Unttetf StstM Offict of Prevention, PtctfcUe*
Envirarmwnat Prottctton And Ibxtc Subitancu
f/EPA Reregistration 5^92222
Eligibility Document
(RED)
Capsaicin
USTD
CASE 4018
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C
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CAPSAION REREGISTRATION EUGIBIIJTY TEAM
Office of Pestida* PTOJ
Biological and Economic Analysis Branch
Wilfred Barr Biological Analysis Branch
Steve Jacobs Biological Analysis Branch
EnvfrflnmcntSlJFate and Effects Division
Heather Mansfield Ecological Effects Branch
William R, Schneider Science Analysis and Coordination
Branch
pealtft Effects Division
I. Thomas McClintock Science Analysis Branch
Christina Swartz Chemistry Branch Reregistration Support
James R. Yowell Occupational and Residential Exposure
Branch
Rep'stration Division
Rame Cromwell Insectitide-Rodenticide Branch
Robert Forrest Insectitide-Rodenticide Branch
Sami Malak Registration Support Branch
Mary L. Waller Registration Support Branch
Special Review and Reregistration Division
^/Ernestine Dobbins Accelerated Reregistration Branch
Policy and Special Projects Stflff
JeanFrane
Office of General Counsel
Eran Gasko
+
Office of Compliance Monitoring
Bevedy Updike
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TABLE OF CONTENTS
PAGE
GLOSSARY OF TERMS AND ABBREVIATIONS
EXECUTIVE SUMMARY
L INTRODUCTION I
H. CASE OVERVIEW 2
A. CHEMICAL OVERVIEW
B. USE PROFILE 2
C. REGULATORY HISTORY 3
m. SCIENCE ASSESSMENT OF CAPSAICIN 3
A. PRODUCT CHEMISTRY ASSESSMENT 3
B. HUMAN HEALTH ASSESSMENT 4
C. ENVIRONMENTAL ASSESSMENT 5
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 7
A. DETERMINATION OF ELIGIBILITY 7
B. TOLERANCE ASSESSMENT 8
V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS 8
'A. DETERMINATION OF ELIGIBILITY 8
B. PRODUCT SPECIFIC DATA REQUIREMENTS 8
C. LABELING REQUIREMENTS FOR END-USE PRODUCTS 8
ii
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VI. APPENDICES
APPENDIX A- Use Patterns Subject to ^registration
APPENDIX B - Generic Data Requirements for Reregistration
of Capsaicin and Data Citations Supporting
Reregistratirais
APPENDIX C - Citations Considered to be Part of the Data
Base Supporting the Reregistration of Capsaicin
APPENDDTD - 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 Groupings of End-Products for Meeting Data
Requirements for Reregistration
Attachment E - EPA Acceptance Criteria
Attachment F - List of all Registrants) sent this DCI
Attachment G - Cost Share/Data Compensation Forms
Application for Registration
1U
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GLOSSARY OF TERMS AND ABBREVIATIONS
CAS Chemical Abstracts Service
CFR Code of Federal Regulations
CSF f!r>nfi^fntial Statement of Formula
i
EPA U.S. Environmental Protection Agency
FDA Food and Drug A^""11' *tratit>p
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
GRAS Generally Recognirad As Safe
MRED Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the EPA.
ppm Parts per Million
RED Reregistration Eligibility Document
iv
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EXECUTIVE SUMMARY *
Pesticide products containing capsaicin as an active ingredient have been registered
since 1962. Currently, capsaicin is registered in ten products as an animal and insect
repellent. It is used to repel dogs in the case of attack, and repel insects, birds, and a
variety of other animals from crops, non-food plants, and specific residential areas. This
-document focuses only on the active ingredient capsaicin.
The Agency is basing its reregistration decision for capsaicin on a risk management
decision. Precautionary label statements are required which should reduce potential
environmental exposure. Further, the Agency has no significant concerns regarding
capsaicin's toricity to humans. Therefore, the Agency believes capsaicin can be used
without causing unreasonable adverse effects in people or the environment and that all
products containing capsaicin as an active ingredient are eligible for reregistration.
Before reregistering each product, the Agency is requiring product specific data to be
submitted within eight months from the issuance of this document. After reviewing these
data and the revised labels, EPA will determine whether or not the conditions of FIFRA
Section 3(c)(S) have been met for each product. The product will be reregistered if its
composition and labeling are acceptable, and its uses will not cause unreasonable adverse
effects to humans or the environment. End-use products containing capsaicin in combination
with other active ingredients will not be reregistered until the Reregistration Eligibility
Documents for all active ingredients contained in that product are issued.
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L INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered
prior to November 1, 1984. The flffyfod 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.
Section 4(g)(2)(A) of FIFRA states that in Phase 5 'the Administrator shall
determine whether pesticides containing such active ingredient are eligible for
reregistration* before calling in product-specific data, section 4(g)(2)(B), and either
reregistering products or taking 'other appropriate regulatory action," sections
4(g)(2)(C) and (D). 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 Section 3(c)(5).
This document presents the Agency's decision regarding the reregistration
eligibility of the active ingredient capsaicin. The document consists of five sections.
Section I is this introduction. Section n describes capsaicin, its uses 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 eligibility
decision for capsaicin and Section V discusses product reregistration requirements.
Additional details concerning the Agency '* review of available data are available on
request.1
EPA's reviews of specific reports and information on the
set of registered uses considered for EPA's analyses nay
be obtained from: EPA, Freedom of Information, 401, H
St., S.W., Washington, D.C. 20460.
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IL CASE OVERVIEW ' * •
A. Chemical Qverviey
Chemical Name: 8-methyl-n-vaniDyl-6-nQn
Empirical Formula: C^H^NC^
Common Name: Capsaicin
CAS Number: 404-86-4
Office of Pesticide Programs Chemical Code: 00611
Basic Sources: oleoresin extract of the Capsicum red pepper
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 capsaicin is in Appendix A.
Type of Pesticide: biochemical pesticide, animal and insect repellent
f.
Pests Repelled: birds, moles, deer, dogs, insects, rabbits, squirrels
Registered Use Sites:
Terrestrial Food - fruits (including berries), vegetables, grains
Terrestrial Non-Food - ornamental plants, trees, and flowers (including roses)
and shrubbery.
Residential Outdoor - ornamental plants, trees, and shrubs, garbage bags,
lawns or gardens.
Residential Indoor - crack and crevice, ant trails carpets and upholstered
furniture
Formulation Types Registered:
Dry powder, liquid formulation and liquid spray ground
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Method and Rates
of Application: Types Of Treatmeot: Rinse, aerial application, spray
Equipment: aircraft, ground boom, pump spray bottle, spray
container, yhalcer can, hydraulic sprayer
Timing As directed by product label
Rate of Application: From dose cannot be catolTat^T to six
pounds per acre.
Use Practices
Limitations: Refer to precautionary label statements.
C. Regulatory History
The United States Department of Agriculture first registered a pesticide
product with capsaicin as a single active ingredient in 1962. This product was a dog-attack
repellent, a use that is still registered 30 years later. Currently, there are ten registered
products containing the active ingredient capsaicin. These products are granular, liquid, and
dust formulations, which are used for the control of buds, animals, and insects and arachnids
in houses, gardens, crop lands, and forests. The Agency has also registered capsaicin in
combination with garlic fAllium sativunrt or oil of mustard (allyl isothiocyanate).
On November 26, 1991 the Agency classified capsaicin as a biochemical
pesticide because it is a naturally occurring biological substance and because it has a non-
toxic mode of action. The source of capsaicin derives from the oleoresin of pepper plants of
the genus Capsicum.
ITJ. firrEJNCK ASSfiSJ^MENT nF CAPSAICIN
EPA has reviewed the scientific data base for capsaicin relying on information
submitted by (he registrants. These are cited in Appendix C.
'A, Product ch^flistry Assessment
The active ingredient capsaicin (oleoresin of capsicum^ is generally obtained
by grinding dried ripe fruits of Capsicum fnitescens L (chili peppers) into a fine powder.
The oleoresin may be obtained by distillation of the powder in an appropriate solvent, and
evaporation of the solvent to yield the liquid oleoresin and associated ratty matter. The ratty
-------
matter is removed by decanting or filtration. The resulting reddish-brown liquid is very
thick; while little odor is associated with the olepresin, the taste is extremely pungent
Dispensatory. 25th Edition).
The manufacturing process used by the primary supplier (Kalsec, Inc.) to
obtain capsaicin powder and oleoresin has been described. Briefly, the peppers are ground,
extracted with food grade hexarie with the resulting extract being filtered through
diatomaceous earth. Following distillation to remove the hexane (level will not exceed 25
ppm), the raw extract is analyzed for color intensity and capsaicinoid content, and then
placed in storage for use in finished products. Batching operations are product-specific with
sequential samples taken after the batching process to insure that the finished product
conforms to specifications.
Upon final approval, the product is packaged and shipped. All operations are
conducted according to Good Manufacturing Procedures.2
B. Human Health Assessment
1. Toxicology Data Base
The potential risks to humans from both dietary and occupational exposure
are considered negligible due to the long history of use by humans as a food
additive/component without any indication of deleterious health effects. Due to the nature of
the subject compound it is unlikely that products containing capsaicin^will have adverse
effects on human health. Consequently, all toxicology data requirements have been satisfied.
No additional generic data will be required.
2. Dietary Exposure
In the absence of lexicological concerns from ingestion of capsaicin because
of its presence in the human diet, the Agency has waived the requirements for the submission
of residue data. However, a tolerance exemption under Federal Food, Drug, and Cosmetic
Act (FFDCA) Section 408 will be established for capsaicin for all currently registered food
uses.
2 See bibliography reference 1
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3. Occupational and Residential Thcoosune •
In Section Htbe Agency provides t brief dcscr^on of the types (rf product
formulations, application methods and sites. The ground formulation re" be applied from Cue
ground or by air as a dust to the foliage of growing crops or with a granular applicator (or
shaker can). The labels require a minimum of 7 days between applications. Except for the
neady-to-use pressurized product the liquid formulations are diluted with water and broadcast
sprayed by aircraft, ground boom, hand-held garden hose, and airblast spray equipment.
Based on the application methods and formulation types, the potential for
eye, dermal and inhalation exposure to mixers, loaders and applicators does exist In
addition, the potential for post-application exposure may be significant from the foliar
treatments applied prior to harvest since pre-harvest intervals are being removed from the
label. .
Based on the lack of significant toxicological concerns for capsaicin, there
are no additional exposure data required at this time.
4. Human Risk Assessment
The potential risks to humans from both dietary and occupational exposure
are considered negligible due to the long history of use by humans as a food
additive/component without any indication of deleterious health effects.
Due to the nature of the subject compound and the required precautionary
statements on the label, EPA concludes that products containing capsaicin will not have
adverse effects on human health.
C. gflyjjiflniTiental Assessment
The basic data requirements for a biochemical pesticide consist of the Tier I
ecological effects studies. Environmental fate (Tier n) and additional ecological effects (Tier
HI) studies are not required for biochemical pesticides unless adverse effects are observed in
Tier I studies. As described below, the Tier I studies have been waived
' 1. Ecological Effects Data
The Agency has no ecological effects or environmental fate data on
capsaicin. As a biochemical pesticide, a reduced data set of four studies would normally be
required: an acute avian oral study, a subacute avian dietary study, a 96-hour fish study, and
a 48-hour aquatic invertebrate study (guideline requirements 154-6,154-7,154-8, and 154-9,
-------
required: an acute avian oral study, a subacute avian dietary study, a 96-hour fish study, and
a 48-hour aquatic invertebrate study (guideline requirements 154-6, 154-7,154-8, and 154-9,
respectively). In the case of capsaicin, the Agency believes that its unique repellent
properties, in conjunction with appropriate label restrictions, can limit the exposure to non-
target species so that waivers can be granted for these ecological effects studies.
The basis for the Agency's position is as follows. Capsaicin is a strong and
immediately-acting irritant by both dietary and dermal routes of exposure. As such, one of
the uses is as a bird repellent. Therefore, for birds and other terrestrial species, the Agency
assumes that these animals will avoid excessive and prolonged exposure and thus minimize,
risk.
However, it should be noted that a bird feeding study (Blumberg, 1990) reported that
capsaicin did not repel birds because birds do not recognize capsaicin as "hot" since they do
not have capsaicin sensitive receptors, and a report of a second bird feeding study (letter of
6/2/82, from £. Schafer) states that ".... based on very limited data, I would expect that a
bird repellent material composed of chili pepper and garlic or their powders would have
minimal effectiveness in the field for its intended purpose on seed-eating birds."
EPA assumes that the product performance studies required by 40 CFR 158.640,
footnote 1, showed that the product worked as a bird repellent. Although, for this type of
product, these efficacy studies must be performed, they are not normally required to be
submitted to the Agency unless, on a case-by-case basis, the Agency decides that review of
the studies is necessary. In order to resolve this apparent discrepancy, the EPA will call in
and review the product performance studies for birds. If these data support the Agency's
rationale concerning exposure of terrestrial animals, avian study requirements will be waived.
p • • .-,..."
EPA will also call in and review the product performance studies for the insect
repellent labels since one label claims jpsegtiriflal activity for a mixture of this active
ingredient and another pesticide. This call-in is necessary since both active ingredients were
believed to have a non-toxic mode of action to the target pest; they have been classified as
biochemical pesticides. If this is not the case, then product reclassification may be warranted.
With respect to aquatic exposure, in Ueu of requiring the two aquatic studies, the
amount of aquatic exposure can be minimized by restrictive label statements. In contrast to
mobile terrestrial species, fish and aquatic species are not able to avoid chemicals that have
become mixed with, or dispersed in, their habitat. Given the lack of information on toxicity
to aquatic species and our inability to estimate exposure, there is great uncertainty about the
risk to the aquatic species. However, the Agency has found no reports of adverse
environmental effects from the previous use of this registered pesticide. As a precaution, the
potential risk may be reduced by reducing the possibility of aquatic exposure. Therefore, the
following statements will be required on the label under the general heading "Precautionary
Statements" and under the subheading "Environmental Hazard": "This product may be toxic
to aquatic organisms. Do not apply to or allow runoff to reach lakes, streams or ponds. Do
-------
not contaminate water by cleaning of equipment or disposal of wastes." In addition, the
Agency will require a maximum application rate on all labels.
^te Data
Because capsaicin is a biochemical pesticide, the requirement for
environmental fate data is contingent upon the results of Tier I ecological effects data
requirements. Since die ecological effects studies have been waived contingent on labeling to
reduce exposure, no environmental fete data will be required.
The Agency does not foresee the potential for significant risks
associated with the specified use of capsaicin, given the labeling restrictions. No hazard or
exposure issues have been identified that need to be addressed further. Therefore, no
ecological effects or environmental fate data are required to support the reregistration of
IV. RISK MANAaK\fl]jjJJT AND PflRF/rTPTRATION DECISION FOR CAPSAICIN
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 has previously identified and required
or waived the submission of the generic (i.e., active ingredient specific) data required to
support reregistration of products containing capsaicin as an active ingredient. The Agency
has completed its review of these generic data and other relevant information and has
determined that the data are sufficient to support reregistration of products containing
capsaicin. Appendix B identifies the data requirements that the Agency considered as part of
its determination of reregistration eligibility of capsaicin. Appendix C identifies references
of information the Agency relied upon for its assessments.
The data and information identified above are sufficient to allow the Agency to
conduct a reasonable risk assessment for the registered uses of capsaicin, The Agency
therefore finds that all products containing capsaicin as an active ingredient for the specified
use patterns are eligible for reregistration (See Appendix A for use patterns). The
reregistration of particular products is addressed in Section V of this document ("Product
Reregistration*).
Although the Agency has found that products containing capsaicin 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 capsaicin, 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. Tffierflijce Assessment
The Agency will propose a tolerance exemption for capsaicin under FFDCA Section
408 for all currently .registered food uses.
V. ACTIONS REOUlKfifl py REGISTRANTS OF ENP-TJSE PRODUCTS
- A. Determin
Based on consideration of information about the active ingredient capsaicin and
the registered use patterns, the products containing this active ingredient are eligible for
reregistration. Section 4(g)(2)(B) of FIFRA calls for. the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has been
made. Hie Agency will review these data and determine whether to reregister individual
products.
B. Product Specific Data Requirements
The product-specific data requirements are stated in Appendix D.
C. Labeling Requirements For End-Use Products
1. The labeling of all products must comply with EPA's current regulations and
requirements. Follow the instructions in the Product Reregistration Handbook with respect
to labels and labeling.
2. The Agency in Section m above describes certain deficiencies regarding
protection of workers and aquatic species and states that label changes are necessary to
support the Agency's conclusion that the use of capsaicin products would not cause
unreasonable risks. These label requirements are;
a. For products containing capsaicin as the only active ingredient the
environmental precaution: .
,*•
"This product may be toxic to aquatic organisms. -Do not apply to or allow
runoff to reach lakes, streams and ponds. Do not contaminate water by cleaning of
equipment or disposal of wastes."
b. For labels with no maximum application limit of capsaicin on the label,
registrants must include proposed maximum application rates for terrestrial food and
terrestrial non-food uses. .
8
-------
c. Registrants must delete from their label a statement for a pie-harvest
interval for products containing capsaicin since the Agency wiH propose a tolerance
exemption for capsaicin under FFDCA Section 408 for all currently registered food uses.
-------
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APPENDIX A
Capsaicin Use Patterns Subject to Reregistration
10
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APPENDIX A Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE Application Type, Application Timing. Application
Equipment
Form
USES ELIGIBLE FOR RBtEGtSTHATION
FOOD/FEED USES
Minimum
Application Rale
Maximum
Application flate
Max.*
Apps.
Ma*. *
Apps.
@
Max."
Hate
Mln. Interval
Between Apps.
@ Max. Rule
(Days)
Restricted
Entry
Interval
(Days)
Geographic
UmiliHiuns
Allowed
DisaHowed
Use limitations
also see
Abbreviations
Apple Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Broadcast, Polar. Aircraft
Broadcast, Fotar. Ground
Spray. Foliar. Aircraft
Spray. Petal lal, Aircraft
Spray. Foliar, Ground
Spray, Petal tal, Ground
0
D
SC/l
SC/L
SC/L
SC/L
na
na
na
na
na
na
6 to Al per A
6 fc At per A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
no)
spec
not
spec
not
spec
not
spec
7
7
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
j
Apricot Use Group: Terrestrial Food Crop
Broadcast, Polar. Aircraft
Broadcast. Fotar, Ground
D
D
na
na
6 to Al per A
6 Ib Al per A .
not
spec
not
spec .
not
spec
not
spec
7
7
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
interval. *
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvesl
interval.
7 days
preharvesl
interval.
7 days
preharvesl
interval.
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APPENDIX A Cas0 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsictiml
STTC Application Type. Application Timing, Application
Equipment
Apricot Use Group: Terrestrial Food Crop
Spray, Foliar. Aircraft
Spray, Petal lal. AJrcrafl
Spray, Foliar, Ground
Spray, Petal tal, Ground
Form
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
Maximum
Application Rale
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
*PPS.
not
.spec
not
spec
not
spec
not
spec
Max.*
Apps.
@
Max.
Rale
not
spec
not
spec
not
spec
not
spec
Min. Interval
Between Apps
(31 Max, Rate
(Days)
7
7
7
7
Beans Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
High volume spray (diute). At emergence,
Hydraulic sprayer
High volume spray (olute), Foliar.
Hydraulic sprayer
Low volume spray (concentrate), At emergence,
Hydraulic sprayer
Low volume spray (concentrate), Foliar. Aircraft
Low volume spray (concentrate), At emergence.
Low volume sprayer
Low volume spray (concentrate), Foliar, Low
volume sprayer
High volume spray (dfcjte), Foliar. Ground
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated .
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
As needed
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Di allowed
Use Limitations
also see
Abbreviations
15 days
preharvesl
interval.
15 days
preharvest
interval.
1 5 days
preharvest
interval.
15 days
preharvest
interval."'
not spec
not spec
no) spec
nol spec
not spec
nol spec
not spec
Limitation s A,
B,C
Limitations A,
B, C
Limitations A,
B. C
Limitations A,
B, C
Limitations A,
6. C
Limitations A,
B. C
15 days
preharvesl
interval.
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APPENDIX A Case 4018, [Capsaicin] Chemical 070701 [Capsaicin.ln Oleoresin of Capsicum!
SITE Applutton Typ«. Application Timing. Application
E«jlpment
Form
Minimum
Application Rale
Maximum
^-Application Rale
Max. t
Apps.
Man. *
Apps.
Max.
Rale
Mln. Interval
Between Apps.
@ Max. Rate
(Days)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Allowed
Oiiutiowi'd
Use Limitations
also sec •"
Abbreviations
Beans Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Spray, Polar. Aircraft
Spray, Seeding. Aircraft
Spriy. Seedfcig. Ground
SC/L
SC/L
SC/L
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
. not
spec
not
spec
not
spec
nol
spec
nol
spec
As needed
As needed
As needed
not spec
not spec
nol spec
15 days
preharvesl
interval.
