United States        Prevention, Pesticides     EPA 738-R-94-033
        Environmental Protection    And Toxic Substances     September 1994
        Agency	(7508W)	
&EPA Reregistration
        Eligibility Decision  (RED)

        Piperalin

-------
         \
v**^?
                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                      WASHINGTON, D.C. 20460
                                                                           OFFICE OF
                                                                     PREVENTION, PESTICIDES
                                                                      AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case Piperalin which
includes the active ingredient 3-(2-Methylpiperidino)propyl 3,4-dichlorobenzoate.  The
enclosed Reregistration Eligibility Decision (RED)  contains the Agency's evaluation of the
data base of this chemical, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will  be eligible for reregistration.  The RED includes the data and labeling
requirements  for products for reregistration. It may also include requirements for additional
data (generic) on the active ingredient to confirm the risk assessments.

       To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include  further instructions.  You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter.  The second set of required responses are due  8 months from the
date of this letter.  Complete and  timely responses will avoid the Agency taking the
enforcement action of suspension against your products.

       If you have questions on the product specific data requirements, the required generic
data, or wish  to meet with the Agency, please contact the Special Review and Reregistration
Division representative, C.P. Moran at (703) 308-8590.

                                                     Sincerely yours,
                                                     Louis P. True, Jr., Acting Director
                                                      Special Review
                                                      and Reregistration Division
Enclosures

-------
              SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
              THE REREGISTRATION ELIGIBILITY DECISION (RED)

1.  DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data.  If product specific data
are required, another DCI letter will be enclosed listing such requirements.  If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data.  Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.

2.  TIME  EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted  as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the  8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.

3.  APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date  of this letter
(RED issuance date).

      a.  Application for Reregistration (EPA Form 8570-1).  Use only an original
application form. Mark it "Application for Reregistration."  Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.

      b.  Five copies of draft labeling which complies with the RED and current regulations
and requirements.  Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies.  Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately.  You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance,  refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in  the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811;  telephone number 703-487-4650).

      c.  Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's  acceptance criteria (attached to the DCI).

      d.  Two copies of the  Confidential Statement of Formula (CSF) for each basic and
each alternate formulation.  The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration.  You have two options for submitting a CSF:  (1) accept the standard certified
limits (see  40  CFR 158.175)  or (2)  provide certified limits that are supported by the analysis
of five batches.  If you choose the second option, you must submit or cite the data for the five
batches along  with a certification statement as described in 40 CFR 158.175(e).   A copy of
the CSF is enclosed; follow the instructions on its back.

-------
      e.  Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.

4.  COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.

5.  WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail:

      Document Processing  Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      EPA, 401 M St. S.W.
      Washington, D.C. 20460-0001

By express:

   Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      Room 266A, Crystal Mall 2
      1921 Jefferson Davis Hwy.
      Arlington, VA 22202

6.  EPA'S REVIEWSEPA  will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections.  EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.

-------
REREGISTRATION ELIGIBILITY DECISION

                PIPERALIN

                  LISTC

                 CASE 3114
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

-------
                         TABLE OF CONTENTS



PIPERALIN REREGISTRATION ELIGIBILITY DECISION TEAM  	i

EXECUTIVE SUMMARY	  vi

I.     INTRODUCTION	1

II.    CASE OVERVIEW	2
      A.   Chemical Overview  	2
      B.   Use Profile 	2
      C.   Regulatory History	3

III.   SCIENCE ASSESSMENT	4
      A.   Physical Chemistry Assessment	4
      B.   Human Health Assessment	4
           1.     Toxicology Assessment	4
                  a.    Acute Toxicity   	4
                  b.    Subchronic Toxicity	5
                  c.    Developmental Toxicity  	5
                  d.    Mutagenicity  	6
           2.     Exposure Assessment	6
                  a.    Occupational and Residential  	6
           3.     Risk Assessment	6
                  a.    Occupational and Residential  	6
      C.   Environmental Assessment	6
           1.     Environmental Fate  	6
                  a.    Environmental Chemistry, Fate and Transport  	7
                  b.    Environmental Fate Assessment	9
           2.     Ecological Effects	10
                  a.    Ecological Effects Data	10
                       (1)    Terrestrial Data	10
                       (2)    Aquatic Data	11
                       (3)    Non-Target Insects Data	12
                  b.    Ecological Effects Risk Assessment	13

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	14
      A.   Determination of Eligibility	14
           1.     Eligibility Decision  	14
           2.     Eligible and Ineligible Uses  	15
      B.   Regulatory Position  	15
           1.     Endangered Species Statement  	15

-------
V.    ACTIONS REQUIRED BY REGISTRANTS  	15
      A.    Manufacturing-Use Products	15
            1.     Additional Generic Data Requirements	15
      B.    End-Use Products  	16
            1.     Additional Product-Specific Data Requirements	16
            2.     Labeling Requirements for End-Use Products	16
      C.    Existing Stocks  	19

VI.  APPENDICES	21
      APPENDIX A. Table of Use Patterns  Subject to Reregistration  	23
      APPENDIX B. Table of the Generic Data Requirements and Studies Used to
            Make the Reregistration Decision	27
      APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
            Reregistration of Piperalin	35
      APPENDIX D. List of Available Related Documents  	43
      APPENDIX E	47
            PR Notice 86-5	49
            PR Notice 91-2	67
      APPENDIX F. Combined Generic and Product Specific Data Call-in	73
            Attachment 1. Chemical Status Sheets	91
            Attachment 2. Combined Generic and Product Specific Data Call-in
                  Response Forms (Form A inserts) Plus Instructions  	95
            Attachment 3. Generic and Product Specific Requirement Status and
                  Registrant's Response Forms (Form B inserts) and Instructions
                   	  101
            Attachment 4. EPA Batching of End-Use Products for Meeting Data
                  Requirements for Reregistration	  107
            Attachment 5. EPA Acceptance Criteria   	  Ill
            Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
                   	  125
            Attachment 7. Cost Share Data Compensation Forms, Confidential
                  Statement of Formula Form and Instructions  	  127
      APPENDIX G. FACT SHEET	  137

-------
PIPERALIN REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:

Biological and Economic Analysis Division

Richard Michell
Phyllis Johnson
Dohl Herzi

Environmental Fate and Effects Division

Mary Frankenberry
Patricia  Ott
Kay Valente-Montague

Health Effects Division

Charles  Frick
Patricia  McLaughlin
San Yvette Williams
Winston Dang

Registration Division

Sidney Jackson
Amelia Acierto
Mark Perry
Sami Malek

Special Review and Reregistration Division

Sue Rathman
Barbara Briscoe

Office of General Council

Kevin Lee

Office of Compliance

Phyllis Flaherty
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Chemical Coordination Branch
Toxicology Branch II
Toxicology Branch II
Occupational and Residential Exposure Branch
Fungicide-Herbicide Branch
Registration Support Branch
Registration Support Branch
Registration Support Branch
Policy, Planning and Operations Branch
Policy, Planning and Operations Branch
Agriculture Branch

-------
ORD




Vivian Williams







PSPS




Jean Frane
                                       n

-------
          GLOSSARY OF TERMS AND ABBREVIATIONS
AE          Acid equivalent

a.i.          Active Ingredient

ARC         Anticipated Residue Contribution

CAS         Chemical Abstracts Service

CSF         Confidential Statement of Formula

DRES        Dietary Risk Evaluation System

DWEL       Drinking Water Equivalent Level (DWEL)  The DWEL represents a medium
             specific (i.e. drinking water) lifetime exposure at which adverse, non
             carcinogenic health effects are not anticipated to occur.

EEC         Estimated Environmental Concentration.  The estimated pesticide concentration
             in an environment,  such as a terrestrial ecosystem.

EP          End-Use Product

EPA         U.S. Environmental Protection Agency

FDA         Food and Drug Administration

FIFRA       Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA      Federal Food,  Drug, and Cosmetic Act

GLC         Gas Liquid Chromatography

GRAS        Generally  Recognized As Safe as designated by FDA

HA          Health Advisory (HA)  The HA values are used as informal guidance to
             municipalities and other organizations when emergency spills or contamination
             situations occur.

HOT         Highest Dose Tested

LC50         Median Lethal Concentration.  A statistically derived concentration of a
             substance that can be expected to cause death in 50% of test animals. It is
                                        in

-------
          GLOSSARY OF TERMS AND ABBREVIATIONS
LD
   50
LDlo

LEL

LOG

LOEL

MCLG
mg/L

MP

MPI

MOE

MRID


N/A

NPDES

NOEL

OPP

PADI
*usually expressed as the weight of substance per weight or volume of water,
air or feed, e.g., mg/1, mg/kg or ppm.

Median Lethal Dose.  A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.

Lethal Dose-low. Lowest Dose at which lethality occurs

Lowest Effect Level

Level of Concern

Lowest Observed Effect Level

Maximum Contaminant Level Goal (MCLG)  The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.

Micrograms Per Gram

Milligrams Per Liter

Manufacturing-Use Product

Maximum Permissible Intake

Margin Of Exposure

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

Not Applicable

National Pollutant Discharge Elimination System

No Observed Effect Level

Office of Pesticide Programs

Provisional Acceptable Daily Intake
                                       IV

-------
          GLOSSARY OF TERMS AND ABBREVIATIONS

PAM        Pesticide Analytical Method

PPE        Personal Protective Equipment

ppb         Parts Per Billion


ppm        Parts Per Million

PRN        Pesticide Registration Notice

Q*!         The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
            Risk Model

RED        Reregistration Eligibility Decision

REI         Restricted Entry Interval

RfD        Reference Dose

RS         Registration Standard

TD         Toxic Dose. The dose at which a substance produces a toxic effect.

TC         Toxic Concentration. The concentration  at which a substance produces a toxic
            effect.

TEP        Typical End-Use Product

TGAI       Technical Grade Active Ingredient

TMRC      Theoretical Maximum Residue Contribution

TLC        Thin Layer Chromatography

WPS        Worker Protection Standard

-------
EXECUTIVE SUMMARY

       The Agency has determined that the uses of piperalin as currently registered will not
cause unreasonable risk to humans or the environment and these uses are eligible for
reregistration. The Agency is requiring an in vivo cytogenetics assay using either a) metaphase
analysis (aberrations) or b) micronucleus assay  (84-2 (b)); and confirmation of the identity of
the major degradates found in the Hydrolysis (161-1), Aerobic Soil metabolism (162-1), and
Anaerobic Soil metabolism (162-2) studies.

       In addition, in  order to assess the leaching potential of the only two major hydrolytic
degradates identified in the required laboratory  studies, quantitative information is needed for
DCBA and 3-(2-methylpiperidino)propyl alcohol in  four soils (163-1).  This information
(preferably in batch equilibrium form) will fulfill the aged portion of the adsorption/desorption
study requirement and  result in a more complete and quantitative environmental fate
assessment for piperalin and its major degradates.

       Before reregistering the product containing piperalin, the Agency may require that
certain product specific data,  a revised Confidential  Statement of Formula (CSF) and a revised
label be submitted within eight months of the issuance of this document. These product
specific data may include product chemistry and acute toxicity testing.  After reviewing these
data and the revised label and finding them acceptable in accordance with Section 3(c)(5) of
FIFRA, the Agency will reregister the product.
                                           VI

-------
I.      INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The  fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.

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

This document presents the Agency's decision regarding the reregistration eligibility  of the
registered uses of piperalin. The document consists of six sections. Section I is the
introduction. Section II describes piperalin, its uses, data requirements and regulatory history.
Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for piperalin. Section
V discusses the reregistration requirements for piperalin. Finally, Section VI is the Appendices
which support this Reregistration Eligibility Decision. Additional details concerning the
Agency's review of applicable data are available on request.

-------
II.    CASE OVERVIEW

      A.     Chemical Overview

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

           Common Name:    Piperalin


           Chemical Name:    3-(2-Methylpiperidino)propyl 3,4-dichlorobenzoate


           CAS Registry Number:    3478-94-2


           OPP Chemical Code:       097003


           Empirical Formula:        C16H21C12N02
             Trade and Other Names:   Benzoic acid, 3,4-dichloro-, 3-(2-methyl-l-
                                       piperidinyl)propyl ester; 1-piperidinepropanol, 2-
                                       methyl-, 3,4-dichlorobenzoate (ester); Pipron
            Basic Manufacturer:       SePRO Corporation

       B.     Use Profile

             The following is information on the current registered uses with an overview of
       use sites and application methods.  Additional information on the use of piperalin can
       be found in Appendix A.

             For piperalin:

             Type of Pesticide:   Fungicide
             Use Sites:    Greenhouse non-food crop: Ornamental herbaceous plants
                          (dahlia, phlox, zinnia and chyrsanthemum); Ornamental woody
                          shrubs and vines (lilac, rose); and Ornamental and/or shade trees
                          (catalpa)

-------
      Target Pests: Powdery mildew


      Formulation Types Registered:    Soluble concentrate/liquid (SC/L)


      Method and Rates of Application:

            Equipment -   High-volume high-pressure sprayer

            Method and Rate -Foliar spray; the rate is V4-l/2 Ib A.1.7100 gal. (V4-l/2
            pint/100 gal); use the high rate if disease is already present

            Timing - apply soon after first leaves expand, or after first symptoms
            appear; apply every 7-10 days, or as needed

      Use Practice Limitations:  Label recommends use with 3 specific surfactants;
                              DO NOT ENTER TREATED AREAS
                              WITHOUT PERSONAL PROTECTIVE
                              EQUIPMENT (PPE) FOR 12 HOURS; DO NOT
                              APPLY THROUGH ANY TYPE OF
                              IRRIGATION SYSTEM;  DO NOT APPLY
                              DIRECTLY TO WATER OR WETLANDS; DO
                              NOT CONTAMINATE WATER, FOOD OR
                              FEED



C.    Regulatory History

      Piperalin (3-(2-methyl piperidino) propyl 3,4-dichlorobenzene) was registered
in the United States in 1964 for use as a fungicide. Only one product containing this
active ingredient is currently  registered.  This product was recently transferred from
DowElanco to SePRO Corporation under the product name Piperon L.C., EPA Reg.
No. 67690-1. The product contains 84.4% active ingredient and is used exclusively
for controlling powdery mildew on ornamentals grown in commercial greenhouses.

-------
III.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

             The only Piperalin product currently registered is an end-use product to be used
       as a fungicide for use on ornamental plants grown in commercial greenhouses.

             Piperalin (84.4%, SePRO)  is a pale yellow viscous liquid with a slightly musty
       straw odor and has density of 1.18 g/cc (9.8 Ib/gal). It decomposes at 208C, miscible
       in acetone, chloroform, dichloromethane,  ethyl acetate and toluene. Its solubility  in
       water at 25C is 200 ppm, 3-5 g/100 in acetonitrile, 5-10 g/lOOml in hexane and 5-10
       g/100ml in methanol. A 50% slurry has a pH of 9.0. The vapor pressure is
       < 1.0 x  107 Torr @ 25C, dissociation constant (pka) is  8.9 (in 66% DMF) and
       octanol/water partition coefficient  (Kow) is 20400 (Log Kow =  4.31). It is stable to heat,
       to metal and metal ions (i.e., Copper, Brass, Stainless steel 304 and 316, Nickel (II)
       chloride [NiCl2], Cuprous chloride [CuCl] and Ferric chloride [[FeCl3.6H20]) for 28
       days at 50C and stable in storage at RT up to about seven (7) years.


       B.    Human Health Assessment

             1.     Toxicology Assessment

                    The toxicological data base on piperalin is adequate and will support
             reregistration eligibility.

                    a.     Acute Toxicity

                           An acute  oral toxicity study in Fischer 344 rats found an LD50 of
                    approximately 800 mg/kg for females and 1419 mg/kg for males, which
                    is toxicity category III (MRID 40503201). An  acute dermal toxicity
                    study with New Zealand white rabbits showed an LD50 greater than 5850
                    mg/kg, which is  toxicity category IV (MRID 40503201). An acute
                    inhalation toxicity study with Fischer 344 rats found the LC50 was
                    greater than 0.5 mg/L, which is toxicity category III (MRID 40503201).

