United States      Prevention, Pesticides   EPA 738-R-93-020
        Environmental Protection   And Toxic Substances   September 1993
        Agency	(7S08W)	
<&EPA  Reregistration

        Eligibility Decision (RE


        Tris(hydroxymethyl)

        nitromethane
                        Recycled/Recyclable
                        Printad with Soy/Canola Ink on paparthat
                        contains at toast SQ% recycled tibar

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                United States
                Environmental Protection
                Agency
                     Prevention, Pesticides
                     And Toxic Substances
                     (7508W)
EPA-738-F-93-016
September 1993
                R.E.D.   FACTS
                Tris(hydroxymethyl)-
                nitromethane
     Pesticide
Reregistration
   Use Profile
    All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered years ago be reregistered to ensure
that they meet today's more stringent standards.
    In evaluating pesticides for reregistration, EPA obtains  and reviews a
complete set of studies from pesticide producers, describing  the human
health and environmental effects of each pesticide.  The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks, EPA then reregisters pesticides that can be used without
posing unreasonable risks 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 the
reregistration case Tris(hydroxymethyl) nitromethane, which  contains the
active ingredient 2-(hydroxymethyl)-2-nitro-l,3-propanediol.

    2-{tydroxymethyl)-2-nitro-l,3-propanediol is used as a microbicide
and bacteriostat in disinfectants and industrial preservatives.  Specifically.
it is used as an industrial preservative in metalworking fluids, secondary nil
field recovery waters,  paper mills and commercial/industrial  water cooling
systems; as an in-can preservative in latex paints, polishes and detergents;
and as a disinfectant to control disease organisms in livestock and poultry
areas on farm premises and equipment.  It is formulated as a soluble liquid
concentrate, powder or pellets, and is  applied through use of a metering
pump in industrial water systems, by pouring into paints and polishes, and
as a spray to farm areas and equipment.

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    Regulatory
         History
      2-(hydroxymethyI)-2-nitro-l,3-propanediol was first registered in the
U.S. in 1955, as an industrial bactericide and slimicide.  EPA has issued
three relevant Data Call-In (DCI) Notices: the Antimicrobial DCI in March
1987, the comprehensive reregistration Phase 4 DCI in September 1992,
and a third DCI in August 1993, the latter for residue data.  Currently,
nine pesticide products are registered which contain this active ingredient.
Human Health
  Assessment
ToKicity
      Studies using laboratory animals indicate that 2-(hydroxymethyl)-2-
nitro-l,3-propanediol is of low to moderate acute toxiciry to mammals.  It
has been placed in Toxicity Category III for acute oral, dermal and
inhalation effects (Toxiciry Category I indicates the greatest degree of acute
toxicity and Category IV the lowest).  It has been placed in Category IV
for eye and skin irritation effects. Since these studies were not conducted
with the technical grade (100%) powder, additional confirmatory acute
inhalation and eye irritation studies are required using that formulation.
      In a subchronic dermal toxicity study using rats, there were no
treatment-related effects observed at any dose level.  In developmental
toxicity studies using rats  and rabbits, treatment-related maternal effects
were observed in the high-dose groups.  No mutagenic  effects were seen in
a battery of studies.
      2-(hydroxymethyl)-2-nitro-l,3-propanediol decomposes to
formaldehyde under alkaline,  warm conditions.  Formaldehyde has been
classified by EPA as a Group Bl "probable" human carcinogen.  The
toxicity of formaldehyde has been a. primary consideration in evaluating the
risks of 2-(hydroxymetliyl)-2-nitro-l,3-propanediol.
Dietary Exposure
      No dietary exposure is expected as a result of the registered uses of
2-(hydroxymethyl)-2-nitro-l,3-propanedioL  Its one potential food use, as a
disinfectant in or on livestock premises and equipment, has been modified
to delete milk house and milking equipment uses, and to add restrictions to
poultry  house uses which  eliminate the means of exposure of edible
livestock tissue or eggs. Therefore, no tolerances (rnaximum residue
limits) or exemptions from tolerances are required.
Occupational and  Residential Exposure
      2-(hydroxymethyl)-2-nitro-l,3-propanediol has many uses that may
involve exposure to workers, and exposure monitoring data were required
to estimate combined inhalation  and dermal exposure of mixers, loaders
and applicators in various use sites.

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      Worker exposure is considered significant for preservative and pulp
and paper mill uses, which involve open pouring methods.  However,
associated risks will be mitigated ten-fold by requiring use of a respirator
and personal protective equipment (PPE) including a long-sleeved shirt and
long pants, and shoes plus socks,
      Worker exposure is considered low for the poultry/livestock
disinfectant use, but is of concern since formaldehyde is an active
ingredient in the product, and since a spray method of application is
involved. Use of PPE and a respirator are required, and will reduce any
exposure ten-fold.
      Worker exposure during cooling tower and metal working fluid uses
is considered very low.  Again, PPE is required to reduce possible
exposure to formaldehyde.
      While post-application worker exposure to formaldehyde is minimal
for most uses of 2-{hydroxymethyl)-2-nitro-l,3-propanediol, the
disinfectant spray used in livestock/poultry premises, which contains the
active ingredient formaldehyde, causes post-application exposure of
concern.  However, EPA's exposure estimate represents the worst case
scenario, and OSHA requires monitoring for formaldehyde before workers
may reenter treated premises.  Therefore, post-application worker exposure
is likely the same or less than exposure during mixing,  loading or applying
the pesticide.
      Similarly, post-application worker exposure to formaldehyde from
use of the parent chemical in pulp and paper mills is of some concern.
Since the Agency's exposure estimate is very conservative, a post-
application inhalation exposure monitoring study is required only as
confirmatory data.
Human Risk Assessment
      Since 2-(hydrosymethyl)-2-nitro-l,3-propanediol has no food uses, no
dietary  risk exists.  Overall, minimal risk and exposure are associated with
the use  of this active ingredient.   The risks associated are due to its
degradation product, formaldehyde.
      EPA has examined  the cancer risks of formaldehyde extensively.
Using the most widely accepted  risk assessment methodology, the Agency
has estimated the refined upper bound cancer risk to mixers, loaders and
applicators from exposure to formaldehyde through use of 2-
(hydroxymethyl)-2-nitro-l,3-propanediol. With PPE and respirators, these
risks range from 1.1 in 100,000 for preservative uses to 2.5  in 1,000,000
for poultry/livestock disinfectant uses.
      Post-application worker exposure to formaldehyde following the
livestock/poultry premise spray use is of concern;  the upper bound risk to
workers is estimated to be 2.5 in 1,000,000.  However, the Agency's
exposure estimate represents the  worst case scenario. Actual risks to
workers should be lower  considering OSHA's formaldehyde monitoring

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                    requirements.  Post-application exposure of pulp and paper mill workers is
                    conservatively estimated to be 2.7 in 100,000.  A post-application
                    inhalation exposure monitoring study is required for this use, as
                    confirmatory information,
Environmental        In evaluating environmental effects, EPA focused on 2-
  Assessment   (hydroxymethyl)-2-nitro-l,3-propanediol rather than its degradation
                    product, formaldehyde.  In the aquatic environment, the active ingredient is
                    relatively stable. As  it breaks down to formaldehyde,  the latter chemical is
                    rapidly dissipated.  Therefore, the parent compound is of greater interest.
                    Environmental Fate
                         Based  on the results of an exposure assessment model, the Agency
                    expects that  2-(hydroxymethyl)-2-nitro-l,3-propanediol used according to
                    the label will result in minimal exposure to the environment. Concern
                    would arise only from its discharge into receiving waters from the
                    industrial uses or in the case of spills,  accidents  or misuse,  A hydrolysis
                    study is required to confirm the chemical's degradation in the environment.
                    Ecological Effects
                         2-(hydroxymethyl)-2-nitro-l,3-propanediol  has a low order of acute
                    oral and dermal toxicity to terrestrial mammals.  It may be slightly toxic to
                    upland game birds, but is practically non-toxic to waterfowl.  It also  is
                    practically non-toxic to freshwater fish species on an acute basis.  It is
                    slightly toxic to freshwater aquatic invertebrates and mollusks, and
                    practically non-toxic to crustaceans.
                    Ecological Effects Risk Assessment
                         EPA conducted  a Tier Ic Estimated Environmental Concentration
                    (EEC) model to assess the residue levels of 2-(hydroxymethyl)-2-nitro-l,3-
                    propanediol in the receiving stream from several use sites.  This model
                    provides a reasonable worst case estimate of the  maximum concentration
                    that may occur immediately downstream from an industrial point source
                    discharge site. The typical EEC values for all uses of this active ingredient
                    are below the levels of concern for fish and invertebrates. Therefore,  the
                    pesticide can be used at typical use sites without producing effluent above
                    levels of concern.  Under a  high exposure scenario, a high degree  of risk
                    would be posed to aquatic organisms.   However, discharge of the pesticide
                    is regulated by the National Pollutant Discharge  Elimination System
                    (NPDES) permit program administered by EPA.  Through this program,
                    the Agency is able to control the discharge of this pesticide and other
                    chemicals so that toxic levels are avoided.
                    Endangered Species
                         The high exposure  scenarios described above exceed the levels  of
                    concern for endangered aquatic organisms. In addition, the typical EEC
                    value for pulp and paper mills exceeds the level  of concern for eiicaugered
                    aquatic invertebrates.   Effluent containing this active ingredient should not

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                        be discharged into streams or waterways where endangered aquatic
                        organisms are known to reside.  EPA is working with the U.S. Fish and
                        Wildlife Service to develop a program to avoid jeopardizing the continued
                        existence of identified species by .the use of pesticides,  When this program
                        goes into effect, endangered species labeling will be required.
   Additional Data
           Required
     The generic data base for 2-(hydroxymethyl)-2~nitro-l,3-propanediol
is substantially complete.  However, for confirmatory purposes, EPA is
requiring acute inhalation and eye irritation studies using the technical
grade powder formulation, a post-application inhalation exposure worker
monitoring study, and a  hydrolysis study.  EPA also is requiring product-
specific data, including chemistry, acute toxicology and efficacy studies, as
well as revised labeling for reregistration.
  Product Labeling
Changes Required
     All end-use products containing 2-(hydroxymethyl)-2-nitro-l,3-
propanediol must comply with EPA's current pesticide product labeling
requirements.  In addition;
»    Effluent Discharge Statement - All end-use products for indoor non-
food uses (industrial uses which discharge effluent), aquatic non-food
industrial uses, or terrestrial non-food uses must bear the following effluent
discharge statement:
     "Do not discharge effluent containing this product into lakes,
     streams, ponds, estuaries, oceans or public waters unless in
     accordance with the requirements of a National Pollutant Discharge
     Elimination System (NPDES) permit and the permitting authority has
     been notified in writing prior to discharge.  Do not discharge effluent
     containing this product to sewer systems  without previously notifying
     the local sewage treatment plant authority.  For guidance contact
     your State Water Board or Regional Office of EPA."
*    Use Site PPE Requirements and Entry Restrictions
     *  In poultry/livestock premises, preservative and pulp and paper
     mills, the PPE requirement for mixer/loader/applicators is:
     "Pesticide handlers must  wear:
      -Long-sleeved shirt and long pants
      —Chemical-resistant gloves
      --Shoes plus socks
     In addition, when engaged in pouring this product,
      -A respirator with either an orgamc-vapor-removing cartridge with
     a prefilter approved for pesticides (MSHA/NIOSH approval number
     prefix TC-23C),  or a canister approved for pesticides
     (MSHA/NIOSH approval number prefix  TC-14G),"

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                      •  For metal working fluids and cooling tower water uses, the PPE
                      requirement for mixer/loader/applicators is:
                      "Pesticide handlers must wear:
                       —Long-sleeved shirt and long pants
                       —Chemical-resistant gloves
                       —Shoes plus  socks"
                      •  In poultry/livestock premises, post-application workers must
                      observe the following use restriction on the labeling in the directions
                      describing use as a disinfectant spray:
                      "Entry by any person—other than a correctly equipped handler-is
                      PROHIBITED in the entire enclosed building/structure from the start
                      of application until aeration reduces the air concentration level of
                      formaldehyde  in the working area to less than 0.75 ppm. The air
                      level concentration of formaldehyde must be measured before entry is
                      permitted.  (OSHA issued a final rule for the PEL for formaldehyde
                      as 0.75 pprn,  May 27, 1992, Federal Register, Vol.  57, p. 22290.)
                      Any handler who enters  the treated area during this entry-restricted
                      period must wear;
                       —Long-sleeved shirt and long pants
                       —Shoes plus  socks
                       —A respirator with either an organic-vapor-removing cartridge with
                      a prefilter approved for pesticides (MSHA/NIOSH approval number
                      prefix TC-23C), or a canister approved for  pesticides
                      (MSHA/NIOSH approval number prefix TC-14G)."

Regulatory         The currently registered uses of 2-(hydroxymethyl)-2-nitro-l,3-
Conclusion   propanediol may pose low level cancer risks to workers from the degradate
                formaldehyde, and could pose risks to aquatic organisms under certain
                conditions as industrial effluent containing the parent chemical is released
                into receiving waters. However, the uses will not cause unreasonable
                adverse effects  to humans or the environment, and are eligible for
                reregistration.
                      Products  containing 2-(nydroxymethyI)-2-nitro-l,3-propanedioi as the
                sole active ingredient will be reregistered once the required product-
                specific data and revised labeling are received and accepted by EPA,
                Products also containing other active ingredients  will be reregistered only
                after the other active ingredients also are determined to be eligible for
                reregistration.

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   For  More        EPA is requesting public comments on the Reregistration Eligibility
Information   Decision (RED) document for Tris(hydroxymethyl)nittomethane during a
                60-day time period, as announced in a Notice of Availability published in
                the Federal Register.  To obtain a copy of the  RED document or to submit
                written comments, please contact the Pesticide Docket, Public Response
                and Program Resources Branch, Field Operations Division (75Q6C), Office
                of Pesticide Programs (OPP), US EPA,  Washington, DC 20460, telephone
                703-305-5805,
                     Following the comment period, the Tris(hydroxymethyl)nitromethane
                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 Tris(hydroxymethyl)nitromethane RED, or  reregistration of individual
                products containing the active ingredient 2-(hydroxymethyl)-2-nitro-lf3-
                propanediol,  please contact the Special Review and Reregistration Division
                (7508W), OPP, US EPA, Washington, DC 20460, telephone 703-
                308-8000.
                     For information about the health effects of pesticides, or for
                assistance in recognizing and managing pesticide poisoning symptoms,
                please contact the National Pesticides Telecommunications Network
                (NPTN). Call toll-free  1-800-858-7378, between 8:00 am and 6:00 pm
                Central Time, Monday through Friday.

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REREGISTRATION ELIGIBILITY DECISION


TRIS(HYDROXYMETHYL)NITROMETHANE
                   LISTC

                 CASE 3149
           ENVmONMENTAL-PROTECTION-AGENCY
             OFFICE-OF PESTICIDE-PROGRAMS
        SPECIAL-REVIEW AND'REREGISTRATHM-DmSION

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                         TABLE OF CONTENTS
2-(HYDROXYMETHYL)-2-NITRO-l ,3-PROPANEDIOL REREGISTRATION
      ELIGIBILITY TEAM	   i

GLOSSARY OF TERMS AND ABBREVIATIONS  	iii

EXECUTIVE SUMMARY	  vi

I.     INTRODUCTION	   1

IL    CASE OVERVIEW	   2
      A.   Chemical Overview	,	   2
      B.   Use Profile	   2
      C.   Regulatory History	   5

III.   SCIENCE ASSESSMENT	   5
      A,   Physical Chemistry Assessment  	   5
           1.    Toxicology Assessment	   6
                 a.    Acute Toxicity	   6
                 b.    Subchronic Toxicity .	  .   7
                 c.    Developmental Toxicity  .	  ,   8
                 d,    Mutagenicity		   8
                 e.    Other Toxicity Considerations	   9
                 f.     Reference Dose	   9
           2.    Exposure Assessment 	  10
                 a.    Dietary  	  10
                 b.    Occupational and Residential		  10
           3.    Risk Assessment	  18
                 a.    Dietary	  18
                 b.    Occupational and Residential	  18
      C.   Environmental Assessment	  22
           1.    Environmental Fate	  22
           2.    Ecological Effects		  22
                 a.    Ecological Effects Risk Assessment	  23
                 b.    Endangered  Species		  25

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	    26
      A.   Determination of Eligibility	,	  .  26
           1.    Eligibility Decision	 . .	,  26
           2.    Eligible and Ineligible Uses   	  27
      B.   Regulatory Position	  27
           I,    Labeling Rationale	  27

V.    ACTIONS REQUIRED BY REGISTRANTS	  28

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      A,    Manufacturing-Use Products	   28
            1.    Additional Generic Data Requirements	   28
            2,    Labeling Requirements for Manufacturing-Use Products	   28
      B.    End-Use Products	   29
            1.    Additional Product-Specific Data Requirements  	   29
            2.    Labeling Requirements for End-Use Products	   29
      C.    Existing Stocks	   31

VI.   APPENDICES	,	   33
      APPENDIX A. Table of Use Patterns Subject to Reregistration	   35
      APPENDIX B. Table of the Generic Data Requirements and Studies Used
            to Make the Reregistration Decision	   49
      APPENDIX C. Citations Considered to be Part of the Data Base Supporting
            the Reregistration of 3149  	   57
      APPENDIX D. List of Available Related Documents	   65
      APPENDIX E.	   69
            PR Notice  86-5	   71
            PR Notice  91-2	  ,	   91
      APPENDIX F. Generic Data Call-in	   97
            Attachment 1. Chemical Status Sheet	  117
            Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
                  Instructions	121
            Attachment 3. Requirements Status and Registrants' Response Forms
                  Inserts (Form B) plus Instructions	126
            Attachment 4. List of Registrant(s) sent this DCI (Insert)   ........  133
      APPENDIX G. Product Specific Data Call-in   	,	135
            Attachment 1, Chemical Status Sheet	151
            Attachment 2. Product Specific Data Call-in Response Forms (Form
                  A inserts) Plus Instructions  	,	  153
            Attachment 3. Product Specific Requirement Status and Registrant's
                  Response Forms (Form B inserts) and Instructions  	157
            Attachment 4. EPA Batching of End-Use Products for Meeting Data
                  Requirements for Reregistration	163
            Attachment 5, EPA Acceptance Criteria	167
            Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                  Notice		,	181
            Attachment 7. Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form	183

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2-(HYDROXYMETHYL)-2-NITRO-l»3-PROPANEDIOL
ELIGIBILITY TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Division
                  REREGISTRATION
Gabe Patrick
Michele Pethel
Cynthia Szymanski

Environmental Fate and Effects Division

Jose Luis Melendez
Richard Lee
Jean Holmes

Health Effects Division

Winston Dang
Jane Smith
Flora Chow
Edwin Budd
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Occupational and Residential Exposure Branch
Chemical Coordination Branch
Chemical Coordination Branch
Toxicology Branch I
Registration Division

Doreen Aviado
Valdis Goncarovs
Bipin Gandhi
Mark Perry

Special Review and Rereglstration Division

Ernestine Dobbins
Kathy Davis

Policy and Special Projects Staff

Brian Hirsh

Office of General Counsel:
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Debbie Mack

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Office of Compliance Monitoring:




Beverly Updike



Office of Research and Development:




Elaine Francis




Office of Water:




Donna Reed
                                        11

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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, Drag, and Cosmetic Act

GRAS       Generally Recognized As Safe as designated by FDA

HOT         Highest Dose Tested

LCSO         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.

LD50         Median Lethal Dose,  A statistically derived single dose that can be expected to
             cause death in 50% of the  test animals when administered by the route  indicated
             (oral,  dermal, inhalation).  It is expressed as  a weight of substance per unit
             weight of animal, e.g., mg/kg.

LDto         Lethal Dose-low, Lowest Dose at which lethality occurs

LEL         Lowest Effect Level

LOEL       Lowest Observed Effect Level

MP          Manufacturing-Use Product

MPI         Maximum Permissible Intake
                                         in

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                  GLOSSARY OF TERMS AND ABBREVIATIONS


MOE        Margin Of Exposure (PAD)

MRID       Master Record Identification (number).  EPA's system of recording and tracking
             studies submitted.

N/A         Not Applicable

NPDES      National Pollutant Discharge Elimination System

NOEL       No Observed Effect Level

OPP         Office of Pesticide Programs

PADI        Provisional Acceptable Daily Intake

ppm         Parts Per Million

Q*i          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.
                                        IV

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EXECUTIVE SUMMARY

       The U.S. Environmental Protection Agency (hereafter referred to as "the Agency") has
conducted a review of the available scientific data and other relevant information supporting the
reregistration of the pesticide active ingredient 2-(hydroxymethyl)-2-nitro-l,3-propanedioI.

       This Reregistration Eligibility Decision (RED) addresses the reregistration of products
containing 2-(hydroxymethyl)-2-nitro-l,3-propanediol for currently registered uses.   Pesticide
products  containing  this active  ingredient are  used as a rnicrobicide  and  bacteriostat in
disinfectants  and preservatives.  It is formulated as a powder, as pellets and as a soluble liquid
concentrate. It is applied to livestock and poultry premises by using a spray application method,
and to metalworking cutting fluids, latex paints, drilling muds and packer fluids, pulp/paper mill
systems,  and evaporative condenser  water  systems by using  metering  pump or  pouring
application methods. The Agency has determined that the uses of 2-(hydroxymethyl)-2-nitro-1,3-
propanediol  as  currently registered may pose  low carcinogenic risks  to workers  from the
degradate formaldehyde and could pose risks to aquatic organisms under certain conditions from
the release of 2-(hydroxymethyI)-2-nitro-l,3-propanediol in industrial effluent  into  receiving
waters.  However, the Agency concludes that the uses will not cause unreasonable risk to human
health or the environment and these uses are eligible for reregistration.

       Accordingly, the Agency has determined that all products containing the single active
ingredient 2-(hydroxymethyl)-2-nitro-l,3-propanediol are eligible for reregistration and will be
reregistered when acceptable labeling and product-specific  data are submitted and/or cited.
Before  reregistering  each product, the Agency  is  requiring that  product-specific  data  be
submitted by the registrants within eight months of the issuance of this document. Additionally,
in order to remain in compliance with  FIFRA, it is the Agency *s position that revised labeling
must be submitted by the registrants within that same time period.  After reviewing these data
the Agency will determine whether the conditions and requirements of FIFRA section 3(c)5 have
been met for the reregistration of these products.   Products  containing other active ingredients
subject  to reregistration will  be  reregistered  only after  each active ingredient has  been
reregistered.

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 I.    INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed
in nine years. There are five phases to the reregistration process.  The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by  the  U.S. Environmental Protection Agency  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)-2-nitro-1,3-propanediol.  The document consists of six
sections. Section  I  is  the  introduction.  Section II  describes 2-(hydroxymethyl)-2-nitro-l,3-
propanediol, its uses, data requirements and regulatory history. Section III discusses the human
health and environmental  assessment based on the data available to the  Agency. Section IV
presents the reregistration decision for 2-hydroxymethyl-2-nitro-l,3-propanediol.  Section  V
discusses the reregistration requirements for products containing this active ingredient. 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.'
    1   EPA's reviews of data on the set of registered uses considered for EPA's analysis may
be obtained from the OPP  Public Docket, Field Operations Division  (H7506C),  Office  of
Pesticide Programs, EPA, Washington, DC  20460.

