United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-93-024
December 1993
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
2-[(Hydroxymethyl)-
aminolethanol
All pesticides sold or used 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 2-
[hydroxymethyl)amino]ethanol.
2-[hydroxymethyl)amino]ethanol is a bacteriostat and fungicide used
as an industrial preservative to prevent bacterial and fungal deterioration of
water-based products including latex paints and adhesives, metalworking
cutting oil fluids, resin emulsions, specialty industrial products and ready-
mixed joint cements. 2-[hydroxymethyl) aminojethanol products are
formulated as soluble and emulsifiable concentrates and liquids. They are
added to industrial products during the manufacturing process using
pouring and pumping methods.
Regulatory 2-[hydroxymethyl)amino]ethanol was first registered hi the United
History States hi 1970 for use as an industrial preservative, and currently is used in
the manufacture of many water-based industrial products. Three pesticide
products are registered which contain this active ingredient.
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Human Toxicity
2-[hydroxymethyl)amino]ethanol generally is of moderate to low
acute toxicity but is a severe eye irritant. It has been placed in Toxicity
Category I, indicating the greatest degree of acute toxicity, for eye effects.
It has been placed in Toxicity Category III for oral, inhalation and dermal
toxicity, and hi Toxicity Category IV, indicating the lowest degree of acute
toxicity, for skin effects. A dermal sensitization study must be submitted
as confirmatory data.
A subchronic toxicity study using rats showed skin reactions hi males
and females at all dose levels, with more severe reactions hi females.
A developmental toxicity study using rats showed a developmental no
observed effect level (NOEL) greater than the highest dose tested. A
maternal NOEL and LOEL were established based on reduced body weight
gain and food consumption, as well as gastrointestinal abnormalities.
This chemical shows some weak evidence of mutagenicity, and two
additional mutagenicity studies are being required as confirmatory data.
Dietary Exposure
2-[hydroxymethyl)amino]ethanol has no registered food or feed uses.
Therefore, no dietary exposure is expected to result from its use as a
pesticide.
Occupational and Residential Exposure
2-[hydroxymethyl)amino]ethanol pesticides are added to industrial
products during the manufacturing process using pour liquid and pump
liquid application methods. During these processes, exposure to workers is
expected. Further, 2-[(hydroxymethyl)amino]ethanol degrades over time to
form ethanolamine and formaldehyde; the latter poses worker exposure
concerns. However, exposure to the parent compound is low, and the
conditions and likelihood of degradation so slight that exposure to
mixers/loaders/applicators and post-application workers would be minimal.
Human Risk Assessment
No food uses of 2-[(hydroxymethyl)ammo]ethanol are registered;
therefore no dietary risks are posed. The potential for occupational
exposure and risk are minimal, provided that protective eyewear and
chemical resistant gloves are used, as required by this RED. The
industrial preservative uses, which involve pouring and pumping
application methods, could involve worker exposure to formaldehyde, a
degradation product of concern. However, based on the conditions of use
and the low exposure associated with the parent compound, exposure of
workers or the general public to formaldehyde is not expected.
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Environmental
Assessment
Environmental Fate
The results of a hydrolysis study indicate that 2-[(hydroxymethyl)
amino]ethanol rapidly degrades in aqueous solutions to ethanolamine and
formaldehyde. Therefore, environmental exposure to the parent compound
is expected to be minimal. This study must be repeated, however, as
confirmatory data.
Ecological Effects
2-[(hydroxymethyl)amino]ethanol is slightly toxic to upland game
buds, bobwhite quail, on an acute oral and a dietary basis. The chemical
is slightly toxic to fish and aquatic invertebrates.
Ecological Effects Risk Assessment
2-[(hydroxymethyl)amino]ethanol is only slightly toxic to avian and
aquatic organisms, and it rapidly degrades in the environment. When this
chemical is used according to the label, minimal exposure to the
environment from the parent compound or its degradates should occur.
Therefore, risk to nontarget organisms is expected to be minimal.
Additional Data
Required
EPA is requiring additional dermal sensitization, mutagenicity and
hydrolysis studies as confirmatory data. The Agency also is requiring
product-specific data including product chemistry and acute toxicity
studies, revised Confidential Statements of Formula (CSF), and revised
product labeling for reregistration of products containing 2-
[(hydroxymethy l)amino] ethanol.
Product Labeling
Changes Required
The labeling of all end-use and manufacturing use products
containing 2-[(hydroxymethyl)amino]ethanol must comply with EPA's
current pesticide labeling requirements. In addition:
• Personal Protective Equipment (PPE) Requirements
Since mixers/loaders/applicators could be exposed during pouring and
pumping application methods, PPE (goggles, eye shield or face shield and
chemical resistant gloves) is required to prevent eye irritation.
• Environmental Hazard Statements
The following effluent discharge statements must appear on product labels:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters, including near marine or
estuarine habitats, 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
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previously notifying the local sewage treatment plant authority. For
guidance contact your State Water Board or Regional Office of the EPA."
Regulatory
Conclusion
For More
Information
The use of registered industrial preservative products containing 2-
[(hydroxymethyl)amino]ethanol will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration. These products will be reregistered
once the required confirmatory generic data, product-specific data,
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 2-[(hydroxymethyl)amino]ethanol during a
60-day time period, as announced in a Notice of Availability published hi
the Federal Register. To obtain a copy of the RED document 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.
Following the comment period, the 2-[(hydroxymethyl)amino]ethanol
RED document 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 2-[(hydroxymethyl)amino]ethanol RED, or reregistration of individual
products subject to this RED, 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, 8:00 am to 6:00 pm Central
Time, Monday through Friday.
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REREGISTRATION ELIGIBILITY DECISION
2-[(HYDROXYMETHYL)AMINO]ETHANOL
LISTC
CASE 3070
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
2-[(HydroxymethyI)amino]ethanol REREGISTRATION ELIGIBILITY DECISION
TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY iv
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History 3
m. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity 5
c. Developmental Toxicity 6
d. Mutagenicity 6
2. Exposure Assessment 6
a. Dietary Exposure 6
b. Occupational and Residential Exposure 7
3. Risk Assessment 10
a. Dietary 10
b. Occupational and Residential 10
C. Environmental Assessment 10
1. Environmental Fate 10
a. Environmental Chemistry, Fate and Transport 10
2. Ecological Effects 11
a. Ecological Effects Data 11
b. Ecological Effects Risk Assessment 12
3. Endangered Species 12
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 12
A. Determination of Eligibility 12
1. Eligibility Decision / Eligible and Ineligible Uses 13
V. ACTIONS REQUIRED BY REGISTRANTS 13
A. Manufacturing-Use Products 13
1. Additional Generic Data Requirements 13
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2. Labeling Requirements for Manufacturing-Use Products .... 13
-B. End-Use Products 14
1. Additional Product-Specific Data Requirements 14
2. Labeling Requirements for End-Use Products . , 15
C. Existing Stocks 15
VI. APPENDICES 17
APPENDIX A. Table of Use Patterns Subject to Reregistration 19
APPENDIX B. Table of the Generic Data Requirements and Studies Used
to Make the Reregistration Decision 23
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of 2-[(Hydroxymethyl)amino]ethanol 29
APPENDIX D. List of Available Related Documents 37
APPENDIX E 41
PR Notice 86-5 43
PR Notice 91-2 63
APPENDIX F. Generic Data Call-In 69
Attachment 1. Chemical Status Sheet 89
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 93
Attachment 3. Requirements Status and Registrants1 Response Forms
Inserts (Form B) plus Instructions 98
Attachment 4. List of Registrants) sent this DCI (Insert) 105
APPENDIX G. Product Specific Data Call-In 107
Attachment 1. Chemical Status Sheet 123
Attachment 2. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions 127
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 131
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 137
Attachment 5. EPA Acceptance Criteria 141
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice 155
Attachment 7. Cost Share Form, Data Compensation Form,
Confidential Statement of Formula Form, and Instructions for
the Confidential Statement of Formula 157
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2-[(Hydroxymethyl)amino]ethanol REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Cynthia Szymanski
Eric Maurer
Environmental Fate and Effects Division
Jean Holmes
Mike Rexrode
James Breithaupt
Health Effects Division
Winston Dang
Linda Kutney
Pat McGlaughlin
Registration Division
Doreen Aviado
Valdis Goncarovs
Amelia Acierto
Ian Blackwell
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Occupational and Residential Exposure Branch
Chemical Coordination Branch
Toxicology Branch n
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Special Review and Rerepistration Division
Mark Wilhite
Bruce Sidwell
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Policy and Special Projects Staff
Carol Peterson
Office of Compliance Monitoring:
Phyllis Flaherty
Office of General Counsel:
Kevin Lee
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
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
GRAS Generally Recognized As Safe as designated by FDA
HDT Highest Dose Tested
Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death hi 50% of test animals. It is usually expressed
as the weight of substance per weight or volume of water, air or feed, e.g. , mg/1,
mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death hi 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.