15 days
preharvesl
interval.
15 days
preharvest
interval.
Beets (Unspecfflcd) Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Band treatment. At planting, Mechanical granule
appUcator
Broadcast, Foiar, Aircraft
Broadcast, Seedhig stage, Aircraft
Broadcast, Polar, Ground
Broadcast, Seedfog stage. Ground
Broadcast, Poslemergence. Shaker can
Sol band treatment, At planting. Shaker can
SoH treatment. At planting. Shaker can
0
D
D
D
0
D
D
b
na
na
na
na
na
na
na
na
2.4 Ib At per A
3.6 b Al per A
3.6 to Al per A
3.6 b Al per A
3.6bA1perA
Dose cannol
be calculated
Dose cannot
be calculated
Dose cannol
be calculated
not
spec
not .
spec
not
spec
not
spec
nol
spec
nol
spec
nol
spec
nol
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
nol
spec
not spec
7
7
7
7
nol spec
nol spec
nol spec
not spec
not spec
not spec
nol spec
not spec
not spec
not spec
not spec
**
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
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APPENDIXA Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE Application Type. Application Timing, Application
Equipment
Broccol Use Group: Terrestrial Food Crop
High volume spray. Foliar. Ground
Spray, Polar. Aircraft
Spray, Seedfcig stage. Aircraft
Spray, Seeding stage. Ground
Form
SC/L
SC/L
SC/L
SC/L
Minimum
Application Hate
na
na
na
na
Maximum
Application Rate
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Brussels Sprouts Use Groups: Terrestrial Food Crop -
High volume spray (dikile}. At emergence.
Hydraulic sprayer
High volume spray (dfkite). Foliar,
Hydrauic sprayer
Low volume spray (concentrate), At emergence,
Hydraulic sprayer
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate). At emergence.
Low volume sprayer
Low volume spray (concentrate), FoHar, Low
volume sprayer
Band treatment. At planting, Mechanical granule
applicator •_ ,
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
D
na
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
2.4 Ib Al per A
Max. t
APPS.
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mai.*
Apps.
-------
APPENDIXA Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicuml
STE Application Typ«. Application Timing. Application
Equipment
Cabbage Use Group: Terrestrial Food Crop
Broadcast. Polar. AircraH
Broadcast, Seeding stage. Aircraft
Broadcast,FoKar, Ground
Broadcast, Seedfog stage. Ground
Broadcast. Postemergence. Shaker can
Sol band treatment. At planting. Shaker can
Sol treatment. At planting. Shaker can
High volume spray (dttute). At emergence,
Hydraulic jsprayer
Hkjh volume spray (di)u(e). Foliar,
Hydraulic sprayer
Low volume spray (concentrate). At emergence,
Hydraulic sprayer
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate). At emergence.
Low volume sprayer
Low volume spray (concentrate), Foliar. Low
volume sprayer
Form
D
D
D
0
D
D
D
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rale
na
na
na
na
na
na
na
na
na
na
na
na
na
Maximum
Application Rate
3.6 Ib Al per A
36 to Al per A
3.6 tt>per A
3.6 to per A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Mai. *
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
hot
spec
not
spec
not
spec
nol
spec
nol
spec
not
spec
not
spec
not
spec
Max, t
Apps,
@
Max
Rut):
not
spec
not
spec
not
spec
nol
spec
not
spec
not
spec
nol
spec
nol
spec
not
spec
hot
spec
nol
Spec
not
spec
nol
spec
Mln. Interval
Between Apps.
@ Max. Rate
(Days)
7
7
7
7
nol spec
not spec
nol spec
not spec
not spec
not spec
not spec
not spec
not spec
Restricted
Enliy
tnter val
(Days)
not spec
not spec
not spec
nol spec
nol spec
not spec
not spec
not spec
not spec
nol spec
not spec.
not spec
not spec
Geographic.
Limitations
Allowed
-
ni'jdllowed
Use Umllutlons
also see
Abbreviations
7 days
preharvest
interval.
7 days
preharvesl
interval.
7 days
preharvest
interval.
7 days
prehcrvest
interval.
Limitations A,
B. C
Limitations A.
B.C
Limitations A.
B, C
Limitations A,
B, C
Limitations A,
B, C
Limitations A,
B. C
-------
APPENDIXA Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE Application Type. AppHcatton Timing. Application
Equipment
Fcum
Minimum
Application Rate
Maximum
Application Rate
Man.'t
Apps.
Max.*
Apps.
@
Max.
Rule
Mln. Interval
Between Apps.
@ Max. Rate
(Days)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Allowed ;
Di-jjllowtd
Use Limitations
also see
Abbreviation?
Cairot (Including tops) Use Group: Terrestrial Food Crop
Band treatment, At planting, Mechanical granule
applcator
Broadcast. Foliar. Aircraft
Broadcast, Seedling stage. Aircraft
Broadcast, Foliar, Ground
Broadcast, SeedUng stage. Ground
D
D
D
0
D
na
na
na
na
na
24 to Al per A
3 6 to Al per A
3.6 ft) A! per A
3.6 to Al per A
3.6lbAlperA
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
.7
7
not spec
not spec
not spec
not spec
not spec
7 days
preharvesl
interval.
7 days
preharvest
interval.
7 days
preharvest
interval. -
7 days
preahrvesl
interval.
Cauliflower Use Group: Terrestrial Food Crop
High volume spray (dfeile). Foliar, Ground
Spray, FoSar. Aircraft
Spray, Seedling stage. Aircraft
Spray, SeerJIng stage. Ground
High volume spray (dilute). At emergence,
Hydraulic sprayer
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
Oose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
As needed
As needed
As needed
As needed
not spec
not spec
not spec
not spec
not spec
not spec
15 days
preharvest
interval.
15 days
preharvest
interval.
1 5 days
preharvest
interval.
15 days
preharvest
interval.
Limitations A,
B,C
Cauliflower Use Group: Terrestrial Food Crop
-------
APPENDIXA- Case 4018, [Capsalcin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum!
SITE Application Type, Application Timing. Application
Equipment
Cauliflower Use Group: Terrestrial Food Crop
High volume spray (dfcite). Foiar,
Hydraulc sprayer
Low volume spray (concentrate), At emergence,
Hydraulic sprayer
Low volume spray (concentrate). Foliar, Aircraft
Low volume spray (concentrate). At emergence,
Low volume sprayer
Low volume spray (concentrate), Foliar, Low
volume sprayer
Form
SC/L
SC/L
SC/L
SC/1
SC/L
Minimum
Application flale
na
na
na
na
' ria
Maximum
Application Rate
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Mm.*
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
Max. f
Apps,
®
Max.
Rate
not
spec
nol
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
IS Ma», Rate
(Days)
nol spec
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
[OoyoJ
not spec
nol spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
also see
Abbreviations
Limitations A,
B, C
Limitations A,
B, C
Limitations A,
B.C
Limitations A,
B. C
Lkmi.ilions A,
B, C
Celery Use Group: Terrestrial Food Crop * . "'
High volume spray (dkite). Fotor, Ground
Spray, Foliar, Aircraft
Spray. Seedbig stage, Aircraft
Spray, Seeding stage. Ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated .
Dose cannot
be calculated
not
spec
not
spec
no!
spec
not
spec
not
spec
not
spec
not
spec
not
spec
As needed
As needed
As needed
As needed
not spec
not spec
nol spec
not spec
Cherry Use Group: Terrestrial Food Crop
Broadcast, Fotar. Aircraft
Broadcast, Foliar. Ground
D
0
na
na
6 to Al per A
6 Ib A) per A
not
spec
nol
. spec
not
spec
not
spec
7
7
not spec
not spec
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
7 days
preharvesl
interval.
7 days
preharvesl
interval.
-------
APPENDIXA- Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE Application Type, Application Timing, Application
Equipment
Cheery Use Group: Terrestrial Food Crop
Broadcast.FoNar. Shaker can
Spray, FoSar. Aircraft
Spray, Petal «al. Aircraft
Spray. Foliar, Ground
Spray. Petal fa». Ground
Form
D
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
na
Maximum
Application Rale
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot.
be calculated
Max.*
Apps,
not
spec
not
spec
not
spec
not
spec
not
spec
Max.*
Apps.
<3l
Max.
Rate
not •
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between App5.
@ Max. Rate
(Days)
7
7
7
7
7
Restricted
Entfy
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
'Gcogiaphlc
Limitations
AHowed
DiGulluwud
Use Limitations
also see
Abbreviations
2 days
preharvesl
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval. ""
15 days
preharvesl
interval.
Com (Unspecified) Us« Groups: Terrestrial Food Crop and Terrestrial (Feed Crop
Band treatment. At planting. Mechanical
granule applcator
Broadcast, Polar, Aircraft
Broadcast. SeedUng stage. Aircraft
Broadcast, Fotar, Ground
D
D
D
D
na
na
na
na
2.4 Ib Al per A
3.6lbAlperA
3.6 to Al per A
3.6 Ib Al per A
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
not spec
not spec
not spec
not spec
7 days
preharvesl
interval
7 days
preharvest
interval.
7 days
preharvesl
interval.
-------
APPENDIX A Case 4018, [Capsaicln] Chemical 070701 fCaosaicin. In Oleoresin of Capsicum]
SITE Appftcatkm Type. Apptc*1km Timing. Application
Equipment
.Form
Minimum
Application Rale
Maximum
Application Rale
Max. t
Apps.
Max, *
Apps.
@
Mai.
Rate
Mln. Interval
Between Apps.
@ Man. Rate
(Days)
Restricted
Entry
Inlet val
(Da ITS)
Geographic
Limitations
Allowed
Otbiillowed
Use Limitations
also see
Abbreviations
Com (Unspecified) Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Broadcast, Seeding stage, Ground
Broadcast, Shaker can. Postemergence
Sol band treatment. At ptenting. Shatter can
Sol treatment. At planting. Shaker can
High volume spray (daute). At emergence.
Hydraulc sprayer
High volume spray (dfeile), Polar.
Hydraulc sprayer
Low volume spray (concentrate), At emergence.
Hydraulic sprayer
Low volume spray (concentrate). Foliar, Aircraft
Low volume spray (concentrate). At emergence.
Low volume sprayer
Low volume spray (concentrate), Foliar. Low
volume sprayer
D
D
0
0
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
na
na
na
na
3.6 to Al per A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Cotton Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Htgh volume spray (dkite). At emergence,
HydrauHc sprayer
High volume spray (dilute). Fottv,
Hydraulic sprayer
Low volume spray (concentrate). At emergence,
Hydraulic sprayer
SC/L
SC/L
SC/L
na
na
na
Oose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvesl
interval.
Limitations A,
B,C
Limitations A.
B, C
Limitations A,
B, C
Limitations A,
B,C
Limitations A,
B, C
Limitations A,
B, C
Limitations A,
B
Limitations A.
B
Limitations A,
B
9 '
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE AppKcaHon Type. Application Timing, Application
Equipment
Form
Minimum
Application Rate
Maximum
Application Rate
Max. #
Apps.
Max. *
Apps.
@
Max.
Rate
Mlh. Interval
Between Apps.
©Max. Flute
(Djys)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Allowed
Dt:,ulloiA/i:d
Use Limitations
also see
Abbreviations
Cotton Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Low volume spray (concentrate), Polar. Aircraft
Low volume spray (concentrate). At emergence,
Low volume sprayer
Low volume spray (concentrate), FoKar, Low
volume sprayer
SC/L
SC/L
SC/L
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
Cucumber Use Group: Terrestrial Food Crop .
High volume spray (dilute), Al emergence.
Hydraulic sprayer
High volume spray (diute), FoBar,
Hydraulic sprayer
Low volume spray (concentrate). At emergence,
Hydraulic sprayer
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate). At emergence.
Low volume sprayer
Low volume spray (concentrate), FoKar, Low
volume sprayer
Spray, Foliar. Aircraft
Spray. Seedling stage, Aircraft
Spray, Foliar, Ground
SC/L
SC/L
SCH
sen.
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not. spec
not spec
not spec
not spec
As needed
As needed
As needed
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Limitations A,
B
Limitations A,
B
Limitations A,
B
Limitations A,
B.C
Limitations A.
B. C ".
Limitations A,
B.C
Limitations A,
B. C
Limitations A,
8, C
Limitations A.
B.C
15 days
preharvest
interval.
15 days
preharvesf
interval.
15 days
preharvest
interval.
10
-------
APPENDIXA Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE AppKortton Type. Appdertloo Timing. Application
Equipment
Cucumber Use Group: Terrestrial Food Crop
Spray, Seeding stage. Ground
Form
SCfl
Minimum
Application Rale
na
Maximum
Application Rate
Dose cannot
be calculated
Max.*
Apps.
not
spec
Max.*
Apps.
@
Man.
Hole
not
spec
Mln. Interval
Between Apps.
© Max. Rale
(Days)
As needed
Restricted
Enlry
Inteival
(Days)
not spec
Geographic
Limitations
Allowed
.Dlsalluvw'd
Use Limitations
also see
Abbreviations
15 days
preharvest
interval.
Cereal Grains Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Band treatment Al planting, Mechanical granule
appttcalor
Broadcast,Folar. Aircraft
Broadcast. Seeding stage, Aircraft
Broadcast. Foiar, Ground
Broadcast, Seeding stage, Ground
0
D
0
D
D
na
na
na
na
na
2.4 to Al per A
3.6 to Al per A
3.6 to Al per A
3.6 fa Al per A
3.6 to Al per A
Fig Use Group: Terrestrial Food Crop
Broadcast. Folar. Aircraft
Broadcast, Foliar, Ground
D
D
na
na
6 to Al per A
6 to Al per A
not
spec
not
spec
not
spec
not
spec .
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not
spec
not
spec
not
spec
not
spec
7
7
not spec
not spec
not spec
not spec
no) spec
not spec
not spec
7 days
preharvesl
interval.
7 days
preharvest
interval
7 days „
preharvest
interval.
7 days
preharvest
interval.
7da,i
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
Grapes Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Broadcast, Foliar. Aircraft
D
na
3.6 tb AlperA
not
spec
not
spec
7
not spec
7 days
preharvesl
interval.
-11
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE AppHcaUon Type. Application Timing. Application
Equipment
Form
Minimum
Application Rate
Maximum
Application Rate
Mr,,,*
. Apps.
Max. *
Apps.
&
Max.
Half
Mln. Interval
Between Apps.
@ Mai. Rate
(Days)
Restricted
Entry
Interval
(Ui^l
Geogiuphlc
LJrnildllan:*
Allowed
Disallowed
Use Limitations
also see
Abbreviations
Grapes Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Broadcast. Polar. Ground
Broadcast, Fotor, Shaker can
Spray. Foliar. Ground
Spray. FoMar, Aircraft
0
0
SC/L
SC/L
na
na
na
na
3.6 to A) per A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
no)
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
7
not spec
not spec
not spec
not spec
•'•
7 days
preharvest
interval.
2 days
preharvesl
interval.
15 days
preharvest
interval.
15 days
preharvesl
interval.
Lettuce Use Group: Terrestrial Food Crop
Band treatment, At planting. Mechanical granule
applicator
Broadcast, Fotar. Aircraft
Broadcast, Seeding stage, Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage. Ground
Broadcast, Postemergence, Shaker can
D
D
0
0
D
D
na
na
na
na
na
na
2,4 Ib.AI per A
3.6 Ib Al per A
3.6 Ib Al per A
3.6 to Al per A
3.6 to Al per A
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
interval. .
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvesl
interval.
12
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oteoresin of Capsicum] |
SITE Application Type, Application Timing. Application
Equipment
Lettuce Use Group: Terrestrial Food Crop
High volume spray (dilute), Foliar, Ground
Sol band treatment. At planting, Shaker can
Sol treatment, At planting, Shaker can
Spray. Foter, Alrenft
Spray. Seeding stage, Aircraft
Spray, Seedling stage, Ground
Fofm
SC/L
D
D
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
na
na
Mailmunv
Application Rate
Dose cannot'
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Mo..*
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Max. *
Apps,
&
Mas,
Rule
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
® Max. Rale
(Days)
As needed
not spec
not spec
As needed
As needed
As needed
Melons Use Groups: Terrestrial Food Crop
High volume spray (dilute). At emergence.
Hydraulic sprayer
High volume spray (dflute). Foter.
HydrauHc sprayer
Low volume spray (concentrate), At emergence,
HydrauHc sprayer
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), At emergence.
Low volume sprayer
Low volume spray (concentrate), Foiar, Low
volume sprayer
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
. not spec
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Qhiillowd
Use Limitations 1
also see ||
Abbreviations
15 days
preharvesl
interval.
IS days
preharvest
interval.
todays*1
preharvest
interval.
1 5 days
preharvesl
interval.
not spec
not spec
not spec
not spec
not spec
not spec
Limitations A,
B. C
Limitations A.
B, C
Limitations A,
B, C
Limitations A,
B. C
Limitations A,
B. C
Limitalions A,
B. C
-------
APPENDIX A Case 4018, [Capsaicfn] Chemical 070701 [Capsaicin, In Oleoresin of Capstcuml
STTE AppfcatlortType, Application Timing. Application
Equipment
Melons Use Groups: Terrestrial Food Crop
Band treatment. At planting. Mechanical
granule applcalor
Broadcast. Polar, Aircraft
Broadcast.Seedfog stage. Aircraft
Broadcast, Foter. Ground
Broadcast, SeecMng stage. Ground
Broadcast. Postemergence, Shaker can
Sol band treatment, At planting, Shaker can
SoH treatment. At planting. Shaker can
Spray. Foliar, Aircraft
Spray, SeedHng stage. Aircraft
Spray, Foliar, Ground
Form
D
D
D
D
D
0
D
D
SC/L
SC/L
SC/L
Minimum
Application Bate
na
na
na
na
na
na
na
na
na
na
na
Maximum
Application Rate
2.4 1b Al per A
3.6 to Al per A
3.6 Ib Al per A
3.6 Ib Al per A
3.6 Ib Al per A
Dose cannot
be calculated
Oose cannot
be calculated
Dose cannot
be calculated
Dose can not
be calculated
Dose cannot
be calculated
Oose cannot
be calculated
Max. i*
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec .
not
spec
not
spec
Max. f
Apps:
®
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mia Interval
Between Apps.
•@ MUM. Rale
(Da/s)
not spec
7
7
7
7
not spec
not spec
not spec
As needed
As needed
As needed
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
also see
Abbreviations
7 days
preharvesl
interval.
7 days
preharvesl
interval.
7 days
preharvesl
interval.
7 days
preharvesl
interval.
15 days
preharvest
interval.
15 days
preharvesl
interval.
15 days
preharvest
interval.
14
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 tCapsaicin, In Oleoresin of Capsicuhil
SITE Application Type. Application Timing. Application
Equipment
Melons Use Groups: Terrestrial Food Crop
Spray. Seeding stage. Ground
Form
SC/L
Minimum
Application Rale
na
Maximum
Application Rate
Dose cannot
be calculated
Man. *
Apps.
not
spec
Max. *
Apps.
Max.
Hale
not
spec
Mln. Interval
Between Apps.
.@Max. Rate
; (Days)
As needed
Restricted
Entry
Interval
(Days)
not spec
Geographic
Limitations
Allowed
Dl^llo^d '
Use Limitations
also see
Abbreviations
15 days
preharvest
interval. .
Melons. Cantaloupe Use Group: Terrestrial Food Crop
Spray, Polar. Aircraft
Spray, Seeding stage. Aircraft
Spray. Foliar. Ground
Spray, Seedktg stage. Ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not,
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Nectarine Use Group: Terrestrial Food Crop
Broadcast. Foliar. Aircraft
Broadcast. Polar, Ground
D
D
na
na
6 to At per A
6 to Al per A
not
spec
not
spec
not
spec
not
spec
As needed
As needed
As needed
As needed
not spec
not spec
not
spec
not spec
! 5 days
preharvest
interval.
IS days
preharvest
interval.
15 days *
preharvesl
interval.
IS days
preharvest
interval.
7
7
not spec
not spec
Orchards (Unspecified) Use Grow: Terrestrial Food Crop
Broadcast.Folar. Aircraft
Broadcast. Polar. Ground
D
0
na
na
6 Ib Al per A
6 Ib Al per A
not
spec
not
spec
not
spec
not
spec
7
7
not spec
not spec
7 days
preharvest
interval.
7 days
preharvesl
interval.
7 days
preharvest
interval.
7 days
preharvesl
interval.
15
-------
APPENDIXA- Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum!
SfTE Apfflcatlon Typ«. Application Timing. Application
Equipment
Form
Minimum
Application Bate
Maximum
Application Hate
Mai. *
Apps.
Ma*.*
Apps.
@
Max.
Rate
Mln. Interval
Between Apps.
