United States
        Environmental Protection
        Aflency
Office of Prevention. Pesticides xx 5*»0/RS-92-208
And Toxic Substances    June 1992
(H-7508W?            PB92-220219
&EPA Reregistration
        Eligibility Document
        (RED)
         Alkyl Amine
         Hydrochloride

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REREGISTRATION ELIGIBILITY DOCUMENT

          Alkyl amine hydrochloride

                    LISTC

                  CASE 3051
        ENVIRONMENTAL PROTECTION AGENCY
           OFFICE OF PESTICIDE PROGRAMS
     SPECIAL REVIEW AND REREGISTRATION DIVISION
                WASHINGTON, D.C.

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      EPA Alkyl amine bydrochloride REREGISTRATION ELIGIBILITY TEAM

Office of Pesticide Programs:

Biological and Econpfnic Analysis Division
Karen Griffin             Biological Analysis Branch
Rafael Prieto              Biological Analysis Branch
Cynthia Szymanski        Biological Analysis Branch
Phyllis Johnson            Biological Analysis Branch
        »
Environmental Fate and Effects Division
Mary Frankenbeny        Science Analysis and Coordination Staff
Art Roybal               Ecological Effects Branch
Ann Stavola              Ecological Effects Branch
Brinson  Conerly-Perks     Environmental Fate and
                           Groundwater Branch

Health Effects Division
Esther Saito              Chemical Coordination Branch
David G. Van Ormer      Chemical Coordination Branch
Melba Morrow            Toxicology Branch n
James Yowell             Occupational and Residential Exposure Branch

Registration Division
Sami Malak              Registration Support Branch
Olga Odiott               Registration Support Branch
Marshall Swindell         Anti-Microbial Program Branch
Karen Leavy              Anti-Microbial Program Branch
Special Review and Reregistration Division
Carol Stangel             Policy, Planning and Operations Staff
Barbara Briscoe           Accelerated Reregistration Branch
Yvonne Brown            Accelerated Reregistration Branch
Betty Crompton           Accelerated Reregistration Branch

Office of General Counsel
Andrea Medici

Office of Compliance Monitoring
Beverly Updike

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                     TABLE OF CONTENTS
GLOSSARY OF TERMS AND ABBREVIATIONS


EXECUTIVE SUMMARY


L INTRODUCTION


H. CASE OVERVIEW


     A.   CHEMICAL OVERVIEW


     B.   USE PROFILE


     C.   REGULATORY HISTORY


    SCIENCE ASSESSMENT OF ALKYL AMINE HYDROCHLORIDE


     A.   DESCRIPTION OF ACTIVE INGREDIENT
     B.
HUMAN HEALTH ASSESSMENT
     C.   ENVIRONMENTAL ASSESSMENT


IV. RISK MANAGEMENT AND REREGISTRATION DECISION


     A.   DETERMINATION OF ELIGIBILrrY


     B.   ADDITIONAL GENERIC DATA REQUIREMENTS


     C.   LABELING FOR MANUFACTURING-USE PRODUCTS


V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS


     A.   DETERMINATION OF ELIGIBILITY
                       •4           * ~-

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



iy


v


 1


 2


 2


  2


  3


 3


 3


 4


 6


 7


 7


 8


 8


 9


 9


 9
  9
                              u

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VI.   APPENDICES

       APPENDIX A - Use Patterns Subject to Reregistration

       APPENDIX B - Generic Data Requirements for Reregistration of Alkyl amine
                   hydrochloride and Data Citations Supporting Reregistration

       APPENDIX C - Citations Considered to be Part of the Data Base
                    Supporting the Reregistration of Alkyl amine hydrochloride

       APPENDIX D - PR Notice 91-2

       APPENDIX E - Pesticide Reregistration Handbook

       APPENDIX F - Product Specific Data Call-In

            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 Acceptance Criteria

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

            Attachment F - Cost Share/Data Compensation Forms
                          Application for Registration
                                       111

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                 GLOSSARY OF TERMS AND ABBREVIATIONS


aui.         Active Ingredient

Agency     U.S. Environmental Protection Agency

CAS        Chemical Abstracts Service

HP      :-r  End-Use Product

EPA        U.S. Environmental Protection Agency

FEFRA      Federal Insecticide, Fungicide, and Rodenticide Act

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

LOAEL     Lowest observable adverse effect level

MUP        Manufacturing Use Product

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

ppm        Parts per Million

RED        Reregistration Eligibility Document
                                       IV

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EXECUTIVE SUMMARY
       This Reregistration Eligibility Document addresses pesticide uses of alkyl amine
hydrochloride.  Alkyl amine hydrochloride products are currently registered for use in
hospitals both human and veterinary and in conmnerEfoi and industrial premises as a
bacteriocide/  fortfn'oytatt rnicrobicidc/""crobiostat and fungicide^ It also is added to
adhesives, paints and emulsions as a preservative. All products containing alkyl amine
hydrochloride as an active ingredient are eligible for reregistration.

    The Environmental Protection Agency (EPA) has conducted a review of the scientific
data base and other relevant information supporting the reregistration of alkyl amine
hydrochloride and has determined that the data base is substantially complete and sufficient to
allow EPA to conduct a reasonable risk assessment.

       The data available to the EPA  supports the conclusion that the currently registered
uses of alkyl  amine hydrochloride will not result in unreasonable adverse effects to the
environment or human health.

       Accordingly, EPA has determined that the registered uses of alkyl amine hydro-
chloride are eligible for reregistration. The decision to reregister specific products will be
made after appropriate 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 labels, the EPA will determine whether or not the conditions
of HFRA 3(c)(5) have been met, that is, whether product labeling and composition are
acceptable and their uses will not cause unreasonable adverse effects to humans  or the
environment.  If these conditions  are met,  EPA will reregister the products.  Those products
which contain other active ingredients will be eligible for reregistration only when the other
active ingredients are determined  to be eligible for reregistration.

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 L     INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
 amended to accelerate Ac 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 registration* before
 calling in data on products and either reregistering products or taking "other appropriate
 regulatory action."  thus, reregistration involves a thorough review  of the scientific data base
 underlying a pesticide's registration.  The purpose of the Agency's  review is to reassess the
 potential hazards arising from the currently registered uses of the pesticide; to determine the
 need for additional data on health and environmental effects; and to determine whether the
 pesticide meets  the "no unreasonable adverse effects" criterion of FIFRA.

       This document presents the Agency's decision regarding the reregistration of alkyl
 amine hydrochloride.  The document consists of six sections.  Section I is the introduction.
 Section H describes  alkyl amine hydrochloride, its uses, data requirements and regulatory
 history.  Section m discusses the human health and environmental assessment based on the
 data available to the Agency. Section IV discusses the reregistration decision for alkyl amine
 hydrochloride.  Section V discusses the reregistration requirements  for alkyl amine
 hydrochloride.  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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      CASE OVERVIEW
A.    Chemical Overview

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

               Name:     p-alkyl amine hydrochloride (as in fatty acids of coconut)
      CAS Registry Number 929-73-7

      Office of Pesticide Programs Chemical Code: 069152

      Empirical Formula:

      Molecular Weight:  221.82
B.    Use Profile

      The following is information on the registered use with specific use sites and
application methods. A detailed table of eligible uses of alkyl amine hydrochloride is in
Appendix A.

      Type of Pesticide:  bacteriocide/bacteriostat, microbicide/microbiostat, fungicide,
                         preservative, self-sanitizer

      Use Sites:          INDOOR MEDICAL:  Hospital/medical institutions premises -
                         human/veterinary

                         INDOOR NONFOOD:  Commercial/institutional/industrial
                         premises/equipment (indoor); adhesives; industrial
                         (preservatives); latex paints (in-can) (preservatives); emulsions,
                         resin/latex/polymer (additives/preservatives)

                         INDOOR RESIDENTIAL: Household/domestic dwellings

     ' Pests: -            Deterioration/spoilage bacteria, including Pseudomonas
                         aeruginosa. Escherichia coli. Staphylococcus aureusr Fungi
                         (mildew)

      Formulation Types
      Registered:         Liquid - ready to use, soluble concentrate/liquid

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       Method and Rates
       of Application:      TYPES OF TREATMENT: Industrial preservative, mop

                          Equipment: Spray, mop
C.     Regulatory History

       A product containing alkyl amine hydrochloride, was first registered in 1971. Since
men, two:other products have been registered.  Alkyl amine hydrochloride products are used
as a self-sanitizer for floors and equipment and as a preservative in paints and other coatings.
Since there are no uses ngwriatfd with human foods or animal feeds, there are no established
tolerances for residues of alkyl amine hydrochloride.
      SCIENCE ASSESSMENT OF ALKYL AMINE HYDROCHLORIDE
      The Agency has conducted a review of the scientific data base for alkyl amine
hydrochloride. The findings are summarized below.
A.    DESCRIPTION OF ACTIVE INGREDIENT

      Two analytical procedures were developed by Huls America, Inc.  Both methods are
filed under MRID 41671201.  One method determines the active ingredient, p-alkyl amine
hydrochloride, and the second determines an inert solvent.

      Alkyl amine hydrochloride, the salt of coconut ofl fatty acids, is a crystalline tree
flowing solid of straw yellow color with very little odor.  It has a water solubility of 44.5
gm/100 ml and an octanol solubility of 4.67 gm/100 ml.  It has a specific gravity of 0.975, a
vapor pressure of IxlCT5 Torr, and an octanol/water partition coefficient of 11 ± 3. Its
melting point is  164-170° C, its dissociation constant (pKJ is 2.3, and its pH is 6.31. It is
stable to hydrolysis  and metabolism over the short term.

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B.
HUMAN HEALTH ASSESSMENT
      The Agency has determined that sufficient data have been submitted to assess the
potential health hazards, exposures and risks from the current registered pesticide uses of
alkyl amine hydrochloride.

1.    Toxicology
      Acute Toxicitv
             ACUTE TOXICITY VALUES
TEST
Oral LD jo
Inhalation IJ^..

Dermal LDjo
Eye effects
Skin effects
Dermal Sensitization
RESULT
(mg/kg)
1058 mg/kg
Waived
> 2000 mg/kg
Waived
Corrosive
mild to strong
CATEGORY
m
I*
m
i*
i*
N/A**
 * Category based on corrosiveness shown in dermal testing.
 ** Not applicable
b.    Subchronic Toxicitv

      A repeat dose dermal 90-day toxicity study was conducted in rats. Animals received
alkyl amine hydrochloride at doses of 0, 50 or 125 mg/kg/day for 13 weeks. The systemic
NOEL was 50 mg/kg/day and the systemic LOEL was 125 mg/kg/day based on the presence
of an inflammatory skin response and a reported increase in adrenal weights (MRID
41735501)-.

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  c.     Chronfo__XQyicity

        Alkyl amine hydrochloride was administered at doses of 0, 25,75 or 150 mg/kg/day to
  pregnant rats on days 6 through 15 of gestation. At the 25 mg/kg/day dose, the compound
  had no effect on mater*1^ animate  The maternal LOBL was dftf"^*11?^ to be 75 mg/kg/day
  based on observations of decreased body weight and decreased food consumption which
  occurred during the treatment period.  The NOEL for developmental tenacity was 75
  mg/kg/day and the developmental LOAEL was 150 mg/kg/day based on increased post-
  Implantation loss and decreased fetal body weight.  However, the Agency believes these
  effects were secondary to the maternal toxicity at the highest dose tested. No developmental
  malformations or variations were observed which could be related to the administration of
  alky! amine hydrochloride. (MRJD 41537601 and 41537602).

  d.     Mutagenicity

        Alkyl amine hydrochloride has not shown genetic toxicity. The compound was
  negative for gene mutations (MRID 41287101), structural chromosome aberrations (MRID
  41287103) and unscheduled DNA synthesis (MRID 41287102).
 2.
Dietarv Exoosure
        There are no registered food uses for alkyl amine hydrochloride. As an antimicrobial
 constituent of liquid floor wax and industrial coatings, the substance has no uses which would
 bring it into contact with food.  Consequently, tolerances have not been established.
 3.     Occupational Exposure

        Occupational exposure to alkyl amine hydrochloride results from the uses of the liquid
 floor wax (hand mop application) and the industrial preservative in paints, adhesives and
 coatings.  The floor wax product contains 0.063 percent active ingredient of the antimicrobial.
 One of the two industrial preservative products contains 25 percent alkyl amine hydrochloride
, and the other, 21.2 percent.  These products are incorporated during the manufacturing
. process of paints, adhesives and coatings.

        Applicator exposure to the antimicrobial would result from the floor-mop application of
 the floor wax products or the manufacture of industrial coatings.  The floor wax product labels
 instruct applicators to get medical attention if skin irritation develops.

        From the industrial  use application, there is a potential for eye, dermal and inhalation
 exposure to workers in the coatings industry.  Technical alkyl amine hydrochloride is in
 Category I for inhalation, eye and dermal irritation. However, labels instruct users to wear
 eye shields, rubber gloves, respirator and protective clothing to mitigate exposure.

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       The Agency has determined that, when used as directed OB the labels, alkyl amine
hydrochloride exposure will be minimal.

4.     Human Risk Assessment

       Hie toxicology studies on alkyl amine hydrochloride and information about its uses are
sufficient for assessing potential human risk.

       Although the acute oral and dermal toxitities are in Category m, alkyl amine
hydrochloride is corrosive (Category I) to the skin and, therefore, also likely to be corrosive to
the eyes and lungs. At 125 mg/kg/day, subchronic dermal testing (rats) shows increased
adrenal weights and an inflammatory skin response. In a developmental toxicity study, also in
rats, the developmental LOAEL was ISO mg/kg/day, based on post-implantation loss and
decreased fetal weight, with no malformations or variations at any dose. Decreased maternal
body weight occurred at lower dose level, 75 mg/kg/day. Because these effects likely were
caused by maternal toxicity as stated above, the Agency believes this does not constitute a
concern for unreasonable risks to workers.

