Reregistration Eligibility Document (RED) Soap Salts


         United States       Office of Prevention, Pesticides
         Environmental Protection   And Toxic Substances      September 1992
         Agency	(H-7508W)	
&EPA  Registration
         Eligibility Document
         (RED)
         Soap Salts

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REREGISTRATION ELIGIBILITY DOCUMENT

                  Soap Salts

                    LISTD

                  CASE 4083
        ENVIRONMENTAL PROTECTION AGENCY
          OFFICE OF PESTICIDE PROGRAMS
     SPECIAL REVIEW AND REREGISTRATION DIVISION
                WASHINGTON, D.C.

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            EPA SOAP SALTS REREGISTRATION ELIGIBILITY TEAM


Office of Pesticide Programs:

Biological and Economic Analysis Branch

Phyilis Johnson      Biological Analysis Branch
Margetie Cogdell    Biological Analysis Branch
William Gross Jr.    Biological Analysis Branch

Environment Fflte and Effects pivision

Roy Bingham        Environmental Fate and Ground Water Branch
Betsy Grim          Science Analysis and Coordination Staff
Carol Belew         Ecological Effects Branch

Health Effects Division

Judy Smith          Occupational and Residential Exposure Branch
Pat McLaughlin      Toxicology Branch II
Chris Swartz        Chemistry Branch II:  Registration Support
Linda Kutney        Chemical Coordination Branch

Program Management and Support Division

BeWanda Alexander  Information Services Branch

Registration  Division

Barbara Madden      Insecticide Rodenticide Branch
Robert Forrest        Product Manager 14-IRB
Daphne Waldo        Insecticide Rodenticide Branch
Ian Blackwell         Registration Support Branch
Walter Francis        Antimicrobial Program Branch
Sami Malak           Antimicrobial Program Branch

Special Review and Reregistration Division

Veronica Dutch      Accelerated Reregistration Branch

Policy and Special Projects Staff

Jean Frane

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Office of General Counsel:
Alan Carpien

Office of Compliance Monitoring:
Beverly Updike
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                      TABLE OF CONTENTS

                                                            Page
GLOSSARY OF TERMS AND ABBREVIATIONS                           v
EXECUTIVE SUMMARY                                           vi

I. INTRODUCTION                                                1

n. CASE OVERVIEW                                              2

     A.   CHEMICAL OVERVIEW                                   2
     B.   USE PROFILE FOR POTASSIUM SALTS OF FATTY ACIDS          2
     C.   USE PROFILE FOR AMMONIUM SALTS OF FATTY ACIDS
     D.   REGULATORY HISTORY                                  4

m.  SCIENCE ASSESSMENT OF SOAP SALTS                           6

     A.   PRODUCT CHEMISTRY ASSESSMENT                        6
     B.   HUMAN HEALTH ASSESSMENT                             7
     C.   ENVIRONMENTAL ASSESSMENT                           10

IV.  RISK MANAGEMENT AND REREGISTRATION DECISION             19
   FOR SOAP SALTS

     A.   DETERMINATION OF ELIGIBILITY                          19
     B.   ADDITIONAL GENERIC DATA REQUIREMENTS                19
     C.   LABELING FOR MANUFACTURING-USE PRODUCTS            19

V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE                 20
  PRODUCTS

     A.   DETERMINATION OF ELIGIBILITY                          20

          1. Product Specific Data Requirements
          2. Labeling Requirements for End-Use Products
VI. APPENDICES

      APPENDDC A -Soap Salt Use Patterns Subject to Reregistration

      APPENDIX B - Generic Data Requirements for Reregistration of Soap

                               iii

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APPENDIX A -Soap Salt Use Patterns Subject to Reregistration

APPENDIX B - Genetic Data Requirements for Reregistration of Soap
               Salts and Data Citations Supporting Reregistration
APPENDIX C - Citations Considered to be Part of the Data Base
          Supporting the Reregistration of Soap Salts
APPENDIX D - PR Notice 91-2

APPENDIX E - Pesticide Reregistration Handbook

APPENDDC F - Generic DCI Data Call-In

     Attachment A - Chemical Status Sheet

     Attachment B - Generic DCI Response Forms
                 (Form A) plus Instructions

     Attachment C - Generic Requirements Status and Registrant's Response
                Forms (Form B) Plus Instructions

     Attachment D - List of all Registrant(s) Sent this DCI

     Attachment E - EPA Acceptance Criteria and PR-Notice 86-5

     Attachment F - Cost Share/Data Compensation Forms

APPENDDC G -Product Specific DCI Response Forms

     Attachment A - Chemical Status Sheet

     Attachment B - Product Specific DCI Response Forms
                  (Form A) plus Instructions

     Attachment C - Requirements Status and Registrants' Response Forms
                  (Form B) plus Instructions

     Attachment D - EPA Groupings of End-Use Products for Meeting Data
                  Requirements for Reregistration

     Attachment E - EPA Acceptance Criteria

     Attachment F - List of all Registrant(s) sent this DCI

     Attachment G - Cost Share/Data Compensation Forms
                  Application for Registration
                                IV

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                  GLOSSARY OF TERMS AND ABBREVIATIONS


A.I.         Active Ingredient

CAS         Chemical Abstracts Service

CFR         Code of Federal Regulations

CSF         Confidential Statement of Formula

EPA         U.S. Environmental Protection Agency

EP         End-Use Product

FDA         Food and Drug Administration

FIFRA       Federal Insecticide, Fungicide, and Rodenticide Act

GRAS       Generally Recognized As Safe


LCW         Median Lethal Concentration. A statistically derived concentration of a
             substance that can be expected to cause death in 50% of test animals.  It is
             usually expressed as the mass of substance per body mass of animal or volume
             of water or feed, e.g., mg/1 or ppm.

LDW         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 mass of
             substance per unit mass of animal, e.g. mg/kg.

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

ppm         Parts per Million

RED         Reregistration Eligibility Document

TGAI        Technical Grade of the Active Ingredient

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EXECUTIVE SUMMARY
This Reregistration Eligibility Document (RED) addresses the pesticide active
ingredients potassium and ammonium salts of fatty acids and their uses in the chemical case
soap salts. Soap salts-containing products are currently registered as acahcides, algaecides,
herbicides, insecticides and animal repellents. They are intended for either residential or
commercial use. All applicable products containing potassium or ammonium salts of fatty
acids as active ingredients and that registered for these uses are eligible for reregistration.

The U.S. Environmental Protection Agency (EPA) has conducted a review of the
scientific data base and other relevant information supporting the reregistration of soap salts
and has determined that the data base is sufficient to allow EPA to make a reregistration
eligibility decision. All data requirements have been submitted or waived for these active
ingredients.

Accordingly, EPA has determined that all products containing potassium or
ammonium salts of fatty acids as the active ingredient are eligible for reregistration and will
be reregistered when acceptable labeling and product specific data are submitted and/or cited.
Before reregistering each product, the EPA is requiring that product specific data and revised
labeling be submitted by the registrants within eight months of the issuance of this document.
After reviewing these data and the revised labels, EPA will determine whether or not the
conditions of FIFRA 3(c)(5) have been met, that is, whether product composition and
labeling are acceptable and the product's uses will not cause unreasonable adverse effects to
humans or the environment. If these conditions are met, EPA will reregister the product.
Any end-use product containing soap salts in combination with other active ingredients will
not_be reregistered until the Agency issues reregistration eligibility decisions for all active
ingredients contained in that product.
VI

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I. INTRODUCTION

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

FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for 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 eligibility for
reregistration of soap salts. The document consists of six sections. Section I is the
introduction. Section II describes soap salts, their 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 discusses the eligibility for reregistration decision
for soap salts. Section V discusses the reregistration requirements for soap salts. Section VI
is the Appendices which support this Reregistration Eligibility Document. Additional details
concerning the Agency's review of applicable data are available on request.1
1 EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OPP Public Docket, Field Operations Division (H7S06C), Office of Pesticide
Programs, EPA, Washington, DC 20460.

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II. CASE OVERVIEW

A. Chemical Overview

The active ingredients potassium and ammonium salts of fatty acids are covered by
this Registration Eligibility Document.

1. Chemical Name: Potassium salts of fatty acids [CU-C,S saturated and C,,
unsaturated], including potassium laureate, potassium myristate, potassium oleate and
potassium ricinoleate.

CAS Registry Number: 10124-65-9

Office of Pesticide Programs Chemical Code: 0079201

Empirical Formula: [C,z-Clg H,-Hy O.-OJK

2. Chemical Name: Ammonium salts of higher fatty acids [C,-C,» saturated and C,,
unsaturated], including ammonium oleate.

CAS Registry Number: 84776-33-0

Office of Pesticide Programs Chemical Code: 031801

Empirical Formula: [CrCu Hr-Hy 0»-Oy]NHt

B. Use Profile Fpr Potassium Salts of Fatty Acids

Mechanism of Action: Insects*- Disrupts the integrity of the exoskeleton by dissolving
portions, causing body fluids to exude from the body and ultimately, death. Plants-Disrupts
the photosynthetic process, thereby killing the plant.

Use Sites:

Terrestrial Food+Feed Crops: Beans, peas, tomatoes, white potatoes, seed and pod
vegetables and other unspecified vegetables; nut crop/nut trees, citrus, pome fruits,
subtropical fruits, grapes, trees and other unspecified fruit; and cotton.

Terrestrial Food Crops: Broccoli, brussels sprouts, cabbage, cauliflower, cucumber,
eggplant, lettuce, melons, okra, pepper, pumpkins, radish, squash (summer), squash

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(winter), squash (zucchini), asparagus, and stone fruits.

Greenhouse Food Crops: fruit trees and other unspecified fruits.

Terrestrial Greenhouse Food Crops: asparagus, cucurbits, flavoring and spice crops, fruiting
vegetables, leafy vegetables, root crop vegetables and other unspecified vegetables.

Indoor Residential: Adult dogs, puppies and cats.

Outdoor Residential: Walks, driveways, ornamental flower beds, trees and shrubs.

Pests:

Spider mites, whiteflies, aphids, squash bugs, flea beetles, green stink bugs, cabbageworms,
leafhoppers, lace bugs, mealybugs, earwigs, grasshoppers, plant bugs, psyllids, sawfly
larvae, scales, tent caterpillars, thrips, fleas, sarcoptic mange mites, wasp, hornets and ants.
The potassium salts are also labeled to control mosses, algae, lichens, liverworts, and
unspecified weeds.

Formulation Types Registered: Liquid and Solid

Single Active Ingredient Products:

Liquid concentrates: 18 to 50.5% potassium salts of fatty acids.
Solid Soap Cake: 25.0% potassium salts of fatty acids.

Ready to Use Sprays: 1.0 to 3.0% potassium salts of fatty acids.

Multiple Active Ingredient Products:

Solid soap cake: 89.0% potassium salts of fatty acids, 0.120% petroleum distillate, 0.084
N-Octyl bicycloheptene dicarboximide, 0.05% piperonal butoxide technical and 0.025%
pyrethrins.

Liquid concentrates: 20.0% potassium salts of fatty acids, and 0.20% pyrethrins.
Ointment: 7.5% soap (anhydrous) and 30% benzyl benzoate.

Ready to Use Spray: 1.0% potassium salts of fatty acids and 0.01% pyrethrins.

Methods and Rates of Application:

Products containing potassium salts of fatty acids are applied as sprays, in a solid form
("soap cake"), and as an ointment. For specifics in application methods and rates on

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 application methods and rates, please refer to Appendix A.

 Limitations:  None



 C.    Use Profile for Ammonium Salts of Fatty Acids


 Mechanism of Action: Negatively affects the olfactory nerves of deer and rabbits.

 Use Sites:

 Terrestrial Food+Feed Crops:  Grapes, cereal  grains,  unspecified vegetables, unspecified
 orchards, unspecified field crops, grass forage/fodder/hay and non-grass forage/fodder/hay.

 Terrestrial Non-Food Crops:  Ornamental herbaceous plants, ornamental lawns and turf,
 ornamental woody shrubs and vines and ornamental shade trees.

 Pests:

 Deer and rabbits

 Formulation Type Registered:  Liquid

 Single Active Ingredient Products:

 Liquid concentrates:   15.0% ammonium soaps  of higher fatty acids.


 Methods and Rates of Application:

 Because of the variation in rates and methods of application  of this chemical, please refer to
 Appendix A for methods and rates of application.

 Limitations:  Do not apply product through any type of irrigation system.  Product is not
 compatible with soluble metallic salts such as zinc, manganese, and iron sulfates.


 D.     Regulatory History
       The first soap salts product with pesticidal uses was registered in 1947.  Currently
there are twenty four "soap" products registered. The May 5, 1990 Federal Register
publication of List D chemicals subject to ^registration, Soap Salts, case 4083, included

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soap, oleic acid, sodium oleate, ammonium oleate, potassium laureate, potassium myristate,
potassium oleate and potassium ricinoleate. However previously in March of 1989 the
Agency determined, "all potassium salts of fatty acids, and all combinations of these
chemicals, to be a 'single active ingredient* for purposes of pesticide registration." An
Agency review of May 4, 1992 determined that this position would only include potassium
salts of Cij-Cu, saturated and unsaturated. "Any other chain length (either shorter or longer)
should be considered a different active ingredient for registration purposes." Presently, of
those chemicals included in Case 4083, only two active ingredients described above are
currently associated with active product registrations. Products containing the remaining
chemicals contained in this case (soap, as discussed below, oleic acid, and sodium oleate),
are cancelled and these active ingredients have been removed from the list of chemicals
subject to reregistration.

EPA published in the Federal Register of January 13, 1982 " an exemption from the
requirement of a tolerance for residues of the insecticide potassium oleate and related C12-C,,
fatty acid potassium salts in or on all raw agricultural commodities when applied in
accordance with good agricultural practices."

The Thompson-Hayward Chemical Company submitted an amendment to add food
uses to the label of their registered product (EPA Reg. No. 1148-13) in July of 1979. This
product, which was transferred December 29, 1982 to the Uniroyal Chemical Company
(EPA Reg. No. 400-383) contains ammonium salts of fatty acids as the active ingredient.
The Thompson-Hayward Company made a formal request for an exemption from the
requirement of a tolerance for ammonium salts of fatty acids in a letter to the Agency dated
September 10, 1980. The request was reviewed by the Agency which had no objections to
the addition of food uses but required results of an inhalation test which was submitted and
found acceptable. The addition of food uses was accepted in 1982.

Though the company made a formal request for an exemption of ammonium salts of
fatty acids from the requirement of a tolerance and the Agency reviewed the data, a formal
notice was not drafted and published in the Federal Register. To correct that oversight the
Agency will draft a proposed exemption from tolerance and publish it in the Federal
Register.

In the Federal Register Notice of May 4, 1988 and as set forth in 40 CFR §153.139,
the Agency determined that "soap", "has no independent pesticidal activity when included in
antimicrobial products for the designated uses, and thus is properly classified as an inert
ingredient." Because EPA has determined that "soap" compounds is not an active ingredient
but rather an inert in antimicrobial products, such products are not subject to the Soap Salts
Reregistration Eligibility Document.

In accordance with the Pine Oil Label Improvement Program (Federal Register dated
June 5, 1980 and PR Notice 80-1) the majority of labels for these antimicrobial products
were revised to include "soap" as an inert ingredient. The Agency has issued a letter on
May 5, 1992 notifying registrants of antimicrobial products that still have "soap" listed under

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the active ingredient statement that the label and Confidential Statement of Formula must be
amended to delete "soap" from the active ingredient statement.

Although most registrants of antimicrobial products listing "soap" as an active
ingredient have voluntarily amended their registrations to redesignate soap as inert, there
remain a small number of registered antimicrobial products for which an amendment to effect
this change has not been submitted to the EPA. While these products are not subject to the
data requirements of the Soap Salts Reregistration Eligibility Document, the registrants of the
products are being notified that the Agency considers antimicrobial products with "soap"
listed on the label as an active ingredient to be misbranded under section 2(q)(l)(A) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Accordingly, unless these
product labels are amended to delete soap as an active ingredient, the Agency may bring
misbranding action under section 12(a)(l)(E) of FIFRA or may cancel such products under
6(b) of FIFRA.

The Food and Drug Administration lists salts of fatty acids, except ammonium, as
additives that may be safely used in foods. This denotation appears in 21 CFR §172.863.
ffl. SCIENCE ASSESSMENT OF SOAP SALTS
The Agency has reviewed the scientific data base for soap salts, primarily relying on
information from published literature submitted by the registrant. These sources of
information are cited in Appendix C.
A. Product Chemistry Assessment
In the May 5, 1990 Federal Register publication of List D chemicals, Soap Salts, case
4083, included soap, oleic acid, ammonium oleate, sodium oleate, potassium laureate,
potassium myristate, potassium oleate and potassium ricinoleate. By definition "ordinary
soap is a mixture of the sodium salts of various fatty acids of natural oils and fats. It is
made by heating oils with caustic soda, salting out the soluble soap formed, and drawing off
the dilute glycerol produced. Thus, common soap is largely a mixture of the sodium salts of
palmitic, stearic and oleic acids. The term soap is also applied to individual components
such as sodium palmitate, sodium stearate, etc. If another metal or basic radical is present
instead of sodium, a modified term such as potash soap, calcium, soap or amine soap is
used (1). This latter category also includes ammonium soaps (ammonium salts of fatty
acids).