@ Max, Hate
(Days)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Alkiwcd
Disallowed
Use Limitations
also see
Abbreviations
Orchards (Unspecified) Use Group: Terrestrial Food Crop
Bwk treatment. Donnant. Hydraulic sprayer
Bark treatment, FoSar, Hydraulic sprayer
Bark treatment, Postharvest. Hydraulic sprayer
Bark treatment. Dormant. Low volume sprayer
Bark treatment. Fotar, Low volume sprayer
Bark treatment. Postharvest, Low volume sprayer
Low volume spray, Dormant, Aircraft
Low volume spray. Foliar, Aircraft
Low volume spray, Postharvest. Aircraft
Low volume spray, Polar. Hydraulic sprayer
Low volume spray, Dormant, Hydraulic sprayer
Low volume spray, Postharvest, HydrauMc
sprayer
Low volume spray, Dormant, Low volume sprayer
Low volume spray. Foliar, Low volume sprayer
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
na
na
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
• Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
hot spec
Limitations A,
B
Limitations A,
B
Limitations A,
B
Limitations A,
B
Limitations A,
B
Limitations A.
B
Limitations A,
B
Limitations A,
B
Limitations A,
B
Limitations A.
B
Limitations !
B
Limitations A,
B
Limitations A,
B
Limitations A,
B
-
-------
APPENDIXA Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicuml
SITE Appfcatton Type. AppfcaUon Timing. Application
Equipment
Form
Minimum
Application Rate
Maximum
Application Hate
Max. *
Apps.
Man. *
Apps.
@
Max.
Rale
Mln Interval
Between Apps.
S> Mai. Rate
(Days)
Restricted
Entfy
Interval
(Days)
Geographic
Limitations
Allowed
Di'jLillnwed
Use Limitations
also see
Abbreviations
Orchards (Unspecified) Use Group: Terrestrial Food Crop
Low volume spray, Postharvest.Low volume
sprayer
Broadcast, Folar, Shaker can
Spray. FoMir, Aircraft
Spray, Petal tal. Aircraft
Spray. FoHar. Ground
Spray. Petal fad. Ground
SC/L
0
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not. spec
Orange Use Groups; Terrestrial Food Crop and Terrestrial Feed Crop
Spray, Foliar. Aircraft
Spray, Petal tal. Aircraft
Spray, Foliar. Ground
Spray. Petal lal, Ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
• be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
7
not spec
not spec
not spec
not spec
Limitations A,
B
2 days
preharvest
interval.
IS days
preharyesl
interval.
15 days
preharvest
Interval.
15 days
preharvesl
interval.
IS days
preharvest
interval.
tSdays
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
17
-------
APPENDIXA Case 4018, fCapsaicinl Chemical 070701 fCaosaicin. In Oleoresin of Capsicum]
STTE Application Type. Application Timing. Application
Equipment
Peach Use Group: Terrestrial Food Crop
Broadcaal.Fotor, Aircraft
Broadcast. Fotar, Ground
Spray. Polar. Aircraft
Spray, Petal fal. Aircraft
Spray. Foliar. Ground
Spray. Petal fat. Ground
Form
D
0
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
na
na
Maximum
Application Hate
6 b Al per A
6 b Al per A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.'*
Apps,
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Max. *
Apps.
@
Max.
Rat;
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
@ Max. Rate
(Days)
7
7
7
7
7
7
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
Gcogruplilc
Limitations
Allowed
Db.illuiwd.
Use I Imitations
also see
Abbreviations
7 days
preharvest
interval.
7 days
preharvesl
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
IS days
preharvesl
interval.
15 days
preharvest
hterval.
Peas (Unspecified) Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop '
High volume spray (diute), At emergence.
Hydraulc sprayer
High volume spray (oHute). Folar.
Hydraulc sprayer
Low volume spray (concentrate), At emergence.
Hydraulic sprayer
Low volume spray (concentrate). Foliar. Aircraft
Low volume spray (concentrate). At emergence,
Low volume sprayer
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not.
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Limitations A,
B. C
Limitations A,
B, C
t Initiations A,
B. C
Limitations A.
B. C
Limitations A.
B. C
'
16
-------
APPENDIX A Case 4018, [Capsalcin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicuml
SITE AppHcatton Type. Application Timing. Application
Equipment
Form
Minimum
Application Rote
Maximum
Application Rate
Mai, *
Apps.
Max. *
Apps.
e
Max.
Rate
Mln Interval
Between Apps.
@ Mai. Rale
(Days)
Restricted
Entry
Interval
(Duysl
Geographic
Limitations
Allowed
ni!,,iii.>wcd
Use Umltallons
also see
Abbreviations
Peas (Unspecified) USA Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Low volume spray (concentrate), Folar, Low
volume sprayer
SC/L
na
not
spec
not
spec
not spec
not spec
Limitations A.
B. C
Peppers Use Group: Terrestrial Food Crop
High volume spray (dhrte). At emergence.
Hydrsulc sprayer
High volume spray (dhite), Folar,
Hydraulc sprayer
Low volume spray (concentrate). At emergence.
Hydraulic sprayer
Low volume spray (concentrate), Folar, Aircraft
Low volume spray (concentrate), At emergence,
Low volume sprayer
Low volume spray (concentrate), Folar, Low
volume sprayer
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
nol
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
-
Limitations A,
B,C
Limitations A,
B,C
Limitations A,
B, C . „
Limitations A,
B. C
Limitations A.
B.C
Limitations A.
8, C
Phm Use Group: Terrestrial Food Crop -
Broadcast, Foiar, Aircraft
Broadcast, Foiar, Ground
Spray. Foliar. Aircraft
Spray, Petal Id. Aircraft
D
D
SC/L
SC/L
na
na
na
na
6 to Al per A
6 to Al per A
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
nol
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
7
nol spec.
not spec
not spec
nol spec
7 days
preharvest
interval.
7 days
preharvesl
interval
15 days
preharvest
interval.
15 days
preharvesl
interval
19
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 {Capsalcin, In Oleoresin of Capsicum!
SITE AppHcathm Type. Application Thnlno. AppUcMbxi
Equipment
Plum Use Group: Terrestrial Food Crop
Spray. Foliar, Ground
Spray. Petal Mt. Ground
Radish Use Group: Terrestrial Food Crop
Broadcast, Poslemergenoe. Shatter can
Sol treatment. At ptanflno;. Shaker can
Soil band treatment, At planting. Shaker con
Smol Fruits Use Group: Terrestrial Food Crop
Broadcast. Fotar, Afrcraft
Broadcast. Foliar. Ground
Spray. Foliar, Aircraft
Spray, FoNar. Ground
Form
SCA.
SC/t
Minimum
Application Rate
na
na
Maximum
Application Rale
Dose cannot
be calculated
Dose cannot
be calculated
Ma..*
Apps.
not
spec
not
spec
Man. *
Apps.
@
Mai.
ftjtc
not
spec
no)
spec
Mln. Interval
Between Apps,
® Man. Rate
(Days)
7
7
D
D
D
0
D
SC/L
SC/t
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
ne
na
na
na
3.6 to Al per A
36 Ib Al per A
Dose cannot
' be calculaled
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
7
7
7
7
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
• also see
Abbreviations
15 days
preharvest
interval.
15 days
preharvest
interval.
M
7 days
preharvest
interval.
7 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvesl
interval.
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 fCapsaicin, In Oleoresin of Capsicum!
SITE Application Type. Application Timing. Application
Equipment
Spinach Use Group: Terrestrial Food Crop
High volume spray (dJute), Polar. Ground
Spray. Polar, Aircraft
Spray. Seeding stage. Aircraft
Spray. Seedng stage. Ground
F
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 [Capsaicirii In Oleoresin of Capsicum]
SITE Apportion Type. Application Timing. Application
Equipment
Form
Minimum
Application flate
Maximum
Application Rate
Max. t
Apps.
Max.*
Apps.
@
Max.
Rate
'Mln Interval
Between Apps.
@ Max. Rate
(Days)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Allowed
1 >!•.,. |.,Wi'(1
Use Limitations
also see
Abbreviations
Sunflower Use Groups: Terrestrial Food Crop and Terreslrial peed Crop
Band treatment. At planting, Mechanical
granule applicator
Broadcast. Fcfer, Aircraft
Broadcast, Seedtag stage, Aircraft
Broadcast, FoNar, Ground
Broadcast, Seedbig stage, Ground
D
0
D
D
D
na
na
na
na
na
2.4 Ib Al per A
3.6 Ib Al per A
3.6 Ib Al per A
3.6 Ib Al per A
3,6 to Al per A
not
spec
not
spec
not
spec
not
spec
not
spec
Tomato Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
High volume spray (dilute), At emergence,
Hydraulc sprayer
High volume spray (dfette). Foliar,
Hydraulic sprayer
Low volume spray (concentrate). At emergence,
HydrauKc sprayer
tow volume spray (concentrate). Foliar, Aircraft
Low volume spray (concentrate), At emergence.
Low volume sprayer
Low volume spray (concentrate), Foliar, Low
volume sprayer
Broadcast. At planting, Mechanical granule
applicator
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
0
na
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Pose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
2.4 Ib Al per A
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
nol spec
nol spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvesl
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
nol
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
nol spec
not spec
not spec
not spec
Limitations A.
B,C
Limitations A,
B, C
Limitations A,
B.C
Limitations A.
B, C
Limitations A,
B,C
Limitations A,
B.C
22
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 [Capsaicih, In Oleoresin of Capsicum]
SITE Applccdon Type. AppUccllcn Tlmlne, Application
Equipment
Form
Minimum
Application Rate
Maximum
Application Rate
/*
Mai. *
Apps.
. Max. *
*PPS.
@
Max.
Hate
Mln. Interval
Between Apps.
® Max. Rale
(Days)
Restilcled
Entry
Interval
(Djyn)
Geographic
Llmi!u1ton5
Allowed
Oisjllowed
Use Limitations
also see
Abbreviations
Tomato Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Broadcast, Polar. Aircraft
Broadcast, Seeding stage. Aircraft
Broadcast, Seeding stage. Ground
Broadcast. Postemergence. Shaker can
High volume spray (dfete). Foliar, Ground
SON band treatment. At planting, Shaker can
Sol treatment At planting. Shaker can
Spray. Foliar, Aircraft
Spray. Seedling stage. Aircraft
Spray, SeedNng stage, Ground
D
0
D
D
SC/L
D
D
SC/L
SC/L
SC/L
na
na
na
na
na
na
na
na
na
na
3.6 to Al per A
3.6t>AlperA
3.6 R> At per A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
not spec
As needed
not spec
not spec
As needed
As needed
As needed
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvesl
interval.
7 days
preharvest,
interval.
IS days
preharvest
interval.
15 days .
preharvest
interval.
IS days
prenarvest
interval.
15 days
preharvest
interval.
23
-------
APPENDIXA- Case 4018, [Capsaicin]Chemical 070701 [Capsaicin.ln Oleoresinof Capsicum]
SITE Apptkattoo Type. Application Timing. AppNcslion
Equipment
Tree Nuts Use Group: Terrestrial Food Crop
Broadcast, Fofar. Aircraft
Broadcast. FoHar, Ground
Bark treatment, Dormant, Hydraulc sprayer
Bark treatment, Fotar. Hydraulic sprayer
Bark treatment. Postharvest. Hydraulc sprayer
Bark treatment. Dormant, Low volume sprayer
Bark treatment, FoRar. Low volume sprayer
Bark treatment, Postharvest, Low volume sprayer
Low votume spray, Dormant, Aircraft
Low volume spray. Foliar, Aircraft
Low volume spray, Postharvesl.Alrcrafl
Low volume spray, FoRar, Hydraulc sprayer
Low volume spray, Dormant, Hydraulc sprayer
Low volume spray, Postttatvest. Hydraulic
sofaver _
Form
D
D
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
na
na
na
na
na
na
na
na
na
na
Maximum
Application Rate
6 Ib Al per A
6 to At per A
Dose cannot
be calculated
Dose Cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Man. »
Apps,
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
MBK. *
Apps.
®
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not.
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
.©Max. Rate
(Days)
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
also see
Abbreviations
7 days
preharvesl
interval.
7 days
preharvesl
interval.
Limitations A,
B
Limitations A,
B
Limitations A,
B
Limjlalions A,
B
Limitations A,
B
Limitations A,
B
Limitations A,
8
Limitations A,
B
Limitations A.
B
Limitations A,
B
Limitations A,
B
limitations A,
B
-------
APPENDIXA- Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE Application Type, Apportion Timing. Application
Equipment
Tree Nuts Use Group: Terrestrial Food Crop
Low volume spray. Dormant. Low volume sprayer
Low volume spray, Fotar. Low volume sprayer
Low volume spray. Postlwvesl.Low volume
sprayer
Form
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
Maximum
Application Hale
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
Apps.
not
spec
not
spec
not
spec
Max. t
Apps.
@
Mai.
Hate
not
spec
not
spec
not
spec
Win, Interval
Between Apps
•@ Mai. Rate
(Days)
not spec
not spec
not spec
Restricted
Entry
Interval
[Days)
not spec
not spec
not spec
Geographic
Limitations
AHowcH
Disallowed
Use UmBatlons
also see
Abbreviations
Limitations A,
B
Limitations A,
B
Limitations A,
B
Vegetables (Unspedfed) Use Group: Terrestrial food Crop
Band treatment, At planting. Mechanical granule
•ppfcalor
Broadcast, Fotar. Aircraft
Broadcast, Seeding stage, Aircraft
Broadcast, Fotar, Ground
Broadcast, Sewing stage. Ground
Broadcast, Postenwrgence, Shaker can
High volume spray (dfcjte), FoSar, Ground
Sol band treatment, At planting. Shaker can
SoH treatment. At planting, Shaker can
O
D
D
D
0
D
SC/L
D
0
na
na
na
na
na
na
na
na
na
2.4K>AlperA
3.6 to Al per A
3.6 fc Al per A
3.6fcAlperA
36 to Al per A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dosecanrtol
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
As needed
not spec
not spec
not spec
not spec
nol spec
not spec
nol spec
not spec
not spec
not spec
not spec
7 days „
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
15 days
preharvest
interval.
25
-------
APPENDIX A Case 4018, [Capsaicin] Chemical 070701 [Capsaicin, In Oleoresin of Capsicum]
SITE ApfdcaUon Type, Application Timing. Application
Equipment
Form
Minimum
Application Rate
Maximum
Application Rale
M«», f
Apps.
Max.*
AppS.
@
Max.
Rate
Mln. Interval
Between Apps,
@ Man. Rate
(Days)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Allowed
Dlodlluwcd
Use Umltallons
also see
Abbreviations
Vegetables (Unspecified) Use Group: Terrestrial Food Crop
Spray. Foliar. Aircraft
Spray, Seeding stage, Aircraft
Spray. StwMng stage. Ground
SC/L
SC/L
SC/L
net
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
As needed
As needed
As needed
not spec
not spec
not spec
15 days
preharvest
interval.
15 days
preharvesl
interval.
15 days
pfeharvesl
interval.
NONFOOD/NONFEED USES
Ornamental Herbaceous Plants Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Spray. FoNar. Aircraft
Spray. Fotar, Ground
SC/L
SC/L
na
na
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
As needed
As needed
not spec
not spec
Ornamental Woody Shrubs and Vines Use Groups: Terrestrial Non Food Crop and Outdoor Residential
Bark treatment. Fotar, Hydraulic sprayer
Bark treatment, Foliar, Low volume sprayer
Low volume spray, Foliar, Aircraft
Low volume spray, Foliar, Hydraulic sprayer
Spray, FoHar, Ground
Low volume spray. Foliar, Low volume sprayer
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
'
Limitations A.
B
Limitations A,
B
Limitations A,
B
Limitations A,
B
1 ' •.
Limitations A,
B
26
-------
APPENDIX A- Case 4018, [Capsaicin] Chemical 070701 [Capsalclnjn Oleoresin of Capsicum]
SITE Application Type. AppHcallon Timing, Application
Equipment
Fwm
Minimum
Application Rale
Minimum
Application Rate
Max. *
Apps.
' Max. *
Apps.
W
Mai
flate
Mhl. Interval
Between Apps.
<3> Max. Rale
(Days)
Restricted
Enlry
interval
(Days)
Geographic
Llmllutlons
Allowed
!>!• ..ll.jwcd
Use Limitations
also see
Abbreviations
Ornamental Woody Shrubs and Vines Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Spray. Foliar, Aircraft
SC/L
na
Dose cannot V not
be calculated J spec
not
spec
As needed
not spec
Omametal and/or Shade Trees Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Bark treatment, Fotar. Low volume sprayer
Low volume spray, Polar, Aircraft
Low volume spray. Fotar, Hydraulic sprayer
Low volume spray. Polar, Low volume sprayer
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
nol spec
nol spec
HousehoW/DomesUcDweWngs Contents Use Group: Indoor Residential
Sprinkle. Whan needed, Equipment not on label
D
na
Dose cannot | not
be calculated H spec
HouseholoVDomesUcDweings Indoor Premises Use Group: Indoor Residential
Contact and/or surface treatment. When needed.
Pump spmy bottle
SC/L
na
Dose cannot I not
be calculated j] spec
not
spec
1.5
not spec
Limitations A,
8
Limitations A,
B
Limitations A,
B
LJfnitations A.
B
Limitations A,
B
nol
spec
As needed
nol spec
HousehoM/DomestlcOweMnqs Outdoor Premises Use Group: Outdoor Residential
Outdoor general surface treatment. When
needed. Pump spray bottle
SC/L
na
Dose cannot not
be calculated || spec
not
spec
As needed
not spec
Humans (Animal Attack Prevehtallve) (Veitabrale Pest Control) Use Group: Indoor Residential
Directed spmy, When needed. Aerosol can
PRL
na
Dose cannot | nol
be calculated | spec
not
spec
nol spec
nol spec
.27
-------
Abbreviations used '
. Header max«maxlmum; mln=mlnlmum; apps=app»catk>ns-,nol spec=not specified: na=nol applicable
Form: D*dust; SC/L-sokible concentrate/liquid PRUpressurized Nquid
Rate: al««cllve Ingredient; A^acre
Utnitatloos: UmHatlon A = Do not apply through any type ol Irrigation system
UtnHalion B « Do not use treated foliage lor animal bedding or feed.
Limitation C * Do not apply after edible parts start to form.
. 28
-------
APPENDIX B
Generic Data Requirements for Reregistration of Capsaicin
Data Citations Supporting Reregistration
11
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for
the pesticide covered by this Reregistration Eligibility Document.
Appendix B contains generic data requirements that apply to the pesticide in all
products, including data requirements for which a "typical formulation" is the test substance.
The data table are generally 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 following letter designations are used for the given use
patterns:
A Terrestrial food
K Residential outdoor
O Residential indoor
Any other designations will be defined in a footnote to the table.
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its
files, this column lists the identifying number of each study. This normally is the Master
Record Identification (MRJD) number, but may be a GS number if no MRID number has
been assigned. Refer to the Bibliography Appendices for a complete citation of the study.
-------
APPENDIX B
GENERIC DATA REQWREMENTS FOR REREGISTRATION OF CAPSAICIN
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
TITLE OF
STUDY
USE PATTERNS
BIBLIOGRAPHIC
CITATION
Product Chemistry
151B-IO
15IB-11
15IB-12
151B-13
15IB-15
1S1B-16
Product Identification AKO
Manufacturing Process AKO
Discussion of Formulation AKO
of Unintentional Ingredients
Analysis of Samples AKO
Certification of Limits AKO
Analytical Methods AKO
Data were obtained from the most recent
confidential statements of formula for ,
registered products.
1
1 Information was obtained from internal files and documents.
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF CAPSAICEV
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
Product Chemistry
151B-17(a)
151B-17(b)
I51B-17(c)
151B-17(e)
151B~17(f)
151B-17(g)
151B-17(h)
151B-17(i)
151B-170)
!51B-17(k)
15IB-17(1)
151B-17(m)
TITLE OF
STUDY
(continued)
Color
Physical State
Odor
Boiling Point
Density or Specific Gravity
Solubility
Vapor Pressure
Ph
Stability
Flam inability
Storage Stability
Viscosity
USE PATTERNS
AKO
AKO
AKO
AKO
AKO
AKO
AKO
AKO
AKO
AKO
AKO
AKO
BIBLIOGRAPHIC
CITATION
I
1
1 ..- .*
1
1
I
1
1
1
Not applicable
1
Waived
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF CAPSAICIN
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
151B-I7(n)
!51B-17(o)
15lB-17(p)
TITLE OF
STUDY
Miscibility
Corrosion Characteristics
Octanoi/H20 Partition
USE PATTERNS
AKO
AKO
AKO
BIBLIOGRAPHIC
CITATION
Waived
Waived
Waived „•
Coefficient
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OP CAPSAICIN
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
Ecological Effects
154-6
154-7
154-8
154-9
TITLE OF
STUDY
•Avian Acute Oral
Avian Dietary
Freshwater Fish LC50
Freshwater Invertebrate
USE PATTERNS
AKO
AKO
AKO
AKO
BIBLIOGRAPHIC
CITATION
Waived
Waived
Waived
Waived
LC50
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF CAPSAICIN
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE TITLE OF USE PATTERNS BIBLIOGRAPHIC
CITATION STUDY CITATION
Environmental Fate
Data requirements do not apply since ecological effects data are waived.
