United States Prevention, Pesticides EPA 738-R-95-017
Environmental Protection And Toxic Substances April 1995
Agency (7508W)
&EPA Re registration
Eligibility Decision (RED)
Dowicil®CTAC
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case Dowicil®CTAC
which includes the active ingredients Dowicil®75 and Dowicil®150. The enclosed
Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the data base of
this [these] chemical [s], its conclusions of the potential human health and environmental risks
of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration.
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 are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Frank Rubis at (703) 308-8184.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (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. 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.
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e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Dowicil®CTAC
LISTC
CASE 3069
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
DOWICIL®CTAC REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Chemical Overview 2
C. Use Profile 3
D. Regulatory History 5
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity 7
b. Subchronic Toxicity 8
c. Developmental Toxicity 10
d. Mutagenicity 10
2. Exposure Assessment 10
a. Occupational and Residential 10
3. Risk Assessment 11
a. Occupational and Residential 11
C. Environmental Assessment 12
1. Environmental Fate 12
a. Environmental Chemistry, Fate and Transport 12
b. Environmental Fate Assessment 13
2. Ecological Effects 17
a. Ecological Effects Data 17
(1) Terrestrial Data 17
(2) Aquatic Data 18
(3) Terrestrial, Semi-Aquatic and Aquatic Plant Data
20
b. Ecological Effects Risk Assessment 21
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 25
A. Determination of Eligibility 25
B. Eligibility Decision 26
C. Regulatory Position 26
1. Risk Mitigation to Handlers 27
2. Potential Formaldehyde Exposure Statement 28
3. Aquatic Industrial Use Statement 28
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4. Endangered Species Statement 28
V. ACTIONS REQUIRED BY REGISTRANTS 29
A. Manufacturing-Use Products 29
1. Additional Generic Data Requirements 29
2. Labeling Requirements for Manufacturing-Use Products 29
B. End-Use Products 30
1. Additional Product-Specific Data Requirements 30
2. Labeling Requirements for End-Use Products 31
C. Existing Stocks 31
VI. APPENDICES 33
APPENDIX A. Table of Use Patterns Subject to Reregistration 35
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 41
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Dowicil®CTAC 51
APPENDIX D. List of Available Related Documents 61
APPENDIX E. PR Notices 86-5 and 91-2 65
PR Notice 86-5 67
PR Notice 91-2 85
APPENDIX F. Product Specific Data Call-in 91
Attachment 1. Chemical Status Sheet 103
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 105
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions Ill
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 115
Attachment 5. EPA Acceptance Criteria 119
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
133
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 135
APPENDIX G. FACT SHEET 145
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DOWICIL®CTAC REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Frank Hernandez
Phyllis Johnson
Michele Cottrill
Rafael Prieto
Environmental Fate and Effects Division
Renee Costello
William R. Effland
Renee Costello
Health Effects Division
Mary Clock
Pat McLaughlin
Mike loannou
Winston Dang
Registration Division
Mary Waller
Wallace Powell
Sami Malak
Special Review and Reregistration Division
Virginia Dietrich
Mark Wilhite
Ron Kendall
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Risk Characterization Analysis Branch
Toxicology Branch I
Toxicology Branch I
Occupational and Residential Exposure Branch
Registration Support Branch
Antimicrobial Program Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Office of Compliance Assurance and Enforcement:
Beverly Updike
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
ADI Acceptable Daily Intake. A now defunct term for refernce dose (RfD).
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 Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
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/L,
mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral,
dermal, inhalation). It is expressed as a weight of substance per unit weight of
animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
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.
jjg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed 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
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! 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
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (hereafter referred to as "the Agency") has
completed an assessment of the potential human health and environmental risks associated with
the pesticide uses of l-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride (Dowicil®
CTAC). There are two active ingredients included in this assessment, Dowicil®75 which
contains a ratio of both the cis- and trans-isomers of l-(3-chloroallyl)-3,5,7-triaza-l-
azoniaadamantane chloride, and Dowicil®150 which contains only the cis-isomer of l-(3-
chloroallyl) -3,5,7-triaza-1 -azoniaadamantane chloride.
This Reregistration Eligibility Decision (RED) also addresses the reregistration
requirements for products containing both Dowicil®75 and Dowicil® 150 for currently
registered uses. These products are used as preservatives in oil recovery drilling muds and
packer fluids, metal working cutting fluids, latex paints, industrial adhesives and coatings,
latex emulsions, detergent floor wax emulsions, floor polishes, inks, laundry starch, spinning
emulsions, and pulp and paper coatings, finishes and printing colors as components of paper
and paperboard intended for use in contact with aqueous, fatty, dry bulk, and dry foods. They
are also applied as microbicides/microbistats to secondary oil injection water as a water
treatment.
The Agency has determined that the uses of Dowicil®75 and Dowicil® 150 as currently
registered will not cause unreasonable risk to humans or the environment and these uses are
eligible for reregistration. The Agency has concerns about the potential for workers to be
exposed to formaldehyde, a degradate, from the industrial and residential uses. However, the
Agency believes that the risks of formaldehyde for the industrial uses is low and should be
regulated by the Occupational Safety and Health Administration (OSHA) through their
formaldehyde monitoring program and the potential for exposure in residential settings is
minimal. The Agency also has concerns about possible adverse affects to aquatic organisms
from the discharge of effluent from industrial uses. However, the Agency is requiring as part
of this RED that product labels be amended to contain appropriate label restrictions for
industrial discharge in the National Pollutant Discharge Elimination System.
Accordingly, the Agency has determined that all products containing either active
ingredient Dowicil®75 or Dowicil® 150 are eligible for reregistration and will be reregistered
when acceptable labeling and product-specific data are submitted and/or cited. Before
reregistering the products containing Dowicil®75 or Dowicil®150, 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 which contain other active ingredients will
be eligible for reregistration only when the other active ingredients are determined to be
eligible for reregistration.
v
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VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the Agency of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide
meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the chemical case Dowicil®CTAC and its two active ingredients Dowicil®75, a racemic
mixture of l-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride, and Dowicil®150, the
cis isomer of this chemical and their registered uses. The document consists of six sections.
Section I is the introduction. Section II describes Dowicil®75 and Dowicil®150, their uses,
data requirements and regulatory history. Section III discusses the human health and
environmental assessment based on the data available to the Agency. Section IV presents the
reregistration decision for Dowicil®75 and Dowicil®150. Section V discusses the reregistration
requirements for Dowicil®75 an Dowicil®150. Finally, Section VI is the Appendices which
support this Reregistration Eligibility Decision. Additional details concerning the Agency's
review of applicable data are available on request.
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II.
CASE OVERVIEW-Dowicil®CTAC
The Agency will use the case name Dowicil®CTAC for the case containing the two
active ingredients Dowicil®75 and Dowicil®150. The active ingredient Dowicil®75 contains
both the cis-(. 53%) and the trans-(. 44%) isomers of l-(3-chloroallyl)-3,5,7-triaza-l-
azoniaadamantane chloride. The active ingredient Dowicil®150 contains only the cis-isomer of
l-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride. The Agency will use the case
name Dowicil®CTAC in this document when referring to both active ingredients together.
There are sections in the assessment were it will be necessary to reference each active
ingredient separately. In those instances the Agency will use the trade names Dowicil®75 and
Dowicil®150 for the specific chemical characteristics or to represent the percentage of active
ingredient being referenced.
A. Chemical Overview-Dowicil®75
Common Name:
Chemical Name:
Dowicil®75
1 - (3-Chloroallyl) -3,5,7-triaza-1 -azoniaadamantane
chloride
CAS Registry Number: 4080-31-3
OPP Chemical Code: 17901
Empirical Formula:
Molecular weight:
C9H16N4C12
251.2
Trade and Other Names: Dowicil® 75
Dowicil® 100
Cinartc 200
XD-1840
Dowicide Q
Quaternium 15
Basic Manufacturer:
Dowco 184
Hexamethylenetetramine chloroallyl chloride
Dow Chemical Company
B.
Chemical Overview-Dowicil®150
Common Name:
Dowicil® 150
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Chemical Name: cis-l-(3-Chloroallyl)-3,5,7-triaza-l-
azoniaadamantane chloride
CAS Registry Number: 51229-78-8
OPP Chemical Code: 17902
Empirical Formula: C9H16N4C12
Trade and Other Names: Dowicil® 150
Dowicil® 200
Hexamethylenetetramine cis-chloroallyl chloride
Basic Manufacturer: Dow Chemical Company
C. Use Profile
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of the uses of Dowicil®CTAC is in
Appendix A.
Chemical: Dowicil®75
Chemical Number: 17901
1 - (3-chloroallyl)-3,5,7-triaza-1 -azoniaadamantane chloride
Type of Pesticide: Microbicide/microbistat (slime forming bacteria and
fungi)
Use Sites:
Aquatic non-food industrial:
Secondary oil recovery injection water
Indoor non-food:
Industrial adhesives and coatings; resin/latex/polymer emulsions;
metalworking cutting fluids; oil recovery drilling muds/packer fluids;
latex(in-can) paints; specialty industrial products; textiles/textile
fibers/cordage; and wet-end additives/industrial processing chemicals.
Target Pests: Slime-forming bacteria and fungi, spoilage microorganisms.
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Formulation Types Registered:
Type: End Use
Form: Solid
Method and Rates of Application:
Types of Treatment:
Microbicide/microbistat for secondary oil injection water-water
treatment-17 to 34 ppm.
Preservative for industrial adhesives, industrial coatings, latex
emulsions, metalworking fluids, latex paints, oil recovery drilling muds
and packer fluids, detergents floor wax emulsions, floor polishes, inks,
laundry starch, spinning emulsions, and pulp and paper coatings,
finishes and printing colors - preservative treatment - 68 to 4455 ppm
active ingredient.
Rate of Application - (See Types of Treatment)
Timing - During manufacture
Use Practice Limitations:
Incompatible with casein in both liquid and dry systems and with some
types of amine-modified clays. For preservation of components of paper
and paperboard intended for use in contact with aqueous, fatty dry bulk,
and dry foods.
Chemical: Dowicil®150
Chemical Number: 17902
cis-1 - (3-chloroallyl)-3,5,7-triaza-1 -azoniaadamantane chloride
Type of Pesticide: Microbicide/microbistat (slime forming bacteria and fungi)
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Use Sites:
Indoor non-food:
Industrial adhesives and coatings; resin/latex/polymer emulsions;
metalworking cutting fluids; latex in-can paints; specialty industrial
products; textiles/textile fibers/cordage; and wet-end additives/industrial
processing chemicals.
Target Pests: Slime-forming bacteria and fungi, spoilage microorganisms.
Formulation Types Registered:
Type: End Use
Form: Solid
Method and Rates of Application:
Types of Treatment:
Preservative for industrial adhesives, industrial coatings, latex
emulsions, metalworking fluids, latex paints, detergents floor wax
emulsions, floor polishes, inks, laundry starch, spinning emulsions, and
pulp and paper coatings, finishes and printing colors - preservative
treatment - 282 to 4700 ppm active ingredient.
Method and Rate - (See Types of Treatment)
Timing - During manufacture
Use Practice Limitations:
Incompatible with casein in both liquid and dry systems and with some
types of amine-modified clays. For preservation of components of paper
and paperboard intended for use in contact with aqueous, fatty dry bulk,
and dry foods.
D. Regulatory History
A pesticide product containing Dowicil®150 was first registered in the United
States in 1964 as a microbicide/microbistat. A second registration for Dowicil®75 was
granted in 1972 for use as a preservative for paints, latexes, metalworking lubricants
and to other industrial formulations to prevent deterioration from bacteria and fungi.
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Dowicil®CTAC meets the requirement of Food Additive regulations under 21
CFR Section 175.105 for use as a preservative in adhesives, 21 CFR 176.1680 as a
preservative of polyurethane resins in contact with dry bulk foods, 21 CFR 176.170 for
preservation of components of pulp and paperboard intended for use in contact with
aqueous and fatty foods, and 21 CFR 176.180 for preservation of paper and
paperboard intended for use in contact with dry foods.
In 1987 the Agency issued the Antimicrobial Data Call-in Notice for chronic
and subchronic toxicity data requirements for these two active ingredients and other
antimicrobials. The Agency issued a second data call-in under reregistration Phase 4 in
of March 1992. This required the registrant to provide appropriate chemistry,
toxicological and environmental fate data on these active ingredients to support
reregistration. This Reregistration Eligibility Decision reflects a reassessment of all
data which were submitted in response to these data call-ins.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The physical chemistry assessment for Dowicil®CTAC was done on
Dowicil®75. The Agency believes that the physical chemistry characteristics of
Dowicil®150 will be similar to Dowicil®75 since they are related isomers.