                           An eye irritation study in rabbits found  mild irritation in
                    unwashed eyes, with all  effects resolved by 48  hours. This is toxicity
                    category III  (MRID 41548701).  A primary dermal irritation study with
                    New Zealand white rabbits, with an exposure time of 24 hours, found
                    moderate to severe irritation. This is equivalent to toxicity category III
                    for a guideline study (MRID 40503201).  A test of dermal sensitization
                    potential with guinea pigs found that piperalin was not a sensitizer
                    (MRID 40678608).

-------
          ACUTE TOXICITY DATA
TEST
Oral LDsn - rat
Dermal LD50 - rabbit
Inhalation LC50 - rat
Eye effects - rabbit
Skin irritation - rabbit
Skin sensitization - guinea pig
RESULTS
800 mg/kg F; 1419 mg/kg M
> 5850 mg/kg
> 0.5 mg/L
mild irritation
severe irritation (24 hr)
non-sensitizer
CATEGORY
III
IV
III
III
III

b.    Subchronic Toxicity

      In a 21-day dermal toxicity study, New Zealand white rabbits
were given piperalin at doses of 0, 50,  150 or 450 mg/kg/day.  No
systemic toxicity was observed and the  NOEL was greater than 450
mg/kg/day (MRID 40509301).

      Other subchronic studies were waived for this case.

c.    Developmental Toxicity

      In a developmental toxicity study, CD rats were administered
doses of 0, 20,  100 or 500 mg/kg/day of piperalin on gestation days 6-
15 by gavage.  The maternal NOEL was 20 mg/kg/day. The maternal
LOEL was 100 mg/kg/day, based on excessive salivation, soiled fur,
decreased  body weight gain and decreased food consumption.  The
developmental NOEL was 100 mg/kg/day.  The developmental LOEL
was 500 mg/kg/day,  based on decreased fetal body weight (MRID
40584901).

-------
             d.     Mutagenicity

                    An Ames mutagenicity test with Salmonella typhimurium strains
             TA1535, TA1537, TA98 and TA100, as well as Escherichia coli strain
             WP2 uvrA-, found piperalin was not mutagenic (MRID 40503203).  A
             mouse lymphoma forward mutation study was negative (MRID
             40503202).  Additional information is required, as confirmation,  on a
             third mutagenicity test, an in vivo cytogenetics assay using either a)
             metaphase analysis (aberrations) or b) micronucleus assay.

       2.     Exposure Assessment

             a.     Occupational and Residential

                    An occupational and/or residential exposure assessment is
             required for an active ingredient if (1) certain toxicological criteria are
             triggered and (2) there is potential exposure to mixers, loaders, or
             applicators during use or to persons entering treated sites after
             application is complete. The Agency has determined that an exposure
             assessment is not required for piperalin since the toxicology criteria are
             not triggered.

       3.     Risk Assessment

             a.     Occupational and Residential

                    Even though there can be significant exposure,  the toxicological
             end-points do not meet the triggers for the requirement of exposure data,
             and the exposure will be minimized by using appropriate label
             precautions.

C.     Environmental Assessment

       1.     Environmental Fate

                    At this time, data requirements in the environmental fate
             guidelines are not fulfilled.  Information is needed to confirm the major
             degradates of piperalin. The Agency has sufficient data for a qualitative
             environmental fate assessment of piperalin.

-------
a.     Environmental Chemistry, Fate and Transport

       (1)    Hydrolysis

                    Based on available hydrolysis data, piperalin
             hydrolyzes very rapidly at pH 9 (half-life of 4.8 hours),
             forming 2 degradates:  DCBA or dichlorobenzoic acid
             and 3-(2-methylpiperidino)propyl alcohol. At pH 7 and
             5, the half-lives were 16.4 days and 714 days,
             respectively.

                    The submitted study provides supplemental
             information, only high pressure liquid chromatography
             (HPLC) was used to identify compounds, with no
             confirmatory method, and it appears as if a major
             degradate, 3-(2-methylpiperidino)propyl alcohol, was not
             analyzed. (MRID# 404075-01)

       (2)    Aerobic soil metabolism

                    Based on a supplemental aerobic soil metabolism
             study, microbially-mediated hydrolysis, in addition to
             chemical hydrolysis, was the most significant degradative
             process which occurred.  The rate of hydrolysis appears
             to be catalyzed by a non-sterile environment, because the
             half-life of piperalin in the hydrolysis experiment at pH 5
             was  714 days but only  96-100 days in an Indiana sandy
             loam soil of pH 5.5.

                    For the  carbonyl labelled portion of the aerobic
             soil metabolism study,  one of the two major hydrolytic
             degradates, DCBA, reached a maximum of 21% of
             applied 14C-radioactivity on day 14 of the 180 day study.
             Apparently, DCBA further degraded because 14C02 levels
             kept increasing throughout the study, reaching a
             maximum of 48.5% of the applied on day 180 (last day of
             study).  Parent steadily declined from 87.4% on day 0 to
             20% on day 180.

                    For the  propyl labelled portion of the aerobic soil
             metabolism study, the other major hydrolytic degradate,
             3-(2-methylpiperi-dino)propyl alcohol,  reached a
             maximum of 10.7% of the applied radioactivity on day 3,
             then declined to 2.9% by day 180.  This degradate
                       7

-------
       apparently further degraded, because 14C02 levels kept
       increasing throughout the study, reaching a maximum of
       16.5% of applied radioactivity on day 180.  Parent
       steadily declined, from 91% of applied on day 0 to 24.9%
       day 180.

             The submitted study provides supplemental
       information, only thin layer chromatography (TLC) was
       used to identify degradates and no confirmatory method
       of analysis was done. This study may be upgradeable if
       confirmatory information is provided, which is consistent
       with reported compound identities and levels determined
       by TLC analysis.  (MRID# 41425201)

(3)     Anaerobic soil metabolism

             Based on supplemental anaerobic  soil metabolism
       data, the most significant process that occurred in an
       Indiana sandy loam soil incubated aerobically for 21 days,
       followed by  60 days' anaerobic incubation, was
       microbially-mediated hydrolysis (in addition to chemical
       hydrolysis).  The anaerobic soil half-life  of piperalin was
       33.8 and 38.1 days for the carbonyl- and propyl-labelled
       piperalin, respectively.

             For the carbonyl portion of the anaerobic soil
       metabolism study, parent decreased over time, from 64%
       of the total 14C-radioactivity applied on day 0 (beginning
       of anaerobic conditions) to 19% on day 60.  Consistent
       with this, levels of 1 of the 2 major hydrolysis degradates,
       DCBA, increased with time, from 16% on day 0 to 58%
       on day 60.  Unextractable soil radioactivity remained
       relatively constant (16%  on day 0 and 20% on day 60).

             For the propyl portion of the anaerobic soil
       metabolism study, parent decreased over the 60 day
       anaerobic period, from 60% of the total 14C found in zero
       day soil samples, to 20% on day 60, while the other
       major hydrolysis product, 3-(2-methylpiperidino)propyl
       alcohol, increased from 3.7% of the applied to 14% by
       day 60.  Non-extractable 14C remained relatively constant
       (15.3% on day 0 and 18.7% on day 60).

-------
                    The submitted study provides supplemental
              information,  only TLC was used to identify metabolites
              and no confirmatory method of analysis was used. This
              study may be upgradeable if confirmatory information is
              provided which is consistent with reported compound
              identities and levels determined by TLC analyses.
              (MRID# 41425202)

       (4)     Leaching and  adsorption/desorption

                    Based on acceptable batch equilibrium data,
              piperalin is immobile, with Freundlich Kd's of 520, 305,
              62.3, 27.6, in an Indiana clay loam, Indiana loam,
              Indiana sandy loam, and Texas sand, respectively.
              Equilibrium time selected was 2 hours, based on an
              equilibrium study conducted for up to 50 hours.  (MRID
              #4242930-01)

                    No quantitative estimates of the leaching potential
              for the only 2 degradates (from hydrolysis) identified in
              the 4 required laboratory studies can be made because
              none were supplied. The aged portion of the leaching
              data requirement (163-1) is unsatisfied.  (MRID #414252-
              03)

b.     Environmental Fate Assessment

              Based on a limited usage pattern and a limited and
       acceptable/supplemental environmental fate data base, the only
       path of dissipation for piperalin appears to be two types of
       hydrolysis: chemical and microbially-mediated hydrolysis.  Two
       major degradates were found:  3,4-dichlorobenzoic acid or
       DCBA and 3-(2-methylpiperidino)propyl alcohol. The rate  of
       hydrolysis appears to be catalyzed by a nonsterile environment,
       as evidenced by half-lives reported in the aerobic and anaerobic
       soil metabolism studies.

              A recurring problem in the hydrolysis, aerobic and
       anaerobic soil metabolism studies was the failure to confirm the
       identity of the degradates by a specific, second method.
       Although piperalin does not appear to be mobile in soils,
       quantitative information is needed for DCBA and 3-(2-
       methylpiperidino)propyl alcohol in four soils to assess their
       leaching potential. These batch equilibrium studies will result in
                       9

-------
              a more complete environmental fate assessment of piperalin and
              its degradates.

                     The Agency is requiring that a confirmatory method of
              analysis be conducted on the aged portion of the leaching and
              adsorption/desorption study (163-1) to identify the major
              degradates of piperalin.

                     If the identity of the major degradates are not confirmed
              by the aged portion of the leaching and adsorption/desorption
              study then the Agency may require additional data for the
              hydrolysis study (161-1), the aerobic soil metabolism study (162-
              1) and the anaerobic soil metabolism study  (162-2).
2.     Ecological Effects

       a.      Ecological Effects Data

              The ecotoxicological data base is adequate to characterize the
       toxicity of piperalin to nontarget terrestrial and aquatic organisms when
       used as labeled "For Use Only in Commercial Greenhouses".

              (1)     Terrestrial Data

                     In order to establish the toxicity of piperalin to birds, the
              following tests are required using the technical grade material:
              one avian single-dose oral (LD50)  study on one species
              (preferably mallard  or bobwhite quail); two subacute dietary
              studies (LC50) on one species of waterfowl (preferably the
              mallard duck) and one species of upland game bird  (preferably
              bobwhite quail or ring-necked pheasant).

                     A honey bee acute  contact LD50 study is required if the
              proposed use will result in honey  bee exposure.


                     (a)    Avian Acute Toxicity

                           There is one avian  toxicity study available, the
                     dietary study listed below.  This was determined to be
                     sufficient for fulfilling the avian testing requirements.
                              10

-------
       (b)    Avian Subacute Dietary Toxicity
Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
%Test
Material
99%
J-^50
>5,380
ppm
Conclusions
practically
nontoxic
(2)
       On a subacute dietary basis, piperalin is practically
non-toxic to birds.  One study on the bobwhite quail
produced LC50  >5,380 ppm.  (MRID #404075-02)

(c)     Avian Reproduction

       Avian reproduction studies are required when
birds may be exposed repeatedly or continuously through
persistence,  bioaccumulation, or multiple applications, or
if mammalian reproduction tests indicate reproductive
hazard. No avian reproduction testing was required for
the greenhouse  uses of piperalin.

Aquatic Data

(a)     Freshwater Fish Toxicity

       In order to establish the  toxicity of a pesticide to
freshwater fish, the minimum data required on the
technical grade  of the active ingredient are two freshwater
fish toxicity studies.  One  study should use a coldwater
species (preferably the  rainbow trout), and the other
should use a warmwater species (preferably the bluegill
sunfish).
Freshwater Fish Acute Toxicity Findings
Species
Bluegill
sunfish
% Test Material
(TGAI)
99.2%
LC50
0.77mg ai/L
Conclusions
highly toxic
                   11

-------
              The results of the 96-hour acute toxicity study indicates
       that piperalin is highly toxic to fish.  (MRID #430122-01)
       (b)     Freshwater Invertebrate Toxicity

              The minimum testing required to assess the hazard of a
       pesticide is a freshwater aquatic invertebrate toxicity test,
       preferably using first instar Daphnia magna or early instar
       amphipods, stoneflies, mayflies, or midges.
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
%Test
Material
(TGAI)
99%
FC
^^50
1.89mgai/L
Conclusions
moderately
toxic
              There is sufficient information to characterize piperalin as
       moderately toxic to aquatic invertebrates. (MRID #404075-04)

(3)     Non-Target Insects Data

              The minimum data required to establish the acute toxicity
       to honey bees is an acute contact LD50 study with the technical
       material. Although beneficial insect testing was not  required,
       honey bee toxicity data was available.
                    12

-------
b.     Ecological Effects Risk Assessment

       (1)     Risk to Terrestrial Animals

              Avian and mammalian species will not be significantly exposed to
       piperalin through the consumption of insect and plant food material
       containing residues of the chemical.  The criterion for the determination
       of hazard and  indication of possibly significant risk from exposure for
       acute avian and mammalian species is a value greater than or equal to
       0.5  for the quotient of the preliminary estimated environmental
       concentration  (EEC) divided by the lowest LD50 value for birds and
       mammals. This is known as the risk quotient (RQ).

       Acute and Dietary RQ = EEC/LD50 or EEC/LC50 > or = 0.5 for birds and mammals

              Based on the available acute toxicity data, piperalin is practically
       non-toxic to birds.  In addition, no significant exposure is expected from
       the  greenhouse use of this chemical.


       (2)     Risk to Aquatic Animals

              Based on the available acute toxicity data, piperalin is highly
       toxic to fish and moderately toxic to aquatic invertebrates.   Exposure
       to nontarget fish and aquatic invertebrates is not expected to occur from
       the  proposed use of the chemical.  Labeling statements are currently
       used regarding environmental hazards from applying the product or
       disposing of it in water.  No significant risks are expected from the
       greenhouse use of this chemical.


       (3)     Risk to Endangered Species

              For endangered avian and mammalian species the risk quotient is
       a value greater than or equal to 0.1.  For endangered aquatic vertebrate
       and invertebrate species, the risk quotient is 0.05.

RQ = EEC/LC50 >  or =  0.1 for endangered birds and mammals, the

RQ = EEC/LC50 >  or =  0.05 for endangered aquatic animals, and the

RQ = EEC/EC25 and the EEC/EC50  > or  = 1 for terrestrial, semi-aquatic and aquatic plants.

              No significant risks to endangered species are expected from the
       greenhouse use of piperalin.
                           13

-------
IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.     Determination of Eligibility

              Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
       relevant data concerning an active ingredient, whether products containing the active
       ingredients are eligible for reregistration.  The Agency has previously identified and required
       the submission of the generic (i.e. active ingredient specific) data required to support
       reregistration of products containing piperalin active ingredients.  The Agency has completed
       its review of these generic data, and has determined that the data are sufficient to support
       reregistration of all products containing piperalin.  Appendix B identifies the generic data
       requirements that the Agency reviewed as part of its determination of reregistration eligibility
       of piperalin, and lists the submitted studies that the  Agency found acceptable.

              The data identified in Appendix B were sufficient to allow the Agency to assess the
       registered uses of piperalin and to determine that piperalin can be used without resulting in
       unreasonable adverse effects to humans and the environment.  The Agency therefore finds that
       all products containing piperalin as  the active ingredient are eligible for reregistration. The
       reregistration of particular products is addressed in  Section V of this document.

              The Agency made its reregistration  eligibility determination based upon the target data
       base required for reregistration, the current guidelines for conducting acceptable studies to
       generate such data and the data identified in Appendix B.  Although the Agency  has found that
       all uses of piperalin are eligible for  reregistration, it should be understood that the Agency
       may take appropriate regulatory action, and/or require the submission of additional data to
       support the registration of products  containing piperalin, if new information comes to the
       Agency's  attention or if the data requirements for registration  (or the guidelines  for generating
       such data) change.

              1.     Eligibility Decision

              Based on the reviews of the  generic data for the active  ingredients piperalin, the
       Agency has sufficient information on the health effects of piperalin and on its potential for
       causing adverse  effects in fish and wildlife  and the environment.  Therefore, the Agency
       concludes that products containing piperalin for all  uses are eligible for reregistration.

              The Agency has determined that piperalin products, labeled and used as specified in
       this Reregistration Eligibility Decision, will not pose unreasonable risks or adverse effects to
       humans or the environment.
                                               14

-------
             2.     Eligible and Ineligible Uses

                    The Agency has determined that all currently registered uses of piperalin are
             eligible for reregistration.

