United States
            Environmental Protection
            Prevention, Pesticides,
            And Toxic Substances
EPA 738-R-97-042
July 1997
Rejection Rate Analysis for
Submissions of Product
Chemistry Data, Confidential
Statement of Formula, and
Product Label for Registration and


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                 Product Chemistry Review Section
                   Registration Support Branch
                      Registration Division
                   Office of Pesticide Program
               U.S.  Environmental  Protection Agency
                            April  1996



     This report was prepared with the collaboration of the
following members of the Product Chemistry Review Section  (PCRS)

Amelia Acierto
Tyrone Aiken
Treva Alston
Michael Clifford (AARP)
Indira Gairola
Dr. Bipin Gandhi
Dr. Sami Malak
Dr. Shyam Mathur
Anna Skapars
Alfred Smith
Dr. Harold Podal'l, Section Head

April 1996


AI - ACTIVE  INGREDIENT  - The component  of  a  pesticide  product
which kills  or  otherwise controls the target pest.

AGENCY - United States  Environmental Protection Agency

ANSI - American National Standards Institute

AOAC - Association of Official Analytical  Chemists

CAS - CHEMICAL  ABSTRACTS SERVICE - A subsidiary of the American
Chemical Society whose  services include the  proper naming and
cataloging of chemicals, with assignment of  a CAS number for each

CFR - CODE OF FEDERAL REGULATIONS - A codification of  the general
and permanent rules published in the Federal Register  by the
executive departments and agencies of the  Federal Government.

listing which includes  among other information the identities and
amount of the ingredients contained in a pesticide formulation.
The form containing this information (EPA  Form 8570-4) is
submitted by the registrant or applicant at  the time of
application  for registration, re-registration, or change in

2,4-D -  2,4-dichlorophenoxy acetic acid

EP - END USE PRODUCT -  A pesticide product whose labeling bears
instructions for using  or applying the product (as packaged and
sold, or after  dilution by the user)  for controlling pests or
regulating plant growth.  The term excludes  products with
labeling which  allows the product for use  in formulating other
pesticide products.

EUP - EXPERIMENTAL USE  PERMIT - A permit authorized under FIFRA,
Section 5, which is granted to applicants allowing- them to
conduct testing of a new  proposed pesticide product and/or use
outside of the  laboratory, generally on 10 acres or more of land
or water surface.  EUPs are most commonly used for larger scale
testing of efficacy and gathering crop residue chemistry data.

regulates, among other  things,  the use of drugs (human and
veterinary), chemicals  in cosmetics and human and animal foods;
this includes the legal requirement of tolerances for pesticide
residues (Sections 408  and 409)  in or on food and feed items.
These tolerances are established by EPA.

law which sets forth the regulations of the sale, distribution,
and use of pesticides in the United States.

GC or GLC - Gas-Liquid Chromatography

GLP - GOOD LABORATORY PRACTICES  -  Standards established in 40 CFR
160 to assure the quality and  integrity of data submitted by
registrants.  Provisions of the  GLP standards include record
•keeping, personnel, and laboratory equipment requirements.

GRAS - Generally recognized as safe as designated by FDA.

GRN - Guideline Reference Number - Reference to the Pesticide
Assessment Guidelines.  Product  chemistry  consists of GRN series
61, 62,  and  63 of the Pesticide  Assessment Guidelines.

INERT INGREDIENT -  Any substance other than the active  ingredient
which in intentionally added  to  a pesticide formulation.

INTEGRATED  FORMULATION - A  formulation  in  which the source  is not
an EPA  registered product or  is  obtained  in a manner that will
not permit  its  inspection by  the Agency per FIFRA.


MP - MANUFACTURING  USE PRODUCT - Any product  intended  (labeled)
for formulation or  repackaging into  other  pesticide products.

 "ME-TOO" PRODUCTS  - An application for  registration of  a
pesticide product  that  is  substantially similar  or  identical  in
 its uses and formulation  to products that are currently

 identification number assigned to data submitted in the form of
 individual studies in support of an administrative  action (e.g.,
 an application for registration, reregistration,  or experimental
 use permit).


 NC - NOMINAL CONCENTRATION -  The amount of an ingredient which is
 expected to be present in a typical sample of a pesticide product
 at the time that the product  is produced, expressed as a
 percentage by weight based on the pure ingredient.

PEST - Any insect, rodent, nematode, fungus, weed, or any other
form of terrestrial or  aquatic plant or animal life or virus,
bacteria, or other micro-organisms on or in living man or other
living animals that is  injurious to health or the environment.
(see FIFRA Section 2  (t)  and  25  (c) (1) .

PESTICIDE - Any substance or  mixture of substance intended for
preventing, destroying, repelling, or mitigating any pest, and
any substance or mixture  or substances intended for use as a
plant regulator, defoliant, or desiccant.

158 that provide registrants  with guidance on how to conduct
required studies.  Copies of  the guidelines can be obtained from
the National Technical  Information Service.

generally issued by the Registration Division to pesticide
registrants that communicates important changes in regulatory
policy or procedures.   Each PR Notice is assigned a two part
number beginning with the year issued and the cardinal number
issued within that year (e.g. 87-1, 87-2, 92-1, etc).  The name
of the notice is derived  from the Pesticide Regulation Division,
a precursor organization  to the Registration Division of the
Office of Pesticide Programs.

review chemists for product chemistry are located.  Within the
organization, it is in  the Registration Support Branch of the
Registration Division.

PAI - PURE ACTIVE INGREDIENT  - An active ingredient that is
purified as close to 100% as  technically feasible.

REGISTRATION NUMBER - The EPA registration number is a
hyphenated, two part number assigned by the Registration Division
to identify each product  registration (e.g., 1253-79); the first
number is the assigned  company number and the second number is
the specific product number.  The registration number is required
by FIFRA to appear on the product's label.

REGISTRATION PROCESS -  The process and final agency action
authorizing the legal sale, distribution, and use of a pesticide
product.  The process includes OPP's consideration of scientific
legal, and regulatory requirements of the product and results in
the agency issuing either a Notice of Registration or a denial to
the applicant.

REREGISTRATION - Section 4 of FIFRA required EPA to reregister
all pesticides originally registered before 1984 on specified
timetable.  Reregistration priority is given to chemicals with
the highest potential for exposure-high volume and food use
chemicals  (List A chemicals).  Through this priority process,
four lists of pesticides  (Lists A,B,C, and D), were established
under FIFRA  '88.  The reregistration process consists of the
following:  the agency identifying the studies necessary to
conduct  human health and  environmental risks assessments;
obtaining  and reviewing these studies and determining where the
pesticide's uses do not pose unreasonable adverse risks.

procedure  is  a written procedure  that conveys procedures for
various  functions performed by  Office of Pesticide Programs  (OPP)
staff.   SOP's address both  technical and administrative matters.

of an active ingredient prior  to  the addition of any additive or

TOLERANCE - The maximum permissible  residue levels for a
pesticide in raw agricultural  products  and processed foods.
Whenever a pesticide is  registered for  use on  a  food or a  feed
 crop, a tolerance (or exemption from the tolerance requirement)
 are enforced by the Food  and Drug Administration and Department
 of Agriculture.   Established tolerances and exemptions
 commodities are listed in 40 CFR Section 180;  tolerances  for food
 additives in food for human consumption are listed in  40  CFR
 Section 185; and tolerances for feed additives in animal  feed are
 listed  in 40 CFR Section 186.



              A survey was made  for FY94  through early FY95 of the overall
         and individual rejection  rates for the various product chemistry
         information submitted.  This pertains to  the CSF, Product Label
         and certain specific product chemistry information (pertaininq to
         characterization of the product,  its manufacture and/or
         formulation, analysis/  and selected physical/chemical
         properties).  The vast  majority  of the submissions reviewed by
         the Product Chemistry Review Section are  end-use producta.  it
         was found that:

              1.  The overall rejection rate in FY94 for all submissions
         was 33 ± 20%.
              2.  The rejection  rate for  the CSF is the highest and that
         for the product chemistry data  (CRN series 61, 62, 63) the
              3.  The rejection  rate for  the Product Label submissions has
         the greatest % variability in the rejection rate.  This may be
         due largely to differences in the degree  of detail of such
         reviews by a few of the chemists.
              Finally, a number  of courses of action are suggested here
         (Section VI) to reduce  the rejection rates.

                        TABLE OF CONTENTS


I.    Introduction	1
II.  Purpose of Product Chemistry Reviews	1
III. Content and Specific Objectives of the
         Product Chemistry Review	-2
IV.  Survey of Overall Rejection Rates	3
V.    Survey of Reasons for Rejecting Different Studies
     A.  Number of CSFs, Product Labels, and
         Product Chemistry Data Submissions
         Reviewed and Rejection Rates	.4
     B.  Reasons and Corresponding Percentages
         for Rejecting the CSF, Product Label,
         and Product Chemistry Data	-5
     C.  Summary of Rejection Rates of Various
         Reasons Comprising an  Overall Average
         Rejection Rate of 28%	-8

VI.  Courses of Action To Reduce Rejection Rates

     Appendix	-9

     I.  Detailed Listing of Reasons for Rejecting the
         CSF,  Product Label, and Product Chemistry
         Information	-9
     II.  List  of Documents Relevant to Product Chemistry
         Requirements	18
    III.  Questions  from Industry and Response from
         PCRS/RSB/RD Regarding this Report	21
     IV.  Minutes of Meeting with Industry	36
     V.  Questions  Raised by Industry During  the  2/29/96
         Meeting	^


I.   Introduction

     A.  Objective

          The objective of this analysis is to delineate the most
     common omissions and/or  flaws  in submissions of product
     chemistry information, Confidential Statement of Formula
     (CSF) , and Product Labels so as to reduce the need for
     resubmissions, and to thereby  expedite the registration
     and/or reregistration process.