Dowicil®CTAC has the following physical chemistry characteristics:
Physical State: Powder at 20°C
Melting Point: 178-210°C
Odor: Slight Amine like
Bulk Density: 0.4 gm/cm3
Solubilities in g/lOOg of solvent at 25°C:
Water 127.2
Methanol (anhydrous) 20.8
Propylene glycol, USP 18.7
Glycerine (99.5) 12.6
Ethanol (absolute) 2.04
Isopropanol (anhydrous) <0.1
Mineral Oil <0.1
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Vapor Pressure: < 1 X 107 mm Hg at 25°C
pH: 5.57at24°C
Octanol/Water Partition Coefficient: Log p = -0.1
Dissociation Constant: Completely ionized in aqueous solution = 97.8%
Stability: Stable under ambient conditions
B. Human Health Assessment
The toxicology data base for Dowicil®CTAC is adequate for reregistration
eligibility. Due to the similarities of the two active ingredients the Agency accepted
toxicology studies conducted using either Dowicil®75 (sometimes referred to under
trademark name Dowicil®100) or Dowicil®150 (sometimes referred to under trademark
name Dowicil®200.)
1. Toxicology Assessment
a. Acute Toxicity
An acute oral toxicity study in rats found the LD50 for
Dowicil®150 was 2664 mg/kg for both sexes (see Table 1). Clinical
signs were lethargy, diarrhea, lacrimation, and tremors, placing
Dowicil®CTAC in toxicity category III (guideline 81-1; MRID
00093902). An acute dermal toxicity study with rabbits found the LD50
for Dowicil®150 was 923 mg/kg, placing Dowicil®CTAC in toxicity
category II (guideline 81-2; MRID 00093902). An acute inhalation
toxicity study with rats found the LC50 was greater than 4.7 mg/L,
placing Dowicil®CTAC in toxicity category IV (guideline 81-3; MRID
42420401).
A primary eye irritation study with Dowicil®150 in rabbits
produced slight to moderate conjunctival redness and slight discharge,
which cleared by 72 hours. There was slight irritation, toxicity category
III (guideline 81-4; MRID 00093902). Dowicil®150, in a primary
dermal irritation study with rabbits, produced a very slight edematous
reaction on intact skin. There was slight irritation placing
Dowicil®CTAC into toxicity category IV (guideline 81-5; MRID
00093902). The dermal sensitization potential of Dowicil®150 was
tested with guinea pigs and it was not a dermal sensitizer (guideline 81-
6; MRID 00093902).
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Table 1. Acute Toxicity Data for DOWICIL®CTAC
Test
Oral LD50-rats
Dermal LD50— rabbits
Inhalation LC50— rats
Eye irritation—rabbits
Dermal irritation—rabbits
Dermal sensitization—
guinea pigs
Results
2664 mg/kg
923 mg/kg
> 4.7 mg/L
slight irritation
slight irritation
non-sensitizer
Category
III
II
IV
III
IV
—
b. Subchronic Toxicity
New Zealand white rabbits were given daily dermal applications of
Dowicil®75 for 13 weeks. The doses were 0, 50, 200, or 1000 mg/kg/day.
The only treatment related effect was a dose-dependent increase in
ulcerative dermatitis, at the treatment site, that was correlated with the
abrasions from clipping. The NOEL for systemic toxicity was 1000
mg/kg/day (guideline 82-4; MRID 40650201).
One study was conducted to determine the level of Dowicil®75 in
the diet which would result in complete acceptance of the diet by rats. Ten
rats/sex/group were administered the chemical in the diet at dosages of 0,
1, 2 or 4 mg/kg/day for 90 days. The only parameters evaluated were body
weight, food consumption and organ weight (absolute and relative). Male
rats in the 4 mg/kg/day group had a significant decrease in body weight at
approximately 36% of the weighing periods. This group also had a
significant decrease in food consumption throughout the study. The
absolute weight of the heart in the 4 mg/kg/day group males was
significantly decreased. The relative weight of the brain and liver were
increased in the 4.0 mg/kg/day group females. This study was classified
as supplementary but was not required for reregistration. The study was
performed to investigate a specific toxicological endpoint (MRIDf 46358).
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In another study, Dowicil®75 was administered in the diet to groups
of 10 rats/sex/group at dosages of 0, 7.5, 15 , 30 or 60 mg/kg/day for 90
days. Mean body weight was significantly decreased in all the treated males
and females throughout the study. Overall mean body weight gain was
decreased in all the treated groups. Mean food consumption was
significantly decreased in the treated males, especially at the beginning of
the study. Although all of the treated female groups had significantly
reduced intake at some time during the study, females were not as
frequently affected as males. Calculation of food efficiency values for the
overall study and for the latter half of the study showed that the major
effect of decreased food intake on body weight occurred at the beginning
of the study. However, the decrease in food efficiency does indicate that
the chemical had a toxic effect on body weight that cannot be accounted for
solely by decreased food consumption. The only other possible effect of
treatment was an increase in the incidence of minimal hepatocellular
swelling in the 60 mg/kg/day group males (0/5 in the control vs. 3/5 in the
60 mg/kg/day group). This study is classified as supplementary due to the
absence of clinical observation data and legible summary tables for the
organ weight data (MRID# 111075).
In a dog study, Dowicil®75 was administered in gelatin capsules to
four beagle dogs/sex/group at dosages of 0, 7.5, 15 or 30 mg/kg/day for
90 days. One female in the 30 mg/kg/day was sacrificed due to general
deterioration on the 84th day of the study; necropsy revealed ascites with
evidence of liver toxicity. The only other lexicologically significant
findings during the study included a significant decrease in the hematocrit,
hemoglobin and white blood count measurements in the 30 mg/kg/day
group males and histopathological changes, especially in the liver, in the
30 mg/kg/day group males and females. The incidence and/or severity of
several findings in the liver were increased in the 30 mg/kg/day group
males and females including the following: obliterative vasculitis and
perivasculitis of the hepatic blood vessels; perivascular and pericholangiolar
infiltration of mononuclear cells; and hyperplasia of the reticuloendothelial
cells lining the hepatic sinusoid. This study is classified as supplementary
due to the absence of legible summary tables for hematology and organ
weight data (MRID#127915).
-------
c. Developmental Toxicity
A dermal developmental toxicity study was conducted with Fischer
344 rats. Doses of 0, 250, or 500 mg/kg/day of Dowicil®75 as a 50%
aqueous solution were applied to the dorsal skin daily on gestation days 6
through 15. No significant adverse effects from treatment with the test
compound were found but the study was considered adequate because the
doses were sufficiently high (guideline 83-3; MRID 40349701).
d. Mutagenicity
Dowicil®75 was mutagenic in the in vitro Chinese hamster ovary
cell HGPRT forward mutation assay with activation but nonmutagenic
without activation (guideline 84-2(a); MRID 40545101). Dowicil®75 was
negative in the rat hepatocyte unscheduled DNA synthesis assay (guideline
84-4; MRID 40545103). It was negative also in the mouse micronucleus
test (guideline 84-2 (b); MRID 40545102).
2. Exposure Assessment
a. Occupational and Residential
Due to its low toxicity and the lack of a toxicological endpoint of
concern, an exposure assessment is not required for Dowicil®CTAC.
However, based on the studies submitted by the registrant (GDLN 161-1,
MRID# 43192101 and MRID# 43577601), the Agency has determined that
formaldehyde is released from the decomposition of Dowicil®CTAC in
aqueous solution. The Agency is concerned with formaldehyde since it has
significant toxic effects of its own, and has been classified by the Agency
as a Group B I/Probable Human Carcinogen (Integrated Risk Assessment
System, 5/1/91).
The potential for exposure to Dowicil®CTAC and/or formaldehyde
exists for two groups of individuals: 1) Occupational—workers involved in
the industrial setting (addition of the biocide during the manufacturing
process); and 2) Residential—individuals in the home setting where
Dowicil®CTAC products may be used.
For residential uses, the Agency has determined that the potential
exposure to Dowicil®CTAC is minimal. A study submitted by the
registrant for carpet adhesives containing Dowicil®CTAC indicates that
formaldehyde does not pose an exposure hazard (MRIDf 43577601).
10
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For industrial uses, the Agency has determined that Dowicil®CTAC
exposure for most workers to is low because of the current use patterns and
available use information. Therefore, exposure to Dowicil®CTAC not of
concern. The Agency believes workers in industrial settings are adequately
protected against exposure to formaldehyde by the Occupational Safety and
Health Administration. OSHA has a comprehensive workplace standard for
formaldehyde for the protection of workers in the industrial setting due to
formaldehyde-release in the workplace. The OSHA formaldehyde standard
was established as a rule in May 1992, and set a permissible exposure level
(PEL) of .75 ppm in the workplace. The standard also proscribes that
certain actions should be taken if monitoring shows levels of .50 ppm. This
standard requires monitoring before workers enter the premises following
use of formaldehyde, or when potential ambient formaldehyde is generated
from other chemicals.
Two incident cases have been reported to the Agency for
Dowicil®CTAC. The first case, reported in June 1993, involved 7 workers
and the specific active ingredient is unknown. This incident was caused by
a misuse of the product. In the second case, reported in August, 1994, a
woman in Texas claimed to have developed chemical sensitivity to
Dowicil®75 in housepaint. From its review of this report, the Agency
considers the information insufficient to show a causal relationship between
Dowicil®75 and the reported chemical sensitivity. Other than these to
cases, no other human incidents have been reported to the Agency.
All uses of Dowicil®CTAC are outside the scope of the Worker
Protection Standard (WPS) and requirements for personal protective
equipment (PPE) for Dowicil®CTAC products are under the jurisdiction of
OSHA. The Agency requires that Dowicil®CTAC labels contain a label
statement advising workers to wear chemical resistant gloves for the open-
pouring of the end-use product.
3. Risk Assessment
a. Occupational and Residential
Based on the use patterns and toxicological information for the
active ingredients Dowicil®75 and Dowicil®150, the Agency has
determined that products containing the above active ingredients, labeled
and used as specified in this RED, will not pose a significant risk to
humans. The Agency further believes potential risks in residential settings
will be insignificant. The occupational risks for potential exposure to
formaldehyde in the work place when Dowicil®CTAC is used are low and
formaldehyde is currently monitored and regulated by OSHA.
11
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C. Environmental Assessment
In summary, Dowicil®CTAC dissipates by abiotic hydrolysis with slightly faster
rates of hydrolysis under acidic conditions than were observed for neutral to alkaline
conditions. Dowicil®75 and Dowicil®150 have both been classified as practically nontoxic
to slightly toxic to avian species, fish, aquatic invertebrates and terrestrial animals. These
chemicals' environmental fate and ecological effects are described in more detail below.
1. Environmental Fate
A hydrolysis study is required for industrial use pesticides in which effluent
is potentially discharged into aquatic environments. This environmental fate
guideline requirement is fulfilled for Dowicil®CTAC.
a. Environmental Chemistry, Fate and Transport
(1) Hydrolysis
Uniformly radio-labeled Dowicil([14C]CTAC), at 58 ppm, degraded
with a registrant calculated half-life of 1.1 days in a sterile pH 5 buffer
solution that was incubated in the dark at 25°C; the hydrolytic half-lives
were 2.7 and 2.2 days for pH 7 and 9 solutions, respectively. Uniformly
radio-labeled [14C]CTAC, at 1,004 ppm in 0.05 M buffer solutions,
degraded more slowly than the 58 ppm test solutions with registrant
calculated half-lives of 6.3, 13 and 26 days for pH 5, 7 and 9 solutions,
respectively. Similar half-lives were reported for both cis- and trans-
isomers within each concentration range test.
The following degradates were identified:
* l-methyl-3,5,7-triaza-l-azoniaadamantane ([14C]-HMTA-CH3);
* the hydrochloride salt of hexamethylenetetramine ([14C]-HMTA;
maximum concentration of less than 7 percent of the applied for
both [14C]-HMTA-CH3 and [14C]-HMTA at 10 days posttreatment);
and
* nonlabeled cis- and trans-3-chloroallylamines.
In the pH 5 solution, [14C]CTAC was a maximum of 59.11 percent
(cis-) and 36.46 percent (trans-) of the applied immediately post treatment
and a maximum of 27.46 percent (cis-) and 12.97 percent (trans-) of the
applied at 1 day posttreatment. At day 5, [14C] CTAC was a maximum of
2.99 percent (cis-) and 1.56 percent (trans-) of the applied.
12
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In the pH 7 solution, [14C]CTAC was a maximum of 59.27 percent
(cis-) and 36.12 percent (trans-) of the applied immediately post treatment
and a maximum of 32.38 percent (cis-) and 21.69 percent (trans-) of the
applied at 1 day post treatment. At day 5, [14C]CTAC was a maximum of
14.54 percent and 7.9 percent of the applied for the cis- and trans-isomers,
respectively.
In the pH 9 solution, [14C]CTAC was a maximum of 45.54 percent
(cis-) and 27.25 percent (trans-) of the applied immediately post treatment
and a maximum of 26.83 percent (cis-) and 16.23 percent (trans-) of the
applied at 1 day post treatment. At day 5, [14C]CTAC was a maximum of
7.96 percent (cis-) and 3.59 percent (trans-) of the applied.
