United States       Office of Prevention, Pesticides
         Environmental Protection   And Toxic Substances      June 1992
         Agency          (H-7508W)          PB92-221829
&EPA  Reregistration
         Eligibility Document
         (RED)
         Citric Acid

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REREGISTRATION ELIGIBILITY DOCUMENT

                CITRIC ACID

                   USTD

                  CASE 4024
        ENVIRONMENTAL PROTECTION AGENCY
          OFFICE OF PESTICIDE PROGRAMS
     SPECIAL REVIEW AND REREGISTRATION DIVISION
               WASHINGTON, D.C.

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           EPA CITRIC ACID REREGISTRATION ELIGIBILITY TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Branch
Phyllis Johnson      Biological Analysis Branch
Ted Czerkowicz     Biological Analysis Branch
Rafael Prieto        Biological Analysis Branch

Environmental Fate and Effects Division
Roy Bingham       Environmental Fate and Ground Water Branch
Martha Sager       Science Analysis and Coordination Staff
Charles Lewis       Ecological Effects Branch

Health Effects Division
James Yowell       Occupational and Residential Exposure Branch
Pat McLaughlin     Toxicology Branch n
Bonnie Kohlligian    Chemistry Branch n
Dave Van Ormer    Science Analysis and Coordination Branch

Program Management and Support Division
BeWanda Alexander  Information Services Branch

Registration Division
Sami Malak         Registration Support Branch
Ruth Douglas       Antimicrobial Program Branch
Mary Waller        Registration Support Branch
Bill Wooge         Antimicrobial Program Branch
Pat Critchlow       Registration Support Branch

Special Review and Reregistration Division
Napoleon Kotey     Accelerated Reregistration Branch

Policy and Special Projects Staff
Jean Frane

Office of General Counsel
Mary Jane Angelo

Office of Compliance Monitoring
Beverly Updike

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                     TABLE OF CONTENTS
                                                           Page
GLOSSARY OF TERMS AND ABBREVIATIONS                        iv


EXECUTIVE SUMMARY                                         y


I. INTRODUCTION                                             1


H. CASE OVERVIEW                                           2


     A.   CHEMICAL OVERVIEW                                2


     B.   USE PROFILE


     C.   REGULATORY HISTORY                               3


m. SCIENCE ASSESSMENT OF CITRIC ACID                        3


     A.   PRODUCT CHEMISTRY ASSESSMENT                       4


     B.   ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT       4


IV. RISK MANAGEMENT AND REREGISTRATION DECISION            6


     A.   DETERMINATION OF ELIGIBILITY                        6


     B.   ADDITIONAL GENERIC DATA REQUIREMENT               6


     C.   LABELING FOR MANUFACTURING-USE PRODUCTS           6


V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS      7


     A.   DETERMINATION OF ELIGIBILITY                        7
    i

         1. Product Specific Data Requirements                        7
         2. Labeling Requirements for End-Use Products                   7
                              11

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                                                                            Page
VI.   APPENDICES

        APPENDIX A - Use Patterns Subject to Reregistration                        8

        APPENDK B - Generic Data Requirements for Reregistration of Citric Acid
                    and Data Citations Supporting Reregistration                   11

        APPENDIX C - Citations Considered to be Part of the Data Base
                    Supporting the Reregistration of Citric acid                    15

        APPENDIX D - PR Notice 91-2                                          17

        APPENDK E - Pesticide Reregistration Handbook                          20

        APPENDK F - Product Specific Data Call-In                              42

            Attachment A - Chemical Status Sheet

            Attachment B - Product Specific DCI Response Forms (Form A) plus
                          Instructions

            Attachment C - Requirements Status and Registrants' Response Forms
                         (Form B) plus Instructions

            Attachment D - EPA Groupings of End-Use Products for Meeting Data
                        Requirements for Reregistration

            Attachment E - EPA Acceptance Criteria

            Attachment F - List of all Registrant(s) sent this DCI

            Attachment G - Cost Share/Data Compensation Forms
                       Application for Registration
                                       111

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                GLOSSARY OF TERMS AND ABBREVIATIONS


CAS        Chemical Abstracts Service

CFR        Code of Federal Regulations

CSF        Confidential Statement of Formula

EPA        U.S. Environmental Protection Agency

FDA        Food and Drug Administration

FIFRA      Federal Insecticide, Fungicide, and Rodenticide Act

GRAS       Generally Recognized As Safe

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

ppm        Parts per Million

RED        Reregistration Eligibility Document
                                      IV

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EXECUTIVE SUMMARY
       This Reregistration Eligibility Document (RED) addresses pesticide uses of citric acid.
Citric acid-containing products are currently registered as disinfectants, sanitizers, fungicides,
and scale remover for use in toilets and food processing equipments. It is intended for either
residential or commercial use. All products containing citric acid as an active ingredient and
registered for these uses are eligible for reregistration.

       The U.S. Environmental Protection Agency (EPA) has conducted a review of the
scientific data base and  other relevant information supporting the reregistration of citric acid
and has determined that the data base is sufficient to allow EPA to make a reregistration
decision.  All applicable toxicology, ecological and environmental effect data requirements
have been waived  for this active ingredient.  The information and data  available to EPA
support the conclusion that the currently registered uses of citric acid will not result in
unreasonable adverse effects to human health and the environment.

       Accordingly, EPA has determined  that all products containing citric acid as the active
ingredient 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 EPA
is requiring that product specific data and  revised labeling be submitted by the registrants
within eight months  of the issuance of this document. After reviewing these data and the
revised labels EPA will determine whether or  not the conditions of FIFRA 3(c)(5) have been
met, that is, whether product composition and labeling are acceptable and the product's  uses
will not cause unreasonable adverse effects to  humans or the environment.  If these
conditions are met EPA will reregister the product.   Any end-use products containing citric
acid in combination with other active ingredients will not be reregistered until REDs are
issued for all active ingredients contained  in that product.

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I.     INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the leregistration 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
(referred to as "the Agency") of all data submitted to support reregistration.

       FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration"  before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action."  thus, reregistration involves a thorough review of the scientific data base
underlying a pesticide's registration.  The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion  of FIFRA.

       This document presents the Agency's decision regarding the reregistration of citric
acid.  The document consists of six sections.  Section I is the introduction. Section n
describes citric acid, its uses, data requirements and regulatory history.  Section  m discusses
the human health and environmental assessment based on the data available to the Agency.
Section IV discusses the reregistration decision  for citric acid.  Section V discusses the
reregistration requirements for citric acid. Section VI is the Appendices which support this
Reregistration Eligibility Document.   Additional details concerning  the Agency's review of
applicable data are available  on request.1
    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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n.    CASE OVERVIEW


A.    Chemical Overview

      The following active ingredient is covered by this Reregistration Eligibility
Document:

      Chemical Name:     Citric acid

      CAS Registry Number:  77-92-9

      Office of Pesticide Programs Chemical Code:  021801

      Empirical Formula:
B.    Use Profile

      The following is information on the registered use with specific use sites and
application methods. A detailed table of eligible uses of citric acid is in Appendix A.
      Type of Pesticide:   Disinfectant, Sanitizer, Virucide, Fungicide, Algicide

      Use Sites:          INDOOR RESIDENTIAL: Toilets, Urinals, Bathrooms

                         INDOOR FOOD: Dairy and food processing equipment, Tanks,
                         Vats, Pails, Pipelines, Closed systems
      Pests:              When combined with other active ingredients: Odor-
                         causing bacteria, Mildew, Pathogenic fungi,
                         Staphylococcus aureus. Adenovirus type 2, Herpes
                         simplex type 1, Influenza A2/Hong Kong, Human
                         Immunodeficiency Virus type 1, Algae
      Formulation Types
      Registered:         End use

      Form:             Liquid ready to use, Soluble concentrate/Liquid

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      Method and Rates
      of Application:      Types Of Treatment: Foam application, Immersion,
                          Circulation method, Spray, Brush-on, Swab

                          Equipment: Foaming apparatus, Brush

                          Timing: When needed

                          Rate of Application: From 208 up to 23000 ppm by
                          volume
      Use Practices
      Limitations:
None
C.    Regulatory History
      EPA registered the first citric acid-containing products in the early 1970's. The
currently registered products (3) are used as fungicides and bactericides sanitizers, virucides,
and algicides in the sites identified in Section n. B. above.  Citric acid is Generally
Recognized As Safe (GRAS) (21 CFR 182.1033) by FDA for use in food.

      Under a memorandum of understanding (MOU) issued on December 22, 1971,  (36
FR 24234), FDA and EPA defined responsibilites in the regulation of food-contact sanitizing
solutions.  FDA approves, under food additive regulations, the use of sanitizers on food-
contact surfaces.  EPA defers to FDA for dietary risk assessments.  This approval includes
the lexicological and dietary residue assessments. EPA focuses on product chemistry,
efficacy, and applicator risk assessments.  Citric acid-containing products registered as
sanitizers for food-contact surfaces fall under this agreement.
      SCIENCE AS^SSMENT OF CITRIC ACID
      EPA has reviewed the scientific data base for citric acid primarily relying on
information from published literature submitted by the registrant.  These are cited in
Appendix C.

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A.     Product Chemistry Assessment

       Citric acid occurs naturally in plants and animal tissues and fluids.  It may be
produced on an industrial scale by mycological fermentation of carbohydrates such as corn
starch and crude sugar solutions (molasses).  Strains of mold used include Aspergittus niger
and Candida htpohtica.  Citric acid may also be extracted from citrus fruits and from
pineapple waste.  One common method of production is submerged fermentation utilizing
glucose as the carbohydrate source for Aspergillus niger.  The mold, produced under
controlled aseptic conditions, is used in specific quantities to seed the sugar solution, along
with sources of assimilable nitrogen, phosphate, magnesium and various trace minerals.

       Citric acid is generally recovered by selectively transferring the citric acid via a
solvent from the aqueous solution containing various by-products to another aqueous solution
in which the citric acid is more concentrated and contains substantially less by-products.  The
final processing steps  begin with a  diluent wash of the aqueous solution by a hydrocarbon
solvent, followed by passage of the acid solution through granular activated-carbon columns.
Effluent from the carbon columns is processed through a conventional sequence of
evaporator-crystallizer steps  to complete the manufacturing process.  Analysis of citric acid
can be accomplished by the use of a liquid chromatography method.

       Citric acid occurs as  colorless, translucent crystal or white granular to fine crystalline
powder at room temperature with a strongly acid taste and is odorless.  The molecular
weight is 192.12.  The melting point is 153°C but it decomposes before boiling.   Citric acid
is completely soluble in water and ethanol; but slightly soluble in chloroform, ethyl acetate,
amyl alcohol, amyl acetate and diethyl ether.  The loose bulk density ranges from 54-57
Ib/ft3 and specific gravity of a 10 percent solution is 1.035.  The pH of citric acid is in the
acidic range, from 0.8 for a 50 percent solution to 2.8 for a 0.1 percent solution. Citric acid
dissociates in solution with a pK. of 4.761.
B.     Environmental And Human Health Assessment

       EPA has developed a normative set of data requirements, set forth in the regulations
(40 CFR Part 158) and the Agency's Reregistration Phase 2 Technical Guidance Document.
These data requirements must be addressed  for pesticide reregistration.  These regulations
and the guidance document specify the necessary data based on factors including use sites,
potential environmental and human (dietary and occupational) exposures, product formulation
types, product application methods, and results of initial (Tier 1) studies.  Due to the diverse
nature and characteristics of pesticide products and their uses subject to reregistration, the
Agency also recognizes the need to modify  the data requirements for specific pesticides,
including waiving certain data requirements because such requirements are inappropriate or
unnecessary for reregistration.

       The case-specific approach to waive individual data requirements has served to
identify the appropriate data requirement  sets for pesticide products. Further, the Agency

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believes there is a category of pesticide active ingredients for which a broadly reduced set of
data requirements are appropriate for reregistration.  Specifically, products in this category
would be exempt from the generic data requirements for toxicology, human exposure,
ecological effects, and environmental fate on the active ingredient.  The Agency believes
there are numerous considerations which, when taken together, can form the basis for a
conclusion that such a reduction in data requirements is appropriate for a particular pesticide
active ingredient, while not compromising human health or environmental safety.

      There are, however, certain data requirements which are essential and may not be
waived. Basic chemistry data on the active ingredient and formulated products are required
for pesticides in this category so that the Agency has reasonable certainty of the pesticide's
identity and chemical/physical characteristics. Also, acute toxicology studies for formulated
products are required for the Agency to determine appropriate product labeling for potential
hazards to those who handle or apply such products.  However, these toxicology studies may
be waived if an assessment of the product formulation, including the inert ingredients,
indicates that such studies are unnecessary to prescribe appropriate labeling.

      In considering citric acid for reregistration eligibility, the Agency believes it is an
active ingredient that should be considered for this broad waiver of the generic data
requirements.  The considerations that lead the Agency to this conclusion are as follows:

       The U.S. FDA lists citric acid as a multiple purpose "generally recognized as safe"
(GRAS) food substance (21 CFR part 182).  Citric acid is also approved by the Joint
FAO/WHO Expert Committee on Food Additives for use in foods without limitation.

      There is no indication  in the  available information on citric acid as provided by the
registrant that suggests that citric acid would constitute a hazard to the public or to the
environment. Citric acid is widely distributed in plants and animals and occurs naturally in
foods in substantial quantities. It is  a well-known intermediate in carbohydrate metabolism
and ingested citrate is considered to  be completely metabolized.

