GUIDANCE  FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS

              CONTAINING

       POTASSIUM BROMIDE (KBr)	

      AS THE  ACTIVE INGREDIENT
           Case Number 342
  ENVIRONMENTAL PROTECTION AGENCY
     OFFICE OF PESTICIDE PROGRAMS

       WASHINGTON, D.C.  20460

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                                                            279S2
                        TABLE  OF CONTENTS
                                                                Page

I.     Introduction 	    1

II.    Regulatory  Position and Rationale      	    4

III.   Requirement for Submission of Generic Data	   18

IV.    Requirement for Submission of Product-Specific
      Data	   27
                                                                  4
V.     Submission  of Revised Labeling  and Packaging                <
      Information	   31

      A.   Label Contents	   31

          1.   Product Name	   31
          2.   Company Name and Address	   31
          3.   Net Contents	   31
          4.   Product Registration Number	   32
          5.   Producing Establishment
              Registration Number	 .  .   32
          6A   Ingredient Statement	.-  .   32
          6B   Pounds Per Gallon Statement	.  .   32
          7v   Front Panel Precautionary Statements ......   32
          7A   Child Hazard Warning Statements. . .'	   33
          7B   Signal Word	   53
          7C   Skull and Crossbones and Word Poison	   33
          7D   Statement of Practical  Treatment 	   33
          7E   Referral Statement 	   33
          8.   Side/Back Panel  Precautionary Labeling 	   33
          8A   Hazard to Humans and Domestic Animals	   3Zf
          SB   Environmental Hazard	   3/t
          8C   Physical or Chemical Hazard	   34
          9   Misuse Statement  	   35
          10A Storage and Disposal Block 	   35
          10B Directions for Use	   35

      B.   Collateral Information	   35

VI.    Instructions for Submission. .	   36

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                             APPENDICES



 III-l      Bibliography.  	

 III-2      FIFRA S3(c)(2)(B) Summary Sheet  -  EPA Form 8580-1 .

 III-3      Certification of Attempt to Enter  Into an Agreement
           With Other Registrants  for Development of Data
           EPA Form 8580-6  	

 IV-1       Product Specific Data Report  (End-Use Products)
           EPA Form 8580-4  . .  .	
V-l         Labeling Requirements, Section 162.10 of 40 CFR 	
 V-2        Table of Labeling Requirements and Sample Labels. .

 V-3        Physical/Chemical Hazards Labeling Statement.  .  . .

 V-4        Storage and Disposal Instructions  	

 Note:      Appendices v-2,  V-5  and V-6 are  not germane to this
           document and are not included.

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                                                                 (1)


                         INTRODUCTION

     The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g)),as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible.
Each registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.

     To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1,
1977. These pesticides will be reviewed in use clusters
which are prioritized on the basis of a ranking scheme giving
preference to pesticides used on food and feed crops.

     The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient.  Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use
of the pesticide poses no potential adverse effects to human
health or the environment.

     The scientific review, which is not contained herein
but is available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data.  However, during the review of these data we are also
looking for potential hazards that may be associated with
the formulated (end-use) products that contain the active
ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.

     EPA has the authority under FIFRA §3(c)(2)(B) to require
that certain registrants submit generic data that will answer
our questions regarding the hazard that may result from the
intended use of the pesticide under review.  Further, §3(c)
(2)(B) provides that these data are to be submitted by
those registrants who do not qualify for the fc rmulator's
exemption [FIFRA §3(c)(2)(D)].  Normally, this means that
the registrants who are responsible for fillii.g the data
gaps are the manufacturina-use product producers (basic

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                                                                (2)
suppliers of the active ingredient).  However, end-use producers
will not qualify for the formulator's exemption if the source of
their active ingredient: (1) is not registered with EPA, and/or
(2) is produced by the registrant's firm, or by a firm which has
ownership in common with the registrant's firm.  These end-use
producers can qualify for the formulator's exemption if they change
their source of supply to a registered source, provided the source
does not share ownership in common with the registrant's firm.  If
the end-use product registrant decides to switch sources, a new
Confidential Statement of Formula, EPA Form 8570-4, must be sub-
mitted to the appropriate Product Manager within 90 days of re-
ceipt of this Guidance Document.  The chart on the following page
shows what is generally required of those who do and do not qual-
ify for the formulator's exemption in the Registration Standards
program.

     If you decide to request the Agency to discontinue the re-
gistration of any of your products subject to the reregistration
requirements of this ;Guidance Document, please notify the Prod-
uct Manager named in the cover letter, within 90 days from
receipt of this document, that you wish to voluntarily cancel the
registration(s).  If you decide to maintain your product registra-
tion(s), you must provide the information described in the follow-
ing pages within the time frames outlined.  EPA will issue a no-
tice of intent to cancel or suspend the registration of any cur-
rently registered product if you fail to comply with the require-
ments set forth in this Guidance Document.

     This Guidance Document will be supplemented by EPA with ad-
ditional information about compliance with data support require-
ments. In Union Carbide Agricultural Products Co., Inc. v Ruckels
haus, EPA was enjoined  from permitting or implementing any use of
data where the submitter's compensation  is to be determined under
Section 3(c)(l)(D) of the FIFRA. EPA  is  assessing  the  implications
of the injunction for the reregistration process.  Because this
situation is currently  unresolved, EPA has decided to proceed with
those requirements in this Guidance Document which do not relate to
compliance with the §3(c)(l)(D) provisions, and to supplement the
document with additional guidance when circumstances permit.
Failure to comply with  the provisions of the subsequent guidance
will also result in issuance by EPA of an intent to cancel the
affected product registration(s).

     Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide.  You
should notify the Agency of interim results of studies in prog-
ress if those results show possible adverse effects.

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                                                               (3)
  PRODUCTS SUBJECT TO THE
  REGISTRATION STANDARDS PROGRAM
  ACTION(S) REQUIRED TO
  MAINTAIN REGISTRATION
I.  Products That Do Not Qualify
   For The Formulator's Exemption

   A. Single Active Ingredient
      Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
   B. Multiple Active Ingredient
      Products
 See Section C(l)(b)on page 7,
 and Section C(3)(b) on page 8
 of this standard,
II.  Products That Do Qualify For
     The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to th-e Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who  also  produce  a  manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified  in the Guidance
Document for manufacturing-use product(s).  Such end-use  products
will be subject to the labeling changes required for  products in "II"
above. If there are no manufacturing-use products registered by any
company end-use products will be required to  be reregistered.

NOTE: If all registrants in  "I" above  fail  to meet  the requirements  in
I-A and B above, then the registrants  in "II" lose  their right  to
qualify for the formulator's exemption and  become subject to the
requirements in I-A and B.                        .     	

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                             (4)

     II REGULATORY POSITION AND RATIONALE


A-  INTRODUCTION

    Registration standards describe the regulatory position
    and rationale for all registered manufacturing-use prod-
    ucts (MUPs) containing the chemical under review as the
    sole active ingredient.  End-use products (EUPs) are
    reviewed only when there are no MUPs registered or when
    a label is changed significantly.  There are no regis-
    tered MUPs containing Potassium Bromide as the sole act-
    ive ingredient.  Furthermore, there is only one regis-
    tered end-use product (EUP) containing this chemical, and
    it contains two other active ingredients.  Therefore this
    standard describes the regulatory position and rationale
    for the unregistered technical grade of Potassium Bromide
    (in the event a prospective registrant wishes to regis-
    ter it as an MUP), and for the only registered use appear-
    ing on the approved label of the registered product con-
    taining this chemical.

    1.  Manufacturing-Use Products (MUPs)

        Potassium Bromide is not registered as a manufact-
        uring-use product (MUP).  The technical grade of the
        active ingredient is available as an unregistered
        material from chemical supply houses, at about 99%
        purity.  The non-pesticidal uses for this chemical
        outnumber and outweigh  in economic importance the
        pesticidal use.  Therefore this standard is a modifi-
        cation of the usual standard:  it applies to the ap-
        proved uses of the only registered product contain-
        ing this chemical, an end-use product containing
        multiple active ingredients.

    2.  End-Use Products (EUPs)

        The registered product containing Potassium Bromide
        as an active ingredient is an end-use Product (EUP):

        SAF-SOL Brand For Istitutional Use
        EPA Registration No. 875-42
        Diversey Wyandotte
        1532 Biddle Ave
        Wyandotte, MI 48192

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                             (5)

    The approved label for the registered product lists
    three active ingredients:

    Sodium Hypochlorite         3.25%
    Potassium Bromide           2.00%
    Sodium Phosphate           89.75%

    The product was registered on August 15, 1960, without any
    supporting acute toxicity data.  The approved label bears
    the signal word WARNING, which places it in toxicity cate-
    gory II, most probably because the rpoduct contains 89.75%
    Sodium Phosphate, a chemical which may be irritating to
    eyes at this concentration.

B•   DESCRIPTION OF THE CHEMICAL

    Potassium Bromide is an old,  well known inorganic
    chemical whose chemical and toxicological properties are
    extensively documented in the published literature.  The
    Merck Index, 4th Edition,  provides the following informa-
    tion for this chemical:  KBr, molecular weight 119.01,
    Br 47.85%. K 23.41%, O 28.74%, colorless crystals or
    white granules, or powder;  density 2.75, melting point
    730°C; 1 gram dissolves in 1.5 ml water or in 250 ml
    alcohol.  The aqueous solution is neutral.  Human Toxi-
    city:  large doses cause central nervous system depression;
    prolonged intake may cause mental deterioration, acneform
    skin eruptions.  Uses;  sedative, anti-convulsant.

    The Chemical Abstracts Service (CAS) Registry number is
    7758-02-3: the EPA Chemical Code Number is 041101.

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                              (6)

 C.   REGULATORY_POSITION  AND RATIONALE

     After reviewing  and  evaluating the available data and
     other relevant  information on Potassium Bromide,  the
     Agency has made  the  following determinations with res-
     pect to the technical grade of the active ingredient
     (TGAI) _!/', and  the end-use registered product.

     1.   Acute Toxicity

         (a) Manufacturing-Use Products

             The technical grade of Potassium Bromide  has not
             been registered as a manufacturing-use  product,
             even though  the chemical appears as an  active in-
             gredient on  labeling accepted for an end-use prod-
             uct. Therefore no one has submitted acute toxicity
             data for the TGAI to support registration as an  MUP.
             Nevertheless, the Agency will not require generation
             of acute toxicity data to register the  TGAI  as an MUP
             unless  the applicant or registrant fails  to  cite or
             submit  relevant information from the published lit-
             erature  to establish the toxicity categories of  the
             TGAI in  accordance with Section 162.10  of Title  40  of
             the Code of  Federal Regulations.

             Rationale:  In accordance with Pesticide  Registration
             Notice  83-4  2/ and 83-4(A) 3/ a registrant has the
             option  of satisfying a data requirement to register
             a pesticide  by submitting or citing relevant data from
             the published literature instead of generating such data
             In the case  of the technical grade of Potassium  Bromide
             a registrant should have no difficulty  in submitting  or
             citing  information from the pubished literature  on  this
             chemical to  satisfy at least some, if not all, of the
             acute toxicity data requirements, listed  in  Table A at
             the end  of this chapter.
I/  For  the purpose of  this  standard  the  technical  grade  of
Potassium Bromide  is defined as  any material  containing 99%
KBr, and containing only  those  impurities generally associated
with the manufacturing  process,  and generally .considered  as  safe.

2/ Pesticide Registration Notice  83-4, June 16,  1984.   Interim
Procedures For Satisfying Registration Data Requirements  Under
Recent Court Actions.