       B.    Regulatory Position

             The following is a summary of the regulatory positions and rationales for piperalin.
       Where labeling revisions are  imposed, specific language is set forth in Section V of this
       document.
              1.     Endangered Species Statement

                    Currently, the Agency is developing a program ("The Endangered Species
              Protection Program") to identify all pesticides whose use may cause adverse impacts on
              endangered and threatened species and to implement mitigation measures that will
              eliminate the adverse  impacts.   The program would require use modifications or a
              generic product label  statement, requiring users to consult county-specific bulletins.
              These bulletins would provide information about specific use restrictions to protect
              endangered and threatened species in the county. Consultations with the Fish and
              Wildlife Service will be necessary to assess risks to newly listed species or from
              proposed new uses.

                    The Agency plans to publish a description of the Endangered Species Program
              in the Federal Register in  1994  and by 1995 have enforceable county-specific bulletins
              available. Because the Agency  is taking this approach for protecting endangered and
              threatened species,  it  is not imposing label modifications at this time through the RED.
              Rather, any requirements for product use modifications will occur in the future under
              the Endangered Species Protection Program.
V.     ACTIONS REQUIRED BY REGISTRANTS

       This section specifies the data requirements and responses necessary for the reregistration of
both manufacturing-use and end-use products.

       A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

                    The generic data base supporting the reregistration of piperalin for the above
             eligible uses has been reviewed and determined to be substantially complete.
                                              15

-------
              For the toxicology data base assessment additional information is required, as
       confirmatory, on an in vivo cytogenetics assay using either a) metaphase analysis
       (aberrations) or b) micronucleus assay.

             In addition, in order to assess the leaching potential of the only two major
       hydrolytic degradates identified in the required  laboratory studies, quantitative
       information (preferably in batch equilibrium form) is needed for DCBA  and 3-(2-
       methylpiperidino)propyl alcohol in four soils (163-1). The aged portion of the leaching
       adsorption/desorption data requirement is required.

B.     End-Use Products

       1.     Additional Product-Specific Data Requirements

             Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
       specific data regarding the pesticide after a determination of eligibility has  been made.
       The product specific data requirements are  listed in Appendix G, the Product Specific
       Data Call-In Notice.

             Registrants must review previous data submissions to ensure  that they meet
       current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to
       conduct new studies.  If a registrant believes that previously submitted data meet
       current testing standards, then study MRID numbers should be cited according to the
       instructions in the Requirement Status and Registrants Response Form provided for
       each product.

       2.     Labeling  Requirements for End-Use Products

       Worker Protection Standard

             Any product whose labeling reasonably permits use in the production of an
       agricultural plant on any farm, forest, nursery,  or greenhouse must comply with the
       labeling requirements of PR Notice 93-7, "Labeling Revisions Required  by the Worker
       Protection Standard (WPS), and PR Notice 93-11, "Supplemental Guidance for PR
       Notice 93-7, which reflect the requirements of EPA's labeling regulations for worker
       protection statements (40 CFR part 156, subpart K). These labeling revisions are
       necessary to implement the  Worker Protection Standard  for Agricultural Pesticides  (40
       CFR part 170) and must be completed in accordance with, and within the deadlines
       specified in, PR Notices 93-7 and 93-11. Unless otherwise specifically directed in this
       RED, all statements required by PR Notices 93-7  and 93-11 are to be on the product
       label exactly as instructed in those notices.

             After April 21, 1994, except as otherwise provided in PR Notices 93-7 and
       93-11, all products within the scope of those notices must bear WPS PR  Notice


                                       16

-------
complying labeling when they are distributed or sold by the primary registrant or any
supplementally registered distributor.

       After October 23, 1995, except as otherwise provided in PR Notices 93-7 and
93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by any person.

       Personal Protective Equipment for Mixer/Loader/Applicators

       For each end-use product, PPE requirements for pesticide handlers will be set
during reregistration in one of two ways:

1.      If EPA has no special acute or other adverse concerns about an active
ingredient, the PPE for pesticide handlers will be established based on the acute
toxicity of the end-use product.  For occupational-use products, PPE  will be
established using the process described in PR Notice 93-7 or more recent EPA
guidelines.

2.      If EPA has special concerns about an active ingredient due to very high acute
toxicity or to certain non-acute effects, such as delayed effects (cancer, developmental
toxicity, reproductive effects, etc):

       -the Agency may establish in the RED  minimum or  "baseline"  handler PPE
requirements for that active ingredient that pertain to all or  most occupational end-use
products containing that active ingredient.

       -these minimum  PPE requirements must be compared with the PPE that would
be designated on the basis of the acute toxicity of each end-use product,  and

       -the more stringent  choice for each type of PPE (i.e., bodywear, hand
protection, footwear, eyewear, etc.)  must be placed on the label of the end-use
product.

       There are no special toxicological concerns about piperalin that warrant the
establishment of active-ingredient-based PPE requirements for pesticide  handlers.

       Restricted Entry Interval

       Under the Worker Protection Standard (WPS), interim restricted entry intervals
(REI) for  all uses within the scope of the WPS are established based on the acute
toxicity of the active ingredient.  The toxicity  categories of the active  ingredient  for
acute dermal toxicity, eye irritation potential,  and skin irritation potential are used to
determine the interim WPS REI.  If one or more of the three acute toxicity effects are
in  toxicity category I, the interim WPS REI is established at 48 hours. If none of the


                                 17

-------
acute toxicity effects are in category I, but one or more of the three is classified as
category II, the interim WPS REI is established at 24 hours. If none of the three acute
toxicity effects are in category I or II, the interim WPS REI is established at 12 hours.
A 48-hour REI is increased to 72 hours when an organophosphate pesticide is applied
outdoors in arid areas.  In addition, the WPS specifically retains two types of REI's
established by the Agency prior to  the promulgation of the WPS: product-specific

REI's established on the basis of adequate data and interim REI's that are  longer than
those that would be established under the WPS.

       Implementation of the WPS (through PR Notice 93-7) in  1993 established a 24-
hour interim REI on piperalin products,  because  data available at that time indicated
that piperalin was in toxicity category II for skin irritation potential. In reviewing the
data submitted for reregistration, EPA determined that piperalin  should be classified as
toxicity category III for skin irritation potential.  EPA has decided that all WPS uses of
piperalin should have a 12-hour REI, since piperalin is classified as category III for eye
irritation potential and skin irritation potential and as category IV for acute dermal
toxicity, and EPA has no special concerns about  other adverse effects.

       Early Entry Personal Protective Equipment

       Personal protective equipment (PPE)  requirements for persons who must enter
areas that remain under a restricted-entry interval are based on the toxicity concerns
about the active  ingredient.  The requirements are set in one of two ways.

1.     If EPA has no special concerns about the  acute or other adverse effects of an
active ingredient, it establishes the  early-entry PPE requirements based on the acute
dermal toxicity,  skin irritation potential, and eye irritation potential of the active
ingredient.

2.     If EPA has special concerns about an active ingredient due to very high  acute
toxicity or to certain other adverse  effects, such as allergic  effects or delayed effects
(cancer,  developmental toxicity, reproductive effects, etc),  it may establish early-entry
PPE requirements that are more stringent than would be established otherwise.

       Since piperalin is classified  as category III for eye irritation potential and skin
irritation potential and category IV for acute dermal toxicity, and EPA has no special
concerns about other adverse effects, the PPE required for  early entry is coveralls,
chemical-resistant gloves, shoes, and socks.
                                  18

-------
       Environmental Hazard Labeling Statement

             This product is toxic to fish.  Do not apply directly to water or to areas where
       surface water is present or to intertidal areas below the mean high water mark.  Do not
       contaminate water when disposing of equipment washwaters.
C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregistration Eligibility Decision (RED).
Persons other than the registrant may generally distribute or sell such products for 50 months
from the date of the issuance of this RED. However,  existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of label
changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.

       The Agency has determined that registrants may distribute and sell piperalin [3-(2-
methylpiperdino)propyl 3,4-dichlorobenzoate] products bearing old labels/labeling for 26
months from the date of issuance of this RED.  Persons other than the registrant may
distribute or sell such products for  50 months from the date of the issuance of this RED.
Registrants and persons other than  registrants remain obligated to meet pre-existing Agency
imposed label changes and existing stocks requirements applicable to products they sell or
distribute.
                                        19

-------
20

-------
VI.  APPENDICES
       21

-------
22

-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
                           23

-------
24

-------
Date 07/20/94  )  Time 13:41
                                                                APPENDIX A  )  CASE 3114,  [Piperalin] Chemical  097003  [Piperalin]
                                                                                                                LUIS 1.4  ) Page  1
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil  Max.
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex.  Apps
  Surface Type (Antimicrobial only) & Effica-      less noted    unless noted Max.  @ Max
  cy Influencing Factor (Antimicrobial only)       otherwise)      otherwise) Dose  Rate
                                                Maximum Dose  Min.  Restr.        Geographic Limitations       Use
                                                 /crop cycle Interv Entry   Allowed                Disallowed  Limitations
                                                    or /year (days) Interv                                     Codes
                                                                    [day(s) ]
USES ELIGIBLE FOR REREGISTRATION

NON- FOOD/NON- FEED
ORNAMENTAL HERBACEOUS PLANTS

Spray., Foliar., Sprayer.

ORNAMENTAL WOODY SHRUBS AND VINES

Spray., Foliar., Sprayer.
SC/L  NA
SC/L  NA
Use Group: GREENHOUSE NON-FOOD CROP

  UC   *   NS                 NS AN

Use Group: GREENHOUSE NON-FOOD CROP

  UC   *   NS                 NS AN

-------
Date 07/20/94  _  Time 13:41                                    APPENDIX A  _  CASE 3114,  [Piperalin] Chemical  097003  [Piperalin]                             LUIS  1.4   _ Page
  HEADER ABBREVIATIONS
  Max. Apps @ Max Rate       :  Maximum number of Applications at Maximum Dosage Rate
  Min. Interv (days)         :  Minimum Interval between Applications  (days)
  Restr. Entry Interv  (days) :  Restricted Entry Interval  (days)

  SOIL TEXTURE FOR MAX APP.  RATE
  *       :  Non-specific
  C       :  Coarse
  M       :  Medium
  F       :  Fine
  O       :  Others

  FORMULATION CODES
  SC/L    :  SOLUBLE CONCENTRATE/LIQUID

  ABBREVIATIONS
  AN      :  As Needed
  NA      :  Not Applicable
  NS      :  Not Specified (on label)
  UC      :  Unconverted due to lack of data  (on label), or with one of following units: bag, bait, bait block, bait pack, bait  station,  bait  station(s),  block,  briquet,
            briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop,  eartag, grains,  lure,  pack,  packet,  packets,  pad,  part,
            parts, pellets,  piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab,  tablet,  tablets,  tag,  tape, towelette,  tray,  unit,  --

  APPLICATION RATE
  DCNC    :  Dosage Can Not be Calculated
  No Calc :  No Calculation can be made
  W       :  PPM calculated by weight
  V       :  PPM Calculated by volume
  cwt     :  Hundred Weight
  nnE-xx  :  nn times  (10 power -xx); for instance,  "1.234E-04" is equivalent to ".0001234"

  USE LIMITATIONS CODES
  C46 :  Do not apply through any type of irrigation system.
  * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS  (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.

-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                          27

-------
28

-------
                               GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Piperalin covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Piperalin in all products,
including data requirements for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

       1.  Data Requirement (Column 1).  The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment  Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.

       2.  Use Pattern  (Column 2).  This  column indicates the use patterns for which the data
requirements apply.  The following letter  designations are used for the given use patterns:

                           A      Terrestrial food
                           B      Terrestrial feed
                           C      Terrestrial non-food
                           D      Aquatic food
                           E      Aquatic non-food outdoor
                           F      Aquatic non-food industrial
                           G      Aquatic non-food residential
                           H      Greenhouse food
                           I       Greenhouse non-food
                           J       Forestry
                           K      Residential
                           L      Indoor food
                           M     Indoor non-food
                           N      Indoor medical
                           0      Indoor residential

       3.  Bibliographic citation  (Column 3).  If the Agency has acceptable data in  its files,
this column lists the identifying number of each study.  This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned.  Refer to the  Bibliography appendix for a  complete citation of the study.
                                          29

-------
30

-------
REQUIREMENT
                          APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Piperalin	
                                               	CITATION(S)
USE PATTERN
PRODUCT CHEMISTRY
61-1       Chemical Identity
61-2A     Start. Mat. & Mnfg. Process
61-2B     Formation of Impurities
62-1       Preliminary Analysis
62-2       Certification of limits
62-3       Analytical Method
63-2       Color
63-3       Physical State
63-4       Odor
63-5       Melting Point
63-6       Boiling Point
63-7       Density
63-8       Solubility
63-9       Vapor Pressure
63-10      Dissociation Constant
63-11      Octanol/Water Partition
63-12      pH
63-13      Stability
63-17      Storage stability
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL

                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                                     ALL
                 93185001, 93185001C, 40478401
                 93185002, 93185002C, 41035501
                 93185002, 93185002C, 41035501, 40478401
                 93185002, 41035501
                 93185002, 41035501
                 93185002, 41035501
                 93185003, 40295601
                 93185003, 40295601
                 93185003, 40295602
                 Inapplicable
                 93185003, 40295601
                 93185003, 40295601
                 93185003, 40295601, 40295602
                 93185003, 40295601, 40295603
                 93185003, 40295601
                 93185003, 40295601, 40295604
                 93185003, 40295601
                 43027701
                 40295601
                                                 31

-------
Data Supporting Guideline Requirements for the Reregistration of Piperalin
REQUIREMENT
USE PATTERN
CITATION(S)
ECOLOGICAL EFFECTS
71-1A
71-2A
72-2A
141-1
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Invertebrate Toxicity
Honey Bee Acute Contact
-
ALL
ALL
ALL

40407502
40407504
18842
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
82-3
82-4
83-3A
84-2A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21 -Day Dermal - Rabbit/Rat
90-Day Dermal - Rodent
90-Day Inhalation - Rat
Developmental Toxicity - Rat
Gene Mutation (Ames Test)
ALL
ALL
ALL
ALL
ALL
ALL
-
-

-
-
ALL
ALL
40503201a
40503201b
40503201c
41548701
40503201b
40678608
Waived
Waived
40509301
Waived
Waived
40584901
40503203
                                  32

-------
Data Supporting Guideline Requirements for the Reregistration of Piperalin
REQUIREMENT
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
ENVIRONMENTAL FATE
160-5 Chemical Identity
161-1 Hydrolysis
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching/Adsorption/Desorption
USE PATTERN CITATION(S)
ALL 40503202
ALL 40503204
More information needed
93185001, 93185001C, 40478401
ALL 40407501
More information is needed on the identity of
the degradates
ALL 41425201
Supplemental but upgradeable
ALL 41425202
Supplemental but upgradeable
ALL 42493001 - acceptable
41425203
Aged portion unsatisfied
                                  33

-------
34

-------
APPENDIX C.  Citations Considered to be Part of the Data
     Base Supporting the Reregistration of Piperalin
                          35

-------
36

-------
                               GUIDE TO APPENDIX C

1.      CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of all studies
       considered relevant by EPA in arriving at the positions and conclusions stated
       elsewhere in the Reregistration Eligibility Document. 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,
       are 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 also
       attempted 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 whenever a 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 4 (d) (4) below for further explanation).  In 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 identifying 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 standard of the American National Standards Institute
       (ANSI), expanded to provide for certain special needs.

       a     Author.  Whenever the author could confidently be identified, the Agency has
             chosen to show a personal author.  When no individual was identified, the
             Agency has shown an identifiable laboratory or testing facility as the  author.
             When no author or laboratory could be identified, the Agency has shown the
             first submitter as the author.

       b.     Document date.  The date of the study is taken directly from the document.
             When the date is followed by a question mark, the bibliographer has deduced
             the date from the evidence contained in the document.  When the date appears


                                           37

-------
       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 the 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.  When authorship is
             defaulted to the submitter, this element is omitted.