       Mutagenicity was not observed for alkyl amine hydrochloride in separate assays for
gene mutations, chromosomal aberrations, or unscheduled DNA synthesis.

       Toxicological and exposure data are adequate for alkyl amine hydrochloride. Prudent
use should not result in any unreasonable hazard. In view of the adequacy of the toxicological
data for alkyl amine hydrochloride, there are no significant exposure concerns other than
providing assurance that the formulated concentrates of this corrosive ingredient contain proper
cautionary statements as addressed in section IV, C.

C.     ENVIRONMENTAL ASSESSMENT
1.     Environmental Fate Assessment

       Alkyl amine hydrochloride is a mixture of closely related compounds of the general
class of quaternary amines.  Diluted in water, it is expected to remain stable to hydrolysis and
degradation over the short term.  In time, the compound would be expected to undergo micro-
bial metabolism, yielding such metabolites as ammonia, chloride, short(er) chain fatty acids,
and finally COj. The use is limited to the inside of buildings which restricts its presence from
exterior environments.  For this reason, the Agency is not requiring any environmental
chemistry data at this time.  The only data the Agency would ordinarily ask for is hydrolysis,
which is required for all registered pesticides regardless of use pattern.  However, in this case,-
a thirty-day hydrolysis study would not be likely to yield any useful information, since little or
no hydrolysis would be expected to take place.

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2.     geological Effects Assessment

       The Agency has reviewed four basic ecotoxicology studies for alley! amine hydro-
chloride. The Agency's conclusions for the avian and aquatic effects studies follows.

a.     Terrestrial Studies

       Alkyl amine hydrochloride is considered to be slightly toxic to upland game birds and
waterfowl with an acute oral LD» value of 989 rug/kg (MRID 41671701).  The avian dietary
study gave ID*, values > 5620 ppm. Based on this information, the chemical is categorized
as practically nontoxic through dietary exposure to upland game birds and waterfowl.
b.
Aouatic Studies
       Two studies were performed to assess aquatic toxicity.  Based on rainbow trout and
Daphnia testing, alkyl amine hydrochloride is classified as highly toxic to freshwater fish with
LCjo values of 0.18 ppm and 0.48 ppm, and very highly toxic to freshwater invertebrates with
LCjo - 0-01 ppm.
3.     Ecological Effects Risk Assessment

       Although some of the studies were deficient in their conduct, they are adequate to
provide the Agency with sufficient information to determine appropriate label precautions.
These label precautions are included in IV. C. Labeling Requirements For Products
Containing Alkyl Amine Hydrochloride.

       No risk assessment was performed for alkyl amine hydrochloride, given the expectation
of no exterior exposure from its indoor use.
IV.  RISK MANAGEMENT AND REREGISTRATION DECISION FOR ALKYL AMINE
HYDROCHLORIDE
A.    Determination of Eligibility

      Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data" concerning an active ingredient, whether products-containing the active
ingredient are eligible for reregistration. the Agency previously has identified and required
or waived the submission of the generic (i.e., active ingredient specific) data required to
support reregistration of products containing alky] amine hydrochloride as an active
ingredient. The Agency has completed its review of these generic data and information from
published literature, and has determined that the data are sufficient to support reregistration

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of products containing alkyl amine hydrochloride.  Appendix B identifies the generic data
that the Agency reviewed as part of its determination of reregistration eligibility of alkyl
amine hydrochloride, and lists the submitted studies that the Agency found acceptable.

       The data identified in Appendix B are sufficient to allow the Agency to conduct a
reasonable risV assessment for the registered wsfs of alkyl amine hydrochloride.  The data
available to the Agency support the belief that the registered uses of alkyl amine hydro-
chloride will not result in unreasonable adverse effects to human health or the environment
The Agency has determined that all products containing alkyl amine hydrochloride as the
active ingredient are eligible for reregistration. The reregistration of particular products is
addressed-in section V of mis document ("Product Reregistration*).

       The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, various articles available in the public literature which are identified in
Appendix C and the data identified in Appendix B.  Although the Agency has found that
products containing alkyl amine hydrochloride are eligible for reregistration, it should be
understood that the Agency may take appropriate regulatory action, and/or require the
submission of additional data to support reregistration of products containing alkyl amine
hydrochloride if new information comes to the Agency's attention or 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 alkyl amine
hydrochloride has been reviewed and determined to be complete.
C.    LABELING REQUIREMENTS FOR ALKYL AMINE HYDROCHLORIDE
      PRODUCTS

      Products labeled for* manufacturing use only as a preservative* must delete the word
•manufacturing* in the Directions for Use section of the label.  Labels on these products
state that "concentrated solutions are corrosive and cause severe eye and skin damage.*
Therefore, labeling for these products  must include the requirement for the use of eye
shields, rubber gloves, a pesticide respirator and protective clothing.  The label  must carry
the skull and crossbones along with the word "poison" because products with alkyl amine
hydrochloride are classified Category I for the inhalation route of exposure.  The
Precautionary Statements section on all labels must include the statement "prolonged or
frequently repeated skin contact may cause allergic reactions in some individuals.*
                                         8

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 1.
LABELING REQUIREMENTS FOR INDUSTRIAL PRESERVATIVE PRODUCTS
      Products labeled for uses as an industrial preservative must contain the following
warning in the Environmental Hazards section of the label:  "This pesticide is tpxic to fish
and aquatic invertebrates. Do not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans or public waters unless this product is specifically identified
and addressed in an NPDES permit.  Do not discharge this product into sewer systems
without previously notifying the sewage treatment plant authority. For guidance, contact
your State Water Board or Regional Office of U.S. EPA.*
2.
LABELING REQUIREMENTS FOR FLOOR WAX PRODUCTS
      Products labeled for use in floor wax formulations must contain 'Avoid contamination
of foods" in the Directions for Use section of the product label.
V.  ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS
A.
DETERMINATION OF ELIGIBILITY
       The active ingredient alkyl amine hydrochloride and the products containing it are
eligible for reregistration based on the reviews of the generic data.  Section 4(g)(2)(B) of
FIFRA calls for the Agency to obtain any needed product-specific data regarding the pesti-
cide 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 product-specific data requirements are stated in Attachment C.
2.
LABELING REQUIREMENTS FOR END-USE PRODUCTS
      The labels and labeling of all products must comply with the Agency's current
regulations and requirements.  Follow the instructions in Section IV. and in the Product
Reregistration Handbook with respect to labels and labeling.  "

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                    APPENDIX A
AlkyI Amine Hydrochloride Use Patterns Subject to Reregistration

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APPENDIX A: USE PATTERNS SUBJECT TO REREGISTRATION FOR (COCO ALKYL)AMINE
HYDROCHLORIDE
an

Fan*
A^^b^kM la^fe
KM.
MK«
Afp
M»#
*»•
M*. •*
(D*-)
*w^» ''
MB '
0*4
«*«
S2S"
U»LMMta
««*>
NON-FOOD/NON-FEED USES - ELIGIBLE FOR REREGICTRATION
ADHESIVES, INDUSTRIAL Use Groups): INDOOR NON-FOOD
Preservative treatment, During
manufacturing, Not on label
V
Preservative treatment. Daring
manufacturing, Not on label
FM/L
SC/L
m
na
Dose cannot be
calculated
Dose cannot be
calculated
Not
•pec
Not
spec
Not
spec
Not
spec
Not
spec
Not
spec
None
None
None
None



EMULSIONS, RESIN/LATEX/POLYMER UseGroup(s): INDOOR NON-FOOD
Preservative treatment, During
manufacturing, Not on label
SOL
na
Dose cannot be
calculated
Not
spec
Not
spec
Not
spec
None
None

.
PAINTS, LATEX ON-CAN) Use Groupfs): INDOOR NON-FOOD
Preservative treatment, During
mamifkntilnno Mm* rut l>h*1
rnanuiacninng, not un lanei
SOL
na
Dose cannot be
calculated
Not
spec
Not
spec
Not
spec
None
None

•
FLOORS (UNSPECIFIED) Use Group(s): INDOOR MEDICAL, INDOOR NON-FOOD, and INDOOR RESIDENTIAL
Mop, Not on label, Mop
RTU
na
Dose cannot be
calculated
Not
spec
Not
spec
Not
spec
Not
Spec
None
A08
•
11

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AbtVi aviationsoscd
  Header.
  max=*muimuin; min-minimum; apps*>application8; not 8pec=not specified; na^not applicable

  Form;
  RTU->retdy-tomse; SC/L«solub1e concentrate/liquid; FM/L=fommlationDot identified/liqtrid

  Uw Unritatioii:
  A08=pnBclean claim

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                           APPENDIX B
           *a.
Generic Data Requirements for Reregistration of Alkyl Amine Hydrochloride and
                 Data Citations Supporting Reregistration

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                              GUIDE TO APPENDIX B
  Appendix B contains listings of data requirements which support the reregistration for the
pesticide covered by this Reregistration Eligibility Document.
                                                                   X
  Appendix B contains generic data requirements that apply to the pesticide in all products,
including data requirements for which a "typical formulation* is the lest substance.

  Hie 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. Use Pattern (Column 2).  This column indicates the use patterns to which the data
requirement applies.  The letter designation M is used for the indoor nonfood use pattern
associated with alkyl amine hydrochloride.

  3. Bibliographic citation (Column 3). 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  (MRID) 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.

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APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF ALKYL AMINE HTDROCHLORIDE
f AND DATA CITATIONS SUPPORTING REREGISTRATION
t
GUIDELINE
CITATION
TITLE OF
STUDY
USE
PATTERNS
BIBLIOGRAPHIC
CITATION
Product Chemistrv
61-1
61-2 (a)
61-2 (b)
62-1
62-2
62-3
63-2 .
63-3
63-4
63-5
63-7
63-8
Chemical identity
Begining material and
manufacturing process
Discussion of Impurities
Preliminary analysis
Certification of limits
Analytical method
Color
Physical state
Odor
Melting point
Density
Solubility
M
M
M
M
M
M
N
M
M
M
M
M
42313101
41671201
41671201
41671202
41671202
41671202
41671203
42332601
41671203
42332601
41671203
42313102

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                                APPENDIX B



GENERIC DATA REQUIREMENTS FOR REREGI8TRATION OF ALKYL AMIHE HYDROCHLORIDE
AND DATA CITATIONS SUPPORTING REREGI8TRATION
GUIDELINE TITLE OF
CITATION STUDY
Product Chemistry cont'd
63 -9 Vapor pressure
63-10 Dissociation constant
63-11 Octonal/water partition
63-12 pH
63-13 Stability
Ecological Effects
71-1 (a) Acute avian oral - quail
71-2 (a) Acute avian dietary - quail
7 1-2 (a) Acute avian dietary - duck
72-1 (a) Fish toxicity - Bluegill
72-1 (b) Fish toxicity - Rainbow Trout
72-2 (a) Invertebrate toxicity
USE
PATTERNS

H
M
M
M
M

H
M
M
M
H
M
BIBLIOGRAPHIC
CITATION

41671203
41671203
41671203
41671203
41671203

41671701
41671702
41671709
41671710
41671703
41671704

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                                APPENDIX B

GENERIC DATA REQUIREMENTS FOR RERE6I8TRATION OF ALKYL AMINE RYDROCHLORIDB
               AND DATA CITATIONS SUPPORTING RERE6I8TRATIOM
GUIDELINE
CITATION
TITLE OF
STUDY
USE
PATTERNS
BIBLIOGRAPHIC
CITATION
Toxicology
81-1
81-2
81-5
81-6

82-2
82-3
83-3 (a)
84-2 (a)
84-2 (b)
84-4
Acute oral tox - rat
Acute dermal tox - rabbit
Primary dermal irritation
- rabbit
Dermal sensitization
t
21-day dermal - rabbit
90-day dermal - rodent
Teratogenicity - rat
Gene nutation - Ames
Structural chromosome
Other genotoxic effects
M
M
M
M

M
M
H
M
H
H
416717-05
416717-06
416717-07
416717-08

421343-01
417355-01
415376-01
415376-02
412871-01
412871-03
412871-02

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                  APPENDIX C
     Citations Considered to be Part of the Data Base
Supporting the Reregistration of Alkyl Amine Hydrochloride

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                         OFFICE OF PESTICIDE PROGRAMS
                    REREGISTRATION ELIGIBILITY DOCUMENT
                                  BIBLIOGRAPHY
 1.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
 Reregistration Eligibility  Document   Primary  sources  for  published literature  in this
 bibliography have been die body of data  submitted to EPA in support of past regulatory
- decisions.    *

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

 3.    IDENTIFICATION OF  ENTRIES.  The  entries in this  bibliography  are sorted
       numerically by Master Record Identifier, or MRID  number.  This number is unique to
       the  citation, and should be used  at any time specific reference is required.  It is not
       related to the six-digit "Accession Number" which has been used to identify volumes of
       submitted studies; see paragraph 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 also is 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 Agency could confidently identify one,  the Agency has
             chosen to show a personal author.  When no individual was identified, the
   '  •       Agency has shown an identifiable laboratory ortesting facility as author.  As a
             last resort, the Agency has shown the first submitter as author.

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

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

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

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

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

      (3)    Submitter.  The  third element is the submitter,  following the phrase
             "submitted by."   When 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, 123456-B; the 26th, 123456-Z; and the
             27th, 123456-AA.

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                                      OFFICE OF PESTICIDE PROGRAMS
                                 REREGISTRATION ELIGIBILITY DOCUMENT
                                               BIBLIOGRAPHY

412871-01   San, R.; Kruel, C. (1989) Salmonella/mammalian-microsome Plate Incorporation Mutagenicity Assay (Ames Test)
               with a Confirmatory Assay:  Cosan 635 Active:  Final Report: Lab Project Number: T8767.501014.
               Unpublished study prepared by Microbiological Associates, Inc. in cooperation with Cosan Chemical Co. 68 p.

