 88 p.
40990402 Osterburg, I. (1987) Troysan Polyphase (IPBC): Two Generation (Dietary
Administration) Reproduction Toxicity Study in the Rat (One Litter per
Generation): Laboratory Project ID 548-511/3. Unpublished study prepared by
Hazleton Laboratories Deutschland GmbH. 359 p.
40990403 McBride, D.; Riach, C. (1988) Troysan Polyphase (IPBC): Assessment of
Genotoxicity in an Unscheduled DNA Synthesis Assay Using Adult Rat
Hepatocyte Primary Cultures: Laboratory Project ID 737447. Unpublished study
prepared by Inveresk Research International. 100 p.
40990404 McCarroll, N. (1984) Troysan Polyphase (IPBC): in vivo Micronuleus Assay in
Mice: Final Report: Laboratory Project ID 2277-103. Unpublished study prepared
by Hazleton Biotechnologies Corp. 40 p.
41412201 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers Association
Antimicrobial Exposure Assessment Study: Lab Project ID: Q626. Unpublished
study prepared by Univ. of Iowa, Institute of Agricultural Medicine and
Occupational Health. 209 p. Has different statistics when compared to 41742601
and 41761201.
41627106 Sousa, J. (1990) Troysan Polyphase P-100: Acute Toxicity to Bluegill Sunfish
(Lepomis macrochirus) Under Flow-Through Conditions Final Report: Lab
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BIBLIOGRAPHY
MRID
CITATION
Project Number: SLI 90-04-3300; 12166.0789.6100.105. Unpublished study
prepared by Springborn Laboratories, Inc. 44 p.
41627107 Sousa, J. (1990) Troysan Polyphase P-100: Acute Toxicity to Rainbow Trout
(Oncorhyncus mykiss) Under Flow-Through Conditions. Final Report: Lab
Project Number: SLI 90-03-3261; 12166.0789.6100. 108. Unpublished study
prepared by Springborn Labs, Inc. 43 p.
41627108 Cameron, B.; Hall, B.; Turton, G.; et al. (1989) Polyphase PI00: Determination
of Acute Toxicity (LC50) to Daphnia (48 h, static): Lab Project Number: IRI
138235; 139972. Unpublished study prepared by Inveresk Research
International. 50 p.
41627109 Bush, R. (1990) Primary Eye Irritation Study in Rabbits with Troysan Polyphase
P-100: Final Report: Lab Project Number: SLS 3228.1. Unpublished study
prepared by Springborn Labs, Inc. 27 p.
41627110 Cuthbert, J. ; Jackson, D. (1989) Troysan Polyphase P100: Primary Skin Irritation
Test in Rabbits: Lab Project Number: IRI 243912. Unpublished study prepared by
Inveresk Research International Ltd. 19 p.
41722901 Troy Chemical Corp. (1990) Product Chemistry-Troysan Polyphase PI00
(3-Iodo-2-Propynyl Butyl Carbamate). Unpublished study prepared by Troy
Chemical Corp. 13 p.
41742601 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers Association
Antimicrobial Exposure Assessment: Lab Project Number: Q626. Unpublished
study prepared by The Univ., of Iowa. 209 p.
41975206 Cattanach, P.; Riach, C. (1989) Troysan Polyphase P100-IPBC 97 (percent):
Testing for Mutagenic Activity with Salmonella typhimuriuum TA 1535, TA
1537, TA 1538, TA 98, TA 100: Lab Project No: 740140: 4896. Unpublished
study prepared by Inveresk Research Int. 52 p.
41975207 Blumhorst, M. (1990) Adsorption/Desorption Studies-Batch Equilibrum for
P-100: Lab Project Number: 147/002. Unpublished study prepared by EPL
Bio-Analytical Services, Inc. 176 p.
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MRID
CITATION
42008202 Mulhern, M.; Finn, J.; Everett, D.; et al. (1989) IPBC: 78 Week Dietary
Carcinogenicity Study in Mice: Lab Project No: 436165: Report No: 7304.
Unpublished study prepared by Inveresk Research International. 803 p.
42008206 Mulhern, M.; Everett, D.; Perry, C.; et al. (1989) 3-Iodo-2-propynyl Butyl
Carbamate (IPBC): 104 Week Dietary Carcinogenicity Study in Rats: Lab Project
Number: 435580: Report No. 7115. Unpublished study prepared by Inveresk
Research International. 972 p.