Material balances ranged from 95.5 to 102.2 percent of the applied
for the 50 ppm [14C]CTAC experiment. Material balances ranged from
94.5 to 104.4 percent of the applied for the 1,000 ppm [14C]CTAC
experiment.
Reaction rates for the [14C]-products suggested that an appreciable
amount of the [14C]-products may be precursors to [14C]-methylene glycol.
Based on an earlier hydrolysis study, formaldehyde forms as a degradation
product of CTAC (Gonsior and Billing, 1984). The current hydrolysis
study indicates that formaldehyde, when present in a dilute aqueous
solution, reacts with water to form the hydrate, methylene glycol. Earlier
research indicates that after the addition of formaldehyde to a pH 7 solution
at 25° C, less than 0.01 percent remained as formaldehyde (Allinger et al.,
1971). The current hydrolysis study considered formaldehyde as an
equilibrium mixture with methylene glycol. This study fulfills the guideline
requirement, (guideline 161-1; MRID 43192101)
b. Environmental Fate Assessment
Information from the above hydrolysis study indicates that
Dowicil®CTAC is nonpersistent and degrades rapidly under acidic (pH 5)
conditions. Under neutral to alkaline conditions (pH 7-to-9),
Dowicil®CTAC degraded more slowly.
13
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Aquatic Tier Ic Estimated Environmental Concentrations (EECs):
The fundamental component of an aquatic exposure assessment for
the Agency is the Estimated Environmental Concentration or EEC. An
aquatic EEC describes the frequency or probability that a chemical will be
found at a certain concentration in a specified environment or group of
environments as the result of its use pattern.
To aid in the aquatic risk assessment, a screening level calculation
called a Tier Ic EEC was developed by the Agency. A Tier Ic EEC
determines the maximum concentration occurring immediately downstream
from an industrial (point source) discharge site, and is calculated using very
conservative assumptions and does not address the environmental fate of the
pesticide, and therefore, may overestimate the true exposure of the
chemical. However, it provides a clear demarcation such that if a Tier Ic
EEC does not exceed the established Level of Concern (LOG), it indicates
that a pesticide poses little or no risk to the aquatic environment. In the
same respect, if the Tier Ic EEC does exceed the LOG, it may indicate that
the pesticide can potentially adversely impact the environment. For risk
assessment, these calculated EECs may be compared to acute exposure
LOCs (based on the fact that these EECs estimate the concentration
immediately downstream from a discharge site and that it assumes no
degradation of the chemical). However, chronic exposure risk assessments
can be conducted using the Tier Ic EECs when a safety factor (1/100 LC50)
is employed.
EECs for high exposure and typical exposure are calculated. The
EECs for the high exposure case are based on a return frequency of l-in-10
years. The high exposure case represents a site that would be expected to
produce larger EECs than 90% of all the sites with the specified use
pattern. A l-in-10 year EEC has a 10% probability of being equalled or
exceeded in any single year at a given site, or could be equalled or
exceeded once every 10 years at that site over a long term average. These
frequency of occurrence and site assumptions are similar to the assumptions
used by the Agency for modeling agricultural pesticides. The EECs
calculated for the typical exposure case represents a site that would be
expected to produce larger EECs than 50% of all the sites with the
specified use pattern.
The Agency may regulate pesticides using the high (maximum)
exposure rather than the typical exposure to provide an added measure of
environmental protection. Typical exposure is provided for refinement to
further characterize the risk. To calculate both EECs, the concentration in
the waste stream was assumed to be the same as the application rate (this
14
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assumes that no degradation occurred in the processing stream). The
concentration in the waste stream was then used to calculate the
concentration in the receiving water body immediately downstream from
the discharge site.
Dowicil®CTAC is also used in pulp/paper mills; however it is not
used in the Whitewater stage of paper making. These waters are reused
several times and are treated with a variety of antimicrobial products.
Dowicil®CTAC is incorporated into the coating materials which provide the
desired aesthetic or strength characteristics of the paper. During the
coating process the water is evaporated and the low residual of
Dowicil®CTAC is incorporated into the coating. Because the exposure of
Dowicil®CTAC from this use pattern is expected to be minimal, Tier Ic
EECs were not calculated for pulp/paper mill use.
Dilution factors used to calculate the EECs were taken from an
array of dilution factors compiled by the Office of Pesticides and Toxic
Substance of EPA (OPTS, 1992). For each use pattern, an appropriate
group of industrial sites was selected to represent the use. Table 1 lists the
Standard Industrial Code (SIC) for each industrial classification chosen for
a particular use pattern. If the use pattern was not specifically listed on the
Industrial Categories Summary Table, the Publicly Owned Treatment
Works (POTW) which may also be referenced as SIC #4952 were used as
the default category.
The application rates of Dowicil®75 and Dowicil®150 and
appropriate dilution factors used to calculate the EECs are listed in
Table 2. The typical EEC was calculated by dividing the waste stream
concentration by the tabulated dilution factor for the mean flow condition
at the median site. The high exposure EEC was calculated by using a
dilution factor which represents a site that would be expected to produce
larger EECs than 90 percent of all sites with the specified use pattern.
15
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TABLE 2. STANDARD INDUSTRIAL CODES, MAXIMUM APPLICATION RATES, AND DILUTION
FACTORS FOR DOWICIL®75 AND DOWICIL®150
USE SITE
DOWICIL®75
Secondary Oil Recovery Water
Metalworking Cutting Fluids— Soluble cutting
oils
Metalworking Cutting Fluids— Recirculating
metalworking lubricants
Wet-End Additives/Industrial Processing
Chemicals
Oil Recovery Drilling Muds/Packer Fluids
SIC
4952
3411
3411
4952
4952
MAX. APPL.
RATES
34 ppm
101 ppm
1688 ppm
1823 ppm
338 ppm
OIL. FACTOR
TYPICAL
710.43
4730.86
4730.86
710.43
126.72
HIGH EXP.
1.00
3.75
3.75
1.00
1.00
DOWICIL®150
Metalworking Cutting Fluids— Soluble cutting
oils
Wet-End Additives/Industrial Processing
Chemicals
3411
4952
1880 ppm
1880 ppm
4730.86
710.43
3.75
1.00
16
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The high and typical exposure aquatic Tier Ic EECs for Dowicil®75 and Dowicil®150 are
listed in Table 3.
TABLE 3. AQUATIC TIER Ic EECs for Dowicil®75 and Dowicil®150
USE SITE
DOWICIL®75
Secondary Oil Recovery Water
Metalworking Cutting Fluids-
Soluble cutting oils
Metalworking Cutting Fluids—
Recirculating metalworking
lubricants
Wet-End Additives/Industrial
Processing Chemicals
Oil Recovery Drilling Muds/Packer
Fluids
TYPICAL EXPOSURE CASE
0.048 ppm
0.021 ppm
0.357 ppm
3 ppm
3 ppm
HIGH EXPOSURE CASE
34 ppm
27 ppm
450 ppm
1823 ppm
338 ppm
DOWICIL®150
Metalworking Cutting Fluids —
Soluble cutting oils
Wet-End Additives/Industrial
Processing Chemicals
0.4 ppm
3 ppm
501 ppm
1880 ppm
2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Data
In order to establish the toxicity of Dowicil®CTAC to birds,
the following tests are required using the technical grade material:
one avian single-dose oral (LD50) study on one species (preferably
mallard or bobwhite quail) and one subacute dietary study (LC50) on
one species of waterfowl (preferably the mallard duck) or upland
game bird (preferably bobwhite quail or ring-necked pheasant).
Given that the use patterns of the products with these two
chemicals are not likely to expose wild mammals or honey bees, the
Agency has not required toxicological testing for these two species.
17
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(a) Avian Acute Toxicity
The Agency has reviewed two studies which indicate that
Dowicil®CTAC ranges from slightly toxic to practically nontoxic
to birds on an acute oral basis (Table 4). The guideline requirement
for the avian acute oral LD50 study is fulfilled, (guidelines 71-1 (a);
MRID 00071725 and 42814703)
Table 4. Avian Acute Oral Toxicity Findings for
Dowicil®CTAC
Species
Mallard Duck
Mallard Duck
%AI
67.5
95
LDsn
> 2510mg/Kg
= 1440 mg/Kg
Conclusion
Practically nontoxic
Slightly toxic
(b) Avian Subacute Dietary Toxicity
Dowicil®CTAC is slightly toxic to practically nontoxic to
birds on a subacute dietary basis (Table 5). The guideline
requirement is fulfilled, (guidelines 71-2(a), 71-2(b); MRID
00074305, 00071726, 42814704, and 42814705)
Table 5. Avian Subacute Dietary Toxicity Findings for
Dowicil®CTAC
Species
Bobwhite quail
Mallard duck
Bobwhite quail
Mallard duck
%AI
67.5
67.5
95
95
lj^-'5o
= 3223 ppm
> 5620 ppm
= 2645 ppm
= 5627 ppm
Conclusion
Slightly toxic
Practically nontoxic
Slightly toxic
Practically nontoxic
(2) Aquatic Data
(a) Freshwater Fish Toxicity
In order to establish the toxicity of a microbicide to
freshwater fish, the minimum data required on the technical grade
of the active ingredient is one freshwater fish toxicity study.
18
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The results of the aquatic toxicity studies indicate that
Dowicil®CTAC is slightly toxic to practically nontoxic to
freshwater fish (Table 6). The guideline requirement for acute
toxicity testing of the technical on freshwater fish is fulfilled
(guidelines 72-1 (a), 72-1 (c); MRID 00125029, 42814701,
42814702).
Table 6. Freshwater Fish Toxicity Findings for
Dowicil®CTAC
Species
Bluegill
Rainbow
Trout
Bluegill
%AI
67.5
91
91
^-'*-y50
59 ppm
> 144 ppm
148 ppm
Conclusion
Slightly toxic
Practically nontoxic
Practically nontoxic
(b) Freshwater Invertebrate Toxicity
The minimum testing required to assess the hazard of a
microbicide to freshwater invertebrates is one freshwater aquatic
invertebrate toxicity test, preferably using first instar Daphnia
magna or early instar amphipods, stoneflies, mayflies, or midges.
At an EC50 of 42 ppm, Dowicil®75 is slightly toxic to Daphnia.
Data for an acute invertebrate toxicity test was submitted for
Dowicil®75 but not for Dowicil®150. However, based on available
freshwater fish toxicity data (see Table 6), which indicate
Dowicil®150 is less toxic than Dowicil®75 to aquatic organisms,
this study would not add any useful scientific information and is,
therefore, waived. The guideline requirement for acute toxicity
testing on freshwater invertebrates is fulfilled, (guideline 72-2(a);
MRID 00125029)
(c) Estuarine/Marine Toxicity
Estuarine/marine acute toxicity studies are required under
the current 40 CFR Part 158 to support use in once-through cooling
towers, oil recovery drilling muds/packer fluids, secondary oil
recovery injection waters, and pulp and paper mills. The
requirement for this category includes a 96-hour LC50 for an
estuarine fish (sheepshead minnow preferred), a 96-hour LC50 for
19
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shrimp (mysid preferred), and a 48-hour embryo-larvae study or a
96-hour shell deposition study (eastern oyster preferred). Estuarine
toxicity testing reveals that Dowicil®150 is slightly toxic to
estuarine organisms. The estuarine data requirements for
Dowicil®150 have been fulfilled (Table 7). (guidelines 72-3(a), (b),
and (c); MRID 43107201, 43107202, and 43107203)
Table 7. Estuarine Acute Toxicity Findings for Dowicil®CTAC
Species
Fish (Silverside)
Oyster
Shrimp
%AI
89.2
89.2
89.2
LC50 or EC50
LC50 = 59 ppm
ECsn = 1 1 ppm
LC50 > 52 ppm
Conclusion
Slightly toxic
Slightly toxic
Slightly toxic
Estuarine/marine organisms acute toxicity studies, 72-3(a),
(b), and (c), have not been submitted for Dowicil®75. If the
relationship between Dowicil®75 and Dowicil®150 for estuarine
organisms is analogous to that for freshwater organisms, it can be
assumed the former is more toxic to estuarine organisms than is the
latter. Therefore, the toxicity to these organisms will likely be
underestimated using the Dowicil®150 data. The Agency has
required this data as confirmatory, in order to establish the toxicity
of Dowicil®75 to estuarine organisms for the secondary oil recovery
injection waters, metalworking cutting fluids, wet end
additives/industrial processing chemicals, and the oil recovery
drilling muds/packer fluids uses.
(3) Terrestrial, Semi-Aquatic and Aquatic Plant Data
Plant testing is not required for
microbicides/microbistats under 40 CFR Part 158. Because
Dowicil®CTAC is a microbicide/microbistat for control of
fungi primarily, aquatic plant toxicity requirements have not
been required.
20
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b. Ecological Effects Risk Assessment
(1) Risk to Terrestrial Animals
The use patterns of Dowicil®CTAC would result in minimal
exposure to terrestrial organisms, therefore terrestrial species are
not likely to be impacted by the use of Dowicil®CTAC.
Dowicil®75 and Dowicil®150 are practically nontoxic to slightly
toxic to upland gamebirds and wild waterfowl.