412871-02   Curren, R. (1989) Unscheduled DNA Synthesis in Rat Primary Hepatocytes Cosan 635 Active:  Final Report:
               Lab Project Number: T8767.380. Unpublished  study prepared by Microbiological Associates, Inc. in
               cooperation with Cosan Chemical Corp. 27 p.

412871-03   Putinan, D.; Morris, M. (1989)  Chromosome Aberrations in Chinese Hamster Ovary (CHO) Cells: Cosan 35
               Active:   Final Report: Lab Study Number T8767.337.  Unpublished study prepared by Microbiological
               Associates, Inc. in cooperation with Cosan Chemical Corp. 28 p.

415376-01   Nemec, M. (1990) A Range-finding Developmental Toxicity Study of Alkyl Amine Hydrochloride in Rats: Lab
               Project Number: WIL-152001. Unpublished study prepared by WIL Research Laboratories, Inc. 205 p.

415376-02   Nemec, M. (1990) A Developmental Toxicity Study of Alkyl Amine Hydrochloride in Rats:  Lab Project
            •   Number:  WIL-152002.  Unpublished study prepared by WIL Research Laboratories, Inc. 316 p.

416712-01   Mahoney, D. (1990) Fungitrol 635W (p-alkyl amine hydrochloride):  Manufacturing Use Product Chemistry.
               Unpublished study prepared by Huls America, Inc. 29p.

416712-02   Mahoney, D. (1990) Fungitrol 635W (p-alkyl amine hydrochloride):  Manufacturing Use Product Chemistry.
               Unpublished study prepared by Huls America, Inc. 16p.                                    >

416712-03   Mahoney, D. (1990) Fungitrot 635W (p-alkyl amine hydrochloride):  Manufacturing Use Product Chemistry.
               Unpublished study prepared by Huls America, Inc. in cooperation with Midwest Research Institute. 4p.

416717-01   Campbell, S.; Hoxter, K. ; Smith, G. (1990) Nuosept (Cosan) 635W:  An Acute Oral Toxicity Study with the
               Northern Bobwhite Quail:  Lab Project Number: WIL 290-103. Unpublished study prepared by Wildlife
               International Ltd.  22 p.

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416717-02    Long, R.; Hoxter, K; Smith, G. (1990) Nuosept (Cosan) 635W: A Dietary LC» Study with the Northern
               Bobwhite Quail.  Lab Project No: WIL290-101. Unpublished study prepared by Wildlife International Ltd.
               17 p.

416717-03    Murphy, D.; Peters, G. (1990) Nuosept (Cosan) 635W: A 96-hour Plow-Through Acute Tenacity Test with the
               Rainbow Trout (Oncorhychus mykiss):  Lab Project No: WIL 290A-103A. Unpublished study prepared by
               Wildlife International Ltd.  22 p.

416717-04    Bellatoni, D.; Peters, G. (1990) Nuosept (Cosan) 63SW:  A 48-hour Flow-Through Acute Toxicity Test with the
               Cladoceran (Daphnia magna):  Lab Project No: WIL 290A-101.  Unpublished study prepared by Wildlife
               International Ltd.  21 p.

416717-05    Naas, D. (1990) Acute Oral Toxicity (LD^) Study in Albino Rats with Alkyl Amine Hydrochloride: Lab Project
               Number:  WIL 159001. Unpublished study prepared by WIL Research Laboratories, Inc.  103 p.

416717-06    Naas, D. (1990) Acute Dermal Toxicity (LD^) Study in Albino Rats with Alkyl Amine Hydrochloride:  Lab
               Project Number.  WIL 152003.  Unpublished study prepared by WIL Research Laboratories, Inc.  33 p.

416717-07    Naas, D. (1990) Primary Dermal Irritation Study in Albino Rabbits with Alkyl Amine Hydrochloride:  Lab Project
               Number: WIL 159002.  Unpublished study prepared by WIL Research Laboratories, Inc. 22 p.
                                         *
416717-08    Naas, D. (1990) Skin Sensitization Study in Albino Guinea-Pigs with Alkyl Amine Hydrochloride:  Lab Project
               Number: WIL 159003.  Unpublished study prepared by WIL Research Laboratories, Inc. 49 p.

416717-09    Long, R.; Hoxter, K; Smith, G. (1990) Nuosept (Cosan) 635W: A Dietary LC» Study with the Mallard:  Lab
               Project No:  WIL 290-102.  Unpublished study prepared by Wildlife International Ltd.  16 p.

416717-10    Murphy, D.; Peters, G. (1990) Nuosept (Cosan) 635W: A 96-hour Flow-Through Acute Toxicity Test with the
               Bluegill (Lepomis macrochirus):  Lab Project No: WIL 290A-102A. Unpublished study prepared by Wildlife
               International Ltd.  22 p.

417355-01    Naas, D. (1990) 90-day Dermal Study in Rats with Alkyl Amine Hydrochloride: Lab Project Number: WIL
               159007.  Unpublished study prepared by WIL Research Laboratories, Inc. 485 p.

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421343-01    Naas, D. (1990) Three Week Dermal Study in Rats with Alkyl Amine Hydrochloric: Lab Project Number.
               WIL 159004. Unpublished study prepared by WE, Research Laboratories, Inc. 160 p.

423131-01    Mahoney, D. (1992) Product Chemistry for Nuosept 63S-W Preservative (Chemical Idnetity):  Lab Project
               Number 920099.  Unpublished study prepared by Huls America! Inc. 8p.          ''

423131-02    Siemann, L. (1992)  Product Chemistry for Nuosept 63S-W Physical and Chemical Characteristics: Lab Project
               Number:  3049-F.  Unpublished study prepared by Midwest Research InsUtite. 25p.'

423326-01    Mahoney, D. (1992) Product Chemistry for Nuosept 635-W Preservative: Lab Project Number 920099.
               Unpublished study prepared by Huls America Inc. 4p.

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APPENDIX D




 FR Notice 91-2

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                 UNITED STATES ENVIRONMENTAL TOOT
                            WASHINGTON, &C. SM60
T10N AGENCY
                             WQTICE tl-2
              NOTICE TO MANUFACTURERS, PRODUCERS, FORMUIATORS,
                       AND REGISTRANTS OF PESTICIDES
            OFFBEOT
            «J« AND TOXIC
               INCES
 ATTENTION:   Persons Responsible for* Federal Registration of
             Pesticide products.

 SUBJECT:     Accuracy of Stated Percentages for.Ingredients
             Statement
 I.   PURPOSE:
     The  purpose  of this  notice is  to clarify the  Office of
 Pesticide  Program's  policy  with respect  to  the  statement of
 percentages   in  a  pesticide's  label's  Ingredient  statement.
 Specifically,  the  amount  (percent  by weight)  of  ingredient(s)
 specified in the  ingredient statement  on the label Bust be stated
 as the nominal concentration of such ingredient (s), as that term is
 defined  in  40   CFR 158.153 (i).  Accordingly,  the Agency  has
 established the nominal concentration as the only acceptable label
 claim for the amount of active ingredient in the product.

 II.  BACKGROUND

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

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

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                              3.
 IV.  PRODUCTS THAT REQUIRE EFFICACY DATA

      All pesticides are required to be efficacious.  Therefore,
 the certified lower limits say not be lover then the minimum
 level to achieve efficacy.  This is extreaely important for
 products which are intended to control pests which threaten the
 public health,  e.g., certain antimicrobial and rodanticide
 products.  Refer to 40 CFR 158.640.

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

 V.   COMPLIANCE SCHEDULE

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

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

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

          (3)   All other products/applications that are
                not subject to (1) and (2) above will have until
                July 1, 1997,  to comply with this Notice.
                Such applications should note •Conversion
                to Nominal Concentration" on the application
                form. These types of amendments will not be
                handled as "Fast Track" applications but
               will be handled as routine requests.
       ". *^*          •               *
VI.  FOR FURTHER INFORMATION

  •  Contact Tyrone Aiken for information or questions concerning
this notice  en (703) 557-5024.
                                Anne E. Lindsay, Director
                                Registration Division (H-7505

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      APPENDIX E
Pesticide Registration Handbook

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-------
    APPENDIX F
Product Specific Data Call-in

-------

-------
                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                           WASHINGTON, D.C. 80460
                       DATA CALL-IN NOTICE
 CERTIFIED MXIL
   OFFICE OF
«8TCOES AtC TOXIC
  SUBSTANCES
 Dear Sir or Madam:
 This Notice requires you and other registrants of pesticide
 products  containing the active ingredient identified in
 Attachment A of this Notice,  the Data  Call-In Chemical status
 sheet..to submit certain 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 must respond as set forth
 in Section III  below.   Your response must state:

      1. Mow you will comply with the requirements set forth in
        this Notice and its Attachments  A through G; or

      2. Why you believe you are exempt from the requirements
        listed  in this  Notice and in Attachment C,
        Requirements Status and Registrant's Response Pornl (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 III-D).

      If you do  not  respond to this Notice,  or if  you do not
 satisfy EPA that you will comply with  its requirements or should
 be exempt or excused from doing so,  then the registration of your
 product(«)'"• 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 B,  Data  Call-in Response Fora,  as well as a
 list  of all registrants who were sent  this Notice (Attachment F).

      The  authority  for  this Notice is  section 3(c)(2)(B)  of the
 Federal Insecticide, Fungicide and Rodenticide Act as amended
 (FIFRA),  7  U.S.C. section I36a(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 sections and seven
 Attachments.   The Notice itself contains information and
 instructions  applicable to all Data Call-In Notices.  The
 Attachments contain specific chemical information and
 instructions.  The six sections of the Notice are:
      Section Z
      Section ZZ
      Section ZZZ
              Why You Are Receiving This Notice
              Data Required By This Notice
              Compliance With Requirements Of This
              Notice
Section XV  - 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
B
C
D

E
F
G
        -  Data  Call-in Chemical Status
        -  pata  Call-In Response fora
        -  Requirements Status and Registrant's Response Fora
        -  %PA Grouping of End-Use Products for fleeting Acute
           Toxicology pata Requirements for Rereaist^ratlon
           EPA Acceptance Criteria
        -  List  of Registrants Deceiving This Notice
        -  Cost  Share and Data Compensation Forms, and Product
           Specific Data Report Form
SECTION I.  KHY YOU ARE RECEIVING THIS NOTICE

     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 II.  pATA REQUIRED BY THIS 1TOTICE

II-A.  PATA ESQUIRED
         *
     •The product specific data required by this Notice are
specified in Attachment C, RequirementsStatus and Registrant * s
Response Form.  Depending on the results of the studies required in
this Notice, additional testing may be required.

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II-B.
                      UBMISSION OF DATA
      You are required to submit the data or otherwise satisfy the
 data requireaents specified in Attachment C, Requirements status
 and Registrant's Response Perm, vithin the timefraaes provided.


 II-C.  TESTING PROTOCOL

      All studies required under this Notice must be conducted in
 accordance with test standards outlined in the Pesticide Assessment
 Guidelines for those studies for which guidelines have been
 established.
    »*
    '- These EPA Guidelines are available from the National Technical
 Information Service (NTIS) , Attn: Order Desk, 5285 Port Royal Road,
 Springfield, Va 22161 (tel: 703-487-4650).

      Protocols approved by the organization for Economic
 Cooperation and Development (OECD)  are also acceptable if the OECD-
 recommended test standards conform to those specified in the
 Pesticide Data Requirements regulation (40 CFR f 158.70).  When
 using the OECD protocols, they should be modified as appropriate so
 that the data generated by the study will satisfy the requirements
 of 40 CFR § 158.  Normally, the Agency will not extend deadlines
 for complying with data requirements when the studies were not
 conducted in accordance with acceptable standards.  The OECD
 protocols are available from OECD,  1750 Pennsylvania Avenue N.W. ,
 Washington, D.C. 20006.

   •   All new studies and proposed protocols submitted in response
 to this Data Call-in Notice must be in accordance with Good
 Laboratory Practices [40 CFR Part 160. 3 (a) (6) ].

 II-D.   REGISTRANTS RECETVTNC PREVIOUS SECTION 3feW21fBl NOTICES
        ISSUED BY THE AGENCY

        Unless otherwise noted herein, this Data Call-in does not in
 any  wav supersede or change the requirements of any previous pat a
 Call-infal . or any "other agreements entered into with the Agency
 pertaining to such prior Notice.  Registrants must comply with the
 requirements of all Notices to avoid issuance of a Notice of Intent
 to Suspend their affected products.
SECTION III.  COMPLIANCE WTTft REQUIREMENTS OF THIS NOTICE

III-A.  SCflEp    FOB pESPOWDINC TO TffE ACENg
     The appropriate responses initially required by this Notice
for product specific data must be submitted to the Agency within 90
days after your receipt of this Notice.  Failure to adequately
respond to this Notice within 90 days of your receipt will be a
basis for issuing a Notice of Intent to Suspend (NOIS) affecting

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 your products. This and other bases for issuance of HOIS due to
 failure to comply with this Notice are presented in Section IV-A
 and IV-B.

 III-B.  OPTIONS TOR RESPONDINC TO TUB AGZWCY

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

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

     There are two forms 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
 Fora, and the Requirements status and Registrant's Response Fora.
 Attachment B and Attachment C.  The Data Call-in Response Form must
 be submitted as part of every response to this Notice.  In
 addition, one copy of the Requirements Status and Registrant's
 Response Form  must be submitted for each product listed on the
 Data Call-%n Response 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 Response Form and Requirements Status and Registrant's Response
 Form (if this form is required}  and initial any subsequent pages.
 The forms contain separate detailed instructions on the response
 options.  Do not alter the printed material.  If you have questions
 or need assistance in preparing your response, call or write the
 contact person(s)  identified in Attachment 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. flf you wish to voluntarily cancel your product,  you must
 submit a completed Data Call-in Response Form, indicating your
 election of this option.   Voluntary cancellation is item number 5
 on the Data Call-in Response Form.  If you choose this option, this
 is the only form that you are required to complete.