42135501
42168201
42168202
FitzGerald, G. (1991) Acute Dermal Study: Troysan Polyphase P-100: Lab
Project Number: 91G-0988. Unpublished study prepared by Toxikon Corp. 15
P-
Siglin, J. (1991) 91-Day Dermal Toxicity Study in Rats with Troysan Polyphase
P-100: Final Report: Lab Project Number: 3228.14. Unpublished study prepared
by Springborn Labs., Inc. 365 p.
Dionne, E. (1991) Troysan Polyphase P-100: Acute Toxicity to Eastern Oyster
(Crassostrea virginica) Under Flow-Through Conditions: Lab Project Number:
91-10-3982: 12166.0791.6102. 504. Unpublished study prepared by Springborn
Labs., Inc. 58 p.
42168203 Machado, M. (1991) Troysan Polyphase P-100: Acute Toxicity to Eastern
Sheepshead Minnow (Cyprinodon variegatus) Under FlowThrough Conditions:
Lab Project Number: 91-10-3983: 12366. 0791.6103.505. Unpublished study
prepared by Springborn Labs., Inc. 58 p.
42168204 Machado, M. (1991) Troysan Polyphase P-100: Acute Toxicity to Mysid Shrimp
(Mysidopsis bahia) Under Flow-Through Conditions: Lab Project Number:
91-10-3954: 12166.0791.6101.515. Unpublished study prepared by Springborn
Labs., Inc. 58 p.
42204301 Hoffman, G. (1990) Acute Inhalation Toxicity Study in the Rat: Troysan
Polyphase P-100: Lab Project Number: 90-8277. Unpublished study prepared by
Troy Chemical Corp. 209 p.
42329301 Blumhorst, M. (1990) Aqueous Hydrolysis of P-100: Lab Project Number:
147-001. Unpublished study prepared by EPL Bio-Analytical Services, Inc. 80
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83
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MRID
CITATION
42329302 Blumhorst, M. (1992) Aerobic Soil Meatbolism Study of P-100: Lab Project
Number: 147-004. Unpublished study prepared by EPL Bio-Analytical Services,
Inc. 217 p.
42430901 Campbell, S.; Lynn, S. (1992) Troysan Polyphase P-100: An Acute Oral Toxicity
Study with the Northern Bobwhite: Lab Project Number: 273-103. Unpublished
study prepared by Wildlife International Ltd. 20 p.
42430902 Campbell, S.; Grimes, J.; Lynn, S.; et al. (1992) Troysan Polyphase P-100: A
Dietary LC50 Study with the Northern Bobwhite: Lab Project Number: 273-104.
Unpublished study prepared by Wildlife International Ltd. 66 p.
42430903 Campbell, S.; Lynn, S. (1992) Troysan Polyphase P-100: A Dietary LC50 Study
with the Mallard Duck: Lab Project Number: 273-105. Unpublished study
prepared by Wildlife International Ltd. 17 p.
42481601 Blumhorst, M. (1992) Anaerobic Aquatic Metabolism Study of P-100: Lab
Project Number: 147-003. Unpublished study prepared by EPL Bio-Analytical
Services, Inc. 252 p.
42481604 Siglin, J. (1992) Teratology Study in Rabbits with Troysan Polyphase P-100:
Final Report: Lab Project Number: 3228.16. Unpublished study prepared by
Springborn Labs, Inc. 243 p.
42587501 Popendorf, W.; Selim, M.; Kross, B. (1992) Chemical Manufacturers Association
Antimicrobial Exposure Assessment Study: Second Replacement to MRID
41761201: Lab Project Number: Q626. Unpublished study prepared by The
University of Iowa. 316 p.
43005701 Larsen, L. (1993) Troysan Polyphase P-100 Guinea Pig Maximization Test: Lab
Project Number: 14148. Unpublished study prepared by Scantox. 28 p.
43491806 Campbell, S.; Beavers, J. (1994) Omacide IPBC: An Acute Oral Toxicity Study
with the Northern Bobwhite: Lab Project Number: 133-114. Unpublished study
prepared by Wildlife Int'l., Ltd. 23 p.
43491807 Campbell, S.; Beavers, J. (1994) Omacide IPBC: A Dietary LC50 Study with the
Northern Bobwhite: Lab Project Number: 133-112. Unpublished study prepared
by Wildlife Int'l., Ltd. 38 p.