Case 4083, soap salts, are comprised of only two active ingredients which are
currently associated with active product registrations. These two chemicals are: (1)
ammonium salts of [C8-C18 saturated and C18 unsaturated] fatty acids, including

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ammonium oleate; and, (2) potassium salts of [C12-C18 saturated and Clt unsaturated] fatty
acids, including potassium laureate, potassium myristate, potassium oleate, and potassium
ricinoleate.
The technical grade of the active ingredient (TGAI) pej s& is not isolated during the
manufacturing process. Given that these active ingredients are exempt from the requirement
of a tolerance (40 CFR §180.1068), the Agency has not required generic data requirements
to be satisfied using the TGAI as the test substance.
B. Human Health Assessment
1. Toxicology Data Base

The lexicological data base on soap salts is adequate and will support registration
eligibility of the active ingredients.
a. Acute Toxicirv
ACUTE TOXICITY DATA

Oral LD50
Dermal LD50
Eye effects
Skin effects
EFFECT, CATEGORY
IV
IV
Irritation
Mild - moderate irritation;
Non-sensitizing
Oral exposure to soaps is generally self-limiting because the taste of soap is easily
recognized and unpleasant. The ammonium soap salts also have a notable ammonia odor that
is limiting. Fatty acids such as oleic acid and related C,2~CU fatty acids are generally
considered to be of low toxicity by the oral route of exposure, and potassium salts of these
fatty acids are not expected to be very toxic. The oral LD50 for oleic acid in rats was 74
g/kg (14).

On human skin, 2.5 mg of soap for 24 hours caused moderate irritation; and 10 mg
of soap on rabbit skin caused mild irritation (14). On human skin, 11,800 mg of the
potassium salt of palmitic acid was irritating (15). For the potassium salt of caprylic acid,
7320 mg was irritating on human skin (15). Stearic acid was mildly irritating to human skin
when 75 mg was applied intermittently for 3 days (15). On rabbit skin, 500 mg of stearic

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acid applied for 24 hours was moderately irritating (IS). Oleic acid was moderately
irritating to human skin when 15 mg was applied intermittently for 3 days; and mildly
irritating to rabbit skin when 500 mg was applied (14).

The potassium salt of oleic acid was irritating when 12 mg were placed in rabbit eyes
(48 hours) (14,15).

b. Metabolism

Fatty acids are normally metabolized by the cells,'where they are oxidized to simple
compounds for use as energy sources and as structural components utilized in all living cells.
Potassium, sodium and ammonium are normally part of the body's metabolism and
electrolyte balance.

c. Reproduction and Developmental Toxicity

When given to mice on days 2-13 of pregnancy, the potassium salts of coco fatty
acids were reported to have an effect on post-implantation mortality at 6 gm/kg, and to cause
musculo-skeletal system abnormalities at 600 mg/kg (15).
d. Mutagenicitv

DNA inhibition was reported with 600 umol/1 of the sodium salt of caprylic acid,
tested with guinea pig kidney cells (15). Unscheduled DNA synthesis was found in mouse
cells with 35 mg/kg of oleic acid (14). Cytogenetic analysis was positive for 2500 ug/L of
oleic acid with hamster fibroblasts and for 100 mg/L with Saccharomyces cerevisiae (14).
2. Dietary Exposure

There is a tolerance exemption for potassium oleate and related C12-CU fatty acid
potassium salts [40 CFR §180.1068]. Salts of fatty acids (not including ammonium salts) are
food additives [21 CFR §172.863]. Residue chemistry data requirements are not applicable
due to the tolerance exemption. While there are registered food uses for ammonium salts of
fatty acids, there is neither a tolerance nor a tolerance exemption for these salts under 40
CFR Section 180. The Agency will correct this discrepancy by proposing a tolerance
exemption.
3. Occupational and Residential pxoosure

Products containing potassium salts of selected fatty acids are used on various crops,
shrubs and trees, as well as household plants. Other uses include moss control in lawns as
well as control of algae, lichens, and liverworts on roofs, walks, and fences, and in

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greenhouses. Ammonium salts of fatty acids are used as a rabbit and deer repellent on
forage and grain crops, vegetables and field crops (unspecified), non-crop areas, nursery
stock and ornamentals, flowers, roses, shrubs, fruit trees and vines.

The end-use product labels for the potassium salts of fatty acids bear the signal word
"CAUTION" and do not recommend any measures to reduce exposure. The labels for the
two end-use product labels for the ammonium soaps of higher fatty acids bear the signal
word "DANGER" due to potential eye irritation and require that users wear protective
eyewear, i.e., glasses, goggles, or faceshield, to protect against ocular exposure. The
products may also cause allergic skin reactions in some individuals, however, no measures
are recommended to reduce skin exposure because the Agency believes allergic reactions are
uncommon and transient.

The lexicological data base on these soap salts is adequate and will support
reregistration. Because the toxicity of these chemicals is generally low, the Agency is not
requiring any exposure data. Exposure to users during application can be significant, but
soaps generally have low toxicity to humans and, there is no reason to expect that pesticide
use in accordance with use directions would constitute any significant hazard. Protective
eyewear is required for ammonium soap salt products to mitigate potential ocular exposure
and irritation for the ammonium salts of fatty acids.
4. Risk Assessment

Soaps are mineral salts of naturally occurring fatty acids. The fatty acids are a
significant part of the normal daily diet, for they occur in dietary lipids which usually
constitute about 90 grams in a day's diet. Residues from the pesticide uses are not likely to
exceed levels of naturally occurring fatty acids in commonly eaten foods. The Food and
Drug Administration lists salts of fatty acids, including the potassium salts, as additives that
may be used as binders, emulsifiers, and anticking agents in food (21 CFR 172.863). Also,
FDA lists oleic acid derived from tall oil fatty acids (21 CFR 172.862), and lists fatty acids,
including capric, caprylic, lauric, myristic, oleic, palmitic, and stearic acids, (21 CFR
172.860) as additives that may be safely used in foods. Stearic acid is generally recognized
as safe for use as an ingredient in food (21 CFR 184.1090). A number of fatty acid salts are
prior sanctioned for uses in food packaging materials (21 CFR 181).

Because of the low acute toxicity (toxicity category IV) of soap salts via oral and
dermal routes, and because residues from the pesticide uses are not likely to exceed levels of
naturally occurring or intentionally added fatty acids in commonly eaten foods, the Agency
believes the risks to applicators and consumers of treated foods are negligible. There is a
risk of permanent eye injury to applicators but this risk can be mitigated by the use of eye
wear protection, i.e., safety glasses, goggles or a faceshield. Protective eyewear is required
for ammonium soap salt products to mitigate potential ocular exposure and irritation.

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C. Environmental Assessment

The Agency has reviewed the data base for environmental effects for potassium and
ammonium salts of fatty acids and has determined that the data base is adequate and will
support reregistration.
1. Environmental Fate Assessment

Hydrolysis of potassium salts of fatty acids was shown not to occur over a period of
43 days (MRID 00164005). This is consistent with the literature on fatty acids, which
indicates that the primary environmental degradation route of fatty acids is by microfloral
action (the cleavage of the carbon chain of fatty acids by oxidative chemistry) as opposed to
hydrolysis. Due to the similarity of chemical structure, it is expected that hydrolysis of the
ammonium salts of fatty acid would be similar to that of the potassium salts of fatty acids.

Studies submitted to the Agency indicate that the half-life of these fatty acids is
approximately less than one day (MRID 00157476). As can be expected, there is very rapid
microbial degradation of fatty acids in soil. Fatty acids and their salts are excellent substrate
for microbial growth, serving both as carbon sources, and as energy sources. The active
ingredient cannot totally dissipate from soil, because there is a natural content of fatty acids
in soil resulting from plant metabolism and by formation by microbial organisms. Fatty
acids constitute a significant portion of the normal daily diet of mammals (including
humans), birds, and invertebrates since they are found in large amounts in the form of lipids
in all living tissues (including seeds). Potassium salts of fatty acids are naturally occurring.
Microbial metabolism of fatty acids has the effect of either converting the degradates to CQ
and ester (if used as an energy source) or converting the carbon content of the fatty acid to
any of the thousands of naturally occurring organic substances produced by the soil
microflora (if used as a carbon source).
2. Ecological Hazard Assessment for Ammonium Salts of Fatty Acids

Topical summaries addressing each data requirement:

(I.) Effects on Birds

Three studies were submitted by Uniroyal Chemical Company Inc. to determine the
effect of ammonium salts of fatty acid on birds. The three studies were determined to be
supplemental because test material used in the study was reported to be only 14.65 percent
pure.
10

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Author
Date
MRID No.
Pederson
Pederson
Pederson
1991
1991
1991
41767112
41767113
41767114
To establish the toxicity of ammonium of fatty acids to birds, the following tests are required
using the technical grade material (TGAI).

A. One avian single-dose oral study on either a waterfowl species (mallard duck) pi
an upland species (bobwhite quail).

B. Two subacute dietary studies: one study on a species of upland game
bird(bobwhite quail) and one study on a waterfowl species (mallard duck).
Studies submitted included:

Study and Species % A.I.
•71-1 Avian Oral-
Bobwhite Quail 14.65
71-2
Bobwhite Quail- 14.65
Mallard Duck 14.65
LD/LC50 Date MRID

2,150ppm 1/91 41767112
5,000 ppm
5,000 ppm
1/91 41767113
1/91 41767114
Fulfills Requirement

Y
Y
Although these avian studies are classified as supplemental (the active ingredient was
determined to be only 14.65 % pure) data could be used to satisfy the data requirement. The
oral LD50 was determined to be 2,150 ppm for mature bobwhite quail given a single oral
dose of ammonium salts of fatty acids (Pederson, 1991, MRID 41767112). The results of 8-
day dietary studies (Pederson, 1991, MRID's 41767113 and 41767114) indicate that the
LC50 for ammonium soap salts is greater than 5,000 ppm for both mallard ducks and
bobwhite quail. The available data indicate that ammonium salts of fatty acids is practically
non-toxic to upland game birds and waterfowl.
Precautionary Labeling
The available toxicity data do not indicate a requirement of precautionary labeling for birds
on products containing Ammonium salts of fatty acids.
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(ii.) Effects on Freshwater Invertebrates
No studies were received on ammonium salts of fatty acids for freshwater
invertebrates. Minimum data requirement to establish the acute toxicity of ammonium salts
of fatty acids to freshwater invertebrates includes:

A. A 48-hour acute study using the technical grade material. Test organisms should
be first installed Daphnfo
Data for aquatic invertebrates used in the hazard assessment were derived from tests
conducted on Potassium Salts of Fatty Acids. Science staff determined that the chemical
properties for all soap salts were very similar. Although this does not necessarily mean the
biological effects are similar, the Ecological Effects Branch has tentatively concluded that the
worst case scenario for Ammonium Salts of Fatty Acids is not likely to be significantly
different than Potassium Salts of Fatty Acids. The core study for Potassium soap salts
indicates that potassium soap salts are highly toxic (LCM = 0-57 ppm) to freshwater
invertebrates (MRID 400662-00).
Precautionary Labeling
This product may be hazardous to aquatic invertebrates. Do not apply directly to
water, areas where surface water is present or to intertidal areas below the mean high water
mark. Do not contaminate water by cleaning of equipment or disposal of water.
(ui.) Effects on Freshwater Fish
The minimum data required for establishing the acute toxicity of ammonium salts of fatty
acids to freshwater fish are two 96-hour freshwater fish studies with the technical grade
active ingredient. The following studies are required:

A. One 96-hour study with a coldwater fish species (preferable rainbow trout)

B. One 96-hour study performed with a warmwater fish species (preferably bluegill
sunfish).

No studies using ammonium salts of fatty acids were submitted under this topic; however, a
tentative position can be taken that because of the similarities of soap salts, the potassium
salts of fatty acid data can probably be substituted for ammonium salts of fatty acids.
12

-------
       Two tests were performed on freshwater fish using the potassium salt technical grade
material.  The LCSO's were determined to be 18.06 ppm and 35.35 ppm for trout and
bluegill respectively.  One study with the typical end-use product performed on fathead
minnows produced a LC50 of 21 ppm.  These data indicate that potassium soap salts, and by
presumption, ammonium soap salts are slightly toxic to both coldwater and warmwater fish
species.
Precautionary Labeling
The available acute toxicity data indicate that precautionary labeling for fish toxicity is not
required.
       (iv.) Effects on Non-Target Insects
       No studies were received on the effects of ammonium salts of fatty acids on non-
target insects.
Precautionary Labeling


Precautionary labeling will be required if data to be submitted indicates a significant risk.


3.  Ecological Hazards Assessment for Potassium Salts of Fatty Acids

       Topical summaries addressing each data requirement:


       (\.) Effects on Birds
       Seventeen studies were submitted from 2 different companies to determine the effect
of potassium salts of fatty acid (soap salts) on birds.  Seven of the 17  studies submitted were
acceptable for use in the risk assessment.  Ten of the studies can be used to supplement the
core data used in the risk assessment.
                                           13

-------
Author Date MRID No.

Grimes 1987 94240004 (TGAI)
Grimes 1987 94240004 (TEP)
Grimes 1987 94240005 (TGAI)
Grimes 1987 94240005 (TEP)
Grimes 1987 94240005
Wildlife Int. Ltd. 1981 00096639A
Wildlife Int. Ltd. 1981 00096639B
Wildlife Int. Ltd. 1981 .00157472
Wildlife Int. Ltd. 1981 00010504 (2 studies)
To establish the toxicity of potassium salts of fatty acids to birds, the following tests
are required using the technical grade material (TGAI).

A. One avian single-dose oral study on either a waterfowl species (preferably mallard
duck) 01 an upland species (preferably bobwhite quail).

B. Two subacute dietary studies: one study on a species of upland game bird
(preferably bobwhite quail and one study on a species of waterfowl (preferably mallard
duck).
The acceptable acute oral toxicity studies are listed below:
D*u Requirement! Tea Bibliographic Validation Company Resulu
Subftance Citation
AVIAN TESTING

7M AviaaOni
Bobwniu TEP 94240004 Supplemental Renter LD50- >2,230 mg/kg
TGAI 94240004 Con Renter LDSO- >2.000mg/k|

Mallard Duck TGAI 00096639B Supplemental Safer LDSO- >2,SIOiQg/kf
TGAI 00096639A Supplement*! Safer LD50- >2J10mf/kf
14

-------
       The acceptable subacute dietary toxicity studies are listed below:
 Data Requiremante
T«*t       Bibliographic  Validation      Company  Reculta
Substanca   Citation
 71-2 Avian Dietary
  Bob whit*
TGAI      00096640   Cora         Safar     LCSO- > 5,620 ppm
TGAI      00010504   Cora         Safar     LCSO- >5,620 ppm
TGAI      00010504   Supplemental   Safar     LCSO. > 10,000 ppm
TEP       942400-05   Supplemental *  Rautar     LCSO* >5,620 ppm
TGAI      942400-05   Cora         Rautar     LCSO- >5,620 ppm
  Mallard Duck
TGAI      942400-05   Cora         Rautar     LCSO- >5,620 ppm
TEP       942400-05   Supplemental   Rautar     LCSO- >5,620 ppm
       An LD50 greater than 2,000 mg/kg was determined for bobwhite quail given a single
oral dose of soap salts (Reuter Company,  1987 MRID 94240004). Also a LD50 greater
2,510 mg/kg was determined for mallard ducks (Safer, 81992, MRID 00096639).
Therefore, soap salts can be considered relatively non-toxic to bobwhite quail and mallard
duck on an acute oral basis.

       Results from the 8-day Subacute Dietary LCSO for mallard ducks and bobwhite quail
were determined to be greater than 5,620 ppm (Safer Company, 1992, MRID 00096640 and
Reuter Company,  1987, MRID 94240005).  These data indicate that soap salts are practically
non-toxic to bobwhite quail and mallard ducks on a dietary basis.
Precautionary Labeling

       The available toxicity data indicates that precautionary labeling for birds on products
containing potassium salts of fatty acids is not required.
       (U) Effects on Freshwater Invertebrates

       Three studies were received and evaluated under this topic.  All studies were found
acceptable for use in a hazard assessment.  However, two of the studies were considered
supplemental in nature because the typical end use product was used in the studies (50%
A.I.),  The studies are listed below:
                                            15

-------
Author

Condrashoff
Condrashoff
Harrison
Date

1979
1979
1986
MRID No.

00030865
00096638
40066200
To establish the acute toxicity of potassium salts of fatty acids to aquatic
invertebrates, the following test is required using technical grade material (TGAI).

A. A 48-hour acute study using the technical grade material. Test organisms should
be first instal Daphnia magna.

The studies acceptable for use in the hazard assessment are listed below:
Data Requirement!
AQUATIC TESTING
Test Bibliographic Validation
Subetanca Citation
Company Reeultt
72-2
Daphnia
Daphnia
Daphnia

TGAI
TGAI
TCAI

00030865
00096638
400662-00

Supplemental
Supplemental
Cora

Safer
Safer
Router

LCSO- 102ppm
LC50- 102ppm
LCSO- .57 ppm
A 48-hour LCSO of 0.57 ppm was found for Daphnia magna exposed to technical
potassium salts of fatty acids (Reuter Company, 1987 MRID 40066200). The results of this
study indicate that potassium salts of fatty acids are highly toxic to aquatic invertebrates.
The results of this study triggers a Dapfrnia life-cycle study. However, this study will not be
needed to assess the effect of potassium salts of fatty acids on aquatic invertebrates, since
due to the expected fate of the material, significant concentrations of the pesticide are not
expected to occur in aquatic environments.
Precautionary Labeling
This product may be hazardous to aquatic invertebrates. Do not apply directly to
water, areas where surface water is present or to intertidal areas below the mean high water
mark. Do not contaminate water by cleaning of equipment or disposal of water.
16

-------
(iii.) Effects of Freshwater Fish
Five studies were evaluated under this topic. All five studies were considered acceptable for
use in a hazard assessment.
Author

Analytical
BioChem.Lab.

Applied Bio.
Science Lab.