(2) Risk to Aquatic Animals
Unlike agricultural pesticides in which aquatic organisms
can be exposed via runoff and/or drift, exposure to nontarget
aquatic organisms could be expected through a point source
discharge of industrial microbicides. In the case of
Dowicil®CTAC, there are several use sites and environmental
conditions where exposure to aquatic organisms is a distinct
possibility. Consequently, the previously mentioned Tier Ic EECs
(see Table 3) were calculated in accordance with current Agency
policy for the following use sites: secondary oil recovery injection
waters, metalworking cutting fluids (two scenarios - soluble cutting
oils and metal working lubricant), wet-end additives/industrial
processing chemicals, and oil recovery drilling muds/packer fluids.
Levels of Concern are criteria used to indicate potential risk
to nontarget organisms. The criteria indicate that a chemical, when
used as directed, has the potential to cause undesirable effects on
nontarget organisms. There are two general categories of LOG
(acute and chronic) for each of the four nontarget animal groups
and one category (acute) for each of two nontarget plant groups.
In order to determine if an LOG has been exceeded, a risk
quotient (RQ) must be derived and compared to the respective
LOG. A risk quotient is calculated by dividing an appropriate
exposure estimate (e.g., the estimated environmental concentration)
by an appropriate toxicity test effect level (e.g., the LC50). In the
case of microbicides, when only an aquatic risk assessment is
performed, the acute effect levels typically are the LC50 (fish) and
the EC50 (invertebrates). The chronic RQ is derived using a safety
factor of 1/100 of the acute effect level. This safety factor enables
the use of the previously mentioned Tier Ic estimated
environmental concentrations.
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The criteria for the presumption of risk as well as the
relation of risk to LOG exceedances for aquatic organisms are
summarized in the following tables. The most sensitive species was
selected, regardless of testing on Dowicil®150 or Dowicil®75:
Table 8. Aquatic Risk LOCs Secondary Oil Recovery Injection Waters for Dowicil®CTAC
SPECIES
Bluegill
Daphnia
Minnow (Silverside)
Oyster, Shell
Shrimp
ACUTE
LC50 (ppm)
59
42
34
1KEC.J
52
RQ
HIGH
EXPOSURE
(EEC/LC50)
0.58
0.81
1.0
3.09
0.65
RQ
TYPICAL
EXPOSURE
(EEC/LC50)
0.0008
0.001
0.001
0.004
0.0009
MAGNITUDE OF LOC EXCEEDANCE
HIGH ACUTE
EXPOSURE
(LOC = RQ > 0.5)
1.2
1.6
2
6.2
1.3
HIGH CHRONIC
EXPOSURE
(LOC = RQ > 0.01)
58
81
100
309
65
For Table 8 the typical acute and chronic exposures did not exceed the LOC.
Application rate = 34 ppm
High Exposure EEC = 34 ppm
Typical Exposure EEC = 48 ppb
Table 9. Aquatic Risk LOCs Metalworking Cutting Fluids - Soluble Cutting Oils for
Dowicil®CTAC
SPECIES
Bluegill
Daphnia
Minnow (Silverside)
Oyster,Shell
Shrimp
ACUTE
LCso
(ppm)
59
42
34
1KECJ
52
RQ
HIGH
EXPOSURE
(EEC/LC50)
0.46
0.64
0.79
2.45
0.52
RQ
TYPICAL
EXPOSURE
(EEC/LC50)
0.0004
0.0005
0.0006
0.002
0.0004
MAGNITUDE OF LOC EXCEEDANCE
HIGH ACUTE
EXPOSURE
(LOC = RQ > 0.5)
No Exceedance
1.28
1.6
4.9
1.04
HIGH CHRONIC
EXPOSURE
(LOC = RQ > 0.01)
46
64
79
245
52
For Table 9 the typical acute and chronic exposures did not exceed the LOC.
Application rate = 101 ppm
High Exposure EEC = 27 ppm
Typical Exposure EEC = 21 ppb
22
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Table 10. Aquatic Risk LOCs Metalworking Cutting Fluids - Metalworking Lubricant for
Dowicil®CTAC
SPECIES
Bluegill
Daphnia
Minnow (Silverside)
Oyster, Shell
Shrimp
ACUTE
LC50 (ppm)
59
42
34
1KEC.J
52
RQ
HIGH
EXPOSURE
(EEC/LC50)
7.63
10.7
13.2
40.9
8.65
RQ
TYPICAL
EXPOSURE
(EEC/LC50)
0.0061
0.0085
0.0105
0.0325
0.0069
MAGNITUDE OF LOC EXCEEDANCE
HIGH ACUTE
EXPOSURE
(LOC = RQ > 0.5)
15.3
21.4
26.4
81.8
17.3
HIGH CHRONIC
EXPOSURE
(LOC = RQ > 0.01)
763
1070
1324
4090
865
For Table 10 the typical acute and chronic exposures did not exceed the LOC.
Application rate = 1688 ppm
High Exposure EEC = 450 ppm
Typical Exposure EEC = 357 ppb
Table 11. Aquatic Risk LOCs Wet End Additives/Industrial Processing Chemicals
SPECIES
Bluegill
Daphnia
Minnow (Silverside)
Oyster, Shell
Shrimp
ACUTE
LC50 (ppm)
59
42
34
11(ECJ
52
RQ
HIGH
EXPOSURE
(EEC/LC50)
30.9
43.4
53.6
165.7
35.1
RQ
TYPICAL
EXPOSURE
(EEC/LC50)
0.05
0.07
0.09
0.27
0.06
MAGNITUDE OF LOC
EXCEEDANCE
HIGH
ACUTE
EXPOSURE
(LOC =
RQ > 0.5)
61.8
86.8
107
332
70.2
HIGH
CHRONIC
EXPOSURE
(LOC = RQ
> 0.01)
3090
4340
5360
16570
3510
TYPICAL
CHRONIC
EXPOSURE
(LOC = RQ
$0.01)
5
7
9
27
6
For Table 11 the typical acute exposure did not exceed the LOC.
Application rate = 1823 ppm
High Exposure EEC = 1823 ppm
Typical Exposure EEC = 3 ppm
23
-------
Table 12. Aquatic Risk LOCs Oil Recovery Drilling Muds/Packer Fluids for
Dowicil®CTAC
SPECIES
Bluegill
Daphnia
Minnow (Silverside)
Oyster, Shell
Shrimp
ACUTE
LCSO (ppm)
59
42
34
H(ECsn)
52
RQ
HIGH
EXPOSURE
(EEC/LCSO)
5.73
8.05
9.94
30.7
6.5
RQ
TYPICAL
EXPOSURE
(EEC/LCSO)
0.05
0.07
0.09
0.27
0.06
MAGNITUDE OF LOC
EXCEEDANCE
HIGH ACUTE
EXPOSURE
(LOC = RQ >
0.5)
11.5
16.1
19.9
61.4
13
HIGH
CHRONIC
EXPOSURE
(LOC = RQ
> 0.01)
573
805
994
3073
650
TYPICAL
CHRONIC
EXPOSURE
(LOC = RQ $
0.01)
5
7
9
7
6
For Table 12 the typical acute exposure did not exceed the LOC.
Application rate = 338 ppm
High Exposure EEC = 338 ppm
Typical Exposure EEC = 3 ppm
Based on the above calculations, the chronic LOC is exceeded for
both the high and typical exposure scenarios of the Tier Ic exposure model
for wet-end additives/industrial processing chemicals and oil recovery
drilling muds/packer fluids. The acute LOC is exceeded for the high
exposure scenarios for all five of the examined uses.
It is important to note, that the assumption of no degradation in the
waste stream is not valid for Dowicil®CTAC because it degrades by abiotic
hydrolysis with reported half-lives ranging from approximately l-to-3 days
for 50 ppm concentrations to approximately 6-to-26 days for 1,000 ppm
concentrations. These calculated Tier Ic EECs are likely overestimates of
the actual environmental concentration which would be found in the
environment. A higher tier EEC calculation which considers the
environmental fate and transport properties of Dowicil®CTAC would
provide a more accurate estimate of the actual environmental
concentrations. However, additional environmental fate data would be
needed in order to calculate the higher tier EEC. Based on the rapid
hydrolysis and the use sites for Dowicil®CTAC, no additional
environmental fate date is required. And, discharge levels are governed
under a NPDES permit granted by state regulatory agencies and the
Agency.
24
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(3) Risk to Endangered Species
The LOG for endangered aquatic species is exceeded when the EEC
value of the exposure model equals or exceeds 1/20 the LC50 values, that
is the risk quotient of the EEC value divided by the LC50 equals or exceeds
0.05. For Dowicil®CTAC the LOCs for risk to endangered species are
exceeded for the high exposure scenario for all modelled uses and for the
typical exposure scenarios for the wet end additives/industrial processing
chemicals and the oil recovery drilling muds/packer fluids. This indicates
that endangered aquatic species are at risk with both high and typical
exposure scenarios. As Dowicil®CTAC will be discharged at a number of
different sites, it is reasonable to assume that endangered species are
located in some of these aquatic habitats. Effluent containing
Dowicil®CTAC should not be discharged into streams or other waterways
where endangered aquatic organisms are known to reside. The Agency
wants to reiterate that the toxicity levels referenced above are based on the
conservative assumption of no degradation and Dowicil®CTAC does
degrade rapidly by abiotic hydrolysis.
The Endangered Species Protection Program is expected to become
final in 1995. Limitations in the use of Dowicil®CTAC will be required
to protect endangered and threatened species, but these limitations have not
been defined and may be formulation specific. EPA anticipates that a
consultation with the Fish and Wildlife Service will be conducted in
accordance with the species-based priority approach described in the
Program. After completion of consultation, registrants will be informed
if any required label modifications are necessary. Such modifications
would most likely consist of the generic label statement referring pesticide
users to use limitations contained in county bulletins.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing Dowicil®CTAC. The Agency has completed
its review of these generic data, and has determined that the data are sufficient to support
reregistration of all products containing Dowicil®CTAC. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of Dowicil®CTAC, and lists the submitted studies that the Agency
found acceptable.
25
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The data identified in Appendix B are sufficient to allow the Agency to assess the
registered uses of Dowicil®CTAC and to determine that Dowicil®CTAC can be used
without resulting in unreasonable adverse effects to humans and the environment. The
Agency therefore finds that all products containing Dowicil®75 and Dowicil®150 as the
active ingredients are eligible for reregistration. The reregistration of particular products
is addressed in Section V of this document. However, the Agency remains concerned, as
discussed above, about the potential exposure and risks associated with formaldehyde in
the workplace and to endangered species. The Agency has notified OSHA that the
potential for exposure to formaldehyde exists from the use of Dowicil®CTAC. OSHA has
agreed to add products containing Dowicil®CTAC to its formaldehyde monitoring
program. The Agency is relying on OSHA's monitoring program to regulate the potential
risks to workers. The Agency is also relying on future implementation of the Endangered
Species Act to have positive effects on exposure and risk reduction.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data and the data identified in Appendix B. Although the Agency
has found that all uses of Dowicil®CTAC are eligible for reregistration, it should be
understood that the Agency may take appropriate regulatory action, and/or require the
submission of additional data to support the registration of products containing
Dowicil®CTAC, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
B. Eligibility Decision
Based on the reviews of the generic data for the active ingredients Dowicil®75 and
Dowicil®150, the Agency has sufficient information on the health effects of
Dowicil®CTAC and on their potential for causing adverse effects in fish and wildlife and
the environment. The Agency has determined that Dowicil®CTAC products, labeled and
used as specified in this Reregistration Eligibility Decision, will not pose unreasonable
risks or adverse effects to humans or the environment. Therefore, the Agency concludes
that products containing Dowicil®CTAC for all uses are eligible for reregistration.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
Dowicil®CTAC. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
26
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1. Risk Mitigation to Handlers
Personal Protective Equipment (PPE) for Handlers (Mixer/Loader/
Applicators)
For each end-use product, PPE requirements for pesticide handlers will be
set during reregistration in one of two ways:
a. If the Agency has no special concerns about the acute 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 will be established using the process described in PR Notice 93-7 or
more recent Agency guidelines.
b. If the Agency has special concerns about an active ingredient due to very
high acute toxicity or to certain other adverse effects, such as allergic
effects or delayed effects (cancer, developmental toxicity, reproductive
effects, etc):
(1) In the RED for that active ingredient, the Agency may establish
minimum or "baseline" handler PPE requirements that pertain to all
or most occupational end-use products containing that active
ingredient.
(2) These minimum PPE requirements must be compared with the
PPE that would be designated on the basis of the acute toxicity of
each end-use product.
(3) 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.
There are no special toxicological concerns about Dowicil®CTAC,
per se, that warrant the establishment of active-ingredient-based PPE
requirements other than chemical resistant gloves for open pouring of end-
use products. This decision is based on the risk assessment which indicates
Dowicil®CTAC is category II for acute dermal toxicity. Therefore, the
Agency is requiring chemical resistant gloves for handlers engaged in open
pouring of end-use products containing Dowicil®75 and Dowicil®150.