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II.    CASE OVERVIEW
      A.    Chemical Overview

             The  following active  ingredient  is covered by  this Reregistration Eligibility
      Decision document:
             Chemical Name:

             Chemical Family:

             CAS Registry Number:

             OPP Chemical Code:

             Empirical Formula:



             Structural Formula:



             Trade and Other Names:
      B.
Basic Manufacturer:

Use Profile
2-(hydroxymethyl)-2-nitro-1,3-propanediol

Tris(HOCH2-)nitromethane

126-11-4

083902

C4H9N05

       N02

HO-CH2-C-CH2-OH

       CHrOH

Tris-Nitro; Cimcool wafers;
Tris{hydroxymethyl)nitromethane;
Nitroisobuty Iglycerol; Trimethylolnitromethane;
Nitrotris(hydroxymethyl)methane

Angus Chemical Company
             The following is information on the current registered uses with an overview of
      use sites and application methods.  A detailed table of the use of 2-(hydroxymethyl)~2-
      nitro-l,3-propanediol is in Appendix A.
             Type of Pesticide:
             Use Sites:
                    Disinfectant (general);
                    microbieide/microMostat  (slime-forming  bacteria  and
                    fungi);   fungieide/ftmgistat;   fungicide;    industrial
                    preservative/preservative (bacteriostat).

                    Terrestrial non-food:
                    oil recovery drilling muds/packer fluids (preservatives)

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                    Aquatic non-food industrial:
                    pulp/paperrnill water systems; commercial/industrial water
                    cooling systems; evaporative condenser  water systems;
                    secondary oil recovery injection water; oil recovery drilling
                    muds/packer fluids (preservatives)

                    Indoor non-food:
                    metalworking  cutting   fluids;   oil   recovery  drilling
                    muds/packing fluids (preservatives);  latex paints (in-can
                    preservative);  specialty  industrial  products-packaged;
                    resin/latex/polymer emulsions, (emulsions, solutions, or
                    suspensions such as detergents and  polishes  containing
                    water); livestock premises and poultry premises.

Target Pests:       Disinfectant for disease organisms found on farm premises
                    and equipment.  Bacteriostat, microbicide/microbiostat for
                    the following organisms:  aerobic slime-forming bacteria
                    (Pseudomonas spp,), anaerobic sulfate-reducing bacteria,
                    such as Desuifovibrio desulfuricans.
Formulation Types Registered:

       Technical grade active ingredient, manufacturing use, end use

       Soluble  concentrate/liquid,  soluble  concentrate/solid, pelleted/tableted,
       crystalline

       (19.2 - 100% active ingredient)


Method and Rates of Application:

       Types of Treatment-

       Industrial preservative  treatment, water treatment, water  recirculating
       system treatment, premise  treatment, transportation vehicle treatment,
       animal equipment treatment

       Equipment -  sprayer, metering pump

       Method  and Rate - Indoor Non-food;

       Metalworking cutting fluids:  313-2500 ppm a.i. by volume

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       Latex paints: 1000-5000 ppm a.L by weight

       Resin/latex/poiymer emulsions:  100-5000 ppm a.i. by weight

       Specialty industrial products:  500-1000 ppm a.i. by weight

       Livestock and poultry premises:  1500 ppm a.i. by volume

       Method and Rate - Aquatic non-food industrial:

       Commercial/industrial  water cooling systems and evaporative condenser
       water systems:  8-500 ppm a.i. by volume; 10 to 609 ppm by weight

       Pulp and paper mill water systems: 570 to 2540 ppm a.i, by weight

       Oil recovery drilling muds/packer fluids:  63-500 ppm a.i. by volume

       Secondary oil recovery injection water: 476-952 ppm a.i. by volume; 580
       ppm to 1159 ppm by weight

       Timing  - As  needed;  during  manufacture; initial,  continuous and
       intermittent feed

Use Practices Limitations:

       The following use practice limitations are currently on labeling  for these
       products:

       "Decomposition occurs in the presence of alkaline materials. Protect from
       vapors of ammonia and amine during handling and storage to prevent
       deterioration and  release of  formaldehyde.    All treated animal  feed
       appliances must be thoroughly scrubbed with detergent and rinsed with
       potable  water prior to  reuse.  Ventilate building,  vehicles, and other
       closed spaces.   Not for use  in  California in one, two,  or all of the
       following systems (depending on the label):   in industrial recirculating
       water systems, in pulp and paper mill process water systems, or as  a
       preservative  in  packaged emulsion, solutions,  or suspensions  such as
       detergents and polishes containing water."

       "Do not use in milking stalls,  milking parlors, or milk houses.  Remove
       all animals, poultry, eggs,  or chicks and feeds from buildings,  vehicles,
       coops, crates,  and  enclosures.  Do  not  house  poultry  or livestock,
       introduce eggs or  chicks, or employ equipment until treatment  has been
       absorbed,  set, or  dried.   Do  not discharge effluent containing this

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                     pesticide into sewage systems without notifying the sewage treatment plant
                     authority.  Do not discharge effluent containing this product into  lakes,
                     streams,  ponds,  estuaries, oceans, or public  water  (NPDES license
                     restriction)."

       C.     Regulatory History

                     2-(hydroxymethyl)-2-nitro-l,3-propanediol was first registered in  the
              United States in 1955 as an active ingredient for use in industrial bacteriocide and
              slimicide  products.   Currently,  nine products are  registered  for use  in
              metalworking fluids systems, oil field systems, cooling water systems, papermills,
              and livestock areas as a preservative, as a disinfectant and  as  a formulating
              technical material. Three Data Call-in Notices for 2-(hydroxymethyl)-2~nitro~ 1,3-
              propanediol have been issued. The Antimicrobial Data Call-in of March 4,  1987,
              required toxicology data and data on applicator exposure to antimicrobial pesticide
              active ingredients in a variety of industrial, commercial, consumer,  and other
              applications and settings.  An industry consortium generated a single exposure
              study  to cover  multiple use patterns for a group of chemicals for consortium
              members.  This applicator exposure  study (M1ID 41412201) was commissioned
              by the Chemical Manufacturers Association and the  study has fulfilled this data
              requirement The second Data Call-In was the comprehensive reregistration Phase
              4 Data Call-In  of September 30,  1992,  in  which chemistry,  ecotox  data,
              hydrolysis and residue data were  required.  The third Data Call-In was  issued
              August 9, 1993  for residue data  in edible livestock tissues or, in lieu of data,
              label changes could be made to eliminate all possible means of exposure from this
              use.   This Reregistration Eligibility Decision reflects a reassessment of all data
              which were submitted in response to reregistration.

III.    SCIENCE ASSESSMENT

       A,     Physical Chemistry Assessment

              2-(hydroxymethyl)-2-nitro-1,3-propanediol is an odorless, white solid which melts
       at  175-176'  C with decomposition.   It is soluble in polar solvents such  as water,
       inethanoi, ethanol, and isopropanol, but insoluble in non-polar solvents like aliphatic and
       aromatic hydrocarbons. This chemical is stable only under  acidic conditions  of pH 5.0
       and below, and is unstable and decomposes to formaldehyde under alkaline conditions
       and at temperatures above 49° C.

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B.     Human Health Assessment

       1.     Toxicology Assessment

       The  toxicology data  base  for  2-(hydroxymemyl)-2-nitro-l,3-propanediol  is
adequate for reregistration eligibility.   Toxicity studies indicate 2-(hydroxymethyl)-2-
nitro-l,3-propanediol has low acute toxicity and that there are no toxicologicai concerns
associated with  this active  ingredient oer se that  lead to significant concerns.   The
Agency has  also determined,  however, that the  degradate  of the  active  ingredient,
formaldehyde, poses a concern.

       Other than the acute inhalation and eye irritation studies using the 100% technical
grade powder, the Tier I studies (guidelines 82-3, 90-day dermal; 83-3, developmental
toxicity; and 84-2, mutagenicity battery) required for antimicrobial type active ingredients
have been satisfied.  The acute inhalation (rat) and eye irritation (rabbit)  studies using
the technical grade powder (100%) are  required as confirmatory data for the  reasons
discussed below.

              a.     Acute Toxicity

                     The acute  studies were conducted  on  the  53,1  -  56.8%  2-
              (hydroxymethyl)-2-nitro-l,3-propanediol  aqueous concentrate solution.
              The table presented below summarizes the results of the acute  studies and
              is intended for general reference only.

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TABLE I.  Acute Toxicity
            Test
    Result
Category
   Acute Oral LD50 (rat)1
1890 mg/kg (m)
1860 mg/kg (f)
   III
Acute Dermal LD50
(rabbit)2
Acute Inhalation LCSO
(rat)3
Eye Irritation (rabbit)4
Dermal Irritation (rabbit) s
Skin Sensitization
(guinea pig) 6
> 2000 mg/kg
2,4 mg/liter
slight irritation
non-irritating
negative
III
III
IV
IV
n/a
I MRID 094711
2 00043222/00094713
3 00094711
4 00094711
5 00094715/00109228
6 00094715
n/a = not applicable
                    Acute toxicity studies were not conducted using the technical grade
             powder (100%).  Additional acute inhalation (rat) and the eye irritation
             (rabbit)  studies are required  using  the  2-(hydroxymethyl)-2-nitro-i»3-
             propanediol technical grade powder form since this form may present the
             greater potential  exposure, hence risk,  as compared with the wafer or
             pellet forms. The aqueous solution is not an appropriate dosage form for
             these studies.   These two studies, although required by  the Agency, are
             considered to be confirmatory because the acute toxicology data base
             suggest 2-(hydroxymethyl)-2-nitro-l,3-propanediol has low acute toxicity
             to mammals.

             b.     Subchronic Toxicity

                    In a 90-day subchronic dermal toxicity study, male and female
             Crl;CD BR rats were treated  dermally for 6 hours per  day, 5 days per
             week  with a  paste of  2-(hydroxymethyl)-2-nitro-l,3-propanediol in
             deionhed water.  Dosage levels were 0, 250, 500 and 1000 mg/kg/day.
             The test  material was  essentially non-irritating  to  the skin, although
             yellowish discoloration was noted at test sites.  There were no treatment-
             related effects  observed at any dosage level.  The NOEL for systemic
             toxicity is >_ 1000  mg/kg/day. (MRID 41021101)

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c.     Developmental Toxicity

       A developmental  toxicity  study  was conducted  with  pregnant
Sprague  Dawley Crl;CD BR rats which were administered daily doses of
0,  50,  375  or  750 mg/kg/day  of  2-(hydroxymethyl)-2-nitro-lf3-
propanediol by gavage on days 6 through  15 of gestation.  Treatment-
related maternal effects were observed only in the high-dose group and
included:  (1) increased mortality  (7/25  or 28% of the group),  (2)
decreased mean body weight  gain, and (3) clinical signs  of toxicity
(including head bobbing,  tremors, and circling  motions).  A treatment-
related  developmental effect,  observed at 375  mg/kg/day  and 750
mg/kg/day, was increased mean number of resorptions per dam.  At 750
mg/kg/day, fetal body weights were also reduced.  Therefore, the NOEL
and LOEL for maternal toxicity are 375 mg/kg//day and 750 mg/kg/day,
respectively.   The NOEL and LOEL for developmental toxicity are 50
mg/kg/day and  375  mg/kg/day,  respectively.   A  slightly increased
incidence of omphalocele in the 750 mg/kg/day fetuses in this study, when
compared to  historical control data,  suggested  the  possibility of an
additional developmental effect. (MRID 41021102/41089301)

       In a second developmental  toxicity study, pregnant New Zealand
white rabbits were administered daily doses of 0, 10, 30 or 75 mg/kg/day
of 2-(hydroxymethyl)-2-mtro-lf3-propanediolby gavage on days 7 through
19 of gestation.  Treatment-related maternal effects were observed only
in the high-dose group and included:  (1) decreased mean body weight
gain,  and (2)  decreased mean food consumption.  No treatment-related
developmental effects were observed in the study.  One omphalocele was
observed in the control group and  one in  the 75 mg/kg/day group.  This
finding was not considered to be treatment-related. Therefore, the NOEL
and LOEL for maternal toxicity are 30  mg/kg/day and 75 mg/kg/day
respectively.  The NOEL for developmental toxicity is _>_ 75 mg/kg/day.
(MRID 42303501)

d.     Mutagenicity

       A Salmonella tvphimurium reverse mutation assay (Ames assay)
was conducted using 2-(hydroxymethyl)-2-nitro-l ,3-propanediol as the test
material.  Strains TA98,  TA100,  TA1535,  TA1537 and TA1538 were
tested without and with S9 metabolic activation. No increases in reverse
mutations were observed at concentrations up to 1000 ug/plate. (MRID
41058101)

       2-(hydroxymethyl)-2-nitro-l,3-propanediol  was   tested   in   a
chromosomal aberration assay using Chinese Hamster Ovary (CHO) cells
                       8

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in vitro without and with metabolic activation up to a cytotoxic level of
2000 ug/ml.  The study  was negative for induction of chromosomal
aberrations. (MRID 41944301)

       2-(hydroxymethyl)-2-nitro-l,3-propanediol was  also tested in an
unscheduled  DNA damage/repair  in  vitro study  using  primary  rat
hepatocytes at concentrations up to 10,000 ug/mi. The test was negative
for inducing unscheduled DNA synthesis.  (MRID 41944302)

e.     Other Toxicity Considerations

        The rat oral  developmental toxicity study (MRID 41021102/
41089301) has not been selected as an endpoint for assessing acute dermal
worker exposure to the parent compound 2-(hydroxymethyl)-2-mtro-l,3-
propanediol because the NOEL for developmental  toxicity via the  oral
route likely overstates the actual hazard. This conclusion is based on the
large gap between the developmental NOEL in the study of 50 mg/kg/day
and the LOEL of 375  mg/kg/day for resorptions which were observed at
an incidence only slightly higher than that of control values.  In addition,
the lack of toxicity of 2-(hydroxymethyl)-2-nitro-l,3-propanediol when
administered to the rat by the dermal route (the most  likely route of
worker exposure or human exposure since there are  no  food uses for this
chemical)  at a dose of 1000 mg/kg/day (limit dose) for 90 days  (MRID
41021101, 932200211) strongly suggests that the dermal absorption of the
test material is limited. In contrast, the test material was maternally toxic
by the oral route  in  the developmental toxicity study (NOEL  of  375
mg/kg/day and LOEL of 750 mg/kg/day)  which incorporated a much
shorter dosing period.

       The  antimicrobial  properties of 2-(hydroxymethyl)-2-nitro-l,3-
propanediol are due  hi large part to the slow release over time of
formaldehyde  (HCHO)  from  the  active  ingredient  under alkaline
conditions.  The rate  of release is  highly dependent on the pH of the
solution and on the temperature (the higher the pH of the solution and/or
the higher the temperature, the faster the release).  Since formaldehyde
has significant toxic effects of its own, and has also been classified by the
Agency as a Group Bl (probable human) carcinogen,  the toxicity of
formaldehyde is a primary consideration in evaluating  the toxicity of 2-
(hydroxymethyl)-2-nitro-l,3-propanediol  and   performing   the   risk
assessment.

f.      Reference Dose

       The Agency has not established a Reference Dose (RfD) for 2-

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       (hydroxymethyl)-2~ratro-l ,3-propanedioI, because it has no food/feed uses
       and  no  subehronic  or  chronic  oral  toxicity  studies  other  than
       developmental toxicity studies in rats and rabbits are available from which
       to derive an RfD,

2.     Exposure Assessment

       a.     Dietary

             No dietary exposure is  expected  as a result of  registered  uses.
       There is one disinfectant use that was identified as a food use  during the
       reregistration process:  treatments in/on livestock premises/equipment,
       No  tolerances exist  for  residues  of  2-(hydroxymethyI)-2-nitro-l,3-
       propanediol in meat, milk,  eggs, or poultry. Presently,  this disinfectant
       use  has  been modified on  the label  by the registrant deleting the milk
       house and milking equipment uses.  The poultry house uses are maintained
       with explicit label restrictions reflecting established Agency nonfood use
       policies  eliminating the means of exposure of edible livestock tissues or
       eggs to 2-(hydroxymethyl)-2-nitro-l ,3-propanediol; therefore, no residue
       data, tolerances or exemptions from tolerances are required.

       b.     Occupational and Residential

             2-(hydroxymethyl)-2-nitro-l,3-propanediol  is  formulated  as  a
       powder, as solid pellets or  as a soluble concentrate liquid.  It is applied
       to livestock/poultry equipment by using a spray application method. It is
       used in metal cutting fluids, drilling  muds and packer fluids,  pulp/paper
       mill systems, and evaporative condenser water systems by using metering
       pump  or  pouring  application methods.   The  active  is  used  as  a
       preservative in  paints, emulsions,  and thickeners,    Under  alkaline
       conditions, this, compound degrades to form formaldehyde which enhances
       its antimicrobial properties.

             2-(hydroxymethyi)-2-njtro-i ,3-propanediol has many uses that may
       involve  exposure  to workers.   This  compound  meets the Agency's
       exposure criteria for requiring exposure monitoring data due to the
       presence of, or degradation to formaldehyde.  These data requirements for
       mixer/loader/applicator can  be met by the  Chemical  Manufacturers
       Association (CMA) exposure assessment database (MRID 41412201). The
       exposure to this compound  by workers can be represented by  five of the
       uses:  paint preservative, pulp and paper mill, cooling tower water,  metal
       cutting fluids and livestock/poultry premises disinfectant.   This database
       was used to estimate mbcer/loader/applicator combined inhalation and
       dermal exposure based on the type of application (e.g., pour solids, low
                             10

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pressure spray)  and the uses in pulp and paper  mill water,  in cooling
tower water, in metal cutting fluids, as a preservative in paints and in
livestock/poultry premises as a disinfectant.  These exposure estimates are
provided in Tables II. and III. below.

       For the poultry/livestock disinfectant use,  the total exposure was
determined for formaldehyde as a result of the degradation of 2-(hydroxy
methyl)-2-nitro-l,3-propanediol   to   formaldehyde   and  from  the
formaldehyde present as an active ingredient.

Mixers/Loaders/Applicators Exposure Assessment - 2-(hydroxymethyl)-2-
nitro-1,3-propanediol

       Preservative   and   pulp   and   paper   mill   use   -    The
mixer/loader/applicator exposure is considered  significant for these uses
(see Table n).  The exposure concern associated with using open pouring
methods (of this solid material)  for pulp and  paper systems and paint
preservatives can be reduced ten-fold by using  a  respirator and personal
protective equipment (PPE),

       Poultry/livestock   disinfectant   -  The  mixer/ioader/applicator
exposure is considered low  for this low pressure disinfectant spray use
(see Table  III);  however, PPE and a respirator  would reduce potential
exposure to mixer/loader/appHcators from formaldehyde.

       Cooling  tower   and   metal   cutting   fluids   -    The
mixer/loader/applicator exposure is considered very low for these uses
(see Table II);  however, PPE would reduce potential  exposure from
formaldehyde.
                       11

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TABLE  II.  Average Daily Dose (or Exposure)  Using the Pure Solid (100% active
ingredient [a.L]) 2-(hydroxymethyl)-2-nitro-l,3-propanediol
POUR SOLIDS
Setting
Preser-
vative
P&P Mills
Cooling
Tower
Metal Fluid
MCS1
(ug/lb ai)
14310
14310
630
14310
Ibai
used
2
50.8
25.4
7.6
Ib ai/
yr
500
1321
660
92
BW2
(kg)
70
70
70
70
Daily
Exp.3
408.86
10,385
228.6
1,554
Annual
Exp,4
102,214
270,009
5,940
18,807
ADD5
280.04
739.75
16,27
51.53
i  MCS = Maximum Credible Sum was derived from CMA Study,
2  BW = Body Weight
3  Daily Exposure (ug/kg/day) = (MCS X Ib ai/used)/BW
4  Annual Exposure (ug/kg/yr) = (MCS X Ib ai used/yr)/BW
s  ADD (ug/kg/day) = Annual Exposure / 365 days
                     = Amortized Average Daily Dose

Assumptions for Table II include the following maximum use rates:
(1). Use as preservative:  0.4 Ibs of pure solid  is  added per 100 gallons of the
    formulation.  Assume  a total of 500 gallons per treatment and 250
    treatments per year.
(2). Use for pulp and paper mill systems:  5.08 Ibs of pure solid per ton of pulp
    or paper (dry  basis).    Assume a total of 10 tons of pulp or paper per
    treatment and 26 treatments per year.
(3). Use for cooling water  tower systems:  5.08 Ibs of pure solid is added per
    1000 gallons of water.  Assume a total of 5000 gallons of water per
    treatment and 26 treatments per year.
(4), Use for metal working fluids:  2.54 Ibs of pure solid is added per 100
    gallons of oil.  Assume a total  of 300 gallons of oil per treatment and  12
    treatments per year.
                                   12

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TABLE III.  Average Daily Dose using the Disinfectant Soluble Concentrate Liquid
containing Two Active ingredients: 19.2%  2-(hydroxymethyI)-2-nitro-1,3-propanediol
and 2.28% Formaldehyde
LOW PRESSURE SPRAY
Setting
Disinfectant
2-(hydroxymethyI)-2-
nitio- 1 3-propanedio!
Formaldehyde
MCS1
(ug/lb ai)

24870
24870
Ibai
used

0,67
0.08
Ibai/
yr

17.5
2.08
BW2
(kg)

70
70
Daily
Exp.3

238.04
28.42
Annual
Exp.4

6217,5
738.99
ADD5

17.03
2.02
i  MCS = Maximum Credible Sum was derived from CM A Study.
2  BW = Body Weight
3  Daily Exposure (ug/kg/day) = (MCS X Ib ai used)/BW
4  Annual Exposure (ug/kg/yr) = (MCS X Ib ai used/yr)/BW
s  ADD (ug/kg/day) = Annual Exposure / 365 days
                     = Amortized Average Daily Dose

Assumptions for Table III;
(I) the density is 9  Ib/gal for the 19.2 % a.i. solution.

(2) one ounce of this disinfectant solution is diluted by 128 oz (one gallon) of water.

(3) assume 50 gallons of such diluted solution per treatment and 26 treatments per year.
the maximum use rate.
             Post-Applicator Exposure Assessment  -  2-(hydroxymethyl)-2-nitro-l,3-
             propanediol

                    Post-application  worker exposure  to  the  active ingredient. 2-
             (hydroxymethyl)-2-nitro-l, 3-propanediol,   is  minimal  for  all   uses
             However, given its degradation to formaldehyde this must be considered
                                    13

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             Mixers/Loaders/Applicators Exposure Assessment - Formaldehyde

                    Based on the available information from the literature, at 25°C and
             pH 7.5, the dissociation rate of 2-(hydroxymethyI)-2~nitro-l ,3-propanediol
             in aqueous phosphate solution is less than 10% in the first 5 days. Higher
             alkalinity and temperature increase the rate of conversion to and percent
             of formaldehyde. The release of 2 moles of formaldehyde from one mole
             of 2-(hydroxymethyl)-2-nitro-l,3-propanediol is shown below:
(CH2OH)3CN02    OH"     2 CH2O + unidentified products
                    (unidentified products could be, e.g., nitroethanol is unstable and
                    could decompose to nitroethene and water).