Obenchain
Date

1985

1981

1986
MRID No.

00157473

00096637

00096636

40066200 (2 studies)
The minimum data required for establishing the acute toxicity of soap salts to
freshwater fish are two 96-hour studies with the technical grade product both coldwater and
warmwater species of fish. The preferred coldwater species is rainbow trout and the
preferred warmwater species is bluegill sunfish).
The acceptable acute toxicity data are listed below:
Dati Requirement*
Ten Bibliographic Validation
Subsume Citation
Company Retulu
AOUATTC TESTING
72-1 Fmhwtttf Fiih
Trout
Fathead Minnow
Blutgill Sunfiih
Bluejill Sunfiih
Trout

TCAl
TEP
TGAI
TGAI
TGAI

00096636
00096637
157473
" 400662
4006200

Supplemental
Supplemental
Core
Supplement*!
Supplemental

Safer
Safer
Safer
Reuter
Reuler

LC50- 18.06 ppm
LC50- 21 ppm
LC50- 35.35 ppm •
LC50- 23 ppm
LC50- 9.19 ppm
Two tests were performed on freshwater fish using the technical grade material. The
LCSO's were determined to be 18.06 pm and 35.35 ppm for trout and bluegill respectively.
One study with the typical end-use product performed on fathead minnows produced a LC50
of 21 ppm. These data indicate that soap salts are slightly toxic to both coldwater and
warmwater fish species.
17

-------
Precautionary Labeling
The available acute toxicity data indicate that precautionary labeling for fish toxicity is not
required.
(iv.) Effects on Non-Target Insects
No studies were received on the effects of soap salts on non-target insects. To
establish the toxicity of soap salts to honey bees, a Honey Bee Acute Contact LD50 test.
This test is required because the use patterns and target crops of soap salt correspond with
the locations and use patterns that may effect pollinators.
4. Environmental Risk Assessment of Potassium and Ammonium Salts of Fatty Acids

As presented above and in Appendix A, pesticide products containing potassium or
ammonium salts of fatty acids are registered for use on a wide array of field, fruit and
vegetable crops and ornamental turf and plants, as well as a few other uses. The active
ingredients applied to these sites are expected to be degrade rapidly, perhaps a half-life of
less then one day. Microbial degradation is the primary path of this rapid degradation.
Therefore, the Agency believes that these chemicals, when used as directed, will not persist
in the environment.

Data reviewed suggest that neither potassium or ammonium salts of fatty acid are very
toxic to upland avian species or waterfowl by either acute or dietary exposure. Therefore,
the Agency believes the potential risks to avian species is minimal.

For aquatic species, the Agency believes the available data on potassium salts of fatty
acid suggest this active ingredient, and probably ammonium salts of fatty acids, are only
slightly toxic to both warmwater and coldwater fish species. However, for aquatic
invertebrates, these chemicals are considered highly toxic. The Agency believes, though,
that the current uses should not result in serious impact to aquatic invertebrates because these
pesticides are not applied directly to water and undergo very rapid microbial degradation in
soil.

No studies were received on the effects of soap salts on non-target insects. To establish
the toxicity of soap salts to honey bees, the Agency is requiring a Honey Bee Acute Contact
LD50 test. This test is required because the use pattern and target crops of soap salts
correspond with the locations and use patterns that may effect pollinators. Based upon the

-------
available data, ammonium and potassium salts of fatty acids should pose minimal threats to
endangered species. This conclusion is tentative pending submission of maximum application
use rates for certain uses.
IV. RISK MANAGEMENT AND REREGTSTRATION DECISION FOR SOAP SALTS
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA requires the Agency to determine, after consideration of
relevant data of an active ingredient whether products containing the active ingredient are
eligible for reregistration. The Agency has considered available data and other factors
including soap salts's natural occurrence, its common use as food items, and the lack of
reported adverse effects information. The Agency has completed its consideration of these
data and other factors and has determined this information is sufficient to support
reregistration of products containing soap salts as an active ingredient. The reregistration of
particular products is addressed in Section V of this document.

Although the Agency has concluded that products containing soap salts are eligible for
reregistration, the Agency may take regulatory actions in the future that would affect the
continued registration of soap salts-containing products if significant new information about
these active ingredients and/or their products comes to the Agency's attention. Such
regulatory action could include requiring the submission of additional, data if the data
requirements for registration (or the guidelines for generating such data) change.
B. Additional Generic Data Requirements
The generic data base supporting the reregistration of products containing soap salts has
been reviewed and determined to be substantially complete for reregistration. However, the
Agency is requiring acute ecotoxicity studies on fish and aquatic invertebrates for ammonium
salts of fatty acids and an acute toxicity study on honey bees for the potassium salt to
confirm its opinion that the potential ecological hazards from these pesticides are not greater
than suggested by the currently available data. See Appendix F for details.
C. Labeling Requirements For Manufacturing-Use Products Of Soap Salts

No manufacturing-use products are registered.

-------
V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS

A. Determination Of Eligibility
Based on the reviews of the generic data for the active ingredients, the products
containing potassium or ammonium salts of fatty acids are eligible for reregistration. As
mentioned above, the Agency is requiring certain ecotoxicology studies to confirm its risk
assessment. These must be conducted and submitted in conformance with specifications in
Appendix F. Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has been
made. The Agency will review these data when they have been submitted and/or cited and
determine whether to reregister individual products.
1. Product Specific Data Requirements
The Agency is requiring certain product chemistry and acute toxicology studies for
end-use products. The specific data requirements are stated in Attachment C.
2. Labeling Requirements For End-Use Products
a. The labels and labeling of all products must comply with the Agency's current
regulations and requirements. Follow the instructions in the Product Reregistration
Handbook with respect to labels and labeling.

b. The following statement must appear under the title Environmental Hazards on
the product labels marketed for outdoor use.

"This product may be hazardous to aquatic invertebrates. Do not apply directly to
water, areas where surface water is present or to intertidal areas below the mean high water
mark. Do not contaminate water by cleaning of equipment, or disposal of water."

c. The active ingredient statement must identify the type of soap salts and not just
list "soap." Therefore, the active ingredient statement must read "ammonium salts of fatty
acid" or "potassium salts of fatty acids."
20

-------
       d.  For products containing ammoniated soaps, safety glasses, or a face shield must
be required under the Precautionary Statements.
       e.   Under the Directions for use, the statement "including but not limited to" for
food/feed uses must be removed and all crops or crop groupings must be listed.
                                          21

-------
             APPENDIX A
Soap Salts Use Patterns Subject to Reregistration

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-------
                  APPENDIX B

Generic Data Requirements for Reregistration of Soap Salts
      and Data Citations Supporting Reregistration
-------
                              GUIDE TO APPENDIX B
    Appendix B contains listings of data requirements which support the reregistration for the
pesticide covered by this Reregistration Eligibility Document.  Also, Appendix B contains
generic data requirements that apply to the pesticide in all products, including data
requirements for which a "typical formulation" is the test substance.

    The data tables generally are organized according to the following format:

    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 out in the Pesticide Assessment Guidelines, which are available
from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161.

    2.  Bibliographic citation (Column 2).  If the EPA has acceptable data in its files, this
column lists the identifying number of each study.  This normally is the Master Record
Identification (MRJD) number, but may be a GS number if no MRID number has been
assigned.  Refer to the Bibliography Appendices for a complete citation of the study.
-------
                                  APPENDIX B

                  Generic Data Supporting Guideline Requirements for
                             Reregistration of Soap Salts
61-1         Chemical Identity
61-2(a)       Description of starting material
             and manufacturing process
                                            94241004, 94244001
                                            94242001,

                                            94241004, 94244001
                                            94242001
6I-2(b)       Discussion of formation of
             impurities

62-1         Preliminary analysis of product
              samples
62-3         Analytical methods to verify
              certified limits
63-2         Color
                                            94241004, 94244001
                                            94242001

                                            94242002

                                            94242002

                                           94241011,94244005
                                           94242003, 94243001
                                           94243002, 94243003
63-3
Physical State
 94241011,94244005
 94242003, 94243001
 94243002, 94243003
63-4
63-5
63-6
Odor
Melting Point
Boiling Point
94241011,94244005
94242003, 94243001
94243002, 94243003

94241011,94244005
94242003, 94243001
94243002, 94243003

94241011,94244005
94242003, 94243001
94243002, 94243003
-------
63-7        Density, bulk density, or specific            94241011, 94244005
            gravity                                  94242003,94243001
                                                     94243002, 94243003
63-8         Solubility                               94241011,94244005
                                                     94242003, 94243001
                                                     94243002, 94243003

63-10        Dissociation Constant                      94241011,94244005
                                                      94242003, 94243001
                                                     94243002, 94243003

63-12        pH                                       94241011,94244005
                                                      94242003, 94243001
                                                      94243002, 94243003

63-13        Stability                                  94241011,94244005
                                                      94242003, 94243001
                                                      94243002, 94243003
-------
RESIDUE CHEMISTRY

EPA waived 40 CFR Pan 158 requirements for reasons discussed in Section III.

OCCUPATIONAL AND RESIDENTIAL EXPOSURE

EPA waived 40 CFR Part 158 requirements for reasons discussed in Section III.

TOXICOLOGY

EPA waived 40 CFR Part 158 requirements and relied on published data cited in the
bibliography.

ENVIRONMENTAL FATE

EPA waived 40 CFR Pan 158 requirements and relied on published data cited in the
bibliography.

                                          Ammon.
ECOLOGICAL EFFECT

71-1   Acute Avian oral quail/duck


71-2   Acute avian diet, quail
72-1   Fish toxicity bluegill
      fish toxicity rainbow trout
                                          417671-12
                                          00096639B
                                          00096639A
                                          417671-13
                                          417671-14
                                           942400-05
Potass.

94240004
00096640
00010504

 00096636
00096637
00157473
00400662
04006200
-------
             APPENDIX C
Citations Considered to be Part of the Data Base
  Supporting the Reregistration of Soap Salts
-------
                               GUIDE TO APPENDIX C

1.     CONTENT 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,
       will be included.

2.     UNITS OF  ENTRY.  The unit of entry in this bibliography is called a "study".  In
       the case of published  materials, this corresponds closely to an article. In the case of
       unpublished materials submitted to the EPA, the EPA 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 EPA has attempted
       also to unite basic documents and commentaries upon them, treating  them  as a single
       study.

3.     IDENTIFICATION OF ENTRIES.  The entries in this bibliography  are sorted
       numerically by Master Record Identifier,  or MRID number.  This  number is unique
       to the citation,  and should be used at any time specific reference is required.  It is not
       related to the six-digit "Accession Number" which has been used to identify volumes
       of submitted studies; see paragraph  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 identifier number is also  to be used whenever specific reference is needed.

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

       a.     Author.  Whenever the EPA could confidently identify one, the EPA has
             chosen to show a personal author. When no individual was identified, the
             EPA has shown an-identifiable laboratory or testing facility as author. As a
             last resort, the EPA has shown the first submitter as author.

       b.     Document date. When the date appears as four digits with  no question marks,
             the EPA took it directly from the document.  When a  four-digit date is
             followed by a question mark the bibliographer deduced the date from evidence
             in the document.  When the date appears as (19??), the EPA was unable to
-------
       determine or estimate the date of the document.
c.      Title.  In some cases, it has been necessary for EPA
       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 EPA in the past, the trailing
       parentheses include (in addition to any self-explanatory text) the following
       elements describing the earliest known submission:

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

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

       (3)    Submitter. The third element is the submitter,  following the phrase
             "submitted by." When 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," standing for "Company
             Data Library." This accession number is in turn followed by an
             alphabetic suffix which shows the relative position of the study within
             the volume. For example, within accession number 123456, the first
             study would be 123456-A; the second,  1234S6-B; the 26th, 123456-Z;
             and the 27th,  123456-AA.
-------
                       OFFICE OF PESTICIDE PROGRAMS
                   REREGISTRATION ELIGIBILITY DOCUMENT
                                 BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY.  This bibliography contains citations of all publications
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Registration  Eligibility Document.   Primary  sources  for published  literature in  this
bibliography have been the body of data submitted to EPA  in support of past  regulatory
decisions.

(1)    94241004 Seidman, B. (1990) Safer, Inc. Phase 3 Summary of MRID 00007049. Data
      Submitted in Support of EPA Registration of Safer's Insecticidal Soap 02:   Product
      Chemistry.  10 p.

(2)    94244001 Seidman, B. (1990) Safer, Inc. Phase 3 Summary of MRID 00007049. Data
      Submitted in Support of EPA Registration of Safer's Insecticidal Soap 02:   Product
      Chemistry. 10 p.

(3)    94242001 Wong, D. (1990) Chevron Chemical Phase 3 Summary of MRID 40157601
      and  Related  MRID 00153393.   Product Identity and Composition of  Orthomite
      Insecticidal Soap: Project 8703674 and CBI 8703674. Prepared by Chevron Chemical
      Company. 16p.

(4)    94242002 Wong, D. (1990) Chevron Chemical Company Phase 3 Summary of MRID
      40157601 and Related  MRID 00153393.   Analysis  and  Certification of Product
      Ingredients of Orthomite  Insecticidal Soap:   Project  8703674 and CBI 8703674.
      Prepared by Chevron Chemical Company.  13p.

(5)    94241011 Seidman, B. (1990) Safer, Inc. Phase 3 Summary of MRID 00007049. Data
      Submitted in Support of EPA Registration of Safer's Insecticidal Soap 02:   Product
      Chemistry. 8 p.

(6)    94244005 Seidman, B. (1990) Safer, Inc. Phase 3 Summary of MRID 00007049. Data
      Submitted in Support of EPA Registration of Safer's Insecticidal Soap 02:   Product
      Chemistry. 8 p.

(7)    94242003 Wong, D. (1990) Chevron Chemical Company Phase 3 Summary of MRID
      00153393.  Physical and  Chemical Characteristics of Orthomite Insecticidal Soap:
      Project 8703674 and CBI 8703674. Prepared by Chevron Chemical Company. 7p.

(8)    94243001 Oberchain, F. (1990) Attack Pesticide  Division Phase 3 Summary of MRID
      00155278 and Related MRIDs 00154643,00155271,00155277. Potassium Salts of Fatty
      Acids-Aphid Mite Attack Product Chemistry, Part One: Unnumbered Project. 22 p.
-------
(9)    94243002 Thompson, Paul A. (1991) The Dissociation constant of Hinder.  Guideline
      Reference  63-10.  17 p.

(10)   94243003 Obenchain, F. (1990) Attack Pesticide Division Phase 3 Summary of MRID
      00155278,  and Related MRIDs OC154643, 00155271, 00155377.  Potassium Salts of
      Fatty Acids-Aphid Mite Attack Product Chemistry, Part Three:  Unnumbered Project
      8 p.

(11)   The Condensed Chemical Dictionary, 7th ed., Reinhold Publishing Co., 1966.

(12)   00164005 McPherson,  B. (1991)  "Effect of Hydrolysis of Safer's Weed and Grass
      Killer."  Guideline Reference Number 161-1 Hydrolysis. lOp.

(13)   00157476 Mozol et al. (1991) "Degradation of Fatty Acids of Lawn Soil and the Related
      MRID 00164 (Fateof Capric and Pelargonic acids in Soil." Guideline Reference 162-1,
      Aerobic Soil Metabolism. I5p.

(14)   Sax, N. I.,  and Lewis, R. J. SR, 1989. Dangerous Properties of Industrial Materials. 7th
      Edition. Van Nostrand Reinhold, New York.

(15)   NIOSH, 1987. Registry of Toxic Effects of Chemical Substances. Washington, DC.

(16)   41767112 Pedersen, Carol A.,  "Hinder: 21-Day Acute Oral LD50 Study in Bobwhite
      Quail," January 24, 1991.  Performing Laboratory: Bio-Life Associates, Ltd., Route 3
      Box 156, Neillsville, WI  54456.   Prepared  for: Uniroyal Chemical Company, Inc.
      Research and Development, 74 Amity Road, Bethany,  CT 065225
(17)   41767113 Pedersen, Carol A.,  "HINDER:   8-Day Acute  Dietary LC50  Study in
       Bobwhite Quail.  "January 23, 1991.  Prepared by Bio-Life Associates, Ltd., Route 3
       Box 156, Neillsville, WI 54456.  Prepared  for:  Uniroyal Chemical Company, Inc.,
       Research and Development, 74 Amity Road, Bethany, CT 065225,

(18)   41767114 Pedersen, Carol A., "HINDER:  8-Day Acute Dietary LC50 Studying in
       Mallard  Ducklings. "January 23, 1991.  Prepared by Bio-Life Associates, Ltd., Route
       3 Box 156, Neillsville, WI  54456. Prepared for: Uniroyal Chemical Company, Inc.,
       Research and Development, 74 Amity Road, Bethany, CT 065225.

(19)   40066200 Reuter Laboratories, Inc. (1987) Submission of Additional Non-target Wildlife
       (bird) Data in Support of Registration for Aphid-Mite Attack Concentrate.  Compilation
       of 4 studies.

(20)   00096636 "Static Acute Toxicity - Fish Bioassay, August 4, 1981".   Prepared  by:
-------
      Applied Biological Sciences Laboratory, 6320 San Fernando Road, Glendate, CA 91201.
      Prepared for Safer Agro, 5271 Old West Saanich Road, R.R.3, Victoria, B.C., Canada
      V8X3X1.

(21)   00157473 " Acute  Toxicity of Safer's Herbicide H2  to  Bluegill  Sunfish (Lepomis
      macrochirust.  November  20,  1985."   Prepared by:    Analytical  Bio Chemistry
      Laboratory, Inc.  P.O. Box 1097, Columbia, MO  65205. Prepared for :  Safer Agro-
      Che m, Ltd., 6761 Kirkpatrick C re sent, R.R.3 Victoria, B.C. Canada V8X3X1.