27
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2. Potential Formaldehyde Exposure Statement
As described in Section III. B. above, available information indicates that
exposure to Dowicil®CTAC and/or formaldehyde exists for occupational workers
involved in industrial settings and for individuals in residential settings where
Dowicil®CTAC containing products may be used. However, the Agency has also
determined that the potential exposure in residential settings are minimal and that
the potential exposure for occupational workers is low and formaldehyde levels in
the workplace are being regulated by OSHA. The Agency notified OSHA of
Dowicil®CTAC's potential formaldehyde release and they have agreed to include
products containing Dowicil®CTAC in their program to monitor for potential
formaldehyde exposure in the workplace.
3. Aquatic Industrial Use Statement
Based on the above (Section III) calculations, the chronic LOG is exceeded
for both high and typical exposure model for wet end additives/industrial
processing chemicals and oil recovery drilling muds/packer fluids. The high
exposure scenario assumes that 90% of the sites had greater mean stream flows for
the low flow condition. This scenario also assumes that no degradation occurred
and that the application rate is the same as the receiving body of water. Further,
assuming that degradation has occurred, there are no directions on the label that
indicate at what intervals replenishment of the product is necessary. A higher tier
EEC calculation taking into account the fate of this chemical would likely further
reduce the estimated risk. The Agency has determined that the appropriate risk
reduction measure is to require NPDES permitting for direct effluent discharges
of all end use products.
4. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered
species to Dowicil®CTAC as discussed above in the science assessment chapter
(Section III.). Currently, the Agency is developing a program ("The Endangered
Species Protection Program") to identify all pesticides whose use may cause
adverse impacts on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
modifications or a generic product label statement, requiring users to consult
county-specific bulletins. These bulletins would provide information about specific
use restrictions to protect endangered and threatened species in the county.
Consultations with the Fish and Wildlife Service will be necessary to assess risks
to newly listed species or from proposed new uses.
The Agency plans to publish a description of the Endangered Species
Program in the Federal Register and have enforceable county-specific bulletins
28
-------
available. Because the Agency is taking this approach for protecting endangered
and threatened species, it is not imposing label modifications at this time through
the RED. Any requirements for product use modifications will occur in the future
under the Endangered Species Protection Program.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of Dowicil®CTAC for
the above eligible uses has been reviewed and determined to be substantially
complete. However, the Agency is requiring that the registrant perform the
estuarine/marine organisms acute toxicity studies, as confirmatory data, on
Dowicil®75 to establish the toxicity of Dowicil®75 to estuarine/marine organisms
for the secondary oil recovery injection waters, metalworking cutting fluids, wet
end additives/industrial processing chemicals, and the oil recovery drilling
muds/packer fluids uses.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product labeling
must be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The MP labeling must bear the following statements under
Directions For Use:
"Only for formulation into an (fill blank with Insecticide,
Herbicide or the applicable term which describes the type of pesticide
uses(s)) for the following uses(s) : (fill in the blank only with
those uses that are being supported by the 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 use group:
29
-------
(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 the support of such
uses(s)."
(b) "This product may be used to formulate products for any
additional uses(s) not listed on the MP label if the
formulator, user group or grower has complied with
U.S.EPA submission requirements regarding the support of
such uses(s)."
Personal Protective Equipment
Handler PPE for Occupational-Use Products
The minimum (baseline) PPE for handlers engaged in open pouring of Dowicil®75
and Dowicil®150 is chemical-resistant gloves.
Note to Registrants: If a product is currently labeled for both Manufacturing Use and End
Uses, the registrant must delete one set of uses in order to make it either an MP or EP.
If the registrant chooses to delete the end uses, it must follow the requirements in this MP
labeling section. If the registrant chooses to delete the MP use (e.g., "For Manufacturing
or Formulation Only Into..."), it must follow the requirements of the EP labeling section
below. In either case, a registrant must submit an application to register a new product
if he wishes to market a product intended for the uses deleted from the current product.
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 EPA 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 MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
30
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2. Labeling Requirements for End-Use Products
Effluent Discharge Labeling Statements
All Dowicil®75 and Dowicil®150 end-use products that may be contained
in an effluent discharged to the waters of the United States or municipal sewer
systems must bear the following revised effluent discharge labeling statement.
"This product is toxic to fish and invertebrates. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans or
other waters unless in accordance with the requirements of a National
Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For
guidance contact your State Water Board or Regional Office of the EPA."
All affected pesticide products distributed or sold by registrants and
distributors (supplemental registrants) must bear the above labeling by October 1,
1995. All products distributed or sold by persons other than registrants or
supplemental registrants after October 1, 1997 must bear the correct labeling.
Refer to PR Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.
Personal Protective Equipment
Handler PPE for Occupational-Use Products
The minimum (baseline) PPE for handlers engaged in open pouring of
Dowicil®75 and Dowicil®150 is chemical-resistant gloves.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
31
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The Agency has determined that registrants may distribute and sell Dowicil®CTAC
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 preexisting Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
32
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VI. APPENDICES
33
-------
34
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
35
-------
36
-------
Date 06/17/94
Time 09:38
APPENDIX A _ CASE 3069, [Dowicil®75 (*)] Chemical 017901 [1-(3-Chloroallyl)-3,5,7-triaza-l-azoniaadamanta
LUIS 1.4 _ Page 1
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max.
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. Apps
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. © Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
Maximum Dose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
ADHESIVES, INDUSTRIAL
Preservative treatment., During FM/S W 473
manufacture., Not on label., Not
Applicable., Not applicable for this use.
COATINGS, INDUSTRIAL
Preservative treatment., During FM/S W 878
manufacture., Not on label., Not
Applicable., Not applicable for this use.
EMULSIONS, RESIN/LATEX/POLYMER
Preservative treatment., During FM/S W 338
manufacture., Not on label., Not
Applicable., Not applicable for this use.
METALWORKING CUTTING FLUIDS
Preservative treatment., During FM/S W 101
manufacture., Not on label., Not
Applicable., Not applicable for this use.
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS
Preservative treatment., During FM/S W 203
manufacture., Not on label., Not
Applicable., Not applicable for this use.
PAINTS, LATEX (IN-CAN)
Preservative treatment., During FM/S W 68
manufacture., Not on label., Not
Applicable., Not applicable for this use.
SECONDARY OIL RECOVERY INJECTION WATER
Water treatment., Not on label., FM/S W 17
Not on label., Not Applicable.,
Not applicable for this use.
Use Group: INDOOR NON-FOOD
W 4455 * NS NS NS NS
Use Group: INDOOR NON-FOOD
W 1823 * NS NS NS NS
Use Group: INDOOR NON-FOOD
W 2025 * NS NS NS NS
Use Group: INDOOR NON-FOOD
W 1688 * NS NS NS NS
Use Group: INDOOR NON-FOOD
W 338 * NS NS NS NS
Use Group: INDOOR NON-FOOD
W 1350 * NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 34 * NS NS NS NS
-------
Date 06/17/94
Time 09:38
APPENDIX A _ CASE 3069, [Dowicil®75 (*)] Chemical 017901 [1-(3-Chloroallyl)-3,5,7-triaza-l-azoniaadamanta
LUIS 1.4 _ Page 2
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment _ Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max.
Rate (AI Tex. Apps
unless noted Max. @ Max
otherwise) Dose Rate
Maximum Dose Min. Restr.
/crop cycle Interv Entry
or /year (days) Interv
[day(s)]
Geographic Limitations
Allowed Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS
Preservative treatment., During FM/S W 270
manufacture., Not on label., Not
Applicable., Not applicable for this use.
TEXTILES/TEXTILE FIBERS/CORDAGE
Preservative treatment., During FM/S W 878
manufacture., Not on label., Not
Applicable., Not applicable for this use.
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS
Preservative treatment., During
manufacture., Not on label., Not
Applicable., Not applicable for this use.
LEGEND
FM/S W 878
Use Group: INDOOR NON-FOOD
W 1823 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1823 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1823 * NS NS NS
HEADER ABBREVIATIONS
Max. Apps ® Max Rate
Min. Interv (days)
Restr. Entry Interv (days)
SOIL TEXTURE FOR MAX APP. I
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
Maximum number of Applications at Maximum Dosage Rate
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
FORMULATION CODES
FM/S : FORM NOT IDENTIFIED/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
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Hundred Weight
nn times (10 power -xx); for instance,
"1.234E-04" is equivalent to ".0001234"
-------
Date 06/29/94
Time 09:38
APPENDIX A _ CASE 3069, [Dowicil®150 (*)] Chemical 017902 [cis-1-(3-Chloroallyl)-3,5,7-triaza-l-azoniaadamanta
LUIS 1.4 _ Page 1
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max.
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. Apps
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. © Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
Maximum Dose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
ADHESIVES, INDUSTRIAL
Preservative treatment., During FM/S W 470
manufacture., Not on label., Not
Applicable., Not applicable for this use.
COATINGS, INDUSTRIAL
Preservative treatment., During FM/S W 940
manufacture., Not on label., Not
Applicable., Not applicable for this use.
EMULSIONS, RESIN/LATEX/POLYMER
Preservative treatment., During FM/S W 470
manufacture., Not on label., Not
Applicable., Not applicable for this use.
METALWORKING CUTTING FLUIDS
Preservative treatment., During FM/S W 940
manufacture., Not on label., Not
Applicable., Not applicable for this use.
PAINTS, LATEX (IN-CAN)
Preservative treatment., During FM/S W 470
manufacture., Not on label., Not
Applicable., Not applicable for this use.
SPECIALITY INDUSTRIAL PRODUCTS
Preservative treatment., During FM/S W 282
manufacture., Not on label., Not
Applicable., Not applicable for this use.
TEXTILES/TEXTILE FIBERS/CORDAGE
Preservative treatment., During FM/S W 940
manufacture., Not on label., Not
Applicable., Not applicable for this use.
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS
Preservative treatment., During
manufacture., Not on label., Not
Applicable., Not applicable for this use.
FM/S W 940
Use Group: INDOOR NON-FOOD
W 4700 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1880 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1410 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1880 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1880 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1880 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1880 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1880 * NS NS NS
-------
Date 06/29/94 _ Time 09:38 APPENDIX A _ CASE 3069, [DowicilII)150 (*)] Chemical 017902 [cis-1-(3-Chloroallyl)-3,5,7-triaza-l-azoniaadamanta LUIS 1.4 _ Page 3
HEADER ABBREVIATIONS
Max. Apps @ Max Rate : Maximum number of Applications at Maximum Dosage Rate
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
FM/S : FORM NOT IDENTIFIED/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 : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
41
-------
42
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Dowicil®CTAC covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Dowicil®CTAC 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
0 Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
43
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44
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Dowicil®75
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
ECOLOGICAL EFFECTS
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
71-1A
Acute Avian Oral - Quail/Duck
MRID# 41679901
MRID# 41679901
MRID# 41679901
MRID# 41679901, 41959501
MRID# 41679901
MRID# 41959502, 41959503
MRID# 41679902
MRID# 41679902
MRID# 41679902
MRID# 41959504
MRID# 41679903, 41959505
MRID# 41679903
MRID# 41679904
MRID# 41679905
MRID# 41679903
MRID# 41679906
MRID# 41679903
MRID# 71725
45
-------
Data Supporting Guideline Requirements for the Reregistration of Dowicil®75
REQUIREMENT
71-1B
71-2B
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
Acute Avian Oral - Quail/Duck
TEP
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
USE PATTERN
F
F
F
F
F
F
F
F
CITATION(S)
MRID# 74305
MRID# 71726
MRID# 125029
WAIVED
MRID# 125029
CONFIMATORY
CONFIMATORY
CONFIMATORY
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-3
83-3A
84-2A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Dermal - Rodent
Developmental Toxicity - Rat
Gene Mutation (Ames Test)
FM
FM
FM
FM
FM
FM
FM
FM
FM
MRID# 93902
MRID# 93902
MRID# 42420401
MRID# 93902
MRID# 93902
MRID# 93902
MRID# 40650201
MRID# 40349701
MRID# 40545101
46
-------
Data Supporting Guideline Requirements for the Reregistration of Dowicil®75
REQUIREMENT USE
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
OCCUPATIONAL RESIDENTIAL EXPOSURE
Supplemental Information
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/Desorption
164-1 Terrestrial Field Dissipation
164-2 Aquatic Field Dissipation
165-4 Bioaccumulation in Fish
165-5 Bioaccumulation - Aquatic
NonTarget
PATTERN
FM
FM
F
F
F
F
F
F
F
F
F
F
F
F
CITATION(S)
MRID# 40545102
MRID# 40545103
MRID# 43577601
MRID# 43192101
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
waived
47
-------
Data Supporting Guideline Requirements for the Reregistration of Dowicil®150
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
MRID# 41679901
MRID# 41679901
MRID# 41679901
MRID# 41679901, 41959501
MRID# 41679901
MRID# 41959502, 41959503
MRID# 41679902
MRID# 41679902
MRID# 41679902
MRID# 41959504
MRID# 41679903, 41959505
MRID# 41679903
MRID# 41679904
MRID# 41679905
MRID# 41679903
MRID# 41679906
MRID# 41679903
ECOLOGICAL EFFECTS
71-1A
Acute Avian Oral - Quail/Duck
MRID# 42814703
48
-------
Data Supporting Guideline Requirements for the Reregistration of Dowicil®150
REQUIREMENT
71-1B
71-2B
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
Acute Avian Oral - Quail/Duck
TEP
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
USE PATTERN
F
F
F
F
F
F
F
F
CITATION(S)
MRID# 42814704
MRID# 42814705
MRID# 42814701
MRID# 42814702
WAIVED
MRID# 43107201
MRID# 43107202
MRID# 43107203
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-3
83-3A
84-2A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Dermal - Rodent
Developmental Toxicity - Rat
Gene Mutation (Ames Test)
FM
FM
FM
FM
FM
FM
FM
FM
FM
MRID# 93902
MRID# 93902
MRID# 42420401
MRID# 93902
MRID# 93902
MRID# 93902
MRID# 40650201
MRID# 40349701
MRID# 40545101
49
-------
Data Supporting Guideline Requirements for the Reregistration of Dowicil®150
REQUIREMENT USE
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
OCCUPATIONAL RESIDENTIAL EXPOSURE
Supplemental Information
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/Desorption
164-1 Terrestrial Field Dissipation
164-2 Aquatic Field Dissipation
165-4 Bioaccumulation in Fish
165-5 Bioaccumulation - Aquatic
NonTarget
PATTERN
FM
FM
F
F
F
F
F
F
F
F
F
F
F
F
CITATION(S)
MRID# 40545102
MRID# 40545103
MRID# 43577601
MRID# 43192101
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
waived
50
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APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Dowicil®CTAC
51
-------
52
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
53
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as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
54
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BIBLIOGRAPHY
MRID
CITATION
Federal Register Notice, Volume 57, Number 102, Department of Labor
(OSHA), Occupational Exposure to Formaldehyde, May 27, 1992.