     B.  Approach

          The approach taken  was to survey the chemists of the
     Product Chemistry Review Section for the reasons why
     submissions are  turned back for additional or corrected
     information.   It should  be noted that this rejection  rate
     analysis applies to  the  current product chemistry  submission
     review^ process.  An  effort  is  currently underway to
     streamline  some  of the product chemistry submission

 II.  Purpose of  Product Chemistry  Reviews

     The purpose of the product chemistry  reviews  is,  in  brief,

      (1) determination  of the completeness of the  submissions to
      meet the  data requirements called for in 40 CFR 158,  the
      Standard  Operation Procedure  (SOP)  for Technicals,  the SOP
      for Manufacturing-Use Products (MPs)  and End-Use Products
      (EPs),  and in certain PR Notices (cited in the Appendix of
      this report);

      (2) determination of the validity of the  data submitted,
      i.e., the method of analysis, methods of  property
      measurement, validation of those methods,  certification of
      Good Laboratory Practice Standards (GLPs)  for certain
      properties, and certification of limits;

       (3) determination of (a) the  internal consistency of the
      data submitted, i.e., is the  CSF consistent with the
      analytical data provided in Guideline Reference Number  (CRN)
      62-1 and 62-2 and (b) the reasonableness of the values,
      e.g., are the values for the  CRN 63 properties internally
      consistent as well  as consistent with the chemical identity
       (ID) and structure  of the active ingredient.

III.  Content  and Specific Objectives of  the  Product Chemistry

      The  information reviewed by PCRS  pertains  to 1) physical and
chemical characterization of the TGAI,  MP and/or EP, 2) the CSF which
Is based on  the above, and 3) the Label which is based on 1) and 2)
above. To  characterize a product, PCRS  chemists  review the
information  provided on the identity of the product/ its
manufacturing  and/or formulation process/  its composition, and
analysis,  and  various physical/chemical properties; the latter of
which are  relevant to identifying the product/ pointing up its
physical and chemical hazards, e.g., flammability, and its proper or
adequate storage and disposal (based on its stability/reactivity
characteristics).  The "studies" reviewed then/  are actually 1)
specific descriptive information such as  on the  manufacturing process
or analytical  method used for the product and 2) values of specific
physical/chemical properties generally  determined by well known and
reproducible methods.

     Specifically/ the following information  is  reviewed as per 40
CFR  158.150  -  158.190 depending upon what is  being registered or

       (1)   the CRN 61, 62, and 63 data  requirements where relevant,
including  requests for waivers,

       (2)   the Confidential Statement of  Formula (CSF), and/or

       (3)   the product Label  for the  following types of products:

            (a)   the technical grade active ingredient  (TGAI)

            (b)   the manufacturing-use product (MP)

            (c)   the end-use  product  (EP)

       The end-use product may consist of  or be derived from any of
the following:

       (1)   the TGAI alone

       (2)   an integrated formulation  process  where the source is not
 an EPA registered product or is  obtained in a manner  that will not
 permit its inspection by the agency as  per FIFRA.

       (3)  non-integrated formulation process employing a registered
 TGAI, or

       (4)   from the MP, involving the addition of other ingredients.

IV.   Survey of Overall  Rejection Rates
     The survey initially made  was  that of the  rejection rates by
each chemist of the product chemistry  submissions and resubmissions
for registration and  reregistration which were  reviewed in FY94.   The
overall results were  as follows:
New submissions/regist.
Mew submissions/reregist
 (*by  10  Chemists)
No.  of Cases

% Relection Rate

      33 i 20
 Excluding the reviews by the chemists with the three highest
 rejection rates, the overall results for the remaining seven chemists
 were as follows:
 Hew submission/regist.
 New submission/reregist.
  No. of Cases

   % Rejection Rate

       23  t  11
  (**reviews of 7  chemists corresponding to 83* of  all reviews  by PCRS)

       It is seen  that the rejection  rates of  the  submissions for
  reregistration dropped by more than 1/2  (from 25  to 12%)  and  that for
  all  resubmissions dropped by about  30%  (from 23  to 16%).   Similarly,
  our  overall  rejection rate for all  product chemistry submissions and
  resubmissions dropped by a third (from  33 to 23%).

       The  lower  rejection rates for a given type  of. submission e.g.,
  new  submissions/registration, are due largely  to a more uniform
  interpretation  of the regulations regarding  the  product chemistry
  requirements.   The inconsistencies, in question, are in part being
  resolved through the use of the same product chemistry review forms
  by the PCRS chemists and by more selective  reviews by the Section
  Head/PCRS.  In addition, as seen below, the  rejection rate survey has
  facilitated our  focusing on those  areas of  our reviews where there
  are  the greatest  inconsistencies.


Survey of Reasons  for  Rejecting Different Studies

Number of CSFs, Product  Labels, and Product Chemistry Data
 Submissions Reviewed  and Rejection Rates
     To  facilitate this analysis, each cheaist was requested to keep
track of the reasons why he or she rejects the CSF, Product Label  or
the product chemistry elements (CRN 61, 62, or 63).  It may be noted
that a particular submission may have more than one reason for its
rejection?  hence, the total % rejected is necessarily greater than the
rejection rate for the submission per se.  The overall total* were A*
Product Chemistry*

23 i 10
14 t 10
12 1  7
% Variability*

 m)by six  chemists
 *)% variability -  (%  deviation/%  rejected)  x  100
 «)GRN Series  61, 62,  and 63

      Thus for 709 CSFs reviewed by six chemists,  23% were rejected,
 with an average deviation of ± 10%; this corresponds to an average %

 ( 10/23 )°x 1009or£43%*he CSF* °£ l3'33*'  **• P««»nt variability is

      The sum of the percentages rejected for the CSF, product label,
 and product chemistry is 49%, while the corresponding overall average
 % rejection  (see Section IV) is in the range of 23 - 33% (according
 to the number of chemists  involved).  This corresponds to about 2
 reasons on the  average  for the rejection of a submission.
 *™- f                  interest to note that while the rejection rat*
 for the CSFs  is the highest, the variability or measure of the
 inconsistencies in the reviews is the lowest, i.e., 43% vs 71% for
 the product label.  There are apparently a greater number of
 requirements  associated with the review of a CSF, although the
 chemists appear here  to be more consistent in their reasons for
 rejecting  a CSF.  The higher percent variability associated with the
 review of  a product label may be due largely to the greater detail
 which a  few chemists  go into in their review of the product label,
 c.f., items 4d and 4e, Miscellaneous Reasons, Product Label, Section
 V. B below.

B.  Reasons and Corresponding Percentages for Rejecting the CSF,
     Product Label, and Product Chemistry Data

     The reasons for rejecting the CSF, product label, and
product chemistry elements along with their corresponding
percentages are as follows:

     Reasons for Rejecting CSF Submissions -  (% rejected for
indicated reason):

1.  Components of inert ingredient are:
     a)  not sufficiently identified, e.g., new trade names
     b)  are new inerts
     c)  are not cleared for the  intended use  [40 CFR 180.1001
          (c) , (d) , or  (e) ] or by FDA under 21 CFR 170-199 such
          as indirect food additives or generally recognized  as
          safe (GRAS), and/or
     d)  Not exempted from requirement of tolerances.

2.  Technical source product for  active ingredient is:
     a)  not registered, has been canceled, or has been
          transferred to a new company.
     b)  not given correctly, or
     c)  for a "roe-too" product a different source is used or
          data for same source is not provided
     .	4 . 5%

3.  Certified limits of active ingredients and inerts are
     incorrect;  should  be based on the nominal concentrations
     and be within those prescribed  under 40  CFR 158.175; or  have
     another reasonable basis.  Certified limits for active
     ingredients in  an  alternate  formulation  should be the same
     as those in the basic  formulation.
     	A 4-
     ———————————————————             —  —————————————————————q^

4.  Nominal concentrations  of  ingredients are not given  or
     calculated  correctly,  i.e.,  not based on the pure active
     ingredients,  do not  agree with  the  label declaration values.

5.  The density,  pH, and/or flammability  are  not specified in the
     CSF  and/or  do not  agree with the corresponding values given
     under  CRN  63-7,-12,  and  -15,  respectively,  in the Product
     Chemistry  submission.

6.  Miscellaneous
     a)  CSF is not provided, not signed, and/or dated
     b)  An inert ingredient of toxicological concern  (List 1)
          is present
     c)  CAS number, sources, and/ or purpose of each component is
          not specified
         Total weight not given or in error
» Reasons for Rejecting  Product Label  Submissions
  Indicated Reason):
                                                     Total  23%

                                                   (% Rejected for
  1.  Ingredient Statement:  a) the  chemical names  of  the  active
       ingredients are  not  identical to those on  the CSF or  are in
       error, or b) the label claim  does not agree  with the  nominal
       concentrations of the ingredients as required by PR Notice
       91-2 or with the lower certified limits  if registered prior
       to 7/1/91.
  2.  The storage and disposal  instructions for  the  pesticide  and
       container are not  in compliance with PR notice  84-1  for
       household use products or PR Notice 83-3  for  all  other  uses.
       ••»••»••.»••.»••_.___....__.__.. . _ __ ___ ______ ____ .«.«. _____ .«..»____ __     A Q.
                                                          — — — — 4-6

  3.  The appropriate physical  and chemical hazard statement
       regarding flammability or explosive characteristics  of  the
       product  is not provided, is incomplete, or is incorrect.
       ------------------------------------------------------- 3%

  4.  Miscellaneous:
       a)  Footnotes to the ingredient statement are missing where
       required such as "contains petroleum distillates"; "contains
       the toxic substance - -  -"; or "contains  methyl alcohol."
       b)  The  label text of the alternate formulation product is
       not identical to that of the basic formulation  as required
       in 40 CFR 152.43.
       c)  Net  weight or  measure of the contents is  missing from
       the label.
       d)  The  percentages for  active and inert  ingredients are
       not aligned according to the decimal point.   The  active and
       inert ingredients  headings are not aligned to the same
       e)  Percentages less than one do not have a zero  preceding
       the decimal point.
       f)  The  EPA registration/establishment number is  missing or
       in error.

e  Reasons for Rejecting Product Chemistry (CRN 61,62,63) Submissions
   - (% rejected for indicated Reason):
®  General Reasons
    1.   Product chemistry data do not agree with CSF or Product
    2.   Data incorrectly referenced (MRIDs, etc.)
    3.   Incomplete data
    4.   Data not provided for unregistered source of active
    5.   Data not provided for end-use product.
    -		 -	 - -  4%
®  CRN 61
    •  Composition incomplete or does not agree with CSF
    •  MSDS's have not been submitted for all active ingredients and
       inert ingredients.
    ®  A description of the manufacturing/formulation process has not
       been provided.  Information  (MSDS's) on starting materials
       used in manufacturing process not provided.  Quantities of
       ingredients used in formulation do not agree with those in
 »  A discussion of the formation of impurities during
    manufacture/formulation, in packaging, or during storage
    has not been provided.