                    The   mixer/loader/applicator  exposure to  formaldehyde  was
             estimated using the average daily dose (ADD), or exposure, estimated for
             mixers/loaders/applicators for 2-(hydroxymethyl)-2-nitro-l ,3-propanediol
             and assuming a 10% degradation to formaldehyde (see Table IV).
                                    14

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TABLE IV.  The Average Daily Dose of Formaldehyde  Based on a 10% Conversion
from 2-(hydroxymemyl)-2-nitro-i,3-propanediol and the Exposures from Tables II, and
III for AH Uses
Setting
Preservative
P & P Mills
Cooling Tower
Metal Fluid
Disinfectant
(two actives)
ADD
2-(hydraxpr*tiiyl)-2-nkrol,3-
ppopanedktl
(ug/kg/day)
280.04
739,75
16.27
51.53
17.03
-
10% ADD
2-(hydroxymethyt)-2-niiro- 1 .3-
piopaaedio!
(ug/kg/day)
28,0
73.97
1.63
5.15
1.7
-
ADD
FormaIdehydeA
{ug/kg/day)
12
31.8
0.69
2.2
0.70 +
2,Q2B = 2.72
A As discussed above, \ mole of 2-(hytSrojtyfnethy]}-2-niTO-l,3-prop8nediol forms 2 moles of formaldehyde- The ADD for Formaldehyde is
calculated as follows, e.g. (28,0 ug/kg/day / molecular weight of formaldehyde) X 2 moles of formaldehyde = 12 ug/fcg/day formaldehyde for
the preservative use.
B The ADD for formaldehyde from Table III.
                     Preservative, pulp and paper mills - The mixer/loader/applicator
              exposure to formaldehyde for these uses should be brief (e.g., less than
              one  hour for each treatment)  since  only  a  small  amount,  if  any,
              degradation   from   2-(hydr0xymethyl)-2-mtro-l,3-pK>panediol   to
              formaldehyde should occur in that short interval.  However, the exposure
              to 2-(hydroxymethyi)-2-nitrG-l,3-propanediol is considered significant for
              these uses. Thus, personal protective equipment is required as well as a
              respirator.  Therefore, what exposure to formaldehyde that might  have
              occurred is reduced ten-fold by using personal protective equipment and
              a respirator.

                     Cooling towers and metal cutting fluids - Since the time needed for
              loading 2-(hydroxymethyl)-2-nitro-l ,3-propanediol products for these uses
              should be brief (e.g. less than an hour for each treatment), the potential
              exposure to the mixer/loader/applicator to 2-(hydroxymethyl)-2-nitro-l,3-
              propanediol  and  formaldehyde  will be  of  relatively short  duration.
              Additionally,  only  a  small amount,  if  any, of degradation from 2-
              (hydroxymethyl)-2-nitro-l,3-propanedioI to formaldehyde should occur in
              that short interval.  For these reasons, the use of a respirator  would not
                                      15

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be an advantage.

       Poultry/livestock disinfectant -  The Agency is concerned about
potential exposure of mixer/loader/applicator to formaldehyde for this use
since formaldehyde is already present as an active  ingredient  in the
product and the application involves a spray method. These workers are
also exposed to the concentrated active ingredients during mixing of the
diluted spray solution. Use of a respirator and PPE would result in a. ten-
fold reduction in the exposure.

Post-Application Worker Exposure - Formaldehyde

       Preservative use, cooling tower, and metal cutting fluids - Post-
application worker exposure to formaldehyde from the degradation of 2-
(hydr0xymethyl)-2-nitro-l,3-propanediol is minimal for the cooling tower
use, the preservative use, and the cutting fluid use because the degradation
conditions, i.e. the very alkaline conditions in  combination with high
temperature, are not likely to occur in these use situations.

       Poultry/livestock disinfectant - Post-application worker exposure
to formaldehyde can be expected as a result of the use of the disinfectant
spray in livestock/poultry premises, because formaldehyde is an active
ingredient in this disinfectant spray and the 2-(hydroxymethyl)-2-nitro-l ,3-
propanediol will  slowly  degrade to formaldehyde.   Therefore,  post-
application inhalation exposure is of particular concern.  Post-application
monitoring data requirements for formaldehyde are being addressed for
poultry houses under the reregistration data call-in for formaldehyde.

         Although the post-application worker exposure is of concern for
the poultry/livestock disinfectant use, the mixer/loader/applicator estimate
actually  represents the worst case  scenario of exposure.   The post-
application worker in the  poultry/livestock building is not exposed to the
concentrated product (used for mixing) or the spray  application of the
formaldehyde.   In addition, part of the application process  is to rinse  all
treated surfaces with potable water  approximately 10  minutes following
spray  application.    Products containing formaldehyde  as  the  active
ingredient for this use are also regulated by the Occupational Safety and
Health   Administration  (OSHA)   which  requires   monitoring   for
formaldehyde before workers enter the premises following treatment. The
OSHA Permissible Exposure Limit (PEL) for formaldehyde is 0.75 ppm.
Therefore, the post-application worker exposure is the same  as (or less
than) that of the mixers/loaders/applicators for the disinfectant use.  PPE
and  respirators are required for workers entering the treated areas before
air level  concentrations for formaldehyde have bees measured.
                       16

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       Pulp  and paper  mills  -  Post-application worker  exposure to
formaldehyde can be expected as a result of the use of 2-(hydroxymethyl)-
2-nitro-l,3-propanedioI  products  in  pulp and paper mills.   The  post-
application worker exposure to formaldehyde  can be  estimated for a
lifetime based on the average daily dose; ADD  X work years/years (life
expectancy);  or, 0,0029  mg/kg/day X 35 work years/70 years  (life
expectancy) = 0.00145  mg/kg/day = LADD.

       In calculating the ADD, the Agency considered converting 10% of
the active to formaldehyde; the concentration in pulp mixture; determining
the vapor  concentration of formaldehyde (if all of the  formaldehyde
converted to the vapor phase); the inhalation rate  for an average worker;
the total formaldehyde  inhaled during an 8 hour work  day; and the
lifetime working exposure.  These and other assumptions include:

1) the temperature is 25°C  and the pH is 7.5,
2) the slow degradation for 2-(hydroxymethyl)-2-nitro-l,3-propanediol.
i.e. only 10% in water is converted into the formaldehyde,
3) a total of 50.8 pounds of 2-(hydroxymethyl)-2-nitro-i,3-propanediol
is added into the pulp mills,
4) 10 tons of pulp was treated with this compound and approximately 10
million gallons of water (37.8 million liters) are used,
5) the molecular weight of 2-(hydroxymethyl)-2-nitro-l,3-propanediol is
151 and the molecular weight of formaldehyde is  30,
6) an alkaline solution where one mole of 2-(hydroxymethyl)-2-m"tro-l ,3-
propanediol is converted to 2 moles of formaldehyde,
7) the partial vapor pressure of formaldehyde at 760 rnmHg, 25 °C, and
a concentration  of  0.02419 mg/L in water can  be converted to vapor
concentration at  0.0177 mg/m3,
8) the worker body weight of 70 kg,  working at the area for 8 hours/day,
5 days a week, 250 days/year, at an inhalation rate of 16.8 m3 of air were
inhaled/day, and
9) lifetime exposure is 35 years in a  lifetime of 70 years.

       This determination of post-application exposure is conservative
since factors resulting in dilution of the formaldehyde concentration were
not considered; e.g., the pulp mixture is generally  not stationary and there
are ventilation systems in mills.  Since this is a very conservative estimate
of the post-application worker exposure and the Agency  may   have
overestimated worker exposure, a post-application inhalation exposure
monitoring study is required for uses in pulp  and paper mill systems.
These data are considered confirmatory by the Agency. This study will
provide the Agency with  a  more accurate estimation of potential  post-
application exposure to workers.
                       17

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             The labeling to protect workers is contained in Section V at the end
       of this document,

3.     Risk Assessment

       a.    Dietary

             There  are  no  food  uses  associated  with  the use   of  2-
       (hydroxymethyl)-2-nitro-l,3-propanediol;    therefore,  no dietary  risk
       assessment was conducted by the Agency.

       b.    Occupational and Residential

             Overall, there is minimal risk associated with the active ingredient,
       2-(hydroxymethyl)-2-rutro-l,3-propanedioL  The exposure to this active
       ingredient for mixers/loaders/applicators is minimal   and there are no
       toxicological concerns associated with this chemical that lead to significant
       risk concerns.

             The risk  of concern associated with the use of products containing
       2-(hydroxymethyl)-2-nitro-l,3-propanediol  is due to the degradation
       product,  formaldehyde,  which  is  slowly  released   from the  active
       ingredient under alkaline conditions and the presence of formaldehyde as
       an active  ingredient in one product.

             For details on the effects and risks associated with formaldehyde.
       the following EPA documents should be consulted:

       Assessment of Health Risks to Garment Workers and Certain     Home
       Residents from Exposure to Formaldehyde. Office of Pesticides  and Toxic
       Substances, U.S.E.P.A., April,  1987, pp. 7-1 to 7-11.

       Formaldehyde Risk  Assessment  Update, Final  Draft, Office of Toxic
       Substances, U.S.E.P.A., June 11, 1991.

       Guidance  for   the  Registration  of Pesticide  Products  Containing
       Formaldehyde and Paraformaldehvde as the Active Ingredient, Office of
       Pesticides and Toxic Substances, Office of Pesticide Programs  (OPP).
       U.S,E.P,A,,May31» 1988.

             In the 1987 risk assessment, the administered dose  was expressed
       as ambient air concentration (formaldehyde concentration in ppm) and was
       used directly as the measure of dose in the risk assessment. In the !99!
       risk assessment, the  administered dose was expressed as an intracellular
                             18

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dose, which was derived from a measurement of the amount of DNA-
protein crosslinking (DPX) in the nasal target cells themselves. The 1991
document presented scientific evidence derived from studies in  rats and
monkeys and a rationale which suggested that use of the DPX data would
provide a more meaningful measure of dose to the target tissue  than the
ambient air concentration and, in turn, would lead to a more accurate risk
estimate.  Also, die 1987  assessment utilized a  lifetime  average  daily
exposure adjustment, whereas the 1991 assessment did not,

       For the purpose of estimating carcinogenic risks to humans, the
1987 document derived an airborne upper bound incremental unit risk of
1.6 x 1Q~2 per ppm (lifetime individual risk, based on continuous exposure
for 70  years).  The 1991 document derived comparable unit risks of 2.8
x 10"3 per ppm and 3.3 x 1O4 per ppm based on the rat and monkey  DPX
data, respectively  (for formaldehyde  concentrations below 0.3 ppm).
These  unit risks  are 6 to 50 times lower than those calculated in 1987.
The Agency believed the risk for humans most likely was between that for
rats and monkeys.

       In 1991,  the EPA Science Advisory Board  (SAB) was asked to
comment  on  the  novel  1991  DPX  methodology   for calculating
carcinogenic  risks for formaldehyde.   The  SAB  response  (in  1992)
expressed reservations regarding the use of the 1991 methodology and
particularly use of the monkey DPX data for this purpose.  Consequently,
there is considerable uncertainty at this time regarding the use of the 1991
risk assessment methodology and the 1991 document; a "final draft", has
not yet been "finalized."  In the interim, prudence dictates that the  1987
methodology should be used for formaldehyde risk assessments.

       IE 1988,  EPA published a  Registration Standard for pesticide
products  containing formaldehyde  and paraformaldehyde.    In  that
Registration Standard,  carcinogenic risks to agricultural workers  were
calculated based on the risk assessment methodology presented in the 1987
OPTS  document referenced previously  in this chapter.   In the  1988
Registration Standard, a Qf of 1.87 x  10'2  (mg/kg/day)4 was used to
calculate carcinogenic risks for agricultural workers. Using this same Qf
and methodology, the estimate of carcinogenic risks associated  with the
five use  patterns  for  2-(hydroxymethyl)-2-nitro-l,3-propanediol are
calculated as follows:

Carcinogenic Risk    =   Q(*   x  LADD

       The LADD is determined  for the five representative  uses by
multiplying the Average Daily Dose (ADD) for formaldehyde for each use
                      19

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         times the fraction of lifetime exposed, i.e. 35 work years / 70 years (life
         expectancy). The LADDs for the five use patterns of 2-(hydroxymethyl)-
         2-nitro-l,3-propanedioI are provided in Table V. below.

TABLE V.  Lifetime Average Daily Dose (LADD) of Formaldehyde
for Five Representative Use  Patterns for Mixers/Loaders/Applicators
Representative
Use Pattern
Preservative
Wood P & P
Cooling Tower
Metal Fluid
Disinfectant
(poultry/livestock)
ADD
Formaldehyde
(mg/kg/day)1
0.012
0.032
0.00069
0.0022
0.0027
LADD
Formaldehyde
(mg/kg/day)
0.006
0,016
0.00035
0.0011
0.0014
   derived from the 1055 conversion of Uie active ingredient w formaldehyde.
         Using these LADD estimates and the Q,,* cited above, the upper bound
  increase  in  carcinogenic risk for each  representative use  pattern, based  on
  mixer/loader/applicator exposure to formaldehyde,  is derived.  These estimated
  excess  carcinogenic risks are presented below (Table VI),
 TABLE VI.  Upper bound Excess Carcinogenic Risk Estimates for
    Mixers/Loaders/Applicators from Exposure to Formaldehyde
                   without PPE and respirators

              Use Pattern           Excess Carcinogenic Risk
             Preservative                   1.1 x 10^

         Wood Pulp & Paper               3.0 x IQ-4
           Cooling Tower                 6.5 x 10"6

         Metal Cutting Fluids               2.1 x 10~5
              Disinfectant                   2.5 x 10"5
          (poultry/livestock)
                               20

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          The actual exposure to formaldehyde is expected to be less than the values  used
    to calculate the carcinogenic risk estimates presented in Table VI since  the conversion
    rate of the active ingredient to  formaldehyde probably would be less than 10%.  In
    addition, mixer/loader/applicator exposure  will  be further  mitigated by  the use of
    personal protective equipment and respirators, which could reduce dermal and primarily
    inhalation exposure to airborne formaldehyde at least ten-fold.  With the use of personal
    protective equipment and respirators for the pulp and paper mill use, the preservative use
    and the disinfectant use, the refined estimate of the upper bound increase in carcinogenic
    risk for each of these three representative use patterns, based on mixer/loader/applicator
    exposure to formaldehyde, is reduced ten-fold.  See Table VII below.  The metal cutting
    fluid   uses   and   the  cooling  tower   uses   involve   minimal   exposure   of
    mixer/loader/applicators to formaldehyde as described above in the section on exposure.
    If PPE,  not including respirators, were  used, the upperbound excess carcinogenic risk
    to formaldehyde would be unchanged from the risk estimates in Table VI,  Respirators
    would not be useful in reducing exposure and risk for these two uses because of  the short
    duration of handling the products under these use conditions, resulting in little time
    available for formaldehyde formation.
     TABLE VII.  Refined Upper bound Excess Carcinogenic Risk Estimates for
Mixers/Loaders/Applicators from Exposure to Formaldehyde with PPE and Respirators

                      Use Pattern           Excess Carcinogenic Risk

                      Preservative                   1,1 x 1Q~5

                  Wood Pulp & Paper               3.0 x 1G'5

                      Disinfectant                   2.5 x 10"6
                   (poultry/livestock)
          Post-application worker exposure to the active ingredient, 2-(hydroxymethyl)-2-
   nitro-l,3-propanediol, is minimal for all uses as described above.   There  are no
   significant lexicological concerns specifically with this active ingredient or exposure
   concerns. The toxicological concerns and the post-application worker exposure risks are
   associated with  formaldehyde.   The risk associated  with  formaldehyde  for  post-
   application workers as a result of the cooling  tower use, the preservative use, and the
   cutting fluid use is minimal, because the degradation conditions,  i.e. the very alkaline
   conditions in combination with high temperature, are not likely.

          Post-application worker exposure to formaldehyde following the livestock/poultry
   premise use is of some concern;  however, the mixer/loader/appiicator exposure estimate
   actually represents the worst case scenario of exposure.  The post-application worker is
   not exposed  to the concentrated product or the spray application  of the formaldehyde.
   In addition, part of the application process is  to rinse all treated  surfaces with potable
   water  approximately 10  minutes following  spray application.    Products  containing

                                        21

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formaldehyde as the active ingredient for this use are also regulated by the Occupational
Safety and Health Administration (OSHA) which requires monitoring for formaldehyde
before workers enter the premises following treatment. The OSHA Permissible Exposure
Limit (PEL) for formaldehyde is  0.75  ppm.  Therefore, the  post-application worker
exposure and risk is the same (or less) than that of the mixers/loaders/applicators for the
disinfectant use.  The post-application worker upperbound excess carcinogenic risk is <_
2.5 X  10~6.

       Post-application worker exposure to formaldehyde can be expected as a result of
the use in pulp and paper mills.  The LADD is 0.00145 mg/kg/day; therefore, the upper
bound excess carcinogenic risk is estimated to be 0.00145 mg/kg/day X Q*1 (1.87 X 10~2
mg/kg/day)  =  2.7 x 10"5.   This  carcinogenic  risk  determination  is considered
conservative since this exposure (LADD) does not consider dilution of the formaldehyde
air concentration, the pulp mixture is  generally not stationary, and there are ventilation
systems in mills. A post-application inhalation exposure monitoring study is required for
uses in pulp and paper mill systems, but these data are considered confirmatory.

C.     Environmental Assessment

       Above,  in  subsection  B.,  the  Agency  discusses  the degradation of 2-
(hydroxymemyl)~2-nitro-l,3-propanediol  to  formaldehyde  and   its  concerns  for
carcinogenic  risks to  workers.   The Agency  does not have  a similar concern for
environmental exposure.    Although  formaldehyde is  slightly  more  toxic to aquatic
organisms than is 2-(hydroxymethyl)-2-mtro-l,3-propanediol (the parent compound), the
parent compound is relatively stable in the aquatic environment.  As it breaks down to
formaldehyde, the latter compound is rapidly dissipated.  Therefore, the Agency focused
its environmental risk assessment on the parent compound.

       1.     Environmental Fate

             The Agency has assessed a hydrolysis study for 2-(hydroxymethyl)-2-nitro-
       1,3-propanediol, but it is not adequate  to characterize the hydrolysis of this
       chemical.  A new study is being required to confirm the rate of degradation of
       the active ingredient and products formed during hydrolysis. It is expected, as
       a result of a model exposure assessment, that this chemical when used according
       to the label,  will pose minimal risk to the environment.  The only concerns for
       environmental  exposure, therefore, would be  in the case of spills, accidents,
       misuse or when it may be discharged in industrial  effluent under a  National
       Pollution Discharge Effluent System (NPDES) permit. This type of discharge is
       discussed further below.

       2.     Ecological Effects

             There are sufficient ecotoxicological data to characterize the  toxicity of

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2-(hydroxymemyl)-2-nitro-l,3-propanediol to nontarget  terrestrial and  aquatic
organisms.  The rat and rabbit lexicological data discussed above in subsection
B. suggest that 2-(hydroxymethyl)-2-nitro-1,3-propanediol (53,1 -56.8 %) has a low
order of acute oral and dermal toxicity to terrestrial mammals (acute oral LDSO
= 1860-1890 mg/kg for rats and >  2000 mg/kg for rabbit dermal toxicity test).

       The avian toxicity of the technical grade (TGAJ) of 2-(hydroxymethyl)-2-
nitro-1,3-propanediol, when extrapolated from the results of subacute  dietary
toxicity data using 50%  a.i. formulated product, was found to be slightly toxic
to upland game birds (>2,500 pprn) and practically non-toxic to waterfowl
(> 40,000 ppm). The subacute dietary data using 2~(hydroxymethyl)-2-mtro-1,3-
propanediol TEP (50%), indicate that this pesticide is practically non-toxic to
upland game bird species (bobwhite quail, LC50 greater than 5,000 ppm,  (MRID
00094706)) and waterfowl species (mallard duck, LC50 greater than 80,000 ppm
(MRID 00094707)) on a subacute dietary basis.

       The available data indicate that 2-(hydroxymethyl)-2-nitro-i, 3-propanediol
is practically non-toxic to rainbow trout (TGAI LC50 = 414 ppm; TEP LC50 >
300 ppm (MRID 00094708)), fathead minnow (TGAI LC50 = 280 ppm  (MRID
42205203)), and bluegill sunfish  (TEP LC50 >  300 ppm (MRID 00094709)).
Therefore,  2-(hydroxymethyl)-2-nitro-l,3-propanediol  can be characterized as
practically non-toxic to freshwater fish species based on acute  toxicity.  Data
using Daphnia magna as the test species indicate that 2-(hydroxymethyl)-2-nitro-
1,3-propanediol is slightly toxic to freshwater aquatic invertebrates (TGAI LC30
= 80 ppm  (MRID 42205204)).  The results of two studies  indicate  that 2-
(hydroxymethyl)-2-nitro-l,3-propanediol is slightly toxic to molluscs (TGAI LC50
22.8 ppm (MRID 42099001)) and practically non-toxic to crustaceans (TGAI LCM
>95.5 ppm (MRID 42099002)).  The estuarine/marine  fish study was  waived
based  on the low toxicity  of 2-(hydroxymethyI)-2-nitro-l,3-propanediol to
freshwater fish.

       a.     Ecological Effects Risk Assessment

             A Tier Ic EEC (estimated environmental concentration) model was
       conducted by the  Agency  to  assess  the  estimated  environmental
       concentration  of  residue   levels  of  2-(hydroxymethyl)-2-nitro-l.3-
       propanediol in the receiving stream from the pulp/paper mills,  cooling
       towers, oil recovery/drilling muds and metal finishing uses.  This model
       provides  an estimate  of the maximum concentration that may occur
       immediately downstream from an industrial (point source) discharge  site.
       The EECs are reasonable worst case, one in ten year EECs. For the high
       exposure case site, it would be expected that the EEC would be equaled
       or exceeded once every ten years, i.e., there is a 10% chance in any given
       year that the EEC will be equaled or exceeded.   The difference in the

                             23

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scenarios is the flow rate of the receiving waters. This is similar to the
site  and  frequency  assumptions  that  are generally being  used for
agricultural pesticides.

       Below, in Table VIII, EEC values are given for high exposure and
typical  exposure  scenarios from  the  different use  patterns  of  2-
(hydroxymethyl)-2-nitro~ 1,3-propanediol.
Table VIII. Tier Ic EECs for 2-(hydroxymethyl)-2-nitro-l ,3-propanediol
Use Site, Type
Metal Working, Group 1*
Metal Working, Group 2",
recovery rate
Metal Working, Group 2**
maintenance rate
Pulp and Paper Mills
Water Cooling Towers,
Evaporative Condensers,
recovery
Water Cooling Towers,
Evaporative Condensers,
maintenance
Secondary Oil Recovery
Injection Water, Drilling
Muds, recovery
Secondary Oil Recovery
Injection Water, Drilling
Muds, maintenance
High exposure
68 ppm
533 ppm
133 ppm
2540 ppm
609 ppm
152 ppm
1000 ppm
1000 ppm
Typical exposure
0.054 ppm
0.422 ppm
0. 105 ppm
7. 100 ppm
0.978 ppm
0.243 ppm
1 .400 ppm
0.703 ppm
* "OO" Wafers, "OO" Powder, S.SX Sump Saver
** "Tris-Nitro 50% Aqueous, Tris-Nitro 25% Aqueous, Tris-Nilro Solid
       A level of concern (LOG) is exceeded when the EEC value equals
or exceeds 1/2 the LC^, values for aquatic organisms. The LOCs for 2-
(hydroxymethyI)-2-nitro-i,3-propanediol are40 ppm forDaphnia and 207
ppm for fish. The typical EEC values are below the LOC values for fish
and invertebrates for all uses. Therefore, if the receiving streams never
                       24

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have a flow rate below their mean flow condition,  there is minima! risk
to aquatic organisms in these waters under those conditions.  However,
the following table indicates a high risk to aquatic organisms from the
high exposure scenario.
Industrial Appl.
Metal Finishing
Pulp/Paper Mills
Cooling Towers
Oil Well Operations
Type of LOC Exceeded for High Exposure
(Indicates High Risk)
Daphnia for all types, including maintenance
operations
Fish only for the recovery operation
Scenario
and recovery
Daphnia and fish
Daphnia for maintenance and recovery
operations
Fish for recovery operation
Daphnia and fish for maintenance and recovery operations
b.     Endangered Species

       The LOC for endangered aquatic species is 1/20 the LCSO values,
which for  2-(hydroxymethyl)-2-nitro-l,3-propanediol is 4 ppm  for
invertebrates and 20.7 ppm for fish. The high exposure scenarios for all
uses of 2-(hydroxymethyl)-2-nitro-l,3-propanediol exceed the LOC for
endangered aquatic organisms.   In addition, the typical EEC value for
pulp  and  paper  mills  exceeds  the  LOC  for  endangered  aquatic
invertebrates.   As 2~(hydroxymethyl)-2-nitro-l,3-propanediol  will  be
discharged at a number of different sites, it is reasonable to assume that
endangered  species are  located in  some  of these  aquatic habitats.
Therefore, effluent containing 2-(hydroxymethyl)-2-nitro-l ,3-propanediol
should not  be discharged into streams  and other waterways where
endangered aquatic organisms are known to reside.