3/ Pesticide Registration Notice  83-4(A),  June 23,  1984.   Supple-
ment to PR Notce 83-4.

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                                                               (7)


        (b)   End-Use Products

             To reregister the end-use product cited in this
             standard the registrant must not only satisfy the
             product specific data requirements specified in
             Table B, but he or she must also satisfy the generic
             items of cata pertaining to the technical grade of
             Potassium Bromide specified in Table A, at the end of
             this chapter.  These include acute toxicity data and
             fish and wildlife data.

             Rationale:  The registrant of the end-use product
             cited in this standard uses an unregistered source
             of the technical grade of the active ingredient.
             This prevents the registrant from qualifying under
             the formulator's exemption as explained on page 1
             of this standard, and in PR Notice 83-4 previously
             cited.

    2.   Chronic Toxicity

        The Agency has concluded that none of the criteria
        for unreasonable adverse effects listed in Section
        162.11 (a) of 40 CFR have been triggered or exceeded
        for the uses specified in this standard.

        Rationale:  A review of relevant information in the
        published literature I/ on Potassium Bromide has raised
        no chronic or long term toxicological concerns for the
        approved pesticidal use. Furthermore, the registered use
        is as a final sanitizing rinse on food contact surfaces.
        Potassium Bromide, in combination with other chemicals
        generally recognized as safe, is cleared for this use
        as an incidental food additive under Section 178.1010
        (b)(l) of Title 21 of the Code of Federal Regulations,
        which is administered by the Food and Drug Administra-
        tion. Each end-use product proposed for this use must
        comply with the provisions of this section.
I/ Appendix III-l, GS-0342-003, Spencer, H. G. et al, Food
Research, 9:11, 1944.

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                                                           (8)

      3.  Ecological Effects

          (a) Manufacturing-Use Products

              To register the technical grade of Potassium Brom-
              ide as a manufacturing-use product a registrant must
              satisfy the data requirements specified in Table A
              at the end of this chapter.

              Rationale:  According to the guidelines I/ the Agency
              requires toxicity data on fish, birds, and aquatic
              invertebrates to support the registration of all
              mamufacturing-use products.

          (b) End-Use Products

              (i)  Registrants of end-use products who qualify un-
                   der the formulator's exemption may register end-
                   use products for the use specified in this
                   standard without having to address or satisfy
                   the data cited above.

                   Rationale:  According to the guidelines, ecolo-
                   gical effects data must be developed by testing
                   the technical grade of the active ingredient or
                   the manufacturing-use product.  In order to be
                   exempt from these data requirements and qualify
                   under the  formulator's exemption, the registrant
                   of the end-use product must purchase a  register-
                   ed manufacturing-use product from another firm
                   for formulation  into the end-use product.

              (ii) Registrants who  do not qualify under the formu-
                   lator's exemption must satisfy the data require-
                   ments specified  in Table A by submitting data
                   developed  with the technical grade of Potassium
                   Bromide.

                   Rationale:  According to the guidelines, ecolo-
                   gical effects data must be developed by testing
                   the technical grade of the active ingredient or
                   the manufacturing-use product. The registered use
                   cited in this standard is an indoor use? it does
                   not pose an additional risk to non-target organ-
                   isms which is not already introduced by the tech-
                   nical grade of Potassium Bromide.  Only when the
                   use of an  end-use product introduces an addition-
                   al risk to non-target organisms, which  has not
                   been addressed by data developed with the MUP,
                   is additional data required of an end-use product.

T7~GuideTines for Pesticide Assessment, Subdivision E, Hazard Eval-
uation, Wildlife and Aquatic Organislms, EPA Document 540/9-82-024,
October 1982, available from the National Technical Information
Service, Springfield, VA, Order No. PB83-1531908.

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                                                               (9)


                In the case of the registered product cited
                in this standard, the registrant uses an
                unregistered source of the technical grade of
                Potassium Bromide.  Therefore, to reregister
                this product, the registrant roust satisfy the
                data requirements specified in Table A, as well
                as those in Table B.  For further clarification
                of this obligation, see pages 1 and 2, Section C(l)(b)
                on page 7 of this standard, and PR Notice 83-4
                previously cited.

    4.  Environmental Fate Chemistry

        No environmental fate chemistry data will be required
        to re-register the currently registered use.  However,if
        a use such as terrestrial, aquatic, or forest use is pro-
        posed for registration, environmental fate chemistry
        data  will be required in accordance with the guide-
        lines I/.

        Rationale:  The currently registered use is an indoor  use:
        to sanitize food handling equipment and utensils in food
        processing establishments.  The registered product is
        used as a very dilute aqueous solution which goes to
        sewage treatment plants through the municipal sewer sys-
        tems.  Here the chemical  is degraded with other compo-
        nents during the treatment process, going from there
        back to receiving natural bodies of water.  Given this,
        and the registered use being an indoor use, environment-
        al fate chemistry data are not required.
!_/ Guidelines for Pesticide Assessment, Subdivision N, Environ-
mental Fate, EPA Document No.  540/9-82-021, Octobrer 1982, a-
vailable from the National Technical Information Service, Spring-
field, VA, Order No. PB83-1539/3.

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                                                              (10)
    5•   Residue Chemistry

        No residue chemistry data will be required to re-
        register the currently registered use.

        Rationale:  Residue chemistry data are required to
        support a petition for a tolerance or an exemption
        from the requirement of a tolerance when a pesticide
        use may result in residues in food, feed, tobacco,
        or other articles used for food or drink for man or
        animals.  For more details on the residue chemistry
        data requirements the guidelines should be consulted.!/

        The registered use for Potassium Bromide is not for
        direct application on a food crop or food as defined
        in the guidelines.  However, the registered use for
        the end-use product is as a final sanitizing rinse
        on food contact surfaces, and food handling equipment
        and utensils in food processing establishments. As
        such it is considered an incidental or indirect food
        additive. Therefore all end-use products proposed for
        this use must be cleared under the provisions of
        Section 178.1010 (b) (1) of Title 21 of the Code of
        Federal Regulations which is administered by the
        Food and Drug Administration, in accordance with
        that Agency's requirements.

        The registered product cited in this standard has been
        cleared under Section 178.1010 (b) (1) of 21 CFR, for
        the registered use.

    6.  Federal or State Re-entry Levels

        It is  not necessary to establish federal or state re-
        entry  levels for Potassium Bromide.

        Rationale:  The registered use is  an  indoor use with no
        application to food crops or fields  involving exposure
        to farm workers or field workers.

     7. Ground Water Contamination

        No data will be required pertaining  to ground water
        contamination.
_!/ Guidelines for Pesticide Assessment, Subdivision O, Residue
Chemistry, EPA Document No. 540/9-82-023, October  1982,  avail-
able from the National Technical Information Service, Spring-
field, VA, Order No. PB83-153981.

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                                                          (11)

    Rationale:

    The registered use for the registered product is an
    indoor use:   to sanitize food handling equipment and
    utensils in food processing establishments.   As such,
    the concentration of Potassium Bromide in the use
    dilution is very small.  Potassium Bromide and other
    chemicals go through municipal sewers, eventually to
    sewage treatment plants, where these chemicals are
    further diluted and broken down in the various stages
    of sewage treatment before finally going back into
    receiving natural bodies of water. Hence, there is no
    concern over ground water contamination.

8.   Registration of Manufacturing-Use Products

    Manufacturing-Use Products containing Potassium Bromide
    as a sole active ingredient may be registered for sale,
    distribution, reformulation, and use, subject to the
    terms and conditions specified in this standard.  Re-
    gistrants must submit or agree to develop additional
    data, as specified  in the tables, in order to maintain
    existing registrations or to permit new  registrations.

    Rationale:  Under FIFRA, the Agency can  not cancel or
    withhold registration simply because data are missing
    or inadequate   (See Sections 3(c)(2)(B)  and 3(c)(7) of
    the FIFRA).  Rather,  issuance of  this standard  provides
    a mechanism for  identifying data  needs.  The data will
    be reviewed and  evaluated when they are  received and
    the Agency will  determine at that time  if they  will
    affect  the registration of Potassium Bromide.

 9•  Registration of  End-Use Products

    In accordance with  PR Notice 83-4,  the  registrant  for  the
    end-use  product  cited in  this standard  is responsible  for
    satisfying the  data requirements  for  the technical grade
    of Potassium Bromide  (Table A), as  well  as those of the
    end-use  product  (Table  B).   (See  also page 1,  §C(l)(b) page 7,
    and §C(3)(b) page  8 of  this  standard.)

    Rationale:  As  stated in  previous sections of  this
    document,  the end-use product cited in  this  standard must
    be reregistered  in  accordance with  this  standard because
    the technical grade of  Potassium  Bromide is  not registered
    as a  manufacturing-use  product.   Furthermore,  since the
    active  ingredient  present  in  the  end-use product comes from
    an unregistered  source,  the  registrant  of the  end-use
    product does  not qualify  under  the  formu\ator's exemption.

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D.  CRITERIA FOR REGISTRATION UNDER THIS STANDARD

    To be covered by this standard, products must contain
    Potassium Bromide as an active ingredient, bear required
    labeling, and conform to the product composition, acute
    toxicity limits, and use pattern requirements listed in
    Section E (3) of this chapter.

    The applicant for registration or reregistration of
    products subject to this standard must comply with all
    terms and conditions described in it, including sub-
    mission of an up-to-date Confidential Statement of
    Formula, submission of revised labeling, and commitment
    to fill data gaps on the schedule specified by the Agency.
    When circumstances permit, the standard will be sup-
    plemented with additional guidance as to data compensa-
    tion under Sections 3(c)(l)(D) and 3(c)(2)(D) of the
    Federal Insecticide, Fungicide, and Rodenticide Act
    (FIFRA), as amended, 7 U.S.C. 136(c)(l)(D) and 136(c)(2)(D).
    Registrants should contact the Agency for specific in-
    structions, including updated information on data re-
    quirements .


E.  ACCEPTABLE RANGES AND LIMITS

    1.  Product Composition

        (a)  Manufacturing-Use Products

             The technical grade  of Potassium Bromide has
             been defined in  this standard  as material con-
             taining 99% KBr, with only  those impurities which
             are usually considered part of  the manufacturing
             process.  If a product of lower purity  is pro-
             posed as a manufacturing-use product  (MUP), the
             standard must be amended to accommodate such a
             product.  In any case, a manufacturing-use prod-
             uct may contain only those  inert ingredients
             which are either part of the manufacturing prod-
             cess,  or are deliberately added to give the prod-
             uct stability or to  serve some  such other useful
             purpose, provided however,  that all inert ingred-
             ients are generally recognized  as safe.  Each MUP
             proposed for registration must  be fully described
             with an appropriate certification of  limits.

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                                                             (13)

        (b)  End-Use Products

            End-use products  proposed  for  registration  under
            this  standard must  be  substantially  similar to the
            product described on page  4  of this  chapter.  A
            product will be considered substantially similar
            to  the  registered product  if it contains the-.same
            active  ingredients  at  approximately  the  same  con-
            centrations, and  if it contains inert ingredients
            generally  considered as safe.   Furthermore  the use
            proposed  for the  product must  be for the same use
            as  that of the  registered  product cited  in  this
            standard,  i.e.  as a final  sanitizing rinse  on food
            contact surfaces, equipment, and utensils in food
            processing establishments.