Allinger, N.L., M.P. Cava, D.C. De Jongh, C.R. Johnson, N.A.
Lebel, and C.L. Stevens. 1971 Organic Chemistry, Worth Publishers,
Inc. New York, NY. pp. 473-474
Gonsior, S.J. and W.L. Billing. 1984. Reaction of l-(3-chloro-cis-2-
propenyl)-3,5,7-triaza-l-azoniatricyclo[3.3.1.1] decane chloride (active
ingredient in Dowicil®200 Preservative) with water-Product studies. The
Dow Chemical Company Report ES-704.
00071725 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: Acute Oral
LD50~Mallard Duck: Project No. 103-204. (Unpublished study received Apr
22, 1981 under 464-403; prepared by Wildlife International Ltd. and
Washington College, submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:244912-B)
00071726 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: Thirteen-day
Dietary LC50-Mallard Duck: Project No. 103-203. (Unpublished study
received Apr 22, 1981 under 464-403; prepared by Wildlife International Ltd.
and Washington College, submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:244912-C)
00074305 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: Eight-day
Dietary LC50-Bobwhite Quail: Project No. 103-202. (Unpublished study
received May 12, 1981 under 464-403; prepared by Wildlife International,
Ltd., submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:245114-A)
00093902 Carreon, R.E.; Yano, B.L.; Kociba, R.J.; et al. (1981) DowcilA(TM)_ 200:
Acute Toxicological Properties: HET K-27342-(46). (Unpublished study
received Jan 26, 1982 under 464-327; submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:246654-A)
00125029 Bailey, R.; Batchelder, T.; Rhinehart, W.; et al. (1977) Toxicity of Dowicil®75
Antimicrobial Agent and Dowicil®200 Antimicrobial Agent to Aquatic
Organisms: ES-191. (Unpublished study received Dec 29, 1977 under
464-403; submitted by Dow Chemical U.S.A., Midland, MI; CDL:232599-A)
55
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BIBLIOGRAPHY
MRID
CITATION
40545101 Linscombe, V.; Gollapudi, B. (1988) Evaluation of Cis/Trans-l-(3
Chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride in the Chinese Hamster
Ovary Cell/Hypoxanthine-guanine-phosphoribosyl Transferase (CHO/HGPRT)
Forward Mutation Assay: Laboratory Project Study ID: TXT:K-027342-064.
Unpublished study prepared by Dow Chemical Co. 22 p.
40545102 McClintock, M.; Gollapudi, B. (1988) Evaluation of Cis/Trans-l-(3
Chloroallyl)-3,5,7-triaza-l-azoniaadamatane chloride in the Mouse Bone
Marrow Micronucleus Test: Laboratory Project Study ID: TXT:K-027342-062.
Unpublished study prepared by Dow Chemical Co. 25 p.
40545103 Gollapudi, B.; McClintock, M. (1988) Evaluation of Cis/Trans-l-(3
Chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride in the Rat Hepatocyte
Unscheduled DNA Synthesis (UDS) Assay: Laboratory Project Study ID:
TXT:K-027342-063. Unpublished study prepared by Dow Chemical Co.
31 p.
40650201 Corley, R.; Cieszlak, F.; Jersey, G. (1988) Cis-Trans-CTAC: 13-week Dermal
Toxicity Study in New Zealand White Rabbits: Laboratory Project Study ID
K-27342-61: K-27342-061. Unpublished study prepared by The Dow Chemical
Co. 224 p.
41679901 Schubert, D.; Wood, D. (1990) Product Chemistry Data for Dowicil®150/100,
Per 40 CFR 158. 120: Lab Project Number: DOWICIL/150/100. Unpublished
study prepared by Dow Chemical U.S.A. 43 p.
41679902 Schubert, D. (1990) Determination of Color, Physical State and Odor of
Dowicil®150/100 Preservative: Lab Project Number: DOWICIL/150 100.
Unpublished study prepared by Dow Chemical U.S.A. lip.
41679903 Schubert, D. (1990) Physical and Chemical Characteristics of Dowcil 150/100
Per 40 CFR 158.120: Lab Project Number: DOWCIL/150/100. Unpublished
study prepared by Dow Chemical U.S.A. 4 p.
41679904 Chakrabarti, A. (1990) Vapor Pressure of DowiciMOO Measured by the
Knudsen-Effusion/Weight Loss Method: Lab Project Number:
MLAL/90/020396. Unpublished study prepared by Dow Chemical U.S.A. 10
P-
56
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MRID
BIBLIOGRAPHY
CITATION
41679905 Bonadies, J.; Reim, R. (1990) Dissociation of DowiciMOO Antimicrobial
Agent in Water: Lab Project Number: ML/AL/90/041494. Unpublished study
prepared by Dow Chemical U.S A. lip.
41679906 Heimeri, J. (1990) pH Determination of DowiciMOO Antimicrobial Agent for
Re-Registration: Lab Project Number: ML-AL/90/080692. Unpublished study
prepared by Dow Chemical USA. 7 p.
41959501 Winnett, K.; Harvey, K. (1991) Preliminary Analysis of Product Samples for
l-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride Antimicrobial Active
Ingredient: Lab Project Number: GPAR-91-60020: 91006.00. Unpublished
study prepared by Dow Chem. Co. 18 p.
41959502 Winnett, K.; Harvey, K. (1991) Validation of an Analytical Method for
Hexamethylenetetramine hydrochlide and Active Ingredient in
l-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamtane chloride Antimicrobial: Lab
Project Number: GP-AR-91-60023. Unpublished study prepared by Dow
Chem. Co. 22 p.
41959503 Winnett, K. (1991) Validation of an Analytical Method for Water and Volatile
Organic Impurities in l-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamantane
chloride Antimicrobial Active Ingredient: Lab Project Number:
GP-AR-91-60028: 91005.00. Unpublished study prepared by Dow Chem. Co.
36 p.
41959504 Walker, L. (1991) Determination of Melting Point/Melting Range of C CTAC
l-(3-chloroallyl-3,5,7-triaza-l-azoniaadamantane chloride) Lab Project
Number: ML-AL 91-020292. Unpublished study prepared by Dow Chem. Co.
8 p.
41959505 Griffin, K. (1991) Determination of Density of CTAC
(l-(3-chloroallyl)-3,5,7-Triaza-l-azoniaadamantane chloride): Lab Project
Number: ML-AL-91-020231. Unpublished study prepared by Dow Chem Co.
9 p.
42814701 Brown, R.; Kirk, H.; Richardson, C.; et al. (1993) CTAC: Evaluation of the
Acute Toxicity to the Bluegill, Lepomis macrochirus Rafinesque: Lab Project
Number: ES-2625. Unpublished study prepared by The Dow Chemical Co.
24 p.
57
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MRID
BIBLIOGRAPHY
CITATION
42814702 Brown, R.; Kirk, H.; Richardson, C.; et al. (1993) CTAC: Evaluation of the
Acute Toxicity to the Rainbow Trout, Oncorhynchus mykiss Walbaum: Lab
Project Number: ES-2624. Unpublished study prepared by The Dow Chemical
Co. 24 p.
42814703 Campbell, S.; Beavers, J. (1993) CTAC Technical: An Acute Oral Toxicity
Study with the Northern Bobwhite: Lab Project Number: 103-392:
DR-0054-34-31: ES-2608. Unpublished study prepared by Wildlife
International, Ltd. 24 p.
42814704 Campbell, S.; Beavers, J.(1993) CTAC Technical: A Dietary LC50 Study with
the Northern Bobwhite: Lab Project Number: 103-390: DR-0054-34-31:
ES-2657. Unpublished study prepared by Wildlife International, Ltd. 21 p.
42814705 Campbell, S.; Beavers, J. (1993) CTAC Technical: A Dietary LC50 Study with
the Mallard: Lab Project Number: 103-391: DR-0054-34-31: ES-2640.
Unpublished study prepared by Wildlife International, Ltd. 21 p.
43107201 Boeri, R.; Kowalski, P.; Ward, T. (1994) CTAC: Acute Toxicity to the
Silverside, Menidia Beryllina: Lab Project Number: 269-DO: ES-2684.
Unpublished study prepared by T. W. Wilbury Labs, Inc. 26 p.
43107202 Boeri, R.; Kowalski, P.; Ward, T. (1994) CTAC: Acute Flow-Through
Mollusc Shell Deposition Test: Lab Project Number: 268-DO: ES-2682.
Unpublished study prepared by T. W. Wilbury Labs, Inc. 24 p.
43107203 Boeri, R.; Kowalski, P.; Ward, T. (1994) CTAC: Acute Toxicity to the Grass
Shrimp, Palaemonetes pugio: Lab Project Number: 267-DO: ES-2683.
Unpublished study prepared by T. W. Wilbury Labs, Inc. 26 p.
43192100 The Dow Chemical Co. (1994) Submittal of Hydrolysis Data in Support of
Reregistration of Dowicil®150 Antimicrobial and Dowicil®75 Preservative,
Dowicil®100 Preservative. Transmittal of 1 study.
43192101 Gonsior, S.; West, R.; Gilbert, J. et al. (1994) The Degradation of
l-(3-Chloroallyl)-3,5,7-Triaza-l-Azoniaadamantane Chloride in Buffered
Solutions: Lab Project Number: ES-2709. Unpublished study prepared by The
Environmental Toxicology & Chemistry Research Laboratory, The Dow
Chemical Co. 73 p.
58
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BIBLIOGRAPHY
MRID CITATION
43388701 Wright, P. (1994) Letter sent to Registration Division dated September 28,
1994 regarding identification of an impurity in Dowicil®75 Preservative.
Prepared by Dow Chemical Co. 1 p.
43577601 Dow Chemical Company, Supplemental Data to Reregistration of 1-
(chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride (CTAC), February 27,
1995, Prepared by Dow Chemical Co.
59
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BIBLIOGRAPHY
MRID CITATION
60
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APPENDIX D. List of Available Related Documents
61
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62
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The following is a list of available documents related to Dowicil®CTAC. It's purpose
is to provide a path to more detailed information if it is needed. These accompanying
documents are part of the Administrative Record for Dowicil®CTAC and are included in the
EPA's Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Dowicil®CTAC RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
63
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64
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APPENDIX E. PR Notices 86-5 and 91-2
65
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66
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PR Notice 86-5
67
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68
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of pesticides.
Subject: Standard format for data submitted under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and certain provisions of the
Federal Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental Protection Agency (EPA) in a
standard format. This Notice also provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA to satisfy data
requirements for granting or maintaining pesticide registrations, experimental use permits,
tolerances, and related approvals under certain provisions of FIFRA and FFDCA. These data
are defined in FIFRA §10(d)(l). This Notice does not apply to commercial, financial, or
production information, which are, and must continue to be, submitted differently under
separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted according to this notice
may be submitted prior to the effective date. As of the effective date, submitted data packages
that do not conform to these requirements may be returned to the submitter for necessary
revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in the Federal Register
(49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32), and
Procedures for Claims of Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
4139 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality. No entitlements to data confidentiality are changed, either by the proposed
regulation or by this notice.