       (4)    Volume Identification (Accession Numbers).  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," which stands 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.
                                    38

-------
                                BIBLIOGRAPHY
MRID
CITATION
40295601     Handy, P. (1987) Physical and Chemical Properties of Piperalin: Laboratory
             Project I.D. PRH8706.  Unpublished study prepared by Lilly Research
             Laboratories.  6 p.

40295602     Handy, P. (1987) Determination of the Solubility of Piperalin in Water and
             Several Organic Solvents: Laboratory Project I.D. PRH8704. Unpublished
             study prepared by Lilly Research Laboratories.  9 p.

40295603     Koenig, D. (1987) Vapor Pressure of Piperalin:  Laboratory Project I.D.
             AAC8717.  Unpublished study prepared by Lilly Research Laboratories.  15 p.

40295604     Handy, P. (1987) Determination of the Octanol/Water Partition Coefficient for
             Piperalin: Laboratory Project I.D. PRH8705. Unpublished study prepared by
             Lilly Research Laboratories.  9 p.

40407501     Koenig, D. (1987) Hydrolysis of Piperalin in Buffer Solution: Laboratory
             Project ID: AAC8718.  Unpublished study prepared by Lilly Research
             Laboratories.  23 p.

40407502     Negilski, D.;  Meyerhoff, R. (1987)  The Toxicity of Piperalin to Juvenile
             Bobwhite in a Five-day Dietary Study: Laboratory Project ID: A00487.
             Unpublished study prepared by Lilly Research Laboratories.  38 p.

40407504     Negilski, D.;  Grothe, D.; Mohr, R. (1987) Acute Toxicity of Piperalin to
             Daphnia magna in a Static-renewal Test System: Laboratory  Project ID:
             C00887.  Unpublished study prepared by Lilly Research Laboratories. 36 p.

40478401     Day, E.; Coghlan, M. (1987) Product Chemistry Data Relationg to Potential
             Formation of Halogenated Dibenzo-P-dioxin  or Dibenzofuran Contaminants in
             Piperalin: EWD8730.  23 p.

40503201     Negilski, D.;  Brown, G.; Markey, T. (1987) The Acute Oral, Dermal and
             Inhalation Toxicity and Primary  Dermal Irritation of Technical Piperalin:
             Project ID: R-0-87, R-0-79-87.  Unpublished compilation prepared by Lilly
             Research Laboratories.  49 p.

40503202     Probst, G. (1987) The Effect of Piperalin on  the Induction of Forward Mutation
             at the Thymidine Kinase Locus of L5178Y Mouse Lymphoma Cells: Project
             ID: 870513MLT2967.  Unpublished study prepared by Lilly Research

                                         39

-------
                                BIBLIOGRAPHY
MRID
CITATION
             Laboratories.  37 p.

40503203     Probst, G. (1987) The Effect of Piperalin on the Induction of Reverse
             Mutations in Salmonella typhimurium and Escherichia coli Using the Ames
             Test: Project ID: 870420AMT2967.  Unpublished study prepared by Lilly
             Research Laboratories.  28 p.

40509301     Negilski, D.; Van Pelt, C.; Torrence, T. (1988) Subchronic (21-Day) Dermal
             Toxicity Study in New Zealand White Rabbits with Technical Piperalin: Project
             ID: B01987. Unpublished study prepared by Lilly Research Laboratories.  479
             P-

40584901     Negilski, D.; Liu, S. (1988) A Teratology Study of Piperalin (EL-211,
             Compound 038648) Administered Orally to CD Rats: Laboratory Project ID
             R13487.  Unpublished study prepared by Lilly Research Laboratories.  365 p.

40678608     Negilski, D. (1988) A Dermal Sensitization Study of Pipron E.G., ...
             Containing Eight Pounds of Piperalin ... per Gallon of Formulation, in Guinea
             Pigs: Project ID. G01287.  Unpublished study prepared by Lilly Research
             Laboratories.  37 p.

41035501     Handy, P. (1989) Manufactured Product Characterization of Technical
             Piperalin: Proj. ID AAC8715.  Unpublished study prepared by Lilly Research
             Laboratories.  25 p.

41425201     Rainey,  D.  (1990) Aerobic Soil Metabolism of CCarbon 14 Piperalin: Lab I.D.
             Number ABC0430.  Unpublished study prepared by  DowElanco, Plant Science
             Chemical Development.  33 p.

41425202     Rainey,  D.  (1990) Anaerobic Soil Metabolism of CCarbon 14 Piperalin Lab
             I.D. Number:  ABC0431. Unpublished study prepared by  DowElanco, Plant
             Science Chemical Development. 32 p.

41425203     Saunders, D. (1990) Piperalin Aged Soil Leaching Study:  Lab I.D. Number:
             DGS8902.  Unpublished study prepared by DowElanco, Plant Science Chemical
             Development.  37 p.

41548701     Negilski, D.; Rock, G.;  Weaver,  D. (1990) The Acute Ocular Irritation of
             Piperalin (EL-211, Compound 038648) in the New Zealand White Rabbit: Lab

                                         40

-------
                                BIBLIOGRAPHY
MRID
CITATION
             Project I.D.: B02290. Unpublished study prepared by Lilly Research
             Laboratories, Toxicology Div.  24 p.

43012201     Weinberg, J.; Kirk, H.;  Miller, J.; et al. (1993) Evaluation of the Acute
             Toxicity of Piperalin to the Bluegill, Lepomis macrochirus Rafinesque: Lab
             Project Number: DECO-ES-2722. Unpublished study prepared by Dow
             Chemical Environmental Toxicity & Chemistry Research Lab. 27 p.

43027701     Jones-Jefferson, T. (1993) Determination of the Stability of Piperalin Technical
             Grade of Active Ingredient (TGAI): Lab Project Number: FOR93123.
             Unpublished study prepared by DowElanco. lip.

93185001     Environ Corp.  (1990) Elanco Products Co.  Phase 3 Summary of MRID
             40478401. Product Chemistry Data Relating to Potential Formation of
             Halogenated Dibenzo-P-Dioxin or Dibenzofuran Contaminants in Piperalin,
             EWD8730. 24 p.

93185002     Environ Corp.  (1990) Elanco Products Co.  Phase 3 Summary of MRID
             41035501. Manufactured Product Characterization of Technical Piperalin,
             AAC8715.  Prepared by Lilly Research Laboratories. 17 p.

93185003     Environ Corp.  (1990) Elanco Products Co.  Phase 3 Summary of MRID
             40295601 and Related MRIDs 40295602, 40295603, 40295604. Physical and
             Chemical Properties  of Piperalin, PRH8706; Determination of the Solubility of
             Piperalin in Water and Several Organic Solvents; Vapor Pressure of Pipertalin,
             AAC8717; and Determination of the Octanol/ Water Partition Coefficient for
             Piperalin, PRH8705.  8 p.
                                         41

-------
42

-------
APPENDIX D.  List of Available Related Documents
                     43

-------
44

-------
       The following is a list of available documents related to Piperalin. It's purpose is to
provide a path to more detailed information if it is needed.  These accompanying documents
are part of the Administrative Record for Piperalin and are included in the EPA's Office of
Pesticide Programs Public Docket.

       1.      Health and Environmental Effects Science Chapters

       2.      Detailed Label Usage Information System (LUIS) Report

       3.      Piperalin RED Fact Sheet

       4.      PR Notice 86-5 (included in this appendix)

       5.      PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
              Statement
                                          45

-------
46

-------
APPENDIX E.  PR Notices 86-5 and 91-2
                  47

-------
48

-------
PR Notice 86-5
      49

-------
50

-------
              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

   tpno1                        WASHINGTON, D.C. 20460

                                  July 29, 1986

                                                            OFFICE OF
                             PR NOTICE 86-5           PREVENTION, PESTICIDES
                                                     AND TOXIC SUBSTANCES


          NOTICE TO PRODUCERS,  FORMULATORS, DISTRIBUTORS
                         AND REGISTRANTS

Attention:      Pers9ns responsible for Federal  registration  of
                pesticides.

Subject:        Standard format for data submitted under  the
                Federal Insecticide, Fungicide,  and Rodenticide
                Act  (FIFRA)  and certain provisions of the Federal
                Food, Drug,  and Cosmetic Act  (FFDCA).

I.    Purpose

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

II.   Applicability

     This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting  or maintaining
pesticide registrations, experimental  use  permits, tolerances,
and related approvals under certain provisions  of FIFRA  and
FFDCA.  These data are defined in FIFRA 10(d)(1).  This Notice
does not apply  to commercial, financial, or production
information, which are, and must continue  to be, submitted
differently under separate  cover.

Ill.  Effective  Date

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

IV.   Background

     On September 26, 1984, EPA published  proposed regulations  in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR 158.32), and  Procedures for Claims  of
Confidentiality of Data (40 CFR 158.33).  These regulations
specify the format for data submitted  to EPA under Section 3 of
FIFRA and Sections 408 and  409 of FFDCA, and procedures  which
must be followed to make and substantiate  claims of confiden-
tiality.  No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.

     OPP is making these requirements  mandatory through  this
Notice to gain  resource-saving benefits from their use before the


                                51

-------
entire proposed regulation becomes final.  Adequate lead time is
being provided for submitters to comply with the new
requirements.

V.   Relationship of this Notice to Other OPP Policy and Guidance

     While this Notice contains requirements for organizing and
formatting submittals of supporting data,  it does not address the
substance of test reports themselves.  "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.

     OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA 3.  The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages.  As of the effective date of this Notice,  the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.

     OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards  (see
40 CFR 154.15 and 155.32).  To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.

     For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party.  That requirement is not altered by this notice, which
applies only to data submitted with an application.

VI.   Format Requirements

     A more detailed discussion of these format requirements
foll9ws the index on the next page, and samples of some of the
requirements are attached.  Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative.  As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.

                             -  INDEX-
                                                            Text Example
                                                            Page   Page
A.   Organization of the Submittal Package	3      17

B.   Transmittal Document	4      11

C.   Individual Studies 	  4

     C. 1  Special Considerations for Identifying Studies  .  .  5

D.   Organization of each Study Volume	6      17

     D. 1  Study Title Page	7      12


                                   52

-------
     D. 2  Statement of Data Confidentiality Claims
                   (based on FIFRA 10 (d) (1)1   	8      13
     D. 3  Confidential Attachment	8      15
     D. 4  Supplemental Statement of Data Confidentiality
            Claims  (other than those based on FIFRA 10(d)(1) )  8      14
     D. 5  Good Laboratory Practice Compliance Statement   .  .  9      16

E.   Reference to Previously Submitted Data 	  9

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

G.   Special Requirements for Submitting Data to the Docket   10
A.   Organization of Submittal Package

     A "submittal package" consists of all studies submitted at
the same time f9r review in support of a single regulatory
action, along with a transmittal document and other related
administrative material  (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.

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

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

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

     - If such materials relate to more than one study  (as for
     example a summary of all studies in a discipline) or to the
     submittal in general, they must be included in the submittal
     package as a separate study  (with title page and statement
     of confidentiality claims).

B.   Transmittal Document

     The first item in each submittal package must be a trans-
mittal document.  This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, 3(c)(2)(B) data
call-in,  6(a)(2) submittal, 9r a special review; the transmittal
date; and a list of all individual studies included in the
 gackage in the order of their appearance, showing (usually by
 uideline reference number)  the data requirement(s)  addressed by
each one.  The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter.  See Attachment 1 for an example of an
acceptable transmittal document.

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

     The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an


                                53

-------
application for an EUP should be subdivided into sections A, B,
C,....  of the petition or application,  as defined in 40 CFR 180.7
and 158.125, (petitions)  or Pesticide Assessment Guidelines,
Subdivision I (EUPs)  as appropriate.

     When a submittal package supports a tolerance petiti9n and
an application for a registration or an EUP, list the petition
studies first,  then the balance of the studies.  Within these two
groups of studies follow the instructions above.

C.   Individual Studies

     A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness.   A study should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title.   Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I.  Each study included in a submittal
 Eackage must be bound as a separate entity.  (See comments on
 inding studies on page 9.)

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

     - Include the total number of pages in the complete study on
     each page (i.e., 1 of 250, 2 of 250,  ...250 of 250).

     - Include a company name or mark and study number on each
     page of the study, e g ,  Company Name-1986-23.    Never reuse
     a study number for marking the pages of subsequent studies.
     When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series,  and each volume is plainly identified
by the study title and its position in the multi-volume sequence.

C.1  Special Considerations for Identifying Studies

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

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

     Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies.   Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices.  When such supplemental reports are
submitted independently of the primary report,  take care to fully
identify the primary report to which they pertain.

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

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

     Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product


                                54

-------
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series  (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides.  The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10,  151-11,  and 151-12; the second
would cover Guidelines 151-13,  151-15,  and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21,  and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25;  the third would
cover Guideline 151-26.

     Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
10(d)(1)(A), (B) ,  or  (C),  and if so must be handled as described
in section D.3.  of this notice.

     c.   Residue Chemistry Studies.   Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code.  The general principle,
h9wever, of limiting a study to the report of a single inves-
tigation still applies fully.  Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop.  When more than one commodity is derived from a
single crop  (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study.  When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
     Each complete study must include all applicable elements in
the list below, in the order indicated.  (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs.   Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element

Study Title Page

Statement of Data
Confidentiality
Claims

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

Cover Sheet to Confi-
dential Attachment
                    When Required                 Example

                    Always                        Page 12

                    One of the two alternative    Page 13
                    forms of this statement
                    is always required

                    If study reports Iaborat9ry   Page 16
                    work subject to GLP require-
                    ments

                    For certain t9xicology studies (When
                    flagging requirements are finalized.)

                    Always - with an English language
                    translation if required.

                    At submitter's option

                    If CBI is claimed under FIFRA
                    10 (d) (1) (A) ,  (B) ,  or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
                    If CBI is claimed under FIFRA
                    10 (d) (1) (A) ,  (B) ,  or (C)      Page 15

                    Only if confidentiality is    Page 14
                    claimed on a basis other than
                    FIFRA 10(d)(1)(A),  (B),  or (C)
                                55

-------
D.I. Title Page

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

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

b.   Data requirement addressed.  Include on the title page the
Guideline number(s)  of the specific requirement(s) addressed by
the study.

c.   Author(s).  Cite only individuals with primary intellectual
responsibility for the C9ntent 9f the study.  Identify them
plainly as authors,  to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.

d.   Study Date.  The title page must include a single date for
the study.  If parts of the study were performed at different
times, use only the date of the latest element in the study.

e.   Performing Laboratory IdentificatJ9n.   If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work.  Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.

f.   Supplemental Submissions.  If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers.   (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary stuay.  Do not include supplements to more than one
study under a single title page).

g.    Facts of Publication.  If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication,  such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.


D.2. Statements of Data Confidentiality Claims Under FIFRA
10(d) (1) .

     Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in 158.33 (b) and (c)    (See
Attachment 3).   These statements apply only to claims of data
confidentiality based on FIFRA 10(d)(1)(A), (B),  or  (C).   Use
the appropriate alternative form of the statement either to
assert a claim of 10(d)(l) data confidentiality  (158.33(b)) or
to waive such a claim (158.33(c)).  In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it.  09 not make CBI
claims with respect to analytical methods associated with pet-


                                56

-------
itions for tolerances or emergency exemptions  (see NOTE Pg 13).

D.3. Confidential Attachment

     If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
10(D)(1)(A),   (B),  or (C) (as described in D.2. above) all such
information must be excised from the body 9f the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised  (See Attachment 5).

     The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment."  An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet.  Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page.   Each passage confined t9 the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
10(d)(1)  on which the confidentiality claim is based.

D.4. Supplemental Statement of Data Confidentiality Claims (See
     Attachment 4)

     If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA 10(d)
(1)(A), (B),  or  (C),  the following provisions apply:

     - The specific information to which the claim applies must
     be clearly marked in the body of the study as subject to a
     claim of confidentiality.

     - A Supplemental Statement 9f Data Confidentiality Claims
     must be submitted,  identifying each passage claimed confi-
     dential and describing in detail the basis for the claim.
     A list of the points to address in such a statement is
     included in Attachment 4 on Pg 14.

     - The Supplemental Statement of Data Confidentiality Claims
     must be signed and dated and must include the typed name and
     title of the official who signed it.