(22)   00096637 "Static Acute Toxicity - Fish Bioassay, August 5,1981". Prepared by Applied
      Biological Sciences Laboratory. Prepared for Safer Agro, 5271 Old West Saanich Road,
      R.R.3 Victoria, B.C. Candada V8X3X1.

(23)   94240004 Obenchain, F. (1990) Attack Pesticide Division Phase 3 Summary of MRJD
      40066202, and Related MRIDs 40053301.  Soap-Aphid  Mite Attack Concentrate/ An
      Toxicity Study with the Bobwhite:   Project 227-103 &  103A.   Prepared  by  Wildlife
      International Ltd. 16p

(24)   94244005 Seidman,  B. (1990) Safer, Inc. Phase 3 Summary of MRID 00007049.  Data
      Submitted in Support of EPA  Registration of Safer's Insecticidal Soap 02:   Product
      Chemistry. 8p.

(25)   00096639A Final Report, Acute Oral LD50 - Mallard Duck. Project Number:   157-109.
      March 30, 1981 Study Prepared by:  Wildlife International  Ltd., Solitude Creek Farm,
      St. Michaels, Maryland 21663. Prepared for: Applied Biological Sciences  Laboratory.

(26)   00096639B Fink, R.; Beavers, J.B.; Joiner, G.;etal. (1981) Final Report:  Acute Oral
      LD50--Mallard  Duck:    Safer's  Insecticidal   Soap tl:    Project No.     157-109.
      (Unpublished  study  received Dec  31, 1981  under 42697-1;  prepared  by  Wildlife
      International, Ltd. and Washington  College, submitted by Safer Agro-Chem, Jamul,
      Calif.;  CDL-.246993-D).

(27)   157472 Safer's Herbicide H2: A Dietary LC50 Study With The Bobwhite, Final Report,
      Project Number:  208-104.  Study Prepared by:  Wildlife  International Ltd.,  Solitude
      Creek Farm, St. Michaels, Maryland 21663.   Prepared Victoria,  British Columbia,
      Canada V8X 3X1.

(28)   00010504 Final Report, Eight day Dietary LC50 Bobwhite Quail.  Project Number: 157-
      107.  April 22, 1981. Study Prepared by:  Wildlife International Ltd., Solitude Creek
      Farm, St. Michaels,  Maryland 2166.   Prepared for:  Applied Biological   Sciences
      Laboratory.

(29)   00096640 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: Eight-day
      Dietary LC50~Bobwhite Quail: Safer's Insecticidal Soap If I:  Project No.  157-107.
      (Unpublished  study  received Dec  31, 1981  under 42697-1;  prepared  by  Wildlife
-------
      International, Ltd, and Washington  College, submitted by Safer Agro-Chem,  Jamul,
      Calif.;  CDL:246993-H).

(30)   00030865 Condrashoff, S.F. *A Testing Program to Determine Acute LCSO Toxicity to
      Aquatic Invertebrates of Safer's Insecticide Soap.  Forty-Eight Hour Protocol  with
      Daphnnia pulex."  Prepared by: Professional Ecological Services, 5271  Old Saanich
      Road, RR3 Victoria British Columbia, VsX3Xl, Canada. Prepared for:  Safer's Inc.
(31)   00096638 Condrashoff, S.F., "A Testing Program to Determine Acute LCSO Toxicity
      to Aquatic invertebrates of Safer's Insecticidal Soap.  Forty-eight Hour Protocol With
      Daphnia pulejc.

(32)   Thompson, Paul A.  (1991) The Dissociation constant of Hinder.  Guideline Reference
      63-10. 17 p.

(33)   Thompson, Paul A. (1991) The Density of Hinder. Guideline Reference 63-7.  11 p.
-------
APPENDIX D




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

                 UNTOD STATtS ENVIRONMENTAL ••OTICTION AGENCY
                            WASMMOTON, O.C.  I04M
                          VI norm §1-1
                          ** *°T*C* **  *
                                                         •UMTAfCIS
             HOTICE TO KAHUPACTTOIRS, PRODUCERS, FORMUIATORS,
                      AND REGISTRANTS OP PESTICIDES
 ATTENTION:   Persons Responsible for Federal Registration of
             Pesticide Products.

 SUBJECT:     Accuracy of stated Percentages for Ingredients
             Statement
 Z.   PURPOSE:

     The  purpose  of this  notics is  to  clarify  the  Office - of
 Pesticide  Program's  policy  with respect to  the  statement of
 percentages   in  a  p«sticids*s  lato«l(s  ingr«di«nt   stataaont.
 Specifically,  th»  amount  (porcant  by vsigbt)  of  ingradiant(a)
 spocifisd  in  ths  ingradiant ttataaant  on tha labal oust ba statad
 as tha noainal concantration of such  ingradiant(s), as that tarn is
 dafinad  in   40  CTR 151.153(i).  Accordingly,  tha Agancy  has
 astAblishad tha nominal concantration as tha only accaptabla labal
 claim for  tha aaeunt of activa ingradiant  in tha product.

 II.  BACRJROUNO

     For sea* ti»a tha Agancy has accaptad two diffarant mathods of
 identifying  on  tha  labal what  percentage is  claiaad  for the
 ingredient (s) contained in  a pesticide.  Seas applicants claiaad  a
 percentage which rsprasantad  a laval between tha  uppar and the
 lowar  certified  liaits.    This was referred  to as tha noainal
 eoncantration.   Other applicants elaiaad  tha lower limit as the
 percentage of  tha ingradiant (s)  that would  ba expected  to be
 present in tbair product at tha and of tha product's  shelf-life.
 Unfortunataly,  this lad to a  great  deal of confusion  aaong  the
 regulated  industry, tha regulators, and tha consumers as to exactly
 how auch of .a given ingradiant was in a given product.  The Agency
 has established tha noainal eoncantration as the only accaptabla
 label claia for the aaount of active ingredient in the product.

     Current regulations  require that the percentage listed in the
active ingredient statement be as precise as possible reflecting
good manufacturing practices  40  CFR 15«.10(g)(3).  Tha certified
 liaita  required  for each active  ingredient  are intended  to
ancoapass  any such "good manufacturing practice* variations 40 CFR
 15S.17S(e)(»).

                                                        flCu MniM fl" "*c
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 Tha uppar and lowar cartifiad limita, which auat  ba proposed in
 eenn*etion with a product's ragistration,  rapraaant tha aaounta of
 an ingradiant that may lagally ba praaant 40 CFH 1st. 179. Tha levar
 cartifiad limit ia uaad  aa tha anforcaabla lewar limit  for  tha
 product composition according to FIFRA aaetion 12(a)(l)(C), whila
 tha nominal concantration  sppaaring on  tha  labal would  ba  tha
 routinaly achiavad eoncantration  uaad for calculation of doaagaa
 and dilutiona.

     Tha nominal concantration would in  fact  atata  tha graatast
 dagraa of accuracy that ia warrantad with raapaet to actual product
 coapoaition  bacauaa tha nominal eoncantration would ba tha amount
 of activa ingradiant typically found in tha product.

     It ia important for ragiatranta to nota that cartifiad limita
 for activa  ingradianta ara  not  eonaidarad to ba  trada aacrat
 information  undar  FXFRA  aaetion  10(b).  In   thia   raapaet  tha
 cartifiad limita will  ba  routinaly providad by EPA to stataa -for
 anforcamant  purpoaaa, ainca tha nominal eoncantration appaaring on
 tha labal  may  not rapraaant  tha  anforeaabla compoaitlon  for
 purpoaaa of  aaetion l2(a)(l)(C).

 ZZZ. UQOZXBCEHTS

     As daacribad balow undar Unit V. • CQIOLXAMd SCHOOL!," all
 currantly ragiatarad products as wall aa  all applications for naw
 ragistration must eomply with thia Hotiea by apaeifying tha nominal
 concantration  axpraaaad as  a parcantags by waight  as tha labal
 claim  in tha ingradiant(a) atatamant and aquivalanea  atatamanta if
 appiicabla   (a.g.,  alamantal  arsanie, aatallic  sine,  aalt of an
 acid).  Zn addition, tha raquiraaant  for parforming aaapla analyaaa
 of fiva or more raprasantativa aamplaa must ba fulf illad. copiaa of
 tha raw analytical  data  must  ba  aubmittad  with  tha  nominal
 ingradiant  labal claim.  Furthar information  about  tha  analyaia
 raquiramant  may bo found  in tha 40  CFt ISt.iTO. All  products ara
 raquirad to provida  cartiflad limits  for  aach  activa, inart
 ingradiant,  impuritiaa of toxicological  aignificanca(i.a., uppai
 limit (a)  only)  and on • easa by  caaa basis ss  apacifiad by  EPA.
 Thaaa  limits ara to ba sat baaad on rapraaantativa  sampling and
 chamic*! analysis(i.«., quality control)  of tha product.
           •*
     Tha format of tha ingradiant atatamant must conform to 40 CFf
 136-Labaling Raquiramanta For Paaticidaa and Davicaa.

     Attar July i, it§7,  all paaticida ingradiant  atatamanta must
bo chaogad to nominal  concantzation.
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 ZV.  PRODUCTS THAT XZQUIRK EFFICACY DATA

     All pastieidas ara raquirad to ba afficaeious.  Tharafara,
 tha cartifiad lovar Haiti »«y net ba lowar than th* minimum
 laval to aehlava afficaey.  Thi* is axtramaly important for
 products which ara intandad to control paata which tltraatan tha
 public haaith, a.9., cat-tain antimicrobial and rodanticida
 products.  Rafar to 40 CFR 131.<40.

     In thosa casas vhara afficacy liaits hava baan astablishad,
 tha Aqancy will not aeeapt cartifiad lovar limit* which ara balow
 chat laval for tha shalf lifa of tha product.
 17.
COMPLIANCE SCHEDULE
     A* daseribad aarliar, tha purpoaa of this Motica is to maka
tha ra^istration proeass mora unifor* and mora manaqaabla for
both tha agancy and tha ratjulatad community,  it is tha Aqancy 'a
intantion to implamant tha raquiramants of this notica as
smoothly as poaaibla so as not to disrupt or daisy tha Aqancy 'a
high priority proqraas, i.a., raraqistration, naw chaaical, or
fast track fFZFlU faction 3(c)(3)(l).  Thar a for a,
applicanta/raqistrant* ara axpactad to comply with tho
raquiramanta of this Ho tic* as follows J

          (1)  Baqinninq July 1, Iffl, all naw product
               raqist rat ions submittad to tba Aqancy
               ar« to comply with th« raqjuiramants of this
               Motica.

          (2)  Haqiatrants having products subject to
               raraqistration undar rTFRA saction 4 (a) ara  to
               comply vita tha racjjiraa«nts of this Motica  whan
               apacific products ara callad ia by tha Aqancy
               undar Pnasa V of tha Jlarogistration Proqraa.

          (3)  All othar products/applications that ara
               not subjact to  (1) and  (3) abova  will hava until
               July i, m?, to comply with this Motiea.
               Such applications should  neta  "Convarsion
               to Moainai Concantration" on tha  application
               form. Thasa typas of aaandaants vill not ba
               handiad aa "Ft at Track* applications but
               vill ba handiad as reutina  r aquas ts.
VI.  F0« mfm »TOI«ATIOII

     Contact: Tyrona Aikan for information or quastions concamim
this notica  en (703)  997*5034.
                                 Anna I. Lindsay, Oiractor
                                 Raqistration Division  (B-7S09
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       APPENDIX E





Pesticide Registration Handbook
-------
 APPENDIX F
Generic Data Call-in
-------
                UNfTEO STATES ENVIRONMENTAL PROTECTION AGENCY
                           WASMNGTON.aC.  1P4W
                       DATA CALL-IN NOTICE


                                                      KSnCDCSANDTOUC
 D«ar sir or Madam:


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

     1. Row you will comply with the requirements set forth in
        this Notice and its Attachments A through G; or
            you believe you are exempt from the requirements
         isted in this Notice and in Attachment C,
e; - < £&$ Repuiremanta Statue and Ragiatrant * a Raaponaa Forml (see
        section III-B) ; or

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

     Zf 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 8, Pafea eaii-in aaaaonaa ram, mm veil as a
list of all registrants who vere sent this Notice (Attachment F) .

     The authority for this Notice is section 3(c)(2)(B) of the
Federal Znsecticide, Fungicide and Rodenticide Act as amended
(FZFRA), 7 U.S.C. section 136a(c) (2) (B) .  Collection of this
information is authorized under the Paperwork Reduction Act by
OMB Approval No.  2070-0107 (expiration date 12*31-92) .
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       This Notice  is divided  into six section* and  seven
 Attachments.  Thm  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  Z   - Why You Are Receiving Ibis Notice
      Section  ZZ  - Data Required By Ibis Notice
      Section  ZZZ - 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:

      A -  Data Call-Tn Chemical Status Sh««t
      & •  Data Call»lR Response Form
      C -  Requirements Status and Registrant's Response  form
      D -  EPA Grouping of Eftd-Ose produeHa for Meeting Acute
           Toxicology Data Requirements for Rereqiatration
      E -   EfA_Acceptance  Criteria
      F -  List of	Registrants Receiving This Notice
      Q «•  Cos^ _Shajreand  Data Compensation Forums,.and Product
           Specific Data Report Form
SECTION X,  WHY YQP ARE RECETVTWC THIS HQTICE

    • The Agency* has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient.  The Agency has
concluded that the only additional data necessary are product
specific data.  No additional generic data requirements are being
imposed.  You have been sent this Notice because you have
product(s) containing the subject active ingredient.

SECTION zz.  PATA RBQPIREP BY TUTS MOTTCT

II-A.  DATA REQUIRED

     The product specific data required by this Notice are
specified in Attachment C, Requirements status and Registrant's
Response rera.  Depending on the results of the studies required in
this Notice, additional testing may be required.
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 IZ— B.   SCHEDULE FOR SUBMISSION OF PATA

     You are required to submit th« data or otherwise satisfy tha
 data raquiramanta apaeifiad in Attachaent C, Requirement* statue
 and Registrant's Response yarn. within tha tiaefraaes provided.


 IZ-C.   TEfi-MKC PROTOCOL
          atudiaa raqulrad under this Notiea must ba conducted in
 aeeordanca with taat standards outlinad in tha Paaticida Aasaaamarit
 Guidelines for thoaa atudiaa for which guidalinaa hava baan
 established.
    w
    ''  Tha«a EPA Guidelines ara available froa tha National Tachnical
 Information Service (NTIS) ,  Attn: Ordar Desk, 5285 Port Royal Road,
 Springfield, Va 22161 (tal:  703-487-4650).

      Protocols approvad by tha Organization for Economic
 Cooparation and Davalopaant  (OECD) ara alao acceptable if tha OECD-
 racoaaandad tast standards conform to thoaa apaeifiad in tha
 Pesticide Data Requirements  ragulation (40 CPU I 158.70).  Whan
 using tha OECD protocols,  thay should ba aodifiad as appropriate so
 that  tha  data  ganaratad by tha study will satisfy tha raquiraaants
 of  40 CFR f 158.  Normally,  tha Agancy will not axtand daadlinas
 for complying  with  data raquiramanta whan tha studias wara not
 eonduetad in aeeordanca with accaptabla standards.  Tha OECD
 protocols ara  availabla froa OECD, 1750 Pennsylvania Avenue N.w.,
 Washington, D.c.  20006.

   •   All  naw studias and proposed protocols aubmittad in rasponsa
 to  this Data Call -In Notice  must ba in accordance with Good
 Laboratory Practices [40 CFR Part 160. 3 (a) (6)J.

 ZI-D.  REGISTRANTS  RECEIVING PREVIOUS SECTION 3felf21fB1 NOTICES
       ISSUED  BY  THE AGENCY

       Unless  otherwise notad herein, this Data Call-in daaa neat in
 anv vav supersede or chance  tha requirements of anv previous Pata
 eaii-Tnf«> . or any "other agreements entered into with tha Agency
 pertaining to  such  prior Notiea.  Registrants Bust comply with tha
 raquiraaants of all Notieas  to avoid issuance of a Notiea of Intant
 to  Suspend their  affected products.


 SECTION III.   COMPLIANCE WITH MOniMMENTS OP THIS NOTICE

 ZII-A.  ff'TTfTrPULTI  r°p PESPONPINC TO THE AGENCY
                                         •.
     Tha appropriata responses initially required by this Notiea
 for product specific data aust ba submitted to tha Agency within 90
days aftar your raeaipt  of this Notiea.  Failure to adequately
respond to this Notiea within 90 days of your receipt will ba a
basis for  issuing a Notiea of Intent to Suspend (NOZS) affecting
-------
 your products. Thin and other bases for issuance of NOZS du* to
 failure to eoaply with this Notice are presented in Section ZV-A
 and ZV-B.

 ZZZ-B.  OPTIONS TOR HeSPOWPTMC TO THE JLggMCY

     The options for responding to this Notice for product specific
 data ares (a) voluntary cancellation, (b) agree to satisfy the
 product specific data requirements imposed by this Notice or (c)
 request a data vaivar(s).  . .-;  •
                            f
                           «v
     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 ZII-C.  A
 discussion of options relating to requests for data waivers is
 contained in Section ZZZ-D.

     There are two form* that accompany this Notice of which,
 depending upon your response, one or both must be used in your
 response to the Agency.  These forms are the Data-Call-in Response
 Form, and the Requirements Status and Registrant'a Response Fora.
 Attachment B and Attachment C.  Tha Data call-In Response Fora must
 be  submitted as part of every response to this Notice.  Zn
 addition, one copy of the Requirements Statue and Registrant's
 Response Form  must be submitted for each product listed on the
 Data Call-In Responaa Form unless the voluntary cancellation option
 is  selected or unless the product is identical to another (refer to
 the instructions for completing the Data call-in Response Form in
 Attachment B).  Please note that the company's authorized
 representative is required to sign the first page of the Data Call-
 in  Reapenaa Fora and Requirements Status and Registrant's Response
 I2ZB (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.  Zf you have questions
 or  need assistance in preparing your response, call or write the
 contact person(s) identified in Attachment A.

