GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
      (REGISTRATION STANDARD)
             CONTAINING

      AS THE ACTIVE INGREDIENT
             PRONAMIDE
       Case number:  GS-0082
  ENVIRONMENTAL PROTECTION AGENCY
    OFFICE OF PESTICIDE PROGRAMS

      WASHINGTON, D.C.  20460
           April 15, 1986

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                       TABLE OF CONTENTS

                                                         Page

INTRODUCTION 	   1

PART I.  REGULATORY ASSESSMENT 	   3

     A.  Description of Chemical	   4
     B.  Agency Assessment 	   5
     C.  Regulatory Position and Rationale 	  17

PART II, REQUIREMENTS FOR REGISTRATION	22

     A.  Acceptable Ranges and Limits	23
     B.  Labeling and Packaging Requirements ......  24
     C.  Submission of Generic Data	28
     D.  Submission of Product Specific Data	34
     E.  Instructions for Submission	  35


APPENDICES

     A - Tables A and B - Data Requirements	38

     B - EPA Index to Pesticide Chemicals	65

     C - Labeling Requirements  	  8S

         1.  Submission of Revised Labeling
         2.  40 CPR 162.10 Labeling Requirements
         3-  Table of Labeling Requirements
         4.  Physical/Chemical Hazards
                Labeling Statement
         5.  Pesticide Storage Instructions
         6.  Container Disposal Instructions
         7.  Farmworker Safety Label Requirements

     D - FIFRA §3(c)(2)(B) Summary Sheet  	 117

     E - Certification of Attempt to Enter Into
         an Agreement with Other Registrants for
         Development of Data	119

     F - Product Specific Data Report   	 121

     G - Formulator's Exemption Statement   	 124

BIBLIOGRAPHY 	 126

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                         INTRODUCTION


The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Section 3(g), directs EPA to reregister all pesticides as
expedltiously as possible.

To carry out this task  EPA has established the Registration
Standards program, which reviews all pesticide products contain-
ing active ingredients first registered before January 1, 1977-
Pesticides are reviewed in use clusters which have been ranked to
give earliest review 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 studies required to maintain the registration
of the pesticide.  These may be either studies which may not
have been required when the product was initially registered or
studies that are now considered insufficient.  EPA's reassessment
results in the development of a regulatory position, contained
in a Registration Standard, on each pesticide and its uses.  The
Agency may require the registrant to modify product labels to
provide additional precautionary statements, restrict the use of
the pesticide to certified applicators, establish reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use of
the pesticide will not result in unreasonable adverse effects on
the environment.

The scientific review, which is not contained in the Registration
Standard, but is available from the National Technical Information
Service, concentrates on the technical grade of the active
ingredient and identifies missing generic data.  However, during
the review of these data, the Agency is also looking f*or potential
hazards that may be associated with the end-use (formulated)
products that contain the active ingredient.  If the /Vgency has
serious concerns, the end-use products will be addressed as part
of the Registration Standards program and regulatory actions, to
the extent necessary to protect the public, will be proposed.

This Registration Standard contains the results of the Agency's
review of products containing pronamide as the sole active
ingredient.  During this review, the Agency evaluated all Section 3,
Section 2i|(c) and intrastate uses registered for pronamide.

Part I of this Standard, Regulatory Assessment, contains a
description of pronamide and a summary of the Agency's assessment
of the chemical.  This  is followed by a more thorough discussion
of the data base and the resulting regulatory position.

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Part II of the Registration Standard,  Requirements for Regis-
tration, addresses the necessary requirements for maintaining
registrations of products containing pronamide,  along with the
instructions for submission of the data and information to the
Agency.
                             - 2 -

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                PART I.  REGULATORY ASSESSMENT
The Agency has conducted a thorough review of the existing
scientific data base on pronamide.  This Part of the Standard
sets forth the results of that review beginning with a descrip-
tion of the chemical and its uses, followed by a discussion of
the risks and benefits associated with the use of pronamide.
A summary of the Agency's review and position precedes the
discussion.

This part concludes with the resulting regulatory position,
and the rationale for these positions.

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                 A.   DESCRIPTION OP CHEMICAL
1.   Description

    Common Name

    Chemical Name
    Empirical Formula    :

    Trade Names          :

    Chemical Abstracts
      Service (CAS) No.  ;

    OPP  (Shaughnessy) No.:

    Use  Profile

    Type or Pesticide    :

    Pest Controlled      :


    Registered Uses

    Predominant Use

    Method of Application


    Mode of Activity


    Rates of Application




    Formulations
Pronamide

3 5-dichloro-N(l,l-dimethyl-2-
propynyl) benzamide
      - or -
[N-(l.l-dimethylpropynyl)-3, 5-
dichlorobenzamide]

C12H11NOC12

Kerb
23950-58-5

101701



Preemergence herbicide

Annual and perennial grasses;
  certain broadleaf weeds

Croplands; noncroplands

Lettuce and alfalfa

Ground spray equipment; incorporation
  aerially: limited hand spray

Inhibition of root and shoot grow ;h
  of germinating weed seedlings

0.5 to 4.0 Ibs. active ingredient
  per acre, depending on crop and
  weed problem

9*J% technical grade
50% formulation intermediate
End-use products: 50% wettable  powder
  <_!% granular formulations  and
  <1% granular formulations  mixed
  with fertilizer

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                      B.  AGENCY ASSESSMENT


The Agency has conducted a thorough review of pronamide and its
scientific data base.  The conclusions reached and requirements
to be imposed as a result of this review are discussed below.

Summary.  The following summarizes the results of the Agency's
assessment of pronamide.

1.  Pronamide poses a limited oncogenic risk for applicators.
    In accordance with the Agency's proposed guidelines for
    carcinogen risk assessment, pronamide has been classified in
    Group C, Possible Human Carcinogen, pending consideration of
    additional data required by this Standard.  This classifica-
    tion is based on a Medical College of Virginia (MCV) 18-month
    mouse oncogenicity study which indicated that hepatocellular
    carcinomas in male mice were present at feeding levels of
    1000 and 2000 ppm.  The results of this study have been
    confirmed and clarified by a subsequent study (MIT).

2.  Pronamide poses applicator exposure and risk which can be
    reduced through the imposition of protective measures
    (protective clothing, restricted use classification, water-
    soluble packaging, etc.).

3.  Pronamide has significant benefits that outweigh the
    identified risks, if protective measures are instituted.

As a  result of this review, the Agency has identified missing
data  which are essential in completing assessment of the environ-
mental  and human  risks associated with the use of pronamide.
These data must be developed in order to maintain registrations
of products or register new products containing pronamide.
Specific data gaps are  listed  in Appendix A, Tables A and B.

The Agency has also determined that certain restrictions or
conditions are necessary to minimize environmental and human  risks.
Significant requirements include continuation, from the RPAR
decision  (see below), of classification as a  restricted use
pesticide and water-soluble packaging for wettable powder end-use
products, and expansion of the protective clothing requirements
imposed by the RPAR decision.   A complete discussion  is contained
in Section C, Regulatory Position and Rationale, of this part;
the specific  label language, when applicable,  is set  forth  in
Part  II.

Background.  An RPAR  (Rebuttable Presumption  Against  Registration,
or Special Review) of pronamide was  initiated  in  1977  on  the  basis
of a  Medical  College  of Virginia  (MCV) 18-month mouse  oncogenicity
study which indicated that mice given  diets containing  0,  1000,

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and 2000 ppm pronamide showed a treatment-related increase in
hepatocellular carcinomas.  The incidence of tumors was observed
at 18 months in male mice only.  At that time, this study provided
the only evidence that pronamide is likely to be a human carcinogen,
After reviewing all the available information, EPA determined that
the cancer risk presumption had not been rebutted, and that the
uses of pronamide posed risks of cancer to certain exposed groups.
The Agency also reviewed information relating to benefits of these
uses, and after considering risks in relation to benefits, deter-
mined that these risks may be reduced by modifying the terms and
conditions of registration for some uses.  The RPAR review was
completed in 1979, and the final decision included the following:

a.  Restricted use classification for 50% wettable powder end-use
    products.

b.  Use of protective clothing during mixing and application of
    wettable powder formulations.

c.   Implementation of water-soluble packaging for wettable powder
     formulations.

d.   Tolerance  on  lettuce  lowered from 2 ppm to 1 ppm  to reduce
     dietary  exposure.

Tolerance Reassessment.   Tolerances have been established for
 residues  of  pronamide  in  or on a wide range of raw agricultural
products  listed  in 40  CFR 180.317.  These tolerances  are:

            Commodity            Tolerance (ppm)

            Alfalfa,  fresh          10.0
            Alfalfa,  forage         10.0
            Alfalfa,  hay             10.0
            Apples                  0.1
            Artichokes               0.1
            Blackberries             0.05
            Blueberries              0.05
            Boysenberries            0.05
            Cattle,  fat             0.02
            Cattle,  kidney          0.2
            Cattle,  liver           0.2
            Cattle,  MBYP  (exc.
               kidney and liver)     0.02
            Cattle,  meat             0.02
            Cherries                 0.1
            Clover                  5.0
            Crown vetch             5.0
            Eggs                    0.02
            Endive (escarole)        2.0
                               - 6 -

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          Goats,  fat                0.02
          Goats,  kidney             0.2
          Goats ,  liver              0.2
          Goats,  MBYP  (exc.
              kidney and  liver)      0.02
          Goats,  meat               0.02
          Grapes                    0-1
          Hogs,  fat                 0.02
          Hogs,  kidney              0.2
          Hogs,  liver               0.2
          Hogs,  MBYP  (exc.
              kidney and  liver)      0.02
          Hogs,  meat                0.02
          Horses, fat               0.02
          Horses, kidney           0.2
          Horses, liver             0.2
          Horses, MBYP  (exc.
              kidney and  liver)      0.02
          Horses. meat              0.02
          Lettuce                  1.0
          Milk                     0.02
          Nectarines                0.1
          Peaches                  0. 1
          Pears                     0.1
          Plums                     0.1
          Poultry, fat              0.02
           Poultry, kidney          0.2
           Poultry, liver           0.2
           Poultry, MBYP  (exc.
              kidney and  liver)      0.02
           Poultry, meat             0.02
           Raspberries               0.05
           Sainfoin                 5.0
           Sheep,  fat                0.02
           Sheep,  kidney             0.2
           Sheep,  liver             0.2
           Sheep,  MBYP (exc.
              kidney and  liver)      0.02
           Sheep,  meat              0.02
           Trefoil                  5.0

Because insufficient  data are available  to fully assess the
established  tolerances for residues of pronamide, any con-
clusions stated herein are subject to  change.

The metabolism of pronamide in plants  and animals is not ade-
quately understood.  Plant metabolites were identified in alfalfa
only.  The data were too  variable to make definite conclusions
about relative abundances of the metabolites.   The data do show
that if the  carbonyl carbon of pronamide remains intact, all of

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the organoextractable terminal residues retain the 3,5-dichloro-
carboxyphenyl substituent.  Additional data are required depicting
the distribution and metabolism of pronamide in alfalfa and lettuce,
If metabolism among these two crops differs significantly, metab-
olism studies will be required for a representative crop in each
crop group for which there is a registered use.

Residues were not characterized in tissues and milk of ruminants
and no poultry data were submitted; therefore, metabolism studies
utilizing ruminants and poultry are required.  Residues in muscles,
fat, kidney, liver, milk, and eggs must be characterized and
quantified.

On receipt of the data, the tolerance definition will be examined
and changed to include only those metabolites found which are of
toxicological concern.

The methods of analysis of pronamide and its 3,5-dichloro-
benzene-containing metabolites (calculated as pronamide) in or
on plant and animal commodities are presently adequate for sample
analyses and tolerance enforcement.

Sufficient  data  are available to ascertain the adequacy of the
established  tolerances for residues of pronamide in or on alfalfa
forage  and  hay,  apples, artichokes, blackberries, blueberries,
cherries,  clover,  crown vetch, grapes, lettuce (head lettuce only),
nectarines,  peaches,  pears, plums, raspberries, sainfoin, and
 trefoil.

The tolerance  for residues in or on "fresh" alfalfa will be
 revoked.   Alfalfa is  available in  two  forms:   forage, which is
 uncut,  and  hay,  which is  the  cut alfalfa.  Therefore, the term
 "fresh" is  a misnomer and  the tolerance will be revoked.  Several
 commodity  definitions and  crop tolerance levels are recommended
 for change as  set out in  Section C of  this Standard.

 Available  data support the established tolerance in head lettuce
 only.  The preharvest interval of  55 days  for  residues in or on
 leaf lettuce is inappropriate as many  varieties mature in 45
 days.  The registrant must either  withdraw the registered use on
 leaf lettuce or revise the label directions so that use on leaf
 lettuce is practical.  If the  registrant proposes a change in
 the use directions,  appropriate  supportive data must be submitted.

 Available data, in conjunction with data  translated  from  lettuce,
 indicate that the use of pronamide on  endive  should  result  in
 residues no greater than 1 ppm.  Therefore,  the tolerance of 2
 ppm should be reduced to 1 ppm for residues of pronamide  in or
 on endive  (escarole).
                               - 8 -

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  2re are no registered uses of pronamide on boysenberries.
  2 established tolerance will be revoked unless appropriate
  sidue data in support of this tolerance are submitted and  i
  ;>istration for this use is secured.
The;
The
residue data in support of this tolerance are submitted and a
registration for this use is secured.

Available data are inadequate to evaluate the established
tolerances for residues in or on animal commodities.
Storage stability data for plant and animal residues must be
submitted.  On receipt of the plant and animal metabolism and
storage stability data, the adequacy of established tolerances
will be determined.

Data are needed to determine whether food/feed additive tolerances
under Section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA)
are needed for processed products of apples, alfalfa, plums, and
grapes.  Under the FFDCA, food additive tolerances may be issued
only if it is established that the use of the food additive will
be safe.  Should food/feed additive tolerances be required, the
Agency's review of data submitted in response to this Standard
will include consideration of Section 409's criterion known as
the Delaney Clause.

The provisional acceptable daily intake (PADI) for pronamide was
based on the NOEL of 7.50 mg/kg in the 2-year dog study  (Larson,
P. and Borzelleca, J.).  It should be noted that this PADI  is
based on systemic toxicity (non-oncogenic).  The current PADI is
0.0750 mg/kg/day and the current published  tolerance for pronamide
has a calculated Total Maximum Residue Concentration (TMRC) of
0.0409 mg/day  (1.5 kg diet).  The percentage of PADI utilized is
0.91%.

Preliminary Risk Analysis.  To assess the potential  risks assoc-
iated with pronamide,  the Agency reviewed  the existing  data base.
Based on  this  review,  dietary risk and applicator exposure  and
risk have been calculated.  The following  is a discussion of  the
results of the risk assessment.

a.  Review of  Toxicological Studies.  The  toxicology data base
    for pronamide  is not complete.  The following discussion
    focuses on data relevant  to the classification  of  pronamide
    in  accordance  with  the EPA draft  Guidelines for Carcinogen
    Risk  Assessment.

    1.  Oncogenicity  Studies.  The Agency  has available three
        studies:"Eighteen month study of  the carcinogenic
        potential  of  Kerb  (RH-315, Pronamide)  in mice," Medical
        College  of Virginia  (MCV), August  30,  1974;  "Chronic
        toxicity study in  the mouse"  by Newberne  et al.,
        Massachusetts  Institute of Technology  (MIT), August 10,
                               -  9  -

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1982; and "Toxicologic study on the effect of adding
RH-315 to the diet of rats for a period of two years,"
(MCV), June 11, 1970;

a.  MCV Mouse Study.  The MCV study indicated that
    hybrid mice, B6C3F1,  a strain with a high background
    incidence of liver tumors, given diets containing
    0, 1000, or 2000 ppm showed a treatment-related
    increase in hepatocellular carcinomas.  The incidence
    of those tumors was observed at 18 months in male
    mice only,  and the results are summarized as follows:
       Dose

          0
       1000
       2000

b.  MIT Mouse Study-
         Tumor Incidence

              7/100
             18/100
              24/99
The
and
                      MIT study was required by the
Agency to confirm and clarify the results of the
MCV study and employed males only of the same strain
(B6C3F1).  Of particular concern were time-to-tumor
and dose-response relationships. Hence, the MIT study
included interim sacrifices and a wider range of dose
levels.  The reported incidence of hepatocellular
carcinomas was as follows:
        Dietary
     Concentrations
Time on diet (months)
6
0/42
	
	
	
	
0/42
15
3/42
0/42
1/42
2/42
2/42
1/42
18
4/42
2/42
3/42
3/42
4/42
6/41
24
6/63
5/63
9/63
12/63
18/63
14/61
             0*
             0**
            20**
           100**
           500**
          2500
      *   Control  group  1.
      **  Control  group  2, not part of the
           6-month  phase of  the study.

     The  following  observations were also noted  in the MIT
     study:

     (1)  While dose-related  carcinomas occurred  late  in
         the lifespan of test mice (at 24 months), other
         proliferative  liver lesions were present at  15
         and 18 months  in the highest dose group.
                       -  10  -

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    (2)  Approximately 60  to 100  percent  (for control  and
        test groups)  of the animals  examined at the end
        of the study  exhibited  proliferative liver lesions
        including hyperplasias,  hyperplastic nodules,
        adenomas, and carcinomas.

    (3)  The number of metastases observed  was not
        consistent with a dose-related  increase.

    (4)  There was no  dose-related effect on mortality of
        treated mice.

c.  Rat  Study.  Pronamide was administered in the diets
    of rats at levels of 0, 30,  100.  and 300 ppm.  No
    toxic effects were noted in the  study and only minimal
    effects on body weights were seen at 300 ppm.  For
    these reasons, it was concluded  that the highest  dose
    level may have been too low and,  therefore, compromised
    the  sensitivity of the study to  assess the carcinogenic
    potential of pronamide.

    The  study had several deficiencies,  the test material
    was  not adequately described and no  data for diet
    analysis were reported.  Clinical chemistry studies
    were not conducted and hematology and urinalysis  were
    performed on only 5 rats/sex/group.   No individual
    data for body weights, food consumption, clinical
    studies, or organ weights were reported, so the
    summary data could not be validated; furthermore, the
    methods for statistical analysis were not specified.
    Because of these deficiencies, EPA cannot determine
    whether a maximum tolerated dose was administered.

Mutagenicity Studies.  The Agency has available to it four
mutagenicity tests:  an in vitro spot assay for  (gene) rever-
sion in Salmonella typhimurium strains TA 1530 and G46, con-
ducted only without metabolic activation;  an in vitro assay
for mitotic recombination at only one dose in Saccharomyces
cerevis iae  D3; a host-mediated assay in mice treated sub-
acutely (5  days)  (by an unstated route of administration)
employing these microbial strains as indicator organisms;
and a cytogenetic assay for chromosomal aberations in
bone-marrow cells of rats.  Although negative results were
reported  for all of  these assays, they are considered un-
acceptable  by current Agency testing guidelines  for adequate
studies because  of major deficiencies in procedure and
reporting.

In the cytogenetic study, data confirming that the assay  was
performed at  the  limits of clinical or cytological toxicity
were not  presented.  Therefore,  it cannot be assessed  if  the

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dose range selected included sufficiently high levels.  In
addition, all aberration parameters were reported to be "0"
for the negative control and for all dosages; although such
results are possible, the data appear to show unusually low
responses and are not consistent with historical control
incidence of aberrations.

Reporting for both iri vitro and the subacute in vivo host-
mediated assays for mutagenesis was inadequate.  Only general
protocols were submitted, which do not clearly define what
was actually done to generate the data.

The Agency is requesting a full battery of studies to
evaluate the mutagenic endpoints (see Table A, Appendix A).

Risk Assessment.  The Agency has classified pronamide
according to the EPA draft Guidelines for Carcinogen Risk
Assessment.  EPA concludes that a tentative classification
of pronamide as a Group  C oncogen (Possible Human Carcinogen)
can be made based on the effects observed in the mouse
studies.

The classification of pronamide as a tentative Group C
oncogen  (providing limited evidence of oncogenicity) relies
on two  studies  in the mouse which showed a dose response in
heptacellular carcinoma.  The MIT study was designed to
confirm  and clarify  the  MCV study which reported an
increase  in hepatocellular carcinoma in male mice only
at  18 months on diets of 1000 and 2000 ppm pronamide.
The MIT study utilized male mice only of the same strain
 vB6C3F1)  with dietary dosages ranging from 20  to 2500
ppm pronamide and  sacrifices scheduled at 6. 15, 18, and
24 months.   The  two  studies together do not provide
 substantially different  information than is provided by
 either  study  alone.   Both studies showed a dose response
 in  heptacellular  carcinomas in  a liver tumor prone
 strain  of mice  and  the  results  of the second study clearly
 indicated that  these dose  related tumors occurred only
 at  the  end of  the  study, i.e.,  there was no decrease in
 the time to malignancy  attributable to exposure to pronamide.
 These studies  in  mice,  together with the existing rat
 study,  constitute only  limited  evidence of oncogenicity,
 leading to a Group C classification.

 Because of the  absence  of  adequate  studies  in  other  species
 or well performed short  term  studies,  EPA  is not able  to make
 a final classification  of  pronamide at this  time.  The addi-
 tional rat bioassay and  short  term  studies  required  by this
 Standard are expected to substantially assist  in determining
 an appropriate final classification for this pesticide.
                         - 12 -

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    The final RPAR decision was based in part on the results of
    the MCV oncogenicity study.  It did not include the results
    of the MIT oncogenicity study which was submitted after the
    final RPAR decision.  The results of the MIT mouse study do
    not significantly alter EPA's assessment of the carcinogenic
    risks to humans.  Since pronamide has been regulated as a
    carcinogen in the past, the Agency has recalculated risks
    based on a more recently accepted statistical model.

c.   Risk Estimation

    Dietary Risks.  Dietary risks were estimated from the
    published tolerances.  A partial listing of dietary risks
    follows:
Meat
Products

Milk/
Dairy

Apples
mg/kg/day

 .000327

 .000069


 .000143


 .000063
                                               Risk
                                    (based on Q* = 1.63x10
                                  10-6 to

                                      10-6


                                      10'6


                                      10-6
                                                   [c]


                                                   [c]


                                                   [cj
TMRC
 .0006833
                                      10~5
                                                   [c]
    The Theoretical Maximum Residue Contribution (TMRC)
    assumes that residues occur at the tolerance level on
    100 percent of the crops and thus overestimates the
    actual dietary exposure.  Using Q-j* = 1.63x10   as
    the proper estimator of oncogenic potency, and the
    multi-stage procedure programmed to fit the data and to
    calculate the upper 95 percent bound on the risk associated
    with expected doses of the compound under study, the
    TMRC risk is lQ-5[c] .
Applicator Risk.
mg/kg/year are:
                      Exposure values for the major uses in
I/  [c] = Group C Classification  (Possible Human Carcinogen), EPA's
         Proposed Guidelines for Carcinogen Risk Assessment.
                              -  13 -

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       Lettuce
     Dermal
                       Inhalation
       Loader

       Applicator
      210

      210
                        0.3

                        Negligible
       Alfalfa

       Loader

       Applicator
     Dermal

       3

       3
                       Inhalation

                         0.004

                         Negligible
   The lifetime average daily dose (LADD) was calculated from
   the following equation:

           LADD = (mg/kg/year) x (1/365) x (35 years
                  exposure/70 years/lifetime)

   Dermal absorption of 100 percent is assumed, therefore,
   perhaps exaggerating risks by an unknown amount.

   Associated  risks to lettuce and alfalfa applicators and
   loaders are:
    LETTUCE

    Loader

    Applicator

    ALFALFA

    Loader

    Applicator
Lifetime Risk



  5 x 10-3 [c]

  5 x 10-3 [c]



  6 x 10-5 rci
                                 Risk with
                                 Protective
                                 Clothing
                           Risk with  Protective
                           Clothing and  Water
                           Soluble Packaging
                1  x  10-3  [c]

                1  x  10-3  [c]



                1  x  10-5  [cl
6 x 10-5 [C]     1  x 10-5  [C]
1  x 10-4 [c]

1  x 10-3 [CJ



1  x 10-6 [c]

1  x 10-5 [c]
I/ [c] = Group C Classification (Possible  Human Carcinogen),  EPA's
         Proposed Guidelines  for Carcinogenic Risk Assessment
                            - 14 -

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Benefits and Use.  Pronamide is an herbicide active on a variety
of annual and perennial grasses and certain annual broadleaf
weeds.  It is taken in by plant roots and, therefore, must be
applied to the soil and taken by water into the root zone in
order to function.  It is most effective against germinating
seedlings but will control some weeds (e.g., annual bluegrass)
after they have emerged.  It is also specially effective against
perennial grasses because it interferes with underground stem
growth as well as root growth.  Pronamide is inactivated by soil
organic matter and, therefore, is not to be used on muck, peat,
or other high-organic content soils.