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43491808 Campbell, S.; Beavers, J. (1994) Omacide IPBC: A Dietary LC50 Study with the
Mallard: Lab Project Number: 133-113. Unpublished study prepared by Wildlife
Int'l., Ltd. 37 p.
43530208 Boeri, R.; Magazu, J.; Ward, T. (1994) Acute Toxicity of Omacide IPBC to the
Fathead Minnow, Pimephales promelas: Lab Project Number: 293-OL.
Unpublished study prepared by T. R. Wilbury Labs, Inc. 28 p.
43530210 Boeri, R.; Magazu, J.; Ward, T. (1994) Acute Toxicity of Omacide IPBC to the
Daphnid, Daphnia magna: Lab Project Number: 292-OL. Unpublished study
prepared by T. R. Wilbury Labs, Inc. 28 p.
43570701 Ampofo, S. (1995) Metabolism of (carbon 14)-IPBC in Rats: Lab Project
Number: 6491/100: TC0457. Unpublished study prepared by Hazleton
Wisconsin, Inc. 393 p.
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Carbamate as a Category E Substance (not a Human Carcinogen): Lab Project
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Corp. 251 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 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).
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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 VT - 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! 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.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
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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 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
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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 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
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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 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.
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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 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.
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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.
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).
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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 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.
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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.
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.
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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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3-IODO-2-PROPYNL BUTYL CARBAMATE (IPBC) DATA CALL-IN CHEMICAL
STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing 3-iodo-2-propynl butyl car hamate
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 reregi strati on of 3-iodo-
2-propynl butyl carbamate (IPBC). 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 3-iodo-2-
propynl butyl carbamate (IPBC) 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 3-iodo-2-propynl
butyl carbamate are contained in the Requirements Status and Registrant's Response. Attachment 3.
The Agency has concluded that additional data on 3-iodo-2-propynl butyl carbamate 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 reregi strati on of all eligible 3-iodo-2-propynl butyl
carbamateproducts.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Richard J. Gebken at (703) 308-8591.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Richard J. Gebken
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Division
Mail Code - 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 2725
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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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The draft copy of part A for the Product Specific DCI is inserted here.
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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 enough to another
product to qualify for this option. I certify that another party in the agreement is
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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 conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C. 1.) 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)
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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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Page 1 of the sample Product Specific DCI (part b) is inserted here.
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Page 2 of the sample Product Specific DCI (part b) is inserted here.
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Page 3 of the sample Product Specific DCI (part b) is inserted here.
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Page 4 of the sample Product Specific DCI (part b) is inserted here.
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EPA'S BATCHING OF PRODUCTS CONTAINING 3-IODO-2-PROPYNYL BUTYL
CARBAMATE AS THE ACTIVE INGREDIENT 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 reregi strati on of products containing the active ingredient 3-Iodo-2-
propynyl butylcarbamate the Agency has batched products which can be considered similar in
terms 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. Notwithstanding 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. The citation of
data conducted on any new formulations (that were presented to the Agency after the publication of
the RED) must be approved if these data are to be used to cover other products in a batch. 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
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Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost 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.
Table 1 displays the batches for the active ingredient 3-Iodo-2-propynyl butylcarbamate
Table 1.
Batch
1
Registration
Number
1258-1219
5383-50
Percent Active Ingredient
3-Iodo-2-propynyl butylcarbamate ... 97%
3-Iodo-2-propynyl butylcarbamate ... 97%
Form
solid
solid
2
1022-575
5383-63
3-Iodo-2-propynyl butylcarbamate ... 40%
3-Iodo-2-propynyl butylcarbamate ... 40%
liquid
liquid
O
577-543
577-547
3-Iodo-2-propynyl butylcarbamate ...
0.50%
3-Iodo-2-propynyl butylcarbamate ...
0.50%
liquid
liquid
4
1022-550
60061-27
60061-78
3-Iodo-2-propynyl butylcarbamate ... 7.60%
didecyl dimethyl ammonium
chloride ... 64.80%
3-Iodo-2-propynyl butylcarbamate ... 7.60%
didecyl dimethyl ammonium
chloride ... 64.80%
3-Iodo-2-propynyl butylcarbamate ... 7.55%
didecyl dimethyl ammonium
chloride ... 64.34%
5-chloro-2-methyl-4-isothiazolin
-3-one ... 0.06%
2-methyl-4-isothiazolin-3-one ... 0.02%
liquid
liquid
liquid
5
5383-80
5383-81
3 -Iodo-2-propynyl butylcarbamate ... 1.3%
3 -Iodo-2-propynyl butylcarbamate ... 1.3%
liquid
liquid
Table 2 lists the products the Agency was unable to batch. These products were not batched
because they were not considered to be similar to other products in terms of acute toxicity.