      Citric acid from living organisms is found naturally  in soil and water. Citrates
leached from rotting vegetation and produced by microorganisms have been detected at low
levels throughout the ecosystem. Citric acid degrades readily when in contact with a variety
of microorganisms that are found in soil,  natural waters or  sewage treatment systems. There
is negligible human and environmental exposure to citric acid as a pesticide as a result of
current registered use patterns, e.g.,  it has a low use rate and  frequency of application.

      . No reports of adverse  effects have been submitted to the Agency for this active
ingredient. Citric acid, is, however, a severe eye irritant and a moderate skin irritant, so
appropriate label precautions are necessary.  There is no indication of any other
significant adverse effects from citric acid to humans or the environment associated with its
use as a pesticide.

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      Based on these factors the Agency does not believe generic data beyond those data
required to satisfy basic product identity and chemistry questions (refer to Appendix B) are
necessary to determine if the current registered uses of this active ingredient pose
unreasonable risks to humans or the environment. Therefore, the Agency waived all generic
data requirements except the basic product identity and chemistry data. The Agency believes
that, based on the above factors,  the registered uses  of citric acid do not pose unreasonable
risks to humans or the environment.
IV. RISK MANAGEMENT AND REREGISTRATTON DECISION FOR CITRIC ACID

A.  Determination
      Section 4(g)(2)(A) of FTFRA requires the Agency to determine, after consideration of
relevant data concerning an active ingredient whether products containing the active
ingredient are eligible for reregistration.  For products containing citric acid as an active
ingredient the Agency waived all generic data requirements except for those basic product
identity and chemistry. These data were submitted and reviewed. In addition to these data,
the Agency has considered the factors discussed above in Section in regarding citric acid's
natural occurrence, common use as a food item, and the lack of reported adverse effects
information. The Agency has completed its consideration of these data and other factors  and
has determined this information is sufficient to support reregistration of products containing
citric acid as an active ingredient. The reregistration of particular products is addressed in
Section V of this document.

      Although the Agency has concluded that products containing citric acid are eligible
for reregistration,  the Agency may take regulatory actions in the future that would affect  the
continued registration of citric acid-containing products if significant information about this
active ingredient and/or its products comes to the Agency's attention.  Such regulatory action
could include requiring the  submission of additional data if the data requirements for
registration (or the guidelines for generating such data)  change.
B.    Additional Generic Data Requirements

      The generic data base supporting the reregistration of products containing citric acid
has been reviewed and determined to be substantially complete for reregistration.  No further
generic data are required.
C.    Labeling Requirements For Manufacturing-Use Products Of Citric Acid

      No manufacturing-use products are registered.

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v.  ACTIONS yF/fliynrcn BY REGISTRANTS OF END-USE PRODUCTS

A.    Determination
      Based on the reviews of the generic data for the active ingredient citric acid, the
products containing this active ingredient are eligible for reregistration. 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 Agency will review these
data when they have been submitted and/or cited and determine whether to reregister
individual products.
  1.  Product Specufic Data Requirements

      The product-specific data requirements are stated in Attachment C.



  2.  Labeling Requirements For End-Use Products

      The labels and labeling of all products must comply with the Agency's current
regulations and requirements. Follow the instructions in the Product Reregistration
Handbook with respect to labels and labeling.

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             APPENDIX A
Citric Acid Use Patterns Subject to Registration

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APPENDIX A
APPENDIX A- CASE 4024, [Citric Acid and salts] Chemical 021801 [Citric Acid]



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APPENDIX A- CASE 4024, [Citric Acid and salts] Chemical 021801 [Citric Acid]


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                    APPENDIX B

Generic Data Requirements for Reregistration of Citric Acid and
          Data Citations Supporting Reregistration

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                              GUIDE TO APPENDIX B
   Appendix B contains listings of data requirements which support the reregistration for the
pesticide covered by this Reregistration Eligibility Document.

   Appendix B contains generic data requirements that apply to the pesticide in all products,
including data requirements for which a "typical formulation" is the test substance.

   The data tables generally are organized according to the following format:

   l.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 out in the Pesticide Assessment  Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA  22161.

   2.Bibliographic citation (Column 2). If the EPA 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 MRDD number has been
assigned. Refer to the Bibliography Appendices for  a complete citation of the study.
                                          12

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                                    APPENDIX B

                   Generic Data Supporting Guideline Requirements for
                              Reregistration of Citric acid
Requirement                               Citric acid
                                             citation
61-1      Chemical Identity                     (1)
61-2(a)   Description of starting material
            and manufacturing process            (1)
61-2(b)   Discussion of formation of
            impurities                           (1)
62-1      Preliminary analysis of product
            samples                             (1)
62-3      Analytical methods to verify
           certified  limits                        (1)
63-2      Color                                 (1)
63-3      Physical State                         (1)
63-4      Odor                                 (1)
63-5      Melting Point                         (1)
63-6      Boiling Point                          (1)
63-7      Density, bulk density, or specific
            gravity                              (1)
63-8      Solubility                              (1)
63-10     Dissociation  Constant                  (1)
63-12     pH                                   (1)
63-13     Stability                               (1)
(1)   For all requirements, information was obtained from product chemistry literature, and
      the specification sheet submitted in response to Phase HI reregistration package.
                                          13

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ECOLOGICAL EFFECTS




EPA waived 40 CFR Part 158 requirements for reasons discussed in section EL



TOXICOLOGY




EPA waived 40 CFR Part 158 generic requirements for reasons discussed in section EL




ENVIRONMENTAL FATE




EPA waived 40 CFR Part 158 requirements for reasons discussed in section m.



RESIDUE CHEMISTRY




EPA waived 40 CFR Part 158 requirements for reasons discussed in section m.



HUMAN EXPOSURE




EPA waived 40 CFR Part 158 requirements for reasons discussed in section m.
The citations listed in the bibliography (Appendix C) were used to support these decisions.
                                      14

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             APPENDIX C
Citations Considered to be Part of the Data Base
  Supporting the Reregistration of Citric Acid

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                        OFFICE OF PESTICIDE PROGRAMS
                   REREGISTRATION ELIGIBILITY DOCUMENT
                                 BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY.  This bibliography contains citations of all publications
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Reregistration  Eligibility Document.   Primary sources for published  literature  in  this
bibliography have been the body of data submitted  to EPA in support of past regulatory
decisions.
(1) Sax, N. I., and Lewis, R. J. SR, 1989. Dangerous Properties of Industrial Materials. 7th
Edition. Van Nostrand Reinhold, New York.

(2) Clayton, G. D., and Clayton, F. E., eds., 1982. Patty's Industrial Hygiene and
Toxicology. 3rd Revised Edition. Wiley Interscience, NY.

(3) FASEB, 1977. "Evaluation of the Health Aspects of Citric Acid, Sodium Citrate,
Potassium Citrate, Calcium Citrate, Ammonium Citrate, Triethyl Citrate, Isopropyl Citrate,
and Stearyl Citrate as Food Ingredients" SCOGS-84.

(4) The Merck Index. Eleventh edition 1989 p. 363. Merck & Co., Inc.

(5) Encyclopedia of Chemical Technology.  Third edition, Vol. 6. A. Wiley Interscience, NY.
                                      16

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APPENDIX D





 PR Notice 91-2

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                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON. D.C,  20460
                           PR MOTIC1 §1*2                  OFFefC*
                           r» AVTJ.I,« »& 4               PESTeeiSANOTOJOC
                                                          SUBSTANCES
              NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
                       AND REGISTRANTS OF PESTICIDES
 ATTENTION:  Persons Responsible for Federal Registration of
             Pesticide Products.

 SUBJECT:    Accuracy of Stated Percentages for Ingredients
             Statement
 I.   PURPOSE:
      The  purpose of  this  notice is  to clarify  the  Office of
 Pesticide  Program's  policy with respect  to  the statement of
 percentages  in  a  pesticide's  label's  ingredient   statement.
 Specifically,  the  amount  (percent by weight)  of ingredient(s)
 specified in the ingredient statement  on the label must be stated
 as the nominal  concentration of such ingredient (s), as that term is
 defined  in  40  CFR  158.153 (i).  Accordingly,  the  Agency  has
 established the nominal concentration as the only acceptable label
 claim for the amount of active ingredient in the product.

•II.  BACKGROUND

      For some time the Agency has accepted two different methods of
 identifying  on  the  label  what  percentage is  claimed  for the
 ingredient(s) contained in a pesticide.  Some  applicants claimed  a
 percentage which represented a  level between the  upper and the
 lower  certified limits.   This  was referred  to as  the nominal
 concentration.   Other applicants claimed the lower limit as the
 percentage of  the  ingredient (s) that would  be expected  to be
 present in their product  at the end of the product's  shelf-life.
 Unfortunately, this led to a great deal of confusion  among  the
 regulated industry,  the regulators, and the consumers as to exactly
 how much of • 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.
 t
      Current regulations require that the percentage listed in the
 active ingredient statement be as precise as possible reflecting
 good manufacturing  practices 40  CFR 156.10(g)(5). The certified
 limits  required  for  each  active  ingredient  are  intended  to
 encompass any such  "good manufacturing practice" variations 40 CFR
 158.175(c)(3).

                                                         nB Printtd on Recyctod Pat

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                                2.
 The upper and lover certified Units, 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 lover
 certified limit is used as the enforceable lover limit  for  the
 product composition according to FZFRA section 12(a)(l)(C),  vhile
 the nominal concentration  appearing  on the label  vould be  the
 routinely achieved concentration used for  calculation of dosages
 and dilutions.

     The  nominal concentration vould in fact  state the greatest
 degree  of accuracy that is warranted vith respect to actual product
 composition because the nominal concentration vould be the amount
 of active ingredient typically found  in the product.

     Zt is important for registrants to note that certified limits
 for active ingredients  are  not  considered to  be trade secret„
 information  under FZFRA  section  10(b).   Zn  this   respect  the
 certified limits vill  be  routinely provided by EPA to States for
 enforcement purposes, since the nominal concentration  appearing on
 the label  nay  not  represent  the  enforceable composition  for
 purposes  of section 12(a)(1)(C).

 ZZZ. REQUIREMENTS

     As described  below under Unit V. " COMPLIANCE SCHEDULE," all
 currently registered products as veil as all applications for new
 registration must comply vith this Notice by specifying the nominal
 concentration  expressed as  a percentage by veight as the label
 claim in the ingredient(s) statement and equivalence statements if
 applicable (e.g., elemental  arsenic, metallic zinc,  salt  of an
 acid).  Zn 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  vith  the nominal
 ingredient label  claim.  Further  information  about  the  analysis
 requirement may be found  in the 40 CFR 158.170. All  products are
 required  to  provide  certified limits  for  each  active,  inert
 ingredient, impurities of toxicological significance(i.e., upper
 limit (s)  only)  and on a case by case basis as specified by  EPA.
 These limits  are to be set based  on representative  sampling and
 chemical analysis(i.e., quality control) of the product.

     The format of the ingredient statement must conform to 40 CFR
 156-Labeling Requirements For Pesticides and Devices.
 •
     After July  1, 19979 all pesticide Ingredient statements  must
be changed to nominal concentration*

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                          .3

 IV.   PRODUCTS THAT R£QUIR£ EFFICACY DATA

      All pesticides are required to be efficacious.  Therefore,
 the  certified lover limit* nay not be lover then the minimum
 level to achieve efficacy.  This is extremely important for
 products vhich are intended to control pests vhich threaten the
 public health, e.g., certain antimicrobial and rodenticide
 products.  Refer to 40 CFR 158.640.

      In those cases vhere efficacy limits have been established,
 the  Agency vill not accept certified lover limits vhich are belov
 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, nev chemical, or
 fast track (FIFRA section 3(c)(3)(B).  Therefore,
 applicants/ registrants are expected to comply vith the
 requirements of this Notice as follows:

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

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

          (3)  All other products/applications that are
               not subject to (1) and  (2) above vill have until
               July 1, 1997, to comply vith this Notice.
               Such applications should note  "Conversion
               to Nominal Concentration" on the application
               fora. These types of amendments vill  not be
               handled as "Fast Track" applications  but
               vill b« handled as routine requests.

VI.   FOR fUift'HEK INFORMATION

     Contact Tyrone Aiken for information or questions concerning
this notice  on (703) 557-5024.
                                            c •
                                Anns E.  Lindsay, Director
                                Registration Division (H-7505

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      APPENDIX E
Pesticide Reregistration Handbook

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    APPENDIX F
Product Specific Data Call-In

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                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                           WASHINGTON, D.C. 20460
                       DATA CALL-IN NOTICE

                                                          OFFICE OF
                                                       PESTCCES AND TOXIC
 CERTIFIED MAIL                             i             SUBSTANCES
 Dear Sir or Madam:
    / •


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

     1. How you will comply with the requirements set forth in
        this Notice and its Attachments A through 6; or

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

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

     If you do not respond to this Notice,  or if  you do not
satisfy EPA that you will comply with  its requirements or should
be exempt or excused from doing so,  then the registration of your
product(s)  subject to this Notice will be subject to suspension.
We have provided a list of all  of your products subject to this
Notice in Attachment B, Data  Call-In Response Form,  as well as a
list of all registrants who were sent  this Notice (Attachment F).

     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).
                                                           Ptfttta en BteyUta Piflff

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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 VT  - Inquiries And Responses To This Notice

     The Attachments to this Notice are:

     A  — Data Call~In Chemical Status Sheet
     B  - Data Call-In Response Form
     C  - Requirements Status and Registrant's Response Form
     D  • EPA Grouping of End~Use Products for Meeting Acute
          Toxicology Data Requirements for Reregistration
     E -  EPA Acceptance Criteria
     F  - List of Registrants Receiving This Notice
     G  - 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(sj containing the subject active ingredient.