GRN 62
 •  If formed by an integrated system, five batch analyses for
    active ingredients, impurities,etc., have not been reported,
 •  The analytical method has not been validated by conducting
    recovery studies; accuracy and precision data are missing;
    sample calculations and associated data (spectral, GC, or
    nmr) have not been provided in support of claimed active
 ®  Where required, Good Laboratory Practice statements have not
    been submitted, cf., 40 CFR 160.105 and 40 CFR 160.135.
     •   Data are incomplete,  needs upgrading,  or are not  submitted
     •   Flammability (63-15)  has not been determined (or  requested to
        be waived with reason provided) on the complete product
        including the propellant; for aerosols, flame extension tests
        are required; for non-aerosols, flash points should be
     «   Corrosion characteristics (63-20) are not determined in
        conjunction with the one year storage stability test (the
        latter which needs to be determined but not provided unless
        specifically requested by the EPA); the corrosivity tests need
        to be provided for materials which the product will coae in
        contact with.

                                                             Total 12%

   C.   Summary of Rejection Rates  of Various  Reasons  Comprising an
   Overall  Average Rejection Rate  of 28%.

        The  rejection rates due to  the various reasons comprising an overall
   average  rejection rate of 28%  (between  the 33%  for 10  chemists and 23%
   for  7  chemists)  are as follows:
      pertaining to inert ingredients (Section VB.l)                    4%
      problem(s)  associated with technical  source  (Section  VB.2)        2.6%
      Incorrect certified limits (Section VB.3)                         2.3%
      incorrect calculation of nominal  concentrations)  (Section VB.4)  2%
      inconsistency or omission of density/pH/flammability              1.1%
      value(s)  (Section VB.5)
   •  miscellaneous reasons for rejecting CSF  (Section VB.6)            1.1%

                                                            Subtotal    13%
   Product  Label
   •  incorrect ingredient statement (Section  VB.l)                     2.9%
   *  inadequate storage and disposal instruction  (Section  VB.2)        2.3%
   •  inadequate physical and  chemical  hazard  statement  (Section VB.3)  1^7%
   •  miscellaneous reasons for rejecting product  label  (Section VB.4)  1.1%
   «  -,   ^  „,_   ,  ^                                          Subtotal    8%
   Eroduct  Chemistry
   •  general reasons  for rejecting product chemistry (see  Section VB)  2.3%
   •  incompleteness or incorrectness CRN 61 information                1.1%
      (see  Section  VB)
   *  incompleteness or incorrectness of  CRN 62  information             1.7%
      (see  Section  VB)
   •  incompleteness or incorrectness of  CRN 63  data (see Section VB)   1.7%
                                                            Subtotal    7%
                                                            Total       28%

   VI.  Courses of  Action to Reduce Rejection  Rate-

        These may be summarized as follows  (see  Appendix  v  for additional
        1.  Revise  CSF to make it more  user-friendly, e.g., provide a
   checklist for industry to complete CSF.
        2.  Allov/ wider certified limits  for the inert ingredients than
   given  in 40  CFR  158.175.  A reason for this should be given.
        3.  Streamline the data requirements for the physical chemical
   properties (CRN  Series 63)  for manufacturing use and end-use products
   (produced by a non-integrated formulation process employing registered
   active ingredients)  by self-certification by the registrant of many of
   the data requirements.
        4.  The review chemists should  continue to meet and agree on all of
   the data requirements for technicals,  manufacturing use, and end-use
   products so  that there is greater consistency in the reviews.


I.  Detailed Listing of Reasons for Rejecting the CSF, Product
Label/ and Product Chemistry Information

•   General Reasons

1.  The chemical composition of a new inert ingredient is not
provided.  If one or more components of the inert ingredient,
such as present in certain dyes or fragrances/ is a new inert
ingredient by itself, then its data requirements must comply with
PR Notice 87-6.  The Registrant is responsible for having the
supplier provide the complete composition of an inert that is not
cleared to the EPA.

2.  The specific TGAI source used is not registered or identified
by the correct EPA registration number such as when transferred
to another company.  Alternatively, one or more of a multi-
technical source may have been canceled.  In such cases, the
Registrant may wish to specify another registered source of the
TGAI in question.  The product chemistry data for a TGAI source
which is not registered must be provided for the registration of
the corresponding MP or EP.

3.  One or more pieces of the requisite product chemistry data
for CRN Series 61, 62, and/or 63 have not been submitted.  In
those cases where the required data  (e.g. a specific physical
chemical property) are not applicable for technical reasons this
should be stated with a brief explanation.  Similarly, for the
reregistration of a pesticide, complete information on the
various TGAI sources must also be provided, i.e., Series 61, 62,
and 63 data including the CSF.

4.  The registrant provides only the CSF when applying for a "ME-
TOO" registration instead of submitting also series 61, 62, and
63 data.

5. If the formulation is for a food use, all inert ingredients
must be exempted from residue tolerance requirements.

6. If the formulation contains a toxic inert ingredient it must
comply with the data requirements specified in PR Notice

7.  For a "ME-TOO" end-use product registration, two or more EPs
on the market are cited by the Registrant.  We need to know the
specific registered EP to which the "ME-TOO" is to be compared.

8.  Multiple technical sources for an active ingredient which
have different AI percentages are cited in a single CSF for an

•  Confidential Statement of Formula [CSF - EPA form 8570-4 (Rev.

     A copy of the CSF form and the directions given on the
reverse side of the yellow copy are given for reference purposes.

    1.  The complete chemical composition of each pesticide
formulation is not provided for the registration of a pesticide;
for application for an amended registration involving a formula
change; or for reregistration of a pesticide.  The CSF must be
filled out completely and according to the instructions specified
on the reverse side of the CSF.

    2.  If the TGAI contains several substances at a
concentration i 0.1% it is advisable to list such components as
follows in Column 10: (a) individually/ if pesticldally active/
(b) as "total other ingredients" if not pesticidally active or
not related to the active ingredient/ and/or (c) "total related
compounds", if related to the active ingredient.

    3.  The nominal concentration of the pure active ingredient
(AI) should be given in parenthesis in Column 13b below the
percentage by weight of the technical source product.  The
nominal concentration is calculated by multiplying the percentage
by weight of the technical source product by the percent active
ingredient in the technical source product.

    4.  The upper and lower certified limits under Columns 14a
and 14b should be based on the nominal concentration of the AI/
in accordance with 40 CFR 158.175 and not on the percentage by
weight of the technical source product.

    5.  Incomplete analysis of inert ingredients (which have not
been previously cleared for use in pesticide products) .  The
chemical nasa, CAS Number/ and percentage present of each
component of an inert must be provided if it has not been
previously cleared.  The sum of the percentages of the components
present in the inert must equal 100%.

    6.  To facilitate the registration process, registrants
should see to it that suppliers provide the requisite  information
if the latter is company "confidential".  Material Safety Data
Sheets (MSDSs) may be supplied if they contain the requisite







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information cited  above  (in  5)).

    7.  The EPA registration number is not specified under Column
12 of the CSF.   Frequently,  the source product has been
transferred but the  new  company number has not been provided.

    8.  One or more  of a multi-technical source has been
previously canceled.

    9.  When  a product is a 100% repack of a registered product,
the name  and  supplier of the product should be specified under
Columns  10 and 11, and the number, 100%, should be specified
under Column  13b.   No certified limits are required under Columns
14a and  14b.   A notation should b« made on the CSF that this
product  is  a  100% repack of a certain registered product.

     10.   Must indicate in block A,."Basic" or "Alternate".   If
more  than one Alternate, must number  "Alternate #1, Alternate #2,

     11.   In Column 10, the  source  product for the active
 ingredient must be entered  separately.

     12.   Flash point/flame  extension  must be given as directed.
 For pressurized products or aerosols, the flame extension test
 should be on  the  entire  mixture  Including the prope11ant (no
 flash point  is  required  here) .~

      13.  Alternate  formulations  must  have the same  certified
 limits for each active  ingredient as  the  basic formulation.

      14.  If  the alternate formulation contains an inert
 ingredient or impurity  of toxicological significance,  tho
 formulation  must have the same upper certified  limit for that
 substance as the basic  formulation.

      15.   For pesticide formulations intended for use on raw
 agricultural commodities after harvest, applied to growing  crops
 or  applied to animals intended for consumption,  the registrant or
 applicant should ensure that the  inert ingredients are exempted
  from the requirement of a  tolerance under 40 CFR 180.1001,
  paragraph CcJ, (d) or  (e).

      16.  Vhen an active ingredient (AI) is formed in an
  integrated system, the  registrant/applicant should specify the AI
  and its certified  limits on the  CSF.

      17.  An  upper  certified limit is required for toxicologically
  significant  impurities  such as  dioxins or nltrosamines, in
  accordance  with  40 CFR 158.175(a)(3).

    18.  For some compounds such as  2,4-D,  the CSF should
indicate the appropriate Association of  Official Analytical
Chemists (AOAC) analytical method number for each active
ingredient and the AOAC manual edition,  in  accordance with PR
Notice 81-4.