LD,0 Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOEL Lowest Observed Effect Level
MP Manufacturing-Use Product
n
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GLOSSARY OF TERMS AND ABBREVIATIONS
MPI Maximum Permissible Intake
MOE Margin Of Exposure (PAD)
MRID Master Record Identification (number). EPA1 s system of recording and tracking
studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q*, The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RED Reregistration Eligibility Decision
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TMRC Theoretical Maximum Residue Contribution.
in
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency, hereafter referred to as the "Agency", has
completed its reregistration assessment of the available data and scientific literature on the
pesticide active ingredient 2-[(Hydroxymethyl)amino]ethanol.
This Reregistration Eligibility Decision document (RED) addresses the eligibility for
reregistration of products containing 2-[(Hydroxymethyl)amino]ethanol as an active ingredient.
2-[(Hydroxymethyl)amino]ethanol is a bacteriostat and fungicide used as an industrial preservative
to prevent bacterial and fungal deterioration of water-based products including latex paints and
adhesives, metalworking cutting oil fluids, resin emulsions, specialty industrial products and
ready-mixed joint cements. The Agency has determined that the uses of 2-
[(Hydroxymethyl)amino]ethanol as currently registered will not cause unreasonable risk to
humans or the environment and these uses are eligible for reregistration. However, the Agency
is requiring additional data on dermal sensitization, mutagenicity and hydrolysis, as confirmatory.
Before reregistering products containing 2-[(Hydroxymethyl)amino]ethanol, 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 hi accordance with Section 3(c)(5) of
FIFRA, the Agency will reregister eligible products. However, 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.
IV
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I. INTRODUCTION
jr
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 reregistration" before calling in data
on products and either reregistering products or taking other appropriate regulatory action. Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from
the currently registered uses of the pesticide; to determine the need for additional data on health
and environmental effects; and to determine whether the pesticide meets the "no unreasonable
adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of 2-[(Hydroxymethyl)amino]ethanol. The document consists of six sections.
Section I is the introduction. Section II describes 2-[(Hydroxymethyl)amino]ethanol, its uses, data
requirements and regulatory history. Section III discusses the human health and environmental
assessment based on the data available to the Agency. Section IV presents the Agency's decision.
Section V discusses reregistration requirements. 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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H. CASE OVERVIEW
jr
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
Chemical Name: 2-[(Hydroxymethyl)ammo]ethanol
CAS Registry Number: 34375-28-5
OPP Chemical Code: 099001
Empirical Formula: C3H902N
Structural Formula: H
I
HOCH^-CH2CH2OH
Molecular Weight 91
Trade and Other Names: Troysan 174, Troysan 364, Nuosept 91
Basic Manufacturers: Troy Chemical Corporation
Huls America Inc.
B. Use Profile
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of these uses of 2-
[(Hydroxymethyl)ammo]ethanol is hi Appendix A.
Type of Pesticide: Bacteriostat (Industrial preservative); Fungicide (fungistat-
mildewstat)
Use Sites: INDOOR NON-FOOD: Incorporated as a preservative in
the manufacture of adhesives, metalworking cutting fluids,
oil recovery drill muds, packer fluids, latex paints, resin
emulsions, specialty industrial products (dispersed colors,
pigment dispersions) and ready-mix joint cements.
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Target Pests: Deterioration/Spoilage Bacteria; Mold/Mildew
*
Formulation Types Registered: TYPE:
Soluble concentrate/liquid; liquid; emulsifiable concentrate.
FORM:
Technical grade active ingredient/end use; end use only.
Method and Rates of Application:
Equipment - Not Specified
Method and Rate -
Industrial preservative treatment; preservative treatment;
equipment treatment. 105 - 2910 ppm a.i.
Timing - During manufacture; not specified on label.
Use Practices Limitations:
Use with adequate ventilation. Not suitable for use in
products with a pH below 3. NPDES permit required. Do
not discharge effluent containing this product to sewer
systems without previously notifying the sewage treatment
plant authority.
C. Regulatory History
The active ingredient 2-[(Hydroxymethyl)amino]ethanol was first registered in the
United States hi 1970 for use as an industrial preservative against bacterial and fungal
deterioration. It is used in the manufacture of water-based products including latex
adhesives, resin emulsions, latex paints, dispersed colors, ready-mix joint cements and
cutting oil fluids.
There are currently three products registered containing 2-[(Hydroxymethyl)
amino] ethanol (Troysan 174, Troysan 364 and Nuosept 91M). Product concentrations
range from 21% to 99.95% active ingredient. Normal use levels for these products range
from 0.05% to 0.30 % after final dilutions, based on the total weight of the formulation.
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SCIENCE ASSESSMENT
*
A. Physical Chemistry Assessment
• Chemical name
• Color
• Physical State
• Odor
• Boiling Point
• Density
• Solubility
• Vapor Pressure
• Dissociation Constant
. pH
• Stability
Storage Stability
2-[(Hydroxymemyl)amino]ethanol
clear, amber @ 20°C
liquid @ 20°C
sharp, amine odor
110°C
1.1545g/ml@25°C
@ 25°C ±0.5°C in octanol, 23.6 ±0.7
g/100 ml; completely miscible in water and
isopropanol
16.4 mm @ 25°C
8.5 ±0.2 @ 25°C
10.66, 1% solution
Stable for 14 days under the following
conditions: ambient temperature (about
23 °C); simulated sunlight; mixed with
aluminum, galvanized steel, stainless steel
metals or zinc ions. Apparently, slightly
affected by exposure to iron (HI) ions and a
marginal loss with exposure to aluminum
ions.
Stable for one month @ 4°C and 50°C and
for 3 months at room temperature.
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B.
Human Health Assessment
1. Toxicology Assessment
The lexicological database on 2-[(Hydroxymethyl)amino]ethanol is
adequate and will support reregistration.
a.
Acute Toxicity
ACUTE TQXICITY SUMMARY
TEST
Oral LDjo - rat*
Inhalation LC^ - rat
Dermal LDso - rat*
Eye effects - rabbit
Skin effects - rabbit*
RESULT
m 1626; f 1422 mg/kg
0.62 mg/L
> 2000 mg/kg
severe irritation
non-irritating
CATEGORY
m
ra
m
I
rv
* The test substance for these studies was 50% 2-[(Hydroxymethyl)amino]ethanol in an innocuous
substrate.
The LCjo found in an acute inhalation test in rats was 0.62 mg/L
(MRID 41925401). An eye irritation study in rabbits found severe
irritation and corneal opacity, some lasting for 21 days (MRID 40327501).
These two studies were conducted with 100% 2-[(Hydroxymethyl)amino]
ethanol.
In a series of studies conducted with 50% 2-[(Hydroxymethyl
(amino)]ethanol hi an innocuous substrate, an acute oral toxicity test in rats
found an LD^ of 1422 mg/kg for females and 1626 mg/kg for males
(MRID 41850601). The dermal LD^ was greater than 2000 mg/kg in rats
(MRID 41 850602) . A primary dermal irritation study with rabbits showed
no irritation (MRID 41850604). A dermal sensitization study with 2-
[(Hydroxymethyl)amino] ethanol must be submitted to fill the requirements
for confirmatory data.
b. Subchronic Toxicity
2-[(Hydroxymethyl)amhio]ethanol was used hi a 90-day dermal
study with Sprague-Dawley rats. Test compound of 98.5% purity was
diluted with water to give a dose of 0, 50, 250, or 1000 mg/kg/day.