SECTION II.  DATA REQUIRED BY THIS NOTICE

II-A^  pATA REQUIRED

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

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 II-B.   gTHEPVLF, FOR SUBMISSION OF DATA

     You are required to submit the data or otherwise satisfy the
 data requirements specified in Attachment C, Requirements Status
 and Registrant's Response Form,  within the timeframes provided.


 II-C.   TESTING PROTOCOL

     All studies required under this Notice must be conducted in
 accordance with test standards outlined in the Pesticide Assessment
 Guidelines for those studies for which guidelines have been
 established.
    «.*
    1 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)].

 II-D.  REGISTRANTS RECEIVING PREVIOUS  SECTION 3fclf2WBl 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-Infsl. or any other agreements entered into with the Agency
 pertaining to- such prior Notice.   Registrants must comply with the
 requirements  of all Notices  to avoid issuance of a Notice of Intent
 to  Suspend their  affected products.


 SECTION  III.   COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

 III-A.    SCHEDULE  FOR RESPONDING  TO  THE AGENCY

     The appropriate responses initially required by this Notice
 for product specific data must be  submitted to the Agency within 90
days after your receipt  of this Notice.  Failure to adequately
 respond to this Notice within 90 days  of your receipt will be a
basis for  issuing  a  Notice of Intent to Suspend (NOIS)  affecting

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 your products. This and other bases for issuance of NOIS due to
 failure to comply with this Notice are presented in Section IV-A
 and IV-B.

 III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

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

    A discussion of how to respond if you choose 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 B and Attachment C.  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 B).  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 A.

    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 pata Call-in Response Form, indicating your
 election of this option.   Voluntary cancellation is item number 5
 on the Data Call-In Response Form.  If you choose this option, this
 is the only form that you are required to complete.

    If you choose to voluntarily cancel your product,  further sale
 and distribution of your product after the effective date of
 cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.

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     2.  Satisfying the Product Specific Data Requirements of this
 Notice.   There are various options available to satisfy the product
 specific data requirements of this Notice.  These options are
 discussed in Section III-C of this Notice and comprise options 1
 through 6 on the Requirements Status and Registrant's Response Form
 and item numbers 7a and 7b on the Data Call-In Response Form.
 Deletion of a use(s)  and the low volume/minor use option are not
 valid options for fulfilling product specific data requirements.

     3.  Request for Product Specific Data Waivers.  Waivers for
 product specific data are discussed in Section III-D of this Notice
 and are covered by option 7 on the Requirements Status and
 Registrant's Response Fora.  If you choose this option, 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  option 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:

      (If)   I will generate and submit data within the specified
           timeframe (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.

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     The tine  frames  in the Requirements Status and Registrant's
 Response Form are the time frames that the Agency is allowing for
 the  submission of completed study reports.  The noted deadlines run
 from the date of the receipt of this Notice by the registrant.  If
 the  data are  not submitted by the deadline, each registrant is
 subject to receipt of a Notice of Intent to Suspend the affected
 registration(s).

     If you cannot submit the data/reports to the Agency in the time
 required by this Notice and intend to seek additional time to meet
 the  requirements (s), you must submit a request to the Agency which
 includes:  (1) a detailed description of the expected difficulty and
 (2)  a proposed schedule including alternative dates for meeting
 such requirements on a step-by-step basis.  You must explain any
 technical or  laboratory difficulties and provide documentation from
 the  laboratory performing the testing.  While EPA is considering
 your request, the original deadline remains.  The Agency will
 respond to your request in writing.  If EPA does not grant your
 request, the  original deadline remains.  Normally, extensions can
 be requested  only in cases of extraordinary testing problems beyond
 the  expectation or control of the registrant.  Extensions will hot
 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. Agree 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 *rtio 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

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

    In order for you to avoid suspension under this option, you may
 not withdraw your offer to share in the burdens of developing the
 data.   In addition,  the other registrant must fulfill its
 commitment to develop and submit the data as required by this
 Notice.   If the other registrant fails to develop the data  or for
 some  other reason is subject to suspension, your registration as
 well  as  that of the  other registrant will normally be subject to
 initiation of suspension proceedings, unless you commit to  submit,
 and do submit the required data in the specified time frame.  In
 such cases, the Agency generally will not grant a time extension
 for submitting the data.

    Option 4. Submitting an Existing Study — If you choose to
 submit an existing study in response to this Notice, you must
 determine that the study satisfies the requirements imposed by this
 Notice.  You may only submit a study that has not been previously
 submitted to the Agency or previously cited by anyone.   Existing
 studies are studies which predate issuance of this Notice.  Do not
 use this option if you are submitting data to upgrade a study. (See
Option 5).

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

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                                 8

    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)
    " '[r]aw data1 means any laboratory worksheets,  records,
    memoranda, notes, or exact copies thereof,  that are the result
    of original observations and activities of a study and  are
    necessary for the reconstruction and evaluation of the  report
    of that study.  In the event that exact transcripts of  raw data
   -have been prepared (e.g.,  tapes which have been transcribed
    verbatim, dated, and verified accurate by signature), the exact
    copy or exact transcript may be substituted for the original
    source as raw data.   'Raw data1  may include photographs,
    microfilm or microfiche copies,  computer printouts,  magnetic
    media, including dictated observations,  and recorded data from
    automated instruments."  The term "specimens",  according to 40
    CFR 160.3(k), means  "any material derived from a test system
    for examination or analysis."

    b. Health and safety studies completed after May 1984 must also
    contain all GLP-required quality assurance and quality  control
    information,  pursuant to the requirements of 40  CFR Part 160.
    Registrants must also certify at the time of submitting the
    existing study that  such GLP information is available for post-
    May 1984  studies by  including an appropriate statement  on or
    attached to the study signed by an authorized official  or
    representative of the registrant.

    c. You must certify  that each study fulfills the acceptance
    criteria  for the Guideline relevant to the study provided i
    the FIFRA Accelerated Reregistration Phase 3 Technical  Guidance
    and that  the study has been conducted according  to the
    Pesticide Assessment Guidelines  (PAG)  or meets the purpose of
   'the PAG (both available from NTIS).   A study not conducted
    according to the PAG may be submitted to the Agency for
    consideration if the registrant  believes that the study clearly
    meets the purpose of the PAG.  The registrant is referred to 40
    CFR 158.70 which states the Agency's policy regarding
    acceptable protocols.  If you wish to submit the  study,  you
    must,  in  addition to certifying  that the purposes of the  PAG
    are met by the study,  clearly articulate the rationale  why you
    believe the study meets the purpose of the  PAG,  including
    copies of any supporting information or  data.  It has been the
    Agency's  experience  that studies completed  prior to January
    1970 rarely satisfied the  purpose  of the PAG and that necessary
    raw data  are  usually not available for such studies.

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

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


   , Option 5f 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 A-  If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA.  You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA.
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.

    Do not submit additional data for the purpose of upgrading a
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.

    This option should also be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency.  You must provide the MRID number of the
data submission as well as the MRID number of the study being
upgraded.

    The criteria for submitting an existing study,  as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies.  Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements.


    Option 6.  Citing Existing Studies ~ If you choose to cite a
study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency.  Acceptable

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                                 10

 toxicology studies generally will have been classified as "core-
 guideline" or  "core minimum."  For all other disciplines the
 classification would be  "acceptable."  With respect to any studies
 for which you  wish to select this option you must provide the MRID
 number of the  study you  are citing and, if the study has been
 reviewed by the Agency,  you must provide the Agency's
 classification of the study.

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

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

 III-D  REQUESTS FOR DATA WAIVERS

    If you request a waiver for product specific data because you
 believe it is  inappropriate, you must attach a complete
 justification  for the request, including technical reasons, data
 and references to relevant EPA regulations, guidelines or policies.
 (Note: any supplemental  data must be submitted in the format
 required by PR Notice 86-5).  This will be the only opportunity to
 state the reasons or provide information in support of your
 request.  If the Agency  approves your waiver request, you will not
 be required to supply the data pursuant to section 3(c)(2)(B) of
 FIFRA.  If the Agency denies your waiver request, you must choose
 an option for  meeting the data requirements of this Notice within
 30 days of the receipt of the Agency's decision.  You must indicate
 and submit the option chosen on the Requirements Status and
 Registrant's Response Form.  Product specific data requirements for
 product chemistry, acute toxicity and efficacy (where appropriate)
 are required for all products and the Agency will grant a waiver
 only under extraordinary circumstances.  You should also be aware
 that submitting a waiver request will not automatically extend the
 due date for the study in question.  Waiver requests submitted
 without adequate supporting rationale will be denied and the
 original due date will remain in force.

 IV.  CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

 IV-A NOTICE OF INTENT TO SUSPEND

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

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                                 11

     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 if 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 if 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 either to:

     a.  Inform  EPA of intent to develop and submit the data
     required by  this Notice on a Data Call-in Response Form and a
     Requirements Status and Registrant's Response Form;

     b.  Fulfill the  commitment to develop and submit the data as
     required by  this Notice; or

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

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

IV-B.  BASIS FOR  DETERMINATION THAT SUBMITTED STUDY IS
    The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for

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                                 12

 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 (if
  • '' applicable), including the incorporation of any changes
     required by the Agency following review.

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

 IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

     EPA has statutory authority to permit continued sale,
 distribution and use of existing stocks of a pesticide product
 which has been suspended or cancelled if doing so would be
 consistent with the purposes of the Act.

     The Agency has determined that such disposition by registrants
 of existing stocks for a suspended registration when a section
 3(c)(2)(B)  data request is outstanding would generally not be
 consistent with the Act's purposes.  Accordingly, the Agency
 anticipates granting registrants  permission to sell, distribute,  or
 use  existing stocks of suspended  product(s)  only in exceptional
 circumstances.   If you believe such disposition of existing stocks
 of your product(s)  which may be suspended for failure to comply
 with this Notice should be permitted,  you have the burden of
 clearly demonstrating to EPA that granting such permission would be
 consistent with the Act.  You must also explain why an "existing
 stocks" provision is necessary, including a statement of the
 quantity of existing stocks and your estimate of the time required
 for their sale,  distribution,  and use.   Unless you meet this burden
the Agency will not consider any  request pertaining to the
continued sale,  distribution,  or  use of your existing stocks after
suspension.

    If you request  a voluntary cancellation of your product(s)  as a
response to this Notice and your  product is in full compliance with

-------
                                 13

 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 a 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 Pp?sIPLF
            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 yoy have any questions regarding the requirements and
 procedures established by this Notice, call the contact person(s)
 listed in Attachment A, the Data Call-Jn  Chemical Status Sheet.

    All responses to this Notice (other than voluntary cancellation
 requests)  must  include a completed Data Call-In Response Form and a
 completed Requirements Status and Registrant's Response Form
 (Attachment B and Attachment C)  and any other documents required by
this Notice, and should be submitted to the contact person(s)
 identified in Attachment A.  If the voluntary cancellation option is
chosen, only the Data Call-in Response Form need be submitted.

-------
                                14
    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
    B
    C
    D

    E
    F
    G
                   ..Daniel M. Barolo, Director
                  ,'•• Special Review and
                      Reregistration Division

               Attachments

Data Call-in Chemical Status Sheet
Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product
Specific Data Report Form

-------
 ATTACHMENT A




Chemical Status Sheet

-------
                                 ATTACHMENT A

             CITRIC ACID: DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

      You have been sent this Data Call-In Notice because you have products containing
citric acid.

      This attachment, the Data Call-in Chemical Status Sheet, contains a point of contact for
inquiries. This attachment is to be used in conjunction with (1) the Data Call-In Notice.  (2)
Attachment B, the Data Call-In Response Form. (3) Attachment C, the Requirement Status and
Registrant's Response Form for product specific data, (4) Attachment D, EPA Grouping  of
End-Use Products for Meeting Acute Toxicology Data Requirements for Reregistration. (5)
Attachment E, EPA Acceptance Criteria. (6) Attachment F, List of All Registrant^ sent this
Data Call-In Notice, and (7) Attachment G, the Cost Share and Data Compensation Forms for
product specific data, and Product Specific Data Report Form for use in replying to this citric
acid Data Call-In.  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

      The additional data requirements needed to complete the database for citric acid are
listed in the Requirements Status and Registrant's Response Form, Attachment C.

      The Agency has concluded that product specific data are needed for citric acid. The
required additional data are listed in Attachment C.

      Depending on the results of the studies required in this Notice, additional testing may
be required.

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Ruth Douglas at (703) 305-6600.  All
responses to this Notice should be submitted to:

                   Document Processing Desk (RED/RD/PM-32)
                   Office of Pesticide Programs
                   U.S. Environmental Protection Agency
                   401  M Street S.W.
                   Washington, D.C. 20460

                   RE: Citric acid

-------
      If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Napoleon Kotey at (703) 308-8523.  All responses to
this Notice should be submitted to:

                    Chemical Review Manager Napoleon Kotey
                    Accelerated Reregistration Branch (H7508W)
                    Special Review and Reregistration Division
                    Office of Pesticide Programs
                    U.S. Environmental Protection Agency
                    401 M Street S.W.
                    Washington, D.C. 20460

                    RE: Citric acid

-------
                  ATTACHMENT B

PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
                 PLUS INSTRUCTIONS

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

                      Product Spec!fie Data


     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.11

     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.