Pronamide is sold as a wettable powder, as a granular material,
or as a granular with fertilizer.  The wettable powder (50 per-
cent active  ingredient (a.i.)) is used for all crop spray uses;
the granular products (0.125-1.0 percent a.i.) are applied to
bermudagrass turf, especially golf courses.

Pronamide is used on:  lettuce (most use occurs in California
and Arizona); alfalfa and other forage legumes for hay (in
the Pacific  northwest and upper midwest and east); alfalfa
and clover seed crops (Pacific northwest); berry crops
(Washington  and Oregon only); ornamental bermudagrass turf,
such as golf courses, playgrounds, athletic fields, and
lawns  (southeastern United States primarily, mostly for golf
courses); woody ornamentals, nursery stock and Christmas
trees  (mostly north central and northwest states where quack-
grass  and other perennial grasses are severe); sugarbeet
seed crops  (Oregon only); globe artichokes in California;
tree  fruits  and grapes  (chiefly in California, some in north-
eastern states);  and fallow land to be planted to wheat,
barley or oats  (Idaho, Oregon, and Washington).

Application  to all sites  except turf is predominantly by
conventional ground spray equipment or by incorporation  (on
some  lettuce).  Often on  lettuce, berries, and seed crops, it
is applied  in bands on or near the  row so that treated acreage
is about  1/2 to  1/3 of planted acreage.  This  reduces residues
of pronamide in  the soil.  Granular  (sometimes plus  fertilizer)
treatments  are used on bermuda turf to carry  the pronamide
through the  thatch to the soil surface.  Aerial application
is occasionally made to  alfalfa  (estimated at about  5 percent).

Rates  of  application range from 0.5 to 4  Ib.  per acre, depending
on the crop  and  the weed  problem.   Except for spring applications
to summer lettuce, August applications to fall lettuce,  and  late
spring applications to alfalfa and  clover seed crops, all  applica-
tions  are made  in late  fall or early winter,  before  the  ground
freezes.  This  is  largely due  to  the need to  apply pronamide  when
the protected crop is dormant.  Because  it  acts as a cell  division
inhibitor,  pronamide will control  growing winter weeds while  not
                             -  15  -

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harming the dormant crop.   This practice also results in minimal
residues in hay and berry crops the following summer.

There are 12 special local needs (Section 24c) registrations:

a.  Aerial application to lettuce - Arizona and California;

b.  Tank mix with "herbicide 273" (endothall) for use on sugar-
    heets - Oregon;

c.  Addition of Kerb 50-W to potassium or phosphate fertilizer to
    provide granular application to alfalfa at the rate of 1.5 -
    4 Ib. a.i. per acre depending on local need Pennsylvania;

d.  Tank mix with dinoseb for established alfalfa - California.

e.  Mixing pronamide with potash or phosphorus fertilizers -
    New York and Oregon;

f.  Fall application at 0.25-0.5 Ib. ai/A to land prior to summer
    fallow before planting to winter wheat, oats, or barley  -
    Idaho, Oregon and Washington;

g.  Directed spray at 4 Ib.ai/A to soil between rows of globe
    artichokes after winter drainage ditching operations -
    California; and

h.  Aerial application at 3 Ib. ai/A to Christmas tree planta-
     tions  - Oregon.
                              -  16  -

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            C.  REGULATORY POSITION AND RATIONALE


Based on review and evaluation of all available data and other
relevant information on pronamide, the Agency has made the
following determinations.  Where labeling requirements are
imposed, specific language in set forth in Part II.

1.  If any of the risk criteria listed in Section 154.7 of
    Title 40 of the U.S. Code of Federal Regulations has been
    met or exceeded, a special review of the chemical is con-
    ducted.  Pronamide has not met any of the criteria, and
    therefore is not being placed into the special review
    process at this time.

    Rationale:  Although pronamide is an oncogen in male mice,
    EPA does not believe that pronamide meets the criterion in
    40 CFR 154.7(a)(2) for initiating a special review.  EPA's
    recently effective final special review rules provide that
    the Administrator may conduct a special review if a pesticide
    use "may pose a risk of inducing in humans an oncogenic
    .  . . effect, which  is of concern in terms of either the
    degree of risk to individual humans or the number of humans
    at some risk .  . ." (see 50 FR 49016, November 27, 1985).
    EPA concludes that the risk of oncogenic effects is not of
    sufficient concern to warrant a special review because the
    most recently computed risk levels are comparable to those
    achieved through the earlier RPAR on pronamide.  Moreover, the
    risk levels are, in  their own right, relatively low and the
    population of individuals the Agency knows are highly exposed,
    i.e, applicators, is quite limited.  Finally, EPA's assess-
    ment of the risk must be tempered by the nature of the quali-
    tative evidence indicating the carcinogenicity of pronamide.
    Thus, the tentative  Group C classification of pronamide
    indicates that the Agency believes that the evidence of
    carcinogenic activity is limited and, therefore, open to
    some doubt.

2.  No new significant tolerances will be considered until the
    Agency has  received  data sufficient to thoroughly evaluate
    pronamide.  The Agency will require metabolism studies
    utilizing ruminants  and poultry, as well as storage stability
    data for plant and animal residues.  Residues  in muscles,
    fat, kidney, liver,  milk and  eggs must be characterized and
    quantified.  Additional data  are required depicting the dis-
    tribution and metabolism of pronamide in alfalfa and  lettuce.
    If metabolism among  these two crops differs significantly,
    metabolism  studies will be required for a  representative
    crop in each crop group for which there is a  registered use.

    Rationale:  The toxicological data base on pronamide  is not
    sufficient  to consider establishment of new significant


                              - 37  -

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    tolerances.   The metabolism  of  pronamide in plants  and  animals
    is  not  adequately  defined.   Plant  metabolites  were  identified
    in  alfalfa  only-   The  data were too variable to make definite
    conclusions about  relative abundances  of metabolites.   Residues
    were not  characterized in  tissues  and  milk of  ruminants and
    uo  poultry  data were submitted. Moreover, EPA has  insufficient
    data to determine  whether  food  additive regulations are required
    for certain processed  foods, as provided under Section 409 of
    the Federal Food,  Drug and Cosmetic Act.

3.  Changes to  the tolerance regulations under 40  CFR 180.317,
    will be proposed  as  follows:

    Present Wording               New  Wording

    Alfalfa (fresh)               (Will be Revoked)
    Boysenberries                 (Will be Revoked)
    Clover                        Clover (forage)
    Crown vetch                   Crown vetch (forage)
    Endive (escarole)  -  2 ppm      Endive (escarole) - 1 ppm
    Sainfoin                      Sainfoin (forage)
    Sheep meat  - 0.2  ppm          Sheep meat - 0.02 ppm
    Trefoil                       Trefoil (forage)

    Rationale:   Alfalfa is used  either as forage (uncut) or hay
    (cut);therefore,  the term  "fresh" is a misnomer and the
    tolerance  should  be revoked.  There are no registered uses for
    boysenberries; unless appropriate residue data in support
    of  this tolerance are submitted and a registration for this
    use  secured,  the tolerance  should be revoked.   Available data,
    in  conjunction with data translated from lettuce, support a
    tolerance  for  endive  (escarole) of 1 ppm; therefore, the
    tolerance  should be reduced from 2 ppm to 1 ppm.  The tolerance
    for sheep  meat has been incorrectly published as 0.2 ppm;
    the  correct  tolerance is 0.02  ppm.  The terminology for the
    remaining  commodities (clover, crown vetch, sainfoin, and
    trefoil) should be changed  to  include the word "forage," vhich
    is  the uncut  form of  these  commodities and the correct deli-
    nition.  This  change  would  be  consistent with the crop
    definitions  listed  in the CFR.

 4.  The Agency will continue to classify 50% wettable powder
    end-use products  as restricted-use pesticides, as required
    by  the RPAR  of pronamide.

    Rationale:   The processes of mixing and applying 50% wettable
    powder products pronamide pose risks to the mixers  and appli-
    cators.  These risks  are discussed under  Section B  of  this
    Part.  The risks  can  be reduced by  requiring,  among other
                               -  18  -

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    things ,  that 50% wettable powder pronamide products only be
    applied  by personnel who have been made aware of these risks,
    i.e.,  certified applicators who have received instructions
    on the safe handling of pesticides, or those under the direct
    supervision of certified applicators.

5.   The following data are required to assess the chronic toxi-
    city of  pronamide:  chronic feeding/oncogenic study (rat);
    teratogenicity (rat); reproduction (2-generation);  mutagenic
    potential; metabolism (general), and dermal penetration.

    Rationale:  These data are normally required by rules in
    40 CFR 158 for products with pronamide's use patterns.  Most
    of the existing studies on pronamide do not meet the guideline
    standards for acceptable studies but provide only limited
    information on the toxicity of pronamide or are unacceptable
    or invalid.  The Agency is, therefore, not able to thoroughly
    assess the chronic toxicity of pronamide.

6.   The following data are required to fully assess the
    environmental fate of pronamide: photodegradation studies
    on soil and in water; aerobic soil and anaerobic aquatic
    metabolism studies; leaching and adsorption/desorption
    studies; volatility studies; field dissipation studies;
    and rotational crop and fish accumulation studies.

    Rationale:  Except for the hydrolysis data, all the
    environmental data are preliminary and do not meet
    guideline standards for acceptable testing.  These data
    are normally required under 40 CFR 158 and are necessary
    to assess the environmental fate and transport and the
    potential exposure to pronamide.

7.  The Agency will require that labels of end-use products
    contain protective clothing statements.  Protective
    clothing  requirements for wettable powder formulations
    were  required by  the RPAR.

    Rationale:  The potential  for oncogenic  risk from pronamide
    use is discussed  in the preceding  Section.  This risk
    can be reduced significantly by requiring persons who
    may have  significant dermal contact with the chemical to
    wear  protective clothing,  thereby  reducing exposure to
    pronamide at a small cost.

8.  The RPAR  for pronamide required that wettable powder
    formulations be packaged  in water  soluble packaging.
    The Agency will continue  this  requirement.
                               - 19 -

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    Rationale:  User exposure and  risks are discussed  in
    Section B.  This packaging technology  reduces mixer/loader
    contact with wettable powder formulations during mixing
    operations, thereby reducing a major source  of  exposure.

9.  Products  containing pronamide must contain general pre-
    cautionary language regarding  dermal and ocular contact
    with products containing pronamide, as required by the
    RPAR.  In addition, labels must also contain direction
    about  the handling of contaminated clothing.

    Rationale:  Because of  the risks  associated  with pronamide
    as  previously discussed, the inclusion of precautionary
    language  will emphasize the need  for users to  exercise
    caution while using pronamide  and will limit risk  if
    contact with  the product occurs.

10.  Restrictions  are being  placed  on  planting of crops, for
    which  pronamide is not  registered,  in  fields previously
     treated with  products containing  pronamide.  Labels of
     end-use  products must contain  rotational crop  statements.

     Rationale:   The crop  restriction  is necessary  due  to  the
     lack of  adequate  residue data  on  rotational  crops.  It
     is the policy of  the  Agency  to impose  restrictions on
     planting  rotational  crops  when data are  insufficient  to
     allow an  assessment  of  the impact of planting  subsequent
     crops.  This  serves  to  protect the  public  from impermissable
     residues  in food  and  feed,  as  well  as  to warn  growers about
     how to avoid impermissible residues.

11.  The Agency will continue to  require  that  labels of granular
     formulations must  include  instruction  for watering turf
     after application  of pronamide,  as  originally  required
     by the RPAR.

     Rationale:  Data on  particle size in  the granular  formula-
     tions indicate that  these  products  do  not  pose the same
     level of risks to the applicator as wettable powders.
     However,  thorough watering of granular formulations of
     pronamide after application will minimize  exposure to
     people entering the treated area and  enhance efficacy-

12.  Hand-spray application of  products  containing  pronamide
     will  be  limited to ornamentals and nursery stock.   This
     is a  continuation of an RPAR requirement.

     Rationale:  Because of the method of application,  hand-
     spray application of products containing pronamide is
     important in the minor uses on ornamentals and nursery
                                - 20 -

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     stock.   Because it is a minor use and because the product
     registered for these uses will be a restricted use pesticide
     requiring protective clothing which can provide hand-spray
     users some protection from exposure to pronamide, such
     uses on ornamentals and nursery stock will be permitted.
     Data indicate that, for other uses, mechanical application
     methods are used.

13.   A reentry interval for currently registered uses of
     pronamide is not required.

     Rationale:  The acute toxicity for pronamide is low
     (Category III).  Additionally, because pronamide is
     primarily a preemergent herbicide, exposure and the
     resultant risks to field workers are expected to be
     minimal.  Therefore, no reentry interval is required.

14.   While the data gaps are being filled, currently registered
     manufacturing-use products (MPs) and end-use products
     (EPs) containing pronamide as the sole active ingredient
     may be sold, distributed, formulated and used in the
     United States, subject to the terms and conditions speci-
     fied in this Standard.  Registrants must provide or agree
     to develop additional data, as specified in Tables A and
     B of Appendix A in order to maintain existing registra-
     tions.  The Agency will issue registrations for sub-
     stantially similar products.  However, significant new
     uses will not be registered until the Agency has received
     data adequate to thoroughly evaluate the risks associated
     with pronamide use.

     Rationale:  Under  FIFRA, the Agency does not normally
     cancel or withhold registration simply because data are
     missing or inadequate  (see FIFRA sections 3(c)(2)(B) and
     Issuance of this Standard provides a mechanism for identify-
     ing data needs.  These data will be reviewed and evaluated
     after which the Agency will determine if additional regula-
     tory changes are necessary.
                                - 21 -

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         PART II.   REQUIREMENTS FOR REGISTRATION
This Part of the Registration Standard discusses data, labeling
revisions and packaging required to maintain existing registra-
tions or register new products containing pronamide.  It also
contains the Instructions for submitting the necessary data
and information to the Agency.

To be covered under this Standard, products must contain
pronamide as the sole active ingredient, bear required label-
ing, and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in this Part.

The applicant for registration or reregistration of products
subject to this Standard must comply with all terms and con-
ditions described in it, including submission of an up-to-
date Confidential Statement of Formula, submission of revised
labeling, commitment to fill data gaps on the schedule specified
by the Agency and, when applicable, offer to pay compensation
as required by 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).  Registration applicants
must contact the Agency for specific instructions, including
updated  information on data requirements and companies whose
data have been used in support of registration.
                               - 22 -

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               A.   ACCEPTABLE RANGES AMD LIMITS
Product Composition Standard.   To be covered under this Standard
products must contain pronamide as the sole active ingredient.
Each technical grade or manufacturing-use formulation proposed
for registration must be fully described with an appropriate
certification of limits.

Acute Toxicity Limits.  The Agency will consider registration
of technical grade and manufacturing-use products containing
pronamide, provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category In
which each product is placed,  as required by ^0 CFR 162,10.

Use Patterns.  To be registered under this Standard,  technical
grade or manufacturing-use products containing pronamide may he
labeled for formulation into end-use products for use only on
the commodities listed below.   Appendix R, EPA Index  to Pesti-
cide Chemicals - Pronamide, lists all registered uses, as well
as the approved maximum application rates and frequencies.

  -Terrestrial, non-domestic,  food uses on-  alfalfa, alfalfa
   (seed crop), apples, globe artichokes, birdsfoot trefoil,
   birdsfoot trefoil  (seed crop), blackberries, blueberries,
   cherries, clover,  clover (seed crop), crown vetch, crown
   vetch (seed crop), endive,  grapes, lettuce, nectarines,
   peaches, pears, plums, prunes, raspberries, sainfoin, and
   sainfoin (seed crop).

  -Terrestrial, non-domestic,  non-food uses on: bermudagrass,
   bermudagrass (seed crop), azalea, azalea (nursery  stock),
   Christmas tree plantations, Douglas fir, Douglas fir
   (nursery stock), fir, fir (nursery stock), forsythia,
   forsythia (nursery stock), holly, holly  (nursery stock),
   juniper, juniper (nursery stock), pine, pine (nursery
   stock), rhododendron, rhododendron (nursery stock), yew,
   and yew (nursery stock).

  -Domestic outdoor uses on:  bermudagrass, centipedegrass,
   St. Augustinegrass, and zoysiagrass.
                              -  23  -

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           B.   LABELING AND PACKAGING REQUIREMENTS


All labeling changes required by this Standard must appear
on all products in channels of trade within two years of
Issuance of this Standard.   As specified packaging for
wettable powder end-use products is a continuation of an
existing requirement, such  packaging must immediately be in
use or, for new products, incorporated at the time of product
introduction.

In addition to the above, the following information must
appear on the labeling:

1.  All Products.  All products must bear appropriate
    labeling as specified in 40 CPR 162.10.  Specific
    information on label requirements are contained in
    Appendix C.

    a.  Ingredient Statement.  The ingredient statement
        must list the  active ingredient as:

            pronamide, 3,5-dichloro-N-(1,1-dimethy1-2-
            propyny1)benzamide. . .%

                               or

            pronamide  [N-(1,l-dlmethylpropynyl)~3 ,5~
            dichlorobenzamide] . . , .%

     b.  Disposal  Statements.   Because pronamide has not
         been  designated  as  an  acute  or  toxic  hazardous waste
         under  the Resource  Conservation  and Recovery  Act
         (RCRA),  the following  is  the  appropriate  pesticide
         disposal  statement  for pronamide products:

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

         The labels  of all  products must  bear  the  appropriate
         container disposal statement (see  Appendix C-6) .

 2.  Technical Grade/Manufacturing-Use Products

     a.  Use Pattern Statements.   Labeling  for all technical
         grade and manufacturing-use pronamide products  must
         state that they are intended for formulation into
         end-use herbicide  products for  the  use patterns  and
         sites, as set forth In the preceding section under
         Use Patterns.  However, no use may be Included


                               - 2U -

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    on  the  label  if  the  registrant  fails  to  agree  to
    comply  with  the  data requirements  for that  use  pattern,
    as  listed  in  Table  A and/or  Table  R,  Appendix  A,  as
    appropriate.

    Precautionary Statements.   Labels  Tor technical grade
    and manufacturing-use pesticide products must  hear
    statements reflecting the  compound's  acute  human  toxi-
    city,  as  specified  in 40  CPR 162.10 (Appendix  C-2),
    and statements pertaining  to environmental  hazard.
    Pronamide  is  in  Toxicity  Category  III for dermal,
    inhalation,  and  eye  irritation  routes of exposure;  the
    required  precautionary statements  associated  with  this
    category,  and the required environmental hazard state-
    ments  are  set forth  below.

      "CAUTION -  Harmful if absorbed through the  skin  or
       inhaled.   Causes  moderate eye irritation.   Avoid
       contact with  the  skin,  eyes, or clothing.   Avoid
       breathing  dust.   Wash  thoroughly with soap  and  water
       after  handling.   Remove contaminated  clothing  and
      "Do not discharge effluent containing this  product  into
       lakes, streams,  ponds,  estuaries,  oceans,  or  public
       water unless this product is specifically  identified
       and addressed in an NPDES permit.   Do not  discharge
       effluent containing this product into sewer systems
       without previously notifying the sewage treatment
       plant authority.  For guidance contact your State  Water
       Board or Regional Office of the EPA."

Statements for End-Use Products.  All end-use products with
outdoor agricultural uses which are applied to crops involv-
ing hand labor are required to bear precautionary label
language about farmworker safety.  Appendix C-7 sets
forth the specific language to be used.  All end-use products
must also bear an environmental hazard precaution (see
Appendix C-2), as set forth below along with additional
required statements:

       "Do not apply directly to water.  Do not
       contaminate water by cleaning of equipment
       n r> rllsnnsal nf washes "
contaminate water by cl
or disposal of wastes."
       "GENERAL PRECAUTIONS:  Avoid contact with eyes,
       skin or clothing."

       "PROTECTIVE CLOTHING:  When mixing, loading or
       applying this product, wear midforearm water-
       proof gloves, long-sleeved shirts and long

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      pants, preferably one piece  (coveralls).
      Hand-spray or hand-spreaders also  require  the
      use of waterproof boots or shoe coverings.
      Wash nondisposable gloves, boots and  shoe
      coverings thoroughly with soap and water
      before removing."

      "If water-soluble packaging  is used,  mixers
      and loaders are  exempted from protective
      clothing  requirements."

      "Protective clothing/equipment is  not needed
      during application if an enclosed  tractor  cab
      with  filtered air supply or  enclosed  cockpit
      is  used."

      "Any  article  of  clothing worn while handling
      product  must  be  cleaned before reusing.  Cloth-
       ing should be  laundered separately from house-
      hold  articles.   Clothing which has been drenched
      or  heavily contaminated should be  disposed of  in
      accordance with  state or  local regulations."

a.   All  50%  wettable  powder  end-use products must be  packaged
    in water-soluble packaging and  bear  the  following
    statements:

       "RESTRICTED  USE  PESTICIDE:   Because pronamide  has
       produced tumors  in  laboratory  animals, this  product
       is  for retail sale  to and  use  only by Certified
       Applicators  or persons  under their direct  super-
       vision,  and  only for  those uses  covered by the
       Certified Applicator's  certification."

       "Crops other than  those on which  pronamide may
       be applied  may not  be planted  in  pronamide-
       treated  soil."

       "Hand-spray applications  of pronamide may  be
       made only to ornamentals  and nursery  stock."

       "Dilution Instructions

       "The enclosed pouches of  this  product are  water
       soluble.  Do not allow pouches to become  wet
       before adding them to the spray  tank.  Do  not
       handle the pouches with wet hands or gloves.
       Always reseal overwrap  bag to  protect remaining
       unused pouches.   Do not remove water soluble
       pouches from overwrap except to  add directly
       to the spray tank."
                          - 26 -

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           "Add the required number of unopened  pouches  as
           determined by the dosage recommendations  into the
           spray tank with agitation.   Depending on  the  water
           temperature and the degree  of agitation,  the  pouches
           should dissolve completely  within approximately  five
           minutes from the time they  are added  to the water."

b.  All pronamide granular formulations must bear the following
    statement:

           "Sites treated with this product must be  thoroughly
           watered after application."
                               - 27 -

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                C.   SUBMISSION OF GENERIC DATA


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, regardless of the
product's unique composition or specific use.  EPA has the
authority under PIFRA section 3(c)(2)(B) to require registrants
to submit data that will answer the Agency's questions regarding
the hazard that may result from the intended use of a pesticide.

This portion of the Registration Standard is issued under the
authority of PIFRA section 3(c)(2)(B).  EPA has determined that
additional generic data described in Table A, Appendix A, must
be submitted to EPA for evaluation in order to maintain in
effect the product registration(s).  As required by FIFRA
section 3(c)(2)(B), registrants are required to take appropriate
steps to comply with this Standard.

Although section 3(c)(2)(B) provides that all registrants are
responsible for these data, the Agency generally imposes generic
data requirements only on the registrants of the manufacturing-
use products  (basic suppliers of the active ingredient) and
other registrants who do not qualify for the formulator's
exemption.  The formulator's exemption applies to a registrant
of a product  if the source of its active ingredient(s):  (1) is
a  registered  product, and (2) is purchased from a source which
does not have  ownership in common with the registrant's firm.

A  producer who  currently does not qualify  for the formulator's
exemption may  qualify by changing its source of supply to a
registered source,  provided the source does not share ownership
in common  with  the  registrant's firm.  A registrant may do so
by submitting a new Confidential Statement of Formula, EPA
Form 8570-4,  identifying the registered source of the active
ingredient, to  the  Product Manager  listed  in Section E of this
Part within 90  days of  receipt  of the Registration Standard,
The chart  on  the following page shows what is generally requii-ed
of those who  do and do  not qualify  for the formulator's exemption
in the Registration Standards program.

Registrants are reminded  that FIFRA section 6(a)(2) requires
that  factual  information  raising concerns  of possible unreason-
able  adverse  effects  of a pesticide must be promptly submitted.
If interim results  of  studies  in progress  show possible adverse
effects,  the  Agency is  to be notified of those interim results.