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

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     2. Satisfying* •the Product Specific Data  Requirements of this
          There are various options available to satisfy the product
 specific data requirements of this Notice.   These options are
 discussed in Section ZII-C of this Notice and comprise options 1
 through 6 on the Requirements Status and Registrant's ResponseForrp
 and item numbers 7a and 7b on.the Data Call-In R»»ponga Fora.
 Deletion of a use(s) and the low volume/minor use option are not
 valid options for fulfilling product specific data requirements.

     3. Request for Product Specific Data Waivers.  Waivers for
 product specific data are discussed in Section ZZZ-D of this Notice
 and are covered by option 7 on the Requirements Status and
 Registrant's Response Form.  Zf you choose this option, you must
 submit both forms as well as any other information/data pertaining
 to the option chosen to address the data requirement.

 ZZI-C  SATISFYING THE DATA REQUIREMENTS OF THIS NQTIC^

      Zf you acknowledge on the Data Call-In  Response Form that you
 agree to satisfy the product specific data requirements (i.e. you
 select option 7a or 7b), then you must select one of the six
 options on the Requirements Status and Reoistrpnt * s Response Form
 related to data production for each data requirement.  Your option
 selection should be entered under item number 9, "Registrant
 Response."  The six options related to data  production are the
 first six options discussed under item 9 in  the instructions for
 completing the Requirements Status and Registrant's Response Fora.
 These six options are listed immediately below with information in
 parentheses to guide registrants to additional instructions
 provided in this Section.   The options are:
        ^
      (1)   I will generate and submit data within the specified
           timeframe (Developing Data)
      (2}   Z 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 am 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 am-citing an existing study that EPA has classified as
           acceptable or  an existing study that has been submitted
           but not reviewed by the Agency (Citing an Existing Study)

     Option 1.  Developing  Data —  Zf you choose to develop the
 equired data it must be in conformance  with Agency deadlines and
 1th other Agency requirements as referenced herein and in the
attachments.  All data generated and submitted must comply with the
Good Laboratory Practice (GLP)  rule (40  CFR  Part 160), be conducted
according to the Pesticide  Assessment Guidelines (PAG), and be in
conformance with the requirements of PR Notice 86-5.

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     The tine frames in the Requirements status and Reentrant '5
 Response Porn are the time 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 (s) .

     If you cannot submit the data/reports to the Agency in the time
 required by this Notice and intend to seek additional time to meet
 the requirements (s),  you must submit a request to the Agency which
 includes:  (1)  a detailed description of the expected difficulty and
 (2)  a proposed schedule including alternative dates for meeting
 such requirements on a step-by-step basis.  You must explain any
 technical  or laboratory difficulties and provide documentation from
 the laboratory performing the testing.  While EPA is considering
 your request,  the original deadline remains.  The Agency will
 respond to your request in writing.  Zf 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 hot
 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 . Agree to Share in Cost to Develop Qa^a —Registrants
may pnly choose this option for acute toxicity data and certain
efficacy data anfl only if EPA has indicated in the attached data
tables that your product and at least one other product are similar
for purposes of depending on the same data.  If this is the case,
.data may be generated for just one of the products in the group.
The registration number of the product for which data will be
submitted aus£ be noted in the agreement to cost share by the
registrant selecting this option.  If you choose to enter into an
agreement to share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name
of the registrant Jrfho will be submitting the data.  You must also
provide EPA with documentary evidence that an agreement has been
formed.  Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a
written statement by the .parties that an agreement exists.  The
agreement to produce the data need not specify 'all of the terms of
the final arrangement between the parties or the mechanism to
resolve the terms.  Section 3(c)(2)(B)  provides that if the parties
cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.


    Option 3.  Offer to Share in 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

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 unsuccessful,  you may request EPA (by selecting this option) to
 •xcrcise its discretion not to suspend your registration(s),
 although you do not comply with the data submission requirements of
 this Notice.  EPA has determined that as a general policy, absent
 other relevant considerations, it vill not suspend the registration
 of a product of a registrant who has in good faith sought and
 continues to seek to enter into a joint data development/cost
 sharing program, but the other registrant(s) developing the data
 has refused to accept your offer.  To qualify for this option, you
 must submit documentation to the Agency proving that you have made
 an offer to another registrant (who has an obligation to submit
 data) to share in the burden of developing that data.  You must
 also submit to the Agency a completed EPA Form 8570-32,
 Certification of Offer to Cost Share in the Development of Data,
 Attachment G.   In addition,  you must demonstrate that the other
 registrant to whom the offer was made has not accepted your offer
 to enter into a costsharing agreement by including a copy of your
 offer.and proof of the other registrant's receipt of that offer
 (such as a certified mail receipt).  Your offer must, in addition
 to anything else,  offer to share in the burden of producing the.
 data upon terms to be agreed 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-Tn Response
 Form and a Requirements Status and Registrant's Response Form
 committing to  develop and submit the data required by this Notice.

     Zn order for you to avoid suspension under this option, you may
 not •withdraw your  offer to share in the burdens of developing the
 data.   Zn addition,  the other registrant must fulfill its
 commitment to  develop and submit the data as required by this
 Notice.   Zf the other registrant fails to develop the data or for
 some other reason  is subject to suspension, your registration as
 veil as  that of the other registrant vill 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 vill not grant a time extension
 for submitting the data.

     Option 4,  ^ubaittina an  Existing Study — Zf you choose to
 submit an existing study in  response to this Notice, you must
 determine that the study satisfies the requirements imposed by this
 Notice.   You may only submit a study that has not been previously
 submitted to the Agency or previously cited by anyone.   Existing   .
 studies  are  studies vhich predate issuance of this Notice.  Do not
 use this option if you are submitting data to upgrade a study. (See
 Option 5).

    You  should be  avare that if the Agency determines that the
 study  is  not acceptable,  the Agency vill require you to comply vith
this Notice, normally vithout an extension of the required date of
 submission.  The Agency may determine at any time that a study is
not valid and needs to be repeated.

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                                 8

    To meet the requirements of the OCX Notice for submitting an
existing Study, all of the following three criteria must be clearly
    a. You must certify at the tine that the existing study is
    submitted that the raw data and specimens from the study are
    available for audit and review and you must identify where they
    are available.  This must be done in accordance with
    the requirements of the Good Laboratory Practice (GLP)
    regulation, 40 CFR Part 160.  As stated in 40 CFR 160.3(j)
    * '[r]aw data* means any laboratory worksheets, records,
    memoranda, notes,  or exact copies thereof, that are the result
    of original observations and activities of a study and are
    necessary for the reconstruction and evaluation of the report
    of that study.  In the event that exact transcripts of raw data
   •have been prepared (e.g.,  tapes which have been transcribed
    verbatim, dated,  and verified accurate by signature}, the exact
    copy or exact transcript may be substituted for the original
    source as raw data.   'Raw data1 may include photographs,
    microfilm or microfiche copies, computer printouts, magnetic
    media,  including dictated observations, and recorded data from
    automated instruments."  The term "specimens", according to 40
    CFR 160.3(k),  means "any material derived from a test system
    for examination or analysis."

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

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

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                                  9

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

     Zf you know of a study pertaining to any requirement  in this
 Notice which does not meet the criteria outlined above but does
 contain factual information regarding unreasonable adverse effects,
 you must notify the Agency of such a study.   Zf such study is in
 the Agency's files, you need only cite it along with the
 notification. Zf not in the Agency's files,  you must submit a
 summary and copies as required by PR Notice  66-5.
            *                v

    . Option S. tJpqradino a study — Zf a study has been classified
 as partially acceptable and upgradeable, you may submit data to
 upgrade that study.  The Agency will review  the data submitted and
 determine if the requirement is satisfied.   Zf the Agency decides
 the requirement is not satisfied, you may still be required to
 submit new data normally without any time extension. Deficient,
 but upgradeable studies will normally be .classified as
 supplemental.  However, it is important to note that not  all
 studies classified as supplemental are upgradeable.  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*  Zf 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 KRXD 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 KRXD 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  6f giting Existing  gtuples — Zf you choose to cite a
study that  has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency.  Acceptable

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                                 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 must provide the Agency's
rclassification of the study.

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

..  .-•  Registrants who select one of the above 6 options  must meet all
 of the requirements described in the instructions for  completing
 the Data Call-In Response Form and the Requirements ,.S;tatus and
 Registrant's Response Form, as appropriate.

 III-D  REQUESTS FOR PATA WAIVERS

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

 IV.   CONSEQUENCES OF FATLDRE TO COMPLY WITH THIS  NQfTCE

 IV-A NOTICE OF INTENT TO SUSPEND

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

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                                 11

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

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

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

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

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

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

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

     8. Failure of the registrant to whom you have tendered an offer
     to, share  in the cost of developing data and provided proof of
     the registrant's receipt of such offer either to:

      a.  Inform EPA of intent to develop and submit the data
      required by this Notice on a  Data Call-in Response Form and a
      Requirements Status and Registrant's Response 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 Notice,  unless  you commit to submit and do
    submit the.required data in the specified time frame.

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

    3.   BASIS  FOR DETERMINATION THAT SUBMITTED STUDY IS
    The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for

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                                 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 effect  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  B6-5.  All studies must be submitted
     in the form  of a final report;  a preliminary report  will not be
     considered to fulfill  the  submission requirement.

 IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

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

     The  Agency has determined  that  such disposition by registrants
 of  existing stocks for  a suspended  registration when a section
 3(c)(2)(B)  data request  is outstanding would generally not be
 consistent with the Act's purposes.  Accordingly, the Agency
 anticipates granting registrants permission to cell, distribute, or
 use existing-stocks of suspended product(s)  only in exceptional
 circumstances.  Zf 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

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                                 13

 all Agency requirements,  you will  have,  under most circumstances,
 one year from the date your 90 day response to  this Notice is due,
 to sell, distribute,  or use existing stocks.  Normally, the Agency
 vill allow persons other  than the  registrant such as  independent
 distributors, retailers and end users to sell,  distribute or use
 such existing stocks  until the stocks are exhausted.  Any sale,
 distribution or use of stocks of voluntarily cancelled products
 containing an active  ingredient for which the Agency  has particular
 risk concerns yill.be determined on a case-by-case basis.
     Requests for voluntary cancellation received alifir 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 unless you demonstrate to the Agency that you are  in full
 compliance with all Agency requirements, including the requirements
 of this Notice.  For example, if you decide to voluntarily cancel
 your registration six months  before a 3 year study is  scheduled to
 be submitted,  all progress reports and other information necessary
 to establish that .you have been conducting the study in an
 acceptable and good faith manner must have been  submitted to the
 Agency,  before EPA will consider granting  an existing  stocks
 provision.
SECTION V.  REGISTRANTS' OBLIGATION TO REPORT
            UNREASONABLE ADVERSE EFFECTS

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

    Zf you' have any questions regarding the requirements and
procedures established by this Notice,- call the contact person(s)
listed in Attachment A, the Data Call-in Chemical status Sheet.

    All responses to this Notice (other than voluntary cancellation
requests) must include a completed Data Call-In Response Form and a
I completed Requirements Status and Registrant's ResponseForm
(Attachment B and Attachment C) and any other documents required by
this Notice, and should be submitted to the contact person(s)
identified in Attachment A. If the voluntary cancellation option is
chosen, only the pataCall-in Response Fern need be submitted.

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                                14
    The Office of Conpliance Monitoring (OCM)  of the Office of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data being generated in response to this Notice.
                             Sincerely yours.
    A  •
    B  -
    C  •
    D  -

    E -
    F  •
    G  -
                   ..Daniel M. Barolo, Director
                  ,'•• Special Review and
                      Reregistration Division

               Attachments

Data Call-in Chemical Status Sheet
Data Call-in Response Form
Requirements Status and Registrant's Response Fora
EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements f017 Rereaistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product:
Specific Data Report Form

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 ATTACHMENT A
Chemical Status Sheet

-------
                                ATTACHMENT A

  ALKYL AMINE HYDROCHLORIDE DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

      You have been sent this Data Call-In Notice because you have products containing
alkyl arnine hydrochloride.

      This attachment, the Paia yaj'-in Chemical Status Sheett 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 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 NoticeT 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 Alkyl Amine Hydrochloride  Data Call-in. Instructions and  guidance
accompany each form.

DATA REQUIRED BY THIS NOTICE

      The Agency has concluded that product specific data are needed for alkyl amine
hydrochloride.  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 Karen Leavy at (703) 305-6966. All
responses to this Notice should be submitted to:

               Document Processing Desk (RED/RD/PM-31)
               Office of Pesticide Programs
               U.S. Environmental Protection Agency
           -    401 M Street S.W.                             .
               Washington, D.C. 20460'

               RE: Alkyl amine hydrochloride


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      If you have any questions regarding this Notice, please contact Betty Crompton at
(703) 308-8067.  All responses to this Notice should be submitted to:

               Chemical Review Manager Betty Crompton
               Accelerated Registration Branch (H7508W)
               Special Review and Reregistration Division
               Office of Pesticide Programs
               U.S. Environmental Protection Agency
               401 M Street S.W.
               Washington, B.C. 20460

               RE: Alkyl amine hydrochloride

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                  ATTACHMENT B

PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
                PLUS INSTRUCTIONS

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Page  1 of  1
United States Environmental Protection Agency Fora Approved
Washington, D. C. 20460 «« NO. 2070-0107
DATA CALKIN RESPONSE ^^ ^ ^^
INSTRUCTIONS: Please type or print In ink. Please read carefully the attached instructions and supply the information requested on this fora.
Use additional sheet(s) If necessary.
1. Company name and Address 2. Case * end Name 3. Date and Type of OCI
HULS AMERICA, INC. 3051 (Coco alkyl ) amine salts PRODUCT SPECIFIC
BOX 365
PISCATAWAY NJ 08855
4. EPA Product
Registration
1100-84
5. I wish to
cancel this
product regis-
tration volun-
tarily.