       Since the discharge of 2-(hydroxymethyl)-2-nitro-l,3-propanediol
is  limited by  the  National  Pollutant  Discharge Elimination System
(NPDES) permit program of the Office of Water, the  Agency would be
able to control the discharge of 2-(hydroxymethyl)-2-niiro-l ,3-propanediol
so that toxic levels are avoided.  Results from modeling indicate that 2-
(hydroxymethyl)-2-nitro-l ,3-propanediol can be used at use sites without
producing effluents above concern levels.
                      25

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IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.    Determination of Eligibility

             Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
       of relevant data concerning an active ingredient, whether products containing the active
       ingredients are eligible for reregistration.   The Agency has previously identified and
       required the submission of the generic (i.e. active ingredient specific) data required to
       support reregistration of products containing 2-(hydroxymethyl)-2-nitro-l,3~propanediol
       as the active ingredient.  The Agency has completed its review of these generic data, and
       has  determined that  the  data are sufficient to support reregistration  of all products
       containing  2-(hydroxymethyl)-2-nitro-l,3-propanediol.    However,  the  Agency is
       requesting confirmatory data for post-application exposure of the degradate formaldehyde
       to workers and hydrolysis of 2-(hydroxymetiiyl)-2-nitro~l,3-propanediol.  It is  also
       requiring product  specific efficacy, chemistry and acute toxicity  data for  labeling
       purposes.  Appendix B identifies the generic data that the Agency reviewed as part of its
       determination of reregistration eligibility of 2-(hydroxymethyl)-2-nitro-l,3-propanediol,
       and  lists the submitted studies that the Agency found acceptable.

             The data identified in Appendix B were sufficient to allow the Agency to assess
       the registered uses of 2-(hydroxymethyl)-2-nitro-l,3-propanediol and to determine that
       2-(hydroxymethyl)-2-nitro-l ,3-propanediol can be used without resulting in unreasonable
       adverse effects to  human health and the environment.  The Agency therefore finds that
       all products containing 2-{hydroxymethyl)-2-nitro-l ,3-propanediol as the active ingredient
       are eligible for reregistration.   The reregistration of particular products is addressed in
       Section V of this document.

             The Agency made its reregistration eligibility determination based upon the target
       data base required for reregistration, the current guidelines for conducting acceptable
       studies  to  generate such data and  the data  identified in Appendix  B.   Although the
       Agency has found that all uses of 2-(hydroxymethyl)-2-nitro-l ,3-propanediol 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 2-(hydroxymethyl)-2-nitro-l,3-propanediol, 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

             Based on  the  review of  the  generic  data  for the  active   ingredient 2-
       (hydroxymethyl)-2-nitro-l,3-propanediol, the Agency has sufficient information on the
       potential health effects of 2-(hydroxymethyl)-2-nitro-l,3-propaaediol, and its degradate
       formaldehyde, and on its potential for causing adverse effects in fish and wildlife and the
       environment.   The  Agency  has  determined  that  2-(hydroxymethyl)-2-nitro-l,3-

                                          26

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propanediol products, labeled and used  as  specified in this Reregistration Eligibility
Decision, will not pose unreasonable risks or adverse effects to human health  or  the
environment as long as label restrictions prescribed in this RED  are followed.
Therefore, the Agency concludes that products containing 2-(hydroxymethyl)-2-nitro-l ,3-
propanediol for all uses are eligible for reregistration.
       2,     Eligible and Ineligible Uses

              The Agency has determined that all uses of 2-(hydroxymethyl)-2-nitro-l ,3-
       propanediol are eligible for reregistration.

B,     Regulatory Position

       The following is a summary of the regulatory positions and rationales for 2-
(hydroxymethyl)-2-nitro-l ,3-propanediol. Where Labeling revisions are imposed, specific
language is set forth in Section V of this document.

       1.     Labeling Rationale

                     Because use of 2-(hydroxymethyl)-2-nitro-1,3-propanediol products
              can result in carcinogenic risk to workers, the Agency is requiring the use
              of certain protective clothing and equipment while handling and applying
              end-use products.

                     Also,  because  certain  uses can  result in  discharge  of 2-
              (hydroxymethyl)-2-nitro-1,3-propanediol into receiving waters, the Agency
              is requiring  labeling that restricts effluent  discharge unless it is under a
              NPDES permit.
                                     21

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                    2.  Confirmatory Data Rationale

                           The Agency is requiring, through a Data Call-in Notice as a part
                    of this document, registrants to submit additional data to confirm the acute
                    toxicity and  exposure estimated from  the current data  base.   Acute
                    inhalation and eye irritation  studies on powdered technical grade 2-
                    (hydroxymethyl)-2-nitro-l ,3-propanediol are required, A monitoring study
                    is  required   to   measure  post-application   inhalation  exposure  of
                    formaldehyde to workers in pulp and paper mills.  Under separate and
                    pre¥ious Data Call-in Notice the Agency has required a similar study for
                    the use of formaldehyde products in poultry houses.  With these data for
                    these exposure studies, the Agency will either confirm the exposure and
                    upper bound  carcinogenic risk estimates or take further regulatory action
                    to mitigate exposure, if necessary.

                           Additionally, the  Agency is requiring a hydrolysis study on 2-
                    (hydroxymethyl)-2-nitro-l,3-propanediol to confirm its degradation in the
                    environment, and especially as it is discharged in effluent into receiving
                    waters from the industrial uses of the products.

                           Based on  its review of these additional confirmatory data,  the
                    Agency will  determine whether the risk reduction measures required in
                    this document were sufficient or whether further measures are necessary.

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

                    As discussed above the Agency is requiring as confirmatory data additional
             studies on  post-application worker inhalation to formaldehyde from the pulp and
             paper  mill use and the poultry house use (under separate Data Call-in Notice).
             Acute  inhalation and eye irritation data  on  2-(hydroxymethyl)-2-nitro-l,3-
             propanediol are also required as confirmatory data. A new hydrolysis study is
             also required to confirm the  degradation of 2-(hydroxpaethyl)-2-nitro-l,3-
             propanediol.  These  generic data requirements are listed in Appendix F.

             2.     Labeling Requirements for Manufacturing-Use Products

                    "Do not discharge  effluent containing this  product into lakes, streams,


                                          28

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       ponds,  estuaries,  oceans, or public  waters  unless  in accordance  with  the
       requirements of a National Pollutant Discharge Elimination System (NPDES)
       permit and the permitting authority has been notified in writing prior to discharge.
       Do  not discharge effluent containing this product to sewer systems without
       previously notifying the  local sewage treatment plant authority.   For guidance
       contact your State Water Board or Regional Office of EPA,"

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.   These requirements include  efficacy,
       product chemistry, and acute toxicology studies.

             Registrants must review previous data submissions to ensure that they meet
       current EPA acceptance criteria (Appendix G; Attachment 5) and if not, commit
       to conduct new studies.  If a registrant believes that previously  submitted data
       meet current  testing standards, then  study MRID  numbers should  be cited
       according to the instructions in the Requirement Status and Registrants Response
       Form provided for each product,

       2.     Labeling Requirements for End-Use Products

             For  end-use products labeled for indoor non-food  (industrial  use with
       effluent), aquatic non-food industrial and terrestrial non-food uses:

             "Do not discharge effluent containing this product  into lakes, streams,
             ponds, estuaries, oceans, or  public waters unless in  accordance with the
             requirements  of  a National Pollutant  Discharge Elimination System
             (NPDES) permit and the permitting authority has been notified in writing
             prior to discharge.  Do not discharge effluent containing  this product to
             sewer systems without previously  notifying the local sewage treatment
             plant authority. For guidance contact your State Water Board or Regional
             Office of EPA."

       Mixer/loader/applicators

       Uses:  Poultry/livestock premises, Preservative, and Pulp and paper mills
       The personal protective equipment (PPE) requirement for such products is:

             "Pesticide handlers must wear:


                                   29

-------
             —Long-sleeved shirt and long pants
             —Chemical-resistant gloves
             —Shoes plus socks
             —In addition: when engaged in open pouring of this product:
             -A respirator with either an organic-vapor-removing cartridge with
             a prefilter  approved  for pesticides (MSHA/NIOSH approval
             number prefix TC-23C),  or a  canister  approved for  pesticides
             (MSHA/NIOSH approval number prefix  TC-14G)

Mixer/loader/applicators

Uses: Metal cutting fluids. Cooling tower  water
The personal protective equipment (PPE) requirement for such products is:

       "Pesticide handlers must  wear:
             -Long-sleeved shirt and long pants
             —Chemical-resistant gloves
             —Shoes plus socks

Post-application workers

Uses: Poultry/livestock premises

      End-use products that contain 2-(hydroxymethyl)-2-nitro-l,3-propanediol
      must be  revised to adopt the entry  restrictions set forth in mis section.
      Place the following use restriction on the labeling  in the  directions
      describing use as a disinfectant spray in livestock and/or poultry premises:

             "Entry by any person — other than a correctly equipped handler —
             is PROHIBITED in the entire enclosed building/strucaire from the
             start of-application until aeration reduces the air concentration level
             of formaldehyde in the  working area to less than 0.75 ppm.  The
             air level concentration of formaldehyde must be measured before
             entry is permitted.  (OSHA issued a final rule for the PEL for
             formaldehyde as 0.75 ppm, May 27, 1992, Federal Register, Vol.
             57, p.22290.) Any handler who enters the treated area during this
             entry-restricted period must wear:

                    -Long-sleeved shirt and long pants
                    —Shoes plus socks
                    —A   respirator  with  either  an  organic-vapor-removing
                    cartridge   with   a  prefilter  approved  for  pesticides
                    (MSHA/NIOSH approval number prefix  TC-23C), or a
                    canister approved for pesticides (MSHA/NIOSH approval
                            30

-------
                           number prefix TO14G).

       The  labels and  labeling of all products  must comply with  EPA's current
       regulations and requirements as specified in 40 CFR §156.10.  Please follow the
       instructions in the Pesticide Reregistration Handbook with respect to labels and
       labeling.

C,     Existing Stocks

       Registrants may generally distribute and sell products  bearing old labels/labeling
for 26 months from the data of issuance of this RED.  Persons other than the registrant
may generally distribute or sell such  products  for 50 months  from the data  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";  Federal  Register.
Volume 56,  No.  123, June 26, 1991.

       The  Agency has  determined  that  registrants may  distribute  and  sell  2-
(hydroxymethyl)-2-nitro-l»3-propanediol products bearing old labels/labeling  for 26
months from the data of issuance of this RED,   Persons other than the registrant may
distribute or sell such products for 50 months from the date of issuance of this RED.
                                    31

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-------
VI.   APPENDICES
       33

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-------
APPENDIX A. Table of Use Patterns Subject to
               Reregistration
                     35

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-------
            APPENDIXA-  CASE 3149, (Tris(HOCH2-)nitromethane]  Chemical 083902  I2-(Hydroxymethyl)-2-n!tro-1,3-propanediol)
SITE    Application Type, Application
        Timing, Application Equiprrwnt
                                          Form
       Minimum
      Application
         Rate
            Maximum
           Application
              Rata
            Max.
             *
           Apps,
Max.
  #
Apps.
  @
Max.
Ruta
  Win,
tntsrval
                                                                                       Appe.
                                                                                        Max,
                                                                                        (Dayo)
Restricted
  Entry
 Interval
                                                         iDoys!
Geographic
Limitations
                                                           A Ho wed
                                                                       Dis-
                                                                     allowed
                                                                                                                                            Use Pattern Limitations
NONFOOO/NONFEED  USES
Comma reialllnduetrtal Watar Cooling Systems  Ua» Groyp(i): Aquatic Non-Food IndUBtrwl
    Water feoirouJoflng eyetem traatmsnt,
    Initial, Not on labsl
    Surfaco Typai na
    Efficacy Influencing Factor  na
                                          sen
      23 ppm by
         Vol
            50O ppm
             by Vol
            not
            spec
 not
spec
not spec
 not apec
                Do not discharge affluent containing thie pesticide
                into Bflwtiyu ey«tems without notifyme the sewage
                treatment plant authority. Do not diachargo effluent
                containing this product into lakM, etroame, ponds,
                astuarioe, oooone. or public water {NPDES licansa
                restriotlonj. Pcoclonn claim.
    Watar raoireulating system treatment,
    Subsequerrtftneintenanee, Not on tabs!
    Sytfaoa Type: na
    Efficacy Influencing Factor:  na
SC1L
8 ppm by
   Vol
126 ppm
 by Vol
                                                                         not
                                       not
                                      spac
        not ep«o
          not epec
                               Do not diachargs affluent contairang thi» p»aticide
                               into sewage eyslams without notifyinfl Itn «iwag»
                               treatment plant authority^ Do not diBehftigfl affluent
                               containina thia product into 1»k»», ttraBmi, pondi.
                               aetuariat, oooans, or public water INPDES licnnie
                               rBalrictionK Preclaan claim.
    Water reciroutating system troatmont,
    Initial, Not on label
    Surface Typo: na
    Efficacy Influencing Factor;  ns
                                         sen.
      23 ppm by
         Vol
            GOO ppm
             by Vo!
            not
            spec
 not
 spec
not spec
          not epec
                              Oo not discharge affluent containing this pesticide
                              into aewaga syetems without notifying the sewage
                              treatment plant authority. Do not discharge affluent
                              containing thia product into lakes, streams, ponde,
                              tstuariat, oceans, or public watar (NPDES license
                              r«*tfiotten), Preolean claim.
    Water recrreulating system treatment",
    Subsaquent/mainlenanca, Not on tab»l
    Surface Type; na
    Efficacy Influenoinfl Factor;  na
SCtL
8 ppm by
   Vol
1 25 ppm
 by Vol
                               not
                               spac
 not
 spec
not apse
 not epec
                Do not dwoharge affluent containing this paeticida
                into aawaga ayitema without notifying ths sewage
                treatment plant authority. Do not discharge efflyent
                oontaining thie product into lakes, Btreams, ponds,
                estuaries, ooeana, or public water WPDES licenae
                rnstrtctirnl. Praclaan claim.
    Watar rcctreulating eystem treatment,
    Initial, Not on label
    Surface Typa: na
    Efficacy Influencing Factor:  na
 Cf
      30 ppm by
          Wt
            609 ppm
             by Wt
            not
                    not
                   sp»e
        not spec
          not spec
                                                           CA
                               Do not discharge affluent containing thie yaaticido
                               into sewage evsteme without notifying the sewage
                               treatment plant authority. Do not discharge effluent
                               contninirg this product into lakes, streams, ponds,
                               estuaries, oceans, or public water (NPDES license
                               restriction). Precleanfor heavily soilod araas.
                                                                                     37

-------
APPENDIX A- CASi 3149, [Tris(HOCH2-)nitromethane] Chemical 083902 [2-(Hydroxymethy()-2-nitro-1,3-propanediotl
SITE Application Type, Application
Timing, Application Equipment
Water reeircufrtinfj eyatsm treatment,
Subsequent/Maintenance, Not on label
SurfaoeTypa: na
Efficacy Influencing Factor: na
Form
Cr
Minimum
Application
Rate
1 0 ppm by
Wt
Maximum
Application
Rate
152 ppm
byWt
Max.
1
Apps.
not
spec
Max.
#
Apps.
ft
Max,
Rale
not
epoc
Min.
Interval
Between
Apps. 


-------
APPENDIX A- CASE 3149, [Tris(HOCH2-}nitromethane] Chemical 083902 [2-(Hydroxymethyl)-2-nitro-1,3-propanedioI]
SITE Application Typa, Application
Timing, Application Equipment
Water racirculating system treatment,
Subsequent/Maintenance, Not on tabat
Surf«e«Type; m
Efficacy Influancing Factor; na
Water faeireulating system treatment,
Initial, Not on label
Surface Type: na
Efficacy fnfluanerng Factor: na
Wator reciroulatmg systam treatmont,
Subsequent/Maintenance, Not on label
Surface Type: na
Efficacy Influencing Factor: na
Form
SC/L
Cr
Cr
Minimum
Application
Rat»
8 ppm by
Vol
30 ppm by
Wt
10 ppm by
Wt
Maximum
Application
Rate
125 ppm
by Vol
809 ppm
by Wt
1 52 ppm
by Wt
Max,
*
Appe.
not
spec
not
spec
not
spac
Max.
t
Apps,
@
Max.
Rate
not
«pao
not
spec
not
apac
Min.
Interval
Between
Apps. (§>
Max,
Rats
(Days)
not ipec
not spac
not sp«c
Restricted
Entry
tntsrwal
(DaysJ
not epec
not spec
not apec
Geographic
Limitations
Allowed



Dis-
allowed

CA
CA
Use Pattern Limitations
Do not discharga afflusnt containing this pesticide
into sewage *y*tema without notify! ng the sewage
treaimant plant authority. Do not discharge effluent
containing thi« product into lakes, stream*, ponds,
• atusriss, oceans, or public water {NPDES license
rettrictiont. Pracfesn claim.
Do not discharge effluent containing this pa»tieide
into sewage systems without notifying th® townyi>
treatment plant authority. Do not dinoharge effluent
containing this product into lakes, atraeme, ponds,
estuaries, aoosne, or public water (NPDES licenea
restriction), Prstbnn for heavily soiled arsae.
Da not discharge effluent containing this pesticide
into sewage eystamo without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product into lakes, etraams, ponds,
actuaries, oceans, or public water (NPDES lioenee
restriction). Prsclean for heavily soiled areas.
Industrial Processing Water Use Group! si: Aquatic Nan-Food Industrial
Water reeireulsting system treatmant.
Initial, Not on label
Surface Type: na
Efficacy Influencing Factor: na
Water lecirculating system treatment,
Stlbsequantrmainlanflnce, Hot on label
Surface Type: n*
Efficacy Influencing Factor: na
Watar recirculatirtg system treatment,
Initial, Not on labol
Surface Type: na
Efficacy Influencing Factor: na
SC/L
sen
SC/L
23 ppm by
Vol
8 ppm by
Vol
23 ppm by
Vol
500 ppm
by Vol
1 2S ppm
by Vol
500 ppm
by Vol
not
specs
not
spec
not
spec
not
spec
not
epoc
not
spoc
not spec
not spec
not spac
not spec
not vpao
not spec



CA
CA

Do not discharge effluent conltining this pesticide
into (sewage systems without notifying the sewage
treatment plant authority. Do not discharge affluent
containing this product into lakes, 8tream», ponds,
actuaries, oce«n«, or public water- (NPDES Noenee
reatriction), Preclean claim.
Do not discharge affluent containing this pesticide
into sewage systems without roti'ytno the sawaga
treatrnsnt plant authority. Do not discharge offiuent
containing this product into lakes, streams, ponds,
actuaries, oceans, or public water (NPDES license
restriction!. Preclean claim.
Do not discharge of flu ant containing thie pesticide
into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product into lakes, etraams, ponds,
estuaries, oceans, or public watar (NPDES license
restriction). Preclean claim.
39

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APPENDIX A- CASE 3149, [Tris(HOCH2-)nitramethan0J Chemical 083902 [2-(HydrGxymethyl)-2-nitra-1,3-propanedioI]
SITE Application Type, Application
Timing, Application Equipment
Water rseirculating ayetem treatment,
Subsequatrt/mainWna-ncB, Mot on label
Sutfao* Typs; na
Etfioaey Influencing Factor: na
Form
SC/L
Minimum
Application
Raw
8 ppm by
Vol
Maximum
Application
Rat*
1 25 ppm
by Vol
Mem,
f
Apps,
not
epae
Max.
*
Appi.
9
Max.
Rate
not
Rpnc
Min.
Interval
Between
App». @
Max,
Rate
IDaye)
not »p«c
Restriotecl
Entry
Intarval
(Days)
not spac
Geographic
Limitations
Allowed

Dis-
allowed

USB Pattat n Limitations
Do not discharge effluent containing this poBtteida
into snwaga systems without notifying the sowugs
trnaimont plant suthority. Do not discharge effluant
containing this product mta lakss, stream*, ponda,
e«tuaries, ooeann, or public water (NPOES licanso
wrtrlctiont. Piecloan claim.
Liveitoek U»»6wupt«): Indoor Non-Food
Animal equipment treatment. Not on
labs). Sprayer
Surface Typo: ns
Efficacy Influencing Factor; na
Animal aquipmant treatnwnt, Not on
label. Not on label
Surface Type; na
Efficacy Influencing Factor: na
Equipment treatment, Not on label,
Sprayar
Surface Type; rid
Efficacy Influencing Factor na
Equipmont treatment. Not on labal. Not
on label
Surface Typa: na
Efficacy Influencing Factor; na
Premiss treatment, Not ort label,
Sprayor
Surface Type: Iwd
Efficacy Influencing Factor: na
Transportation vehicle trsaimerw, Not
on labs), Sprayar
Surface Typo; hard
Efficacy Influencing Factor: na
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
1 500 ppm
by Vol
1 SOO ppm
by Vol
1 SOO ppm
by Vol
1500 ppm
byVol
! 500 ppm
byVoi
1 500 ppm
by Vol
1 500 ppm
by Voi
1 SOO ppm
by Vol
1 600 ppm
by Vol
1 SOO ppm
by Vol
1 SOO ppm
by Vol
1 500 ppm
by Vol
not
Bpee
not
spec
not
•pec
not
spec
not
spec
not
spec
not
•pec
not
spec
not
tpee
not
•pec
not
spec
not
epoc
not spec
not «p«c
not epac
not spec
not apso
not spec
not spac
not spso
not spec
not spec
not spac
not spec