EPA may  suspend the registration of products unless, within  the
specified  time, the registrant  informs  EPA how it will satisfy
 the requirements  of this  Standard.  Any  such suspension will
 remain in  effect  until  the  registrant has  complied  with the
 terms  of this Standard.
                               -  28  -

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                                        ACTION(S) REQUIRED TCf
                                        MAINTAIN REGISTRATION
PRODUCTS SUBJECT TO THE
REGISTRATION STANDARD
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 Standard.
   B. Multiple Active Ingredient
      Products
                                    These products will not be
                                    reregistered at this time.
                                    However, generic data required
                                    to continue the registration of
                                    the active ingredient under
                                    review, as described in the
                                    Registration Standard, will be
                                    required and some labeling
                                    precautions may also be
                                    required.
II.  Products That Do Qualify For
     The Formulator's Exemption
                                    Only when additional restric-
                                    tions or labeling are needed to
                                    protect humans or the environ-
                                    ment 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 the 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 Registration
Standard 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 data  require-
ments in I-A and B above, the registrants in "II" lose their right
to qualify for the formulator's exemption and become subject to the
data requirements in I-A and B.	
                                -  29 -

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1.   What Generic Data Must be Submitted.  Registrants may
    determine which generic data must be submitted by consult-
    ing Table A, Appendix A.  That table lists the generic data
    needed to evaluate the continued registrabillty of all
    products, and the dates by which the data must be submitted.
    The required studies must be conducted in accordance with
    EPA approved protocols (such as those contained in the
    Pesticide Assessment Guidelines I/) or data collected under
    the approved protocols of the Organization for Economic
    Cooperation and Development (OECD).  If registrants do not
    wish to develop data in support of certain uses appearing in
    their labeling, they may delete those uses at the time they
    submit revised labeling.

    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 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, Appendix A.
    EPA may  possess data on certain "typical formulations" but
    not others.

 2.  Options  Available for Complying With Requirements to Submit
    Data.  Within 90  days of receipt of this Standard, registrants
    must  submit  to EPA a completed copy of the form entitled
    "PIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form 8580-1
    (Appendix  D), for each  of their products.  On that form,
    registrants must  state  which of the following methods they
    will  use to  comply with the requirements of this Standard:

    a.  Notify EPA that they will submit the data, and either
        submit the existing data they believe will satisfy the
        requirement,  or state that they will generate the data
        by conducting testing.  If the  test procedures they will
        use  deviate  from  (or are not specified in) the Pesticide
        Assessment Guidelines or protocols contained in the
        Reports  of Expert  Groups to the Chemicals Group, Orgaii-
         zation for Economic Cooperation and Development (OECD)
        Chemicals  Testing  Programme, they must enclose the proto-
        cols they  will  use.

                              OR
     The Pesticide Assessment  Guidelines  are  available  in  hard
     copy or microfiche from the National Technical  Information
     Service, 5285 Port Royal  Road,  Springfield,  VA   22161.
                               -  30  -

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

                           OR

 c.   File with EPA a completed "Certification of Attempt  to
     Enter Into an Agreement With Other Registrants  for Develop-
     ment of Data," EPA Form 8580-6 (Appendix E)l/

                           OR

 d.   Request that EPA amend their registrations  by deleting
     the uses for which the data are needed.

                           OR

 e.   Request voluntary cancellation of the reglstration(s)  of
     the products for which the data are needed.
FIFRA sec. 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.  In EPA's opinion, joint data develop-
ment by all registrants subject to a data requirement 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 unnecessarily large
number of animals to testing.  As noted earlier, EPA has
discretion 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 should encourage joint
testing rather than duplicative testing, and that suspension
should be withheld in certain cases to further this goal.
Accordingly, if (1) a registrant has informed EPA of its intent
to develop and submit data required by this Standard; and
(2) a second registrant 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)(ill); and (3) the first regis-
trant has declined to agree to enter into a cost-sharing agree-
ment, EPA will not suspend the second firm's registration.
                           - 31 -

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^.   Procedures for Requesting Changes in Testing Methodology
    and Extensions of Time.   EPA recognizes that registrants
    may disagree with the Agency's conclusions regarding the
    appropriate ways  to develop the required data or how quickly
    the data must be  submitted.  If the test procedures a regis-
    trant plans 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, Organ-
    ization for Economic Cooperation and Development (OECD)
    Chemicals Testing Programme, the registrant must submit the
    protocol for Agency review prior to the initiation of the
    test.

    If a registrant believes  it will need more time to generate
    the required data than is allowed by EPA's schedule, the
    registrant 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 the registrant believes that an extension is
    appropriate.  While EPA  considers the request, the regis-
    trant must strive to meet the deadline for submitting the
    required data.

4 .   Procedures for Requesting a Waiver of the Data Requirement.
    If a registrant believes  that a data requirement does not
    (or should not) apply to  its product or its uses, the
    registrant must provide  EPA with a statement of the reason
    why it believes this is  so.  The statement must address the
    specific composition or  use factors that Lead the regis-
    trant to believe  that a  requirement does not apply.  Since
    the Agency has carefully  considered the composition and
    uses of pesticide products in determining that a data
    requirement applies, EPA  does not anticipate that many
    waivers will be granted.   A request for waiver does not
    automatically extend the  timeframes for developing required
    data, and if the waiver  request is denied, the registration
    may be suspended  if the  registrant fails to submit the data.

5 .  Existing Stocks Provision Upon Suspension or Cancellation.
    EPA may permit continued  sale and distribution of existing
    stocks of a pesticide product which has been suspended or
    cancelled if doing so would be consistent with the purposes
    of EIERA.  However, the Agency has determined that if a
    registration is suspended for failure to respond to a data
    call in  request under PIPRA section 3(c)(2)(B), an existing
    stocks provision is not consistent with the Act.  Accord-
    ingly, the Agency does not anticipate granting permission
    to sell  or distribute existing stocks of suspended product
    except  in  rare circumstances.  If a registrant believes
    that its  product will be suspended or cancelled and that an
    existing stocks  provision  should he granted, the registrant

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has the burden of clearly demonstrating to EPA that grant-
ing such permission would be consistent with the Act.   The
following information must be included in any request  for
an existing stocks provision:

a.  Explanation of why an existing stocks provision is
    necessary, including a statement of the quantity of
    existing stocks and an estimate of the time required
    for their sale or distribution.

b.  Demonstration that such a provision would be consistent
    with the provisions of PIPRA.

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           D.   SUBMISSION OF PRODUCT SPECIFIC DATA
Note:   This Section applies only to 50 percent formulation
intermediates (FI), not to end-use products.

A necessary first step in determining which statements must
appear on a 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 F) ,
to fill gaps Identified by EPA concerning the product.  Under
the authority of FIFRA section 3(c)(2)(B), EPA has determined
that registrants must submit these data to EPA in order to
reregister their product(s).

Table B, Product-Specific Data Requirements for Manufacturing
Use Products, of Appendix A, lists the product specific data
registrants must submit.  Data that are required to be sub-
mitted are identified in that table under the column entitled
"Must Data Be Submitted Under §3(c)(2)(B) . " These data must
be submitted not later than 6 to 12 months, as indicated on
the table, after receipt of this Registration Standard.

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               E.  INSTRUCTIONS FOR SUBMISSION


This section describes what raust be submitted and the timeframes
for the submissions.  Addresses are provided at the end of this
section.

1.   Requirements

    a.   For Technical Grade/Manufacturing-Use Products Containing
        Pronamide as the Sole Active Ingredient

        (1) Within 90 days from receipt of this Standard, regis-
            trants must submit the "FIFRA Section 3(c)(2)(B)
            Summary Sheet," EPA Form 8580-1 (Appendix D).

        (2) Within 6 months from receipt of this Standard, regis-
            trants must submit-

            (a) Confidential Statement of Formula, FPA Form
                8570-4.

            (b) Two copies of draft labeling, including the
                label and associated brochures.  If current
                labeling conforms to the requirements of this
                Standard and the results of the short-term
                data, such labeling must be submitted.  The
                labeling should be either typewritten text
                on 8-1/2 x 11 Inch paper or a mockup of the
                labeling suitable for storage in 8-1/2 x 11
                inch files.  The draft label must indicate
                the intended colors of the final label, clear
                indication of the front panel label, and the
                intended type sizes of the text.

            (c) Evidence of compliance with data support require-
                ments of FIFRA section 3(c)(l)(D).  Refer to
                40 CFR 152.80-152.99 for requirements.

        (3) Within the times set forth in Table A, Appendix A,
            registrants must submit all generic data, unless
            they  request and are granted a waiver or extension,
            or they are eligible for the formulator's exemption

    b.  For Technical Grade/Manufacturing-Use Products Contain-
        ing Pronamide In Combination With Other Active Ingredient^

        (1) Within 90 days from receipt of this Standard, regis-
            trants must submit the "FIFRA Section 3(c)(2)(B)
            Summary Sheet," EPA Form 8580-1  (Appendix D).

-------
    (2)  Within the  times  set  forth in Table A,  Appendix A,
        registrants must  submit  all generic data,  unless
        they request and  are  granted a waiver or extension,
        or they are eligible  for the formulator's  exemption.

c,   For  End-Use Products  Containing Pronamide Alone or In
    Combination With Other Active Ingredients

    (1)  Within 90 days from receipt of this Standard, regis-
        trants must submit the "PIPRA Section 3(c)(2)(B)
        Summary Sheet," EPA Form 8580-1 (Appendix  D).

    (2)  Within 6 months from receipt of this Standard, regis-
        trants must submit:

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

        (b) Two copies of draft  labeling,  including the label
            and associated brochures.  If  current  labeling
            conforms to the requirements of this Standard and
            the results of the short-term  data, such labeling
            should be submitted.  End-use  product  labeling
            must comply specifically with  the instructions
            in this Standard.  Labeling should  be  either type-
            written text on 8 1/2 x 11 inch paper  or a mockup
            of the labeling suitable for storage in 8 1/2 inch
            files.  The draft label must indicate  the intended
            colors of the final  label, clear indication of the
            front panel label, and the intended type sizes of
            the text.

    (3)  Within the times set forth in Table A,  Appendix A,
        registrants must submit  all generic data,  unless they
        request and are granted  a waiver or extension or they
        are eligible for the formulator's  exemption.

 d.  Products  Qualifying for Formulator's Exemption.  With tn
    90 days from receipt of this Standard, registrants must
    submit  a  Pormulator's Exemption Statement,  Appendix f.
    They must  also submit a current Confidential Statement of
    Formula or certify that the Confidential Statement of
    Formula on file is complete, current and accurate.

 e.  For Intrastate Products Containing Pronamide Either as
    the Sole  Active Ingredient or  in Combination with other
    Active  Ingredients.These products are being called in  for
    full  Federal registration.  Producers of these products  are
    being  sent a letter  instructing  them how to submit an  appli-
    cation  for registration.
                          -  36  -

-------
Submissions to Product Manager.  Applications and other
required information should be submitted to the Product
Manager, Registration Division.  If, for any reason, any
test is delayed or terminated so that the agreed schedule
cannot be met, the Product Manager must be notified as
soon as it becomes clear that the schedule cannot be met.

The address for submissions to the Product Manager is:

             Mr. Robert J. Taylor
             Product Manager  (Team 25)
             Registration Division (TS-767C)
             Office of Pesticide Programs
             Environmental Protection Agency
             401 M St., SW.
             Washington, D.G.  20460
             Phone No. (703)  557-1800

Submissions to the Office of  Compliance Monitoring.  If,
on  the VIFRA Section 3(c)(2) (B) Summary Sheet, a regls-
trant commits to develop the  data, requests a minor chemical
exemption, presents arguments  that a data requirement is not
applicable, or submits protocols or modified protocols for
Agency review, the registrant must also submit a copy of the
Summary Sheet (and any supporting information) to the Office
of  Compliance Monitoring, which will be monitoring the data
generated  in response to this Standard.  Actual studies are
not to be  submitted.

If  for any reason any test is delayed or terminated so that
the agreed schedule cannot be met, the Office of Compliance
Monitoring must be notified as soon as it becomes clear that
the schedule cannot be met.

The address for submission to the Office of Compliance
Monitoring is:

             Laboratory Data  Integrity Program
             Office of Compliance Monitoring  (EN-342)
             Environmental Protection Agency
             401 M St., SW.
             Washington,  D.C.  20460
                          - 37 -

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                          APPENDIX A
             TABLE A:   GENERIC DATA REQUIREMENTS
                       FOR PRONAMIDE (9H% Technical)

             TABLE B:   PRODUCT SPECIFIC DATA REQUIREMENTS
                       FOR PRONAMIDE (50% PI)
Data must be submitted within the timeframes listed on Tables A
and B based on the issuance date of the Registration Standard.

The following symbols are used on Tables A and B.  For more infor-
mation, refer to 40 CFR 158, Data Requirements for Pesticide
Registration.
Test Substance

    TGAI = Technical Grade of the Active Ingredient
    PAI  = Pure Active Ingredient
    PAIRA= Pure Active Ingredient, Radiolabelled
    TEP  = Typical End-Use Product
    EP   = End-Use Product

Guideline Status

    R    = Required
    CR   = Conditionally Required

Use Patterns

    A = Terrestrial, Food Crop
    B = Terrestrial, Non-Food
    C = Aquatic, Food Crop
    D = Aquatic, Non-Food
    E = Greenhouse, Food Crop
    F = Greenhouse5 Non-Food
    G = Forestry
    H = Domestic Outdoor
    I = Indoor
                                    38

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                        TABLE A
GENERIC DATA REQUIREMENTS FDR PRONAMIDE (94% Technical)
Guideline Citation and Test Guidelines
Name of Test Substance Status
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Disclosure TGAI R
of Ingredients
61-2 - Description of Beginning Materials TGAI R
and Manufacturing Process
61-3 - Discussion of Formation of TGAI R
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis TGAI CR
62-2 - Certification of Ingredient Limits MP P
62-3 - Analytical Methods to Verify HP R
Certified Limits
Physical and Chemical Characteristics
63-2 - Color TGAI R
63-^ - Physical State TGAI P
63-4 - Odor TGAI R
Are Data
Required
Yes No
FJ
Fx]
Fx]

Fx]
Fx]
Fx]
FJ
FJ
Fxl
Fx]
FJ
FJ

FJ
FJ
FJ
Fx]
Fx]
FJ
Footnote Data Must Be Sub-
Number mitted Within Time
Frames Listed Below

1 6 months
2 6 months

3 12 months
4,5 12 months
4,6 12 months


7 6 months
                       - A-l  -

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                                                         TABLE A
                                 GENERIC DATA REQUIREMENTS FDR PRONAMIDE (9*1% Technical)
Guideline Citation and
Name of Test
Test Guidelines
Substance Status
Are Data footnote
Required Number
Yes No
Data Must Be Sub-
mitted Within Time
Frames Listed Below
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-17
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
- .Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- PH
- Stability
- Storage Stability
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
MP
R
R
R
R
R
R
CR
CR
R
R
O
[11
O
O
O
Ex]
[x]
[x]
[x]
n
[x]
[x]
ra
[x]
ra
n
O 8
n
O 9
[x]





6 months
6 months
6 months
6 months

Cther Requirements

64-1  - Submittal of Samples
TGAI, PAI
CR
n
[x]
                                                         - A-2  -

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                                                           TABLE A
                                  GENERIC DATA REQUIREMENTS  TOR PRONAMIDE (9^4%  Technical)
 §138.120  Product  Chemistry  (Continued)

 _!/ The  registrant must  submit details of  the manufacturing process,  including  the  relative  amounts  of  beginning
   materials, a description of  the  equipment used  to  produce  the product,  reaction conditions   the  duration  of
   each step of the  process, purification procedures  and  quality control measures, the name and address  of the
   manufacturer,  producer or supplier of  each beginning material used, and a copy  of all available  technical
   specifications, data sheets,  and other documents in which  the manufacturer, producer, or supplier of  the
   beginning material describes  its composition and properties,
 2/ A discussion of each impurity believed to be present at X>.1% based on  knowledge of the  beginning materials,
   all  possible chemical reactions  and any contamination  must be provided.
 37 Five or more representative  samples must be analyzed for the amount of  active ingredient and each impurity
   present for which a  certified limit is required (greater than 0.1%).
 _V Since  no MP's  are registered, tests must be conducted  on the TGAI.
 *2/ Upper  and lower limits for pronamide and upper  limits  for each impurity present at 0.1%  must be provided  and
   certified.
 6/ The  registrant must  submit quantitative methods to detect pronamide and all impurities and inerts for which a
   certified limit is required.  Each method must  be  accompanied by  validation studies of the precision and
   accuracy of the method.
 77 The  submitted  description of  the odor  ("mild, inoffensive") is not sufficiently descriptive:  a new description
   must be submitted.
 8/ Data on the octanol/water partition coefficient have been submitted, but were not reviewed in time for Inclusion
~  in the Registration  Standard.
 9/ Since  no Information was provided as to the sensitivity  to metal  ions and metal, stability at evalated
~  temperatures,  and sensitivity to sunlight, additional  data are required.
                                                           - A-3 -

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                                                         TABLE A
                                 GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
Does EPA Have Must Additional Data Be
Data To Satisfy Bibliographic Submitted Under FIFHA
Data Requirement Composition This Requirement? Citation §3(c) (2) (B)? Time Frames
For Data Submission
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
Plants PAIRA Partially
Livestock PAIRA and Plant Partially
Metabolites
171-4 - Residue Analytical Method
Plant Residues TGAI and Metabolites Yes
Animal Residues TGAI and Metabolites Yes

00107953 00107958
00107957 GS0082-01
00107954
00107958

00035563 00107958
00035565 00107959
00035566 00107960
00070933 00107961
00070934 00107965
00074523 00107967
00077215 00125382
00107957

Yes!/ - 18 months^/
Yes!/ - 18 months

No
171-4   Storage Stability                TEP

171-4 - Magnitude of the Residue-
         Residue Studies for Each
         Food Use

        Crop Group 1 - Leafy Vegetables^/

        o Crop 1  - Endive
          — Crop Field Trials            TEP
No
                      YesV
Yes
00107957
No
                                                         - A-4 -

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                                                          TABLE A
                                  GENERIC DATA REQUIREMENTS TOR FRONAMIDE  (94% Technical)
Data Requirement
Composition
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic
  Citation
Must Additional Data Be
Submitted Under PIFRA
§3(c)(2)(B)? Time Frames
For Data Submission
§158.125 Residue Chemistry (Continued)

 171-4 - Magnitude of the Residue - Residue Studies  (Continued)
         o Crop 2 - Lettuce
           — Crop Field Trials
         o Crop 3 - Rhubarb
           — Crop Field Trials
TEP
TEP
         Crop Group 2 - Pome Fruits Group°/
         o Crop  1 - Apples
           -- Crop Field Trials
         o Crop 2 - Pears
           — Crop Field Trials
         Crop Group 3 ~ Stone Fruits Group
TEP
TEP
         o Crop 1 - Cherries
           -- Crop Field Trials

         o Crop 2 - Nectarines
           — Crop Field Trials
TFP
TFP
Yes
No
Partially
Yes
Yes
Yes
     00070933
     00107957
     00107958
     00035563
     00074523
     00035564
     00074523
     00074523


     00074523
                       No!/
 Yes9/  - 18 months2/
      No
      No
      No
                                                          - A-5 -

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                                                          TABLE A
                                  GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94t Technical)
Data Requirement
                                 C/omposition
 Does  FPA  Have  Data
 To  Satisfy  This
 Requirement?   (Yes,
 No  or Partially)
                                                                            Bibliographic
                                                                              Citation
                                                          Must Additional Data
                                                          Be Submitted Under
                                                          FIFRA § 3(c)(2)(B)?
                                                          Time Frames for Data
                                                          Submission
§158.125 Residue Chemistry (Continued)

 171-4 - Magnitude of the Residue - Residue Studies (Continued)
         o Crop 3 - Peaches
           — Crop Field Trials

         o Crop 4 - Plums
           — Crop Field Trials
                                     TCP
                                     TEP
         Crop  Group  4  -  Small  Fruits  and  Berries  Group12/
 o  Crop 1  - Blackberries
   — Crop Field Trials

 o  Crop 2  - Blueberries
   — Crop Field Trials

 o  Crop 3  - Boysenberries
   — Crop Field Trials

 o  Crop 4  - Grapes
   — Crop Field Trials

 o  Crop 5  - Raspberries
   —  Crop  Field  Trials

Crop Group 5 - Grass Forage,
 TEP


 TEP


 TEP


 TEP


 TEP

and Hay Group!5/
Yes


Partially




Yes


Yes


No


Partially


Yes
o Crop 1 - Grass forage, fodder and hay
  — Crop Field Trials              TEP
                                                                            00035565
                                                                            00074523

                                                                            00074523
                                                                                    00107960


                                                                                    00035566
                                                                                    00074523


                                                                                    00107960
                                                          No
                                                       Yes!!/ - 18 months2
                                                                                              No
                                                                                              No
                                                                                                   Yes!!/ - 18 months2
                                                                                           Yes!l/ - 18 months?
                                                                                               No
                                                            No
                                            Nol/

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                                                            TABLE A
                                   GENERIC  DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
  tta Requirement
                                 Composition
Does EPA Have Data
To Satisfy This
Requirement?  (Yes,
No, or Partially)
       Bibliographic
         Citation
               Must  Additional Data
               Be  Submitted Under
               FIFRA §  3(c)(2)(B)?
               Time  Frames For Data
               Submission
  .58.125 Residue Chemistry  (Continued)

     -4 - Magnitude of the  Residue - Residue  Studies  (Continued)

          Crop Group  6 - Non-Grass Animal  Feeds  Group 16/
          o Crop  1  -  Alfalfa  forage  and hay
            —  Crop Field  Trials
                                     TEP
           o Crop  2  -  Clover  forage and hay
            —  Crop Field Trials               TEP
          o Crop  3  - Crown Vetch Forage and  Hay
            —  Crop Field Trials
                                     TEP
          o Crop 4  - Sainfoin Forage and Hay
            — Crop Field Trials               TEP
o Crop 5 - Trefoil Forage and Hay
  — Crop Field Trials

Miscellaneous Commodities

o Crop 1 - Artichokes
  -- Crop Field Trials

o Crop 2 - Safflower Seed
  — Crop Field Trials
                                               TEP
Partial
                                                     Yes
Yes
                                                     Yes
Yes
                                                              Yes
                                                              No
                       00077215
                       00125382
00033380  00107965   Yes!!/ - 18 months.2/
00107958  00107967
00107958


00107965


00107965


00107965
                            Nolly
                                         No!/
c_n
                                                           - A-7 -

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                                                           TABLE A
                                   GENERIC DATA REQUIREMENTS FOR PRONAMIDE (9b% Technical)
                                                              Does EPA Have Data                       Must Additional Data
                                                              To Satisfy This                          Be Submitted Under
                                                              Requirement?  (Yes,    Bibliographic     FTFRA § 3(c)(2)(B)?
Data Requirement                          Composition         No, or Partially)        Citation        Time Frames For Data
_ _ _ __ _ Submission _

§158.125 Residue Chemistry  (Continued)

      -4 -  Magnitude of the  Residue - Residue Studies (Continued)

           Meat/Milk/Poultry/Eggs           TGAI or Plant      No                       -               Naif?/
                                            Metabolites
V Registrants must submit data depicting the distribution and metabolism of ring-labeled [C] pronamide in:  (i)
   alfalfa harvested 25, 45, and 120 days after a post-emergent broadcast application using a rate sufficient to permit.
   complete characterization of all l^C-residues , and (ii) lettuce harvested 55 days after a post-emergent broadcast
   application preceded by a preplant or preemergent broadcast application at rates sufficiently high to permit complete
   characterization of l^C-residues.  If bound residues (i.e., residues not extracted by the solvent(s) used) represent
   a significant proportion of the terminal residue, analyses must include hydrolysis and reextraction of plant
   residues to determine the nature of conjugated residues of pronamide.   If metabolism among these two representative
   crops is found to differ significantly, metabolism will be required for a representative crop In each crop group for
   which there is a registered use for pronamide.   Representative samples from the above-described tests must also be
   analyzed by the enforcement methods to ascertain that all metabolites of concern are detected.
2/ Registrants are provided 18 months to submit data commencing with the first planting season after issuance
   of the Standard, consistent with PR Notice 85-5.  Data are due no later than January 1988.
3/ Registrants must submit metabolism studies utilizing ruminants and poultry.  Animals must be dosed for 3 days  with
   ring-labeled [^C]  pronamide at a concentration in the total diet which will result in sufficient residues in  the
   tissues,  milk,  and  eggs for characterization.   Animals must be sacrificed within 24 hours of the final dose (milk
   ar !  eggs  must be collected twice daily).   ^C-Residues must be characterized and quantified in muscle, fat, kidney,
   1 ,ver,  milk,  and eggs.   Samples from the studies should also be analyzed by the enforcement methods to ascertain
   I nab  all  metabolites  of concern are determined.
                                                            - A-8  -

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                                                          TABLE A
                                  GENERIC DATA REQUIREMENTS FOR PRONAMIDE (9H% Technical)
 158.125 Residue Chemistry (Continued)