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF CAPSAICIN
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
Tpxicplogy:
152B-10
152B-11
152B-12
152B-13
152B-14
I52B-15
152B-16
152B-I8
TITLE OF
STUDY
•
Acute Oral Toxic ity
Acute Dermal Toxichy
Acute Inhalation
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
Hypersensitivity*
Immunotoxicity
USE PATTERNS
AKO
AKO
AKO
AKO
AKO
AKO
AKO
AKO
BIBLIOGRAPHIC
CITATION
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF CAPSAICIN
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
152B-20
I52B-21
I52B-22
152B-23
152B-17
TITLE OF
STUDY
90-Day Feeding (1 Species)
90-Day Dermal-Rat
90-Day Inhalation-Rat
Teratogenicity (1 Species)
Mutagemcity (Ames)
USE PATTERNS
AKO
AKO
AKO
AKO
AKO
BIBLIOGRAPHIC
CITATION
Waived
Waived
Waived
Waived
Waived
-------
-------
APPENDIX C
Citations Considered to be Fart of the Data Base
Supporting the Reregistration of Capsaicin
-------
OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
Chemical Name: Capsaicin
1. Letter from J. Gordon Dixcn, AJRI, dated December 1991, providing a description of the
manufacturing process, including composition and purity of starting and intermediate materials;
a complete list of the names and amounts of ingredients in the products; physical and chemical
properties, descriptions of analytical methods used to determine the identity and concentrations
of active ingredients and impurities, in sufficient detail to permit repetition and validation of
those methods; results o analytical procedures including raw data; and a theoretical discussion
of the impurities which may be sent in the product~e.g., unreacted starting materials or products
formed by degradation of the.active ingredient and the reasons why such impurities might not
be present in the product.
-------
APPENDIX D
PR Notice 91-2
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
i>
-------
The upper and lower certified limits, which must be proposed in
connection with a product's registration, represent the amounts «f
an-ingredient that may legally be present 40 CFR 158.175. The lower
certified limit is used as the enforceable lower limit for the
product composition according to FIFRA section 12(a)(1)(C), while
the nominal concentration appearing on the label would be the
routinely achieved concentration used for calculation of dosages
and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual product
composition because the nominal concentration would be the amount
of active ingredient typically found in the product.
It is important for registrants to note that certified limits
for active ingredients are not considered to be trade secret
information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing on
the label may not represent the enforceable composition for
purposes of section l2(a)(l)(C). .
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered, products as well as all applications for new
registration must comply with this Notice by specifying the nominal
concentration expressed as a percentage by weight as the label
claim in the ingredient(s) statement and equivalence statements if
applicable (e.g., elemental arsenic, metallic zinc, salt of an
acid). in addition, the requirement for performing sample analyses
of five or more representative samples must be fulfilled. Copies of
.the raw analytical- data must be submitted with the nominal
ingredient label claim. Further information about the analysis
requirement may be found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert
ingredient, impurities of toxicological significance(i.e., upper
limit(s) only), and on a case by case basis as specified by EPA.
These limits are to be set based on representative sampling and
chemical analysis(i.e., quality control) of the product.
The format.of the ingredient statement must conform to 40 CFR
156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pssticid* ingredient statements must
changed to nominal concentration.
-------
3.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lover limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 158.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c) (3) (B) . Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product
registrations submitted to the Agency
are to comply with the requirements of this
Notice.
(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
fora. 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 on (703) 557-5024.
*CC"«...
-------
APPENDIX E
Pesticide Registration Handbook
-------
APPENDIX F
Product Specific Data Call-In
-------
United Stater, (• nv i ronmenta 1 Protection Agency
Washinqton, D. C.. 20460
DATA CALL-IN RESPONSE
Page 1 of 1
Form Approved
OMB No, 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in int. Please read carefully the attached instructions and supply the information requested on this form.
IKe add i t i ona I shcrt(s) if nci rss.iry.
1. Conpany name and Address
ARI, INC.
BOX 999
GRIFFIN GA 30224
2. Case * and Name
4018 Capsaicin
*.- IP* Product
Registration
7754-38
5. 1 wish to
cancel this
product regis-
tration volun-
t ar i I y.
6. Generic Data
Aa. I am claiming a Generic
D.ita Exception because I
obtain the active ingredient
from the source €PA regis-
tration muter 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.
3. Date and Type of DCI
PRODUCT SPECIFIC
7. Product Specific Data
7a. Hy product is a HUP and
I agree to satisfy the HUP
requirements on the attached
for* entitled "Requirements
Status and Registrant's
Response."
7b. Ny product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification
I certify that the sta1rmt-nts node on this form and all attachments are true, accurate, and complete.
I acknowledge that nny knowingly false or misleading statement may be punishable by fine, (imprisonment
or both under applK;*Mr Inw.
Signature and Title o( Craiipnny's Authorised Hepresent.it ive
10. Name of Company emit or t
9. Date
11. Phone Number
-------
Page" 1 of 2
Unitori Stntos Environmental Protection Agency
Washington, D. C. 20-160
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSIRUCTIONS: Pleas* type or print in ink. Please read carefully the attached instructions and supply the information requested
Use ndctitinri.il sheet(«) if necessary.
1. Company name and Address Z. Case » and Name
ARI, INC. 4018 Capsaicin
BOX 999 .
GRIFFIN GA 30224 EPA Reg. No. 7754-38
4. Guideline
Requirement
Nunixr
151B-10
151B-11
151B-12
P*
151B-13
151B-15
151B-16
1518-17 (b)
151B-17(f )
151B-17(i)
1518-17(1)
151B-17(m)
151B-17(n)
151B-17(o)
5. Study Title
Prod Chen - Biochemical
Product identity
Manufacturing process (1)
Discussion of formation of (?)
ununtcnt ionat ingrdients
Analysis of samples (3)
Certification of limits
Analytical methods
Physical state
Dens p t y
pH (6)
Storage stabil ity
Viscosity (8)
Hisrihility (9)
Corrosion characteristics
R
0
1
O1
o
1
Progress
Reports
1
?
V
6. Use
Pattern
ABC K O
ABC K O
ABC K 0
ABC K 0
ABC K O
ABC K O
ABC K 0
ABC K O
ABC K O
ABC K O
ABC K 0
ABC K 0
ABC K 0
7. test
on this form.
3. Date and
Form Approved
OMB Ho. 2070-0107
Approval Expires 12-31-92
Type of OCl
PRODUCT SPECIFIC
ID/ 7754-RD-2292
Substance
EP
EP
EP .
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that the statements made on this form and all attachments art true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under ?ppl icabl'- Inn.
Signature and title of Company's Author i red Representative
12. Name of Company Con -id .
8. Tine
Fran
te
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Rnponse
If. Date
13. phone Number
-------
Page 2 of 2
Unitod Stater, Environmental Protection Agency Form Approved
Washington, D. C. 20460 c«B MO. ?070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information re.igp orw) .
8. Tine
Frame
8 mos.
8 mos.
8 mos.
8 mos,
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
-------
I.KAIT r n 1' Y ' °f 2
Unitod st-.ntos Environment.-!] Protection Agency
Washington, b. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
try: HP = imnu far I IM inq use product; (P - end use product; provided formulalors purchase their active ingredient (s) fro* a registered source, they need not submit or cite
data pertaining to the purchased product. (NOIE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the. product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.); IEP * typical end-use product;
ICAI = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pore" active ingredient, radiolabeled.
Use Categories Key:
A • Terreseri.il fnorl rrnp B - Terrestrial food feed crop C - terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Irxhr-lr i.-i| G • A»|unt ic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - forestry
It - Rcsidenti.it outdoor I • Indoor food « - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: Ifhe following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.)
Prod Cheat - Biochnaic.il
1 If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process witi suffice if the pesticide is not already under
full scale prodiirl ion. '
? If the product is not alrendy under full scale production and an experimental use permit is being sought, a discussion of impurities shall be. submitted to the extent
this informntion is available,
1 Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end-use products
will be, required on a ruse-by-rase basts. For'pest ic ides in the production stage, a rudimentary product analytical method and data nil) suffice to support an
experimental use permit.
6 Required if test substance is dispersible with Hater,
8 Required if product is a I iojuid.
9 Required if product is an ewulsifioble liquid and is to be diluted with petroleum solvents.
Acute Toxic - Biochmtic.il
5 Incidents must be reported, if they occur.
Efficacy - Invertebrate Control Agents •
1 The agency has waived nil rerfi.irements to submit efficacy data for invertebrate control agents for nonpubt ic health uses. However, each registrant must ensure
through testing th.n his pdi"^ 'hat """ "r«^^ r^ll. Registrants that make label
from killinq- to "rrpoll i^». subraitltng or citing data registrants have the option to change the label ct.i*
-------
_D:_K A F T C O I' Y
United jtfiticu Lnvi ronmontu 1 Protection Agency
W.ir.liincjton, U, C, 20460
FOOTNOTES AND KEY DAMNATIONS FOR GUIDELINE REQUIREMENTS
Case / and N.irac: 4018 Capsaicin
Footnotes (cont.): ,
Efficacy - Vertebrate Control Agents
1 The agency has waived all requirements to sulmit efficacy data (or vertrbrate control agents unless the pesticide product bears a claim to control vertebrates (such
at rodents, birds, bats, canids, and skunks) lhat may directly or indirectly transmit diseases to hunans. However, each registrant mist ensure through testing that
hii products are efficacious when used in accordance uith label directions and tcmnrnly accepted pest control practices. The registrant awt develop and Mintain
tha relevant data upon which the determination of efficacy is ho'.eti. The Agency reserves the right to require, on a case-by-case basis (e.g., significant new uiei
or benefits data In casgs of speciol reviews) submission of efficacy data for any pesticide product, registered or proposed for registration when necessary.
Th* Agency has determined *hat suUnission of efficacy data is required to support the claims made for products claimed to repel vertebrate aniaiali.
-------
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
P.iqo 1 Of 1
form Approved
OHB No. 2070-0107
Approval Expires 12-11-92
INSTRUCT IONS; Please type or print in ink. Please read carefully the attached (instructions and supply the information requested on this for*.
Use additional shcet(s) if necrw.iry.
1. Company name and Address
CHAMPON'S 100% NATURAL PRODUCTS, INC
2706 N.W. 91ST AVE
CORAL SPRINGS FL 33065
2. Case (and Name
4018 Capsaicin
J. Date and Type of DCI
PRODUCT SPECIFIC
4. IPX Product
Registration
5. I uish 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
from the source EPA regis-
tration nuXter listed below.
6b. I agree to satisfy Generic
Data requirements is indicated
on the attached for* entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. Hy product is • HUP and
I agree to satisfy the MJP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response.*
7b. Hy product i* an EUP and
! agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant'*
Response.*
61966-2
N,A.
N.A.
8. Certification
1 certify that the slatoments m.ido on this form and all attachments are true, accurate, and couplete.
I acknowledge that any kimuingly false or misleading statement may be punishable by fine, inprisonmenl
or both under applir.ihlr |r1w.
Signature and title of Company's Authorized Representative
10. Name of Company Com del
9. Date
11. Phone Nuifcer
-------
Pago 1 of
Unitod Stater, Knv i ronmenta 1 Protection Agency
Washington, U. C. 204GO
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 shcot(s) if necessary.
•1. Conpany name and Address 2. Case * and Name
CHAMPON'S 100% NATURAL PRODUCTS, INC 4018 Capsaicin
2706 N.W. 9 1ST AVE
CORAL SPRINGS FL 33065 EPA Reg . No. 61966-2
4. Guide I ine
Requirement
Number
151B-10
151B-11
151B-12
t»
151B-13
151B-15
151B-16
151B-17(b)
151B-17(f)
151B-17{i)
15JH 17(1)
ISlB-l? {m)
151B-17(n)
151B-17(o)
5. Study Title
Prod Chm - Biochemical
Product identity
Hanufacturing process (1)
Disrussiort of formation of (?)
ununtcnt ional ingrdients
Analysis of samples (3)
Certification of limits
Analytical methods
Fh/siiiit state
DPI,-. Hy
P« (6)
Stornqe stability
Viscpsity (fl)
Hiscihility <9)
Corrosion characteristics
R
0
0
C
u
L
Progress
deports
1
/
3
6. Use
Pattern
ABC K O
ABC K O
ABC K O
ABC K 0
ABC K 0
ABC K O
ABC K O
ABC K O
ABC K O
ABC K 0
ABC K O
ABC K 0
ABC K 0
1. Test
on this fora.
I. Date and
Form Approved
OMB No. 2070 0107
Approval Expires 12-51-92
Type of DC I
PRODUCT SPECIFIC
ID# 61966-RD-2298
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
iu. certincation
I certify that the slnlrmrnts made on this form and alt attachments are true, accurate, and conplete
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under nfipl ir.ihlr law.,
Signature and fi'tle of Company's Author iied Representative
??. Name nf ConfMny Inrttnrl ^
•
B. Tine
fra*
1C
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
11. Date
13. Phone Nuitwr
-------
Page 2 of
United -.States Environmental Protection Agency _ . Form Approved
Washington, D. C. 20460 OHB HO. ZOTO-oior
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Approval l..pir«, 12-31-92
INSTRUCIIOHS: Please type or print in ink. Please read carefully
Use additional shect(s) it nrccisary.
1. Company name and Address
CHAMPON'S 100% NATURAL PRODUCTS, INC
2706 N.W. 91ST AVE
CORAL SPRINGS FL 33065
^. GUI del ine
Rpquirnwnt
Nunfcer
152B-13
-.1528-14
152B-16
ft
95-11
96-6
96-11
96-18
96-19
i. Study title
Acute Tonic - Biochemical
Primary rye irritation
Primary dermal irritation
Hypersensitivity ii« fents (5)
Efficacy - Invertebrate Control Agents
Prnnisfs Trrattmits
Lnboratory efficacy (1,56)
rvaluntion
EM it. icy - Vertebrate Control Agents
Avian repel lents (1)
RtKierit icides in orchards (1)
Doqir-itic dog and cat (1)
repot tents
Browsing animal repellents (1)
Initial to indicate f rr 1 1 1 if .it ion as to Informix inn on this pngc
,iije one).
the attached instructions »nd supply the information requested on tnts Torp.
2. Case # and Name 1. Date and Type of DC!
4018 Capsaicin PRODUCT SPECIFIC
IDf 61966-RD-2298
EPA Reg. No. 61966-2
R
0
0
0
1
Progress
Reports
1
?
3
6. Use
Pattern
ABC K O
ABC K O
ABC K 0
K M 0
ABC K
ABC K
ABC K
ABC JK
7. test
Substance
EP
EP
EP
•
EP
,
EP
EP
EP
EP
K. Ti*e
frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos .
8 mos.
8 mos.
8 mos.
9. Registrant
Response
Date
-------
A I' T <• () I' V ; ......... ___ ________ _________ __. _________ ..... _____
Unit »vl .st.it.os Environmont.nl Protection Aqency
Wnr.hincjton, I). C. 20460
FOOTNOTES AND KEY DEFJNATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
Of
Key: HP = imnul nc tininq-usr piodurt; CP = end use product; provided tormulators purchase their active ingredient{s) fro* a registered source, they need not submit or cite
cfntn pertaining
-------
I) u A F T _r o I- v _... : _'
United st.it.c-K Knv ironmnnt n 1 Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DKFLNATIONS FOR GUIDELINE REQUIREMENTS
Case / and Nome: 4018 Capsaicin
Page 2 of 2
Footnotes (cont.):
efficacy - Vertebrate Control Agents
1 The agency has waived all requirements to submit efficacy data for vertebrate control agents unless the pesticide product bears • clam to control vertebrates (suet)
•s rodents, birds, bats, canids, and skunks) thai may directly or indirectly transmit diseases to himans. Houewer, each registrant imst ensure through tt«ting ttot
his products »re efficacious when used in accordance uith label directions and comncnly accepted pest control practices, the registrant aust dev«lop and Mlntaln
the relevant dat* upon which the determination of efficacy is based. The Agency reserves the right to require, on a case-by-case bast* (e.g., •ignlflewrt n** tn«
or benefits data ln^cases_of special reviews) submission of efficacy data for any pesticide product, registered or proposed for registration when necntary.
Th* Agency hat determined that sutmission of efficncy data ii required to support the claims made for products claimed to repel vertebrate aoi»»tm.
-------
Page 1 of
United states Knvironmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
IHSIoiti i IONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) it nnccssary.
1. Company name and Address 2. Case * and Name
CHAMPON'S 100% NATURAL PRODUCTS, INC 4018 Capsaicin
2706 N.W. 91ST AVE
CORAL SPRINGS FL 33065
4. £P» Product
Reuistralion
61966-1
S. 1 wish to
cancel this
product regis-
trnt ion volun
tarjly.
6. Generic Data
6a, 1 am claimimg a Generic
Data Exemption because I
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 form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. .Product Specific
Form Approved
OMB No. 2070-0107
Approval Expires 17-31-92
on this for*.
3. Date and Type of DC!
PRODUCT SPECIFIC
Data
7a. My product is a HUP and
1 agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
•
0. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applu.ililr I.-IH.
Signature and. Title o( Company's Aulhorired Representative
10. Name o( Conirknny Contact " "
7b- Hy product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
for* entitled "Requirements
Status and Registrant's
Response." .
*/ •
9. Date
11.
Phone Number
-------
P ng e 1 of 2
United Stnten Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSIRUCtlONS: Please .type or print in ink. Please read carefully
Use additional shcet(s) if necessary.
1 . Conpany name and Address
CHAMPON'S 100% NATURAL PRODUCTS, INC
2706 N.W. 91ST AVE
CORAL SPRINGS FI, 33065
4. Guideline
Requirement
Number
151B-10
l^1^-!!
151B-12
151B-13
151B-15
151B-16
151B-17(b)
15lB-17(f)
151B-17 ( i)
1518-17(1)
151B-17(m)
15lB-17(n)
1518-17(0)
5. Study title
Prod Oirm - Bioche*ie»l
Product identity
Manufacturing process (1)
Discussion of formation of (Z)
unintentional tngrdients
Analysis of samples (3)
Certification of limits
Analytical methods
Physical state
Dens i : y
pH (6)
Stop ago stabi 1 i ty
Viscosity (B)
Misrilnlity (9)
Cnrroiion characteristics
the attached instructions and supply the information requested
2. Case 1 and Name
4018 Capsaicin
EPA Reg. No. 61966-1
p •
R
n
t
Q
C
0
1
Progress
Reports
1
2
3
6. Use
Pattern
ABC K O
ABC K 0
ABC K 0
ABC K 0
ABC K 0
ABC K O
ABC K O
ABC K . O
ABC K O
ABC K 0
ABC K O
ABC K O
ABC K O
7. Test
on this form.
Form Approved
OMB No. 2070-0107
Approval Expires 12-31 -?Z
3, Date end Type of OCI
PRODUCT SPECIFIC
ID# 61966-RD-2297
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that the stn<™»nts made on this form and all attachments are true, accurate, and carpi etc
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, i irpr i sormen t
or both under t<- (,TH_
Signature and Title of Coopany's Authorized Representative
12. Mamc of Company Contact •
11.
13.
8. Time
Fran
e
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Date
Phone Nimber
9. Keflistrant
Response
«•
-------
Page 2 of
' United States Environmental Protection Agency FO™ Approved
Washington, D. C. 20160 we HO. 20/0010?-
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Approval Expires 1Z-J1-92
INSTRUCUUNS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional shcct(s) if rtpr.ess.iry.
1. Company nan* and Address 2. Case * and Name 1. Date and Type of DEI
CHAMPON'S 100% NATURAL PRODUCTS, INC 4018 Capsaicin PRODUCT SPECIFIC
2706 N.W. 91ST AVE ID#. 61966-RD-2297
CORAL SPRINGS FL 33065 EPA Reg. No. 61966-1
4. Guideline
Requirement
Mtmbcr
152B-13
152B-14
152B-16
95-11
96-6
96-11
96-18
96-19
S. Study Title
Acifte Ionic - 8ioche»ical
Primary eye irritation
Primary dermal irritation
Hypersensitivily incidents (5)
Efficacy - Invertebrate Control Agents
Prciiiseit TrcntMrnts
Laboratory efficacy (1,56)
evaluation
tilj racy - Vcrttbrate Control Agents
AVI, in repellents (1)
Rodent icides in orchards (1)
Dime-it ic dog and cat (1)
repellents
Browsing animal repellents (1)
V
K
0
0
0
(
Progress
Reports
1
2
J
*
6. Use
Pattern
ABC K O
ABC K O
ABC K O
K M 0
ABC K
ABC K
ABC K
ABC JK
7. Test
Substance
EP
EP
EP
EP
EP
EP
EP
EP
rnitial to tnrtiratr rcrti fic.it ion as to information on this page Date
(lull ten! of rep 1 1 \ jrfii ion is un pogr one).