    2 .   Acu_te_ Toxicity  _Limits

        (a)  Manufacturing-Use  Products

            The  Agency  will  consider registration of  technical
            grade  products  and manufacturing-use  products con-
            taining  Potassium  Bromide for any proposed acute
            toxicity categories, provided that the registrant
            submits  enough  relevant information,  either from
            the  published  literature or from other sources, to
            establish  the  various acute toxicity categories for
            the  various routes of exposure, thereby permitting
            the  Agency to  prescribe appropriate precautionary
            statements, consistent  with Section 162.10 of 40 CFR.

        (b)  End-Use  Products

            The  only product containing this chemical was re-
            gistered before 1975, without any supporting acute
            toxicity data,  because  at that time the Agency did
            not  routinely  require acute toxicity data for all
            pesticides.  To reregister this product or to re-
            gister similar products the registrant must submit
            acute toxicity data I/  (oral LDso, dermal 1*050'
            and  eye irritation data) specific to the particular
            end-use product.  This  is required to establish the
            acute toxicity categories for these potential routes
            of exposure, and  thus enable the Agency to prescribe
            appropriate precautionary statements in accordance
            with Section 162.10 of 40 CPR.  See Table B at the
            end  of this chapter.
I/ Guidelines for Pesticides Assessment, Subdivision F. Hazard
Evaluation to Humans and Domestic Animals, Document No.
540/9-82-025, October, 1982, available from the National Technical
Information Service, Springfiled, VA, Order No.  PB83-1.>36.

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                                                              (14)

        .Use. JPatterns

        To be registered under this standard,  manufacturing-
        use products  containing Potassium Bromide may be la-
        beled for formulation into end-use products only for
        the following use:   as a final sanitizing rinse on food
        contact  surfaces, food handling equipment, and uten-
        sils in  food  processing establishments.   All end-use
        products containing this use must comply with the
        provisions of Section 178.1010 of Title  21 of the Code
        of Federal Regulations, which is administered by the
        Food and Drug Administration.

        Furthermore,  this is the only use which  has been ap-
        proved for the registered end-use product.  To regis-
        ter this chemical for additional uses  a  registrant must
        submit an application to amend this standard, and
        address whatever additional data requirements such
        uses would incur.
F.   REQUIRED LABELING

    All manufacturing -use products and end-use products must
    bear appropriate labeling as specified by Section 162.10
    of 40 CFR.  For more details on these general labeling
    requirements see Chapter V of this standard.  The follow-
    ing specific comments apply to the labeling for pesti-
    cides containing Potassium Bromide.

    1.  Ingredient Statement

        The ingredient statement for Manufacturing-Use Prod-
        ucts and End-Use Products must appear on the front
        part of the label as:

             Potassium Bromide              	%

    2.  Use Patterns

        The label for all manufacturing use products must
        state that they are intended for formulation
        into end-use products only for the aforementioned  .
        use patterns.  Labeling must specify sites, which
        are listed in Section E(3) of this chapter.  A li-..
        miting factor will be data that support these use
        patterns.  No use may be included on the label where
        the registrant fails to agree to comply with the
        data requirements in either Table A or Table B of
        this standard for that use pattern.  Besides this,
        the label for an MUP must state that each formu-
        lator must satisfy EPA's requirements to register
        each formulated product.

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                                                          (15)
        Precaut^onar^ Statements

        (a) Manufacturing-Use Products

            (i)  Labels  for  all manufacturing-use  products
                containing  Potassium  Bromide must bear  state-
                ments reflecting  the  product's  acute  human
                toxicity  as explained previously  at Section
                E(2)(a) of  this chapter.

           (ii)  The  following environmental hazard statement
                must appear on the  label  of all MUPs, under
                the  required heading  as designated below:

                ENVIRONMENTAL HAZARDS:  Do not  discharge ef-
                fluent  containing this active  ingredient  in-
                to lakes, streams,  ponds,  estuaries,  oceans,
                or public waters  unless this  product  is speci-
                fically identified  and addressed  in an  NPDES  I/
                permit.   Do not discharge effluent containing
                this product to sewer systems  without previous-
                ly notifying the  sewage treatment plant author-
                ity. For guidance  contact your State Water
                Board or  Regional Office  of  the EPA.

          (iii)  Depending on the  results  of  the environmental
                effects data required to  register the MUP  the
                label may require a fish  and/or wildlife hazard
                statement,  as  specified  in Section 162.10(h)(2)(ii)
                of 40 CFR.   For  the data  requirements see  Table
                A at the  end of  this  chapter.

        (b)   End-Use Products

             The requirement for  the  environmental hazard  statement
             listed in  (a)(ii)  above  also applies to  the label  for the
             end-use product cited in this standard because  the use
             is  an industrial  use,  i.e.  as a final sanitizing  rinse
             for food  handling equipment  and utensils in food
             processing establishments.
I/ National Pollution Discharge Elimination System

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                                                              (16)
            Labeling for each end-use product must bear
            appropriate precautionary statements specific
            for the product as formulated.  These state-
            ments must reflect the acute toxicity cate-
            gories established by data relevant to the
            particular product in question, in accordance
            with Section 162.10 of 40 CFR.  For the data
            requirements see Table B at the end of this
            chapter.

G.  TOLERANCE REASSESSMENT

    The registered use for Potassium Bromide does not in-
    volve direct application to a food crop or to feed.
    If a registrant proposes to register the chemical for
    direct application to a food crop, tobacco, or feed,
    or to other articles used for food or drink for man or
    animals, residue chemistry data will be required to
    support a petition for a tolerance, or an exemption
    from the requirement of a tolerance.

    The registered use is as a final sanitizing rinse for
    food contact surfaces, food handling equipment and
    utensils in food processing establishments.  As such
    this use is considered an incidental food additive.
    Products proposed for this use must be cleared
    under Section 178.1010 of 21 CFR, which is administered
    by the Food and Drug Administration.  This use has been
    addressed at Section C(5) of this standard.

H.  EFFICACY DATA REQUIREMENTS

    Section 162.18-2(d)(2) of 40 CFR requires that "efficacy
    data specific to each product that bears a claim to con-
    trol organisms that may pose a threat to human health,
    either directly or through transmittal of disease" must
    be submitted to support the registration of such a prod-
    uct.  Each antimicrobial product intended to control
    microorganisms infectious to man in any area where these
    microorganisms may present a health hazard falls under
    the requirement of this section.  Microbiological efficacy
    data are product specific;  data for one product can not be
    used to support registration of another product unless the
    two products are identical.   Even then confirmatory data
    is required to register a product relying on data developed
    with another product.

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                                                           (17)
   The specific data requirements for end-use products in-
   tended to provide health related benefits can be found
   in the guidelines for product performance JL/.  Besides
   satisfying these requirements each end-use product pro-
   posed for use as a final sanitizing rinse on food contact
   surfaces, food handling equipment, and eating utensils
   in food processing establishments, must comply with FDA's
   regulations at Section 178.1010 of 21 CFR.

   In the case of the only registered product referred to  in
   this standard, the efficacy data requirements have been
   satisfied.
I/ Pesticide Assessment Guidelines, Subdivision G, Product
Performance, EPA Document No. 540/9-82-026, November 1982,
available from the National Technical Information Service,
Springfield, VA, Order No. PB83-153924.

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                                                           (18)
HI.    REQUIREMENT FOR SUBMISSION OF GENERIC DATA

     A.  This portion of the guidance document is a Notice
         issued under the authority of FIFRA Section 3(c)(2)(B)
         and describes, in table format, the data required
         for maintaining the registrability of each product.
         Additionally, a bibliography (Appendixm-1) is
         included that identifies that data considered as
         part of the data base supporting this standard.  EPA
         has determined that additional generic data described
         in this Notice must be submitted to EPA for evaluation
         in order to maintain in effect the i
         of your product(s) identified as an
         the cover letter accompanying this
         As required by FIFRA Section 3(c)(2i
egistration(s)
attachment to
uidance document.
(B), you are
         required to take appropriate steps to comply with
         this Notice.

         EPA may suspend the registration of each of those products
         unless, within the specified time, you have informed EPA
         how you will satisfy the requirements of this Notice.
         Any such suspension will remain in effect until you have
         complied with the terms of this Notice.

     B.  What Generic Data I/ Must Be Submitted.  You may ascertaij
         which generic data you must submit by consulting Table A
         at the end of this chapter.  That table shows all the
         generic data needed to evaluate the continued registrabili
         of all products, and the dates by which the data must be
         submitted.  The required data must be submitted and any
         necessary studies must be conducted in accordance with
         EPA-approved protocols, the Pesticide Registration
         Guidelines 2/, or data collected under the approved
         protocols of the Organization for Economic Cooperation
         and Development (OECD).  If you wish not to develop data
         which are necessary to support the registration or
         reregistration of certain uses appearing in your labeling,
         you may delete those uses at the time you submit your
         revised labeling.

         Also for certain kinds of testing (generally ecological
         effects), EPA requires the test substance to be a "typical.
         formulation," and in those cases EPA needs data of that

     I/ Generic data pertain to the properties or effects of a
 particular ingredient, and thus are relevant to an evaluation of
 the risks of all products containing that ingredient (or all such
 products having a certain use pattern), regardless of any such
 product's unique composition or use.  Product-specific data relate
 only to the properties or effects of a product with a particular
 composition (or a group of products with closely similar corapositij

     2/ The Pesticide Registration Guidelines were reproposed on
 November 24, 1982 in 47 Federal Register 53192.

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                                                           (19)


        type for each major formulation category (e.g.,  emulsifiable
        concentrates, wettable powders, granulars,  etc.)  These
        are classified as generic data and when needed are
        specified in Table A.  EPA may possess data on certain
        "typical formulations" but not others.  Note;  The "typical
        formulation" data should not be confused with product-
        specific data (Table B) which are required on each
        formulation.  Product-specific data are further explained
        in Chapter IV of this document.

    C.  Options Available for Complying With Requirements
        to Submit Data

        Within 90 days of your receipt of this Notice you must
    submit to EPA a completed copy of the form entitled "FIFRA
    Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1,  Appendix
   J1I-2] for each of your products.  On that form you must
    state which of the following methods you will use to comply
    with the requirements of this Notice:

    1.  (a) Notify EPA that you will submit the data, and

        (b) either submit the existing data you believe
            will satisfy the requirement, or state that
            you will generate the data by conducting
            testing.  If the test procedures you will
            use deviate from (or are not {specified in)
            the Registration Guidelines or protocols
            contained in the Reports of Expert Groups
            to the Chemicals Group, Organization for
            Economic Cooperation and Development (OECD)
            Chemicals Testing Programme, you must enclose
            the protocols you will use.

    2.  Notify EPA that you have entered into an agreement
        with one or more other registrants to jointly
        develop (or share in the cost of developing) the
        data.  If you elect this option, you must notify EPA
        which registrant(s) are parties to the agreement.

    3.  File with EPA a completed "Certification of Attempt to
        Enter Into an Agreement With Other Registrants for
        Development of Data" (EPA Form 8580-6, AppendixZEI-3)V

    4.  Request that EPA amend your registration by deleting the
        uses for which the data are needed.  (This option is not
        available to applicants for new products.)
     V FIF1XA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement.  The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued at bottom of nexc. page)

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                                                            (20)
    "5.   Request  voluntary  cancellation  of  the  registration(s)
         of your  products for  which  the  data  are needed.   (This
         option is  not  available  to  applicants  for  new  products.)