 V The storage intervals and conditions of storage of samples used to support all established tolerances for residues in
    or on plant commodities must be submitted.  These data must be accompanied by data depicting the percent decline in
    residues of pronamide at the times and under the conditions specified.  After receipt of these data, the adequacy of
    the tolerances will be evaluated.  All residue data requested in this Standard must be accompanied by data regarding
    the storage length and conditions of samples analyzed.  These data must be accompanied by data depicting the stability
    of residues under the conditions and for the time intervals specified.  Since the nature of the residue in plants and
    animals has not been adequately described, if the requested metabolism data reveal additional metabolites of
    toxicological concern, additional data depicting the stability of such metabolites in storage will be required.
 V A crop group tolerance Is not appropriate unless a use is proposed, and residue data submitted, for celery and
    spinach, representative commodities.  In addition, additional data are required for lettuce (leaf lettuce only).
 fi/ The available data provide adequate support for the established tolerance covering residues of pronamide in or on
    l-i^--id lettuce only.  The registrant must either withdraw the registered use on leaf lettuce or revise the label
     1 i f-^-A.ions to delete the post-emergent application method.  If the registrant proposes a change in the use directions,
    appropriate supportive residue data must be submitted.
 7/ Mo conclusions regarding the adequacy of this proposed tolerance will be made at this time, because the data
    submitted in support of the tolerance are under review.
 ft/ A crop group tolerance is not appropriate unless data are submitted depicting residues of pronamide and its
    metabolites in or on mature pears harvested from trees which received a single directed spray application of the
    SO percent wettable powder at 4 Ib. ai/A the previous fall following harvest.  Tests would have to be conducted in
    California and Washington, which produce >70% of U.S. pears.
 9/ The registrants must submit data indicating the level of residues in wet pomace, dry pomace,  and juice processed
    from apples bearing measurable weathered residues.  Use of exaggerated application rates may  be necessary to obtain
    measurable residues in the raw commodity.  If residues concentrate in any of these processed  commodities, appropriate
    food/feed additive tolerances must be proposed.
10/ Adequate data are available to support the established tolerances for the representative commodities, cherries,
    peaches, and plums/fresh prunes, all at 0.1 ppm.  Since registered usage on these crops is identical, it is
    recommended that a crop group tolerance of 0.1 ppm be proposed.
ll/ The registrants must submit residue data from dried prunes processed from fresh prunes bearing measurable weathered
    residues.  Exaggerated rates may be necessary to achieve measurable initial residues in fresh prunes which are to be
    processed into dried prunes.  If concentration occurs, an appropriate food additive tolerance must be proposed.
                                                           - A-Q -

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                                                             TABLE A
                                     GENERIC DATA REQUIREMENTS FOR PRONAMIDE  (94* Technical)
  §158.125 Residue Chemistry (Continued)

  12/ A crop group tolerance is not appropriate unless  residue data  and proposed uses are submitted  for cranberries
      and strawberries, representative commodities.
  137 There are no registered uses of pronamide on boysenberries,  The tolerance for residues of pronamide in or on
      boysenberries will be cancelled unless  the registrant  proposes a use and submits appropriate residue data in support
      of the established tolerance, or if the proposed  use directions and limitations are identical  to those for black-
      berries, the registrant may use translatable data from blackberries and raspberries in support of the established
      tolerance.
  1_V The registrants must submit data indicating residues of pronamide in raisins, wet pomace, dry pomace, raisin waste,
      and juice processed fron grapes bearing measurable weathered residues.  Use of exaggerated application rates may be
      necessary to obtain measurable residues in the  raw commodity.  If residues concentrate in any of these processed
      commodities, appropriate food/feed  additive tolerances  must be proposed.
  157 Data submitted  in support of a crop group tolerance are pending.
 T5/ Based on the available  data for the representative raw  agricultural commodities alfalfa and clover, it i.s
      recommended  that a crop group tolerance of 10 ppm  be proposed  for the residues of pronamide and its metabolites
      in  or on non-grass  animal feed  forage and  hay.  Tolerances for alfalfa (10 ppm) and clover (5 ppm) do not vary ny
     more than a  factor of 5 from the tolerances  for any crop in the group.  These data satisfy the requirements for
     crop group tolerance establishment.
 177 The registrant must submit  data depicting  residues  in or on alfalfa seed from alfalfa bearing measurable weathered
     residues.  An appropriate tolerance must be proposed If  residues are higher in the seed than in the raw
     agricultural commodity.
  87 Sufficient data are available to support the tolerance  for the combined residues of pronamide and its metabolites
  ~  in or on clover.  The commodity definition  "clover" in 40 CPR 180.317 will be changed to "clover (forage)," the
     presently accepted term for this commodity.  While data  have been submitted for clover hay, a raw agricultural
     commodity of clover, a corresponding tolerance has not been proposed or established.  The registrant should propose
     a tolerance for residues of pronamide and its metabolites in or on clover hay; a level of 5 ppm is recommended.
     In lieu of such a proposal, the registrant may propose a crop group tolerance (see footnote 16).
  97 Sufficient data are available to support the tolerance for the combined residues of pronamide and its metabolites
  "  i :  or on crown vetch forage.  The commodity definition "crown vetch" in 40 CFR 180.317 will be changed to "crown
     vetch forage," the presently accepted term for this commodity.  No data have been submitted for crown vetch hay,
     a  raw agricultural commodity of crown vetch, nor has a corresponding tolerance been proposed.  The registrant
     should  submit a proposal for a tol^ance for residues In or on crown vetch hay; a level of 5 ppm is recommended,
     based on translatable clover hay data.   In lieu of such a proposal,  the registrant may propose a crop group
     tolerance (see footnote 16).

&»
DO
                                                           - A-1O -

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                                                           TABLE A
                                   GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
§158.125 Residue Chemistry (Continued)

20/ Sufficient data are available to support the tolerance for the combined residues of pronamide and its metabolites
    in or on sainfoin.  The commodity definition "sainfoin" will be changed to "sainfoin forage," the presently
    accepted term for this commodity.  While data have been submitted for residues in or on sainfoin hay, a raw
    agricultural commodity of sainfoin, a corresponding tolerance has not been proposed.  The registrant should
    propose a tolerance for residues of pronamide and its metabolites in or on sainfoin hay; a level of 5 ppn is
    recommended, based on translation from clover hay.  In lieu of such a proposal, a crop group tolerance can
    be proposed (see footnote 16).
21/ Sufficient data are available to support the tolerance for the combined residues of pronamide and its metabolites
    in or on trefoil.  The commodity definition "trefoil" will be changed to "trefoil forage," the presently accepted
    term for this commodity.  No data have been submitted for trefoil hay, a raw agricultural commodity of trefoil
    nor has a corresponding tolerance been proposed.  The registrant should submit a proposal for a tolerance for
    residues in or on trefoil hay; a level of 5 ppm is recommended, based on translatable clover hay data.   In lieu
    of such a proposal, the registrant may propose a crop group tolerance (see footnote 16).
227 The nature of the residue in animals has not been adequately described.  On receipt of the requested animal
    metabolism data, the appropriate nature of tolerances for residues in animal products will be determined and
    the adequacy of the available data on the magnitude of residues In animal products will also be determined.
                                                          - A-ll  -

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                                                            TABLE A
                                    GENERIC DATA REQUIREMENTS FOR PRONAMDE (9^% Technical)
Data Requirement
Composition
  Use
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
or Partially)
Bibliographic
  Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames For Data
Submission
§158.130  Environmental Pate

 Degradation Studies-Lab

 161-1 -  Hydrolysis

 Photodegradatlon

 161-2 - In water

 161-3 - On soil

161-4 - In Air

Metabolism Studies-Lab

162-1 - Aerobic Soil

162-2 - Anaerobic  Soil

162-3 - Anaerobic  Aquatic

L62-4 - Aerobic  Aquatic

Mobility Studies

163-1 - Leaching and
        Adso rpt ion/Desorpt ion
 TGAI or PAIRA    A,B,H
 TGAI or PAIRA

 TGAI or PAIRA

 TGAI or PAIRA



 TGAI or PAIRA

 TGAI or PAIRA

 TGAI  or PAIRA

TGAI or  PAIRA
 A,B,H

 A

 N/A3/

 N/A3/
TGAI or PAIRA    A,B,H
                Yes
                        00107980
A,B
A
N/A3/
No
No

  No

  No
               No
                  No



                  Yes - 9 months!,/

                  Yes^/
                  Yes - 27 monthsl/
                                         Yes5/ -  12 months!
                                                          - A-12 -

-------
                                                           TABLF, A
                                  GFNFRIC  DATA  REQUIREMENTS  FOR PRONAMIDE (94% Technical)
Does EPA Have
Data To Satisfy
Use This Require-
Data Requirement Composition Pattern ment? (Yes, No
or Partially)
§158.130
Environmental Fate (Continued)
Must Additional Data
Be Submitted Under
Bibliographic FIFRA § 3(c)(2)(B)?
Citation Time Frames For Data
Submission

Mobility Studies (Continued)
163-2 -
163-3 -
D is si pa
164-1 -
164-2 -
164-3 -
164-4 -
Volatility (Lab) TEP A No
Volatility (Field) TEP A No
t.ion Studies-Field
Soil TEP A,B,H No
Aquatic (Sediment) TEP N/Al/
Forestry TEP N/Al/
Combination and N/A^/
Yes - 12 months
Reserved^/
Yes - 27 months!/



         Tank Mixes

164-5 - Soil, Long-term

Accumulation Studies

165-1 - Rotational Crops
         (Confined)

165-2 - Rotational Crops
         (Field)
 TEP
PAIRA
 TEP
No
No
No
Reserved!/



Yes - 39 months


Reserved?/
                                                         - A-13 ~

-------
                                                          TABLE A
                                  GENERIC DATA REQUIREMENTS FOR PRONAMIDE (9*1% Technical)
                                                             Does EPA                           Must Additional Data Be
                                                   Use       Have Data To      Bibliographic    Submitted Under FIPRA
Data Requirement                 Composition     Pattern     Satisfy This        Citation       § 3(c)(2)(B)? Time Frames
__ _ _ _ _ Requirement? _ For Data Submission _

§158.130 Environmental Fate (Continued)

  Accumulation Studies (Continued)

  165-3 - Irrigated Crops            TEP

     -4 - In Pish                TGAI or PAIRA   A,B              No              -                   Yes - 12 months
  165-5 - In Aquatic Non-Target      TEP         N/Al/
            Organisms
_!/  Data  for  this requirement submitted  In response to the May 1984 Special Data  Call  In  Notice  for Ground Water Data
    have  been determinal  to  be  Invalid.  Therefore, new or additional data must be  submitted.  Additional data to
    supplement the previously submitted  studies Include raw data to support conclusions;  material  balance;  incubation
    tanperature and pH; in addition, the solutions were not buffered; the test substance  was not Identified sufficiently;
    the light source was  not specified;  and the test was for less than 30 days.
21  Data  to fill this requirement have been submitted but have not been  reviewed.
3/  Not required for this chemical.
\l  Data  are due in June  1986,  in accordance with the May 1984 Special Data Call  In Notice  for Ground Water Data.
5_/  Adsorption/desorptlon data  are required for Domestic Outdoor use patterns.  For the other use  patterns,  either
    adsorptlon/desorption or any of the  other methods (e.g. TLC, column) will be  acceptable.
6/  Data  will be required unless the results of the laboratory volatility study indicate  these data are  unnecessary .
7/  Tata  will be required unless the results of the field dissipation study indicate these  data  are unnecessary.
B/  ata  will be required unless the results of the confined crops study indicate these data are unnecessary.
                                                        - A-lU -

-------
                        TABLE A
GRNERIC DATA REQUIREMENTS FOR PRONAMIDE
                                                                                 Technical)
Data Requirement Composition
§158.135 Toxicology
Acute Testing
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity
- Rabbit
•'-! 1 - -! - Acute Inhalation Toxicity
- Rat
8l -4 - Primary Eye Irritation
8l-5 - Primary Dermal Irritation
81-6 - Dermal Sensitization
81-7 - Delayed
TGAI
TGAI
TGAI
MP
MP
MP
TGAI
Use
Pattern
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
N/Ai/
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Yes
Yes
Yes
Yes
Yes
Yes

Bibliographic
Citation
00083663
00083663
00083663
00083663
00126574
00062605

Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
No
No
No
No
No
No

       Neurotoxicity - Hen

Subchronic Testing

82-1 - 90-Day Feeding
        - Rodent, and

        - Non-rodent (Dog)
                                      TGAI
            M/AfL/
en
                                                           - A-15 -

-------
                          TABLE A
  GENERIC DATA REQUIREMENTS FOR PRONAMIDE
                                                                                 Technical)
  Data Requirement
Composition
  Use
Pattern
  §138.135 Toxicology (Continued)

   Subchronlc Testing (Continued)

   82-2  -  21-Day  Dermal  -  Rabbit       TGAI

   82-3  -  90-Day  Dermal  -  Rabbit       TGAI

   82-4  -  90-Day  Inhalation:           TGAI
           -  Rat

   82-5  -  90-Day  Neurotoxicity:        TGAI
           -  Hen

           -Mammal

  Chronic Testing

  83-1 - Chronic Toxicity -          TGAI
          2 species:
            - Rodent, and

            - Non-rodent (Dog)

  83-2 - Qncogenicity -              TGAI
          2 species:
            - Rat (preferred), and

            - Mouse (preferred)
              N/A?/

              N/AfV

              N/A2/


              N/Al/
             A,B,H

             A,B,H



             A,B,H

             A,B,H
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
or Partially)
Bibliographic
  Citation
              No

              Partially



              No

              Yes
"Must Additional Data
 Be Submitted Under
 FIFRA §  3(c)(2)(B)?
 Time Frame for Data
 Submission
                    00107968
                    Yes - 50 months

                    No



                    Yes - 50 months

                    No
CJl
                                                          - A-16 -

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                                                             TABLE A
                                     GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
Data
§158.
Use
Requirement Composition Pattern
135 Toxicology (Continued)
Does EPA Have
Data To Satisfy
This Require- Bibliographic
ment? (Yes, No Citation
or Partially)

Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission

Chronic Testing (Continued)
83-3
- Teratogenicity - TGAI
2 species:
- Rat A,B,H
- Rabbit A,B,H
No
Yes 00148064
00148065
Yes - 15 months3/
No
   83-4 - Reproduction  - Rat
            2-generation
                             TGAI
   Mutagenicity Testing

   84-2 - Gene Mutation  (Ames Test)  TGAI

   84-2 - Structural Chromosomal     TGAI
           Aberration

   84-4 - Other Genotoxic Effects    TGAI

   Special Testing
A,B,H




A,B,H

A,B,H


A,B,H
                              No
   85-1

   85-2

   86-1
- General Metabolism

- Dermal Penetration

- Domestic Animal
   .Safety
PAI or PAIRA  A,B,H

   Choice     A,B,H

   Choice      N/AfL/
No

No


No



No

Mo
Yes - 39 months




Yes -  9 months

Yes - 12 months


Yes - 12 months



Yes - 24 months

Yes - 12 months
cn
                                                         - A-17 -

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                                                            TABLE A
                                   GENERIC DATA REQUIREMENTS FDR PRONAMIDE  (9H% Technical)
  §158.135  Toxicology  (Continued)

  _!/  Pronamide  is  neither an organophosphate, nor an analog of a neurotoxic compound, hence, no delayed neurotoxicity
      study is required.
  _2/  Not applicable to exposure conditions.
  3/  Data  for this requirement submitted in response to the October 1982 Data Call In Notice have been determined  to
      be invalid.  Therefore, new data must be submitted.
ON
                                                          - A-18 -

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                                                            TABLE A
                                    GENERIC DATA REQUIREMENTS FOR PRONAMIDE  (94% Technical)
Does EPA Have
Data To Satisfy
Use This Require- Bibliographic
Data Requirement Composition Pattern ment? (Yes, No Citation
or Partially)
Must Additional Data
Be Submit ted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
5158.115 Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 -
71-2 -
71-3 -
71-1 -
71-5 -

Aquatic
72-1 -


Acute Avian Oral Toxicity TGAI A,B,H Yes
Avian Subacute Dietary TGAI A,B,H Yes
Toxicity
-Upland Game Bird, and
-Waterfowl
Wild Mammal Toxicity TGAI N/Al/
Avian Reproduction TGAI N/AfL/
Simulated Field and Actual TEP N/A^/
Testing - Mammals and Birds
Organism Testing
Freshwater Fish Toxicity
- Coldwater Fish Species TGAI A,R,H Yes
- Varmwater Fish Species TGAI A,B,H Yes
00107997
00107993
00107991
00108002
00108003






00107996
00107196
00107996
No
No






No
No
  72-2  -  Acute Toxicity to           'TGAI
           Freshwater Invertebrates
A,B,H
Yes
                                                           - 4-19 -
00098313
                                        Mo
(J1

-------
                                                          TABLK A
                                  GSNTRRIC DATA R^UIRd'IRMTS  TOR PRONAMIDF.
                                                                                 Technical)
Use
Data Requirement Composition Pattern
§15B.145 Wildlife and
Aquatic Organisms (Continued)
Does F,PA Have
Data TO Satisfy
This Require-
ment? (Yes, Mo
or Partially)


Bibliographic
Citation


Must Additional Data
Be Submitted Under
FIFRA § 3(c)(?)(B)?
Time Frame for Data
Submission


 Aquatic Organism ^Testing
72-3 - Acute Toxicity to
        Kstuarine and ferine
        Organisms

72-4 - Fish Early Life Stage
        and Aquatic Invertebrate
        Life-Cycle
  72-5 - Fish - Life-Cycle

  72-6 - Aquatic Organism
          Accumulation
                                      TGAI
                                      TCAI
                                    TCAI
N/A2/



N/A£?/



N/A2/
                              TCAI, PAI or
                               degradation
                                 product
  72-7  -  Simulated or  Actual
          Field Testing  - Aquatic
          Organisms
                                     TTCP
 \J Data not normally required  for  these  uses.
 2/ Data not required due to  low  toxicity and  low expected ecological effect.
01
CD
                                                          - A-20 -

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                                                          TABLE A
                                  GENERIC DATA REQUIREMENTS TOR PRONAMIDE (94% Technical)
)ata Requirement
    . 155  Nontarget  Insect
Nontarget  Insect Testing  -
Pollinators
   -1 - Honey bee acute
         contact toxicity
 41-2 - Honey bee  -  toxicity
         of residues on
         foliage
   -4 - Honey bee subacute
         feeding study
141-5 - Field testing for
         pollinators

Nontarget Insect Testing -
Aquatic Insects

142-1 - Acute toxicity to
         aquatic insects

142-1 - Aquatic insect
         life-cycle study

I 42-3 - Simulated or actual
         field testing for
         aquatic insects
Composition
    Use
  Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
or Partially)
Bibliographic
  Citation
    TGAI

    TEP
A,B,H

N/Al/
Yes
00028772
    TEP
N/Al/
Must Additional Data
Be Submitted Under
PIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
No
                                                                     Reserved?./
                                                                     Reserved^/


                                                                     Reserved^/


                                                                     Reserved^/
                                                        - A-21 -

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                                                          TABLE A
                                  GENERIC DATA REQUIREMENTS FOR PRORAMDE (94% Technical)
                                                             Does EPA Have                           Must Additional Data
                                                             Data To Satisfy                         Be Submitted Under
                                                  TIse        This Require-       Bibliographic       FIFRA 5 3(c)(2)(B)?
Data Requirement                Composition     Pattern      ment?  (Yes, No       Citation          Time Frame for Data
 	or Partially)	Submission	

§158-155 Nontarget Insect (Continued)

 1^3-1 - Nontarget Insect                                                                            Reserved^/
         Testing - Predators
 thru    and Parasites

 143-3
 If Because data from the acute contact tests indicate low toxicity,  data on residual toxicity are not required,
 2/ This requirement is reserved pending development of test methodology.
 3/ Data reviewed to date do not indicate any need for a field study.
 5/ This requirement is reserved pending further evaluation to determine what and when data should be required, and
    to develop  appropriate test methods.
                                                         -  A-22  -

-------
                                            TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING PRONAMIDE (50% PI)
Ideline Citation and
me of Test
                             Test
                           Substance
                                                    Guidelines
                                                      Status
                                                                     Are Data
                                                                     Required
                                                                    Yes      No
                  Footnote
                   Number
Data Must Be
Submitted Within
Time Frames
Listed Below
58.120 Product Chemistry

Product Identity

61-1 - Product Identity and Disclosure     MP
        of Ingredients

61-2 - Description of Beginning Materials  MP
        and Manufacturing Process
6l-3 - Discussion of Formation of
        Impurities

Analysis and Certification of Product
                              MP
                                           R
                                           R
                                                        R
O      ra
[xi      n

[x]      n
Ingredients
62-1
62-2
62-3
- Preliminary Analysis
- Certification of Limits
- Analytical Methods to Verify
Certified Limit
MP
MP
MP
CR
R
R
[x]
^
[x]
n
cj
n
Physical and Chemical Characteristics
63-2
63-2
- Color
- Physical State
MP
MP
R
R
n
n
[x]
[x]
     6 months


    12 months
                                                                                               6 months

                                                                                               6 months

                                                                                               6 months
                                            - B-l  -

-------
                                            TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PRONAMIDE (50% PI)
Guideline Citation and
Name of Test
Test
Substance
Guidelines
Status
Data Must Be
Are Data Footnote Submitted Within
Required Number Time Frames
Yes No Listed Below
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics (Continued)
63-4
63-7
63-12
63-1^
63-15
63-16
63-17
63-18
63-19
63-20
- Odor
- Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Misclbillty
- Corrosion Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
R
R
CR
CR
CR
R
R
CR
CR
R
[_]
[J
n
u
n
CD
rj
n
O
n
[x]
[x]
[x]
[x]
[x]
ro
[x]
[x]
[x]
[x]
Other Requirements
64-1 -
ON
ro
Submit tal of samples

MP

CR
- B-2 -
O

[x]


-------
                                                           TABLE  B
              PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE  PRODUCTS  CONTAINING  PRONAMIDE (50% FI)
 3roduct Chemistry §158.120  (Continued)

 L/ The registrant must submit details of  the manufacturing process,  including  the  relative amounts  of  beginning
   materials, a description of the equipment used to produce the product,  reaction conditions, the  duration  of  each step
   of the process, purification procedures and quality control measures, the name  and address of the manufacturer,
   producer or supplier of  each beginning material used, and a copy  of all available technical specifications,  data
   sheets, and other documents in which the manufacturer, producer,  or supplier  of the beginning material describes its
   composition and properties.
2/ A discussion of each impurity believed to be present at X).l% based on  knowledge of the beginning materials, all
   possible chemical reactions and any contamination must be submitted.
3/ Five or more representative samples should be analyzed for the amount of active ingredient and each impurity present
   Tor which a certified  limit is required (greater than 0.1%}.
V Upp>--r .ind lower limits for pronamide and for each intentionally added inert,  and upper limits for each impurity
   pi-i••:>.-1it at 0,1% (w/w) must be provided and certified.
5/ The registrant must submit quantitative methods to determine pronamide and  all  impurties and inerts for which a
   certified limit is required (greater than 0.1%).  Each method must be accompanied by validation studies of the
   precision and accuracy of the method.
ON
CM
                                                          - B-3

-------
                                                          TABLE B
              PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PRONAMIDE  (50%
Data Requirements
Composition
Does EPA  Have
Data ^o Satisfy
This Require-
ment? (Yes, No
or Partially
Bibliographic
  Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
§158.
135 Toxicology

Acute Testing
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat MP Yes
- Acute Dermal Toxicity MP Yes
- Rabbit
- Acute Inhalation Toxicity MP Yes
- Rat
- Primary Eye MP Yes
Irritation - Rabbit
- Primary Dermal MP Yes
Irritation - Rabbit
- Dermal Sensitization MP No
00085504 No
00085505
00133112
00085505 No
000855H
00133112 No
00085505 No
00133H2
00085505 No
00133112
Yes - 9 months
       Guinea Pig
                                                          - B-4  -

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                 APPENDIX B






EPA INDEX TO PESTICIDE CHEMICALS  -  PRONAMIDE
                                                          65

-------
                     EPA Index  to Pesticide  Chemicals

             3,5-DICHLORO-N-U,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

TYPE PESTICIDE:   Herbicide

FORMULATIONS:
FTT50%1
G    (0.32%, 0.33%, 0.4%, 0.9%,  1%)
WP   (50%)

GENERAL WARNINGS AND LIMITATIONS;  A selective, soil active herbicide  used
for the preemergence or early postemergence control of many broadleaf
weeds and grasses.  Moisture in the form of rain, melting snow,  or  irri-
gation is necessary to move the chemical into the root zone of germinat-
ing weeds.  Apply  in 20 to 50 gallons of water per acre by ground,  or  in
5  to 10 gallons by air.  Aerial applications should be made only where
specified.  Use a  low pressure  sprayer for ground applications.  Pronamide
is most effective  in coarse to  medium textured soils with less than 4
percent organic matter content.  Where a dosage range is given,  use the
lower dosage  on coarse and medium textured soils and the higher  dosage on
fine soils.   For best results,  apply to a clean soil surface, free  of  de-
caying crop or weed aebris.  Pronamide is more effective in cool weather;
degradation of the chemical occurs on the soil surface in warm weather.
If application is  made when air temperature  is above 85 F (29.4  C), chem-
ical should be incorporated to  a shallow depth, or watered into  the soil
as soon as  possible after application.  When a band application  is  made,
reduce dosage in proportion to  band area actually treated.  According  to
Position  Document/4 on pronamide, products with more than 1 percent a.i.
should be classified for restricted use.