     1. 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.  Zf you wish to voluntarily cancel your product, you must
submit a completed Pata call-in Response Fora, indicating your
election of this option.   Voluntary cancellation is item number 5
en the Data Call-In Response Form. Zf you choose this option, this
is the only form that you are required to complete.

     Zf 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 ZV-c.
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                                  5

     2. Satisfying the Product Specific Pata Reoulgeaents cf
          There are various option* available to satisfy the product
 •pacific data requirements of this Notice.  These options ara
 discussed in Section Jli-c of this Notice and comprise options 1
 through 6 On tha Requirements Statue and Regietrant'e Reeponee Form
 and item numbers ?a and 7b on tha Pata eail-Tn  RMPQIIM Form.
 Delation of a usa(s) and tha low volume/minor usa option ara not
 valid options for fulfilling product spaeific data requirement*.

     3. Remaeet tor Product Specific Pata Waiveya.  Waivers for
 product specific data ara discussed in Section  XII-D of this notice
 and ara covered by option 7 on tha Requirements Statue and
 Reerietrant's Response Fern,  if you choose this option, you Bust
 submit both forms as wall as any other information/data pertaining
 to. the option chosen to address the data requirement.
   ••
 ZZI-C  SATISFYING THE PATA REQtTIREMEMTfi QP THIS MQTTgg

      If you acknowledge on the Pata call-in Reeponee Form that you
 agree to satisfy the product specific data requirements (i.e. you
 select option 7a or 7b),  then you Bust select one of the six
 options on the Reaulrmnts Statue and Reoiatirant * a Response Form
 related to data production for each data requirement.  Your option
 selection should be entered under itea 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 Retirements Statue 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)   Z 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)
      (3)   Z have made offers to cost-share (Offers to Cost Share)
      (4)   z an submitting an existing study that has not been
           submitted previously to the Agency by anyone (Submitting
           an Existing Study)
      (5)   Z am submitting or citing data to upgrade a study
           classified  by EPA as partially acceptable and upgradeable
           (Upgrading  a Study)
      (6)   Z aa citing «n 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 i.  Developing  Data —~  Zf 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  (CLP)  rule (40  CFR Part 160),  be conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
conformanc* with the requirements of PR Notice 86-5.
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     The time  frames in the Requirements Statusand Registrant's
 Response Fora are the tin* frames that the Agency is allowing for
 the submission of completed study reports.  The noted deadlines run
 from the date of the receipt of this Notice by the registrant.  If
 the data are  not submitted by the deadline, each registrant is
 subject to receipt of a Notice of Intent to Suspend the affected
 registration(•).

     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. Aoree to Share in Cost to Develop Data ••Registrants
 may only choose this option for acute toxicity data and certain
 efficacy data ajQfl 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 immh«y of the product for which data will be
 submitted ami be noted in the agreement to cost share by the
 registrant selecting this option.  Zf 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 Mho 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 nead not specify all of the terms of
 the  final arrangement between the parties or the mechanism to
 resolve the terms.   Section 3(e)(2)(B)  provides that if the parties
 cannot resolve the terms of the agreement they may resolve their
 differences through binding arbitration.


    Option a.  Offer to Share iq the Cost of Data Development  —
This option only applies to acute toxicity and certain efficacy
data as described  in option 2 above.  If you have made an offer to
pay in an attempt  to enter into an agreement or amend an existing
agreement to meet  the requirements of this Notice and have been
-------
 unsuccessful,  you Bay request EPA (toy selecting this option) to
 exercise its discretion not to suspend your rsgistrstionCs),
 although you do not comply with tha data submission requirements of
 this Motiea.  EPA has determined  that as a general policy, absant
 othar ralavant considerations,  it vill not suspend tha ragistration
 of a product of a registrant who  has in good faith sought and
 continues to saak to enter into a joint data development/cost
 sharing program, but the other registrant(s) developing the data
 has refused to accept your offer. To qualify for this option, you
 aust submit documentation  to the  Agency proving that you have Bade
 an offer to another registrant (who has an obligation to submit
 data) to share in the burden of developing that data.  You Bust
 also submit to the Agency  a completed EPA Fora 8570*32,
 Certification  of Offer to  Coat Share in the Development of Data,
 Attachment 6.   Zn addition,  you Bust demonstrate that tha other
 registrant to  whom the offer vaa  Bade has not accepted your offer
 to enter into  a costsharing agreement by including a copy of your
 offar.and proof of tha other registrant*s receipt of that offer
 (such as a certified aail  receipt).  Your offer Bust, in addition
 to anything else,  offer to share  in the burden of producing the.
 data upon terms to be agreed or failing agreement to be bound by
 binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
 and must not qualify this  offer.   The other registrant must also
 inform EPA of  its election of an  option to develop and submit the
 data required  by this Notice by submitting a Data call-in Reaponaa
 form and a Reauirenenta Statue  and Registrant's Response Form
 committing to  develop and  submit  the data required by this Notice.

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

    Option 4.  Submitting an K3ci.gti.no 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 Bay only submit a study that has not been previously
 submitted to the Agency or previously cited by anyone.   Existing
 studies are studies which predate iasuanca of this Notice.  Do not
use this  option if you are submitting data to upgrade a study.  (See
Option S).

    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 say determine at  any time that a study is
not valid and needs to be repeated.
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    To Beet the requirements of the DCI Notice for submitting an
existing Study, all of the following three criteria nuat be clearly


    a. You aust certify at th« tiae that the existing study is
    submitted that tba rav data and specimens froa tha study ara
    availabla for audit and raviav and you must idantify vhere thay
    ara availabla.  This suit ba dona in accordance with
    tha requirements of tha Good Laboratory Practiea (CLP)
    regulation, 40 CFR Part 160. As statad in 40 CFR 160.3(j)
    * *Cr]av data* aaans any laboratory vorkshaats, records,
    aemoranda, notas, or axaet copias tharaof, that ara tha rasult
    of original observations and aetivitias of a study and ara
    nacassary for tha reconstruction and avaluation of tha raport        s
    of that study.  In tha avant that exact transcripts of rav data
   •hava baan praparad (e.g.,  tapas which hava baan transeribad
    verbatim, dated,  and varifiad  accurata by signatura), tha axact
    copy or axaet transcript aay ba substitutad for tha original
    sourca as rav data.   'Rav data1 aay includa photographs,
    aicrofila or aicroficha copias, coaputar printouts, aagnatic
    aadia,  including dietatad obsarvations, and racordad data from
    autoaatad instruments."  Tha tara "specimens", according to 40
    CFR 160.3(k),  aaans "any aatarial darivad froa a tast systam
    for axaaination or analysis.**

    b. Raalth and safaty studias coaplatad aftar May 1984 Bust also
    contain all GLP-raquirad quality assurance and quality control
    information,  pursuant to tha requirements of 40 CFR Part 160.
    Ragistrants Bust also cartify  at tha tiaa of submitting tha
    axisting study that such CLP information is availabla for post-
    May 1984  studias by including  an appropriata stataaant on or
    attached to tha study signad by an authorized official or
    raprasantativa of tha registrant.

    c. You  aust cartify that aach  study fulfills tha accaptanca
    critaria  for tha  Guideline relevant to tha study provided in/au^h-cA&N
    tha PZFRA Accelerated Reregistration Phase 3 Technical Guidance;,
    and that  tha study has baan conducted according to tha
    Pasticida Assessment Guidelines (PAG) or aeets tha purpose, of
    tha PAG (both  availabla froa NTIS).  A study not conducted
    according to tha  PAG aay ba submitted to tha Agency for
    consideration  if  tha registrant believes that tha study clearly
    Beets tha purpose of tha PAG.  Tha registrant is referred to 40
    CFR 158.70 vhich  states tha Agency's policy regarding
    acceptable protocols.  If you vish to submit tha study, you
    Bust, in  addition to certifying that tha purposes of the PAG
    ara  aet by the study,  clearly articulate the rationale vhy you
    believe tha study Beats tha purpose of tha PAG,  including
    copies  of any  supporting information or data.   Zt has been the
    Agency's  experience  that studies completed prior to January
    1970 rarely satisfied the purpose of tha PAG and that necessary
    rav  data  ara usually not available for such studies.
-------
     If you submit en existing study, you *ust certify that the
 study meets all requirements of the criteria outlined above.

     If you know of • study pertaining to any requirement in this
 Notice which does not meet tha eritaria outlined above but doaa
 contain factual information ragarding unreasonable adverse affacts,
 you must notify tha Agency of such a study.  If such  study is in
 tha Agency1* files, you naad only cita it along vith tha
 notification. If  not in tha Agency's filss, you Bust submit a
 summary and copias as required by PR Notice t6*S.
                            f

   , Option s. Upgrading » study — If a study has baan classifiad
 as partially accaptabla and upgradaabla, you may submit data to
 upgrada that study.  Tha Agancy will review tha data submitted and
 datarmina  if tha  requirement is satisfied.  Zf tha Agancy dacidas
 tha  requirement is not satisfied, you may still be required to
 submit nev 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.  Zf 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 A*  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 should also 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 number 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 — Zf you choose to cite a
study that has bean previously submitted to EPA, that study must
hsve been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency.  Acceptable
-------
                                 10

 toxicology studies generally will  have been classified as "core-
 guideline* or "core minimum."  For all other disciplines the
 classification would be "acceptable."  * With respect to any studies
 for which you wish to select this  option you Bust provide the MRID
 number of the study you are citing and, if the study has been
 reviewed by the Agency, you Bust provide the Agency's
e classification of the study.

     Zf you are citing a study of which you are not  the original
 data submitter, you Bust submit a  completed copy of EPA Form
 8570-31, Cartif ieation with Raaaeet to Data Compensation
:   .*  Registrants who select one of the above  6 options Bust Beet all
 of the requirements described in the instructions for completing
 the Data Call-in Response Form and the Requirements Status end
 Registrant's Response Form, as appropriate.

 XIX-D  BEQTTESTS PQR DATA WXTVERS

     Zf you request a waiver for product specific data because you
 believe it is inappropriate,  you Bust attach a complete
 justification for the request,  including technical reasons, data
 and references to relevant EPA regulations,  guidelines or policies.
 (Note: any supplemental  data Bust 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.  Zf the Agency  approves your waiver request, you will not
 be required to supply the data pursuant to section 3(c) (2) (B)  of
 FZFRA.  Zf 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 Bust indicate
 and submit the option chosen on the Requirements status and
 Registrants RMPQM« Form.  Product specific data requirements for
 product chemistry,  acute toxicity and efficacy (where appropriate)
 are required for all products and the Agency will grant a waiver
 only under extraordinary circumstances.  You should also  be aware
 that submitting a waiver request will n££ 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.

 ZV»   CONSEQUENCES OP yAIHTRg  TO COMPLY WTTH THIS NOTICE

 ZV»A NOTICE OF INTENT TO SUSPEND

     The Agency Bay  issue a Notice of Zntent to Suspend products
 subject to this Notice due to failure by a registrant to  comply
 with the requirements of this Data Call-Zn Notice, pursuant to
 FZFRA section 3(c)(2)(B).   Events which Bay be the basis  for
 issuance of a Notice of  Zntent  to Suspend include, but are not
 limited to,  the following:
-------
                                 11

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

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

     3*  Failure to submit on the required schedule an adequate
     progress rsport on a study if required by this No ties.

     4.  Failure to subnit on the required scbsduls accsptabls
     data as required by this Notice.

     5.  Failura to taJcs a rsquirsd action or submit adsquata
    - information partaining to any option chossn to addrass the data
     requirements (s.g.,  any rsquirsd action or information
     partaining 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 studiss, as required by Section III-C
     of this Notics.

     7. Withdrawal of an of far to shars 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 dsvsloping data and provided proof of
     the registrant's receipt of such offer either to:

     a.  Inform EPA of intent to develop and submit the data
     required by this Notice on a Data Call-in 8««pon«e Form and a
                   Status and Refii«trant*e Reepenee Form;
     b. Fulfill the commitment to develop and submit the data as
     required by this Notice; or

  •  c. Otherwise take appropriate steps to meet the requirements
    stated in this Notics, 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.

JV-B.  BASIS FOR PETEBMTNATIOW THAT SUBMITTED STOPY TS
    The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
-------
                                 12

 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 affect  levels to be tested or attained, duration of
 .  ,  test, and, as applicable. Good Laboratory Practices.
   *
  ;. .2.   EPA requirements regarding the submission of protocols (if
   •'applicable),  including the incorporation of any changes
     required by  the  Agency following review.

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

 IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PROQPCT5

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

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

    If you request a voluntary cancellation of your product (s)  as a
response to this  Notice and your product is in full compliance with
-------
                                 13

 mil Agency requirements,  you will have, under most circumstances,
 one year from tha data your 90 day response to this Notice is due,
 to Mil, distribute,  or use existing stocks.  Normally, tha Agency
 vill allow parsons othar  than tha registrant such as indapandant
 distributors, ratailars and and usars to sail, 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 vill be determined on a case-by-case basis.

     Bequests for voluntary .cancellation received after the 90 day
 response period required  by .this Notice vill 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 ujoliai you demonstrate  to the Agency that you are in full
 compliance vith 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  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 vill consider granting an existing stocks
 provision.


 SECTION V.   REGISTRANTS *  OBLIGATION TO REPORT POSSIBLE
                          DVERSE EFFECT
    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.  TMOUTRTEfi AMD RESPONSES TO THIS NOTICE

    Zf you have any questions regarding the requirements and
procedures established by this Notice, call the contact person (s)
listed in Attachment A, the Pata eali-Tn ehanteal
    All responses to this Notice (other than voluntary cancellation
requests) must include a completed Pata call-in Response Form and a
completed Requirements Status and Registrant's Rasponsa Form
(Attachment B and Attachment C) and any other documents required by
this Notice, and should be submitted to the contact pars on (s)
identified in Attachment A. Zf the voluntary cancellation option is
chosen, only the Data Call-Tn R««pon«> Porn need be submitted.
-------
                                14
    Tb* Office of Compliance Monitoring (OCM)  of the Office of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data b«ing generated in response to this Notice.
                             Sincerely yours.
                            .Daniel M.  Barolo,  Director
                             Special Review and
                               Jteregistration Division
                        Attachments
    A
    B
    C
    D
    £ -
    F  -
    6  •
- Date Cell-1
                      Status Sheet
Data Call-in Response Form
R«quir«aent« Status and Ragiatrant'a Rasoonse Form
EPA grouping ef End-Uea Produeta for Maatino Aeuta
Toxicology Data R«ouiren«nta for Reraaietration
EPA Acceptance Criteria
List of Registrants Receiving Thia Kotlee
Coat Share and Data Cenpensation Forma, and Product
Specific Data Report Form
-------
    ATTACHMENT A "




CHEMICAL STATUS SHEET
-------
                                 ATTACHMENT A

        SOAP SALTS: GENERIC DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION
       You have been sent this Data Call-In Notice for generic data because you have products
containing soap salts.

       This attachment, the Data Call-in Chemical Status Sheet, contains a point of contact for
inquiries.  This attachment is to be used in conjunction with (1) the Data Call-In Notice. (2)
Attachment B, the Data Call-In Response Form. (3) Attachment C, the Requirement Status and
Registrant's Response Form for generic data,  (4) Attachment D, List of Al}. Registrants Sent
this Data Call-in Notice. (5) Attachment E, EPA Acceptance Criteria. (6)  Attachment F, Cost
Share and Data Compensation Forms for generic data, and Generic Data Report Form for use
in replying to this soap salts Data Call-In. Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
      The additional data requirements needed to complete the database for soap salts are listed
in the Requirements Status and Registrant's Response Form. Attachment C.

      The Agency has concluded that generic data are needed for soap salts.  The required
additional data are listed in Attachment C.

      Depending on the results of the studies required in this Notice, additional testing may be
required.
INQUIRIES AND RESPONSES TO THIS NOTICE
      If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Veronica Dutch (703) 305-8585. All responses to this
Notice should be submitted to:

                    Chemical Review Manager Veronica Dutch
                    Accelerated Reregistration Branch (H7S08W)
                   Special Review and Reregistration Division
                    Office of Pesticide Programs
                   U.S. Environmental Protection Agency
                   401 M Street S.W.
                   Washington, D.C. 20460
                    RE:  Soap  salts
-------
              ATTACHMENT B

GENERIC DATA CALL-IN RESPONSE FORMS (Form A)
             PLUS INSTRUCTIONS
-------
                    SPECIFIC INSTRUCTIONS FOR
                  THE  DATA CALL-IN RESPONSE FORM
     This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act.  Fill out this form each time you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."

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

     Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information.  Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.


INSTRUCTIONS

Item 1.   This item identifies your company name, number and
          address.

Item 2.   This item identifies the case number, case name, EPA
          chemical number and chemical name.

Item 3.   This item identifies the date and type of data call-in.

Item 4.   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.   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.  You do not need to complete any item on
-------
          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.   Enter the date of signature.

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

Iten 11.  Enter the phone number of your company contact.
-------
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-------
                   ATTACHMENT C

GENERIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
              (Form B) PLUS INSTRUCTIONS
-------
              SPECIFIC INSTRUCTIONS FOR COMPLETING
      TEC REQUIREMENTS STATUS AND REGISTRANT'! RESPONSE FORK

                          generic Patj,s.


     This fora is designed to bs used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act.  Although the lam i» the saae for
both product specific and generic data,  instructions for
completing the forms differ slightly.  Specifically, options for
satisfying prpduct specific data requirements do not include (1)
deletion of uses or (2) request for a low volume/minor use •
waiver.  These instructions are for completion of y«n«rie flat*
requirements.

