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

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REREGISTRATION ELIGIBILITY DOCUMENT

                CITRIC ACID

                    LISTD

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

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           EPA CITRIC ACID REREGETRATION ELIGIBILrrY 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 Reregistrarion 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
GLOSSARY OF TERMS AND ABBREVIATIONS                         iv


EXECUTIVE SUMMARY                                           v


L INTRODUCTION                                              1


H. CASE OVERVIEW                                            2


     A.   CHEMICAL OVERVIEW                                  2


     B.   USE PROFILE


     C.   REGULATORY HISTORY                                 3


HI.  SCIENCE ASSESSMENT OF CITRIC ACID                         3


     A.   PRODUCT CHEMISTRY ASSESSMENT                        4


     B.   ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT        4


IV.  RISK MANAGEMENT AND REREGISTRATTON 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
    ,

          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

        APPENDIX 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

        APPENDDC E - Pesticide Reregistration Handbook                          20

        APPENDDT 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.
                                       f    \  ft
                                      /i^ /^-

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I.      INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to
be completed in nine years.  There are five phases to the reregistration process.  The first
four phases of the process focus on identification of data requirements to support the
reregistration of an active ingredient and the generation and submission of data to fulfill the
requirements.  The fifth phase is a review by the U.S. Environmental Protection Agency
(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 ffl 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: C
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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.
m.
                 ASSTESSMFNT OF rrnac 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 Aspergillus niger
 and Candida lypolytica.  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 REREGISTRATION DECISION FOR CITRIC ACID

A.  Determination of Eligibility

       Section 4(g)(2)(A) of FIFRA 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 REQUIRFn By y^GISTRANTS OF END-USE PRODUCTS

A.    Determination Of Eligibility

      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 Reregistration

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



fttm

FOOD/FEED USES

R.U

Moinwn

UK*
AH*

Mix.*
*«- *
MntlMi

M....I tvrm. •
MuilhM
(thy*

fc*T
Mvvrf
(0^1

OMonrHg
LMttHm
Alovwl

DM-*

UbiUiriMlm


Dairies/Choose Processing Plant Equipment (Food Contact) Use Group(s): Indoor Food
Circulation method. Not on label. Not on label
Surface Type: Hard
Efficacy Influencing Factor: na
Immersion, Not on label, Not on label
Surface Type: Hard
Efficacy Influencing Factor: na
Spray, Not on label. Not on label
Surface Type: Hard
Efficacy Influencing Factor: na
SC/L
SC/L
SC/L
260 ppm by
Vol
260 ppm by
Vol
521 ppm by
Vol
260 ppm by
Vol
26O ppm by
Vol
521 ppm by
Vol
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec.
not spec
not spec
not spec
not spec
not spec



Food Processing Plant Equipment (Food Contact) Use Group(a): Indoor Food
Circulation method, Not on label, Not on label
Surface Type: Hard
Efficacy Influencing Factor: na
Immersion, Not on label. Not on label
Surface Type: Hard
Efficacy Influencing Factor: na
Spray, Not on label. Not on label
Surface Type: Hard
Efficacy Influencing Factor: na
SC/L
SC/L
SC/L
260 ppm by
Vol
260 ppm by
Vol
521 ppm by
Vol
260 ppm by
Vol
260 ppm by
Vol
521 ppm by
Vol
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec










Preclean
claim.
2 minutes
contact time.
Preclean
claim.
2 minutes
contact time.
Praclean
claim.
2 minutes
contact time.

Preclean
claim.
2 minutes
contact time.
Preclean
claim.
2 minutes
contact time.
Preclean
claim.
2 minutes
contact time.

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


Fan,

Rn
NONFOOD/NONFEED USES
Bathroom Premises/Hard Surfaces Use Group(s):
Foam application, Not on label, Foaming apparatus
Surface Typa: Hard
Efficacy Influencing Factor: na
Mirinun

M».«
App..

thx.»
*«-.•
MU.KIM

Mbvhhnd
1-lwnAfv..*
flhrt

B—rict«<
&*T
buntl
lO^i

(hwH.
UiriMim
Mtowtrf

DlMllvwvd

UoUmlMlom

Indoor Residential
SC/L
1 5333 ppm
by Vol
46000 ppm
by Vol
not
spec
not
spec
not spec
not spec


2 minutes
contact time.
Toilet Bowls (Interior Surfaces) Use Group(s) Indoor Residential
Pour-on, Not on label, Brush
Surface Type: Hard
Efficacy Influencing Factor: na
RTU/L
dose cannot
be calculated
dose cannot II not
be calculated II spec
B
not
spec
not spec
not spec



Urinals (Interior Surfaces) Use Group(s): Indoor Residential
Swab, Not on label, Bowl mop
Surface Type: Hard
Efficacy Influencing Factor: na
RTU/L
dose cannot
be calculated
dose cannot
be calculated
not
spec
not
spec
not spec
not spec



Abbreviations used
    Header:      max = maximum; min^minimum; apps = applications; not spec = not specified;
    Form:        RTU/L = ready to use/liquid ; SC/L = soluble concentrate/liquid
    Rate:        ai« active ingredient;  ppm -parts par million; Vol-=volume
       not applicable
10

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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 registration for the
pesticide covered by this Registration 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 (MRED) number, but may be a GS number if no MRID number has been
assigned.  Refer to the Bibliography Appendices for  a complete citation of the study.

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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 in reregistration package.
                                           13

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ECOLOGICAL EFFECTS




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




TOXICOLOGY




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




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 in.




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  reguktory
decisions.
(1) Sax, N. I., and Lewis, R. J. SR, 1989. Dangerous_Prpperties of Industrial Materials. 7th
Edition. Van Nostrand Reinhold, New York.

(2) Clayton, G. D., and Clayton, F. E.t eds., 1982. Party'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 NOTIC1 »l-2                  OfFCSW
                                                         KSTCDES AND TOXIC
                                                           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
 d*£inf? ^  ^°   CF?  "S• «3
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                                 2.


 III.  REQUIREMENTS
     As described below under Unit V. « COMPLIANCE
currently registered products as well
                     proucs as well wucti
 registration must comply with this Notice by specif yinV tee
 concentration  expressed as  a percentage  by ^ w^igh^  L

              n"
                                     and eival.nc.   an
           ad?i;n€ltBental.arSenic'  Mt«"ic zinc, salt  oY an
      .    addition, the requirement for performing sample analyses
 he  rJw  »;!?^ri^**;n!atiV* "Bpl*8 mumt b« ^Ifilled. copies H




iSi^ironli?^1" °f  toxicolo9ic»l .ignificance(i../r  ^S
These liJ^irrt/h/  ClSt.bL,Ca**  basi*  as »P««=ified  by EPA.
xnese J-i»it» are  to  be set based on representative  sa»lina and
chemical analysis ( i. e. , quality control)of th7 product*


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  IV.  PRODUCTS THAT REQUIRE EFFICACY DATA
 V.  COMPLIANCE SCHEDULE
                                SS
 applicants/registrants are expected to comply with the
 requirements of this Notice asfollows:

           (1)   Beginning July if  1991,  all new product
                registrations submitted to the Ag«ncy
                ar« to comply with the r«quir«»«nt« of this
                Notice.

           (2)   Registrants having products subject to
                raregistration under FXFRA section  4 (a) are to
                coaply with the requirements of this MoticI when
                specific  products  are called in by  the Agency
                under Phase V of the Reregistraticm Progra..

           (3)   All  other products/applications that are

               ?S?v*f J?«,t0«.(1)  *"? (21  *bov* wil1 h»v
               July 1, 1997,  to co«ply  with this Notice.
               Such applications  should note "Conversion
               to Nominal  Concentration"  on the application
               5or»; These types  of amendments will not be
               £??? S !*  ^ast TracJe"  »PPlications but
               will be handled  as routine requests.

VI.  FOR flUd'EER ZHFORKATIOM
                                          or
                                 "C<~— *- c .
                                Anne B. 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
CERTIFIEDMAIL
                                                         OFFICE OF
                                                      PESTICIDES AND TOXIC
                                                         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 G;  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).
                                                           Prinad on RfcytiK Ptpff

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instructions
                                                  and seven
                                                        and
       Si «  :"
                                Wlth
                                                  Of  This
            ,    •     notice
       Section IV  - Consequences Of Pailure To Comply with

       Section v   - Registrants' Obligation To Report

       Section VI  - In^iriL ?nHao°nable Adve"e Effects
                     inquiries And Responses To This Notice

       The Attachments to this Notice are:


       B   I
         " ^^A^^nts st^^nc.  -•^Tp^m-
              of  the  subject  active  iS™J  *f suPP°rt continued
concluded that the only addition?  da?*  n^*'   The Agency has
specific data.   NO additional generic ^  "ecessary are product
imposed.  YOU have been sent this Jo?i«  h  ret^lreme«ts  are being
product(s) containing the              '
SECTION II.  DATA P^nr^n By TOTC ^^

I:E-A".  DATA REQTTTPirn
                 c            uen               « •»

                                                                 in

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II-B.  SCHEDULE FOB SUBMISSION OF DATA

     You are required to submit the data or otherwise satisfy the
data requirements specified in Attachment C,  ppqu1remeTfts Status
"* pM?«Vrani-- P-«*me« 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.