-------
Page  1 of  1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460 OHB NO. 2070-0107
DATA CALL-IN RESPONSE , . „ „ M
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet (s) if necessary.
1. Company name and Address 2. Case f and Name 3. Date and Type of DC I
ECOLAB INC. 4024 Citric acid, and salts PRODUCT SPECIFIC
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. EPA Product
Registration
1677-90
5. 1 wish to
cancel this
product regis-
tration volun-
tarily.

6. Generic Data
6a. I em claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as Indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a HUP and"
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

8. Certification 9. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number

-------
Page  1 of  1
United .States Environmental Protection Agency Form Approved
Washington, D. C. 20460
* OMB Mo. 2070-0107
DATA CALL-IN RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name 3. Date and Type of DCI
ECOLAB INC. 4024 Citric acid, and salts PRODUCT SPECIFIC
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. EPA Product
Registration
1677-100
5. I wish to
cancel this
product regis-
tration volun-
tarily.

6. Generic Data
6a. I am claimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.

6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a HUP and'
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

7b. My product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response. "

8. Certification 9. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number

-------
Page  1 of  1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460 OHB NO. 2070-0107
DATA CAIi-IN RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary. v
1. Company name and Address 2. Case 9 and Name 3. Date and Type of DC1
CANTOL INC 4024 Citric acid, and salts PRODUCT SPECIFIC
2211 N AMERICAN STREET
PHILADELPHIA PA 19133
4. EPA Product
Registration
5664-4
5. I wish to
cancel this
product regis-
tration volun-
tarily.

6. Generic Data
6a. I am claimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
. t rat ion number listed below.
N.A.

6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
;i .

7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

8. Certification 9. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number

-------
                                                                                                    Page  1  of
                              United States Environmental Protection Agency
                                          Washington,  D. C.  20460
                        - LIST OF  ALL REGISTRANTS  SENT THIS DATA CALL-IN NOTICE

                              Case # and Name: 4024   Citric acid, and salts
Co. Nr.   Company Name
                          Additional Name
Address
City  & State
Zip
001677
005664
ECOLAB INC.
CANTOL INC
370 WABASHA ST. ECOLAB CENTER
2211 N AMERICAN STREET
 ST PAUL MN
 PHILADELPHIA PA
55102
19133

-------
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 (MP)
          or 7b (EP) on this form, provide the EPA registration
          numbers of your source(s) and complete and submit the
          "Generic Data Exemption" form; 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 (MP) 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 (EP) 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 roust respond with
          Option 7 (Waiver Request) for each study for which you
          are requesting a waiver.  See Item 6 with regard to
          identical products and data exemptions.

Items 8-11.  Self-explanatory.

NOTE;     You may provide additional information that does not
          fit on this form in a signed letter that accompanies
          this form.  For example, you may wish to report  that
          your product has already been transferred to another
          company or that you have already voluntarily cancelled
          this product.  For these cases, please supply all
          relevant details so that EPA can ensure that its
          records are correct.

-------
                       ATTACHMENT C

PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
                 (FORMS B) PLUS INSTRUCTIONS
                           AND
                       PR NOTICE 86-5

-------
Page  1 of  3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print (n ink. Please read carefully
Use additional sheet(s) if necessary.
1 . Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. Guideline
Requi rement
Number


61-1
61-2 (a)


61-2 (b)
,
62-1
62-2
62-3
63-3
63-7
63-12
63-14
63-15
63-16
the attached instructions and supply the information requested

2. Case # and Name
4024 Citric acid, and salts

EPA Reg. No. 1677-90
5. Study Title
Prod Chew - Regular Che»ical
Product identity 4 compositiond)
Descrtp of starting materials, (1,2)
production & formulation
proe
Discussion of formation of (1,3)
tmpurttfes
Preliminary analysis (1,4)
Certification of limits (1.S)
Analytical method (1)
Physical state
Density
pH (9)
Oxidizing or reducing action (10)
FlammabUfty (11)
Explodability (12)
10. Certification
















R
I
C
£
















Progress
Reports

1

















2

















3
















6. Use
Pattern



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ABCDEFGHIJKLMNO


ABCDEFGHIJKLMNO

ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test






on this form.

3. Date and
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92


Type of DC I
PRODUCT SPECIFIC
ID# 1677-RD-1899


Substance



EP
EP

*
EP

EP
EP
EP
EP
EP
EP
EP
EP
EP

I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative

-
12. Name of Company Contact


















11.




13.








,










8. Time
Frame






8 mos.
8 mos*




8 mos.


8 mos.
8 mos.
8 mos.
B mos. .
8 mos.
8 mos.
8 mos.
8 mos*
8 mos.
Date




Phone Number
9. Registrant
Response

























-------
Page  2 of  3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. Guideline
Requirement
Number
63*17
63-18
63*1$
63-20
63-*2l
81-1
81-2
81-3
81-4
81-5
81-6
5. Study Title
$tor«g* stability (16)
Viscosity (13)
WscfbUlty (14)
Corrosion characteristics (17)
Dielectric breakdown voltage (15)
Acut«F To^fc <• Regular Chofcal
the attached instructions and supply the information requested
2. Case * and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-90


Acute oral toxlcity-rat (1,36,37)
Acute dermal (1,2,37)
t
-------
Page  3 of  3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print In ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. Guideline
Requirement
Nunfcer
91-2
5. Study Title
Food Preceration and gating
Establishments
AOAC flormfctdat and (1,2,10)
detergent sanitizer
method
the attached instructions and supply the information requested
2. Case * and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-90


I

Progress
Reports
1

2

3

6. Use
Pattern

Initial to indicate certification as to information on this page
(full text of certification is on page one).
t
7. Test
Substance
on this form.
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92

3. Date and Type of DC I
PRODUCT SPECIFIC
ID# 1677-RD-1899

EPl ,
8. Time
Frame
8 WOS.
9. Registrant
Response

Date

-------
                                 	Page    1  of   2
                                           United  States  Environmental  Protection Agency
                                                            Washington,  D.  C.  20460
                                  FOOTNOTES  AND KEY  DEFINATIONS  FOR GUIDELINE  REQUIREMENTS

                                           Case  f  and Name:  4024   Citric acid,  and  salts
Key: HP « manufacturing-use product; EP » end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE:  If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements  Identified in the tables.]; TEP « typical  end-use product;
TGA1 - technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
  A - Terrestrial food crop       B - Terrestrial food feed crop    C - Terrestrial  nonfood crop     D -  Aquatic food crop           E - Aquatic nonfood outdoor
  F - Aquatic nonfood Industrial   G - Aquatic nonfood residential   H - Greenhouse food crop         I -  Greenhouse nonfood crop     J - Forestry
  K - Residential outdoor         I - Indoor food                   N - Indoor nonfood              N -  Indoor Medical              0 - Indoor residential

Footnotes:  [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S  RESPONSE form.]


Prod CheM - Regular Chearfcal

 1  Requirements pertaining to product identity, composition, analysis, and certification of Ingredients are  detailed further in  the following sections:  *158.155 for
    product identity and composition (61-1);   M58.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); •158.167 for
    discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1);  «158.175 for certification of limits (62-2); and  M58.180 for enforcement
    analytical methods (62-3).
 2  A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
    use permit is being sought.                                                                                  ,•<
 3  If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
    the extent this information is available.
 A  Required to support the registration of each manufacturing-use product (including registered TGAIs) as  well as end-use products produced by an integrated system.
    Data on other end-use products will be required on a case-by-case basis.  For pesticides in the development state,  a rudimentary product analytical  method and data
    will  suffice to support an experimental use permit.
 5  Certified limits are not required for inert  ingredients in products proposed for experimental use.
 9  Required if test substances are dispersible with water.
10  Required if product contains an oxidizing or reducing agent.
11  Required if product contains combustible  liquids.
12  Required if product is potentially explosive.
13  Required if product is a liquid.
14  Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15  Required if end-use product is liquid and is to be used around electrical equipment.
16  Basic manufactures are required to provide the Agency with a sample of each TGAI  used to formulate a product when the new TGAI is first used as a formulating
    ingredient in products registered under FIFRA.  A sample of the active ingredient  (PAI) suitable for use  as an analytical standard is also required at this time.
    Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis.   Material safety data sheets should accompany samples as
    specified by OSHA in 29 CFR 1910.1200.


Acute Toxic - Regular Cheaical

 1  Not required if test material is a gas or  highly volatile.
 2  Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will  be classified as Toxicity Category I on the basis

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	Page   2  of   2

                                       .  United  States Environmental  Protection  Agency
                                                          Washington,  D.  C.  20460

                                 FOOTNOTES  AND  KEY  DEFINATIONS  FOR GUIDELINE  REQUIREMENTS

                                         Case  f  and  Name:  4024    Citric acid,  and salts


 Footnotes  (cont.):


    of potential eye and dermal  irritation effects.
  3 Required  if the product consists of,  or under conditions of use will  result in, an inhalable material (e. fl., gas,  volatile substances,  or aerosol/particulate).
  4 Required  unless repeated dermal exposure does not occur under conditions of use.
 36 Special testing (acute, subchronic, and/or chronic) is required for organophospates,  and may be required for other  cholinesterase inhibitors and other pesticides
    which have demonstrated a potential to adversely affect the visual  system. Registrants should consult with the agency for development of protocols and methodology
    prior to  Initiation of studies.
 37 Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing may meet  the criteria for restriction to use by certified
    applicators specified in 40  CFR 152.170(b) or the criteria for initiation of  special  review specified in 40 CFR 154.7 (a)(1).


 Efficacy - Antimicrobial Agent

  1 Efficacy  data for antimicrobial agents that claim to control pest microorganisms that may pose a threat to human must be submitted.
  2 Comparative product performance data  are required to be developed and maintained in the registrant's file and must  be submitted to the Agency on a case-by-case basis
    for risk/benefit analyses such as for public interest findings and  cases of special review.
 10 Required  for products to be  used on food contact surfaces, which include quaternary ammonium compounds (QAC) chlorinated trisodlum phosphate, and anionic
    detergent-acid formulations.

-------
Page  1 of  3
United States Environmental Protection Agency
Washington, D. C. 20460




REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1 . Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. Guideline
Requirement
Number

61-1
61-2 (A)


61-2 (b)

62-1
62-2
62-3
63-3
63-7
63-12
63-14
63-15
63-16
5. Study Title


Prod Che* - Regular Cheafcal
Product identity ft compos! tion(1)
Descrfp of starting materials, (1,2)
production & formulation
proc
Discussion of formation of (1,3)
fmpurttfes
Preliminary analysis (1,4) '
Certification of Umtts <1,S)
Analytical method (1)
Physical state
Density
pH (9)
Oxidizing or reducing action (10)
Flammabtttty (11)
Explodability (12)
10. Certification
the attached instructions and supply the information requested

2. Case 0 and Name
4024 Citric acid, and salts

EPA Reg. No. 1677-100



















i
i,
i
















Progress
Reports
1
















2
















3
















6. Use
Pattern


ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO


ABCDEFGHIJKLMNO

ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
•





on this form.

3. Date and
Form Approved

OMB No. 2070-0107
Approval Expires 12-31-92


Type of DCI
PRODUCT SPECIFIC
ID# 1677-RD-1900


Substance


EP
EP


EP

EP
EP
EP
EP
EP
EP
EP
EP
EP

I certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative


12. Name of Company Contact

















11.




13.


















8. Time
Frame




8 mos.
8 mos.




8 mos.


8 mos.
8
. mos.
8 mos.
8 mos*
8 mos.
8 mos.
8 mos.
8 mos *
8 mos.
Date




Phone Number
9. Registrant
Response
























-------
                        United  States Environmental Protection Agency
                                       Washington,  D.  C.  20460
                        REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
                                                                                             Page   2 of   3

                                                                                          Form Approved

                                                                                          OMB No. 2070-0107

                                                                                          Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink.  Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address
  ECOLAB INC.
  370  WABASHA  ST.  ECOLAB CENTER
  ST PAUL MN   55102
                                2. Case # and Name
                                  4024   Citric  acid,  and salts

                                  EPA Reg. No.  1677-100
                                        3. Date and Type of DCI
                                          PRODUCT SPECIFIC
                                          ID#  1677-RD-1900
4. Guideline
Requi rement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
63-18
63-19
63-20
63-21
81-1
81-2

81-3
31-4
81-5
81-6
  Storage stability          (16)
  Viscosity                (13)
  HiscibUity              (H)
  Corrosion characteristics    (17)
  Dielectric breakdown voltage (15)

Acute Toxic - Regular Cheancat

  AcUt« oral toxlcity-rat     (i,3o,37>
  Acute dermal              (1,2,37)
   toxtcfty-rabbft/rat
  Acute Inhalation toxicity-rat (3)
  Primary eye irrttatton- rabbit (2)
  Primary dermal irritation    (1,2)
  Dermal sensftfzation       <4)
        ABCDEFGHIJKLMNO
        ABCDEFGHIJKLMNO
        ABCDEFGHIJKLMNO
        ABCDEFGHIJKLMNO
        ABCDEFGHIJKLMNO
        ABC&EFGHIJKLMNO
        ABCDEFGHIJKLMNO

        ABCDEFGHIJKLMNO
        ABCDEFGHtJKLMNO
        ABCDEFGHIJKLMNO
        ABCDEFGHIJKLMNO
                   EP
                   EP
                   EP
                   EP
                   EP
                   EP
                   EP

                   EP
                   EP
                   EP
                   EP
                   Efficacy •*• Antimicrobial Agents - Public
                    Health Uses
                   Medical. Dental. Mortuary, and
                    8  mos,
                    8  mos.
                    8  mos.
                    8  mos.
                    8  mos,
                    8  mos*
                    8  mos.