OPP is making these requirements mandatory through this Notice to gain resource-
saving benefits from their use before the entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements.
69
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V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3. The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages. As of the effective date of this Notice,
the screen will include in its criteria for acceptance of application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional
copy of any data submitted to the docket. Please refer to Page 10 for more information about
this requirement.
For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for the application. Typically, many
requirements are satisfied by reference to data previously submitted—either by the applicant or
by another party. That requirement is not altered by this notice, which applies only to data
submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements follows the index on the next
page, and samples of some of the requirements are attached. Except for the language of the
two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)
which cannot be altered, these samples are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be altered to reflect the
submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(l)) 8 14
D. 5 Good Laboratory Practice Compliance Statement 9 16
70
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E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for review in
support of a single regulatory action, along with a transmittal document and other related
administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as described in this Notice. The
transmittal and any other administrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then be bound separately.
Submitters sometimes provide additional materials that are intended to clarify,
emphasize, or otherwise comment to help Product Managers and reviewers better understand
the submittal.
- If such materials relate to one study, they should be included as an appendix to that
study.
- If such materials relate to more than one study (as for example a summary of all
studies in a discipline) or to the submittal in general, they must be included in the
submittal package as a separate study (with title page and statement of confidentiality
claims).
B. Transmittal Document
The first item in each submittal package must be a transmittal document. This
document identifies the submitter or all joint submitters; the regulatory action in support of
which the package is being submitted--i.e., a registration application, petition, experimental
use permit (EUPj, §3(c)(2j(B) data call-in, §6(aj(2) submittal, or a special review; the
transmittal date; and a list of all individual studies included in the package in the order of their
appearance, showing (usually by Guideline reference number) the data requirement(s)
addressed by each one. The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be included in the transmittal
document as well, if it is known to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data submittal package supporting a
registration application should be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data submittal package supporting a
petition for tolerance or an application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7 and 158.125, (petitions) or
Pesticide Assessment Guidelines, Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and an application for a
registration or an EUP, list the petition studies first, then the balance or the studies. Within
these two groups of studies follow the instructions above.
C. Individual Studies
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A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. A study should be identifiable and distinguishable
by a conventional bibliographic citation including author, date, and title. Studies generally
correspond in scope to a single Guideline requirement for supporting data, with some
exceptions discussed in section C.I. Each study included in a submittal package must be
bound as a separate entity. (See comments on binding studies on page 9.)
Each study must be consecutively paginated, beginning from the title page as page 1.
The total number of pages in the com-plete study must be shown on the study title page. In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either of the following:
- Include the total number of pages in the complete study on each page (i.e., 1 of 250,
2 of 250, ...250 of 250).
- Include a company name or mark and study number on each page of the study, e g ,
Company Name-1986-23. Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in mul-tiple volumes is permissible
so long as the entire study is pag-inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification, because they address
Guidelines of broader than normal scope or for other reasons.
a. Safety Studies. Several Guidelines require testing for safety in more than one
species. In these cases each species tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed analyses, historical control
data, and the like are often associated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the primary report, take care
to fully identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end use product and covered by
a single title page, may be bound together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data within a submittal package
submitted in support of an end-use product produced from registered manufacturing-use
products should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical product, other
manufacturing-use product, an experimental use permit, an import tolerance petition, or an
end-use product produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
equivalent subject range for biorational pesticides. The first of the three studies in a complete
product chemistry submittal for a biochemical pesticide would cover Guidelines 151-10,
151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial pesticide would cover
Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and
151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
handled as described in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3, and 153-4 are extremely
broad in scope; studies addressing residue chemistry requirements must thus be defined at a
level below that of the Guideline code. The general principle, however, of limiting a study to
the report of a single investigation still applies fully. Data should be treated as a single study
and bound separately for each analytical method, each report of the nature of the residue in a
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single crop or animal species, and for each report of the magnitude of residues resulting from
treatment of a single crop or from processing a single crop. When more than one commodity
is derived from a single crop (such as beet tops and beet roots) residue data on all such
commodities should be reported as a single study. When multiple field trials are associated
with a single crop, all such trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in the list below, in the order
indicated. (Also see Page 17.) Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the page number of this notice
where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required
Always
One of the two alternative
forms of this statement
is always required
Example
Page 12
Page 13
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
, (B),or(C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10(d)(l)(A), (B),or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA§10(d)(l)(A), (B), or (C)
D.I. Title Page
A title page is always required for each submitted study, published or unpublished.
The title page must always be freely releasable to requestors; DO NOT INCLUDE CBI ON
THE TITLE PAGE. An example of an acceptable title page is on page 12 of this notice.
The following information must appear on the title page:
a. Study title. The study title should be as descriptive as possible It must clearly identify
the substance (s) tested and correspond to the name of the data requirement as it appears in the
Guidelines.
b. Data requirement addressed. Include on the title page the Guideline number (s) of the
specific requirement (s) addressed by the study.
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c. Author (s). Cite only individuals with primary intellectual responsibility for the content
of the study. Identify them plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on the title page.
d. Study Date. The title page must include a single date for the study. If parts of the
study were performed at different times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports work done by one or more
laboratories, include on the title page the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number (s) for the work. Clearly distinguish
the laboratory's project identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on or supplement to another
previously submitted study, or if it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously submitted study,
along with the EPA Master Record Identifier (MRID) or Accession number of the earlier
study if you know these numbers. (Supplements submitted in the same submittal package as
the primary study should be appended to and bound with the primary study. Do not include
supplements to more than one study under a single title page).
g. Facts of Publication. If the study is a reprint of a published document, identity on the
title page all relevant facts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(l).
Each submitted study must be accompanied by one of the two alternative forms of the
statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)
and (c) (See Attachment 3). These statements apply only to claims of data confidentiality
based on FIFRA §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must
include the typed name and title of the official who signs it. Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claim is made that a study includes confidential business information as defined
by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by
a reference number cited within the body of the study at the point from which the passage was
excised (See Attachment 5).
The Confidential Attachment to a study must be identified by a cover sheet fully
identifying the parent study, and must be clearly marked "Confidential Attachment." An
appropriately annotated photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the body of the study, beginning
with page 1 of X on the title page. Each passage confined to the Confidential Attachment
must be associated with a specific cross reference to the page(s) in the main body of the study
on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any portion of a submitted study
other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be clearly marked in the
body or the study as subject to a claim of confidentiality.
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- A Supplemental Statement of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential and describing in detail the basis for the
claim. A list of the points to address in such a statement is included in Attachment 4
on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims must be signed and dated
and must include the typed name and title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory work subject to GLP
requirements specified in 40 CFR 160. Samples of these statements are shown in Attachment
6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page
plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
for review. This prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenTof the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform 8 1/2 by 11 inch white
paper, printed on one side only in black ink, with high contrast and good resolution. Bindings
for individual studies must be secure, but easily removable to permit disassembly for
microfilming. Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than black ink.
• Make sure that photocopies are clear, complete, and fully readable.
• Do not include oversize computer printouts or fold-out pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any attachments or
appendices, are present and in correct sequence.
Number of Copies Required - All submittal packages except those associated with a
Registration Standard or Special Review (See Part G below) must be provided In three
complete, identical copies. (The proposed regulations specified two copies; three are now
being required to expedite and reduce the cost of processing data into the OPP Pesticide
Document Management System and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Standard or Special Review
must be provided in four copies, from one of which all material claimed as CBI has been
excised. This fourth copy will become part of the public docket for the RS or SR case. If no
claims of confidentiality are made for the study, the fourth copy should be identical to the
other three. When portions of a study submitted in support or an RS or SR are claimed as
CBI, the first three copies will include the CBI material as provided in section D of this
notice. The following special preparation is required for the fourth copy.
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• Remove the "Supplemental Statement of Data Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you claim as confidential,
even if it does not fall within the scope of FIFRA §10(d)(l)(A), (B), or (C).
Do not close up or paraphrase text remaining after this excision.
• Mark the fourth copy plainly on both its cover and its title page with the phrase
"Public Docket Material - contains no information claimed as confidential".
V. For Further Information
For further information contact John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+ Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
+ Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the
type of request (e.g. experimental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-pondence with Project
Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-smittal letter. This
remains an acceptable practice so long as all four elements are included.
* Indicate which of the joint submitters is empowered to act on behalf of all joint
submitters in any matter concerning data compensation or subsequent use or
release of the data.
Company Official: Name
Signature
Company Name
Company Contact:
Name Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
Januarys, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
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Page 1 of X
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(l)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information
contained in this study on the basis of its falling within
the scope of FIFRA 6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
2. Claim of confidentiality under FIFRA §10(d)(l)(A), (B), or (C).
Information claimed confidential on the basis of its falling
within the scope of FIFRA §10(d)(1)(A), (B), or (C) has been
removed to a confidential appendix, and is cited by cross-
reference number in the body of the study.
Company:
Company Agent: Typed Name Date:.
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should note that it is OPP policy
that no permanent tolerance, temporary tolerance, or request for an emergency exemption
incorporating an analytical method, can be approved unless the applicant waives all claims of
confidentiality for the analytical method. These analytical methods are published in the FDA
Pesticide Analytical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical methods, for which confidentiality
claims have been made, to the submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information must be included within a Supplemental Statement of Data Confidentiality Claims:
• Identify specifically by page and line number (s) each portion of the study for
which you claim confidentiality.
• Cite the reasons why the cited passage qualifies for confidential treatment.
• Indicate the length of time—until a specific date or event, or permanently—for
which the information should be treated as confidential.
• Identify the measures taken to guard against undesired disclosure of this
information.
• Describe the extent to which the information has been disclosed, and what
precautions have been taken in connection with those disclosures.
• Enclose copies of any pertinent determinations of confidentiality made by EPA,
other Federal agencies, of courts concerning this information.
• If you assert that disclosure of this information would be likely to result in
substantial harmful effects to you, describe those harmful effects and explain
why they should be viewed as substantial.
• If you assert that the information in voluntarily submitted, indicate whether you
believe disclosure of this information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is
used in the study in place of
the following paragraph(s) at
the indicated volume and page
references.
DELETED WORDS OR PHRASEj. Ethylene Glycol
PAGE LINES REASON FOR THE DELETION
FIFRA REFERENCE
6 14 Identity of Inert Ingredient
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is
used in the study in place of
the following paragraph(s) at
the indicated volume and page
references.
DELETED PARAGRAPH(S):
( )
( Reproduce the deleted paragraph(s) here
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is
used in the study in place of
the following paragraph(s) at
the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Example 2.
This study does not meet the requirements of 40 CFR Part
160, and differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director
Example 3.
The submitter of this study was neither the sponsor of
this study nor conducted it, and does not know whether it
has been conducted in accordance with 40 CFR Part 160.
Submitter
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
LEGEND
• Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
* When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
•
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PR Notice 91-2
85
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86
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I ^?7 ° UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\**Af£f
V***^ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91 -2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of Pesticide Program's policy with
respect to the statement of percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient
statement on the label must be stated as the nominal concentration of such ingredient(s), as that
term is defined in 40 CFR 158.153(i). Accordingly, the Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
II. BACKGROUND
For some time the Agency has accepted two different methods of identifying on the
label what percentage is claimed for the ingredient (s) contained in a pesticide. Some applicants
claimed a percentage which represented a level between the upper and the lower certified
limits. This was referred to as the nominal concentration. Other applicants claimed the lower
limit as the percentage of the ingredient(s) that would be expected to be present in their
product at the end or the product's shelf-life. Unfortunately, this led to a great deal of
confusion among the regulated industry, the regulators, and the consumers as to exactly how
much of a given ingredient was in a given product. The Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in the active ingredient statement
be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended to encompass any such "good
manufacturing practice" variations 40 CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed in connection with a
product's registration, represent the amounts of an ingredient that may legally be present 40
CFR 158.1/5. The lower certified limit is used as the enforceable lower limit for the product
composition according to FIFRA section 12(a)(l)(C), while the nominal concentration
appearing on the label would be the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest degree of accuracy that is
warranted with respect to actual product composition because the nominal concentration would
be the amount of active ingredient typically found in the product.
It is important for registrants to note that certified limits for active ingredients are not
considered to be trade secret information under FIFRA section 10 (b). In this respect the
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certified limits will be routinely provided by EPA to States for enforcement purposes, since
the nominal concentration appearing on the label may not represent the enforceable
composition for purposes or section 12(a)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all currently
registered products as well as all applications for new registration must comply with this
Notice by specifying the nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence statements if applicable (e.g.,
elemental arsenic, metallic zinc, salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be fulfilled. Copies of the raw
analytical data must be submitted with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert ingredient, impurities of toxicological
significance (i.e., upper limit(s) only) and on a case by case basis as specified by EPA. These
limits are to be set based on representative sampling and chemical analysis (i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40 CFR 156-Labeling
Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must be changed to nominal
concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore, the certified lower limits may
not be lower then the minimum level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the public health, e.g., certain
antimicrobial and rodenticide products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established, the Agency will not accept
certified lower limits which are below that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make the registration process
more uniform and more manageable for both the agency and the regulated community. It is
the Agency's intention to implement the requirements of this notice as smoothly as possible so
as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new
chemical, or fast track (FIFRA section 3(c)(3)(B). Therefore, applicants/registrants are
expected to comply with the requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations submitted to the Agency
are to comply with the requirements of this Notice.