   < 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
uslna the OECD protocols, they should be modified as appropriate so-
Si? 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)].

U-D   pEGISTRANTS RECEIVTNG PREVIOUS SECTION 3fcU2*'m NOTICES
        TSSPEP  BY THE AGENCY

        Unless  otherwise  noted  herein, this  pata  Call-in does  not in
anv  wav «™«ygftde  or chancre  the  requirements  of  anv previous  Pata
Call-lnfsl,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 WTTH REQUIREMENTS  OF THIS  NOTICE

 III-A.   peHEPULE FQP 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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                                                  2
  IJI"B-  OPTIONS FOR RESPOfif.iNG To
                                            *""
         '°ne °°Py °f the ^cmirem^l-g status »^ pfl:^^nt.-

               must be submitted for each product listeS  on  the

                       nttt
                                        panyutod
Ss
ss a


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                        "
                                             .o










 Iir"C SATISFYING THE n^Tft pEQUTRRKK^PS OF


 .""-"^rSSSSSsgHt-ss,






                                     within
CD


(2)  I have entered into an agreement with one or more



III  f^Ht^'^^^^^^^tfSS^L
(4)  I am submittina an existing study that has not been
         •^—•- ^M'*4>,^M W^4J.M ^7 W ^4^4 V 1



     (5)  clM.TSSi^18?^  Citing data to uP*rade a study

         ,«   j.    y EPA as Partially acceptable and uporadeable
         (Upgrading a Study)                        "Fy«aeaDj.e



     (6)  acce table9 *" exis^in? studv ***** EPA has classified
    Option l

                           ~ If

                                            o
according to the Pesticide A..«MnuiliJn  (PM)'
confonnance with the requirements of PR Notice Ie-5.  '

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

    If you cannot submit the data/reports to the Agency in the time
required by this Notice and intend to seek additional time to meet
the requirements (s) , you must submit a request to the Agency which
includes: (1) a detailed description of the expected difficulty and
(2) a proposed schedule including alternative dates for meeting
such requirements on a step-by-step basis.  You must explain any
technical or laboratory difficulties and provide documentation from
the laboratory performing the testing.  While EPA is considering
your request, the original deadline remains.  The Agency will
respond to your request in writing.  If EPA does not grant your
request, the original deadline remains.  Normally, extensions can
be requested only in cases of extraordinary testing problems beyond
the expectation or control of the registrant.  Extensions will not
be given in submitting the 90-day responses.  Extensions will not
be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.

     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 wij.1 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 *rho 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_r 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)
    w '[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 data'  may include photographs,
    microfilm or microfiche copies,  computer printouts,  magnetic
    media,  including dictated observations,  and recorded data  from
    automated instruments."  The  term "specimens",  according to 40
    CFR 160.3(k),  means  "any material  derived from  a  test system
    for examination or analysis."

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

    c.  You  must certify that each study fulfills the acceptance
    criteria for the Guideline relevant to the study provided in,Aii_ ^  v^
    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.

-------

                                            no?e ttat not .11
                                                    r
                                                                ;^
    This option should  also be used to cite data th»i- h» =
previously.submitted to upgrade a study? but haS no? ve?
reviewed by the Agency.  YOU must —   •'   -      nOt yet
data submission
upgraded.
protocol compliance with Agency"e^r2ents?  ^ regardln*

-------
                                10

toxicology studies generally will  have been classified as "core-
guideline" or "core minimum.11  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, Certificatiop_jtfj.fch Respegt to Data Compensation
  .-•  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
Reg istrant * 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 Tq 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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                                        this Notice within 9°
              5? S^mit °n the re<3ui«d schedule an acceptable
  proaresrenn™    f V*? ret^ired  schedule  an adequate
  progress report on a study if required by this  Notice?
                                       8chedule
                               action or submit adequate
                              °pti°n chosen to addr*** the data
Dain«  «                  *3 action or information
pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sha?ing of L2L or
the formation of Task Forces,  failure to comply with the ?erms
dLa? a*reement °^ arbitration concerning joint data

            "   UUre
 d                                  enng  on   ata
 waiver      "   UUre t0 C°mply With an? ^enns of a
   nH           •Jb»lt supportable certifications as to the
 p? ?hii JJStJce      ted Studies<  as "quired by Section IIi-c

                                           «=o.t of developing

 8.  Failure of the registrant to whom you  have tendered an offer
 tL reSLtrant"sC?St °f.devel°Ping da^a and  P^vidld proSf of
 me- registrant's  receipt of such  offer either to:

  a.  Inform EPA of intent to develop and submit the  data

                                                          and a

                              develop and submit the data
                              Steps to meet the requirements
                     , unless you commit to submit and do
submit the required data in the specified time frame?

9.  Failure to take any required or appropriate steos  not
mentioned above, at any time following^! Issuancfof ?Sis

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

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                                   13
 all Agency requirements,  you will  have,  under most circumstances

    enr £SrS%dat«  y°Ur  9°  day «sP°"se to Sis NoSSe is Iu4,
   sell, distribute,  or use  existing  stocks.   Normally,  the Agencv

             r                                                    *
                                                        ,

                re?fi!^Cr t5"1 ?* «*istrant •««* as indepndent
                retailers and end users to sell, distribute or us*
  such existing stocks until the stocks are exhausted!  Any sale
  distribution or use of stocks of voluntarily cancelled product^
  containing an active ingredient for which the Agency has particular
  risk concerns will be determined on a case-by-clse basil.


      Requests for voluntary cancellation received after the so d»v
  response period required by .this Notice wil? no? JSSt in      *
                            .                                 e
exJsSnH?^ ^ additionaj- time to sell, distribute, or uL
existing stocks beyond a year from the date the 90 day response was
due  ns you demonstrate to the Agency that you are in full
                                                you are  n full




 to iSSlilh'thii ?™9^SS Hep0rtS and °ther  information necessary
 ^o establish that you have been conducting the study  in an
 acceptable and good faith manner must havl been submitted to  the

 pr"ov?s"ion?                                                    ^
 SECTION V.  REGISTRANTS' OBLTr.ATTQN TO RFPQRT PQ5.gTBT.T-
             UNREASONABLE APVBP.qE EFFECT.?      rW*!"^

     Registrants are reminded that FIFRA section 6(a)f2) states thai-
 if at any time after a pesticide is registered a rJiirtrlnt Sa
 additional factual information regarding unreasonable adverse
 effects on the environment by the pesticide, the registrant s
 submit the information to the Agency.   Registrants

           a
                                         effects onman or the

                                continues as long as toe products
SECTION VI.  INQUIRIES AND RESPQKggs TO THTfi


    If you have any questions regarding the reouirements
procedures established by this Notice, call Se^cSSSSt
listed in Attachment A, the Data Call !Tn
                                                                 :
chosen, only the Pata Call-Tn RefinQng
-------
                          14
Th® Offic® of Compliance Monitoring
                                        of the
                      Sincerely yours.
                     .Daniel M. Barolo, Director
                      Special Review and
                        Reregistration Division

                 Attachments

                        Status fiftgo*-
                                                Form
  - Data Call-Tn
~ Data Call-in Resprmea
- Requirements status and
                                    or Meeting Acute
      '^^^^^^^^^^^^^—^^^^^^^^
  EPA Acceptance
       of Registrants
  Specific  Data  Report

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 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 NQTTCE

       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

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      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

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                   ATTACHMENT B

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

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

                      Product specific 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."

     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.

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     62  Analysis and certification of Product Ingredients


               GUIDANCE FOR SUMMARIZING STUDIES
2  Degree of accountability or closure in analyses in It. 11.

3. Chemical names of tcxic impurities which vere analyzed for
   levels <0.1%.
*•
                                       of method (.)  in  item  14.
5
   Statement  of precision and accuracy
    analyzed in item #1


    of how limits were determined.
 .. Proposed -PP« certified limit for
                                        lmits were determined
    ferlfffelTim^ ,!f
    latter) .

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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?




"" - bb^=*^^^                         -
         Munsell color system
 63-3 ^'i^^^oa 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
        luch  as  "garlic-like, characteristic of aromatic

        compounds"
     	 Observed at  room temperature


63-5 Melting Point
        Reported in  C'
     	 Any observed decomposition repprted


63-6 Boiling Point

     — PrltSure iSder which B.P. measured reported
     	 Any observed decomposition reported

63-7 Density,  Bulk Density,  Specific  Gravity





         registered  products may be reported in Ibs/ft  or

         Ibs/gallon.]