6. Generic Data
6a. 1 am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.

6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached fora entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product la a HUP and
1 agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."


7b. Ny product 1 s an EUP end
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

8. Certification 9. Date
1 certify that the statements nade on this fora and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number

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Page 1 of 1
United States Environmental Protection Agency form Approved
Washington, D. C. 20460 <« NO. amnnor
DATA CALL-IN RESPONSE ^{ ^ ^^
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this fora.
Use additional sheet(s) if necessary.
1. Company name and Address 2. case f and Name 3. Date and Type of OC1
HULS AMERICA, INC. 3051 (Coco alkyl)araine salts PRODUCT SPECIFIC
BOX 365
PISCATAWAY NJ 08855
4. EPA Product
Registration
1100-85
S. 1 wish to
cancel this
product regis-
tration volun-
tarily.

6. Generic Data
6a. 1 am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.

6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a NUP and
I agree to satisfy the NUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."


7b. My product is an CUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

8. Certification 9. Date
I certify that the statements made on this form and alt attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable Ian.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number

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Page  1 of
United States Environmental Protection Agency < For* Approved
Washington, D. C. 20460 ' ONB NO. 2070-0107
DATA CALKIN RESPONSE ^^ ^ ^^
f
INSTRUCTIONS: Please type OP print in ink. Please read carefully the attached instructions and supply the information requested on this fom.
Use additional sheet (s) If necessary.
1. Company name and Address 2. Case * and Name 3. Date and Type of OCI
CARROLL COMPANY 3051 (Coco alkyl)amine salts PRODUCT SPECIFIC
2900 W. KINGSLEY RD.
GARLAND TX 75041
*. EPA Product
Registration
4313-37
5. 1 wish to
cancel this
product regis-
tration volun-
tarily.

6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
fro* the source EPA regis-
tration number listed below.
N.A.
fib. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. Hy product is a HUP and
1 agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."


7b. Ny product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

8. Certification 9. Date
1 certify that the statements nade on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact It- Phone Number

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'•*A

-------
                       ATTACHMENT C

PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
                 (FORMS B) PLUS INSTRUCTIONS
                           AND
                       PR NOTICE 86-5

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                                                                                                                 Page   1 of  3,
                        United States Environmental Protection Agency
                                       Washington,  D.  C.  20460
                        REQUIREMENTS  STATUS  AND REGISTRANT'S RESPONSE
                                                                                           Fora Approved

                                                                                           0KB No. 2070-0107

                                                                                           Approval Expires 12-31-92
INSTRUCTIONS: Please'type or print in fnk.  Please read carefully the attached instructions and supply the information requested on this fora.
Use additional sheet(e) if necessary.
1. Company name and Address
  CARROLL COMPANY
  2900 W.  KINGSLEY RD.
  GARLAND TX   75041
                                2. Case f and Name
                                   3051   (Coco  alkyl)amine salts

                                   EPA Reg.  No.  4313-37
                                        3. Date and Type of DC1
                                          PRODUCT  SPECIFIC
                                          ID# 4313-RD-1910
4. Guideline
Requirement
Ninocr
5. Study Title
Progress
Reports
                                                6. Use
                                                Pattern
                                                                     7. Test
                                                                     Substance
8. Tin
Fr
9. Registrant
Response
                   Prod
        -Regular Chemical
61-1
                      production ft formulation
                   ' -•         *
61-2(b)
J-"Uv' - ,
62-1
             j*  \ ***
62-3
'63-2
63-3
63-4'
63-7
63-1?
63-14
  Product identity ft compost tton(1)
 " Desert? o* starting
                       (1,3)

                       (1.4)
                       (1,5)
                       (1)
Density

Oxidizing or reducing action (10)
        ABCDEPGHIjMNO
        ABCDEFGHIJKLMNO
                                                                     ff
                                                                   EP
                                                                                                 ,
                                                                                          8 mos.
  Discussion of formation of
'? \^ Impurities,^ - ' \' *
  Preliminary analysis
* 'Certification of Halt*
  Analytical method
A' Color "f^ ^ ' ^ ^" C"f"
  Physical state
                                                ABCDEFGHIJKLMNO

                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                                                ABCDEFGHIJKLMNO
                            BP ^ ^_ ^J^
                             ",-.*• "*N^^^j"1^*,? ;t""t^s
                              -
                            EP
                            gp'
                            EP
                            Jip.

                            EP
                            EjP
                            EJp
  8 mos.

  8 mos.

  8 mos.

  8 mos.
                                                                                          8 mos.
                                                                                       '',8^08^!
                                                                                          8 mos.
10. Certification
I certify that the statements made on this fora and all attach
I acknowledge that any knowingly false or misleading statement
or both under applicable law.
Signature and Title of Company's Authorized Representative
                            iments are true, accurate, and complete.
                             may be punishable by fine, imprisonment
                                                                             11. Date
12. Name of Company Contact
                                                                             13. Phone Number

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Page  2 of
United States Environmental Protection Agency
Washington, D. C. 20460
'. REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions end supply the information requested
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case f and Name
CARROLL COMPANY 3051 (Coco alkyl)amine salts
2900 W. KINGSLEY RD.
GARLAND TX 75041 EPA Reg. No. 4313-37
4. Guideline
Requirement
Number
63-16 * "
63^17 :*'*VT~
63-18
63-19 ~\'^ *'?*'
63-20
' S'o -I "*<, "• , i. „
81-2
^•f s-' j"t •• >•* < yf A-H/
% V" ; x , " -
81-3
81*4 - ^'v-; "r
81-5
6 »4 ^it' ' * ' " ^
OJL— V ^ i ^
^' '^ ,• * •- •• $• ^Trt'-
''•• ..
!>''•. « ' , "t >
5. Study Title
^ ^ w* ^ * > * f^\ v-i* '5 •; ' •• L ^ "" v ^ v />4,ri«B«P»DT«>tTy^ ^ *•* j^\ s v , / \»Tj ^ ^
ExplodabUity (12)
^78tor*g« itaWUiiy " 'v<;~'' " ^15) ^i""
Viscosity (13)
Corrosion characteristics
Jteute'fo^l tf^ fteafiiaf "ijneartfB^ ' ' ""* *" • "
^'Acu^Vr.1' bxici^rat ' ^^(1,36,37> V
Acute dermal (1,2,37)
Acute Inhalation toxlcity-rat (3)
Primary eyelfritatfon-rabbit (2)
Primary dermal Irritation (1,2)
'' ,. p^mui swtsiTiZfttfoti C^J
tf f icacv - Amfiirtcrobfot ^9en^» - Pub^fc "
Health Usca
* > ~* '•
-.;•"•""••, '
Miscellaneous Indoor Hard

\
>.

2
"•?,
•"'fv
••<
3
'" •£
^vv s ^
6. Use
Pattern
ABCDEFGHIJKLKHO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
* * 't
ABCDEFGHlJKLWNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
' * •» S*- %
Initial to indicate certification as to information on this page
(full text of certification Is on page one).
"
'
7. Test
Substance
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-9!
on this fora.
3. Date and Type of DC!
PRODUCT SPECIFIC
IDf 4313-RD-1910

.pfc^'t^oyift^ "<1!'?|^^»''
gp ' ^' " J
EP
EP' "*' "
Sim *f>'* ^^ '- T4
BiF"/ ',x o
EP~«,~,«^v
EP"
»*'-'- s^x^:
EP
Epr-;' --•




V S "*
ys>y \"~ ••*•
/ '"' v
^ " 1 /
* iA
•• ^ jrt
J
8. Time
Frame
8 mos.
8 mos.
8 mos.
\ M s .fc^jiVIS^ f^f'
"• £ ^% jHTjBi •> '
8 mos.
X" ' ,' '\ '
8 mos.
8 mos.
v >•
»^VN + ••''-;;
9. Registrant
Response
>y$*%<*{ \ ^
i'' ;':'/ <:
Vftf ™~',S'-^'5C*' '
Date

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Page  3 of  3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print In Ink. Please read carefully
Use additional sheet(s) If necessary.
l» COffipOfiy FMM6 MM Adur6S$
CARROLL COMPANY'
2900 W. KINGSLEY RD.
GARLAND TX 75041
4. Guideline
Requirement
Number
91-2
S. Study Title
?
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                                                                                                  Page  1 of	1
                              United states Environmental Protection Agency
                                          Washington,  D. C.  20460
                         LIST OF ALL REGISTRANTS  SENT THIS DATA CALL-IN NOTICE
                             Case  f and Name:  3051   (Coco alkyl)amine salts tV
Co. Nr.   Company Name
Additional Name
Address
City  &  State
Zip
001100      HULS AMERICA, INC.
004313      CARROLL COMPANY
                       BOX 365
                       2900 V. KINGSLEY RO.
                      PISCATAWAY NJ
                      GARLAND TX
                     08855
                     75041

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                                                                                                                Page   1 of
                     I
                        United States Environmental  Protection Agency
                                       Washington,  D. C.  20460

                        REQUIREMENTS  STATUS AND  REGISTRANT'S RESPONSE
                                                                                          Font Approved

                                                                                          OMB No. 2070-0107

                                                                                          Approval Expires 12-31-92
INSTRUCTIONS: Please type or print In Ink. Please read carefully the
Use additional sheet(s> if necessary.
                                  attached instructions and supply the Information requested on this form.
1. Company name and Address
  HULS AMERICA,  INC.
  BOX  365
  PISCATAWAY NJ   08855
                                  Case # and Name
                                  3051   (Coco alkyljamine  salts

                                  EPA Reg.  No.  1100-84
                                                         3. Date and Type of DCI
                                                          PRODUCT  SPECIFIC
                                                          ID#  1100-RD-1908
4. Guideline
Requirement
Number
5. Study Title
                 Progress
                 Reports
 6. Use
 Pattern
7. Test
Substance
                   8. Time
9. Registrant
Response
61-1
61-2(A)
61-2(b)
   •L «•  •,  C
62-1
62-2; -<'
62-3
63-2 " ;
63-3
63-4
63-7
63-12
63-14
Prod Chm - Regular Chemical


  Product Identity I eompositiond)
  Descrfp of starting (Bat*ri«l8,(1(2)
   production ft formulation
 (1,3)


 (1,4)
-(1,5)
 (1)
 Discussion of formation of
  „ 1mpuHtt«e ,
 Preliminary analysis
 v Certification o* Unit* "
 Analytical method
 Color  -  '     v -J
 Physical  state
 Odor ' ~*  »-^s-r->,
        ""       i     •. s
 Density
 Oxidizing or reducing action (10)
                         ABCDEFGHIJKLMNO
                         ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO

ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
                    EP
                    8  fflOS.
EP

EP

EP

EP

EP
                                                           <*% V
                                            EP
                    8  mos.
                 N.JV.V.  rt V>v < « ^
                   •-  ! /u^   < '
                    B  mos.
                    »'  jne«;!
                    8  mos.
                   :s  aos
                    8  mos.
                   'smoB
                    8  mos.
                   ^8va6s
                    8  mos.
10. Certification
I  certify that the statements made on this form and alt attachments at
I  acknowledge that any knowingly false or misleading statement may be
or both under applicable law.

Signature and Title of Company's Authorized Representative	
                                  •e true, accurate, and complete.
                                  punishable by fine,  imprisonment
                                                                            11. Date
12. Name of Company Contact
                                                                            13. Phone Number

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Page 2 of _3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
l
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the Information requested
Use additional sheet (8) If necessary.
1. Company name and Address 2. Case * and Name
HULS AMERICA, INC. 3051 (Coco alkyl)anine salts
BOX 365
PISCATAWAY NJ 08855 EPA Reg. No. 1100-84
4. Guideline
Requirement
Nu*er
63-16 ^ 	 [ ^
63-18
63-20 ^
ai-i\ *-:'•' - r*
81-2
•» "" "•' ^ "" S
81-3
81-4 :*v , \ -
81-5
8l~6 / ; ' /'; '
' * < T
5. Study Title
^-fVammsbltfiY""""-; *, " \ (11)'-' -"
Explodablllty (12)
Viscosity (13)
Corrosion characteristics
^1b1elecfcrlt%1wB«kd6t "'," '"
> - • - i '•• ••
wv*M*%>wt ff w. s^. v • V y^ f ^ f>. ?•, -A> f ^ f f v
: Acute oral tO«!icfty*rat ' (1, 36,37)
Acute dermal (1,2,37)
-" twc{c1ty:rabbn/fat ^ "' -h
Acute Inhalation toxiclty-rat (3)
' Primary eye IrrltatfWrabbit t2> ,
Primary denial Irritation (1,2)
; Dermal sensft (cation (4)
ffflcacv - Ahtfarfcrobfai Aoents - Public
Health uses
Miscellaneous Indoor Hard

\
-
Progress
Reports
1
-X
•• x
v %•!:
i
2
•i v
At"
•• -^ t
ff ^
3
< %
•,
fr fftf
;"*
Vl \
•,
f **•*
•j
6. Use
Pattern
ABCD£FGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMKO
ABCDEFdHtJKLMNO
ABCDEFGHIJKLMNO
*. c\ •*
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLHN0
^ •• /
s •> ' /
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
EP>">U;'/-
EP^^^ ^_
BP"
El* ,TT5"C vP
EP_^
BP^T— -
EP
EP "
W\" T
EP
f n, -,Wf V#A f f
^ f&f- "*• -
t V f ",
•C
Form Approved
OHB No. 2070-0107
Approval Expires 12-31-92
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 1100-RD-1908

