Reregistration Eligibility Decision (RED) Soap Salts


        Unhid States       Office of Prevention, Pesticides
        Environmental Protection   And Toxic Substances
       . Agency	(H-750SW}	
&EPA Reregistration
        Eligibility  Document
        (RED)
        Soap Salts

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United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-750SW)
EPA-738-F-92-013
September 1992
&EPA R.E.D. FACTS
Soap Salts
Pesticide All pesticides sold or used in the United States must be registered by
Reregistration EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Document, or RED. This
fact sheet summarizes the information in the RED for soap salts.
Use Profile
Soap salts include the two pesticide active ingredients potassium salts
of fatty acids (including potassium laurate, potassium myristate, potassium
oleate and potassium ricinoleate), and ammonium salts of fatty acids
(ammonium oleate).
Potassium salts of fatty acids are used as insecticides, acaricides,
herbicides and algaecides. They are used to control a variety of insects
and mosses, algae, lichens, liverworts and other weeds, in or on many
food and feed crops, ornamental flower beds, house plan,s, trees, shrubs,
walks and driveways, and on dogs, puppies and cats.
Ammonium salts of fatty acids are used as a rabbit and deer repellent
on forage and grain crops, on vegetables and field crops, in orchards, and
on nursery stock, ornamentals, flowers, lawns, turf, vines, shrubs and
trees.
Regulatory The first pesticide product containing soap salts as an active
History ingredient was registered in 1947. Currently, 24 registered pesticide
products contain soap salts. Some of these products also contain other
active ingredients.

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When EPA published reregistration List D in the Federal Register on
May 5, 1990, Soap Salts (case 4083) contained eight active ingredients,
However, four of these were combined into the single active ingredient,
potassium salts of fatty acids; three others were cancelled and are no
longer subject to reregistration. Thus, two active ingredients remain.
Potassium salts of fatty acids used on food and feed crops have been
exempted from the requirement of a tolerance (or maximum residue limit)
for all raw agricultural commodities since 1982 (please see 40 CFR
180.1068). They are generally recognized as safe (GRAS) by the Pood
and Drug Administration (FDA) (please see 21 CFR 172.863). Although
ammonium salts of fatty acids also were exempted from tolerance
requirements k 1982, public notice was not provided. To correct this
oversight, EPA will publish an appropriate Federal Register notice soon.
In 1988, EPA determined that soap salts have "no independent
pesticidai activity" in antimicrobial products, and must be classified as inert
ingredients in those products (please see 40 CFR 153.139.) Therefore,
antimicrobial pesticides that contain soap salts as inert ingredients are not
subject to this RED. Antimicrobials that still contain soap salts as active
ingredients are considered misbranded and are subject to misbranding
enforcement action or cancellation.

Human Health Toxieity
Assessment Soap salts are of low toxicity when taken orally or exposed briefly to
the skin, and have been placed in Tbxicity Category IV (indicating the
lowest level of toxicity) for these acute effects. However, they can cause
mild or moderate irritation when exposed to the skin for longer periods of
time. Ammonium salt products also can cause permanent eye damage.
Fatty acids normally are metabolized, forming simple compounds that
serve as energy sources and structural components used in all living cells.
However, soap salts caused reproductive and mutagenic effects when
administered to laboratory animals at high doses.
-Dietary Exposure
Although people could be exposed to low levels of soap salts on
foods, these residues pose no known health risks. Soaps are mineral salts
of naturally occurring fatty acids. These fatty acids are a significant part
of the normal daily diet. Residues from the pesticide uses of soap salts are
not likely to exceed levels of naturally occurring fatty acids in commonly
eaten foods. Again, both potassium and ammonium salts of fatty acids are
exempted from tolerance requirements, and potassium salts are generally
recognized as safe by FDA.
Occupational and Residential Exposure
People applying soap salts may be exposed to these compounds.
Potassium salts are of low toxicity to humans, and there is no reason to

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expect that reasonable use will constitute any significant hazard. However,
protective eyewear is required while applying the ammonium salts of fatty
acids to prevent permanent eye injury. •»
Human Risk Assessment
Soap salts are of low acute toxicity when taken orally or exposed to
the skin. Residues from the pesticide uses of soap salts are not likely to
exceed levels of naturally occurring ratty acids in commonly eaten foods.
Thus, EPA believes the risks of the soap salts to applicators and consumers
are negligible. The risk of eye injury to applicators of the ammonium salts
can be mitigated by use of protective eyewear.