(2) Registrants having products subject to reregistration under FIFRA section 4 (a)
are to comply with the requirements of this Notice when specific products are
called in by the Agency under Phase V of the Reregistration Program.
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(3) All other products/applications that are not subject to (1) and (2) above will
have until July 1, 1557, to comply with this Notice. Such applications should
note "Conversion to Nominal Concentrations on the application form. These
types Or amendments will not be handled as "Fast Track" applications but will
be handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Product Specific Data Call-in
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92
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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
ofyour 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 A through G; 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 ofyour products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
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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 Grouping or End-Use Products tor Meeting Acute Toxicology Data
Requirements tor Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
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, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
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)].
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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
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 or 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
b on the Data Calf-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
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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 111-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
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)
I have made offers to cost-share (Offers to Cost Share)
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.
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Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option tor acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you choose
to enter into an agreement to share in the cost of producing the required data but will not be
submitting the data yourself, you must provide the name of the registrant who will be submitting
the data. You must also provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^), 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 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.
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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.
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 aU deficiencies in the study identified by EPA.
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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.
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(cj(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
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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).
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
UNACCEP TABLE
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)
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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.
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 3D 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
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unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data CalHn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment Z 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 Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
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Attachment 1. Chemical Status Sheet
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Dowicil®CTAC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Dowicil®CTAC.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Dowicil®CTAC. 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 Dowicil®CTAC 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 Dowicil®CTAC are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on Dowicil®CI AC are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible Dowicil®CTAC products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Dowicil®CTAC, please
contact Ron Kendall at (703) 308-8068.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Franklin Gee at (703) 308-8008.
(703) 308-8184.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Frank Rubis
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Dowicil®CTAC
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
105
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106
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes. If you are
requesting a data waiver, answer yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
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 me 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 pertainingto 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
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
108
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"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.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c) (2) (B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
109
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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.
110
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
in
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112
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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 guidelines 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, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (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 Documents 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.
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 on 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
committing to submit or provide the required data; if the required study is not
submitted on time, my product my be subject to suspension.
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 require 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.
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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.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (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.l.) apply.
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) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
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 require 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 chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
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 cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
114
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
115
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116
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No toxicology batching is required for this case.
117
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118
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Attachment 5. EPA Acceptance Criteria
119
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120
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
121
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active
ingredient and each intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at _>_
0.1% by weight and for certain toxicologically significant impurities (e.g., dioxinsV
nitrosamines) present at <0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts
Service (CAS) Registry Number for each active ingredient and, if available, for each
intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any
company assigned experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes
composition, properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in
each step and the parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1)
each impurity which may be present at _>_ 0.1% or was found at > 0.1% by product
analyses and (2) certain toxicologically significant impurities (see #3)7~
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use
a table to present the information in items 6,7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each
active ingredient and all impurities present at > 0.1%.
2. Degree of accountability or closure _>_ ca 98%7~
3. Analyses conducted for certain trace" Toxic impurities at lower than 0.1% (examples,
nitrosamines in the case of products containing dinitroanilines or containing secondary or
tertiary amines/alkanolamines plus nitrites; polyhalogenated dibenzodioxins and
dibenzofurans). [Note that in the case of nitrosamines both fresh and stored samples must
be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above
samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed
ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added
inert along with explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at _>_ 0.1% and for certain
lexicologically significant impurities at
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile
liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of
aromatic compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of
liquids reported with reference to water at 20° C. [Note: Bulk density of registered
products may be reported in lbs/ft3 or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including
those used in formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher
temperature if pressure too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25°C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
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Experimentally determined and description of procedure provided (preferred method-45
Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.T Dosing, single oral may be administered over 24 hrs.
4/ Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal
whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.^ Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.1 Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours before dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to
prevent ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on
toxicity and expected use or contains particles of inhalable size for man (aerodynamic
diameter 15 jam or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (_j^2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual
concentration of respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or
particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 2 f hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of < 2 or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until
normal or 14 days (whichever is shorter).
11.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pH of < 2 or > 11.5.
3. One oTthe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6.1 Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
132
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Attachment 6. List of All Registrants Sent This Data Call-In
(insert) Notice
133
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134
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Attachment 7. Cost Share Data Compensation Forms,
Confidential Statement of Formula Form and Instructions
135
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136
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138
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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
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.
139
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140
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P/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
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-223, 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:
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
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 firm(s) 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
Dale
Name and Title (Please Type or Print)
EPA Form 8570 32 (5/91) Replaces EPA Form 8580. which is obsolete
141
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142
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
\
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 a nd 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.
Product Name
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)(Fj 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
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
Name and Title (Please Type or Print)
143
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144
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APPENDIX G. FACT SHEET
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-016
April 1995
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Dowicil®CTAC
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 3069, Dowicil®CTAC.
Dowicil®CTAC is used as a microbicide/microbistat for secondary oil
injection water-water treatment and as a preservative for industrial adhesives
and coatings; resin/latex/polymer emulsions; metalworking cutting fluids;
oil recovery drilling muds/packer fluids; latex(in-can) paints; specialty
industrial products; textiles/textile fibers/cordage; and wet-end
additives/industrial processing chemicals.
The case Dowicil®CTAC contains the two active ingredients
Dowicil®75 and Dowicil®150. The active ingredient Dowicil®75 contains
both the cis-(. 53%) and the trans-(. 44%) isomers of l-(3-chloroallyl)-
3,5,7-triaza-l-azoniaadamantane chloride. The active ingredient
Dowicil®150 contains only the cis-isomer of l-(3-chloroallyl)-3,5,7-triaza-l-
azoniaadamantane chloride.
Regulatory
History
A pesticide product containing Dowicil®150 was first registered in the
United States in 1964 as a microbicide/microbistat. A second registration,
for Dowicil®75, was granted in 1972 for use as a preservative for paints,
latexes, metalworking lubricants, and other industrial formulations to
prevent deterioration from bacteria and fungi.
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Human Health
Assessment
The food additive use of Dowicil®CTAC to preserve adhesives, resins,
pulp, and paperboard that contact foods is regulated by the Food and Drug
Administration (please see 21 CFR Sections 175.105, 176.1680, 176.170,
and 176.180).
In 1987, EPA issued the Antimicrobial Data Call-In (DCI) Notice to
obtain chronic and subchronic toxicity data for Dowicil®CTAC and other
antimicrobials. The Agency issued a second DCI under reregistration Phase
4 in March 1992, requiring the registrant to provide chemistry, toxicology,
and environmental fate data on these active ingredients to support
reregistration.
Toxicity
In laboratory animal studies measuring acute toxicity, technical grade
Dowicil®CTAC has been shown to cause moderate effects by the dermal
route, placing it in Toxicity Category II (the second-highest of four
categories) for dermal toxicity. It has been shown to produce slight
irritation in eye and dermal irritation studies, placing it in Toxicity Category
III for eye irritation and Toxicity Category IV for skin irritation. It is
slightly toxic in oral toxicity studies, placing it in Toxicity Category III for
oral toxicity. In an acute inhalation study, Dowicil®CTAC was found to be
slightly toxic, placing it in Toxicity Category IV. This chemical is not a
skin sensitizer based on studies using guinea pigs.
A 90-day dermal toxicity study in rabbits established the NOEL for
systemic toxicity as 1000 mg/kg/day.
Dowicil®CTAC was mutagenic in the in vitro Chinese hamster ovary
cell HGPRT forward mutation assay with activation, but was nonmutagenic
without activation. It was negative in two other mutagenicity studies.
Dietary Exposure
No dietary exposure is expected from the pesticide uses of
Dowicil®CTAC since no food or feed uses are registered.
Occupational and Residential Exposure
Due to its low toxicity and the lack of a toxicological endpoint of
concern, an exposure assessment was not required for Dowicil®CTAC.
However, formaldehyde is released when Dowicil®CTAC decomposes in
aqueous solution. EPA is concerned because formaldehyde has been
classified as a Group Bl "probable human carcinogen."
The potential for exposure to Dowicil®CTAC and/or formaldehyde
exists for occupational workers involved in the industrial setting and for
individuals in the home setting. For residential uses, the Agency has
determined that potential exposure to Dowicil®CTAC is minimal. For
industrial uses, most workers' exposure to Dowicil®CTAC is low because of
current use patterns. In addition, workers in industrial settings are protected
by the Occupational Safety and Health Administration's (OSHA's)
comprehensive workplace standard for formaldehyde, with a permissible
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Environmental
Assessment
exposure level (PEL) of .75 ppm in the workplace. EPA has notified
OSHA of Dowicil®CTAC's potential to release formaldehyde and OSHA
has agreed to include these products in their workplace monitoring program.
Since Dowicil®CTAC causes moderate acute dermal toxicity (Toxicity
Category II), EPA is requiring that labels contain a statement advising
workers to wear chemical resistant gloves for open-pouring of the end-use
product.
Human Risk Assessment
Since Dowicil®CTAC has no food or feed uses, dietary risk is not
expected. The chemical causes moderate acute dermal toxicity. Therefore,
to protect applicators' skin during open pouring of end-use products, EPA is
requiring appropriate label precautions regarding use of protective clothing
(chemical resistant gloves). Although Dowicil®CTAC releases
formaldehyde in aqueous solutions, minimal risk is expected in residential
settings. Occupational risks are low due to the chemical's use pattern and
because OSHA will monitor workers' exposure to formaldehyde during
industrial uses of Dowicil®CTAC. No human health risk of concern is
therefore expected.
Environmental Fate
Dowicil®CTAC dissipates by abiotic hydrolysis. It is not persistent
and degrades rapidly under acidic conditions. Under neutral to alkaline
conditions, it degrades more slowly.
Ecological Effects
Both Dowicil®75 and Dowicil®150 are practically nontoxic to slightly
toxic to birds, fish, aquatic invertebrates, and terrestrial animals.
Ecological Effects Risk Assessment
The use patterns of Dowicil®CTAC result in minimal risk to terrestrial
organisms. Risk to nontarget aquatic organisms can be expected through
point source discharge of industrial microbicides. In the case of
Dowicil®CTAC, there are several use sites and environmental conditions
where exposure to aquatic organisms is a distinct possibility.
Based on Agency calculations using an exposure model, the chronic
level of concern (LOG) for aquatic species is exceeded in both typical and
high exposure scenarios for wet-end additives/industrial processing
chemicals and oil recovery drilling muds/packer fluids. The acute LOG is
exceeded in high exposure scenarios for all five use patterns examined.
Endangered aquatic species also are at risk under both typical and high
exposure scenarios.
It is important to note, however, that the Agency's calculations likely
overestimate the actual concentrations which would be found in the
environment. Also, discharge levels are governed by NPDES permits
granted by state regulatory agencies and EPA. Based on its rapid hydrolysis
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and use sites, no additional environmental fate date are required for
Dowicil®CTAC.
Additional Data
Required
Product Labeling
Changes
Required
Regulatory
Conclusion
For More
Information
EPA is requiring product-specific data including product chemistry
efficacy data, revised Confidential Statements of Formula (CSFs), and
revised product labeling for reregistration of products containing
Dowicil®CTAC.
The labels of all registered pesticide products containing
Dowicil®CTAC must comply with EPA's current pesticide labeling
requirements. In addition:
Effluent Discharge Statement - All end-use (and manufacturing use)
products that may be contained in an effluent discharged to the waters of the
U.S. or municipal sewer systems must bear the following statement:
"This product is toxic to fish. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or other
waters unless in accordance with requirements of the National
Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge.
Do not discharge effluent containing this product to sewer systems
without previously notifying the local sewage treatment plant
authority. For guidance contact your State Water Board or Regional
Office of EPA."
Handler PPE for Occupational-Use Products - The minimum
(baseline) personal protective equipment (PPE) for handlers engaged in open
pouring of Dowicil®75 and Dowicil®150 is chemical-resistant gloves.
The use of currently registered pesticide products containing
Dowicil®CTAC in accordance with approved labeling will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
These Dowicil®CTAC products will be reregistered once the required
product-specific data, revised Confidential Statements of Formula, and
revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Dowicil®CTAC during a 60-day time period,
as announced in a Notice of Availability published in the Federal Register.
To obtain a copy of the RED or to submit written comments, please contact
the Pesticide Docket, Public Response and Program Resources Branch,
Field Operations Division (7506C), Office of Pesticide Programs (OPP),
US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
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703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA. GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the Dowicil®CTAC RED document
also will be available from the National Technical Information Service
(NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
703-487-4650.
For more information about EPA's pesticide reregistration program,
the Dowicil®CTAC RED, or reregistration of individual products containing
Dowicil®CTAC, please contact the Special Review and Reregistration
Division (7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 8:00 pm Eastern Standard
Time, Monday through Friday.
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