*•,'**- ^*/i
.# A* V ^S3^/C <&•
$ ffVt. ^^VV ,.
•.4fvn ^g., ,
^•s / A *,

8. Time
Frame
8 nos .
8 nos.
8 nos.
8 nos.
: 'W^J!'"
8 nos.
8 mos.
>-.F „ ,

,•*- ^ ' , .,,'•

9. Registrant
Response
**$W$l>Wf v,
** \ '
"'*" V % f**\ ft * v
V ft WJ f V»V -A ^ •. ^ A

s ""'-r**

Date

-------

-------
                         United  States  Environmental  Protection  Agency
                                        Washington,  D. c. 20460

                         REQUIREMENTS STATUS AND  REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in Ink.  Please read carefully the attached instructions end supply the Information requested on thia for*.
Use additional aheetCa) If necessary.
                                                                                               Page   3 of  3

                                                                                            Font Approved

                                                                                            OMB No. 2070-0107

                                                                                            Approval Expires 12-31-92
1. Company name and Address
  HULS AMERICA,  INC.
  BOX 365
  PISCATAWAY  NJ   08855
                                2. Case f and Name
                                   3051   (Coco alkyl)amine  salts

                                   EPA Reg. No.  1100-84
                                                         3. Date and Type of DCI
                                                           PRODUCT SPECIFIC
                                                           ID#  1100-RD-1908
4. Guideline
Requirement
Winter
5. Study Title
                Progress
                Reports
6. Use
Pattern
 7. Test
 Substance
8. Time
frame
9. Registrant
Response
91-2
  Self-sanitizing test
(1.2)
              LMNO
EP
  8 BIOS,
initial to indicate certification as to information on this page
(full text of certification is-on page one).
                                                                                   Date

-------

-------
                        United States Environmental  Protection  Agency
                                       Washington,  D. C. 20460
                        .REQUIREMENTS  STATUS  AND REGISTRANT'S RESPONSE
                        .
                                                                                                                 Page   1 of  3
                                                                                                              Form Approved
                                                                                                              OMB No. 2070-0107
                                                                                                              Approval Expires 12-31-92
INSTRUCTIONS: Please type or print In Ink.  Please read carefully the attached instructions and supply the Information requested on this form.
Use additional aheet(s) if necessary.
1. company name and Address
  HULS AMERICA, INC.
  BOX  365
  PISCATAWAY NJ   08855
                                                   2. Case * and Name
                                                     3051   (Coco  alkyl)amine salts

                                                     EPA  Reg.  No.  1100-85
                                                                                 3. Date and Type of DCI
                                                                                   PRODUCT SPECIFIC
                                                                                   ID#  1100-RD-1909
4. Guideline
Requi rement
Number
                   5. Study Title
                                         Progress
                                         Reports
6. Use
Pattern
                    7. Test
                    Substance
8. Time
Frame
9. Registrant
Response
                   Prod Chen - Regular Chemical
61-1
                   '  Product Identity t compost t1on<1)
61-2(b)

62-1

62-3

63 ~3/-<
63-7

63-14
   production & formulation
^ t prttf ^  , * J  -     ','  '','f,
  Discussion of formation of   (1,3}
•'"["^impuritles^ ^ >  ,  -  ^;-^r^
  Preliminary analysis        (1,4)

  Analytical method          (1)
    t   > •. •.
  Physical state

  Density

  Oxidizing or reducing action  (10)
  •. *. t  f V Jf^ 1 A 0SVhVt £ p'O*. ' V  *• ' W, .
  •* "* ff>^\^  fl.   °  "  :
ABCDEFGHIJKLMNO
ABCDEFGHLJKLMNO


ABCDEFGHIJKLMNO
   S f    '. ^ '. '. \ J  \  J  ;
  f •"          J  '    ;
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
                                                                    EP
                                        8 mos
                   EP

                   EP
                   EP
                   EP
                                                                                       EP
                                                                                       EP
                                                                                       EP
                                                                                       EP
    mos
    mos
    mos
    mos

    mos

    mos
                                                                                                                   ^ *v«
10. Certification
t certify that the statements made on this form and all attachments are true, accurate, end complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine. Imprisonment
or both under applicable'law.
Signature and Title of Company's Authorized Representative
                                                                                               11. Date
12. Name of Company Contact
                                                                                               13. Phone Number

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                                                                                                            Page   2 of   3
                       United  States Environmental Protection  Agency
                                      Washington,  D. C*  20460

                       REQUIREMENTS STATUS AND  REGISTRANT'S RESPONSE
                                                                                       CMS No. 2070-0107

                                                                                       Approval Expires 12-31-92
INSTRUCTIONS: Please type or print In Ink.  Please read carefully the attached Instructions and supply the Information requested on tM» form.
Use additional sheet(s) If necessary.
1. Company name and Address
  HULS AMERICA,  INC.
  BOX 365
  PISCATAWAY NJ   08855
                               2. Case f and Name
                                 3051   (Coco alkyl)amine salts

                                 EPA Reg.  No.  1100-85
                                       3. Date and Type of DC!
                                         PRODUCT SPECIFIC
                                         ID# 1100-RD-1909
4. Guideline
Requlrement
Number
5. Study Title
Prpgress
Reports
                                                                 6. Use
                                                                 Pattern
                                                                                    7. Test
                                                                                    Substance
                                     8. Tine
                                     Frame
9. Registrant
Response
63-15
63-16
A«K  M 44 fjff J J  *OX 1. •" W4XW*;
^ a*  JL *      •.•• v
63-18


63-20
€3-21  ^ --"^
 Explodabiltty
  toVaVTs
 Viscosity
                                          (12)
                                                                 ABCDEPGHIJKLMNO
                                                                 ABCDEFGHIJKLMNO
                                                                 ABCDEFGHUJOHNO W^TTS
                                          <13)
                                         ! -^-^
                    Acute dermal              (1,2,37)
                  ^/vL v.    ' « i i" i "• '-f-'--ff^f. •* *).; & ^   f .-.-,
                  :,\ -toXicity-ratbft/rat-;;^^^ ^  -

                    Acute Inhalation toxicity-rat (3)
                       (1,2)
                    Prlnary dernal Irritation
                    Derwl
ABCDEPGHUKLMNO EP
ABCDEFGHIJKLMNO EP

ABCDEFGHIJKLMNO EP
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEPGHIJKLMNO
                          EP
                          __^-'.
                          JEF
                                                                                                       8  mos.
                                                                                                       • s ,••*.";'",> ''*
                                                                                                       Jvs ^ ^"c •. ' ' *
                                                                                                       8  mos.
                                                                                                       «:»oc
                                                                                                       8  mos.
                                                                                                                       " f * '">'
                  EHtcacV . AntWcrobial
                    Health Uses


                  MlseeUaneoua Indoor Hard
Initial to Indicate cert I float Ion as to Information on this page
(full text of certification Is on page one).
                                                             Date

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-------
                         United  States  Environmental  Protection  Agency
                                        Washington,  D. c,  20460

                         REQUIREMENTS STATUS AND  REGISTRANT'S RESPONSE
                                                                                               Page   3 off.  3

                                                                                            For* Approved

                                                                                            OMB No. 2070-0107

                                                                                            Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in Ink.  Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(t) if necessary.
1. Company name and Address
  HULS AMERICA,  INC.
  BOX  365
  PISCATAWAY  NJ   08855
                                 2. Case « and Name
                                   3051   (Coco alkyl)amine  salts

                                   EPA Reg. No.  1100-85
                                                         5. Date and Type of DCI
                                                           PRODUCT SPECIFIC
                                                           ID#  1100-RD-1909
4. Guideline
Requirement
Number
5. Study Title
                Progress
                Reports
6. Use
Pattern
 7. Test
 Substance
8. Time
Frame
9. Registrant
Response
91-2
  Self-sanitizing test
(1.2)
              IMNO
EP
  8  mos,
initial to indicate certification as to information on this page
(full text of certification is on page one).
                                                                                   Date

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                                                                                                                                            Page    1 of	2
                                           United  States  Environmental  Protection Agency
                                                            Washington,  D.  C.  20460
                                  FOOTNOTES  AND KEY  DEFIHATIOHS  FOR GUIDELINE REQUIREMENTS

                                          Case  f  and Nane:  3051    (Coco alkyl)a«ine  salts
Keys m • Mnufecturlng-uM product; EP • end-use product; provided formal ators purchase their active Ingredlent(s) fro* • registered source, they need not subirtt or elte
date pertaining to the purchased product. OWE: If a product Is a 100 percent repackage of another registered product that Is purchased, and any use for the product does
not differ freai those of the purehssed and registered source, users are not subject to any data requirements Identified In the tables.]; TCP • typical end-use product;
TCAI • technical greda of the active Ingredient; PAI • "pure" active Ingredient; HUM • "pure" active Ingredient, radlolsbeted.
Use Categories Key:
                                                                  C - Terrestrial nonfood crop
                                                                  H • Greenhouse food crop
                                                                  N • Indoor nonfood
A - Terrestrial food crop
F - Aquatic nonfood Industrial
K • lesldentlal outdoor
                                 • • Terrestrial  food feed crop
                                 6 - Aquatic nonfood residential
                                 I • Indoor food
0 - Aquatic food crop
I * 6rCCftnOtaY)£ AQftrOOfl
• - Indoor Nodical
E • Aquatic nonfood outdoor
J • Forestry
0 - Indoor residential
 Footnotes:  irhe following notes are referenced In eoluan two (5, Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE fora.!
 1  Requirements pertaining to product  Identity,  composition, analysts, and certification of Ingredients are detailed further In the following sectional  *«8.1S5 for
    product Identity and composition (61-1);  *158.160, 158.162, and 158.165 for description of starting materials end manufacturing process <«1-2);  •1S8.167 for
    discussion of formation of Impurities (61-3); *158.170 for preliminary analysis (62-1);  «158.175 for certification of limits <62-2); and  *158.180 for aiifniuamin
    analytical methods (62-3).
 t  A schematic diagram and/or brief description of the production process will suffice If the pesticide Is not alreeaV under full acale production and an experleentel
    use permit Is being sought.
 3  If the pesticide is net already under full scale production and an experimental use permit Is sought, a discussion of wtntentlonsl Ingredients shall be submitted to
    the extent this Information Is available.
 4  Required to support the registration of eeeh  manufacturing-use product (Including registered TGAIs) as well as end-use products produced by an Integrated system.
    Data on other end-use products will be required on • eese-by-case basis.  For pesticides In the development state, • rudimentary product analytical method and data
    will suffice to support an experimental use permit.
 S  Certified limits are not required for Inert Ingredients In products proposed for experimental use.
 9  Required If test substances are disperslble with water.
10  Required If product contains an oxidizing or  reducing agent.
11  Required If product contains combustible liquids.
12  Required If product Is potentially explosive.
13  Required If product Is a liquid.
14  Required If product Is an emulslflable liquid and la to be diluted with petroleum solvents.
15  Required If end-use product Is liquid and is  to be used eround electrical equipment.
16  Basic manufactures are required to provide the Agency with a sample of each TfiAl used to formulete a product when the new TGAI Is first used as • formulating
    Ingredient In products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard Is also required at this time.
    Samples of end-use products produced by en Integrated system must be submitted on a eese-by-case basis.  Material safety data sheets should accompany samples as
    specified by OSHA In 29 CFR 1910.1200.


Acute Tonic - Regular Chemical

 1  Not required If test materiel  Is a gas or highly volatile.
 2  Not required If test materiel  is corrosive to skin or has pN less Mian 2 or greater than 11.5; such a product will be classified as Toxlclty Category I on the basis

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                                                                                                                                  frage    2 of   2
                                       United  States  Environmental  Protection Agency
                                                        Washington,  D.  C.  20460

                                FOOTNOTES AMD KEY  DEPUTATIONS  FOR GUIDELINE  REQUXltBMEHT3

                                       Case I and Mane:  3051   (Coco alkyl)a*ine  salts
Footnotes  (cont.):


    of potential ay* anddenwl Irritation effect*.
 $  Required If the product constate of, or infer conditions of use will result In, en Inhslable Material (o.  f., fas, volatile aubataneea, or aeraaol/partlculate).
 4  Required unless repealed densal exposure does not occur under conditions of use..
36  Special testing (acute, aubchronlc, and/or chronic) la required for organophospatea, and eay be required for other chollnesterese Inhibitor* and other peatlcldes
    Mhlch have deaenatrated a potential to adversely affect the vlauai aysten.  Kegtutranta should consult Mlth the aguney for developaent of protoeole and avthodology
    prior to Initiation of atudlea.
57  Testing of the EF dilution la required If It can be reasonably anticipated that the results of euch teatlnf say ejtet the criteria for restriction to us* by certified
    applicators specified In 40 CFR 152.170(b> or the criteria for Initiation of special review specified In 40 CFR 154.7 (a)<1).
Efficacy - Antimicrobial Aeent

 1 efficacy data for anthricroblal agents that clala) to control peat ailcroorganlsaa) that nay poa* • threat to huaan oust be euterfttad.
 2 Comparative product perforaenca Ate are required to be developed and Mlntelned In the registrant's file end aust be subsritted to the Agency on •
   for rlak/baneflt analyses such aa for public Interest findings and cases of special review.
                                                                                                                                               baela

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               SPECIFIC INSTRUCTIONS TOR COHPLZTINO
     9EE BEQUIREIfEiaS STATUS AND REGISTRANT'S RESPONSE TOTM


                      Product Specific Data


     Ibis fora is designed to be 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  torn is the sane
for both product and generic data, ingtruetiona for completing
the fonts differ slightly.  Specifically, options for satisfying
product 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 product apecifie data
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.  PO KOT 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 suggestions 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.

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2.   I have entered into an agreement with one or sore
     registrants to develop data jointly (Cost Sharing).  I
     am submitting a copy of this agreement and a completed
     •Certification With Respect To Data Compensation
     Requirements" form.  X understand that this option is
     available only for acute toxicity or certain efficacy
     data only if ZPA 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
  .v  or provide the requirement data? if the required study
 -~  is not submitted on time, my product may be subject  to
     suspension.