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63-8 Solubility       Hi stilled water and representative polar and
     — SS^£^. S£SS5, those'used i" «*«**«**
         2nd analytical methods for the pesticide

     —          £ S/SS SHo^er units li*e PP» acceptable if
         sparingly soluble)
63-9 Vapor Pressure

     — £asuredents2Lde
         low to measure at 25" C)
                                          by extrapolation from
                                                 if pressure too
                                           conventional units
 63-10  Dissociation Constant
          Experimental  method  described         ,creferablY
     - Temperature of measurement specified {preferably
          about 20 - 25' C)

 63-11  octanol/water Partition Coefficient
 ""12^          folfoSin/dilutfon'or dispersion in distilled

          water

 63—13 Stability                .       - metal determined
      — ISSililfat'norSaf andnelevated temperatures
      	 Sensitivity  to  sunlight determined

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            63 Physical and Chemical characteristics



                GUIDANCE FOR SUMMARIZING STUDIES


Ihe fouowin, criteria.apply to «- technical ^e of the active
ingredient being reregistered.


 1. Description of color.
 2  Description of physical state.

                          point  (in
                ol      nP^x   S.; «- sP-i«o Cavity.
     nc
  7*  indication of  solubility.
  8'  indication of  vapor pressure

 ji  SSSSS of  SSSS^S-
 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?

        Identify material tested  (technical, end-use product, etc)
        At least 5 young adult rats/sex/group
        Dosing, single oral may be administered over 24 hrs.

        Josef SJSST^iSE to^etermlne a toxicity category
        or a limit dose  (5000 mg/kg).
        Individual observations at least once a day.
        observation period to last at least 14 days, or until all
        test animals appear normal whichever is longer.
        individual daily observations.
        individual body weights.
        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


!  The form of pesticide tested,  e.g.  solid,  liquid,  percent
   S in technical, end-use product,  etc.
2  The number of animals/dose/sex tested.
3'. Dosing route and regimen.
4. vehicle used
   least 14 days.           ,
7  summarization of body weights
        r?f£S.nS. Acceptance crite.i,

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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?
 "IB	xdentify material tested (technical, end-use product, etc)

         At Iea^_^0^nimal%bbit2r2^0-3.0 kg or guinea pigs 350-
         450 gm.
         Dosing, single dermal.
         Dosing  duration *t_least ^hours.^ vehicle  is  unknown.
                                  to determine a toxicity  category

                                     'shaved at  least  24 hours
      of body surface area.
wii:n <* porous nonirritating cover
and to prevent ingestion.
   _   1  _ ^_ _ _ r* ft ^ \T
          individual observations at least once a day
          observation period  to  last at leasr x*
          Individual body weights.
          cross 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
                                           surface)
iS".  occluslon'of test material on plication site
    longer).                 .
12  summarization of body weights
13. Summarization of gross necropsy         criteria
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?
 ,.__ Identify material                 y
 2.     Product is a gas, a solict wnicn » *  v             contains
     ~
           l^ast  5ng  adult  rats/sex/group
 3.	
 4.	

   *      least 19%  oxygen content.^     ^ relative humidity 40-60%.


 f:EE £SS Hell°fconie'n"»tions of test .nateria! in

 9.	 Honiior *««Jym^c^arti£ed£^or a^oKc^y category
 10.	 Doses teste , su  1     ar.-i-.nal concentration of respirable
         substance).         .
 11      Individual observations at
 12"	 observation period to last
 ,,*	 individual body weights.
 £4'	 cross necropsy on all animals.

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          81-3 Acute Inhalation Toxicity  in the Rat


                GUIDANCE FOR SUMMARIZING STUDIES


 !.  The  form.ofpesticide tested^e.g.,  solid,  liquid, percent AI

               f '4-1-1  i ntiaTability of test substance
 3*  The  number of animals/sex/dose
 ^  SuSer0of0chaSeraaiirncnSges"our and the percent oxygen

       ' "'for SaSer air teuperature and relative humidity
 9'. Results of ;f *°s°l P?rtic^e-size determina i^ attainable)

i?; ?nd!viduaieobservat!onsaoneday of'dosing and for at least  14

      Jf      .  •	_.C \^n/l*T tJOTrttl^S
 12. sSSarization  of body weights

                            -
 13.
"14,

-------
            81-4 Primary Eye Irritation in the Rabbit

                       ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?
6.
7.
8,
 *'	 de^alTrr™9at"oroVhaV7*pH of < 2 or >
 34;— Dosln" Instiuation into the conjunotival sac of one eye
                     if a liquid; 0.1 ml or not more than 100 ing  if
          0r

         21 days (whichever is shorter).
         individual daily observations.
  Criteria marked with a * are supplemental and may not be required
  for every study.

-------
          81-4  Primary Eye Irritation in the Rabbit




                GUIDANCE FOR SUMMARIZING STUDIES




1  The form of pesticide  tested,  e.g.,  solid, liquid, percent AI


   State^Steriaf'is^ttosive, cause severe dermal irritation

   or has a pH of <2  or >11.5

3. Number of adult rabbits ^sted

4  state method  of dosing, i.e.,  me»L.j.xo.«»*.j.*'»

   conjunctival  sac of one eye per animal


I'. NO!! wh^therStseoUdd or granular test material has been ground to



7. statfwSether eyes were washed andrt what time  post

    1 TISt 1_L 13. w lOll lIiOwi*>»^                   _3J^.P-*^-i -r*>* T 4~ S»^ T OTl
   State  whether eyes were examined and graded  for  irritation






10.  significance^ changes from Acceptance Criteria

-------
               81-5 Primary Dermal Irritation Study





                        ACCEPTANCE CRITERIA





Does your study *eet the following acceptance criteria?
 11.*
 1.


          pH of <2 or > ll.a.

 3        6 adult animals.

 4J	!  Dosing, single dermal.
  5*Dosing duration 4 hours.         ,  t least 24 hours prior
   —^^^~^^^~~     »   _»_ *     ^ •^ ^x ^^A f^UQfi ^!!L ^3 I 1 |J kJ tsti ci ** •*• *^**' "^
 7>	 Application site aPProxP^£ a gauze patch held in place




 T" SSrSSSFwasned with water, without  trauma to


                 :ion site              «,-Arted for irritation at 1,
             .	j	^-i^-o ova-mined and graaea iot xj.j-->-v-_   ^	

10.
                      7a.i
           {whichever is shorter).
           individual daily observations.
   criteria marKed with a  *  are supplemental and may not be retired


   for every study.

-------
              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

 I!  P^paraTion  ^SilSSS^lt. (shaved or dipped at specified
    time before  dosing)
 7.  Area of application site
 8  Method for occlusion of application site
 I'  Note removal of test material and if skin was washed with water
10'.  State times  post application when site  was graded for

11.  individual observations for day of dosing and individual
    daily observations thereafter
12.  Significance of changes from Acceptance Criteria.

-------
          81-6 Dermal Sensitization in the Guinea Pig


                       ACCEPTANCE CRITERIA


dose your study meet the following acceptance criteria?

1      Identify material tested (technical, endTuse Product, etc)
l'-_	 stuSy not required if material is corrosive or has a

3      one°of~therfollowing 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
 4p	 complete  description of test

 IS'-— ?:£rSSo£5 essentially  as described in reference
6.	 -
       document.
        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.

-------
          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
I'. Note" aSnerence 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

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

                    Case  i  and Name: 4024   Citric acid, and  salts
                          Additional Name
ECOLAB INC.
CANTOL INC
370 UABASHA ST. ECOLAB CENTER
2211 N AMERICAN STREET
                                                                       ST PAUL UN
                                                                       PHILADELPHIA PA
55102
19133

-------
             ATTACHMENT G




COST SHARE AND DATA COMPENSATION FORMS

-------
                          United States  Environmental Protection  Agency
                                      Washington, DC  20460
   .WrtfCP/V     CERTIFICATION  WITH  RESPECT TO
   ^^^^^^^f ^K   ^1  ^^^^^^^fc     ~~                      — - -  	— •^ - • »^» ^ • • ** *• •
                                                                              Form Approved


                                                                              OMB No. 2070-0106


                                                                              Approval  Eiplroi 12-31-92
                          DATA  COMPENSATION  REQUIREMENTS

Public reporting burden for this collection of information is estimated to average 15 minutes P^6?^^'
time to reviewSxi instructions, searching existing data sources, gathering and mamta.n.ng the data needed, and
                         collection of information. Send comments regarding the burden est.mate or any other
                                              .
                       intern-Bon, Mud* suggestions for reducing this bu,rden- to Chief
                                                                                      n   o the
  sp                              ,                                    ,
Branch PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC
ofSgemert l  and Budget. Paperwork Reduction Project (2070-0106). Wash,ngton. DC 20503
 Please (III In blanks  below.