There were skin reactions, including inflammation, dermal fibres is,
epithelial hyperplasia, and ulceration, in males and females at all dose
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levels, with more severe reactions in females. There were no other effects
related to test article administration. The NOEL and LOEL for systemic
effects were greater than 1000 mg/kg/day, which was the highest dose
tested (MRID 41586901).
c. Developmental Toxicity
In a developmental toxicity study, Sprague-Dawley rats were given
0, 100, 250, or 500 mg/kg/day of this chemical by gavage on days 6-16
of gestation. The developmental NOEL was greater than 500 mg/kg/day,
the highest dose tested. The maternal NOEL was 250 mg/kg/day and the
LOEL was 500 mg/kg/day, due to reduced body weight gain and food
consumption along with gastrointestinal abnormalities (MRID 41604601).
d. Mutagenicity
An Ames test in Salmonella tvphimurium with 57.58% 2-
[(Hydroxymethyl)amino] ethanol in an innocuous substrate found weak
mutagenic activity hi the TA100 strain. However, there was no mutagenic
activity in four other strains of S^ tvphimurium (TA98, TA1535, TA1537,
and TA1538), with or without metabolic activation (MRID 41850101). In
another Ames study, 98% pure 2-[(Hydroxymethyl)amino]ethanol was
mutagenic in the TA100 strain of S.. tvphimurium and one strain
[WP2uvrA"(pKM101)] of Escherichia coli. with or without metabolic
activation. It was not, however, mutagenic in the TA98, TA1535,
TA1537, and TA1538 strains of ^ty^himunum (MRID 42001501). This
compound was found to be mutagenic when tested in L5178Y mouse
lymphoma cells, with or without metabolic activation (MRID 42293801).
A mutagenicity data gap was identified for initial testing for in vivo
bone marrow cytogenetics (e.g., aberration or micronucleus test). Also, as
follow-up for positive tests in two gene mutation assays, a test for
interaction with germ cell DNA is required, (e.g., aberration in
spermatagonia and/or spermatocytes; UDS in germ cells; or DNA binding
studies). Both of these mutagenicity tests are considered required but
confirmatory.
2. Exposure Assessment
a. Dietary Exposure
2-[(Hydroxymethyl)amino]ethanol is not used on food, feed or
processed commodities; therefore dietary exposure is not expected.
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b. Occupational and Residential Exposure
There are three major products containing the active
ingredient 2-[(hydroxymethyl)amino]ethanol: 1) Troysan 174 (EPA Reg.
No. 5383-11) containing 97% active ingredient, 2) Troysan 364 (EPA
Reg. No. 5383-47) containing 21 % active ingredient, and 3) Nuosept 91M
(EPA Reg. No. 1100-86) containing 99.5% active ingredient.
2-[(Hydroxymethyl)amino]ethanol is used as a bacteriostat and
mildew inhibitor (e.g. as an in-process preservative) in the manufacture of
aqueous adhesives, as a treatment for in-plant maintenance of non-food
process equipment, as a preservative for aqueous cutting oil compositions,
or to provide in-can preservative properties for adhesives, paints, etc.
2-[(Hydroxymethyl)amino]ethanol is used in all products where
water is a primary component. Normal use levels range from 0.1% to
0.3% based on the total weight of the formulation. 2-
[(Hydroxymethyl)amino]ethanol is a liquid, so the pour liquid and pump
liquid application methods have been used to estimate exposures to this
substance.
Since 2-[(hydroxymethyl)amino]ethanol is used in industrial
systems, worker exposure to workers is expected. 2-[(Hydroxy
methyl)amino]ethanol meets EPA's criteria for mixer/loader/ applicator
exposure monitoring data requirements, data for which have been
submitted in the Chemical Manufacturers Association (CMA)
Antimicrobial Exposure Assessment Study. (The registrant is a member
of the CMA Antimicrobial Exposure Assessment Group).
2-[(Hydroxymethyl)amino]ethanol degrades over time to form
ethanolamine and formaldehyde. There are potential worker exposure
concerns to the degradation products, primarily formaldehyde.
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Worker exposure estimates are presented in the following tables.
TABLE 1: A Summary of Mixer/loader/Applicator Exposure to 2-
[(Hydroxymethyl)amino]ethanol at the Significant Work Sites
PRODUCT
Troysan 174
Troysan
174
Troysan
174
Troysan
174
USE SITE
Preservative
(adhesives)
Preservative
(cutting fluid)
Preservative
(adhesives)
Preservative
(cutting fluid)
APPLICATION
METHOD
Pour Liquid
Pour Liquid
Pump Liquid
Pump Liquid
ROUTE OF
EXPOSURE
I,D
I,D
I,D
I,D
ADE*
(mg/kg/d)
9.99xlO-3
3.08xlO'3
0.77xlO-3
14.46xlO-3
Footnotes:
Route Of Exposure; D = Dermal, I = Inhalation
* ADE = Amortized Average Daily Exposure
TABLE 2. Detailed Mixer/loader/applicator Exposure Determination for Troysan 174 (EPA
Reg. No. 5383-11) by Open Pouring Liquid Application Method.
POUR LIQUID
Setting
Preser-
vative
Cutting
Fluid
MCS*
(ug/lb. a.i.)
130
100
Ibai/
used
7.86
7.86
Ibai/
yr
1964
786
BW
(kg)
70
70
Daily
Exposure
(ug/kg/d)
14.60
11.23
Annual
Exposure
(ug/kg/yr)
3,647.43
1,122.86
ADE
(ug/kg/d)
9.99
3.08
MCS Maximum Credible Sum (ug/lb a.i.) from CMA Study.
BW = Body Weight (Average adult body weight, 70 kg)
ADE = Amortized Average Daily Exposure
Assumptions for Tables 2 and 3:
8
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Assume 300 gallons of adhesives, or latex paint, or cutting fluids were treated with the
maximum application rate (0.3 %) based on the total weight of the formulation (equivalent
to 7.86 Ib of a.i. per 300 gallons of product). Assume the number of applications were
250 uses per year for adhesives, and 100 uses for cutting oil.
TABLE 3. Detailed Mixer/loader/applicator Exposure Determination for Troysan 174 (EPA
Reg. No. 5383-11) by Pump Liquid Application Method.
PUMP LIQUID
Setting
Preservative
Cutting Fluid
MCS*
( (ug/lb. ».i.)
10
470
Ibai/
used
7.86
7.86
Ibai/
yr
1964
786
BW
(kg)
70
70
Daily
Exposure
(ug/kg/d)
1.12
52.77
Annual
Exposure
(ug/kg/yr)
280.57
5,277.43
ADE
(ug/kg/d)
0.77
14.46
MCS Maximum Crec
ible Sum (ug/lb a.i.) from CMA Study.
BW = Body Weight (Average adult body weight, 70 kg)
ADE = Amortized Average Daily Exposure
Assumptions are the same as for Table 2.
Applicator/Post-Application Worker Exposure
The mixer/loader/applicator exposure summarized above represents a
worst-case scenario because the maximum use rate was used for all of the use
patterns for this compound. The exposure to 2-[(hydroxymethyl)amino]ethanol is
low. Preservatives are used to extend the shelf life of paints and adhesives, and
metal cutting fluids. Although they eventually degrade, the degradation is not
rapid or the preservative would have no usefulness. Although there is potential
for an initial exposure to the degradation products, ethanolamine and
formaldehyde, adverse human health effects from this acute exposure are not
expected. The exposure to the parent compound 2-[(hydroxymethyl)
aminojethanol is low and the conditions and likelihood for degradation so slight
that the exposure to mixer/loader/applicators and post-application workers would
be minimal.