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

     Items 1 through 8 (inclusive)  will have been preprinted on
the form.  You must complete all other items on this form by
typing or printing legibly.

     Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information.  Send comments regarding
the burden estimate or.any other aspect of this collection of
information, including suggesting for reducing this burden,' to
Chief, Information Policy Branch,  PM-223, U.S. Environmental  -
Protection Agency, 401 M St., S.W., Washington, D.C. 20460? and
to the Office of Management and Budget,  Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
IKSTRDCTIQK8
                                          *
Item 1.   This item identifies your company name,  number,  and
          address.

Item 2.   This item identifies the case number,  ease name, EPA
          chemical number and chemical name.

Item 3.   This item identifies the date and type of data call-in.

Item 4.   This item identifies the guideline 'reference numbers of
          studies required to support the product(s) being
          reregistered.  These guidelines, in addition to
          requirements specified in the Data Call-in Notice,
          govern the conduct of the required studies.

Item 5.   This item identifies the study title associated  with
          the guideline reference number and whether protocols
          and 1, 2, or 3-year progress reports are required to be
   \      submitted in connection with the study.   As noted in
          Section ZIZ of the Data Call-In Notice,  90-day progress
          reports are required for all studies.

          If an asterisk appears in Item 5, EPA has attached
          information relevant to this guideline reference number
          to the Requirements Status and Registrant's Response
          Form.

Item 6.   This item identifies the code associated with the use
          pattern of the pesticide.  A brief description of each
          code follows:

          A              Terrestrial food
          B              Terrestrial feed
          C              Terrestrial non-food
          D              Aquatic food
          E • •            Aquatic non-food outdoor
          F   .          Aquatic non-food industrial
         •C              Aquatic non-food residential
          H      '        Greenhouse food
          I              Greenhouse non-food crop
          J              Forestry
          X              Residential
          L              Indoor food
          M              Indoor non-food
          N              Indoor medical
          O              Indoor residential
-------
 Xt«B» 7.   .This item identifies the code assigned to the substance
           that must be used for testing.  A brief description of
           •ach code followss

                         End-Use Product
                         Manufacturing-US* Product
                         Manufacturing-Use Product and Technical
                         Grada Active Xngradiant
                         Port Activa Zngradiant
                         Pura Activa Zngradiant and Metabolites
                         Pure Active Ingredient or Pure Active
                         Ingredient Radiolabelled
                         Pure Active Ingredient Radiolabelled
                         Pure Active Ingredient Radiolabelled and
                         Metabolites
                         Pure Active Ingredient Radiolabelled and
                         Plant Metabolites
                         Typical End-Use Product .
                         Typical End-Use Product, Percent Active
                         Ingredient Specified
                         Typical End-Use Product and Metabolites
                         Typical End-Use Product or Pure Active
                         Ingredient and Metabolites
                         Technical Grade Active Ingredient
                         Technical Grada Active Ingredient or
                         Pure Active Ingredient
                         Technical Grada Active Ingredient or
                         Pure Active Ingredient Radiolabelled
                         Technical Grade Active Ingredient or
                         Typical End-Use Product
                         Metabolites
                         Impurities
                         Degradates
                         See: guideline comment
MP
MP/TGAI

PAI
PAI/M
PAI/PAIRA

PAIRA
PAIRA/M

PAIRA/PM

TEP
TEP  	%

TEP/MET
TEP/PAI/M

TGAI
TGAX/PAI

TGAI/PAIRA

TGAI/TEP.

MET
IMP
DECK
*
•Item 8.   This item identifies the time frame allowed for
          'submission of the study or protocol identified in
          item 2.  The time frame runs from the date of your
          receipt of the Data Call-In Notice.

Item 9.   Enter the appropriate Response Code or Codes to show
          how you intend to comply with each data requirement.
          Brief descriptions of each code follow.  The Data Call-
          in Notice contains a fuller description'of each of
          these options.                 .

          1.   .(Developing Data) I will conduct a new study and
               submit it within the time frames specified in item
               8 above.  By indicating that I have chosen this
               option, X certify that X will- comply with all the
-------
      requirements pertaining to the conditions for
      subaittel of this study a* outlined in th« Data
      Call-In Notice and that I will provide the
      protocols and progress  reports required in item 5
      above.

. 2.   (Agreement to Cost Share) Z have entered into an
      agreement with one or more registrants to develop
      data jointly.  By indicating that Z have chosen
      this option, Z certify  that Z will comply with all
      the requirements pertaining to sharing in the cost
      of developing data as outlined in the Data Call-In
      Notice.

 3.   (Offer to Cost Share) Z have made an offer to
      enter into an agreement with one or nore
      registrants to develop  data jointly.  Z am
      submitting a 'copy of the form "Certification of
      Offer to Cost Share in.the Development of Data"
      that describes this offer/agreement.  By
      indicating that Z have'Chosen this option, Z
      certify that Z will comply with all the
      requirements pertaining to making an offer to
      share in the cost of developing data as outlined
      in the Data Call-In Notice.

 4.   (Submitting Existing Data) Z am submitting an
      existing study that has never before been
      submitted to EPA.  By indicating that Z have
      chosen this option, Z certify that this study
      meets all the requirements pertaining to the
      conditions for submittal of existing data outlined
    .  in the Data Call-In Notice and Z have attached the
      needed supporting information along with this
      response.           '                 •

 5.   (Upgrading a Study) Z am submitting or citing data
      to upgrade a study that EPA has classified as
      partially acceptable and potentially upgradeable.
      By indicating that Z have chosen this option, Z
     ^certify that Z have net all the requirements
      pertaining to the conditions for submitting or
      citing existing data to upgrade a study described
      in the Data Call-in Notice.  Z am indicating on
      attached correspondence the Master Record
      Zdentification Number (MRID) that EPA has assigned
      to the data that Z am citing as veil as the MRID
      of .the study Z am attempting to upgrade.

 6.   (Citing a Study)  Z an citing ah existing study
      that has been previously classified by EPA as
    .  acceptable,  core, core  minimum, 'or a study that
-------
               has not yat been reviewed by ths Agsncy.  I mm
               providing ths Agency's clarification of ths
               study.

           7.    (Misting Uses) I an attaching an application for
               amendment to ay rsgistration dslsting ths usss for
              . which ths data ars rsquirsd.
               •
           ••    (Lev Volume/Minor tfss Waivsr Request) Z havs rsad
               ths statamsnts concsrning low volums-minor uss
               data waivsrs in ths Data Call-in Notics and X
               rsqusst a low-volume minor uss waivsr of ths data
               requirement.  Z an attaching a detailed
               justification to support this waivsr rsqusst
               including, among other things, all information
               rsquirsd to support ths rsqusst.  Z undarstsnd .
               that, unlsss modified by ths Agency in writing,
               ths data rsquirsmsnt all statsd in ths Notics
               govsrns.

           9.    (Rsqusst for Waivsr of Data) Z havs rsad ths
               statsnsnts concsrning data waivsrs othsr than low-
               volume minor-use data waivsrs in ths Data Call-in
              • Notics and Z rsqusst a waivsr of ths data
               rsquirsnsnt.  Z an attaching an identification of
               ths basis for this waivsr and a dstailsd
               justification to support this waivsr 'rsqusst.  His
               justification includss, among othsr things, all
               information rsquirsd to support ths rsqusst.  Z
               undsrstand that, unlsss nodifled by ths Agsncy in
               writing, ths data rsquirsmsnt as statsd in ths
               Notics govsrns.

Ztsm 10. .  This itsm must bs signed by an authorizsd
           rsprsssntativs of your company.  Ths person signing '
           must includs his/hsr title, and must initial and dats
           all othsr pagss of this form.
*              •»                   •                      "
Ztsa 11*   Entsr ths dats of signaturs.

Ztsa 12.   Entsr ths nams of ths psrspn EPA should contact with
           qusstions rsgarding your rssponss.

Ztsm 13.   Entsr ths phons numbsr of your -company 'contact*
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                  ATTACHMENT D
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
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     ATTACHMENT E




EPA ACCEPTANCE CRITERIA
-------
                          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
-------
               61 Product Identity and Composition


                       ACCEPTANCE CRITERIA


Does your study meet the following accep'tance 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 toxicologically 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
      ±jir_j_n 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
-------
8. (continued)

      	 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 > p.l% or  was found at > 0.1% by product analyses
      and (2) certain toxicologically significant impurities
      (see #3)
-------
               61 Product Identity and Composition


               GUIDANCE FOR SUMMARIZING STUDIES


The following criteria apply to the technical grade of the active
ingredient  being reregistered.   Items  1,  2,  3,  and  5 can  be
satisfied  for most registered  products  by submission of  the
Certified Statement of Formula Ingredients Page  (EPA Form 8570-4).
Items 7  and 8 can  be  satisfied for most technical  grade active
ingredients  (TGAIs)  by submission of a flow  chart with chemical
equations  for  each intended  chemical  reaction.   The  flow  chart
should include complete chemical structures  and  names  for each
reactant and product of all the reactions.


1. Name of technical material  (include product name  and trade name,
   if appropriate).
2. Description of each active and intentionally-added inert
   ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
   those toxicologically significant impurities present at <0.l%.
4. The purpose of each active and intentionally-added inert
   ingredient.
5. Chemical name and Registry Number for each active and
   intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
   and any experimental or internal code number for each active
   ingredient.
7. Description of each beginning material in the manufacturing
   process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
   chemical theory.
-------
       62 Analysis and Certification of Product Ingredients


                       ACCEPTANCE CRITERIA

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

Does your study meet the following acceptance criteria?

 1.	 Five or more representative samples (batches in case of
       batch process) analyzed for each active ingredient and all
       impurities present at > 0.1%
 2.	 Degree of accountability or closure > ca 98%
 3.	 Analyses conducted for certain trace toxic impurities at
       lover 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 lover certified limits proposed for each active
       ingredient and intentionally added inert along with
       explanation of how the limits were determined
 8.	Upper certified limit proposed for each impurity present at
       > 0.1% and for certain toxicologically significant
       impurities at <0.1% along with explanation of how limit
       determined
 9.	 Analytical methods to verify certified limits of each
       active ingredient and impurities (latter not required if
       exempt from requirement of tolerance or if generally
       recognized as safe by FDA) are fully described
10.	Analytical methods (as  discussed in #9) to verify certified
       limits validated as to their precision and accuracy
-------
       62  Analysis  and Certification of Product  Ingredients


                 GUIDANCE FOR SUMMARIZING STUDIES


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


 1. Number of representative samples analyzed for all active
    ingredients and all impurities at > 0.1%.

 2. Degree of accountability or closure in analyses in item #1.

 3. Chemical names of toxic impurities which were analyzed for
    levels <0.l%.

 4. Brief description(s) of analytical method(s) used to measure
    active ingredients and impurities in items #1 and #3.

 5. Statement of precision and accuracy of method(s) in item #4.

 6. Chemical name and quantities observed (range, mean, standard
    deviation) for each ingredient (actives and impurities)
    analyzed in item #1.

 7. Proposed upper and lower certified limits for each active
   . ingredient and  intentionally added inert with brief explanation
    of how limits were determined.

 8. Proposed upper certified limit for each impurity present at
    >-0.l% and certain toxicologically significant impurities at
    
-------
             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 gr the specific gravity of liquids reported with
         reference to water at 20° C.  [Note: Bulk density of
         registered products may be reported in Ibs/ft  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 Kg (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 77350)
     	 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
-------
             63  Physical and Chemical Characteristics


                GUIDANCE FOR SUMMARIZING STUDIES


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


 1. Description of color.
 2. Description of physical state.
 3. Description of odor.
 4. Indication of melting point (in c°).
 5. Indication of boiling point (in Cc).
 6. Indication of density,  bulk density, and specific gravity.
 7. Indication of solubility.
 8. Indication of vapor pressure.
 9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.
-------
                          SUBDIVISION F
Guideline              Study Title

  81-1      Acute Oral Toxicity in the Rat
  81-2      Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
  81-3      Acute Inhalation Toxicity in the Rat
  81-4      Primary Eye Irritation in the Rabbit
  81-5      Primary Dermal Irritation Study
  81-6      Dermal Sensitization in the Guinea Pig
  81-7      Acute Neurotoxicity in the Hen
-------
               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.	 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 ing/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 a * are supplemental and may not be required
for every study.
-------
              81-1 Acute Oral Toxicity in the Rat


               GUIDANCE  FOR  SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid,  percent
   AI in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
   least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria
-------
   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
         before 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 a * are supplemental and may not be required
for every study.
-------
   Bl-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig


                GUIDANCE  FOR  SUMMARIZING STUDIES


 1. The form of pesticide tested, e.g., 'solid, liquid, percent AI
    in technical,  end-use product, etc.
 2. The number of animals/sex/dose
 3. Weight range of animals
 4. Verification of single, dermal exposure
 5. Duration of dermal exposure
 6. Statement of vehicle control
 7. Doses tested and results
 8. Preparation of application site
 9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual observations on day of dosing and for at
    least 14 days  or until all animals appear normal (whichever is
    longer).
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
-------
            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 nay produce a significant
        vapor hazard based on toxicity and expected use or contains
        particles of inhalable size for man (aerodynamic diameter
        15 urn 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.
-------
           81-3 Acute Inhalation Toxicity in the Rat


                GUIDANCE  FOR SUMMARIZING STUDIES


 1. The form of pesticide tested, e.g.,  solid,  liquid,  percent AI
    in technical,  end-use product, etc.
 2. Statement of the inhalability of test substance
 3. The number of animals/sex/dose
 4. Duration of inhalation exposure
 5. Number of chamber air changes/hour and the percent oxygen
    content of chamber air
 6. Ranges for chamber air temperature and relative humidity
 7. Air flow rate
 8. Analytical concentrations of test material in breathing zone
 9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
    days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
-------
            81-4 Primary Eye Irritation in the Rabbit


                       ACCEPTANCE CRITERIA



Does your study aeet 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 a * are supplemental and may not be required
for every study.
-------
          81-4 Primary Eye Irritation in the Rabbit


                GUIDANCE FOR SUMMARIZING STUDIES


 1. The form of pesticide tested,  e.g.,  solid,  liquid,  percent AI
    in technical,  end-use product, etc.
 2. State if material  is corrosive, cause severe dermal irritation
    or has a pH of <2  or >ll.5
 3. Number of adult rabbits tested
 4. State method of dosing,  i.e.,  instillation into the
    conjunctival sac of one eye per animal
 5. Dose administered
 6. Note whether solid or granular test material has been ground to
    a fine dust
 7. State whether eyes were washed and at what time post
    instillation (not less than 24 hours)
 8. State whether eyes were examined and graded for irritation
    before dosing and at what periods after dosing
 9. Individual daily observations afterwards, until eyes are normal
    or for 21 days
10. significance of changes from Acceptance Criteria
-------
               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 cm.
 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 a * are supplemental and nay not be required
for every study.
-------
               81-5  Primary Dermal Irritation Study


                 GUIDANCE FOR SUMMARIZING STUDIES


 1. The form of pesticide tested, e.g.,  solid,  liquid,  percent AI
    in technical, end-use product,  etc.
 2. State if material is corrosive, has a pK <2 or >11.5, or has a
    dermal LD 50 <200 mg/kg
 3. Number of adult animals tested
 4. Amount applied
 5. Duration of dermal exposure
 6. Preparation of application site (shaved  or clipped at specified
    time before dosing)
 7. Area of application site
 8. Method for occlusion of application site
 9. Note removal of  test material and if skin was washed with water
10. State times post application when site  was graded for
    irritation
11. Individual observations for day of dosing and individual
    daily observations thereafter
12. Significance of changes from Acceptance Criteria.
-------
           81-6 Dermal Sensitization in the  Guinea  Pig


                       ACCEPTANCE CRITERIA


dose your study meet the following acceptance criteria?

1*	 Identify material tested (technical,  end-use product, etc)
2.	 Study not required if material is corrosive or has a
       pH of <2 or > 11.5.
3.	 One of the 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.i	 Reference for test.
6.	 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 a * are supplemental and may not be required
for every study.
-------
          81-6 Dermal Sensitization in the Guinea Pig


                GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested,  e.g.,  solid,  liquid,  percent AI
   in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
   the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
-------
               81-7 Acute Neurotoxicity in the Hen

                       ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

 1.     Study performed on an organophosphate cholinesterase
        inhibiting compound.
        Technical form of the active ingredient tested.
        Positive control utilized.
        Species utilized, domestic laying hen 8-14 months of age.
        Dosing oral by gavage or capsule (dermal or inhalation
        may be used).
        An acute oral LD is determined.
        Dose tested equal to an acute oral LD or a limit test of
        5000 mg/kg.
 8.*,	._ Dosed animals may be protected with atropine and/or 2-
        PAH.
        Sufficient test animals so that at least 6 survive.
        Negative (vehicle) control group of at least 6 hens
        Positive control of at least 4 hens, (if used)
        Test dose repeated if no signs of delayed neurotoxicity
        observed by 21 days after dosing.
        Observation period 21 days after each dose.
        Individual daily observations.
        Individual body weights.
        Individual necropsy not required.
        Histopathology performed on all animals.  Tissue to be
        fixed in sin preferably using whole animal perfusion
        techniques.  At least three sections of each of the
         following tissues:
            _brain, including medulla oblongata
            "spinal cord; upper cervical, mid-thoracic and
            "lumbro-sacral regions
            _tibial nerve; proximal regions and branches
            "sciatic nerve
Criteria marked with a * are supplemental and may not be required
for every study.
-------
            ATTACHMENT F'




COST SHARE AND DATA COMPENSATION FORMS
-------
     r/EPA
                           United States  Environmental Prottctlon Agency
            Washington. DC 20460
                                                 OUB Mo.
  CERTIFICATION  WITH  RESPECT TO
DATA  COMPENSATION  REQUIREMENTS
                                                 fora Approved
Approval expires 124142
  PubOc reporting burden for this collection of information Is estimated to average 15 minutes per response, Including
  time tor reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
  completing and reviewing the collection of Information. Send comments regarding the burden estimate or any other
  aspect of this collection of information, Including suggestions for reducing this burden, to Chief, Information PoDcy
  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.