 Company  Nam*
                                                                          EPA  Reg.
 Product  Name
I Certify that:

1   For each study cited in support of registration or reregistration under the Federal Insecticide. Fungicide and
 '  R^emicide Abt (FlFRA) thaYis an exclusive use study, I am the original data submrtter, or I have obtamed the
   written permission of the original data submitter to cite that study.
    negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount ot
    compensation due, if any.  The companies I have notified are:
    [ ]  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)(D(D) of FIFRA for the stydies I have cHed in support of

    registration or reregistration under FIFRA.	^__
  	•	'           "          ~~   ~              I Oil*
   Slgnitur*



  Nam* «nd Tltlo (Plus* Typo or Print)
  GENERAL OFFER TO PAY: ! hereby offer and agree to pay compensation to other persons with regard to the
              reregistration of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(cH2}(D).
                                                                            D»t*
  Signttur*
   Ntmi ind T1U» (PU«* Typo or Print)




   .^M.^•»*—^^•^P-B—^«—
                 '

  EPA Form 8570-51  (4*00)

-------
   ?/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 Expires 12-31-92
Public reporting burden for this collection of information Is estimated to average 15 minutes per response, including
time tor 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, lo Chief, Information Policy
Branch PM-223, U.S. Environmental Protection Agency, 401 M St.. S.W., Washington. DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503,
Please fill in blanks below.
 Company Name
 Product Name
                                                                          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 (FtFRA), if necessary. However, my company would prefer to
e.nter into an agreement with one or more registrants to develop jointly or share in the cost  of developing
data.

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

-------
                  ruuiimanutl rroiecitan A
                  Washington, DC20460
V>ERA     Product Specific
                   Data Report
Registration
Guideline No.

                                                       Testing not
                                                     required for my
                                                      product lifted
                                                        above
                                                                     \ em complying with
                                                                    Data Requirements bv
I 634
63-7
634
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
1 63-19
1 63-20
63-21'
Sec. 158.135
Toxicology
81-1
81-2
I 81-3
61-4
81-5
I 81-6
Boiling point
Density, bulk-density, or spec
Solubility
Vapor pressure
Dissociation constant
Octanof /water partition coeffic
PH
Stability
Oxidizing/reducing reaction
Rammability
Explod ability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage

Acute oral toxicity, rat
Acute dermal toxicity, rabbit /]
Acute inhalation toxicity, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal sensitization
                                                                   Citing MR ID No
    Sec. 158.120
      Product
     Chemistry
                 Identity of Ingredients
                 Statement of composition
                 Discussion of formation of ingredients
                 Preliminary analysis
                 Certification of limits
                        methods for enforcement limit*
                                                                              Submitting Data
                                                                                (AflacfceoV
                                                                              (Chtck t>»tow)
                                                                                               Form Approved
                                                                                               OMB #2070-0057
                                                                                               Expires 11-30-89
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  knowinojy SsTor  mfsfeadfna
       statement may be punishable by fine or imprisonment orV^Srap^icableTaw     9
Typed Name and Title
                                    Signature
EPA Form 8580-4 (Rev. 5-B8) Previous edition is obsolete
                                                                              Date

-------
       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.  '  Analytical methods (as discussed in #9)  to verify certified
       limits validated as to their precision and accuracy

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Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name
ECOLAB INC. 4024 Citric acid, and salts
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. EPA Product
Registration
1677-90
5. f 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
Form Approved
OHB No. 2070-0107
Approval Expire* 12-31-92
pn this form.
3. Date and Type of DC1
PRODUCT SPECIFIC
Data
7a. My product is a MUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

8. Certification
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
10. Name of Company Contact

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."

9. Date
11. Phone Number

-------
Page  1 of  1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) if necessary.
1. Company name and Address H. Case # arid Name
ECOLAB INC. 4024 Citric acid, and salts
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.

8. Certification
I certify that the statements made on th
I acknowledge that any knowingly false o
or both under applicable law.
Signature and Title of Company's Authori
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. t agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response.11
N.A.
is form and all attachments are true, accurate, and coqplete.
r misleading statement may be punishable by fine, imprisonment
zed Representative

7. Product Specific
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
Data
7a. «y product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."


10. Name of Company Contact

7b. My product is an EUP and
t agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

9. Date
11. Phone Number

-------
Page  1 of  1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460 OMB NO. 207o-o,or
DATA CALL-IN RESPONSE Approyal Expirc8 ^.^
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 narae and Address 2. Case * and Name 3. Date and Type of DCI
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 claiming 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. Hy product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
\ .

7b. Hy 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 °- 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 H- phone Number

-------
                                                                                                   Page  1 of   1
                              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      ECOLAB INC.                                          370 WABASHA ST. ECOLAB CENTER   ST PAUL MN              55102
005664      CANTOL INC                                          2211 N AMERICAN STREET        PHILADELPHIA PA           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."

Itejn -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 must respond with
          Option 7 (Waiver Request) for each study for which you
          are requesting a waiver.  See Item 6 with regard to
          identical products and data exemptions.

Items 8-11.   Self-explanatory.

NOTE;     You may provide additional information that does not
          fit on this form in a signed letter that accompanies
          this form.  For example, you may wish to report that
          your product has already been transferred to another
          company or that you have already voluntarily 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

-------
                         United  States  Environmental Protection Agency
                                         Washington,  D,  C.  20460
                         REQUIREMENTS STATUS  AND REGISTRANT'S  RESPONSE
                                                                                                 Page   1 of  3

                                                                                             Form Approved

                                                                                             OK8 Bo. 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. 1677-90
                                          3. Date and Type of DCI
                                           PRODUCT  SPECIFIC
                                           ID#  1677-RD-1899
 4. Guideline
 Requi rement
 Number
5. Study Title
progress
Reports
                                                                      6. Use
                                                                      Pattern
                                                                                          7.  Test
                                                                                          Substance
                                        8. Time
                                        Frame
                                                                                                      9. Registrant
                                                                                                      Response
                    Prod Chan - Regular Chemical
61-1
61-2(fa)

62-1

62-3



63-14

63-16
                      Product identity
               i composition{1)
                                     - .:;rria te
                       production 6 fo mutation
                     Discussion of formation of    (1,3)

                     Preliminary analysis        (1,4)
                    pCe^tif.feitf'(Sn'i.oJFii.tJuittia i-^y;^ :Cf^5j
                     Analytical method           (1)
                    iij^j^leii-
                     Density

                     Oxidizing or reducing a tion  (10)
                    ii'Fiattsbt'tltyi:
                     Explodability              (12)
        ABCDEFGHIJKLMNO
                                                                                          EP
                                                                                          EP:.
                                                                                                               8  mos.
ABCDEFGHIJKLMNO

ABCbEFGHIJKLMNC)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNb
                                                                      ABCEFGHIJKLMNb
                                                                      ABCDEFJSHiJKBQIp:
                                                                      ABCbEFGHIJKLMNb
                                                                      ABepEFGHIJKLMiKJ
                                                                      ABcbEFGHIjkLMNO
                                                                      EP
                                                                      EP::;
                                                                      EP
                                                                      |fii
                                                                      EP
                                                                      $
                                                                      EP
                                                                      EP:::
                                                                      EP
                                                                                                                8 mos.

                                                                                                                8 mos.
                                                 ...  ....
                                                  8 mos.
                                                  &;;;;;M^:i;
                                                  8 mos.
                                                 ;8$iM
                                                  8 mos.
                                                 ;&j;:fii6^ii;:;;
                                                  8 mos.
10. Certification
I  certify that the statements mode 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	
                                                                              11. Date
12. Name of Company Contact
                                                                                                  13. Phone Number

-------
                        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
Use additional sheet(s)  if necessary.
                                                  the attached instructions and supply the information requested on this form.
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.  1677-90
                                        3. Date and Type of DCI
                                         PRODUCT SPECIFIC
                                         ID# 1677-RD-1899
4. Guideline
Requirement
Number
                   5. Study Title
Progress
Reports
6. Use
Pattern
                                                                                      7. Test
                                                                                      Substance
8. Time
Frame
9. Registrant
Response
63-18
                   |:i ;3tjara3*; it |W $£ |;t;|; ;jf-^ V:;-: ^: it:16) :•
                     Viscosity                (13)
63-20
                    Corrosion characteristics    (17)
                  ? $$-t%y«£tr! i ic Wea&wi! ?mi$ aSe^^iS); '•.

                                   '•afreaf&lVr:::-:::::':::
        ABCDEFGHIJKLMNO
        ABCDEFGHijKLMNO
        ABCDIFGHIJKLMHO
        ABCbEFGHIJKLMNO
81-2

81-3'

81-5
                    Acute dermal              (1,2,37)


                    Acute inhalation toxicity-rat (3)
                    Primary dermal irritation    (1,2)
                    ••:# BjTwfeserHsi tf za t toft ;• ::^;h\ i.; •;; •; /•( 4) '•'•••; ^; t;
                          ;. /tfiti 'iiilTcrbbii it Aocnts • - '. Publ ic - :
       ABCDEPGHIJKLMNO
       ABCDEFGHIJKLMNO

       ABCDEFGHIJKLMNO
       ABCDEFGHIJKLMNO
       ABCDEFGHIJKLMNO
       ABCDEFGHUKLMNO
                   EP
                   EP
                   EP
                   EP
                   EP
                   EP
                   EP

                   EP
                   EP
                   EP
                   EP
                    Health Uses
  8 mos.
  8 mos.
  8 mos.
  8 mos.
  8
  8 mos.
  8 mos.