    D.   Procedures for Requesting Changes  in Testing Methodology
         and  Extensions of  Time

         EPA  recognizes that you  may disagree with  our  conclusions
         regarding  the  appropriate ways  to  develop  the  required
         data or  how quickly the  data must  be submitted.   If  the
         test procedures you plan to use deviate from  (or  are not
         specified  in)  the  registration  guidelines  or protocols
         contained  in the reports of the Expert Groups  to  the
         Chemical Groups, Organization for  Economic Cooperation
         and  Development (OECD) Chemicals Testing Programme,  you
         must submit the protocol for Agency  review prior  to  the
         initiation of  the  test.

         If you think that  you will  need more time  to generate the
         required data  than is allowed by EPA's schedule,  you may
         submit a request for  an  extension  of time.  The extension
         request  must be submitted in writing to the Product
         Manager.  The  extension  request should state the  reasons
         why  you  conclude that an extension is  appropriate.   While
         EPA  considers  your request, you must strive to meet  the
         deadline for submitting  the required data.
 (Footnote  continued from previous  page)
      In EPA's  opinion,  joint data  development by all registrants
 who  are subject to the  requirements  to submit a pertinent  item
 of data or a cost-sharing agreement  among all such registrants
 is clearly in  the  public interest.  Duplication of testing could
 increase costs,  tie up  testing facilities,  and subject an  unneces-
 sarily  large number of  animals to  testing.
      As noted earlier,  EPA has discretion not to suspend  the
 registration of a  product when a registrant fails to submit data
 required under FIFRA Section 3(c)(2)(B).   EPA has concluded that
 it is appropriate  to exercise its  discretion not to suspend in
 ways which will  discourage duplicative testing.  Accordingly, if
 (1) a registrant has informed us of  his  intent to develop  and
 submit  data required by  this Notice; and (2) a second regis-
 trant informs  EPA  that  it has made a bona fide offer to  the
 first registrant to share in the expenses of the testing [on
 terms to be agreed upon  or determined by arbitration under FIFRA
 Section  3(c)(2)(B)(iii)J;  and (3)  the first registrant has declined
 to agree to enter  into a cost-sharing agreement, EPA will  not
 suspend the second firm's  registration.   While the first firm is
 not required to  agree to jointly develop data, EPA is not  required
 to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.

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                                                ± n    (T*
                  GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
Composition
(Unregistered
Data Requirement Product) I/
S158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients


61-2 - Statement of Composition
61-3 - Discussion of Formation of
Ingredients
Analysip and certification of Product
Ingredient's
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
TGAI


TGAI
TGAI

TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectio
No or Partially) Citation 3(c) ( 2) ( B) ?2/ 2/
Totally


partially
N/A

N/A
N/A
N/A
Totally
Totally
Totally
Totally
Totally
Totally
GS 0342-001
GS 0342-002
MRID 00019750
MRID 00007445
GS 0342-002
Standard Ref's


-
-
-
Standard Ref's
Standard Ref's
Standard Ref's
Standard T.rsf's
Standard Ref's
Standard Ref's
No


Yes


-
-
—
No
No
No
No £
No
No
Specific Gravity

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                                                        TABi
                          GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
Data Requirement
                                           Composition
                                           (Unregistered
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
Bibliographic
Must Additional
Data Be Submitted
Under FIFRA Section
 3(c)(2)(B)?2/ 2/
SI 58. 120 Product Chemistry
(continued)
63- 8 - Solubility XGAI
63-12 - pH . TGAI
63-13 - Stability XGAI

Totally Standard Ref's No
Totally Standard Ref's No
Totally Standard Ref's No
  I/ Composition:  TGAI - Technical grade of the active ingredient; PAI
     several test substances determined on a case-by-case basis.
  2/ Data must be submitted no later than
            Pure active ingredient; Choice = Choice of
                                                                                                                       K>
                                                                                                                       to

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                                                       TABLE  A
                               GENERIC DATA  REQUIREMENTS  FOR POTASSIUM BROMIDE (99%  purity or higher)
I/ Use 2/
Data Requirement Composition Patterns
S158.135 Toxicology


Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation

Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/

ACUTE TESTING:
81-1
81-2
81-3
81-7
- Oral LD5Q - Rat
- Dermal LD$Q - Rabbit
- Inhalation LC$Q - Rat
- Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
I
I
I
I
No
No
No
No
Yes 4/
Yes 4/
Yes 4/
Yes 4/
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding -
Rodent, Non-rodent
- 21-Day Dermal - Rabbit
- 90-Day Dermal - Rabbit
- 90-Day Inhalation -
TGAI
TGAI
TGAI
TGAI
I
I
I
I
N/A
N/A
N/A
N/A
_
-
-
-
        Rat

82-5 - 90-Day Neurotoxicity-
        Hen/Mammal
TGAI
N/A

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                                                      TABLE A
                        GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
S158.135 Toxicolog
         (continue
I/ Composition:  PAI * Pure active ingredient; PAIRA = Pure active ingredient,  radiolabelled;  Choice = Choice of several
   test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows:  A=Terrestrial, Food Crop;  B=Terrestrial,  Non-Food;  C=Aqautic,  Food Crop;
   D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor;  I=Indoor.
3/ Data must be submitted no later than  	.
4/ These data apply to the Technical Grade of potassium Bromide (99%  purity or  higher) .  To date it has not been
   registered as a Manufacturing Use Product for formulation into pesticides.  If  a registrant  proposes to reg-
   ister this product as an MUP pesticide, it is very likely that information  addressing these requirements may be
   obtained from the published literature, otherwise the registrant would have  to develop these data to establish
   the various acute toxicity categories for the TGAI or other MUP products, so that appropriate precautionary
   labeling can be prescribed in accordance with Section 162.10 of 40 CFR.

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                                                       TABLE A
                        GENERIC  DATA REQUIREMENTS FOR POTASSIUM BROMIDE  (99% purity  or  higher)
                                                                                                    Must Additional
                                                                                                    Data Be Submitted
                                                                                                    Under FIFRA Section
                                                                                                     3
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                                                      TABLE A
                        GENERIC DATA REQUIREMENTS FOR POTASSIUM BROMIDE (99% purity or higher)
  S158.145 Wildlife and Aquatic Organisms
           (continued)

I/ Composition:  TGAI « Technical grade of the active ingredient; PAI = pure active ingredient;
   TEP » Typical end-use product;                                                                         .       ,
2/ The use patterns are coded as follows:  A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; C-Aquatlc,  tooo crop;
   D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse , Non-Food; G=Forestry; H=Domestic  Outdoor;  I=Indoor.
3/ Data must be submitted no later than _ ^ _    «
I/ These tests must be developed with the Technical Grade of potassium Bromide (99% purity or higher) to support
   registration as a Manufacturing Use pesticide for the indoor uses specified in this standard. If the uses are
   expanded to include other than indoor uses more data will be required.

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                                                             (27)
      REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA

    Note:  This chapter applies only to manufacturing-use products,
not end-use products.

    A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA of product-specific data* listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix  l¥-l)
to fill  "gaps" identified by EPA concerning your product.  Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
reregister your product(s).  All of these data must be submitted
not later than six months after you receive this guidance document

    "Product-Specific Data Requirements for Manufacturing-Use
Products" appearing  in Table B permit you to determine which
product-specific data you must submit.  This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
      */  Product specific data pertains to data that support the
 formulation which is marketed; it usually includes product
 chemistry data and acute toxicology data.

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                PRODUCT SPECIFIC DATA REQUIREMENTS FOR
                  TABLE B
                 END USE PRODUCT SAP SOL:
                               EPA REG NO: 875-42  3/
                                                                                                       Must Additional
                                                                                                       Data Be Submitted
                                                                                                       Under  FIFRA Section
                                                                                                        3(c)(2)(B)?2/
Data Requirement
Composition"
          Does EPA Have Data
          To Satisfy This
I/ 4/     Requirement?  (Yes,
          No or Partially)
Bibliographic
  Citation
S158.120 Product Chemistry

  Product Identity

  61-1 - Identity of Ingredients

  61-2 - Statement of Composition

  61-3 - Discussion of Formation
           of Ingredients

  Analysis and Certification
  of Product Ingredients!

  62-1 - Preliminary Analysis

  62-2 - Certification of Limits

  62-3 - Analytical Methods for
          Enforcement of Limits

  Physical and Chemical
  Character istics"

  63-2 - Color

  63-3 - Physical state

  63-4 - Odor

  63-7 - Density, bulk density, or
          specific gravity
     EP

     EP

     EP
     EP

     EP

     EP
     EP

     EP

     EP

     EP
          Totally

          Partially

          Partially
          N/A

          partially

          Totally
          Totally

          Totally

          Totally

          Totally
EPA Reg No 875-42

EPA Reg No 875-42

EPA Reg No 875-42
EPA Reg No 875-42

Standard Ref's
Standard Ref's

EPA Reg No 875-42

Standard Ref's

EPA Reg No 875-42
 No

 Yes

 Yes
Yes

 No
 No

 No

 No

 No
M
00

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Data Requirement
Composition"
          Does EPA Have Data
          To Satisfy This
I/ 4/     Requirement?  (Yes,
   	No or Partially)
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under FIFRA Section
  3(c)(2)(B)?2/6/
S158.120 Product Chemistry
     (continued)

  63-12 - pH

  63-14 - Oxidizing or reducing
           action

  63-16 - Explodability

  63-17 - Storage Stability

  63-20 - Corrosion Characteristics
    EP

    EP


    EP

    EP

    EP
          Totally

          Totally


          Partially 4/

          Totally

          Totally
00007442

EPA Reg No 875-42


EPA Reg No 875-42

00007442

00007442
        No

        No


        Yes

        No

        No
  !_/ Composition:MP =Manufacturing-use product;Choice =Choice ofseveraltest substances determined on acase-by-'
  ~~  case basis.
  2/ Data must be submitted no later than	  	.
  _3/ In view of its commercial availability as an engraving and photographic processing chemical, there is no
     requirement under the FIFRA (or need) to register technical potassium bromide for manufacturing use.
  4/ The active ingredients of SAP SOL* Brand Sanitizer are 2.00% potassium bromide, 3.25% sodium hypochlorite
     and 89.75% trisodium phosphate (as a hydrate salt). Since anhydrous hypochlorite may be explosive, information
     is needed concerning the hydrated form of sodium hypochlorite used in formulating SAP SOL* Brand Sanitizer.
  j>/ For the technical potassium bromide used in formulating SAP SOL*, the Diversey Corporation is required to
     submit the detailed composition data available from their supplier(s). This composition data should include the
     amounts of lead and other heavy metal impurities. For the marketed product, information is needed concerning
     the quality control procedures and a discussion of impurities that are expected to form during the commercial
     life of the product.
  6/ These chemistry data requirements apply for the reregistration of SAP SOL* (EPA Reg No 875-42) under this
     Standard. They will not support registration of another end use product unless the product in question is
     identical and then only with the permission from the owner to cite it. A registrant of any other end use
     product containing potassium bromide would be required to address all of the applicable product chemistry
     requirements specified in section 158.120 of 40 CFR.                                                            K?

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                                                        TABLE B
              PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING POTASSIUM BROMIDE
Data Requirement
Composition'
                                                 I/
Does EPA Have Data
To Satisfy This
Requirement?  (Yes,
No or Partially)
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under FIFRA Section
 3(c)(2)(B)?2/
S158.135 Toxicology

  ACUTE TESTING

  81-1 - Oral LDso - Rat

  81-2 - Dermal LDso ~ Rabbit

  81-3 - Inhalation LC$Q - Rat

  81-4 - Primary Eye
          Irritation - Rabbit

  81-5 - Primary Dermal
          Irritation - Rabbit

  81-6 - Dermal Sensitization -
         Guinea Pig
MP

MP

MP

MP


MP


MP
       No

       No

       N/A

       No


       No


       NO
                       Yes

                       Yes



                       Yes


                       Yes


                       No
  I/ Composition: MP = Manufacturing-use product.
  2/ data must be submitted no later than 	

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                                                              (31)
V.   SUBMISSION  OF  REVISED LABELING  AND PACKAGING INFORMATION

    Note:  This  section  applies       to manufacturing-use  products,
and  end-use products.