D.5. Good Laboratory Practice Compliance Statement

     This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160.  Sam-
ples of these statements are shown in Attachment 6.

E.    Reference to Previously Submitted Data

     DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it.   A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review.  This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study.  References to pre-
viously submitted studies smpuld not be included in the transmit-
tal document,  but should be incorporated into the statement of
the method of support for the application.

F.    Physical Format Requirements

     All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed 9n one side only in
black  ink,  with high contrast and good res9lution.  Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming.  Check with EPA for special


                                57

-------
instructions bef9re submitting data in any medium other than
paper, such as film or magnetic media.

Please be particularly attentive to the following points:

         Do not include frayed or torn pages.

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

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

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

         Do not bind any documents with glue or binding tapes.

         Make sure that all pages of each study, including any
          attachments or appendices, are present and in correct
          sequence.

     Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below)  must be provided In three complete,  identical
copies.  (The prop9sed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)

G.   Special Requirements for Submitting Data to the Docket

     Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised.   This
fourth copy will become part of the public docket for the RS or
SR case.  If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three.  When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice.  The following
special preparation is required for the fourth copy.

         Remove the "Supplemental Statement of Data
          Confidentiality Claims".

         Remove the "Confidential Attachment".

         Excise from the body of the study any information you
          claim as confidential, even if it does not fall within
          the scope of FIFRA 10(d)(1)(A), (B),  or  (C).  Do not
          close up or paraphrase text remaining after this
          excision.

         Mark the fourth copy plainly on both its cover and its
          title page with the phrase "Public Docket Material -
          contains no information claimed as confidential".
                                58

-------
V.    For Further Information

     For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
                              /S/

                         James W. Akerman
                         Acting Director,
                         Registration Division
Attachment 1.   Sample Transmittal Document
Attachment 2.   Sample Title Page for a Newly Submitted Study
Attachment 3.   Statements of Data Confidentiality Claims
Attachment 4.   Supplemental Statement of Data Confidentiality
               Claims
Attachment 5.   Samples of Confidential Attachments
Attachment 6.   Sample G9od Laboratory Practice Statements
Attachment 7.   Format Diagrams for Submittal Packages and Studies
                                59

-------
                          ATTACHMENT 1

       ELEMENTS  TO  BE  INCLUDED  IN THE  TRANSMITTAL  DOCUMENT*

1.   Name and address of submitter  (or all joint submitters**)

"Smith Chemical  Corporation              Jones Chemical Company
 1234 West Smith Street       -and-      5678 Wilson Blvd
 Cincinnati, OH 98765                    Covington, KY 56789



"Smith Chemical  Corp will  act as  sole  agent  for all submitters.

2.   Regulatory action in support of which this package is
     submitted

Use the EPA identification number  (e.g. 359-EUP-67) if you know
it.  Otherwise describe the type of request  (e.g.  experimental
use permit, data call-in - of xx-xx-xx date).

3.   Transmittal date

4.   List of submitted studies

     Vol 1.    Administrative materials - forms, previous corres-
               pondence with Project Managers, and so forth.

     Vol 2.    Title of first study in the submittal (Guideline
               No.)

     Vol n     Title of nth study in the submittal (Guideline
               No.)

     *    Applicants commonly provide this information in a tran-
          smittal letter.   This remains an acceptable practice so
          long as all four elements are included.

     *    Indicate which of the J9int submitters is empowered to
          act on behalf of all joint submitters in any matter
          concerning data compensation or subsequent use or
          release of the data.


Company Official: 	
                    Name                Signature

Company Name       	

Company Contact:  	 	
                    Name                Phone
                                60

-------
                   ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
                    Study Title
   (Chemical name)  - Magnitude  of  Residue  on  Corn
                  Data  Requirement
                  Guideline 171-4
                       Author
                   John C. Davis
                 Study  Completed On
                  January 5, 1979
               Performing Laboratory
           ABC Agricultural Laboratories
                 940 West  Bay Drive
               Wilmington,  CA  39897
               Laboratory Project ID
                     ABC 47-79
                    Page 1 of X
   (X is the total number of pages in the study)
                         61

-------
                            ATTACHMENT 3

             STATEMENTS  OF DATA CONFIDENTIALITY CLAIMS

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

        STATEMENT OF NO  DATA CONFIDENTIALITY CLAIMS
   No  claim of  confidentiality is made for any information contained  in this
   study on the basis of  its falling within the scope of FIFRA
   610(d)(1)(A),  (B),  or (C).


   Company 	


   Company Agent: 	Typed Name	 Date:	


   	Title	  	Signature	
2. Claim of confidentiality under FIFRA 10(d)(1)(A),  (B),  or (C).
   Information  claimed confidential on the basis of its falling within the
   scope of FIFRA 10(d)(1)(A),  (B), or (C) has been removed to a
   confidential appendix, and is  cited by cross-reference number in the body
   of  the study.


    Company: 	


    Company Agent: 	Typed Name	 Date:	


   	Title	  Signature 	
             STATEMENT OF DATA  CONFIDENTIALITY  CLAIMS

NOTE: Applicants for  permanent or temporary tolerances  should
note that  it is OPP policy that no permanent tolerance,  temporary
tolerance,  or request for an emergency  exemption incorporating an
analytical  method, can be approved unless the applicant  waives
all claims  of confidentiality for the analytical method.   These
analytical  methods are published in the FDA Pesticide Analytical
Meth9ds  Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods,  for which confidentiality claims have been  made,  to the
submitter,  to obtain  the  confidentiality waiver before  they can
be processed.
                                  62

-------
                          ATTACHMENT 4

      SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
     For any portion of a submitted study that is not described
by FIFRA 10(d)(1)(A), (B),  or (C),  but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:

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

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

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

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

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

         Encl9se C9pies of any pertinent determinations of
          confidentiality made by EPA, other Federal agencies, of
          courts concerning this information.

         If y9u assert that disclosure of this information would
          be likely to result in substantial harmful effects to
          you, describe th9se harmful effects and explain why
          they should be viewed as substantial.

         If you assert that the informati9n in voluntarily sub-
          mitted, indicate whether you believe disclosure of this
          information might tend to lessen the availability to
          EPA of similar information in the future, and if so,
          how.
                                63

-------
                                   ATTACHMENT 5

              EXAMPLES OF SEVERAL  CONFIDENTIAL ATTACHMENTS

Example  1.  (Confidential  word or phrase  that has  been  deleted
from  the study)
    CROSS REFERENCE NUMBER 1       This cross reference number is used in the study in place of the
                                     following paragraph (s) at the indicated volume and page
                                     references.
    DELETED WORDS OR PHRASE:              Ethylene Glycol
    PAGE         LINES  REASON FOR THE DELETION                      FIFRA
    REFERENCE
     6            14     Identity of Inert Ingredient                           10(d)(C)
    28           25
    100           19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
 CROSS REFERENCE NUMBER 5       This cross reference number is used in the study in place of the
                                   following paragraph (s) at the indicated volume and page
                                   references.
  DELETED PARAGRAPH(S) :
        (                                                                   )
        (       Reproduce the deleted paragraph (s) here                              )
 PAGE         LINES REASON FOR THE DELETION               FIFRA REFERENCE
  20.           2-17   Description of the quality control process           1 0 (d) ( 1) (C)
Example 3. (Confidential pages that have been deleted from the study)
 CROSS REFERENCE NUMBER 7      This cross reference number is used in the study in place of the
                                  following paragraph (s) at the indicated volume and page
                                  references.
 DELETED PAGES(S): are attached immediately behind this page

 PAGES        REASON FOR THE DELETION               FIFRA REFERENCE
 35-41.        Description of product manufacturing process             10 (d) (1) (A)
                                           64

-------
                             ATTACHMENT 6.

            SAMPLE GOOD LABORATORY PRACTICE STATEMENTS

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

           Submitter 	

           Sponsor   	
Example 2.
    This study does not meet the  requirements of 40  CFR  Part 160, and
    differs  in the following ways:

    1.	

    2.	

    3.	

          Submitter	

          Sponsor	
          Study Director_
Example 3.
    The submitter of this study was neither the sponsor of this study nor
    conducted  it, and does not  know whether it has  been conducted in
    accordance with 40 CFR Part 160.

          Submitter
                                    65

-------
                              ATTACHMENT  7.
                     FORMAT OF THE SUBMITTAL PACKAGE
                       Transmittal Document

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

                                   Other materials about the submittal
                                   (e.g., summaries of groups of studies
                                   to aid in their review).

                                           Studies submitted as unique
                                           to the format below.
                      FORMAT OF SUBMITTED STUDIES
                 Study title page.

                      Statement of Confidentiality Claims.

                           GLP and flagging* statements - as appropriate.

                                 Body of the study, with English
                                 language translation if required.
                                     Appendices to the study.
                                          Title Page of the Confidential
                                          Attachment.
                                             Confidential Attachment.
                                               Supplemental Statement
                                               of Confidentiality Claims
                                      When flagging requirements
                                      are finalised.
                 Documents which must be submitted as
                 appropriate to meet established requirements.

                      Documents submitted at submitter's option.
LEGEND
                                       66

-------
PR Notice 91-2
      67

-------
68

-------
              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                             WASHINGTON, B.C. 20460
                                                         OFFICE OF
                                                     PREVENTION, PESTICIDES
                                                     AND TOXIC SUBSTANCES
                          PR NOTICE 91-2

         NOTICE  TO MANUFACTURERS,  PRODUCERS,  FORMULATORS,
                  AND REGISTRANTS OF PESTICIDES

ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement

I.  PURPOSE:

     The purpose of this notice is to clarify the Office of
Pesticide P^gram's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount  (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that  term
is defined in 40 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.

II.  BACKGROUND

     For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the  only
acceptable label claim for the amount of active ingredient in the
product.

     Current regulations require that the percentage listed  in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175 (c) (3) .

     The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C),  while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.

     The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual


                                69

-------
product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.

     It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b).  In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).

III. REQUIREMENTS

     As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s)  statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid).  In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e.,  upper limit(s) 9nly) and on a case by case
basis as specified by EPA.  These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.

     The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.

     After July 1,  1997, all pesticide ingredient Statements must
be changed to nominal concentration.

IV. PRODUCTS THAT REQUIRE EFFICACY DATA

     All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy.  This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.

     In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

     As described earlier,  the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs,  i.e.,  reregistration,  new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:

     (1)  Beginning July 1, 1991, all new product registrations
          submitted to the Agency are to comply with the
          requirements of this Notice.
                                70

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

     (3)  All other products/applications that are not subject to
          (1) and  (2) ab9ve will have until July 1, 1997, to
          comply with this Notice. Such applications should note
          "Conversion to Nominal Concentrations on the
          application form. These types Or amendments will not be
          handled as "Fast Track" applications but will be
          handled as routine requests.

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.


                                   /s/
                         Anne E. Lindsay, Director
                         Registration Division (H-7505C)
                                71

-------
72

-------
APPENDIX F.  Combined Generic and Product Specific
                  Data Call-In
                       73

-------
74

-------
                         GENERIC AND PRODUCT SPECIFIC
                               DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:

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

       1.     How you will comply with the requirements set forth in this Notice and its
             Attachments  1 through 7; or

       2.     Why you believe you are exempt from the requirements listed in this Notice and
             in Attachment 3 (for both generic  and product specific data),  the Requirements
             Status and  Registrant's Response Form,  (see section III-B); or

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

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice  will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2.  All products are listed on both the
generic  and product specific Data Call-in Response Forms.   Also included is a list of all
registrants who were sent this Notice  (Attachment 6).

       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).  Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and  2070-0057 (expiration date 3-31-96).

       This Notice is divided into six sections and seven Attachments.  The Notice itself
contains information and  instructions applicable to all Data Call-In  Notices.  The Attachments
contain  specific chemical information and instructions.  The six sections of the Notice are:

Section  I     -      Why You are Receiving this Notice
Section  II    -      Data Required by this Notice
Section  III   -      Compliance with Requirements of this Notice
Section  IV   -      Consequences of Failure to Comply with this Notice
Section  V    -      Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section  VI   -      Inquiries and Responses to this Notice

       The Attachments to this Notice are:

       1 -    Data Call-In Chemical  Status Sheet
                                          75

-------
       2 -    Generic Data Call-in and Product Specific Data Call-in Response Forms with
             Instructions
       3 -    Generic Data Call-In and Product Specific Data Call-In Requirements Status
             and Registrant's Response Forms with Instructions
       4 -    LPA Grouping or End-Use Products for Meeting Acute Toxicology Data
             Requirements tor Reregistration
       5 -    LPA Acceptance Criteria
       6 -    List or Registrants Receiving This Notice
       7 -    Cost Share and Data Compensation Forms


SECTION I. WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient (s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation  identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because
you have product (s)  containing the subject active ingredients.


SECTION II. DATA REQUIRED BY THIS NOTICE

II-A. DATA REQUIRED

       The data required by this Notice are specified in the  Requirements Status and
Registrant's Response  Forms: Attachment 3 (for both generic and product specific data
requirements).  Depending on the results of the studies required in this Notice, additional
studies/testing may be required.

II-B. SCHEDULE FOR SUBMISSION OF DATA

       You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status  and Registrant's Response Forms (Attachment 3) within the
timeframes provided.

II-C. TESTING PROTOCOL

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

       These EPA Guidelines are available  from the  National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).

       Protocols approved  by the  Organization for Economic Cooperation and Development
(OECD) are  also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40  CFR  158.70). When using the
C"ECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40  CFR  158.  Normally, the Agency will not extend
deadlines for complying with data requirements when the  studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
Street, N.W., Washington, D.C. 20036  (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).

       All new studies and proposed  protocols  submitted in response to this Data Call-In
Notice must  be in accordance with Good Laboratory  Practices [40 CFR Part 160].
                                         76

-------
II-D.   REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
       BY THE AGENCY
       Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-in (s),  or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice  of Intent to Suspend their affected
products.


SECTION III.       COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

       You must use the correct forms and instructions when completing your response to  this
Notice.  The type of Data Call-In you must comply with  (Generic or Product Specific) is
specified in item number 3 on the four Data Call-in forms (Attachments 2 and 3).

III-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

       The appropriate responses initially required by this Notice  for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS  due to failure to comply with this Notice are presented in Section IV-A and
IV-B.

III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

       1. Generic Data Requirements

       The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation,  (b) delete use(s), (c) claim generic data exemption, (d)  agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver (s).

       A discussion of how to respond if you choose the  Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying the generic  data requirements of this Notice is
contained in Section III-C. A discussion of options relating to requests for data waivers is
contained in Section III-D.

       Two forms apply to generic data requirements,  one or both of which must be used in
responding to the Agency, depending upon your response. These  two forms are the
Data-CalHn Response Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments Z and 3, respectively).

       The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted  if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration^).  Please note  that the company's authorized representative is required to
sign  the first page of both Data Call-in Response Forms and the Requirements Status and
Registrant's Response Forms (if this form is required) and initial any subsequent pages. The
forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing your response, call or write the
contact person (s) identified in Attachment  1.

       a.     Voluntary Cancellation -

       You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product (s)  containing the active ingredient that is the subject  of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific


                                          77

-------
Data Call-in Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In Response Form(s). If you
choose this option, these are the only forms that you are required to complete.

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

       b.     Use Deletion -

       You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and Registrant's Response Form (Attachment 3), a
completed application tor amendment, a copy of your proposed amended labeling, and all
other information required for processing the application.  Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
You must also complete a Data Call-In Response Form by signing the certification, item
number 8.  Application forms tor amending registrations may be obtained from the
Registration Support Branch, Registration Division,  Office of Pesticide Programs, EPA,  by
calling (703)      ~~-~
       If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.

       c.     Generic Data Exemption -

       Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning  an active ingredient if
the active ingredient in the product is derived exclusively from purchased,  registered pesticide
products containing the active ingredient.  EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product  which would qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of  FIFRA. To  qualify,
all of the following requirements must be met:

       (i).  The active ingredient in your registered product must be present solely because of
       incorporation of another registered product which contains the subject active ingredient
       and is purchased from a source not connected with you;


       (ii).  Every registrant who is the ultimate source of the active ingredient in your
       product subject to this DCI must be in compliance with the requirements of this Notice
       and must remain in compliance; and

       (iii). You must have provided to EPA an accurate and current " Confidential Statement
       of Formula" for each of your products to which this Notice applies.

