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 @ 20C

liquid @ 20C

sharp, amine odor

110C

1.1545g/ml@25C

@ 25C  0.5C  in  octanol, 23.6 0.7
g/100 ml; completely miscible in water and
isopropanol

16.4 mm @ 25C

8.5 0.2 @ 25C

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 @ 4C and 50C 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.

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       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

-------
             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

-------
                           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

-------
       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

-------
              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

-------
       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

-------
16

-------
VI.   APPENDICES
       17

-------
18

-------
APPENDIX A.  Table of Use Patterns Subject to
               Reregistration
                    19

-------
20

-------




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-------

-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                        23

-------
24

-------
                               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

-------
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

-------
30

-------
                               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.
                          5ww.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 610(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.
                            61

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62

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PR Notice  91-2
      63

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64

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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

                                 65

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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.
                                66

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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.
                                  67

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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
                               68

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APPENDIX F. Generic Data Call-In
               69

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70

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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).

                                           71

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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.
                                         72

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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.

                                        73

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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

                                   74

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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
                              75

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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

                                         85

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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
                                         88

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Attachment 1. Chemical Status Sheet
                89

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90

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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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92

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Attachment 2. Generic DCI Response Forms Inserts (Form
                 A) plus Instructions
                          93

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94

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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
                       98

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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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104

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Attachment 4. List of Registrant(s) sent this DCI (Insert)
                          105

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106

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APPENDIX G. Product Specific Data Call-In
                  107

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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;  yU 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


                                           118

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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^' ylaie 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 nnrir.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
   ...	- . ^...MA>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
                                         121

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122

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Attachment 1. Chemical Status Sheet
                123

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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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125

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126

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Attachment 2. Product Specific Data Call-In Response
      Forms (Form A inserts) Plus Instructions
                        127

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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.
                                          129

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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
                        131

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132

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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.
                                            135

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136

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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       137

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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

                                          139

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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
                                        140

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Attachment 5. EPA Acceptance Criteria
                 141

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142

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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
                                          143

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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).
                                                  144

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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.
                                                  145

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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
          20-25C)
                                                  146

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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
                                                 147

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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
                                              148

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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.
                                                149

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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.
                                                   150

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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.
                                                 151

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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.
                                                   152

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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.
                                                  153

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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.
                                                  154

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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.


                                                  161

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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 Numbr
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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