                    8  mos.
                    8  mos.
                    8  mos.
                    8  mos.
Initial to indicate certification as to information on this page
(full text of certification is on page one).
                                                               Date

-------
Page  3 of  3
United States Environmental Protection Agency
Washington, D. C. 20460


REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. Guideline
Requirement
Number
91-2,3
91*2
91-2
5. Study Title


Allied Enviror^ent*
AOAC use-dilution method (1,2)
AOAC fungitidal test (1,2)
Virucidal activity study (1,2)
the attached instructions and supply the information requested

2. Case # and Name


4024 Citric acid, and salts

EPA Reg. No. 1677-100






|
X
8



Progress
Reports
1



2



3


•
6. Use
Pattern








Initial to indicate certification as to information on this page
(full text of certification is on page one).
MN
MN
MN
7. Test
Substance

EP
EP
EP
on this form.

3. Date and
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92


Type of DCI
PRODUCT SPECIFIC
ID# 1677-RD-1900








8. Time
Frame


8 mos.
8
i mos.
8 mos.
9. Registrant
Response




Date

-------
                                                                                                                                              Page   1 of    2
                                           United  States  Environmental  Protection  Agency
                                                            Washington,   D.  C.  20460
                                  FOOTNOTES  AND KEY  DEFINATIONS  FOR GUIDELINE REQUIREMENTS
                                           Case  f  and Name:  4024    Citric  acid,  and  salts
Key: HP « manufacturing-use product; EP « end-use product; provided formulators purchase their active  ingredient(s) from a registered source,  they need not submit or cite
data pertaining to the purchased product.[NOTE:  tf a product is a 100 percent  repackage of another  registered product that is purchased,  and any use for the product  does
not differ  from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.];  TEP » typical end-use product;
TGAI = technical grade of the active ingredient;  PAI « "pure" active ingredient; PAIRA = "pure" active ingredient,  radiolabeled.
Use Categories Key:
  A - Terrestrial food crop       B • Terrestrial food feed crop     C -  Terrestrial nonfood crop     0 - Aquatic  food crop           E -  Aquatic nonfood outdoor
  F - Aquatic nonfood Industrial   G - Aquatic nonfood residential    H -  Greenhouse food crop        1 - Greenhouse nonfood crop     J -  Forestry
  K - Residential outdoor         L - Indoor food                   M -  Indoor nonfood              N - Indoor Medical              0 -  Indoor residential

Footnotes:  [The following notes are referenced in column two (5. Study  Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]


Prod Che* - Regular Chemical

 1  Requirements pertaining to product identity,  composition, analysis, and certification of ingredients are detailed further in the following sections:  *158.155 for
    product identity and composition (61-1);  •158.160, 158.162, and 158.165 for description of starting materials  and manufacturing process (61-2);  *158.167 for
    discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1);  *158.175  for certification of limits (62-2); and   *158.180 for enforcement
    analytical methods (62-3).
 2  A schematic diagram end/or brief description of the production process will suffice if the pesticide is not already under full scale  production and an experimental
    use permit is being sought.                                                                                   ,.
 3  If the  pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional  ingredients shall be submitted to
    the extent this Information is available.
 A  Required to support the registration of each  manufacturing-use product (including registered TGAIs) as well as  end-use products produced by an Integrated system.
    Data on other end-use products will be required on a case-by-case basis.   For pesticides in the development state, a rudimentary product analytical method and data
    will suffice to support an experimental use permit.
 5  Certified limits are not required for inert  ingredients in products proposed for experimental use.
 9  Required if test substances are dispersible with water.
10  Required if product contains an oxidizing or  reducing agent.
11  Required if product contains combustible liquids.
12  Required if product is potentially explosive.
13  Required if product is a liquid.
14  Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15  Required if end-use product  is liquid and is  to be used around electrical  equipment.
16  Basic manufactures are required to provide the Agency with a sample of each TGAI used to formulate a product when the new TGAI is first  used as a formulating
    ingredient in products registered under FIFRA. A sample of the active ingredient (PAD suitable for use as an  analytical standard is also required at this time.
    Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis.  Material safety data sheets  should accompany samples as
    specified by OSHA in 29 CFR  1910.1200.


Acute Toxic - Regular Chearical

 1  Not required if test material is a gas  or highly volatile.
 2  Not required If test material is corrosive to skin or has pH less than 2 or greater than 11.5;  such a product will be classified as Toxicity Category I on the basis

-------
	Page   2 of   2

                                         United States  Environmental  Protection  Agency
                                                         Washington,  D.  C.  20460

                                 FOOTNOTES  AND  KEY  DEFINATIONS  FOR GUIDELINE REQUIREMENTS

                                         Case  f and Name:  4024   Citric  acid,  and  salts    '

                                                                                                                                                         £
 Footnotes  (cont.):                                                                                                                              i


    of potential eye and dermal Irritation effects.                                                                                                           i
  3 Required if the product consists of, or under  conditions of use  will result In, an inhalable material (e. g.,  gas, volatile substances, or aerosol/partIculate).      j
  4 Required unless repeated-dermal exposure does  not occur under conditions of use.                                                                              !
 36 Special  testing (acute, subchronic, and/or chronic) is  required  for organophospates, and may be required for other cholinesterase inhibitors and other pesticides
    which have demonstrated a potential to adversely affect the visual system.  Registrants should consult with the agency for development of protocols and methodology
    prior to initiation of studies.
 37 Testing  of the EP dilution  is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
    applicators specified in 40 CFR 152.170(b) or  the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).


 Efficacy - Antimicrobial Agent
                                             f                                                                                                           •
  1 Efficacy data for antimicrobial agents that claim to control pest microorganisms that may pose a threat to human must be submitted.                                ;
  2 Comparative product performance data are required to be developed and maintained in the registrant's file and  must be submitted to the Agency on a case-by-case basis
    for risk/benefit analyses such as for public interest findings and cases of special  review.
 10 Required for products to be used on food contact surfaces, which include quaternary anmoniun compounds (QAC) chlorinated tHsodium phosphate, and anlonic
    detergent-acid formulations.


                                                                                                                                                         i

-------
Page  1 of  A
United .States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
CANTOL INC
2211 N AMERICAN STREET
PHILADELPHIA PA 19133
4. Guideline
Requi rement
Number


61-1
61-2 (A)


61-2 (b)

62-1
62-2
62-3
63-3
63-7
63-12
63-14
63-15
63-16
5. Study Title



Prod Che* - Regular Chemical
Product identity & eompositiond)
Desert p of starting materials, (1,2)
production & formulation
proe
Discussion of formation of (1,3)
impurities
Preliminary analysis (1,4)
Certification of limits (1,$)
Analytical method (1)
Physical state
Density
pH <9)
Oxidizing or reducing action (10)
flamnabUity (11)
Explodability (12)
10. Certification
the attached instructions and supply the information requested

2. Case ft and Name
4024 Citric acid, and salts

EPA Reg. No. 5664-4




















&
A
5
L
















Progress
Reports
1

















2

















3










1






6. Use
Pattern



ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO


ABCDEFGHIJKLMNO

ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test






on this form.

3. Date and
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92


Type of DC I
PRODUCT SPECIFIC
ID# 5664-RD-1901


Substance



EP
EP

X -.
EP
*
EP
EP
EP
EP .
EP
EP
EP
EP
EP

1 certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative


12. Name of Company Contact


















11.




13.



















8. Time
Frame






8 mos.
8 mos.




8 mos.


8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Date




Phone Number
9. Registrant
Response

























-------
Page  2 of
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary. v
1. Company name and Address
CANTOL INC
2211 N AMERICAN STREET
PHILADELPHIA PA 19133
4. Guideline
Requirement
Number
€3-17
63-18
€3*19
63-20
63-21
81-2
81-3
81-4
81-5
81-6
91-2
5. Study Title
Storage stability <16)
Viscosity (13)
MIscibHity W>
Corrosion characteristics (17)
Dielectric breakdown Voltage (15)
petite toxic - Regular Chenfcat
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
the attached instructions and supply the information requested on this form.
2. Case # and Name 3. Date and Type of DCI
4024 Citric acid, and salts PRODUCT SPECIFIC
ID# 5664-RD-1901
EPA Reg. No. 5664-4


Acute oral toxidty-rit <1,36,37>
Acute dermal (1,2,37)
toxlcity* rabbit/rat
Acute inhalation toxicity-rat (3)
primary eye irrftatf on- rabbit <25
Primary dermal irritation (1,2)
Dermal sensittzaHon (4)
Efficacy - Antimicrobial Agents - Public
Health Uses
Bathroom Surfaces-Premises
AOAC vse-di lut t on method < 1 , 2 >

K

Progress
Reports
1
-
2

3
*
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MNO
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
EP
EP
EP
EP
EP
-i
x% i
EP
EP
EP
EP
EP
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos,
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response

Date

-------
                                 	Page    1  of   2
                                           United  States  Environmental  Protection  Agency
                                                            Washington,   D.  C.  20460
                                  FOOTNOTES  AND KEY  DEFINATIONS  FOR GUIDELINE REQUIREMENTS
                                           Case  I  and Name:  4024    Citric  acid,  and  salts
Key: MP • manufacturing-use product; EP = end-use product; provided formulators purchase their active ingredient(s) from a registered source,  they need not submit or cite
data pertaining to the purchased product.[NOTE:  If a  product is a 100 percent  repackage of another registered product that is purchased, and any use for the product does
not differ  from those of the purchased and registered source, users are not  subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGA! - technical grade of the active ingredient;  PAI  « "pure" active ingredient; PAIRA = "pure" active ingredient,  radiolabeled.
Use Categories Key:
  A - Terrestrial food crop       B • Terrestrial food  feed crop     C -  Terrestrial nonfood crop     0 - Aquatic  food crop            C - Aquatic nonfood outdoor
  F - Aquatic nonfood Industrial  G - Aquatic nonfood residential    H -  Greenhouse food crop         I - Greenhouse nonfood crop      J - Forestry
  K - Residential outdoor         L - Indoor food                   N -  Indoor nonfood               N - Indoor Medical              0 - Indoor residential

Footnotes:  [The following notes are referenced In column two (5. Study  Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]


Prod Chea - Regular Cheat caI                    -

 1  Requirements pertaining to product identity,  composition, analysis, and  certification of ingredients are detailed further in the following sections:  *158.155 for
    product identity and composition (61-1);  "158.160,  158.162, and 158.165 for description of starting materials  and manufacturing process (61-2);  *158.167 for
    discussion of formation of Impurities (61-3); *158.170 for preliminary analysis (62-1);  *158.175 for certification of limits (62-2); and  *158.180 for enforcement
    analytical methods (62-3).
 2  A schematic diagram and/or brief description of the  production process will suffice if the pesticide is not already under full scale production and an experimental
    use permit is being sought.
 3  If the  pesticide is not already under full scale  production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
    the extent this information is available.
 4  Required to support the registration of each  manufacturing-use product (including registered TGAIs) as well as  end-use products produced by an integrated system.
    Data on other end-use products will be required on a case-by-case basis.   For pesticides in the development state,  a rudimentary product analytical method and data
    will suffice to support an experimental use permit.
 5  Certified limits are not required for inert  ingredients in products proposed for experimental use.
 9  Required if test substances are dispersible with  water.
10  Required if product contains an oxidizing or  reducing agent.
11  Required if product contains combustible liquids.
12  Required if product is potentially explosive.
13  Required If product is a liquid.
14  Required if product is an emulsifiable liquid and is to be diluted with  petroleum solvents.
15  Required if end-use product is liquid and is  to be used around electrical  equipment.
16  Basic manufactures are required to provide the Agency with a sample of each TGAI used to formulate a product when the new TGAI is first used as a formulating
    ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable  for use as an  analytical standard is also required at this time.
    Samples of end-use products produced by an integrated system must be submitted on a case-by-case  basis.  Material safety data sheets should accompany samples as
    specified by OSHA in 29 CFR 1910.1200.


Acute Toxic - Regular Chenical

 1  Not required if test material is a gas or highly  volatile.
 2  Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5;  such a product will  be classified as Toxicity Category I on the basis

-------
	Page   2  of   2

                                         United  States Environmental  Protection Agency
                                                          Washington,   D.  C.   20460

                                 FOOTNOTES  AND  KEY  DEFINATIONS  FOR  GUIDELINE  REQUIREMENTS

                                         Case  I  and  Name:  4024    Citric acid,  and  salts

 Footnotes  (cont.):


    of potential eye and dermal  Irritation effects.
  3  Required if the product consists of,  or under conditions of use will  result in, an inhalable material (e. g., gas,  volatile substances, or aerosol/portIculate).
  4  Required unless repeated dermal exposure does not occur under conditions of use.
 36  Special  testing (acute, subchronlc, and/or chronic) Is  required for organophospates,  and may be required for other  choltnesterase inhibitors and other pesticides
    which have demonstrated a potential to adversely affect the visual  system.  Registrants should consult with the agency for development of protocols and methodology
    prior to Initiation of studies.
 37  Testing  of the EP dilution is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
    applicators specified in 40  CFR 152.170(b) or the criteria for initiation of special  review specified In 40 CFR 154.7 (a)(1).