8. Tim
Frame
8 mos .
8 mos.
8 IDOS.
8 mos .
8 mos .
8 mos.
8 mos.
8 mos.
•.
9. Registrant
Response
*i>
-------
Page 1 of ?
n K A i T (" o -i- Y
(in it fit .'itritns Knv i ronmnptn I Protection Aqorlcy
Wnr.hinqton, [). C. 20.460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case j and Name: 4018 Capsaicin
Key: HP = .wnufarturing «""• produrt; FP = end use product; provided fori.il.tors porches* their active ingredient(s) fro* a registered source, they need not .ub.it^orefte
dnta perta.ning lo the purchased prrxJurt. fNOTE: If a product is a 100 percent repackage °< »™ther registered product that is purchased, and any use *<*"•« •jr<"*t "**
not differ fro* Ihose of the purchased and registered source, users are not subject to any data requirements identified in the tobies.]; TEP = typlt.l «nd-u»e prottKt;
ir,*l = technical otndr- o( ihc nctivr ingredicnl; P»l - "pore" active ingredient; P*IB» = "pure" active ingredient, r«diol»be(ed.
A IerrrMri.il (ood rrop B JerreitrinI food feed crop C Terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
f Aqunlir nonfood Industrial G Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
1C Hcsirfenli.il oul.tooi I Indoor food M • Indoor nonfood H - Indoor Medical 0 - Indoor residential
Footnotes: tlho (ollnvinn rwH-s are referrored in colom t«o (5, Study Title) of the REQUIRtHENTS STATUS AND RECIST*AIIT'S BESPOtlSE forai.J
Prod Chm - Riorhnnuat
1 If an eiprrinputnl (I-;P pormit is being sought. • schematic diagram and/or description of the manufacturing process uill suffice tf the pesticide U not already under
full scale production.
2 If the prodtirt is not nlrrndy under full scalr production arid an e«perimental use permit is being sought, a discussion of iiapurtties shall be submitted to th« extent
this in)oiM.vton is nvnilnhlr.
3 Required to siipnor[ rrgis|rBtion of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other «nd-u»e produpti
Mill be required on a resr by-case basis. For pesticides in the production stage, a rudimentary product analytical method and data will suffice to support *n
exprrimenial u-.r permit.
6 Required if test mjhstnnce i', dispersible with water. '
8 Reqifired if product is a liquid.
9 Required if piodurt is nn mutsifinble liquid and is to be diluted with petroleum solvents.
Acute Ionic - Biochemical
5 Incidents mu<:l he reported, it they occur.
Efficacy • Invertebrate Control Agents •
1 The tgency has unived nil riHuiirfflirents to submit efficacy data for invertebrate control agents for nonpublic health uses. However, each registrant Must ensure
through testing th.it his products nre efficacious when used in accordance with label directions and connwnly accepted pest control practices. The rejUtraot Must
develop and mnintnin the irlrv.int data upon which the determination of efficacy is based. The Agency reserves the right to require, on a case-by-case bails (e.0.,
signif icnnl n™ tw, n. l^nHtts d.ita in cases of special reviews) submission of efficacy data for any pesticide product, registered or proposed for registration
when necess.iry.
• i
" chlilfof "I'i'uT '.h" '7°ct'rid-11 f>r^r"" •>' products containing Capsaicin indicates that these products repel I. Registrants that make tabet
fr«"iM inq" ," ",,(l, '" °r Clt<1 ""•• >n HeU °' submltti"9 or citing data registrants have the option to change the label claim
-------
j1 Y __.-.-_..
IJni U;U litiitc:; Kiwi roninont.i 1 Protection Agency
W,i-,hintjtori, D. C. 20460
FOOTNOTES AND KKY UHF1 NATIONS 'FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
Footnotes (cont.): ,
ffficacy - Vertebrate Control Agents .
1 The agency has waived all requirements to submit efficacy data for vertebrate control agents unless tht pesticide product bears a elai" to control vertebrates (such
•t rodsnts, birds, bats, canids. and skunks) lhat may directly or indirectly Uansmit diseases to humans. However, each registrant must ensure through testing that
hit products are efficacious when used in accordance with label directions and comnenty accepted pest control practices. The registrant mist develop and Maintain
the relevant data upon which the determination of efficacy is based. Ihe Agency reserves the right to require, on a ease-by-case basic (e.g., algnlflont new uses
or benefit* data In cases of sjwcial revieus) submission of efficacy data for any pesticide product, registered or proposed for registration when necessary.
Ttw Agency has determined thjl sutmission of efficacy data is required to support the claims made for products claimed to repel vertebrate animals.
-------
Page 1 of
United .states Environmental Protection Agency Form Approved
Washington, D. C. 20460 OMB MO 2070^0107
DATA CALL-IN RESPONSE Approvl|l Expjres 12.31_92
INSTRUCIIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case « and Name 3. Date and Type of DCI
MTLLER CHEMICAL AND FERTILIZER CORPO 4018 Capsaicin PRODUCT SPECIFIC
BOX 333
HANOVER, PA 17331
4. EPA Product
Registration
72-574
5. 1 wish to
cancel this
product regis-
trat ion 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 form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a HUP and
1 agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification o,_ pate
1 certify that the Ktatemenls rmdt? on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under nppl ir.ihlr Inu. • "
Signature and litle of Company's Authorised Representative
7b. My product it an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
.
tO. N«ne of company Contact 11. Phone Nurter
-------
1 of
'Unitnd stntos. l-invi ronmental Protection Agency
Washington, D. C. 204GO
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) if nefessnry.
t. Conpany name and Address 2. Case * and Name
MILLER CHEMICAL AND FERTILIZER CORPO 4018 Capsaicin
BOX 333
HANOVER, PA 17J31 EPA Reg. No. 72-574
4. Guideline
ftec|Ui rement
Murtwr
151B-10
151B-11
151B-12
151B-13
151B-15
151B-16
151B-17(b)
151B-17(f)
151B-17(i)
1516-17(1)
151B-17(m)
151B-17(n)
151B-17(o)
S. Study Title
Prod fhrw Btochenicnl
Product identity
Manufacturing process (1)
Discussion of formation of (2)
ununtent ional ingrdients
Ann lysis of snmples (1)
Certification of limits
Analytical methods
Physical stale
Density
pH ' <6)
Stnp age stabi I ity
Vivrosi ty (8)
Misrihil jty (9)
Corrosion character ist ics
p-
R
n
0
i.
u
i
Progress
Reports
1
?
i
6. Use
Pattern
ABC K 0
ABC K 0
ABC K O
ABC K 0
ABC K O
ABC K 0
ABC K O
ABC K 0
ABC K 0
ABC K O
ABC K 0
ABC K 0
ABC K 0
1. Test
on this form.
I. Date and
form Approved
OHB No. 2070-0107
Approval Expires 12-31-92
Type of OCI
PRODUCT SPECIFIC
ID/ 72-RD-2289
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Cert if icat ion
1 certify that the statements made on this form nnd all attachments are true accurate and ccmplete
1 acknowledge that m.y Inowingly false or misleading statement may be punishable by fine, imprisonment
or both under n|ij>l it,ihlr [.-HI.
Signature and Title o( Company's Authorised Representative
1?. Name- of L'nni(>.-)ny Cimtnrt "^ "" _____ . __
»
11.
13.
0. Tine
Fran
le
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos .
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Date
Phone Number
9. Registrant
Response
-
„
-------
Page 2 of
United .st.it.os llnvi ronmental Protection Agency FO™ Approved
Washington, D. C. 20160 OHB Ho. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 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(s) it necessary.
1. Company name and Address 2. Case * and Name 3. Date and Type of DC!
MILLER CHEMICAL AND FERTILIZER CORPO 4018 Capsaicin PRODUCT SPECIFIC
BOX 333 ID/ 72-RD-2289
HANOVER, PA 17331 EPA Reg. No. 72-574
4. Guideline
Requirement
152B-13
152B-14
152B-16
95-11
96-6
96-11
96-18
96-19
•>. Study Title
Acute Tonic - Biochemical
Primary eye irritation
Primary dermal irritation
Kyprrsensil ivity incidents (5)
Effir.icy - Invertebrate Control Agents
Premises Treatments
laboratory efficacy (1.56)
evaluation
fflif.K-y - Vertebrate Control Agents
Avian repel lents (1)
Rnlrnlic ides in orchards (1)
Dimiestic dog and cat (1)
inpcllents
Browsing animal repellents (1)
V
K
n
r
0
i.
o
I
Progress
Reports
1
2
i
6. Use
Pattern
ABC K O
ABC K O
ABC K O
K M O
ABC K
ABC K
ABC K
ABC JK
l...l.nl to indicate m 1 1 1 leaf ion as to informal ion on thisp.iijc "' Z~, '
-------
li R A !•• r f n !• v '_ ___ _____ Page 1 of
Miii tod St. fit.ps Environment .T I Protection Agency
Wnr.hinqton, I). C. 20460
FOOTNOTES AND KEY DEFJNATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
Kry: MP t immlartur inq-usr product; fP = end uip product; provided formutators purchase their active ingredient(s) from a registered source, they need not sutxatt or cite
data pertn inin<] to ihr p«irrhi)srd pro "hlch the d-termi^tion of efficacy is based. The Agency reserves the right to require, on a c.se-by-case basis (e.g..
when n s ^ "' ' '" "*" °' ^^ ^'^ sutalissi<"> °< ef"«cV data for any pesticide product, registered or proposed^for registration
56 Available data on the insr-tl ir idnl properties of products containing Capsaicin indicates that these products repell. Registrants that make label
claims of '"kill m<)" will ocrd to sulmit or cite data. In I ieu of submitting or citing data registrants have the option to change the label claim
from kill imp" tn "lejiol I inq".
-------
D R A F T
0_P Y _ ..... ________________
United StaLei; I;MV i romnenta 1 Protection Agency
Wash i nylon, U. C. 204GO
l-'OOTNOTKi: AND KEY DKK I NATIONS FOR GUIDELINE REQUIREMENTS
Case / nnd N;ime: 4018 Capsaicin
2 of
Footnotes (cont.):
Efficacy - Vertebrate Control Agents
1 Ihc agency has waived all requirements to !.uOmit efficacy data tin' vertebrate control agents unless the pesticide product bears • claim to control vertebrates (tuch
•i rodents, birds, bats, canfds, and skunks) that may directly or indirectly transmit diseases to hunans. However, each registrant Must ensure through testing that
hi* products are efficacious when used in accordance with label .directions and connicnly accepted pest control practices, the registrant autt develop and Mtntain
the relevant data upon which the determination of efficacy is based. The Agency reserves the right to require, on • case-by-cnse b»si» (»,g., afgnlfic«nt new IMC*
or benefits d*ta In cases of special reviews) submission of efficacy data for any pesticide product, registered or proposed for registration when necessary.
The Agency has determined th t sulmission of effleecy data is required to support the claims nwde for products claimed to repel vertebrate animal*.
-------
United .States Environmental Protection Agency
Washington, D. C, 20460
DATA CALL-IN RESPONSE
Page 1 of 1
Form Approved
0KB Mo. 2070-0107
Approval Expires 1Z-31-92
IHSIRUCtlONS: Please type or print in ink, please read carefully the attached instructions and supply the information requested on this form.
Use additional shcct(s) if npcoss.iry.
1. Company name and Address
NORTH HEALTH CARE
1515 ELMWOOD ROAD
ROCKFORD 1L 61101
2. Case * and Hame
4018 Capsaicin
3. Date Mid Type of DCI
PRODUCT SPECIFIC
4. EPA Product
Registration
5. 1 wish to
canrel this
product regis-
trat ion volun-
. tari|y.
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed belou.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is * HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status end Registrant's
Response."
7b. Hy product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8668-1
N.A.
N.A.
8. Certification
1 certify that the statement!; made 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 .i|if>l ir.ilitp Inu.
Signature and Title of Company's Authorized Represent ativc
9. Date
inpony Cnntiict
11. Phone Number
-------
Page 1 of
United Stater, Environmental Protection Agency form Approved
Washington, D. C. 20460 am No. ZuTO-Olor
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Approval Expire, 12-31-92
INSTRUCT IONS: Please type or print in ink. Please read carefully
Use additional sheet (s) if necessary.
1. Ccnpany name and Address
NORTH HEALTH CARE
1515 ELMWOOD ROAD
ROCKFORD IL 611Q1
4. Guide I ine
Requirement
Number
151B-10
151B-11
151B-12
"•
151B-13
151B-15
1518-16
151B-17(b)
151B-17(f )
151B-17(i)
151B-17{1)
l51B-17(m)
151B-17(n)
1518-17(0)
5. Study, Title
Prod Chrm - BiochcMical
Product identity
Manufacturing process (1)
Discussion of formation of <2)
ununtcnt i ooal ingrdicnts
Analysis of samples (3)
Cert if ic.it ion of limits
Analytical methods
Physical state
Density
pM (6)
Storoije stnbi 1 ity
Viscosity (fl)
Hisri|>il ity (9)
Corrosion characteristics
the attached instructions »nd supply the information requested on mis for».
2. Case * and Name 3- D««e »"d Type of DC|
4018 Capsaicin PRODUCT SPECIFIC
ID# 8668-RD-2293
EPA Reg. No. 8668-1
R
0
0
O
I
Progress
Reports
1
?
J
6. Use
Pattern
ABC K 0
ABC K .0
ABC K O
ABC K O
ABC K 0
ABC K 0
ABC K O
ABC K O
ABC K 0
ABC K O
ABC K 0
ABC K 0
ABC K 0
7. lest
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. K«gl*tr*nt
Response
10. Certification 1^ Oalt
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may
or both Under applicable Inu.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
be punishable by fine, imprisonment
13. Phone Number
-------
Page 2 of 2
Unitnd r.tatos Environmental Protection Agency Form Approved
Washington, D. C. 204GO we *,. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Approval Expires 1Z-31 -92
IMSIRUCUONS: Please type or print in ink. Please read carefully the attached instructions and supply the mformation requested on this torm.
Use additional sheeHs) if necessary.
•:1. • Company nnnw and Address 2- Case * and Name . J. Date *nd Type of DCI
NORTH HEALTH CARE 4018 Capsaicin PRODUCT SPECIFIC
1515 ' ELMWOOD ROAD ID* 8668-RD-2293
ROCKFORD IL 61101 EPA Reg. No. 8668-1
4. Guide) ine
Requi rement
Nl.itwr
152B-13
152B-14
152B-16
" •" A
95-11
96-6
96-11
96-18
96-19
5. StiKiy Title
Acute Toxic - Biochoicsl
Primary eye irritation
Primary dermal irritation
Hypersensitivity incidents (5)
trfifiixv - Invertebrate Control Agents
Prrmises Tr«-«tmwits
Laboratory efficacy <1,56)
? val uat ion.
lldfiuy - Vertrbrate Control Aqcnts
Avinn repellents (I)
fiiKlont icides in orchards (t)
Dnmestic dog and cat (1)
•repellents
Browsing animal repellents (1)
R
0
O
0
L
Progress
Reports
1
2
3
6. Use
Pattern
ABC K O
ABC K O
ABC K O
K M 0
ABC K
ABC K
ABC K
ABC JK
7. lest
Substance
•
EP
EP
EP
EP
EP
EP
EP
EP
Iniiiol to indic.ite rfri 1 1 icat ion as to inlornut ion on this page Date "
(lull tent of rei t if iratinn is on pagr onp).
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
-------
Page 1 of 2
Un itr>c] st.rttos Knvi ronment^l Protection Agency
Washington, D. C. 20460
KFjQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
List? additional sheet Cs) if lire cssniy.
1 . Company nwne anrl Aflcii rss
XTTRIUM LABS INC
415 W PERCHING HD
CHICAGO Jl, r.0609
U . Gu i do I i ne
Requirement
ttinlxr
151B-10
151B-11
151B-12
A
151B-13
151B-15
151B-16
151B-17(b)
15lB-17(f).
151B-17(i)
1516-17(1)
151B-17(m)
15IB-17(n)
15lB-17(o)
S. Study Title
Prod Chrm - Biochmical
Product identity
Manufacturing prtKess (1)
Disrur:sion of formation of (2)
ununtent ional ingrdicnts
An.ilysis of samples (J)
Crr( i f irnt ion of limit!;
Annlytirnl methods
Physical state
Oenstiy
1* (6)
stor.iiic stabi 1 i ty
Vi-ico'iity (8)
HI-.I iliil tty (9)
Corrosion characteristics
the attached instructions and supply the information requested
2. Case * and Name
4018 Capsaicin
EPA Reg. No. 5464-6
R
0
1
0
L
O
I
Progress
Reports
1
/
3
6. Use
Pattern
ABC K O
ABC K O
ABC K O
ABC K O
ABC K 0
ABC K 0
ABC K 0
ABC K O
ABC K 0
ABC K O
ABC K O
ABC K O
ABC K O
7. lest
on this fora.
3. Date and
form Approved
OH6 No. 2070-0107
Approval Expires 12-31-92
Type of DCI
PRODUCT SPECIFIC
IDl 5464-RD-2290
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. cert if ir.il ion
1 certify that the siiiirmonts mpdc on this form and all attachments are true, accurate, and conplete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under nppl irnhlo t;m.
Signature and Title of Con^ony ' s Author iicci Representative
12. Name of Confinny fi>ot,-i<-t
fl. Time
Fran
le
8 mos.
8 nos.
8
8
8
8
8
8
8
8
8
8
B
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
ntos.
9. legist rant
Response
11. Oat*
13. Phone Nutter
-------
Page 2 of
United Stntns l- nvi ronmenta 1 Protection Agency Form Approved
Washington, ;D. C. 20460 OMB MO. 2070 0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Approval Expires «-J1 -92
INSTRUCTIONS: Please type or print in ink. Please read carefully Ihe attached instructions and supply the information requested on this for».
Use additional sheet (s) il necessary.
1. Conpany name and KM, ess 2. Case » and Name 3. Date and Type of DC)
XTTRIUM LAhS INC 4018 Capsaicin PRODUCT SPECIFIC
415 W PURSUING RD *D# 5464-RD-2290
CHICAGO IL 60609 EPA Reg. No, 5464-6
4. Guide) ine
Requirement
Number
152B-13
152B-14
152B-16
- • * •
95-11
•
96-6
96-11
96-18
96-19
5. Study lit(e
Acute Tonic • Biochemical
Primary eye irritation
Primary dermal irritation
Hypersensit ivity incidents (5)
Efficacy - Invertebrate Control Agents
Promises Treatments
laboratory efficacy (1,56)
evaluation
ffficacy - Vertebrate Control Agents
Avian repellents (1)
Rodent ic ides in orchards (1)
Domestic dog end cat (1)
r ppp 1 1 enl s
Browsing animal repellents (1)
R
0
1
0
L
O
u
Progress
Reports
1
i
3
6. Use
Pattern
ABC K O
ABC K O
ABC K 0
K M 0
ABC K
ABC K
ABC K
ABC JK
initial to indirntc rerl if ir.tlinn .is to infornvit ion on this page Date
(full text of ceM i f ii .it inn is on pngc one).
7. Test
Substance
EP
EP
EP
•
EP
EP
EP
EP
EP
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Regfctrant
Response
-------
Page 1 of
United States Environmental Protection Agency
Washincjton, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please typo or print in ink. Please read carefully the attached instruction-; and supply the information requested
Use additional sheet)1.) if ncccssnry.
1 Confhiny name and Address 2- Case # and Name
SEVANA CO. 4018 Capsaicin
5336 E. EASTERBY DR.
FRESNO CA 93727 EPA Reg. No. 47319-1
4. Guideline
Requirement
Nuntwr
151B-10
151B-11
151B-12
*w
151B-13
151B-15
151B-16
151B-17{b)
151B-17(f)
151B-17(i)
1516-17(1)
151B-17(m)
151B-17(n)
151B-17(o)
">. Study Till*
Prod Chef* - BiocKcMical
Product identity
Hnnuf actor ing process <1)
Oisrussion of formation of (2)
unintentional ingrdients
Analysis of samples (!)
Certification of limits
Analytical methods
Physical state
Dens it'/
pH (6)
Stornqe stability
VisroKity (8)
Mine ibility (9)
Corrosion characteristics
R
0
1
o
0
I-
Progress
Reports
1
?
H
6. Use
Pattern
ABC K O
ABC K O
ABC K O
ABC K O
ABC K , 0
ABC K O
ABC K O
ABC K O
ABC K O
ABC K O
ABC K 0
ABC K O
ABC K 0
7. Test
on this form.
3. Pate and
Form Approved
OMB No. 2070-0107
Approval Expires 12-11-92
Type of DC!
PRODUCT SPECIFIC
ID# 47319-RD-2294
Substance
EP
EP
EP
EP.