  Pleat* flll In blank* below.
CoafMf NMM
CboaUeal Nam*
Company Number
EPA Chomloal Numoor
 ICettfy that-

 t.  For each study cited In support of reregtstratfon under the Federal Insecticide, Fungicide and Rodentteide Act
    (RFRA) 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 cfte that study.

2.  That for each study died in support of reregistratton 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 companyfjes) that submitted data  I have cited and have offered to: (a) Pay compensation for those data
    to accordance with section 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 RFRA and the amount of compensation due, V any. The
    companies I have notified are: (check one)

    11  AD companies on the data submitters' Bst for he active Ingredient listed on this form (CBe-Ail
        Method or Cite-AB option under the Selective Method).  (Also sign the General Offer to Pay
        betow.)

    U  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 w8h section 3{e)(l)(D) of RFRA for the studies I have cfled in support of
    (•registration under RFRA,
•IgMtBro
Dal*
NaoM antf Titto (Ploaao Typo Of PtfcrtJ
GENERAL OFFER TO PAY: I hereby offer gjid agree to pay cornperisation to other persons, wfthregart to the
reregW/stlon of my products, to th extent required by FIFRA section 3(c)(l)(D) and 3(0(2X0).

SlgMhtro
Oato
NaoM anf tltlo (Ptoaao Typo or Print)

EPA Pom SS7041 (4.SO)
-------
      r/EPA
                         United States Environmental  Protaetlon Aganey
                                     Washington,  DC  20460
                            CERTIFICATION OF OFFER  TO COST
                         SHARE  IN THE  DEVELOPMENT OF DATA
Form Approved

OMB No. 20704141

Appro**) Eipir**  12.Ji.92
   Public reporting burden (or 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.

  Pleat* fill In blanks below.
*»».«, *..
Chemical Nam*
*
Company Number
EPA Chemical Number
  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 Rodentfcjde 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)(iti) 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):
   Naa* *f
                                                                          DM* •» Otter
 Caftmeatten;

 I certify tna^ajnotyauttiorfeed to rtpftsenttrtteompaty                                     have made on
 this form and all attachments therein are tiue, accurate, and complete. I acknowledge that any knowingly false or
 misleading statement may be purtfshabJt by fine or iniorisoflment or both under appOcabte law.
Stgittturt *l
                      Airthvtw*
                                                                           Oil*
 Nam a»d Tilt* (Ptost* Typ* M MM)
EPA fern UTO42
-------
     APPENDIX G
Product Specific Data Call-in
-------
    ATTACHMENT A




CHEMICAL STATUS SHEET
-------
                                 ATTACHMENT A

             SOAP SALTS: DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Data Call-In Notice because you have products containing
soap salts.

       This attachment, the Data Call-in Chemical Status Sheet, contains a point of contact
for inquiries.  This attachment is to be used in conjunction with (1) the Data Call-In Notice,
(2) Attachment B, the Data Call-In Response Fopn. (3)  Attachment C, the Requirement
Status and Registrant's Response Form for product specific data, (4) Attachment D,  EPA
Grouping of End-Use Products for Meeting Acute Toxicology Data Requirements for
Reregistration. (5) Attachment E, EPA Acceptance Criteria. (6) Attachment F, List of All
Registrants') sent this Data Call-In Notice, and (7) Attachment G, the Cost Share and Data
Compensation Forms for product specific data, and Product Specific Data Report Form for
use in replying to this soap salts Data Call-In.  Instructions and guidance accompany each
form.


DATA REQUIRED BY THIS NOTICE

      The additional data requirements needed to complete the database for soap salts are
listed in the Requirements Status and Registrant's Response Form. Attachment C.

      The Agency has concluded that product specific data are needed for soap salts.  The
required additional data are listed in Attachment C.

      Depending on  the results of the studies required in this Notice, additional testing may
be required.


INQUIRIES AND RESPONSES  TO THIS NOTICE
      If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Robert Forrest (703) 305-6600.  All
responses to this Notice should be submitted to:

                   Document Processing Desk (RED/RD/PM-14)
                   Office of Pesticide Programs
                   U.S. Environmental Protection Agency
                   401 M Street S.W.
                   Washington, D.C. 20460

                   RE: Soap salts
-------
                  ATTACHMENT B

PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
                PLUS INSTRUCTIONS
-------
 INSTRUCTIONS FOR COMPLETING  THE  "DATA CALL-IN RESPONSE" FORM FOR
                      PRODUCT SPECIFIC DATA

Item 1-4. Already completed by EPA.

Item 5.   If you wish to  voluntarily cancel  your product,  answer
          "yes."  If you choose this option,  you will not have to
          provide the data required by the Data Call-In Notice and
          you will not have to complete any other forms.   Further
          sale and distribution of your product after the effective
          date  of cancellation  must  be in  accordance with  the
          Existing  Stocks provision of-the  Data  Call-In  Notice
          (Section IV-C).

Item 6.   Not applicable since this form calls in product specific
          data  only.   However,   if your  product  is  identical  to
          another product and you qualify for a data exemption, you
          must respond with "yes" to Item 7a (MUP) or 7B (EUP)  on
          this form, provide the EPA registration numbers of your
          source(s);  you would  not complete  the "Requirements
          Status and Registrant's Response" form.  Examples of such
          products  include repackaged products  and Special Local
          Needs  (Section 24c)  products  which  are  identical  to
          federally registered products.

Item 7a.  For each manufacturing use product (MUP) for which you
          wish to maintain registration, you  must  agree to satisfy
          the data requirements by responding "yes."

Item 7b.  For each  end  use product  (EUP)  for which you  wish to
          maintain registration,  you must agree to satisfy the data
          requirements by responding "yes."   If you are requesting
          a  data  waiver,  answer "yes"  here; in  addition,  on the
          "Requirements  Status   and  Registrant's  Response"  form
          under  Item 9,  you  must  respond  with Option  7  (Waiver
          Request) for each  study  for which  you are requesting a
          waiver. See Item 6 with regard to identical products and
          data exemptions.

Items 8-11.  Self-explanatory.

NOTE;     You may provide additional information that does not fit
          on this form  in a  signed letter that accompanies this
          form.   For example, you may  wish to  report  that your
          product has already been transferred to  another company
          or  that you  have  already  voluntarily  cancelled  this
          product.   For these cases, please supply  all relevant
          details so that EPA  can ensure that  its  records are
          correct.
-------
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                       ATTACHMENT C

PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
                  (Forms B) PLUS INSTRUCTIONS
                            AND
                       PR NOTICE 86-5
-------
     INSTRUCTIONS  FOR  COMPLETING THE  "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA

Item 1-3  Completed by  EPA.   Note  the unique  identifier  number
          assigned by EPA in Item 3.  This number must be used in
          the transmittal  document  for  any data submissions  in
          response to this Data Call-in Notice.

Item 4.   The guideline reference numbers  of  studies required to
          support  the   product's  continued   registration  are
          identified.     These guidelines,  in  addition  to  the
          requirements specified in the Notice, govern the conduct
          of the required studies.  Note'that series 61 and 62 in
          product chemistry  are  now listed under 40 CFR 158.155
          through 158.180, Subpart C.

Item 5.   The study title associated with the guideline reference
          number is identified.

Item 6.   The use pattern(s)  of the pesticide associated with the
          product specific requirements is (are) identified.  For
          most product specific data requirements, all use patterns
          are .covered by  the data requirements.  In the  case of
          efficacy data,  the required  studies  only pertain  to
          products which have the use sites and/or pests indicated.

Item 7.   The substance to be tested is identified  by  EPA.   For
          product specific data, the product as formulated for sale
          and distribution is the test substance, except in rare
          cases.

Item 8.   The due date for submission of  each study is identified.
          It is normally based on 8  months after  issuance  of the
          Reregistration Eligibility Document unless EPA determines
          that a longer time period is necessary.

Item 9.   Enter only one of the following response codes for each
          data requirement to show how you intend to comply with
          the data  requirements  listed  in this  table.   Fuller
          descriptions of each  option  are contained  in  the Data
          call-in Notice.

     1.   I will generate and submit data by the specified due date
          (Developing Data).  By indicating that I have chosen this
          option,   I  certify that  I will  comply with all  the
          requirements pertaining to the conditions  for submittal
          of this study as outlined in the Data Call-In Notice.

     2.   I  have  entered  into an   agreement  with   one or  more
          registrants to develop data jointly (Cost Sharing).  I am
          submitting a copy of this agreement.  I  understand that
          this  option  is available  only  for  acute toxicity  or
          certain efficacy data and only if EPA indicates  in  an
          attachment to  this Notice that  my product is  similar
-------
     enough to another product to qualify for this option.  I
     certify that another party in the agreement is committing
     to submit or provide the required data; if the required
     study is not submitted on time, my product may be subject
     to suspension.

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

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

5.   By the specified  due date,  I will submit or cite data to
     upgrade a  study  classified by the Agency  as  partially
     acceptable and upgradable  (Upgrading a Study).   I will
     submit evidence of the  Agency's review indicating that
     the  study  may  be  upgraded  and  what  information  is
     required to do 'so.  I will provide the MRID or Accession
     number of the study at the due date.   I understand that
     the conditions for this option outlined Option 5 in  the
     Data Call-In Notice (Section III-C.l.}  apply.

6.   By the specified  due date,  I will cite an existing study
     that  the Agency  has  classified  as  acceptable  or  an
     existing study that has been  submitted  but not reviewed
     by the Agency  (Citing an Existing Study).  If I am citing
     another registrant's study, I understand that this option
     is available only for acute toxicity or certain efficacy
-------
          data and  only if the cited  study was conducted  on my
          product, an identical product or a product which EPA has
          "grouped" with one or more other products for purposes of
          depending on  the same  data.   I  may also choose this
          option if I am citing my own data.  In either case,  I
          will provide  the MRID  or  Accession number(s)  for the
          cited data on  a "Product Specific Data Report"  form or in
          a similar format.  If I  cite another registrant's data,
          I will submit  a completed "Certification with Respect To
          Data Compensation Requirements" form.

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

Items 10-13.  Self-explanatory.

NOTE:     You may provide additional  information that does not.fit
          on this form  in a  signed  letter that  accompanies this
          form.    For  example,  you may wish to report  that your
          product has already been transferred to another company
          or  that  you  have  already  voluntarily cancelled  this
          product.  For these  cases, please supply all relevant
          details so  that EPA  can ensure that .its  records  are
          correct.
-------
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       f     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                        MA4HINGTON. O.C. 204tO

                                                    XL 2 9 06
                          PF  NOTICE 86-5


          NOTICE TO PRODUCERS,  FORMULATORS, OISTRI1UTORS
                         AND  REGISTRANTS

  Attention!   Person*  responsible  for Federal registration of
              pesticides.

  Subjects     Standard format for  data subaitted under the Federal
              Insecticide, Fungicide, snd Rodenticide Act (PXFXA)
              and certain  provisions of the Federal Food, Drug,
              and Cosmetic Act  (FFDCA).

  I.

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

  XZ.  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, toleraneee, and related
  approvals under certain  provision* of F1FRA and FFDCA.  These
  data are defined in  FIPRA SlO(dHl).  This Notice does not apply
  to commercial,  financial, or  production information, which are*
  and must continue  to be, submitted differently under separate
  cover.

  III. Effective  Date

      This notice is  effective on November 1, 1916.  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.

  XV.  Background

      On September  2«, 1»M, EPA  published proposed  regulations
  in the federal  Register  (49 Pit 37956) which include Requirements
  for Data Submission  (40 CPU 1159.32), and Procedures for Claim*
 of Confidentiality of Data  (40 CFR S1S8.33).  These regulation*
-------
 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-
 -  ality.   N"  *ncitl  .its   i l.i'.a  *  -fide.." \al it/ are c;ufuz2,
 either by  the proposed  regulation  or by this notice.

      OPP is making  these  requirements mandatory through this
 Notice to  gain resource*saving benefits from their use before the
 entire proposed regulation becomes final.  Adequate Iea4 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 organising 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 organised and presented within the study Deport.
 The data reporting  guidance  will be  compatible with submittal
 format requirements described in this Notice.

      OPP has  also promulgated a policy (PR  Notice 36-4 dated
 April  15,  1986) that provides for  early screening of certain
 applications  for  registration under  PZKRA S3.  The objective  of
 the screen is to  avoid  the additional costs and prolonged delays
 associated with handling  significantly incomplete application
 packages.  As of  the effective date of this Notice, the tcreen
 will  include  in its criteria for acceptance of application
 packages the  data formatting requirements described herein.

     OPP has  als6 established • public docket  which imposes dead-
 line.*  for  inserting into  the docket documents  submitted in con-
 nection 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  aore information about this requirement,

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

vz.  Format Requirements

     A more detailed discussion of these format requirements
follows the index en the  next page,  and samples of  some ef  the
requirement*  ere  attached.   Except for the  language of  the  two
alternative forma ef the Statement ef Data  Confidentiality  Claims
 (shown  in  Attachment 3) which cannot be altered, theae  samples
are illustrative.   Aa long at the  required  information  io  included
and clearly identifiable, the form of the  samples may be  altered
to reflect the  submitter's preference.
-------
                         - INDEX -

A,
B,
r.
D.



f ,
F.
G.
*
I
Organization of the Submittal Package ........


C.I Special Considerations for Identifying Studies. .

D. 2 Statement of Data Confidentiality Claims
(based on FIFRA S10(d)(D) 	 	 	

D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA flO(d)U))
0.5 Good Laboratory Practice Compliance Statement . .
Physical Format Requirements ft Number of Copies . . .
Special Requirements for Submitting Data to the Docket
r*
-------
 B.    Transffittal  Document

      The first ittm in tach  submittal  package must  0*  a  trans*
 .?:f:-l  '*?-•«.-.   *'-i - •*   "•• •-.  ii-M-,'-. i; ies  the  s.rir..;*. .-r  ir a*. I
 joint submitters;  the  regulatory  action  in  support  of  which the
 package is being  submitted—i.e.,  a  registration  application,
 petition,  experimental use permit (EUP),  §3(c)(2HB) data call-in,
 56(a) (2) submittal, or a special  review;  the transmittal date;
 and a list of all  individual studies included in  the package  in
 the order  of  their appearance, showing (usually by  Guideline
 reference  number)  the  data requirement(s) addressed by each one.
 The EPA-assigned  number for  the regulatory  action (e.g. the
 registration, EUP, or  tolerance petition  number)  should be
 included in the transmittal  document as-well, if  it is known  to
 the submitter.  See Attachment 1  for a.n  example of  an  acceptable
 transmi.teal document.

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

      The list of  included  studies in the  transmittal of  a data
 submittal  package  supporting a petition  for tolerance  or  an
 application for an EUP should be  subdivided into  sections A,  B,
 C,...,  of  the petition or  application, as defined in 40"CFR
 180.7 and  158*125, (petitions) or Pesticide Assessment Guidelines,
 Subdivision I (EUPS) as appropriate.

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

 C.    Individual Studies

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

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

      •  Include the total number of pages in the complete study
       on  each page (ie,,  1  of 250,  2  of  250,  ...250 of  250).

     - Include a company nan* 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
 volumes is permissible so long  as  th*  e«t«re *tj-1y  i* ja-it*:-!*
 .:. ^ *;r.»i«; »*.i*<» *r,c «a>.n ,  and if  so must be handled
 ss  described in section 0.3* of this notics.
-------
      c.   Residue Chemistry studies.  Guidelines 171-4,  153-3,
     ^1-4 AT* *xr.r«"el" uread ir. «row  *tj-iies nd-lressinc,
     aje en em 1$ try requirement* /tusc t«i»a o« uwtiOeO §c d
 lev*! below that of the Guideline code.   The general principle,
 however, 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  resi-
 dues resulting from treatment of a tinglt crop or  from proces*
 sing a single crop.  When more than one  commodity  it derived
 from a single crop (such as beet tops and beet roots)  residue
 data on all such commodities should be reported as • single
 study,  when multiple field trials are-associated  -»ith •
 single crop, all such trials should be reported as « single
 study.

 D.    Organization of Each Study Volume

      Fach 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
 Clauns

 Certification of Good
 Laboratory Practice
  •

 Flagging statements


 Body of Study


 Study Appendices

 Cover Sheet  to CenfI*
 dential Attachment

 CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
 When  Require.'                     Example

 Always                            page 12

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

 If study  reports laboratory      Page 16
 work  subject  to CLP require-
 ments

 For certain toxicology studies.  (When
 flagging  requirement* are finalised.)

 Always  -  with  an English language
 translation if required.