The worker exposure will be reevaluated pending the results of the
hydrolysis study on 2-[(hydroxy methyl)amino]ethanol required based on the
Environmental Fate Assessment.
-------
3. Risk Assessment
a. Dietary
There are no registered food or feed uses of 2-
[(Hydroxymethyl)amino]ethanol, and therefore, dietary exposure or risk
from 2-[(Hydroxymethyl)amino]ethanol is not expected.
b. Occupational and Residential
One eye irritation study in rabbits (conducted with 100% a.i.)
demonstrated severe eye irritation and corneal opacity lasting for 21 days
(MRID 40327501). The potential for occupational (mixer/loader/
applicator) exposure or risk from 2-[(Hydroxymethyl)amino]ethanol is
minimal provided that appropriate protective eyewear and gloves are used.
Therefore, a restriction requiring protective eyewear and chemical resistant
gloves must be included on all labels.
There are no special exposure or risk concerns for the post-
application workers, consumers or residential occupants who are not likely
to be exposed to products containing 2-[(Hydroxymethyl)amino]ethanol.
2-[(Hydroxymethyl)amino]ethanol degrades over time to form
ethanolamine and formaldehyde. There are potential risk concerns
associated with the degradation product, formaldehyde; however, based
on the uses, the conditions of use and the low exposures associated with
^ the parent compound, adverse human health risk concerns resulting from
the presence of formaldehyde are not expected.
The worker exposure and risk will be reevaluated pending the
results of the hydrolysis study on 2-[(hydroxymethyl)amino]ethanol
required based on the Environmental Fate Assessment.
C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
A hydrolysis study is required for industrial microbiocides hi which
effluents are potentially discharged into aquatic environments. This study
will determine if and under what conditions the pesticide degrades in
aqueous solution and identifies any significant environmental degradation
products if degradation occurs.
10
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The results of the hydrolysis study submitted suggest that 2-
[(hydroxymethyl)amino]ethanol, the parent compound, rapidly degrades in
pH 5, 7, and 9 aqueous solutions. The primary degradates, ethanolamine
and formaldehyde, represent approximately 100% of the applied parent
compound hi this study. Therefore, based on the use pattern and the results
of the hydrolysis study, environmental exposure to 2-
[(hydroxymethyl)amino]ethanol is expected to be minimal However, this
study must be repeated, since the initial samples are believed to have been
contaminated. A new study will allow the Agency to confirm the
assumptions used in the worker exposure risk assessment.
2. Ecological Effects
a. Ecological Effects Data
There are enough ecotoxicological data to characterize the toxicity of
2-[(hydroxymethyl)amino]ethanol to nontarget terrestrial and aquatic
organisms. The avian toxicity of the technical grade (TGAI) of 2-
[(hydroxymethyl)amino]ethanol was found to be slightly toxic to upland
game birds, bobwhite quail, both on an acute oral basis (LD5o=1743
mg/kg, MRID 42109701) and on a dietary basis (LC^ 3755 ppm, MRID
42472501).
The bobwhite quail dietary UCX study with technical 2-
[(hydroxymethyl)amuio]ethanol was deemed supplemental because it failed
to test up to 5000 ppm and failed to establish an LC^. This deficiency
does not decrease the value of the study to show that technical 2-
[(hydroxymethyl) amino]ethanol is no more than slightly toxic to birds.
Acute aquatic testing with fish and aquatic invertebrates shows that
this chemical is slightly toxic to these organisms. Due to 2-
[(hydroxymethyl)amuio]ethanol' s use pattern, chronic fish and invertebrate
studies are not required. The rainbow trout test with technical 2-
[(hydroxymethyl)amino]ethanol indicates only slight toxicity (LC^^O.S
ppm, MRID 42595402). This study was supplemental because of marked
variation in the measured test concentrations compared to the nominal test
levels. However, since no fish died at the maximum measured test
concentration of 60.3 ppm, it indicates that technical 2-[(hydroxymethyl)
aminojethanol is no more than slightly toxic to fish. The results of an
acute study using Daphnia magna as the test species indicates that this
chemical is slightly toxic to freshwater aquatic invertebrates (EC50=25 2
ppm, MRID 42595401).
11
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No estuarine or marine testing was provided or reviewed. These
studies are not required. Likewise, testing with plants and beneficial
insects (bees) is not required for these use patterns because minimal
exposure is anticipated.
b. Ecological Effects Risk Assessment
The ecological effects risk assessment for 2-[(hydroxymethyl)
aminojethanol supports this chemical's eligibility for reregistration. The
laboratory data indicate that 2-[(hydroxymethyl)amino] ethanol is only
slightly toxic to avian and aquatic organisms. Also, the results of the
hydrolysis study suggest that the parent compound rapidly degrades into
ethanolamine and formaldehyde in aqueous solution. It is expected that
when this chemical is used according to the label, there will be minimal
exposure to the environment from the parent compound or degradates.
Therefore, the risk to nontarget organisms with the use of 2-
[hydroxymethyl)amino]ethanol is expected to be minimal.
3. Endangered Species
Since ethanolamine is only slightly toxic to birds, fish and aquatic
invertebrates, and exposure to fish or wildlife is expected to be minimal or
nonexistent, endangered species are not expected to be affected.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for 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 2[(hydroxymethyl)amino]ethanol. 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
2[(hydroxymethyl)amino]ethanol. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregistration eligibility of
2[(hydroxymethyl)amino]ethanol, and lists the submitted studies that the Agency found
acceptable.
The data identified hi Appendix B are sufficient to allow the Agency to assess the
registered uses of 2[(hydroxymethyl)amino]ethanol and to determine that it can be used
12
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without resulting in unreasonable adverse effects to humans and the environment. The
Agency therefore finds that all products containing 2[(hydroxymethyl)amino]ethanol as
the active ingredients are eligible for reregistration. The reregistration requirements for
particular products are addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data and the data identified hi Appendix B. Although the Agency
has found that all uses of 2[(hydroxymethyl)amino]ethanol 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
it, if new information comes to the Agency's attention or if the data requirements for
registration (or the guidelines for generating such data) change.
1. Eligibility Decision / Eligible and Ineligible Uses
Based on the reviews of the generic data for the active ingredients
2[(hydroxymethyl)amino]ethanol, the Agency has sufficient information on its
health effects and on its potential for causing adverse effects to fish and wildlife
and the environment. Therefore, the Agency concludes that products containing
2[(hydroxymethyl)amino]ethanol for all uses are eligible for reregistration since,
as labeled and used as specified in this Reregistration Eligibility Decision, they
will not pose unreasonable risks or adverse effects to humans or the environment.
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 2[(Hydroxymethyl)
amino]ethanol for its current uses has been reviewed and determined to be
substantially complete. The Agency is requiring confirmatory data on
mutagenicity, hydrolysis and dermal sensitization, as described in Appendix F.
2. Labeling Requirements for Manufacturing-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10.
13
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Based on the reviews of the generic data, the Agency has detemined that
current labels will have to be revised to be in compliance with PR Notice 91-2,
that requires the use of the nominal concentration in the ingredient statement.
A label restriction must require the following Personal Protective
Equipment (PPE): chemical resistant gloves, goggles, eye shield, or face shield
to prevent eye irritation.
In addition, all manufacturing-use products must contain the following
statements:
"Do not discharge effluent containing this product into lakes,
streams, ponds, oceans, or other waters, including near marine or
estuarine habitats, 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 ofthe EPA."
All affected 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.
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.
14
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2. Labeling Requirements for End-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified hi 40 CFR §156.10.
The same environmental hazard and Personal Protective Equipment (PPE)
label statements indicated for the manufacturing use apply to indoor non-food
industrial uses. Refer to subsection A. above for these labeling requirements.
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; State of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell
2[(Hydroxymethyl)amino]ethanol 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.