Registrants of these products are responsible for meeting the acute toxicity data requirements for
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each product individually. These products may not cite acute toxicity/ irritation data derived from
any other products in this RED. The registrant may cite preexisting data conducted on their
individual product if it exists and it meets current Agency standards.
Table 2.
Registration Number
200-125
341-46
748-277
748-292
1022-516
1022-540
1409-50
1409-51
1409-59
1719-41
1719-42
4091-9
5383-18
5383-51
5383-52
5383-55
5383-73
5383-74
5383-75
5383-76
5383-78
5383-79
5383-83
6836-200
8177-71
8177-72
Percent Active Ingredient
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
Bis (tributyl) oxide
3-Iodo-2-propynyl butylcarbamate
Bis (tributyl) oxide
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
l,3-Bis(hydroxymethyl)-5,5-dimethyl-
hydantoin
Hydroxymethyl-5,5-dimethyl-
hydantoin
3-Iodo-2-propynyl butylcarbamate
Bis (tributylin) Oxide
3-Iodo-2-propynyl butylcarbamate
. 0.53%
. 0.50%
. 0.50%
... 2.5%
... 6.0%
... 0.5%
... 2.4%
... 0.5%
... 0.5%
... 0.5%
... 0.5%
... 0.5%
... 40%
... 80%
... 40%
... 17%
... 15%
... 20%
... 10%
... 20%
...0.1%
... 0.5%
... 0.2%
... 0.5%
... 0.5%
4.5%
... 87%
... 0.4%
0.05%
0.30%
0.63%
Form
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
solid
solid
liquid
liquid
liquid
liquid
solid
liquid
liquid
liquid
liquid
liquid
liquid
117
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Registration Number
8177-73
11599-2
39492-47
42768-8
46614-1
51578-1
52782-1
53354-1
56601-2
60061-21
60061-28
60061-30
60061-88
60061-89
60061-90
60061-91
63836-1
Percent Active Ingredient
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
3-Iodo-2-propynyl butylcarbamate
Barium metaborate
... 0.57%
0.4%
... 0.8%
... 0.8%
... 0.53%
... 0.58%
... 0.5%
... 0.5%
... 0.23%
... 5.97%
... 0.5%
... 2.5%
... 4.0%
... 0.5%
...3.09%
... 2.4%
...0.16%
... 9.0%
Form
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
The placing of two products into a batch means that these products are able to share acute toxicity
data interchangeably. However, bridging means that one product (a) should be able to cite data
from another product (b), but the other product (b) is not allowed to cite data on the first product
(a). In doing so, product (a) must not change a toxicity category from a I to a II, III or IV. Product
(a) must also not change a toxicity category III or IV to a I or II. It is also assumed that product (a)
will be no more likely to be a dermal sensitizer. At times, the Agency will allow a registrant to
bridge data from a product while having to conduct one or two studies to cover studies were the
Agency is concerned about potential differences in toxicity categories.
Table 3 presents products which may bridge acute toxicity data from the technical products in batch
#1 with the exception of the primary eye irritation study:
Table3.
Registration Number
5383-51
5383-52
Percent Active Ingredient
3-Iodo-2-propynyl butylcarbamate ... 80%
3-Iodo-2-propynyl butylcarbamate ... 40%
Form
solid
solid
Again, the registrant of these two products may not cite the primary eye irritation study conducted
on the technical product to cover these two products, but may cite technical data of the other five
118
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acute toxicity/ irritation studies. The data cited on the technical product must be acceptable by
Agency standards and guidelines.
119
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Attachment 5. List of All Registrants Sent This Data Call-In (insert) Notice
120
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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.
121
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USB-
United States Environmental Protection Agency
Washington, D.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 oth<
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 o
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
125
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
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)
126
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The following is a list of available documents for IPBC that may further assist you in
responding to this Reregi strati on 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 ftp on FTP.EPA.GOV, or using WWW (World Wide Web)
on WWW.EPA.GOV., or contact Dee Henderson at (703)-308-8167.
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 IPBC.
The following documents are part of the Administrative Record for IPBC 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
127
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