 At submitter's option
 If  CBI  is claimed under FIFRA
 flOfdHlUA),  (B>, or (C)

 If  CBI  is claimed under FIFRA
, «20(d)fl)(A>,  
-------
 D.I  Titl* Pag*

      A title page U Always required for each submitted study,
 published or unpublished.  The title page must always  be £r*«ly
 releasable to requestors; DO NOT INCLUDE CBI ON THE TITL* PACE.
 An example of an acceptable tir.le 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.   Oata requirement addressee.  Include on the title page the
 Guideline numberls)  of the specific requirement!s)  addressed  by
 the study.

 c.   Author(s).   Cite only individuals with primary intellectual  •
 responsibility for the content of the study.  Identify them
 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 Identification.  *lf 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  CPA questions raised with respect to an earlier study,
 include on  the title page elements a. through d.  for the previously
 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 study.  Do
 not include supplements to more than one study under a single
 title page).
           .                                   •       ,
g.   factsof  Publication.   Xf  the study is a reprint  of a pub-
 iished document,  identify on the title page all relevant facts
of publication, such  as the journal title*  volume,  issue* inclusive
page numbers, and publication date.
-------
 D.2.  Statements  of  Data  Confidentiality Claims under FIFRA §10(c!
-------
      This  statement  is  required if the study contains laboratory
 work subject  to CLP  requirements specified in 40 CFR 160.  sam-
 ples of  these  statements are shown in Attachment 6.

 E,    Reference to PreviouslySubmitted Data

      DO  NOT RESUMIT 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 to 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 should not be included in the  transmit-
 tal document,  but should be incorporated into the statement of
 the method of  support  for the application.

 r..   Physical  Format Requirements

      All elements In the data submittal package must -be  on uniform
 S 1/2 by 11 inch white  paper, printed on one side only  in black
 ink,  with  high contrast and good resolution.  Bindings  for indi-
 vidual studies must  be  secure, but easily removable to  permit
 disassembly for microfilming.  Check with EPA for special
 instructions before  submitting data in any medium other than
 paper, such as film  or  magnetic media.

 Please be  particularly  attentive to the following pointsi

  o  Do  not include  frayed or torn pages.

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

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

  o  Do  not include  overtise computer printouts or  fold-out pages.

  e  Do  not bind any documents with glue or binding tapes.

  o  Make  sure that  all pages of each study, including  any attach-
      ments 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 6 below) must be provided in three complete,  identical
eopiea.  (The  proposed  regulations specified two copies* three
are now  being  required 'to expedite and reduce the  coat  of  proces-
sing  data  into the OFF  Pesticide Document Management System and
getting  it into review.)
-------
 G.    Special  Requirements  for  Submitting  Data  to  the Docket

      Data suomittal  packages associated witn a  registration Scan*
 dard or special  Review  must be providtd in  four copies, from on*
 of  which all  mattrial claimed  as CBI has  bwtn excised.  This
 fourth copy will become part of the public  docket  for the RS or
 SR  c«se.   1C  no  claims  of  confidentiality are made for the study,
 trie fourth copy  should  be  identical to the  other  three.  Whan
 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 0 of this notice.  The following
 special preparation  is  required for the fourth copy.

  o  Remove the  'Supplemental  Statement- of  Data Confidentiality
      Claims'.

  o  Remove the  'Confidential  Attachment*.

  o  Excite from the body  of the study any  information you claim
      as confidential, even if  it does not fall within the scope
      of FIFRA llO(d)UHA), 
-------
                           ATTACHMENT  1.

       CLEMENTS TO BE INCLUDED IN  THE  TRANSMITTAL DOCUMENT*



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

     TSmith Chemical Corporation         Jon«s Chemical Company
      1214 west Smith Street       -and-' 5678 Wilson Blvd
      Cincinnati,  OH 98765            •   Covlngton, KY 56789

     fSAith Chemical Corp.  will act  as  sole agent for all submitters.

 2. Regulatory action in support ct  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. experi-
    mental 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 trans-
        mittal letter.   This remains an acceptable  practice so
        long  as all  four elements  are  included.

    **   Indicate which  of the  joint  submitters is empowered to
        act on behalf of all joint submitters in any matter con-
        cerning data compensation  or subsequent use or release
        of  tht data.
Company OffleiAlt
                  Name                    Signature

Company Namei                             '
Company Contacts  _^_^^^^__^^^_^^^__        _,,
                  Nam*                             Phone
-------
                   ATTACHMFNT 2.
SAMPLE STUDY TITLE PACE FOR A NEWLY SUBMITTED STUDY

                    Study TitU
  (Chemical namt)  -  Magnitudw of  Rtsidu*  on  Corn

                  Data tHquir«»ant
                  Guidallna 171-4

                       Author
                   John C.  Davia
                 Study Complatad On
                  January 5, 1979
               Ptrtorroing Laboratory
           ABC Agricultural Laboratori«a
                 940 H«»t Bay Orlva
                Wilmington, CA 39897
               Laboratory Project ID
                     ABC 47-79
                    Pag* 1 of X
   (X ia th« total numbtr of pagaa tn tha studyI
-------
                                JCTAWEJ.T 3.

                  STArmofis or DATA ooNnDevn«.m CLAIMS



1.  NO claim of confidantiality jndar FIFRA $10(d)(l)(A),(B), or (C)


                   stnworr or NO DMA ODNFinxriALmr CLAIW
   No claim of cunCidontlality it mada for any information oantainad in this starty
   on tha basis of its fining within tha seep* of FIPRA $10{d)(l)(A),  (B), or (C).
                   TiU»	    	Signature
2.  Claim of eonfirttntialtty undtr FIFWk flO(d)(l)(A),  (B), or (C).
                            Or OAXA OCNTICEWriALmf CIAZMS
   Information clainvd confidantial on tha baais of its falling within tha scope
   of  FIFRA flO(d)(l)(A)» (B), or (C) htf ha«n ranovad to a oonfidantial appandix,
   and is eitad by crosa-rtfsranca nmtoar in tha body of tha audy.
   Oanpanyt
   Ooapany Agentt               TVpsd Vmm                    Bitai

   	Tttla	    	Siqnaturs
 NORt  Applicants for pamanant or tan^orary tolaranca* should note that it
 is OPP policy that no patraanant tolaranoa, tanporary tolaranoa, or raquast for
 «n aasitfsnuy ajw^ption incorporating an analytical raathod, can ba approval
 unlasa tha applicant waivM all elains of confidantiality for tha analytical
 •attad.  Ihsa* analytical •athoda ar» publishsd in tha FM Paaticioa Analyt-
 ical Hftthodi Nanial, and tharafora cannot ba clainad as confidantial.  OPP
 jnylsajsnu this policy by raturning subnittad analytical nathods, for «tiich
 which confidantialicy elaiM havs baan aaUt, to tha s^mittar, to obtain
 tha coftfidantiality waivar  bafora thsy can ba


                                    13
-------
                        ATTACHMENT 4.

    SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
     for any portion of • submitted study that is  not  described
by FIFRA SlOtdXIHA), 
-------
                    EXAKPLES OP SEVERAL CONFIDENTIAL ATTACHMENTS

   aBsle  1   (Confidential word or phrase that  has been deleted fron the study)
                                                                                 I
 CfOSS REFERENCE NUMBER   1     This crQM reference number is used in th* study    !
                               in place of the  following words or phrase at the    I
                               indicated volume and page references.

 OELETH) WORDS OR PHRASEi        EthvUm Clvool-

   fftt LINE   REASON FOR THE DELETION                         FIFRA REFERENCE

    6    14    Identity of Inert Ingr»di«nt                     flOfdHlHC)
   28    25                 '                           .
   100    19
     It 2  (Confidential paragraph(sj^ that  have bMn deleted from the study)
CROSS .1CFEREHCE NUMBER   5    This cross reference amber  is used in the study
                              in place of the  following paragraphs ) at the
                              indicated \clkiw and page references.

OELEflD'BIBM3APH(S> I
   (                                                                      )
   <              Reproduce the deleted paragraph; s) here                  )
   (                         .                                             )
       .LIMBS  REASON FOR TOE DELETION                         FTFRA REFERENCE   I
                                             .                  -   (

   20  «-T7   Description of the quality control process        SlOtdHlHC)
          IConf idential  osoes that have been deleted from the study)
                NUMBER   7   this crass reference number noted on a place-holder
                             page is used  in place of  the following whole pages
                             at the indicated volume and page references.

                      attached  Immediately  behind this  page.

  HCTT8)      REASON  FOR THE DELETION                          riFEA REFERENCE

   39-41       Description of product manufacturing process      |10
-------
                          ATTACH"™? *5.

            SAMPLE GOOD LABORATORY PRACTICE STATEMENTS

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

      Submitter ^____________m________-______—.

      Sponsor  ...
      .Study Director
Exampl* 2.
  This study dots not meet th« rsquirwntnts of  4C  CPR
  Part 160, and differs in th« following wayst
  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	.
-------
                        ATTACHMENT 7.
                FORMAT OP THE SUBWITTAL PACKAGE
LEGEND
                  Tranamittal OoeuiMnt.
                      Related Administrative Material*
                      (e.g.. Method of Support Statement, etc.)
                     I       Other materials about the  aubmittal
                      — — (e.g., summaries of group* of  studies
                            to aid in their review).

                                   Studies, submitted  a* unique
                                   phy*ieel entities,  according
                                   to the format below.
                  FORMAT OP 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.

                                -1       Supplemental Statement
                                  , .	* of Confidentiality Claims.

                                     ' When flagging requirement*
                                       arc financed.
                Documents.which must be submitted as
                appropriate to meet established requirements.
               •l
                I     Documents submitted at submitter's option,
-------
               ATTACHMENT D

EPA GROUPING OF END-USE PRODUCTS FOR MEETING
    DATA REQUIREMENTS FOR REREGISTRATION
-------
 IPA'S  BATCHING OF END-USE PRODUCTS CONTAINING SOAP  SALTS  AS TEE
 ACTIVE INGREDIENT FOR MEETING ACUTE TOZICITY DATA REQUIREMENTS FOR
 RBREGISTRATION

     In  an ««.jr.*~t  to reduce the  time,  resources and  number of
 animals needed tx fulfill the acute toxicity data requirements for
 reregistratiT  z2   end-use   products  containing  the   active
 ingredients so*2 salts, the Agency has batched products which can
 be  considered  similar  in  terms  of  acute toxicity.     Factors
 considered in the sorting process include each product's  active and
 inert  ingredients (identity, percent  composition  and  biological
 activity),  type of formulation  (e.g.,  emulsifiable  concentrate,
 aerosol,  wettable powder,  granular,  etc.),  and  labeling  (e.g.,
 signal word,  use classification,  precautionary  labeling,  etc.).
 Note  that  the Agency   is  not  describing  batched  products  as
 "substantially similar" since some products within  a batch may not
 be considered  chemically similar or have identical use patterns.

     Batching  has been accomplished using the  readily available
 information described above, and frequently acute toxicity data on
 individual  end-use products has  been  found  to  be incomplete.
 Notwithstanding the batching process, the Agency reserves the right
 to require, at any time, acute toxicity data for an  individual end-
 use product should the need arise.

      Registrants of end-use products within a batch  may choose to
 cooperatively  generate,  submit or  cite a single  battery  of six
 acute  toxicological studies to represent all the products within
 that batch.    It is the registrants' option to participate in the
 process  with  all  other registrants,  only  some of   the  other
 registrants,  or only their own products  within  a  batch,  or to
 generate all the required acute toxicological studies for each of
 their own products.   If a registrant chooses to generate the data
 for a batch, he/she must use one of the products within the batch
 as  the test  material.    If  a registrant chooses to  rely upon
 previously submitted acute toxicity data, he/she may do so provided
 that the data base is complete and valid by today's standards  (see
 acceptance criteria attached),  the formulation tested  is  considered
 by EPA to be  similar  for acute toxicity, and the  formulation has
 not been significantly altered since submission and acceptance of
 the acute toxicity data.   '  Regardless of  whether new  data is
 generated or existing data is referenced, registrants must clearly
 identify the test material by EPA Registration Number.

     In   deciding  how  to  meet  the  product   specific  data
 requirements,  registrants must follow  the directions given in the
 Data Call-In Notice and its attachments appended to the RED. The
 DCI Notice contains two response  forms which are to be completed
 and submitted  to the Agency within 90  days of receipt.  The first
 form,  "Data  Call-In Response," asks whether the registrant will
meet the  data requirements  for  each product.  The  second form,
 "Requirements Status and Registrant's Response," lists the product
specific data required for each product, including the standard six
 acute toxicity tests.  A registrant who wishes to participate in  a
-------
batch must decide whether he/she will provide the data or depend on
someone  else  to  do  so.    If a registrant  supplies  the  data to
support  a  batch of  products, he/she must  select  one of  the
following  options:   Developing Data  (Option  l),  Submitting an
Existing Study (Option 4), Upgrading an Existing study  (Option 5)
or Citing an Existing Study (Option 6).  If a registrant  depends on
another's data, he/she must choose among:  Cost Sharing (Option 2),
Offers to Cost Share  (Option 3) or Citing an  Existing Study (Option
6). If a registrant  does not want to participate in a batch, the
choices are Options 1,   4, 5 or 6.   However, a registrant should
know that choosing not to participate in a batch does  not preclude
other registrants in the  batch  from citing his/her  studies and
offering to cost share (Option 3)  those .studies.

     Soap salts refer to the active ingredients potassium salts of
fatty acids and ammonium salts of  fatty acids.  Batches  1,2,3, and
4 (Table 1) consist of products that  have  potassium salts of fatty
acids as the active ingredient.   Batch 5 (Table 2) consists of two
products that have  ammonium  salts of fatty acids as the active
ingredient.

     Table 1
Batch
1

2
EPA Reg. No.
239-2564
36488-32
36488-33
36488-36
42697-02
42697-10
42697-11
42697-13
42697-16
42697-22
.•---y?«ll ifcb.^' •
36488-31
42697-06
42697-35
53219-05
% Potassium
Salts of Fatty
Acids
2.0%
2.0%
1.5%
2.0%
2.0%
2.0%
. 1.5%
2.0%
1.5%
3.0%
',*V .-•
25.0%
25.0%
18.0%
18.0%
Formulation Type
Ready-To-Use .Solution
Ready-To-Use Solution
Ready-To-Use Solution
Ready-To-Use Solution
Ready-To-Use Solution
Ready-To-Use Solution
Ready-To-Use Solution
Ready-To-Use Solution
Ready-To-Use Solution
Ready-To-Use Solution

Emulsifiable Cone.
Ready-To-Use Solution
Emulsifiable Cone.
Emulsifiable Cone.
-------

3

4

42697-01
42697-15
53219-06

42697-07
53219-04

49.0%
50.5%
49.0%

40.0%
40.0%

Soluble Cone.
Soluble Cone.
Soluble Cone.

Soluble Cone.
Soluble Cone.
     Table 2
Batch
5
EPA Reg. No.
400-383
400-429
% Ammonium
Salts of
Fatty Acids
15.0%
15.0%
Formulation
Type
Flowable cone.
Soluble Cone.
     Table 3 lists those products the Agency was unable to batch.
These products were either considered not to  be similar to other
products  for purposes  of acute  toxicity  or  the Agency  lacked
sufficient information for decision making.

     Table 3
UNBATCHED PRODUCTS
EPA Reg. No.
42697-33
42697-34
CONTAINING SOAP SALTS AS THE ACTIVE
% Active Ingredients
0.07%
2.05%
1.40%
41.00%
- pyrethrum extract
- potassium salts of
fatty acids
- purified pyrethrum
extract
- potassium salts of
fatty acids
Formulation Type
Soluble Cone.
Soluble Cone.
-------
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-------
                  ATTACHMENT F




LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
-------
            ATTACHMENT G




COST SHARE AND DATA COMPENSATION FORMS
-------
     P/EPA
                           United States  Environmental  Protection  Ageney
            Washington,  DC 20460
                                                 OU8 No. 207(M)1Q«
  CERTIFICATION  WITH  RESPECT TO
DATA  COMPENSATION  REQUIREMENTS
                                                 form Approved
Approval Expire* 13-31.92
  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 HUM
CftoatMl NMM
Company Number
EPA CftemlMl Number
 (Certify that

1 .  For each study cited In support of rereglstratton 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 cfte that study.

2.  That for each study died in support of reregistratton under RFRA that is NOT an exclusive use study, I am the
    original data submitter, or f have obtained the written permission of the original data submitter, or t have notified in
    writing the company(1es) that submitted data t have cited and have offered to: (a)  Pay compensation for those data
    in accordance with section 3(c)(1)(D) and 3(c){2)(D) of FIFHA; and (b) Commence negotiation to determine which
    data are subject to the compensation requirement of FIFRA and the amount of compensation due, H any. The
    companies I have notified art: (check one)

    []   AB companies on the data submitters' Bst for he active ingredient Osted on this form (Cite-All
        Method or Cite-All option under the Selective Method). (Also sign the General Offer to Pay
        betow.)
        sheets, or indicated on the attached •Requirements Status and Registrants' Response Form,*

3. That I riav* previously complied wftn section 3(C)(1XD) of FIFHA tor the studJts I have cfled In support of
   reregistratton under FIFRA.
•IfMtiir*
Oil*
HUM sod Till* (HMM Typo or PttoQ
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, win regard to the
reregfrtratton of my products, to th extent required by FIFRA section 3
-------
     P/EPA
United States Environmental Protection  Agency
            Washington, DC 20460
   CERTIFICATION OF  OFFER TO  COST
SHARE IN THE  DEVELOPMENT  OF DATA
Farm Approved

OMB No. 2070-0106

Approvil Explf»i 12-31.92
  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*
Chemical Nun*
Company Number
EPA Chemical Number
 i Certify  that:

 My company is willing to develop and submit tha data required by EPA under the authority of the Federal
 insecticide. Fungicide and Rodenttode 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):
       of n*»(a)
                                                                           Paw of Offer
 leertymttlamdUyauthorbedtorepresaftlrieconvaty                                    have made on
 trasfonn art alattactvmts thereto ai* true, aeoirM^             t acknowledge that any knowingly false or
 misleading statement may be purtsnaole by fine or imprisonment or bom urder applicable law.
 Stouter* of CaBMftr** Autfwrfutf
                                                                          Oat*
 NMM and Tin* (Ploaa* Tyt* «r Mnf)
f»A fttm Sf704a
-------
-------