 Efficacy - Anti-icrobial Agent

  1  Efficacy data for antimicrobial agents that claim to control pest microorganisms that may pose a threat to human must be submitted.
  2  Comparative product performance data  are required to be developed and maintained in the registrant's file and must  be submitted to the Agency on a case-by-case basts
    for risk/benefit analyses such as for public Interest findings and  cases of special review.
 10  Required for products to be  used on food contact surfaces, which include quaternary ammonium compounds (QAC) chlorinated trisodium phosphate, and anionic
    detergent-acid formulations.

-------
              SPECIFIC INSTRUCTIONS FOR COMPLETING
      THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM

                      Product Specific Data


   •  This form is designed to be used for registrants to respond
to call-ins 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 product
specific 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.  PQ NOT use this form for any other
active ingredient.

     Items 1 through 8 (inclusive) will have been preprinted on
the form.  You must complete all other items on this form by
typing or printing legibly.

     Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed,  and completing and
reviewing the collection of information.  Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223,  U.S.  Environmental
Protection Agency, 401 M St., S.W.,  Washington,  D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C.  20503.

-------
 INSTRUCTIONS  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 Itea 3.  This number oust be used in
           the transaittal  document for  any data  submissions  in
           response  to this Data Call-In Notice.
        • •            .                    •

 Item 4.    The guideline reference  numbers of studies required to
           support   the  product1*  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 nov listed under  40 CFR 158.155
           through 158.180, Subpart C.

 Itea 5.    The study title associated'with the guideline reference
           number is identified.

 Itea 6.    The use pattern(s) of the pesticide associated with the
           product specific requirements is (are) identified.   For
          most product specific data requirements, all use patterns
           are covered by the data requirements.   In the  case of
          efficacy  data,  the  required studies  only pertain  to
          product/ which have the use sites and/or pests indicated.
                                   *
 Itea 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. •   . • • ••

 Itea 8.   The due date for submission of each study is identified.
          It  is normally based on  8 months,  after issuance of the
          Reregistration Eligibility Document unless EPA^deteraines
          that a longer time period is necessary.

Itea 9.   Enter only'one of the following response  codes  for  each
          data requirement to show how you intend  to comply  vita
          the  data  requirements listed  ia  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 vith one  or acre
          registrants to develop data jointly (Cost Sharing).  I
          am  submitting a copy of this agreement and a completed
          "Certification   With  Respect   To  Data   Compensation
          Requirements11  fora.   I understand  that  this option is
          available  only for acute toxicity or certain efficacy

-------
      data and only if EPA indicates in an attachment to this
      Notice  that ay product  is sioilar  enough to another
      product to  qualify for  this  option. .  Z certify that
      another party in the agreement is committing to submit
      or provide the required data; if the required study is
      not submitted  on time,  ay product  nay  be subject to
      suspension.       '      •    .    • .  •      '  .'

 3.   Z have Bade offers to share in the cost to  develop data
      (Offers to Cost Share).  Z 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 ay product is similar enough to
      another product  to  qualify for  this  option.   Z  aa
      submitting evidence that  Z have made an offer to another
      registrant (who has  an obligation to submit  data)  to
      share in the cost of that data.   Z aa also  submitting a
      completed "Certification  of Offer to  Cost Share in the
      Development  Data1' fora.  Z aa including a copy  of ay
      offer and proof of the other registrant's receipt of that
      offer.   Z aa identifying the party which is committing
      to submit or provide  the  required  data; it the required
      study is not submitted on  time, ay product aay be subject
      to suspension.   Z understand  that  other  terms  under  .
      Option  3 in the Data Call-in Notice  (Section III-C.l.)  '
      apply as veil.

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

6.    By the specified due date, Z vill submit or cite data to
      upgrade  a  study classified  by the  Agency as partially
      acceptable and upgradable (Upgrading  a study).* Z vill
      submit  evidence of  the  Agency's review indicating that
      the  study may be  upgraded  and   what information  is
      required to do so.  Z vill provide the MRID or Accession
      number of the *tu4y at the due date.  Z understand that
      the conditions for this option outlined Option  5 in the
      Data Call-In Notice (Section III-C.l.) apply.

6.    By the "specif ied due date, Z vill 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

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          i another registrant's study, Z understand that this option
          •is available only for acute toxicity or certain efficacy
           data and only if the  cited  study was  conducted  on &y
           product, an identical product or a product which EPA has
          : "grouped" with one  or more ''other  products for purposes
           of depending on the sane data.  Z nay also choose this
          .option if  z aa citing ay own data.   Zn either case, Z
          yill provide the XRXD or Accession number(s)  for the
           cited, data  on a  "Product Specific Data  Report" fora or
           in a siailar format. • If  Z cite another, registrant's
           data,  Z will  submit a  completed "Certification  with
           Respect To Data Compensation Retirements" fora.
                                               •   f  •
     7.    Z  request  a waiver  for. this  study  because  it  is
           inappropriate for ay product  (Waiver Request).   Z aa
          attaching  a complete  justification  for this  request,
          including  technical reasons,  data and references  to
          relevant EPA regulations, guidelines or policies.  [Note:
          any  supplemental data  must  be submitted in the format
          required by P.R. Notice 86-5].  Z understand  that this
          is ay  only opportunity to state the reasons or provide
          information in support of ay request.   Zf the Agency
          approves ay waiver  request,  Z will not be  required* to
          supply the data pursuant to Section 3(c) (2) (B)  of FIFRA.
          Zf the Agency denies ay waiver request,  Z must choose a
          aethod  of meeting the data requirements  of  this Notice
          by the due date stated by this Notice.  Zn  this case, Z
          aust,  within  30 days  of ay receipt of the  Agency's
          written decision,  submit  a revised  "Requirements Status
          and  Registrant's Response"  Fora indicating the  option
          chosen. •   Z also  understand  that  the deadline  for
          submission of data  as specified by  the original  data
          call-in notice will  hot change.

Ztems 10-13.   Self-explanatory.

          You aay provide additional information that does not fit
          on  this fora in a signed letter that accompanies  this
          form.   For  example,  you  may wish to  report that  your
           roduct has already  been transferred to  another company
           r  that you have already voluntarily  cancelled  this
           roduct.  For these  cases, please  supply all  relevant
           etails so that  EPA can ensure that its  records  are
           orrect.

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       3     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
-r     *                 WASHINGTON, O.C. 20460

 **"*'                                               JUL29B86
                                                          orricc or
                          PR NOTICE 86-5           PMTICIDMANOTOXICVUMTANCM
        •_ NOTICE TO PRODUCERS,  FORMULATORS,  DISTRIBUTORS
                         AND REGISTRANTS

  Attentions   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
       ••ISMMMMIMMM^^IMMMB^H^B^^^                            «

       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 S10(d)(l).  This Notice does not apply
  to  commercial,  financial, or  production  information, which are,
  and must  continue to be,  submitted  differently under separate
  cover.

  III.  Effective  Date

       This notice is effective on November  1, 1986.  Data formatted
  according to this notice  may  be submitted  prior to the effective
  date.   As of the effective date, submitted data packages that  do
  not conform to  these requirements may be returned to the submitter
  for ,necessary revision.

  IV.   Background

       On September 26,  1984, EPA published  proposed regulations
  in  the  Federal  Register  (49 FR 37956)  which  include Requirements
  for Data  Submission (40  CFR S158.32),  and  Procedures for Claims
  of  Confidentiality of  Data (40 CFR  $158.33).  These regulations

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specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
-.: ality.  No entiti   .its  .•> <1ata c .-f ide/^ial ity are chared,
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 alsb established a public docket  which imposes dead-
line.s for inserting into the docket documents  submitted in con-
nection 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 re-
quirement 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.

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                         - INDEX -
                                                          Text Exarnle
                                                          Page  Page

A. Organization of the Submittal Package	    3    17

B. Transmittal Document	    4    11

C. individual Studies  	 	    4

   C.I Special Considerations for Identifying Studies. .    5

D. Organization of each Study Volume	    6    17

   D.I Study Title Page	    7    12

   D.2 Statement of Data Confidentiality Claims
        (based on FIFRA $10(d)(l)) 	    8    13
   D.3 Confidential Attachment 	    8    15

   D.4 Supplemental Statement of Data Confidentiality
        Claims (other than those based on FIFRA SlO(d)(l)]  8    14
   D.5 Good Laboratory Practice Compliance Statement . .    9    16

E. Reference to Previously Submitted Data  	 .    9

F. Physical Format Requirements t Number of Copies ...    9

G. Special Requirements for Submitting Data to the Docket  10

                          **************
A.   Organization of Submittal Package

     A 'submittal package1 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).

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B.   Transmittal Document

     The first item in each submittal package must be a  trans-
ir.it* al .'-ru.r* .t.  Tri- c1.  -••:••;  id>?ririfies  the SubrcUtjr 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), S3(c)(2)(B) data call-in,
$6(a)(2) submittal, or a special review; the transmittal date;
and a list of all individual studies included in  the package in
the order of their appearance, showing (usually by Guideline
reference number) the data requirement(s) addressed by each  one.
The EPA-assigned number for the regulatory  action (e.g.  the
registration, EUP, or tolerance petition number) should  be
included in the transmittal document as well, if  it is known to
the submitter.  See Attachment 1 for an example of an acceptable
transmittal document.

     The list of included studies in the transmittal of  a data
submittal package supporting a registration application  should
be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.

     The list of included studies in the transmittal of  a data
submittal package supporting a petition  for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 4CfCFR
180.7 and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.

     When a submittal package supports a tolerance petition  and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies.  Within  these
two groups of studies follow the instructions above.

C.   Individual Studies

     A study is the report of a single scientific investigation,
including all supporting analyses required  for logical complete-
ness.   A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date,  and
title.  Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with  some exceptions dis-
cussed in section C.I.  Each study included in a submittal package
must be bound as a separate entity.   (See comments on binding
studies on page 9.)

     Each study must be consecutively paginated, beginning from
the title page as page 1.  The total number of pages in  the  com-
plete study must be shown on the study title page.  In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either  of
the following:

     - Include the total number of pages in the complete study
       on each page (ie., 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.

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      When a single  study is extremely  long,  binding  it  in multiple
 volumes is permissible  so long  as  the  entire study is pz^inat^
 ..-; a iir^ic aeries,  ana eacn volume  is plainly  identified by the
 study title and its  position in the  multi-volume  sequence.


 C.I  Special Considerations for Identifying  studies

      Some studies raise special problems  in  study identification,
 because they address Guidelines of broader than normal  scope or
 for other reasons.

      a.  Safety  Studies.   Several Guidelines  require  testing  for
 safety in more  than  one species.   In these cases  each species
 tested should be reported as a  separate study, and bound
 separately.

      Extensive  supplemental reports  of pathology  reviews, feed
 analyses,  historical control data, and the like are  often assoc-
 iated with safety studies.   Whenever possible these  should be
 submitted with  primary  reports  of  the  study, and  bound  with  the
 primary study as appendices.  When such supplemental reports are
 submitted independently of  the  primary report, take  care  to  fully
.identify the primary report to  which they pertain.

      Batteries  of acute toxicity tests, performed on the  same end
 use product and covered by  a single  title page, may  be  bound
 together and reported as a  single  study,

      b.    Product Chemistry Studies.  All product chemistry  data
 within a submittal package  submitted in support of an end-use
 product produced from registered manufacturing-use products
 should be bound as a single study  under a single  title  page.

      Product chemistry  data submitted  in  support  of  a techni-
 cal product, other manufacturing-use product, an  experimental
 use permit,  an  import tolerance petition, or an end-use prod-
 uct 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  covet 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 S10(d)(l)(A),  (B), or  (C),  and if so must be handled
 as described in section D.3.  of this notice.

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      c.   Residue Chemistry Studies.  Guidelines  171-4, 153-3,
 and  ^53-4 are extreme!"" broad  in  *cope? studies addressing
 residue chemistry requirements mubc  tiius oe uctineo ac 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 resi-
 dues resulting  from treatment of  a single crop or from proces-
 sing a single crop.  When more than  one commodity is derived
 from a single crop (such as beet  tops and beet roots) residue
 data on all  such commodities should  be reported as a single
 study.  When multiple field trials are associated with a
 single crop, all such trials should  be reported as a single
 study.

 D.    Organization of Each Study Volume

      Each complete study must include all applicable elements in
 the  list below, in the order indicated.  (Also see Page 17.)
 Several of these elements are further explained in the following
 paragraphs.  Entries in the column headed 'example' cite the
 page  number  of  this notice where the element is illustrated.
Element

Study Title Page

Statement of Data
Confidentiality
Claims

Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices

Cover Sheet to Confi-
dential Attachment
  t
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
 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

 For certain toxicology studies.  (When
 flagging  requirements are finalized.)

 Always  -  with an  English language
 translation if  required.

 At submitter's  option
 If  CBI  is  claimed  under  FIFRA
 S10(d)(l)(A),  (B),  or  (C)

 If  CBI  is  claimed  under  FIFRA
, S10(d)(l)(A),  (B), or  (C)

 Only  if  confidentiality  is
 claimed  on a basis  other than
 FIFRA 510(d)(l)(A),  (B),  or  (C)
Page 15


Page 14

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D.I  Title Page

     A  title page  is always  required  for each submitted study,-
published or unpublished.  The title  page must always be  freely
releasable to requestors; DO NOT  INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable  title page is on page 12 of this
notice.  The following information must appear on the title
page:

a.  '•• Study title.  The study title should be as descriptive as
possible.It must clearly identify the substance(s) tested and
correspond to the  name of the data requirement as it appears
in the Guidelines.

b.   Data requirement addressee.  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 roust 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,identify on the title page all relevant  facts
of publication, such as the  journal title, volume, issue, inclusive
page numbers, and publication date.