       To apply for the Generic Data Exemption you must submit a completed Data Call-in
Response Form, Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number  6a on the  Data Call-in Response Form. If you claim a generic data exemption
you are not required to compiete the Requirements Status and Registrant's  Response Form.
Generic Data Exemption  cannot be selected as an option tor responding to  product specific
data requirements.

       If you are granted a Generic Data  Exemption,  you rely on the efforts of other persons
to  provide the Agency with the required data. If the registrant^) who have committed to
generate and submit the required data fail to take appropriate  steps to meet requirements or are
no longer in compliance with this Data Call-In Notice, the Agency will consider that both they
and you are not compliance and will normally initiate proceedings to suspend the registrations


                                          78

-------
of both your and their product(s), unless you commit to submit and do submit the required
data within the specified time.  In such cases the Agency generally will not grant a time
extension for submitting the data.

       d.    Satisfying the Generic Data Requirements of this Notice

       There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section III-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-in Response Form,  if you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form as weii as any other information/data
pertaining to the option chosen to address the data requirement.  Your response must be on the
forms marked "GENERIC"  in item number 3.

       e.    Request for Generic Data Waivers.

       Waivers for generic data are discussed in Section III-D.l.  of this Notice and are
covered by options 8 and 9 of  item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
       2. Product Specific Data Requirements

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

       A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C.2. A discussion of
options relating to requests for data waivers is contained in Section III-D.2.

       Two forms apply to the product specific  data requirements one or both of which must
be used in responding to the  Agency, depending upon your response.  These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
for product specific data (contained in Attachments 2 and 3, respectively).  1 he Data CallTn
Response Form must be submitted as part of every response to this Notice.  In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product  listed on the Data Caii-ln Response Form uniess the voluntary  cancellation option
is selected. Please note that  the company's authorized representative is required to sign the
first page of the Data Call-In Response Form and Requirements Status and Registrant s
Response Form  (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options.  Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.

       a.     Voluntary Cancellation

       You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product (s) containing the active ingredient  that is the subject of this Notice. If you wish
to  voluntarily cancel your product, you must submit a completed  Data Call-In Response Form,
indicating your election of this option. Voluntary cancellation is item number b on both the
Generic and Product Specific Data Call-in Response Forms.  If you choose this
option, you must complete both Data Call-In response forms. These are the only forms that
you are required to complete.


                                           79

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

       b.     Satisfying the Product Specific Data Requirements of this Notice.

       There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section III-C.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form  and item numbers 7a and 7b (agree to satisfy the product
specific data requirements for an MUP  or EUP as applicable) on the product specific Data
Call-in Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those  options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the  Reregistration Eligibility
Decision document.

       c.     Request for Product Specific Data Waivers.

       Waivers for product specific data are discussed in Section III-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's  Response Form.  If you choose this option, you must submit the Data Call-In
Response Form and the Requirements Status and Registrant's Response Form as well as any
other information/data pertaining to the option chosen to address the data requirement.  Your
response must be on the forms marked  "PRODUCT SPECIFIC" in item number 3.

III-C SATISFYING THE DATA REQUIREMENTS  OF THIS NOTICE

       1.     Generic Data

       If you acknowledge  on the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic Requirements Status and Registrant's Response Form
related to data production for each  data requirement.  Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed
immediately below with information in  parentheses to guide you to additional instructions
provided in this Section. The options are:

       (1)    I will generate and submit data within the specified timeframe (Developing
             Data)
       (2)    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost  Sharing)
             I have made offers to cost-share  (Offers to Cost Share)
             I am submitting an existing study that has not been submitted previously to the
             Agency by anyone (Submitting an Existing Study)
       (5)    I am submitting or citing data to upgrade a study classified by EPA as partially
             acceptable and upgradeable (Upgrading a Study)
       (6)    I am citing an existing study that EPA has classified as acceptable or an existing
             study that has been submitted but not reviewed by the Agency (Citing an
             -i-i.-i.   Oj_1\                                      OJVO
             Existing Study)

Option 1. Developing Data

       If you choose to develop the required data it must be in conformance with Agency
deadlines and with other Agency requirements as referenced herein and in the attachments. All
data  generated and submitted must comply with  the Good Laboratory Practice (GLP) rule (40


                                          80

-------
CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be
in conformance with the requirements of PR Notice 86-5. In addition, certain studies require
Agency approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wish to use a protocol which differs from
the options discussed in Section II-C of this Notice, you must submit a detailed description of
the proposed protocol and your reason for wishing to use it. The Agency may choose  to reject
a protocol not specified in Section II-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.

       A progress  report must be submitted for each study within 90 days from the date you
are required to commit to generate or  undertake some other means to address that study
requirement, such as making an offer  to cost share or agreeing to share in the cost of
developing that study.  This 90-day progress report must include the date the study was or will
be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies)  or individuals who are or will be conducting the study.

       In addition, if the time frame for submission of a final report is more  than 1 year,
interim  reports must be submitted at 12 month  intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to  the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the  status of the study must be included as well as a full
description of any problems encountered since  the last progress report.


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

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

Option 2. Agreement to Share in Cost to Develop Data

       If you choose to enter  into an agreement to share  in the cost of producing  the required
data but will not be submitting the data yourself, you must provide the name  of the registrant
who will be submitting the  data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence  may be your letter offering to join in an
agreement and the  other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not  specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the  parties cannot resolve the terms of the  agreement they
may resolve their differences through  binding arbitration.
                                           81

-------
Option 3. Offer to Share in the Cost of Data Development

       If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice.  EPA has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration  of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant^)  developing the data  has refused to accept the offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to another
registrant (who has an obligation to submit data) to share in the burden of developing that
data. You must also submit to the Agency a completed EPA Form 8570-32, Certification of
Offer to Cost Share in the  Development of Data, Attachment 7.  In addition, you must
demonstrate that the other  registrant to whom the offer was made has not accepted your offer
to enter into a cost-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that  offer (such as a certified mail  receipt).  Your offer must, in addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed to
or, failing agreement,  to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(Bj(iii) and must not qualify this offer. The other  registrant must also inform EPA of its
election of an option to develop and submit the data required  by this  Notice by submitting a
Data Call-In Response  Form and a Requirements Status and Registrant's Response Form
committing to  develop  and submit the data required  by this Notice.

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

Option 4. Submitting an Existing Study

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

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


       To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly  Met:

       a.      You must certify at the time that the existing study is submitted that the raw
              data and specimens from the study are available for audit and review and you
              must identify where they are available. This must be done in accordance with
              the requirements of the Good  Laboratory Practice  (GLP) regulation, 40  CFR
              Part 160. As stated in 40 CFR 160.3  'Raw data' means any laboratory
              worksheets, records, memoranda, notes, or exact copies thereof, that are the
              result of original observations and activities of a study and are necessary for the
              reconstruction and evaluation  of the report of that study. In the event that exact
              transcripts of raw  data have been prepared (e.g., tapes which have been


                                           82

-------
              transcribed verbatim, dated, and verified accurate by signature), the exact copy
              or exact transcript may be substituted for the original source as raw data. 'Raw
              data' may include photographs, microfilm or microfiche copies, computer
              printouts, magnetic media, including dictated observations, and recorded data
              from automated instruments." The term "specimens", according to 40 CFR
              160.3, means "any material derived from a test system for examination or
              analysis."

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

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

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

       If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns,  or issues were addressed
in the final protocol and study.

       If you know of  a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
                                           83

-------
Option 5.  Upgrading a Study

       If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified! as supplemental are upgradeable. If you have questions
regarding  the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade  an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale" of how the deficiencies have been remedied or
corrected  and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number (s)  of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.

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

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

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

Option 6.  Citing Existing Studies

       If you choose to cite a study  that has been previously submitted to EPA, that study
must have been previously classified by EPA  as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies  generally will have been
classified  as "core-guideline" or "core-minimum."  For ecological effects studies, the
classification generally would be a rating of "core."  For all other disciplines the classification
would be  "acceptable." With respect to any studies for which you wish to select this option,
you must  provide the MRID number of the study you are citing and, if the study has  been
reviewed  by the Agency, you must provide the Agency's classification of the study.

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

       2.  Product Specific Data

       If you acknowledge on the product specific Data Call-in Response Form that you agree
to satisfy the product specific data requirements (i.e. you select option (a or Yb), then you
must select one of the six options on the Requirements Status and Registrant's  Response Form
related to  data production for each data requirement.  Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under  item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form.  These six options are listed immediately below with
information in parentheses to guide registrants to additional instructions provided in this
Section. The options are:

       (1)    I will generate and submit data within the specified time-frame (Developing
              Data)
       (2)    I have entered into  an agreement with one or more registrants to develop data


                                           84

-------
                    (Cost Sharing)
             1 have made offers to cost-share (Offers to Cost Share)
             I am submitting an existing study that has not been submitted previously to the
             Agency by anyone (Submitting an Existing Study)
       (5)    I am submitting or citing data to upgrade a study classified by EPA as partially
             acceptable and upgradeable (Upgrading a Study)
       (6)    I am citing an existing study that EPA has classified as acceptable or an existing
             study that has been
             submitted but not reviewed by the Agency (Citing an Existing Study)

Option 1. Developing Data  The requirements for developing product specific data are the
same as those described for generic data (see Section III.C.I, Option 1)  except that normally
no protocols or progress reports are required.

Option 2. Agree to Share in Cost to Develop Data  If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
III.C.I, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has  indicated in the attached data tables that  your
product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost share by the registrant selecting this option.

Option 3. Offer to Share in the Cost of Data Development The same requirements for
generic data (Section lll.C.l., Option 3)  apply to this option. This option only applies  to acute
toxicity and certain efficacy data as described in option 2 above.

Option 4. Submitting an Existing Study  The same requirements described for generic data
(see Section lll.C.l" Option 4) apply to this option for product specific data.

Option 5. Upgrading a  Study  The same requirements described for generic data (see Section
lll.C.l., Option b) apply to this option for product specific data.

Option 6. Citing Existing Studies  The same requirements described for generic data (see
Section lll.C.l" Option 6) apply to this  option for product specific data.

       Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing  the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (lll.C.l.), as appropriate.


III-D REQUESTS FOR DATA WAIVERS

       1.     Generic Data

       There are two types of data waiver responses to this Notice.  The first is a request for a
low volume/minor use waiver and the second  is a waiver request based on your belief  that the
data requirement(s) are not appropriate for your product.

       a.     Low Volume/Minor Use Waiver

             Option 8 under item 9 on  the Requirements Status and Registrant's Response
       Form. Section 3(c)(2)(A) of FIFRA  requires EPA to consider the appropriateness of
       requiring data for low volume, minor use pesticides.  In implementing this provision,
       EPA considers low volume pesticides to be only those active ingredients whose total
       production volume  for all pesticide registrants is small. In determining whether to grant
       a low volume, minor use waiver, the Agency will consider the extent, pattern and
       volume of use, the  economic incentive to conduct the testing, the importance of the


                                           85

-------
pesticide, and the exposure and risk from use of the pesticide. If an active ingredient is
used for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient are low volume and the combined volumes
for all uses are also low, then an exemption may be granted, depending on review of
other information outlined below. An exemption will not be granted if any registrant of
the active ingredient elects to conduct the testing. Any registrant receiving a low
volume minor use waiver must remain within the sales figures in their forecast
supporting the waiver request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual
sales reports. The Agency will respond to requests for waivers in writing.

       To apply for  a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:

       (i). Total company sales (pounds and dollars)  of all  registered product(s)
containing the active ingredient.  If applicable to the active ingredient, include foreign
sales for those products that are  not registered in this country but are applied to sugar
(cane or beet), coffee,  bananas,  cocoa, and other such crops. Present the above
information by year  for each of the past five years.

       (ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.

       (iii)  Total  direct production cost of product (s) containing the active ingredient
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed separately.

       (iv)  Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product (s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.

       (v) A list of  each data requirement for which you seek a waiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test)  of conducting the testing needed to fulfill each of these
data requirements.

       (vi)  A list of each data requirement for which you are not seeking any waiver
and the  estimated cost to you (listed separately for each  data requirement and associated
test) of conducting the testing needed to fulfill each of these data requirements.

       (vii)  For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product (s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the  active
ingredient.
                                     86

-------
       (viii)  A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, providing information that
is as quantitative as possible.  If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active ingredient in terms of  its
benefits, you should provide information on any of the following factors,  as applicable
to your product(s):  (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management,  (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient after use  and on its
persistence in the environment, and (d) description of its usefulness against a pest(s)  of
public health significance.

       Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the
request for a waiver.

b.      Request for Waiver of Data

       Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement should
not apply because the requirement  is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
submit the current label(s) of your product(s)  and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.

       You will be informed  of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the  data are required for your product(s)  you must choose a   ~~
method of meeting the requirements of this Notice within the time frame provided by
this Notice.  Within 30 days of your receipt of the Agency's written decision, you must
submit a revised Requirements Status and Registrant s Response Form indicating the
option chosen.

2. Product Specific Data

       If you request a waiver for  product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations,  guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will be the only opportunity to state the reasons  or provide
information  in support of your request. If the Agency approves your waiver request,
you will not be required to supply  the data pursuant to section 3(c)(2)(B) of FIFRA.  If
the Agency denies your waiver request,  you must choose an option for meeting the data
requirements of this Notice within  30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form.  Product specific data requirements tor product
chemistry, acute toxicity and  efficacy (where  appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the
due date for the study in  question.  Waiver requests submitted~without adequate
supporting rationale will  be denied and the original due date will remain in force.
                                    87

-------
SECTION IV.       CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
                    JNUTHJK

IV-A  NOTICE OF INTENT TO SUSPEND

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

       1.     Failure to respond as required by this Notice within 90 days  of your receipt of
             this Notice.

       2.     Failure to submit  on the required schedule an acceptable proposed or final
             protocol when such is required to be submitted to the Agency for review.

       3.     Failure to submit  on the required schedule an adequate progress report on a
             study as required  by this Notice.

       4.     Failure to submit  on the required schedule acceptable data as required by this
             Notice.

       5.     Failure to take a required action or submit adequate information pertaining to
             any option chosen to address the data requirements (e.g., any required action or
             information pertaining to submission or citation of existing studies or offers,
             arrangements, or  arbitration on the sharing of costs or the formation of Task
             Forces, failure to  comply with the terms of an agreement or  arbitration
             concerning joint data development or failure to comply with  any terms of a data
             waiver).

       6.     Failure to submit  supportable certifications as to the conditions of submitted
             studies, as required by Section III-C of this Notice.

       7.     Withdrawal of an offer to share in the cost of developing required data.

       8.     Failure of the registrant to whom you have tendered an offer to share in the cost
             of developing data and provided proof of the registrant's receipt of such offer
             or failure  of a registrant on whom you rely for a generic data exemption either
             to:

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

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

             iii. Otherwise take appropriate steps to meet the requirements stated in this
             Notice,

             unless  you commit to submit and do submit the required data in the specified
             time frame.

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

-------
IV-B.  BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
       UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:

       1)      EPA requirements specified in the Data Call-In Notice or other documents
       incorporated by reference (including, as applicable, EPA Pesticide Assessment
       Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
       regarding the design, conduct,  and  reporting of required studies. Such requirements
       include, but are not limited to,  those relating to test material, test procedures, selection
       of species, number of animals,  sex  and distribution of animals, dose and effect levels to
       be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.

       2)      EPA requirements regarding the submission of protocols, including the
       incorporation of any changes required by the Agency following review.

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

IV-C  EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

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

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

       If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to  sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell,  distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily  cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.

       Requests for voluntary cancellation received after the 90 day  response period required
by this Notice will not result in the agency granting any additional time to sell, distribute,  or
use existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency  that you are in  full compliance with all Agency requirements,
including the requirements  of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress


                                           89

-------
reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.


SECTION V.      REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
                   LJJMREASONABLE ADVERSE EFFECTS

       Registrants are  reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.