•  Label (40CFR 156.101

    1.  The label claim concentration of the AI is not the same
as its nominal concentration as per  PR Notice 91-2.  Some
flexibility is allowed in the case of sodium hypochlorlte bleach
products which are relatively unstable and  require up to 25%
over-formulation for the product to  have a  reasonable shelf-life
in commerce.  Some leeway is therefore allowed here in the
selection of the nominal concentration and  lower certified limit
for the Confidential Statement of Formula,  so that the customary
label claim used for such products may still be used.

    2.  The headings in the ingredient statement for the active
ingredient* and inert ingredients are not the same type size, not
aligned to the same margin, or are not equally prominent.

    3.  Trademark or proprietary names are  used for the active
Ingredient.  The name used shall be  the  accepted common name if
there is one, followed by the chemical name.  The common name may
be used alone, only if it is well known,  such as the ANSI name
established by the American National Standards Institute.  If no
common name has been established, the chemical name alone shall
be used.

    4.  Pesticidally active ingredients  should be listed
separately in the ingredient statement as required in PR Notice

    5.  The "STORAGE AND DISPOSAL" statement is deficient.
Industrial and agricultural products marketed in containers over
one gallon for liquids and over five pounds for dry material
should be labeled in accordance with PR  Notice 83-3.  Household
or domestic use products marketed in containers one gallon or
less for liquids and five pounds or  less for dry material (except
for lawn fertilizer products or lawn pesticide products up to 50
pounds, aa long as directions are for domestic use) should be
labeled in accordance with PR Notice 84-1.  Products containing
CALCIUM HYPOCHLORITE should txa labeled in accordance with the
ERRATA SHEET for PR notice 84-1 dated April 12, 1984.

    6.   The registration number is  not  cited on product.

    7.   The net contents or measure of contents are not
specified on the label.  This should usually be placed on the
bottom of the main label.  If the pesticide is a liquid, the net
contents should be expressed in conventional U.S. units of fluid
ounces, pints, quarts and gallons.  If the pesticide is a solid
or semisolid, viscous or pressurized, or is a mixture of liquid
and solid,  the net contents shall be expressed in terms of
weight, expressed as avoirdupois pounds and ounces.

    8.  The ingredient statement is not in accordance with 40 CFR
156.10(g) (1) .  The label should contain the name and percentage
by weight of each active ingredient, and the total percentage by
weight of the inert ingredients.

    9.  The ingredient statement is not placed on the front panel
of the label.

   10.  If  the pesticide formulation contains 10% or more of
petroleum distillates or xylene-boiling range products in the
formulation, the label should contain the following statement,
with  a footnote to the inert ingredients below the ingredient
statement:   "Contains petroleum distillates" or  "contains xylene
range aromatic solvent."

   11.  The statement:   "This product contains the toxic
substance  [name]" should be included on the label when such
substances  are present, as required in PR Notice 87-6.

   12.  On  some labels, the "PHYSICAL OR CHEMICAL HAZARDS"
statement  is missing or  incomplete.  Warning statements on the
flammability or explosive characteristics of the pesticide are
required  in accordance with 40 CFR  156.10(h)(2)(iii).

   13.  If  the  pesticide  product  is  sprayed around electrical
outlets or  electrical  equipment,  the  following  statement should
be added  under th«  "PHYSICAL OR  CHEMICAL HAZARDS" heading:   "Do
not  use this product  in  or on  electrical equipment due to the
possibility of shock  hazard."

    14.  The solvent  used  in the pesticide  formulation should  be
included  la the inert ingredients on the  label  claim.

    15.  Percentages  less  than  one percent  should have a  zero
preceding the decimal point,  and the decimal  points  of  the
percentages of all  the ingredients should be  aligned.

    16.  The manufacturing-use  product label should  state  the
 following:   "This product is  for formulating  end-use products

   17. In the case of Experimental Use Permits (EUPs), the
statement Experimental Use Permit should be given on the label as
required by 40 CFR 172.6.
•  Series 61, 62, 63 Data
      Series 61 Data
    1.  The data given in the analysis does not agree in the case
of "Me-Too" products.
    2.  All of the starting materials including solvent and
catalysts are not properly identified.
    3.  No MSDSs are provided.
    4.  The quantities of the starting materials used par batch
(or fed per unit time, if the process is continuous) and amount
of product produced are not indicated.
    5.  A simplified process flow chart is not given.
    6.  Impurities cited in the CSF are not discussed in CRN 61-
3, i.e., the source and cause of formation, where known.
    7.  The registrant does not clearly identify the product
(TGAI, MP, or EP) for which the product chemistry data is
    8.  The chemical identity (or identities, including molecular
formula, molecular weight, and structure, where known) and
composition of the TGAI, MP and/or EPs are not clear.
    9.  CSF components are not supported by the analytical data.
   10.  CAS numbers are not provided or are incorrect.
   11.  IUPAC nomenclature not followed.
   12.  The synthetic method and reaction conditions, including
order of addition of reactants (if batch), are not indicated.
        Series 62 Data
    1.  The analyse* of five  (5) production batches are not
    2.  The analytical methods used do not follow the GLP

    3.  The analysts provided do not concur with  the
corresponding figures in the CSF, e.g.,  the lower and upper
certified  limits ere not clear  from the  analysis.

    4.  Reason  for upper and lower certified  limits exceeding  the
standards  (40 CFR 158.175(b)(2)) not discussed.

    3.  The analytical method has  not  been validated by recovery
studies to assure a  100% material  balance.

    6.  The analytical method used is  not adequately described or
referenced to enable verification  of  the analyses if required.

    7.  The  registrant does not submit analytical method for the
TGAZ  produced  in an  integrated  formulation system.

    8.   inadequate validation of the analytical method for the
AZs and/or no  indication of the use of GLPs for certain data,
i.e., GRH Series 62-1,  62-3,  63-8, 63-9, 63-11, and 63-17.

     9.   Upper and lower certified limits are not provided.

     10. Analytical data presented, e.g., XR,  MS, GC, or IQCR, are
 not Interpreted.
       Series 63 Data

      1.  Certain generic data for the AI are not provided when it
 is produced as an admixture (with solvent and/or other
 components) and not isolated,  i.e., 61-1, 62-3, 63-3 (when neat)
 and  63-8  through 63-11 data.

      2.  Description of method  used to determine a physical
 chemical  property is not given, e.g., Series 63-13 pertaining to
 stability is sometime described as simply "stable", without
 reference to the conditions/ etc.

      3.   Units  of measurement for  a physical  chemical property are
 not  given or  are  not in the most  useful form,  e.g., vapor
 pressure should be  given at 25* C in mm Hg or torrs.

      4.  The registrant relies  solely on data for the  PAX  (for
 other than generic  data) rather than what is called for in  the
 Table under 40 CPU 158.190.

      5.  The data for GRH 63-13 (stability) is used
  Interchangeably with 63-17  (storage stability).

II.   List of Documents Relevant to Product Chemistry
40CFR 158.150 - 158.190

21CFR 170-199

PR Notice 81-4  dtd 9/30/81:

PR Notice 83-3  dtd 3/29/83:

PR Notice 84-1  dtd  2/17/84:
PR Notice 87-6  dtd  5/12/87
PR Notice 90-1  dtd  5/1/90:
PR Notice 91-2  dtd  5/2/91:
PR Notice 52-5 dtd 10/9/92:
PR Notice 94-8 dtd 9/7/94:
Code of Federal Regulations/
Protection of Environment
Parts 150-189, Revised July
1, 1994, pp 107-114.

Food and Drugs

Label Improvement Program:
Label Revisions to
Accommodate New AOAC Methods
of Chemical Analysis.

Label Improvement Program:
Storage and Disposal Label
Clarification of Label
Improvement Program for
Farmworker Safety and
Pesticide Storage and
Disposal Instructions.

Inert Ingredients in
Pesticide Products; Policy

Inert Ingredients in
Pesticide Products; Revised
Policy Statement

Accuracy of Stated
Percentages for Ingredient

Product Chemistry Data
Requirements for Registration
and Reregistration of End
Use Products

Water Soluble Packaging  (WSP)

                                   A ,* ,.7 an <:{ ;  <   HZ	
[ DowEIanco
February 1, 1996

Document Processing Desk
Office of Pesticide Programs (7504Q
U. S. Environmental Protection Agency
Room 266A. Crystal MaO i
1921Jeflersoa Davis Highway
Ar lington. VA 22201

Attcaticn: Mr. HareME. Fodafl (7505W)


 I am certainty glad to see tfatf the aestiag ** h«v« tst!. bees woridnf toward £« several weds
 now be held this ™*«fr This kner a to address deoals mociated with the mffitng tad to make
 ceruic that the bass ace all covered between all parties involved. Tie specific amogesveas by my
 undemanding are as foUowK

                 Rate Aii«hr«iB Mecttaa.'
          Due:       Febnuoy 29,1996
          Timer      9:00 am - 3:00 pm
          Locarier    Oyseal Statiom Coeftfeac* Room

 Representatives from several Xndostxy Orzaaszatjna, iadodisf AC?A. CSMA, CMA, aad CfDA have
 beat iztvited. Ray McAllister, Director of RcgolatDcy Attain of AGFA (202 ST2-3
 ibe invotvcxoent of mdosizy ua/wiuuuiB aad a wtvjtfnnmree of ACPA has as
  I had previous^ flu wanted to year ofBce a draft of the qaestJcas/unintncHtf catagflai to daa that are in
  response to the July 1995 Protect Chearisoy Rejeetioa Rate Acalysis dm was pccfndi by yo« office,
  j^ COCv rtf tnJa^ nfM*s&nw/QQ^B]^9B^^t QDCS^DBDft IS GK3O9BBI WiOfc tlUl *6ttEf IS 8^L CQQ3fiHt COmnF vO w^QC^C OP
  No changes have beea oads sines the dzaft was prepared aad shared whfc yo*
  With regard to the pcoftaa fee thts»e«jaf on Febnary 29, l996,pleaMi
  suggcstioeafer any additieas or ehascex an wekwa*.
   Merfya L. Tone*, PhJX
   Repcesmring Dowgaacar
   U.S. Regulatory, Toxicctofi «a*
   (317) 337-4736 (FAX>