Preclean claim. Propar ventilation required. Remove
aniimla prior to treatment, Remova fead and water
prior to treatment. 10 minutes contact time. Pofabla
water rinse !non-t«Bidual claim).
Praetaan claim. Proper ventilation rsquiiad. Ramove
animnls prior to trsatmerit. Ftomove faed and water
prior to treatment. 10 mirurta* contact lima, Potabls
water rinea (non-residual claim).
Preclaan claim. Proper vantilation required. Remova
ammalB prior to treatmtnt. Removo feed and water
prior to treatment. 10 minutes contact lima. Potable
water rinse (non-rmdual claim).
Preelaen claim. Propnr vantilation roquirad. Remove
animals prior to treatment, Rornova feed and water
prior to trnntment. 10 minutas corrtaot time. Potable
watar rinaa (nrm-ratidual claim!.
Practean claim. Proper ventilation required. Ramove
animal* prior to treatmtnt. Remova feed and water
prior to tr»atm«nt, 10 minutes contact time. Potable
watar rinse (non-residual claim).
Pwcleiin claim. Proper vantilation required. Remove
animal 8 prior to traatrrwnt. Remove fead and water
prior to treatment. 10 mlnutea contact lime. Potabla
water rinee (non-reaidual claim).
Motalworking Cutting Fluids Use QfoupfsS: Aquatic Non-Food Industrial
40

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APPENDIX A CASE 3149, (Tris(HQCH2-Jnitromethane] Chemical 083902 [2-(Hydroxymethyl)-2-mtro-1,3-propaneciio!J
SITE Application Type, Application
Timing, Application Equipment
PrBBarvativB treatment. Initial, Not on
label
Surface Typa: na
Efficacy Influencing Factor: na
PresetvBtitffl treatment,
Subsequont/mamtenanot, Not on label
Surface Typ»: na
Efficacy Influencing factor; na
Preservative treatment. Initial, Not on
label
Surface Typa; na
Efficacy Influ»ncing Factor: na
Preservative treatment,
Subsequent/maintenance, Not on label
Surface Type: na
Efficacy Influencing Factor: na
Preservative treatmant. Initial, Not on
label
Surface Typo: na
Efficacy Influencing Factor: na
Industrial preservative treatment.
During manufacture. Not on label
Surface Type: na
Efficacy Influencing Factor; na
Preservative treatment. Initial, Not on
labal
Surface Type: na
Efficacy Influencing Factor; na
Preservative treatment,
Subsequent/maintenance, Not on label
Surface Type: na
Efficacy Influencing Factor: no
Form
sc/s
sc/s
sc/s
sere
PfT
SC/L
SC/L
SC/L
Minimum
Application
Rate
pprn
cannot be
calculated
ppm
cannot be
ealculatad
ppm
cannot ba
calculated
ppm
cannot ba
calculated
ppm
cannot bo
calculated
1000 pprn
(from label)
1 2SO ppm
by Vol
313 ppm
by Vol
Maximum
Application
Rat*
ppm
cannot be
calculated
ppm
cannot ba
calculated
ppm
cannot ba
calculated
pprn
cannot bo
calculated
ppm
cannot be
calculated
2000 ppm
(from label!
2500 ppm
by Vol
625 ppm
by Vol
Max.
#
Apps,
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
apac
Max.
»
App«.
@
Max.
Rate
not
upnc
not
epdo
not
spec
not
spec
not
ap««
not
spue
not
spec
not
epac
Min.
Interval
Between
Appe. @
Max,
Rate
(Days)
not apec
not spec
not spec
not spec
not apoc
not spei;
not apes
not tpeo
ReBtrictad
Entry
Intervnt
(Day«|
not apse
not apeo
not epoc
not spec
not spec
not apec
not ep«c
not spec
Geographic
Limitstioni
Allowed








Dis-
allowed








Use Patlarn Limitations





Do not discharge affluent containing this pesticide
into Bnwage aystams without notifying thi sawage
treatment plant authority. Do not discharge affluent
containing this product into lake*, etreams, ponds,
sstuariee, ocaane, or public water (NPDES licenao
r«»trioticn). 6.0 pH frninimum), 8.0 pH (maximum).
Do not discharge effluent containing this pesticide
into Bewafle aysteme without notifying the oownge
treatment plant authority. Do not discharge sfflusnt
containing this product into lakes, atroarm, ponds,
astuariea, ocaanB, or public water (NPD6S licenge
restriction).
Do not discharge affluent containing this pasticide
into aewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product Into lakes, streams, ponds,
estuaries, oceans, or public water (NPQES licensa
restriction}.
41

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APPENDIXA- CASE 3149, [Tris(HOCH2-)nitromethane] Chemical 083902 t2-(Hydroxymethyl}-2-nitro-1 ,3-propanediol]
SITE Application Type, Application
Timing, Application Equipment
Industrial preservative treatment.
During manufacture. Not on label
Surface Type: na
Efficacy Influencing Factor; rw
Prase rvattvo treatment, Initial, Not on
tabs!
Surface Type: na
Efficacy Influencing FsotOf; na
Preservative treatment,
Sub8«qu«nt/mnintsnHHC9, Not on labal
Surface Type: na
Efficacy Influencing Factor: na
Industrial preservative treatmant. Not
on label, Not on label
Surface Type; na
Efficacy Influencing Factor; ne
PraoBrvalive treatment, Initial, Not on
lahul
Surface Type: na
Efficacy Influencing Factor; na
Preservative trsatrmnt.
Subsequent/maintenance, Mot on label
Surfaea Type: na
Efficacy Influencing Factor; na
Form
SC/L
SC/L
SC/L
Cr
Cr
Cr
Minimum
Application
Rate
1000 ppm
(from lab oil
1 250 ppm
by Vol
313 ppm
by Vol
1000 ppm
{from label)
tOOO ppnn
(from label)
250 ppm
(from label)
Maximum
Application
Rate
2000 ppm
(from laball
2500 ppm
by Vol
626 ppm
by Vol
2000 ppm
(from label)
2000 ppm
{from labell
500 pprn
(from labelj
Max,
#
Apps,
not
spec
not
spec
not
spac
not
spec
not
spec
not
spec
Max,
*
Apps,
@
Max.
Rate
not
apec
not
spec
not
spec
not
spec
not
spec
not
spec
Min.
Interval
Between
Appe, @
Max.
Rats
(Days)
not *pac
not spec
not apec
not spec
not spec
not spac
ftostrictod
Entry
Intarval
(Daysl
not opec
not spec
not apec
not »pac
not apae
not spftc
Gaographic
Limitations
Allowed






Die-
allowed






Usa Pattern Limitations
Do not discharge efflunnt containing thig paeticide
Into eewago nvstoms without notifying the oawogo
treatmant plant authority. Do not discharge affluent
containing this product into InkeF, Btraatnt, ponds,
eatunriBS, ocsans, or public water (NPDES lioariB*
raetrlotion). 6.0 pH (minimum). 8.O pH |ma»muinS.
Do not discharge affluant containino tbis pesticide
into aewaga syatnme without notifying the sownge
traatment plant authority. Do not disoharga affluent
containing this product Into lakes, streams, ponds,
estuarioe, ooeana, of public water INPDES license
MBtrictionl .
Do not discharge effluent containing thia pesticide
into »ewaga systems without notilying ths «»weg«
treatment plant authority. Do nol di«ch*rg
-------
APPENDIX A- CASE 3149, [Tris{HQCH2-)nttromethaneJ Chemical 083902 [2-{HvdroxymethyI)-2-nitra-1,3-propanediol]
SITE Application Typa, Application
Timing, Application Equipment
Preservative treatment, Not on label.
Mot on label
Surface Type; na
Efficacy Influencing Factor: na
Preservative treatment. Hot on label.
Not on lobe)
Surface Type: na
Efficacy Influencing Factor; na
Preservative treatment, Not en label,
Not on label
Surface Type: na
Efficacy Influencing Factor: na
Form
SC/L
SC/L
Cr
Minimum
Application
Rate.
63 pprn by
Voi
63 pprn by
Vol
ppm
cannot be
calculated
Maximum
Application
Rote
50O ppm
by Vol
BOO ppm
by Vol
ppm
cannot be
calculated
Max.
V
App*.
not
spec
not
spec
not
epee
Max,
1
Appn.
e>
M»x.
R*t»
not
Spec
not
spec
not
spec
Min,
Interval
Between
Apps. (§>
Max.
Rele
(OayB)
nor. epec
not epec
not «pec
Rsstficted
Entry
Intflrval
IDaye)
not epac
not spao
not epeo
Geographic
LimitBtiont
Allowed



Dis-
allowed



Uuo Pattnrn Limitations
Oo not discharge affluent oontaining this paeticide
into sawaga syBtsme wilhoyt notifying the sewage
treatment ptant authority- Do not discharge efflunnl
containing this product into lakes, streams, ponds,
estuariae, oceans, or public water fNPDES liconse
taetriction) .
Do not discharge effluent containing this pasticidA
into sewaga systams without notifying th« eawage
treatment plant authority. Do not discharga affluent
containing this product into lakes, etrsame, ponds,
e«tuariaB, ocaarte, or public water INPDES license
restriction).
Do not discharge effluent containing this pesticida
into sewags systams without notifying the sewage
treatment plant authority. Do not discharge effluant
containina this product into lakes, streams, ponds,
eetuariaB, oooane, or public water (NPDES license
reettiction).
Paints, Latox (tn-Can) USB Group(e): Indoor Non-Food
Industrial preservative treatment,
During manufactura. Not on label
Sutfece Type: r»a
Efficacy Influsncing Factor: nt
Industrial preservative treBtment, Not
on labsl, Not an label
Surface Type: na
Efficacy Influencing Factor: na
SC/L
Cr
1000 ppm
oyWr
ppm
caonot be
cateutatod
5000 ppm
by Wt
ppm
cannot foe
calculated
not
spec
not
spac
not
•pec
not
epac
not spec
not spac
not ppac
not spe«




Do not discharge effluent containing this pesticide
into sewage systems without notifying tha Re wage
treatment plant authority. Do not dischargs affluent
containing this product into lakes, streams, ponds,
estuaries, oceana, or public water INPDES license
restriction).
Oo not discharge effluent containing this paaticide
into sewage systems without notifying tho sewaga
treatment plant authority. Do not discharge effluent
containing this product into lakes, streams, ponds,
asUjanee, oceans, or public water INPDES license
restriction).
Poultry (Egg/Meat) Use Groupie): Indoor Non-Food
Animaf equipment treatment, Not on
label, Sprayer
Surface Type: na
Efficacy Influencing Factor: na
SC/L
1 BOO ppm
by Vol
1600 ppm
by Vol
not
spoc
not
spac
not spec
not spec


Praclaan claim. Propaf vantilation requirecf. Ramova
animals ptior to treatment. Remove feed and water
prior to treatment. 10 minutes contact time. Potable
water rinse (non-residual claim!.
43

-------
APPENDIX A- CASE 3149, [Tris{HQCH2-)nitromethane] Chemical 083902 [2-(Hydroxymethvl>-2-nitro-1r3-propanediol]
SITE Application Type, Application
Timing, Application Equipment
Animal equipment treatment Not on
label. Not on label
Surface Type; n»
Efficacy Influencing Factor: na
Equipment treatment. Not on labul,
Sprayer
Surfaca Typa; na
Efficacy Influencing Factor: ns
Equipment treatment, Not on label, Not
on label
Surfaca Type: na
iffioacy Influencing Factor: na
Pfemise treatment, Not on label,
Sprayer
Surface Type: hard
Efficacy Influencing Factor: na
Transportation vehicle treatment, Not
on label, Sprayar
Surface Typo: hard
Efficacy Influencing Faotor: no
Form
SC/L
SC/L
SC/L
SC/L
SCIL
Minimum
Application
Rat*
1 500 ppm
hyVol
1 BOO pprn
by Vat
1 500 ppm
by Vol
1600 ppm
by Vol
1 500 ppm
by Vol
Maximum
Application
Rate
1 500 ppm
by Vot
1 500 ppm
by Vol
1 500 ppm
by Vot
1SOO ppm
by Vol
1500 ppm
by Vol
Max.
#
Apps,
not
epac
not
spec
not
spec
not
apse
not
spec
Max.
f
Apps.
@
Max.
Rats
not
epac
not
spec
not
spec
not
spec
not
spec
Mfn.
Interval
Between
Apps. ©
Mex.
Rata
IQaycl
not spec
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not epsc
not spoc
not spec
not spec
Geographic
Limitations
Allowed





Dis-
allowed





Use Pattern Limitations
Praclean claim. Proper ventilation required. Remove
animate prior to treatment. Remove foed and water
prior to treatment. 10 minutes contact 1im«. Potable
water rinse (non-reeidual claim!.
Preclean claim. Proper ventilation roquired. Remove
animals prior to treatment. Removo feed and water
prior to treatment. 10 minutss contact time. Potable
water rinaa (non-residual elaim>.
Pracloan claim. Propsr vantilation required. Remove
animals prior to treatment. Remove feed and water
prior to treatment. 10 minutss contact time. Potable
water rinse (non-roeidual claiml.
Preclean claim. Proper ventilation required. Remove
animals prior to treatment. Remove (eed and water
prior to treatment. 10 minutes contact time. Potable
water rinse (non-rosidyai claim).
Preetaan cteim, Proper ventilation required. Remove
animals prior to treatment. Rarnove feed and water
prior to treatment. 1O minutes contact time. Potabla
water rinse (non-residual claiml.
Pulp/Paper Milt Water Systems Usa GroupM; Aquatic Non-Food Industrial
Wator treatment, Continuous feed
(initial). Metering pump
Surface Type: na
Efficacy Influencing Factor: na
W»tsr treatment, Intermittent
(s)ugXinitial), Metering pump
Surface Type: na
Efficacy Influencing Factor: na
SC/L
sea
631 ppm
by Wt
631 ppm
by Wt
2i25 ppm
by Wt
2525 ppm
by Wt
not
epac
not
spec
not
spec
not
spec
not spec
not spac
not spoc
not spue


CA
CA
Do not discharge effluent containing this pesticide
into iews0» «ystems without notifying tha eawago
treatment plant authority. Do not discharge effluent
containing this product into lakea, etf earns, ponds,
SBtuariee, ooeana, or publis walor INPDES liceneo
restrictionr.
Do not discharge effluent containing this pssticids
into eewoga systams without notifying th» 8awag«
treatmarrt plant authority. Do not discharge effluent
containing thie product into lakes, streams, ponds,
estuaries, oceans, or public water {NPDES license
restriction!.

-------
APPENDIX A CASE 3149, (Tris(HOCH2-)nitromethane] Chemical 083902 [2-(Hydraxymethyl)-2-nitro-1,3-propanediol]
SITE Application Type, Application
Tinning, Application Equipment
Water treatment, Continuous feed
(initial), Metering pump
Surface Type: no
Efficacy Influencing Factor: na
Water treatment, Intermittent
fslugHinitiall, Matafing pump
Surface Type; na
Efficacy Influencing Factor; na
Water treatment. Continuous feed
(initial). Metering pump
Surface Type: iw
Eflioacy Influencing Factor: nn
Water treatment. Intermittent
(elug)(initialS, Metering pump
Surface Type: na
Efficacy Influencing Factor: na
Form
SC/L
SC/L
Cr
Cr
Minimum
Application
Rate
170 ppm
by Wt
870 ppm
byWt
835 ppm
by Wt
635 ppm
by Wt
Maximum
Application
Rate
2280 ppm
byWt
2280 ppm
by Wt
2540 ppm
by Wt
2i40 ppm
byWt
Max.
t
Apps,
not
spec
not
spec
not
spac
not
up tic
Max.
f
Apps,
9
Max,
Rats
not
spee
not
spac
not
spec
not
spec
Min.
Interval
Between
App6, 6
Max.
R*t«
(Days)
not epec
not spec
not spec
not epsc
Restricted
Entry
Intarval
(Days|
not spae
not ip«c
not spac
not spec
Geographic
Limit attons
Allow/ad




Dis-
allowed


CA
CA
Usa Pattarn Limitations
Do not diacharga affluent containing this pesticide
into s*waga eyetnn-e without notifying the sawage
traatment plant authority. Do not discharge efllusnt
containing this product into lakes, streams, pindo.
BStuan'sB, oceans, or public w«tar {NPDES license
raetriction).
Do not diecharga effluent containing this pesticida
into sewage Bystame without notifying the sewage
treatment plant authority. Do not discharga affluent
containing this product into lakes, itraams, ponds,
estuaries, oceans, or public water (NPDES licanso
rastrictionl.
Do not discharge aflluant containing thie posticide
into sewage systems without notifying the wwags
treatment plant authority. Do not Bischarge sffluant
containing this product into lakes, streams, ponds,
astuariaa, oceans, or public water {NPDES license
restriction).
Do not discharge affluent containing this pesticide
into sawago systems without notifying tha aewaga
treatment plant authority. Do not discharge effluent
containing this product into lakoe, straama, ponds,
estuaries, ocsens, or public water (NPDES license
restriction).
Secondary Oil Recovery Injection Water Use GrouplsH Aquatic Non-Food Industrial
Watar treatment. Continuous feed
(initial). Watering pump
Surface Typa: na
Efficacy Influencing Faodor: na
Water treatment. Continuous feed
(subsequent), Matering pump
Surface Typa: na
Efficacy Influencing Factor: na
sen
SC/L
476 ppm
hyVol
476 ppm
by Vol
952 ppm
byVol
476 ppm
by Vol
not
spec
not
spec
not
spac
not
spec
not spec
not epoc
not apoc
not »pao




Do not discharge affluent containing this pesticide
into sewage systems without notifying the sewage
treatment plant authority. Do not discharge affluent
containing this product into lakes, stream», ponds,
flstunrioe, oceans, or public water (NPDES license
restriction).
Do not discharge effluent containing thie pesticide
into sa wage systems without notifyino tha sewage
treatment plant authority. Do not discharge effluent
containing this product into lakse, streams, ponds,
e«tuariei, oceans, of public water (NPDES license
restriction).
45

-------
APPENDIXA CASE 3149, [Tris(HOCH2-)nitromethane] Chemical 083902 [2-(Hydroxymethyl)-2-nitro-1,3-propanediol]
SITE Application Type, Application
Tiffiint), Application Equipment
Water treafmant, Intermittent
(Blutfllinitial), Maturing pump
Surface Type: m
Efficacy Influencing Factor; rta
Water treatment, Continuous lead
(initiall, Catering pump
Surface Type; na
Efficacy Influencing Factor; na
Water treatment, Continuous feed
(subeaquantl, Matsring Pump
Surfnea Typo: na
Efficacy Influencing Factor: na
Water treatment, (ntermtttarrt
MygHWtial!, Metering pump
Surface Type; no
Efficacy Influencing Factor; n»
Water treatment, Continuous food
(initial), Metering pump
Surface Typo: na
Efficacy Influencing Factor: na
Water treatment. Continuous feed
(subsequent). Metering pump
Surface Type: na
Efficacy Influencing Factor: na
Form
sen
sen
SCIL
SC/L
Cr
Cf
Minimum
Application
Rate
478 ppm
by Vol
476 ppm
by Vol
478 ppm
by Vol
478 ppm
by Vol
580 ppm
byWt
680 ppm
by Wt
Maximum
Application
Rata
952 ppm
by Vol
952 ppm
by Vol
470 ppm
by Vol
952 ppm
bvVoi
11 S3 ppm
by Wt
580 ppm
byWt
Max,
*
Apps,
not
spec
not
spec
not
spec
not
spat;
not
spec
not
spec
Max.
ff
Apps.
<§>
Max.
Rats
not
spec
not
upac
not
spec
not
spec
not
spec
not
spec
Win.
Interval
Batwe«n
App«, @
Max.
Rate
(Daye)
not spec
not spec
not spec
not spec
not spec
not spec
Restricted
Entry
Intsrval
(Days)
not spec
not epac
not epsc
not spoc
not spao
not spec
Geographic
Limitations
Allowed






Dis-
allowed






Use Pattern Limitations
Do not discharge effluent containing thie pesticide
into sewage *y«t«ms without notifying the eewage
treatment plant authority. Do not dischargs affluent
containing this protfuet into lakoe, streams, ponds,
astuariee, oceans, or public watar (NPDES ticensn
restriction).
Do not discharge effluont containing thie pesticide
into sowngo systernB without notifying tha sewagB
treatment plant authority. Do not discharge effluent
containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction).
Do not discharge effluent containing this psstictde
into sewage systems without notifying Ihe sewage
treatment plant authority. Do not discharge offtuont
containing this product into takes, streams, ponds,
estuaries, oceans, or public water {NPDES license
restriction).
Do not discharge affluent containing this pesticide
into sewage systems without notifying tha sewage
treatment plant authority. Do not discharge effluent
containing thie product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDCS license
restriction}.
Do not discharge «fflusnt containing this pesticide
into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product into lakes, streams, ponds,
actuaries, oceans, or public water (MPDES license
restriction!.
Do not diBcharflB affluent containing this pesticide
into sewage systems without notifying the sewage
treatment plant authority. Do not discharge effluent
containing this product into lakes, streams, ponds,
estuaries, oceans, or public watar (NPDES license
restriction).

-------
APPENDIXA- CASE 3149, lTris(HOCH2-)nitramethane] Chemtcal 083902 [2-(Hydroxymethvl)-2-nitro-1,3-propanediol]
SITE Application Type, Application
Timing, Application Equipment
Water treatment, Intermittent
(nl'.ig! (initial), Metsring pump
Surface Type: na
Efficacy Influencing Factor; na
Form
Cr
Minimum
Application
Rate
S80 ppm
by Wt
Maximum
Application
Rate
1 1 59 ppm
byWt
Max.
»
Apps.
not
spec
Max.
i
Apps.
@
Mnx.
Rate
not
Spec
Min.
Intarval
Betwenn
Apps. (P
Max.
Rata
(Days}
not eooc
Rsetfiotod
Entry
Interval
(Days)
not epsc
Geographic
Limitations
AHowad

DlK
allowed

Usa Pattern Lirntta!ions
Do not discharge affluent containing this pesttoido
into aawana eystemB without notifying the Bowaga
treatment plant authority. Do not discfiarga affluent
containing this product into lakaa, streams, ponde,
eetuariea, OBeans, or public water (NPDES liconae
rastrietion).
Speciality Industrial Products UBO Groupie); Indoor Non-Food
Preservative traatmant. Not an labs!,
Not on labal
Surface Type: na
Efficasy Influencing Factor; na
Preservative treatment. Not on label.
Not on label
Surl»e» Typa: na
Efficacy Influencing Factor: na
Preservative tcaatmant. Not on label,
Not on label
Surface Type: na
Efficacy Influencing Factor; na
SC/L
SCfl
Cr
500
ppm/gat by
Vol
(from label)
500
ppmfgal by
Vol
(from label)
500
ppm/gaf by
Wt
{from label)
1000
ppm/jjal by
Vol
(from labal)
1000
ppm/gal by
Vol
{tram label!
1000
ppm/gal
by Wl
(from label)
not
upoc
not
epec
not
spec
not
spoc
not
epao
not
sp@c
not spec
not epeo
not spec
not spec
not spec
not apae



CA

CA
Do not diBchnrge effluent containing this pesticide
into aowage oyetame without notifying the eewaga
treatment ptnnt authority. Do nnt diechargs efftyent
containing thia product into lakas, streams, pondls,
eatuarias, oeeana, or public water (NPDES hconse
restriction).
Do not di«olia»go affluent containing thii (•••ticid«
into sewage systemn without nofit-ying th» tuwnyn
traatrnent plant authority. Do no( discharg* effluent
contaitiing this product into Inkss, alfQama, ponds,
satunriaB, oceans, or public water. .(NPDES II cans 8
restriction).
Do not dischargo afflusnt containing this pssticide
into sswaga systBms without notifying the sewaga
treatment plant authority. Do not discharge affluent
containing this product Into lakas, streams, ponds,
estuaries, oceans, or public water (NPDES liceneo
roetrictionl.
Abbrevijliorn usad
    Header:      max = maximum; min *>minimum; apps-applicationB; not spac = not spacified; na = not appficable
    Form:        SC/L = solubl8 concentratefliquid; SC/S= soluble eonoanlrata/aolid; Cr = cryelallinB; P/T = pBllated/tahlatad
    Rato;        ai =actiw8 ingredient;  ppm = parts par million; Vol = volume;  Wt= woight;  gal = gallon
                                                                                           47'

-------

-------
APPENDIX B.  Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                          49

-------

-------
  TRIS(HYDROXYMETHYL)NITROMETHANE: DATA CALL-IN CHEMICAL STATUS
SHEET

INTRODUCTION

      You have been sent this Generic Data CalOn Notice because you have product(s)
containing  TRJS(HYDROXYMETHYL)NITROMETHANE.