SECTION VI.      INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(sj listed in Attachment 1, the Data Call-in Chemical Status
Sheet.

       All responses to this Notice must include completed Data Call-in Response Forms
(Attachment 2|and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and product specific data) and any other documents required
by this Notice, and should be submitted to the contact person(s) identified in Attachment 1.  If
the voluntary cancellation or generic data exemption option is chosen, only the Generic and
Product Specific Data Call-in Response Forms need be submitted.

       The Office of Compliance (OC) of the Office of Enforcement  and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.

                                 Sincerely yours,
                                 Louis P. True, Jr., Acting Director
                                 Special Review and
                                  Reregistration Division
Attachments
       The Attachments to this Notice are:

       1 -    Data Call-In Chemical Status Sheet
       2 -    Generic Data Caii-ln and Product Specific Data Call-In Response Forms with
             Instructions
       3 -    Generic Data Call-in and Product Specific Data Call-In Requirements Status
             and Registrant's Response Forms with Instructions
       4 -    EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregistration
       5 -    EPA Acceptance Criteria
       6 -    List of Registrants Receiving This Notice
       7 -    Confidential Statement of Formula, Cost Share and Data  Compensation Forms
                                          90

-------
Attachment 1. Chemical Status Sheets
                91

-------
92

-------
PIPERALIN DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

      You have been sent this Generic Data Call-In Notice because you have product(s)
containing Piperalin.

      This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point or contact tor inquiries pertaining to the reregistration of
Piperalin.  This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form  (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this Piperalin Generic Data Callln (Attachment F).
Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE
      The additional data requirements needed to complete the generic database for Piperalin
are contained  in the Requirements Status and Registrant's Response, Attachment C.  The
Agency has concluded that additional product chemistry data on Piperalin are needed. These
data are needed to fully complete the reregistration of all eligible Piperalin products.

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you  have any questions regarding the generic data requirements and procedures
established by this Notice, please contact C.P.  Moran at  (703) 308-8590.

      All responses to this Notice for the generic data requirements should be submitted to:

             C.P. Moran, Chemical Review Manager
             Planning and Reregistration Branch
             Special Review and Registration Division  (H7508W)
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C.  20460
             RE:  Piperalin
                                         93

-------
PIPERALIN DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Piperalin.

       This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact tor inquiries pertaining to the reregistration of
Piperalin.  This attachment is to be used in conjunction with (1)  the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form  (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria  (Attachment 5), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Piperalin Product
Specific Data Call-In (Attachment 7).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the  database  for Piperalin are
contained in the Requirements Status and Registrant's Response, Attachment 3.  The Agency
has concluded that additional data on Piperalin are needed tor specific products. These data are
required to be submitted to the Agency within the time  frame listed.  These data are needed to
fully complete the reregistration of all eligible Piperalin products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the generic  database  of Piperalin, please contact
C.P. Moran at (703) 308-8590.
       If you have any questions regarding the product specific data requirements and
procedures established by  this Notice,  please contact C.P. Moran at (703) 308-8008.

       All responses to this Notice for the Product Specific data requirements should be
       submitted to:
             C.P. Moran
             Chemical Review Manager Team 81
             Product Reregistration Branch
             Special Review and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE: Piperalin
                                         94

-------
Attachment 2. Combined Generic and Product Specific
  Data Call-In Response Forms (Form A inserts) Plus
                   Instructions
                        95

-------
96

-------
   Instructions For Completing The "Data Call-in Response Forms" For The Generic And
                             Product Specific Data Call-In


                                  INTRODUCTION

 These instructions apply to the Generic and Product Specific "Data Call-In Response Forms"
 and are to be used By registrants to respond to generic and product specific Data Call-Ins as
     part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act.  The type of data call-in (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response" forms
                                  must be completed.

  Although the form is the same for both generic and product specific data, instructions for
  completing these forms are different. Please read these  instructions carefully before filling
                                    out the forms.

  EPA has developed these forms individually for each registrant, and has preprinted these
  forms with a number of items.  DO NOT use these forms for  any other active ingredient.

Items 1 through 4 have been preprinted on the form.  Items 5 through 7 must be completed by
 the registrant as appropriate. Items 8 through 11 must be completed by the registrant before
                          submitting a response to the Agency.

   The public reporting burden for  this collection of information is estimated to average 15
   minutes per response, including time for reviewing instructions, searching existing data
    sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any  other aspect of
   this collection of information, including suggestions for reducing this burden, to Chief,
 Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
     St., S.W., Washington, D.C.  20460; and to the Office of Management and Budget,
            Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
                                          97

-------
    INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
                       Generic and Product Specific Data Call-in


 Item l.ON BOTH FORMS:  This item identifies your company name, number and address.

Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
                             number and chemical name.

   Item  3.ON BOTH FORMS:  This item identifies the type of Data Call-in.  The date of
                               issuance is date stamped.

 Item 4.ON BOTH FORMS: This item identifies the EPA product  registrations relevant to
 the data call-in.  Please note that you are also responsible for informing the Agency of your
 response regarding any product that you believe may be covered by this Data Call-in but that
   is not listed by the Agency in Item 4. You must bring any such apparent omission to the
     Agency's attention within the period required for submission of this response form.

Item 5.ON BOTH FORMS: Check this item for each product registration you wish to cancel
voluntarily. If a registration  number is listed for a product for which  you previously requested
   voluntary cancellation, indicate in Item 5 the date of that request. Since  this Data Call-in
 requires both generic and product specific data, you must complete item 5  on both Data Call-
  in response forms.  You do not need to complete any item on the Requirements Status and
                            Registrant's Response  Forms.

   Item  6a.ON THE GENERIC DATA FORM: Check this Item if the Data  Call-In is for
 generic data as indicated in  Item 3 and you are eligible for a Generic Data Exemption for the
  chemical listed in Item 2 and used in the subject product.  By electing this exemption, you
   agree to the terms and conditions of a Generic Data Exemption as explained in the Data
                                   Call-In Notice.

If you are eligible for or claim a Generic Data Exemption, enter  the EPA registration Number
       of each registered source of that active ingredient that you use in your  product.

   Typically, if you purchase an EPA-registered product from one or more other producers
   (who, with respect to the incorporated product, are in compliance with this  and any other
                         outstanding Data Call-In Notice), and


    INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
                       Generic and Product Specific Data Caii-in


 incorporate that product into all your products, you may complete this item for all products
    listed on this form. If, however, you produce the active ingredient yourself, or use any
  unregistered product (regardless of the fact that some of your sources are registered), you
        may not claim a Generic Data Exemption and you may not select this item.

   Item 6b.ON THE GENERIC DATA  FORM: Check this Item if the Data Call-in is for
    generic data as indicated in Item 3 and if you are  agreeing to satisfy the generic data
 requirements of this Data Call-In. Attach the Requirements Status and  Registrant's Response
               Form that indicates how you will satisfy those requirements.

         NOTE: Item 6a and 6b are not applicable for Product Specific Data.
                                         98

-------
   Item 7a.ON THE PRODUCT SPECIFIC DATA FORM:  For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to satisfy the data
                            requirements by responding "yes."

  Item Tb.For each end use product (EUP) for which you wish to maintain registration, you
              must agree to satisfy the data requirements by responding "yes.

                           FOR BOTH MUP and EUP products

 You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product
 is identical to another product and you qualify for a data exemption.  You must provide the
  EPA registration numbers of your source (s); do not complete the Requirements Status and
  Registrant's Response form.  Examples of such products include repackaged products and
     Special Local  Needs (Section 24c) products which are identical to federally registered
                                        products.

  If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option 7 (Waiver
              Request)  for each study for which you are requesting a waiver.

              NOTE:  Item 7 a and 7b are not applicable for Generic Data.


    INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
                         Generic and Product Specific Data Caii-ln


  Item 8.ON BOTH FORMS:  This certification statement must be signed by an authorized
 representative of your company and the person signing must include his/her title.  Additional
     pages used in  your response must be initialled and dated in the space provided for the
                                      certification.

                 Item 9.ON BOTH FORMS:  Enter the date of signature.

    Item 10.ON BOTH FORMS:  Enter the name of the person EPA should contact with
                            questions regarding your response.

      Item 11.ON BOTH FORMS: Enter the phone number of your company contact.
   Note:    You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you
          may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
          product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct.
                                           99

-------
100

-------
Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
                   and Instructions
                         101

-------
102

-------
Instructions For Completing The "Data Call-in Response Forms" For The Generic And Product
Specific Data Call-In


INTRODUCTION

These instructions apply to the Generic and Product Specific "Data Call-In Response Forms" and
are to be used by registrants to respond to generic and product specific Data Call-Ins as part of
EPA's Reregistration Program under the Federal Insecticide, Fungicide, and Rodenticide Act.
The type of data call-in (generic or product specific) is indicated in item number 3 ("Date
and Type of DCI") on each form.  BOTH "Data Call-In Response" forms must be completed.

Although the  form is the same  for  both generic and product  specific data, instructions  for
completing these forms are different. Please read these instructions carefully before  filling  out
the forms.

EPA has developed these forms individually for each registrant,  and has preprinted these forms
with a number of items. DO NOT use these forms for any other active  ingredient.

Items 1 through 4 have been preprinted on the form.  Items 5 through 7 must be completed by
the registrant as appropriate.  Items 8 through  11 must be completed by the registrant before
submitting a response to the Agency.

The public reporting burden for this collection of information is estimated to average 15 minutes
per response, including time for reviewing instructions, searching existing  data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information.
Send  comments regarding the burden estimate or  any other aspect of this collection of
information, including suggestions for reducing this burden, to Chief,  Information Policy Branch,
Mail Code 2136, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C.
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D.C.  20503.
                                          103

-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in


Item l.ON BOTH FORMS: This item identifies your company name, number and address.

Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
number and chemical name.

Item 3.ON BOTH FORMS: This item identifies the type of Data Call-In. The date of issuance
is date stamped.

Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant to the
data call-in. Please note that you are also responsible for informing the Agency of your response
regarding any product that you believe may  oe covered by this Data CalHn but that is not listed
by the Agency in Item 4. You must bring any such apparent omission to the Agency's attention
within the period required for submission of this response form.

Item 5.ON BOTH FORMS: Check this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request.  Since this Data Call-In requires
both generic and product specific data, you must complete item 5 on both Data Call-In response
forms.  You do not  need to complete any item  on the Requirements Status and Registrant's
Response Forms.

Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-in  is for generic
data as indicated in Item  3 and you are eligible for a Generic Data Exemption for the chemical
listed in Item 2  and used in the subject product.  By  electing this exemption, you agree to the
terms and conditions of a Generic Data Exemption as explained in the Data Call-in Notice.

If you are eligible for or claim a Generic Data Exemption, enter the EPA registration Number
of each registered source of that active ingredient that you use in your product.

Typically, if you purchase an EPA-registered product from one or more other producers (who,
with respect to the incorporated product, are in compliance with this and any other outstanding
Data Call-in Notice),  and


INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Caii-in


incorporate that product into all your products, you  may complete this item for all products listed
on this form. If, however, you  produce the active ingredient yourself, or use any unregistered
product (regardless of the fact that some of your sources are registered), you may not claim a
Generic Data Exemption and you may  not select this item.

Item 6b.ON THE GENERIC DATA FORM: Check this Item if the Data Call-in  is for generic
data as indicated in Item 3 and if you are agreeing to satisfy the generic  data requirements of this
Data Call-In. Attach the Requirements Status and Registrant's Response Form that  indicates  how
you will satisfy those  requirements.

NOTE: Item 6a and 6b are not applicable for Product Specific Data.
                                         104

-------
Item 7a.ON THE PRODUCT SPECIFIC DATA FORM:  For each manufacturing use product
(MUP)  for which  you wish  to  maintain registration, you must agree to satisfy the data
requirements by responding "yes."

Item Tb.For each end use product  (EUP) for which you wish to maintain registration, you must
agree to satisfy the data requirements by responding "yes."

FOR BOTH MUP and EUP products

You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product is
identical to another product and you qualify for  a data exemption.   You must provide the EPA
registration numbers of your source(s); do not complete the Requirements Status and Registrant's
Response form. Examples of such products include repackaged products and Special Local Needs
(Section 24c) products which are identical to federally registered products.

If you are requesting a data waiver, answer '"yes" here; in addition, on the "Requirements Status
and Registrant's Response" form under Item 9, you must respond with option 7 (Waiver Request)
for each study for which you are requesting a waiver.

NOTE:  Item 7 a and 7b are not applicable for Generic Data.


INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific  Data Call-in


Item 8.ON BOTH FORMS:  This certification statement must be signed by an  authorized
representative of your company and the person signing must include his/her title.   Additional
pages used in your  response  must be  initialled  and  dated  in  the space  provided for the
certification.

Item 9.ON BOTH FORMS:  Enter the date of  signature.

Item 10.ON BOTH FORMS:  Enter the name of the person EPA should contact with questions
regarding your response.

Item 11.ON BOTH FORMS:  Enter the  phone  number of your company contact.
   Note:    You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you
          may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
          product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct.
                                           105

-------
106

-------
Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       107

-------
108

-------
                     BATCHING




Since there is  only one product, no batching is required.
                          109

-------
110

-------
Attachment 5. EPA Acceptance Criteria
                in

-------
112

-------
                          SUBDIVISION D
Guideline      Study Title

Series 61      Product Identity and Composition
Series 62      Analysis and Certification of Product Ingredients
Series 63      Physical and Chemical Characteristics
                               113

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


ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	    Name of technical material tested (include product name and trade name, if appropriate).

2.	    Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
          intentionally-added inert ingredient.

3.	    Name and upper certified limit for each impurity or each group of impurities present at _>_ 0.1% by weight
          and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at < 0.1%.

4.	    Purpose of each active ingredient and each intentionally-added inert.

5.	    Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
          Registry Number for each active ingredient and, if available, for each intentionally-added inert.

6.	    Molecular, structural, and empirical formulas, molecular weight or weight  range, and any  company
          assigned experimental or internal code numbers for each active ingredient.

7.	    Description of each beginning material in the manufacturing process.
          	  EPA Registration Number if registered;
                 for other beginning materials, the following:
          	  Name  and address of manufacturer or supplier.
          	  Brand name, trade name or commercial designation.
          	  Technical  specifications or data sheets by which manufacturer or supplier describes composition,
                 properties  or toxicity.

8.	Description of manufacturing process.
          	  Statement of whether batch or continuous process.
          	  Relative amounts of beginning materials and order in which they are added.
          	  Description of equipment.
          	  Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
                 parameters that are maintained.
          	  Statement of whether process involves intended chemical reactions.
          	  Flow chart with chemical equations  for each intended chemical reaction.
          	  Duration of each step of process.
          	  Description of purification procedures.
          	  Description of measures taken to assure quality of final product.

9.	    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
          which may be present at _>_ 0.1% or was found at _>_ 0.1% by product  analyses  and  (2)  certain
          lexicologically significant impurities (see #3).
                                                   114

-------
                            62 Analysis and Certification of Product Ingredients


                                         ACCEPTANCE CRITERIA

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

Does your study meet the following acceptance criteria?

 1.	  Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
         and all impurities present at >  ff. 1%.
 2.	  Degree of accountability or closure _>^ ca 98%.
 3.	  Analyses conducted for certain trace toxicTmpurities at lower than 0.1% (examples, nitrosamines in the case
         of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
         polyhalogenated dibenzodioxins and dibenzofurans).  [Note  that in the case of nitrosamines both fresh and
         stored samples must be analyzed.].
 4.	  Complete and detailed description of each step in analytical method used to analyze above samples.
 5.	  Statement of precision and accuracy of analytical method used to analyze above samples.
 6.	  Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
 7.	  Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
         explanation of how the limits were  determined.
 8.	  Upper certified limit proposed for each impurity present at j>_ 0.1% and for certain lexicologically significant
         impurities at < 0.1% along with explanation of how linnTdetermined.
 9.	  Analytical methods to verify certified limits of each active  ingredient and impurities (latter not required if
         exempt from requirement of tolerance  or if generally recognized as safe by FDA) are fully described.
10.	Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
                                                    115

-------
                                 63 Physical and Chemical Characteristics

                                        ACCEPTANCE CRITERIA


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

Does your study meet the following acceptance criteria?