  8 mos.
  8 mos,
  8 mos.
  8 wos.
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 fn 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
9X-2
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
Food Preparation and Eatfnfl
Establishments
AQAC germkidal and (1,Z,10)
detergent sanitizer
method

L

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).
L
7. Test
Substance
on this form.
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92

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

EP, ,
8. Time
Frame
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  |  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;
 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     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          L  -  Indoor food                   H - 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 Chen - 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,  158.16Z, and 158.165 for  description of starting materials and manufacturing process (61-2);   *158.167 for
    discussion of formation of impurities  (61-3);  *156.170 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, e 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 emulsiftable  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 Chenicat

 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  #  and  Name:  4024    Citric  acid,  and  salts
Footnotes  (cont.)J


    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/particulate).
 *  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 choUnesterase 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  Generative 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 (OAC) chlorinated trtsodium phosphate, and anionic
    detergent-acid formulations.                                                                            ,

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

                           REQUIREMENTS  STATUS AND  REGISTRANT'S RESPONSE
                                ""'
                                           "*
                                                       ** '""*"" 1'nStructions 9nd S(«*Y the information requested on this form.
                                                                                                                          Page   1 of   3
                                                                                                                       Form Approved

                                                                                                                       OMB Ho. 2070-0107

                                                                                                                       Approval Expires 12-31-92
 1. Company name and Address
   ECOLAB INC.
   370  WABASHA  ST. ECOLAB CENTER
   ST PAUL MN   55102
 4. Guideline
 Requirement
 Number
 6i-i"""":':':':'::
(S1-2 (b)

62-1

62-3


63-7:


63-14

63-16
                     5. Study Title
                     Prod Chew - Regular Chemical
                        production & formulation
                     :';; >•;; -:t mpur.l t j «s.-;:;-.; ? .;•;•;; ?::; ::i;
                      Preliminary analysis
                     :;; Certif jeatl joVi" ^crf ffitft 1
                      Analytical  method
                     .ijPhy&f ca I ::s tatif:; [ /;: •; {;; \ 'A
                      Density


                      Oxidizing  or reducing
                      Explodability
FER
2. Case # and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-100

anical
xnpositiond )
on of (1,3)
(1,4)
1 '$ £'#-7/fT;S )-;.- ::;."
(1)
c ion (10)
(12)
:'^:
• i'j! '.• '

Tr.
0

:;;;;
:;;••;
::•-
Progress
Reports
1
:i:i:i-;;
'.^y-
•:•::•>•
:;.;•:;:•
2
:4;;:;;:':
:: iV:.;'.
,::::>:•;.-.:.
:^K
3
;;|;;|;
'/"•••.::
-,<•<•';.?.
:rJ:;'
6. use
Pattern
ABCbEFGrilJKlMo
ABCDEFGHiJkLMNO
ABCDEFGHiJKLMNO
ABCDEEGHIJKLMNO:
ABCbEFGHIJkLMNO
ABCDEFGHIJKLMNO
ABCDEFGHiJKLMNO
ABCDEFGHIJKLMNO
ABC,DEFGHItrKLMW0
ABCDEFGHUKLMNO
7. Test
Substance
£p --•—---—
E'p •*••< •---• "l--J •
E- :.,,:,. --.-..-,::::,
3P'""" ":':::'":"'"'--':
3P'::::
EP' """!VI>:"
                                                                                                            3. Date and Type of DCI
                                                                                                              PRODUCT SPECIFIC
                                                                                                              ID#  1677-RD-1900
 0. Certification

  certify that the statements made on this form and ell attachments are true, accurate, and complete
  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. Date
                                                                                                                   8. Time
                                                                                                                   Frame
                                                                                                                    8  mos.
 8 mos.
f-;-:^;;?!:.;;: :;i--:':-:::;.;
 8 mos.

 8 mos.

 8 mos.

 8 mos.

 8 mos.
            9. Registrant
            Response
                                                                                                      13. Phone Number

-------
                        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
Use additional sheet(s) if necessary.
                                                      attached instructions and supply the information requested on this form.
1. Company name and Address
  ECOLAB  INC.
  370  WABASHA ST. ECOLAB CENTER
  ST PAUL MN  55102
                                                      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
                                                          1    2    3
 A. Use
 Pattern
 7. Test
 Substance
8. Tine
Frame
9. Registrant
Response
63-18

63-20
81-2

: ' -v.-. •..'::::.'
81-3


81-5
•i Stolfigfl; isjatli i;i-ty:i; 5; >! I ?? 'l\
Viscosity
                                            (133
                     Corrosion characteristics    (17)
                    ?j> if$e;
                   P Xc|itf :$e|i:; tostst tTr-t-itiiv! ::>;:; i;;:; ti*3(Sv3^ii;
                     Acute dermal              (1,2,37)
                   :!:'•;:: :i:j-l^;fc| ^ i^bfef tff at ;| SIB *^ I ^;: g \ ;;-;;•; "& \
                     Acute inhalation toxicity-rat (3)
                   ;:;|: Jl^ffiM^^I i*Hta;li<3^ i^bb^t i (z y i !^x£ i;
                     Primary dermal irritation    (1,2)
ABqpffiF^alJ^LMNp
ABCDEFGHIJKLMNO
ABCJ^FGH|J^LHNQ
ABCbEFGHIjkLMNO
ABCDEFGHIJKLMNO
EP
EP
                   -fef f ii-aW:^ ^An^Tm cridbjat !• Ada-its' ^ Pub lie;
                     Health Uses
                   Medical, Dental. Hortuarv, and
                                                ABCDEFGHIJKLMNO

                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLWO
                    EP

                    EP

                    EP
  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
Requt rement
Nunber
91-2,3
91-2
91-2
the attached instructions and supply the information requested;
2. Case # and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-100
5. Study Title
At i ted EfTvirohmcnts .KH • T- ':. :: ?£i " -: •• '• :- '::. • :: '; ;/- J
AOAC use-dilution method (1,2)
•" ' AOAC f
-------
                                                                                                                                             Page1  of   2
                                          , United  States Environmental  Protection  Agency
                                                             Washington,  D.  C.  20460
                                  FOOTNOTES AND  KEY  DEFINATIONS  FOR GUIDELINE  REQUIREMENTS
                                           Case  #  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;
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      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          L - Indoor food                   K -  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 Chenical

 1  Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed  further in the following sections:  *158,155 for
    product identity ond 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);  M58.175  for certification of limits (62-2); and  *15B.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 end 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.
H  Required if product is an emulsffiable 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 Chemical

 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  |  and  Name:  4024    Citric acid,  and  salts
Footnotes  (cont.)i

   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.r gas, volatile substances, or aerosol/partfculate).
 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
                                            j;
 1 Effiracy data for antimicrobial agents that claim to control pest microorganisms that may pose a threat to human must be submitted.
 1 Cooperative 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 (OAC) chlorinated trisodium phosphate, and anionic
   detergent-acid formulations.

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                                                                                                                    Page   1  of  a
                         United  States  Environmental  Protection Agency
                                         Washington,  D. C.  20460
                         REQUIREMENTS STATUS AND  REGISTRANT'S RESPONSE
                                                                                             Form Approved

                                                                                             OMB Ho. 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)  ff necessary.
 1. Company name and Address
   CANTOL INC
   2211  N AMERICAN STREET
   PHILADELPHIA PA  19133
                                 2. Case # and Name
                                   4024   Citric acid,  and salts

                                   EPA Reg.  NO.  5664-4
                                                                                                      3. Date and Type of OCI
                                                                                                        PRODUCT  SPECIFIC
                                                                                                        ID#  5664-RD-1901
 4. Guideline
 Requi rement
 Number
5. Study Title
                                                             Progress
                                                             Reports
                                                  6. Use
                                                  Pattern
                                                                      7. Test
                                                                      Substance
                    8. Time
                    Frame
           9. Registrant
           Response
61-2(b)

62-i'"V"'::"

62-3

63-7

63-14 :'"

63-16
Prod Chan - Regular Chemical

  Product identity & composition(l)

    production & formulation

  Discussion of formation of   (1,3)
if £f ;:•:•? jiifiiH it t ts; ^;! ?] & [ ;•;
  Preliminary analysis        (1,4)

  Analytical method          (1)

  Density
                                                                     ABCDEFGHIJKLMNO
                                                                     AB^DEFGHiJKLMNO
                                                                     EP
                     Oxidizing or reducing
                                                                     ABCDEFGHIJKLMNO

                                                                     ABCDEFGHiJKLMNO
                                                                     ABCDEFGHIJKLMNO
                                                                     ABCDEFGHtiJKLMNb:
                                                                     ABCDEFGHIJKLMNO
                   ction  (10)
                     Explodability
                                             (12)
                                                 ABCDEFGHIJKLMNO
                                                 ABCDEFGHIiTKLMNO
                                                 ABCDEFGHIJKLMNO
EP:

EP

EP"

EP

EP"
                                                                                                               8 mos.
                                                                                                              liar;
                                                                                           8  mos
                                                                                           8  mos.
8 mos.