Environmental Environmental Fate
Assessment Hydrolysis of potassium salts of fatty acids (and probably also of
ammonium salts) does not occur over a period of 43 days. The half-life of
these fatty acids is estimated to be less than one day. As can be expected,
microbial organisms rapidly degrade fatty acids in soil. Soap salts cannot
dissipate totally in soil, however, because soil has a natural content of fatty
acids resulting from plant metabolism and microbial action. Fatty acids are
a significant part of the normal daily diet of mammals, birds and
invertebrates.
Ecological Effects
Ammonium salts of fatty acids are used outdoors as a rabbit and deer
repellent. They are practically non-toxic to upland game birds and
waterfowl. Their other potential hazards were estimated using data from
the potassium salts.
Acute and subacute toxicity studies using potassium salts of fatty
acids indicate that soap salts are relatively non-toxic to birds. They are
slightly toxic to both coldwater and wanmwater fish species. The
potassium salts are highly toxic to aquatic invertebrates.
No studies regarding the effects of the soap salts on non-target insects
were available for review. Such studies still are required. In addition,
product use rate information is needed to confirm that soap salts pose a
minimal threat to endangered species. f.
Environmental and Ecological Risk Assessment
Pesticides containing potassium or ammonium salts of fatty acids are
used on a wide array of outdoor sites. Once applied, however, the soap
salts are degraded quickly in soil by microbes, and do not persist in the
environment. The soap salts pose minimal risks to birds and are only
slightly toxic to fish. They are highly toxic to aquatic invertebrates.
However, since soap salts are not applied directly to water, their current
uses should not seriously impact aquatic invertebrates. Additional studies
are needed to assess their effects on non-target insects. The soap salts
should pose minimal threats to endangered species. In summary, based on

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                        the data reviewed, EPA finds that the soap salts will not cause
                        unreasonable adverse effects on the environment.
   Additional Data
           Required
     EPA has waived all generic data requirements for the soap salts
except basic product identity and chemistry studies and acute ecotoxicity
studies, which were submitted and reviewed,  EPA is requiring honeybee
toxicity data for potassium salts and confirmatory ecotoxicity studies on
fish and aquatic invertebrates for ammonium salts of fatty acids to confirm
that these pesticides do not pose significant ecological  hazards.  Product-
specific chemistry and acute toxicology studies also are required for
reregistration.
  Product  Labeling        The labels of all registered soap salts products must comply with
Changes Required   EPA's current pesticide labeling requirements.  In addition,
                             *  Products with outdoor uses and the manufacturing use product
                             must bear the following label statement: "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."
                             *  Labeling of all products must include appropriate precautionary
                             statements,
                             *  Labeling of ammonium salts products must require use of
                             protective eyewear (safety glasses, goggles or faceshield).
                             •  Labels must upgrade the ingredients statement by declaring
                             potassium salts or ammonium salts of fatty acids, rather than "soap".
                             »  Labels of products for crop uses must be upgraded by stating
                             specific crops and/or crop groups.
        Regulatory
        Conclusion
     * All registered pesticide products containing the active ingredient
soap salts are not likely to cause unreasonable adverse effects in people or
the environment, and are eligible for reregistration.  These products will be
reregistered once the required additional generic data, product-specific data
and revised labeling are received and accepted by EPA.
     * Registered products containing soap salts as well as other active
ingredients, will be  reregistered once the other active ingredients also are
determined to be eligible for reregistration.
          For More        EPA is requesting public comments on the Reregistration Eligibility
       Information   Document (RED) for soap salts during a 60-day time period, as announced
                        in a Notice of Availability published in the federal Register. To obtain a
                        copy of the RED or to submit written comments, please contact the Public

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Response and Program Resources Branch, Field Operations Division (H-
7506C), Office of Pesticide Programs (OPP), US EPA, Wellington, DC
20460, telephone 703-305-5805.
     In the future, the soap salts RED will be available from the National
Technical Information Service (NTIS), 5285 Port Royal Road, Springfield,
VA 22161, telephone 703-487-4650.
     For more information about soap salts or about EPA's pesticide
reregistration program, please contact the Special Review and
Reregistration Division (H-7508W), OPP, US EPA, Washington, DC
20460, telephone 703-308-8000. For information about reregistration of
individual soap salts products, please contact PM learn 14, Registration
Division (H-7505C), OPP, US EPA, W&shington, DC 20460, telephone
703-305-6600.
     For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call  toll-free 1-800-858-7378, 24 hours a day,  seven days a
week, or fax your inquiry to 806-743-3094.

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        United States       Office of Prevention, Pesticides
        Environmental Protection   And Toxic Substances      September 1992
        Agency         (H-7508W)
&EPA  Reregistration
         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

Phyllis Johnson      Biological Analysis Branch
Margette Cogdell     Biological Analysis Branch
William Gross Jr.    Biological Analysis Branch

Environmental Fate and Effects Division

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
                                       n

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                      TABLE OF CONTENTS

                                                             Page
GLOSSARY OF TERMS AND ABBREVIATIONS                           v
EXECUTIVE SUMMARY                                            vi

I. INTRODUCTION                                                1

D. 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

IH.  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

      APPENDIX 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 Registration

APPENDIX B - Generic 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

APPENDIX 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 Registrants) Sent this DCI

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

     Attachment F - Cost Share/Data Compensation Forms

APPENDIX 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


LC50         Median Lethal Concentration.  A statistically derived concentration of a
            substance that can be expected to cause death in 50% of test animals.  It is
            usually expressed as the mass of substance per body mass of animal or volume
            of water  or feed, e.g., mg/1 or ppm.

LD50         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 acaricides, 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 wDl 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 (H7506C), 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 Reregistration Eligibility Document.