Livestock Tolerances;
     Cattle  (fat, meat and mbyp
     except kidney and liver)        0.02 ppm
     Cattle  (kidney and liver)        0.2  ppm
     Eggs                             0.02 ppm
     Goats (fat,  meat and mbyp                     .
     except kidney and liver)        0.02 ppm
     Goats (kidney  and liver)         0.2  ppm
     Hogs  (fat,  meat and  mbyp
      except kidney and liver)        0.02 ppm
     Hogs  (kidney and liver)          0.2  ppm
     Horses (fat,  meat and  mbyp
      except kidney and liver)        0.02 ppm
     Horses (kidney and liver)        0.2  ppm
     Milk                            0.02 ppm
     Poultry (fat,  meat and mbyp
      except kidney and liver)        0.02 ppm
     Poultry (kidney  and  liver)       0.2  ppm
     Sheep (fat,  meat  and mbyp
      except kidney and  liver)        0.02 ppm
     Sheep (kidney and  liver)          0.2  ppm


 *Pronamide
   Kerb
   N-(1,1-dimethylpropyny1)-3,5-dichlorobenzamide

 Issued:   1-17-84                1-101701-1

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                                EPA Index to Pesticide Chemicals

                        3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BMZAMIDE

           DEFINITION OF TERMS:
           a.i.  *= active ingredient
           lb = pounds
           mbyp = meat byproducts

           TIME REQUIRED FOR CONTROL;  Three to 5 weeks are required to control an-
           nual bluegrass.

           MODE OF ACTION;  Pronamide affects the meristematic tissues of roots re-
           sulting in cell enlargement, necrosis, and an increase in nuclear volume
           in the treated apices.  Premature differentiation and maturation of root
           tissues with eventual vacuolation of the apical meristematic cells com-
           pletely inhibits root growth.
           3ROADLEAF WEEDS CONTROLLED;

PEWAIBE       Black nightshade
?FGAEBF       Burning nettle
PADABBA       Carpetweed
PAZAOBB       Common chickweed
PBDAEBA       Common lambsquarters
PEDADBA       Common purslane
PBGADAA       Dodder
PEWAIBG       Hairy nightshade
PCOAFBA       Henbit
PDAAHBD       Little mallow
PBKBDBB       London rocket
PAZADBC       Mouseear  chickweed
 5DAEBI       Nettleleaf  goosefoot
r'LAAGBM       Pale smartweed
PEAAGBD       Prostrate knotweed
PCQBYBH       Red clover
PBKAHBA       Shepherdspurse
PBGAFBL       Tall morningglory
PEWAKBA       Tomato  (volunteer)
PBKAFBE       Wild mustard
PBKBABA       Wild radish
      (b)
      (b)
      (b)
      (a)
      (b)
      (b)
      (b)
      (b)
      (b)
      (b)
      (b)
      (a)
      (b)
      (b)
      (b)
      (b)
      (b)
      (b)
      (b)
      (b)
      (b)
                (a) Preemergence and early postemergence control.
                (b) Preemergence control only.
            Issued:  1-17-84
1-101701-2
67

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                                EPA Index to Pesticide Chemicals

                        3 ,5-DICHLORO-N-d,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

           GRASSES AND OTHER MONOCOTS  CONTROLLED:
CABMBE       Alta fescue
CACKBA       Annual bluegrass
CABSAA       Barley (volunteer)
CABHB3       Barnyardgrass
CAADAA       Bentgrass
CACXAA       Bluegrass
CACHBB       Canarygrass
CAATBM       Downy brome
CACEBD       Fall panicum
CABSBC       Foxtail barley
CABIBA       Goosegrass
CABZBA       Italian ryegrass
CACKBD       Kentucky bluegrass
CABFBF       Large crabgrass
CABKAA       Lovegrass
CAAOAA       Oat
CABB3A       Orchardgrass
CABZBC       Perennial  ryegrass
CAACBA       Quadcgrass
CACTAA       Rye (volunteer)
CABRBA       Velvetgrass
CADFBA       Wheat  (volunteer)
CAAOBB       Wild  oat
CACUBD       Yellow  foxtail
      (a)

      (a)
      (b)
      (a)

      (b)
      (a)
      (b)
      (a)
      (b)
      (a)
      (a)
      (b)
      (b)
      (a)
      (a)
      (a)
      (a)
      (a)
      (a)
      (a)
      (a)
      (b)
                (a)  Preemergence  and  early  postemergence  control.
                (b)  Preemergence  control  only.
            Issued:  1-17-84
1-101701-3
68

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                      EPA  Index  to Pesticide  Chemicals

             3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

Site, Dosage            Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)

TERRESTRIAL FOOD CROP

  (Agricultural Crops)

  General Warnings and Limitations:  Crop rotation instructions:
  1. When rotation crops  other  than artichoke, lettuce, endive or escarole
     are to be. planted in treated areas, knock down the beds and cross-
     disc the field before planting.
  2. When pronamide treatment is to be followed by a rotation crop within
     6 months of application, make bed-top or band applications.
  3. When pronamide treatment of 0.5 Ib a.i./A or higher will be followed
     by small grains  or grasses within 1 year, treatment should be limited
     to band or bed-top application.
  4. a. When pronamide treatment is aade at  0.5 Ib a.i./A, artichoke,
        lettuce, endive and  escarole may be  planted immediately; beans,
        corn, cotton, sorghum,  carrots, celery, broccoli, cabbage, cauli-
        flower, cucurbits, spinach, sugarbeets, onions and tomatoes may
        be  planted after  3 months; wheat, barley, oats and grasses may be
        planted after 6 months.
     b. When pronamide treatment is made at  1 Ib a.i./A, artichoke, let-
        tuce, endive  and  escarole may be planted immediately; beans,
        corn, cotton, sorghum,  carrots and celery may be planted after 3
        months; broccoli, cabbage, cauliflower, cucurbits, spinach,
        sugarbeets, onions and  tomatoes may  be planted after 4 months;
        wheat, barley, oats  and grasses may  be planted after 9 months.
     c. When pronamide treatment  is made at  1.5 Ib a.i./A, artichoke,
        lettuce, endive and  escarole may be  planted immediately; beans,
        corn, cotton, sorghum,  carrots and celery may be planted after 4
        months; broccoli, cabbage, cauliflower, cucurbits, spinach,
        sugarbeets, onions,  and tomatoes may be planted after 6 months;
        wheat, barley, oats  and grasses may  be planted after 9 months.
     d. When  pronamide  treatment  is made at  2 Ib a.i./A, artichoke, let-
        tuce, endive  and  escarole  may  be planted immediately; beans,
        corn, cotton, sorghum,  carrots and celery may be planted after 5
        months; broccoli, cabbage, cauliflower, cucurbits, spinach, sugar-
        beets, onions and tomatoes may be planted after 7 months; wheat,
        barley, oats  and  grasses  may be planted after 12 months.
 Issued:   1-17-84                1-101701-4

-------
23U01AA
23001BA
Site, Dosage
and Formulation
(Ib a.i./A)

  Alfalfa
                                EPA Index to Pesticide Chemicals

                        3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

                                   Tolerance, Use, Limitations
               0.5-2
               (50% WP)
                0.75-1
                (50%  WP)
 23001BA
   Alfalfa (seed crop)
                1.5-2
                (50% WP)
                1.5
                (50% WP)
N.F. (seed)
10 ppm (fresh alfalfa, forage and hay)
Do not graze treated fields or harvest for forage
or hay for these intervals:
25 days in areas West of Mississippi River, when
the dosage is up to 1.5 Ib a.i./A;
45 days in areas West of Mississippi River, when
the dosage is 1.5 to 2 Ib a.i./A;
120 days in areas East of Mississippi River, when
the dosage is up to 2 Ib a.i./A.
Do not use more than 2 Ib a.i./A per crop season.

General Information:  If fall treated alfalfa
should be killed in winter, do not plant small
grains or grass crops in the same field in the
spring.

Postemergence.  Broadcast.  Apply to established
alfalfa during  fall or winter after the last cut-
ting when temperatures are cool.  Apply to fall
seeded alfalfa  after  the trifoliate stage.  Ap-
plication to  spring seeded alfalfa should be made
the following fall or early winter.

Postemergence.  Broadcast.  Spring application
for control of  downy  brome.  Apply just before or
just  after  germination of  downy  brome.

Also  refer  to Alfalfa (see^i  crop) for more infor-
mation pertinent only to that site.

N.F.  (seed)
 10 ppm (fresh alfalfa, forage and hay)

Use limited to  CA,  ID, NV, OR,  UT, and WA.
 Broadcast.   Spring application  for preemergence
 control of  dodder  in  established alfalfa.   Incor-
 porate lightly  at  the time of application and
 furrow irrigate within 7  days.

 Use limited to  CA,  ID,  NV, OR,  UT, and WA.
 Broadcast.   Spring application  for  preemergence
 control of  dodder  in established alfalfa.  Flood
 the field within 1 to 3 days after  application.

 Also refer to Alfalfa for additional use and dose
 information.
            Issued:  1-17-84
                                 1-101701-5

-------
•OOIAA
,002AA
014AA
,003AA
:004AA
.003AA
i005AA
i006AA
bite, Dosage
and Formulation
Ub a.i./A)

  Apple
  Cherry
  Grapes
  Nectarine
  Peach
  Pear"
                              EPA Index to Pesticide Chemicals

                      3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

                                 Tolerance,  Use,  Limitations
             1-4
             (50% WP)
1013AA
   Artichoke,  Globe
             (50% WP)
             2-4
             (50% WP)
0.1 ppm
Do not graze or feed treated foliage to livestock.
Do not use more than 4 lb a.i./A per season.
Directed spray.  Broadcast or band.  Make a single
application in the fall after fruit is harvested,
but prior to leaf-drop and before the soil freez-
es.  Application may be made to bearing or non-
bearing trees and vines.  Use only on established
plantings.  Do not use on seedling trees or vines
less than 1 year old, or on fall transplanted
stock within 1 year of transplanting or on spring
transplanted stock within 6 months of transplant-
ing.

0.1 ppm
Sixty day preharvest interval.

General Information:  Apply only once per crop
season.  Rainfall or overhead sprinkler irrigation
is essential within 1 to 3 days after application
to activate the  chemical.  When dosage exceeds 2
lb a.i./A, do not plant anything except artichokes
for 18 months.   For dosages up to 2  lb a.i./A,
follow crop rotation instructions given under
General Warnings and Limitations for Agricultural
Crops.

Posttransplant.  Band  application  over  the  row.
Apply after  transplanting  the  crowns but  before
new shoots have  3 to 4  leaves.  Apply  preemergent
to  the weeds.   Do not  use  on  peat  or muck soils.

Postemergence.   Band  application  over  the row.
Apply to  established  crop  preemergent  to  the weeds
and before  artichoke  leaves are  more than 16
inches long.   Use  the higher  dosage on fine soils.
          Issued:   1-17-84
                                          1-101701-6

-------
                                    Index to Pesticide Chemicals
                        3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
           Site,  Dosage
           and Formulation
           (Ib a.i./A)
                      Tolerance,  Use,  Limitations
23011AA
23D1LBA

23003AA
23003BA
23T-24AA
23024BA

23021AA
23021BA
 nino2AA
 D1009AA
Birdsfoot Trefoil
Birdsfoot Trefoil
 (seed crop)
Clover
Clover (seed crop)
Crown Vetch
Crown Vetch (seed
 crop)
Sainfoin
Sainfoin (seed crop)
               0.5-2
               (50% WP)
 Birdsfoot Trefoil
  (seed crop)

 Blackberry
 Raspberry

   1-3
   (50% WP)
Blueberry
               1-2
               (50% WP)
5.0 ppm
N.F. (seed)
Do not graze treated fields or harvest for forage
for 120 days.  Do not use more than 2 Ib a.i./A
per crop season.
                      General Information:   If fall-treated legumes
                      should be killed in winter,  do not plant small
                      grains or grass crops in the same field in the
                      spring.

                      Broadcast,  Apply to established legumes during
                      fall or winter after the last cutting when tem-
                      peratures are cool but before the ground freezes.
                      Apply to fall-seeded legumes after the trifoliate
                      stage.  Application to spring-seeded legumes
                      should be made the following fall or early winter.
See Birdsfoot Trefoil cluster.

0.05 ppm
Do not use more than 3 Ib a.i./A per year.

Use limited to OR and WA.. Broadcast or band.
Apply to established berries, and make only  1 ap-
plication per year.  Apply in fall or winter,
preferably during November or December.  Do not
apply when ground is frozen.  Do not apply to
newly transplanted berries for at least 3 months.
Use 1 to 2 Ib a.i./A for control of annual blue-
grass, and 2 to 3 Ib a.i./A for control of peren-
nial ryegrass and quackgrass.

0.05 ppm
Do not use more than 2 Ib a.i./A per year.

Use limited to OR and WA.  Broadcast or band.
Apply to established berries, and make only  1 ap-
plication per year.  Apply in fall or winter,
preferably during November or December.  Do  not
apply when ground is frozen.  Do not apply to
newly transplanted blueberries until the roots
are well established.
            Issued:   1-17-84
                                           1-101701-7

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'13015AA
 13020AA
Site, Dosage
and Formulation
Clb a.i./A)

  Cherry

  Clover

  Clover  (seed crop)

  Crown Vetch

  Crown Vetch  (seed
   crop)

  Endive  (Sscarole)
  Lettuce
                                EPA Index to Pesticide Chemicals

                        3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

                                   Tolerance,  Use,  Limitations
               1.5-2
               (50% WP)
               1-2
               (50% WP)

               1-2
               (50% WP)
             Grapes

             Lettuce

             Nectarine

             Peach

             Pear

             Plum

             Prune

            Issued:
See Apple cluster.

See Birdsfoot Trefoil cluster.

See Birdsfoot Trefoil cluster.

See Birdsfoot Trefoil cluster.


See Birdsfoot Trefoil cluster.

2 ppm (endive (escarole))
1 ppm (lettuce)
Fifty-five day preharvest interval on lettuce.

General Information:  Do not make more than 1 ap-
plication per crop season.  Do not use on peat or
muck soils.  Do not use more than 1.5 Ib a.i./A
on Val Temp, Grande Verde, and Prima Verde vari-
eties of crisp lettuce, or on endive and escarole.
Apply preemergence to the weeds, and water into
the soil immediately after application.

Preplant soil incorporation.  Broadcast or band.
Where rainfall is not dependable or overhead
spinkler irrigation is not used, shallow preplant
incorporation followed by furrow irrigation is
recommended.
                         Preplant or preemergence,
                         face application.
                           Broadcast or band sur-
          1-17-84
Postemergence.   Broadcast  or  band  surface ap-
plication.   Apply  before or after  thinning of
lettuce.

See  Apple  cluster.

See  Endive (Escarole)  cluster.

See  Apple  cluster.

See  Apple  cluster.

See  Apple  cluster.

See  Apple  cluster.

See  Apple  cluster.

         1-101701-8

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                                EPA  Index  to Pesticide  Chemicals

                       3,5-DICHLORO-N-(l,l-DIMETKYL-2-PROPYNYL)BENZAMIDE
          Site, Dosage
          and Formulation
          (Ib a.i./A)

            Raspberry

            Sainfoin
Tolerance,  Use,  Limitations



See Blackberry cluster.

See Birdsfoot Trefoil cluster.
             Sainfoin  (seed  crop)   See Birdsfoot Trefoil cluster.
           TERRESTRIAL NON-FOOD  CROP
             (Agricultural Crops)

33017BA      Bermudagrass (seed
              crop)
               0.5-1.5
               (50% WP)
N.F.  (seed)
Do not graze treated areas or feed  clippings  to
livestock.

Broadcast application for annual bluegrass  con-
trol.  Apply at any stage of annual bluegrass
growth from preemergence to seed formation.   Use
the  lower dosage for preemergence or early  post-
emergence control.  Use the higher  dosage for
late postemergence control and when longer  pre-
emergence residual control is desired.   Irrigation.
or.rainfall within 24 hours of application  is de-
sirable.  May be applied by air.
            Issued:   1-17-84
                                           1-101701-9

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                             EPA  Index  to Pesticide  Chemicals

                     3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

        Site,  Dosage            Tolerance, Use, Limitations
        and Formulation
        (lb a.i./A)

          (Ornamental Plants and Forest Trees)

I22AA      Azalea
I22DA      Azalea (nursery
           stockT
105AA      Christmas Tree Plan-
           tations
144AA      Douglas-Fir
H4DA      Douglas-Fir (nursery
           stock)
151AA      Fir"
151DA      Fir (nursery stock)
)62AA      Forsythia
)62DA      Forsythia  (nursery
170AA      Holly
)70DA      Holly (nursery
           stock)
173AA      Juniper
173DA      Juniper  (nursery
           stock)
)98AA      Pine
398DA      Pine (nursery
           stock)"
118AA      Rhododendron
U8DA      Rhododendron
           (nursery  stock)
130AA      Yew
130DA      Yew  (nursery stock)
            1-2                  Broadcast or band.  Make a single application in
            (50% WP)             fall prior to leaf-drop and before the soil
                                 freezes.  Apply over the top of ornamentals or as
                                 a directed spray to the soil.  Moisture is neces-
                                 sary as rainfall or overhead sprinkler irrigation
                                 to move the chemical into the soil.  Use only on
                                 established plantings.  Do not use on seedling
                                 trees or shrubs less than 1 year old, or on fall
                                 transplanted stock within 1 year of transplanting,
                                 or on spring transplanted stock within 6 months
                                 of transplanting.

          Azalea  (nursery
          ~ stock)                See Azalea cluster.
         Issued:   1-17-84                1-101701-10
                                                                                             75

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                                EPA. Index to Pesticide Chemicals
33017AA
Site, Dosage
and Formulation
(Ib a.i./A)

  Bermudagrass
                        3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

                                  Tolerance, Use, Limitations
               0.92-2.75 oz a,
                5,000 sq.ft
               (1% G)
               (50% WP)

               1.85-2.77 oz a.
                5,000 sq.ft
               (0.33% G)
                   i./
                   i./
               0.92-2.75 oz a.i./
                5,000 sq.ft
               (50% WP)
               0.87 oz a.i./
                5,000 sq.ft
               (0.322 G)

               0.85 oz a.i./
                5,000 sq.ft
               (0.4% G)

               0.81 oz a.i./
                5,000 sq.ft
               (0.9% G)
General Information:   Use for control of annual
bluegrass in bermudagrass golf courses, lawns,
and playing fields.  Do not spray on fairways or
other areas that may drain onto bentgrass greens,
or to areas overseeded with sensitive cool season
grasses.  Do not apply to areas that are to be
overseeded with cool season grasses within 90
days before seeding.   Do not use on golf greens.
Dichondra, bluegrass, annual and perennial rye-
grasses, fescues, zoysia, and bentgrass are sen-
sitive to pre- and postemergence applications of
pronamide.  May be used for elimination of winter
overseeded cool season grasses.

Broadcast application for annual bluegrass con-
trol.  Apply at any stage of annual bluegrass
growth from preemergence to seed formation.  Use
the lower dosage for preemergence or early post-
emergence control.  Use the higher dosage for
late postemergence control and when longer resid-
ual preemergence control is desired.  Irrigation
or rainfall within 24 hours of application is
desirable.

Restricted Use Pattern.  Applications should be
made only by certified applicators or persons
under their direct supervision.  Broadcast appli-
cation for annual bluegrass control.  Apply at
any stage of annual bluegrass growth from pre-
emergence to seed formation.  Use the lower dosage
for preemergence or early postemergence control.
Use the higher dosage for late postemergence ^n-
trol and when longer residual preemergence control
is desired.  Irrigation or rainfall within 24
hours of application is desirable.
                        season grasses.   For "c^te^'of 7^rblue^ass
                        throL?n^lme a     ltS §ermiQation in the fall
                        through the spring.   For elimination of winter
                        overseeded cool  season grasses and conversion to
                        bermudagrass on  golf  greens  and  tees, apply ln
                        spring when the  weather is  favorable for
                        bermudagrass growth.
           Issued:   1-17-84
                                           1-101701-11
                                                                                             76

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                      EPA Index  to  Pesticide  Chemicals

             3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

Site, Dosag£            Tolerance, Use, Limitations
and^Formulation
(IbT.i./A)

  Bermudagrass (continued)

     1.73 oz a.i./5,000   Broadcast  application for control of Kentucky
     3q«ft               bluegrass  and  bentgrass in areas other than golf
     (0.32j£ G)            greens  and tees.  Apply anytime when these grasses
                         are  actively growing.
     1.7 oz a.i.75,000
     sq.f t
     (0,4% G)

     1.62 oz a.i.75,000
     sq.f t
     (0.9% G)

  Douglas-Fir            See  Azalea cluster.

  Douglas-Fir  (nursery
    stock)                See  Azalea cluster.

  Fir                    See  Azalea cluster.

  Fir  (nursery  stock)    See  Azalea cluster.

  Forsythia              See  Azalea cluster.

  Forsythia  (nursery
    stock)                See  Azalea cluster.

  Holly                 See  Azalea cluster.

  Holly (nursery  stock) See  Azalea cluster.

  Juniper                See  Azalea cluster.

   Juniper  (nursery
    stock)"      See Azalea cluster.

   Pine                  See Azalea cluster.

   Pine (nursery stock)  See Azalea cluster.

   Rhododendron          See Azalea cluster.

   Rhododendron (nursery
    _stoc_k)~          "    See Azalea cluster.

   Yew                   See Azalea cluster.

   Yew  (nursery stock)   See Azalea cluster.