      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
TRIS(HYDROXYMETHYL)NITROMETHANE. 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 B), (3) the Requirements Status and Registrant's Form (Attachment C),
(4) a list of registrants receiving this DCI (Attachment D), (5) the EPA Acceptance Criteria
(Attachment E), and (6) the Cost Share and Data Compensation Forms in replying to this
TRIS(HYDROXYMETHYL)NITROMETHANE Generic Data Call-in (Attachment F).
Instructions and guidance  accompany each form.

DATA REQUIRED BY THIS  NOTICE
      The additional data requirements needed to complete the generic database for
TRIS(HYDROXYMETHYL)NITROMETHANE are contained in the Requirements  Status
and Registrant's Response. Attachment C.  The Agency has concluded that additional product
chemistry data on TRIS{HYDROXYMETHYL)NITROMETHANE are needed.  These data
are needed  to fully complete the reregistration of all eligible
TRIS(HYDROXYMETHYL)NITROMETHANE products.

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding the generic data requirements and procedures
established  by this Notice, please contact ERNIE DOBBINS at (703)  308-8071.
      All responses to this Notice for the generic data requirements  should be submitted to;

            ERNIE DOBBINS, Chemical Review Manager
            ACCELERATED REREGISTRATION BRANCH
            Special Review and Registration Division (H7508W)
            Office of Pesticide Programs
            U.S.  Environmental Protection Agency
            Washington, D.C.  20460
            RE:  TRIS(HYDROXYMETHYL)NITROMETHANE
                                      51

-------
                               GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case 3149 covered by this Reregistration Eligibility Document. It
contains generic data requirements that apply to 3149 in all products, including data
requirements for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

       1.  Data Requirement (Column 1).  The data requirements are listed in the order in
which they appear in 40 CFR Part 158.  the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service,  5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.

       2.  Use Pattern (Column 2).  This column indicates  the use patterns  for which the
data requirements apply.  The following letter designations  are used for the  given use
patterns:

                           A     Terrestrial food
                           B     Terrestrial feed
                           C     Terrestrial non-food
                           D     Aquatic food
                           E     Aquatic non-food outdoor
                           F     Aquatic non-food industrial
                           G     Aquatic non-food residential
                           H     Greenhouse food
                           1      Greenhouse non-food
                           J      Forestry
                           K     Residential
                           L     Indoor food
                           M     Indoor non-food
                           N     Indoor medical
                           O     Indoor residential

       3.  Bibliographic citation (Column 3).  If the Agency has acceptable data in its files,
this column lists the identifying number of each study.  This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned.  Refer to the Bibliography appendix for a complete citation of the study.
                                          52

-------
               APPENDIX B

Data Supporting Guideline Requirements for the Reregistration of
       TRIS(HYDROXYMETHYL)N1TROMETHANE
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63- 1 1
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
OctanoI/Water Partition
PH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42958001
42958001
42958001
42958001
42958001
42958001
42958001
42958001
42958001
42958001
WAIVED
42958001
42958001
42806301
42806301
42958001
42958001
42958001
                       53

-------
Data Supporting Guideline Requirements for the Reregistration of
       TWS{HYDROXYMETHYL)MTRQMETHANE
REQUIREMENT
USE PATTERN
CITATION(S)
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
724A
72-1B
72-1 C
72-1 D
72-2A
72-3A
72-3B
72-3C
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout- TEP
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
F
F
F
WAIVED
WAIVED
94706, 94707
42205203
94709
94708
94709
42205204
WAIVED
42099001
42099002
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
ALL
ALL
ALL
ALL
ALL
94711
43222
DATA GAP
DATA GAP
94711, 109228
                          54

-------
              Data Supporting Guideline Requirements for the Reregistration of
                      TRIS(HYDROXYMETHYL)NITROMETHANE
REQUIREMENT USE PAITERN
81-6
82-3
83-3A
83-3B
84-2A
84-2B
84-4
Derma! Sensitization - Guinea Pig
90-Day Dermal - Rodent
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
Gene Mutation (Ame§ Test)
Structural Chromosomal
Aberration
Other Genotoxie Effects
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
N/A
41021101
41089301
42303501
41058101
41944301
41944302
OCCUPATIONAL/RESIDENTIAL EXPOSURE
233
234
Estimation of Dermal Exposure at
Indoor Sites
Estimation of Inhalation Exposure
at Indoor Sites
ALL
ALL
41412201
DATA GAP
ENVIRONMENTAL FATE
161-1      Hydrolysis
ALL
DATA GAP
                                         55

-------

-------
APPENDIX C.  Citations Considered to be Part of the
   Data Base Supporting the Reregistration of 3149
                        57

-------

-------
                               GUIDE TO APPENDIX C

 1.     CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of all
       studies considered relevant by EPA in arriving at the positions and conclusions stated
       elsewhere in the Reregistration Eligibility Document.  Primary sources for studies in
       this bibliography have been the body  of data submitted to EPA and its predecessor
       agencies  in support of past regulator}' 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


                                          59

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       the date from the evidence contained in the document.  When the date appears
       as (19??), the Agency was unable to determine or estimate the date of the
       document.

c.      Title,  In some cases, it has been necessary for the Agency bibliographers to
       create or enhance a document title.  Any such editorial insertions are  contained
       between square brackets.

d.      Trailing parentheses.  For studies submitted to the Agency in the past, the
       trailing parentheses include (in addition to  any self-explanatory text) the
       following elements describing the earliest known submission;

       (1)    Submission date.  The date of the earliest known submission appears
             immediately following the word "received."

       (2)    Administrative number.  The next element immediately following the
             word "under" is the registration number, experimental use permit
             number, petition number, or other administrative number associated
             with the earliest known submission.

       (3)    Submitter.  The third element is the submitter.  When authorship is
             defaulted to the submitter, this element is omitted.

       (4)    Volume Identification (Accession Numbers).  The final element in the
             trailing parentheses identifies the EPA accession number of the volume
             in which the original submission of the study appears.  The  six-digit
             accession number follows the symbol "CDL," which stands  for
             "Company Data Library." This accession number is in turn followed
             by an alphabetic suffix which shows the relative position of the study
             within the volume.
                                   60

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                                BIBLIOGRAPHY
MRID
CITATION
00043222    Wilbur, S.; Parekh, C. (1980) Acute Dermal Toxicity of P-2350 (Tris nitro
             Concentrate): PLR-109; CKP8Q/59; SW80/3.  (Unpublished study received
             Sep 15, 1980 under 271-39; submitted by International Minerals & Chemical
             Corp.,  Terre Haute, Ind.; CDL;243245-G)

00094706    Ralston Purina  Company (1978) CDietary LCae50-« Determination in Bobwhite
             Quail |  : RT No. 8032836.  (Unpublished study received Feb  1, 1982 under
             271-40; submitted by International Minerals & Chemical Corp., Terre Haute,
             Ind.; CDL:246754-B)

00094707    Ralston Purina  Company (1978) CDietary LCs50~> Determination in Mallard
             Ducklings  | : RT No,  8032836.  (Unpublished study received  Feb 1, 1982
             under 271-40; submitted by International Minerals & Chemical Corp., Terre
             Haute,  Ind.; CDL:246754-C)

00094708    Lee, T. (1973) Report: WARF No. 3051213.  (Unpublished study, including
             letter dated May 3, 1973 from R.F. Pureell to Terrence Lee, received Feb 1,
             1982 under 271-40; prepared by Warf Institute,  Inc., submitted by
             International Minerals & Chemical Corp., Terre Haute, Ind.; CDL:246754-D)

00094709    Ralston Purina  Company (1978) Analysis for Fish Acute Toxicity (Rainbow
             Trout, Bluegill): RT No. 8032836.  (Unpublished study received Feb 1, 1982
             under 271-40; submitted by International Minerals & Chemical Corp., Terre
             Haute,  Ind.; CDL:246754-E)

00094711     Parekh, C.K. (1979) LDae5Q-i and Eye Irritation of Tris Nitro Concentrate
             (P-2350): Report No. PLR-77. (Unpublished study received Feb  1, 1982
             under 271-40; submitted by International Minerals & Chemical Corp., Terre
             Haute,  Ind.; CDL:246755-B)

00094713     Wilbur, S.; Parekh, C. (1980) Acute Dermal Toxicity of P-2350 (Tris Nitro
             Concentrate): Report No. PLR-109.  (Unpublished study received Feb 1, 1982
             under 271-40; submitted by International Minerals & Chemical Corp., Terre
             Haute,  Ind.; CDL:246755-D)

00094715     Parekh, C.  (1980) Acute Toxicity of P-2350 (Tris Nitro Concentrate): Report
             No. PLR-135.  (Unpublished study received Feb 1T 1982 under 271-40;
             submitted by International Minerals & Chemical Corp., Terre  Haute, Ind.;

                                        61

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                                BIBLIOGRAPHY
 MRID
CITATION
             CDL:246755-F)

00109228    Parekh, C, (1981) Acute Toxicity Profile of Tris Nitro Concentrate (P-2350):
             Report No. PLR-146.  (Unpublished study received May 18,  1982 under
             271-40; submitted by International Minerals & Chemical Corp., Terre Haute,
             IN; CDL:247864-B)

41021101    Naas, D. (i 989) Tris Nitro Brand of 2-hydroxymethy 1-2-nitro-1, Spropanediol:
             90-day Dermal Toxicity Study in Rats: Project No, Wil-129005.  Unpublished
             study prepared by Wil Research Laboratories, Inc.  637 p.

41021102    Nemec, M. (1988) Tris Nitro Brand of
             2-hydroxymethyl-2-nitro-l,3propanediol: A Range-finding Teratology Study in
             Rats:  Project No. Wil-129001.  Unpublished study prepared by Wil Research
             Laboratories, Inc.  87 p.
41058101    Desai, L. (1988) Tris Nitro Brand of 2-Hydroxymethyi-2-nitro-l,3propanediol:
             Ames Bacterial/Microsomal Plate Incorporation Assay: Project No. 88G-0017.
             Unpublished study prepared by Toxikon Corp.  14 p.

41089301    Nemec, M. (1989) Tris Nitro Brand of
             2-Hydroxymethyl-2-nitro-l,3propanediol: A Teratology Study in Rats: Project
             No. WIL-129002. Unpublished study prepared by WIL Research Laboratories,
             Inc. 220 p.

41412201    Popendorf, W.; Seiim, M.; Kross,  B, (1990) Chemical Manufacturers
             Association Antimicrobial Exposure Assessment Study: Lab Project ID: Q626.
             Unpublished study prepared by Univ, of Iowa, Institute of Agricultural
             Medicine and Occupational Health. 209 p.

41944301    Paika, I. (1991) Chromosome Aberrations in Chinese Hamster Ovary (CHO)
             Cells: Tris Nitro: Lab Project Number: 90G-0538. Unpublished study
             prepared by lexicon Corp. 60 p,

41944302    Paika, I. (1991) Unscheduled DNA Synthesis in Rat Liver Primary Cultures:
             Tris Nitro: Lab Project Number: 90G-0537.  Unpublished study prepared by
             Toxicon Corp. 64 p.
                                         62

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                                BIBLIOGRAPHY
MRID
CITATION
42099001     Graves, W.; Peters, G, (1991) Tris Nitro: A 96-Hour Shell Deposition Test
             with the Eastern Oyster (Crassostrea virginica): Final Report: Lab Project
             Number: 288A-1Q3.  Unpublished study prepared by Wildlife International.
             Ltd.  41 p.

42099002     Murphy, D.; Peters,  G. (1991) Tris Nitro: A 96-Hour Flow-Through Acute
             Toxicity Test with the Saltwater Mysid (Mysidoopsis bahia) : Final Report:
             Lab Project Number: 288-102A.  Unpublished study prepared by Wildlife
             International.  35 p.

42205203     Bowman, J. (1989) Acute Toxicity of Tris Nitro to Fathead Minnow
             (Pimephales promelas): Lab Project Number: 38249, Unpublished study
             prepared by ABC Labs., Inc.  68 p.

42205204     Forbis, A. (1989) Acute Toxicity of Tris Nitro to Daphnia magna: Lab Project
             Number: 38250.  Unpublished study prepared by ABC Labs., Inc. 57 p

42303501     Nemec, M.  (1992) A Developmental Toxicity Study of Tris Nitro in Rabbits:
             Lab Project Number: 129008. Unpublished study prepared by WIL Research
             Laboratories, Inc.  286 p.

42806301     Bollmeier, A.  (1993) Supplemental Product Chemistry: TRIS NITRO Brand of
             Tris(HydroxymethyI) Nitromethane.  Unpublished study prepared by ANGUS
             Chemical Co.  7 p,

42958001     Bollmeier, A.  (1993) Supplemental Product Chemistry: TRIS NITRO brand of
             tris(hydroxymethyl)nitromethane.  Unpublished study prepared by ANGUS
             Chemical Company.  32 p.
                                        63

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APPENDIX D.  List of Available Related Documents
                     65

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       The following is a list of available documents related to 3149.  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 3149 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.     3149 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
                                          67

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APPENDIX E. PR Notices 86-5 and 91-2

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PR Notice 86-5
     71

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               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

   ,t                         WASHINGTON, D.C. 20460

                                 July 29, 1986

                                                            OFFICE OP
                            PR NOTICE 86-5             PREVENTION, PESTICIDES
                                                      AND TOXtC SUBSTANCES

          NOTICE TO PRODUCERS,  FORMULATQRS,  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.

Ill- 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 PR 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


                                73

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specify the format for data submitted to EPA under Section 3 of
FlFRA 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.

                                74

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                             - INDEX-
                                                            Text Example
                                                            Page   Page
A.   Organization of  the Submittal Package   .........  3      17

B.   Transmittal Document	4      11

C.   Individual Studies  	  .....  	  4

     C. 1  Special Considerations for  Identifying Studies .   .  5

D.   Organization of  each  Study Volume	6      17

     D. 1  Study Title Page		7      12
     D. 2  Statement  of Data  Confidentiality Claims
                   (based on FIFRA §10 (d) (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

P.   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).
                                75

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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) (25  submittal, or  a special review; the transmit:tal
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 CPR  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 cr.
     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.

                                76

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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.1  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.
                                77

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      c.  Residue Chemistry Studies.    Guidelines  171-4,  153-3,
 and  153-4 are extremely broad  in  scope;  studies addressing
 residue chemistry requirements must  thus be  defined  at  a level
 below that of the Guideline  code.  The general principle,
 however, of limiting a study to the  report of a single  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
 all  such commodities should  be reported  as a single  study.  When
 multiple field trials are associated with a  single crop,  all such
 trials should be reported as a single study.
D.
Organization of Each Study Volume
     Each complete-study must  include all  applicable  elements  in
the list below, in the order indicated.   (Also^ see  Page  17.)
Several of these elements are  further explained in  the following
paragraphs.   Entries in the column headed "example"  cite  the
page number of this notice where  the element  is illustrated.
Element

Study Title Page

Statement of Data
Confidentiality
Claims

Certification of Good
Laboratory Practice
                    When Required                 Example

                    Always                        Page 12

                    One of the two alternative    Page 13
                    forms of this statement
                    is always required

                    If study reports laboratory   Page 16
                    work subject to GLP require-
                    ments
Flagging statements
Body of Study
Study Appendices

Cover Sheet to Confi-
dential Attachment
                    For certain toxicology studies  {When
                    flagging requirements are finaliz;ed.}

                    Always - with an English language
                    translation if required.

                    At submitter's option

                    If CBI is claimed under FIFRA
                    §10 (d) (D (A) ,  (B) ,  or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
                    If CBI is claimed under FIFRA
                    S10(d)(1)(A),  (B) ,  or  (C)     Page 15

                    Only if confidentiality is    Page 14
                    claimed on a basis other than
                    FIFRA §10{d)(1)(A),  (B),  or  (C)
                                78

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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 INCLTJDE 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.
                                79

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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)(1) data confidentiality  (§158,33(b)} or
to waive such a claim  (§l58.33(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
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B),  or (C)»  the following provisions apply:

     -  The specific information to which the claim applies must
     be clearly marked in the body 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.

                                80

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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 Submitted Data

     DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOE 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 .not be included in the transmit -
tal document, but  should be incorporated into the  statement of
the method of support for the application,

P.   Physical Format Requirements

     All elements  in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resolution.  Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming.  Check with EPA for  special
instructions before submitting data in any medium  other than
paper, such as film or magnetic media.

Please be particularly attentive to the following  points:

     *    Do not include frayed or torn pages.

     •    Do not include carbon copies, or copies  in other than
          black ink.

     •    Make sure that photocopies are clear, complete, and
          fully readable,

     *    Do not include oversize computer printouts or fold-out
          pages.

     *    Do not bind any documents with glue or binding tapes,

     »    Make sure that all pages of each study,  including any
          attachments or appendices, are present and in correct
          sequence.

     Numberof 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 Syscer.
and getting it into review.)
                                81

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G.
Special Requirements for Submitting 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,

     »    Remove the "Supplemental Statement of Data
          Confidentiality Claims".

     »    Remove the "Confidential Attachment".

     »    Excise from the body of the study any information you
          claim as confidential, even if it does not fall within
          the scope of FIFRA §10(d)(1)(A), (B), or  {C}.  Do not
          close up or paraphrase text remaining after this
          excision,

     »    Mark the fourth copy plainly on both its cover and its
          title page with the phrase "Public Docket Material -
          contains no information claimed as confidential",
V.
 For Further Information
     For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division,  (703) 305-5240.
                         i«s V.  Ak train
                       Acting Oirtctor,
                       ftvgiaeration 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
                                82

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                          ATTACHMENT 1

       ELEMENTS  TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*

1.   Name and address of submitter  (or all joint submitters**)

+Smith Chemical Corporation              Jones Chemical Company
 1234 West Smith Street        -and-      5678 Wilson Blvd
 Cincinnati, OH 98765                    Covington, KY 56789



"""Smith Chemical Corp will act  as sole agent for all submitters.

2.   Regulatory action in support of which this package is
     submitted

Use the EPA identification number  (e.g. 359-EUP-67) if you know
it.  Otherwise describe the type of request  (e.g. experimental
use permit, data call-in - of  xx-xx-xx date),

3.   Transmittal date

4.   List of submitted studies

     Vol 1.    Administrative  materials - forms, previous corres-
               pondence with Project Managers, and so forth,

     Vol 2.    Title of first  study in the submittal  (Guideline
               No.)

     Vol n     Title of nth study in the submittal  (Guideline
               No. )

     *    Applicants commonly  provide this information in a tran-
          smittal  letter,  This remains an acceptable practice so
          long as  all four elements are included.-

     *    Indicate which of the joint submitters is empowered to
          act on behalf of all joint submitters  in any matter
          concerning data compensation or subsequent use or
          release  of the data,


Company Official:.
                    Name                Signature

Company Name:	:	
Company Contact;  ____^_^________.^_   	
                    Name                Phone
                                83

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                   ATTACHMENT 2

SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY

                    Study Title

   (Chemical  name)  - Magnitude  of  Residue  on  Corn

                  Data  Requirement

                  Guideline 171-4

                       Author

                   John C,  Davis

                 Study  Completed On

                  January 5,  1979

               Performing Laboratory

           ABC Agricultural Laboratories
                 940 West Bay Drive
               Wilmington, CA  39897

               Laboratory Project ID

                     ABC 47-79
                    Page 1 of X
   (X  is  the  total  number of pages in the study)

                         84

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                           ATTACHMENT  3

            STATEMENTS OF DATA CONFIDENTIALITY CLAIMS

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
contained in this study on the basis of
the scope of FIFRA 6§10 (d) (I) (A) , (B) ,
Company
Company Aqent : Typed Name
Title
any information
its falling within
or (C) .
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) Si) (A),  (B), or  (C) has been
  removed to a confidential appendix, and is cited by
  cross-reference number in the body of the study.
  Company:
  Company Agent; 	Typed Name	 Date:.

   •	Title	  		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.
                                85

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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:

     »    Identify specifically by page and line number(s)  each
          portion of the study for which you claim
          confidentiality.

     »    Cite the reasons  why the cited passage qualifies for
          confidential  treatment.

     •    Indicate the  length of time — until a specific date or
          event,  or permanently--for which the information should
          be treated as confidential.

     «    Identify the  measures taken to guard against undesired
          disclosure of this information.

     »    Describe the  extent to which the information has been
          disclosed,  and what precautions have been taken in con-
          nection with  those disclosures.

     »    Enclose copies of  any pertinent determinations of
          confidentiality made by EPA,  other Federal agencies, of
          courts  concerning this information,

     »    If you  assert that disclosure of this information would
          be likely to  result in substantial harmful effects to
          you,  describe those harmful effects and explain why
          they should be viewed as substantial.

     •    If you  assert that the information in voluntarily 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.
                               86

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                               ATTACHMENT 5

             EXAMPLES OF  SEVERAL CONFIDENTIAL ATTACHMENTS

Example  1.  (Confidential word or phrase Chat has  been deleted
from the study)
   CROSS REFERENCE NUMBER l.  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:	gt-T-iyl one a] ycv-n	

   PAGE     LIME  REASON .FOR  THE DELETION                   FIFRA REFERENCE

      6     14    Identity of Inert Ingredient              §10(d)(!)(C}
     12     25
    100     19                "                                   "
Example 2.  (Confidential  paragraph{s) that have been deleted from the study)
  CROSS REFERENCE NUMBER 5, This cross reference number is used in the study
                           in place of the following paragraph(s) at the
                           indicated volume and page references.

   DELETED PARAGRAPH(S}:
      {                                                                }
      (     Reproduce  the deleted paragraph(s) here                     )
      (                                                                )

 PAC3E       LINES REASON FOR THE DELETION                   FIFRA REFERENCE

  20.       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  7. 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 LINEg      REASON FOR THE DELETION                   FIFRA REFERENCE

  20,  2-17  Description  of the product manufacturing process   §10(d)(1)(A)
                                     87

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                                 ATTACHMENT 6.

                  SAMPLE GOOD LABORATORY PRACTICE  STATEMENTS

Example l.	           	
      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.
    3.
          Submitter

          Sponsor	
          Study Director
Example __3_._
    The submitter of this study  was  neither the sponsor of this study nor
    conducted  it,  and  does not  know whether  it  has been  conducted  in
    accordance with 40 CFR Part  160,

          Submitter

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                         ATTACHMEHT 7.
                 FORMAT OP THE SUBMITTAL PACKAGE
                   Transntittal Document.
                       Belated Administrative  Materials
                       (e.g., Method of Support Statement, etc.)
                             Other materials  about  the submittal
                             (e.g., summaries of groups of »tjdies
                             to aid in their  review).
                                    Studies,  submitted as  unique
                                    physical  «ntiti«f, according
                                    to the format  below.
                   FORMAT OF SUtHITTtD STUDIES
LEGEND
                  title page.