    The Agency requires  applicants for registration  or reregistra-
tion to ensure that each label  (1) contains  accurate,  complete,
and sufficient instructions and precautions,  reflecting the
results of data  concerning the product and its  ingredients,  and
(2) incorporates labeling format  and terminology which .are suffi-
ciently standardized to  avoid user confusion. '

    As part of your application,  you '.will be  required  to submit
draft labeling consistent with:   applicable  product-specific
data; the precautionary  statements and use directions;  and the
regulations concerning classification  [40 CFR Sl62.11(c)], pack-
aging [40 CFR §162.16],  and labeling [40 CFR §162.10,  Appendix
V-l and v-2], as indicated by the following  paragraphs  of  this
section of the guidance  document.

    You will be  informed later when  you must  submit  the revised
labeling set forth  in this guidance  package.

    A.  Label Contents

        40 CFR §162.10 (Appendix  V-l)  requires  that  certain  spe-
    cific labeling  statements must appear at  certain locations
    on the label.   This  is referred  to as format labeling.
    Specific label  items listed below  are keyed to Tables  D,  E,
    and F (Appendix VI-2).

        Item 1.   PRODUCT NAME - The  name, brand,  or  trademark is
    required to  be  located on the front panel,  preferably  centered
    in the upper part of the panel.  The name of a product will
    not be accepted if it is false or  misleading.  See  Appendix
    V-l.  [40 CFR §162.lO(b)]

        Item 2.   COMPANY NAME AND ADDRESS - The name and address
    of the registrant or distributor is required on  the label.
    The name and address should preferably be located  at the
    bottom of the front  panel or  at  the end of  the label text.
    See Appendix" V-l. ,[40 CFR 5162.10(c)]
                i
        Item 3.   NET CONTENTS - A net  content statement is required
    on all labels.   The  preferred location is the  bottom of  the
    front panel •immediately above the  company name and  address,
    or at the end of the label text.   The net contents  must  be
    stated in term?, of weight, expressed as avoirdupois pounds

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                                                             (32)
and ounces, and stated in terms of  the  largest suitable unit,
i.e., "1 pound 10 ounces" rather  than "26 ounces."   In
addition to the required units specified, net contents may be
expressed in metric units.  See Appendix V-l.  [40 CFR
Sl62.10(d)]

    Item 4.  EPA REGISTRATION NUMBER -  The  registration
number assigned to the pesticide  product must appear on the
label, preceded by the phrase "EPA  Registration No.," or "EPA
Reg. No.*  The registration number  must be  set in type of a
size and style similarito other print on that part of the
label on which it appears and must  run  parallel to it.  The
registration number an
-------
                                                           (33)
Size of Label        Signal Word as Re-    "Keep Out of Reach
on Front Panel       quired Minimum Type       of Children"
in Square Inches     Size All Capitals         as Required

5 and under                6 point              6 point
above 5 to 10             10 point              6 point
above 10 to 15            12 point              8 point
above 15 to 30            14 point             10 point
over 30                   18 point             12 point

    Item 7A.  CHILD HAZARD WARNING STATEMENT - All labels are
required to have the statement "Keep Out of Reach of Children*
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix v-1.  [40 CFR §l62.10(h) (1) (ii) 1

    Item 7B.  SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement.  See Appendix V-1.
[40 CFR §162.10 (h)(l)(i)l

    Item 7C.  SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal toxicity, the word "Poison" shall appear on
the label in rett on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
proximity to the word poison.  See Appendix V-1.  [40 CFR
    Item 7D.  STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid. or other) shall appear on
the label of pesticide products  in toxicity Categories I,
II, and III.  See Appendix V-1.   [40 CFR Sl62.10(h)(l) (ill)] .

    Item 7E.  REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for  all products, unless all
required precautionary statements appear on the front panel.
See Appendix V-1.   [40 CFR $162.10(h) ( 1) ( iii) ]

    Item 8-  SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The .preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline.  Each
of the three hazard warning statements must be headed by the
appropriate hazard title.  See Appendix V-1.  [40 CFR $162.10

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                                                           (34)
    Item 8A.  HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions taken to avoid
accident, injury or damage.  See Appendix V-l.  [40 CFR §162.10
    Item 8B.  ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage.  See Appendix V-l.  [40 CPR
    Item 8C.  PHYSICAL OR CHEMICAL HAZARD
                          •
    1.  Flammability statement.  Precautionary statements
        relating to flammability of a product are required
        to appear on the label if it meets the criteria in
        Appendix v-3.  The requirement is based on the results
        of the flashpoint determinations and flame extension
        tests required to be submitted for all products.
        These statements are to be located in the side/back
        panel precautionary statements section, preceded by
        the heading * Physical/Chemical Hazards.*  Mote that
        no signal word is used in conjunction with the flam-
        mability statements.       i

    2.  Criteria for declaration of non-flammability.  The
        following criteria will be used to determine if a
        product is non-flammable:

        a.  A "non-flammable gas* is a gas (or mixture of
            gases) that will not ignite when a lighted match
            is placed against the open cylinder valve.

        b.  A "non-flammable liquid" is one having a flash-
            point greater than 350° F (177*C) as determined
            by the method specified in 40 CFR $163.61-8(c) (13)
            (ii) of Subpart D.

        c.  A * non-flammable aerosol* is one which meets the
            following criteria:

            i.  The flame extension is zero inches, using the
                method specified in 40 CFR $163.61-8(0 (13) (ii) ;

           ii.  There is no flash back; and

          iii.  The flashpoint of the non-volatile liquid
                component is greater than 350°F (177°C),
                determined by the method specified in 40 CFR
                Sl63.61-8(c)(13Hi).

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                                                          (35)
    3.   Declaration of  non-flammability.   Products which meet
        the  criteria for non-flammability specified above may
        bear the notation "non-flammable" or "nonflammable
        (gas, liquid, etc.)"  on the label.

        It may appear as a substatement to the ingredients
        statement, or on a back or side panel, but shall not
        be highlighted or emphasized (as with an inordinately
        large type size) in any way that may detract from
        precaution.

    4.   other physicjal/cfaemical hazard statements.  When
        chemistry data submitted in accordance with 40 CFR
        §163.61-10(1) demonstrate hazards of a physical or
        chemical nature other than flammability, appropriate
        statements of hazard will be prescribed.  Such
        statements may address hazards of explosivity,
        oxidizing or reducing capability, or mixing with
        other substances to produce toxic fumes.

    Item 9.   MISUSE  STATEMENT - The following statement  is
required on your label:  "It is a violation of Federal law to
use this product in  a manner inconsistent with its labeling."
See Appendix V-l.   [40 CFR $162.10(1)(2)(ii)1

    Item 10A. i STORAGE AND DISPOSAL-BLOCK -  All  labels  are
required to bear storage and disposal statements.  These
statements are developed for specific containers, sizes, and
chemical content.   Make certain that the  statement you use
pertains specifically to your product.  These instructions
must be grouped and appear under  the heading  "Storage and
Disposal" in  the directions for use.  This  heading must  be
set in the same type sizes as required for  the child hazard
warning.  Refer to Appendix V-5 for the  latest specific
storage and  disposal product label  statements.

    Item 10B.   DIRECTIONS  FOR USE - Directions for use must
be  stated in terms which can be easily read and understood by
the average  person likely  to use  or to supervise  the use of
the pesticide.  When followed, directions must be adequate to
protect the  public from fraud and from personal injury  and to
prevent unreasonable adverse effects on  the environment. See
Appendix .V-l.   [40 CFR §162.10]

B.  Collateral  Information

    Bulletins,  leaflets,  circulars, brochures, data  sheets,
flyers, and other graphic  printed matter which  is referred  to
on  the  label or which is to  accompany  the product are  termed
collateral  labeling.  Such labeling may  not bear  claius or
representations that differ  in  substance from those  accepted
in  connection with registration  of the  product.   It  should  be
made part of the  response to this notice and submitted  for  review,

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                                                           (36)
VI.   INSTRUCTIONS FOR SUBMISSION

    All applications prepared in response to this Notice should
be addressed as follows:

    [Product Manager]
    Phone No. (703)	
    Registration Division (TS-767)
    Office of Pesticide Programs
    Environmental Protection Agency
    Washington, D.C.  20460

A.  For each manufacturing-use product for which continued
    registration is desired:

    1.  Within 90 days from'receipt of this document, you must
        submit the "FIFRA Section 3(c)(2)(B) Summary Sheet"
        EPA Form 8580-1.  Refer to Appendix III-2 with
        appropriate attachments.

    2;  Within 6 months from receipt of this document registrants
        must submit:

        a.  Confidential Statement of Formula, EPA Form 8570-4.

        b.  Product Specific Data Report, EPA Form 8580-4
            (Appendix IV-1)»

        c.  Two copies of any required product-specific data.

    3.  Within the time set forth in Table A, all generic data
        must be submitted by the affected registrants).

Note;  If for any reason any required test is delayed or
       aborted so that meeting the agreed submission time
       will be delayed, notify the Product Manager listed
       above.

B.  For each affected product for which continued registration
    is desired* within 90 days from receipt of this document
    submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
    Form 8580-1r Appendix III-2) with appropriate attachments.

C.  You will be  informed at a later date when you must submit
    your Application for Amended Pesticide Registration (EPA
    Form 8570-1) and the revised  labeling set forth  in this
    guidance package.

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                                               Appendix III-l
                                                             (37)
                  OFFICE OF PESTICIDE PROGRAMS
               Registration Standard Bibliography


  Citations  Considered  to be Part  of the  Data  Base  Supporting
                Registrations Under the standard
MRID 00007445
MRID 00007442
MRID 00019750
GS-0342-001
GS-0342-002
 Diversey  Corporation  (1957) Presence of
 Hypobromite  in SAP-SOL  (PX-829) Solution.
 (Unpublished study  received Nov. 6, 1957
 under  875-42; CDL:  022231-A)

 Diversey  Corporation  (1962?) SAF-SOL as a
 sanitizer for use in  Food Processing Plants.
 (Unpublished study  received Feb 18, 1963
 under  875-42; CDL:  022229-A)

 A.; Carrera, R.T.;  Kelley, M.J. (1961) Informa-
 tion on conversion  rate of Bromide to Hypobromite
 in solutions of Diversey PX-1216.  (Unpublished
 study  received Oct. 5, 1961 under 875-45;
 submitted by Diversey Chemical Co., Des plains,
 111.,  CDL: 231083-P)
Smith, M.K. (1983) Qualitative Use.
Document for Potassium Bromide
                                                    Assessment
EPA (1983) The Calcium and Sodium Hypochlorite
Salts, Pesticide Registration standard part I
(Unpublished)