15
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16
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VI. APPENDICES
17
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18
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APPENDIX A. Table of Use Patterns Subject to
Reregistration
19
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20
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-------
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
23
-------
24
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case 2-[(Hydroxymethyl)amino]ethanol covered by this Reregistration
Eligibility Decision Document. It contains generic data requirements that apply to 2-
[(Hydroxymethyl)amino]ethanol 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
£ Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identify ing number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GSM number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
25
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26
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APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of 2-
[(Hydroxymethyl)amino]ethanol
29
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30
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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 Registration 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
31
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the date from the evidence contained hi the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency hi 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 hi the
trailing parentheses identifies the EPA accession number of the volume
hi 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.
32
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BIBLIOGRAPHY
MRID
CITATION
40327501
41743801
41743802
41743803
41743804
41743805
41850601
41850602
41850604
41925401
Cuthbert, I; Can, S. (1986) Acute Eye Irritation Test: Compound 174: IRI
Project No. 235629: IRI Report No. 3704. Unpublished study prepared by
Inveresk Research International. 20 p.
Troy Chemical Corp. (1990) Product Chemistry for Troysan 174, Product
Identity and Composition 2(Hydroxymethyl)amino ethanol : Lab Project
Number: TCCREREG90/174AA. Unpublished study. 12 p.
Troy Chemical Corp. (1990) Product Chemistry for Troysan 174, Preliminary
Analysis, Certification of Limits and Analytical Methods to Verify Certified
Limits: Lab Project No: TCCREREG90 174AB. Unpublished study. 10 p.
Troy Chemical Corp. (1990) Product Chemistry for Troysan 174, Physical and
Chemical Characteristics: Lab Project Number: TCCREREG90 174AC.
Unpublished study. 4 p.
Siemann, L. (1990) Product Chemistry for Troysan 174 Physical and Chemical
Characteristics Solubility Study: Lab Project Number: 9555-F(02).
Unpublished study prepared by Midwest Research Institute. 13 p.
Siemann, L. (1990) Product Chemistry for Troysanb 174 Physical and
Chemical Characteristics: Dissociation Constant: Lab Project No: 9555-F(02).
Unpublished study prepared by Midwest Research Institute, lip.
Cuthbert, J.; D'Arcy-Burt, K. (1988) Troysan Polyphase 174P: Acute Oral
Toxicity (LD50) Test in Rats: Lab Project Number: 240733: 199003.
Unpublished study prepared by Inversek Research International. 30 p.
Cuthbert, J.; D'Arcy-Burt, K. (1988) Troysan Polyphase 174P: Acute Dermal
Toxicity (Limit) Test in Rats: Lab Project Number: 240733 : 1990A3.
Unpublished study prepared by Inversek Research International. 19 p.
Cuthbert, J.; D'Arcy-Burt, K. (1988) Troysan Polyphase 174P: Primary Skin
Irritation Test in Rabbits: Lab Project Number: 240733: 1990D3. Unpublished
study prepared by Inversek Research International. 19 p.
McDonald, P. (1986) Troysan 174: Acute Inhalation Toxicity Study in Rats:
Lab Project Number: IRI 635385: 3676. Unpublished study prepared by
Inveresk Research International. 43 p.
33
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MRID
BIBLIOGRAPHY
CITATION
42109701
42198901
42198902
42293801
42323001
42472501
42473403
Campbell, S.; Grimes, J.; Smith, G. (1991) Troysan 174 2-Hydroxy
methylaminoethanol: An Acute Oral Toxicity Study with the Northern
Bobwhite: Lab Project Number: 273-102. Unpublished study prepared by
Wildlife International Ltd. 21 p.
Anthony, C. (1991) Troysan 174: Product Chemistry: Vapor Pressure: Lab
Project Number: 04015. Unpublished study prepared by Case Consulting
Labs., Inc. 8 p.
Anthony, C. (1991) Troysan 174: Product Chemistry: pH (1% Solution): Lab
Project Number: 04015. Unpublished study prepared by Case Consulting
Labs., Inc. 8 p.
Cattanach, P.; Riach, C. (1992) 2-0(Hydroxymethyl)Amino | Ethanol (HMAE)...
Mouse Lymphoma Assay: Lab Project Number: 752161. Unpublished study
prepared by Inveresk Research Intl. 77 p.
Siemann, L. (1992) Product Chemistry for Troysan 174: Physical and Chemical
Characteristics: Stability Study Addendum: Lab Project Number: 9555-F(02).
Unpublished study prepared by Midwest Research Institute. 21 p.
Hakin, B.; Rodgers, M.; Anderson, A. et al. (1992) Troysan 174/Nuosept 91
Subacute Oral Toxicity (LC 50) to Bobwhite Quail: Lab Project Number: TCC
1/920565. Unpublished study prepared by Huntington Research Centre Ltd
32 p.
Spraggins, R. (1992) Determination of Percentage of the Active Ingredient in
Troysan 174 i.e. 2(Hydroxy Methyl) Amino | ethanol Using High Pressure
Liquid Chromatography-Addendum I: Lab Project Number: SCOC-01.
Unpublished study prepared by Scientific Consultants of Colorado. 15 p.
42542901
42556901
Krygsman, A. (1992) Technical Specifications of Beginning Materials: Troysan
174-Addendum I: Lab Project Number: 174-REREG 92C4. Unpublished study
prepared by Van Waters & Rogers, Inc.; Dow Chemical Comp. and
Hoechst-Celanese Comp. 20 p.
Mahoney, D. (1992) Preliminary Analysis: 2-(Hydroxymethylamino)ethanol.
Unpublished study prepared by Huls America, Inc. 4 p.
34
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MRID
BIBLIOGRAPHY
CITATION
42556902 Siemann, L. (1992) Product Chemistry for Troysan 174: Physical and Chemical
Characteristics Stability Study Addendum: Lab Project Number: 9555-F(02).
Unpublished study prepared by Midwest Research Institute. 21 p.
42595401 Swigert, J.; Smith, G. (1992) Troysan 174: A 48-hour Flow-through Acute
Toxicity Test with the Cladoceran (Daphnia magna): Amended Final Report:
Lab Project Number: 273A-101A: TCCREREG 92 174F1. Unpublished study
prepared by Wildlife International Ltd. 98 p.
42595402 Swigert, J.; Smith, G. (1992) Troysan 174: A 96-hour Flow-through Acute
Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss) Amended Final
Report: Lab Project No. 273A-102; TCCREREG 92 174F2. Unpublished study
prepared by Wildlife International Ltd. 99 p.
42884801 Wertz, P. (1993) Troysan 174 Product Analysis: Lab Project Number: ADC
PROJECT#1279: ADC REPORTtfl279-3. Unpublished study prepared by
Analytical Development Corporation. 134 p.
42884802 Wertz, P. (1993) Troysan 174 Storage Stability: Lab Project Number: ADC
PROJECT#1279: ADC REPORTtfl279-2. Unpublished study prepared by
Analytical Development Corporation. 617 p.
35
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36
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APPENDIX D. List of Available Related Documents
37
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38
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The following is a list of available documents related to 2-
[(Hydroxymethyl)aminojethanol. 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 2-[(Hydroxymethyl)amino]ethanol 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. 2-[(Hydroxymethyl)amino]ethanol 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
39
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40
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APPENDIX £. PR Notices 86-5 and 91-2
41
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42
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PR Notice 86-5
43
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44
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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)(1). 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
45
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specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. 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.
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.
46
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- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. transmit tal.'Document 4 n
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) (1)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1)) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
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 admin-
istrative 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).
47
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B. Transmittal Document
The first item in each submittal package must be a trans-
mittal 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 (EUP), §3(c)(2)(B) data
call-in, §6(a)(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 of the studies. Within these two
groups of studies follow the instructions above.
C. individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. 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 Guide-
line requirement for supporting data, with some exceptions dis-
cussed 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.
48
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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 assoc-
iated 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)(1)(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
49
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Residue Chemistry
Guidelines 171-4 153-3
'
, -
-J 53'Vre 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 inves-
tigation 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 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
al* ?u?h 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
i-h* iK comPle^e sj;udy 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 foliowing
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 Require^
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
work subject to GLP require-
ments
Example
Page 12
Page 13
Page 16
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
§10(d)(1)(A), (B), or (C)
CBI Attachment if CBI is claimed under FIFRA
§10(d)(1)(A), (B), or (C) Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA §10(d)(1)(A), (B), or (C)
50
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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.