8 mos.

8 raos.

8 mos.
10. Certification
I  certify that the statements made on this form and all attachments are true, accurate, and conplete.
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	
                                                                             11. Date
12. Name of Company Contact
                                                                                                 13. Phone Number

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Page  2 of
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S 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
CANTOL INC 4024 Citric acid, and salts PRODUCT SPECIFIC
2211 N AMERICAN STREET ID# 5664-RD-1901
PHILADELPHIA PA 19133 EPA Reg. No. 5664-4
A. Guideline
Requirement
Number
63-18'
63-2 O'"""""""" """"""""""
81-2
81-3" " """ "" ""
:8&r4':} :-:: !:x.i:iilliii:'::
81-5
5. Study Title
^^t^^ij^ltr^-^^^^"1^!^.^^-'^-' ^
Viscosity (13)
•! !; |:; Hi Sx ic s*v Regular Chenf ca t'i;'1: ';". ':• ;:.'::•-.; f; '" '-.• " '•
\ ;;';i.;;,:AciiJtflii srat| jtflji ji,e j:ty*fflt;';: « ;: H^X t '» ^i ^^ I -! :':
Acute dermal (1,2,37)
Acute inhalation toxicity-rat (3)
Primary dermal irritation (1,2)
: £f°f f cacy; •? Anti nicrobi a i Aqer^tig :" ^' ;PtibE i c : •. : :. ; '
Health Uses
Bathroom Surfaces-Premises
si;!;.;; ' M&&. '\i$& y Uiitlbh' • method !.:; i: Ci C 1 ; 2 ) - ' :";: ^ .• ; t: >:^

R
0
•;•;:.

Progress
Reports
1
>: /."'".;!":[

2
i!:::.-:-.;.:

3
: • :: ::-:: :•-•'
'.:•••'•: '!'•:!'
• - -.-.- . >
: ':::.:"•:

6. Use
Pattern
ABCDEHGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHUKLMNO
ABCDEFGHijKLMNO
ABCDEFGHiJKLMNb
ABCDEFGHIJKLMNO
ABCDEF.GHIJ:KLMNO
:^-^':Mm&^MftO

7. Test
Substance
EP"'"""""""""""""" "'""
EP""""""""'""" " """:: :'
T
'- - '.-••*:'•• •'• ••••'••••••• •• ••• •• •• •• ; '•• ;• •• • '•, ••;•••; ;' :; •:• /•'; . •:• . •'•;
-Tp-T^'-.-'' -::-'-:- :•••••:••;••'••- :- ••• ':-••• '••;•: '•-£•• '••'•:':•• ': ;'.
^^::,,,,,,:,,:-,,:1:::::,:,:,,
EP"""""""""""
EP
8. Time
Frame
8 mos.
8 mos.
J ;8::::;mbW;
8 mos.
8 mos.
8 mos.
9. Registrant
Response
^^?.;:*;^f;"r"!
: v.:.'.: •: .'::H:: .:::l- ::- : -.:--.-.: -:'-:: :• :::'::--
IH .;:"•!:•.•:• •.-.'••' .•.-.• -• .;.-:• •:/.:;';...-:•/
^.•i ;'.:. • "'•,•.•:• •. ":-•.. : • ":'.• :i'./.' :> :. ;•
Initial to indicate certification as to information on this page Date
(full text of certification is on page one).

-------
  	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; PA1  = "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        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 AMD  REGISTRANT'S RESPONSE form.]


Prod Che*  - Regular Chonical                    •-

 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  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 fs 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 (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 Chemical

 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  #  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 fn, an inhalable material te.  g., gas,  volatile substances, or aerosol/paniculate).
 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 (n 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 trisodium phosphate and anionic
    detergent-acid formulations.

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               SPECIFIC  INSTRUCTIONS FOR COMPLETING
      TEE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORK

                      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 reregistratlon 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 (l)
 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 fora individually for each data call-
 in addressed to each registrant, and has preprinted this fora
 with  a number  of items.  DO HOT use this form for any other
 active ingredient.

      Items 1 through 8  (inclusive) will have been preprinted on
 the form.  Vou 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
  REGISTRANT'S RESPONSE"  FORM FOR PRODUCT SPBClf 1C DATA
        •»'*•«,
  Ittn 1-3  Completed by EPA.   Note the unique  identifier number
           assigned  by EPA in Item 3.  This number must be used in
           •cne  transmittal  document  for  any data  submissions  in
          Response  to this Data Call-in Notice.

  Itea 4..   The Guideline reference numbers  of studies required to
                          product's  continued   registration  are
                          Thesa «tti<»«lin«»f   in  addition  to  the
                        specified in the Notice, govern the conduct
                  .r*?ui3iftd •*««•••  Note that series 61 and 62 in

                                                   40 CI* 158*155
                                      vith the
 Itea 6.    The use pattern (s)  ef the pesticide  associated vith the
           product specific requirements  is  (are)  identified.  For
           aost product specific data requirements, all use pattern!
           are covered by the data  requirements.   In the ca«™
           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
           SS  S?S*StCtf41C d?ta'v the Produ<=t as formulated for sale
                         °n       *  teSt  substanc«' «xcept in rare
          c«e.
Itea 8.   The due date for submission of each study is identified.
          It is normally based on  8  aontbs  after issuance of thi
          SJf Igisf "tlo» 1l11»ibilit3r Socum.it unless EPA SeteraineJ
          that a longer time period is necessary.          «»."«

Itea 9.   Enter only 'one of the following response codes foreach
          data r.qulg.a.pt to .how hov you  intend to  comgly
          the data  requirements  listed  in  this  table.

                               °Pti0n  *" contain«d ^ the
         I-vill generate and submit data by the specified due date
         (Developing Data) .  By indicating that I have chosen thi!
         option,  I  certify that  I  will  comply  with Tall thJ
         requirements pertaining to the conditions for submittal
         of this study as outlined in the Data Call-in Notic"
                                     cc
         ».quir«.at.» form.   I  ad.tand that «,«***.?,""?*
         av.il.bl. »1,  for .cut.            '

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

3.   I have made offers to share in the cost to develop data
     (Offers to  Cost Share).  I understand that this option
     is available only for acute toxicity or certain efficacy
     data and only if EPA indicates in an attachment to this
     Data Call-in Notice that  ay product is slnilar enough to
     another  product to  qualify  for  this  option.   I  am
     submitting evidence that  I  have Bade  an offer to another
     registrant  (who  has an  obligation to submit  data)  to
     share in the cost of that data.   I am also submitting a
     completed "Certification of Offer  to Cost Share in the
     Development Data"  form.   I aa  including a copy  of  ay
     offer and proof of the other registrant's receipt of that
     offer.   I  am identifying the  party which is  committing
     to submit or provide the required data; it the required
     study is not submitted on time, ay product may be subject
     to  suspension.    I  understand  that  other terms  under
     Option 3  in the  Data Call-in  Notice (Section III-C.l.)
     apply as well.

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

5    By the specified due date,  I will submit  or cite data to
     upgrade  a study classified by the Agency as partially
     acceptable  and upgradable  (Upgrading a Study).'  I will
     submit evidence  of  the Agency's review indicating that
     the  study  may be  upgraded  and  what  information  is
     required to do so.  X will  provide  the MRID or Accession
     number of the ttudy 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.
                           i.
6.   By the'specified due date,  I will cite an existing study
     that  the  Agency has classified  as  acceptable or  an
     existing study that has been submitted but not reviewed
     by the Agency (Citing an Existing Study).  If I am citing

-------
          ! another registrant's study, I understand that this option
          •is available only for acute toxicity or certain efficacy
          data and  only if the cited study  was conducted on my
          product, an identical product or a product which EPA has
          •"grouped" with one or more'other products  for purposes
          of depending on the same data.  I may also choose  this
          ioption if I  am citing my  own  data.  In either case, I
          will provide  the KRID or  Accession number (s)  for the
          cited data on a  "Product Specific Data Report" fora er
          in a similar format.   If  I cite another, registrant's
          data,  I  will submit  a completed  "certification  With
          Respect To Bata Compensation Requirements"  form.

     7.   1  request  a waiver  for . this  study  because  it is
          inappropriate for my  product (Waiver Request).  I am
          attaching a  complete justification  for this  request,
          including technical  reasons,  data and  references to
          relevant EPA regulations, guidelines or policies.  [Note:
          any supplemental data must be submitted in the format
          required by P.R. Notice 86-5],  I understand  that  this
          is my only opportunity to state the reasons or provide
        '  Information in support  of my request.   If the Agency
          approves my waiver request, I will not be required-to
          supply the data pursuant to Section 3(c)(2)(B)  of FIFRA.
          If the Agency denies  my  waiver request,  I must choose a
          method of meeting the data requirements of this Notice
          by the due date  stated by  this Notice.   In  this case, I
          must, within  30  days  of   my  receipt of  the  Agency's
          written decision, submit a*revised  "Requirements Status
          and Registrant's Response"  Form  Indicating the option
          chosen. •  I   also  understand  that  the deadline  for
          submission of data  as specified by the original  data
          call-In notice will hot  change.
                                  •      .               ^
Items 10-13.  Self-explanatory.