Mr. Harold E. Podall C1505W)
Febfuay I, 1996
PlgC 2
                       Prefect Ctaeiftry Xejcctta JUtt Auiy*
    Welcome 4 Meco'ng Purpose
Peter Canfleiai, USEPA or
Stevt Johuoo. USEPA
                                               Ray McAllisBH, ACPA
    Objechts of Meeting and Places* Deafl*

    Review of Rejecoon Rate Anaijrns
    DcatikdSuagnaryaf afl Cunclvainn/AgirBneaa  Faciiitt

    Oibet Needed TnfiniiLjiio»
                                                 HmUPobO, USEPA
                                                       loots, Dowdneo

The Agricultural Crop Protection Association has taken the
initiative to solicit and compile comments from meab«? companies
and from other related chemical business associations  on the
recently released  EPA Rejection Rate-Product Chemistry Report
from the office of Harold Podall.  This effort is for  the purpose
of identifying any items in the report that require further
clarification, to  challenge policy or practices that are deemed
inappropriate, and to suggest changes as may be helpful. This
exercise has resulted in only a limited number of comments  which
suggests that most registrants have  found that actions taken in
recent times have  been timely, consistent and reasonable.  The
Product Chemistry  Review Section  is  to be commended for the
quality of their actions and especially in this case,  their focus
on continuous  improvement.   At the same time, certain  actions
could further  improve overall registration actions. The
following is a compilation of items  that we suggest should  be
discussed further.

     car General

          Generation of the CSF is a guideline requirement,
          however it is not always  identified as such  in a
          separate report.   Changes  to the CST are often
          submitted by cover letter  without study due  to EPA
          Product Manager's filing requirements.  Zt might  be
          helpful to track a CSF in  the same manner as a study
          amendment, noting the KRID number of the prior

          A check-list  for industry to complete a CSF  would
           further lower the rejection rate.

           Clear direction should be provided to include
           registered purity of the technical in a given location.

           Bov are  files on  inert ingredients kept?  If trade
           names change  on proprietary  inerts or blends of inerts,
           how are  file  numbers used to capture these changes  and
           how can registrants provide most accurate references?

Off ipeoifio - rage S

      (3)  The requirement that the active ingredient(s)
      certified limits comply with 40 cnt 15S.175 range of
      limits is understood; however, the requirement is
      applied  inconsistently and should be addressed here as
      a pioTiificant issue.  The rang* of limits for inert
      ing-radiants often need to be relatively vide in order
      to produce  products according to formulation
      performance standards such as vettability, emulsion
      characteristics, pellet friability, suspensioa
      properties, etc.  Further inert ingredient* can not
      generally be analyzed for.  Setting arbitrarily narrow
      limits serves no purpose and product submissions should
      not  be rejected on this basis.

      (4)  It is very helpful to add the label claim on the
      CSF  for  convenient and accurate reference.  Some
      registrants report the label claim for active
      ingredients at the bottom of the CSP fora and if the
      form is  updated, this could be added as an item to be

      (5)   Is reporting of the density, pB and flammability
      really needed or even appropriate on the CSF?  This is
      not confidential information and should not be provided
      to others  from this document.  This should be shared
      from the Product Chemistry Reports.

      (6)   What  is the intent for signing the CSF?  It
      generally  is not signed by a manufacturing
      representative who vould realistically have control of
      the process.  Other documents such as the label are not
      signed but accuracy of the document are understood to
      be accepted by  the  registrant providing the documents.

      (6)  Eov are  impurities of very low levels (ppm) best
      reported?   It  is not  realistic to  include them in
      column 13  where the  total weight is to be reported.

      (e)  Bow are  inert  ingredients that are sometimes added
      or  sometimes  not added to be  reported in columns 13 end
      14  This situation  occurs in  some  cases when minor
      inerts may or may not be needed to achieve correct
      properties such as  pH, color, wetting properties, etc.
      or  in cases such as spraying  a foam control agent as
      needed  to  control  foaming during manufacturing.  Some
      registrants have bean advised in these cases to report
      a very  low level of the  inert (0.001%) just to capture
      it  as an inert that may  be  used.

»*ge « • label

     CSF and Label
     difficult  to
                           la the ingredient veigata for  the
                        important tout la many case® are
                             risibility la these eas«« i«
tag* 7 • euioelime  €&

     USES' s ere  required for in«rt ingredients.  If
     alternate •eurces of inerts are used, are USD's
     the MW MUTO* also
                ^k^bsV & M ^ ^> vs^ev4Hk% v VN^^^B • vfe ^
                ^•smT^^BBL^Li^L^B ^E^sV^H^H.^^^L^Bm^B ^^D C

                of impurities during
      maaafaotttrias/fonMlatioo bay* not b««a
      g«o*r*l discussion including reasonably
      e&smieal reactions should suffios.
      Lack of agreement with quantities of ingredients
      in formulation with that reported in the CSF  is
      expected because batches are usually pilot scale  if  a
      study vbereas CSF utilises typical commercial batdi
      amounts for convenient mathematical conversion, i.e.
      100 pounds.  Are typical amounts in a batoli for the
      of real importance to the Agency?

                   Ires use of the registered purity of  an
      The CSF
      active ingredient,  whereas production amounts typically
      reflect actual  assay of the technical and adjustment of
      solvent or carrier are made in formulation process.
      Could the CSF and directions be provided in electronic
      form with built in calculations made where appropriate,
      i.e., totals and calculations limits of actives,
      correcting for  purity?

  Vage 7  • Guideline €2

      Five batch analyses are und«rstood to only be required
       for formulated products produced by an integrated
       system •upon request".  Heed for five (5) batdi
       analyses would be improved with clearer directions for
       integrated and non- Integra ted processes.

       Data  used as confirmatory to validated analytical
       r^tthods  (spectral, CC, or NKR) bav« generally not been
       provided and we beli«v« this should not be routinely

tags 7 • Guideline «J
     The requirement for conducting and reporting storage
     stability and corrosion characteristics tests needs to
     be clarified.

     Kissing data cannot be addreased vithin a study,  only
     by a vaiver.  This requires coordination of the
     registration manager and scientist submitting the
     study.  Can reasons for not completing required data be
     included in the study, while complying vith CLP
     requirements)?  Waivers could be included in the study
     review, industry often utilises the same vaiver
     response for every product submission for the same
     active  ingredient, vast ing reviav time and inflating
     tha rejection rate.

     Corrosion  continues to be a required element vhen it is
     tied to a  conditional study (storage stability) that is
     not submitted unless requested or negative in findings
     are identified (PR Notice 92-5).  Corrosion should be
     conditional or better defined to reduce the number of
     rejections and vaiver requests.
 Page 10
      (8 Under "General Reasons)   When reporting multiple
      aources of technical vith different Active ingredient
      percentages, could a single CSP fora ba prepared if
      agreement could be reached on the format or should an
      alternate CSP be prepared in each case?  One registrant
      has suggested soae ideas hov this could ba

      (2 Under "CSP) Options  "b" and "c" have in several
      cases been rejected previously.  A consistent policy
      needs to be applied here.  We support use of options
      "b" and "c" but using them should not result in
      rejections and delaya.

      (3 Under "CSP")  one registrant reported that tha
      nominal concentration vas identified vith a note at
      tha bottom of the CSP to avoid confusion Vith the
      numbers appearing in a  column and being confused and
      inappropriately added vith other numbers in column 13.

       (10 Under "CSP") Further clarification and sharing of
      ideas  on hov "Alternate" or  "Basic" formulation options
      should be reported  is proposed.

(it Under *CSF)  Tcis requirement for reporting
XOAC analytical Bethod number is nev and is not
necessarily appropriate.   Isporting tbs
Bethod should bs preferred.  Z& another  part of
report, tbs need to follow IUPJLC noBsnclatart i*
stated.  Tbese points need to bs clarified.

Other • When an active ingredient is not isolated, it is
preferred in many  cases to report tbe percent active
ingredient and impurities on tbe basis of tbe
as if it vere isolated.  1
                         fhis rtquirts additional
  request to better understand tbs statistical analysis
     in tbe report vas Bade by one registrant.  OB vbat
basis vere three revieverm (and  some times four)	
from tbe analysis and bov vas tbs overall rejection
rate of 2t% arrived at?

What vas tbe Bake-up of tbe reviewers:  Were tbey  all
or partially contract revievers?   If contract reviovers
vere used, does tbis explain soae of the variation
What quality Btasurss ars plannsd to •nsurs
consistancy in judgamsnt on tbs part of diffsrsnt

Will tbis analysis bs rspeatsd and prograss tovard
consistancy in rsvisv of studias bs rsportsd?

Raj set ion rats would bs rsducsd with »ors  formal
eoBBunication and vrittan guidancs form Product
CbaBistry Rsvl«v Ssction, i.a. issuance of SOP for
tschnieals, B&nufacturing us« products and and

Guidance iu format ion is typically subBltted in tbs form
of a study,  particularly for GRV 62 and «3.  Tbs
studies can only address conducted experiBents and
cannot include the absence of data as prescribed under
vaiver requests, which are subsitted under a cover
 letter by the registrant.

 Directions for the CSF should be consistent with those
 included in reregistration docvaents, which are Bore
 specific in completing physical property data, notably
 density which only adressess liquids  and solids.
 Directions for form  (§570-4) itaa 7,  only  addresses
 requireBents  for  formulated products.

Other considerations  forwarded as part  of this exercise
have been to explore  application of tha "Self
Cartif ication"  ccncapt to product chemistry packages  at
laast for salaotad cases.   Tba registrant* would also
like to better  understand how C8F filas am saintained
in IPA and to axplora means to assura that  both tha
registrant's and Agency's records are currant and
correct.  There have  also been challenges to the nev
requirement that two  original CSP's be  provided with
registration actions.