                St*t«ment o£ Confidentiality Claims.

                    GLP *nd flagging* »tat«m«nts - at  appropriate.
                              at th« »tudy,  with English
                         language tranalation if required.
                                        to th* atudy,
                                 Title Page of the Confidential
                                 Attachment.

                                      Conf Wenciai Attachment.
                                          Supplemental Statement
                                          of Confidentiality Claims,
                                      * Mien flagging requirements
                                        are finalized.
                 Documents which wust &e auboitted a*
                 appropriate to *«et e«tabli«h«d requirement*.
                 ^
                      Documents submitted at submitter'a option,
                             89

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PR Notice 91-2
      91

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               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                            WASHINGTON, O.C. 20460
                                                          flFFICE OF
                                                         PREVENTION, PESTICIDES
                                                         4NO 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(1). 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


                                93

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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,11 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 011
representative sampling and chemical analysis{i.e., quality
control) of the product.

     The format of the ingredient statement must conform to 40
CFR IBS-Labeling Requirements For Pesticides and Devices.

     After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
                                94

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IV. PRODUCTS THAT REQUIRE EFFICACY DATA

     All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153,640.

     In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

     As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B).  Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:

     (1)   Beginning July 1, 1991,  all new product registrations
          submitted to the Agency are to comply with the
          requirements of this Notice.

     (2)   Registrants having products subject to reregistration
          under FIFRA section 4(a) are to comply with the
          requirements of this Notice when specific products are
          called in by the Agency under Phase V of the
          Reregistration Program.
                                95

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      (3)  All other products /applications that are  not  subject  to
           (l) 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.
                                   C^»— «—  £-" •

                                 Ann* E. fcirtdaay, Director
                                 Registration Division  (M-75OS

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APPENDIX F. Generic Data Call-in
               97

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                         GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires  you and other registrants  of pesticide products  containing the active
ingredient(s) identified in Attachment I 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 in Section III below.  Your response must state:

1.     how you will comply with the requirements set forth in this Notice and its Attachments
       1 through 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 III-B);
       or,

3,     why you believe EPA should not require your submission of data in the manner specified
       by this Notice  (see section E-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 produet(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 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. 2070-0107
(expiration date 12-31-92).


                                          99

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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 II     -      Data Required By This Notice
       Section III    -      Compliance With Requirements Of This Notice
       Section IV    -      Consequences Of Failure To Comply With This Notice
       Section V     -      Registrants' Obligation To Report Possible Unreasonable
                          Adverse Effects
       Section VI    -      Inquiries And Responses To This Notice

    The Attachments to this Notice are:

       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
reevaluation 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 ingredients).

SECTION n. 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.
                                         100

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       C.    TESTING PROTOCOL

             All studies required under this Notice must be conducted in accordance with test
       standards outlined in the Pesticide Assessment Guidelines for those studies for which
       guidelines have been established.

             These EPA Guidelines are available from the National Technical Information
       Service (NTIS), Attn:  Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel:
       703-487-4650).

             Protocols  approved by  the  Organization  for  Economic  Cooperation  and
       Development (OECD) are also  acceptable if  the OECD-recommended test standards
       conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
       158.70).  When using the OECD protocols, they should  be modified as appropriate so
       that the data generated by the study will satisfy the requirements of 40 CFR  §  158.
       Normally, the Agency will not extend deadlines for complying with data requirements
       when the studies  were not conducted in accordance with  acceptable standards.  The
       OECD  protocols are  available  from OECD, 1750  Pennsylvania  Avenue  N.W.,
       Washington, D.C, 20006.

             All new studies and proposed protocols submitted in response to this Data Call-In
       Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a}(6)].
      D.     REGISTRANTS  RECEIVING  PREVIOUS SECTION 3(cV2YB) 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-Infs). 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 FV-A and IV-
      B,


                                        101

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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 III-C.  A discussion of options relating to requests for data
waivers is contained in Section III-D.

       There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency.  These forms are
the Data-Call-in  Response Form (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 produet(s) containing the  active
       ingredients) 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 W-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 ail other information required for
       processing the application. Use deletion is option number 7 on the Requirements
       Status  and Registrants Response Form. You must also complete a Data Call-in


                                   102

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Response Form by signing the certification, item number 8. Application forms for
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)
in 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) in 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 in 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 in compliance  with
this Data Call-in Notice, the Agency will consider that both they and you are not
in compliance and will normally initiate proceedings to suspend the registrations
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       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
       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 III-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 III-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),
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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) rale (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.  In  addition, certain studies require Agency
approval of test protocols in advance of study initiation,  Those studies for which
a protocol must be submitted  have been identified  in 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 in Section II-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 II-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 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 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
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affected registration(s).

       If you cannot submit the data/reports to the Agency in the time required
by this Notice and intend to seek additional time to meet the 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 on a step-by-step basis.   You must explain any
technical or laboratory difficulties and provide documentation from the laboratory
performing the testing.  While EPA is  considering your request, the original
deadline remains.  The Agency will respond to your request in writing.  If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be  requested only  in  cases of extraordinary testing problems beyond the
expectation or control  of the  registrant.  Extensions  will not be given in
submitting the 90-day responses.  Extensions will not be considered if the request
for extension is not made in a timely fashion; in no event shall an extension
request be  considered if it  is submitted at  or after the lapse of the subject
deadline.

Option 2. Agreement to  Share in Cost to Develop. Data   --

       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
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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 to whom the offer was made has not accepted your offer to enter into
a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt).  Your offer
must, in  addition to anything else, offer  to share in the burden of producing the
data upon  terms to be agreed or failing  agreement  to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this
offer.  The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-in
Response Form and a Requirements Status and Registrant's Response Form
committirig 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:
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       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 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 requirement(s) 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 FIFEA 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 then: forecast supporting the waiver request in order to remain qualified


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for such waiver.  If granted a waiver, a registrant will be required, as a condition
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 product(s), as part of your 90-day
response to this Notice:

       a.      Total company  sales  (pounds  and dollars)  of  all  registered
       product(s) containing the active ingredient(s), If applicable to the active
       ingredients),  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 produces) 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 product(s)
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              containing  the active ingredient(s) (following the parameters in item d
              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
       produces),  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 your product(s). you
       must choose a method of meeting the requirements of this Notice within the time
       frame provided by this Notice. Within 30 days of your receipt of the Agency's
       written decision, you must submit a revised Requkements Status and Registrant's
       Response Form indicating the option chosen.
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IV.    CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

       A.     NOTICE OF INTENT TO SUSPEND

             The Agency may issue a Notice of Intent to  Suspend products subject to this
       Notice due to failure by a registrant to comply with the requirements of this Data Call-In
       Notice, pursuant to FIFRA section 3(c)(2)(B).  Events which  may  be  the basis for
       issuance of a Notice of Intent to Suspend include, but are not limited to, the following:

             1,      Failure  to respond as required by this Notice within 90  days  of your
                    receipt of this Notice.

             2.      Failure to submit on the required schedule an acceptable proposed or final
                    protocol when such is required to be submitted to the Agency for review,

             3.      Failure to submit on the required schedule an adequate progress report on
                    a study  as required by this Notice.

             4,      Failure to submit on the required schedule acceptable data as required by
                    this Notice.

             5.      Failure to take a required action or submit adequate information pertaining
                    to any option chosen to address the data requirements  (e.g., any required
                    action or information pertaining to  submission or citation of  existing
                    studies or offers, arrangements,  or arbitration on the  sharing of  costs or
                    the formation of Task Forces, failure  to comply  with the terms of an
                    agreement or arbitration concerning joint data  development or failure to
                    comply with any terms of a data waiver).

             6.      Failure  to submit supportable  certifications  as  to  the conditions of
                    submitted studies,  as required by Section III-C of  this Notice.

             7.      Withdrawal of an offer to share in the cost of developing required data.

             8.      Failure of the registrant to whom you have tendered an offer to  share in
                    the cost of developing data and provided proof of  the registrant's receipt
                    of such offer, or failure of a registrant on whom  you rely for a generic
                    data exemption either to:

                    a.     inform EPA of intent  to develop and submit the data requked by
                    this Notice on a Data Call-in Response Form and  a Requirements Status
                    and Registrant's Response Form: or,

                    b.     fulfill the commitment to develop and submit the data as  required


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             by this Notice; or,

             c.     otherwise take appropriate steps to meet the requirements stated in
             this Notice, unless you commit to submit and do submit the required data
             in the specified time frame.

       9,     Failure to take any required or appropriate steps, not mentioned above, at
       any time following the issuance of this Notice.
B.     BASIS  FOR  DETERMINATION  THAT   SUBMITTED   STUDY   IS
       UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to
Suspend. The grounds for suspension include, but are not limited to, failure to meet any
of the following:

       1.     EPA requirements specified in the Data Call-In Notice or other documents
       incorporated by  reference (including, as applicable, EPA Pesticide Assessment
       Guidelines,  Data  Reporting Guidelines,  and  GeneTox Health  Effects Test
       Guidelines) regarding the design,  conduct, and reporting of required studies.
       Such requirements include, but are not limited to, those relating to test material,
       test procedures,  selection of species, number of animals, sex and distribution of
       animals, dose and  effect levels to be tested or attained, duration of test, and, as
       applicable, Good Laboratory Practices.

       2.     EPA requirements regarding the submission of protocols, including the
       incorporation of any changes required by the Agency following review,

       3.     EPA requirements  regarding the reporting of data, including the manner
       of reporting,  the completeness of results, and the adequacy of any required
       supporting (or raw) data, including, but not limited to,  requirements referenced
       or included in this Notice or contained in PR 86-5.  All studies must be submitted
       in the form of a final report; a preliminary  report will not be considered to fulfil!
       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.
                                                      -     ****»  A.
                                             Ekniel M. Barolo, Djleetor
                                             Special Review    /
                                               and Reregistration Division
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Attachment 1. Chemical Status Sheet
                117

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3149: DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You  have been  sent this  Generic Data Callln Notice because you have product(s)
containing 3149.

       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 3149.  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 B), (3) the Requirements Status and Registrant's Form
(Attachment C), (4) a  list of registrants receiving this DCI (Attachment D),  (5) the  EPA
Acceptance Criteria (Attachment E), and (6) the Cost Share and Data Compensation Forms in
replying  to  this 3149  Generic  Data  Call-In  (Attachment F),   Instructions  and guidance
accompany  each form.

DATA REQUIRED BY THIS NOTICE
       The  additional data requirements needed to complete the generic database for 3149 are
contained in the Requirements Status and Registrant's Response. Attachment C.  The Agency
has concluded that additional product chemistry data on 3149 are needed. These data are needed
to fully complete the reregistration of all eligible 3149 products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding  the generic  data requirements and  procedures
established by this Notice, please contact Ernie Dobbins at (703) 308-8071.
       All responses to this Notice for the generic data requirements should be submitted to:

             Ernie Dobbins, Chemical Review Manager
             Accelerated Reregistration Branch
             Special Review and Registration Division (H7508W)
             Office of Pesticide Programs
             U.S.  Environmental Protection Agency
             Washington, D.C.  20460
             RE:  3149
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Attachment 2. Generic DCI Response Forms Inserts (Form
                 A) plus Instructions
                         121

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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 identifies 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 in
              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,

Tfem 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 Registrants*
 Response Forms Inserts (Form B) plus Instructions
                       126

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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, B.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 produces) 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 in Section III 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 ActiveIngredientRadiolabelledandMetabolites
                    PAIRA/PM          Pure Active Ingredient Radiolabelled  and Plant
                                        Metabolites
                    TEP                 Typical End-Use Product
                          *             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  identifies 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 submiftal 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 in 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) 1 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,

Item 12.      Enter the name of the person EPA should contact with questions regarding your
             response.

Item 13,      Enter the phone number of your company contact.
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Attachment 4. List of Registrant(s) sent this DCI (Insert)
                          133

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APPENDIX G. Product Specific Data Call-In
                  135

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                               DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice  requires you  and other  registrants of pesticide products  containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
submit certain product specific  data  as noted herein to the  U.S.  Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient.  Within 90 days after you receive this Notice
you must respond as set forth in Section III below.  Your response must state;

       1.     How you will comply  with the requirements set forth in  this Notice and  us
              Attachments A through G; or

       2.     Why you believe you are exempt from the requirements listed in this Notice and
              in Attachment 3,   Requirements  Status and Registrant's  Response Form, (see
              section III-B); or

       3.     Why you believe EPA should not require your submission  of product specific
              data in the manner specified by this Notice (see section III-D),

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a lisi 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 II -   Data Required By This Notice
       Section III-   Compliance With Requirements Of This Notice
       Section IV -  Consequences Of Failure To Comply With This Notice
       Section V -  Registrants' Obligation To Report Possible Unreasonable Adverse
                    Effects
       Section VI -  Inquiries And Responses To This Notice

    The Attachments to this Notice are:

       1   -   Data Call-In Chemical Status  Sheet
       2  -   Product-Specific Data Call-In Response  Form
       3   -   Requirements Status and Registrant's Response Form
       4  -   EPA 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 II.  DATA REQUIRED BY THIS NOTICE

II-A.  DATA REQUIRED

       The  product  specific  data required  by this  Notice are specified  in  Attachment  3,
Requirements Status and Registrant's Response Form.  Depending on the results of the studies
required in this  Notice, additional  testing may be required.

II-B.  SCHEDULE FOR SUBMISSION OF DATA
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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.
H-C.  TESTING PROTOCOL

    All  studies required under this Notice must be conducted  in accordance  with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.

      These EPA Guidelines are available from the National Technical Information  Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161  (tel: 703-487-4650).

      Protocols approved by the Organization for  Economic Cooperation  and  Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide  Data  Requirements regulation  (40 CFR § 158.70).   When using the OECD
protocols,  they should be modified as appropriate so that the data generated by the study will satisfy
the requirements of 40 CFR § 158.  Normally, the Agency will not extend deadlines for complying
with data  requirements when the studies were  not  conducted in accordance with acceptable
standards.  The OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, B.C. 20006.

      All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance  with Good Laboratory Practices [40 CFR Part 160,3(a)(6)].

H-D.  REGISTRANTS RECEIVING PREVIOUS SECTION 3fcK2)fB)  NOTICES
     ISSUED BY THE AGENCY

     Unless otherwise noted herein, this Data Call-in does not in any way supersede or change the
requirements of any previous Data Call-In(s). or any other agreements entered into with the Agency
pertaining  to such prior Notice.   Registrants must comply with  the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.

SECTION III, COMPLIANCE WITH REQUIREMENTS OF  THIS NOTICE

HI-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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 in-B.  OPTIONS FOR RESPONDING TO THE AGENCY

       The options for responding to this Notice for product specific data  are: (a) voluntary
 cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
 (c) request a data waiver(s).

       A discussion of how to respond if you chose the Voluntary Cancellation option is presented
 below,   A  discussion of the various  options available  for satisfying the product  specific data
 requirements of this Notice  is contained in Section III-C.  A discussion of  options relating to
 requests  for data waivers is contained in Section III-D.

       There are two forms that accompany this Notice of which, depending upon your response,
 one or both must be used in your response to  the Agency.  These forms are the Data-Call-in
 Response Form, and the Requirements Status and Registrant's  Response Form. Attachment 2  and
 Attachment 3. The Data Call-in Response Form must be submitted as part of every response to this
 Notice,   In addition, one copy of the Requirements Status and Registrant's Response Form must
 be  submitted for each product listed on the Data Call-in Response Form unless the voluntary
 cancellation option is selected or unless the product is identical to  another (refer to the instructions
 for completing the Data Call-in Response Form in Attachment  2). Please note  that the company's
 authorized  representative is required to sign the first page of the Data Call-In Response Form and
 Requirements Status and Registrant's  Response Form (if this form is  required) and initial  any
 subsequent pages. The forms contain separate detailed instructions  on the response options. Do not
 alter the printed material. If you have questions or need assistance in preparing  your response,  call
 or write the contact person(s) identified in Attachment 1.

       1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
 voluntary cancellation of your product(s) containing the active  ingredient that is the subject of this
 Notice.  If you wish to voluntarily cancel your product, you must submit a completed Data Call-in
 Response Form, indicating your election of this option.  Voluntary  cancellation is item number 5
 on the Data Call-In Response Form. If you choose this option, this is the only form  that you are
 required to complete.

      If you chose to voluntarily cancel your product, further sale and distribution of your product
 after the  effective date of cancellation must be in accordance with the Existing Stocks provisions
 of this Notice which are contained in Section IV-C.
       2.  Satisfying the Product Specific Data Requirements of this Notice  There are various
options available to satisfy the product specific data requirements of this Notice.  These options are
discussed  in Section III-C of this Notice and comprise options 1  through 6 on the Requirements
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
Form.  Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.

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       3. Request for Product Specific Data Waivers.   Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form.  If you choose one of these options, you must submit both forms
as  well  as  any other information/data pertaining  to the option chosen  to  address  the  data
requirement,

III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data production
for each  data requirement.   Your option selection should be  entered under  item  number  9,
"Registrant Response." The  six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrant's Response
Form.   These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this  Section. The options are:

       (1)    I will generate and submit data within the specified time frame (Developing Data)
       (2)    I have entered into an agreement with one or more registrants to develop data jointly
              (Cost Sharing)
       (3)    I have made offers to cost-share (Offers to Cost Share)
       (4)    I am submitting an existing study  that has not  been  submitted previously to the
              Agency by anyone (Submitting an Existing Study)
       (5)    I am submitting or citing data to upgrade a study classified by EPA  as partially
              acceptable and upgradeable (Upgrading a Study)
       (6)    I am citing an existing study that EPA has classified  as  acceptable or an existing
              study that has been submitted but not reviewed by the Agency (Citing  an Existing
              Study)

       Option 1. Developing Data — If you choose to develop the required data it  must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments.   All data generated and submitted must comply with the Good  Laboratory
Practice  (GLP) rule (40 CFR Part  160),  be conducted  according to the Pesticide  Assessment
Guidelines (PAG), and be in conformance  with the requirements of PR Notice 86-5.

      The tune 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 dils Notice by the registrant.  If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).

      If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes:  (1) a detailed description  of the expected difficulty  and (2) a proposed schedule


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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 in writing.  If EPA does not grant your request, the original deadline
 remains.  Normally, extensions can be requested only  in cases of extraordinary testing problems
 beyond the expectation or control of the registrant. Extensions will not be given in submitting the
 90-day responses.  Extensions will not be considered if the request for extension is not made in a
 timely fashion; in no event shall an extension request be considered if it is submitted at or after the
 lapse of the subject deadline.

       Option 2, Agreement to Share  in Cost to Develop Data  — Registrants may only choose this
 option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
 data tables that your product and at least one other product are similar for purposes of depending
 on the same data.  If this is the case, data may be generated  for just one of the products  in the
 group.  The  registration number of the product for which data  will be submitted must be noted in
 the agreement to cost share by the registrant selecting this option.  If you choose to enter into an
 agreement to share in the cost of producing the required data but will not be submitting the data
 yourself,  you must provide the name of the registrant who will be submitting the data.  You must
 also provide EPA with documentary evidence that an agreement has been formed.  Such evidence
 may be your letter offering to join in an agreement and the  other registrant's acceptance of your
 offer, or a written statement by the parties that  an agreement exists. The agreement to produce the
 data need not specify all of the terms of the final arrangement between the parties or the mechanism
 to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve  the terms  of the
 agreement they may resolve their differences through binding arbitration.

       Option 3. Offer to Share in the Cost of Data Development — This option only applies to
 acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
 to pay  in an attempt to enter into an agreement or amend an existing agreement to meet the
 requirements of this Notice and have  been unsuccessful, you may request EPA {by selecting this
 option) to exercise  its discretion not to suspend your registration(s),  although you do not comply
 with the data submission requirements of this Notice, EPA has determined that as a general policy,
 absent other relevant considerations, it will not suspend the registration of a product of a registrant
 who has in good faith sought and continues to seek to enter  into a joint data development/cost
 sharing program, but the other registrant(s) developing the data has refused  to accept your  offer.
 To quality for this  option, you must submit documentation to  the Agency proving  that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden
of developing that data.  You must also submit to the  Agency a completed  EPA Form 8570-32.
Certification of Offer to Cost Share in the Development of Data, Attachment 7.  In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such  as a certified mail receipt).  Your  offer must, in addition to
anything else, offer to share in the burden  of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must
not qualify this offer.  The other registrant must also inform EPA of its election of an option to


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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 diat if the Agency determines  that the study is not  acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date  of submission. The Agency may determine at any time  that a study is not  valid and needs to
be repeated.

       To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:

       a.     You must certify at the time that the existing study is submitted that the raw data and
             specimens from the study are available for audit and review and you must identify
             where they are available.  This must be done in accordance with the  requirements
             of the Good Laboratory Practice (GLP)  regulation, 40 CFR Part 160. As  stated in
             40 CFR   160,3(j) "  'raw  data*  means any  laboratory worksheets,  records,
             memoranda,   notes, or  exact copies  thereof,  that are  the  result  of  original
             observations and  activities of a study and  are necessary for the reconstruction and
             evaluation of the report of that study. In the event that exact transcripts of raw data
             have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
             verified accurate by signature), the exact copy or exact transcript may be substituted
             for the original source as raw data. 'Raw data' may include photographs, microfilm
             or  microfiche copies, computer printouts,  magnetic media,  including  dictated
             observations,  and  recorded  data   from   automated instruments."    The  term
             "specimens",  according to 40 CFR 160.3(k),  means "any material  derived from a
             test system for examination or analysis."

      b.     Health and safety studies completed after May  1984 must also contain all GLP-
             required  quality  assurance  and quality  control information,  pursuant  to the

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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
              NTIS).  A study  not conducted  according to the PAG may  be submitted to the
              Agency for consideration if the registrant believes that the study clearly meets the
              purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
              Agency's policy regarding acceptable protocols. If you wish to submit the study, you
              must,  in addition  to certifying that the purposes of the PAG are met by the study,
              clearly articulate the rationale why you believe the study meets the purpose of the
              PAG, including copies of any supporting information or data.   It has been the
              Agency's experience that studies completed prior to January 1970 rarely satisfied the
              purpose of the PAG and that necessary raw data are usually not available for such
              studies.


       If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.

       If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined  above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the  Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.

       Option 5. Upgrading a Study — If a study has been classified  as partially acceptable and
upgradeable, you  may submit data to upgrade that study.   The  Agency will  review  the data
submitted and determine if the requirement is satisfied. If the  Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental.  However, it is
important to note  that not all studies classified as  supplemental are upgradeable.  If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1.  If you submit data to upgrade an existing study you must
satisfy or supply information to correct 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 MRJD 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 etch of those criteria
 as well as a certification regarding protocol compliance with Agency requirements.

       Option 6. Citing Existing Studies  — If you choose to cite a study that has been previously
 submitted to EPA, that study must have been previously classified by EPA as acceptable or it must
 be  a  study which has not yet been reviewed by the Agency,  Acceptable  toxicology studies
 generally will  have been  classified  as  "core-guideline"  or "core minimum."   For all  other
 disciplines the classification would be "acceptable," With respect to any studies  for which you wish
 to select this option you must provide the MRID number of the study you are citing and,  if the
 study has been reviewed by the Agency, you must provide the Agency's classification of the study.

       If you are citing a study of which  you are not the original data submitter, you must submit
 a completed  copy  of  EPA Form  8570-31,  Certification with Respect to Data Compensation
 Requirements.