-------
                                                                                  OMB Approval No. 20004468 (Expires 7.2-3)
                   FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
                                                                                          EPA REGISTRATION NO.
                                                                                                                 (38)
  PRODUCT NAME
    .*PUCANTS NAME
                                                                                        DATE GUIDANCE DOCUMENT ISSUED
    With rwpect to the requirement to submit "generic" data imposed by the FIFRA section 3(CH2HB) notice contained in the referenced
    Guidance Document I am responding in the following manner
       D1. I wil submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or ere not
            specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
            Chemicals Testing Programme, I enclose the protocols that I will use:
       O 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following date
          . requirement! The tests, and any required protocols, will be submitted to EPA by:
    NAME OF OTHER REGISTRANT
       Dl I endose e completed "Certification of Attempt to Emv Into MAgrMinattwftii Other Registrars
       i     respect to the following deta requirement!:
       D 4* I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
      D 5. I request voluntary cancellation of the registration of this product (This option is not avaRaUe to applicants for new products.)
r
nEGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
 EPA Form 8680-1 (1042)

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                                          APPENDIX HI-3

                                          OMB Approval No. 2000-0463 (Ex
                                                                                                           (39)
> qualify, certify A LL^ four items)
     CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
          FOR DEVELOPMENT OF DATA
am duly authorized to
tents of a Notice under
to submit data concern! n<
represent the following firm(s) who are subject to the require-
FIFRA Section 3(c)(2)(B) contained in a Guidance Document
3 the active ingredient:
NAME OF FIRM






GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER





My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to ente
nto an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following require
items or data:
My firm hat offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to b
tound by an arbitration decision under FIFRA Section 3(c)(2){B)(iii) if final agreement on all terms could not be reached otherwise. This offer was mad
to the following firm(s) on the following data(s):
NAME OF FIRM




DATE OF OFFER




lever, none "if those firm(s) accepted mv offer.
"'  	=M-«»« uwi •_. r-i iiwi au»t,Ciiu me registration is; or my nrm s proauciisr, IT any or tne Tirms named in paragraph (3) abovi
ave agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inforn
« whether my firm must submit data to avoid suspension of its registration^) under FIFRA Section 3(c)(2)(B). (This statemen
 ws not apply to applicants for new products.)  I give EPA permission to disclose this statement upon request.
ED NAME
                                                SIGNATURE
                                                                                                   DATE

-------
                                                          Appendix
                                                                                  (40)
                       PSODDCT SPECIFIC DMA REPORT
EEA. Registration No._
_Guidanee Document fcr_
             Date
Registration
Guideline No.
SVOOXS
(^lUMI JWpJf
61-1
6l-i
61-3
62-1
62-2
62-3
63-2
63-3
i»3— 4
- - i»_§
6; -6
63-7
63-8
63-4
63-16
63-ii
61-2
&-' 2
43-14
«-: 5


53-8

— O-20
- 83-21


"§1-1
41-3
81-4
ai-s
ai-6
Name of Test

Identity c£
ingredients
Statement of
conoositicn
Discuss icn of
formation of
ingredients
Preliminary
analysis
Certification o£
limits
Analytical methods
limits
rolrr
Physical state
ddcr
Melting point
Boiling point
Density, bulfc-
density, or
specific gravity
Sninfevil-ity
Vapor pressure
Dissociation
constant
Octanol/taater
partition
coefficient
pH
Stahility
Oxidizin9/c«dL>cuig
reaction
riiMintij. ; ,tV
E»plcdab:Jity
Storage stability
VSOMltV
H g^Mlil-yr
characteristics
doun voltage

Acute oral LD-50,
rat
Acute dermal
U>-50

LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Parma 1 aeRSitlZa—
ticn
Test not
required
for my
product
listed
above
(check
below)


































I an complying with
data requirements by
Citing MRID»


































Submit-
ting
Data
(At-
tached)


































(Par EPA Ose Only)
Assigned



































-------
                             APPEND I.
Chapter  1   Environmental  Protection Agency                 Sec  162.10
                       •                      *v
                  9162.10  Labeling requirements.
                   (a)  General-(\)  Contents  of the
                  label. Every  pesticide  products shall
                  bear a label  containing the informa-
                  tion specified by the Act and the regu-
                  ations in this Part. The contents of a
                 label  must show clearly and  promi-
                 nently the following:
                   (i) The name, brand, or trademark
                 under which the product is sold as pre-
                 scribed  in  paragraph   The  name and address of the
                 producer, registrant, or  person for
                 whom produced as prescribed in para-
                 graph (0 of this section;
                  (Hi) The  net contents as prescribed
                 m paragraph 
-------
§ 162.10

  (iv)   The   product   registration
number as prescribed in paragraph (e)
of this section;
  (v)  The  producing  establishment
number as prescribed in paragraph (f)
of this section;
  (vi) An  ingredient statement as pre-
scribed  in   paragraph  (g)  of  this
section;
  (vil) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
  (viii) The  directions for use as pre-
scribed in paragraph (i) of this section;
and
  (ix) The use  classificatlon(s) as pre-
scribed in paragraph (j) of this section.
  (2) Prominence and legibility, (1) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the  labeling by the  Act or
the regulations in this part  must be
clearly legible to a person with normal
vision, and  must be placed with such
conspicuousness  (as compared  with
other  words, statements, designs, or
graphic  matter on  the labeling) and
expressed in such terms as to  render it
likely  to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
  (ii) All required label text must:
  (A) Be  set In 6-point or larger type;
  (B) Appear on a clear contrasting
background; and
  (C) Not be obscured or crowded.
  (3) Language to be uted. All required
labelor labeling text shall appear in
the English language. However,  the
Agency may require or the applicant
may propose additional text  in other
languages as Is considered necessary to
protect  the public. When additional
text in another language is necessary,
all labeling requirements will  be ap-
plied equally to both the English and
other-language versions of the label-
Ing.
   (4) Placement of Label—(i) General
The label shall appear on or be secure-
ly  attached to the immediate contain-
er of  the pesticide product.  For pur-
poses  of this  Section, and  the mis-
branding provisions of the  Act, "se-
curely  attached" shall mean  that a
label can reasonably be  expected to
remain affixed during the foreseeable
               P?T_\°4 9* use. If the im-
                              APPENDlf?

   Title 40—Protection of Environment
 wrapper or outside container through
 which the label cannot, be clearly read,
 the label must also  be securely at-
 tached to such outside, wrapper or con-
 tainer, if it is a part of the package as
 customarily distributed or sold.
   (II)  Tank cars and  other bulK con-
 tainers—(.A) Transportation. While  a
 pesticide product is in transit, the ap-
 propriate  provisions of 49  CFR Parts
 170-189, concerning the transportation
 of hazardous materials, and specifical-
 ly those provisions concerning the la-
 beling, marking and placarding of haz-
 ardous materials and  the vehicles car-
 rying them, define the  basic Federal
 requirements. In addition,  when  any
 registered  pesticide product is trans-
 ported in a  tank  car,  tank truck or
 other mobile or portable bulk contain-
 er, a copy of the accepted label must
 be attached  to the shipping papers,
 and left with the consignee at the time
 of delivery.
   (B) Storage.  When  pesticide prod-
 ucts are  stored  in bulk  containers,
 whether mobile or stationary, which
 remain in the  custody of  the user, a
 copy of the label of labeling, including
 all appropriate directions for use, shall
 be securely attached  to the container
 in the immediate vicinity  of the dis-
 charge control valve.
   (5)  Falte or  misleading  statements.
 Pursuant to  section 2(q)(l)(A) of the
 Act, a pesticide or a  device declared
 subject  to  the   Act  pursuant  to
, S ,162.16, is misbranded if its labeling is
 false  or  misleading In  any particular
 including both pesticidal and non-peg-
 ticidal claims. Examples of statements
 or  representations in  the  labeling
 which constitute  mlsbranding include:
   (i) A false or misleading statement
 concerning  the  composition of  the
 product;
   (ii) A false or misleading statement
 concerning  the effectiveness  of the
 product as a pesticide or device;
   (lit) A false or misleading statement
 about the value  of  the product for
 purposes  other than  as a pesticide or
 device;
   (iv) A false or misleading comparison
 with other pesticides or devices;
   (v)  Any statement  directly or indi-
 rectly implying that  the pesticide or
  "
      (cont'd)

 .Copter I—Environmental Protection Agency
                                                162.10
 any agency of  the Federal Govern*
 ment;                              I
  (vi) The name of a pesticide which
 contains two or more principal active
 ingredients if  the  name suggests one
 or  more but  not  all  such  principal
 active  ingredients  even though the
 names of the  other ingredients are
 slated elsewhere in the labeling;
  (vil) A true statement used in such a
 way as to give a false or misleading im?
 pression to the purchaser;
  (viii) Label disclaimers which negate
 or detract from labeling statements re-
 quired under the Act and these regulaf
 tions;
  (Ix) Claims as to the safety of the
 pesticide or  its ingredients, including
 statements such as "safe," "nonpoison-
 ous,"  "noninjurious,"  "harmless1'-  or
 "nontoxic to  humans and  pets" with
 or without such a qualifying phrase  as
 "when used as directed"; and
  (x) Non-numerical  and/or compara-
 tive statements on  the safety of the
 product, including but not limited to:
  (A)  "Contains all  riatural ingredi-
 ents":
  (B) "Among the  least  toxic chemi-
 cals known"          1
  (C) "Pollution approved"
  (6) Final printed labeling, (i) Except
 as provided in paragraph (a)(6)(ii) of
 this  section,  final  p
 must be submitted  am
 to registration. However, final printed
 labeling need not be submitted until
 draft label texts havefbeen provision-
 ally accepted by the Aaency.
  (Ii) Clearly legible reproductions or
 photo reductions will be accepted for
 unusual labels  such ias those  silk-
 screened directly onto  glass or metal
 containers or large bag or drum labels.
 Such reproductions must be of micro-
 film reproduction quality.
  (b) Name, brand, on trademark. (1)
 The name, brand, or trademark under
 which the pesticide  product is  sold
shall appear on the front panel of the
 label.
  (2)  No name, brand,  or  trademark
may appear on the label which:
  (i) Is false or misleading, or
  (ii) Has not been  approved by  the
Administrator through registration or
supplemental registration as an addi-
 tional name cmrsuant to 5 162.B(bU4V
rinted  labeling
 accepted prior
    (c) Name and address of producer,
  registrant,  or person  for whom pro-
  duced. An  unqualified nair^  and ad-
  dress given on the label  shall be con-j
  sidered as the name and address ol the
  producer. If the registrant's name ap-
  pears on the label and the registrant is
  not; the producer, or if the name of the
  person for  whom the pesticide was
i  produced appears on the  label, it must
  be qualified  by appropriate  wording
  such as "Packed for • • •," "Distribut-
  ed by • • *," or "Sold by • • •" to show
  that the name is not that of the pro-
  ducer.
    (d) Net weight or measure of con-
  tents.  (1) The net weight or measure
  of icontent shall  be exclusive of wrap-
  pers or  other materials  and shall  be
  the  average content unless explicitly
  stated as a minimum quantity.
    (2) If  the pesticide is  a liquid, the
  net  content  statement  shall be  in
  terms of liquid measure at 68° F (20°C)
  and shall be expressed in conventional
  American units of fluid ounces, pints,
  quarts, and  gallons.
    (3) If the  pesticide is solid or semiso-
  lid, viscous or pressurized, or is a mix-
  ture of liquid and solid,  the net con-
  tent statement  shall be  in  terms  of
  weight    expressed   as   avoirdupois
  pounds and  ounces.
   (4) In all cases, net content shall be
  stated  in  terms of the largest suitable
  units, i.e., "1 pound 10 ounces" rather
  than "26 ounces."
   (5) In addition  to the required units
  specified, net content  may  be  ex-
  pressed in metric units.
   (6) Variation  above minimum con-
  tent or around an average is permissi-
  ble only to  the  extent that it repre-
  sents deviation   unavoidable  in  good
  manufacturing   practice.  Variation
  below a stated minimum is not permit-
  ted.  In no case shall the  average con-
  tent of the packages in a shipment fall
  below the stated average content.
   (e)  Product registration   number.
 The  registration  number assigned to
 the pesticide product at  the time of
 registration  shall appear on the label,
 preceded  by  the  phrase "EPA Regis-
 tration No.," or the phrase "EPA Reg.
 No." The  registration number shall be
 set in type of a size and style similar to
 other print  on that part  of the label
                                                        CO