3.   2 have made offers to share in the cost to develop data
     (Offers to Cost Share).  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 Data Call-In Notice that my product
     is similar enough to another product to qualify for
     this option.  I am submitting evidence that I  have make
     an offer to another registrant (who has an obligation
     to submit data) to share in the cost of that data.  Z
     am also submitting a completed "Certification  of Offer
     to Cost Share in the Development Data11 form.   Z am
     including a copy of my offer and proof of the  other
     registrant's receipt of that offer.  Z 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. Z
     understand that other terms under Option 3 in  the Data
     Call-in Notice (Section III-C.l.) apply as veil.

4.   By the specified due date, Z 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 ZZZ-C.l.)  and will
     meet the attached acceptance criteria (for acute
     toxicity.and product chemistry data).   Z will attach
     the needed supporting information along with this
     response.  Z also certify that Z have determined that
     this study will fill the data requirement for  which  Z
     have indicated this choice.

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Items 10-13    Self-explanatory.

NOTE!     you may provide additional information that does not
          fit on thi* fora in a signed latter that accompanies
          this form.  For example,  you Bay wish to report that
          your product has already  been transferred to antoher
          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
       v  records are correct.

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           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                       WASHINGTON. D.C. 20460
                                                   JUL29G66
                         PR NOTICE 86-5
                                                Of
                                     MSTICIDCS AMD TOXIC SWMTANCK*
         NOTICE TO PRODUCERS, FORMULATORS,  DISTRIBUTORS
                        AND REGISTRANTS
 Attentions
 Subject:
Persons responsible for Federal registration  of
pesticides.

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

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

 II.   Applicability

      This PR Notice applies to all data that are submitted  to  EPA
 to satisfy data requirements for granting  or maintaining pesticide
 registrations,  experimental use permits, tolerances, and related
 approvals under certain  provisions of FIFRA  and FFDCA.   These
 data  are defined in FIPRA S10(d)(l).   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, 1986.  Data formatted
 according to this notice may be submitted  prior to the  effective
 date.   As of the effective date, submitted data packages that do
 not conform to  these requirements 'may be returned to the submitter
 for necessary revision*

 IV.   Background

      On  September 26,  1984, EPA published  proposed regulations
 in the Federal  Register  (49 FR 37956) which  include Requirements
 for Data Submission (40  CFR 5158.32), and  Procedures for Claim*
of Confidentiality of  Data (40 CFR $158.33).  These regulations

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  specify the format  for data submitted to EPA under Section  3 of
  FIPRA and Sections  408 and 409 of FFDCA, and procedures  which
  must be followed  to make and substantiate claims of confiden-
  tiality.   No entitlements to data confidentiality are changed,
  either by the proposed regulation or by this notice.

       OPP  is making  these requirements mandatory through  this
  Notice to gain resource-saving benefits from their use before  the
  entire proposed regulation becomes final.  Adequate lead time  is
  being provided for  submitters to comply with the new requirements.

  v-    Relationship of this Notice to Other OPP Policy and Guidance

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

      OPP  has  also promulgated a policy (PR Notice 86-4 dated
 April 15,  1986) that provides for early screening of certain
 applications  for registration under FIFRA 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  screen
 will include  in its criteria for acceptance of application
 packages the data formatting requirements described herein.

      OPP has also established a public docket which imposes dead-
 lines for inserting into the docket documents submitted  in con-
 nection with Special Reviews and Registration Standards  (see
 40  CFR 5154.15 and 5155.32).   To meet these deadlines, OPP is
 requiring  an additional  copy of any data submitted to the docket.
 Please refer to Page 10  for more information about this  requirement.

      For several years,  OPP has required that each application for
 registration or other action include a list of all applicable
 data  requirements and an indication of how each ia 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  is not altered  by this notice, which applies only to
 data  submitted with  an application.

 VI.   Format Requirements

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

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                          -  INDEX -
                                                         Text Example
                                                         Page  Page
A.
B.
C.

.D»







E.
F.
G.



C.I Special Considerations for Identifying Studies. .


D.2 Statement of Data Confidentiality Claims


D.4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA $10{d)(l)J
D.S Good Laboratory Practice Compliance Statement , .

Physical Format Requirements & Number of Copies . . .
Special Requirements for Submitting Data to the Docket
3
4
4
5
6
7

8
8

8
9
9
9
10
17
11


17
12

13
15

14
16



                          **************
A.   Organization of Submittal Package

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

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

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

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

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

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  B.   Transmittal Document

      The first item in each submittal package must be a trans-
  j&ittal document*  This document identifies the submitter or all
  joint submitters; the regulatory action  in support of which the
  package is being submitted—i.e., a registration application,
  petition, experimental use permit (EUP),  S3(c)(2)(B) data call-in,
  $6{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 an example of an acceptable
  transmittal document*

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

      The list of included studies in the  transmittal of- a data
 submittal  package supporting a  petition  for tolerance or an
 application for an EUP should be subdivided into sections A,  B,
 C,.... of  the petition or application, as defined in 40 CPR
 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 EUP, list the petition
 studies  first,  then the balance of  the studies.  Within these
 two groups  of studies follow the instructions above.

 C.   Individual  Studies

     A study  is  the report of a single scientific  investigation,
 including all supporting analyses required for  logical complete-
 ness*  A study should be identifiable and distinguishable  by a
 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  a submittal package
must be bound as  a  separate  entity.   (See comments on binding
 studies on page 9.)

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

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

     - Include a company  name or mark and study number on each
       page of the study,  e.g., Company  Name-1986-23.   Never reuse
       a  study number for marking the pages  of  subsequent studies.

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       When a single study  is extremely long, binding  it  in multiple
  volumes is permissible so long as the entire study is paginated
  in a single series, and each volume is plainly identified by  the
  study title and  its position in the multi-volume sequence.
  c»l   Special Considerations for Identifying Studies

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

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

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

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

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

      Product chemistry data submitted in support of a techni-
 cal product, other manufacturing-use product, an experimental
 use permit,  an import tolerance petition, or an end-use prod-
 uct produced from unregistered source ingredients, should be
 bound  as  a single study for each Guideline series (61, 62,
 and 63}  for  conventional pesticides, or for the equivalent
 subject  range for biorational pesticides.  The first of the
 three  studies in a complete product chemistry submittal for
 a biochemical pesticide would cover Guidelines 151-10, 151-11,
 and 151-12;  the second would cover Guidelines 151-13, 151-15,
 and 151-16i  the third would cover Guideline 151-17.  The
 first  study  for a microbial pesticide would cover Guidelines
 151-20,  151-21,  and 151-22; the second would cover Guidelines
 151-23 and 151*25;  the third would cover Guideline 151-26.

     Note particularly that product chemistry studies are
 likely to contain Confidential Business Information  as defined
 in FZPRA  510(d)(l)(A), (B), or (C), and it so oust be handled
 as described in section 0.3. of this notice.

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       c.    Residue Chemistry_S tud ie s«  Guidelines 171-4,  153-3,
  and 153-4  are extremely broad in scope; studies addressing
  residue  chemistry requirements must thus be defined at a
  level below  that of the Guideline code.  The general principle,
  ^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 single crop or from  proces-
  sing  a single crop.  When more than one commodity is derived
  from  a single crop (such as beet tops and beet roots) residue
  data  on all  such commodities should be reported as a single
  study*.  When multiple field trials are associated with  a
  single crop, all such trials should be reported as a single
  study.

  D»   Organization of Each study volume

      Each complete study must include all applicable elements  in
  the list below,  in the order indicated.  (Also see Page  17.)
 Several of  these  elements are further explained in the  following
 paragraphs.  Entries in the column headed 'example1 cite the
 page number of this notice where the element is illustrated.
 Element

 Study Title Page

 Statement of Data
 Confidentiality
 Claims

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

Cover Sheet  to Confi-
dential Attachment
     _»

CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
When Required                    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 GLP require-
ments

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

Always - with an English language
translation if required.

At submitter's option
If CBI is claimed under  FIFRA
S10(d)(l)(A),  (B), or  (C)

If CBI is claimed under  FIFRA
  SioCdJUHA).  (B), or  (C)

Only if confidentiality  is
claimed on a basis other than
FIFRA SlO(d)(l)(A)f  (B), or (C)
Page 15


Page 14

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 D.I  Title Page

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

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

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

 c.    Author(s).   Cite only individuals with primary intellectual
 responsibility  for  the  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.  If the study reports
 work  done by one or more laboratories, include on the title page
 the name and address of the  performing laboratory or laboratories,
 and the laboratory's internal project number(s) for the work.
Clearly distinguish the laboratory's project identifier from any
other  reference numbers provided by the study sponsor or submitter,
f.
Supplemental Submissions.  If the study is a commentary on
      SUPI	
or  supplement to another previously submitted study, or if it
responds  to EPA 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 CPA 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.   Facts  of  Publication,   if the study is a reprint, of a pub-
lished document,  identify on .the 'title page all relevant facts
of publication, such as the journal title, volume, issue, inclusive
page numbers,  and publication date.

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  D.2. Statements of Data Confidentiality Claims Under FIFPA §10(d)(l}.

      Each submitted study must be accompanied by one of the two
  alternative forms of the Statement of  Data Confidentiality Claims
  specified in the proposed regulation in $158.33 (b) and (c).
  (See Attachment 3) These statements apply only to claims of data
  confidentiality based on FIFRA S10(d)(1)(A), (B), or (C).  Use
  the appropriate alternative form of the statement either to
.assert a claim of 5lO(d)(l) data confidentiality (<15B.33(b»
  or to waive such a claim (5158.33(c)).  In either case, the
  statement must be signed and dated, and must include the typed
  name and title of the official who signs it.  Do not make CBI
 claims with respect to analytical methods associated with petitions
  for tolerances or emergency exemptions (see NOTE Pg 13).

 D.3.  Confidential Attachment

      If the claim is made that a study includes confidential busi-
 ness  information as defined by the criteria of FIFRA S10(d)(1)(A),
 (B),  or (C)  (as described in D.2.  above) all such information must
 be  excised from the body of the  study  and confined to a separate
 study-specific Confidential Attachment.  Each passage of CBI so
 isolated  must  be identified by a reference number cited within the
 body  of the  study at the point from which the passage was excised
 (See  Attachment S).

      The  Confidential  Attachment to a  study must be identified by a
 cover sheet  fully identifying the parent study, and must be clearly
 marked  'Confidential Attachment.'   An  appropriately annotated
 photocopy of the  parent  study title page may be used as this cover
 sheet.  Paginate  the Confidential Attachment separately from the
 body  of the study,  beginning  with  page 1 of X on the title  page.
 Each  passage confined  to the Confidential Attachment must be assoc-
 iated with a specific  cross reference  to the page(s) in the main
 body of the study on which  it is cited, and with a reference to  the
 applicable passage(s)  of  FIFRA 510(d)(l) on which the confidentiality
claim is  based.
D.4. Supplemental Statement of Data Confidentiality Claims
     Attachment 4)
(See
     If you wish to make a claim of confidentiality  for any
portion cf a submitted study other than described by PIFRA S10(d)
(IMA), (B), or (C), the following provisions  apply:

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

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

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

                                8

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 D.5  Good Laboratory Practice Compliance Statement

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

 £•   Reference to Previously Submitted Data

      DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
 FOR ANOTHER PURPOSE unless EPA specifically requests it.  A copy
 of the title page plus the MRID number (if  known)  is sufficient
 to allow us 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.

 F.   Physical Format Requirements  .

      All elements in the data submittal  package must be  on uniform
 8  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  points:

   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 oversize.computer printouts or fold-out pages.

   o   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  G  below)  must be provided in  three complete,   identical *
copies.   (The proposed regulations  specified two  copies; three
are now being required to expedite  and  reduce the cost of proces-
sing data  into the  OPP Pesticide Document  Management System and
getting  it into review.)

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  G.   Special Requirements for Submitting Data tothe Docket

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

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

   o  Remove  the  'Confidential Attachment'.

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

   o  Mark the fourth copy plainly on both its cover and its  title
      page with the phrase "Public Docket Material - contains no
      information  claimed  as  confidential*.
 V.
For Further Information
      For further information contact William C. Grosse, Chief,
 Information Services Branch, Program Management and Support
 Division, (703-557-2613).
                          /James W. Akerman
                           /Acting Director,
                            Registration Division
Attachment  1.
-Attachment  2.
Attachment'  3.
Attachment  4.
Attachment  5.
Attachment  6.
Attachment  7.
         Sample  Transmittal Document
         Sample  Title Page for a Newly Submitted study
         Statements of Data Confidentiality.Claims
         Supplemental Statement of Data Confidentiality Claims
         Samples of Confidential Attachments
         Sample  Good Laboratory Practice Statements
         Format  Diagrams for Submittal Packages and  studies
                                10

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                           ATTACHMENT 1.
       ELEMENTS TO BE INCLUDED IN THE TRANSHITTAL DOCUMENT*

 1. Name and address of submitter (or all  joint  submitters**)
     rSmith Chemical Corporation        Jones Chemical Company
      1234 West Smith Street      -and-  5678 Wilson  Blvd
      Cincinnati, OH 98765              Covington, KY 56789
     rSmith Chemical Corp. will act as sole  agent for all submitters,
 2. Regulatory action in support c£ 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 the data.
Company Official:
                  Name                     Signature
Company Names     ^__
Company Contact:
                  Name                             Phone
                                11

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                   ATTACHMENT  2.
SAMPLE STUDY TITLE PAGE FOR  A  NEWLY SUBMITTED STUDY

                    Study Title
  (Chemical name)  -  Magnitude of Residue on Corn
                  Data  Requirement
                  Guideline  171-4
                       Author
                   John C. Davis
                Study  Completed on
                  January 5, 1979

              Performing Laboratory
           ABC Agricultural  Laboratories
                940  West Bay  Drive
               Wilmington,  CA 39897

              Laboratory Project ID
                     ABC 47-79
                   Page  1 off X
  (X is the total number of pages  in.the study)

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                                 ATTACHMENT 3.