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 D.2.  Statements of Data Confidentiality Claims Under FIFRA $10(d)(l).

      Each  submitted study must be accompanied by one of the two
 alternative  forms of  the Statement of  Data Confidentiality Claims
 specified  in  the proposed regulation in $158.33 (b) and (c).
 (See  Attachment 3) These statements apply only to claims of data
 confidentiality based on FIFRA S10(d) (1) (ATTTB), or (C).  Use
 the appropriate alternative  form of the statement either to
 assert  a claim of $10(d)(l)  data confidentiality ($158.33(b))
 or  to waive  such a claim (S158.33(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 petitions
 for tolerances or emergency  exemptions (see NOTE Pg 13).

 D.3.  Confidential Attachment

      If the  claim is made that a study includes confidential busi-
 ness  information as defined  by the criteria of FIFRA S10(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
 coyer sheet  fully identifyinj 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 assoc-
 iated 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 SlO(d)U) 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 tne typed name
      and title of the official who signed it.

                                8

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 D.5  Cood Laf-ratory  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
 FOR ANOTHER PURPOSE unless  EPA specifically requests it.  A copy
 of  the title  page  plus  the  MRID  number  (if  known) is sufficient
 to  allow us to retrieve the study immediately for review.   This
 prevents duplicate entries  in the Agency  files, and saves you
 the cost of sending more  copies  of  the  study. References to pre-
 viously  submitted  studies should not be included in the  transmit-
 tal document, but  should  be incorporated  into the statement of
 the method of support for the application.

 F.    Physical Format  Requirements

      All elements  in  the  data submittal package must "be  on  uniform
 8 1/2 by 11 inch white  paper, printed on  one  side only in black
 ink, with high contrast and good resolution.   Bindings for  indi-
 vidual 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 pointst

  o  Do  not include frayed  or torn  pages.

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

  o  Make sure that photocopies  are clear,  complete, and fully
      readable.

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

  o  Do  not bind any  documents with glue  or binding tapes.

  o Jlake sure that all pages of each study,  including any  attach-
      ments or appendices, are present and in  correct sequence.

'      Number of Copies Required - All submittal*packages  except
 those associated with a Registration Standard or Special Review
 (see Part G below) must be  provided in  three  complete,  identical
 copies.   (The proposed  regulations  specified  two copies; three
 are now  being required  to expedite  and  reduce the cost of proces-
 sing data into the OPP  Pesticide Document Management System and
 getting  it into review.)

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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.

  o  Remove the 'Supplemental Statement of Data Confidentiality
     Claims'.

  o  Remove the 'Confidential Attachment'.

  o  Excise from the body of the study any information you claim
     as confidential, even if it does not fall within the scope
     of FIFRA SlO(d)dHA), (B), or (C).   Do not close up or
     paraphrase text remaining after this excision.

 .o  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 William C. Grosse, Chief,
Information Services Branch, Program Management and Support
Division, (703-557-2613).
                            ames W. Akerman
                           Acting Director,
                           Registration 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
                               10

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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

     fSmith Chemical Corp. will act as sole agent for all submitters,

 2.  Regulatory action  in support cf 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. experi-
    mental 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 trans-
       mittal 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 con-
       cerning  data compensation or subsequent use or release
       of the data.
Company Official:
                  Name                    Signature

Company Name:     	
Company Contact:	     	
                  Name                            Phone
                               11

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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
   fX is the total number of pages in the study)
                         12

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                                 JCTKSMEST 3.

                   STATEMENTS OF DATA CONFIDENTIALITY CLAIMS




1.  No claim of confidentiality under FIFRA $10(d)(l)(A),(B),  or (C)


                    STATEMENT OP NO DATA CONFinEWnALITY CLAIMS
   No claim of confidentiality is made for any information contained  in this study
   on the basis of its fAll ing within the scope of FIFRA S10(d)(l)(A),  (B),  or (C).
   Company
   Conpany Agent:                Typed Name                     Date:

   	Title	   	Signature
2.  Claim of confidentiality under FIFRA S10(d)(l)(A),  (B),  or (C).
                    STATEMENT OF DATA CONFIDENTIALITY CLAIMS
   Information claimed confidential on the basis of its falling within the scope
   of FIFRA SlO(d)UHA), (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 Analyt-
  ical Methods Manual, and therefore cannot be claimed  as confidential.  OPP
  implements this policy by returning submitted analytical methods, for which
  which  confidentiality claims have  been maue,  to the submitter, to obtain
  the confidentiality waiver  before  they can  be processed.


                                     13

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                        ATTACHMENT 4.

    SUPPLEMENTAL STATEMENT OP 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*

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

 'o  Cite the reasons why the cited passage qualifies for
     confidential treatment.

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

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

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

  o  Enclose copies of any pertinent determinations of confi-
     dentiality made by EPA, other Federal agencies, or courts
     concerning this information.

  o- -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.

  o  If you  assert that the information is 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.
                              14

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                                   AITACttEHT 5.

                    EXAMPLES OP SEVERAL CONFIDENTIAL ATTACHMENTS

Example 1  (Confidential word or phrase that has been deleted fron the study)


CROSS REFERENCE NUMBER	1_    This cross reference number is used in the study
                               in place of the following words or phrase at the
                               indicated volume and page references.

DELETED WORDS OR PHRASE:	Ethylene Glycol	

  BftSE  LINE   REASON FOR THE DELETION                          FIFRA REFERENCE

    6    14    Identity of Inert Ingredient                      S10(d)(l)(C)
   28    25                 "                           .
  100    19
Example 2  (Confidential paragraph(s) that have been deleted from the study)


CROSSiUEFERENCE 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.
DELElHyH»AGRAPH(S):
   (                                                                       )
   (              Reproduce the deleted paragraph(s) here                  )
   (                                                                       )

  PAGE.-LINES  REASON FOR THE DELETION                          FTFRA REFERENCE

   20   *-T7   Description of the quality control process        S10(d)(l)(C)
        3  TConfidential pages that have been deleted from the study)
CROSS .SERHBCE 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.

DELgEDPICE(sy;  are attached immediately behind this page.

  BPCEtSi      REASON FOR THE DELETION                          FIFRA REFERENCE

   33-41       Description of product manufacturing process      S10(d)(l)(A)
                                        15

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                          ATTACH"FNT 6.
            SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
   This study meets the requirements for 40 CFR Part 160
      Submitter  •
      Sponsor .
      Study Director 	
Example 2.
  This study does not meet the requirements of 4C CFR
  Part 160,  and differs in the following ways:
  1.
  2.
  3.
     Submitter
     Sponsor
     Study Director
Example 3.
   The submitter of this study was neither the sponsor of this
   study nor conducted it, and does not know whether it has
   been conducted in accordance with 40 CFR Part 160*
     Submitter     	     	
                               16

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                        ATTACHMENT 7.
                FORMAT OP THE SUBMITTAL PACKAGE
LEGEND
                  Transmittal Document.
                      Related Administrative Materials
                      (e.g.. Method of Support Statement, etc.)
                            Other materials about the submittal
                            (e.g., summaries of groups of studies
                            to aid in their review).
                                   Studies, submitted as unique
                                   physical entities, according
                                   to the format below.
                  FORMAT OF SUBMITTED STUDIES
Study title page.

    Statement of Confidentiality Claims.

        GLP and flagging* statements - as appropriate.

             Body of the study, with English
             language translation if required.

                 Appendices to the study.

           	      Title Page of the Confidential
               ' ...    Attachment.

           , — -*""• i       Confidential Attachment.
                   I •""
                ^.J	i       Supplemental Statement
             x-""       I . 	  of Confidentiality Claims.
           -n
             I     *•"     * When flagging requirements
             u. •"•"'          are finalized.
            L--T
                Documents which must be submitted as
                appropriate to meet established requirements.

                     Documents submitted at submitter's option.

                             17

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               ATTACHMENT D

EPA GROUPING OF END-USE PRODUCTS FOR MEETING
    DATA REQUIREMENTS FOR REREGISTRATION

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EEA'S nprrngTCM NOT TO BATCH END-QSE PPnni*i«g CONTAINING CI'IKIC ACID FOR HJKHJUEU
OF MEETING ACOTE TOXICITY DATA REOJDIEEMEtnS PCR
      In an effort to reduce the tine, resources and number of animals nocdod to
 fulfill  the acute  tenacity data requirements for reregistration of end-use
 products containing the active ingredient citric acid, the Agency considered
 batching end-rose products.  This process involves grouping similar products  for
 purposes of acute tcodcity.  Factors considered in the sorting process include
 each product's active and inert ingredients (identity,  percent composition  and
 biological  activity), type  of formulation  (e.g., emulsifiable  concentrate,
 aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word,  use
 classification, precautionary labeling, etc.).

      However, batching of end-use  products containing citric  acid was  not
 possible after considering the available information described above. Table I
 lists all  the end-use products containing citric acid.   These products were
 either considered not to be similar for purposes of acute tcodcity or the Agency
 lacked sufficient information for decision making purposes. Registrants of these
 products are responsible for meeting the acute tcodcity  data requirements  for
 each product.

      Registrants must generate all the required acute tcodcological studies for
 each  of their products.   If  a  registrant  chooses to  rely upon  previously
 submitted acute tcodcity data,  he/she may do so provided that the data base is
 complete and valid by today's standards (see acceptance criteria attached).

     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 Dd Notice contains two response forms which are to be
 completed and submitted to the Agency within 90 days of receipt. The first form,
 "Data  Can-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 tcodcity tests.  A registrant must
 select one of the following options: Developing Data (Option 1),  Submitting an
Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6).  Since the  end-use  products containing citric acid
could not be batched, registrants cannot choose from the remaining options: Cost
sharing (Option 2) or Offers to Cost Share (Option 3).

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Table I.  End-Use Products Containing citric Acid
EPA REG. NO.
1677-90
1677-100
56M-4
X of Cftrfc Acid ft Other Active Ingredients
20.0X - Citric Acid
22.5X - Phosphoric Acid
2.0X - Oecanoic Acid
6.0X - Octanoic Acid
4.6X - Citric Acid
16.4X - Phosphoric Acid
1.0X • Citric Acid
8.SX - Phosphoric Acid
5.0X - SutfMic Acid
3.0X - Oxalic Acid
1.0X - Gluconic Acid
1.2X - Sodium Xylene sulphonatt
Formulation Type
Liquid
Liquid
Liquid

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     ATTACHMENT E




EPA ACCEPTANCE CRITERIA

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                          SUBDIVISION D
Guideline              Study Title

Series 61      Product Identity and Composition
Series 62      Analysis and Certification of Product Ingredients
Series 63      Physical and Chemical Characteristics

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               61 Product Identity and Composition


                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	 Name of technical material tested (include product name and
      trade name, if appropriate)
2.	 Name,  nominal concentration, and certified limits (upper and
      lower) for each active ingredient and each intentionally-
      added inert ingredient
3.	 Name and upper certified limit for each impurity or each
      group of impurities present at > 0.1% by weight and for
      certain toxicologically significant impurities (e.g.,
      dioxins, nitrosamines) present at <0.1%
4.	 Purpose of each active ingredient and each intentionally-
      added inert
5.	 Chemical name from Chemical Abstracts index of Nomenclature
      and Chemical Abstracts Service (CAS)  Registry Number for each
      active ingredient and, if available, for each intentionally-
      added inert
6.	 Molecular, structural, and empirical formulas, molecular
      weight or weight range, and any company assigned experimental
      or internal code numbers for each active ingredient
7.	 Description of each beginning material in the manufacturing
      process
      	 EPA Registration Number if registered; for other
           beginning materials,  the following:
      	 Name and address of manufacturer or supplier
      	 Brand name,  trade name or commercial designation
      	 Technical specifications or data sheets by which
           manufacturer or supplier describes composition,
           properties or toxicity
8.	 Description of manufacturing process
      	 Statement of whether batch or continuous process
      	 Relative amounts of beginning materials and order in
           which they are added
    i  	 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

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8. (continued)

      	 Flow chart with chemical equations for each intended
           chemical reaction
      	 Duration of each step of process
      	 Description of purification procedures
        "   Description of measures taken to assure quality of final
           product

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

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               61 Product Identity and Composition


               GUIDANCE  FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient  being reregistered.   Items  1,  2,  3,  and  5 can  be
satisfied  for most  registered  products by submission  of  the
Certified Statement of Formula  Ingredients Page  (EPA Form 8570-4).
Items 7  and 8 can be  satisfied  for most technical  grade active
ingredients  (TGAIs) by submission of a flow  chart  with chemical
equations  for  each intended chemical  reaction.   The  flow  chart
should include  complete chemical structures  and names  for  each
reactant and product of all the reactions.


1. Name of technical material (include product name and trade name,
   if appropriate).
2. Description of each active and intentionally-added inert
   ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
   those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
   ingredient.
5. Chemical name and Registry Number for each active and
   intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
   and any experimental or internal code number for each active
   ingredient.
7. Description of each beginning material in the manufacturing
   process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
   chemical theory.

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       62 Analysis and  Certification of Product Ingredients
                       ACCEPTANCE CRITERIA

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

Does your study meet the following acceptance criteria?