There is  interest in exploring with The Agency tha
preparation of  a nev CSP fora following discussion of
 the above items.  Lastly we believe that there may be
 benefit in holding a formulation seminar with
 representatives from formulation laboratories, industry
 registration representatives, and the Product Chemistry
 Review Section.  This could provide insight and
 understanding both for the reviewers and tha
 registration representatives.  Most of the above issues
 can be resolved by improved consistency and clearer
 guideline direction.  Separate activities involving the
 rewriting of 40 CFR 158 and the Pesticide Assessment
 Guidelines will also be helpful.

 After the Product Chemistry Review Section has the
 opportunity to review the comments in this document,
 industry representatives will make every effort to find
 a date before Christmas that will allow a meeting in
 the Washington, D.C. area to discuss details of the
 issues in an open forum setting.  We look forward to
 this opportunity.

        ftespons* to
                         On Sejeotiea ftate Analysis

         Generation of the  CSP U « guideline..
         five C8F is often associated with
         for filiaf purposes within the Agensy.  Tit* €SP~is,
         however, the official document which reflects  the
         registrant's specific product and it is treated as
A efeeefc list  for industry to oomplete.
Sine* eaofe item on the CSP is
could generally serve as a
fee filled in,  ai
                                                 tfef» «F
                                                Ml  itees are to
                    and any blanks should fes readily noticed.

     Clear direction should be provided to include .......
     The composition of the technical is listed on the CSP.
     This provides an explicit and detailed suKtary of the
     composition of the CSP.

     Botr are files on inert ingredients kept?
     Piles on inert ingredients are generally filed
     according to the manufacturer and kept in a separate
     file area.  Piles are generally updated when new
     information is provided.
     S)   Tb« r*quir«a«nt that th« activ« ingredient* (•)
          certified limits comply with 40 CPR 15t.l75	
          Xgree.   This area is one which atftds to be

     €)   It is very helpful to add the label claim....
          Agree.  This is generally dona.

     7)   Is reporting of the dansity,	
          Since the CSP serves as a summary of the composition of
          the product, these characteristics help to further
          describe the product.

     8)   What  is the intent  for signing tb« CSP?
          The comments are  relevant,  and th« signing of th« CSP
          may not be  needed.   Hov«v«r, the signing does
          demonstrate a  lev«l of responsibility with the company.
          Presumably, the person signing assumes the
          responsibility for correctness.

      9)   Bow are  impurities of vary low  Isvsls  (ppm)....
          Impurities  of very low levels are reported as found.
          Xf no levels are detected,  then the  leval reported is
          usually the detection limit (Per ax&sple, 
           10)   lev ara  inert ingredients  that ara sometimes addad	
                 Tha usual  procedure is to  identify those  ingradiants
                 that  ara actually addad to tha product.   Zf other
                 ingradiants are available  vhich oould b«  us«d,  than
                 such  ingradiants ara listed as alternates.   Tbo levels
                 listed under those actually addad ara considered to
                 refer also to any alternate unless otherwise Indicated.
                 Any  inerts vhich may ba added should be 1 is tad.  The
                 levels vhich may ba expected to be added  should ba

       11.  Coordinating  changes in tha ingredient weight* for CiF and
       label  ara important  but in many casas ara difficult to achieve.
       Flexibility in these cases is needed.
        Ghangas in ingrodiant vaights ara parmittad at long as tha
        parcant by vaight of pura activa ingradiant remains tha sama.
        Tha vaights of inert ingradiants may ba variad as long as tha
        parcant by vaight of all inart ingradiants is tha
        12.  USDS' s ara required for inert ingradiants.   Zf alternate
        sources of inarts ara used, ara MSDS's from that source also
        KSD6'» ara not required to be subsitted for inert ingredients
        from end-use products unless the inert ingredient is a nav inert
        as specified in PR Notice 91-2.  MSDS may be required on case by
        case basis.

        13.  Degree of details required in discussion on the formation of
        impurities during manufacturing/formulation have not bean
        consistent.  A general discussion including reasonable feasible
        chemical  reaction should suffice.


        For non- integrated  formulations where active ingredient sources
        ara EPA registered,  a  general discussion is adequate, unless the
        impurity  is  toxicologically  significant.  For products produced
        by integrated  formulation  in vhich case the source of active
        ingredient is  not  EPA  registered, then a complete detailed
        discussion of  impurities  is  required.

14.  Lac* of agroaaant with quantities of ingredient*
formulation vith that reported la the Ctr U expected
batches are usually pilot seal* ia a study, vberaas C?F utilises
typical commercial batch amounts for oonvaaiaat »ath«iiatioai
ooaversioa, i.o. 100 pounds,  are typical amounts ia a batch for
tha Ctr of raal importance to tha agency?
 raflact tha typical
                           of  Formula and tha labal claim ahoul4
                            praaant in  tha fonailata4 pro^stf
                          la tha lovar and uppar eartifla€ limits.

              Tba CSF roquiras uaa of ragiatarad wurity of an
actlva iagradiaat, vharaaa production amouata typiemlly rafloot
actual aaaay of tha tachnical  and adjuataant of aolvai^ or
oarriar ara aada in foranlatioa procaaaaa.  Could th* CSV and
Airaotiona bo providad  ia alactroaic fora vita built ia
calculations aada vfcara appropriata, i.a.r totala and calculation
of liaita of aotiva, oorracting for purity?

amavar to Qw«itioa  us


Q«**tiom  i
Questioa  17 1   Data used as confirmatory to validated analytical
methods  (spectral, GC, or KXR) have generally Dot be«n provided
and we believe this should not be routinely needed.

Aaswwr to Questiom 17 1

Analytical methods for new technicals vill need to b» validated
by the XPA's laboratory in Beltsville, Maryland.  Therefore,
product  samples  (GRH-1) , complete description of the method,
company  validated data, method precision, method accuracy, staple
calculation, and sample chroma togramn are needed to be submitted
to KPA's laboratory for validation.  Published methods acceptable
to the scientific community  (AOAC, ACS, ASTK, company scientists,
etc.) can be referenced. Further, EPA approved enforcement
methods for technical sources, can be referenced when submittinf
 for registration or reregistration of products containing these

 Question Its  The requirement for conducting and reporting
 storage stability and corrosion characteristics needs to be

 Answer to Question its

 The storage stability and corrosion characteristics studies,
 requirements  of  GRNs  63-17 and 63-20, respectively should be
 conducted for at least one year vhen the product is stored in
 commercial packaging  materials under ambient warehouse
 conditions.   Some registrants, tend to take the short cut and
 conduct  a short  term  stability study  (14 to 30 days) , a
 requirement of CRN 63-13  for the  technical grade of active
 ingredient. The  chemist  promptly  rejects this information
 requesting  compliance with the guidelines.  Both studies can be
 conducted simultaneously and the  results can be submitted in the
 form of  sample  analysis  to satisfy the storage stability and
 visual  observations to  satisfy the corrosion characteristics.

      7 -Guide line 63
       19)   Kissing data cannot be addressed within a study; only
            by a vaiver.  Reasons for not completing required data
            are often included in the study.  The presence of CLP
            requirements does not prevent a discussion of missing

       20)   Corrosion continues to be a required element when it is
            tied to a conditional study (storage stability) ........
            The test for corrosion is a separate test for the
            product.  The applicants often make the association
            with storage stability since it  is convenient.

tl.  (ft Smdar "asmaral laasoma")  ifeam rsportimf
of tooaaioal vitto «if faraat aetiva  iagredlamt pateaa
a simgla Car form ba prsparsd if agrtamaat soaid to®
tas format or smomld am  altarmata cm? ba fnpAr«4 ia
             vith 4if f«r«Bt «otiv«
            siagl* OF.  Za ftooordaao* vitfc 40 CF1
                                                          nay te
do mot qualify  as am altarnata forsulatiea.
            fba Inatructlona eo tte C8f {Itm 10)
                          aboold b« lUt«d.

 pelvam IS
                             vita a mot* at t** better •£
                   vita ta« atab«n app^agimg im a
               amd iaappropriatrtj a4d«4 vita otaav
      This is an aoe*pt*bl« practice. IB aooordano« vith PR-Mot ic«
 91-2, th« iabal elaim must «qual th« noainal ooneantratiee.
 8Lnc« thara i« no plae« on th« CSF for t2M nominal oojy>3ntr«tion,
 placing it at tfca bottom and identifying it vita an astariak ia
 14.   (&• o&dar "CST^) rartaar olarifieatioa amd abazim  of i«aaa
 om mov "mltarmata1* or "Ba»lo» formolatiea optioas
 raportad ia proposad.
      With tlM prosant format  of  the CSF, th« r^istrmnt ia to
  chock  tho box vhich id«ntifi«s tho formulation aa basic or
  altamata.  If  th«r« is moro  than on« altarnato, thtso should bs
  distinguishod should lat«r r«f«r«nc« bscom« n«c«ssary« i.a..
  altarnats 1, 2, ate.

*••  (1 , uader «*€«?•)
        ,               Tsis requirem
*&*lytio*l »etmo4  lumber is »ow aa4
                                     it for reportiag tae
   -.	—- -  ... ..  _-  —  — *• aot aeoessarilT
appropriate,  lepertimg tae  emforoemeat metao4 sae«14 be
preferred.  la aaotaer  pert  of tae report, tae aoee*  to  follow
      nomeaolature is stated.  Taese poiats aee4  to
     In accordance with the Pesticide Assessment Guidelines   a
description of  the analytical methods must be provided.  The
description should be  a detailed description of each  stop  in  the
analytical method and  a statement of the precision and accuracy
of the analytical method.   However,  a method may be referenced
which is standard for  determining the per cent of the component
involved.                                                ^^

     Since the  ZUPAC provides standard rules for naming  chemical
compounds, its  guidelines/rules  are  to be used for naming
chemical compounds.

29.  otaer-wasa am aotivs  iagredieat is aot isolated, it is
preferred ia maa? oases to report tae pereeat active  iagradiant
tad impurities  em the  basis of the teeaaioal as if it wars
isolated.   This requires  additional disoussioa.