       Registrants who select one  of the above 6 options must meet all of the requirements
 described in the instructions for completing the Data Call-in Response Form and the Requirements
 Status and Registrant's Response Form, as appropriate.

 ni-D  REQUESTS  FOR DATA WAIVERS

             If  you request a waiver   for product specific  data because  you believe it is
 inappropriate, you must attach a complete justification for the request, including technical reasons,
 data and references  to relevant EPA regulations, guidelines or policies,  (Note; any supplemental
data must be  submitted in  the  format required  by PR Notice 86-5).   This will be the only
 opportunity to state  the reasons or provide information in support of your request. If the Agency
 approves your waiver  request, you will  not be required to supply the  data pursuant  to section
 3(c)(2)(B) of FIFRA.  If the Agency denies your waiver request,  you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate  and submit the option chosen on the Requirements Status and Registrant's
Response Form.  Product specific  data requirements for product chemistry,  acute toxkity  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 III-C of this Notice.

       7.      Withdrawal of an offer to share in the cost of developing required data.

       8.      Failure of the registrant  to whom you have tendered an offer to  share in the cost of
             developing data and provided proof of the registrant's receipt of such offer or failure
             of a registrant on whom you rely for a  generic data exemption either to:

              a,      inform EPA of intent to develop and submit the data required by this Notice
                    on a Data CalHn 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


                                           146

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                    Notice, unless you commit to submit and do submit the required data in the
                    specified time frame.

       9,     Failure to lake any required or appropriate steps, not mentioned above, at any time
              following the  issuance of this Notice.

 IV-B   BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
 UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required time) is
 unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.  The grounds for
 suspension include, but are not limited to, failure to meet any of the following:

       1. EPA requirements specified in the Data Call-in Notice or other documents incorporated
       by  reference (including, as  applicable,  EPA  Pesticide Assessment  Guidelines,  Data
       Reporting Guidelines, and GeneTox  Health Effects Test Guidelines) regarding the design,
       conduct,  and reporting of required studies.  Such requirements include, but are not limited
       to, those relating to test material, test procedures, selection of species, number of animals,
       sex and distribution of animals, dose and effect levels to be tested or attained, duration of
       test, and, as applicable, Good Laboratory Practices.

       2. EPA requirements regarding the submission of protocols, including the  incorporation of
       any changes required  by the Agency following review.

       3. EPA  requirements regarding the  reporting of data, including the manner of reporting,
       the completeness of results, and the adequacy of any required supporting (or raw) data,
       including, but not limited to, requirements referenced or included in this Notice or contained
       in PR 86-5.  All studies must be submitted in the form of a final report;  a  preliminary
       report will not be considered to fulfill the submission requirement.

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 widi
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 m 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


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 quantity of existing stocks and your estimate of the time required for their sale, distribution, and
 use.  Unless you meet this burden the Agency will not consider any request pertaining to the
 continued sale, distribution, or use of your existing stocks after suspension.

       If you request a voluntary cancellation of your product(s) as a response to this Notice and
 your product is in  full compliance with all  Agency requirements,  you will have, under most
 circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
 or use existing stocks.  Normally, the Agency will allow persons other than the registrant such as
 independent distributors, retailers and end users to sell, distribute or use such existing stocks until
 the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
 containing an active ingredient for which  the Agency has particular risk concerns  will be
 determined on case-by-case basis.

       Requests for voluntary cancellation received after the 90 day response period required by
 this  Notice will  not result in the Agency granting any additional time to sell, distribute, or use
 existing stocks beyond  a year from the  date the 90 day response was due unless you demonstrate
 to the Agency that  you are in full compliance  with  all Agency requirements,  including the
 requirements of this Notice.  For example, if you decide to voluntarily cancel your registration six
 months before  a 3  year study  is scheduled  to be  submitted, all progress  reports and other
 information necessary to establish that  you have been conducting the study  in an acceptable and
 good faith manner must have been submitted to the Agency, before EPA will consider granting an
 existing stocks provision,

 SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
 UNREASONABLE ADVERSE EFFECTS

       Registrants are  reminded that FIFRA  section 6(a)(2) states that  if at any time after a
 pesticide is registered a  registrant has additional factual information regarding unreasonable adverse
 effects on  the environment  by the pesticide,  the registrant shall submit  the  information to the
 Agency. Registrants must notify the Agency of any factual information they  have, from whatever
 source, including but not limited to interim or preliminary  results of studies, regarding unreasonable
 adverse effects on man or the environment. This requirement continues as long as the products are
 registered by the Agency,

 SECTION  VI.  INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures  established by this
Notice,  call the contact person(s) listed  in Attachment 1,  the Data Call-In Chemical Status Sheet.

       All  responses to this Notice  (other than voluntary cancellation requests and generic data
exemption  claims) must  include a  completed  Data  Call-in Response Form and a  completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact  person(s) identified hi  Attachment 1.   If the  voluntary cancellation or generic data
exemption option is chosen,  only the Data Call-In Response Form need be submitted.
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       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,
                                                            ^c,  /
                                        3faniel M. Barolo, Direcj^fr1"
                                       Special Review and    *
                                         Reregistration Division
Attachments
       1  -   Data Call-in Chemical Status Sheet
       2  -   Product-Specific Data Call-in Response Form
       3  -   Requirements Status and Registrant's Response Form
       4  -   EPA  Grouping  of  End-Use  Products   for  Meeting  Acute  Toxicology  Data
             Requirements for Reregistration
       5  -   EPA Acceptance Criteria
       6  -   List of Registrants Receiving This Notice
       7  -   Cost Share and Data Compensation Forms, and Product Specific Data Report Form
                                          149

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Attachment 1. Chemical Status Sheet
                151

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 3149 DATA CALL-IN CHEMICAL STATUS SHEET

 INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have
 produci(s) containing 3149,

       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 reregistratkm of
 3149.  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 B), (3) the
 Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End[-]Use
 Products for Meeting Acute Toxicology Data Requirement (Attachment D), (5) the EPA
 Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DCI (Attachment F)
 and (7) the Cost Share and Data Compensation Forms in replying to this 3149 Product Specific
 Data Call[-]In (Attachment G),  Instructions and guidance accompany each form.

 DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the database for 3149 are  contained
 in the Requirements Status and Registrant's Response, Attachment C.  The Agency has
 concluded that additional data on 3149 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 3149 products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any  questions regarding the generic database of 3149, please contact at
(703) 308-8071.

       If you have any  questions regarding the product specific data requirements and
procedures established by this Notice, please contact Frank  Rubis at  (703) 308-8184.

       All responses to this  Notice for the Product Specific data requirements should be
       submitted to:
             Frank Rubis
             Planning  and  Reregistration Branch (H7508W)
             Special Review and Reregistration Branch
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C.  20460

             RE: 3149
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Attachment 2. Product Specific Data Call-In Response
      Forms (Form A inserts) Plus Instructions
                        153

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154

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INSTRUCTIONS  FOR COMPLETING THE  "DATA CALL-IN RESPONSE"  FORM FOR
PRODUCT SPECIFIC DATA

Item 1-4,     Already completed by EPA.

Item 5.      If you wish to voluntarily cancel your product, answer "yes".  If you choose this
             option, you will not have to provide the data required by the Data Call-In Notice and
             you will not have to complete any other forms.  Further sale and distribution of your
             product after the effective date  of cancellation must be  in accordance with  the
             Existing Stocks provision of the Data Call-In Notice (Section IV-C).

Item 6.      Not applicable since this form calls in product specific data only. However, if your
             product is identical to another product and you qualify for a data exemption, you
             must respond with "yes" to Item 7a (MUP) or  7B (EUP) on this form, provide the
             EPA 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 in a signed letter
       that accompanies this form.  For example, you may wish to report that your product has
       already been transferred to another that you have already voluntarily cancelled this product.
       For these cases, please supply all  relevant  details so that EPA can ensure that its records
       are correct.
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INSTRUCTIONS   FOR   COMPLETING  THE   "REQUIREMENTS   STATUS   AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA

Item 1-3.      Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
              This number must be used in the transmittal document for any data submissions in
              response to this Data Call-In Notice,

Item 4.       The guidelines  reference numbers  of studies required to  support the product's
              continued  registration  are  identified.   These  guidelines, in  addition to  the
              requirements specified in the Notice,  govern the conduct of the  required studies.
              Note that series  61 and 62 in product chemistry  are now listed under 40 CFR
              158.155 through 158.180, 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 Snaring).  I am submitting a copy of this agreement.  I understand [hat
              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 ihe
              agreement is committing to submit or provide the required data; if the required study
              is not submitted on time, my product my be subject to suspension.

              3.     I have made offers to share in the cost to develop data (Offers to Cost Share i

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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, nay product may be
 subject to suspension.  I understand that other terms under Option 3 in the Data
 Call-In Notice (Section III-C.l.) apply as well.

 4.      By the specified due date,  I will  submit an existing study that has not been
 submitted previously to  the Agency by anyone (submitting an Existing Study).  I
 certify  that this study will meet all the requirements for submittal of existing data
 outlined in option 4 in the Data Call-In Notice (Section III-C.L) and will meet the
 attached acceptance criteria (for acute toxicity and product chemistry data).  I will
 attach the needed supporting information  along with this response, I also certify that
 I have  determined that this study will fill the data  requirement for which I have
 indicated this choice,

 5.      By the  specified due date, I will submit or cite data  to upgrade a  study
 classified by the Agency as partially acceptable and upgrade (upgrading a study).
 I will submit evidence of the Agency's review  indicating that the  study may be
 upgraded and what information is required  to do so.  I will provide the MRID or
 Accession number of the study at the due date. I understand that the conditions for
 this Option outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply.

 6.     By the specified due date,  I will  cite an existing study that the Agency has
 classified as acceptable or an existing study that has been submitted but not reviewed
 by the Agency (Citing an Existing  Study). If I am citing another registrant's study,
 I understand that this option is available only for acute toxicity or certain efficacy
 data and only if the cited study was conducted on my product, an identical product
 or a  product which EPA has "grouped"  with  one or more other products for
 purposes of depending on tlie same data.  I may also choose this option if I am citing
 my own data.  In either case, I will provide die 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  repletions, 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 caj-m notice will not change.

Items 10-13,   Self-explanatory.

       NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this  form.   For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily cancelled this
product.  For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       163

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EPA'S  BATCHING  OF a-ChydroxymethyD-Z-nitro-l^-propanediol  PRODUCTS  FOR
MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

       In an effort to reduce the time, resources and number of animals needed to fulfill
the acute toxicity data requirements for reregistration of end-use products  containing the
active ingredient 2-(hydroxymethyl)-2-nitro-lJ3-propanediol, the Agency has batchedproducts
which can be considered similar for purposes of acute toxicity. Factors considered in the
sorting  process include  each product's  active and  inert ingredients  (identity,  percent
composition and biological  activity), type of formulation (e.g., emukifiable 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 tie 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 end-use products within a batch may choose to cooperatively generate,
submit or cite a single battery of six acute lexicological studies to represent all the products
within that batch. It is the registrants' option to participate  in the process with all other
registrants, only some of the  other registrants, or only their own products within a batch, or
to generate all  the required  acute lexicological 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 DCJ  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

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an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing
Study (Option 6). If a registrant depends on another's data, he/she must choose among:
Cost Sharing  (Option 2), Offers to Cost 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 Ms/her studies and offering to
cost share (Option 3) those studies.

       Only nine products have been found which contain  2-(hydroxymethyl)-2-nitro-l»3-
propanediol as an active ingredient. Since some products differ in regard to the active and
inert ingredients, formulation type, labeling and acute toxicity, two batches (Table I) and a
"no batch" category (Table H) have been formed as follows:
Table I
Batch
1
2
EPA Reg. No.
4808-1
4808-2
48301-1
48301-33
48301-4
48301-11
2-(hydroxymethyl)-2-nitro-l,3-
propanediol
98.5%
98.5%
100%
100%
50%
50%
Fonaulation
Type
Solid
Solid
Solid
Solid
liquid
Liquid
      Table H lists three products that were either considered not to be similar or the
Agency lacked sufficient information, for decision making and were not placed in any batch.
Registrants  of these  products  are responsible  for meeting  the  acute  toxicity  data
requirements separately for each product.

Table H
EPA Reg. No.
134-65
48301-10
48301-17
2-(nydroxymethyl)-2-nitro-l,3-
propanediol
19.2%
98.5%
25%
Formulation
Type
liquid
Solid
liquid

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Attachment 5. EPA Acceptance Criteria
                167

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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
                                         169

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                                  61 Product Identity and Composition


 ACCEPTANCE CRITERIA


 Does your study meet the following acceptance criteria?

 1,	    Name of technical material tested (include product name and trade name, if appropriate).

 2.__	     Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
           intentionally-added inert ingredient.

 3.         Name and upper certified limit for each impurity or each group of impurities present at  >_ 0,1% by
           weight and for certain toxicologically  significant impurities (e.g., dioxins,  aitrosamines)  present at


 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      Mowing:

          	  Name and address  of manufacturer or supplier.
          	  Brand name, trade name  or commercial designation.
          	  Technical specifications or data sheets by which manufacturer or supplier describes composition,
                properties or toxicity,

 8.	Description of manufacturing process.
          	  Statement of whether batch or continuous process.
          	  Relative amounts of beginning materials and order in which  they are added.
          	  Description of equipment,
          	  Description of physical conditions {temperature, pressure, humidity) controlled in each step and
                the parameters that are maintained.
          	  Statement of whether process involves intended chemical reactions,
          	  Flow chart with chemical equations for each intended chemical reaction.
          	  Duration of each step of process.
                Description of purification procedures.
          	  Description of measures taken to assure quality of final product.

9.	    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
          which may be present at  _>_ 0,1% or was found at _>_ 0.1% by product analyses and (2) certain
          toxicologically significant -impurities (sec #3),
                                                  170

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                           62 Analysis and Certification of Product Ingredients


                                       ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8.

Does your study meet the following acceptance criteria?

 1.	  Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
         and all impurities present at > 0.1%.
 2.	  Degree of accountability or closure .>. £§ 98%.
 3.	  Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the
         case of products containing dmitroanilmes or containing secondary or tertiary amines/alkanolamines plus
         ninites; 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.
 1.	  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 toxicologieally
         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.
                                                  171

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                                63 Physical and Chemical Characteristics

                                        ACCEPTANCE CRITERIA


 The following criteria apply to the technical grade of the active ingredient being reregistered.

 Does your study meet the following acceptance criteria?

 63-2 Color
    	   Verbal description of coloration (or lack of it)
    	   Any intentional coloration also reported in terms of Munsell color system

 63-3 Physical State
    	   Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
     	   Based on visual inspection at about 20-25° C

 63 -4 Odor
    __	   Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
           compounds"
    	   Observed at room temperature

 63-5 Melting Point
    	   Reported in °C
     	   Any observed decomposition reported

 63-6 Boiling Point
    	   Reported in °C
    	   Pressure under which B.P.  measured reported
    	   Any observed decomposition reported

 63-7 Density, Bulk Density, Specific Gravity
    	   Measured at about 20-25° C
    	   Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported
           with reference to water at 20" C, [Note: Bulk density of registered products may be reported in Ibs/ft3
           or Ibs/gallon.]

63-8 Solubility
    	   Determined in distilled water and representative polar and non-polar solvents, including those used in
           formulations and analytical methods for the pesticide
    	   Measured at about 20-25° C
    	   Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)

63-9 Vapor Pressure
    	   Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
           pressure too low to measure at 25" C)
    	   Experimental procedure described
    	   Reported in mm Hg (torr) or other conventional units

63-10 Dissociation Constant
    	   Experimental method described
    	   Temperature of measurement specified (preferably about
           20-25 °C)
                                                  172

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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
                                                   173

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                                           SUBDIVISION F
Guideline          Study Title

 81-1           Acute Oral Toxiciiy 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
                                                 174

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                                  81-1  Acute Oral Toxkity in the Rat


                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 !.___   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 iirs.
 4.'    Vehicle control if other than water,
 5.	Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
 6.	Individual observations at least once a day.
 7.	Observation period to last at least 14 days, or until all  test animals appear normal whichever is longer.
 8.	Individual daily observations,
 9.	Individual body weights,
10.	Gross necropsy on all animals.
                    Criteria narked with an * are supplemental and may not be required for eveiy study.
                                                   175

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                      81-2  Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig


                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.       At least 5 animals/sex/group.
 3,*	Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4%	 Dosing, single dermal.
 5	    Dosing duration at least 24 hours,
 6.*	Vehicle control, only if toxicity of vehicle is unknown.
 7.	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 8.	Application site clipped or shaved at  least 24 hours before dosing.
 9.	Application site at least 10% of body surface  area.
10.	Application  site covered with a porous nonirritating cover to retain test material and to prevent
        ingestion,
11.	Individual observations at least once  a  day.
12.	Observation period to last at least 14 days.
13.	Individual body weights,
14,	Gross necropsy on all animals.
                    Criteria marked with an * are supplemental and may not be required for every study,
                                                  176

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                               81-3 Acute Inhalation Toxicity in the Rat


                                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2,	Product is a gas. a solid which may produce a significant vapor hazard based on toxicity and expected use
        or contains panicles of inhalable size for man (aerodynamic diameter 15 ^m 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 1+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.
                                                  177

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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 _>,! 1.5.
 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
        an,  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 tnd may not be required for evety study.
                                                  178

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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 dosiag,
 7.	Application site approximately 6 cm1.
 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 gnd graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
        days (whichever is shorter),
i 1 .^	  Individual daily observations.
                    Criteria mariced with an * are supplemental and may not be required for every study.
                                                  179

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                              81-6  Dermal Sensitization in the Guinea Pig

                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

1,	 Identify material tested (technical, end-use product, etc).
2,	Study not required If material is corrosive or has a
      pH of <2 or ^.11.5.
3.	One of the following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig  maximization test
         	  Split adjuvant technique
      	Buehler test
      	Open epicutaoeous 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 wiflj an * are supplemental and may not be required for eveiy study.
                                                  180

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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                              Notice
                                181

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Attachment 7, Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form
                             183

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oo
Confidential Business Information: Does Not Contain National Securit]
UnM*d SIMS* f nvh wvtnnnl Proi^etian Agency
g^ QftittrtPMtlcWtPMWimilTS-Wl
^Of t Hr\, Confidential Statement of Formula
1 . Sam* and Addrew of Applf:un/ft»al*trBni//nc/yrf«W Corfu;
3. Product Him
EPA USE ONLY








10 Component! in Formulation (tin w »ctuton
% by WmgM
4 Uppw L^*MI b UniwlvniE
















'^T-









20. Ptiont Ma. //nctoi/e Ana Cwtt)
21. Daio
          tPA Form IS70-4  (H»v.  12-911)    Pf wtoui wJlllon* «r» obiolei*   If you can photocopy inis. pltas« submit an addilwnal copy. Whl» -   EPA  FMe Copy
                                                                                                                                                                YoUow -
                                                                                                                                                                                copy

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Instructions for Completing the Confidential Statement of Formula

          The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
          copies of the form are required.  Following are basic instructions:

               a.  All the blocks on the form must be filled in and answered completely,

               b.       If any block is not applicable, mark it N/A.

               c.       The CSF must be signed, dated and the telephone number of the responsible party
                       must be provided.

               d.       All applicable  information which is on the product specific data submission must
                       also be reported  on the CSF.

               e.       All weights reported under item 7 must be hi pounds per gallon for liquids and
                       pounds per cubic feet for solids.

               f.       Flashpoint must  be in degrees Fahrenheit and flame extension in inches,

               g.       For all  active ingredients,  the EPA Registration Numbers for the currently
                       registered source products must be reported under column 12.

               h.       The Chemical  Abstracts Service (CAS) Numbers for all actives and inerts and all
                       common names for the trade names must be reported.

               i.       For the active ingredients,  the percent purity of the  source products must be
                       reported  under column 10 and  must be exactly the same as on the  source
                       product's label.
               j.       All the weights in columns 13.a. and 13,b. must be in pounds, kilograms, or
                       grams. In no case will volumes be accepted.  Do not mix English and metric
                       system units (i.e., pounds and kilograms).

               k.       All the items under column 13.b. must total 100 percent.

               1.       All items under columns 14.a. and 14.b, for the active ingredients must represent
                       pure active form.

               m.      The upper and lower certified limits for ail active and inert ingredients must
                       follow the 40 CFR 158.175 instructions. An explanation must be provided if the
                       proposed limits are different than standard certified limits.

               n.       When new CSFs are submitted and approved, all previously  submitted CSFs
                       become obsolete for that specific formulation.

                                                   187

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                          United  States Environmental  Protection Agency
                                       Washington,  DC  20460
                             CERTIFICATION OF OFFER TO COST
                           SHARE IN THE DEVELOPMENT  OF DATA
                                                                             Form ApprovwJ

                                                                             OMB No. 2070-0106
                                                                                      2ffT»MMIS7

                                                                             Approvtl  Explrt*
 Public reporting burden lor triis collection of Infoimatton is estimated to average 15 minutes per response, including
 time for reviewing instructions, starching 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, indudmg suggestions for reducing this byrden, 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 20S03.

 Please flit  in blanks toe km.
CompH&v Kuurac'
IVmtuci FXitmt*
Company Nimtbtr
KPA M*j. N«.
 I Certify tnat:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodentlcide 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 mads to the following firm(s) on the folio wing
 date{s):
  NMIM at Rrm{*)
                                                                              0»t« of Orftr
Certification:
 certify that I am duly authorized to represent the company named above, and that the statements that I  have made on
this form and afl attachments therein are tme, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punisnawe by fine or imprisonment CK both under applicable law.
Slgniiert of Company1 1 Authorized R*prt**ntitJv*
Data
Nam» »nd TJii« (Pteast Typ* or Print)
EPA Fu«iSS7«-S2 (SSI)
                             A Fen* 8SM, w ttdi fa
                                                189

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    ?,EPA
                         United Stat** Environmental
                                     Washington, OC
                            CERTIFICATION WITH
                          DATA  COMPENSATION
Protection Agency
204M
RESPECT  TO
REQUIREMENTS
 PubUe reporting Duidcn for this cofltctkxi of trrfomtwion it estimated to average 15 minutes per response, inducing
 time for rtvitwine, instructions, searching existing data setvcas, fathering and maintaining the data needed, and
 campltting and f eviewing the coDtciion ef irtornyaion. S«nd commtnts mganfing th« buidtn esllmaw or any other
 aspad of this collector of information, inducSng suggtstiom for reducing mil bur&n. to CNef r Information Poticy
 Srantfi. PM.223, U.S. EftwowiwnaJ FreMdion Agtncy, 401 M St^ S.W.. Washington, DC 20460: and to the Offic*
 ef Managcmert and Budo«t Paptfwork Rwjuctkwi Proj«t (207WHOC}. Washington, OC 20503,

        (IB In biarHts  bttow.
)C«rWytnat
   Floderticid* Act {FIFRA} that Is an txdusK* use audy J afn jht oogna! data sirtamlttr, or ! h«v» obUtfied th«
         ptrroisiion of Vw original data fubrnitwr 10 at* that study.
   That lor tacd study dad In support of ragfetntion si rtngtstration undtr FIFRA tn«t« NJOTw wduvvt u«
   study, t am tnt ettginai data tubmttir, or l havt ottaintd tht wrtttft ptrmiwion el Ow original data subm««f, or i
   h«v«ncffitdinwriiir9tfMe9RViny(it^                                         (a) Pay
   comptreaioo for tDost data In acoorflanc* with sictions 3
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