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that the st.i'tnnpnls made on this form and a!) attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, inprisonment
or both under appl ir.il>lr Inn.
Signature and Title of Coi^iny ' s Authorized Representative
1?. Name of Company Conl.tct . •• " "
B. Time
FrM
le
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
11. Date
t3. Phone Number
-------
page 2 of 2
United Stnteiv Environmental Protection Agency Form Approved
Washington, D. C. 20460 w. »,. zoTO-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Approval Expires 12-51-92
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional '.hcct(s) if nocess.iry.
1 . Conpany name and Address
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
4. Guideline
Requirement
Hunter
152B-13
152B-14
152B-16
^
95-11
96-6
96-11
96-18
96-19
5. Study Title
Acute loKtc - liochemical
Primary eye irritation
Primary dermal irritation
Hypersensitivity incidents (5)
Efficacy - Invertebrate Control Agents
Premises Trenlnents
laboratory efficacy {1,56)
evaluation
Eflicncy - Vertebrate Control Agents
Avinn repellents (1)
Rodent ic ides in orchards (1)
Dnmcstic dog end cat (1)
repellents
Browsing animal repellents (1)
Initial to indicate tr>M if icat ion as to inf' ..ition on this page
ifull text of rectification is on p.tgc one).
the attached instructions and supply the information requested on this form.
2. Case * and Name I. Date and Type of DCI
4018 Capsaicin PRODUCT SPECIFIC
ID# 47319-RD-2294
EPA Reg. No. 47319-1
R
0
O
c
o
L
Progress
Reports
1
2
3
6. Use
Pattern
ABC K O
ABC K O
ABC K O
K M 0
ABC K
ABC K
ABC K
ABC JK
7. lest
Substance
EP
EP
EP
EP
EP
EP
EP
EP
8. Tine
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. RegUtrant
Response
Date
-------
Page 1 of
1
United st.itcn Environmental Protection Agency
Washington, D. C. 204GO
DATA CALL-IN RESPONSE
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
INSlRUCllOltS: Pleas* type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use iidditionnl sheet(s) if notfssnry.
1, Company name and Address
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
2. Case * and Name
4018 Capsaicin
3. 0»te and Type 'of DCI
PRODUCT SPECIFIC
t. EPA Product
Registration
S. I wish to
cancel this
product regis-
tration volun-
tarily.
6, Generic Data
j am claiming (Generic
6a.
Data f iiempt ton because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b, I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is • HUP and
I agree to satisfy the HUP
requirements on th« attached
form entitled "Requirements
Status and Registrant's
Response."
7b. Hy product it an tUP and
I agree to patUfy the EUP
requirement* on the attached
form entitled "Requirements
Status and Registrant's
Response."
47319-4
N.A.
N.A.
8. Cert if icat ion
I certify that the statements mnde on this form and alt attachments arc true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may tw punishable by fine, irtpr jsorment
or both under npplirnhlr Inn.
Signature and litle ol
Authorized Representative
10. Name of Company Contnft
9. Date
11, Phone Number
-------
Cage 1 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
Use additional shret(s) if nrcessnry.
1. Company name and Address
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
It. Guidel inc
Requirement
Number
151B-10
151B-11
151B-12
&
151B-13
151B-15
151B-16
I51B-17(b)
151B-17(f )
151B-17(i)
1518-17(1)
151B-17(lh)
151B-17(n)
lbxB-17(o)
5. Study litle
Prod Chen - Biochemical
Product identity
Manufacturing process (1)
Discussion of formation of (?)
ununtent ional ingrdients
Analysis of sanples (3)
Certi f icat ion of limits
An.il/tical methods
Physical state
Density
pH (6)
Stornqe stabi 1 < ty
Viscosity (8)
Mitiribi lity (9)
Corrofion characteristics
the attached instructions and supply the information requested
2. Case * and Name . .
4018 Capsaicin
EPA Reg.. No. 47319-4
R
0
0
t
u
1
Progress
Reports
1
i
*>
6. Use
Pattern
ABC K 0
ABC K 0
ABC K O
ABC K O
ABC K O
ABC K ' O
ABC K O
ABC K O
ABC K O
ABC K O
ABC K O
ABC K O
ABC K O
7. Test
on this form.
3. Date and
Form Approved
OHB No. 2070-0107
Approval Expires 12-11 -92
Type of DC1
PRODUCT SPECIFIC
ID# 47319-RD-2296
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that the st.ilrmpnts imde on this form and all attachment* are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may
or both under ajipl ic.ibtr l,iw_
Signature and litlc of Cnifi,iny'K Authorized Representative
be punishable by fine, imprisonment
12. Name of Company Coit.it t
,
11.
15.
-
0. Tine
Fran
K
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Date
Phone Number
9. ftegiitrant
Response
-------
Page -2 of 2
United states Environmental Protection Agency Form Approved
Washington, D. C. 20460 OMB Mo. Z070-OW
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Approval Empires 12-31 -«
. INS 1 RUCTION'S:" PI e»sr type or print in ink. Please read carefully the attached instructions »nd supply the information requested on this for*.
Use addition.il sheet(s) i( octcs-mry.
1. Company name ami address 2- Case * and Name J. Date and Type of DCI
SEVANA CO. 4018 Capsaicin PRODUCT SPECIFIC
5336 E. EASTERBY DR. ID* 47319-RD-2296
FRESNO CA 93727 EPA Reg. No. 47319-4
A. GUI del me
Requirement
Number
1S2B-13
152B-14
152B-16
i*
95-11
96-6
96-11
96-18
96-19
S. StuiJy Title
Acute Toxic - Diochcnicat
Primary eye irritation
Priimry dermal irritation
Mypersensi t ivi ty incidents (5)
efficacy - Invertebrate Control Agents
Premises Treatments
laboratory efficacy (1,56)
evaluation
Efficacy - Vertebrate Control Agents .
Hvinn repellents (1)
fltKlrnt ic ides in orchards (1)
Dnmrstic dog and cat (1)
rnpcllcnts
Bious ing animal repellents (1)
V
R
?
0
0
L
Progress
Reports
1
Z
3
6. Use
Pattern
ABC K 0
ABC K 0
ABC K 0
K M 0
ABC K
ABC K
ABC K
ABC JK
7. Test
Substance
EP
EP
EP
EP
EP
EP
EP
EP
Initial to indiraip fcrt 1 1 irol too as to information on this pngc Date" '
(full tent of cert i f inirion is on pjigc one).
8. Tine
8 BIOS.
8 roos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
-------
,- Y
°f
linitod sr.nton Knvironmpnt.nl Protection Agency
Wnsh-inqtbn, D.-C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
«ey- MP ^manufacturing use product; EP = end-use product; provided f ormu I at or s purchase their active ir»gredirnl = typical end-US* product;
ICAI = technical gi .idr- of the active ingredient; P*r = "pore" active ingredient; PAIRA = "pure" active ingredient, radiolabeted.
Use Categories Key: ^_ _
A - terrestrial Inodrrnp R Terrestrial food feed crop C - Terresjtrial nonfood crop 0 - Aquatic food crop I - Aquatic nonfood outdoor
f - Aquatic mm r nnd lreliislri.il C - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - forestry
K firsidrnti.il mjtflooi L Indoor food H • Indoor nonfood W - Indoor Medical 0 - Indoor residential
Footnotes: llhc following notrs are referenced in colunti tuo (5. Study title) of the RfOUIREHENTS STATUS AND REGISTRANT'S RESPOHSE fon*.]
Prod Chcm - B iothnitic.il
t If nn r«p<-i imrnt.i) ii',e permit is being sought, a schematic diagran and/or description of the manufacturing process will suffice if the pesticide i* not already under
full sralr prodm I ion.
2 If thr prodtiri is not nlre»dy under full scale production and an experimental use permit is being sought, a discussion of iapurities shall be submitted to th* Mttnt
Ihir, inform.it irwi ic. iivn i I ,-ibl r .
3 Required to -uinxirt reqi«it t at ion of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end-use products
wi'it be required on a cpsc by car.<- basis. For pesticides in the production stage, • rudimentary product analytical method and data Mill suffice to support an
experimental use permit.
6 Required if test substnnre is dispersible with water.
8 Required if product is 4 liquid.
<" Required if product is an emjlsif inble liquid and is to be diluted with petroleum solvents.
Acute Toxic - Biochemical
5 Incidents must be rrnorlrd, if they occur.
Efficacy - Inwrtebrale Control Agents
1 The agency hai waived all requirements to submit efficacy data for invertebrate control agents for nonpublic health uses. However, each registrant aust ensure
through testing thai his products nre efficacious when used in accordance with label directions end comenly accepted pest control practices. The registrant must
develop and imintnin (he relevant dat* upon which the determination of efficacy is based. The Agency reserves the right to require, on • case- by- ewe bMfs (e.g.
significant nen u«es ,.p l«-iM-fits data in cases of special reviews) submission of efficacy data for any pesticide product, registered or proposed for registration '
when necesK.iry. *
^
-------
I, K A I T r i) I- V ' .'. ..._.; '. Page I of
lliii.tocl stntrr; Environmental Protection Agency
Washington, I). C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
(try: HP - m,ini;f,irtiM inq-use product; fP = end-use produrt; provided fornutators purchase their active ingredient(s) from a registered source, they need not submit or cite
dnta pertaining to thr purchased product. (HOIt: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those nl the purehnsrd and registered source, users are not subject to any data requirements identified in th* tables.); HP * typical end-use product;
THAI = technir.il gi.idc of tt)f nrlive ingredient; PAI - "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
lisp Catr^orirfi Key: - ' '
A - terrestrial food i i op H • lerresfrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E • Aquatic nonfood outdoor
F - Arjuntir nonfood lrvtrttri.il f, - Aquatic nonfood residential H • Greenhouse food crop I * Greenhouse nonfood crop 1 - forestry
K - Residrnti.il mil'ioui I - Indoor food H- Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: |ll«- lolInning notes are referenced in column two (5, Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.)
Prod Chrm - Riorhemir.il
1 If an enporiment.il use permit is bring sought, a schematic diagram nod/or description of the manufacturing process will suffice if the pesticide is not already under
full scale piodiirl inn.
2 If the prockirt is not nlrendy under full scale production and an experimental use permit is beifig sought, a discussion of impurities shall be submit ted to the extent
this infoiin.il inti is jivnil.ihle.
3 Required to Mirfxirl regislrntion of each manufacturing-use product and end use products produced by an integrated formulation system. Data oh other end-use products
will ttf retired on a case liy rase basis. For pesticides in the production stage, a rudimentary product analytical method and data will suffice to support an
enperflnental use permit.
6 Required if tcsl suhsl.Wr is dispersible with water.
8 Required if produrt is a liquid.
9 Required if produrt is an nnulsifinble liquid and is to be diluted tilth petroleum solvents.
Acute Ionic - Biochmic.il
5 Incident* must ho reportrd, if they occur. •
Efficacy.- Invertebrate Cnntrnl Agents .
1 The agency h« «,iived n|l reT-nrements to submit efficacy dnt» for invertebrate control agents for nonpublic he.tth uses. Hoover, each registrant suit ensure
through testmg th.it h,s pro-h^cts are efficacious i*en used in eccordance «ith label directions and comenly accepted pest control practices The registrant •
develop and nunt.nn .he .rlevnnt data upon -hich the determination of efficacy is based. The Agency reserves the right to require on a
or
56
claims of "killing" wit) ed 7 ' " >" "™ll;* containing Capsaicin indicates that these products repel (. Registrants that make label
fr«n krllim," to ".^H,^-. ° """" "' '"* dat"' '" ''*" °' Submiltin9 or Citing data registrants have the option to change the label claim
-------
U R A I' T C O I'
I'.xjo 2 ot
United Stat fs Hnv i romiiontii I I'rotuct ion Agency
Washington, U, C. 20460
FOOTNOTES AND KKY I)|-:i/I NATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
Footnotes (cont.):
Efficacy - Vertebrate Control Agents
1 The agency has waived ell requirements to submit efficacy data fm vertebrate control agents unless the pesticide product bears a claim to control vertebrates (such
•t rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that
his products »re efficacious when used in accordance with label directions and contncnly accepted pest control practices. The registrant nun develop and Maintain
the relevant data upon which the determination of efficacy is based. The Agency reserves the right to require, on a case-by-case basis (e.g., algnlftcant new ine>
or benefits data in cases of special reviews) submission of efficacy data for any pesticide product, registered or proposed (or registration when necessary.
Ih* *gency has determined th t submission o( efficacy data is required to support the claims made for products el»imett to repel vertebrate aniMals.
-------
1 of 1
UnitocJ St.it.es Environmental Protection Agency
Washington, I). C. 20460
DATA CALL-IN RESPONSE
IMSIRUCnoNS: Pleas* typo or print in ink. Please read carefully the attached instruetions and supply the information requested on this for*.
IKe addi tional shcrt(s) if nrressnry.
form Approved
OHB No. 2070-0107
Approval Expires 12-31-92
1.- Company name and Address
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
2. Case * end Name
4018 Capsaicin
4. EPA Product
Registret ion
47319-2
5. 1 wish to
cancel this
product regis-
tr.il ion volun-
tarily.
6. Generic Data
6a. 1 am claiming a Generic
Data Etempt ion because I
obtain the active ingredient
from the source EPA regis-
tration nunfcer Listed below.
N.A.
At). I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
3. Date and Type of DC]
PRODUCT SPECIFIC
7. Product Specific Data
7a. Hy product is • HUP and
I agree to satisfy the »M>
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to sat!ify the EUP
requirements on the attached
form entitled "Bequirements
Status and Registrant's
Response.*
8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that an/ knowingly false or misleading statement may be punishable by fine, imprisonment
or both under appl ic.ibtr Inx, .
Signature and Title of Con^any's Authorized Represents!ive
9. Date
10, Name of Confirmy Cont.icl
11. Phone Number
-------
1 Ol
United States' Envi ronmental Protection Agency
Wnr.hincjton, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS; Please type or print in ink. Please read carefully
Use additional sheet(s) it nrccssary.
1, Company name and Address
SEVAN A CO.
5336 E. EASTERLY DR.
FRESNO CA 93727
4 . Gu i de I i ne
Requirement
Number
151B-10
151B-11
151B-12
ff
151B-13
151B-15
151B-16
151B-17(b)
151B-17(f)
15lB-17(i)
1516-17(1}
151B-17(m)
151B-17(n)
151B-17(o)
5. Study Title
Prod Chm - Biochemical
Product identity
HiKKjfac luring process <1>
Discussion of formation of (?)
ununt ent i ona 1 irtgrdients
Analysis of sanples (1)
Ccrti ficat ion of limits
Analytical methods
Physical state
Dersity
pH (6>
Stornne stabi lity
visrosity (8)
Hist-ihility (9)
Corrosion characteristics
the attached instruct torts and supply the information requested
2, Case » and Name
4018 capsaicin
EPA Reg. No. 47319-2
R
0
T
0
L
0
Progress
Reports
1
2
J
6. Use
Pattern
ABC K O
ABC K O
ABC K O
ABC K O
ABC K 0
ABC K O
ABC K ,O
ABC K O
ABC K O
ABC K O
ABC K 0
ABC K 0
ABC K 0
7. t*st
on this ton*.
Form Approved
OMB No. 2070 0107
Approval Expires 12-31-92
3. Date and Type of OCI
PRODUCT SPECIFIC
ID# 47319-RD-2295
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
1 certify that the stntrmrnts made on this torn and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may
or both under appl ir.ililr l,in.
Signature and Title ot Company's Authorized Representative
be punishable by fine, imprisonment
12. Name of Company Cudr.nct
,
11.
.
U.
8. Tine
Fran
le
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos..
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Date
Phone Number
9. Registrant
Response
-------
Page 2 of
United States Knvi ronmental Protection Agency
Washington, D. C. 204GO
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSIRUCIIONS: Please type or print in ink. Pleas* read carefully the attached instructions end supply the information requested
IKe- additional sheet (s) if necessary.
U Company name and Address 2. Case * and Kw*
SEVANA CO. 4018 Capsaicin
5336 E. EASTERBY DR.
FRESNO CA 93727 EPA Reg. No. 47319-2
t . Gu i de 1 i ne
Requirement
Nunbcr
152B-13
152B-14
152B-16
n
95-11
96-6
96-11
96-18
96-19
5. Sturly title
Acute Toxic - Biochontcat
Primary eye irritation
Primary dermal irritation
Hyper sensitivity incidents (5)
Efficacy - Invertebrate Control Agents
Prrwisrs Freatiactits
laboratory efficacy (1,56)
evaluation
Efficacy - Vertebrate Control Agents
Avinn repellents . (t>
Rodrnticidcs in orchards (1)
Domestic dog and cat (1)
repellents
Browsing animal repellents (1)
R
0
1
0
0
L
Progress
Reports
1
?
3
6. Use
Pattern
ABC K O
ABC K O
ABC K 0
K M 0
ABC K
ABC K
ABC K
ABC JK
T. test
Substance
EP
EP
EP
EP
4
EP
EP
EP
EP
initial to indicate rr>rt il iratinn as to information on this page • Date
{lull text of certification is on pnqe one).
form Approved
OMB No. 2070-0107
Approval Expires 12-31*92
on this fora.
1. Date «nd Type of PCI
PRODUCT SPECIFIC
ID# 47319-RD-2295
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response .
-------
Of
United St. it PS Ivn-vironra'pntn I Protection Agency
W.nr.hinqton, 0. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
fry: HP - nnnu f .11 1 in i nq • use product; FP = end-u";e product; provided formulators purchase their active ingredient(s) from a registered source, they need not subatt or cite
d.-ita pertaining to Ihr purchased product . [NuIE : Jf a product is I (00 percent repackage of another registered product that is purchased, and any use for the product doc*
not differ Irom tho-.r nl the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
I Ml - technical qi .idr of (he arnve ingredient; PAI = "pure" active ingredient; PAIR* - "pure" active ingredient, radiolabeted.
Use Categories Key:
C - terrestrial nonfood crop
H • Greenhouse food crop
M - Indoor nonfood
* - TerreMr i.il food crop
r - Aquatic nonfood Indiisirinl
ft - Terrestrial food feed crop
f. - Aquatic nonfood residential
L - Indoor food
D • Aquatic food crop
I - Greenhouse nonfood crop
N - Indoor Medical
E • Aquatic nonfood outdoor
J - forestry
0 - Indoor residential
K - Residential outdooi
Footnotor,: Jlne following note-: are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.!
Prod Chrm - Biorhrnic.il
1 If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under
full scate prorhit t ion.
2 If the product is not alrendy under full scale production and an enperimental use permit is being sought, a discussion of impurities shall be submitted to the extent
this informnlinn is nvnilable.
3 Required to siifijKii I reqistrntion of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end-use products
wilt IM> requited nn a case hy-rase l)nsis. for pesticides in the production stage, a rudimentary product analytical method and data Mill suffice to support an
eiipor imental if.f permit.
6 Required if tr-it M*ist,inre is dispersible with water.
8 Required if prndiH t is a liquid.
9 Required if product is an emulsifi.ible liquid and is to be diluted with petroleum solvents.
Acute Tonic - Biochemical
15 Incidents must be reported, if they occur,
Efficacy - Invertebrate Control Agents
1 The agency has wived nl t requirements to submit efficacy data for invertebrate control agents for rwnpublic health uses. However, each registrant must ensure
through testing th.it. h,<; prmfucts are efficacious when used in accordance with label directions and conmenly accepted pest control practices The registrant MMt
develop and mnmt.in. (he "relevant data upon which the determination of efficacy is based, the Agency reserves the right to require^ on a case-by-case basis («•
''-''"''e""';,!1''" " ° '" l>r'1C
-------
Unitcul stiit.c:.; l.iw i ronmont.j 1 Protection Agency
, p. c. 204 (>0
KOOTNOTKS AND KKY OKFINATIONS FOR GUIDELINE REQUIREMENTS
Case / und Name: 4018 Capsaicin
Footnotes (cont.): .
Efficacy • Vertebrate Control Agents
1 The agency has waived all requirements to sulmit clficacy data lor vcitcbrale control agents unless the pesticide product bears a clain to control vertebrates rodents, birds, bats, canids, and skunks) tlxit may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that
his products are efficacious when used in accordance with label directions and comvnly accepted pest control practices, the registrant au*t develop and Mintain
the relevant data upon which the determination of efficacy is based. The Agency reserves the right to require, on a case-by-case basic
-------
United Stater. Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
TSsiitUCllONS: rleas717pe or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional shrft(s) if nrccsK,iry. ___
Page 1 of 1
Form Approved
OMB to. 2070-0107
Approval Expires 12-31-92
1. Company name and Address
XTTRIUM LABS INC
415 W PERSIIING RD
CHICAGO IL 60009
2. Case * and dame
4018 Capsaicin
3. Date and Type 'of DCI
PRODUCT SPECIFIC
4. EPA Product
Registration
5464-6
V I wish to
cancel this
pr'oduct regis-
tration yolun-
tan ly.