     An active  ingredient  is to  be reported as it is  or  will  be
used in the formulation.

   27.  The rejection  rate  analysis  for new submissions for
   registration, new submissions  for raregistration, and
   resubmissions were  made  before  (33 ± 20%) and after (23  ± 11%)
   three chemists transferred  from the Section.  The figures were
   arrived at by simply asking each chemist to estimate his/her
   rejection rate for  the  indicated type of submission.
        For the rejection rates of the Confidential statement of
   f?*!??* i?Fa)i Lab€l*'  and Product chemistry information (CRN
   61-63), the  rejection rate  analysis was conducted with the
   current group of six chemists.  Each chemist kept track of his or
   her rejections of the CSFs, Labels, and Product Chemistry (CRN
   Series 61, 62 and 63 information)  and of the reasons for the
   rejection of the latter, over a period of about 6 months.   The
   results were then tabulated, i.e., 23 t 10% for the CSPs,  14 ±
   10% for the  Labels  and 12 ± 7% for the Product Chemistry
   including a  breakdown of the rejections for each reason.

   28.  one of  the reviewers is supported under a contract  with the
   American Association of Retired Persons (AARP).  NO other
   contractor was used.  The variations in the rejection rates
   appear to be due largely to the differences among the chemists  in
   their interpretation of the data requirements and of the adecuacy
   of the information provided.                                    *

29.    (1)   By  continued checking of tha  Product Chemistry reports
of tha chemists by tha Section Bead (or  taam leader)  to
facilitate consistent reviews by tha chemists and (2) by
continued maating with tha chemists as a group to review and
aoraa upon tha Coda of Federal of Regulation* (crm) for ton
product  Chemistry (plus tha CSF or Confidantial statsjmejit of

      Peer review meetinga (with a chairman) similar to those
conducted by tha Industrial Chemistry Branch of OPPT for their
ptfX raviaws has been triad but were not particularly baaaficial.
gm»p meetings may ba triad again, possible with a saallar, mora
sal act group of submissions.

30.  Tha rajaction rates have decreased significantly in tb* past
24 months, i.e., from about 50% to 23%,  particularly in tha area
of tha product chemistry properties  (CRN Series 63).  Tha
rajaction  rataa in general will continue to ba monitored and an
analyses of tha rejection rates repeated if necessary, e.g., if
tha rajaction rate exceeds 10%  (and  there  is no clear reason or
 solution for  this).

 31.   SOPs  for Technical, Manufacturing Use and End Use Products
 vill  ba updated according to  the  need and  our resources.

 32.   Where required  for the pure  active  ingredient,  tha backup
 data may be waived provided a relevant  literature  reference ia
 cited.   Data  may  also ba waived for a technical, manufacturing-
 use product or end-use product if there is a sound technical
 raason  for not obtaining such data.  We ara  currently looking
 into tha streamlining of specific  data requirements for the CRN
 Series  63 properties, relevant to our current  reviews and  future

 33.  We currently require the pH, density, and flammability,
 where technically sound, for the reregistration as well as tha
 registration of a technical,  KP or EP (pertinent to  any exposure
 and/or physical/chemical hazard from the handling/use of the
 product).  Such information should be on the CSF and consistent
 vith tha  values or information in the latest product chemlatry
  information.  This information where relevant should also  b*
  provided  for aerosola  (for the liquid phase for pH and density,
  and  for the  entire product for flaraability determination).

         $41  Other considerations forwarded as part of thia
exercise have been to sxplore application of tha
•felf certification* concept to product chemistry packages* tt
least Cor selected casas.  Tha regiatrants would also  ilka to
better understand how CSF files are maintained in IF*  and to
explore »^an» to a**ur» that both th«  r*gi§tr*nt'« and &g«ncy'c
raoord* ar« ourr«at and oorract.  Tbaro hava also b««B ehallanga*
to tha nav r«quir«»ant that two original CSF' a b« providad vith
ra^iatration action*.

JLanrar to Quaatioa 34 1

On tha Uaua of Product Oxamiatry Salf-Cartificatioat  At praaant
a coudttaa i*  looking into tha faaaibility of a "Salf-
Cartification"  program that vill covar product
 On tha  iaaua  of maintaining tha CSF filaa:    Bard copiaa  of tha
 CSF's ara  circulatod to tha acianca branchac for raviav,  than
 filad in tha  corresponding jackat* in ona brovn anvalopa  attachad
 to tha  jackat's intarior covar.  Tba antira jackat U CBI that
 can  ba  chackod only by rogulatora claarad for handling CBI
 information.   All CSF' a, old and nav, ara foldad and atorad in
 tha  saaa anvalop*.  In addition, tha Pro j act Coordination Sac t ion
 of tha  Ragiatration Support Br&nch/RO ia currant ly scanning tha
 CSFs of all products, a program that may taka mora than two yaars
 to complata.   Zf and when CBI  information can ba diaaaminatad
 alactronically aaong OPP'a program officaa, tha chamiats  vill
 hava tha option of using alactronic CSFs for rafarancas instaad
 of hard copias that requira borrow ing tha full jackat and mora
 tima to process.

 On tha iasua of requiring two  original CSFa va ars not avara of
 this requirement.

Question lit   There  is  interest im Deploring vitb tte Jtaeaoy tha
preparation of a nov CSF form folloving discussion of the abovo
items.   Lastly ve boliovo that there may be benefit im holding a
Formulation Seminar  vith representatives from formuUtioa
laboratories, industry  registration representativea, i
Chemistry lavlev Section.  This could provide iasigStt
understanding both for  tho revievers and the registrar
representatives.  Most  of the above issues can bo resolved by
improved consistency and clearer guideline direction*.  Separate
activities involving the revriting of 40 CFft IS* and f
                      Guidelines vill also be helpful.
                 om lit
 OB tbo iacoo of tbo C8F vo agroo.  * rovlaod C87 earn bo
 frioadly and oxplioit.  Sovoral isouao will noo4 to bo e£ariflo4,
 inel«diag but not limltod tot  CBZ and ooa-CBX information,
 nominal oonooatrations, product purity, product typo
 (inooetieido, barbieido, ote.) and elaoo  
Meeting with Industry and Association on 2/29/96 at CS-1 to Discuss
    Rejection Rate Analysis

    The purpose of this meeting was to discuss the responses from the
Product Chemistry Review Section (PCRS) to the questions and
suggestions by Industry on this Rejection Rate Analysis report. The
agenda of the meeting, questions and suggestions from Industry on how
to improve the product chemistry reviews and reduce the rejection
rate/ and PCRS's answers are attached.  Also attached are key
comments and suggestions made at the meeting on how to improve the
product chemistry reviews.  These pertained largely to the CSF
(Confidential Statement of Formula) to make it more "user friendly"
to the submitter or registrants.  It was agreed that OPP would be
receptive to a specific proposal from industry involving a .revised
and improved fora for the CSF.

                                                H. Podall

              HATSBP BY
               PBRTMKTHq  TO THB  COKFIDgirriXl.
IC8F1 1
            There is a need for an KRXD number to track the CSF.
Answers  The CSF is currently bain? tracked by ona or more MRJDs in
connection vith or as part of the submit tad data.  Upon reviewing
tha  submitted data,  raflactad  on tha CSF,  rafarancas ara made to
tha  Reg. *o.  and data on tha CSF.  Therefore, additional tracking
sheets vili not ba nacassary.

Question;  Is it nacassary to usa cartifiad limits for inarts?

xn«vers     Cartifiad   limits   for   inarts  ara   regulated   by
40CFR158.155(b) , (c)«(d) .   With tha  axcaption  of  enforcing  tha
nominal concantrations and limits for tha activa ingredients and
thosa  of  toxicological concarn,  anforcamant mathods  for othar
 ino^adiants ara not ragulatad (40CFRI158.180) .  It follovs that tha
 limits  for ingradiants of non  toxicological  concarn  ara  flaxibla.
             Thara  is naad for flexibility in raporting
             «t -
 Xnav«r:   Sinca  altarnata formulations ara considared as similar
 products,   tha regulations  of  40CFRI152.43  apply.    Similar  or
 Substantially  Similar  Products rafars  to products  of similar
 composition which  (a) hava tha sama nominal concantrations of tha
 activa  ingradiants  as  thosa  of tha  ragistarad product  (labal
 claim);  (b)   unlika  tha  regulations  of  [40CFR§152.43(1) ],  tha
 cartifiad  limits  for aach activa ingredient  should  be within the
 standard limits  of  4OCFRf 158.175; (c) tha inert ingredients are
 claarad for  food/non-food uses,* (d) substitution of an inert vith
 another should not affect the  physical/chemical properties  of the
 product;   (a) tha upper  limits of ingredients  of  toxicological
 concarn  must not exceed those  found in the  registered product
  [40CFRS152.43 (2) ];  (f)  the upper limits  of ingredients of non
  toxicological concern ara flexible; (g) the labal text/precautions
  of  similar products  must be identical [40CFRS152.43 (3) ];  (h) the
  anforcamant analytical methods must b« suitable for  use on similar
  products  (40CFR§152.43(4) ];  and  (i) minor  changes  in labeling
  and/or composition from a currently  registered  product should not
  s'ignificantly increase the risk to man and the environment.  It
  should be noted  that product similarity is compared against one
  registered product, not two or nore.  When more than one alternate
  formulation  under the  same Reg. No.  and of tha same date,  it  is
  preferable to distinguish between the formulations  by designating
  them as "Alt l","Alt 2", etc.
  Question;   Tha  current CSF,  Fora  8570-4,   is not suitable  for
  technicals.  There is  a  need  to develop one.

   Answer;   Tha industry workgroup will contribute to developing, a

more  "Friendly  user  Form"  that may  accommodate  technicals  and
standardize the vay the  nominal concentration  can  be  expressed on
the CSFs.