                   STATEMENTS OP DATA CONFIDENTIALITY CLAIMS




 1.  No claim of confidentiality under FIFRA S10(d)(l)(A),(B), or (C)
                    STATEMENT OP NO DATA CONFIDENTIALITY CLAIMS
   No claim of confidentiality is made for any  information contained in this stjdy
   on the basis of its filling within the scope of FIFRA SlO(dKlMA), (B),  or (C).
   Company
   Company Agent:
Typed Name
                    Title
   Date:

Signature
2.  Claim of confidentiality under FIFRA $10(d)(l)(A),  (B), or (C),
                    STATEMENT OP DATA CONFIDENTIALITY CLAIMS
   Information claimed confidential on the basis of  its  falling within the scope
   of FIFRA $10(d)(l)(A), (B), or (C)  has been renoved to a confidential appendix,
   and is cited by cross-reference number in the body of the study.
   Company:
  Ccnpany Agent:
Typed Name
                   Title
   Date:

Signature
 NOTE:  Applicants  for permanent or tenporary tolerances should note that  it
 is OPP policy that no permanent tolerance,  tenqporary tolerance, or request for
 an emergency exemption  incorporating .an analytical method,  can be approved
 unless the applicant  waives all claims of confidentiality for the analytical
 method.  These analytical methods  are  published in the FT* Pesticide Analyt-
 ical Methods Manual,  and therefore cannot be claimed as confidential.  OPP
 implement* this policy  by returning submitted analytical methods, Cor which
 which confidentiality claims  have  been made, to the  submitter, to obtain
 the confidentiality waiver before  they can  be processed.
                                      13

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                        ATTACHMENT 4.

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

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

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

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

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

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

  o  Enclose copies of  any pertinent determinations of confi-
     dentiality made by EPA,  other Federal agencies, or courts
     concerning  this information.

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

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

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                                              5.
                     EXAMPLES OP SEVERAL CONFIDENTIAL ATTACHMENTS

  Example 1  (Confidential word or phrase that has been deleted from the study)
 CR3SS REFERENCE NUMBER
 DELETED WORDS OR PHRASE:
                      Hi is cross reference number is used  in the study
                      in place of the following words or phrase at the
                      indicated volume and page references.

                       Ethylene Glycol              ____^______
PftGE  LINE   REASON FOR THE DELETION

             Identity of inert Ingredient
                                                                FIFRA REFERENCE
     6
    28
   100
14
25
19
 Example 2  (Confidential paraqraph(s) that have been deleted fran the study)
 CROSS-REFERENCE NUMBER	5_   This cross reference number is used in the study
                              in place of the following paragraphs) at the
                              indicated volume and page references.

 DELEZBXBBAGRAPH(S):
                  Reproduce the deleted paragraphs) here                  )


   	  REASON FOR THE DELETION                          FIFRA REFERENCE

   20.*  «7   Description of the quality control process        S10{dXl)(C)
Exanpte 3  ^Confidential
                     that have been deleted fron the study)
CROSS.
   39-41
      NUMBER   7    This cross reference number noted on a place-holder
                    page is used in place of the following whole pages
                    at the indicated volume and page references.

      t  are attached immediately behind this page.
     REASON FOR THE DELETION                          FIFRA REFERENCE

     Description of product manufacturing process      S10(d)(l)(A)
                                        15

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                          ATTACHMENT 6.

             SAMPLE GOOD  LABORATORY PRACTICE STATEMENTS
 Example 1.
    This study meets  the  requirements for 40 CFR part 160

       Submitter        _._.	

       Sponsor 	
       Study  Director
Example 2.
  This study does not meet the requirements of 40 CFR
  Part 160, and differs in the following ways:
  1.

  2.

  3.
     Submitter

     Sponsor
     Study Director
Example 3.
   The submitter of this study was neither the sponsor  of  this
   study nor conducted it, and does not know whether  it has
   been conducted in accordance with 40 CPR Part  160.
   * i                          *
     Submitter          _	  '  	
                               16

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                         ATTACHMENT 7.
                 FORMAT OF THE SUBMITTAL PACKAGE
                   Transniittai Document.
                       Related Administrative Materials
                       (e.g.. Method of Support Statement, etc.)
                             Other materials about  the  submittal
                     _] """'"" (e.g., summaries of  groups of  studies
                   **N  to aid in their review).

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

                Statement of Confidentiality Claims.

                    GLP and flagging*  statements - as appropriate.

                         Body of the study, with English
                         language translation if required.

                             Appendices to the study.

                                 Title Page of the Confidential
                          1 ..-•••  Attachment.
LEGEND
                              I
                                      Confidential Attachment.
                              j- — •%       Supplemental Statement
                                  , .	  of Confidentiality Claims,

                              ^-"J   * When flagging requirements
                           "^          are finalized.
                Documents  which must be submitted as
                appropriate  to meet established requirements.
                I
Documents submitted  at  submitter's option.
                              17

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!

I I
I I
i
     s

      s

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     ATTACHMENT D




EPA ACCEPTANCE CWTERIA

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                          SUBDIVISION D
Guideline

Series 61
Series 62
Series 63
        Study Title

Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics

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               61 Product Identity and Composition
                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

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

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

3.	 Name and upper certified limit for each impurity or each
      group of impurities present at > 0.1% by weight and for
      certain 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

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

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

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               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 <0.1%.
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.

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       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.
 4.
   •



 5.
   *



 6._



 7.
   •




 8;
Analyses conducted for certain trace toxic impurities at
lower than 0.1%  (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
samples must be analyzed.}

Complete and detailed description of each step in analytical
method used to analyze above samples

Statement of precision and accuracy of analytical method
used to analyze above samples

Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient

Upper and lower certified limits proposed for each active
ingredient and intentionally added inert along with
explanation of how the limits were determined

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

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 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

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       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 > O.lt.

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

 3. Chemical names of toxic impurities which were analyzed for
    levels <0.1%.

 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
    >=0.1% and certain toxicologically significant impurities at
    <0.1% with brief explanation of how limits were determined.

 9. Brief description of analytical method(s) used to verify
    certified limits (if same methods as item #4, may reference
    latter).

10. Statement of precision and accuracy of method(s) in item #9
    (may reference item #5 if applicable).

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             63 Physical and Chemical Characteristics
                       ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered.

Does your study meet the following acceptance criteria?

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

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

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

63-5 Melting Point
     	 Reported in c°
     	 Any observed decomposition reported

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

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

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

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

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

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

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             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/vater partition coefficient.
11. Indication of PH.
12. Description of stability.

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                           SUBDIVISION F
 Guideline

   81-1
   81-2
   81-3
   81-4
   81-5
'  81-6
   81-7
           Study Title

Acute Oral Toxicity in the Rat
Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
Acute Inhalation Toxicity in the Rat
Primary Eye Irritation in the Rabbit
Primary Dermal Irritation Study
Dermal Sensitization in the Guinea Pig
Acute Neurotoxicity in the Hen

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               81-1 Acute Oral Toxicity in the Rat
                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

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

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              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

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   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 gin, rabbits 2.0-3.0 Xg 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.

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


                 GUIDANCE FOR SUMMARIZING STUDIES


 l. 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

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            81-3 Acute Inhalation Toxicity in the Rat
                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	 Identify material tested (technical, end-use product, etc)
 2.     Product is a gas, a solid which may produce a significant
        vapor hazard based on toxicity and expected use or contains
        particles of inhalable size for man (aerodynamic diameter
        15 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 rog/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.

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           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

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            81-4 Primary Eye Irritation in the Rabbit
                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

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

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           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 >11.5
 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

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               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 i,
         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 may not be required
for every study.

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               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  pH <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.

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           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 > U.S.
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.*,	 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.

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           81-6  Dermal  Sensitization in the Guinea Pig
                GUIDANCE FOR SUMMARIZING STUDIES
1. The fora 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

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               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.
 2.	 Technical form of the active ingredient tested.
 3.*,	 Positive control utilized.
 4.	 Species utilized, domestic laying hen 8-14 months of age.
 .5.	 Dosing oral by gavage or capsule (dermal or inhalation
        may be used).
 6.	An acute oral LD is determined.
 7.	 Dose tested equal to an acute oral LD or a limit test of
        5000 mg/Xg.
 8.*	 Dosed animals may be protected with atropine and/or 2-
        PAM.
 9.	 Sufficient test animals so that at least 6 survive.
10.	 Negative (vehicle) control group of at least 6 hens
11.i	 Positive control of at least 4 hens, (if used)
12.	 Test dose repeated if no signs of delayed neurotoxicity
        observed by 21 days after dosing.
13.	 Observation period 21 days after each dose.
14.     Individual daily observations.
15.	 Individual body weights.
16.	 Individual necropsy not required.
17.	 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
            "lurabro-sacral regions
            _tibial nerve; proximal regions and branches
            "sciatic nerve
Criteria-marked with a * are supplemental and may not be required
for every study.

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                  ATTACHMENT E




LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

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                                                                                                  Page   1  of  1.
                             United States Environmental Protection  Agency
                                          Washington,  D. C.  20460
                         LIST  OF AM. REGISTRANTS  SENT THIS DATA CALL-IN NOTICE
                             Case  f  and Name:  3051   (Coco alkyl)araine salts  *''
Co. Nr.   Company Name
Additional Name
Address
City  &  State
                                                                                                    Zip
001100      HULS AMERICA, INC.
004313      CARROLL COMPANY
                       BOX 365
                       2900 W. KINGSLEY RD.
                      PISCATAUAY NJ
                      GARLAND TX
                     08855
                     75041

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            ATTACHMENT F




COST SHARE AND DATA COMPENSATION FORMS

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1         *

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     r/EPA
United  States  Environmental Protection Agency
            Washington, DC 20460
   CERTIFICATION  WITH RESPECT TO
 DATA  COMPENSATION  REQUIREMENTS
Form Approved

OUB No. OT04106

Approval  Eiplr«a 12-1142
  Pubic reporting burden for this collection of information is estimated to average 15 minutes per response. Ineiuding
  time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
  completing and reviewing the collection ol 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.
Ccxpiny NMM
•
Product Name

EPA Reg. Mo.
 I Certify that:

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

    That for each study cfted in support of registration or reregistratton under FIFRA that is NOT an exclusive use
    study, i am the original data submitter, or I have obtained the wrttten permission oi the original data submitter, or I
    have notffied in writing the company(ies) that sub-mined data I have cited and have offered to: (a)  Pay
    compensation for those data in accordance with sections 3(c}(i}(D) and 3(c)(2)(D) of FIFRA: and (b) Commence
    negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount ot
    compensation due, if any. The companies I have notified are:
    I ]  The companies who have submitted the studies listed on the back ol this form or attached
        sheets, or indicated on the attached •Requirements Status and Registrants' Response Form,"

 3.  Thai I have previously complied with section 3(C)(1)(D} of FIFRA for the studies I have tiled in support of
    registration or reregistratton under FIFRA.
Signature
Oat*
Mam* and TUte (PIMM Typ* of Print)
 GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
 registration or reregistratton of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2}(0).
I
Sfgnatvrt
Dm
Nam* and Tltta (Pl*«»t Trp* ftr Print)
EPA Fo»« IC70-91 («••&}

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

OMB No. 2070-0106

Approval Eiplres 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 Name
                                                 Company Number
  Chemical Name
                                                 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 Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
 enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
 data.

 My firm has offered in writing to enter into such an agreement.  That offer was irrevocable and  included an
 offer to be bound by arbitration decision under section 3(c)(2){B)(iii) of FIFRA if final agreement on all
 terms could not be reached otherwise. This offer was made to  the following firm(s) on the following
 date(s):
  Name of F(rm(»)
                                                  Date of Offer
 Certification:
 I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
 this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
 misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Name and
of Company'a Authorized Representative
Title (Pieaae Type or
Dal*
Print)
EPA Form 1570-32

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*   -4     I
                                                                                                                                                                                                              i      I

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I US Environmental Prpttctien Agency Registration Standard tot:
a^^ Washington, DC 20460
IfeEPA . Product Specific
TWtrj-\ Datg Re£ Qrt
•i 	 *m+mmm1mi.
nPyleMi •HWI
Guideline No.
Sec. 158.120
Product
Chemistry
ei-i
ei-2 r*-*
01*2 n»)
62-1
62-2
62*3
63-2
63-3
«M
63-3
834
63-7
I 634
1 63-9
1 63-10
m 63-n
^ 63-12
1 63-13
1 63-14
63-15
63-16
63-17
63-16
63-19
63-20
63-21
Sec. 158.135
Toxicoioov
•M
•1*2
•V3
•t.4
ai-5
•1-6
NftRUI 0f T ittt

•fwAtfty Of fnQfflMMfltS
Statement of oomposHlen
Discussion of formation of (nertdicfit*
Preliminary analysis


Analytical method* for •nteronnant limits
Color
Physical ttat*
Odor
MtlttnQ point
Boiling point
Onsity. bulk-dtnsrtv, or specific orsvity
Solubility

vapor prnsurv
Dissociation oonstant
Octsnel/wsttr partition ootfficiant
PH
Stability
Oxidizing/radueing raaction
RammabiNty
f«plodabifity
Storag* stability
viscosity
Miscibility
Corrosion Charactaristics
>*
•
















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EPA Hegistration Mumper

Data Requirements bv •
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Supmjttne Data
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>offR Approved
OMB42070-OOS7
Expires 11^049
(For EPA Use
Only)
Axwssi0n
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- V -•*_• '.. -. ' •-.- ./: ' - •--.'" ' . " ""
Certification
1 certify that the statements 1 have made on this form and all attachments thereto are
•true, accurate, and complete. 1 acknowledge that any knowingly false or misleading
I statement may be punishable by fine or imprisonment or both under applicable law.
(Typed Name and rifle
Signature
Data
IF A Form aMo-4 {Rov. M6} Previous edition is obsotete.

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