6. Generic Data
6a. I am cloimirog a Generic
Data Enemplion because I
obtain (he active ingredient
front the source EPA regis-
tration number I istcd 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. Hy product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled •Requirements
Status and Registrant's
Response."
7b. Hy product is an EUP and
t agree to satisfy the EUP
requirements on the attached
for* entitled "Requirements
Status and Registrant's
Response."
8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete,
[ acknowledge that any knowingly false or misleading statement may be punishable by fine, inprisonment
or both under npplicnhlp Inn. .
Signature and litle of Company's Authorised Representative
10. Hame of Coni(jniiy
9. Date
11. Phone Number
-------
i) R A FT C 0_ l> Y . I',KJ<> 7 ot
United Utat.cs Knvi r.o'nmenta I Protection Agency
Washinyton, U. C. 20160
FOOTNOTES AND KEY DKFiNATIONS FOR GUIDELINE REQUIREMENTS
Case / and Nome: 4018 Capsaicin
Footnotes (cont.)-
Efficacy - Vertebrate Control {\gcnts .
\ Ihc agency his waived ell requirement*, to butmii efficacy data for vn< trl>rate control agents unless the pesticide product bears a claiii to control vertebrites (such
at rodents, birds, bats, cinids, «nd i.Vuiiks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that
hie products ire efficacious when used in accordance with label directions and conmcnly accepted pest control practices. The registrant unit develop »nd (Maintain
the relevant data upon which the de term run ion of efficacy is based, the Agency reserves the right to require, on a case-by case basic (e.g., lignlf leant new use*
or benefit! data In cases of special reviews) submission of efficacy data for any pesticide product, registered or proposed for registration when necessary.
ill* Agency has determined thrt submission of efficacy data is required to support the claims made for products claimed to repel vertebrate minis.
-------
,, K A r T r ,, r Y • ; _..__ , Pa(3e 1 of
lln it oil .r;t,itrr, Environmental Protection Agency
Wnshinqton, l>. C. 20160
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case f and Name: 4018 Capsaicin
Key: HP = manufacturing-use prorhirt; fP = rnd-use product; provided fornulators purchase their active ingrectientle. ' •
3 Required, 10 support registration of each manufncturinq-use product and end'use products produced by an integrated formulation system. Data on other end-use product*
will be required nn n case by case basis, for pesticides in the production stage, a rudimentary product analytical method and data Mill suffice to support an
experimental ul;r permit. , '
6 Required if test sulisl.inrf is dispcrsiblc with water.
6 Required if ptodutt is a liquid.
9 Required if product is an enrlsifiable liquid and is to be diluted with petroleum solvents.
Acute Toxic - Biochemical
5 Incidents musl be rrrwited. if they occur. ;
Efficacy - Invertebrate Control Agents
1 The agency has waived nil irquirements to submit efficacy data for invertebrate control agents for nonpublic health uses. However, each registrant must ensure
through testing th.n h,s products are efficacious when used in accordance with label directions and coimenty accepted pest control practices The resist rant must
develop and mamtam the relevant data upon which the determination of efficacy is based. The Agency reserves the right to require, on a case by-case basic (e g
significant new uses m henrfHs d.ita in cases of special reviews) submissipn of efficacy data (or any pesticide product, registered or proposed for ' '
56 cl'a'ilf o* ^ut^m ^^ ^!"*« ^ "-« •»?*"«» "pell. Registrants that **. I .be!
from killing" . n ", r,K-11 ",9». ' "" of subn"lt'"9 «•" citing data registrants have the option *o change the label claim
-------
United States Environmental Protection Agency
Washington, D, C. 204GO
DATA CALL-IN RESPONSE
Page 1 of 1
Form Approved
owe No. 2070-0107
Approval Expires 12-11-92
INSIRUfUONS: please type or print in ink. please read carefully the attached instructions and supply the information requested on this for*.
Use additional sheet {•;) if necessary. -,
1, Company name and Address.
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
2. Case * and Name
4018 Capsaicin
J. Date and Type 6f DCI.
PRODUCT SPECIFIC
4. EPA Product
Rcgistl.it ion
47319-1
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6,1. I am claimimg a Generic
Data Exemption because I
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 form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. Hy product is a HUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My 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
I certify that the statements made 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 appl irnhlr low.
Signature and Title of Comp.iny's Authorised Representative _^
10. Name of Com|>.iny Contact
9. Dat*
11. Phone Number
-------
DRAT ']' C O I1 Y
2 of
United ytaLt'S lJivironmcnt.il Protection Agency
Woshinyton, D. C. 20460
KOOTNOTKS AND KliY DIUM NATIONS FOR GUIDELINE REQUIREMENTS
Case / iind Name: 4018 Capsaicin
Footnotes (cont.):
Efficacy - Vertebrate Control Agents
1 U.« igency has Halved all requirements to submit efficacy data lor vertebrate control agents unless the pesticide product bears a clai* to control vertebrates (such
•t rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However, e»ch registrant must ensure through testing that
hie products are efficacious when used in accordance with Label directions and conncnly accepted pest control practices. The registrant «u»t develop and Maintain
the relevant data upon which the determination of efficacy is based. I he Agency reserves the right to require, on a cat*-by-case basic (e.g., stgntfleant new u*c»
or benefits data In cases o< special revitus) submission of efficacy data for any pesticide product, registered or proposed for registration yhen necessary.
Th* Agency has determined thai sutinis&ion of efficacy data is required to support the claims made for products claimed to repel vertebrate aniiaals.
-------
D K A !•' T
U I1
ol
lin i Luil i;'t;ili;:j Knvi romiu?nt.j 1 I'rotection Ayency
Washington, U. C. 204CO
'TKS ANL> KEY DKKINATIONS KOK GUIDELINE REQUIREMENTS
Case / and Name: 4O18 Capsaicin
Footnotes (cont.):
Efficacy - Vertebrate Control Agents . -.
1 Ihe agency has waived tit requirement!; to submit efficacy data for vertebrate control agents unless the pesticide product bears a claim to control vertebrates (such
as rodent*, birds, bats, canidj, and ikuiks) that may directly or indirectly transmit diseases to hunans. However, each registrant must ensure through testing th*t
hie products are efficacious uhen used in accordance with label directions and connienly accepted p«st control practices. The registrant aust develop and maintain
the relevant data upon which the determination of elfitnty is based, the Agency reserves the right to require, on * case-by-cos* b»«it (e.g., tlgoifleant new UMS
or benefits data in cases j>f special reviews) subaission of elfit.icy data lor any pesticide product, registered or proposed for registration when necessary.
The Agency has determined llul submission of efficnty data is required to support the claims made for products claimed to repel vertebrate aninatc.
-------
Page 1 of 2
T C O I1 Y ..... "-- ' ~~~'
Unite.I St.itrr, FnvJronmont--.il Protection Aqency
Washington, U. c. 20160
KOOTNOTKS AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4018 Capsaicin
l*e Catcgorip .err: Terres,rin. food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
Footnotes: rihr foll.o-in, not« are referenced in col™ two (5. Study Tit.e, of the REOUIRErrtNTS STATUS «W_KGISTUHT'S RESK*S€ tan..]
Prod Chfm • .Biorhrxic.il
1 tf an MpPr.^ntM .«- permit is being sought, a schematic diagram and/or description of the manufacturing process .ill. suffice if the pestlcfde U not already under
2 .Vlhe^rTrr. '.irr-Tdy ur^cr fuil M.l. production «* M eIlperiBen,.l use permit i, being sou*,. . discussion of Cities sh.lt be .ub»itt«d to th. ...en,
3 pirrd «rnon of each ^fac.urir^-us* product «d errf use promts produced by .r, inte.r.trt '^ulation •„*». D.t. on oth«r «££
will be roquirpd ewt « t««f by case bnsis. for pts» ic ides in the production stage, . rudimentary product analytic,! method and data Mill suffice to tupoort
enperincnlal usr* permit.
6 Required if test Mihstnnee IK Hispcrsible with vmter.
0 Required if (» cxJm I is n liquid.
V Required il product is no onulsif inble liquid and is to be diluted uith petroleum solvents.
Acute Toxic - Biochnnic.il - .
5 Incidents must be rcpoi Irtl, if they occur.
Efficacy - liwertcfcrntc Control Agents -
V The agency has waivrd nil requirements to submit efficacy data for invertebrate control agents for rwnpublic health uses. However, each registrant mitt ensure
through tcstirnj thn( his r«nffcicts nre efficncious uhen used in accordance with label directions and comenly accepted pest control practices. Th* registrant PUSt
develop arxJ mnintnin Kir relpvnnt data upon which the determination of efficacy is based. The Agency reserves the right to require, on • ease-by-ewe b**(* («-§.,
signif icnnr rvw
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ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
PLUS INSTRUCTIONS
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SPECIFIC INSTRUCTIONS YOU COMPLETING
THE REQUIREMENTS STATUS AND REOISTRAKT'S RZSPON0B 7ORM
Product Specifie Data
This form in 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 Ifira !• the same
for both product and generic data, instructions for completing
the forms 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 specific qata
requirements.
EPA has developed this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items. DO NOT use this form for any other
active ingredient.
Items 1 through 6 (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*f S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number
assigned by EPA in Item 3. This number must be used in
the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to
support the product's continued registration are
identified. These guidelines, in addition to the
requirements specified in the Notice, govern the
conduct of the required studies. Note that series 61
and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference
number is identified.
Item 6. The use pattern(s) of the pesticide associated with the
product specific requirements is (are) identified. For
most product specific data requirements, all use
patterns are covered by the data requirements. In the
case of efficacy data, the required studies only per-
tain to products which have the use sites and/or pests
indicated.
Item 7. The substance to be tested is identified by EPA. For
product specific data, the product as formulated for
sale and distribution is the test substance, except in
rare cases.
Item 8. The due date for submission of each study is
identified. It is normally based on 8 months after
issuance of the Reregistration Eligibility Document
unless EPA determines that a longer time period is
necessary.
Item 9. Enter only enc of the following response codes for each
data requirement to show how you intend to comply with
the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data
Call-in Notice.
1. I will generate and submit data by the specified due
date (Developing Data). By indicating that I have
chosen this option, I certify that I will comply with
all the requirements pertaining to the conditions for
submittal of this study as outlined in the Data Call-In
Notice.
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2. I have entered into an agreement with one or »ore
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*1 fora. I understand that this option is
available only for acute toxicity or certain efficacy
data only if EPA indicates in an attachment to this
Notice that ny product is similar enough to another
product to qualify for this option. 1 certify that
another party in the agreement is committing to submit
or provide the requirement data; if the required study
is not submitted on time/ ny product nay be subject to
suspension.
3. I have made offers to share in the cost to develop data
(Offers to Cost Share). I understand that this option
is available only for acute toxicity or certain
efficacy data and only if EPA indicates in an
attachment to this Data Call-In Notice that ay product
is similar enough to another product to qualify for
this option. Z 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. I
am also submitting a completed "Certification of Offer
to Cost Share in the Development Data" form. I am
including a copy of sty offer and proof of the other
registrant's receipt of that offer. I am identifying
the party which is committing to submit or provide the
required data; if the required study is not submitted
on time, my product may be subject to suspension. I
understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well.
4. By the specified due date, I will submit an existing
study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study). I
certify that this study will meet all the requirements
for submittal of existing data outlined in Option 4 in
the Data Call-in Notice (Section III-C.l.) and will
meet the attached acceptance criteria (for acute
toxicity and product chemistry data). I will attach
the needed supporting information along with this
response. I also certify that I have determined that
this study will fill the data requirement for which I
have indicated this choice.
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5. By the specified due date, I will submit or cite data
to upgrade a study classified by the Agency as
partially acceptable and upgradable (Upgrading a
Study). I will submit evidence «f the Agency1s review
indicating that the study nay be upgraded and what
information is required to do so. Z vill provide the
HRIO or Accession number of the study at the due date.
I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section
III-C.l.) apply.
6. By the specified due date, I will cite an existing
study that the Agency has classified as acceptable or
an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If
I am citing another registrant's study, I understand
that this option is available only for acute toxicity
or certain efficacy data and only if the cited study
was conducted on my product, an identical product or a
product which ZPA has "grouped" with one or more other
products for purposes of depending on the same data. I
may also choose this option if I am citing my own data.
In either case, I will provide the MRID or Accession
number(s) for the cited data on a "Product Specific
Data Report" form or in a similar format. If I cite
another registrant's data, I will submit a completed
"Certification With Respect To Data Compensation
Requirements" form.
7. I request a waiver for this study because it is
inappropriate for my product (Waiver Request). I am
attaching a complete justification for this request,
including technical reasons, data and references to
relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand
that this is my only opportunity to state the reasons
or provide information in support of my request. If
the Agency approves ay waiver request, I will not be
required to supply the data pursuant to Section
3(c) (2) (B) of FIFRA. if the Agency denies my waiver
request, I must choose a method of meeting the data
requirements of this Notice by the due date stated by
this Notice. In this case, I must, within 30 days of
ay receipt of the Agency's written decision, submit a
revised "Requirements Status and Registrant's Response"
Form indicating the option chosen. I also understand
that the deadline for submission of data as specified
by the original data call-in notice will not change.
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Items 10-13 Self-explanatory.
You nay provide additional information that does not
fit on this form in a signed letter that accompanies
this form. For example, you »ay 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
records are correct.
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ATTACHMENT A
Chemical Status Sheet
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ATTACHMENT A
CAPSAICIN: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Data Call-In Notice because you have products containing
capsaicin.
This attachment, the Data j^ajl-in Chemical Status Sheet, contains a point of contact for
inquiries. This attachment is to be used in conjunction with (1) the Data Call-in Notice. (2)
Attachment B, the Data Call-in Response Form. (3) Attachment C, the Requirement Status and
Registrant's Response Form for 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 Registrant*1 si sent this
Data Call-in Notice, and (7) Attachment G, the Cost Share and Data Compensation Forms for
product specific data, and Product Specific Data Report Form for use in replying to this
capsaicin Data Call-In. Instructions and guidance accompany each form.
DATA REQTTTRTD pv THIS NOTICE
The additional data requirements needed to complete the database for capsaicin are listed
in the Requirements Status and Registrant's Response Form. Attachment C,
The Agency has concluded that product specific data are needed for capsaicin. The
required additional data are listed in Attachment C.
Depending on the results of the studies required in this Notice, additional testing may be
required.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Robert Forrest at (703) 305-6600. All
responses to this Notice should be submitted to:
Document Processing Desk (RED/RD/PM-14)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Capsaicin
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If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Ernestine Dobbins at (703) 308-8071. All responses
to this Notice should be submitted to:
Chemical Review Manager Ernestine Dobbins
Accelerated Reregistration Branch (H7508W)
Special Review and Reregistration Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Capsaicin
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ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
(FORMS B) PLUS INSTRUCTIONS
AND
PR NOTICE 86-5
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J UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
f WASHINGTON. OX. *&4*0
JUL29B66
•» ..*._...... ». * ~
PR NOTICE 86*5 »*«Tieiot» **e
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attentions Persona responsible for Federal registration of
pesticides.
Subject! Standard format for data submitted under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and certain provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA).
I. Purpose "
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining pesticide
registrations, experimental use permits, tolerances, and related
approvals under certain provisions of FIFRA and FFDCA. These
data are defined in FIFRA $10(d)(l). This Notice does not apply
to commercial, financial, or production information, which are,
and must continue to be, submitted differently under separate
cover.
HI. 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 Claims
of Confidentiality of Data (40 CFR 5158.33). These regulations
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specify the format for data submitted to EPA under Section 3 of
FIFRA and sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits front 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 96-4 dated
April 15, 1966} that provides for early screening of certain
applications for registration under FIFRA $3. 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 $154.15 and $155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this requirement,
•
For several years, OPP has required that each application for
registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support for the application. Typically,
many requirements are satisfied by reference to data previously
submitted—either by the applicant or by another party. That re-
quirement 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 son* of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is included
and clearly identifiable, the form of the samples may be altered
to reflect the submitter's preference.
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- INDEX -
Text Example
Page Page
«•
B.
c.
D.
E.
F.
G.
C.I Special Considerations for Identifying Studies. .
0.2 Statement of Data Confidentiality Claims
(based on FIFRA $10(d)(D)
D.4 Supplemental Statement of Data Confidentiality
Claims {other than those based on FIFRA SlO(dMD)
D.5 Good Laboratory Practice Compliance Statement . .
Physical Format Requirements 4 Number of Copies ...
Special Requirements for Submitting Data to the Docket
j
4
4
5
6
7
8
8
8
9
9
9
10
1 1
17
•> *
12
A
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B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted—i.e., a registration application,
petition, experimental use permit (EUP), §3(c)(2)(B) data call-in,
S6(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) th-e data tequirement(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,
Cf.... of the petition or application, as defined in 40 CFR
180.7 and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an 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 « 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 tie.* 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or nark and study number on each
page of the study, *.g,t Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
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When a single study is extremely long, binding it in multiple
volumes is permissible so long as the entire study is paginated
in a single series, and each volume is plainly identified by the
study title and its position in the multi-volume sequence.
C.I 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 Chem is t ry Studies. All product chemistry data
within a s'u bin it t a 1 package subm i t ted 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 • 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.
Hote particularly that product chemistry studies are
likely to contain Confidential Business Information as defined
in FIFRA 510
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c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in lscop«j 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.
It 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
SlO(d)UHA), (B>, or (C)
If CBI is claimed under FIFRA
<10{d)(l)(A), (B), or (C)
Only if confidentiality is
claimed on a basis other than
FIFRA §10(d)(l)(A), (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 TITL5 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 addressee. Include on the title page the
Guideline number(s) of the specific requirements) addressed by
the study.
Ct 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 nay also appear on
the title page.
d. Study pate. The title page must include a single date for
the study. If parts of the study were performed at different
timesr 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 & commentary on
or supplement to another previously submitt*d 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 EPA Master Record Identifier (MRID)
or Accession number of the earlier study if you know these numbers.
(Supplements submitted in the same submittil 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 SlOtdJ(i).
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 KIFRA $10{d)(1)(AT7~TB), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of S10(d)(l) data confidentiality («l58.33(b))
or to waive such a claim (5158.33(c)).. In either casef the
statement must be signeJ 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 bust-
ness information as defined by the criteria of FIFRA $10(d)(1)(A),
(B), or (C) (as described in D.2. above) all such information must
be excised from the body 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 5).
The Confidential Attachment to a study must be identified by a
cover sheet fully identifying the parent study* and must be clearly
marked 'Confidential Attachment.1 An appropriately annotated
photocopy of the parent study title page nay 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 passaged) of FIFRA SlO(dHl) on which the confidentiality
claim is based.
0.4* Supplemental Statement of Data Confidentiality Claims (See
Attachment 4) •
If you wish to make a clain of confidentiality for any
portion of a submitted study other than described by PIPRA S10(d)
(1)(A), (B), or (C)f the following provisions apply;
- The specific information to which the claim applies mast 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 CLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RES.U8MIT 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 aide 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 subnittal 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.)
-------
G. Special Requirements for Submitting Data to the 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 excited. 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
Claims'. •
'Supplemental Statement of Data Confidentiality
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(dHlHA),
-------
ATTACHMENT 1.
ELEMENTS TO BE INCLUDED IN^THE TRANSMITTAL DOCUMENT*
1. Name ancLaddress of submitter
-------
ATTACHMENTS.
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X Is the total number of pages in th« study)
•12
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ATTACHMENT 3.
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No. claim'of confidentiality under FIFRA $10(d)(l)(A)«(B), or (C)
STATEMENT OF NO DATA CONFireNTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this stjdy
on the basis of its filing within the scope of FIFRA S10(d)(l)(A), (B)( or (C).
Company
Company Agent:
Typed Naroe
Title
Cate:
Signature
2. Claim of confidentiality under FIFRA SlO(dMlHA), (B), or (C).
STATEMENT OP QKTA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling within the scope
of FIFRA SlO(dKlMA),
-------
ATTACHMENT 4.
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA 510(4)(1)(A), (B), or , 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(s) 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 time—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 night tend to lessen the availability to
EPA of similar information in the future, and if so, how.
14
-------
KTACWENT s.
EXAMPLES OP SEVERAL CONFIDENTIAL ATTACHMENTS
Example i (Confidential word or phrase that has been deleted fron the stjdy)
CROSS REFERENCE NUMBER 1
4WMH
DELETED WORDS OR PHRASE:
PAGE LINE
This 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
6
28
100
14
25
19
REASON FOR THE DELETION
Identity of Inert Ingredient
FIFRA REFERENCE
SlOfdHlXC)
Example 2 (Confidential paraqraph(s) that have been deleted from the study)
CROSS ."REFERENCE NUMBER
This cross reference nurcber is used in the study
in place of the following paragraph(s) at the
indicated volune and page references.