63-2 Color
   	  Verbal description of coloration (or lack of it)
   	  Any intentional coloration also reported in terms of Munsell color system

63-3 Physical State
   	  Verbal description of physical state provided using terms such as "solid,  granular, volatile liquid"
   	  Based on visual inspection at about 20-25  C

63-4 Odor
   	  Verbal description of odor (or lack of it) using terms such as "garlic-like,  characteristic of aromatic
          compounds"
   	  Observed at room temperature

63-5 Melting Point
   	  Reported in  C
   	  Any observed decomposition reported

63-6 Boiling Point
   	  Reported in  C
   	  Pressure under which B.P. measured reported
   	  Any observed decomposition reported

63-7 Density, Bulk Density, Specific Gravity
   	  Measured at about 20-25 C
   	  Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
          reference to water at 20 C.  [Note: Bulk  density of registered products may be reported in lbs/ft3 or
          Ibs/gallon.]

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

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

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

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

   	  Data supporting reported value provided

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

63-13 Stability
   	  Sensitivity to metal ions and metal determined
   	  Stability at normal and elevated temperatures
   	  Sensitivity to sunlight determined
                                                   116

-------
                                           SUBDIVISION F
Guideline         Study Tide

 81-1           Acute Oral Toxicity in the Rat
 81-2           Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3           Acute Inhalation Toxicity in the Rat
 81-4           Primary Eye Irritation in the Rabbit
 81-5           Primary Dermal Irritation Study
 81-6           Dermal Sensitization in the Guinea Pig
                                                  117

-------
                                    81-1 Acute Oral Toxicity in the Rat


                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

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

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


                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 animals/sex/group.
 3.*	Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4.	Dosing, single dermal.
 5.	Dosing duration at least 24  hours.
 6.^	Vehicle control, only if toxicity of vehicle is unknown.
 7.~	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 8.	Application site clipped or shaved at least 24 hours oefore dosing.
 9.	Application site at least 10% of body surface area.
10.	Application site covered with a porous nonirritating cover to retain test material and to prevent
        ingestion.
11.	Individual observations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                     Criteria marked with an * are supplemental and may not be required for every study.

-------
                                 81-3 Acute Inhalation Toxicity in the Rat


                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
        or contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
 3.	At least 5 young adult rats/sex/group.
 4.	Dosing, at least 4 hours by inhalation.
 5.	Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
 6.	Chamber temperature,  22 C (+_2), relative humidity 40-60%.
 7.	Monitor  rate of air flow.
 8.	Monitor  actual concentrations of test material in breathing zone.
 9.	Monitor  aerodynamic particle size for aerosols.
10.	Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
        respirable substance).
11.	Individual observations at least once a day.
12.	Observation period to last at least  14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                                                   120

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


                                         ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

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

                                                    J. Lj i

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

                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive or has a pH of < 2 or > 11.5.
 3.	6 adult animals.
 4.	Dosing, single dermal.
 5.	Dosing duration 4 hours.
 6.	Application site shaved or clipped at least 24 hours prior to dosing.
 7.	Application site approximately 6 cm2.
 8.	Application site covered with a gauze patch held in place with nonirritating tape.
 9.	Material removed, washed with water, without trauma to application site.
10.	Application site examined and graded for irritation at 1, 24,  48 and 72 hr, then daily until normal or 14 days
        (whichever is shorter).
11.^	Individual daily observations.
                     Criteria marked with an * are supplemental and may not be required for every study.

                                                    J. Lj Lj

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

                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	Identify material tested (technical, end-use product, etc).
2.	Study not required if material is corrosive or has a
      pHof <2or  >11.5.
3.	One offhe following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      	Mauer optimization test
      	Footpad technique in guinea pig.
4.	Complete description of test.
5.^	Reference for  test.
G.~	Test followed  essentially as described in reference document.
7.	Positive control included (may provide historical data conducted within the last 6 months).
                     Criteria marked with an * are supplemental and may not be required for every study.

                                                    J. Lj O

-------
124

-------
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                             Notice
                               125

-------
126

-------
Attachment 7. Cost Share Data Compensation Forms, Confidential
         Statement of Formula Form and Instructions
                           127

-------
128

-------
s

s

8
g.
UJ
5
2
a.

^

o
s
9
h~
8
6
z
CO
O
_^
?
o
Q.
Q.
|
O
11


.^^
10
(0
^J
N

O

uj

1

1
"*
'C
3
u

CO
"5
1
j




u
(U
m
c
0
VI
c.
o
3
. E
c -
 1?
to
ir- *:
-00 O
Environmental Protec
Pesticide Programs (T
Washington, DC 2046O
1 Statement
So* (D
2| ~
go 0)
 ."2
3 1^
c
o
o




D.
LJJ
4cff^
^*^^
























fi
0
o
a.
N
1


o
u
a
o
ct
0
CO
tfi
CD
o

o
c
(D
E
(0
cvi












I
Q
Q.
N
5
c
(D
W
?
S
CC
~
1

^-
"o
%
0)
o
c
(D
(D
Z




^

i
E
o
LL
V
^
5

^
c
0
u
CD



b
z
e
(0
0)
\
o>
2
^J
1
i
LU
X)




1
>
CO

[
\
b
z
c
o
a
1
a:
*






















i
a
z
s
1

a.
m


c
o
U)
c
(D
LU
0)
(Q
\
C
"o
a.
^:
(D
LL,
CT)












X
a.
GO




S
c
ID
Q

J
OQ
O
. Pounds/Ga
^



























- c
o
3

|

|

c |
"*
5"

^^
^ s
^ a
n>
"
1
c *
(D If
00
E 
O 3
o e_
tsi
igU.0
u_t i C
UJ C fc
f>
*~ (D

b
Z
0?
(C
<
LU







e & Address
E
z
^
a
3
U)
^




II
./if as actually introdL
nonly accepted chem
tar./
~~KC
irmulatior
G/Ve coi
dCASnu

"  "
3i |
11*
1-2 1
".
3g-
 o t
2.g
z
0
UJ
co
<
0.
UJ

































































































































































































































































































































































































































































































































































































O
O
"

G)
>
>
2
o
K
-






























"5
u
0
a
c
>
o
Q.
Q
O
E
a
a
o
a.

(b







2
Q

01


%
tj

^
o
-g

6
c
o
a.
Q
CM
























9
jH
O)








"ra
^

?
i
1
"o
c

CO

129

-------
130

-------
Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required.  Following are basic instructions:
     a. All the blocks on the form must be filled in and answered completely.
     b.       If any block is not applicable, mark it N/A.
     c.       The CSF must be signed, dated and the telephone number of the responsible party must be provided.
     d.       All applicable information which is on the product specific data submission must also be reported on the
              CSF.
     e.       All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet
              for solids.
     f.       Flashpoint must be in degrees Fahrenheit and flame extension in inches.
     g.       For all active ingredients, the EPA Registration Numbers for the currently registered source products
              must  be reported under column 12.
     h.       The Chemical Abstracts Service (CAS) Numbers for all actives  and inerts and all common names for
              the trade names must be reported.
     i.       For the active ingredients, the percent purity of the source products must be reported under column 10
              and must be exactly the same as on the source product's label.
     j.       All the weights in columns 13.a. and  13.b.  must be  in pounds,  kilograms, or grams.  In no case will
              volumes be accepted. Do not mix English and metric system units  (i.e., pounds and kilograms).
     k.       All the items under column 13.b. must total  100 percent.
     1.       All items under columns 14.a. and  14.b. for the active ingredients must represent pure active form.
     m.      The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
              instructions. An explanation must be provided  if the proposed limits are different than standard certified
              limits.
     n.       When new CSFs are submitted and approved, all previously submitted  CSFs become obsolete for that
              specific formulation.
                                                   131

-------
132

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


OMB No.  2070-0106
         2070-0057

Approval  Expires 3-31-96
 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

 Please fill In  blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
 I Certify that:

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

 My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
 offer  to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on  all
 terms could not be reached otherwise. This offer was made to the following firm(s) on the following
 date(s):
  Name of Firm(s)
                                                                            Date of Ofler
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I  have made on
this form and all attachments therein are true, accurate, and complete.  I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
 Signature of Company's Authorized Representative
                                                                            Date
 Name and Title (Please Type or Print)
 EPA Form 8570-32 (5/91)    Replaces EPA Form 8580, which is obsolete
                                                 133

-------
134

-------
     &EPA
United  States Environmental Protection Agency
             Washington, DC 20460
   CERTIFICATION  WITH RESPECT  TO
 DATA  COMPENSATION REQUIREMENTS
OMt M*. 2070-0107
         2070-0037
Approval  E>plr 3-3I-96
  Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
  time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
  completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other
  aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
  Branch. PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
  of Management and Budget, Paperwork Reduction Project (2070-0106), Washington. DC 20503.

  Please fill In blanks below.
Company Nam*
Product NM
Company Numbar
EFA Rg. MO.
 I Certify that:

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

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

3.  That I have previously complied with section 3(c)(i )(D) of FIFRA for the studies I have cited in support of
    registration or reregistration under FIFRA.
Signature
Date
Nam* and Till* (PI**** Typ* or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to me
registration or reregistration of my products, to the extent required by FIFRA sections 3(O(1)(D) and 3(c)(2)(D).
Signature
Date
N*m and Title (PIMM Typ* or Print)
EPA Form 570-31

-------
136

-------
APPENDIX G. FACT SHEET
          137

-------
138

-------
                  United States
                  Environmental Protection
                  Agency	
                       Prevention, Pesticides
                       And Toxic Substances
                       (7508W)	
EPA-738-F-94-029
September 1994
                  R.E.D.   FACTS
                  Piperalin
      Pesticide
Registration
    Use Profile
     All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment.  Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
     In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers,  describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks.  EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
     When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 3114, piperalin.

     Piperalin is a fungicide used  to control powdery mildew on
ornamental plants, shrubs, vines and trees grown in commercial green
houses. It is formulated as a soluble concentrate/liquid, and is applied as a
foliar spray using a high-volume high-pressure sprayer.  Use practice
limitations include a recommendation to use with three specific surfactants,
and prohibitions against entering treated areas without personal protective
equipment (PPE) for 12 hours, applying the pesticide through any type of
irrigation system, applying directly to water or wetlands, and contaminating
water, food or feed.
    Regulatory        Piperalin was first registered as a pesticide in the U.S. in 1964.
        History   Currently, only one product is registered which contains this active
                  ingredient. The product contains 84.4% piperalin and is used only to
                  control powdery mildew on ornamentals grown in commercial greenhouses.

-------
 Human Health
   Assessment
Environmental
   Assessment
Toxicity
     In studies using laboratory animals, piperalin generally has been
shown to be of relatively low acute toxicity. It causes only slight dermal
toxicity and has been placed in Toxicity Category IV (indicating the lowest
degree of acute toxicity) for this effect. It also is not a skin sensitizer.
Piperalin is slightly toxic through the oral and inhalation routes, causes mild
eye irritation, and causes moderate to severe skin irritation; it has been
placed in Toxicity Category III for  each of these effects.
     Piperalin caused no systemic  toxicity in a subchronic dermal toxicity
study using rabbits. In a developmental toxicity study using rats, piperalin
caused excessive salivation, soiled fur, decreased body weight and decreased
food consumption in  the mothers.   The lowest observed effect level  (LOEL)
was the highest dose  tested, based on decreased  fetal body weight. A third
mutagenicity test is required to confirm the Agency's finding so far that
piperalin is not mutagenic.
Dietary Exposure
     Piperalin has no registered food uses, so dietary exposure is not a
concern.
Occupational and  Residential  Exposure
     Based on current use patterns, workers may be exposed to piperalin
during and after application in greenhouses.  However, piperalin is of
sufficiently low toxicity that an exposure assessment was not conducted.
Human Risk Assessment
     Piperalin has no registered food uses so no dietary risks are posed.
Even though applicators can be exposed to significant amounts of piperalin,
this pesticide poses little toxicity concern.  Workers' exposure will be
minimized  through product labeling requirements.

Environmental Fate
     Piperalin hydrolyzes very rapidly at pH 9 forming two degradates,
DCBA or dichlorobenzoic acid and 3-(2-methylpiperidino)propyl alcohol.
Microbially-mediated and  chemical hydrolysis are the most significant
degradative processes.  In  soil metabolism studies, the parent compound
decreased over time while  the two degradates increased.
     Piperalin is immobile in several types of soil.  However, additional
information is  needed to confirm the identity and determine the leaching
potential of piperalin's  degradates.
Ecological Effects
     While additional studies are needed to determine its acute toxicity to
birds, piperalin is practically nontoxic to birds on a subacute dietary basis.
Because piperalin is only used indoors (inside greenhouses), avian
reproduction studies are not required.  Piperalin is highly toxic  to fish and
moderately toxic to aquatic invertebrates.

-------
    Additional  Data
            Required
  Product Labeling
Changes Required
Ecological Effects Risk Assessment
     Piperalin is practically nontoxic to birds, highly toxic to fish, and
moderately toxic to aquatic invertebrates. However, birds and mammals
will not be significantly exposed to piperalin through consumption of insect
and plant food containing residues of this pesticide.  Exposure to fish and
aquatic invertebrates also is not expected to occur since piperalin is used
only inside greenhouses, and since labeling prohibits use practices that
would contaminate water.  No significant risks to birds, fish or aquatic
invertebrates are expected.  Similarly, no significant risks to endangered
species are expected from the use of piperalin.

     EPA is requiring the following additional generic data for piperalin to
confirm its regulatory assessments and conclusions:  an additional
mutagenicity study, data confirming the identity of the major degradates,
studies to determine the leaching potential of the two major hydrolytic
degradates.
     The Agency also is requiring product-specific data including product
chemistry and acute toxicity  studies, a revised Confidential Statement of
Formula (CSF) and revised labeling for reregistration.

     The registered piperalin end-use product must comply with EPA's
current pesticide product labeling requirements, and with the following:
Personal Protective Equipment (PPE) for Mixers/Loaders/ Applicators
     There are no special toxicological concerns that warrant the
establishment of active-ingredient-based  PPE requirements for pesticide
handlers.
Early Entry PPE
     Since piperalin is of relatively low acute toxicity and the Agency has
no special concerns about other adverse  effects, the PPE required for early
entry is coveralls, chemical-resistant gloves, shoes, and socks.
Restricted Entry Interval (REI)
     The interim REI established for piperalin under the Worker Protection
Standard (WPS)  was 24 hours because data at that time indicated that
piperalin was in Toxicity Category II for skin irritation potential.  In
reviewing the data, EPA determined that piperalin should be in Toxicity
Category III for skin irritation potential.  Therefore, piperalin must have
only a 12-hour REI.
Environmental Hazard Labeling Statement
     The following statement is required on end-use product labeling:
     "This product is toxic to fish.  Do  not apply directly to water or to
     areas where surface water is present or to intertidal areas below the
     mean high water mark. Do  not contaminate water when disposing of
     equipment washwaters."

-------
 Regulatory
Conclusion
   For More
Information
     Use of the currently registered product containing piperalin in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment.  Therefore, all uses of the
product are eligible for reregistration.
     This product will be reregistered once the required  product-specific
data, revised Confidential Statement of Formula and revised labeling are
received and accepted by EPA.

     EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for piperalin during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written  comments, please
contact the Pesticide Docket,  Public Response and Program Resources
Branch,  Field Operations Division (7506C),  Office  of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
     Electronic copies of the RED and this fact sheet can be downloaded
from the  Pesticide Special Review and Reregistration Information System at
703-308-7224, and also can be reached on the Internet via
FEDWORLD.GOVand EPA's gopher server, EARTH1.EPA.GOV.
     Printed copies of the RED and fact sheet can be obtained from EPA's
National  Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH  45242-0419,  telephone
513-489-8190, fax 513-489-8695.
     Following the comment period, the piperalin RED document also will
be available from the National Technical Information Service  (NTIS), 5285
Port Royal Road, Springfield, VA  22161, telephone 703-487-4650.
     For more information about EPA's pesticide reregistration program,
the piperalin RED, or reregistration of individual products containing
piperalin, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
     For information about the health effects of pesticides, or for assistance
in recognizing and managing  pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN).  Call toll-
free 1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.

-------