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 pub-
lished document, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
51
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D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
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)(1)(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)(1) 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
?n ?fxa submitted studY other than described by FIFRA §10(d)
(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential 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
52
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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. Sam-
.ples of these statements are shown in Attachment 6.
E. Reference to Previously flybmitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUHRLLXIJSU 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 pre-
viously submitted studies should net be included in the transmit-
tal document, but should be incorporated into the statement of
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:
g Do not include frayed or torn pages.
3$ Do not include carbon copies, or copies in other than
black ink.
g Make sure that photocopies are clear, complete, and
fully readable.
g Do not include oversize computer printouts or fold-out
pages.
g 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.)
53
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G.
Snecial Reouirements for Submittina Data to the Docket
Data submittal packages associated with a Registration Stan-
dard 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 of 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.
5 Remove the "Supplemental Statement of Data
Confidentiality Claims".
$ Remove the "Confidential Attachment".
8 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) (1) (A), (B) , or (C) . Do not
close up or paraphrase text remaining after this
excision.
j£ 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.
5w»w.a&*
ts W. Aktziun
Actins oirtctor,
*«giatrati0fi Division
Attachment 1
Attachment 2
Attachment 3
Attachment 4
Attachment 5
Attachment 6
Attachment 7
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality
Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
54
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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. Reoulatorv action in support of which this package is
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
55
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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 Comnleted On
January 5f 1979
Performing Labor ^t-rvry
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Pro-jenf- rn
ABC 47-79
. , Pa9e 1 of X
(X is the total number of pages in the study)
56
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1. No claim of confidentiality under FIFRA §10(d)(1)(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:
Title
Typed Name
Date:
Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B) , or
(C) .
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
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:
Title
Typed Name
Date:
Signature
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.
57
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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)(1)(A), (B), or (C) , but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
g Identify specifically by page and line number(s) each
portion of the study for which you claim
conf ident iality.
3$ Cite the reasons why the cited passage qualifies for
confidential treatment.
3£ Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
3$ Identify the measures taken to guard against undesired
disclosure of this information.
3$ Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
3$ Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
3$ 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.
3$ If you assert that the information in voluntarily sub-
mitted, 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.
58
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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 words or phrase at the
indicated volume and page references.
DELETED WORDS OR PHRASE:
LINE REASON FOR THE DELETION
6
12
100
14
25
19
Identity of Inert Ingredient
FIFRA REFERENCE
§10 (d) (1) (C)
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):
20.
Reproduce the deleted paragraph(s) here
LINES REASON FOR THE DELETION FIFRA REFERENCE
2-17 Description of the quality control process §10(d)(1)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 2 This cross reference number noted on a place-
holder page is used in place of the following
whole pages at the indicated volume and page
references.
DELETED PAGE(S): are attached immediately behind this page.
pAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the product manufacturing process §10(d)(1)(A)
59
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter —
Sponsor — ; _
Study Director
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.
- °f Jh±/ 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. «u«-ueu. m
Submitter
60
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ATTACHMENT 7.
FORMAT OP THE SUBHZTTAL PACKAGE
Transmittal Document.
Belated 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
physical entities, according
to the format below.
FORMAT OF SUBMITTED STUDIES
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.
LEGEND
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.
I
Documents submitted at submitter's option.
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PR Notice 91-2
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j JL UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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 of 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
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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
.158.175. The lower certified limit is used as the enforceable
lower limit for -the product composition according to FIFRA
section 12(a)(1)(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
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 of section 12(a)(1)(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.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
health, e.g., certain antimicrobial and
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 reaistration process more uniform and more manageable for
both tne agency and the regulated community It is the Agency's
intention to implement the requirements of this notice as
smoShly as possible so as not to disrupt or delay the Agency 's
high priority programs, i.e., ^registration, new chemical, or
fait Lack (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 ^registration
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, 1997, 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.
Ann* fi. tindaay, Director
R*giatrAtion Division (Ji-7505
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APPENDIX F. Generic Data Call-In
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CTNRRIC DATA CALL-IN NOTICE
MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet.
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth hi Section m below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments
1 through 4; 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 ffi-B);
or,
3 why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section ffl-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
produces) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-in Response Form, as well as
a list of all registrants who were sent this Notice (Attachment 4).
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. 207O-0107
(expiration date 12-31-92).
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This Notice is divided into six sections and five 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 H - Data Required By This Notice
Section HI - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
revaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because you
have product(s) containing the subject active ingredient(s).
SECTION H. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The 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.
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.
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C. TESTING PROTOCOL
r
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 hi accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cK2)(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 anv previous Data Call-Ms), 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 ffl. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice 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.
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B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained in Section ffl-C. A discussion of options relating to requests for data
waivers is contained in Section ffl-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 (Attachment 2) and the Requirements Status and Registrant's
Response Form (Attachment 3). The Data Call-In Response Form must be submitted as
part of every response to this Notice. 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 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(s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-In Response Form.
indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only
form that you are required to complete.
If you choose 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. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you wish
to amend your registration to delete uses, you must submit the Requirements
Status and Registrant's Response Form, a completed application for amendment,
a copy of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Data Call-In
Response Form by signing the certification, item number 8. Application forms for
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amending registrations may 'be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an
applicant for registration of a product is exempt from the requirement to submit
or cite generic data concerning an active ingredient(s) if the active ingredient(s)
hi the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must be met:
a. The active ingredient(s) hi your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source not
connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be hi compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-in Response Form. Attachment 2 and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data Call-In Response
Form. If you claim a generic data exemption you are not required to complete
the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer hi compliance with
this Data Call-In Notice, the Agency will consider that both they and you are not
hi compliance and will normally initiate proceedings to suspend the registrations
of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
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not grant a time extension for submitting the data.
#
4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice. These options are
discussed in Section ffl-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and option 6b and 7 on the
Data Call-In Response Form. If you choose option 6b or 7, you must submit both
forms as well as any other information/data pertaining to the option chosen to
address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section ffl-D of
this Notice and are covered by options 8 and 9 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.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first
six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed immediately below
with information in parentheses to guide registrants to additional instructions provided in
this Section. The options are:
1. I will generate and submit data within the specified time frame
(Developing Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
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(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 hi conformance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols hi advance of study initiation. Those studies for which
a protocol must be submitted have been identified hi the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you wish to use a
protocol which differs from the options discussed hi Section E-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
in Section E-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means
to address that study requirement, such as making an offer to cost-share or
agreeing to share in the cost of developing that study. A 90-day progress report
must be submitted for all studies. This 90-day progress report must include the
date the study was or will be initiated and, for studies to be started within 12
months of commitment, the name and address of the laboratory(ies) or individuals
who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified in the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
The time frames hi the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
completed study reports or protocols. 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).
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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 requirement(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 oa 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 riot be given in submitting
the 90-day responses. Extensions will not be considered if the request for
extension is not made in a timely fashion; in no event shall an extension request
be considered if it is submitted at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data —
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 -
If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with
the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has in good faith sought and continues
to seek to enter into a joint data development/cost sharing program, but the other
registrant(s) developing the data has refused to accept your offer. To qualify for
this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share
in the burden of developing that data. You must also submit to the Agency a
completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data. In addition, you must demonstrate that the other registrant
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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, hi addition to anything else, offer to share hi 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 hi 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 hi the specified time
frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4. Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate
issuance of this Notice. Do not use this option if you are submitting data to
upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
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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
hi accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7)" 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(7), 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 hi the FIFRA Accelerated
Registration 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, hi 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
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meets all requirements'of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by .the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
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 a study is hi the Agency's files, you need
only cite it along with the notification. If not in the Agency's files, you
must submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study —
If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data normally
without any time extension. Deficient, but upgradeable studies will normally be
classified as supplemental. However, it is important to note that not all studies
classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing
study you must satisfy or supply information to correct all deficiencies in the study
identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated
as acceptable to EPA. Your submission must also specify the MRID number(s)
of the study which you are attempting to upgrade and must be in conformance
with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of being
upgraded.