 Issued:  1-17-84                1-101701-12                                       77

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                                EPA Index to Pesticide Chemicals

                       3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

           Site,  Dosage             Tolerance, Use, Limitations
           and  Formulation
           (Ib  a.i./A)

           FORESTRY

             Christmas  Tree  Plan-
              tations               See  TERRESTRIAL NON-FOOD  CROP,  Azalea cluster,


           AERIAL AND  TANK MIX APPLICATIONS

001500       Aerial  Application

AAAAAA         —                  Refer  to

                                   TERRESTRIAL  NON-FOOD CROP
                                    (Agricultural Crops)
                                   Bermudagrass (seed crop)
            Issued:  1-17-84                1-101701-13                                       78

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                              EPA Index to Pesticide Chemicals

                     3,5-DICHLORO-N-C1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

        Listing of Registered  Pesticide  Products  by Formulation

.0.0002   50% formulation  intermediate
          3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide  (101701)
            000707-00098

,0.3204   0.32%  granular
          3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide  (101701)
            000538-00084

fl.3304   0.33%  granular
          3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide  (101701)
            000557-01906

10.4004   0.4%  granular
          3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide   (101701)
            000538-00118

i!)J004   0.9%  granular
          3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide  (101701)
             000538-00115

11.0004    1%  granular
           3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide  (101701)
             005481-00170

 J0.0006   50% wettable  powder
           3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide  (101701)
             000707-00159   002169-00248


 59999     State Label Registrations

         AZ Reg. No.
             000707-07623

         CA Reg. No.
             000707-04595   005481-07509

         FL Reg. No.
             002342-06948

         KS Reg. No.
             000707-04594

         NM Reg. No.
             000707-06619

          OR Reg.  No.
              000707-07620

          WA Reg.  No.
              000707-04596
          Issued:  1-17-84                1-101701-14                                         79

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I3001BA
'A001AA
13018AA
Z3011AA
I3011BA
 H002AA
U009AA
 15002AA
 13003AA
 '.300 3BA
                     EPA Index to Pesticide Chemicals

             3 , 5-DICHLORO-N-C 1 , l-DIMETHYL-2-PROPYNYL) BENZAMIDE

                                Appendix B

Listing of Registration Numbers by Site and Formulation

TERRESTRIAL FOOD CROP

  (Agricultural Crops)

  Alfalfa
  (50% WP)
    000707-00159

  Alfalfa (seed crop)
  (50% WP)
    000707-00159

  Apple
  (50% WP)
    000707-00159

  Artichoke. Globe
  (50% WP)
    000707-00159

  Birdsfoot Trefoil
  (50% WP)
    000707-00159

  Birdsfoot Trefoil
    (seed  crop)
  (50% WP)
    000707-00159

  Blackberry
  (50% WP)
    000707-00159

  Blueberry
  (50% WP)
    000707-00159

  Cherry
  (50% WP)
    000707-00159

  Clover
  (50% WP)
    000707-00159

  Clover  (seed  crop)
  (50% WP)
    000707-00159
 Issued:   1-17-84
                                 1-101701-15
                                                                                            80

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                                SPA Index  to Pesticide  Chemicals

                       3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

                                          Appendix B

          Listing of Registration Numbers by Site and Formulation (continued)

 S024AA       Crown Vetch
            (.507. WP)
              000707-OOL59

 )024BA       Crown Vetch (seed
            'crop!
            (50% WP)
              000707-00159

 ]015AA       Endive (Escarole)
            (50% WPl~
              000707-00159

 IU14AA       Grapes
            (50% WP)
              000707-00159

 3020AA       Lettuce
            (50% WP)
              000707-00159

 5003AA       Nectarine
            (50% WP)
              000707-00159

 '500 4AA       Peach
            (50% WP)
              000707-00159

 K003AA       Pear
            (50% WP)
              000707-00159

 '5005AA       Plum
            (50% WP)
              000707-00159

 ]5006AA       Prune
            (50% WP)
              000707-00159

31006AA       Raspberry
            T50% WP)
              000707-00159

23021AA       Sainfoin
            (50% WP)
              000707-00159
          Issued:  1-17-84
                                          1-101701-16
81

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23021BA
                     EPA Index to Pesticide Chemicals

             3 ,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

                                Appendix B

Listing of Registration Numbers by Site and Formulation (continued)

  Sainfoin (seed crop)
  (50% WP)
    000707-00159
J30173A
34022AA
34022DA
33017AA
 35044AA
 :ERRESTRIAL NON-FOOD CROP

  (Agricultural Crops)

  Bermudagrass (seed
   crop)
  (50% WP)
    000707-00159

  (Ornamental Plants and Forest Trees)

  Azalea
  (50% WP)
    000707-00159

  Azalea  (nursery
   stock)"
  (50% WP)
    000707-00159

  Bermudagrass
  (0.32%  G)
    000538-00084

  (0.33%  G)
    000557-01906

  (0.4% G)
    000538-00118

  (0.9% G)
    000538-00115

  (1% G)
    005431-00170
   (50% WP)
     000707-00159

   Douglas-Fir
   (50% WP)
     000707-00159
                              002169-00248
            Issued:   1-17-84
                                            1-101701-17

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15044DA
15051AA
15051DA
J4062AA
 S4062DA
 J4070AA
 34070DA
 35073AA
 35073DA
 35098AA
 35098DA
                      EPA Index  to  Pesticide Chemicals

             3 , 5-DICHLORO-N-C L , l-DIMETHYL-2-PROPYNYL) BENZAMIDE

                                 Appendix B

Listing of Registration  Numbers by Site  and  Formulation  (continued)

              (nursery
   stock)_
  (50% WP)
    000707-00159

  Fir
  (50% UP)
    000707-00159

  Fir  (nursery  stock)
  (50% WP)
    000707-OOL59

  Forsythia
  (50% WP)
    000707-00159

  Forsythia  (nursery
    stock)
  (50% WP)
    000707-00159

  Holly
  (50% WP)
    000707-00159

  Holly  (nursery
    stock)
   (50% WP)
    000707-00159

  Juniper
   (50% WP)
    000707-00159

  Juniper (nursery
    stock)
   (50% WP)
     000707-00159

   Pine
  I5~0% WP)
     000707-00159

   pi.ne  (nursery
    stock)
    (50%  WP)
     000707-00159
  Issued:   1-17-84
                                  1-101701-18
                                                                                               83

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J41 Li3DA
 35130AA
                     EPA Index to Pesticide Chemicals

             3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE

                                Appendix B

Listing of Registration Numbers by Site and Formulation (continued)

  Rhododendron
  (50% WP)
    000707-00159

  Rhododendron
   (nursery sTock.)
  (50% WP)
    000707-00159

  Yew
  (50% WP)
    000707-00159

  Yew  (nursery  stock)
  (.50% WP)
    000707-00159
/30005AA
            FORESTRY
   Christmas  Tree  Plan-
    tations
              (50% WP)
                000707-00159
            Issued:   1-17-84
                                            1-101701-19

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               APPENDIX  n

         LABELING REQUIREMENTS
1.  Submission of Revised Labeling
2.  40 CPR 162.10 Labeling Requirements
3-  Table of Labeling Requirements
4.  Physical/Chemical Hazards Labeling
       Statement
5-  Pesticide Storage Instructions
6.  Container Disposal Instructions
7•  Farmworker Safety Label Requirements
                                                            85

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                           APPENDIX  C-l

                  SUBMISSION  OF  REVISED  LABELING


PIFRA requires each product to be  labeled  with accurate, complete
and sufficient instructions and  precautions,  reflecting the
results of data concerning the product and its ingredients.
Labeling requirements  are  set out  in 40  CFR 162.10 (Appendix
0-2) and are summarized for products containing this active
ingredient in Appendix C-3-  Applications  submitted in response
to this Standard must  Include draft  labeling  for  Agency review.

If revised labeling information  complying  with this Appendix and
the requirements described in Part II of the  Standard, is not
submitted, EPA may issue a notice  of intent to cancel the regis-
tration under FIFRA sec. 6(b)(l).

A.  LABEL CONTENTS.  40 CPR 162.10 requires that  certain specific
    labeling statements appear at  certain  locations on the label.
    This is referred to as format  labeling.  Specific label items
    listed below are keyed to Appendix C-3.

    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.

    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 be located at  the bottom of the
    front  panel or at the  end of the label text.

    Item 3-  NET CONTENTS  - A net  contents statement Is required
    on all  labels  or on the container of the pesticide.  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 expressed in the largest
    suitable  unit, e.g., "1 pound,  10 ounces" rather than  "26
    ounces."   In addition  to English units, net contents may be
     expressed  in metric units.  [40 CFR l62.10(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  similar  to other print on that part of the label
     on  which  it  appears and must  run parallel to  it.  The  regis-
     tration  number and the required  identifying phrase  must not
     appear in  such a manner  as to suggest  or  Imply  recommendation
     or  endorsement of  the  product by the  Agency.   [40 CPR  Ifi2.10(e)]
                                                                  86

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  _   5.   EPP^STABL^SHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final  establishment  at
which the product was produced, and may appear  in any suitable
location on the label or immediate container.   It must also
appear on the wrapper or outside container of  the package if  the
EPA establishment number on the immediate container cannot be
clearly read through such wrapper or container.  [40 CPR l62.10(f)]

Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required on the front panel.  The ingredients  statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel.  It must not be
placed in the body of other text.  [40 CFR l62.10(g)]

Item 6B.  POUNDS PER GALLON STATEMENT - For liquid agricultural
formulations,the pounds per gallon of active ingredient must be
indicated on the label.

Item 7.  FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline.  The table below shows the minimum type
size requirements for various size labels.

    Size of Label        Signal  Word           "Keep Out of Reach
    on Front Panel       Minimum Type Size       of Children"
    in Square  Inches     All Capitals	     Minimum Type Size

    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  -  The statement  "Keep
Out of Reach of  Children"  must  be  located  on the  front panel
above the signal word except where contact  with  children  during
distribution or  use  is  unlikely.   [40  CFR  162.10(h)(1)(ii)]

Item 7B.  SIGNAL WORD -  The signal word (DANGER,  WARNING,  or
CAUTION) is required  on  the front  panel immediately below
the child hazard warning statement.   [40  CFR  162.10 (h)(l)(i)]

Item 7C.  SKULL  & CROSSBONES  AND WORD  "POISON" - For products
assigned a  toxicity  Category  I  on  the  basis of oral,  dermal,
or  inhalation  toxicity,  the word "POISON" shall  appear on the
label  in red on  a background  of distinctly contrasting color and
the  skull and  crossbones shall  appear  in immediate proximity to
the  word  "POISON."   [40  CFR 162.10(h)(1)(i)1
                                                                 87

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Item 7D.   STATEMENT OF PRACTICAL  TREATMENT - A statement of
practical treatment (first  aid  or other)  shall appear on the
label of  pesticide products In  toxiclty Categories I, II,
and III.   [40  CPR l62.10(h)(1)(111)1

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.
[40 CFR I62.10(h)(l)(lil)]

Item 8.  SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary  statements 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.  [40  CPR 162.10 (h)(2)]

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  to be taken to avoid
accident, injury or damage.  [40 CPR 162.10 (h)(2)(i)]

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.  [40 CPR 162.10(h)(2)(ii)]

Item 8C.  PHYSICAL OR CHEMICAL HAZARD -

1.  Plammabllity  statement.  Precautionary statements relating
     to flammability of  a product are required to appear on the
     label  if  it meets the  criteria in Appendix C-4.  The require-
     ment  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." Note that no signal
     word  is used  in  conjunction  with the  flammability statements,

 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.
                                                               88

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    b.   A "non-flammable liquid" is one having a flashpoint
        greater than 350°P (177°C),

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

        i.   The flame extension is zero inches;

        ii.   There is no flashback; and

        ill. The flashpoint of the non-volatile liquid component
             is greater than 350°P (177°C).

3-  Declaration of non-flammability.  Products which meet the
    criteria for non-flammability specified above may bear the
    notation "non-flammable" or "non-flammable (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 physical/chemical hazard statements.  When chemistry
    data demonstrate hazards of a physical or chemical nature
    other than flamrnablllty, 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 9A.  RESTRICTED USE CLASSIFICATION - PIPRA section 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use.  Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be Imposed by regulation).

The Agency has determined that certain formulations of pronamide
are to be restricted.  The Regulatory Position and Rationale
states which products containing this active ingredient are
classified for restricted use.  The draft label(s) for these
products submitted to the Agency as part of the application
must reflect this determination (see below).

If a registrant does not believe that its product should be
classified for restricted use, the registrant must submit any
information and rationale with its application for reregistration.
During the Agency's  review of the  application, the proposed
classification determination will be evaluated in accordance
with the provisions  of 40 CPR I62.11(c).  The  registrant will  be
notified of the Agency's classification decision.
                                                              89

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1.   For products  classified  for  restricted  use,  the following
    label requirements  apply:

    a.   The statement "Restricted  Use  Pesticide" must appear at
        the top of the  front panel of  the  label.  The statement
        must be set in  type  of  the same  minimum  size as required
        for human hazard signal  word.  (40  CPR 162.10(h)(1)(iv))

    b.   Directly below  this  statement  on the front  panel, a
        summary statement of the terms of  restriction must  appear
        (including the  reasons  for restriction if specified in
        the Standard).   If use  is  restricted to  certified appli-
        cators, the following statement  is  required:  "For  retail
        sale to and use only by  Certified  Applicators or  persons
        under their direct supervision and  only  for those uses
        covered by the  Certified Applicator's Certification."

2,  For products with some but  not all uses restricted, if  stated
    in the Regulatory Position  and Rationale section, several
    courses of action are available:

    a.   The product may be labeled for restricted use.  The label
        may include uses that are unrestricted,  but they  may not
        be distinguished on the label  as being unrestricted.

    b.  All restricted uses may be deleted from the label (submit
        draft  labeling bearing only unrestricted uses).

    c.  Two separate products with identical formulations,  one
        bearing only unrestricted uses and the other bearing
         restricted uses, may be registered.  To do so, submit
        two applications for reregistration, each containing all
        forms  and  necessary labels.  Both applications should be
        submitted  simultaneously.  The products will be assigned
         separate  registration numbers.

 Item 9B  -  There  is no Item  9B.

 Item 9C.   MISUSE  STATEMENT  - All products must bear the misuse
 statement,  "It is  a  violation of Federal law to use this product
 in  a manner  inconsistent with its labeling." This statement
 appears  at the beginning of the directions for use, directly
 beneath  the  heading  of  that section.

 Item 10A.   REENTRY STATEMENT -  A  reentry interval has not been
 established  by the Agency for this chemical.

 Item 10B - There  is  no  Item 10B.

 Item 10C-	STORAGE AND  DISPOSAL BLOCK -  All  labels  are  required
 to  bear  storage  and  disposal statements.  These  statements  are
                                                                90

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    developed  for specific  containers,  sizes,  and  chemical
    content.   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.   Part  II
    of the Standard contains the  specific disposal statement
    for pronamide and Appendix 0-6 sets forth the  appropriate
    container  disposal statements.

    Item 10D.   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.  [40 CFR 162,10]

B.  COLLATERAL LABELING.  Bulletins, leaflets, circulars,
    brochures, data  sheets, flyers, or other written or 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 claims 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  Standard and  submitted for review.
                                                                  91

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                                                    Appendix C-2
Chapter 1—Environmental Protection Agency


SL62.10  Labeling requirements.

  (a)  General—(1)   Contents of the label.  Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part.  The contents of  a
Label must show clearly and prominently the following:
  (i)  The name, brand, or trademark under which the product  is
sold as prescribed in paragraph (b) of this section;
  (ii)  The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph  (c) of  this
sect ion;
  (iii)  The net contents as prescribed in paragraph (d) of this
section;
  (iv)  The product registration number as prescribed in paragraph
(e) of this section;
  (v)  The producing establishment number as prescribed in  para-
graph  (f) of this section;
  (vi)  An ingredient statement as prescribed in paragraph  (g)  of
this sect ion;
  (vii)  Warning or precautionary statements as prescribed  in
paragraph  (h) of this section;-
  (viii)   The directions for use as prescribed in paragraph (i)
of this section; and
  (ix)  The use classification(s) as prescribed in paragraph  (j)
of this section.
  (2}  Prominence and legibility.  (i)  All words, statements,
graphic representations, designs or other  information required  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, state-
ments, 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 customary conditions of purchase
and  use.
   (ii)  All  required label text must:
   (A)  Be  set  in 6-point or larger type;
   (3)  Appear on a clear contrasting background; and
   (C)  Not be obscured  or crowded.
   (3)  Language to be used.  All required  label or 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 applied equally to both the English and
other-language  versions of the labeling.
   <4>  Placement of Label—(i)  General.   The label"  shall  appear
on or be  securely attached to  the  immediate container of  the
                                                                   92

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pesticide product.   For purposes of  this  Section,  and the mis-
branding provisions  of the Act,  "securely attached"  shall mean
tnat^a label can  reasonably be expected  to  remain  affixed during
the foreseeable conditions and period of  use.   If  the immediate
container is enclosed within a wrapper or outside  container
through which  the  label cannot be clearly read,  the  label must
also be securely  attached to such outside wrapper  or container,
if it  is a part of the package as customarily  distributed or
sold.
  f^'  Tank cars  and other bulk containers — (A)   Transportation.
While a pesticide  product is in  transit,  the  appropriate
provisions of  49  CFR Parts 170-189,  concerning  the transportation
of hazardous materials, and specifically  those  provisions con-
cerning the labeling, marking and placarding  o£  hazardous materials
and the vehicles  carrying them,  define the  basic  Federal require-
ments.  In addition, when any registered  pesticide product is
transported in a  tank car, tank  truck or  other  mobile or portable
bulk container, a  copy of the accepted label  must  be attached to
the shipping papers, and left with  the consignee  at  the time of
de 1 i ve ry .
  (3)   Storage.   When pesticide  products  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  discharge control
valve .
  (5)   False 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 § 162.15, is  misbranded  if  its labeling is
false or misleading  in any particular including  both pesticidal
and non-pesticida1 claims.  Examples of  statements or representations
in the labeling which constitute misbranding  include:
  (i)   A false or misleading statement concerning  the composition
of the product;
  (11)  A false or misleading statement  concerning the. effectiveness
of the product as  a  pesticide or device;
  (iii)  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
dev ices ;
  (v)   Any statement directly or indirectly implying that the
pesticide  or device  is recommended  or endorsed by any agency of
the Federal  Government;
  (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 stated elsewhere in  the  labeling;
  (vii)  A true statement used in such a way as to give  a false
or misleading  impression to the  purchaser;
  (viii)  Label disclaimers which negate or detract  from  labeling
statements required  under the Act and  these regulations;
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  (ix)   Claims as to the safety of the pesticide  or its ingredients,
including statements such as. "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with  or without such
a crualifving phrase as "when used as directed";  and
  (x)   Non-numerical and/or comparative statements  on the safety
of the  product, including but not limited to:
  (A)   "Contains all natural ingredients";
  (B)   "Among the least toxic chemicals1 known"
  (C)   "Pollution approved"
  (6)   Final printed labeling.  (i)  Except as provided in
paragraph (a ) (6 ) (ii ) of this section, final printed labeling must
be submitted and accepted prior to registration.   However, final
printed labeling need not be submitted until draft  label texts
have been provisionally accepted by the Agency.
  (ii)   Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels.  Such
reproductions must be of microfilm reproduction  quality.
  (b)   Name, brand, or 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  additional name
pursuant -to § 162.6(b)(4).
  (c)   Name and address of producer, registrant,  or person for
whom produced.  An unoualified n 5~'.e and =.o^re^o  giv-en on the
laoei  snail oe considered as the name and address  of the producer.
If the  registrant's name appears on the label  and  the registrant
is not  the producer, or if the name of the person  for whom the
pesticide was produced appears on the label,  it  must be qualified
by appropriate wording such as "Packed for ***,"  "Distributed by
***,"   or "Sold by  ***** to show that  the name  is not that of the
oroduce r .
  (d)   Net weight or measure of contents.  ( 1)   The net weight or
measure of content  shall be exclusive of wrappers 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 semisolid,  viscous or
pressurized,  or  is  a  mixture of liquid and solid, the net content
statement shall  be  in  terms of weight expressed  as avoirdupois
pounds  and  ounces.
  (4)    In all cases,  net content shall be stated in terms oE the
 largest  suitable  units,  i.e.,  "1  pound  10 ounces" rather  than
 11 26 ounces . "
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  (5)  In addition  to  the  required  units  specified,  net content
may be expressed  in me trie•units.
  (6)  Variation  above  minimum  content  or around  an  average is
permissible only  to the extent  that it  represents deviation
unavoidable in good manufacturing  practice.   Variation below a
stated minimum  is not  permitted.   In no case  shall the average
content 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 Registration
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 on which it  appears and shall run  parallel 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 registration  number.  The producing
establishment registration number  preceded by the phrase "EPA
Est. ", of 'the final establishment  at which the product was produced
may appear in any suitable location on  the label  or  immediate
container.  It must appear on  the  wrapper or  outside container of
the package if  the  EPA establishment registration number on the
immediate container cannot be  clearly read through such wrapper
or conta iner.
  (g)  Ingredient statement—(1)   General.  The label of each
pesticide product must bear a  statement which contains the name
and percentage by weight of each  active ingredient,  the total
percentage by weight of all inert  ingredients; and if the pesticide
contains arsenic  in any form,  a statement of  the  percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be  designated by  the  term "active
ingredients" and  the inert ingredients  by the term "inert
ingredients," or  the singular  forms of  these  terms when appropriate.
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 contain  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.  (i)  The  ingredient
statement is normally  required on the front panel of  the label.
If there is an  outside container 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.
   (ii)  The  text  of the ingredient statement 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.
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  (3)   Names to be  used  in ingredient statement.  The  name  used
for each ingredient shall be the accepted common  name,  if  there
is one, followed by the  chemical name.  the common  name  may be
used alone only if  it is well known.  If no common  name  has been
established, the chemical name alone shall be used.   In  no  case
will the use of a trademark or proprietary 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  o£  ingredients
shall be saated in  terms of weight-to-weight.  The  sum  of  per-
centages 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 ingredient 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 precise as possible reflecting good manufacturing
practice.  If there may  be unavoidable variation  between manu-
facturing batches,  the value stated for each active  ingredient
shall be the lowest percentage which may be present.
  (6)   Deteriorat ion.  Pesticides which change in chemical
composition significantly must meet the following labeling  re-
qu i remen ts:
  (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]."
  (LI)  The product must meet all label claims ap to the expiration
time indicated on the label.
  (7)   Inert ingredients.  The Administrator may  require the name
of any inert ingredient(s) to be listed in the ingredient  statement
if he determines that such ingred ient ( s) may pose a  hazard  to man
or the environment.
  (h)  Warnings and precautionary statements.  Required  warnings
and precautionary statements concerning the general  areas  of
toxicological hazard including hazard to children,  environmental
hazard, and physical or chemical hazard fall into two  groups; those
required on the front panel of the labeling and those  which may
appear elsewhere.  Specific requirements concerning  content,
placement, type size, and prominence are given below.
  (1)  Required front panel statements.  With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity  Category  of the
pesticide.  The category is assigned on the basis of the highest
hazard shown by any of the  indicators in  the table  below:
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Hazard Indicators

Oral ID
50
1 nhal at Ion LC
50
Dermal LD
50
Eye effects
Skin affects

1
1
»
Up to and
I Includ Ing
50 mg/kg
Up to and
Includ Ing
.2 mg/l Itar
Up to and
Includ Ing
200 mgAg
Corros Ive;
cornea 1- opac 1 1>
not ravers Ib I a
«*! thin 7 days
Corrosive

Toxicity (
II
From 50 thru'
500 mg/Xg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Cornea 1 opacity
ravers Ible
within 7 days;
Irritation
pars 1 st Ing for
7 days
Severs Irritation
at 72 hours

rateqorles
1 1 1
From 500 thru
5000 mg/kg
From 2 thru
20 ing/ 1 1 tar
From 2,000 thru
20.000
No corneal opacity;
Irritation
revers Ible
within 7 days
Moderate Irritation
at 72 nours


IV
Greatar than
5000 mg/kg
Greater than
20 mg/t Iter
Greater than
20,000
Mo 1 rr 1 tat Ion
Mild or si Ight
Irritation at
72 nours
  (i)   Human hazard signal word.--(A}  Toxicity Category  I.  All
pesticide products meeting the  criteria of Toxicity Category I
shall bear on  the  front panel  the signal word  "Danger."   In
                                      to Toxicity  Category  I on
                                      dermal  toxicity  (as  distinct
                                      word  "Poison" shall  appear
addition if the product was assigned
the basis of  its oral,  inhalation  or
from skin and eye local effects) the
in red on a background  of distinctly
skull and crossbones shall appear  in
word "poison. "
  (B)  Toxicity Category II.
                                      contrasting  color  and  the
                                      immediate  proximity  to  the
criteria of Toxicity Category
the signal word  "Warning."
  (C)   Toxicity Category  III.
criteria of Toxicity Category
the signal word  "Caution."
  (D)   Toxicity Category  IV.
criteria of Toxicity Category
the signal word  "Caution."
All pesticide
II shall bear
products meeting the
on the front panel
                               All  pesticide  products meeting  the
                               III shall  bear  on  the  front  panel

                               All pesticide products meeting  the
                               IV shall  bear on the  front  panel
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  (E)   Use of signal words.  Use of any signal  word(s)  associated
with a higher Toxicity Category is not permitted  except when the
Agency determines that such labeling is neces'sary to prevent
unreasonable adverse effects on man or the environment.   In no
case shall more than one human hazard signal word appear on the
front panel of -a label.
  (ii)  Child hazard warning.  Every pesticide  product  label shall
bear on theEfont panelthe"statement "keep out of reach of
children."  Only in cases where the likelihood  of contact with
children during distribution, marketing, storage  or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator  waive  this
requ i rement.
  (iii)  Statement of
Ca teaorv
             practical  treatment—(A)  Toxicitv
I
o r
             A statement of practical treatment  (first  aid
oche r)  shal1 appear on the front panel of the label of  all
pesticides falling into Toxicity Category I on  the  basis  of  oral,
inhalation or dermal toxicity.   The Agency may,  however,  permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See  statement of
practical treatment on back panel" appears on the  front panel
near the word "Poison" and the  skull and crossbones.
  (3)  Other toxicity categories.  The statement of practical
treatment is not required on the front panel except as  described
in paragraph (h)(1)(iii)(A) of  this section.  The  applicant  may,
however, include such a front panel statement at his  option.
Statements of practical treatment are, however,  recuired  elsewhere
on the  label in accord with paragraph (h)(2) of  this  section if
t:iey do not appear on the front panel.
  (iv)   Placement and prominence.  All the required front panel
warning statements shall be grouped together on  the Label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to  be  over-
looked  under customary conditions of purchase and  use.  The
collowing table shows the minimum type size requirements  for the
front panel warning statements  on various sizes  of  labels:

Size of label front panel
in square inches
5 and under 	
Above 5 to 10 	
Above 10 to 15 	
Above 15 to 30 	
Over 30 	
Poir
Required
signal word,
all capitals

i n


18
its
"Keep out
of reach of
Children"



i n
I U
12
                                                                       98

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   (2)   Other  required warnings  and  precautionary statements.   The
 warnings  and  precautionary statements as  required  below  shall  appear
 together  on the label under the general  heading "Precautionary
 Statements" and under appropriate subheadings  of "Hazard  to Humans
 and  Domestic  Animals,"  "Environmental Hazard"  and  "Physical or
 Chemical  Hazard."
   (  *•)   Hazard  t?o humans  and domestic animals.   (A)   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  to be  taken  to avoid  accident, injury
 or damage.   The precautionary paragraph  shall  be immediately
 preceded  by the appropriate harard  signal  word.
   (B)   The  following table depicts  typical precautionary  statements.
 These  statements must be  modified or expanded  to reflect  specific
 ha za rds .
                          Precautionary  statements by toxlc'ty category
Tox I c I rr |__	
category	Oral,  Inhalat'on, or dermal toxlclty
                                           Skin and
                                                      local effects
 IV
Fatal (poisonous) If swallowed [Inhaled or
 absorbed through sklnl.  Do not  breathe
 vapor Idust!  or spray  ulstl.  Do not get
 In eyes, on skin, or on clothing {Front
 panel statement of- practical treatment
 requ I red . 1 .