 1.	 Five or more representative samples (batches in case of
       batch process) analyzed for each active ingredient and all
       impurities present at > 0.1%
 2.	 Degree of accountability or closure > ca 98%
 3.	 Analyses conducted for certain trace toxic impurities at
       lower than 0.1% (examples, nitrosamines in the case of
       products containing dinitroanilines or containing secondary
       or tertiary amines/alkanolamines plus nitrites;
       polyhalogenated dibenzodioxins and dibenzofurans)  [Note
       that in the case of nitrosamines both fresh and stored
       samples must be analyzed.]
 4.	Complete and detailed description of each step in analytical
       method used to analyze above samples
 5.	 Statement of precision and accuracy of analytical method
       used to analyze above samples
 6.	 Identities and quantities (including mean and standard
       deviation) provided for each analyzed ingredient
 7.	 Upper and lower certified limits proposed for each active
       ingredient and intentionally added inert along with
       explanation of how the limits were determined
 8.	 Upper certified limit proposed for each impurity present at
       > 0.1% and for certain toxicologically 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._J	Analytical methods (as  discussed in #9) to verify certified
       limits validated as to their precision and accuracy

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       62 Analysis  and  Certification of Product Ingredients


                 GUIDANCE  FOR SUMMARIZING STUDIES


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


 1. Number of representative samples analyzed for all active
    ingredients and all impurities at > 0.1%.

 2. Degree of accountability or closure in analyses in item #1.

 3. Chemical names of toxic impurities which were analyzed for
    levels <0.1%.

 4. Brief description(s) of analytical method(s)  used to measure
    active ingredients and impurities in items #1 and #3.

 5. Statement of precision and accuracy of method(s) in item #4.

 6. Chemical name and quantities observed (range,  mean, standard
    deviation) for each ingredient (actives and impurities)
    analyzed in item #1.

 7. Proposed upper and lower certified limits for each active
    ingredient and  intentionally added inert with brief explanation
    of how limits were determined.

 8. Proposed upper certified limit for each impurity present at
    >=0.1% and certain toxicologically significant impurities at
    <0.1% with brief explanation of how limits were determined.

 9. Brief description of analytical method(s) used to verify
    certified limits (if same methods as item #4,  may reference
    latter).

10. Statement of precision and accuracy of method(s) in item #9
    (may reference item #5 if applicable).

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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 C8
     	 Any observed decomposition reported

63-6 Boiling Point
     	 Reported in Ce
     	 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/ft  or
         Ibs/gallon.]

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

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

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

63-11 Octanol/water Partition Coefficient
     	 Measured at about 20-25" C
     	 Experimentally determined and description of procedure
         provided (preferred method-45 Fed. Register 77350)
     	 Data supporting reported value provided

63-12 pH
     	 Measured at about 20 - 25° C
     	 Measured following dilution or dispersion in distilled
         water

63-13 Stability
     	 Sensitivity to metal ions and metal determined
     	 Stability at normal and elevated temperatures
     	 Sensitivity to sunlight determined

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             63 Physical and Chemical Characteristics


                GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.


 1. Description of color.
 2. Description of physical state.
 3. Description of odor.
 4. Indication of melting point (in C°).
 5. Indication of boiling point (in C").
 6. Indication of density, bulk density, and specific gravity.
 7. Indication of solubility.
 8. Indication of vapor pressure.
 9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.

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                          SUBDIVISION F
Guideline              Study Title

  81-1      Acute Oral Toxicity in the Rat
  81-2      Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
  81-3      Acute Inhalation Toxicity in the Rat
  81-4      Primary Eye Irritation in the Rabbit
  81-5      Primary Dermal Irritation Study
  81-6      Dermal Sensitization in the Guinea Pig

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               81-1 Acute Oral Toxicity in the Rat


                      ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	 Identify material tested  (technical, end-use product, etc)
 2.	 At least 5 young adult rats/sex/group
 3.	 Dosing, single oral may be administered over 24 hrs.
 4.*,	 Vehicle control if other than water.
 5.	 Doses tested, sufficient to determine a toxicity category
        or a limit dose (5000 mg/kg).
 6.	 Individual observations at least once a day.
 7.	 Observation period to last at least 14 days, or until all
        test animals appear normal whichever is longer.
 8.	 Individual daily observations.
 9.	 Individual body weights.
10.	 Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.

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              81-1 Acute Oral Toxicity in the Rat


               GUIDANCE  FOR  SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
   AI in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
   least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria

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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 a * are supplemental and may not be required
for every study.

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


                GUIDANCE FOR SUMMARIZING STUDIES
 1. The form of pesticide tested, e.g.,  solid,  liquid,  percent AI
    in technical, end-use product, etc.
 2. The number of animals/sex/dose
 3. Weight range of animals
 4. Verification of single, dermal exposure
 5. Duration of dermal exposure
 6. Statement of vehicle control
 7. Doses tested and results
 8. Preparation of application site
 9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual observations on day of dosing and for at
    least 14 days or until  all animals appear normal (whichever is
    longer).
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria

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            81-3 Acute Inhalation Toxicity in the Rat


                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	 Identify material tested  (technical, end-use product, etc)
 2.	 Product is a gas, a solid which may produce a significant
        vapor hazard based on toxicity and expected use or contains
        particles of inhalable size for man (aerodynamic diameter
        15 urn or less).
 3.	 At least 5 young adult rats/sex/group
 4.	 Dosing, at least 4 hours by inhalation.
 5.	 Chamber air flow dynamic,  at least 10 air changes/hour, at
        least 19% oxygen content.
 6.	 Chamber temperature, 22°  C (±2), relative humidity 40-60%.
 7.	 Monitor rate of air flow
 8.	Monitor actual concentrations of test material in breathing
        zone.
 9.	 Monitor aerodynamic particle size for aerosols.
10.	 Doses tested, sufficient to determine a toxicity category
        or a limit dose (5 mg/L actual concentration of respirable
        substance).
11.	 Individual observations at least once a day.
12.	 Observation period to last at least 14 days.
13.	 Individual body weights.
14.	 Gross necropsy on all animals.

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           81-3 Acute Inhalation Toxicity in the Rat


                GUIDANCE  FOR SUMMARIZING STUDIES
 1. The form of pesticide tested, e.g., solid, liquid,  percent AI
    in technical, end-use product, etc.
 2. Statement of the inhalability of test substance
 3. The number of animals/sex/dose
 4. Duration of inhalation exposure
 5. Number of chamber air changes/hour and the percent oxygen
    content of chamber air
 6. Ranges for chamber air temperature and relative humidity
 7. Air flow rate
 8. Analytical concentrations of test material in breathing zone
 9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
    days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria

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            81-4 Primary Eye Irritation in the Rabbit


                       ACCEPTANCE CRITERIA



Does your study meet the following acceptance criteria?

 1.	 Identify material tested (technical, end-use product, etc)
 2.	 Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of < 2 or > 11.5.
 3.	 6 adult rabbits
 4.	 Dosing, instillation into the conjunctival sac of one eye
        per animal.
 5.	 Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if
        a solid, paste or particulate substance.
 6.	 Solid or granular test material ground to a fine dust.
 7.	 Eyes not washed for at least 24 hours.
 8.	 Eyes examined and graded for irritation before dosing and
        at 1, 24,  48 and 72 hr, then daily until  eyes are normal or
        21 days (whichever is shorter).
 9.*,	 individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.

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           81-4  Primary Eye Irritation in the Rabbit


                GUIDANCE FOR SUMMARIZING STUDIES
 1. The form of pesticide tested,  e.g.,  solid,  liquid,  percent AI
    in technical, end-use product, etc.
 2. State if material  is corrosive, cause severe dermal irritation
    or has a pH of <2  or >11.5
 3. Number of adult rabbits tested
 4. State method of dosing, i.e.,  instillation into the
    conjunctival sac of one eye per animal
 5. Dose administered
 6. Note whether solid or granular test material has been ground to
    a fine dust
 7. State whether eyes were washed and at what time post
    instillation (not less than 24 hours)
 8. State whether eyes were examined and graded for irritation
    before dosing and at what periods after dosing
 9. Individual daily observations afterwards, until eyes are normal
    or for 21 days
10. Significance of changes from Acceptance Criteria

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               81-5  Primary  Dermal  Irritation Study


                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc)
 2.	 Study not required if material is corrosive or has a
         pH of <2 or > 11.5.
 3.	 6 adult animals.
 4.	 Dosing, single dermal.
 5.	 Dosing duration 4 hours.
 6.	Application site shaved or clipped at least 24 hours prior
         to dosing
 7.	 Application site approximately 6 cm.
 8.	Application site covered with  a gauze patch held in place
         with nonirritating tape
 9.	 Material removed,  washed with water,  without trauma to
         application site
10.	Application site examined  and  graded for irritation at 1,
         24, 48 and 72 hr,  then daily until normal or 14 days
         (whichever is shorter).
11.*	 Individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.

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               81-5  Primary Dermal Irritation Study


                GUIDANCE FOR SUMMARIZING STUDIES
 1. The form of pesticide tested, e.g.,  solid,  liquid,  percent AI
    in technical, end-use product, etc.
 2. State if material is corrosive, has a pH <2 or >11.5, or has a
    dermal LD 50 <200 mg/kg
 3. Number of adult animals tested
 4. Amount applied
 5. Duration of dermal exposure
 6. Preparation of application site (shaved or clipped at specified
    time before dosing)
 7. Area of application site
 8. Method for occlusion of application  site
 9. Note removal of test material and if skin was washed with water
10. State times post application when site was  graded for
    irritation
11. Individual observations for day of dosing and individual
    daily observations thereafter
12. Significance of changes from Acceptance Criteria.

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           81-6  Dermal Sensitization  in the Guinea Pig


                       ACCEPTANCE CRITERIA


dose 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 epicutaneous test
       	 Mauer optimization test
       	 Footpad technique in guinea pig
4.	 Complete description of test
5.*	 Reference for test.
6.	 Test followed essentially as described in reference
       document.
7.	 Positive control included (may provide historical data
       conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required
for every study.

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           81-6  Dermal Sensitization in the Guinea Pig


                GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g.,  solid,  liquid,  percent AI
   in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
   the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria

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                    ATTACHMENT F




LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

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                              United  States Environmental Protection Agency
                                          Washington, D.  C. 20460
                        -LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
                              Case  #  and Name:  4024  Citric acid, and salts
                                                                                                   Page  1  of
Co. Nr.   Company Name
                         Additional  Name
Address
City  &  State
Zip
001677
005664
ECOLAB INC.
CANTOL INC
370 UABASHA ST. ECOLAB CENTER
2211 N AMERICAN STREET
 ST PAUL MN
 PHILADELPHIA PA
55102
19133

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             ATTACHMENT G




COST SHARE AND DATA COMPENSATION FORMS

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    r/EPA
United States  Environmental  Protection Agency
            Washington,  DC  20460
   CERTIFICATION  WITH  RESPECT TO
 DATA  COMPENSATION  REQUIREMENTS
Form Approved

OUB No.  2070-0106

Approval  Eiplre* 12.11-92
 Public reporting burden tor this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106). Washington, DC 20503.

 Please fill In blanks below.
Company Nam*
Product Name

EPA Reg. No.
I Certify that:

1.   For each study cited in support of registration or reregistratfon under the Federal Insecticide, Fungicide and
    Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
    written permission of the original data submitter to cite that study.

2.   That for each study cited in support of registration or ^registration under FIFRA that is NOT an exclusive use
    study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
    have notified in writing the company(ies) that submitted data I have cited and have offered to:  (a)  Pay
    compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
    negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
    compensation due, if any.  The companies I have notified are:
    [ I  The companies who have submitted the studies listed on the back of this form or attached
        sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,"

3.  That I have previously complied with section 3(c)(1)(D) of FIFRA for the studies I have cited in support of
    registration or ^registration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or ^registration of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D).
I Signature
Date
Name and Title (Pleaae Type or Print)
EPA Form 1570-31 (4-90)

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

OMB No. 2070-0106

Approval E*plre* 12.31-92
 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

 Please fill In blank* btlow.
  Company Nam*
 Product Name
                                                 EPA Reg.  No.
 I Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary.  However, my company would prefer to
 e.iter into an agreement with one or more registrants to develop jointly or share in the cost of developing
 data.

 My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
 offer to be bound  by arbitration decision under section  3(c)(2)(B)(iii) of FIFRA if final agreement on  all
 terms could not be reached otherwise.  This offer was made to the following firm(s) on the following
 date(s):
  Nama of Firm(a)
                                                  Data of Offar
Certification:
 I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
 this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
 misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Nama and
of Company'a Authorised Representative
Title (Please Type or
Date
Print)
EPA Form 1570-32

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US Environmental Protection Agency Registration Standard for:
Washington, DC 20460
SERA Product Specific
Data Report
Registration
Guideline No.
Sec. 158.120
Product
Chemistry
61-1
61-2 fa^
ei-2fl»)
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
634
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-16
63-19
63-20
63-21
Sec. 158.135
Toxicology
81-1
81-2
81-3
81-4
81-5
814
Name of Test

Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
PH
Stability
Oxidizing/reducing reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage

Acute oral toxicity, rat
Acute dermal toxicity, rabbit /rat /g .pig
Acute inhalation toxicity, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal sensitizatlon
Testing not
required for my
product listed
above
(ChKktHtow)
•
















,
















EPA Registration Number
I am complying with
Data Requirements by •
Citing MR ID No.


































Submitting Data
(Attached)
(CtHCktHtow)


































Form Approved
OMB #2070X057
Expires 11 -30-69
(For EPA Use
Only)
Accession
numbers
• assigned









*
























Certification
I certify that the statements I have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
Typed Name and Title
Signature
Date
EPA Form 5560-4 (Rev. 548} Previous edition is obsolete.

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