          You may provide additional information that does not fit
          on this fora  in  a signed  letter that accompanies  this
          fora.  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  £?A can  ensure  that  its  records are
       *   correct.

-------
    \     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
    /                 WASHINGTON. O.C. 20460

                                                   JUL29I986
                        PR NOTICE 86-5           PMTICIOM A HO TOXIC «UMTAHCM


        NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
                       AND REGISTRANTS

Attention:  Persona 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 Coc-aetic Act (FFDCA).

I.   Purpose

     To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format.  This Notice also
provides additional guidance about, and illustrations of, the
required formats.

II.  Applicability

     This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining pesticide
registrations, experimental use permits, tolerances, and related
approvals under certain provisions of FIFRA and FFDCA.  These
deta are defined in FIFRA SlO(d)d).  This Notice does  not apply
to commercial, financial, or production information, which are,
and must continue to be, submitted differently under separate
cover.

III. Effective Date

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

IV.  Background

     On September  26,  1984, EPA published  proposed  regulations
in the  Federal Register (49 FR 37956) which  include Requirements
for Data  Submission  {40 CFR $158.32), and  Procedures for Claims
of Confidentiality of  Data  (40 CFR 5158.33).   These regulations

-------
      y the format for data submitted to EPA under Section 3 of
 l    and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
- alitj.  NO entitl   -nts  , -lata c .-f ide^iality are cnar^d,
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 Hoti«« 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
Aoril  15,  1986)  that provides for  early  screening  of  certain
 applications  for  registration under FIFRA S3.   The objective  of
 the  screen  is  to  avoid  the  additional costs ™d *     ^Stlon" *
 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  als6 established a public  docket which imposes dead-
 lines for inserting  into the  docket documents submitted in con-
 nection with Special Reviews  and Registration Standards (see
 40 CFR $154.15 and 5155.32).  To meet these deadlines,  OPP is
 requiring an additional copy  of any data submitted to the docket.
 pleasirefer to Page 10 for more inf^mTtion about this requirement.

      For several years, OPP has required that each application for
 registration or olher 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 refinements 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 10  }J«l«J»d
  and clearly  identifiable,  the  form of  the  samples may  be  altered
  to reflect the submitter's preference.

-------
                         - INDEX -
                                                          Text Example
                                                          Page  Page

A. Organization of the Submittal Package	     3    17

B. Transmittal Document	     4    11

C. Individual Studies  	     4

   C.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 PIFRA S10(d}(l)) 	     8    13
   D.3 Confidential Attachment 	     8    15  ,

   D.4 Supplemental Statement of Data Confidentiality
        Claims {other than those based on FIFRA $10(dHl)J  8    14
   D.5 Good Laboratory Practice Compliance Statement .  .     9    16

E. Reference to Previously Submitted Data  	     9

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

G. Special Requirements for Submitting Data to the Docket  10

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

     A 'subraittal package' consists of all studies submitted at
the same time for review in support of a single regulatory action,
along with a transmittal document and other related administrative
material (e.g. the method of support statement, EPA Forms 8570-1,
8570-4, 8570-20, etc.) as appropriate.

     Data submitters must organize each submittal package as
described in this notice.  The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume.  Each study  included in the submittal package must then
be bound separately.

     Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.

  -  If such materials relate to one study, they should be
     included as an  appendix to that study.

  -  If such materials relate to more than one study (as  for
     example a summary of all studies in a discipline) or to  the
     submittal in general, they must be included in the subraittal
     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-
 irif-l  .'--rj.-..;..':.   ~'-i--  •? .   TV; • i  identifies the £ubmUt?r or aM
 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,
 S6(a){2)  submittal,  or  a special review;  the transmittal date;
 and  a list of all  individual studies included in the  package in
 the  order  of their appearance, showing (usually by Guideline
 reference  number)  the data  requirement(s)  addressed by each one.
 The  EPA-assigned  number for the  regulatory action {e.g.  the
 registration, EUP,  or  tolerance  petition  number)  should be
 included  in the  transmittal document as well, if  it is known to
 the  submitter.   See Attachment 1 for an example of an acceptable
 transmittal document.

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

      The  list of  included studies  in the  transmittal  of  a data
 submittal  package  supporting a petition for tolerance or an
 application for an  EUP  should be subdivided into  sections A, B,
 C,....  of  the petition  or application,  as  defined in  40~CFR
 180.7 and  158.125,  (petitions) or  Pesticide Assessment Guidelines,
 Subdivision I (EUPs) as appropriate.

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

 C.   Individual Studies

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

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

     - Include the total number of pages in the complete  study
       on each page (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 patinat  "-P.,;.!*  iciies,  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 cover Guidelines
 151-20, 151-21, and  151-22? the second would cover Guidelines
 151-23  and  151-25;  the third would  cover Guideline  151-26.

       Note particularly that  product chemistry  studies  are
 likely  to contain  Confidential Business  Information as  defined
 in FIFRA  SlO(d)UHA), (B),  or (C),  and  if  so  must  be  handled
 as described in section  D.3..of this  notice.

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tigation still
                                   or  each  analytical method,
a                                 «
sing a single crop.  wh?n "°5* **"   and beet roots)  residue
is ofs0  t  ,
       crop
                                    b. reported as a .ln.1.
study.

D.   organization of Each Study Volume
     k	 complete
the list below, i0,^6
Several of these
                                                              in
                           are
                           "*
 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
    i
  CBI Attachment
                                   « ^plained in th. following
                                   headed  'example' cite the
                                     element  is illustrated.
                                                           Example

                                                           Page 12

                                                           page 13



                                                           page 16
                         When Require^

                         Always

                         One of the two alternative
                         forms of this statement
                         is  always required. '

                         If  study reports  laboratory
                         work  subject  to GLP  require-
                         ments

                          For certain  toxicology •tudi«.  (JJh.n
                          flagging  requirements are finalized.)

                          Always -  with an English language
                          translation  if required.

                          At submitter's option

                          If CBI is claimed under VlFRA
                          5lO(d)UHMr , 
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D.I  Title Page

     A title page is  always  required  for each
page:

a    Study title.  The study title should  be  as descriptive as
possible!7 It must clearly identify the  substancets) tested and
Correspond to the name of the data requirement as  it appears
in the Guidelines.

b    Data reouirement addressed.   Include  on  the  title  page the
Guideline naSber(s) ot 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
nllinly as authors, to distinguish them from the  performing
la^atory,  study sponsor, or other names  that may also appear on
the  title page.
 d.    Study  Date.  The title page must include a       ,:
 the  study!   If  parts of the study were performed at different
        use  onlyPthe date of the latest element in the study.
 e.    Performing  Labnr^ry  identification. • If ^%?
 work done by one or  more  laboratories, include on the «
 the nlSe and address of the performing laboratory or lab oratories,
 and the laboratory's internal project ™mb%r(?> J?ff^ £om'any
 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 ^
 Responds to EPA questions raised  with respect  to an /"J1" JJ^ly

 ^IsTsSt^^^

                        M-iiS SffltSi'S-llS; « S.-SSS;
 title page).

 g.   Pacts of Publication.  If the study is a repr int of  a  pub-
 lished document, identity on the title page all relevant  f^s
 of publication, such as the journal title,  volume, issue,  inclusive
 page numbers, and publication date.

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D.,.  Statements of Data Confidentiality Claim* tmd.r  PIf» SlO.dHl


              * kto j efc-        «.»._ ^«nf irtentiality Claims
     tacn  »u	        statement of Data Conr laentiai J.VJT
     E.cn submitted study       .
alternative forms of th« S"£T?!JJ0° !„ «158.33 (b)  and  (c).

                       d.    -                     --
                             t
assert a claim of SIIMOMA; «  ^3(en    In either case,  the
or to waive such a claim <*J^.33(c)^   in e     jde the typed
statement must be signed and dated,  «™  "«   ^ not ^a^e CBI   .
name and title of the <>"" "J^J^SSS. associated with petitions
                          y           (see NOTE P9 »1.
   3  Confidential Attachment

     I£ th.
                           -
                   ie
                                   -hich the passage

 (See Attachment 5).

      The confioenti.l Attachment  to a st^V -« be "JJttf

                     sua  n
                                            =
       with a specific «°","!r'id  and with a reference to the

       ibjrP:siS.?:)"5i  "rS*""^" «• "hich the ^tia"ti
  claim is based.