May be fatal If shallowed [Inhaled or
 absorbed through the skin!.  Co  not breathe
 vapors [dust or spray  mlstl.  Do not gat In
 eyes, on skin, or on clothing. [Appropriate
 first aid statements required.1.

Harmful If swallowed (Inhaled or  absorbed
 through the skint.  Avoid breathing vapors
 (dust or spray mlstl.   Avoid contact *Ith
 skin [eyes or clothing!.  [Appropriate
 first aid statement required.I.

[Ho precautionary statements required.].
                                            I
Corrosive, causes eye and skin damage (or
 3k'n 'i—Itatlonl.  Do not gar In eyes,  on
 skin, or on cloth'ng. Wear goggles or face
 sfifefd and rubber gloves when handling.
 Harmful or fatal  If swallowed.
[Aoproor'ate '•'-st aid sTat-^nent requ'-ed.l

Causes eye (and skin] Irrltat'on.  Do not
 get  In eyes, on skin, or on clothing.
 Harmful  If swallowed.   [Appropriate first
 aid  statement required.!.
                                              Avoid contact with skin,  eyes or clothing.
                                               In case of contact Immed I 3taly flush
                                               eyes or skin with plenty of water.  Get
                                               medical attention If Irritation persists.
                                              I No precautionary statements required.!
   (ii)    Environmental hazards.   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
                                                                                  99

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    damage.   Examples  of the  hazard  statements and  the circumstances
    under which they are required follow:
       (A)   If a pesticide intended  for outdoor use  contains an  active
     ingredient with a  mammalian acute  oral  L&$Q of  100 or  less,  the
    statement "This Pesticide  is Toxic to Wildlife"  is required.
       (B)   ff a pesticide intended  for outdoor use  contains an  active
     ingredient with a;fish acute LC50  of  1  ppm or  less,  the statement
     "This Pesticide is Toxic  to Fish"  is  required.
       (C)   If a pesticide intended  for outdoor use  contains an  active
     ingredient with an avian  acute oral LD$Q of 100  mg/kg  or less,  or
    a  subacute dietary LC5Q of  500 ppm or less/ the  statement "This
     Pesticide is Toxic to Wildlife"  is required.
       (D)   If either  accident  history  or  field studies demonstrate
     that use  of the pesticide  may result  in  fatality to  birds,  fish
    or mammals, the statement  "This  pesticide is extremely toxic  to
    wildlife  (fish)"  is required.
       (E)   For uses  involving  foliar  application to  agricultural
    crops,  forests, or shade  trees,  or for  mosquito  abatement
     treatments, pesticides  toxic to  pollinating insects  must bear
    appropriate label  cautions.
       (F)   For all outdoor  uses other  than  aquatic  applications  the
     label must bear the caution "Keep  out of lakes,  ponds  or streams.
     Do not  contaminate water  by cleaning  of  equipment or disposal of
    wastes, "
       (iii)   Physical  or chemical hazards.   Warning  statenents  or the
     f laminab i 1 i ty or explosive  cnaracteristics of the pesticide  are
     required  as follows:
              Flash point               |	Required text	


	(A)  PRESSURIZED CONTAINERS	
                                     .         ,                  _

 -Ijsn point at or Oelo* 20*F; If tnere is a    |  Extremely flammable.  Contents under
   •ijsnbacK at jny valve ooening.            |   Keep a«ay  from fire, sparks, and
                                     |   surfaces.  Oo not puncture or Incinerate     !
                                     I   container.  Exposure to temperatures 3b3ve   '
                                     |   I30"F may  causa bursting.                 j
 Flasn 3oint above 20*F and not over 3Q'f or i t  \  Flammable.  Contents  under pressure. Keep away |
   the flame extension is more than 18 in. long  |   from heat, sparKs,  and open flame. Oo not   |
   at a distance of 6 In. from the  flame.      |   puncture or Incinerate container.  Exposure to|
                                     |   temperatures above  130*F may cause bursting.  |
 All otner pressurized containers	|  Contents under pressure. Oo not use or store  |

                                     |   near heat  or open flame.  Oo not puncture or  ]
                                     |   Incinerate container.  Exposure to tempera-  j
                                        tures above 130*F may cause bursting.       I
                         (BlNONPRESSURIZED CONTAINERS
| At or below 20'F	»	j  Extremely flammable.  Keep away from fire.
I                                     (   sparks, and heated surfaces.
| Above 20'F and not over 80'F	|  Hammable.  Keep away from heat and open flame.
| Above 30-F and not over 150'F	|  Oo not use or store near heat or open f|am*.
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  ( x }   Directions  for  Use— ( 1)   General requirements— ( i )   Adequacy
and clarity of  directions.   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.
•vnen collowed,  directions  must  be  adequate to protect the  public
from fraud ar^d  from personal  injury and to prevent unreasonable
adverse effects  on  the environment.
  (ii)   Placement  of directions for use-  Directions may appear
on any portion  of  the  label  provided  that they are conspicuous
enough to be easily read by  the user  of the pesticide product.
Directions for  use  may appear on printed or graphic matter which
accompanies the  pesticide  provided  that:
  (A)   If required  by  the  Agency,  such printed or graphic  matter
is securely attached to  each  package  of the pesticide, or  placed
within the outside  wrapper  or bag;
  (B)   The label bears a reference  to the directions for use  in
.accompanying leaflets  or circulars, such as "See directions in
the enclosed circular."  and
  (C)   The Administrator determines that it is not necessary  for
such directions  to  appear  on  the label.
  ( i- i i )   Exceptions to requirement  for direction for use— ( A )
Detailed directions for  use  may be  omitted from labeling-of
pesticides which are intended  for use onlv by manufacturers of
products other  than pesticide products in their regular manu-
facturing processes, provided  that:
  (_!_)   The label clearly shows  that the product is intended for
use  only in manufacturing  processes and specifies the type(s )   of
products involved.
  (2)   Adequate  information  sucn as technical data sheets  or
bulletins, is available  to the  trade  specifying the type of
product involved and its proper use in manufacturing processes;
  (_3)   The product  will  not come into the hands of the general
public except after incorporation  into finished products;  and
  (4_)   The Administrator determines that such directions are  not
necessary to prevent unreasonable adverse effects on man or the
env i ronment.
  (3)   Detailed  directions  for  use  may be omitted from  the  labeling
of pesticide products  for  which sale  is limited to physicians,
veterinarians,  or  druggists,  provided that:
  (_!)   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 effects 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 pesticide products  which are intended  for  use  only by  formulators
in preparing pesticides  for sale to the public, provided  that:
  (_U   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;


                                                                   101

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  (2)   The label clearly states 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  products
involved;
  (3)   The product as finally manufactured, formulated,  mixed,  or
repackaged'1^ registered; and
  (4_)   The Administrator determines that such directions are  not
necessary to prevent unreasonable adverse effects on man or  the
env ironment.
  (2)   Contents of Directions for Use-  The directions  for use
shall  include the following,  under the headings "Directions  for
Use" :
  (i)   The statement of use classification as prescribed in
I62.10(j) immediately under the heading "Directions  for  Use."
  (ii)  Immediately below the statement of use classification,
the statement "It is a violation of Federal law to  use  this
product in a manner inconsistent with its labeling."
  ( i. L i )   The s i te ( s )  of application, as for example  the  crops,
animals, areas, or objects to be treated.
  (Lv)  The target pest(s) associated with each site.
  (v)   The dosage rate associated with each site and pest.
  (vi)  The method of application, including instructions  for
dilution, if required, and type(s^ of application, apparatus or
equipment requried.
  (vii)   The frequency and timing of applications necessary  to
obtain effective results without causing unreasonable adverse
effects on the environment.
  (viiLl  Spec"! fie 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 pesticide and its container, meeting the requirements  of
40 CFR Part 165.  These instructions shall be grouped and  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 warning (See Table in  § 162. 10(h)( 1)( iv) .)
  (x)   Any limitations or restrictions on use required  to  prevent
unreasonable adverse effects, such as:
  (A)   Required  intervals between application 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]
  (E)   For restricted use pesticides, a statement that  the
pesticide may be applied  under  the direct supervision of a
certified applicator who  is not physically present  at the  site  of
application but  nonetheless available to the person-applying  the
pesticide, unless the Agency has determined that  the pesticide
may only be applied under  the direct supervision  of a certified
applicator who  is physically present.
                                                                      102

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  (F)  Other pertinent  information  which  the  Administrator
determines  to  be  necessary  for  the  protection of  man and the
env ironment.
  (^  Statement  of  Use  Classification.   By October 22,  1976,  all
pesticide products must  bear  on  their  labels  a statement of  use
classification as described  in  paragraphs  (j)(l)  and (2)  of  this
section.  Any  pesticide  product  for which  some uses are  classified
for general use and  others  for  restricted  use shall be  separately
labeled according to the labeling  standards set forth in this
subsection, and shall be marketed  as separate products  with
different registration  numbers,  one bearing directions  only  for
general use(s) and the  other  bearing directions for restricted
use(s) except  that,  if  a product has both  restricted use(s)  and
general use(s), both of  these uses  may  appear on  a  procuct labeled
for restricted use.  Such products  shall  be subject to  the
provisions  of  § 162 . 10( j)( 2).
  (i)  General Use Classification.   Pesticide products  bearing
directionsfor use(s)classified general  shall be labeled  with
the exact words "General  Classification"  immediately below the
heading "Directions  for  Use."   And  reference  to the general
classification that  suggests  or  implies  that  the  general  utility
of the pesticide  extends beyond  those  purposes and  uses  contained
in the Directions for Use will  be  considered  a false or  misleading
statement under che  statutory definitions  of  misbranding.
  (2)  Restricted Use Classification.   Pesticide.products  bearing
direction for  use(s) classified  restricted shall  bear statements
of restricted  use classification on the  front panel as  described
be low:
  (i)  Front panel statement  of  restricted use classification.
(A)  At the top of the  front  panel  of  the  label,  set in type of
the same minimum  sizes  as required  for  human  hazard signal words
(see  table  in  § 162. 10{h)(1)( iv) ) ,  and  appearing  with sufficient
prominence  relative  to  other  text  and  graphic material  on  the
front panel to make  it  unlikely  to be  overlooked  under  customary
conditions  of  purchase  and  use,  the statement "Restricted  Use
Pesticide"  shall  appear.
  (3)  Directly below this  statement on the  front panel, a summary
statement of  the  terms  of restriction  imposed as  a  precondition
to registration shall appear.   If use  is restricted to  certified
applicators,  the  following  statement is required:  "For retail
sale to and use only by  Certified  Applicators or  persons under
their direct supervision and  only for  those  uses  covered by the
Certified Applicator's  certification."   If,  however, other
regulatory  restrictions  are  imposed, the Administrator will define
the appropriate wording  for  the  terms  of restriction by regulation
  (k)  Advertising.   [Reserved]


(40 FR 28268,  July 3, 1975;  40  FR 32329, Aug.  1, 1975;  40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786,  Feb. 9, 19781
                                                                      103

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                                         APPENDIX C-3 - TABLE OF LABELING REQUIREMENTS
ITEM
1
2
3
H
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est, 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.
O

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ITEM
7C
7D
7E
^B
~8A
~8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, 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.
CD
en

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ITEM
8C
9A
9C
10A
IOC
10D
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading 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 other directions for
use.
May be in metric as well as U.S. units
o

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                           APPENDIX
Criteria
            PJJISICAL-CHEMICAL HAZARDS

                              Required Label  Statement
I.  Pressurized Containers

    A.  Flashpoint at or below
        20°P; or if there is a
        flashback at any valve
        opening.
    B.
    C.
Flashpoint above 20°F
and not over 30°F; or
if the flame extension
is more than 18 inches
long at a distance of
fi inches from the
valve opening.

All other pressurized
containers
II.  Non-Pressurized  Containers

    A.  Flashpoint  at or  below
        20°F.
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.
    B.
    C.
    D.
Flashpoint above 20°F
and not over 80°F.

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

Flashpoint above
150°F.
 Flammable.  Keep away  from
 heat  and open  flame.

 Do  not  use  or  store near
 heat  and open  flame.

 None  required.
                                                                   107

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                         APPENDIX  C-5

             STORAGE  INSTRUCTIONS  FOR  PESTICIDES


Heading:   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."

Storage Instructions:   All  product labels are required to have
appropriate storage instructions.  Specific  storage instructions
are not prescribed.  Each registrant must develop  its 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, Includ-
    ing 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.

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.  General storage instructions
    for household products should emphasize storage in original
    container and placement in locked storage areas.
                                                                  108

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                         APPEMDIX  C-6

               gQNTAINER_DIS_p_QSAL  INSTRUCTIONS

  e label of each product must  bear  container disposal Instructions
appropriate to the  type  of  container.

l'  °°S|sti^_j.is^_p_roducts_ must  bear  one  of  the  following
    container rHsnnsai  04--,-4-,-,„,„„..-,>.
^~S±ii^ — i^pe 	 Statement
Non-aerosol products
(bottles, cans, 1ars)
Non-aerosol products
(bags)
Aerosol products
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.
    All other  products  must  bear container disposal instructions
    based  on container  type,  listed below:
 Container Type
Statement
Metal
containers
(non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of In a sanitary landfill, or by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of In a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse Cor equivalent! . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
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.
                                                                      109

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                                                        APPENDIX C-7
  A
            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
     V                WASHINGTON, D.C. 20460
                                                          OFFICE OF
                                                  PESTICIDES AND TOXIC SUBSTANCES

                                                       MAR 2 9
                       PR NOTICE 83-2

             NOTICE TO MANUFACTURERS, FORMULATORS
              AND REGISTRANTS OF PESTICIDES

Attention:  Persons Responsible for Federal  Registrations  of
           Pesticides

This notice is to inform you that the labels  of  all  outdoor
agricultural use products which are applied  to crops whose
culture requires hand labor are required to  bear the following
information under the Farmworker Safety Label Improvement Program.
No application for amended registration is  required, provided
you use the exact wording contained in this  Notice.  All affected
products released for shipment after December 31, 1984 must be
relabeled accordingly.

For the purposes of this Label Improvement  Program,  the terms
"reentry intervals", "farmworkers", and "protective  clothing"
used in this notice are as defined in 40 CFR 170.2.   Reentry
interval means the period of time immediately following the
application of a pesticide to a field when  unprotected workers
should not  enter. Farmworker refers to any  person or persons
engaged in  agricultural hand labor in the field. Protective
clothing means, at least, a hat or other suitable head covering,
a long sleeved shirt and long legged trousers or a coverall type
garment (all of closely woven fabric covering the body, including
the arms and legs), shoes and socks.

The term hand labor tasks, as used in this  Notice, is defined as
commonly recognized crop production activities such as harvesting,
detasselling, thinning, weeding, topping, planting,  sucker removal
summer pruning, moving irrigation equipment and other hand labor
tasks performed in the field by farmworkers who will come
in substantial contact with pesticide treated surfaces, such  as
plants or plant parts. For the purposes of  this notice, mixing,
loading, flagging, and equipment operation  are considered  to  be
part of the application of the pesticide and are not normally
considered  to be hand crop production tasks, and therefore, are
                                                                   110

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                          Page 2
      ,      to these provisions.  At a minimum,  the  following
crops nave been determined to employ hand labor  tasks:

Citrus Fruit
Cucurbits
Fruiting Vegetables
Leafy Vegetables
Root Crop Vegetables
                               Onions
                               Pome Fruits
                               Stone Fruits
                               Tobacco
                               Small Fruits
                               Corn (hybrid
                     Figs
                     Mango
                     Olives
                     Pineapples
                  (berries, grapes,  nuts
                  seed, sweet and pop)
 Registrants are responsible for determining  whether  use of  their
 products would involve any other crop activities  that meet  the
 definition for hand labor tasks normally  performed by farmworkers
 and are, thus, subject to this Notice.

 While  "scouting"  for determining efficacy may  result in potential
 exposure,  it is not considered to be  a  commonly recognized  hand
 labor  crop production task customarily  performed  by  farmworkers
 and therefore would normally be excluded  from  the hand labor
 criteria of this  Notice.   However,  if the definition of hand
 labor  would cover scouting for a particular  use,  then these
 provisions would  apply.

 I.  PRODUCTS AFFECTED:
All products  with Outdoor agricultural  uses which are applied  to
crops utilizing  hand  labor tasks  will be  required to bear general
precautionary label  language  about  farmworker  safety (see Section
II.A.)  In  addition,  the  labels  of the following pesticides,
either  as  sole active ingredients or  in combination with other
pesticides, must bear specific  precautionary label language
about reentry and farmworker  safety (see  Section II. A. and B.).
Ethyl Parathion
Methyl Parathion
Azinphos Methyl
Demeton
Monocrotophos
Phosalone
Carbophenothion
Endrin
                                              Matasystox-R
                                              Bidrin
                                              Ethion
The requirements  set  forth  in  this Notice  do  not  apply  to:  (1)
Mosquito abatement  treatments  and related  public  pest control
programs; (2) Greenhouse  treatments;  (3)  Livestock  and  other
animal treatments;  (4)  Treatment of golf  courses,  forest  uses
and similar nonagricultural areas; (5)  Any uses,  except pesticides
with systemic modes of  action,  for which  soil incorporation
required.
                                   is
                                                               1 1 1

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                              Page 3


The reentry intervals for the eleven pesticides listed above and EPN
were established through regulation at 40 CFR 170.  EPN was, excluded
from this label improvement action because an RPAR is currently
under negotiation. Registrants will be notified separately of
requirements resulting from the RPAR action.

EPA, as part of the reregistration process, is evaluating the
reentry intervals and protective clothing requirements for all
pesticides including the ones addressed in this label improvement
program. Registrants will be advised through  the Registration
Standards Program if future label changes are necessary.

II. REQUIRED LABEL CHANGES:

The following statements contain either the exact wording -that
must appear on the affected product labels, or are explicit in
Indicating the type of information that must  be conveyed  in
specific portions of the label text. See attached sample  product
label for proper placement of each statement  listed in this
Section (A and B) .

A. General Worker Protection Statements;

The labels of all products covered by this notice must bear the
following general precautionary statements about farmworker
safety- See the sample label provided in attachment B for .the
proper location for these statements.

   1. "Do not apply this product in such a manner as to directly or
      through drift expose workers or other persons. The  area being
      treated must be vacated by unprotected  persons."

   2. "It is a violation of Federal Law to use this product in a
      manner inconsistent with its labeling."

   3. The labels of all products in Toxicity  Category I aod II,
      in addition to the English signal word,, must include the
      Spanish language equivalent on the front panel.  The
      appropriate Spanish signal word, "PELIGRO" (for DANGER) or
      "AVISO" (for WARNING) must appear in capital letters of the
      same type size as the equivalent English signal word.
                                                                     112

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                           Page 4
4. Agricultural products in Toxicity Category  I  and  II  must
   Dear minimum Spanish language precautionary statements.
   ine following precautionary statement must  be placed on
   the label in proximity to the Spanish signal  word:

   "PRECAUTION AL USUARIO: Si usted no lee  Lngles, no  use
   este producto hasta que le etigueta haya sido explicado
   ampliamente" .

   (TRANSLATION:  TO THE USER: If you cannot read English, do
   not use this product until the label has been fully  explained
   to you. The English translation of the Spanish precautionary
   statement is not reguired to appear on ynur product  label.)

5. All agricultural use products applied to crops utilizing
   hand labor tasks, except as specified in Section  B  (1) of
   this Notice, must bear the following label  statement:

   "Do not enter treated areas without protective clothing
   until sprays have dried (or, if appropriate,  dusts  have
   settled) . "

6. "Because certain states may require more restrictive
   reentry intervals for various crops treated with  this
   product, consult your State Department of Agriculture for
   further information."

7. "Written or oral warnings must  be given to workers  who are
   expected to be  in a  treated area or  in an area about to  be
   treated with this product.  (Indicate  specific oral  warnings
   which inform workers of areas or  fields that may  not be
   entered without  specific  protective  clothing, period of
   time field must  be vacated  and  appropriate actions  to take
   in case of accidental exposure.)  When oral warnings are
   given,  warnings  shall be  given  in  a  language  customarily
   understood by workers. Oral warnings  must  be  given  if
   there is reason  to believe  that written warnings cannot be
   understood by workers. Written  warnings must  include the
   following information:  '(Appropriate  signal  word DANGER or
   WARNING).  Area  treated with  (name  of pesticide) on  (date
   of application). Do  not enter without appropriate protective
   clothing for "( insert here  reentry interval  for your_prod_uc_t_)_.
   (insert here actions to take  in case of  accidental
   exposure.)1" This statement may either  appear on the  label
   (see Attachment  B for specific  location) or  on the  labeling
   accompanying the product.
                                                                 113

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                                Page  5
  B.  Specific Reentry and  Farmworker Safety Statements;

     Because of their inherent  human toxicity and to reduce risks for
     crop use patterns utilizing  hand labor,  the Agency  has determined
     that all products with reentry intervals established through
     40 CFR 170 must bear  the  following  label statement:
                     treated  areas  for  (insert here appropriate
                                   /-« H ^ »- 4-  V*»^1 /~*t»r ^  VI/-MIV-C; 11 n 1 d o c?
'Do  not enter                   	
 reentry  time  interval from chart below
 appropriate protective clothing is
                                               )_ hours
                                           worn."
  unless
Ethyl Parathion...48 hrs.
Metasystox-R	48 hrs.
Methyl Parathion..48 hrs.
Azinphos Methyl...24 hrs.
                    Reentry  Intervals

                    Monocrotophos....48  hrs,
                    Phosalone	24  hrs,
                    Carbophenothion..48  hrs,
                    Endrin	48  hrs
Demeton,
Bidrin.,
Ethion.,
.48 hrs,
.48 hrs,
.24 hrs,
  III. Compliance:

  It is the responsibility of the registrants to ensure that the
  labels of their products, including distributor products, contain
  specific instructions pertaining to farmworker safety. Existing
  stocks of products in channels of trade (that is, out of the
  registrant's physical possession) prior to December 31, 1984.
  need not be relabeled. All products released for shipment after
  December 31, 1984, must meet the requirements of this Notice, or
  they will be deemed misbranded under Section 2(q)(l)(G). Failure
  to revise product labeling in accordance with this Notice may
  also result in the initiation of cancellation proceedings.