LAGRAPH(S):
Reproduce the deleted paragraph(s) here
PAGE..LTfffS REASON FOR THE DELETION
20.* +J7 Description of the quality control process
FIFRA REFERENCE
SlO(d)UMC)
Example 3 ^Confidential
that have been deleted from the study)
CROSS
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.
are attached immediately behind this page.
REASON FOR THE DELETION
ascription of product manufacturing process
FIFRA REFERENCE
S10(d)QHA>
-------
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.
Submitter
16
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmit tal Document.
Related Administrative Materials
(e.g., Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies, submitted as unique
physical entities, according
to the format below.
FORMAT OF SUBMITTED STUDIES
LEGEND
Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
... Confidential Attachment.
— 1 Supplemental Statement
,.—— of Confidentiality Claims,
-*** * When flagging requirements
•re finalized.
Documents which must be submitted as
appropriate to meet established requirements.
1
I Documents submitted at submitter's option.
J 17
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ATTACHMENT D
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
DATA REQUIREMENTS FOR REREGISTRATION
-------
EPA"6 BATCHING OF CAPSAICIN END-USE PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of
animals needed to fulfill the acute toxicity data requirements for
reregistration of end-use products containing the active ingredient
capsaicin, the Agency has batched products which can be considered
similar for purposes of acute toxicity. Factors considered in the
sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable
powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially
similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Batching has been accomplished using the readily available
information described above, and frequently acute toxicity data on
individual end-use products has been found to be incomplete.
Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual end-
use product should the need arise.
Registrants of end-use products within a batch may choose to
cooperatively generate, submit or cite a single battery of six
acute toxicological studies to represent all the products within
that batch. It is the registrants' option to participate in the
process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to
generate all the required acute toxicological studies for each of
their own products. If a registrant chooses to generate the data
for a batch, he/she must use one of the products within the batch
as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided
that the data base is complete and valid by today's standards (see
acceptance criteria attached), the formulation tested is considered
by EPA to be similar for acute toxicity, and the formulation has
not been significantly altered since submission and acceptance of
the acute toxicity data.
In deciding how to meet the product specific data
requirements, registrants must follow the directions given in the
Data Call-in Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed
and submitted to the Agency within 90 days of receipt. The first
form, "Data Call-In Response," asks whether the registrant will
meet the data requirements for each product. The second fdrm,
"Requirements Status and Registrant's Response," lists the product
specific data required for each product, including the standard six
acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on
someone else to do so. If a registrant supplies the data to
support a batch of products, he/she must select one of the
-------
-2-
following options: Developing Data (Option 1), Submitting an
Existing Study (Option 4), Upgrading an Existing Study (Option 5)
or Citing an Existing Study (Option 6). If a registrant depends on
another's data, he/she must choose among: Cost Sharing (Option 2),
Offers to Cost Share (Option 3) or Citing an Existing Study (Option
6) . If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should
know that choosing not to participate in a batch does not preclude
other registrants in the batch from citing his/her studies and
offering to cost share (Option 3) those studies.
Table I shows two batches.
batch 2 contains five products.
Batch 1 contains two products and
Table I.
Batch Number
1
:' "'"' \ •; '
2
EPA REG. NO.
47319-1
47319-2
;.vv« />/#?
5464-6
7754-37
7754-38
8668-1
61966-1
X of Capsafcin fi Other
Active Ingredients
12. OX Capsaicin
5. OX Garlic
12. OS Capsaicin
5.0% Garlic
$',&*.? -.*+<'<§' * ,Vi#v' -, ', &&— ", '--^V^'"
-"* • *.*&0. l ~ *-$*&, ^ -\'v - '**' \ "" %, :•
0.35X - Cepssicin
0.35X - Capsaicin
1.0X - Capsaicin
1.0X - Capsaicin
0.625% - Capsaicin
0.216% - AtLy Isothiocyanate
Formulation
Type
. Dust
Dust
^v^V/*^"''
^JisL: ' * " ffXR~
Pressurized
spray liquid
Pressurized
spray liquid
Pressurized
spray liquid
Pressurized
spray liquid
Pump spray
liquid
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-3-
Table II lists the products which could not be batched. These
products were not considered similar for purposes of acute
toxicity. The registrants of these products are responsible for
meeting the acute toxicity data requirements specified in the data
matrix for end-use products.
Table II.
EPA REG. NO.
72-574
47319-4
61966-2
% of Capsaicin t Other
Active Ingredients
2.5* - Capsaicin
36. OX - Capsefcin
24. OX - Garlic
0.625S - Capsaicin
0.216X - Ally Isothiocyanate
Forffljlatfon Type
Liquid
Liquid
Dust
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ATTACHMENT E
EPA ACCEPTANCE CRITERIA
-------
Subdivision M
Guideline Ref. No, 15iB-lO
December 24, J989
IStB-lO Product identity
ACCEPTANCE CRITERIA
Does your study meet UK following acceptance criteria?
1. Product name and trade name (if different)
2. ___ Name, nominal concentration, and certified limits (upper and lower) for each active
ingredient and each intentionally-added inert ingredient
3. _ Name and upper certifies tmit for each impurity or each group of impurities present at
£0.1% by weight and for certain lexicologically significant impurities (e.g., microbial toxins.
diorins. aitrosamines) 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. ___ Product name, trade name, and common name (if established) for each active ingredient
7. Molecular, structural, and empirical formulas, molecular weight or weight range, and any
company assigned experimental or internal code numbers for each active ingredient
S. 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
r Technical specifications or data sheets by which manufacturer or supplier «K-t.rihcs
composition, properties or toxiciry
9. Genus ami species (and strain, subspecies, isolate, etc., if applicable) from which the
biochemical was isolated or with which it is commonly associated
10. ___ Specificity of biochemical activity, the mode of action, and field rates at which the
biochemical is active/proposed (units at/A, etc.)
11. Similarity to the naturally-occurring biochemical, if not derived from a biological enuu.
H. An updated Confidential Statement of Formula must be provided (EPA Form 85?0-4 icv.
9/87).
13. • Any known or suspected hazards of the biochemical to man, (he environment, or nomargct
species.
Criteria marked with a * are supplemental and may not be required for every study.
C-213
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* Subdivision M
Guideline Ref. No. 15 IB-11
December 24, 1989
15 IB-11 Manubcturug Process
ACCEPTANCE CRITERIA
Does your study meet the foUowiag acceptance criteria?
1- Description of manufacturing process or extraction/isolation steps if obtained from a
biological entity. •
2. i. ' Statement of whether batch or continuous process, if applicable
3. Relative amount of beginning materials and order in which they are added
4. Description of equipment
5- Description of physical conditions (temperature, pH, pressure, humidity) controlled in each
step and the parameters that are maintained
6 . Statement of whether process involves intended chemical reactions
7. Flow chan with chemical equations for each intended chemical reaction
8. Duration of each step of process
9. Description of purification procedures
10. Description of measures taken to assure quality of final product including identity of the
biological source, if applicable
11. A clear presentation of the stage at which inerts are intentionally added, if and when any
concentration is effected, the material to bt used as the manufacturing use product (W
whether-MP registration is sought, and whether a TCAI/MP is sold and/or shipped.
Criteria marked with a ' tre supplemental and may not be required for every study.
C-216
-------
Subdivision M
Guideline Ref. No. 15 IB- 12
December 24, 1989
13 IB- 12 Docosiion of Formation of Unintended Ingredients
ACCEPTANCE CRITERIA
Does your study meet the following •rr*pt*itt^ criteria?
I. _ Discussion of formation of impurities based on established chemical theory addressing (1)
each impurity which may be present at i 0.1% or was found it 2 0.1% by product analyses
and (2) certain lexicologically significant impurities present at < 0.1% by weight
Criteria marked with a * are supplemental and nay not be required for every «tudy.
C-217
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Subdivision M
Guideline Ref. No. 151B-13
December 24, 1989
L51B-13 Analysis of Samples
ACCEPTANCE CRITERIA
Does pur study meet the following acoeptince 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 fc a 98%
3. _ Analyses conducted for certain trace toxic impurities at tower than 0.1% (examples,
nitrosamines in the case of products containing diniiroanilines or containing secondary or
tertiary amines/alkanolamines plus nitrites; polyhalogenated dibeiuodioxins and
dibenzofurans) (Note that in the case of nitrosamines both fresh and stored samples should
be analyzed.]
4. Complete and detailed description of each seep in analytical method used to analyze above
samples
5. Statement of precision and accuracy of analytical method used to analyze above samples
6. Identities and quantities (including mean and standard deviation) provided for each analyzed
ingredient
7. The test material is to be the purest pesticidal grade commercially produced prior to
intentional addition of inerts. Generally/this test material is the same as that used for
certain nnntarget and human hazard testing and is identical to, or equivalent to the technical
grade. AJW differences from the test substance used for hazard testing should be noted
Criteria marked with * "-are supplemental and may not be required for every study.
C-218
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Subdivision Si
Guideline Ref. No. 151B-13
December 24.1989
151B-13 Analysis of Sampks
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
I. __ Five or more representative samples (batches in case of batch process) analyzed for each
active ingredient and all impurities present at i 0.1%
2. ___ Degree of accountability or closure fc H 98%
3. __ Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples,
aitrosamines in the case of products containing dinitroanilines or containing secondary or
tertiary amines/alxanolamines plus nitrites; polyhalogenated dibenzodioxins and
dibenzofurans) [Note that in the case of nitrosamines both fresh and stored samples should
be analyzed.]
4. Complete and detailed description of each step in analytical method used to analyze above
samples
5. __ Statement of precision and accuracy of analytical method used to analyze above samples
6. _ Identities and quantities (including mean and standard deviation) provided for each analyzed
ingredient
7. ___ The test material is to be the purest pesttcidal grade commercially produced prior to
intentional addition of tnerts. Generally, this test material is the same as that used for
certain nnntarget and human hazard testing and is identical to, or equivalent to the technical
grade. Any differences from the test substance used for hazard testing should be noted.
Criteria narked with a '.are supplemental and may not be required for every study.
C-218
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SERA
unittd states Envlronmtntal Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMI Ne.
Approval liplrt* 134142
PubBc it tag burden for this collection of information it estimated to average 15 minutes ptr response, Indudinj
timer'" . .wing instrudions. Marching existing data sources, gathering and maintaining the data needed, rj*
comply * and reviewing the cofledion ot information. Send comments regarding the burden estimate
•sped of this collection of information, Including suggestions for reducing this burden, to Chief, Womua^r. .\jiicy
Sranch, PM-223, U.S. Environmental Protedton 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 fin In blanks below.
Company Nam*
Product- Name
EPA Reg. No.
I Certify that:
My company is wflling 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 tnter into such an agreement. Thai offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iif) 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 •! FJnn(t)
Date c: •«•?
I
CertHieaften:
I certify mat I am duly authorized 19 repwient the company »ir , d above, or,. * thr " nt? *Mt 1 *»fl» « sr
misleading statement may be punishable by fine or imprisonment or both under applicable lav.
aigntiurt *f Company'* Aulherlt** H»pre»*Matlvt
Oat*
Nana and Tllit (Piaaaa Typa or Print)
T- « "
f PA Form SS7042
-------
US Environmental Protection Agency Registration Standard for;
Washington. DC 20460
AFPA . Product Specific
wcw Dafa R(£ort
R90fS»T«wOf1
Guideline No.
Sec. 158-120
Product,
Chemist, y
•1.1 ."
81-2 (*^
61-2(*»)
62-1
62-2
624
63-2
169-3
6M
6*3
8W
63-7
6M
63-8
63-10
63-11
63-12
63-13
63-U
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
81.1
01-2
f1-*
!1|4
15
1* "
>v,
MvTWOfTtt!
i
SlAttnyni of composition
Oiseutsion of fomwtion of «n«jr»d!«nt»
PrcKminw analyiit
Cen)fidtion of limtts
wwiytim metnooi tor etiior^
Color
Physical suit
Odor
Melting point
Boning point
Density. bullKensity. or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
PM
Stability
j^ , . — . ,
Rtmmsbilrty
Eyptodabimy
Storage stability
Vlseesrty
Miscibility
Corrosion Charaeteristics
Dielectric breakdown voltage
Acute (y-'tpficrtv. rat
Acute dermal to«ieriy. mbbft /rat /s . v IK
Acute Inhalation torieisv. rat
Pnntavy vyt Innftatofi* -•owt
PHmary dermal inHattf «n
jeirnai sensrazaoon
Testing not
required for my
pioduct listed
above
fCnsekeetow)
•
•
EPA Registration NumtMr
1 am complying with
Data Reouirements bv •
Citing MB ID No.
Submitting Data
ptaacnecy
(Cnec*c»tow;
OMB «2CttX>05?
Eipires 11-3049
(For EPA Use
•flnrv'
^•sesston
iBir ^trs
• •Mr ' C
Certification
1 certify that the statements I have made on this form and all attachments thereto are
• trCw, uCC-.dte, and rT|3fter7- acknowledge that arty knowingly false or misleading
statement may be pr Stable Define ut imprisdftmBht or both under applicable law.
Typtd Ntfmaftd TUt
SiQnature
•
Date
CPA rorm KUO-I Wev. S-U) Previous edition • obsolete.
-------
ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
-------
LIST OF REGISTRANTS BEING SENT THIS NOTICE
NAME
j Inc.
Champion's 100Z Natural Products, Inc.
Miller Chemical and Fertilizer Corp.
North Health Care
Sevana Company
XTTRIUM Labs Inc.
ADDRESS
Box 999, Griffin, Ga. 30224
2706 N.W. 91st Avenue, Coral Springs, Fl. 33065
Box 333, Hanover, PA. 17331
1515 Elmwood Road, Rockford, II. 61101
5336 East Easterby Drive, Fresno, CA. 93727
415 W. Pershing Rd., Chicago, II 60609
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ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
-------
Subdivision M
Guideline Ref. No. 152B-IS
December 24,1989
152B45 HypeneasiiMty
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. _ Technical form of the active ingredient tested, (for reregistration only)
2. _ Study not required if material is corrosive or has a pH of 1 2 or 2 11-5.
3. ___ One of the following methods is utilized;
._ Freund's complete adjuvant test
_ Guinea pig maximization test
_ Split adjuvant technique
„_ Buehler test
___ Open epicutaneous test
_ Mauer optimization test
__ Footpad technique in guinea pig
Other test accepted by OECD »peciM
4. 1 Complete description of test
5.* Reference for test.
6. ___ Test followed essentially as described in reference document
7." Positive control included.
Criteria marked with • * are supplemental and may not be required for every study.
C-228
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Subdivision M
Guideline Ref. No. 1S2B-14
December 24,1989
152B-14 Primary Dermal Irritation
ACCEPTANCE CRITERIA
Doc* your study meet the following acirptance criteria?
1. _ Technicil form of the active ingredient tested (for reregistration only)
2. _ Study not required if material is corrosive or has a pH of i 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 hour prior to dosing.
7. _ Application site approximately 6 cnr.
8. Application site covered with a gauze patch held in place with aonirritating tape
9. Material removed, washed with water, without trauma to application site
10. Application site examined and graded for irritation at 1,24.48 and 72 hr, then daily until
normal or 14 days (whichever b shorter).
II.* Individual observations for the entire day of dosing.
12.* Individual daily observations.
Criteria marked with a • are supplemental and may not be required for every study.
C227
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Subdivision M
Guideline Ref. No. 152B-I3
December 24.1989
152B-13 Primary Eye Irritation
ACCEPTANCE CRITERIA
Docs your study meet the feOowiag acceptance criteria?
I. r, _ Technical form of Die active ingredient tested, (for reregistntion only)
2. __ Study not required if material is corrosive, causes severe dermal irritation or has a pH of 3 2
or i 1L5.
3." 6 adult rabbits
4. ___ Dosing, instillation into the eonjunctival sac of one eye per animal
3." Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or rticulate
substance.
6. ^__ Solid or granular test material ground to a fine dust
7. __ Eyes not washed for at least 24 hours.
& _ 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 dairy observations.
Criteria marked with a • are supplemental and may not be required for every study.
\
C-226
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Subdivision M
Guideline Ref. No. 151B-17
. December 24,1989
O. Corrosion Characteristics
Data on corrosion characteristics provided (experimental method described) 91 "
reasonable explanation given for lack of oorrosiveness based on nature of product
(e.g., lack of extreme pH; unreactive)
P. Octanol/water Partition Coefficient
__ Measured at about 20-25'C
__ Experimentally determined and description of procedure pvided (preferred method-
45 Fed. Register 77350)
Dau supporting reported value provided
Criteria marked with a ' are supplemental and may not be required for every study.
0222
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Subdivision M
Guideline Ref. No. 1S1B-1?
December 24, 1989
1. pH
J. Stability
higher temperature if pressure loo low to measure at 2S*Q
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
Measured at about 20-25*C
Measured following dilution or dispersion in distilled water
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
K. Flammability
____ Flash point reported in *F or 'C
___ Flame extension or flame projection reported to nearest centimeter or nearest inch
L Storage Stability
M. Viscosity
^^^M
^^^
N. Miscibiliry
Product stored in its commercial package or smaller one of same construction and
materials
Amount of active ingredient determined in product at beginning and end of test
period (duration of at least one year £i for a product which degrades sufficient
duration to support expiration date)
Any deterioration or degradation products determined
Product examined for physical changes at end of test
Product stored at about 20-23'C (and 50% relative humidity if permeable packaging)
21 under warehouse conditions reflecting expected storage
Report includes duration and conditions of storage, quantitative analyses of active
ingredient, and identification of any deterioration, degradation products, or physical
changes (and consequences of latter on safe handing and use of product)
Determined at about 20-25'C
Reported in poises, itokes. or other conventional units
Determined at about 20-25*C
Product mixed with petroleum solvents whose composition reflects those on label and
at rate on label
Mixture examined for separation after 30 minutes
Criteria marked with a * are supplemental and may not be required for every study.
C-221
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Subdivision M
Guideline Ref. No. 1S1B-17
December 24. 1989
151B-17 Physical aod Chemical Properties
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
A. Color
_ Verbal description of coloraiion (or lack of it)
_ Any intentional coloration also reported in terms of Munsell color system
B. Physical State
Verbal description of physical state provided using terns such as 'solid, granular.
volatile liquid'
Based on visual inspection at about 20*25*C
COdor
Verbal description of odor (or lack of it) using terms such as "garlic-like,
characteristic of aromatic compounds'1
Observed at room temperature
D. Melting Point
_. Reported in "C
Any observed decomposition reported
E. Being Point
__ Reported in *C
.. Pressure under which B.P. measured reported
___ Any observed decomposition reported.
F. Density, Bulk Density, Specific Gravity
" Measured at about 2C-1>'C
. Density/bulk density rtported in g'ml QT the specific gravity of liquids reported with
reference to water at 2.TC (NOTE: For a solid in paniculate form a measurement
of bulk density may be substituted for measurement of density.]
G. Solubility
— Determined in distilled water, -n-octanol 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/lOOml (other units like ppm acceptable if sparingly soluble)
R Vapor Pressure
; _.. Measured at *25*C (or calculated by extrapolation from measurements made at
Criteria marked with a ' are supplemental and may not be required for every study.
C-220
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Subdivision M
Guideline Ref. No. 1S1B-15
December 24, 1989
151B-1S CenifiauoB of Umio
ACCEPTANCE CRITERIA
Does your atody meet the following acceptance criteria?
1. ___ Upper and lower certified limits proposed for each active ingredient and intentionally added
inert along with explanation of how the limits were determined
2. _ - ' Upper certified limit proposed for each impurity present at i 0.1% and for certain
lexicologically significant impurities at < 0.1% along with explanation of how each limit is
determined
3. __ Analytical methods to verity certified limits of each active ingredient and impurities (Utter
not required if exempt from requirement of tolerance or if generally recognized as safe by
FDA) are fully described
4. __ Analytical methods to verify certified limits validated as to their precision and accuracy-
Criteria marked with a • are supplemental and may not be required for every study.
C-219
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r/EPA
Unlttd States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OKI Mo.
Public reporting burden for this collection of information is estimated to average 15 mlnutts par response, including
fjme tor reviewing instructions, tstrching axisting data souiets, 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 tNs collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401M St.. S.W., Washington. DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106). Washington. DC 20503.
Please fin In blanks below.
C>MBMtfMf MkaVt
Product Name
EPA Reg. No.
1 Certify that:
«— t t*r
t.
For each study died in support of registration or registration under the Federal Insecticide. Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
That for each study cfled h support of registration or ^registration under FIFFU that is NOT an exclusive use
study, t am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified in writing the oompany(ie$} that submitted data I have cried 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 of
compensation due. If any. The companies i have notified are:
£ I The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form."
3. That I have previously complied with section 3{c)(i)(0) of RFRA for the studies f have dted in support of
registration or reregistratton under FIFRA.
SJ|i»tiir«
Oat*
Nut* «* Till* (PIMM TyM «r Pital)
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)(D).
aigKttw*
D*t*
HUM eatf Tltlt (PIMM Ty<» «r frir.:;
SS?fio|1 (4-tO)
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