-------
§ 162.10

allel  to  it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
  (f)  Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the  phrase "EPA Est.". of the
final establishment at which the prod-
uct was  produced may  appear in  any
suitable  location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of  the
package if the EPA establishment reg-
istration number on  the Immediate
container  cannot  be   clearly  read
through such wrapper or container.
  (g) Ingredient statement—(I) Gener-
al The label of each pesticide product
must bear  a statement which contains
i he name and percentage by weight of
each active ingredient, the total  per-
centage  by weighv of all inert ingredi-
ents; and if the pesticide contains ar-
senic In any  form, a statement of the
percentages of total and water-soluble
arsenic  calculated as  elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients." or the singu-
lar forms of  these terms when appro-
priate. Both terms shall be In  the
same type size, be aligned to the same
margin and be equally prominent.  The
statement "Inert Ingredients, none" is
not required for pesticides which  con-
 tain  100  percent  active ingredients.
 Unless the Ingredient statement  is a
complete analysis of the pesticide, the
 term "analysis" shall not be used  as a
 heading for the ingredient statement.
  (2) Position of ingredient statement.
 (1) The ingredient statement is  nor-
 mally required on  the front panel of
 the label.  If there is  an outside  con-
 tainer or wrapper through which the
 ingredient statement cannot be clearly
 read, the  ingredient statement must
 also  appear on such outside container
 or wrapper. If the size or form of the
 package  makes it  impracticable to
 place the ingredient statement on the
 front panel  of the label, permission
 may  be granted for  the  ingredient
 statement to appear elsewhere.
  Titl* 40—Protection of environment

  (ii) The text of the ingredient state-
ment  must run parallel  with  other
text on the panel on which it appears,
and must  be clearly  distinguishable
from and must not be placed in  the
body of other text.
  (3) Names to be  used in ingredient
statement.  The name used for each in-
gredient   shall  be  the  accepted
common name, if  there  is one,  fol-
lowed by  the chemical  name. The
common name may be used alone only
if it is well  known. If no common name
has  been  established,  the chemical
name alone shall be used. In no case
will the  use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under  the
authority of Section 25(c)(6).
  (4) Statements of percentages. The
percentages  of ingredients shall  be
stated in  terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be  100.
Percentages shall not be expressed by
a range of  values such as "22-25%." If
the uses of the pesticide product  are
expressed as weight of active ingredi-
ent per  unit area,  a statement of  the
weight of  active ingredient per unit
volume  of the pesticide  formulation
shall  also  appear  in the ingredient
statement.
  (5) Accuracy of  stated  percentages.
The percentages given shall be as  pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated  for
each  active  ingredient shall  be  the
lowest  percentage which may   be
present.
  (6)  Deterioration. Pesticides  which
change  in chemical  composition  sig-
nificantly must meet the following la-
beling requirements:
  (i) In  cases where it is  determined
that a pesticide formulation changes
chemical  composition  significantly,
the product  must  bear the following
statement  in a prominent  position on
the label:  "Not for sale or use after
[date]."
  (11) The product must meet all label
claims up  to the expiration time indi-
cated on the label.
  (7) Inert ingredients. The Adminis-
trator may require the name of  any
          —cnv.ronm.h.ol Protection Agency
   inert ingredient(s) to be  li.sted in tho


  £S=££w=
                                                              § 162.10
                                        w
                                                  P'ommenceare
                                          warning statement, the text re
Hazard indicator
	
OraILD,. 	
Inhalation LCM...
Dermal LD,. 	
1 Eye effects 	
S*m effects 	
' 	 Toxicily categories " " "" 	 -
	 L. :' I
Up lo and including 50
fig/kg.
Up lo ana including 2
mg/liier.
Up to and including 200
mg/kg
Corrosive; cornea!
opacity not reve/sible
within 7 days. '
Corrosive 	 '
From 50 Ihru 500 mg/kg
From 2 thru 2 m
-------
£ 162.10

placement of the statement of practl-
:al treatment is some  reference such
Is "See statement of practical treat-
ment on back panel" appears on the
iront panel near  the  word  "Poison"
rtnd the skull and crossbones.
~ vB) Other  toxicity  categories.  The
Statement of practical treatment is not
required on the front panel except as
 '.-Bribed In paragraph (hXIXiiiXA) of
 ins section. The applicant may, how-
, ver. include such a front  panel state-
  cnt  at  his option.  Statements  of
 jiactical treatment are, however, re-
 ,ulred   elsewhere  on  the   label  in
 .ccord  with  paragraph (hX2) of this
 >..-ction if they  do not  appear  on the
  i ont panel.
   (iv) Placement and prominence. All
 •ne require front panel warning state-
 ments  shall be  grouped  together  on
 the label, and shall appear with suffi-
 cient  prominence  relative   to  other
 front panel text and graphic material
 co make them  unlikely  to  be  over-
  ooked under customary conditions of
 purchase and use. The following table
 nhows the minimum type  size require-
 ments  for the  front  panel  warning
 statements on various sizes of labels:
                                                                   APPEMDIX V-l

                                          Titlo 40—Protection of Environment      {
Sue ot label Iront panel m tquare
inch*.
5 and under ..
Above S lo 10
Above 10 to 15 	
Above 15 to 30 	
Over 30 	

Poi
Requited
signal
word. > . ^
                                                                                                                                      (iii) Exceptions  to requirement for' "J
                                                                                                                                    direction for use—(A) Detailed  direc-
                                                                                                                                    tions for use may be omitted from  la-
                                                                                                                                    beling of pesticides wjiich arp intended

-------
  162.10

 or use only by manufacturers of pred-
 icts  other than pesticide products in
 heir regular manufacturing processes,
 >rovided that:
  (7) The label clearly shows that the
 product  is intended  for  use  only in
 manufacturing processes and specifies
 .he type(s) of products Involved.
  12}  Adequate  information such as
technical data sheets or bulletins,  is
available to  the  trade  specifying the
type  of  product  involved  and  Its
proper  use in manufacturing process-
es;
  (3) The product will  not come  Into
the hands of the general public except
.ifier incorporation into finished prod-
ucts; and
  <4) The Administrator .determines
that such directions are not necessary
to prevent  unreasonable  adverse  ef-
fects on man or the environment.
  (B) Detailed directions  for use may
be omitted from the  labeling of pesti-
cide  products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
  U) The label clearly states that the
product is for use only by physicians
or veterinarians;
  (2) The Administrator  determines
that such directions are not necessary
to prevent  unreasonable  adverse  ef-
fects on man or the environment; and
  (3) The product Is also  a drug and
regulated under the  provisions of the
Federal Food, Drug and Cosmetic Act.
  (C) Detailed directions  for use may
be omitted from the  labeling of pesti-
cide  products v.:-.ich  are intended for
use  only by  formjl_.v->rs in preparing
pesticides for sale to the  public,  pro-
vided that:
  (1) There  is  information  readily
available to the formulators  on the
composition, toxicity, methods of use,
applicable restrictions  or  limitations,
and  effectiveness  of the product for
pesticide purposes;
  (2) The label clearly  strtes that the
product is intended  for  use only in
manufacturing,  formulating,   mixing,
or repacking for use as  a pesticide and
specifies the type(s) of  pesticide prod-
 ucts involved;
  (3) The product as finally manufac-
 tured,  formulated, mixed, or  repack-
 aged is  registered; and
  Tltl* 4O—Protection or Environment

  (4)  The  Administrator  determines
that such directions are  not necessary
to prevent  unreasonable  adverse  ef-
fects on man or the environment.
  (2)  Contents of Directions for Use.
The directions for  use  shall  include
the following, under the  headings "Di-
rections for Use":
  (i) The statement of  use classifica-
tion as prescribed in 162.10(j) immedi-
ately under the  heading  "Directions
for Use."
  (ii) Immediately  below  the state-
ment of use classification, the state-
ment "It is a  violation of  Federal law
to use this product in a manner incon-
sistent with its labeling."
  (iii) The site(s) of application, as  for
example the crops,  animals, areas, or
objects to be treated.
  (iv) The  target pest(s) associated
with each site.
  (v)  The dosage rate associated with
each site and pest.
  (vi) The method of application,  in-
cluding instructions for dilution, if re-
quired,  and type(s) of application  ap-
paratus or equipment required.
  (vii) The frequency and timing of  ap-
plications necessary to obtain effective
results  without  causing  unreasonable
adverse effects on the environment.
  (viii) Specific limitations on  reentry
to areas where the pesticide has been
applied,  meeting  the  requirements
concerning  reentry  provided  by  40
CFR Part 170.
  (ix) Specific directions  concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements  of 40  CFR Part 165. These
instructions  shall  be  grouped ana
appear  under  the heading  "Storage
and  Disposal." This heading must be
set in type of  the same minimum sizes
as required  for the child hazard warn-
ing (See Table in  I 162.10(h)(l)(iv).)
  (x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
  (A) Required intervals between  ap-
plication and  harvest  of food  or feed
crops.
  (B) Rotational crop restrictions.
  (C) Warnings as required against use
on certain crops,  animals, objects, or
in or adjacent to certain areas.
  (D) [Reserved]

                                         ^
                                                                         §162.11
                                               "Reted
                                         appear.
  to be necessary
  man and
                           o
                           or
                                       s
                                      of
                                          of the terms of
                                          a  precondition
                                          appear. If Use i*
                                                                         " shall
                                                                             on
                                                                     -
                                                                     lmP°sed as
                                                                          sha»
rections  only  for
the other  bearin*
stricted tue^SS
has both restrS
use(s), both of
   a product

                            Me<'}  and
                               for  re'
                               Product
                                                  43
                                                                       32329.
                                   '•
 heading "Dle<
 erence to  the
 that suggeste or
 eral  utility  of  tt
 beyond those pur«>£
 tained in the DlreS
considered a fa s
                           " 5°!? the
                            And re*-
                              *en'
                           extends
                              con'
                            wi» be
                            state-
                              ae-
                    ry definitions
ment under the
ofmisbranding
  (2)  Restricted  USP  m
Pesticide products  hL Clas^cation.
for  use(S) c?3?ed^   ?*  directi°n
bear statement o          "*  sha11
                                                                          Ur
   front panel

-------
                                                                                       APPENDIX  V-2
LABELING REQUIREMENTS OP THE FIFRA,  AS AMENDED (REFER TO TOE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Rag. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement

Above signal
word
Immediately
below child
hazard
warning
COMMENTS

If registrant is not the producer, must
be qualified by "Packed for . . .,"
-Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.

All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements. ^
.p»
&
•^s

-------
APPENDIX  V-2 (continued)
ITEM
1C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precau t ionary
statejnents
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, .11, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.

Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS



Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee "?
caution where applicable. Ci

-------
APPENDIX  V-2 (continued)
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement pf
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked

Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS

Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.


Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
                       co

-------
                                                        Appendix V-2 (cont'd)
                                                                          (49)
                             RESTRICTED USE PESTICIDE
MITIONARY STATEMENTS
IZAROS TO HUMANS
OOMESTC ANM/
   DANGER
H3NMENTAL HAZARDS/
SCAL OR CHEMCAL
 HAZARDS  tff\
 •CnONSFOR USEpO
 JfTRY STATEMENT
 (N Apple**)  /
 ORY OF APPUCATOR
DRAGE AND
MSPOSAL
g     —
 U.:
                           RESTRICTED USE
                               PESTICIDE
                         FOR RETAL SALE TO AND APPLICATION ONLY BY
                        CERTIFIED APPLICATORS OR PERSONS UNDER THEIR
                                DIRECT SUPERVISION
                           PRODUCT
                               NAME
                        ACTIVE NGREDENT:
                        MERT MGREDCNTS.

                        TOTAL;
                                             1OOOO%
                         THIS PRODUCT CONTAMS  LBS OF  PER GALLON
                      KEEP OUT OF REACH OF CHILDREN
                          DANGER — POISON
                            STATEMENT OF PRACTICAL TREATMENT
                    f SWALLOWED:
                    FNHALED=
                     FON!
                     FNEYE5:
                     SEE SCE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
                     MFC BY	
                     TOWN, STATE    .
                     ESTABLISHMENT NO. =
                     EPA REGISTRATION NO.
                               NET CONTENTS:
                                                              CROP:
                                                              CHOP:
                                                              CROP:
                                                              CHOP:
                                                              CROP:
                                                                WARRANTY STATEMENT

-------
                                                               (50)
                                                   Appendix  V-3
                    PHYSICAL-CHEMICAL HAZARDS
Criteria
I.  Pressurized Containers

    A.  Flashpoint, at or below
        20°F; or if there is a
        flashback at any valve
        opening.
    B.  Flashpoint above 20°F
        and not over 80 °F; or
        if the flame extension
        is more than 18 inches
        long at a distance of
        6 inches from the
        valve opening.

    C.  ALL OTHER PRESSURIZED
        CONTAINERS
II.  Non-Pressurized Containers

    A.  Flashpoint at or below
        20 "F.
    B.  Flashpoint above 20'F
        and over 80°F.

    C.  Flashpoint over 80*F
        and not over  150°F.

    D.  Flashpoint above
        150*F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces.  Do not
puncture or incinerate
container.  Exposure to
temperatures above 130°F
may cause bursting.

Flammable.  Contents under
pressure.  Keep away from
heat, sparks, and flame.  Do
not puncture or incinerate
container.  Exposure to
temperatures above 130"F
may cause bursting.

Contents under pressure.
Do not use or store near
heat or open flame.  Do not
puncture or incinerate
container.  Exposure to
temperatures above 130°F
may cause bursting.
Extremely  flammable.   Keep
away  from  fire,  sparks,  and
heated  surfaces.

Flammable.   Keep away  from
heat  and open flame.

Do not  use or store near
heat  and open flame.

None  required.

-------
                                                               (51)
                                               Appendix  V~£*

       •STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES

All products are required to bear specific label instructions
about storage and disposal.  Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL.  Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."  The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
                                  IRequired type size
 Size of label                    I   for the heading
 front panel in                   I   STORAGE AND DISPOSAL
 square inches	I   (all capitals)	
110 and under	6 point
I Above 10 to 15	8 point
I Above 15 to 30	10 point
I Over 30	  . 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable fr,om other directions for use.
Blocking storage and disposal statements with a sol)id line is
suggested as a means of increasing their prominence.

A.  Storage Instructions;

All product labels are required to have appropriate storage
instructions.  Specific storage instructions are not prescribed.
Each registrant must develop his own  storage instructions,
considering, when applicable, the following factors:

1.  Conditions of storage  that might  alter the composition or
    usefulness of the pesticide.  Examples could be temperature
    extremes, excessive moisture or humidity, heat, sunlight,
    friction, or contaminating substances or media.

2.  Physical requirements  of storage  which might adversely
    affect the container of the product and its ability to
    continue to function properly.  Requirements might include
    positioning of the container in storage, storage or damage
    due to stacking, penetration of moisture, and ability to
    withstand shock or friction.

3.  Specifications for handling the pesticide container,
     .ncluding movement of  container within the storage area,
    proper opening and closing procedures  (particularly  for
    opened containers), and measures  to minimize exposure
    while opening or closing container.

-------
                                                              (52)
                                                 Appendix
                                                 (continued)

4.  Instructions on what to do if the container is damaged in
    any way,  or if the pesticide is leaking or has been
    spilled,  and precautions to minimize exposure if damage occurs

5.  General precautions concerning locked storage, storage in
    original container only,  and separation of pesticides
    during storage to prevent cross-contamination of other
    pesticides, fertilizer,  food, and feed.

6.  Genera:, storage instructions for household products should
    emphasize storage in original container and placement in
    locked
storage areas
B.  Pesticide Disposal Instructions;

The label of all products,  except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal.  The statements listed below contain the exact wording
that must appear on the label of these products:

1.  The labels of all products,  except domestic use, must
    contain the statement,  "Do not contaminate water, food,
    or feed by storage or disposal."        .
         j         !        '     ' -;             	
2.  Except those products intended solely for domestic use,
    the labels of all products that contain active ingredients
    appearing on the "Acutely Hazardous" Commercial Pesticide
    Products List (RCRA "E" List) at the end of this appendix
    or are assigned to Toxicity Category I on the basis of
    oral or dermal toxicity, skin or eye irritation potential,
    or Toxicity Category I or II on the basis of acute inhala-
    tion toxicity must bear the following pesticide disposal
    statement:

    "Pesticide wastes are acutely hazardous.  Improper dis-
    posal of excess pesticide, spray mixture, or rinsate is
    a violation of Federal Law.  If these wastes cannot be
    disposed of by use according to label instructions,
    contact your State Pesticide or Environmental Control
    Agency, or the Hazardous Waste representative at the
    nearest EPA Regional Office for guidance."

    The labels of all products, except those intended for
    domestic use, containing active or inert ingredients
    that appear on the "Toxic" Commercial Pesticide Products
    List (RCRA "F" List) at the end of this appendix or
    presently meet any of the criteria in Subpart C, 40 CFR
    261 for a hazardous waste must bear the following pesticide
    disposal statement:

-------
                                                 Appendix   V
                                                 (continued)

    "Pesticide wastes  are toxic.   Improper disposal of excess
    pesticide,  spray mixture,  or  rinsate is a violation of
    Federal Law.   If these wastes cannot be disposed of by
    use according to label instructions, contact your State
    Pesticide or  Environmental Control Agency,  or the Hazardous
    Waste representative at the nearest EPA Regional Office
    for guidance."

    Labels for all other products, except those intended for
    domestic use, must bear the following pesticide disposal
    statement:

    "Wastes resulting  from the use of this product may be
    disposed of on site or at an approved waste disposal
    facility."

3.   Products intended  for domestic use only must bear the
    following disposal statement:  "Securely wrap original
    container in several layers of newspaper and discard in
    trash."

C.   Container Disposal Instructions

    The label of each product must bear container disposal
    instructions appropriate to the type of container.

        A-ll products intended for domestic use must bear one
        of the following container disposal statements:
                                                               (53)
Container Type
FNon-aerosol products
{(bottles, cans, jars)
1 Non-aerosol products
1 (bags )
I Aerosol products
Statement
Do not reuse container (bottle, can, jar;.
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
    2.  The labels  for all other products must bear container disposal
        instructions, based on container type, listed below:
Container Type
I Metal
I containers
1 (non-aerosol)
1
1
I Plastic containers
I
1
!
|Glass containers
!
Statement
Triple rinse (or equivalent). Then offer i
for recycling or reconditioning, or puncture!
and dispose of in a sanitary landfill, or byl
other procedures approved by state and local I
authorities . 1
Triple rinse (or equivalent). Then orrer i
for recycling or reconditioning, or puncture 1
and dispose of in a sanitary landfill, or I
incineration, or, if allowed by state and
local authorities, by burning. If burned, i
stay out of smoke. '
Triple rinse (or equivalent). Then dispose 1
of in a sanitary landfill or by other
approved state and local procedures. 1

-------
                                                              (54)
                                              Appendix   V—
                                              (continued)
Container Type
1 Fiber drums
jwith liners
1
1
|
1
1
1
1 Paper and
1 plastic bags
1
1
|
1 Compressed gas
1 cylinders
Statement
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
  ^Manufacturer may replace this  phrase with one indicating whether
  and how fiber drum may be reused.

2. The labels for all other products must bear container
   disposal instructions, based on container type, listed
   on the first page of this Appendix.

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                                                                 (55)


                                                  Appendix   V-#
                                                  (continued)


 Pesticides  that  are hazardous  wastes  under  40 CFR 261.33(e) and  (f)
 when  discarded.

       "Acutely Hazardous"  Commercial  Pesticides  (RCRA  "E" List)
                    Active  Ingredients,  (no  inerts);~

 Acrolein
 Aldicarb
 Aldrin
 Allyl alcohol
 Aluminum phosphide
 4-Aminopyridine
 Arsenic acid
 Arsenic pentoxide
 Arsenic trioxide
 Calcium cyanide
 Carbon disulfide
 p-Chloroaniline
 Cyanides (soluble cyanide  salts, not  specified elsewere)
 Cyanogen chloride
 2-Cyclohexyl-4,6-dinitrophenol
 Dieldrin
 OiO-Di'ethyl S-[2-ethylthio)ethyl] phosphorodithioate
      (disulfoton,  Di-Syston)
 0,0-Diethyl 0-pyrazinyl phosphorothioate  (Zinophos)
 Dimethoate
 0,0-Dimethyl 0-p-nitrophenyl phosphorothioate  (methyl parathion)
 4,6-Dinitro-o-cresol and salts
 4,6-Dinitro-o-cyclohexylphenol
 2,4 Dinitrophenol
 Dinoseb
 Endosulfan
 Endothall
 Endrin
 Famphur
 Fluoroacetamide
 Heptachlor
 Hexanethyl tetraphosphate
 Hydrocyanic acid
 Hydrogen cyanide
Methomyl
 alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA,  schradan)
 Parathion

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                                                               (56)
                                                 Appendix  V
                                                 (continued)
      "Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
                    Active Ingredients continued;

Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate   (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on ,-the "Acutely Hazardous" List (RCRA. "E" List).

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                                                 Appendix  V-# (57)
                                                 (continued)
        "Toxic" Commercial Pesticide Products (RCRA "F" List-)
                         Active Ingredients;

Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)p-thalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
    (kepone, chlordecone)
1,2-Dibromo-3-chloropropane  (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12*)
3,5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide  (pronaraide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane  (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts   (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane  (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate  (chlorobenzilate)
Ethylene dibromide  (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid

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                                                 Appendix  V—
                                                 (continued)
        "Toxic" Commercial Pesticide Products  (RCRA "F" List.)
                         Active Ingredients:

Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol)   (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl Tcetone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene  (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene ;dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane  (Freon 11*)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid  (2>4,5-T)
Xylene

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                                                Appendix   V
                                                (continued)
                                                               (59)
 "Toxic"  Commercial  Pesticide Products (RCRA "F"  List)
  Inert Ingredients;
 Acetone
 Acetonitrile
 Acetophenone
 Acrylic acid
 Aniline
 Benzene
 Chlorobenzene
 Chloroform
 Cyclohexane
 Cyclohexanone
 Dichlorodifluoromethane (Freon 12®)
 Diethyl phthaiate
 Dimethylamine
 Dimethyl phthaiate
 1,4-Dioxane
• Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane  (Freon 11®
Vinyl chloride
Xylene

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