Question;  References were made, during the meeting, to a recent FR
Notice  pertaining to  revising the product chemistry  Guidelines.
Industry wanted to know the number and date  of publication.

Answer:  One industry member stated that he has access to published
Notices and he will provide the number and date of publications to
industry members.

Question;  There is a need to standardize the nominal concentration
on the CSF.

Answer;  This issue  and the  next  (17) are part of upgrading the
current CSF cited under issues  I4 above.

 Question;    There  is  a need to  standardize  the density units
 required in box 7 of the CSF.

 Answer;  Depending on the  nature  of the product, densities can be
 expressed in g/ml, g/cc,  Ibs/gal  or lbs/ft3-

 Question;  Is there  a need to sign the CSF?
The purpose  of signing the CSF is to provide  a  contact
  Question;  How are toxic components of end-use products documented
  on the CSFs?

  Answer;  Ingredients designated by the Agency as  toxicologically
  significant  as  per PR Notice 90-1 should  be  listed on the CS~s of
  pesticide products.   The percentages by weight off such ingredients
  should be listed  in Column 13 (b)  and the upper limits  in Column
  14 (a).

  Questiop; What is the deadline for compliance with PR Notice 91-2
  pertaining to enforcing the nominal concentrations  on the labels of
  products undergoing  reregistration?

  Answer:  The deadline for products undergoing registration  is July,
  1997.    The  deadline  for  reregistration  runs parallel to  the
  decision-making process on  reregistration actions  even if  they are
  delayed  to  or  beyond  the year 2002  as mandated by congressional

  Quest ion,;  How are inerts of finite amounts  listed on -the CSFs?

   Answer;   They may be listed in percentages or parts per million if

so determined.
           What is the situation vith electronic forms of the CSF«?
Answer;    Because the  CSFs are classified  documents,  electronic
forms  are not in use at this tiae.
 Question;  Bov can missing data and data vaiver* b« justified?

 Answer;  Kissing data can be justified by stating tte«t the testing
 is in progress  or is not applicable as per PR notice 52-5*  Data
 waivers  can  be  justified  on the  basis  of  regulatory  .and/or
 scientific reasons.   Examples;  the requirement is not applicable
 because  the  product  is  solid,  or  liquid,  do*s  not  contain a
 combustible  liquid,  is not recommended for use  around electrical
 equipment, etc.   Kissing data and data vaiver not accompanied by a
 statement,  are  entered  in the  computer  systea  as  data  gaps.
 Therefore,  it is  advisable  for applicants to make the  necessary
 statements .

 Question; The corrosion characteristics continues  to be a required
 element when it is tied to a conditional study (storage stability) .
 The corrosion characteristics study should be conditional or better
 defined to reduce the number of rejections and vaiver requests.

 Answer;  The corrosion characteristics  and storage stability  are
 tvo  separate  properties  which  can be  determined  separately.
 However,  since both studies have common  experimental  design  and
  duration, both  tests can be carried out simultaneously.

  Question;    Is  there a  need  to report  impurities from  cross
  contamination  on the CSFs?

  Answer:  Carryover impurities of toxicological  concern  from cross
  contamination should be reported to  the Agency.   There  is no need
  to report cross contaminants on the  CSFs.

   Question;   What  are  the implications  of  the  ongoing  project
   pertaining to Product Chemistry Self-Certification?

   Answer;  An OPP coaaittee    has looked  into  the feasibility of
   "Self-Certification"    which    would    cover    non- integrated
   manufacturing-use  and end-use pesticide products.   It  is  planned
   that  a PR Notice will be  published  during this  fiscal year, for
   solicitation  of public comments prior  to final publication.  The
   program should  achieve  its stated  objective  of  streamlining,
   simplification and acceleration of the registration/reregistration
   process for such products.

Question;   What are the reasonf  of requiring duplicate  copits of
the CSFS?

Answer;  The Product Chemistry Review Section is not aware of such
regulations.  Duplicate copies, however, My facilitate the review

Question;    Ingredients of pesticidal  activity/  should they be
listed separately on the label and CSFs?

Answers Tes.  As per PR notice 81-4,  each ingredient of pesticidal
Activity at >  0.1% by weight  should be  listed separately  on the
label  and CSF  as "Related Compounds".     Ingredients of  non-
pesticidal activity are Included with the inert ingredient* on both
the label and CSF.

Question:   Should net hods  of  analysis  be provided  for  toxic
 Ingredients as per PR notice -81-4?

 Ansver; Tes.  Methods for  the active ingredients, impurities, and
 those of  toxicological concern are required as per 40CFTIS138.HO.

 Question:  What comprises  a trade secret?

 Answer;   On  the  basis  of  FIFRASlO(l) (A), (B),  or  (C),  product
 chemistry data requirements which are considered to be trade secret
 or "CBI", meaning Confidential Business Information, comprises GRRs
 61-2,  61-3, 62-1 and  62-2.  The analytical methods  for  the active
 Ingredients  are  non-CBI, whereas   methods for  ingredients  ot
 toxicological   concern,  If  any,  are CBI.    The  CSFs, although
 containing non-CBI information, are considered CBI.  Labels of all
 products are non-CBI.  It should be noted that the certified limits
  for the active ingredients on  the CSFs are non-CBI.  The limits are
 made available to the states  for  enforcement.

  Question;   What  are the requirements  of the  Good  Laboratory
  Practices Standard (GLP)?

  Answer;  As per  40 CFR 160.135 all provisions of  the GLP standards
  described  in  Part 160 of 40 CFR apply to CRN  62-1  (preliminary
  analysis), 62-3 (enforcement  analytical method), 63-8 (solubility),
  63-9  (vapor pressure), 63-11  (K^) and  63-13 (stability).

        All provisions of the GLP standards, except  those listed un 40
  CFR  160.135(b),  apply  t'o  the  following  properties;    product
  identity 61-1, manufacturing process 61-2, discussion of impurities
  61-3,  certification of   ingredient limits  62-2,  color  63-2*,
  physical state 63-3, odor 63-4*, mj>.  63-5*, b.p. 63-6*',  density
  63-7,   dissociation constant 63-10*, pH 63-12, oxidising/reducing
  action   63-14, flammability 63-15, explodability 63-16,  storage

stability  63-17,  viscosity  63-18,  miscibility 63-19,  corrosion
characteristics  63-20,  dielectric breakdown voltage 63-21.  Those
properties with  asterisks are required only for technicals and not
CPs unless the EPs are produced  in an  integrated system.

Question:  Is the Agency  checking to  see if they have the
           fragrance data before  requesting it?

Answer:   Yes.  A search  is  always performed in Agency's Chemical
           Vocabulary/ where all  inert ingredients  including dyes
           and perfumes are  entered once complete chemical.
           identity is received.  However,  for each  different trade
           name, complete chemical identity is required  unless it
           appears  in Chemical Vocabulary*

 Question: Seven percent  of the rejections for  the  CSFs  are  due to
           inert ingredient deficiencies.  Would  EPA be able  to
           identify how many of these were due  to dye/fragrance

 Answer:   About 1%.  There  are many cases where registrant will
           enter up to 40 alternate dyes and fragrances.

 Question: How many dye/fragrances have been outright rejected
            due to the lack  of  sufficient information in the
            last 5 years?

  Answer:   This question mayhaveto be further clarified. If  the
            use  of the term  sufficient information  is meant to
             Include the necessary toxlcological, ecotoxicological,
             and  environmental fate data, the answer would be few,
             if any rejections. If sufficient information means
             compositional information only, the number would be
             significantly greater. Unfortunately, many fragrances
             are  not accepted due to the lack of compositional
             information.  If a new component exceeds 0.1% in the
             formulated product, it is considered a  new inert

   Question:  How much time is  spent (estimated) dealing with  the
             dye/fragrance issues?

   Answer:   Dyes  and fragrances  are  considered inert ingredients.
             It  takes about  the same  time to verify a particular
             dye and/or perfume in the formula as any other inert
              ingredient unless it is a new dye or a new perfume
              for which  the complete chemical identity is required.

Question:  Why can't the Agency provide a  list of all
           dye/fragrances that have been accepted for certain
           use products( e.g., antimicrobials)?

Answer:    A listing of accepted dyes and  fragrances by product
           type may be construed as trade  secret information that
           is protected from disclosure under section 10 of FXFRA.
           An alternative would be a  listing of dyes and/or
           fragrances, preferably by  trade name and manufacturer.
           Before such a list could be disseminated, EPA would
           liXely need the consent of the  fragrance/dye
           manufacturers to list their products by trade name.
           Our previous experience indicate at least some of the
           manufactures may b« reluctant  (if not opposed to)
           providing such consent.  One alternative that is
           currently available to  registrants is to inquire
           whether  we  have the requisite  information on a given
           dye or fragrance prior  to  using that component in a

 Question: Would the  Agency be willing to sit down with
            formulators and dye/fragrances suppliers to develop a
            system  that works  better  than the current one?

 Answer:    The Agency is certainly willing to  consider ways to
            enhance its efficiency in the regulation of pesticides,
            including suggestions for improvements  in this area.

 Question: Some rejections occur because the percentages for
            active and inert ingredients are not aligned according
            to the decimal point or the active and inert
            ingredients headings are  not aligned to same margin.
            Are  all product chemistry reviews in agreement with
            this? Many household products do not seem to  follow
            this format.

  Answer:   This is a  labeling issue  and the final printed  label
            is expected  to comply with what is required in

  Question:  Is  the  Label  Review Manual consistent with 40CFR
             for the placement of  Ingredient statement?

  Answer:    Yes. The Label Review  Manual  is consistent with
             40CFRS156.10(6)(2)(i). For  further information on
             this,  you may contact  Mr. Jim Downing of the Labeling
             group of the Registration Support branch

Question: What  is  being  don*  in  regards to possible  siodifi cat ions
          of the csr?

Answer:   The Product  Cheaistry  Review Section is currently
          reviewing the  suggestions  Bade  by  an Industry Workgroup
          headed up by Dr.  Lyn Lail  of Clba-Geigy.