1. Chemical Name; Potassium salts of fatty acids [C,:-C18 saturated and Cu
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: [CirCig HK-Hy O,-Oy]K

2. Chemical Name: Ammonium salts of higher fatty acids [Cg-C]8 saturated and Clg
unsaturated], including ammonium oleate.

CAS Registry Number: 84776-33-0

Office of Pesticide Programs Chemical Code: 031801

Empirical Formula: [C8-C,g H^-Hy Ox-Oy]NH4

B. Use Profile For 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, sawfiy
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 reregistration, 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 C12-Ctg, 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 C,2-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.
M. 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 CIS unsaturated] fatty acids, including

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ammonium oleate; and, (2) potassium salts of [C12-C18 saturated and Clg unsaturated] fatty
acids, including potassium laureate, potassium myristate, potassium oleate, and potassium
ricinoleate.
The technical grade of the active ingredient (TGAI) per fig 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 reregistration
eligibility of the active ingredients.
a. Acute Toxicitv
TFST
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 C12--Cig 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 (15) . 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. Mutagenicity

DNA inhibition was reported with 600 umol/1 of the sodium salt of eaprylic 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 Saccharomycej cerevisiae (14).
2. Dietary Exposure

There is a tolerance exemption for potassium oleate and related Ci2-Clg 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 Exposure
**

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. RiskAssessment

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 an ticking 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 CO2
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
MRTD 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) or
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:

% A.I.

14.65
Study and Species
71-1 Avian Oral-
Bobwhite Quail
71-2
Bobwhite Quail-
Mallard Duck
14.65
14.65
LD/LC50

2,150 ppm

5,000 ppm
5,000 ppm
Date MRID

1/91 41767112

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
LC5Q 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 Labelins
The available toxicity data do not indicate a requirement of precautionary labeling for birds
on products containing Ammonium salts of fatty acids.
11

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("*) 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 Paphnia magna.

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 (LC50 = 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.
(Hi.) 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

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       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.
       Ov.) 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;


       (i.) 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

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       Author
            Date
MRID No.
       Grimes
       Grimes
       Grimes
       Grimes
       Grimes
       Wildlife Int. Ltd.
       Wildlife Int. Ltd.
       Wildlife Int. Ltd.
       Wildlife Int. Ltd.
            1987
            1987
            1987
            1987
            1987
            1981
            1981
            1981
            1981
94240004 (TGAI)
94240004 (TEP)
94240005 (TGAI)
94240005 (TEP)
94240005
00096639A
00096639B
00157472
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) fir an upland species (preferably bobwhite quail).

       B.  Two subacute dietary studies: one study on a species of upland game bird
(preferably bobwhite quail an2,250mj/kg
TGAI      94240004      Core         Reuter     LD50- > 2,000 mg/kg

TGAI      00096639B     Supplemental    Safer      LD50= >2,510rog%
TGAI      00096639A     Supplemental    Safer      LD50= > 2,510 ing/kg
                                            14

-------
       The acceptable subacute dietary toxicity studies are listed below:
 Data Requirements
Test       Bibliographic   Validation
Substance   Citation
            Company   Rasults
 71-2 Avian Dietary
  Bob white
TGAI
TGAI
TGAI
TEP
TGAI
OOOS6640
00010504
00010504
942400-05
942400-05
Cor*
Cor*
Supplemental
Supplemental
Core
Safer
Safer
Safer
Router
Reuter
                                                                  LC50 - > 5,620 ppm
                                                                  LC50- > 5,620 ppm
                                                                  iCSO- > 10,000 ppm
                                                                  LC50* > 5,620 ppm
                                                                  LC50- > 5,620 ppm
  Mallard Duck
TGA!
TEP
                                942400-05
                                942400-05
Core
Supplemental
Reuter
Reuter
LC50.
LC50-
> 5,620 ppm
>S,620 ppm
       An LD50 greater than 2,000 rag/kg was determined for bob white 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 LC50 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

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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 Requirements
Test Bibliographic Validation
Substance Citation
Company Results
AQUATIC TESTING
72-2
Daphnia
Daphnia
Daphnia

TO At
TGAI
TGAI

00030865
00096838
400662-00

Supplemental
Supplemental
Core

Safer
Safar
Reuter

LC50- 102ppm
IC50- 102ppm
LC50 - .57 ppm
A 48-hour LC50 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 Daphnia 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

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(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
BioChera.Lab.

Applied Bio.
Science Lab.

Obenchain
Date

1985

1981

1986
MRIP 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:
DaU Requirements
Test
Substance
Bibliographic
Citation
Validation
Company Results
AQUATIC TESTING
72-1 FreihwMer Fish
Trout
Fathead Minnow
Bluegil! Sunfish
Bluegill Sunfish
Trout

TGAJ
TEP
TGAJ
TGA1
TGAI

00096636
00096637
157473
400662
4006200

Supplemental
Supplemental
Core
Supplemental
Supplemental

Safer
Safer
Safer
Reuter
Reuter

LC50= 18.06 ppm
LC50= 21 ppm
LC50=35.35ppm
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

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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

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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 REREGISTRATION 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 Qf Soap Salts

No manufacturing-use products are registered.

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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