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency. You
must provide the MRID number of the data submission as well as the MRID
number of the study being upgraded.
The criteria for submitting an existing study, as specified hi Option 4
above, apply to all data submissions intended to upgrade studies. Additionally
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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 ecological effects studies, the classification generally would be
a rating of "core." 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.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirements) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver — Option 8 on the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume,
minor use waiver the Agency will consider the extent, pattern and volume of use,
the economic incentive to conduct the testing, the importance of the pesticide, and
the exposure and risk from use of the pesticide. If an active ingredient(s) is used
for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient(s) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified
for such waiver. If granted a waiver, a registrant will be required, as a condition
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of the waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your produces), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
produces) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s) by
year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting the
testing needed to fulfill each of these data requirements.
f. A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of produces)
containing the active ingredient(s) (following the parameters in item d
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above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of the
active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient(s) in terms
of its benefits, you should provide information on any of the following
factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data -Option 9 on the Requirements Status and
Registrant's Response Form. This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You must
also submit the current label(s) of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for vour product(s). vou
must choose a method of meeting the requirements of this Notice within the time
frame provided bv this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
jr
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 ni-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: or,
b. fulfill the commitment to develop and submit the data as required
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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.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.
The grounds for suspension include, but are not limited to, failure to meet any of the
following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies. Such
requirements include, but are not limited to, those relating to test material, test
procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner
of reporting, the completeness of results, and the adequacy of any required
supporting (or raw) data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will not be considered to fulfill
the submission requirement.
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 Federal Insecticide, Fungicide, and
Rodenticide Act.
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The Agency has determined that such disposition by registrants of existing stocks
'for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an
"existing stocks" provision is necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale, distribution, and use. Unless
you meet this burden the Agency will not consider any request pertaining to the continued
sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow
persons other than the registrant such as independent distributors, retailers and end users
to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products containing an active
ingredient(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was due
unless you demonstrate to the Agency that you are in full compliance with all Agency
requirements, including the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3 year study is scheduled to be
submitted, all progress reports and other information necessary to establish that you have
been conducting the study in an acceptable and good faith manner must have been
submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
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SECTION VI.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person 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 Call-In Response Form (Attachment 2) and a
completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person 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,
Daniel M. Barolo, Director
Special Review
and Registration Division
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Attachment 1. Chemical Status Sheet
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2-[(Hydroxymethyl)amino]ethanol DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing 2-[(Hydroxymethyl)amino]ethanol.
This Generic 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 2-
[(Hydroxymethyl)amino]ethanol. This attachment is to be used in conjunction with (1) the
Generic Data Call-In Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3)
the Requirements Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving
this DCI (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost
Share and Data Compensation Forms in replying to this 2-[(Hydroxymethyl)amino]ethanol
Generic Data Callln (Attachment F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for 2-
[(Hydroxymethyl)amino]ethanol are contained in the Requirements Status and Registrant's
Response. Attachment C. The Agency has concluded that additional product chemistry data on
2-[(Hydroxymethyl)amino]ethanol are needed. These data are needed to fully complete the
reregistration of all eligible 2-[(Hydroxymethyl)amino]ethanol products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and proced
established by this Notice, please contact Mark Wilhite at (703) 308-8586.
All responses to this Notice for the generic data requirements should be submitted to:
Mark Wilhite, Chemical Review Manager
Accelerated Registration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 2-[(Hydroxymethyl)amino]ethanol
lures
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed
by the registrant as appropriate Items 8 through 11 must be completed by the registrant
before submitting a response to the Agency.
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 suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St, S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D C 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number
and chemical name.
Item 3. This item identities the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the Agency
of your response regarding any product that you believe may be covered
by this data call-in but that is not listed by the Agency in Item 4. You
must bring any such apparent omission to the Agency's attention within the
period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
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Item 6a. Check this item if this'data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions, of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are hi
compliance with this and-any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this item
for all products listed on this form If, however, you produce the active
ingredient yourself, or use any unregistered product (regardless of the fact
that some of your sources are registered), you may not claim a Generic
Data Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates
how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product
(EUP) as indicated in Item 3 and if your product is an end use product for
which you agree to supply product-specific data. Attach the Requirements
Status and Registrant's Response Form that indicates how you will satisfy
those requirements.
Item 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
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Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
Item 11. Enter the phone number of your company contact.
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Attachment 3. Requirements Status and Registrants1
Response Forms Inserts (Form B) plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request
for a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 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 suggesting for reducing this burden, to Chief, Information Policy Branch,
PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460;
and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
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submitted in connection with'the study. As noted hi Section HI of the Data
Call-In Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and
Registrant's Response Form.
Item 6. This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
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 crop
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade
Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant
Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active Ingredient
Specified
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TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient
and Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical
End-Use Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
'"See: guideline comment
Item 8. This item identities the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the
Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data
Call-in Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the time
frames specified in item 8 above. 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 and that I will provide the protocol and progress reports required
in item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements pertaining
to sharing in the cost of developing data as outlined in the Data Call-in
Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of
Data" that describes this offer/agreement. By indicating that I have chosen
this option, I certify that I will comply with all the requirements pertaining
to making an offer to share in the cost of developing data as outlined in the
Data Call-In Notice.
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4. (Submitting Existing Data) I am submitting an existing study that has never
before been submitted to EPA. By indicating that I have chosen this
option, I certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-In Notice
and I have attached the needed supporting information along with this
response.
5 (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data to upgrade a study described hi the Data Call-In Notice. I am
indicating on attached correspondence the Master Record Identification
Number (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other things,
all information required to support the request. I understand that, unless
modified by the Agency in writing, the data requirement as stated in the
Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
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Item 11. Enter the date of signature. '
ft
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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Attachment 4. List of Registrant(s) sent this DCI (Insert)
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APPENDIX G. Product Specific Data Call-In
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DATA TATJ.-TN NQTTCE
CERTIFffiD MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section HI 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 IH-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as
a list of all registrants who were sent this Notice (Attachment 6).
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).
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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 n - Data Required By This Notice
Section HI- Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of 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 H. DATA REQUIRED BY THIS NOTICE
H-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.
H-B. SCHEDULE FOR SUBMISSION OF DATA
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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.
n-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
hi 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 hi response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
H-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 then* affected products.
SECTION ni. 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.
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m-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 m-C. A discussion of options relating to
requests for data waivers is contained in Section ffl-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must be
submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions of
this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options are
discussed in Section ffl-C of mis Notice and comprise options 1 through 6 on the Requirements
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.
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3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section ffl-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. *-"s
m-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 hi the instructions for completing the Requirements Status and Registrant's Response
Form. These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registrations).
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
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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 hi 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 hi submitting the
90-day responses. Extensions will not be considered if the request for extension is not made hi a
timely fashion; hi no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
Option 2. Agreement tn Share in Cost to Develop Data - Registrants may only, choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending
on the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted in
the agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share hi 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 hi option 2 above. If you have made an offer
to pay hi an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share hi 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, hi addition to
anything else, offer to share hi 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
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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.
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 data1 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
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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
NITS). 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 hi the Agency's files, you need only
cite it along with the notification. If not in the Agency's files, you must submit a summary and
copies as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
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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 n.ta Compensation
Requirements. "—K
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.
HI-D REQUESTS FOR DATA WATVRRfi
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
l^n^T^T T^eSt; y°U Wm n0t * required t0 Supply ** data Pursuant to sec"on
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision
You must indicate and submit the option chosen on the Requirements Status and Registrant
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
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
" ~ *
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section ffl-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
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Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified hi the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies. Such requirements include, but are not limited to, those
relating to test material, test procedures, selection of species, number of animals, sex and
distribution of animals, dose and effect levels to be tested or attained, duration of test, and,
as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary report
will not be considered to fulfill the submission requirement.
