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
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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
-------
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
-------
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
-------
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
-------
'•*A
-------
ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
(FORMS B) PLUS INSTRUCTIONS
AND
PR NOTICE 86-5
-------
-------
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^
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-
EP
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EP
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EP
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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 ^
^' '^ ,• * •- •• $• ^Trt'-
''•• ..
!>''•. « ' , "t >
5. Study Title
^ ^ w* ^ * > * f^\ v-i* '5 •; ' •• L ^ "" v ^ v />4,ri«B«P»DT«>tTy^ ^ *•* j^\ s v , / \»Tj ^ ^
ExplodabUity (12)
^78tor*g« itaWUiiy " 'v<;~'' " ^15) ^i""
Viscosity (13)
Corrosion characteristics
Jteute'fo^l tf^ fteafiiaf "ijneartfB^ ' ' ""* *" • "
^'Acu^Vr.1' bxici^rat ' ^^(1,36,37> V
Acute dermal (1,2,37)
Acute Inhalation toxlcity-rat (3)
Primary eyelfritatfon-rabbit (2)
Primary dermal Irritation (1,2)
'' ,. p^mui swtsiTiZfttfoti C^J
tf f icacv - Amfiirtcrobfot ^9en^» - Pub^fc "
Health Usca
* > ~* '•
-.;•"•""••, '
Miscellaneous Indoor Hard
\
>.
2
"•?,
•"'fv
••<
3
'" •£
^vv s ^
6. Use
Pattern
ABCDEFGHIJKLKHO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
* * 't
ABCDEFGHlJKLWNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
' * •» S*- %
Initial to indicate certification as to information on this page
(full text of certification Is on page one).
"
'
7. Test
Substance
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-9!
on this fora.
3. Date and Type of DC!
PRODUCT SPECIFIC
IDf 4313-RD-1910
.pfc^'t^oyift^ "<1!'?|^^»''
gp ' ^' " J
EP
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8. Time
Frame
8 mos.
8 mos.
8 mos.
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"• £ ^% jHTjBi •> '
8 mos.
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8 mos.
8 mos.
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9. Registrant
Response
>y$*%<*{ \ ^
i'' ;':'/ <:
Vftf ™~',S'-^'5C*' '
Date
-------
-------
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
-------
-------
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
-------
-------
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.
-------
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.
-------
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.
-------
-------
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
-------
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.
-------
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
-------
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
-------
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
-------
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
-------
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
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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
>*
•
.
EPA Hegistration Mumper
Data Requirements bv •
CWnflMBlDNo.
Supmjttne Data
Ittftcfwo?
fQiifck Oetow)
-••
>offR Approved
OMB42070-OOS7
Expires 11^049
(For EPA Use
Only)
Axwssi0n
ftumbtrt
- 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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