  If you wish to make changes not specified in this Notice, or to
  modify any of the required statements, you must submit an
  application for amended registration to the address listed below:
          (Product Manager for your product listed in Attachment
           Registration Division (TS-767-C)
           U.S. Environmental Protection Agency
                                                          A)
                                                                      114

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                              Page 6
IV. Further  Information:
Questions on  this  Notice may be directed  to  the appropriate  Product
Manager or Richard King, Policy &  Liaison Staff,  Registration
Division, at  (703)  557-0592.
                        / ~ -- "- I "'  '   '   v_-   -
                       Douglas  p. Campt,  Director
                       Registration  Division  (TS-767-C)
Attachments
  A. Product  Manager Assignments  (Attachment A not included)
  B. Sample Product Label
                                                                         115

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             ATTACHMENT B - Sample Label
 Label
 Statements
'choice  of
one  location
PRECAUTIONARY STATEMENTS

  HAZARDS TO HUMANS

  (4 DOMESTIC ANIMALS)

     DANGER
                 STORAGE AND
                   DISPOSAL
                STORAGE      -   •
                DISPOSAL
              CROP —-
                                              RESTRICTED USE

                                                  PESTICIDE
                                           For retail sale to anj use only by Certified
                                           Applicators or persons under their direct
                                           supervision and only for Uose us^\, covered by
                                           the Certified Applicator's certi f ic.ition.
                                              PRODUCT
                                                   NAME
                                           ACTIVE INGREDIENT

                                           INERT INGREDIENTS
                                           TOTAL
                                           THIS PRODUCT CONTAINS  IBS OF   PER
                                          KEEP OUT OF REACHJ^CHILDREN
                                             DANGiBFT—POISON
                              STATEMENT OF PRACTICAL TREATMENT
                       IF SWALLOWED;
                       IF INHALED	
                       IF ON SKIN =^=^
                       IF IN EYES	
                                       SLE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
                                       MFG BY-	  • "•
                                       TOWN. STATE :—   :
                                       ESTABLISHMENT NO —
                                       LPA REGISTRATION NO
                                                 NET CONTENTS:
                                                                                      A(3)
                                                                                   Equivalent
                                                                                   Spanish
                                                                                   Signal
                                                                                   Word
                                                                                      A( 4 )
                                                                                   Spanish
                                                                                   St a tement
                                                                                   Reqarding
                                                                                   Inability  t
                                                                                   \ead  Englis

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           APPENDIX  D
PIPRA §3(c)(2)(B)  Summary Sheet
       (EPA Form 8580-1)
                                                     1  17

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                                                                                    OMB Approval No. 2OOOO468 .
                  FIFHA SECTION 3
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               APPENDIX E
 Certification of Attempt to Enter Into
an Agreement with Other Registrants for
          Development of Data
           (EPA Form 8580-6)

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                                                                              OMB Approval No. 20OOO468 .
(To qualify, certify ALL four tttmsl
                                         CERTIFICATION OF ATTEMPT TO ENTER
                                    INTO AN AGREEMENT WITH OTHER REGISTRANTS
                                               FOR DEVELOPMENT OF DATA
 1. I am duly authorized to represent the following firm(s) who are subject to the require-
   ments of a Notice under FIFRA Section 3(c)(2)(B) contained  in a Guidance Document
   to submit data concerning the active ingredient:
                                                                                     GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
                                     NAME OF FIRM
                                                                                              EPA COMPANY NUMBER
 (This firm or group of firms is referred to below as "my firm".)
 2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
   into an agreement with one or  more other registrants to develop jointly, or to share in the cost of developing, the following required
   items or data:
    My firm has offered in writing to enter into such an agreement. Copies of thp offers are attached. That offer was irrevocable and included an offer to be
    bound bv 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 made
    to the following firm(s) on the following dzte(s):
                                     NAME OF FIRM
                                                                                                 DATE OF OFFFR
 However, none of those firm(s| accepted my offer.
 4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
   have agreed to submit the data listed in paragraph  (2) above in accordance with the Notice. I  understand EPA will promptly inform
   me whether my firm  must submit data to  avoid suspension of its registration(s) under FIFRA Section 3(c|(2)(B). (This statement
   does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
 TYPED NAME
                                                     SIGNATURE
                                                                                                        DATE
EPA Form 8S8O-6 (10-82)
                                                                                                                      120

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         APPENDIX P
Product  Specific Data Report
     (EPA Form  8540-1)
                                              121

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                      PRODUCT SPECIFIC DATA REPORT
EPA Registration No._
_Guidance Document for_



            Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test

Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity-
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pH
Test not
required
for
product
listed
above
( check
below)


















Method of complying
with
data requirements
Citing MRID#


















Submit-
ting
Data
(At-
tached)


















(For EPA Use Only)
Accession Numbers
Assigned


















                                                                               122

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Registration
Guideline No.
61FI3
63-14
63 15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Fiammability
Explodabillty
Storage stability
I Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage

Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for
product
listed
above
( check
Delow)
















Method of complying
with
data requirements
Citing MRID#
















Submit-
ting
Data
(At-
tached )
















(For EPA Use Only)
Accession Numbers
Assigned
"















12


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          APPENDIX G






Pormulator's Exemption Statement
                                                 124

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                     FORMULATOR'S EXEMPTION STATEMENT
                             (40 CFR 152.85)
EPA File Symbol/Ren  M
               /Ke3- No-	Product Name

Applicant's Name and Address"
AS^n futl]orized representative of the aool icant for registration  of  the
product  identified above, i hereby certify that:

   (1)  This product contains the active ingredient(s):  	
   (2)  Each active ingredient listed in paragraph (1) is present solely
as the result o£ the incorporation into the product (during formulation re-
packaging) oE another product which contains that active ingredient,  which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.

   (3)  Indicate by circling  (A) or  (B) below which paragraph applies:

   (A)  An accurate Confidential Statement of Formula (EPA Form 8570-4) for
   the above identified product  is attached to this statement.  That formula
   statement indicates, by  company name,  registration number and product
   name, the source of the  active ingredient(s)  listed in paragraph (1).

                                  OR

   (B)  The Confidential Statement of  Formula dated	 on file  ^ith
   the EPA is complete, current  and  accurate and contains  the information
   required on the current  CSF Form  No. 8570-4.   The  registered soureefs)
   of the active ingredient(s) listed  in  paragraph (1)  is/are listed l>-low:

   Active ingredient                 Source:  Product  name  and Reg. Mo.
                            Signature

                                Title
   EPA  Form             (April  1985)

                                                                                   125

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BIBLIOGRAPHY
                                    126

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              Guide to Use of This Bibliography


X-   CONTE^F_BIBLIOGRAPHY.  This bibliography contains
    citations of all studies considered relevant by EPA in
    arriving at the positions and conclusions stated elsewhere
    in the Standard.  Primary sources for studies in this
    bibliography have been the body of data submitted to EPA
    and its predecessor agencies in support of past regulatory
    decisions.  Selections from other sources including the
    published literature, in those instances where they have
    been considered, will be included.

2,   UNITS OF ENTRY.  The unit of entry in this bibliography
    is called a "study."  In the case of published materials,
    this corresponds closely to an article.  In the case of
    unpublished materials submitted to the Agency, the Agency
    has sought to identify documents at a level parallel to
    the published article from within the typically larger
    volumes in which they were submitted.  The resulting
    "studies" generally have a distinct title (or at least a
    single subject), can stand alone for purposes of review,
    and can be described with a conventional bibliographic
    citation.  The Agency has attempted also to unite basic
    documents and commentaries upon them, treating them as a
    single study.

3-   IDENTIFICATION OF ENTRIES.  The entries in this bibliography
    are sorted numerically by "Master Record Identifier," or
    MRID, number.  This number is unique to the citation, and
    should be used at any time specific reference is required.
    It is not related to the six-digit "Accession Number"
    which has been used to identify volumes of submitted
    studies; see paragraph Md)(4) below for a further explana-
    tion,   [n a few cases, entries added to the bibliography
    late in the review may be preceded by a nine-character
    temporary identifier.  These entries are listed after
    all MRID entries.  This temporary identifier number is
    also to be used whenever specific reference is needed.

4.   FORM OF ENTRY.  In addition to the Master Record Identifier
    (MRID), ~~each~entry consists of a citation containing
    standard elements followed, in the case of material
    submitted to EPA, by a description of the earliest known
    submission.  Bibliographic conventions used reflect the
    standards of the American National Standards Institute
    (ANSI), expanded to provide for certain special needs.

    a.  Autoor.  Whenever the Agency  could confidently  identify
        orveTThe Agency has chosen to show a personal  author-
        Whe-i no individual was Identified, the Agency  has  shown
                                                                     127

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    an identifiable laboratory or testing facility as author.
    As a last resort,  the Agency has shown the first submitter
    as author.

b.  Document Date.   When the date appears as four digits
    with no question marks, the Agency took it directly from
    the document.  When a four-digit date is followed by a
    question mark,  the bibliographer deduced the date from
    evidence in the document.  When the date appears as
    (19??), the Agency was unable to determine or estimate
    the date of the document.

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

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

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

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

    (3)  Submitter-  The third element is the submitter,
         following the phrase "submitted by."  When author-
         ship is defaulted to the submitter, thin element is
         omitted.

    (^)  Volume Identification (Accession Number).  The final
         element in the trailing parentheses identifies the
         EPA accession number of the volume in which the
         original  submission of the study appears.  The six-
         digit accession number follows the symbol "CDL,"
         standing  for  "Company Data Library-"  This accession
         number is in  turn followed by an alphabetic suffix
         which shows the relative position of the study
         within the volume.  For example, within accession
         number 123^56, the first study would be 123456-A;
                                                                128

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                      OFFICE OF PESTICIDE PROGRAMS
      r-* *•    .  REGISTRATION STANDARD BIBLIOGRAPHY
      Utations Considered to be Part of the Data Base Supporting
               Kegistrations Under the Pronamide Standard

  MR ID           CITATION

00028772 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1973)  Toxicity of
            Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
            ratory Studies.  Rev.  By Univ. of California—Riverside, Dept.
            of Entomology.  Riverside, Calif.: UC, Agricultural  Extension
            Service.  (Also in  unpublished submission received Apr 2, 1980
            under 464-556; submitted by Dow Chemical U.S.A., Midland, Mich.;
            CDL:242149-Z)

00033380 Lodge, M.D.; Santelmann, P.W.; Lawrence, S.C.; et al. (1972) Ana-
            lytical Results of  Kerb Residue: R.A.R. No. 2-71-128.  (Unpub-
            lished study including R.A.R. nos. 2-70-71, 2-70-86, 2-70-78...,
            received  Dec 20, 1972 under 3F1317; submitted by Rohm & Haas
            Co., Philadelphia,  Pa.; CDL:092251-A)

00035563 Choi let, C.C.; Chennault, B.; Ryan, J.B.; et al. (1973) Analytical
            Results of Kerb Residue: R.A.R.  No. 2-69-160.  (Unpublished
            study including R.A.R. nos. 2-71-240, 2-71-241, 2-71-242..., re-
            ceived Aug 23, 1973 under 4G1426; submitted by Rohm & Haas Co.,
            Philadelphia,  Pa.;  CDL:093801-D)

00035564 Choi let, C.C.; Lawrence, S.C. (1972) Analytical Results of Kerb
            Residue:  R.A.R. No. 2-71-239.   (Unpublished study including
            R.A.R. no. 2-72-333, received Aug 23, 1973 under 4G1426; submit-
            ted by Rohm &  Haas  Co.,  Philadelphia, Pa.; CDL:093801-E)

00035565 Chollet, C.C.; Lawrence, S.C. (1972) Analytical Results of  Kerb
            Residue:  R.A.R. No. 2-71-195.   (Unpublished  study including
            R.A.R. no. 2-72-110, received Aug 23, 1973 under  4G1426;  submit-
            ted by Rohm &  Haas  Co.,  Philadelphia, Pa.; CDL:093801-F)

00035566 Lawrence, S.C.;  Neidlinger,  T.J.;  Doughty,  C.C.; et  al.  (1972)  Ana-
            lytical  Results of  Kerb  Residue:  R.A.R.  No.  2-69-66.   (Unpub-
            lished study  including R.A.R.  nos.  2-71-155,  2-71-258,  2-72-
            005...,  received Aug 23,  1973  under  4G1426;  submitted  by  Rohm  &
            Haas Co., Philadelphia,  Pa.;  CDL-.093801-G)

00062605 Sinkeldam,  E.J.  (1974) Sensitization  Test  with  Kerb  Technical  in
            Guinea Pigs:  Report No.  R 4448.   (Unpublished study  received
            Feb 25,  1977  under  707-98;  prepared  by  Central  Instituut  voor
            Voedingsonderzoek  TNO, Netherlands,  submitted by  Rohm  &  Haas
            Co., Philadelphia,  Pa.;  CDL:233726-C)

00070933 Rohm  and Haas Company  (1981)  Kerb(R)  50-W  Herbicide  (707-98):
            Lettuce  Residue  Studies.   Interim rept.  (Unpublished  study re-
            ceived Mar 5,  1981  under 707-98; prepared in cooperation with
            Craven Laboratories,  Inc.;  CDL:244519-A)
                                    -1-
                                                                              129

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                      OFFICE OF PESTICIDE PROGRAMS
                   KEG1SIRAI10N SIANDARD BIBLIOGRAPHY
      Citations Considered to be Part of the Data Base Supporting
               Registrations Under the Pronamide Standard


  MRID           CITATION

00070934 Adler, I.L.; Gordon, C.F.; Haines, L.D.; et al.  (1972)  Determina-
            tion or residues from herbicide N-(l,l-dimethylpropynyl)-3,b-
            dichlorobenzamide by electron capture gas-liquid chromatography.
            Journal or the Association of Official Analytical  Chemists
            55(4):802-805.  (Also in unpublished submission received Mar 5,
            1981 under /0/-98; submitted by Rohm & Haas Co., Philadelphia,
            Pa.; CDL:244519-B)

00074523 Rohm & Haas Company (1979) Summary and Discussion: Kerb.  (Com-
            pilation; unpublished study received Jun 24,  1981 under /0/-159;
            CDL:070157-A)

00077215 Rohm & Haas Company (1980) Summary and Discussion: Kerb(R).
            (Compilation; unpublished study received Jun  24, 1981 under
            707-159; CDL:070158-A)

00083663 Powers, M.B. (1970) Final Report: Acute Oral—Rats; Draize Eye--
            Rabbits; Acute Dermal--Rabbits; Primary Skin—Rabbits; Acute
            Inhalation Exposure—Rats: Project Nos. 417-337; 417-339;
            417-341; 41/-340; 41/-338.  (Unpublished study received Mar
            13, 1971 under 1F1139; prepared by TRW, Inc., submitted by
            Rohm & Haas Co., Philadelphia, Pa.; CDL:090919-C)

00085504 Larson, P.S.; Borzelleca, J.F. (1968) Acute Oral Toxicity of RH-
            315, W.P. in Albino Rats.  (Unpublished study received Jun 15,
            1969 under 9G0821; prepared by Medical College of Virginia,
            Dept. of Pharmacology, submitted by Rohm & Haas Co., Philadel-
            phia, Pa.; CDL:091422-B)

0008bb05 Powers, M.B. (1966) Acute Oral Administration—Rats; Acute Eye
            Irritation—Rabbits; Acute Dermal Application—Rabbits; Acute
            Oral Administration—Dogs: Project No. 417-179 and No. 41/-180.
            Final  rept.   (Unpublished study received Jun 15, 1969 under
            9G0821;  prepared by Hazleton  Laboratories, Inc., submitted by
            Rohm & Haas Co., Philadelphia, Pa.; CDL:091422-C)

0008bbll Larson, P.S.; Borzelleca, J.F.  (19V?) Percutaneous Toxicity Study
            of  RH-315 WP  in  Rabbits.  (Unpublished study received Jun 15,
            1969 under 9G0821; prepared by Medical College of Virginia,
            Dept. of Pharmacology, submitted by Rohm & Haas Co., Philadel-
            phia,  Pa.; CDL:091422-I)

00098313 Vilkas, A.G.; Browne, A.M.  (1980) The Acute Toxicity of Kerb Tech-
            nical  (No Clay)  to the Water  Flea Daphnia magna Straus:  UCCES
            Project  No.  11506-33-43.  (Unpublished study received Apr 1,
            1982 under 707-159; prepared  by Union  Carbide  Corp., submitted
            by  Rohm  & Haas  Co.,  Philadelphia, Pa.; CDL:247155-A)


                                   ~2~                                           130

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                      OFFICE Oh PESTICIDE PROGRAMS
        , ..    „    GISIRATION STANDARD BIBLIUGHAPHY
        tatTons Considered to be Part ot the Data Base Supporting
               Registrations Under the P~onamide Standard


  MR ID           CITATION

00107196 McCann, J.  (1971) Kerb 50-U: Bluegill: Test No. 325.  (U.S.
            Agricultural Research Service, Pesticides Regulation Div.,
            Animal  Biology Laboratory; unpublished study; CDL:130346-A)

00107949 Larson, P.; Borzelleca, J.  (1970) Toxicologic Study on the Effect
            of Adding RH-315 to the  Diet of Beagle Dogs for a Period of Two
            Years.   (Unpublished study received Mar 12, 1971 under  1F1139;
            prepared by Medical College of Virginia, Dept. of Pharmacology,
            submitted by Rohm & Haas Co., Philadelphia, PA; CUL:090918-A)

00107953 Yih, R.; Swithenbank, C. (1970) Identification of Metabolites of
            N-(l,l-dimethylpropynyl)-3,5-dichlorobenzamide in Soil  and Al-
            falfa.   (Unpublished study received Mar 12, 1971 under  1F1139;
            submitted by Rohm & Haas Co., Philadelphia, PA; CDL:U9U918-G)

00107954 Yi'h, R.; Swithenbank, C. (1970) Identification of Metabolites of
            N-(l,l-dimethylpropynyl)-3,5-dichlorobenzamide in Rat and Cow
            Urine and Rat Feces.  (Unpublished study received Mar 12, 1971
            under 1F1139; submitted  by Rohm &  Haas Co., Philadelphia, PA;
            CDL:090918-H)

00107957 Rohm & Haas Co. (1971) Results of Tests on the Amount of Residue
            Remaining in or on Lettuce and Related Cnops and Soil Including
            a Description of the Analytical Method: Kerb.  (Compilation;
            unpublished study  received Mar 11,  1971 under  1F1139; COL:
            090917-A; 090916)

00107958 Rohm & Haas Co. (1969) Results of Tests on the Amount of Residues
            Remaining on or  in Crops,  Animal  Tissues,  Milk,  and  Soil  Inves-
            tigated and the  Analytical Methods  Used: RH-315.   (Compila-
            tion; unpublished  study  received  Jun  16,  1969  under  9G0821;  CDL:
            091423-A)

00107959 Rohm & Haas Co. (1970) Ke-b:  3,5-Dichloro-N-(1,1-dimethyl-2-propy-
            nyl)  Benzamide:  Report on  a  Study To  Determine Residue  Levels  in
            Eggs  and Tissues  from  Poultry  Feed Kerb.   (Compilation; unpub-
             lished  study received  on unknown  date  under 9G0821;  CDL:
            091424-A)

00107960 Rohm & Haas Co. (1972) Results  of  Tests  on  the Amount  of Residues
            Remaining in the  Treated Canefruit Crops;  A Description of  the
            Analytical  Method:  Kerb  75-W.   (Compilation;  unpublished
            study received  May 15,  1973  under 3F1317;  CDL:09212«-A)
                                   -3-
                                                                                13

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                      OFFICE OF PESTICIDE PROGRAMS
                   REGISTRAIIUN STANDARD BIBLIOGRAPHY
      Citations  Considered to be Part of the Data Base Supporting
               Registrations Under the Pronamide Standard


  MRID           CITATION

00107961 Rohm & Haas Co. (1969) Residues ot RH-315 in Lettuce, Alfalfa
            and Milk.  (Compilation; unpublished study received Feb 17,
            1971 under 1F1139; CDL:093447-A)

0010/965 Rohm & Haas Co. (1972) Results of Tests on the Amount of Residue
            Remaining in or on Alfalfa, Clover, Crown Vetch, Sainfoin and
            Trefoil (Birdsfoot), Including a Description ot the Analytical
            Method: Kerb.  (Compilation; unpublished study received Dec
            20, 1972 under 3F1317; CDL:092250-A; 092252)

00107967 Rohm & Haas Co. (1974) Analytical Methods and Residues: Kerb.
            (Compilation; unpublished study received Sep 9, 1974 under
            5F1552; CDL:094214-A)

00107968 Smith, J. (1974) Eighteen Month Study on the Carcinogenic Potential
            of Kerb (RH-315; Pronamide) in Mice.  (Unpublished study re-
            ceived Sep 16, 1974 under 3F1317; prepared in cooperation with
            Medical College of  Virginia, submitted by Rohm & Haas Co.,
            Philadelphia, PA; CDL:094304-A)

0010/980 Rohm and  Haas Co. (1973) A  Study or the Hydrolysis ot the Herbicide
            Kerb in Water: Laboratory 23 Technical Report No. 23-73-8.  (Un-
            published study received Apr 27, 1973 tinder  70/-113; CDL:
            120314-A)

00107993 Shellenberger,  T.  (1971) Subacute Toxicity Evaluation of Kerb 3,5-
            dichloro-N-(l,l-dimethyl-2-propynyl)-benzamide with Young Adult
            Bobwhite Quail  (A  Seven  Day Range Finding Study): GSRI Project
            No. NC-501.   (Unpublished study received May 16, 1972 under /O/-
            98; prepared  by Gulf  South Research  Institute, submitted by
            Rohm & Haas  Co.,  Philadelphia,  PA;  CDL:120402-N)

00107994 Shellenberger,  T.  (1971) A  Subacute Toxicity and Tissue Residue
            Study  of Kerb 3,5-dichloro-N-(1 ,l-dimethyl-2-propynyl)-ben-
            zamide Herbicide  in  Young Adult Bobwhite Quail: GSRI Project
            No. NC-501.   Final  rept.  (Unpublished study received May 16,
            1972 under  707-98;  prepared by  Gulf South Research  Institute,
            submitted by Rohm  & Haas Co.,  Philadelphia,  PA; CUL:120402-0)

00107996 Binns, R.;  Clark,  G.  (1969)  The  Acute  Toxicity  to  Fish of An Exper-
            imental  Herbicide  RH-315-75WP:  2932/69/358.   (Unpublished study
            received Jun 22,  1970 under  707-EX-63;  prepared by  Huntingdon
            Research Centre,  Eng.,  submitted by Rohm  &  Haas Co., Phila-
            delphia, PA; CDL:123888-A)
                                   -4-

                                                                              132

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                      OFFICE OF PESTICIDE PROGRAMS
                   REGISTRATION STANDARD BIBLIOGRAPHY
      Citations Considered to be Part ot the Data Base Supporting
               Registrations Unde^ the Pronamide Standard


  MRID           CITATION

00107997 Robinson, D.; Shi I lam, K. (1969) Toxicity  ot  RH-315 to  the Japanese
            Quail and the  Mallard  Duck:  2839/69/265.   (Unpublished study  re-
            ceived Jun 22,  1970 under 707-EX-63; prepared  by Huntingdon
            Research  Centre, Eng.s submitted by  Rohm  & Haas  Co.$ Phila-
            delphia,  PA; CDL:123888-B)

00108002 Fink, R. (1975) Eight-day Dietary  LC50--MaI Iard  Duck:  Technical
            Kerb: Project  No.  129-107.   Final  rept.  (Unpublished study  re-
            ceived Feb 25,  1977 under 707-98;  prepared by  Truslow Farms
            Inc., submitted by Rohm & Haas  Co.,  Philadelphia,  PA; CDL:
            233/23-A)

00108003 Fink, R. (1975) Eight-day Dietary  LC50--Bobwhite  Quail: Technical
            Kerb: Project  No.  129-106.   Final  rept.  (Unpublished study  re-
            ceived Feb 25,  1977 under 707-98;  prepared by  Truslow Farms
            Inc., submitted by Rohm & Haas  Co.,  Philadelphia,  PA; CDL:
            233723-B)

00125382 Rohm & Haas  Co. (1982) Kerb  50-W Herbicide Use on Artichokes.
            (Compilation;  unpublished study received  Feb  4,  1983 under
            707-159;  CDL:249475-A)

00126574 WARF  Institute, Inc.  (1972)  Report: WARF  No.  2060619,   (Unpub-
            lished study received  Apr 23, 19/4 under  b38-115;  submitted by
            O.M.  Scott & Sons  Co., Marysville, OH;  CDL:028337-B)

00133112 Powers,  M.  (19/0)  Acute Oral--Rats/Draize  Eye--Rabbits/Acute De~»
            mal--Rabbits/Primary Skin--Rabbits/Acute  Inhalation  Exposure--
            Rats: Kerb 50-W.   Final rept.   (Unpublished study  received Feb
            25,  1971  under 707-98; prepared  by Hazleton Laboratories, Inc.,
            submitted by Rohm  & Haas  Co., Philadelphia, PA;  CDL:OU43b8-A)

00148064 Costlow, R.; Kane, W. (1985) Range-finding Teratology Study with
            Kerb  in  Rabbits: Report No.  83R-025.   Unpublished study prepared
            by Rohm  and Haas Co. 145  p.

1)0148065 Costlow, R.; Kane, W. (1985) Teratology Study with Kerb  Technical
00148065 tostm  ,^ ingred1ent)  in  Rabbits:  Report  No. 83R-026.  Unpub-
             lished'study prepared  by  Rohm and  Haas  Co.  151 p.
      nm  YTh   R •  Swlthenbank,  C.;  McRae, D.  (1970) Transformation or
     -U01  Tin,  "'•      N_(1  j.dimethyIpropyny1)-3,5-dichIorobenzarmde
             soil.  Weed  SCI.'  18:604-607.
i n
                                   •5-
                                                                                13

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