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
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of existing stocks and your estimate of the time required for their sale, distribution, and use Unless
you meet this burden the Agency will not consider any request pertaining to the continued sale
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell distribute
or use existing stocks. Normally, the Agency will allow persons other than the registrant such w
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. "»mcu
Requests for voluntary cancellation received afisr the 90 day response period required by this
Notice will not result in the Agency granting any additional time to sell, distribute, or use exLing
stocks beyond a year from the date the 90 day response was due unless you demonstrate to the
$S^' y°laie ta *? CTPlianCe ^ •" Agency "Wtena*, including the requirements
of ttus Notice. For example, if you decide to voluntarily cancel your registration six months before
to JSSiSS f "^ J? S!!bmitted' •" pr0greSS rep0rts •nd other ^'"nation necessary
to esablish tot 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 PnssiBT c
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 Agencv
Registrants must notify the Agency of any factual information they have, from whatever source'
mcludmg but not hmited to interim or preliminary results of studies, regarding unreasonable adverse
SECTION VI. INQUIRIES AND RRSPONSES TO THI
If you have any questions regarding the requirements and procedures established by this
Nouce, call the contact person(s) listed in Attachment 1, the Data Call-in n»nrir.i
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption clauns) must include a completed Data Call-in n^pn- JL, aTa ^mpleS
SfcS fT «***#«*'* *«*""*• F"™ (Attachment 2 and Attachment 3 for pE
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified m Attachment 1. If the voluntary cancellation or generic data eSmpti™
otion is ch - ^"npnon
... —-— . ^««...M«A>y WUUWWUaUVJll \JL 1
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
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Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
5 -
6 -
7 -
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Grouping of End-Use Products for Meeting Acute Toxicology
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Form
Data
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Attachment 1. Chemical Status Sheet
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2-[(HYDROXYMETHYL)AMINO]ETHANOL DATA CALL-IN CHEMICAL STATUS
SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
produces) containing 2-[(Hydroxymethyl)amino]ethanol.
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 2-
[(Hydroxymethyl)amino]ethanol. 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 2-
[(Hydroxymethyl)amino]ethanol 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 2-[(Hydroxymethyl)
amino]ethanol are contained in the Requirements Status and Registrant's Response. Attachment
3. The Agency has concluded that additional data on 2-[(Hydroxymethyl)ammo]ethanol 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 2-
[(Hydroxymethyl)amino]ethanol products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of 2-[(Hydroxymethyl) amino]
ethanol, please contact Mark Wilhite at (703) 308-8586.
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: 2-[(Hydroxymethyl)amino]ethanol
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126
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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128
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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 hi accordance with the
Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls hi 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 reregistration 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 hi a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another 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.
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130
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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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, Subpart c.
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).
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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 ni-C.l.) apply as well.
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 m-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 ffl-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
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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.
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136
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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138
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EPA'S BATCHING OF PRODUCTS CONTAINING 2-HYDROXYMETHYL AMINO
ETHANOL FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of end-use products containing the active ingredients
2-hydroxymethyl amino ethanol, the Agency has batched products which can be considered
similar in terms of acute toxicity. Factors considered in the sorting process include each
product's active and inert ingredients (identity, percent composition and biological activity), type
of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products within
a batch may not be considered chemically similar or have identical use patterns.
Batching has been accomplished using the readily available information described above, and
frequently acute toxicity data on individual end-use products has been found to be incomplete.
Notwithstanding the batching process, the Agency reserves the right to require, at any time, acute
toxicity data for an individual end-use product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute lexicological studies to the products within the batch. It is the
registrants' option to participate in the process with the other registrant, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting Existing Studies (Option 4), Upgrading Existing Studies
(Option 5) or Citing Existing Studies (Option 6). If a registrant depends on another's data,
he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing
an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices
are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate
in a batch does not preclude other registrants in the batch from citing his/her studies and offering
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to cost share (Option 3) those studies.
There are three products which are affected by this RED on the basis of their containing 2-
hydroxymethyl amino ethanol as an active ingredient. Batch 1 (Table 1) consists of the two
products that have been batched together on the basis of their similar formulations.
Table 1
Batch No.
EPA Reg. No.
1100-86
5383-11
% 2-Hydroxymethyl
amino ethanol
==
99.95%
97.0%
Formulation
Type
=
liquid
liquid
Table 2 lists the product which could not be batched. This product was not considered
similar for purposes of acute toxicity. The registrant of this product is responsible for meeting
the acute toxicity data requirements specified in.the data matrix for end-use products.
Table 2.
EPA Reg. No.
==
5383-47
% Active Ingredients
=======
21% 2-hydroxymethyl
amino ethanol
29% bis
(tributyltin) oxide
Formulation Type
=
liquid
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Attachment 5. EPA Acceptance Criteria
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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
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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 lexicologically significant impurities (e.g., dioxins, 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
lexicologically significant impurities (see #3).
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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 J>. 0.1 %.
2. Degree of accountability or closure j>. ca 98%.
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 <0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
accuracy.
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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 hi 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 20-25p 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 hi 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)
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63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C • •
- 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-. 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/fcg).
6. Individual observations at least once a day.
I' 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 * arc supplemental and may not be required for every study.
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81-2 Acute Dermal toxidty 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. 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 * arc supplemental and may not be required for every study.
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81-3 Acute Inhalation Toridty 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 IS pm 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 (±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 conjunctiva! 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 paniculate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 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
pHof <2or >.11.5.
3. One of the 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. 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.
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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
155
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156
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Attachment 7. Cost Share Form, Data Compensation Form,
Confidential Statement of Formula Form, and Instructions for the
Confidential Statement of Formula
157
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158
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- I
3
ii
18 "5
2
Is
4
ut cE
US
159
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160
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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 hi and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be hi pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in niches.
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 hi columns 13.a. and 13.b. must be hi 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.
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162
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r/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 Explros 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 nil In blanks below.
Company None
Company Ninber
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)(DI) 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):
Nim« of Flrm(a)
Dato 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 Raproaantatlvo
Data
Nan* and Till* (Picas* Typ* or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which la obsolete
163
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164
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r/EPA
United States Envlronmtnui Protection Agency
Washington, DC 20480
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
N*. 2070-01Q1
2070-90S7
3-31-96
Pubic reporting burden tor this coBtctton of information is tstimattd to avtraga 15 minutts por rtsponst, including
timt for reviewing instructions, starching existing data sources, gathtring and maintaining tht data needed, and
coRtMing and reviowirig the colectlon of Monw^ Strtdcoinmantsftgardingths burdsn astimattoranyothtr
aspect of this colltdton of information, including suggsstions 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 fin In blanks below.
'**^V™* ••••••
Product •*»•
Company Numb«r
DA Mg. Mo.
I Certify mat
1. For each study cited in support of registration or reregistnttion under me Federal Insedidde. Fungicide and
Rodentidde Act (FIFRA) that to an exclusive use study ,1 am the origirtal data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
2. That for each stucydtod in support of registrar
study. I am the original data submtter. or I have obtained the wrtten permission of the orio^cttasubmffler. or I
have notified in writing the company(ies) that submitted data I have tited and have offered to: (a) Pay
compensation for those data in accordance wan sections 3(C)(1)(D) and 3(c)(2XD) of FIFRA: and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due. • any. The companies I have notified are: (cheek one)
(] The conpanies who havt submitted the studies listed on the back of this fonn or attached
sheets, or indicated on the attached -Requirements Status and Registrants' Response Form."
3. That I have previously compted wth section 3(c)(i)(D) of FIFRA for the studies I have dted in support of
registration or ret egettratton under FIFRA.
Signature
NMW Mtf Tito (PIMM Type «r MM)
Date
GBIERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to tht
registration or reregistrition of my products, to the extent required by FIFRA sections 3(C)<1)(D) and 3(c)(2)(D).
DM*
NMM »n4 Tlte
Typ* «r Print)
EPA
SS7e-S1
165
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