  D.4. .u^l—n.  Statement  of Data Confidentiality Clai»s  (See
      Attachment 4)

                                -'^sM
                                              apply.
          ()  or  c   the
       claim of  confidentiality.
                                                         is

        included in Attachment 4 on Pg 14.
        and"title of the official who
                                t

                                  8

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r 5  r-^d T»i*.-"atory Practice Compliance Statement
pies of these statements are shown in Attachment 6.
E   Reference to Previously Submitted Data




 the method of support for the application.
 F.   physical Format Requirements
     all  elements in the data submittal  package must-be on uniform
 * 1/9 ii  ?l^nch white paper, printed on one side only in black
 £SHb"r^
 tt:^sx/£«sKi& sr. ys/2-ss nz^.«
 paper, such as film or magnetic media.
 Please be particularly attentive to the following points:
     Do not  include frayed or torn pages.
     DO not  include carbon copies, or copies  in other than
     black ink.
   o
   o
   o  Make sure that photocopies are  clear, complete, and  fully
      readable.
      Do not include oversize computer printouts or fold-out pages.
   o  Do not bind  any documents with glue or binding tapes.
   n  Make sure that all pages of each study, including any attach-
   °  menls or appendices? Ire present and in correct seq.ence.
      w,,mh*r of conies Required - All submittal-packages except



  getting it  into review.)

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             Requirements for Submitting Data to the Docket
?he fourth copy  hould be identical to the other three.  When
         of "'study submitted in support of an RS or SR are

    ras^rov^
special preparation is required for the fourth copy.

  o  Remove the 'Supplemental Statement of Data Ccnf identiality
     Claims' .

  o  Remove the 'Confidential Attachment'.
                                                       up
           the  fourth  copy  plainly  on both  its  cover  and  its  title
      page  with the  phrase  "Public  Dock.t M.t. rial  -  contains no
      information  claimed as  confidential .

 V.    For Further  information

      For further  information contact William C.  GrO8S®'9hfef '
 information Services  Branch, Program Management  and  Support
 Division, (703-557-2613).
                             ames W. Akerman
                               ing Director,
                            Registration Division
  Attachment  1.
  Attachment  2.
  Attachment  3.
  Attachment  4.
  Attachment  5.
  Attachment  6.
  Attachment  7.
                                  »
Sample Transmittal Document
lan,ple Title Page for a Newly Submitted Study
statements of Data confidentiality Claims
lupplemental 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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  ELEMENTS
                          ATTACHMENT  1.
               TO BE  INCLUDED  IN  THE  TRANSMITTAL DOCUMENT*
        address of submitter (or- all joint submitters-)
1.  «™» «nd
    tBiith Chemical Corporation
                                                   „ 5S7B9
           Chemical Corp. will act as sole agent for all submitters.
2. o^l.torv acti^ in sunnort of -*!«* this package is submitted
       the EPA  identification number (e.g. 359-EUP-67) if you
                                       rtt       "P
 3. Transmittal  date
 4. List  of  submitted  studies
   vol  1.   Administrative  materials  -  forms,
            pondence with Project  Managers,, and so forth.
Vol 2.  Title
                  of first study in the submittal (Guideline No.)
      •
    voi n.  Title of nth study in the submittal (Guideline No.)
        of the data.
  Company  Official:
  Company Name:
  Company Contact:
                    Name
                                        Signature
                    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
    CX is the total number of pages In the study)

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                 STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
  NO da* of confidentiality ur*er FIFRA S10(d), or (C)



                  STATEMENT OF NO DATA CONFIFEtfTIALm CLAIMS
2.  Claim
   im of confidentiality under FIFPA |10(d)(l), or (C).
                    STATEMENT OF DK» CONFIDENTIALm CLAIMS
    Conpany:


    Ccnpany Agent
^  Wlicants tor
is OPP policy that no permanent tolerance,
                                                             , can be

                                        13

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                       ATTACHMENT 4.

    SUPPLE«ENTAL STATIST OF DATA CO-FIDENTIAUT*
        t
Confidentiality Claims?
                                                      o. o.t.
      be  treated  as  confidential
      necUon with those disclosures.
       should be viewed as s
                                         future,
                                 14
  •0  cit. th. r...on. why th. elt.d                   for
     confidential treatment.

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                  EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
          (confidential vgrd^r^rase that has been deleted fro* the study)
CKSS H^E «»_j_    w^«srsix^^r-"Si
                            indicated volume and page references.
DELETED WORDS OR PHRASE:.
  pftGE  LIRE  REASON FOR THE DELETION
    6    14   identity  of Inert Ingredient
   28    25               ;
  100    19
                                                         FTFRA REFERENCE
                                                          SlO(dHlHC)
          (CMf i*ntUl
                                   that haw beer, delete erg, the studyl
                            indicated volume and page references.
                 Reproduce the deleted paragraph(s) here

                            DELETION
    20
        4-T7   Description of the quality control process
                                                                    )
                                                                    )
                                                          FIFRA REFERENCE
                                                           S10(d)(l)<0
 BcMpteB  XConfidential fiages that have been deleted fron the study)
            	
             ,-r aiut,™   7   This cross reference number noted on a place-holder
 CRQSS.MH5BCE ttJMBER _7_  Tms cross^ ^ ^^ ^ ^ followir^ ^^ ^^
                            at the  indicated  volume and page references.
                :  are attached iimediately behind this page.
                PP^ FOR THE DELETION                       FIFRA REFERENCE
                Description of product manufacturing process      S10(d)(1) (A)
                                      15

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                          ATTACHMENT 6.

            SAMPLE GOOD LABORATORY PRACTICE STATEMENTS

Example 1.
   This study meets the requirements for 40 CFR Part 160

      Submitter	„	.	

      Sponsor 	___	
      Study Director
Example 2.
  This study does not meet the requirements of 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
                Transwittal Document.

                     Related Administrative  Materials
                     (e.g., Method  of  Support  Statement,  etc.)


                          Other materials about  the submittal
                     	  (e.g., summaries of groups  of  studies
                     """^      aid in their review).
to
                                  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
                         I  .. -   Attachment.
LEGEND
                             I  •'
          confidential Attachment.

              Supplemental Statement
              of Confidentiality Claims,

          * when flagging requirements
            are finalized.
                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 (TROUFIWU OF

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             NOT TO BKKH EMD-ffiE HOODCTS
                        OOA RBQcnraMans
classificaUan, precautionary labeling, etc.).
each product

      •

                               tt






 Sring (Option 2) or Offers to C3ost Share  (Option 3).

-------
 I.   EreKtee  Products Contaiiung Citric Acid
                    X of Citric Acid I Other Active Ingredient*
1677-100
5664-4
20.0X - Citric Acid
22.5X - Phosphoric Acid
 2.OX - Decanolc Acid
 6.OX - OctanoJe Acid

 4.6X - Citric Acid
16.4X • Phosphoric^

 1.0X - Citric Acid
 B.5X - Phosphoric Acid
 5.OX - Sulfaoic Acid
 3.0X - Oxalic Acid
 1.0X - Gluconic Acid
 1.2X •  Sodium Xylene »ul;
                                                                             Liquid
                                                                             Liquid
                                                     at*

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     ATTACHMENT E




EPA ACCEPTANCE CRITERIA

-------
       -  "                 SUBDIVISION D








Guideline              Study Title







Series 63      Physical and Chemical

-------
               61 Product Identity and Composition



                        ACCEPTANCE CRITERIA



D0es your study  meet the following acceptance criteria?

1     Name  of  technical material tested (include product  name and

 *	 trade name,  if appropriate)      certified limits (upper and

2.	^me,  nominal•  ^^^YJ^ient and each  intentionally-
3      Name and upper certit.ea limit for *-£ /^i^or
J-	  „	 „*  o.-L* DY  -^7^,, /= a
                                         it impurities (e.g.,

                               orossnt 3.t ^0»i*           t     _
                               ingredient and each intentlonaliy-
4^     1*111-0086 01 tsa»-ii  u^- -~.- J-iiy
                      •F-rn-m chemical Abstracts  i:
 5.	 Chemicax n^u^^rjjm^criem^^,^       Registry «—^ r—  -----
                                                 each intentionally-
       added  inert^^^^  ^^ empirical formulas, molecular^

 6.
                              Number if registered; for other
        	; Brand name,  tr^Jc^^n°ror°S?rsheets by which
             I ^s^^Xiil J-V^G'*-  o^^***1^              j—^.* j VN*^*o  /^^^TT^nf^Sl^L T_ Oil *
        __—.^^—                   HV^T^I "i ^7™ QSSCITIC®^  WWIM^'^'^•*• *^-t-*^* r

             properties or toxicity

  8.    Description  of  m^nuJajJUJ1bltch°or continuous process
             Statement  or wne^ner «  .„„•__ materials and order
        	' Relative  amounts of beginning materials.

        	' which  they are added
              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
           jjeow^. A-.f wi»»** ^**~r         _   .   ^ ««*«n v&
          -       •  ,i  .  _ .e _*—. .^ mi** AC T~a IT^T) TLO a09U.J. ts
Description  of  purifica^ion proceau^
Description of measures taken to assure quality
product
Q      Discussion of formation of
9'— chemical theory addre^ing^i) ^^ 0^^-r;^ctAnalyses


       (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.

-------